Biological testing device and method of operating the biological testing device

Abstract

To provide a biological examination device and a biological examination method capable of examining a health condition of a subject in a more multifaceted manner by effectively using a blood pressure test and an HRV measuring test.SOLUTION: A biological examination device includes: a blood pressure measuring part for pressurizing the upper limb and / or the lower limb with a cuff mounted on a subject to measure the blood pressure of the subject; an HRV measuring part for measuring the HRV (Heart Rate Variability) of the subject; a determination part for determining the health condition of the subject on the basis of a change in an HRV measurement value measured by the HRV measuring part when the cuff pressure is changed by the blood pressure measuring part.SELECTED DRAWING: Figure 2

Description

Technical Field

[0001] The present invention relates to a biological examination apparatus and a biological examination method for examining the health state of a subject using a cuff.

Background Art

[0002] Conventionally, there is a blood pressure pulse wave examination apparatus as an apparatus for examining the vascular state of a subject using a cuff. The blood pressure pulse wave examination apparatus measures CAVI (Cardio Ankle Vascular Index) and PWV (Pulse Wave Velocity) as indices of arteriosclerosis. PWV is the speed at which the wave generated when the heart pumps blood into the aorta propagates through the arterial vessel wall, and the faster it is, the harder the blood vessel is. PWV is obtained by measuring the pulse waves at two points on the blood vessel and their propagation time (PWT), and dividing the distance between these two points by the propagation time.

[0003] A blood pressure pulse wave examination apparatus capable of measuring PWV is described in, for example, Patent Document 1. A blood pressure pulse wave examination apparatus capable of measuring CAVI in addition to PWV is described in, for example, Patent Document 2.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Patent Document 2

Summary of the Invention

Problems to be Solved by the Invention

[0005] Incidentally, blood pressure and pulse wave analyzers generally have electrocardiogram (ECG) functions in addition to the blood pressure and pulse wave analysis function used to examine arteriosclerosis and other conditions. ECG functions include 12-lead ECG testing, arrhythmia testing, rhythm measurement testing, master test testing, post-stress testing, stress testing, and HRV (Heart Rate Variability) measurement testing.

[0006] Here, HRV measurement is a test that assesses the autonomic nervous system activity of a subject by detecting heart rate variability and fluctuations based on the RR interval of the subject's electrocardiogram. Based on the HRV measurement results, it is possible to evaluate autonomic nervous system-related heart diseases and autonomic neuropathy caused by diabetes. Generally, HRV measurement is performed by measuring the electrocardiogram of the subject while they are lying supine on a bed, similar to a resting electrocardiogram.

[0007] The present invention provides a biomedical examination device and biomedical examination method that can more comprehensively examine the health status of a subject by effectively utilizing blood pressure testing and HRV measurement testing. [Means for solving the problem]

[0008] One aspect of the biological testing apparatus of the present invention is A blood pressure measurement unit that measures the blood pressure of a subject by applying pressure to the subject's upper and / or lower limbs using a cuff attached to the subject, An HRV measurement unit for measuring the HRV (Heart Rate Variability) of the subject, A determination unit that determines the health status of the subject based on the change in the HRV measurement value measured by the HRV measurement unit when the cuff pressure is changed by the blood pressure measurement unit, It is equipped with.

[0009] One aspect of the present invention's biological examination method is: The steps include measuring the blood pressure of a subject by applying pressure to the subject's upper and / or lower limbs using a cuff attached to the subject, The steps include measuring the HRV of the subject, A step of determining the health status of the subject based on the HRV measurement value when the cuff pressure changes, Includes. [Effects of the Invention]

[0010] According to the present invention, the health status of the subject is determined based on the change in HRV measurement value when the cuff pressure is changed, thereby realizing a biomedical examination device and biomedical examination method that can examine the health status of the subject from a more multifaceted perspective. [Brief explanation of the drawing]

[0011] [Figure 1] Block diagram showing the overall configuration of the blood pressure pulse wave analysis device according to the embodiment. [Figure 2] Block diagram showing the main components of the embodiment [Modes for carrying out the invention]

[0012] Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings.

[0013] <1> Overall configuration of a blood pressure and pulse wave analysis device Figure 1 is a block diagram showing the overall configuration of a blood pressure pulse wave analysis device according to an embodiment of the present invention.

[0014] In Figure 1, the main body 1a of the blood pressure pulse wave testing device 1 is equipped with a calculation processing unit 10, an input unit 70, a display unit 80, a display control unit 81, a printing unit 91, a storage unit 92, an audio output unit 93, a blood pressure pulse wave measurement unit 30, a heart sound measurement unit 40, an electrocardiogram measurement unit 50, and a pulse wave measurement unit 60.

[0015] The blood pressure pulse wave measurement unit 30 includes an upper arm measurement control unit 31 and a lower limb measurement control unit 32. The upper arm measurement control unit 31 is connected to the right upper arm cuff 21R and the left upper arm cuff 21L via hoses 21h, and the lower limb measurement control unit 32 is connected to the right ankle cuff 22R and the left ankle cuff 22L via hoses 22h.

[0016] The blood pressure and pulse wave measurement unit 30 has an oscillometric blood pressure measurement function and an air bag type pulse wave measurement function.

[0017] The upper limb measurement control unit 31 includes a pressure sensor 33, a signal processing circuit that performs predetermined signal processing such as amplification on the detection signal from the pressure sensor 33, a pump and an exhaust valve for supplying and discharging air to and from the cuffs 21R and 21L, and a computer having a CPU (Central Processing Unit), a ROM (Read Only Memory), a RAM (Random Access Memory), various interfaces, etc. that controls this air supply and discharge operation. The upper limb measurement control unit 31 pressurizes the internal pressure of the cuffs 21R and 21L (hereinafter, the internal pressure of the cuff is referred to as "cuff pressure") by introducing air into the rubber bladders of the cuffs 21R and 21L via the hose 21h, and depressurizes the cuff pressure of the cuffs 21R and 21L by discharging air from the rubber bladders. The cuff 21R is attached to the right upper arm of the subject, and the cuff 21L is attached to the left upper arm of the subject. The target value of the cuff pressure after pressurization is different between the case of pulse wave measurement and the case of blood pressure measurement, and can be set individually.

[0018] In the case of pulse wave measurement, the upper limb measurement control unit 31 detects the fluctuation of the cuff pressure of the cuffs 21R and 21L after pressurization as a pulse wave signal by the pressure sensor 33, and outputs the detected pulse wave signal to the arithmetic processing unit 10. Pulse wave measurement is performed in response to a request from the arithmetic processing unit 10. Note that for pulse wave measurement, only one of the two cuffs 21R and 21L may be used, or both may be used.

[0019] In the case of blood pressure measurement, while the upper limb measurement control unit 31 detects the vibration of the cuff pressure of the cuffs 21R and 21L by the pressure sensor 33 during decompression, it detects the cuff pressure with the most significant increase in amplitude as the systolic blood pressure, and detects the cuff pressure with the most significant decrease in vibration as the diastolic blood pressure. Then, the upper limb measurement control unit 31 outputs blood pressure signals indicating the detected systolic blood pressure and diastolic blood pressure to the arithmetic processing unit 10 respectively. Blood pressure measurement is performed in response to a request from the arithmetic processing unit 10. When there is a request from the arithmetic processing unit 10, usually, the right-side blood pressure measurement using only the cuff 21R and the left-side blood pressure measurement using only the cuff 21L are sequentially performed, but these blood pressure measurements may also be performed in parallel.

[0020] The lower limb measurement control unit 32 includes a pressure sensor 34, a signal processing circuit that performs predetermined signal processing such as amplification on the detection signal from the pressure sensor 34, a pump and an exhaust valve that supply and discharge air to and from the cuffs 22R and 22L, and a computer having a CPU, a ROM, a RAM, various interfaces, etc. that controls this supply and discharge operation. The lower limb measurement control unit 32 pressurizes the cuff pressure of the cuffs 22R and 22L by introducing air into the rubber bladders of the cuffs 22R and 22L via the hose 22h, and decompresses the cuff pressure of the cuffs 22R and 22L by discharging air from the rubber bladders. The cuff 22R is attached to the right ankle of the subject, and the cuff 22L is attached to the left ankle of the subject. The target value of the cuff pressure after pressurization is different between the case of pulse wave measurement and the case of blood pressure measurement, and can be set individually. Since the operations of the lower limb measurement control unit 32 during pulse wave measurement and blood pressure measurement are the same as those of the upper limb measurement control unit 31, detailed description thereof is omitted here.

[0021] The computers of the upper limb measurement control unit 101 and the lower limb measurement control unit 32 perform arithmetic processing and the like for blood pressure and pulse wave measurement described below by executing the control program stored in the ROM with the CPU.

[0022] In this embodiment, the blood pressure pulse wave measurement unit 30 is provided with an upper limb measurement control unit 31 and a lower limb measurement control unit 32, but the upper limb measurement control unit 31 and the lower limb measurement control unit 32 may be integrated into a single unit.

[0023] A heart sound microphone 23 is connected to the heart sound measurement unit 40. Limb electrocardiogram electrodes 24a and chest electrocardiogram electrodes 24b are connected to the electrocardiogram measurement unit 50. Amorphous pulse wave sensors 25a and 25b are connected to the pulse wave measurement unit 60.

[0024] The arithmetic processing unit 10 is a computer that includes a CPU, ROM, RAM, various interfaces, etc. The arithmetic processing unit 10 executes the control program stored in the ROM using the CPU.

[0025] The calculation processing unit 10 controls the blood pressure pulse wave measurement unit 30, the heart sound measurement unit 40, the electrocardiogram measurement unit 50, and the pulse wave measurement unit 60 (hereinafter referred to as "each biological information measurement unit").

[0026] Furthermore, the arithmetic processing unit 10 receives biological information supplied from each biological information measurement unit. When it is necessary to display the received biological information on the screen, it edits or converts it into display data and outputs it to the display unit 80. When it is necessary to print the information on report paper, it edits or converts it into print data and outputs it to the print unit 91. The arithmetic processing unit 10 also stores the received biological information in the storage unit 92 as appropriate, and reads the stored biological information.

[0027] Furthermore, the arithmetic processing unit 10 performs waveform analysis of the biological information received from each biological information measurement unit. In the waveform analysis, it detects characteristic parts (section points) in the waveform. Examples of characteristic parts include the start of the second heart sound, the rising part of the pulse wave in the upper arm, the rising part of the pulse wave in the ankle, the pulse wave notch, the pulse wave notch in the upper arm, and so on.

[0028] The calculation processing unit 10 calculates the degree of arteriosclerosis based on the analysis results and the numerical values ​​(e.g., blood pressure) indicated by the received biological information. The calculation processing unit 10 also measures HRV based on the electrocardiogram.

[0029] The process for calculating arteriosclerosis will be explained in detail. The calculation processing unit 10 determines the brachial-ankle pulse wave velocity (baPWV) and the heart-ankle pulse wave velocity (haPWV) as pulse wave propagation velocities, and also determines the ankle-brachial pressure index (ABI) as the lower limb-upper limb blood pressure ratio. In other words, the calculation processing unit 10 calculates the ankle-brachial pressure ratio (ABI) and pulse wave velocity (PWV) using the pulse wave detected by the blood pressure pulse wave measurement unit 30. The calculation processing unit 10 also calculates the subject's blood pressure value using the pulse wave detected by the blood pressure pulse wave measurement unit 30. Furthermore, the calculation processing unit 10 also calculates indices such as the cardio-ankle vascular index (CAVI), which is calculated based on the heart-ankle artery pulse wave velocity (haPWV). Here, the calculation control unit 10 calculates CAVI by correcting the cardiac-ankle arterial pulse wave velocity haPWV with a logarithmic pulse wave. As is well known, the brachial-ankle pulse wave velocity baPWV and the cardiac-ankle arterial pulse wave velocity haPWV are indicators of vascular stiffness, and the ankle-brachial index (ABI) is an indicator of vascular blockage.

[0030] Furthermore, the arithmetic processing unit 10 receives input and instructions from the user via the input unit 70, and, according to the received content, sets the functions related to each of the biometric information measurement units, display unit 80, printing unit 91, storage unit 92, and audio output unit 93, and controls the start and stop of their respective operations.

[0031] The display unit 80 is a display device having a display screen such as an LCD (Liquid Crystal Display), and displays biological information, analysis results, and arteriosclerosis degree, etc., input as display data from the arithmetic processing unit 10 on the screen.

[0032] The printing unit 91 mainly consists of a paper feeding mechanism and a print head, and prints biological information, analysis results, and arteriosclerosis degree, which are input as print data from the calculation processing unit 10, onto the paper.

[0033] The memory unit 92 is composed of a hard disk drive, a writable optical disk drive, non-volatile memory, etc., and is capable of storing information from the arithmetic processing unit 10. In addition, the memory unit 92 records biological information measured by each biological information measurement unit, namely electrocardiograms, pulse waves, and heart sounds.

[0034] The audio output unit 93 mainly consists of a speaker and outputs guidance voice or notification sound according to guidance data or notification sound output instruction signals input from the arithmetic processing unit 10.

[0035] The input unit 70 consists of a keyboard, mouse, buttons, touch panel, etc., and receives input and instructions from the user and sends them to the arithmetic processing unit 10.

[0036] The pulse wave measurement unit 60 supplies the pulse wave signals of the subject detected by amorphous pulse wave sensors 25a and 25b, which are appropriately attached to the subject, to the calculation processing unit 10. This allows for the measurement and analysis of the pulse wave. One of the amorphous pulse wave sensors 25a and 25b is attached, for example, to the subject's carotid artery, and the other is attached, for example, to the subject's femoral artery or knee.

[0037] The electrocardiogram measurement unit 50 supplies the electrocardiogram signals detected by the limb electrocardiogram electrode units 24a and the chest electrocardiogram electrode unit 24b attached to the subject to the calculation processing unit 10. This allows for the measurement and analysis of the electrocardiogram. The limb electrocardiogram electrode unit 24a typically consists of four electrocardiogram electrodes attached to the right wrist, left wrist, right ankle, and left ankle, respectively. Regarding the electrocardiogram electrodes for both ankles, it is preferable that they are designed so that attachment to both ankles is not hindered by the right ankle cuff 22R and the left ankle cuff 22L. The chest electrocardiogram electrode unit 25b typically consists of six electrocardiogram electrodes attached to six locations on the chest, respectively.

[0038] The heart sound measurement unit 40 supplies the heart sound signal detected by the heart sound microphone 23 attached to the subject to the processing unit 10. This enables the measurement and analysis of heart sounds.

[0039] <2> Main component configuration of this embodiment Figure 2 is a block diagram showing the main components of the blood pressure pulse wave analyzer according to this embodiment. In this embodiment, the control unit 101, HRV measurement unit 102, and determination unit 103 of the configuration shown in Figure 2 are provided in the arithmetic processing unit 10. As described above, the arithmetic processing unit 10 is a computer having a CPU, ROM, RAM, various interfaces, etc. The arithmetic processing unit 10 realizes the functions of the control unit 101, HRV measurement unit 102, and determination unit 103 by executing control programs stored in ROM using the CPU.

[0040] The control unit 101 controls the operation of the blood pressure pulse wave measurement unit 30, the electrocardiogram measurement unit 50, the HRV measurement unit 102, and the determination unit 103. For example, the control unit 101 controls the on and off operation of these parts. The control unit 101 also controls the cuff pressure applied by the blood pressure pulse wave measurement unit 30 to the cuffs 21R, 21L, 22R, and 22L.

[0041] The HRV measurement unit 102 receives the electrocardiogram obtained by the electrocardiogram measurement unit 50 and measures the subject's HRV. For example, the HRV measurement unit 102 measures heart rate variability and heart rate fluctuations based on the RR interval and power spectrum of the electrocardiogram over a predetermined period (e.g., 2 minutes or more), and outputs this as an HRV measurement value to the determination unit 103.

[0042] The determination unit 103 determines the health status of the subject based on the HRV measurement value measured by the HRV measurement unit 102 when the cuff is pressurized by the blood pressure pulse wave measurement unit 30.

[0043] For example, the determination unit 103 determines the subject's health status based on the degree of change between the first HRV measurement value when cuffs 21R, 21L, 22R, and 22L are set as the first cuff pressure by the blood pressure pulse wave measurement unit 30, and the second HRV measurement value when cuffs 21R, 21L, 22R, and 22L are set as a second cuff pressure greater than the first cuff pressure by the blood pressure pulse wave measurement unit 30. Typically, the first cuff pressure is zero (e.g., before pressurization or after depressurization), and the second cuff pressure is the maximum cuff pressure during blood pressure pulse wave measurement by the blood pressure pulse wave measurement unit 30, for example, around 200 mmHg.

[0044] In this study, non-healthy individuals with vascular or autonomic nerve disorders tend not to experience autonomic nerve abnormalities when pressurized with cuffs 21R, 21L, 22R, and 22L, compared to healthy individuals.

[0045] In this invention, focusing on this point, the change in the subject's HRV measurement value when pressurization is applied with a cuff during blood pressure pulse wave measurement is observed, and the smaller the change in the HRV measurement value, the more it is determined that there is damage to the blood vessels or autonomic nerves and that the person is far from being in a healthy state.

[0046] Furthermore, the HRV measurement values ​​that the determination unit 103 uses for determination are not limited to the first HRV measurement value corresponding to the first cuff pressure and the second HRV measurement value corresponding to the second cuff pressure. In short, the determination unit 103 should determine the health status based on the change in the HRV measurement value when the cuff pressure changes during blood pressure pulse wave measurement, using the knowledge that the smaller the change in the HRV measurement value in relation to the change in cuff pressure, the greater the damage to blood vessels or autonomic nerves.

[0047] The determination results from the determination unit 103, and the measurement results of blood pressure, pulse wave, and arteriosclerosis degree from the blood pressure and pulse wave measurement unit 30, are displayed on the display unit 80 via the display control unit 81.

[0048] <3> summary As described above, according to this embodiment, a blood pressure measurement unit (blood pressure pulse wave measurement unit 30) that measures the blood pressure of the subject by pressurizing the subject's upper and / or lower limbs with cuffs 21R, 21L, 22R, and 22L attached to the subject, an HRV measurement unit 102 that measures the subject's HRV, and a determination unit 103 that determines the subject's health status based on the change in the HRV measurement value measured by the HRV measurement unit 102 when the cuff pressure is changed by the blood pressure measurement unit (blood pressure pulse wave measurement unit 30), thereby realizing a biological examination device and biological examination method that can effectively utilize blood pressure examination and HRV measurement examination to examine the subject's health status from a more multifaceted perspective.

[0049] In particular, by effectively utilizing the fluctuations in cuff pressure during blood pressure measurement to perform HRV measurement, the total examination time can be shortened compared to when HRV measurement is performed alone.

[0050] Furthermore, since health status can be presented based on HRV measurement in addition to the results of blood pressure and pulse wave measurement, healthcare professionals will be able to make a more multifaceted assessment of the patient's health status.

[0051] The embodiments described above are merely examples of how the present invention can be implemented, and the technical scope of the present invention should not be limited by them. In other words, the present invention can be implemented in various ways without departing from its gist or its main features.

[0052] In the above-described embodiment, the HRV measurement unit 102 was described in the case where HRV is measured based on an electrocardiogram, but for example, HRV (heart rate variability) may be measured based on a pulse wave.

[0053] The above-described embodiment describes the application of the present invention to a blood pressure pulse wave testing device 1. However, the present invention is not limited to this, and essentially only requires a cuff that pressurizes the upper and / or lower limbs of the subject, an HRV measurement unit that measures the subject's HRV, and a determination unit that determines the subject's health status (which may also be called a disability) based on the change in the HRV measurement value when the cuff pressure changes. Therefore, the present invention can also be applied to, for example, a Holter electrocardiograph having a cuff and an HRV measurement function, or a vital signs monitor having a cuff and an HRV measurement function. [Industrial applicability]

[0054] The present invention is broadly applicable to biological testing devices and methods for examining the health status of a subject using a cuff. [Explanation of Symbols]

[0055] 1. Blood pressure and pulse wave analyzer 10. Arithmetic Processing Unit 21R, 21L, 22R, 22L Cuff 30 Blood pressure and pulse wave measurement unit 50 Electrocardiogram Measurement Unit 101 Control Unit 102 HRV Measurement Unit 103 Judgment section

Claims

1. A blood pressure measurement unit that measures the blood pressure of a subject by applying pressure to the subject's upper and / or lower limbs using a cuff attached to the subject, An HRV measurement unit for measuring the HRV (Heart Rate Variability) of the subject, A determination unit that determines the health status of the subject based on the change in the HRV measurement value measured by the HRV measurement unit when the cuff pressure is changed by the blood pressure measurement unit, Equipped with, The health condition determined by the determination unit is the vascular condition. A biomedical testing device.

2. The determination unit determines the vascular condition based on the degree of change between the HRV measurement value when the cuff is set to a first cuff pressure by the blood pressure measurement unit and the HRV measurement value when the cuff is set to a second cuff pressure greater than the first cuff pressure by the blood pressure measurement unit. The biological examination apparatus according to claim 1.

3. The first cuff pressure is zero, and the second cuff pressure is the maximum cuff pressure during blood pressure measurement by the blood pressure measurement unit. The biological examination apparatus according to claim 2.

4. The system further includes a calculation unit that calculates CAVI (Cardio Ankle Vascular Index) based on the pulse wave of the subject. A biological examination apparatus according to any one of claims 1 to 3.

5. A method for operating a biological examination device, The biomedical examination device measures the blood pressure of the subject when the subject's upper and / or lower limbs are pressurized by a cuff attached to the subject. The biomedical examination device measures the subject's HRV, The biomedical testing device generates information regarding the subject's health status based on the change in HRV measurement value when the cuff pressure changes. Includes, In the step of generating the aforementioned health status information, information regarding the vascular status is generated. How to operate a biomedical testing device.

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