WO2021095813A1 - 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
WO2021095813A1
WO2021095813A1 PCT/JP2020/042297 JP2020042297W WO2021095813A1 WO 2021095813 A1 WO2021095813 A1 WO 2021095813A1 JP 2020042297 W JP2020042297 W JP 2020042297W WO 2021095813 A1 WO2021095813 A1 WO 2021095813A1
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WIPO (PCT)
Prior art keywords
blood pressure
cuff
pressure measurement
mode
sphygmomanometer
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2020/042297
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English (en)
French (fr)
Japanese (ja)
Inventor
幸哉 澤野井
新吾 山下
美佳 江副
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Omron Healthcare Co Ltd
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Omron Healthcare Co Ltd
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Priority to CN202080078778.8A priority Critical patent/CN114727771B/zh
Priority to DE112020005566.3T priority patent/DE112020005566T5/de
Publication of WO2021095813A1 publication Critical patent/WO2021095813A1/ja
Priority to US17/739,262 priority patent/US20220257129A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61B5/02225—Measuring pressure in heart or blood vessels by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers using the oscillometric method
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6824—Arm or wrist
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient; User input means
    • A61B5/742—Details of notification to user or communication with user or patient; User input means using visual displays
    • A61B5/7435—Displaying user selection data, e.g. icons in a graphical user interface
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient; User input means
    • A61B5/746—Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient; User input means
    • A61B5/7475—User input or interface means, e.g. keyboard, pointing device, joystick
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0247—Pressure sensors

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.
  • the wrapping determination is performed after the blood pressure measurement start switch is turned on and immediately before the blood pressure measurement is started, and if the cuff is not properly (exactly) wrapped around the measurement site, the cuff is used.
  • the subject is notified of the rewinding, and blood pressure measurement is started if the cuff is properly (tightly) wrapped around the area to be measured. Therefore, according to this technique, the blood pressure is measured with the cuff properly wound, and the obtained measurement result is highly reliable.
  • Patent Document 1 can be applied to normal blood pressure measurement (in other words, blood pressure measurement during non-sleeping), it is directly applied to so-called nighttime blood pressure measurement in which a subject measures blood pressure while sleeping. Can not. The reason is that in the nighttime blood pressure measurement, the subject is sleeping, and even if the subject is notified of the result of the wrapping determination at the time of blood pressure measurement, the sleeping subject cannot rewind the cuff.
  • the present invention has been made to solve the above-mentioned problems, and to provide a sphygmomanometer and a blood pressure measuring method capable of accurately measuring blood pressure when measuring blood pressure while the subject is sleeping.
  • Another object of the present invention is to provide a program for causing a computer to execute such a blood pressure measurement method.
  • the sphygmomanometer of this disclosure A sphygmomanometer that temporarily presses the wrist as a measurement site with a blood pressure measurement cuff and measures blood pressure by the oscillometric method using a pressure sensor that detects the pressure inside the cuff.
  • a mode operation unit for inputting mode instructions for switching modes to the nighttime blood pressure measurement mode that automatically starts blood pressure measurement according to a predetermined schedule. As the mode instruction is input and the mode shifts to the nighttime blood pressure measurement mode, the cuff is temporarily pressurized to a pressure lower than the cuff pressure used for the blood pressure measurement, and based on the output of the pressure sensor.
  • the first determination unit that determines the winding state of the cuff, and It is characterized in that it is provided with a notification unit for notifying the determined cuff winding state as the cuff winding state is determined.
  • the "mode operation unit” may be, for example, a switch provided in the main body of the sphygmomanometer and accepts a switch-on by the user as an instruction, or exists outside the sphygmomanometer. It may be configured by a communication unit that receives instructions from a smartphone or the like via wireless communication.
  • “With the transition to the nocturnal blood pressure measurement mode” typically refers to the time when the transition to the nocturnal blood pressure measurement mode is performed, but the subject still falls asleep, for example, within 5 minutes from that time. It may be within the time expected not to be done.
  • “as the winding state of the cuff is determined” typically refers to the time when the winding state of the cuff is determined, for example, within 5 minutes from that point. In addition, it may be within the time expected that the subject has not yet fallen asleep.
  • the "cuff wrapping state” refers to a state indicating the suitability of wrapping the cuff with respect to the part to be measured.
  • cuff wrapping state refers to a state indicating the suitability of wrapping the cuff with respect to the part to be measured.
  • the cuff tightly wound around the measurement site (“tight winding”), “perfectly” wound (“perfect winding”), or loosely wound? It refers to which state of (“Yuru winding”) is in.
  • the subject inputs a mode instruction for switching the mode to the nighttime blood pressure measurement mode in which the blood pressure measurement is automatically started according to a predetermined schedule by the mode operation unit. Then, as the mode instruction is input and the sphygmomanometer shifts to the nighttime blood pressure measurement mode, the first determination unit temporarily lowers the cuff to a pressure lower than the cuff pressure used for the blood pressure measurement. The pressure is applied to the pressure sensor, and the wound state of the cuff is determined based on the output of the pressure sensor. As the winding state of the cuff is determined, the notification unit notifies the determined cuff winding state.
  • the subject can recognize the suitability of wrapping the cuff around the measurement site. Therefore, for example, if the cuff is improperly wound and the cuff is loosely wound (“Yuru winding”), the subject is placed in a “perfect” winding state (“perfect winding”). Can be fixed.
  • the sphygmomanometer automatically starts blood pressure measurement according to a predetermined schedule in the nighttime blood pressure measurement mode. As a result, in the nocturnal blood pressure measurement mode, the blood pressure is measured by the oscillometric method with the cuff wrapped in an appropriate state. Therefore, according to this sphygmomanometer, accurate blood pressure measurement can be performed when the blood pressure is measured while the subject is sleeping.
  • the above mode instruction indicates an instruction to switch the mode between a normal blood pressure measurement mode in which blood pressure is measured according to an input blood pressure measurement instruction and a nighttime blood pressure measurement mode in which blood pressure measurement is automatically started according to the above schedule.
  • the cuff is temporarily pressurized to a pressure lower than the cuff pressure used for the blood pressure measurement, and the pressure sensor is used.
  • a second determination unit for determining the suitability of the cuff winding state is provided according to a normal determination standard in which the degree of the cuff winding state is determined in advance based on the output.
  • the first determination unit determines the suitability of the cuff wrapping state according to a strict determination criterion in which the degree of the cuff wrapping state is shifted to a tighter direction than the normal determination criterion. It is characterized by doing.
  • the "degree of wrapping state of the cuff” refers to the degree from the state in which the cuff is loosely wrapped around the part to be measured to the state in which it is tightly wrapped.
  • the second determination unit in the normal blood pressure measurement mode, is lower than the cuff pressure used for the blood pressure measurement before the blood pressure measurement instruction is input and the blood pressure measurement is performed.
  • the cuff is temporarily pressurized to the pressure, and based on the output of the pressure sensor, the suitability of the cuff's wound state is determined according to a normal determination standard in which the degree of the cuff's wound state is determined in advance. Therefore, by performing the blood pressure measurement only when the wound state of the cuff is "appropriate" as in the conventional example, the measurement result obtained in the normal blood pressure measurement mode becomes highly reliable. ..
  • the first determination unit is a strict determination in the nighttime blood pressure measurement mode in which the degree of the cuff wrapping state is shifted to a tighter direction than the normal determination criterion.
  • the suitability of the wound state of the cuff is determined.
  • the notification unit notifies the determined cuff winding state. From this notification, the subject can recognize the suitability of wrapping the cuff around the measurement site.
  • the subject can correct the cuff winding state to the extent that the cuff winding state is determined to be "appropriate” according to the strict determination criteria. Therefore, when the sphygmomanometer automatically starts the blood pressure measurement according to the schedule in the nighttime blood pressure measurement mode, even if the subject does not correct the cuff wrapping state, the cuff wrapping is seen from the normal criterion. It is expected that the condition will be maintained "appropriately”. Therefore, according to this sphygmomanometer, accurate blood pressure measurement can be performed in the nighttime blood pressure measurement mode.
  • the first determination unit and the control unit that deactivates the notification unit are provided.
  • the subject is expected to be in a sleeping state at the stage of shifting to the above-mentioned nighttime blood pressure measurement mode and waiting for the blood pressure measurement schedule. It seems that the sleeping subject does not notice even if the notification by the notification unit is attempted. Therefore, in the sphygmomanometer of this embodiment, when the blood pressure measurement is automatically started according to the schedule in the nighttime blood pressure measurement mode, the control unit deactivates the first determination unit and the notification unit. To. Therefore, when the blood pressure measurement is automatically started according to the schedule, neither the determination of the cuff winding state nor the notification of the determined cuff winding state is performed. This prevents the first determination unit from making a useless determination and the notification unit from attempting useless notification. Therefore, it can contribute to power saving.
  • 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 a blood pressure measuring unit, a mode operation unit, and a blood pressure measuring unit that temporarily presses the wrist with the blood pressure measuring cuff and measures the blood pressure by an oscillometric method using a pressure sensor that detects the pressure in the cuff. It is characterized in that the first determination unit and the notification unit are mounted.
  • 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 temporarily presses the subject's area to be measured with a blood pressure measurement cuff and measures the blood pressure by an oscillometric method using a pressure sensor that detects the pressure inside the cuff.
  • the sphygmomanometer is provided with a mode operation unit for inputting a mode instruction for switching the mode to a nighttime blood pressure measurement mode in which blood pressure measurement is automatically started according to a predetermined schedule.
  • the above blood pressure measurement method is As the mode instruction is input and the mode shifts to the nighttime blood pressure measurement mode, the cuff is temporarily pressurized to a pressure lower than the cuff pressure used for the blood pressure measurement, and based on the output of the pressure sensor. , Judge the winding state of the above cuff, It is characterized in that, as the winding state of the cuff is determined, the determined winding state of the cuff is notified.
  • accurate blood pressure measurement can be performed when the blood pressure is measured while the subject is sleeping.
  • 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.
  • FIG. 1 shows a schematic configuration of a wrist-type sphygmomanometer (hereinafter, appropriately referred to as “blood pressure monitor”) 100 according to an embodiment of the present invention.
  • the sphygmomanometer 100 measures blood pressure in a normal mode in which blood pressure measurement is started immediately after the blood pressure measurement switch is turned on, and at a predetermined reserved time or at a reserved time after a predetermined time has elapsed from the designated time. Has a night mode to start.
  • the sphygmomanometer 100 includes a cuff 10 for measuring blood pressure wrapped around a part to be measured of a subject, and a sphygmomanometer main body 20 integrally attached to the cuff 10.
  • the sphygmomanometer 100 of the embodiment is a wrist-type sphygmomanometer. Therefore, the cuff 10 has an elongated band shape so as to be wrapped around the subject 200, for example, the left wrist 210.
  • the cuff 10 contains an air bag 12 (see FIG. 3) for pressing the left wrist 210.
  • a carla (not shown) having appropriate flexibility may be provided in the cuff 10.
  • the sphygmomanometer body 20 is integrally attached to a substantially central portion of the band-shaped cuff 10 in the longitudinal direction.
  • the portion to which the sphygmomanometer main body 20 is attached is planned to correspond to the palm side surface (palm side surface) 210a of the left wrist 210.
  • the sphygmomanometer body 20 has a flat, substantially rectangular parallelepiped shape along the outer peripheral surface of the cuff 10, and is formed small and thin so as not to interfere with the sleep of the subject 200.
  • the corners connecting the upper surface of the sphygmomanometer body 20 (the surface appearing in FIG. 1) and the side surface surrounding the upper surface (the surface appearing in FIG. 1) are chamfered in a curved surface.
  • a display unit (notification unit) 30 forming a display screen and an instruction from the subject 200 are input.
  • An operation unit 40 is provided.
  • the display unit 30 includes an LCD (liquid crystal display), and according to a control signal from a CPU (central arithmetic processing device) 110 described later, predetermined information such as systolic blood pressure (unit: mmHg) and diastolic blood pressure (unit; It is configured to display mmHg), pulse (unit: beat / minute), and the winding determination result of the cuff 10 described later.
  • the display unit 30 may be either an organic EL display or an LED (light emitting diode).
  • the operation unit 40 has a plurality of buttons or switches operated by the subject 200.
  • the operation unit 40 includes a blood pressure measurement start switch 42A for the subject 200 to input the blood pressure measurement instruction in the normal mode, and a night measurement switch 42B for the subject 200 to input the blood pressure measurement instruction in the night mode. ..
  • the blood pressure measurement start switch 42A functions as a switch for stopping the blood pressure measurement during execution when the switch is pressed during the blood pressure measurement.
  • normal blood pressure measurement refers to blood pressure measurement that is started immediately after the blood pressure measurement start switch 42A is turned on.
  • nighttime blood pressure measurement refers to blood pressure measurement automatically performed, for example, during sleep of the subject 200 according to a predetermined schedule, based on an instruction input through the nighttime measurement switch 42B.
  • Blood pressure measurement performed according to a predetermined schedule is, for example, blood pressure measurement performed at a predetermined time such as 1:00, 2:00, or 3:00 at midnight, or, for example, two hours after the night measurement switch 42B is pressed. / Or a blood pressure measurement performed 4 hours later.
  • the blood pressure measurement switch 42A and the night measurement switch 42B are both momentary type (self-recovery type) switches, and are configured to be turned on only while being pressed down and returned to the off state when released. Has been done.
  • FIG. 3 shows the block configuration of the sphygmomanometer 100.
  • the air bag 12 included in the above-mentioned cuff 10 and various fluid control devices (described below) included in the sphygmomanometer main body 20 are connected by an air pipe 50 so that fluid can flow.
  • the sphygmomanometer body 20 includes a CPU 110 which is a control unit, a memory 112 which is a storage unit, a power supply unit 114, a pressure sensor 62, a pump 72, and a valve. It has 82. Further, the sphygmomanometer main body 20 includes an A / D conversion circuit 64 that converts the output of the pressure sensor 62 from an analog signal to a digital signal, a pump drive circuit 74 that drives the pump 72, and a valve drive circuit 84 that drives the valve 82. Has. The pressure sensor 62, the pump 72, and the valve 82 are connected to the air bag 12 so as to allow fluid flow through the air pipe 50.
  • the memory 112 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. I remember.
  • the memory 112 is also used as a work memory for temporarily storing various information during program execution.
  • the memory 112 in the embodiment is configured as a program storage unit, and a normal blood pressure measurement program and a nocturnal blood pressure measurement program for calculating blood pressure by the oscillometric method, which will be described later, and a cuff 10 wrapped state in the normal blood pressure measurement.
  • a normal wrapping determination program for determining the wrapping state and a night wrapping determination program for determining the wrapping state of the cuff 10 in nighttime blood pressure measurement are stored.
  • the CPU 110 is configured to control the operation of the entire sphygmomanometer 100. Specifically, the CPU 110 outputs the pressure sensor 62 by the pressure control unit that drives the pump 72 or the valve 82 according to the program for controlling the sphygmomanometer 100 stored in the memory 112, and the night wrapping determination program described later.
  • the first determination unit that determines the winding state of the cuff 10 based on the above
  • the second determination unit that determines the winding state of the cuff 10 based on the output of the pressure sensor 62 by the normal winding determination program described later, and later. It is configured as a measurement execution unit that performs blood pressure measurement by a normal blood pressure measurement program or a nocturnal blood pressure measurement program.
  • the CPU 110 also displays the blood pressure value obtained by performing the blood pressure measurement and the winding determination result of the cuff 10 on the display unit 30 and stores it in the memory 112.
  • the power supply unit 114 includes a secondary battery, a CPU 110, a pressure sensor 62, a pump 72, a valve 82, a display unit 30, a memory 112, an A / D conversion circuit 64, a pump drive circuit 74, and a valve drive circuit. It is configured to supply power to each part of 84.
  • the power supply unit 114 is also configured to be able to switch the on / off state, and when the blood pressure measurement switch 42A is continuously pressed for, for example, 3 seconds or more in the off state, the power supply unit 114 is turned on.
  • the pump 72 is configured to supply air as a fluid to the air bag 12 through the air pipe 50 in order to increase the pressure in the air bag 12 built in the cuff 10.
  • the valve 82 is configured to expel air from the air bag 12 through the air pipe 50 by opening or to hold the cuff pressure by closing to control the cuff pressure.
  • the pump drive circuit 74 is configured to drive the pump 72 based on a control signal given from the CPU 110.
  • the valve drive circuit 84 is configured to open and close the valve 82 based on a control signal given from the CPU 110.
  • the pressure sensor 62 and the A / D conversion circuit 64 are configured to detect the cuff pressure.
  • the pressure sensor 62 in the embodiment is a piezoresistive pressure sensor, and detects and outputs the cuff pressure of the air bag 12 as an electric resistance due to the piezoresistive effect.
  • the A / D conversion circuit 64 converts the output (electrical resistance) of the pressure sensor 62 from an analog signal to a digital signal and outputs it to the CPU 110. In the embodiment, the CPU 110 acquires the cuff pressure according to the electric resistance output from the pressure sensor 62.
  • Blood pressure measurement program calculates the blood pressure of the subject 200 having the sphygmomanometer body 20 attached to the left wrist 210.
  • Blood pressure measurement programs usually include a blood pressure measurement program and a nocturnal blood pressure measurement program.
  • the normal blood pressure measurement program assumes that the subject 200 sits on a chair or the like and keeps the left wrist 210 to which the sphygmomanometer body 20 is attached at the same height as the heart of the subject 200.
  • the nocturnal blood pressure measurement program assumes that the subject 200 lies on a bed or the like and the left wrist 210 to which the sphygmomanometer body 20 is attached is placed at a position lower than the heart of the subject 200.
  • the CPU 110 obtains a pulse wave signal from a pulse wave fluctuation component included in the cuff pressure obtained by the pressure sensor 62, and stores the pulse wave signal in the memory 112. Use the program to calculate blood pressure values (maximum blood pressure and diastolic blood pressure).
  • the wrapping determination program determines whether the subject 200 wraps the cuff 10 around his or her left wrist 210 in a “perfectly wound state”.
  • the tightly wound state means that the length around the cylinder formed when the cuff 10 is wound around the left wrist 210 is substantially equal to the length around the left wrist 210, and the appropriate pressure is applied to the left wrist 210.
  • the state of giving a state in which the cuff 10 is wound around the left wrist 210 tighter than in a tightly wound state and a greater pressure is applied to the left wrist 210 is referred to as a "tight winding state”.
  • a state in which the cuff 10 is wound around the left wrist 210 more loosely than in a tightly wound state and a small pressure is applied to the left wrist 210 is referred to as a "yuru winding state”.
  • the cuff pressure of the cuff 10 gradually increases with time while the pump 72 supplies air to the air bag 12 of the cuff 10. As shown in FIG. 4, the relationship between this time and the cuff pressure differs depending on the winding state of the cuff 10.
  • the relationship between the time and the cuff pressure in the tightly wound state is shown by solid lines 310 and 320.
  • the relationship between the time and the cuff pressure in the tightly wound state is shown by the broken lines 312 and 322.
  • the relationship between the time and the cuff pressure in the yuru-wound state is shown by the alternate long and short dash lines 314 and 324.
  • the solid line 310 on the left side of the figure uses a small size cuff
  • the solid line 320 on the right side of the figure shows the relationship between time and cuff pressure when a large size cuff is used.
  • the broken line 312 on the left side of the figure shows the relationship between the time and the cuff pressure when the small size cuff is used and the broken line 322 on the right side of the figure uses the large size cuff. ..
  • the one-dot chain line 314 on the left side of the figure uses a small-sized cuff
  • the broken line 324 on the right side of the figure shows the relationship between the time and the cuff pressure when a large-sized cuff is used.
  • the first time 336 which is the time required for the cuff pressure to rise from the first pressure P1 to the second pressure P2 (P1 ⁇ P2), reflects the wound state of the cuff 10. For example, the closer the cuff 10 is wound to the tight winding, the smaller the first time 336 becomes, and the closer the cuff 10 is wound to the loose winding, the larger the first time 336 becomes.
  • the cuff 10 has a second time of 346 for the cuff pressure to rise from the third pressure P3, which is larger than the first pressure P1 and the second pressure P2, to the fourth pressure P4 (P3 ⁇ P4). Reflects the size of. For example, the smaller the size of the cuff 10, the smaller the second time 346, and the larger the size of the cuff 10 the larger the second time 346.
  • the pressures P1, P2, P3 and P4 are set to, for example, 10 mmHg, 15 mmHg, 25 mmHg and 35 mmHg, respectively. However, these pressures are not limited and may be determined based on the measured values in a range lower than the cuff pressure (measured diastolic blood pressure (diastolic blood pressure)) used for blood pressure measurement.
  • FIG. 5 shows a first time 336 when the cuff pressure changes from the first pressure P1 to a second pressure P2 and a second time 346 when the cuff pressure changes from the third pressure P3 to the fourth pressure P4. Shows the relationship with.
  • the circles indicate the relationship between the first time 336 and the second time 346 actually measured in the tightly wound state.
  • the triangular marks indicate the relationship between the first time 336 and the second time 346 actually measured in the yuru-wound state.
  • the characteristic curve in the perfect winding state indicated by the circle shows a gentler gradient than the characteristic curve in the loose winding state.
  • the second time 346 increases according to the first time 336. Therefore, the first time 336 and the second time 346 show a roughly linear relationship in both the tightly wound state and the loosely wound state.
  • the relationship between the first time 336 and the second time 346 shown in FIG. 5 is based on the normal blood pressure measurement (blood pressure measurement performed while the subject 200 is sitting in a chair).
  • the normal perfect winding threshold 350 shown by the linear function of the solid line is set as a normal determination standard (normal determination standard) for determining the winding state of the cuff 10. Then, when the blood pressure measurement start switch 42A is turned on with the cuff 10 wrapped around the left wrist 210 of the subject 200, air is supplied to the cuff 10 and the first time is based on the change in the cuff pressure at that time.
  • the 336 and the second time 346 are measured, and by comparing the relationship between the first time 336 and the second time 346 with the normal perfect winding threshold 350, whether or not the cuff 10 is in the perfect winding state (or yuru). Whether or not it is in a wound state) is determined.
  • the blood pressure measurement at night (the blood pressure measurement performed when the subject 200 is in the lying position) is performed a plurality of times according to a predetermined schedule as described above, so that the cuff 10 tends to loosen easily. Therefore, in nighttime blood pressure measurements, the cuff 10 is preferably wrapped more tightly so that it does not loosen easily. Therefore, with respect to the nighttime blood pressure measurement, the nighttime perfect winding threshold (second reference value) 360 is such that the winding state of the cuff 10 in the nighttime blood pressure measurement is compared with the judgment standard (normal judgment standard) in the normal blood pressure measurement.
  • the degree of the wound state of the cuff 10 is usually set below the perfect winding threshold 350 so as to be a strict determination standard (strict determination standard) shifted in a tight direction.
  • a strict determination standard strict determination standard
  • the night measurement switch 42B is turned on with the cuff 10 wrapped around the left wrist 210 of the subject 200, air is supplied to the cuff before the subject goes to bed, and based on the change in the cuff pressure at that time.
  • the first time 336 and the second time 346 are measured, and by comparing the relationship between the first time and the second time with the nighttime perfect winding threshold, whether or not the cuff is in the perfect winding state (or (Whether or not it is in a swaying state) is judged.
  • the temporary function of the normal winding threshold value 350 and the temporary function of the nighttime perfect winding threshold value 360 are set in, for example, the following formulas 1 and 2. However, these functions are just an example, and the threshold may be defined by other functions.
  • the CPU 110 calculates the first time 336 and the second time 346 based on the cuff pressure obtained by the pressure sensor 62, and these first time 336. And the point identified from the second time 346 (the point represented on FIG. 5) is the region above the corresponding normal winding threshold (temporary function) 350 or nighttime perfect winding threshold (temporary function) 360. It is determined whether the cuff is in the loose winding state or the perfect winding state depending on whether it is in the winding area) or in the lower area (perfect winding area). The determination result is displayed on the display unit 30, for example.
  • Normal blood pressure measurement will be described.
  • a normal blood pressure measurement instruction (mode instruction) is issued. It is output to the CPU 110.
  • the CPU 110 drives the pump 72 and the valve 82 to increase the cuff pressure of the cuff 10 and press the left wrist 210.
  • FIG. 6 shows an operation flow when the subject 200 performs a normal blood pressure measurement with the sphygmomanometer 100. During this normal blood pressure measurement, the subject 200 wearing the sphygmomanometer 100 on the left wrist 210 keeps sitting on a chair or the like.
  • step S2 of FIG. 6 when the subject 200 presses the blood pressure measurement switch 42A provided on the sphygmomanometer main body 20 and inputs a normal blood pressure measurement instruction, the CPU 110 presses the pressure sensor 62.
  • Initialize step S2). Specifically, the CPU 110 initializes the processing memory area, stops the pump 72, and adjusts the pressure sensor 62 to 0 mmHg (sets the atmospheric pressure to 0 mmHg) with the valve 82 open. ..
  • the CPU 110 closes the valve 82 via the valve drive circuit 84 (step S3), and then drives the pump 72 via the pump drive circuit 74 to pressurize the cuff 10 (air bag 12).
  • Start step S4.
  • the CPU 110 controls the pressurizing speed of the cuff pressure, which is the pressure inside the air bag 12, based on the output of the pressure sensor 62 while supplying air from the pump 72 to the air bag 12 through the air pipe 50.
  • step S4 is repeated.
  • the CPU 110 has a time when the cuff pressure changes from the first pressure P1 to the second pressure P2, that is, the first time 336, and the cuff pressure is the third from the change in the cuff pressure output by the pressure sensor 62.
  • the time from the pressure P3 to the fourth pressure P4, that is, the second time 346 is obtained.
  • the CPU 110 stores the memory based on the acquired first time 336 and second time 346.
  • the winding state of the cuff 10 is determined using the above-mentioned normal winding determination program stored in 112, and if the cuff 10 is in a loose winding state, the characters "Please rewind” or the cuff 10 is in a perfect winding state. If so, the characters "wrapping is appropriate” are output to the display unit 30 (step S6).
  • the blood pressure measurement only when the wound state of the cuff 10 is "appropriate” the measurement result obtained in the normal blood pressure measurement mode becomes highly reliable.
  • step S7 the CPU 110 determines the blood pressure values (maximum blood pressure and diastolic blood pressure) using the above-mentioned normal blood pressure measurement program stored in the memory 112 based on the pulse wave signal acquired at this time. calculate.
  • the cuff pressure is preset to the upper limit pressure (for safety, for example, 300 mmHg). The process of steps S4 to S8 is repeated unless the value of) is reached.
  • step S8 When the blood pressure value is calculated (when branching to YES in step S8), the CPU 110 stops the pump 72 (step S9), opens the valve 82 (step S10), and removes the air in the cuff 10 (air bag 12). Control to exhaust.
  • the CPU 110 displays the calculated blood pressure value on the display unit 30 (step S11), and controls the blood pressure value to be stored in the memory 112.
  • a nighttime blood pressure measurement program will be implemented according to a predetermined schedule.
  • the night measurement switch 42B is pressed down again by the time until the blood pressure monitor 100 measures the blood pressure of the sleeping subject at night (for example, within the waiting time until the time when the predetermined night blood pressure measurement program is executed). If so, the nocturnal blood pressure measurement will be instructed to stop and the nocturnal blood pressure measurement program will not be executed.
  • a predetermined time for example, 4 hours
  • a predetermined time for example, 7:00 am
  • a nocturnal blood pressure measurement program is carried out every fixed time (for example, 2 hours).
  • the nighttime blood pressure measurement program includes a program (not shown) for determining the measurement time, and this time determination program The measurement time is determined based on.
  • the implementation schedule of nighttime blood pressure measurement is not limited to this, and the nighttime blood pressure measurement program may be set to be executed at a predetermined reserved time, for example, 1:00 am, 2:00 am, or 3:00 am.
  • FIG. 7 shows an operation flow when the subject 200 performs nighttime blood pressure measurement with the sphygmomanometer 100.
  • the subject 200 wearing the sphygmomanometer 100 on the left wrist 210 keeps lying on a bed or the like.
  • step S101 of FIG. 7 when the subject 200 presses the nighttime measurement switch 42B provided on the sphygmomanometer main body 20 and inputs a nighttime blood pressure measurement instruction, the CPU 110 winds the cuff 10.
  • the program for determining the state is switched from the normal winding determination program to the nighttime winding determination program and set (step S102).
  • the CPU 110 initializes the pressure sensor 62 (step S103). Specifically, the CPU 110 initializes the processing memory area, stops the pump 72, and adjusts the pressure sensor 62 to 0 mmHg (sets the atmospheric pressure to 0 mmHg) with the valve 82 open. ..
  • step S104 the CPU 110 closes the valve 82 via the valve drive circuit 84 (step S104), and then drives the pump 72 via the pump drive circuit 74 to pressurize the cuff 10 (air bag 12). Start (step S105).
  • step S105 When the cuff pressure output by the pressure sensor 62 does not reach a predetermined pressure (when branching to NO in step S106), the CPU 110 repeats step S105, and from the change in the cuff pressure output by the pressure sensor 62, the CPU 110 repeats the step S105.
  • a first time 336 when the cuff pressure changes from the first pressure P1 to the second pressure P2 and a second time 346 when the cuff pressure changes from the third pressure P3 to the fourth pressure P4 are obtained.
  • the CPU 110 uses the acquired first time 336 and second time. Based on 346, the winding state of the cuff 10 is determined using the above-mentioned night winding determination program stored in the memory 112, and if the cuff 10 is in a loose winding state, the characters "Please rewind” or If the cuff 10 is in the perfectly wound state, the characters "winding is proper" are output to the display unit 30 (step S107).
  • the suitability of the wrapping state of the cuff 10 is determined according to the above-mentioned strict determination criteria.
  • the subject can correct the winding state of the cuff 10 to the extent that the winding state of the cuff 10 is determined to be "appropriate” according to the above-mentioned strict determination criteria. Therefore, when the sphygmomanometer 100 automatically starts the blood pressure measurement according to the schedule in the nighttime blood pressure measurement mode, even if the subject does not correct the wrapping state of the cuff, the cuff's It is expected that the wrapping state will be maintained "appropriately”. Therefore, according to the sphygmomanometer 100, accurate blood pressure measurement can be performed in the nighttime blood pressure measurement mode.
  • the CPU 110 is controlled to stop the pump 72 (step S108), open the valve 82 (step S109), and exhaust the air in the cuff 10 (air bag 12).
  • the CPU 110 determines whether or not the measurement time is determined by the predetermined schedule (step S110), and if it is not the measurement time defined by the schedule (when branching to NO in step S110), the said. Wait until the measurement time comes.
  • step S110 When the measurement time is reached (when branching to YES in step S110), the CPU 110 initializes the pressure sensor 62 in the same manner as in step S2 of FIG. 6 (step S111).
  • the CPU 110 closes the valve 82 via the valve drive circuit 84 (step S112), and subsequently drives the pump 72 via the pump drive circuit 74, as in steps S3 and S4 of FIG.
  • Pressurization of the cuff 10 is started (step S113).
  • the CPU 110 controls the pressurizing speed of the cuff pressure, which is the pressure inside the air bag 12, based on the output of the pressure sensor 62 while supplying air from the pump 72 to the air bag 12 through the air pipe 50.
  • step S114 similarly to step S7 of FIG. 6, the CPU 110 uses the above-mentioned nocturnal blood pressure measurement program stored in the memory 112 based on the pulse wave signal acquired at this time to obtain blood pressure. Calculate the values (maximum blood pressure and diastolic blood pressure).
  • the cuff pressure is preset to the upper limit pressure (for safety, for example, 300 mmHg). ) Is not reached, the processing of steps S113 and S114 is repeated.
  • the CPU 110 stops the pump 72 (step S116), opens the valve 82 (step S117), and enters the cuff 10 (air bag 12). Control to exhaust air.
  • the CPU 110 displays the calculated blood pressure value on the display unit 30 (step S118), and controls the blood pressure value to be stored in the memory 112.
  • the CPU 110 determines whether or not all the blood pressure measurements defined in the above schedule are completed (step S119). If the blood pressure measurement defined in the above schedule is still scheduled (when branching to "incomplete" in step S119), the CPU 110 returns to step S110 and is the next measurement time defined in the above schedule. If it is not the measurement time (when branching to NO in step S110), it waits until the measurement time is reached.
  • the CPU 110 repeats the processes of steps S111 to S118, and in step S119 again, all the processes specified in the above schedule. Determine if the blood pressure measurement is complete.
  • the CPU 110 does not operate the nighttime winding determination program in steps S103 to S109 so that unnecessary winding determination is not performed while the processing of steps S111 to S118 is repeated. Therefore, when the blood pressure measurement is automatically started by the second and subsequent processes of steps S111 to S118 according to the above schedule, neither the determination of the winding state of the cuff 10 nor the notification of the determined winding state is performed. As a result, it is possible to prevent the CPU 110 from making a useless determination and attempting a useless notification. Therefore, it can contribute to power saving.
  • the cuff 10 In the above-mentioned normal and nighttime blood pressure measurement, if the cuff 10 is in a loosely wound state, the characters "Please rewind” are displayed, or if the cuff 10 is in a perfect wound state, the characters “Wrapping is appropriate” are displayed.
  • the subject 200 can grasp the wound state of the cuff 10 before the blood pressure measurement is actually performed.
  • the subject 200 can stop the blood pressure measurement and rewind the cuff 10. Therefore, since the cuff 10 is easily wrapped around the left wrist 210 of the subject 200 in a tightly wound state, the blood pressure of the subject 200 can be accurately measured even when the subject 200 is sleeping.
  • the nighttime wrapping determination program performed in the nighttime blood pressure measurement determines the wrapping state of the cuff 10 under a smaller threshold value than the normal wrapping determination program, that is, strict conditions, the subject 200 is in a more tightly wound state.
  • the cuff 10 is urged to be wound in a slightly tightly wound state.
  • the blood pressure is measured by the oscillometric method with the cuff wrapped in an appropriate state. Therefore, according to this sphygmomanometer, accurate blood pressure measurement can be performed when the blood pressure is measured while the subject is sleeping.
  • the sphygmomanometer 100 is a type that presses the wrist as the measurement site (the left wrist 210 is used in the embodiment, but the right wrist may also be used), the subject 200 sleeps as compared with the type that presses the upper arm. It is expected to be difficult to prevent (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, the sphygmomanometer 100 is suitable for nighttime blood pressure measurement.
  • the sphygmomanometer 100 is integrally and compactly configured as a wrist-type sphygmomanometer, the subject 200 is easy to handle.
  • the CPU 110 switches from the normal wrapping determination program to the night wrapping determination program in order to determine the wrapping state of the cuff 10 under severe conditions in step S102 in the nighttime blood pressure measurement, as shown in FIG. ,
  • the normal wrapping determination program may be carried out even in the blood pressure measurement at night without switching.
  • the CPU 110 calculates the blood pressure in the process of pressurizing the cuff 10 (air bag 12), but the blood pressure may be calculated in the process of depressurizing the cuff.
  • the sphygmomanometer 100 has the characters "Please rewind” if the cuff 10 is in a loosely wound state, or the characters “Wrapping is appropriate” if the cuff 10 is in a perfect wound state.
  • the display unit 30 for displaying is provided, the subject may be notified of the winding determination result by the voice notification unit that notifies the content of the character by reading it out by voice.
  • the sphygmomanometer 100 includes a blood pressure measurement switch 42A to which a normal blood pressure measurement instruction is input and a night measurement switch 42B to which a nighttime blood pressure measurement instruction is input.
  • the signal receiving unit of the sphygmomanometer receives an instruction (mode instruction) from an existing smartphone or the like via wireless communication, and the signal received by this signal receiving unit is output to the CPU from a normal blood pressure measurement switch or a nighttime measurement switch. It may be replaced with a signal.
  • the sphygmomanometer 100 is configured such that the blood pressure measurement switch 42A outputs a normal blood pressure measurement instruction signal to the CPU 110, and the nighttime measurement switch 42B outputs a nighttime blood pressure measurement instruction signal to the CPU 110.
  • a normal blood pressure measurement instruction signal (mode instruction) is output to the CPU
  • the nighttime The signal (mode instruction) of the blood pressure measurement instruction may be output to the CPU.
  • the sphygmomanometer body 20 is integrally attached to the cuff 10, but is provided separately from the cuff and flows through the cuff 10 (air bag 12) and fluid through a flexible air tube. It may be connected if possible.
  • the normal blood pressure measurement program, the nocturnal blood pressure measurement program, the normal wrapping determination program, the nocturnal wrapping determination program, and their flows are stored in the memory 112 as software, but a CD (compact disc) or a DVD. It may be recorded on a non-temporary medium such as (digital universal disc) or flash memory.
  • a substantial computer device such as a personal computer, a PDA (Personal Digital Assistance), or a smartphone, the computer device is made to execute the above-mentioned program and flow. be able to.
  • 100 Sphygmomanometer, 10: Cuff, 30: Notification unit (display unit), 40: Mode operation unit, 62: Pressure sensor, 110: First judgment unit (CPU), 210: Wrist.

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