JP6948643B2 - Pulmonary function test device - Google Patents

Description

The present invention relates to a respiratory function testing device that tests the respiratory function of a subject.

Chronic Obstructive Pulmonary Disease (hereinafter referred to as "COPD") is a disease in which the amount of air remaining in the lungs after exhalation (hereinafter referred to as "residual air volume") increases due to airflow obstruction. In addition, when breathing becomes faster and the expiratory time is shortened by an action such as exercise, the amount of residual air further increases. This phenomenon is called dynamic lung hyperinflation. When the amount of residual air increases, the next inspiration will be performed with insufficient calling, and the amount of inspiration will decrease, causing dyspnea. In the state of dynamic pulmonary hyperinflation, the maximum inspiratory capacity (hereinafter referred to as "IC"), etc. is determined immediately after the subject is made to perform some kind of exercise or breathing faster than the resting state. It can be confirmed by measuring.

For example, as shown in Non-Patent Document 1, there is a method in which a subject is made to breathe faster than a resting state (hereinafter referred to as hyperventilation) for 30 seconds in accordance with the movement of the metronome, and then IC measurement is performed immediately after that. Proposed. In this case, the ventilation measurement at the time of hyperventilation and the IC measurement are combined to form one lung air volume fractionation test. When changing the hyperventilation rate to be performed by the subject, a doctor, nurse, or laboratory technician (hereinafter referred to as the tester) changes the setting of the metronome after each lung volume fractionation test, and then. , The next lung volume fractionation test, ie, ventilation measurement and IC measurement during hyperventilation is performed.

"Effects of bronchodilators on dynamic hyperinflation following hyperventilation in patients with COPD", "Asian Pacific Society of Respirology (2007) 12, 93-99"

In the conventional test method as described above, in order to allow the subject to breathe in a predetermined cycle, a metronome is prepared separately from the respiratory function test device for IC measurement, and then a predetermined operation cycle is set in the metronome. It was inconvenient for the inspector.

The present invention has been made based on such a background, and an object of the present invention is to provide a respiratory function test device capable of causing a subject to breathe at a predetermined cycle.

The following measures were taken to solve the above problems. The description of the best mode for carrying out the invention described later and the reference numerals used in the drawings are added in parentheses for reference, but the components of the present invention are not limited to those added.

The means 1 is a respiratory function test device (spirometer 100) for inspecting the respiratory function of the subject, and sets the setting means (CPU 14, operation keys 17, display 18) capable of setting a reference cycle, and the subject's respiratory cycle. Guidance notification means (display 18, speaker 20, notification lamp 21) for executing guidance notification for guiding to the reference cycle (first breath: RR1, second breath: RR2, third breath: RR3) set by the setting means. ) And.

Further, the means 2 is a respiratory function test device of the means 1.
The setting means can set a plurality of different reference cycles (RR1 to RR3), and can set the order of performing guidance notification (first breath to third breath) for each reference cycle, and the guidance notification means. Is characterized in that the guidance notification is executed based on the reference period and the order set by the setting means.

Further, the means 3 is a respiratory function test device of the means 2, and is
After the guidance notification of the predetermined reference cycle is completed, the guidance notification means shifts to the guidance notification of the next reference cycle based on the predetermined operation (operation of the operation key 17) (when the first measurement is completed). For example, the guidance notification corresponding to RR2 is executed according to the transition operation, and if the second measurement is completed, the guidance notification corresponding to RR3 is executed according to the transition operation).

Further, the means 4 is a respiratory function test device of the means 2, and is
After the guidance notification of the predetermined reference cycle is completed, the guidance notification means shifts to the guidance notification of the next reference cycle based on the completion of the inspection corresponding to the reference cycle (the first measurement corresponding to RR1 is completed). Then, the guidance notification corresponding to RR2 is automatically executed, and when the second measurement corresponding to RR2 is completed, the guidance notification corresponding to RR3 is automatically executed).

Further, the means 5 is a respiratory function test device of the means 2, and is
When the guidance notification means is executing the guidance notification based on the reference cycle and the order set by the setting means, the set reference cycle can be changed based on the change operation (first measurement). RR2 can be changed after the end, and RR3 can be changed after the end of the second measurement).

Further, the means 6 is a respiratory function test device of the means 2, and is
It is characterized by including an inspection result display means (display 18) for displaying the inspection results (results of the first measurement to the third measurement) for each reference cycle (RR1 to RR3) in a comparable manner.

Further, the means 7 is a respiratory function test device of the means 6.
The test result display means (display 18) has a maximum inspiratory position (first to third maximum inspiratory positions) and a maximum expiratory position (first expiratory position) inspected after the end of the guidance notification for each reference cycle (RR1 to RR3). It is characterized by displaying test results (maximum inspiratory volume IC1 to IC3, preliminary expiratory volume ERV1 to ERV3, vital capacity VC1 to VC3, forced vital capacity FVC1 to FVC3) based on at least one of the third maximum expiratory position.

Further, the means 8 is a respiratory function test device of the means 6 or 7, and is
The test result display means (display 18) is used every reference cycle (RR1 to RR3) for the forced vital capacity (forced vital capacity FVC1 measured after the first respiration, after the second respiration) that was inspected after the end of the guidance notification. It is characterized in that the test results based on the measured vital capacity FVC2 and the forced vital capacity FVC3) measured after the third respiration are displayed.

Further, the means 9 is any respiratory function testing device selected from the means 6 to 8.
The test result display means (display 18) is used for each reference cycle (RR1 to RR3) to check the preliminary expiratory volume (preliminary expiratory volume ERV1 measured after the first respiration, after the second respiration) after the end of the guidance notification. It is characterized in that the test result based on the measured preliminary expiratory volume ERV2 and the preliminary expiratory volume ERV3) measured after the third respiration is displayed.

Further, the means 10 is any respiratory function testing device selected from the means 6 to 9.
The test result display means (display 18) has an expiratory position (first to third expiratory positions) and an inspiratory position (first to third expiratory positions) during the guidance notification period or after the guidance notification ends at each reference cycle (RR1 to RR3). 3 It is characterized in that at least one of the rises of the intake position) is displayed in a graspable manner.

Further, the means 11 is any respiratory function testing device selected from the means 1 to 10.
The respiratory cycle measuring means (flow sensor 50, pressure sensor 11) for measuring the respiratory cycle of the subject and the respiratory cycle measured by the respiratory cycle measuring means are the reference cycle (RR1 to RR3) of the guidance notification being executed. Includes a cycle determining means (CPU 14) for determining whether or not there is a match, and when it is determined by the cycle determining means that there is no match, a predetermined notification is performed (measured RR and set RR). If a deviation of 5 or more occurs between the two, the display 18 and the speaker 20 notify that the actual respiratory cycle deviates from the induction target respiratory cycle).

Further, the means 12 is a respiratory function test device of the means 11.
If it is determined by the respiratory cycle determination means (CPU14) that they do not match, the inspection is stopped (if there is a deviation of 10 or more between the set RR and the measured RR, the inspection is automatically performed. It is characterized by (discontinue).

Further, the means 13 is any respiratory function testing device selected from the means 1 to 12, and the means 13 is a respiratory function testing device.
The guidance notification indicates to the subject the period for exhalation and the period for inspiration (the period for exhalation and the period for inspiration are guided by the image of the character displayed on the display 18, and the period for inspiration is guided from the speaker 20. The output sound effect guides the timing of switching from exhalation to inspiration and the timing of switching from inspiration to exhalation).

Further, the means 14 is a respiratory function test device of the means 13.
The feature is that the period for exhaling and the period for inspiring in the guidance notification can be set (for example, the ratio of the inspiratory time indicated by the character to the length of the expiratory time can be set to 1: 2). And.

Further, the means 15 is any respiratory function testing device selected from the means 1 to 14.
Includes a first light emitting device (expiratory lamp 24) and a second light emitting device (intake lamp 22).
During the period when the guidance notification is not performed, the first light emitting device (breath lamp 24) is made to emit light when the subject's exhalation is detected, and the second light emitting device is emitted when the subject's inspiration is detected. (Intake lamp 22) is made to emit light, and in the guidance notification, the first light emitting device (expiration lamp 24) is made to emit light when exhalation is promoted based on the set reference period (RR1 to RR3), and the set reference is emitted. The second light emitting device (intake lamp 22) is made to emit light when prompting intake based on a cycle.

Further, the means 16 is a respiratory function test device of the means 15.
Including a third light emitting device (plateau lamp 23)
During the period when the guidance notification is not performed, the third light emitting device (plateau lamp 23) is made to emit light when the respiratory end of the subject is detected.
Respiratory cycle measuring means (pressure sensor 11) for measuring the respiratory cycle of the subject,
Further including a cycle determining means (CPU14) for determining whether or not the respiratory cycle measured by the respiratory cycle measuring means matches the reference cycle of the guidance notification being executed.
When it is determined by the respiratory cycle determination means (CPU14) that they do not match (when a deviation of 5 or more occurs between the measured RR and the set RR), the third light emitting device (plateau lamp). 23) is characterized by emitting light.

Further, the means 17 is any respiratory function testing device selected from the means 1 to 16.
It is a differential pressure type respiratory function tester that can inspect the respiratory flow rate based on the differential pressure before and after the resistor (screen 55) provided in the respiratory path (flow sensor 50).
A pressure sensor (pressure sensor 11) for detecting the differential pressure between the first pressure port (40) and the second pressure port (41), and
Zero point adjustment (processing to store the output value of the pressure sensor 11 (or the measured differential pressure calculated based on the output value) in the state where the differential pressure should be zero) is executed based on the output value of the pressure sensor. It is characterized by including a zero point adjusting means (CPU 14).

Further, the means 18 is a respiratory function test device of the means 17, and is
A first path (differential pressure tube 30) capable of transmitting pressure from the front portion of the resistor (screen 55) located on the breathing port side (connection port 52 side) to the first pressure port (40), and the resistor. At least a second path (differential pressure tube 31) capable of transmitting pressure from the rear portion of the body (screen 55) opposite to the breathing port side (connection port 52 side) to the second pressure port (41) is provided. Be,
The first pressure port and the front portion were pressure-connected, and the first pressure port and the second pressure port were pressure-blocked (the pressure on the front side of the screen 55 was transmitted to the first pressure port 40). However, the pressure on the rear side of the screen 55 is not transmitted to the first pressure port 40.) The inspectable state, the first pressure port and the front part are pressure-blocked, and the first pressure port and the second pressure The port is pressure-connected (the pressure on the front side of the screen 55 is not transmitted to the first pressure port 40, but the pressure (atmospheric pressure) on the rear side of the screen 55 is transmitted to the first pressure port 40 and the second pressure port 41. ) Adjustable state and controllable,
The zero point adjusting means is characterized in that the zero point adjustment is executed based on the output value of the pressure sensor (pressure sensor 11) in the adjusted state.

Further, the means 19 is a respiratory function test device of the means 18.
A third path (tube 34) capable of transmitting pressure from the second path (differential pressure tube 31) to the first path (differential pressure tube 30) is provided.
Based on the operation of the control valve (valve V1 and valve V2, or three-way valve), the first path is opened and the third path is closed to control the inspectable state, and the first path is set to the inspectable state. It is characterized in that the adjusted state is set by setting the closed state and opening the third path.

Further, the means 20 is a respiratory function test device of the means 19.
A first control valve (valve V1) is provided on the resistor (screen 55) side of the first path (differential pressure tube 30) with respect to the connection portion with the third path (tube 34), and the third path (valve V1) is provided. A second control valve (valve V2) is provided in the path (tube 34).
The first control valve (valve V1) is opened, while the second control valve (valve V2) is closed to control the inspectable state, and the first control valve (valve V1) is moved. The second control valve (valve V2) is controlled to the adjusted state by opening the closed state.

Further, the means 21 is any of the respiratory function test devices selected from the means 17 to 20, and the zero point adjustment can be executed every reference cycle (RR1 to RR3) (RR1, RR2, RR3). , Zero point adjustment can be performed each time the induced respiratory cycle changes).

Further, the means 22 is any of the respiratory function test devices selected from the means 1 to 21, and is a test result regarding the temporal vital capacity (COPD staging according to% FEV1.0 and% FEV1.0). , Display the relationship with the test result regarding the maximum inspiratory volume or the preliminary expiratory volume (decrease rate of IC1, IC2, IC3 with respect to IC0, or increase rate of ERV1, ERV2, ERV3 with respect to ERV0, etc.). It is characterized by.

Further, the means 23 is any respiratory function testing device selected from the means 1 to 22.
COPD staging (stages I-IV) and test results regarding maximum inspiratory volume or preliminary expiratory volume (decrease rate of IC1, IC2, IC3 relative to IC0, or ERV1, ERV2, relative to ERV0, It is characterized by displaying the relationship (such as the rate of increase of ERV3).

Further, the means 24 is a respiratory function test device of the means 23, and is
COPD staging (stage I) based on maximum inspiratory volume or preliminary expiratory volume (decrease rate of IC1, IC2, IC3 relative to IC0, or increase rate of ERV1, ERV2, ERV3 relative to ERV0, etc.) ~ IV stage) is included in the stage classification determination means (CPU14).

According to the present invention, it is possible to make a subject breathe at a predetermined cycle.

FIG. 1 is a functional block diagram showing an example of a spirometer. FIG. 2 is an external perspective view showing an example of the main body of the spirometer. FIG. 3 is a diagram showing an example of a flow sensor included in the spirometer. FIG. 4 is a diagram showing an example of time transition of respiratory capacity. FIG. 5 is a diagram showing an example of the time transition of the respiratory capacity during continuous measurement. FIG. 6 is a diagram showing an example of a screen for setting the respiratory cycle to be induced. FIG. 7 is a diagram showing an example of display information for guiding the measured respiratory cycle to the set respiratory cycle. FIG. 8 is a flowchart showing an example of notification during continuous measurement. FIG. 9 is a diagram showing an example of the reduction rate of the maximum intake amount IC. FIG. 10 is a diagram showing an example of an increase rate of the expiratory position during hyperventilation. FIG. 11 is a diagram showing the relationship between the reduction rate of the maximum inspiratory volume IC and the% FEV1.0 and COPD staging. FIG. 12 is a diagram showing the average reduction rate of the maximum inspiratory volume IC for the subjects corresponding to each stage I to IV classification in COPD.

Hereinafter, the spirometer 100, which is an example of the respiratory function test device according to the present invention, will be described with reference to the drawings. In the following description, the respiratory flow rate may be referred to as "flow" and the respiratory capacity may be referred to as "volume".

[1-1. Configuration of spirometer 100]
FIG. 1 is a functional block diagram showing an example of the spirometer 100, and FIG. 2 is an external perspective view showing an example of the main body 10 of the spirometer 100. Further, FIG. 3 is a diagram showing an example of the flow sensor 50 and the pressure sensor 11 included in the spirometer 100.

As shown in FIGS. 1 and 2, the spirometer 100 includes a main body 10, a flow sensor 50, and the like. The main body 10 includes an operation key 17, a display 18, a printer 19, a speaker 20, a notification lamp 21, a pressure sensor 11, an A / D converter 12, a CPU 14, a ROM 13, a RAM 15, an RS232C connector 16, and the like.

The flow sensor 50 shown in FIG. 3 is detachably provided on the main body 10, and one end of the differential pressure tube 30 and the differential pressure tube 31 is connected. The other ends of the differential pressure tube 30 and the differential pressure tube 31 are connected to the first pressure port 40 and the second pressure port 41 of the pressure sensor 11 provided in the main body 10, respectively. The details of the configuration of the flow sensor 50 will be described later.

The operation keys 17 are assigned preset functions such as display of measurement item setting screens and measurement condition input screens, measurement start and measurement end, and the inspector presses down each key. Performs the corresponding function. The operation key 17 also includes a print key to be operated when printing out the data output to the display 18. Further, it is provided with 10 numerical keys 0 to 9 and direction keys (not shown) for setting measurement items, inputting measurement conditions, inputting subject information such as age and height, and the like. The display 18 may be configured by a touch panel type display so that measurement items can be set, measurement conditions can be input, subject information can be input, and the like by operating the display.

As shown in FIG. 2, the notification lamp 21 is composed of an intake lamp 22, a plateau lamp 23, and an exhalation lamp 24. As will be described later, during the period when the respiratory cycle is not induced, the inspiratory lamp 22 emits light while the subject is inhaling, and the exhaled lamp 24 emits light during exhalation. The plateau lamp 23 emits light in a state where the flow is reduced and is below a predetermined threshold value (a state in which the change in volume is close to zero) to notify the end of intake (the plateau during the emission of the intake lamp 22). (Light emission of the lamp 23) and notification of the end of exhalation (light emission of the plateau lamp 23 while the exhalation lamp 24 is emitting light) are performed. In the following description, the notification is performed by the light emission of the notification lamp 21 provided in the main body 10, but an image imitating the notification lamp 21 is displayed on the display 18, and the intake lamp 22, the plateau lamp 23, and the plateau lamp 23 are displayed. The image corresponding to the exhalation lamp 24 may be configured to emit light or blink.

The flow sensor 50 generates a differential pressure corresponding to the respiratory flow rate. As shown in FIG. 3, the flow sensor 50 includes a connection port 52 for connecting a filter and a mouthpiece (not shown). When the subject holds the handle 56 of the flow sensor 50 and breathes through the mouthpiece connected to the connection port 52, a differential pressure is generated in the flow sensor 50, and this differential pressure is the differential pressure tube. It is transmitted to the pressure sensor 11 in the main body 10 via the 30 and the differential pressure tube 31. As a result, the respiratory flow rate is measured, and the measured respiratory flow rate is integrated to measure the respiratory capacity such as vital capacity.

The pressure sensor 11 outputs an analog signal corresponding to the detected differential pressure. In this example, it is a semiconductor differential pressure sensor, a differential pressure detecting unit for detecting the differential pressure transmitted by the differential pressure tubes 30 and 31, and a voltage corresponding to the differential pressure detected by the differential pressure detecting unit. It is equipped with an output terminal for outputting.

The A / D converter 12 is for converting an analog signal into a digital signal. In this example, it is a semiconductor A / D converter, and an analog signal output from the output terminal of the pressure sensor 11 is converted into a digital signal that can be processed by the CPU 14 described later, and is output from the digital output terminal.

The CPU 14 controls the operation of each component to be connected by executing the measurement program stored in the ROM 13 with the RAM 15 as a work area, or receives a signal from each component to perform various processes. It is what you do. In this example, the process of calculating the respiratory flow rate such as the expiratory flow rate and the inspiratory flow rate is performed based on the digital signal which is the output from the A / D converter 12 and shows the value corresponding to the differential pressure. This calculation process is performed based on the relational expression between the differential pressure and the respiratory flow rate stored in advance. That is, the differential pressure is specified from the digital signal, and the specified differential pressure is input to the relational expression to calculate the respiratory flow rate. Further, in this example, the respiratory capacity (volume) is calculated by integrating the respiratory flow rate (flow). The flow signal and volume signal measured in this way are stored in the RAM 15, and when the measurement is completed, the measurement data stored in the RAM 15 is stored in the ROM 13. The measurement data stored in the ROM 13 can be displayed on the display 18.

The ROM 13, which is a non-volatile memory, stores the measurement data as described above, and also stores the measurement program for the respiratory function. In addition, voice data for guidance is also stored in the ROM 13, and this voice data is reproduced by the speaker 20. The display 18 is an LCD display, which is provided on the upper surface of the main body 10 and outputs predetermined data to the screen by performing output control from the CPU 14 via an LCD driver circuit (not shown). The printer 19 is, for example, a thermal printer, and print control is performed from the CPU 14 via the driver of the thermal head to visually output predetermined data on paper. For example, the printer 19 is displayed on the display 18. Print the existing data. The speaker 20 is a voice output means for urging the subject to exhale or inhale by voice guidance, and outputs voice based on voice data stored in ROM 13 in advance.

The RS232C connector 16 is a terminal for transmitting and receiving data via a device outside the spirometer such as a PC and a cable for RS232C. In this example, the interface with the external PC is an RS232C connector, but the interface is not limited to this and may be another interface.

[1-2. Configuration of flow sensor 50]
The flow sensor 50 will be described in detail with reference to FIG. A connection port 52 for connecting a filter or a mouthpiece is provided on the side surface of the flow sensor case 51 which is a housing of the flow sensor 50. A handle 56 for gripping the flow sensor case 51 is provided below the flow sensor case 51.

A screen 55 is arranged in the flow pipe 53 in the flow sensor case 51 as a resistor that causes respiratory resistance. The screen 55 is a mesh-like object and is arranged so as to restrict the flow of gas. When a gas flow occurs in the flow pipe 53, a differential pressure is generated before and after the screen 55. The pressure before and after the screen 55 is applied to the first pressure port 40 and the first pressure port 40 of the pressure sensor 11 via the differential pressure tube 30 and the differential pressure tube 31 connected to each of the pressure ports arranged before and after the screen 55. 2 It is configured to be transmitted to the pressure port 41. That is, the differential pressure tube 30 transmits the pressure in front of the screen 55 (on the connection port 52 side) to the first pressure port 40 of the pressure sensor, and the differential pressure tube 31 transmits the pressure behind the screen 55 to the second pressure of the pressure sensor. Communicate to port 41.

The differential pressure tubes 30 and 31 shown in FIG. 3 are from the tubes on the outer side of the main body (flow sensor 50 side) of the differential pressure tube connection ports 32 and 33 shown in FIG. 2 and from the differential pressure tube connection ports 32 and 33. Is also configured by connecting the tube on the inside of the main body (pressure sensor 11 side) via the differential pressure tube connection ports 32 and 33. The differential pressure tube connection ports 32 and 33 shown in FIG. 2 are located on the upstream side (flow pipe 53 side) of the valve V1 shown in FIG.

The pressure sensor 11 of the main body 10 measures the flow velocity of the gas flowing in the flow pipe 53, that is, the respiration flow rate by detecting the pressure difference transmitted to the first pressure port 40 and the second pressure port 41 of the pressure sensor. can do. This respiratory flow rate is also called the respiratory flow rate. The flow sensor of this type is a so-called differential pressure type, and in this example, since the screen 55 is a mesh-like object, it has no moving part, so that it is inexpensive and does not easily break down. .. The resistor arranged in the flow pipe 53 may have a movable portion. For example, a flexible valve may be arranged in the flow pipe to generate a differential pressure according to the flow before and after the valve by changing the shape of the valve according to the flow.

[1-3. Zero point adjustment]
As a calibration of the respiratory function test device, there is a zero point adjustment performed in order to eliminate a measurement error caused by an electrical change or a change in temperature and humidity that occurs in the pressure sensor 11. The zero point adjustment is an output value of the pressure sensor 11 when there is no difference in pressure transmitted to the first pressure port 40 and the second pressure port 41 of the pressure sensor 11 (the differential pressure becomes zero). This process defines (or the measured differential pressure calculated based on the output value) as the zero point of the respiratory flow rate, and is usually performed for each measurement. When performing zero point adjustment in a conventional respiratory function test device, it is necessary for the subject to remove the mouthpiece to block the exhalation and inspiration that flow into and out of the respiratory function test device so that the differential pressure is zero. be. That is, since the next test cannot be started while the zero point adjustment is being performed, it is impossible to continuously carry out the lung air volume fractionation test without interruption.

For example, in the conventional respiratory function test, when the vital capacity and the like are tested three times in a row, at least before the start of the first test, after the end of the first test, and before the start of the second test, and the second time. It is necessary to adjust the zero points between the end of the inspection and before the start of the third inspection. Specifically, the flow in the case of continuously inspecting the vital capacity and the like three times in a conventional respiratory function inspection device is as follows. First, the tester operates the test device to adjust the zero point, and then the subject wears the mouthpiece to perform the first test. After the first examination, the subject removes the mouthpiece, and the examiner operates the examination device to adjust the zero point. The subject then wears the mouthpiece and a second examination is performed. After the second examination is completed, the subject removes the mouthpiece, and the examiner operates the examination device to adjust the zero point. Then, the subject wears the mouthpiece and the third examination is performed.

On the other hand, the spirometer 100 of the present embodiment has a mechanism including valves V1 and V2 described below, and by controlling the mechanism, the zero point adjustment of the respiratory flow rate is performed without interrupting the inspection. It is a structure that can be done. Both valves V1 and V2 are composed of two-way solenoid valves.

As shown in FIG. 3, the differential pressure tube 30 is provided with a valve V1. By setting the valve V1 to "open", the front of the screen 55 (connection port 52 side) and the first pressure port 40 are pressure-connected, and the pressure in front of the screen 55 (connection port 52 side) is the first pressure. It is transmitted to the port 40. By closing the valve V1, the front of the screen 55 (connection port 52 side) and the first pressure port 40 are pressure-blocked, and the pressure in front of the screen 55 (connection port 52 side) is the first pressure. Not transmitted to port 40.

Further, a tube 34 connecting the differential pressure tube 30 and the differential pressure tube 31 is provided between the valve V1 and the first pressure port 40 in the differential pressure tube 30, and the valve V2 is further provided in the tube 34. Has been done. By opening the valve V2, the differential pressure tubes 30 and 31 are pressure-connected, and by closing the valve V2, the differential pressure tubes 30 and 31 are pressure-blocked.

At the time of a normal respiratory function test, the valve V1 is set to "open" and the valve V2 is set to "closed" so that the testable state is set. As a result, the pressure on the front side (connection port 52 side) of the screen 55 in the flow pipe 53 is transmitted to the first pressure port 40 of the pressure sensor 11 by the differential pressure tube 30, and is transmitted to the rear side (open to the atmosphere) of the screen 55. The pressure on the side) is transmitted to the second pressure port 41 of the pressure sensor 11 by the differential pressure tube 31.

When adjusting the zero point on the spirometer 100, the valve V1 is set to "closed" and the valve V2 is set to "open". As a result, the front side of the screen 55 in the flow pipe 53 is pressure-blocked from the first pressure port 40, and the rear side of the screen 55 is pressure sensor 11 via both the differential pressure tube 31 and the differential pressure tube 30. It is pressure-connected to the second pressure port 41 and the first pressure port 40 of the above. That is, even when the subject is breathing while holding the mouthpiece, the pressure transmitted to the first pressure port 40 and the second pressure port 41 of the pressure sensor 11 via the differential pressure tube 30 and the differential pressure tube 31. It is possible to make a state in which there is no difference between the two. Therefore, the subject can adjust the zero point without removing the mouthpiece.

The opening and closing of the valves V1 and V2 and the execution of the zero point adjustment process are controlled by the signals output from the CPU 14. Specifically, for example, the zero point adjustment is automatically executed at the timing before the start of one measurement such as the vital capacity, and the examination is started after the completion of the zero point adjustment. Alternatively, the zero point adjustment is automatically executed at the timing after the completion of one measurement, and the next inspection is started after the completion of the zero point adjustment. The inspection operator operates a predetermined operation key 17 (for example, a dedicated key for executing the zero point adjustment, a start key for starting the inspection, an end key for ending the inspection, or the like). Depending on what has been done, the zero point adjustment process may be executed.

In the flow pipe 53, the mouthpiece of the subject is connected to the front opening side (connection port 52 side) of the screen 55, while the rear opening side (opposite side to the connection port 52) of the screen 55 is the atmosphere. It is open to the public. Therefore, in the flow pipe 53, the rear side of the screen 55 is less affected by the subject's respiration at the time of zero point adjustment than the front side of the screen 55. Therefore, the pressure transmitted to the first pressure port 40 and the second pressure port 41 of the differential pressure sensor 11 via the differential pressure tube 31 and the differential pressure tube 30 at the time of zero point adjustment is on the front side of the screen 55 (connection port 52). It is preferable to use the pressure on the rear side of the screen 55 as described in the above example, instead of the pressure on the side).

In addition, in FIG. 3 and the above description, the mechanism which combined the two valves V1 and V2 which are two-way valves and the control thereof have been described, but instead of the valves V1 and V2, one three-way valve (Sangi valve) is used. It may be provided so that the same function can be realized. Regarding this three-way valve, the above-mentioned V1 and V2 may have an integrated function, allowing the transmission of pressure from the front side of the screen 55 to the first pressure port 40, while the differential pressure tube. From the inspectable state (for example, the state where the drive valve of the three-way valve blocks the connection port of the differential pressure tube 30 with the tube 34) and the front side of the screen 55 to block the transmission of pressure from the differential pressure tube 30 to the differential pressure tube 30. An adjusted state that blocks the transmission of pressure to the first pressure port 40 while allowing the transmission of pressure from the differential pressure tube 31 to the differential pressure tube 30 (for example, the drive valve of the three-way valve is the tube 34 in the differential pressure tube 30. It suffices if it is possible to switch between the state in which the upstream side (the front side of the screen 55) is closed from the connection port with and.

In the form shown in FIG. 3, a tube 34 for transmitting the pressure on the rear side (open to the atmosphere) of the screen 55 to the first pressure port 40 in the adjusted state is provided. Such a tube 34 It may be configured not to provide. For example, an opening hole (a hole for pressure-connecting the atmospheric side and the inside of the differential pressure tube 30) is formed in the differential pressure tube 30, the opening hole in the differential pressure tube 30 is closed, and the front of the screen 55 is formed. The first pressure port 40 is opened by opening the opening hole and closing the upstream side (front side of the screen 55) of the opening hole in the first connection state that allows the transmission of pressure from the side to the first pressure port 40. The configuration is such that it can be switched to the first open state, which is pressure-connected to the atmosphere side through the open hole.

Similarly, an opening hole (a hole for pressure-connecting the atmospheric side and the inside of the differential pressure tube 31) is formed in the differential pressure tube 31, and the opening hole in the differential pressure tube 31 is closed and the screen 55 is closed. The second pressure port 41 is in a second connection state that allows pressure to be transmitted from the rear side to the second pressure port 41, and by opening the opening hole and closing the upstream side (rear side of the screen 55) of the opening hole. Is configured to be switchable to the second open state, which is pressure-connected to the atmosphere side through the open hole. In such a configuration in which the tube 34 is not provided, the differential pressure tubes 30 and 31 can be controlled to be in the inspectable state by setting them in the first connection state and the second connection state, respectively, and the first open state and the second are available, respectively. It can be controlled to the adjusted state by setting it to the open state.

[2-1. Volume signal]
Next, the procedure for measuring the respiratory capacity measured by the spirometer 100 (CPU14 or the like) and the measurement contents of the respiratory function test will be described with reference to FIG. When the subject grasps the flow sensor 50 and breathes (expiration and inspiration) with a mouthpiece (not shown) attached to the connection port 52 of the flow sensor 50 in the mouth, the respiration measuring means (flow sensor 50) is performed. , Differential pressure tubes 30 and 31, pressure sensor 11, A / D converter 12, CPU14, etc.) to measure the respiratory flow rate (flow), and further measure the respiratory capacity (volume) as an integrated value of the respiratory flow rate. The time-series data of the respiratory flow rate measured here is accumulated in the RAM 15, and for example, as shown in FIG. 4, a curve (X-axis) is time and vertical axis (Y-axis) is respiratory capacity (as shown in FIG. 4). Hereinafter referred to as a volume curve) is displayed on the display 18.

FIG. 4 is an example of the time transition of the respiratory capacity when the maximum inspiratory volume (IC) and the vital capacity (VC) are measured. Generally, in these respiratory function tests, the subject is first made to take a resting breath for a predetermined time, the resting ventilation measurement is performed, and then the IC and VC measurements are performed as the main test. Further, in this test, the preliminary expiratory volume (ERV) may be calculated from the difference between the vital capacity (VC) and the maximum inspiratory volume (IC). Further, instead of the vital capacity (VC), the forced vital capacity (FVC) may be measured by making a sudden call from the maximum inspiratory position.

In the resting ventilation measurement, the resting inspiratory position and the resting expiratory position are measured, and then the maximum inspiratory position and the maximum expiratory position are measured in this test. Here, the resting inspiratory position is the volume in the state of inhaling during resting breathing, and the resting expiratory position is the volume of the state of exhaling during resting breathing. The maximum inspiratory position is the volume in the state of inhaling as much as possible, and the maximum expiratory position is the volume in the state of exhaling as much as possible.

Each inspiratory position and each expiratory position is specified by the CPU 14. As a method of specifying the maximum inspiratory position and the maximum expiratory position, for example, the time when the time derivative value of the volume signal changes from positive to negative (the time when the volume signal changes from increasing to decreasing) is specified, and the measurement at that time is performed. The data is specified as the peak of inspiration during the respiratory cycle. Similarly, the time at which the time derivative of the volume signal changes from negative to positive is specified and specified as the peak of exhalation in the respiratory cycle.

Further, the maximum inspiratory position and the maximum expiratory position may be specified by determining whether or not the respiratory flow rate (flow) is equal to or less than a predetermined value. This is a method that utilizes the characteristic that the respiratory flow rate becomes almost zero at the maximum expiratory point or the maximum inspiratory point when a person performs maximum expiratory or maximum inspiratory with maximum effort. That is, when the subject performs maximum exhalation, the flow rate of exhaled breath gradually decreases and becomes almost zero at the maximum exhalation position, and when performing maximum inspiration, the flow rate of inhaled breath gradually decreases and maximum inspiration. It becomes almost zero in the place. Therefore, if the absolute value of the respiratory flow rate is less than or equal to the predetermined value set near zero, or if the change in the time integral value (volume) of the respiratory flow rate is less than or equal to the predetermined value set near zero, the maximum is possible. It can be determined that exhalation or inspiration was performed by the effort of.

[2-2. Continuous inspection]
Next, the continuous inspection by the spirometer 100 of the present embodiment will be described with reference to FIGS. 5 to 8. The continuous examination described below is particularly effective as a means for examining dynamic pulmonary hyperinflation, but the present invention is not limited thereto. Since the function of the spirometer 100 is the same as that described with reference to FIGS. 1 to 4, the description of the overlapping portion will be omitted.

In the following description, as a notation indicating the respiratory rate, the respiratory rate per minute, that is, the respiratory cycle is referred to as RR (Respiratory Rate). For example, RR = 20 means 20 times per minute (3 seconds per breath), RR = 30 means 30 times per minute (2 seconds per breath), and RR = 40 means 40 times per minute. The respiration rate (1.5 seconds per respiration) is shown.

FIG. 5 is an example of the time transition of the respiratory capacity during the continuous examination described below. The volume curve with the horizontal axis (X-axis) as time and the vertical axis (Y-axis) as the respiratory capacity is displayed on the display 18 at any time during the examination and can be printed by the printer 19 after the examination is completed. Further, the measurement data is stored in the RAM 15 after the inspection is completed. FIG. 6 is an example of a screen for setting the respiratory cycle to be induced. FIG. 7 is an example of display information for guiding the respiratory cycle of the subject to the set respiratory cycle. FIG. 8 is a flowchart for explaining an example of the notification process by the voice output from the speaker 20 and the light by the notification lamp 21 and the processing performed by the CPU 14 during the continuous inspection.

The continuous inspection in this embodiment is composed of a basic inspection, a main inspection 1, a main inspection 2, and a main inspection 3, and as shown in FIG. 5, the basic inspection, the main inspection 1, the main inspection 2, and the main inspection 3 are in this order. , It is performed continuously without interruption. The basic examination consists of a rest ventilation measurement followed by a basic measurement. The tests 1 to 3 consist of ventilation measurements during the first to third respirations and subsequent first to third measurements, respectively. The first to third respirations are hyperventilations that the subject is made to perform in a predetermined respiration cycle for a predetermined time. In the present embodiment, the respiration cycle is set to RR1 = 20 in the first respiration, RR2 = 30 in the second respiration, and RR3 = 40 in the third respiration, and the respiration time of the first to third respirations is 30 seconds each. Set to. Hereinafter, the continuous inspection will be described in chronological order with reference to FIGS. 5 to 8.

First, the examiner operates the operation key 17 to input subject information such as the subject's ID number, gender, age, height and weight. The input information is stored in the ROM 13 via the CPU 14. The subject information is used for comparing and referring to the standard value data of the respiratory function for each gender and age stored in the ROM 13 in advance and the measured value data of the subject.

Next, the tester operates the operation keys 17, 10 numerical keys 0 to 9 (not shown), and direction keys to set the test contents of the respiratory function test to be performed. Specifically, the contents of the continuous inspection include inspection items (IC, VC, etc.), basic inspection measurement items (rest ventilation measurement and subsequent basic measurement items), and main inspection measurement items (1st to 3rd respiration). Ventilation measurement at the time and subsequent items of the 1st to 3rd measurements), the number of times this test was performed (3 times in this case), and the number of times this test was performed (in this case, during the 1st to 3rd breaths) Enter each RR set value (RR1 = 20, RR2 = 30, RR3 = 40), each respiration time (in this case, all 30 seconds), and the like. In this way, the respiratory cycle to be the guidance target is set, and the order of induction in each respiratory cycle (in this case, the order of RR1 = 20, the second is RR2 = 30, and the last is RR3 = 40). Become).

Here, the measurement items are a resting inspiratory position, a resting expiratory position, a maximum inspiratory position, a maximum expiratory position, and the like. By inputting inspection items (IC, VC, ERV, etc.) or selecting from the menu, the inspection operator sets in advance so that the measurement items required for each inspection are automatically selected, simplifying the input work. It may be changed. The input information is stored in the RAM 15 via the CPU 14, and the CPU 14 controls the measurement and notification of the continuous inspection based on these setting information.

Further, when the number of times the main examination is performed is input by the operation key 17, as shown in FIG. 6, a screen for setting the respiratory cycle according to the set number of times the test is performed is displayed on the display 18. In this example, since 3 is set as the number of times the main test is performed, the respiratory cycle (RR1 to RR3) corresponding to each of the three main tests is input to the setting screen.

In this example, RR1 = 20 is input because the respiratory cycle is to be induced to 20 times / minute in the first main examination. In this case, one breathing cycle is 3.0 seconds. Further, since the time ratio between inspiration and expiration in one respiratory cycle is set to 1: 2, the subject is guided so that the inspiration period is 1.0 second and the expiration period is 2.0 seconds. Further, in the second main examination, since the respiratory cycle is to be induced to 30 times / minute, RR2 = 30 is input. In this case, one breathing cycle is 2.0 seconds. Further, since the time ratio between inspiration and expiration in one respiratory cycle is set to 1: 2, the subject is guided so that the inspiration period is 0.7 seconds and the expiration period is 1.3 seconds. Furthermore, in the third main examination, since the respiratory cycle is to be induced to 40 times / minute, RR3 = 40 is input. In this case, one breathing cycle is 1.5 seconds. Further, since the time ratio between inspiration and expiration in one respiratory cycle is set to 1: 2, the subject is guided so that the inspiration period is 0.5 seconds and the expiration period is 1.0 second.

In this way, it is assumed that the RR is gradually increased (the respiratory cycle is shortened) as the main examination progresses. The time ratio between the inspiratory period and the expiratory period is not limited to 1: 2 as in this example, but may be set to another time ratio such as 1: 3, and is set to a different time ratio for each main test. You may.

FIG. 7 is an example of an image displayed on the display 18 in order to guide the respiratory cycle of the subject to the set cycle. In this example, the character displayed on the screen waving a flag to alternately promote inspiration and expiration. Here, as shown in FIG. 7, the period during which inspiration is promoted by the character and the period during which exhalation is promoted are determined based on the respiratory cycle set in FIG. 6 and the time ratio between inspiration and exhalation. Further, during the period in which the character promotes inspiration, a first sound effect (which is a sound effect having a relatively high frequency) imitating the sound of a whistle is output from the speaker 20. Then, during the period in which the character promotes exhalation, a second sound effect (which is a sound effect having a relatively low frequency) imitating the sound of a whistle is output from the speaker 20.

As a result, the subject inhales in accordance with the character's inspiration guidance and the first sound effect, and exhales in accordance with the character's exhalation guidance and the second sound sound (according to this, the first effect). The actual breathing cycle of the subject is guided to the set breathing cycle (by switching between inspiration and expiration in accordance with the switching timing of the sound (high frequency) and the second sound effect (low frequency)). (Approaching), and the time ratio between inspiration and expiration of the subject is also guided (approaching) to the set time ratio.

Next, the flow of continuous measurement shown in FIG. 8 will be described. When the subject holds the mouthpiece in his mouth and breathes, the spirometer 100 detects the input of a signal, that is, the start of breathing of the subject by the output from the pressure sensor 11 (S10: point A in FIG. 5). The CPU 14 starts the measurement and notification control of the continuous examination, the voice "Please breathe comfortably" is output from the speaker 20, and the basic examination is started (S20).

(Basic inspection)
In the basic examination, first, the rest ventilation measurement is performed during the rest breathing for a predetermined time (for example, 30 seconds), the rest exhalation position, the rest inspiratory position, the expiratory time, the inspiratory time, etc. are measured, and the measurement data is accumulated in the RAM 15. NS. Hereinafter, in the measurement of each expiratory position and inspiratory position, the expiratory time and the inspiratory time are also measured at the same time, and the measurement data is processed by the CPU 14 at any time and stored in the RAM 15.

Following the rest ventilation measurement, the maximum inspiratory position and the maximum expiratory position are measured as basic measurements. The spirometer 100 outputs a voice "take a full breath" from the speaker 20 and urges the subject to inhale as much as possible. The CPU 14 specifies the time when the time derivative value of the volume signal changes from positive to negative, and specifies the measurement data at that time as the maximum intake position. Subsequently, a voice "Exhale to the end" is output to encourage the subject to exhale as much as possible (S30). The CPU 14 specifies the time when the time derivative of the volume signal changes from negative to positive, specifies it as the maximum expiratory position, and completes the basic measurement.

After the completion of the basic measurement, the CPU 14 calculates the maximum inspiratory volume IC0 after resting breathing from the difference between the resting expiratory position and the maximum inspiratory position (S40). Further, the vital capacity VC0 after resting breathing may be calculated from the difference between the maximum inspiratory position and the maximum expiratory position, or the preliminary expiratory volume ERV0 after resting breathing may be calculated from the difference between the vital capacity and the maximum inspiratory position. good.

In S20 and S30, not only the guidance of respiration by the image and voice displayed on the display 18 described above, but also the guidance by the light emission of the notification lamp 21 shown in FIG. 2 is performed at the same time. The notification lamp 21 is composed of an inspiratory lamp 22, a plateau lamp 23, and an exhaled lamp 24. The inspiratory lamp 22 emits light while the subject is inhaling, and the exhaled lamp 24 emits light during exhalation. The plateau lamp 23 emits light when the expiratory flow rate is equal to or less than a predetermined value (or when the change in the time integral value (volume) of the respiratory flow rate is equal to or less than a predetermined value).

Specifically, when the subject takes a resting breath, the inspiratory lamp 22 emits light during inspiration, and the exhalation lamp 24 emits light during exhalation (S20). Subsequently, when the maximum intake is performed, the intake lamp 22 emits light, and when the intake flow rate becomes equal to or less than a predetermined value (or when the change in the time integral value (volume) of the respiratory flow rate becomes equal to or less than a predetermined value), the plateau lamp 23 further emits light. It emits light. The subject confirms that both the inspiratory lamp 22 and the plateau lamp 23 are emitting light, and shifts to the maximum exhalation. When the subject makes a maximum call, the expiratory lamp 24 emits light, and when the expiratory flow rate falls below a predetermined value (or when the change in the time integral value (volume) of the respiratory flow rate falls below a predetermined value), the plateau lamp 23 further emits light. It emits light. The subject confirms that both the exhalation lamp 24 and the plateau lamp 23 are emitting light, and ends the call (S30).

Further, in the above description, the plateau lamp 23 is assumed to emit light when the expiratory flow rate or the inspiratory flow rate is equal to or less than a predetermined value (or when the change in the time integral value (volume) of the respiratory flow rate is equal to or less than a predetermined value). However, after the CPU 14 specifies the maximum expiratory position and the maximum inspiratory position based on the time differential value of the volume signal being equal to or less than a predetermined value, the plateau lamp 23 is made to emit light by outputting a light emission signal command. You may.

As described above, in the basic examination, the subject is allowed to perform resting breathing for a predetermined time, the resting expiratory position and the resting inspiratory position are measured as the resting ventilation measurement, and then the maximum inspiratory position and the maximum expiratory position are measured as the basic measurement. This is the same test as normal lung capacity measurement. The measurement data obtained in the basic inspection will be used as the reference data for the subsequent main inspections 1 to 3.

(Main inspection 1)
Subsequently, the main inspection 1 is continuously performed without interruption. In this test 1, the subject is made to breathe for 30 seconds in a respiratory cycle of RR1 = 20 as the first breath, and the first expiratory position is measured as the first respiratory ventilation measurement (S50: points B to C in FIG. 5). point). Subsequently, as the first measurement, the first maximum inspiratory position and the first maximum expiratory position are measured (S60: points C to D in FIG. 5). The maximum inspiratory volume IC1 after the first respiration is calculated from the difference between the first expiratory position and the first maximum expiratory position (S70). Further, the vital capacity VC1 after the first respiration is calculated from the difference between the first maximum inspiratory position and the first maximum expiratory position, and the preliminary expiratory volume after the first respiration is calculated from the difference between the vital capacity after the first respiration and the first maximum inspiratory position. ERV0 may be calculated.

Hereinafter, the main inspection 1 will be described in detail from S50 in chronological order. Following the calculation of the lung activity VC0 after resting breathing (S40), the spirometer 100 outputs a voice saying "Please breathe for 30 seconds according to the blinking of the lamp" from the speaker 20, and the inspiratory lamp 22 and the exhaled breath. The lamps 24 are alternately emitted to encourage the subject to repeat breathing in a respiratory cycle of RR1 = 20 (S50: point B in FIG. 5). Here, in the case of RR1 = 20, the inspiratory lamp 22 is based on the set time ratio of inspiration and expiration (for example, 1: 2) based on the length of each breath being 3 seconds. And the exhalation lamp 24 is made to emit light alternately. In this example, the light emission time of the intake lamp 22 is 1.0 second, and the light emission time of the exhalation lamp 24 is 2.0 seconds.

The subject inhales when the inspiratory lamp 22 emits light while visually observing the inspiratory lamp 22 and the exhaled lamp 24 which emit light alternately together with the image of the character displayed on the display 18, and when the exhaled lamp 24 emits light. The operation of exhaling is repeated for a predetermined time (30 seconds in this case). At this time, breathing is performed in accordance with the timing of the sound effect output from the speaker 20.

For 30 seconds during the first breath, as the first respiratory ventilation measurement, the first expiratory position corresponding to the resting expiratory position during resting breathing and the first inspiratory position corresponding to the resting inspiratory position during resting breathing are set for each breath. It is measured and the measured data is stored in the RAM 15.

(Respiratory cycle error notification)
During the first respiration (S50), the CPU 14 compares the subject's respiration cycle (measured RR) calculated based on the respiration flow (flow) with the set RR (RR1 = 20 in this case). When a deviation of a predetermined value or more (for example, a deviation of 5 or more) is detected, a respiratory cycle error notification is performed by voice output from the speaker 20. If the above deviation becomes larger than a predetermined value (for example, if a deviation of 10 or more occurs), or if the above deviation continues for a predetermined number of breaths (for example, 3 times) or more, the inspection is automatically stopped. , Set to notify that fact. By doing so, the next first measurement is performed only when the first respiration is appropriately performed in the set respiration cycle, and the reliability of the measurement data obtained in this test 1 is improved. The time per breath calculated based on the respiratory flow rate (flow) may be compared with the time per breath (3 seconds) according to the set RR1.

Further, a plurality of stages may be provided for the respiratory cycle error notification. In that case, as a first step, when the above deviation approaches a predetermined value, the subject is notified to adjust the respiratory cycle. Then, the subject adjusts the respiratory cycle according to the notification, and sets the error to be cleared when the subject returns to the predetermined respiratory cycle within the predetermined time or the number of breaths. As the second step, if the deviation becomes larger or if the respiratory cycle is not returned within the predetermined time or the number of breaths, the examination is automatically stopped and the notification is set to that effect. By doing so, it is possible to avoid redoing the examination, which is a burden on the subject, as much as possible.

Further, in the above description, the respiratory cycle error notification is performed by voice output, but the notification lamp 21 may emit light, a character message may be displayed on the display 18, or a combination of these may be used for notification. good. When the notification lamp 21 is used, it may be set to perform error notification by a method such as blinking the plateau lamp 23 which is not used during the first respiration or emitting light in a color different from the normal time.

Further, when the CPU 14 detects a deviation of a predetermined value or more (for example, a deviation of 10 or more) between the measured respiratory cycle and the set respiratory cycle, the subject is set. It may be difficult to breathe in the respiratory cycle (the respiratory cycle that is the guidance target). In such a case, the CPU 14 executes the respiratory cycle error notification, displays the respiratory cycle setting screen shown in FIG. 6 again, and displays the respiratory cycle currently set as the guidance target (for example, the value of RR1). You may be prompted to change.

The examiner re-enters the target respiratory cycle on the setting screen shown in FIG. 6 so that the burden is less than the current target respiratory cycle (so that the respiratory speed can be slowed down). The CPU 14 again guides the subject's breathing with the character image, the notification lamp 21, the sound effect output from the speaker 20, etc., with the changed breathing cycle as the guidance target. In this way, when it is determined that it is difficult for the subject to breathe in the respiratory cycle that is the induction target, the respiratory cycle that is the induction target may be changed during the measurement. ..

(Method of identifying the first expiratory position)
Next, a method for specifying the first expiratory position will be described. As shown in FIG. 5, the volume curve during the first breath is not parallel as in the rest breath, but gradually rises along the time series. That is, the first expiratory position and the first inspiratory position gradually move upward from the start time to the end time of the first respiration. This increase in the first expiratory position and the first inspiratory position is a phenomenon that occurs because the subject is made to breathe faster than the resting breath, so that the exhalation deficiency due to dynamic lung hyperinflation becomes prominent.

In order to calculate the maximum inspiratory position IC1, it is necessary to specify the first expiratory position in consideration of the above phenomenon. Therefore, in FIG. 5, the last expiratory position of the first respiration is used as the first expiratory position in the calculation of IC1. If the last expiratory position of the first breath becomes unstable, use the penultimate expiratory position. Alternatively, the average value of the expiratory positions of the last several times (for example, three times) of the first breath is set as the first expiratory position and used for the calculation of IC1.

After the end of the first respiration, the process proceeds to the first measurement (S60: point C in FIG. 5). Since the notification mode by the display 18, the speaker 20, and the notification lamp 21 at the time of the first measurement is the same as that at the time of the basic measurement, the description thereof will be omitted.

The spirometer 100 outputs a voice "take a full breath" from the speaker 20 and urges the subject to inhale as much as possible. As in the basic measurement, the CPU 14 specifies the first maximum intake position. Subsequently, a voice "Exhale to the end" is output to encourage the subject to exhale as much as possible (S60). Similar to the basic measurement, the CPU 14 identifies the first maximum expiratory position, and the main examination 1 is completed. In addition, in FIG. 5, there is a place where the volume curve is slightly lowered to the expiratory side after the last one of the first breaths is completed and before the first maximum inspiration is performed. Since it is the result of a reaction in which a subject who is conscious of "breathing a full chest" makes a slightly large exhalation in a conditioned reflex, it is ignored as measurement data.

Next, the CPU 14 calculates the difference between the specified first expiratory position and the first maximum inspiratory position measured by the first measurement as the maximum inspiratory amount IC1 after the first respiration (S70).

Following S70, the CPU 14 determines whether or not all the inspections have been completed. In this embodiment, since the inspector has set "the number of times of the main inspection is 3" before the start of the continuous inspection, the CPU 14 determines that all the inspections have not been completed (S80: No), and sets S50. Go back and move on to main inspection 2. At this time, the inspection item name IC1 is updated to IC2.

(Main inspection 2)
Subsequently, the main inspection 2 is continuously performed without interruption. The set value of RR is changed from RR1 = 20 to RR2 = 30. Since the processing is the same as that of the main inspection 1 except for the processing according to the set value of RR, the description of the common parts will be omitted.

In this test 2, the subject is made to breathe for 30 seconds at a speed of RR2 = 30 as the second breath, and the second expiratory position is measured as the second respiratory ventilation measurement (S50: from point D in FIG. 5). E point). Subsequently, as the second measurement, the second maximum inspiratory position and the second maximum expiratory position are measured (S60: points E to F in FIG. 5). Subsequently, the maximum inspiratory volume IC2 after the second respiration is calculated from the difference between the second expiratory position and the second maximum expiratory position (S70). Following S70, the CPU 14 determines that all the set inspections have not been completed (S80: No), and proceeds to the main inspection 3. At this time, the inspection item name IC2 is updated to IC3.

(Main inspection 3)
Subsequently, the main inspection 3 is continuously performed without interruption. The RR setting value is changed from RR2 = 30 to RR3 = 40. Since the processing is the same as that of the main inspection 1 and the main inspection 2 except for the processing according to the set value of the RR, the description of the common parts will be omitted.

In this test 3, the subject is made to breathe for 30 seconds at a speed of RR2 = 40 as the third breath, and the third expiratory position is measured (S50: points F to G in FIG. 5). Subsequently, as the third measurement, the third maximum inspiratory position and the third maximum expiratory position are measured (S60: points G to H in FIG. 5). Subsequently, IC3 is calculated from the difference between the third expiratory position and the third maximum expiratory position (S70). The CPU 14 determines that all the preset tests have been completed after the three main tests have been completed (S80: Yes), outputs a voice "The test will be completed" from the speaker 20, and the subject. Notifies the end of the inspection (S90).

(Change in hyperventilation time during continuous examination)
As described above, the hyperventilation rate to be performed by the subject was set on the spirometer 100 as the respiratory cycles RR1 to RR3 of the first breath to the third breath before the start of the basic test, and corresponded to each set value during the test. Notification is performed. Therefore, the basic examination, the main examination 1, the main examination 2, and the main examination 3 can be continuously performed without interruption due to the change in the setting of the hyperventilation rate.

(Zero point adjustment during continuous inspection)
As described in FIG. 3, the zero point adjustment in the spirometer 100 is performed with the subject holding the mouthpiece by controlling the opening and closing of the valves V1 and V2 shown in FIG. 3 by the CPU 14. Is possible. That is, the subject does not need to remove the mouthpiece from the time when breathing is started through the mouthpiece (S10: point A in FIG. 5) to the end of all examinations (S90: point H in FIG. 5). Therefore, the basic inspection, the main inspection 1, the main inspection 2, and the main inspection 3 can be continuously performed without interruption for the zero point adjustment.

The zero point adjustment in the continuous examination of FIG. 5 is performed by the control of the CPU 14, and the execution timing is when the subject's respiratory signal is detected (point A in FIG. 5), before the start of main examination 1 (point B in FIG. 5), and the present. Before the start of inspection 2 (point D in FIG. 5) and before the start of main inspection 3 (point F in FIG. 5). Specifically, the period before the start of the main test 1 is the period from the measurement of the maximum expiratory position of the basic measurement to the start of the first respiration, and the period before the start of the main test 2 is the period from the measurement of the first maximum expiratory position of the first measurement to the first. 2 The period until the start of respiration is shown as the period from before the start of this test 3 to after the second maximum expiratory position measurement of the second measurement to the start of the third respiration. Further, if necessary, it may be further carried out before the first to third measurements (points C, E, and G in FIG. 5).

In S30 or S60, after detecting the end of measurement of each maximum expiratory position, the CPU 14 continuously controls valves V1 and V2 to adjust the zero point. Since the time required for the zero point adjustment is about 2 seconds, the subject can start the first to third respirations according to the notification from the next respiration after the maximum exhalation (S50). The zero point adjustment corresponding to this inspection 1-3 is automatically executed, but the present invention is not limited to this, and the zero point adjustment may be executed according to the operation of the operation key 17. good.

As described above, regarding the hyperbreathing cycle, the first respiration is set to RR1 = 20, the second respiration is set to RR2 = 30, and the third respiration is set to RR3 = 40, before the maximum inspiratory position and the maximum expiratory position are measured. The subject is guided to breathe gradually faster.

In FIG. 5, the maximum inspiratory volume IC in each test is IC0 (basic test), IC1 (main test 1), IC2 (main test 2), IC3 (main test 3), and the vital capacity VC is VC0 (basic test). The volumes of VC1 (main inspection 1), VC2 (main inspection 2), and VC3 (main inspection 3) are shown by solid lines with arrows at both ends. Here, the value of IC decreases in the order of IC0, IC1, IC2, and IC3. This is a phenomenon that becomes apparent when the subject is made to perform the first to third respirations before each IC measurement, and the greater the degree of dynamic lung hyperinflation of the subject, the greater the degree of IC decrease.

Further, in FIG. 5, the preliminary expiratory volume ERV in each test is shown as ERV0 (basic test), ERV1 (main test 1), ERV2 (main test 2), and ERV3 (main test 3), and ERV0 is used as a reference (100). %), The sizes of ERV1, ERV2, and ERV3 are shown by images of balloons. This makes it easier for the tester to grasp how the gas remaining in the lungs of the subject increases (the subject gradually becomes unable to exhale) each time the test is repeated.

In each test, the forced vital capacity (FVC) may be measured instead of the vital capacity (VC). That is, in the basic examination and the main examinations 1 to 3, by having the subject make a quick call from the maximum inspiratory position, FVC0 (basic examination), FVC1 (main examination 1), FVC2 (main examination 2), FVC3 (main inspection 3) may be measured.

In the above description, the inspector sets the inspection contents before the start of the continuous inspection, and after the start of the continuous inspection, the continuous inspection automatically proceeds under the control of the CPU 14, but the present invention is limited to this. Instead, the continuous inspection may be performed by operating the operation key 17 of the inspector. Specifically, the start of the first to third breaths, the basal measurement, and the start of the first to third measurements are started by the examiner pressing the start key assigned to the operation key 17. Alternatively, the end of the first to third breaths, the basal measurement, and the end of the first to third measurements are terminated by the examiner pressing the end key assigned to the operation key 17.

Further, each respiratory cycle and order set before the start of the continuous examination may be changed by displaying the setting screen (FIG. 6) before each main examination and operating the operation key 17 of the examiner. Further, before the start of the continuous examination, the continuous examination is started without setting each respiratory cycle and order, and the setting screen (FIG. 6) is displayed before each main examination, and the operation key 17 of the examiner is displayed. The respiratory cycle in this test may be set by the operation of.

Further, the CPU 14 starts a continuous inspection based on each predetermined respiratory cycle and order (initial setting) regardless of the setting operation, and the inspection performer displays a setting screen (FIG. 6) as necessary. , Each respiratory cycle and order may be arbitrarily changed by operating the operation key 17. In this way, by making it possible to set or change the respiratory cycle as the guidance target after the start of the continuous examination, it is possible to perform the measurement in consideration of the condition of the subject.

(Action and effect)
As described above, in order to investigate the state of dynamic pulmonary hyperinflation in subjects with COPD disease in detail, a pulmonary air volume fractionation test consisting of ventilation measurement during hyperventilation and subsequent maximum inspiratory position measurement is performed. , A method of continuously changing the hyperventilation rate is effective. However, in the prior art as shown in Non-Patent Document 1, it is necessary to change the cycle setting of the metronome according to the hyperventilation rate to be performed next by the subject after the completion of one lung air volume fractionation test. .. While the tester is changing the metronome settings, the next test cannot be started, so the above-mentioned lung air volume fractionation test cannot be performed continuously.

Specifically, when a conventional respiratory function test device is used, the test is interrupted after the main test 1 and the main test 2 due to the setting of the metronome and the zero point adjustment. The subject's breathing gradually approaches resting breathing over time during the interruption, and returns to complete resting breathing as the interruption time increases. The interruption time depends on the time required for setting the metronome and adjusting the zero point, and these also depend on the work proficiency of the inspector, so the time from suspending the inspection to restarting the inspection is not constant. Therefore, the respiratory state (degree of deviation from resting breathing) of the subject at the time of resuming the test is not constant, and as a result, the reliability of the measurement data obtained by the test is low.

On the other hand, in the spirometer 100 of the present embodiment, since it is not necessary to set the metronome and it is not necessary to interrupt the examination for zero point adjustment, the conventional respiratory examination apparatus as described above is used. This problem is avoided and it is possible to obtain highly reliable measurement data.

In addition, in the above-mentioned lung air volume fractionation test, since it is necessary to have the subject perform hyperventilation at a predetermined cycle and then perform maximum inspiration, the subject is required as compared with a normal respiratory function test. The procedure of breathing movements to be performed increases. However, the conventional respiratory function test device is provided with a notification function for inducing the above-mentioned lung air volume fractionation test and a notification function for prompting the above-mentioned lung air volume fractionation test to be continuously performed. Therefore, it is difficult for the subject to perform the respiratory movement according to the procedure.

In addition, when using a conventional respiratory function test device, the tester confirms whether the subject is hyperventilating according to the movement of the metronome, measures the hyperventilation time, adjusts the zero point, and informs the subject. Since it is necessary to perform guidance by calling out at the time of measurement, the work load increases as compared with a normal respiratory function test.

On the other hand, in the spirometer 100 of the present embodiment, the subject can easily perform the breathing operation according to the examination procedure by the notification by the voice during the examination and the light emission of the lamp. At the same time, the tester does not need to set the metronome, adjust the zero point, and guide the respiratory movement by calling the subject in detail, which greatly reduces the work load.

(IC reduction rate)
FIG. 9 is an example in which the degree of decrease of IC0 to IC3 is graphed for each subject A to C using the measurement data obtained as a result of the continuous examination shown in FIG. The vertical axis (Y-axis) is the IC reduction rate with reference to IC0 (0%). The degree of COPD symptoms of the subject was mild in subject A, moderate in subject B, and severe in subject C. In FIG. 8 and the following description, the reduction rate of the IC based on IC0 is calculated, but the standard may be appropriately set by the inspector. For example, the reduction rate of the IC based on IC1 may be set. It may be used as an index.

As shown in FIG. 9, the reduction rate based on IC0 increases in the order of subjects A, B, and C according to the degree of COPD symptoms. In subject C with severe symptoms, IC3 is reduced by about 60% compared to IC0. On the other hand, in the case of subject B with moderate symptoms, IC3 decreased by about 20% as compared with IC0, and in the case of subject A with mild symptoms, the decrease was only 10% or less.

The dotted line shown as subject C'in FIG. 9 is the result of performing the same continuous examination after subject C was treated with medication or the like. IC3 is reduced by about 40% as compared with IC0, and it can be seen that the symptoms are improved as compared with before the treatment.

Regarding the graphs of FIG. 9 and FIG. 10 described later, the measurement result curves of each subject are provided as a three-dimensional graph in which the Z axis, which is the time axis, is further provided in addition to the X axis related to the measurement item and the Y axis related to the measurement result. It may be possible to easily grasp how the is changing in time series. This makes it easy to understand how the measurement result curve of a specific subject changes before and after treatment or medication.

(Rate of exhaled breath increase during hyperventilation)
From the measurement data obtained as a result of the continuous examination shown in FIG. 5, it is also possible to analyze the degree of dynamic lung hyperinflation of the subject using an index other than IC. As an example, FIG. 10 is a graph obtained by calculating the rate of increase in the expiratory position during the first to third respirations and graphing it as an index of dynamic pulmonary hyperinflation. The vertical axis (Y-axis) of FIG. 10 is the rate of increase in the expiratory position in each of the first and last breaths of the first to third breaths. Similar to FIG. 9, the degree of COPD symptom is mild in subject A, moderate in subject B, and severe in subject C.

As shown in FIG. 10, the rate of increase in the expiratory position during the first to third respirations is higher in subjects with severe COPD symptoms. In subject C with severe symptoms, the expiratory position increased by about 20% in the first and last breaths of the first breath, and the first and last breaths of the third breath. In, the expiratory position has risen by 50% or more. On the other hand, in the case of subject B with moderate symptoms, the rate of increase in the expiratory position during the third respiration is about 25%, and in the case of subject A with mild symptoms, the rate of increase in the expiratory position during the third respiration is about 25%. Is about 10%.

(Slope of volume curve during hyperventilation)
It is also possible to use the degree of inclination of the volume curve during the first to third respirations shown in FIG. 5 as an index of dynamic lung hyperinflation. For example, the degree of inclination of the volume curve during the first to third respirations is indexed by linear approximation, curve approximation, or logarithmic approximation of the data consisting of the expiratory positions of each respiration during the first to third respirations. Further, when indexing, the inspiratory position and the center value of the amplitude may be extracted instead of the expiratory position, or a combination thereof may be used. By carrying out continuous examinations using the spirometer 100, it is possible to quantify and quantitatively analyze the degree of dynamic lung hyperinflation in this way.

It is also possible to use data other than those described above as an index. For example, the tidal volume during rest breathing (difference between resting expiratory position and resting inspiratory position) and the tidal volume during the first to third breaths (first to third expiratory positions and first to third inspiratory positions). It is also possible to compare using the difference in rank) as an index.

Further, in the basic examinations and the first to third examinations described above, the measurement is performed in the order of the maximum inspiratory position and the maximum expiratory position, but this may be performed in the order of the maximum expiratory position and the maximum inspiratory position. Alternatively, the maximum expiratory position, the maximum inspiratory position, and the maximum expiratory position may be performed in this order. Alternatively, only the maximum inspiratory position required for calculating the maximum inspiratory volume IC may be measured, and the maximum expiratory position may not be measured.

Further, in the basic tests and the first to third tests described above, the maximum inspiratory position and the maximum expiratory position, which correspond to the normal measurement of vital capacity, are measured, but the present invention is not limited to this. For example, the above-mentioned forced vital capacity may be measured. In that case, the subject may be set to notify the subject to exhale from the maximum inspiratory position to the maximum expiratory position as quickly as possible.

(Relationship between forced expiratory volume in 1 second (FEV1.0) and maximum inspiratory volume (IC))
In the diagnosis of COPD, the staging is determined based on the forced expiratory volume in one second (FEV1.0) of the subject. The forced expiratory volume in one second (FEV1.0) is the amount of breath that can be exhaled in the first second when measuring the forced vital capacity (FVC). The forced expiratory volume in 1 second (FEV1.0%) is the ratio of the forced expiratory volume in 1 second (FEV1.0) to the forced vital capacity (FVC). When the forced expiratory volume in 1 second (FEV1.0%) is less than 70%, COPD is diagnosed. Furthermore, the stage of COPD is determined by the value of forced expiratory volume in 1 second (% FEV1.0), which is the ratio of the measured forced expiratory volume in 1 second (FEV1.0) to the standard value of forced expiratory volume in 1 second obtained from gender, age, and height. Classification is diagnosed.

FIG. 11 shows the forced forced vital capacity (FVC) obtained by measuring the forced vital capacity (FVC) after resting breathing for each subject, and the forced expiratory volume in 1 second (% FEV1.0), and the method separately shown in FIG. 5 described above. The relationship with the reduction rate of IC obtained by measuring IC0, IC1, IC2, and IC3 based on is shown.

As shown in FIG. 11, when the value of forced expiratory volume in 1 second (% FEV1.0) is 80% or more, it is diagnosed as stage I (mild airflow obstruction) of COPD staging. When the value of forced expiratory volume in 1 second (% FEV1.0) is 50% or more and less than 80%, it is diagnosed as stage II (moderate airflow obstruction) of COPD staging. When the value of forced expiratory volume in 1 second (% FEV1.0) is 30% or more and less than 50%, it is diagnosed as stage III (severe airflow obstruction) of COPD staging. If the forced expiratory volume in 1 second (% FEV1.0) is less than 30%, it is diagnosed as stage IV (extremely severe airflow obstruction) in the COPD staging.

In FIG. 11A, the horizontal axis (X-axis) is the reduction rate of IC1 with respect to IC0 [(IC1-IC0) × 100 / IC0], and the vertical axis (Y-axis) is the standard forced expiratory volume in 1 second (%). The relationship between the two when FEV1.0) is set is shown. As a result of obtaining an approximate straight line between X and Y at this time, Y = 0.4546X + 63.829, and the coefficient of determination R ² is 0.1153.

In FIG. 11B, the horizontal axis (X-axis) is the reduction rate of IC2 with respect to IC0 [(IC2-IC0) × 100 / IC0], and the vertical axis (Y-axis) is the standard forced expiratory volume in 1 second (%). The relationship between the two when FEV1.0) is set is shown. As a result of obtaining an approximate straight line between X and Y at this time, Y = 0.7006X + 72.532, and the coefficient of determination R ² is 0.3245.

In FIG. 11 (c), the horizontal axis (X-axis) is the reduction rate of IC3 with respect to IC0 [(IC3-IC0) × 100 / IC0], and the vertical axis (Y-axis) is the standard forced expiratory volume in 1 second (%). The relationship between the two when FEV1.0) is set is shown. As a result of obtaining an approximate straight line between X and Y at this time, Y = 0.7258X + 77.05, and the coefficient of determination R ² is 0.4261.

As shown in FIGS. 11 (a) to 11 (c), the reduction rate of IC (IC1, IC2, IC3) based on IC0 measured after resting breathing and the forced expiratory volume in 1 second used for COPD staging. The relationship with (% FEV1.0) gradually increases as the hyperventilation rate increases (the respiratory cycle becomes shorter) as the main test increases (main tests 1 to 3 shown in FIG. 5). Is designed to indicate. Therefore, the rate of decrease in IC based on IC0 can be used for the diagnosis of COPD. For example, based on the fact that the reduction rate of IC3 [(IC3-IC0) × 100 / IC0] based on IC0 is -60%, the COPD staging class is severe stage III (severe airflow obstruction). Alternatively, it can be estimated that there is a high possibility of stage IV (extremely high airflow blockage). In the measurement of forced vital capacity (FVC), the burden on the subject is heavy because it is necessary to make an effort from the maximum inspiratory position and make a call at once, but it is possible to estimate the staging of COPD to some extent without doing this. It becomes.

On the other hand, as shown in FIG. 11C, there are cases where the rate of decrease in IC3 is close to -40% even for subjects who fall under stage I in the COPD staging, and in the COPD staging. In some cases, the rate of decrease in IC3 is close to -60% even for subjects who fall under stage II. It can be said that the subjects who fall under these cases feel the same pain in daily life as the severely ill patients, even though the diagnosed staging is relatively mild. And, in daily life, since there is almost no case of making an effort from the maximum inspiratory position to make a sudden call, the maximum inspiratory volume (FEV1.0) that accompanies a change in respiratory rate is higher than the forced expiratory volume in one second (FEV1.0). From the viewpoint of QOL (Quolity of life), it can be said that the index showing the degree of decrease in IC) is more realistic.

Therefore, in order to investigate the state of dynamic lung hyperinflation in subjects with COPD disease in detail, not only tests related to time lung capacity (1 second dose, 2 seconds dose to 5 seconds dose, etc.) but also excess lung capacity It is effective to continuously perform lung volume fractionation tests, which consist of measurement of ventilation during respiration and subsequent measurement of maximum inspiratory position, by changing the hyperventilation rate.

FIG. 12 is a graph showing the average rate of decrease in IC for subjects corresponding to each stage classification (stage I to stage IV) of COPD. In this example, the rate of decrease of IC1 with respect to IC0 [(IC1-IC0) × 100 / IC0] is -0.04 on average for stage I subjects and average for stage II subjects. In the case of stage III subjects, the average is -16.09, and in the case of stage IV subjects, the average is -17.65. The rate of decrease of IC2 with respect to IC0 [(IC2-IC0) × 100 / IC0] is -4.37 on average for stage I subjects and-on average for stage II subjects. In the case of 17.46 and III stage subjects, the average is -29.58, and in the case of IV stage subjects, the average is -31.80. The rate of decrease of IC3 with respect to IC0 [(IC3-IC0) x 100 / IC0] is -4.65 on average for stage I subjects and-on average for stage II subjects. In the case of the subjects of stage 23.32 and III, the average was -36.33, and in the case of the subjects of stage IV, the average was -40.96.

Here, in the spirometer 100 of the present embodiment, the CPU 14 measures the forced expiratory volume in one second (FEV1.0) of the subject to calculate the forced expiratory volume in one second (% FEV1.0) of the subject, and the subject is in COPD. It is possible to determine whether or not there is, and in the case of COPD, it is possible to determine which stage classification (stage I to stage IV) it belongs to. Then, it is possible to display these determination results on the display 18. Further, the CPU 14 calculates the average reduction rate of ICs for subjects belonging to each stage classification in COPD, and displays the average reduction rate of ICs for each stage classification as a graph as shown in FIG. Is also possible.

As a result of calculating the reduction rate of IC for each subject belonging to each stage classification of COPD, the reduction rate of IC3 with respect to IC0 [(IC3-IC0) × 100 / IC0] is the total shown on the right side of FIG. It became a value. First, for the stage I subjects, the maximum was 28.75 and the minimum was -30.62 for 20 samples (the average value was -4.65). Further, the standard deviation σ based on the normal distribution was 18.13, the average value + 1σ was 13.48, and the average value -1σ was -22.78. Based on this result, the CPU 14 determines that if the rate of decrease of the IC3 with respect to the IC0 is less than 0 and is -22.78 or more, the possibility of the I period is high, and the display 18 indicates that fact. It is possible to display.

For stage II subjects, the maximum was 22.17 and the minimum was -57.52 for 70 samples (average value was -23.32). Further, the standard deviation σ based on the normal distribution was 15.26, the average value + 1σ was −8.06, and the average value -1σ was −38.57. Based on this result, the CPU 14 determines that if the rate of decrease of IC3 with respect to IC0 is −8.06 or less and −38.57 or more, the possibility of stage II is high, and this is determined. It can be displayed on the display 18.

For stage III subjects, the maximum was -9.02 and the minimum was -59.22 with respect to the number of samples 32 (average value was -36.33). Further, the standard deviation σ based on the normal distribution was 12.47, the average value + 1σ was -23.86, and the average value -1σ was −48.81. Based on this result, the CPU 14 determines that if the rate of decrease of IC3 with respect to IC0 is -23.86 or less and -48.81 or more, the possibility of stage III is high, and this is determined. It can be displayed on the display 18.

For stage IV subjects, the maximum was -20.87 and the minimum was -66.36 with respect to the number of samples 14 (average value: -40.96). Further, the standard deviation σ based on the normal distribution was 13.24, the average value + 1σ was −27.72, and the average value -1σ was −54.20. Based on this result, the CPU 14 determines that if the rate of decrease of IC3 with respect to IC0 is −27.72 or less and −54.20 or more, the possibility of stage IV is high, and this is determined. It can be displayed on the display 18.

In addition, other determination methods may be adopted for the staging of COPD. For example, in the CPU 14, based on the graph shown in FIG. 12, the reduction rate of the IC (any of IC1 to IC3, particularly IC3 is particularly preferable) with respect to IC0 is less than 0, and the average value in the I period (IC3). In the case of -4.65) or more, it is judged that the possibility of stage I is high, and it is less than the average value of stage I (-4.65 in the case of IC3) and the average value of stage II (IC3). In the case of -23.32) or more, it is judged that the possibility of stage II is high, and it is less than the average value of stage II (-23.32 in the case of IC3) and the average value of stage III (IC3). In the case of -36.33) or more, it is judged that the possibility of stage III is high, and if it is less than the average value of stage III (-36.33 in the case of IC3), the possibility of stage IV is possible. It may be determined that the sex is high.

In this way, it is possible to determine the staging of COPD based on the test result of the maximum inspiratory volume IC and display the determination result on the display 18. According to the results shown in FIG. 12, the measurement results when the pulmonary air volume fractionation test consisting of the ventilation measurement during hyperventilation and the subsequent maximum inspiratory position measurement were continuously performed with the hyperventilation rate changed. It is possible to determine the staging of COPD based on (IC1 to IC3, ERV1 to ERV3).

In the example of FIG. 11, the relationship between the decrease rate of IC (IC1, IC2, IC3) based on IC0 measured after resting breathing and the forced expiratory volume in 1 second (% FEV1.0) is shown. Not limited to this, the relationship between the rate of increase in ERV (ERV1, ERV2, ERV3) based on ERV0 measured after resting breathing and the forced expiratory volume in 1 second (% FEV1.0) is shown. Is also good. Specifically, (a) the horizontal axis (X-axis) is the rate of increase of ERV1 with respect to ERV0 [(ERV1-ERV0) × 100 / ERV0], and the vertical axis (Y-axis) is the standard forced expiratory volume in 1 second (Y-axis). A graph showing the relationship between the two when% FEV1.0) is created, and an approximate straight line between X and Y is obtained. Similarly, (b) the horizontal axis (X-axis) is the rate of increase of ERV2 with respect to ERV0 [(ERV2-ERV0) × 100 / ERV0], and the vertical axis (Y-axis) is the standard forced expiratory volume in 1 second (% FEV1). A graph showing the relationship between the two when .0) is set, and an approximate straight line between X and Y is obtained. Further, (c) the horizontal axis (X axis) is the rate of increase of ERV3 with respect to ERV0 [(ERV3-ERV0) × 100 / ERV0], and the vertical axis (Y axis) is the standard forced expiratory volume in 1 second (% FEV1. A graph showing the relationship between the two when 0) is created, and an approximate straight line between X and Y is obtained.

Further, in the example of FIG. 12, the reduction rate of IC for each stage classification (stage I to stage IV) is displayed on the display 18, but the preliminary expiratory volume for each stage classification (stage I to stage IV). The rate of increase in ERV may be displayed on the display 18. Specifically, the average value of the rate of increase of ERV1 with respect to ERV0 [(ERV1-ERV0) × 100 / ERV0] and the increase of ERV2 with respect to ERV0 for each stage classification (stage I to stage IV). The average value of the rate [(ERV2-ERV0) × 100 / ERV0] and the average value of the rate of increase of ERV3 with respect to ERV0 [(ERV3-ERV0) × 100 / ERV0] are calculated. Then, as in the case of IC, a graph regarding the rate of increase in ERV is created for each stage classification (stage I to stage IV) and displayed on the display 18. Further, as in the case of IC, the staging of COPD may be determined based on the measured rate of increase in ERV, and the determination result may be displayed on the display 18.

In the above explanation, the hyperventilation rate is set to RR1 = 20 for the first respiration, RR2 = 30 for the second respiration, and RR3 = 40 for the third respiration, and each RR is breathed for 30 seconds. The set value and breathing time are not limited to these. The resting RR varies depending on the age of the subject and the degree of COPD symptoms, and may be adjusted by the examiner in consideration of these factors. For example, in the case of a subject with mild symptoms, an IC test after breathing for 30 seconds at RR4 = 50 is further performed as the main test 4. On the contrary, in the case of a subject with severe symptoms, the main test 3 is not performed and the test is completed by the main test 2. Alternatively, the increase in RR is reduced and adjusted, such as RR1 = 20, RR2 = 25, and RR3 = 30. Further, the hyperventilation time may be adjusted to be shorter or longer than 30 seconds.

In the above description, the respiratory cycle of the subject is guided to the target cycle by each means of the information displayed on the display 18, the voice output from the speaker 20, and the light emission of the notification lamp 21. , Any one or two of these means may be used. Further, during the first to third breaths, character information that counts down the remaining time and the remaining number of breaths of each of the first to third breaths may be displayed on the display 18.

10 ... Main body 11 ... Pressure sensor 13 ... ROM
14 ... CPU
15 ... RAM
17 ... Operation keys 18 ... Display 20 ... Speaker 21 ... Notification lamp 50 ... Flow sensor 100 ... Spirometer

Claims (23)

A respiratory function testing device that tests the respiratory function of a subject.
Setting means that can set the reference cycle that is the guidance target of the respiratory cycle,
The guidance notification means for guiding the respiratory cycle of the subject to the reference cycle set by the setting means is included, and the guidance notification means is executed by at least one of the display means, the light emitting means, and the sound output means.
The setting means can set a plurality of different reference cycles, and can also set the order of performing guidance notification for each reference cycle.
The guidance notification means is a respiratory function testing device that executes guidance notification based on a reference cycle and an order set by the setting means. The respiratory function test device according to claim 1.
The guidance notification means is a respiratory function test device that shifts to the guidance notification of the next reference cycle based on the operation of the operation unit for starting the test of the respiratory function after the guidance notification of the predetermined reference cycle is completed. The respiratory function testing device according to claim 1 or 2.
The guidance notification means is a respiratory function test device that shifts to the guidance notification of the next reference cycle based on the completion of the inspection corresponding to the reference cycle after the guidance notification of the predetermined reference cycle is completed. A respiratory function testing device selected from claims 1 to 3.
When the guidance notification means executes guidance notification based on the reference cycle and order set by the setting means, the set reference cycle can be changed based on the change operation. .. A respiratory function testing device selected from claims 1 to 4.
A respiratory function test device including a test result display means for displaying test results for each reference cycle in a comparable manner. The respiratory function test device according to claim 5.
The test result display means is a respiratory function test device that displays test results based on at least one of the maximum inspiratory position and the maximum expiratory position inspected after the end of the guidance notification for each reference cycle. The respiratory function testing device according to claim 5 or 6.
The test result display means is a respiratory function test device that displays test results based on the forced vital capacity tested after the end of the guidance notification for each reference cycle. A respiratory function testing device selected from claims 5 to 7.
The test result display means is a respiratory function test device that displays test results based on the preliminary expiratory volume inspected after the end of guidance notification for each reference cycle. A respiratory function testing device selected from claims 5 to 8.
The test result display means is a respiratory function test device that displays an increase in at least one of the expiratory position and the inspiratory position during the guidance notification period or after the guidance notification ends for each reference cycle in a manner that can be grasped. A respiratory function testing device that tests the respiratory function of a subject.
Setting means that can set the reference cycle that is the guidance target of the respiratory cycle,
Guidance notification means for inducing the respiratory cycle of the subject to the reference cycle set by the setting means by at least one of the display means, the light emitting means, and the sound output means, and the guidance notification means.
Respiratory cycle measuring means for measuring the respiratory cycle of the subject,
The respiratory cycle measured by the respiratory cycle measuring means and the cycle determining means for determining whether or not the difference between the reference cycle of the executed guidance notification is within a predetermined range are included.
A respiratory function test device that gives a predetermined notification when it is determined by the cycle determination means that the difference is not within a predetermined range. The respiratory function test apparatus according to claim 10.
A respiratory function test device that discontinues the test when the cycle determination means determines that the difference is not within a predetermined range. A respiratory function testing device selected from claims 1 to 11.
The guidance notification is a respiratory function test device that indicates to a subject a period during which exhalation should be performed and a period during which inspiration should be performed. The respiratory function test apparatus according to claim 12.
A respiratory function test device capable of setting a period during which exhalation should be performed and a period during which inspiration should be performed in the guidance notification. A respiratory function testing device that tests the respiratory function of a subject.
Setting means that can set the reference cycle that is the guidance target of the respiratory cycle,
Including a guidance notification means for executing at least a guidance notification for guiding the respiratory cycle of the subject to the reference cycle set by the setting means by the light emitting means.
The light emitting means includes a first light emitting device and a second light emitting device.
During the period when the guidance notification is not performed, the first light emitting device is made to emit light when the subject's exhalation is detected, and the second light emitting device is made to emit light when the subject's inspiration is detected.
In the guidance notification, a respiratory function that causes the first light emitting device to emit light when prompting exhalation based on a set reference cycle, and causes the second light emitting device to emit light when prompting inspiration based on a set reference cycle. Inspection device. The respiratory function test apparatus according to claim 14.
The light emitting means includes a third light emitting device.
During the period when the guidance notification is not performed, the third light emitting device is made to emit light when the respiratory end of the subject is detected.
Respiratory cycle measuring means for measuring the respiratory cycle of the subject,
Further including a cycle determining means for determining whether or not the difference between the respiratory cycle measured by the respiratory cycle measuring means and the reference cycle of the executed guidance notification is within a predetermined range.
A respiratory function test device that causes the third light emitting device to emit light when it is determined by the respiratory cycle determining means that the difference is not within a predetermined range. It is a differential pressure type respiratory function tester that can inspect the respiratory flow rate based on the differential pressure before and after the resistor provided in the respiratory path.
Setting means that can set the reference cycle that is the guidance target of the respiratory cycle,
The guidance notification means for guiding the respiratory cycle of the subject to the reference cycle set by the setting means is included, and the guidance notification means is executed by at least one of the display means, the light emitting means, and the sound output means.
The differential pressure between the first pressure port connected to the front part of the breathing path on the side of the breathing port from the resistor and the second pressure port connected to the rear part on the side opposite to the front part of the breathing path. A pressure sensor for detection and
And zero point adjustment means for performing a zero-point adjustment on the basis of the output value of the pressure sensor, only including,
The zero point adjusting means includes the first pressure port and the first pressure port after the examination of the respiratory cycle of the subject corresponding to the first reference cycle is completed and before the examination of the respiratory cycle of the subject corresponding to the second reference cycle is started. 2 A respiratory function test device that performs the zero point adjustment by connecting to a pressure port in a pressure manner. The respiratory function test apparatus according to claim 16.
Wherein the first path capable of transmitting pressure from the front to the first pressure port, a second path capable of transmitting pressure to the second pressure port from said rear, but provided with at least,
An inspectable state in which the first pressure port and the front portion are pressure-connected and the first pressure port and the second pressure port are pressure-blocked, and the first pressure port and the front portion Is pressure-blocked and can be controlled to an adjusted state in which the first pressure port and the second pressure port are pressure-connected.
The zero point adjusting means is a respiratory function test device that executes zero point adjustment based on an output value of the pressure sensor in the adjusted state. The respiratory function test apparatus according to claim 17.
A third path capable of transmitting pressure from the second path to the first path is provided.
Based on the operation of the control valve, the first path is opened and the third path is closed to control the inspectable state, the first path is closed and the third path is open. A respiratory function test device that puts the adjusted state into the adjusted state. The respiratory function test apparatus according to claim 18.
A first control valve is provided on the resistor side of the first path with respect to the connection portion with the third path, and a second control valve is provided on the third path.
The first control valve is opened while the second control valve is closed to control the inspectable state, and the first control valve is closed while the second control valve is closed. A respiratory function test device that controls the adjusted state by setting it to the open state. Any respiratory function testing device selected from claims 16 to 19.
A respiratory function test device capable of performing the zero point adjustment every reference cycle. A respiratory function testing device that tests the respiratory function of a subject.
Setting means that can set the reference cycle that is the guidance target of the respiratory cycle,
Guidance notification means for inducing the respiratory cycle of the subject to the reference cycle set by the setting means by at least one of the display means, the light emitting means, and the sound output means, and the guidance notification means.
A measuring means for measuring the maximum inspiratory volume or preliminary expiratory volume of the subject after the guidance notification is executed includes.
A respiratory function test device that graphically displays the relationship between the time lung capacity of the subject and the measurement result regarding the maximum inspiratory volume or the preliminary expiratory volume of the subject. A respiratory function testing device that tests the respiratory function of a subject.
Setting means that can set the reference cycle that is the guidance target of the respiratory cycle,
Guidance notification means for inducing the respiratory cycle of the subject to the reference cycle set by the setting means by at least one of the display means, the light emitting means, and the sound output means, and the guidance notification means.
A measuring means for measuring the maximum inspiratory volume or preliminary expiratory volume of the subject after the guidance notification is executed includes.
A respiratory function test device that graphically displays the relationship between the staging of COPD and the measurement results regarding the maximum inspiratory volume or preliminary expiratory volume of the subject. The respiratory function test apparatus according to claim 22.
A respiratory function testing device including a staging determination means for determining the staging of COPD based on the maximum inspiratory volume or preliminary expiratory volume of the subject.

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