WO2004080303A1 - System for measuring respiration function and its application - Google Patents

Abstract

A system (10) for measuring the respiration waveform by means of a thoracic respiration measuring unit (100a) and an abdominal respiration measuring unit (100b). Each measuring unit (100) comprises a part (110) for sensing the volumetric variation at a measuring part, and a securing part (120) for arranging the sensing part (110) at the measuring part. The sensing part (110) senses the variation of pressures being applied from the securing part (120) and the measuring part. A control unit (200) controls measurement and acquires an output from the measuring unit (100). With such an arrangement, waveforms of thoracic respiration and abdominal respiration can be acquired independently. Waveforms thus acquired are analyzed by an analytic unit (300) and referred to an respiration function database (350) thus obtaining medical remarks concerning the respiration function of a subject.

Description

 Description Respiratory function measurement system and its application

 The present invention relates to a technique for measuring respiratory function, and more particularly, to a measurement system for measuring respiratory function, and a technique for analyzing a measurement result obtained by the measurement system. Background art

 The most basic test for respiratory function, spirometory, is a test method that directly measures the amount of air coming in and out of the mouth and records it over time. An intraoral manometer, also known as a respiratory muscle function test, also measures the expiratory and inspiratory pressure of a closed respiratory system directly orally. These respiratory tests are frequently performed because they are simple, accurate and highly reproducible.However, since they are measured through the mouth, they can be used in situations where the subject is moving, such as during sleep or exercise. It is not suitable for measurement or long-time continuous measurement.

On the other hand, 絰 measurement of intrathoracic pressure and lung compliance by esophageal balloon, turtle generated by breathing by placing a band-shaped coiled sensor on the chest and abdomen, R RIP respiratory inductive plethysmography that divides into ventilation Is an indirect respiratory function test that does not directly measure expiration and inspiration, unlike the aforementioned respiratory function test method. These respiratory tests have the disadvantage that the operation is complicated and the burden on the patient due to invasion is large. In addition, RIP is difficult to calibrate the ventilation volume, and the strip sensor may shift during the measurement, and it lacks quantitative and reproducibility. Even the measurement of the tidal volume at rest (Tidal Volume) measured after calibration using the flow volume curve is said to have an accuracy of about 10%. Non-invasive testing with high prevalence has not yet been established. Disclosure of the invention The present invention has been made in view of such a problem, and an object of the present invention is to provide a technique for realizing unrestricted respiratory function measurement with good reproducibility, capable of quantitative and continuous measurement. One embodiment of the invention relates to a measurement system. The measurement system is a measurement system for measuring a respiratory function, comprising: a first measurement unit for detecting a change in a first measurement site of a subject associated with a respiratory movement; A second measurement unit for detecting a change in the measurement unit, a control unit for obtaining outputs from the first measurement unit and the second measurement unit, and an analysis unit for analyzing the output obtained by the control unit And a first measurement unit and a second measurement unit, wherein the first measurement unit and the second measurement unit have a sensing unit for sensing a pressure change applied from the measurement site, a fixing unit for disposing the sensing unit on the measurement site, and hints it it, the surface area detection unit comes into contact with the measuring portion position is, 0. 5 0 mm ² or more 2. 0 mm ² you, wherein the less is o

Another embodiment of the present invention also relates to a measurement system. The measurement system is a measurement system for measuring a respiratory function, comprising: a first measurement unit for detecting a change in a first measurement site of a subject associated with a respiratory movement; and a second measurement unit of the subject associated with a respiratory movement. A second measurement unit for detecting a change in the measurement site, a control unit for obtaining outputs from the first measurement unit and the second measurement unit, and an analysis unit for analyzing the output obtained by the control unit. The first measurement unit and the second measurement unit each include: a sensing unit for sensing a pressure change applied from the measurement site; and a fixing unit for disposing the sensing unit at the measurement site. The sensing unit has a cavity therein, and the control unit includes an initial pressure adjusting unit for sending gas into the sensing unit to adjust the pressure to a predetermined initial pressure. Characterized in that it is adjusted to 1 0 c mH ₂ 0 or 3 0 c mH ₂ 0 or less.

The measurement system may further include a measurement control unit that specifies a suitable combination of the surface area of the sensing unit and the initial pressure as a measurement condition. The measurement control unit may further specify a frequency at which the analysis unit analyzes the measurement result. The frequency may be greater than or equal to 0.1 Hz and less than or equal to 1.0 Hz. These measurement conditions were determined by the present inventors. It was clarified by experiments. In the description of the experiment described later, these measurement conditions will be described in detail.

 Yet another embodiment of the present invention also relates to a measurement system. This measurement system is a measurement system for measuring a respiratory function, comprising: a first measurement unit for detecting a change in a first measurement unit of a subject accompanying a respiratory movement; (2) a second measurement unit for detecting a change in the measurement site, a control unit for obtaining outputs from the first and second measurement units, and an output obtained by the control unit. A first measuring unit and a second measuring unit, wherein the first measuring unit and the second measuring unit include a sensing unit for sensing a pressure change applied from the measurement site, and a fixing unit for disposing the sensing unit at the measurement site. The analysis unit includes an airway condition determination unit that determines a condition of a subject's airway stenosis or obstruction based on a measurement result at rest.

 The analysis unit may further include a respiratory muscle state determination unit that determines a state of a respiratory muscle of the subject. The respiratory muscle state determination unit may determine the state of the respiratory muscle based on the measurement result at rest. The airway condition determining unit or the respiratory muscle condition determining unit may further refer to the measurement result by spirometry. The following description of the embodiments clearly shows that the present measurement system has a simple and low-cost function that can accurately grasp the state of airway narrowing or obstruction and the state of respiratory muscles. become. Note that any combination of the above-described components and any conversion of the expression of the present invention between a method, an apparatus, a system, and the like are also effective as embodiments of the present invention. BRIEF DESCRIPTION OF THE FIGURES

 The above and other objects, features and advantages will become more apparent from the preferred embodiments described below and the accompanying drawings.

 FIG. 1 is a diagram showing a configuration of a measurement system according to an embodiment.

 2 (a) and 2 (b) are diagrams schematically showing the appearance of the measurement unit.

 FIG. 3 is a diagram showing a state in which a measurement unit is worn on a subject.

Figures 4 (a), (b) and (c) are cross-sectional views of the part where the measurement unit is mounted. O

 FIG. 5 is a diagram illustrating another example of the fixing unit.

 FIG. 6 is a diagram schematically showing the appearance of the control unit.

 FIG. 7 is a flow chart showing a procedure for measuring a respiratory function using the measurement system of the present embodiment.

 FIG. 8 is a flowchart showing a procedure for analyzing a respiratory function using the measurement system of the present embodiment. FIG. 9 is a diagram showing the individual and information of a subject who has performed a respiratory function test by the measurement system of the present embodiment.

 FIG. 10 is a diagram showing a temporal change in the internal pressure of the sensing unit when the lung volume fraction is measured using the healthy subject as a subject by the measurement system of the present embodiment.

 FIGS. 11 (a) and 11 (b) are diagrams showing measurement results of vital capacity of healthy subjects as subjects using the measurement system of the present embodiment and Spirome.

 FIGS. 12 (a) and 12 (b) are diagrams showing measurement results of the preliminary expiratory volume of healthy subjects as subjects using the measurement system of the present embodiment and Spirome.

 FIGS. 13 (a) and 13 (b) are diagrams showing measurement results of the preliminary inspiratory volume for healthy subjects as subjects using the measurement system of the present embodiment and Spirome.

 FIGS. 14 (a) and 14 (b) are diagrams showing measurement results of the maximum inspiratory volume of healthy subjects as subjects using the measurement system of the present embodiment and Spirome.

 FIGS. 15 (a) and 15 (b) are diagrams showing measurement results of tidal volume of healthy subjects as subjects using the measurement system of the present embodiment and Spirome.

 FIG. 16 is a diagram showing a change over time of the internal pressure of the sensing unit when the effort system call curve is measured using a healthy subject as a subject by the measurement system of the present embodiment.

 FIGS. 17 (a), (b) and (c) are diagrams showing a mouth-to-volume curve measured by a measurement system of the present embodiment with a healthy subject as a subject.

 FIGS. 18 (a) and 18 (b) are diagrams showing measurement results of forced vital capacity of healthy subjects as subjects using the measurement system of the present embodiment and Spirome.

FIGS. 19 (a) and (b) show the measurement system and Spirome overnight of this embodiment. FIG. 7 is a diagram showing a measurement result of a 1-second amount using a healthy person as a subject.

 FIGS. 20 (a) and 20 (b) are diagrams showing the results of measurement of the maximum expiratory flow rate of healthy subjects as subjects by the measurement system and Spirome overnight of the present embodiment.

 FIG. 21 is a diagram showing a temporal change in the internal pressure of the sensing unit when the resting ventilation is measured using a healthy person as a subject by the measurement system of the present embodiment.

 FIGS. 22 (a) and 22 (b) are diagrams showing measurement results of resting ventilation in healthy subjects as subjects using the measurement system of the present embodiment and Spirome overnight.

 FIGS. 23 (a) and 23 (b) are diagrams showing the results of measurement of tidal volume by using the measurement system of the present embodiment and Spirome overnight on healthy subjects.

 FIGS. 24 (a) and 24 (b) are diagrams showing measurement results between peaks of a waveform of a healthy person as a subject by the measurement system of the present embodiment and Spirome.

 FIG. 25 is a diagram showing the relationship between the chest data and the abdominal data when the resting ventilation is measured using the healthy subject as the subject by the measurement system of the present embodiment.

 FIG. 26 is a diagram showing the relationship between chest data and abdominal data when the effort system call curve is measured using the healthy subject as a subject by the measurement system of the present embodiment.

 FIGS. 27 (a) and 27 (b) are diagrams showing the results of measuring the vital capacity of a patient with a respiratory disease using the measurement system of the present embodiment and Spirome.

 FIGS. 28 (a) and 28 (b) are diagrams showing the results of measurement of the pre-expiratory volume for a patient with a respiratory disease using the measurement system of the present embodiment and Spirome overnight.

 FIGS. 29 (a) and 29 (b) are diagrams showing measurement results of the preliminary inspiratory volume for a patient with a respiratory disease using the measurement system of the present embodiment and Spirome.

 FIGS. 30 (a) and 30 (b) are diagrams showing measurement results of the maximum inspiratory volume of a respiratory disease patient as a subject by the measurement system of the present embodiment and Spirome.

 FIGS. 31 (a) and 31 (b) are diagrams showing measurement results of a tidal volume of a patient with a respiratory disease by the measurement system of the present embodiment and a spirometer.

FIGS. 32 (a) and 32 (b) are diagrams showing the results of measurement of forced vital capacity of a patient with a respiratory disease using the measurement system of the present embodiment and Spirome. Figures 33 (a) and (b) show the measurement system and Spirome overnight of this embodiment. FIG. 7 is a diagram showing the measurement results of the maximum expiratory flow rate for a patient with a respiratory disease. FIGS. 34 (a) and 34 (b) are diagrams showing measurement results of resting ventilation in a patient with a respiratory disease using the measurement system of the present embodiment and Spirome. FIGS. 35 (a) and 35 (b) are diagrams showing measurement results of a tidal volume of a respiratory disease patient as a subject by the measurement system of the present embodiment and Spirome.

 36 (a) and 36 (b) are diagrams showing measurement results between peaks of a waveform of a respiratory disease patient as a subject by the measurement system of the present embodiment and Spirome. FIG. 37 is a diagram showing a change over time of the internal pressure of the sensing unit when the effort call curve is measured using the measurement system of the present embodiment as a subject for a respiratory disease patient.

 FIG. 38 is a diagram showing a flow volume curve measured by the measurement system of the present embodiment using a patient with a respiratory disease as a subject.

 FIG. 39 is a diagram showing the relationship between the internal pressure rise value of the sensing unit and the maximum expiratory flow rate during forced exhalation.

 FIG. 40 is a diagram illustrating a configuration of an analysis server according to the embodiment and a terminal that accesses the analysis server.

 FIGS. 41 (a), (b), (c), (d), and (e) are diagrams showing examples of use of the rehabilitation assistance device according to the embodiment.

 FIG. 42 is a flowchart showing the procedure of the rehabilitation assistance method according to the embodiment.

 FIG. 43 is a diagram showing the relationship between the internal pressure rise value at the time of a forced call and the amount per second. FIG. 44 is a diagram for explaining pressure related to the pulmonary-thoracic system.

 FIG. 45 is a diagram illustrating a relationship between the surface area of the sensing unit and the measurement sensitivity. BEST MODE FOR CARRYING OUT THE INVENTION

The present inventors have found that the dynamics of the chest and abdominal wall depend on the activities of the intercostal and oblique muscle groups that control respiration and the diaphragm, and it is not possible to conduct a respiratory function test by observing these exercises. I thought. The following describes a technique for measuring the pressure applied from the chest and abdominal wall using a measurement unit arranged around the chest and abdominal wall to capture the dynamics of the chest and abdominal wall. Will be explained. Some of these techniques are disclosed in WO 02/069878 pamphlet filed by the present inventors.

 FIG. 1 is a configuration diagram of a measurement system 10 according to an embodiment of the present invention. The measurement system 100 mainly includes a measurement unit 100 for measuring a subject's respiratory condition and a control unit 200 including a control unit 200 for obtaining an output from the measurement unit 100. , And an analysis unit 300 for analyzing the output obtained by the control unit 200. In FIG. 1, a part of the configuration of the control unit 200 and the analysis unit 300 is realized by an arbitrary computer, a CPU, a memory, a program loaded in the memory, and the like in terms of hardware components. However, here we draw a functional block realized by their cooperation. Therefore, it will be understood by those skilled in the art that these functional blocks can be realized in various forms by hardware only, software only, or a combination thereof.

The measurement unit 100 is an example of a first measurement unit, a chest respiration measurement unit 100a 1 for measuring dynamic changes near the chest wall, and an abdominal wall as an example of a second measurement unit. Includes abdominal respiratory measurement unit 100b to measure nearby dynamic changes. The chest respiratory measurement unit 100a and the abdominal respiratory measurement unit 100b each sense a change in the dynamics of the measurement site by a change in the atmospheric pressure inside the sensing unit. Thereby, the measurement system 10 of the present embodiment can independently measure the data corresponding to the chest respiration and the data corresponding to the abdominal respiration. Moreover, it is a great advantage that data with good reproducibility and quantitatively high reliability can be obtained. 2A and 2B schematically show the appearance of the measurement unit 100. FIG. FIG. 2 (a) is a view of the measurement unit 100 seen from the side in contact with the body of the subject, and FIG. 2 (b) is a view seen from the back side. The measurement unit 100 is composed of a sensing unit 110 for sensing the pressure applied from the measurement site along with the subject's breathing motion, and a fixed unit 12 for disposing the sensing unit 110 near the measurement site. Including 0. The sensing unit 110 has a cavity therein and has a bag-like shape, and senses a pressure given from a measurement site by a change in atmospheric pressure inside the sensing unit. The sensing unit 110 includes, as an example of a first connection unit, A tube 114 for sending gas into the inside from the pressurizing pump 220 and a tube 112 for sending gas to the pressure gauge are provided as an example of the second connection portion. The sensing unit 110 is stored in a storage unit 116 provided in the fixed unit 120. The fixed part 120 has a band-like shape, and the sensing part 110 is arranged at the measurement site so as to be wound around the body of the subject. A material such as a soft cloth may be used for the fixing portion 120 so that the material can be easily wound around the body of the subject. In addition, a material with low elasticity such as canvas may be used so that the subject does not expand or contract significantly due to the breathing motion of the subject. The fixing portion 120 is provided with bonding portions 122a and 122b for bonding both ends when the fixing portion 120 is wound around the body of the subject. The bonding portions 122a and 122b may be hook-and-loop fasteners, fasteners, or the like.

 FIG. 3 shows a subject wearing a chest respiratory measurement unit 100a and an abdominal respiratory measurement unit 100b. The chest respiration measurement unit 100a is worn around the subject's rib cage. The abdominal respiratory measurement unit 100b is worn around the subject's diaphragm. When the measurement unit 100 is worn on the subject, the sensing unit 110 is first brought into close contact with the measurement site, and is fixed so as to be wrapped around the body of the subject at the fixing unit. At this time, since there is a case where there is a difference between left and right in the muscle strength of the respiratory muscle, the position of the sensing unit 110 may be determined in consideration of the subject's dominant arm. For example, the position where the sensing unit 110 is brought into close contact may be unified on the dominant arm side of the subject or on the opposite side. The position where the sensing unit 110 is brought into close contact may be unified with the left or right body of the subject. From the viewpoint of measurement sensitivity, it is preferable that the sensing unit 110 be disposed at a site where the dynamic change accompanying respiration is large. That is, the sensing unit 110 may be arranged around the nipple in the chest respiratory measurement unit 100a, and around the umbilicus in the abdominal respiratory measurement unit 100b.

FIGS. 4A, 4B and 4C show cross sections of a portion where the measuring unit 100 is mounted. FIG. 4 (a) shows a state in which gas is sent from the pressurizing pump 220 to the inside of the sensing unit 110 after the measurement unit 100 is mounted, and the initial pressurization is performed. Gas is introduced into the sensing unit 110, and a gap is created between the fixed unit 120 and the measurement site. Sucking In order to correctly measure the volume change of the measurement part during the inspiration, it is necessary to keep the sensor unit 110 under a certain pressure even during the maximum inhalation. Is going. Adjusting the initial pressurization value also has the significance of keeping measurement conditions constant. Fig. 4 (b) shows the situation when the subject inhales. When the subject inhales, the volume near the subject's thorax and diaphragm increases, so that the sensing unit 110 is compressed between the subject's torso and the fixed unit, and the internal pressure increases. Fig. 4 (c) shows the situation when the subject calls. When the subject calls, the volume near the subject's thorax and diaphragm decreases, so the gap between the subject's torso and the fixed part increases, and the air pressure inside the sensing unit 110 decreases. In this manner, the change in the dynamics of the chest and abdominal wall near the thorax and the diaphragm can be sensed from the change in the internal pressure of the sensing unit 110.

 When this measurement system is used as a rehabilitation assisting device, the sensing unit 110 functions as a pressurizing unit. That is, by introducing gas into the sensing unit 110 to increase the volume of the sensing unit 110, the body of the subject is pressed to apply a predetermined load. The subject performs rehabilitation by performing breathing under load. At this time, the measurement unit 100 may be mounted so that the sensing unit 110 presses the excretion site of the subject, and the rehabilitation may be performed by a squeezing technique.

FIG. 5 shows another example of the fixed part 120. In the example of FIG. 5, a hook 124 for inserting the other end is provided at one end of the fixed portion 120. Attach the other end of the hook to the hook at the time of mounting, pull it sufficiently, and fix it with the adhesive part. The bonding portion 122 may be a hook-and-loop fastener, a fastener, or the like. According to the measurement unit 100 shown in FIG. 5, even when the subject wears the measurement unit 100, the measurement unit 100 can be easily and appropriately fixed. FIGS. 2 to 5 show an example in which the fixed portion 120 has a band shape and the sensing portion 110 is fixed so as to be wound around the body of the subject. In the case of 0, it is sufficient that the sensor 110 can be fixed to the measurement site. The sensor 110 may be attached to the measurement site, or the sensor 110 may be located between the measurement site and the fixed unit 120. Form to sandwich It may be.

 Returning to FIG. 1, the description of the control unit 200 and the analysis unit 300 will be continued. The control unit 200 has an initial pressure adjustment unit 210, a pressure pump 220, a pressure gauge 230, a recording unit 240, a measurement control unit 250, an indicating unit 260, and a display unit 2. 70, a transfer section 280, and a condition input section 290.

 Before the measurement of the respiratory function, the initial pressure adjusting section 210 controls the pressurizing pump 220 to send gas into the sensing section 110 and adjust the pressure to a predetermined initial pressure. The initial pressure may be set within a range in which the ratio between the change in the volume of the measurement site and the change in the atmospheric pressure in the sensor 110 is substantially constant, or the change in the volume of the measurement site and the change in the sensor 110 may be set. May be set within a range in which the ratio of the change of the atmospheric pressure to the change in pressure changes linearly. If the initial pressure is too high, it may place a burden on the subject, and the respiratory condition may not be measured correctly.If the initial pressure is too low, the pressure change inside the sensor 110 will not follow the volume change of the measurement site. Could be. The initial pressure may be adjusted to a range in which a change in air pressure inside the sensing unit 110 can be appropriately converted into a change in volume at the measurement site or a volume at the time of breathing.

 The initial pressure adjusting unit 210 may adjust the initial pressure to be substantially constant for a plurality of measurements of the subject. As a result, the measurement conditions can be kept constant for multiple measurements on the same subject, and the measurement results can be quantitatively compared. The initial pressure adjusting unit 210 may adjust the initial pressure to be substantially constant for the measurement of a plurality of subjects. As a result, the measurement conditions can be kept constant for the measurement of a plurality of subjects, and the measurement results can be compared quantitatively. As described above, since the measurement can be performed under uniform conditions by the initial pressure adjusting unit 210, reliable data with high reproducibility can be obtained. The initial pressure may be determined based on the subject's sex, body fat percentage, chest girth, abdomen girth, medical history, vital capacity, or the size of the sensor 110.

After the initial pressure regulator 210 introduces gas into the sensor 110, measurement is performed while maintaining the amount of gas inside the sensor 110. This allows the conditions to be kept constant during the measurement. The sensing unit 110 may be provided with a valve to prevent the gas once introduced from flowing out. The pressure pump 220 sends gas so that the pressure inside the sensing unit 110 becomes a predetermined initial pressure. When this system is used as a rehabilitation assisting device, gas is sent into the sensing unit 110 by the pressurizing pump 220 until a predetermined load pressure is reached.

 A pressure gauge 230 as an example of a pressure sensor measures the air pressure inside the sensing unit 110. As the pressure gauge 230, any known pressure gauge or pressure sensor may be used. In the present embodiment, a pressure sensor that converts pressure into a voltage signal using a piezoresistive element is used.

 The recording unit 240 samples the measurement data measured by the pressure gauge 230 at a predetermined sampling frequency and records it as a respiration waveform data. The recording unit 240 may record the measurement data in a memory provided inside the control unit 200, or may record the measurement data in a storage medium such as a floppy disk, CD-ROM, or MO. Good. Further, the configuration may be such that the recording unit 240 is not provided, and the measurement data is directly transferred to the analysis unit 300. In the present embodiment, the voltage signal measured by the pressure gauge 230 is recorded in a memory provided inside the recording unit 240, and is transferred to the analysis unit 300 by the transfer unit 280. The voltage signal may be converted to a digital signal by an A / D converter as needed. Further, the voltage signal may be converted into a pressure value and then recorded, or may be converted into a gas volume or an air speed using a predetermined conversion formula and then recorded. The condition input unit 290 receives information on measurement conditions from a subject or a measurer. For example, the condition input section 290 contains the types of data to be measured, the subject's gender, age, height, weight, chest, abdomen, body fat percentage, history and other personal information, measurement date, number of measurements Information such as temperature, atmospheric pressure, and humidity may be accepted. These information may be recorded by the recording unit 240 in association with the measurement data as needed, or used for control in the measurement control unit 250 and analysis in the analysis unit 300. You may.

The measurement control unit 250 sets the initial pressure adjustment unit 210, pressurizing pump 220, recording unit 240, and indicator unit 260 to perform measurement according to the type of data to be measured. Control at least one of the The measurement control unit 250 receives the condition input unit 290 It may have a table for determining the content and procedure of measurement based on various conditions. For example, the gender of the subject and the initial pressure may be stored in a table in association with each other, or the type of data to be measured and the sampling frequency of the data at the time of recording may be stored in a table in association with each other. Is also good. The measurement may be controlled with reference to this table.

 In addition, a measurement procedure suitable for the type of data to be measured may be instructed to the subject via the instruction unit 260. At this time, the content of the instruction may be determined based on the measurement condition received by condition input unit 290. For example, when measuring the effort vital capacity FVC, in order for the subject to inhale until it reaches the maximum inspiratory position, monitor the measured value with a pressure gauge 230, and until the measured value stabilizes to a constant value. You may instruct, for example, "Keep inhaling until you can't breathe in." If you judge that the measured value has stabilized to a certain value, you may instruct, for example, "Exhale at a stretch." Thus, an appropriate measurement procedure may be instructed while observing the subject's respiratory condition. In order to perform an appropriate measurement, a standard respiratory waveform may be held, and the timing of issuing an instruction while comparing the respiratory waveform with the subject's respiratory waveform may be provided.

 When the present measurement system 10 is used as a rehabilitation assistance device, the measurement control unit 250 may control a rehabilitation program. The rehabilitation program may be held in advance by the measurement control unit 250 and selected based on the conditions received by the condition input unit 290, or may be selected by the condition input unit 290. A configuration in which a rehabilitation program can be input may be employed. At this time, the instruction unit 260 may instruct the patient on the rehabilitation procedure. For example, in the case of a patient who needs respiratory rehabilitation under pressure, pressure is increased to a predetermined pressure by a pressure pump 220, and rehabilitation is performed in which the patient breathes under pressure for a predetermined time.

The instruction unit 260 instructs the subject to perform an appropriate respiratory motion according to the type of data to be measured. The instruction unit 260 may output the instruction transmitted from the measurement control unit 250 to the subject, or the instruction unit 260 may determine a necessary instruction. The instruction may be output as visual information by the display unit 270 or a speaker. Any of them may be output as audio information.

 The display unit 270 displays information such as the value measured by the pressure gauge 230 and the type of data being measured. The display unit 270 may be used as an interface when receiving information from a measurer through the condition input unit 290.

 The transfer unit 280 transfers the measured data to the analysis unit 300. The transfer unit 280 may transfer the measurement data to the analysis unit 300 via a cable connecting the control unit, the software 200, and the analysis unit 300, or a telephone network. Alternatively, the transfer may be performed using a wired or wireless communication means such as a mobile phone network, the Internet, infrared rays, and radio waves. When the recording unit 240 records the data on the recording medium, the data is transferred to the analysis unit 300 by the recording medium, and the transfer unit 280 may not be provided.

 The analysis unit 300 includes a measurement data overnight acquisition section 310, an analysis section 320, a display section 340, and a respiratory function data pace 350. The measurement data acquisition unit 310 acquires data measured by the measurement unit 100 and the control unit 200. The analysis unit 320 is a waveform generation unit 322, a lung volume fraction calculation unit 324, an effort call curve analysis unit 326, a flow volume curve analysis unit 328, and an abdominal contribution ratio calculation unit 3. 29, Includes waveform characteristic extraction section 330, airway condition determination section 331, respiratory muscle state determination section 3333, and data pace inquiry section 3332. The analysis unit 300 may function as the analysis device 300 independently of the measurement device 50. The analysis unit 300 and the analysis device 300 may be realized by a general computer.

 The measurement data acquisition unit 310 acquires the measurement data from the control unit 200. The measurement data includes the chest data obtained by measuring the volume change near the rib cage and the abdominal data obtained by measuring the volume change near the diaphragm. These data may be represented by the atmospheric pressure inside the sensing unit 110, or may be converted into a change in volume of the measurement site or a volume at the time of breathing.

The waveform generation unit 3222 generates a respiratory waveform data from the measurement data acquired by the measurement data acquisition unit 3110. In this system, chest data obtained by measuring volume changes near the rib cage and abdominal data obtained by measuring volume changes near the diaphragm Then, a respiratory waveform data is generated. At this time, the chest data and the abdomen data may be weighted by a predetermined ratio to generate the respiratory waveform data. The weighting ratio may be determined according to, for example, the abdominal contribution rate, personal information such as the gender of the subject, and the history of the subject. When generating the respiratory waveform data, the waveform generating unit 3222 may remove extremely discrete data, for example, or may have affected the data by moving the subject during the measurement. Possible parts may be removed. The respiratory waveform curve may be smoothed by a spline function or Bezier function. If there is a difference between the peak positions of the chest and abdomen, the peak positions may be corrected to generate respiratory waveform data.

 The lung volume fraction calculating unit 324 as an example of the calculating unit calculates the lung volume fraction based on the respiratory waveform data generated by the waveform generating unit 322. The effort call curve analysis unit 326 as an example of the calculation unit calculates the effort vital capacity, the amount of one second, and the like based on the respiratory waveform data shaped by the waveform generation unit 322. The flow volume curve analyzer 328 as an example of the calculator calculates the maximum expiratory flow rate and the like based on the flow volume curve obtained by differentiating the effort breathing curve. The abdomen contribution ratio calculation unit 329 as an example of the calculation unit calculates the abdomen contribution ratio from the chest data and the abdomen data. Each value may be calculated from chest data, abdominal data, and respiratory waveform data. The detailed calculation method for each will be described in detail in Experiments 1 to 4.

 The waveform characteristic extraction unit 330 extracts characteristic portions of the waveform shape of the respiratory waveform data, chest data, and abdominal data. For example, the peak positions of the respiratory waveforms of the chest and abdominal data are shifted, the peaks of the flow-volume curve are flattened, and the flat part appears after the peak of the mouth-volume curve. Is also good. The waveform characteristic extraction unit 330 stores in advance the characteristics of the shape to be extracted, and determines whether the respiratory waveform data of the subject matches the characteristics to extract the characteristics of the waveform. You may.

The airway condition judging unit 331 judges the condition of airway stenosis or obstruction by referring to the respiratory waveform data, the effort respiratory curve, or the flow volume curve. Airway condition judgment The cutout 3 311 is located inside the sensor 110, which is worn near the subject's thorax or diaphragm when the subject starts exhaling When the waveform indicates that the air pressure of the subject has increased, it may be determined that the airway of the subject is narrowed or obstructed. In the case of a healthy individual without airway stenosis, a waveform in which the air pressure in the cavity decreases with exhalation is measured, but in the case of a patient with an obstructed airway, the airflow in the stenotic part during exhalation is limited. Also, it has been confirmed that the air pressure in the cavity, that is, the chest data or the abdominal data increases, due to factors such as abnormal respiratory muscle movement during exhalation. Such a phenomenon is characteristic of an asthmatic patient having a symptom of airway stenosis, and the airway condition determining unit 331 is not suspicious of airway stenosis for a subject showing such a measurement result. You may decide that there is. The details of this phenomenon will be discussed based on the results of experiments described later. The airway condition determination unit 331 may determine the degree of narrowing or obstruction of the airway based on the increase in air pressure inside the sensing unit 110 at the time of exhalation. For example, if the pressure increase is steep, the pressure increase amount is large, or the time until the increased pressure returns is long, the degree of airway obstruction may be determined to be high. . The degree of obstruction of the airway may be determined using the slope of the effort call curve, the higher derivative, the integral value, the shape, the height of the beak, and the like as indices. The degree of airway narrowing or obstruction may be determined by hydrodynamic analysis of the respiratory waveform during exhalation.

Furthermore, the airway condition determination unit 331 may determine the condition of airway narrowing or obstruction based on the measurement result at rest. As will be described later, according to the measurement of this system, there is a correlation between the measurement result at rest and the measurement result at forced call, so the measurement result at forced call should be estimated from the measurement result at rest. Thus, the condition of airway stenosis or obstruction can be ascertained. For example, if the pressure reading in the measurement of ventilation at rest is higher than normal, the airway may be constricted, requiring strong breathing power even at rest. The degree of stenosis or obstruction may be quantitatively determined not only from the presence or absence of airway stenosis or obstruction, but also from the absolute value of the measurement result, the amount of change, and the deviation from the measurement result of the healthy group. The reason for the high pressure value in the measurement of ventilation at rest may be that the strength of the respiratory muscles is strong. As described above, the state of airway narrowing or obstruction may be determined in further consideration of the measurement result at the time of forced expiration.

 The respiratory muscle condition judging unit 3 3 3 judges the condition of the respiratory muscle of the subject by referring to the respiratory waveform data, the effort call curve, or the flow volume curve. For example, when the lung volume fraction is measured, if the pressure value is lower than that of the group of healthy subjects, it may be determined that the cause is decreased respiratory muscles or chronic fatigue. The state of the respiratory muscles may be determined by combining the measurement results of this system with the measurement results of air volume and air velocity in breathing using spirome. For example, as described later, the spike mouth meter measured the amount of one second, but despite the fact that it was determined that there was an obstructive disorder, the steep pressure increase that appeared in the measurement at the time of forced paging by this system was small. In this case, it may be determined that the muscular strength of the respiratory muscles is reduced. Like the respiratory tract condition judging unit 331, the respiratory muscle state judging unit 33 may also judge the state of the respiratory muscle based on the measurement result at rest.

 The database query section 3 3 2 includes respiratory function indicators such as lung volume fraction, forced vital capacity, 1 second volume, maximum expiratory flow rate, respiratory waveform, forced respiratory curve, flow volume curve, and abdominal contribution rate The medical finding is acquired by referring to the respiratory function database 350 based on the characteristics of the respiratory waveform extracted by the waveform characteristic extracting unit 330 and the like. At this time, information such as the subject's sex, age, height, weight, body fat percentage, chest circumference, abdominal circumference, and past medical history may be further referred to.

 The display section 340 displays measured chest data, abdominal data, respiratory waveform data, calculated respiratory function indices, and information such as medical findings obtained from the respiratory function database 350 on a liquid crystal display. Display on the device.

The respiratory function database 350 includes respiratory functions such as lung volume fraction, forced vital capacity, 1 second volume, maximum expiratory flow rate, respiratory waveform, forced respiratory curve, flow volume curve, abdominal contribution rate, etc. Stores information such as indices and characteristics of respiratory waveforms in association with medical findings. At this time, the subject's gender, age, height, weight, body fat percentage, medical history, etc. may be considered. For example, correlate the characteristic that the peak of the flow volume curve is flattened with the medical finding that there is a suspected upper airway stenosis. May be stored. Medical findings included not only the name of the respiratory disease estimated from the measurement results, but also the condition of the respiratory tract, respiratory muscles and other organs, the extent of the disease, and suggestions for appropriate rehabilitation programs and exercises. You may.

 In FIG. 1, the measuring unit 100 and the control unit 200 are collectively referred to as a measuring device 50, but they need not be integrally configured. Further, each constituent member may be provided in another unit. For example, a pressure pump 220, a pressure gauge 230, a recording unit 240, etc. may be provided on the measurement unit 100 side, a condition input unit 290, a display unit 270, etc. May be provided on the analysis unit 300 side. The control unit 200 and the analysis unit 300 may be integrally configured. It is understood by those skilled in the art that various combinations can be considered with a high degree of freedom in configuration. The respiratory function database 350 may be provided in an external server or the like, and the respiratory function database 350 may be accessed by communication means such as a network.

 The measuring device 500 and the analyzing device 300 may be provided at separate places. At this time, the data measured by the measuring device 50 may be provided to the analyzing device via an external storage medium such as a floppy disk, a CD-ROM, or an MO, or may be transmitted to the analyzing device via a network. May be provided. According to this, the measurement data can be analyzed even in an environment where there is no nearby analyzer, for example, when the subject is living in a non-medicated village or a depopulated area such as a remote island. In the measurement device 50 of the present embodiment, the measurement unit 100 can be mounted relatively easily, so that the measurement can be performed by the subject himself or with the help of his family. It is also possible for the subject to carry the measurement device 50 at home and perform the measurement, and then send the data to the hospital to obtain the doctor's findings. Therefore, even if it is difficult for the patient to go out, the doctor can be properly diagnosed. Also, for example, a patient in the sleep apnea syndrome group (SAS) can wear the measurement unit 100 while sleeping at home, etc., and continuously measure the respiratory state during sleep, thereby improving the airway. Diagnosis of obstruction status and degree of symptoms can be made.

Further, the measuring device 50 of the present embodiment is used as a rehabilitation assisting device. In this case, the respiratory condition during rehabilitation can be monitored, so that the value of the load applied to the subject during rehabilitation can be appropriately evaluated. Further, even after the rehabilitation is completed, the respiratory function test can be continuously performed with the measurement unit 100 attached, so that the effect of the rehabilitation can be appropriately evaluated. In addition, the patient can easily operate it, so rehabilitation can be performed even in an environment that cannot be assisted by a doctor or physiotherapist. For example, rehabilitation can be performed at home, and the measurement data during and after rehabilitation can be transferred to a hospital and consulted by a doctor.

 Further, the measuring device 50 of the present embodiment can be used in various scenes, not limited to medical sites. For example, a measuring device 50 may be provided at a sports facility so that the user can check the respiratory condition before exercise and after exercise. It can also monitor respiratory status during aerobic exercise. As described above, the measurement system 10 and the measurement device 50 of the present embodiment are convenient to carry, easy to mount and operate, and can be used by various users in various scenes. FIG. 6 schematically shows the appearance of the control unit 200. On the outer surface of the control unit 200, there are provided a speaker 1 as an example of the indicator 260, a liquid crystal display as an example of the display 270, and an input for inputting conditions to the condition input unit 290. A cable 282 connector is provided for transferring the measurement data to the analysis unit 300 by the kinematic interface 292 and the transfer unit 280. Also, a tube 114 for the pressurizing pump 220 to send gas into the sensor 110 and a tube 112 for measuring the internal pressure of the sensor 110 are connected.

FIG. 7 shows a procedure for measuring a respiratory function using the measurement system 10 of the present embodiment. First, the subject wears the chest respiration measurement unit 100a and the abdominal respiration measurement unit 100b (S100). Here, when performing rehabilitation (Y in S102), rehabilitation of respiratory function is performed (S104), and then the test is passed to a respiratory function test. If rehabilitation is not performed (N of S102), skip S104. Prior to the respiratory function test, Gas is introduced into the section from the pressurizing pump 220 to perform initial pressurization (S106). Subsequently, the measurement of the respiratory function is performed while maintaining the gas amount inside the sensing unit 110 (S108).

 FIG. 8 shows a procedure for analyzing the respiratory function using the measurement system 10 of the present embodiment. First, the measurement data acquisition unit 310 acquires the measurement data overnight (S200). Subsequently, respiratory waveform data is generated from the measurement data acquired by the waveform generating section 32 (S202). Subsequently, the lung volume fraction calculating unit 324 calculates the lung volume fraction (S204), and the effort call curve analysis unit 326 calculates the effort vital capacity, the amount of one second, and the like. (S206), the flow volume curve analysis unit 328 calculates the maximum expiratory flow rate and the like (S208), and the abdomen contribution ratio calculation unit 329 calculates the abdomen contribution ratio and the like (S2 0 9). Subsequently, the waveform characteristic extraction unit 330 extracts a characteristic portion of the respiratory waveform (S210). Further, the airway condition judging unit 331 judges the condition of airway narrowing or obstruction with reference to the respiratory waveform data, the effort curve or the flow volume curve (S211). Further, the respiratory muscle state judging unit 333 judges the state of the respiratory muscle (S2122). Subsequently, the database query unit 3 3 2 relies on the respiratory function database 3 5 based on data such as lung volume fractionation, forced vital capacity, maximum expiratory flow rate, abdominal contribution rate, and characteristics of respiratory waveforms. With reference to 0, a medical finding for the subject is obtained (S213). Finally, the analysis result is displayed on the display section 34 (S2 14)

 FIG. 40 shows a configuration of the analysis server 400 and the terminal 500 that accesses the analysis server 400 according to the embodiment. The analysis server 400 receives an analysis request from the terminal 500 located in a hospital or the like via the Internet 600, and based on the received measurement data, the respiratory function data 350 And sends the analysis result to the terminal 500. In the present embodiment, the Internet 600 has been described as an example of a network, but a wired or wireless network such as a mobile phone network or a public network may be used.

The analysis server 400 has a communication unit 410 for communicating with the terminal 500 via the network 600, and a reception unit 4 3 for receiving a data-based reference request via the network. 0, authentication unit 4 40 that authenticates the user who refers to the database, 'setting data overnight acquisition unit 310, analysis unit 320, respiratory function database 350, and medical It includes a transmission unit 420 for transmitting analysis results such as findings to the terminal 500. Among the configurations of the analysis server 400, those having the same functions as those of the configuration shown in FIG. 1 are denoted by the same reference numerals.

 The analysis server 400 first accepts a data-based reference request via the in-net network 600 by the reception unit 430, and then the authentication unit 440 sends the user to the data-based server. It authenticates whether the user is permitted to refer. Once authenticated, similar to the analysis unit 300 shown in FIG. 1, the measurement data acquisition unit 310 acquires the chest data and the abdomen data, and the waveform generation unit 3222 acquires the respiratory waveform data. An overnight generation is generated, and the waveform characteristic extraction unit 330 extracts chest data, abdominal data, and the characteristics of the waveform shape of the respiratory waveform data, and the airway condition determination unit 331 determines the airway stenosis state. Then, the respiratory muscle condition judging section 333 judges the state of the respiratory muscles, and the database inquiry section 332 queries the respiratory function database 350 to obtain medical findings. The medical findings are transmitted from the sending section 420 to the user via the event 600. A charging unit for charging a user who has referred to the database may be further provided.

 The analysis server 400 shown in FIG. 40 mainly manages the respiratory function database 350 and provides an inquiry service therefor. The lung volume fraction calculation unit 32 Configurations such as 4 are omitted, but of course, these configurations may be provided. A configuration such as a lung volume fraction calculation unit 324 may be provided on the terminal 500 side. At this time, the measurement data acquisition unit 310 may acquire a respiratory function index such as a lung volume fraction from the terminal 500.

 The terminal 500 transmits the data measured by the measuring device 500 to the analysis server 400 via the measurement data transmission unit 520, the analysis server 400 and the event server 600. The communication unit 510 includes a communication unit 510 for communication, an analysis result obtaining unit 530 for obtaining an analysis result from the analysis server 400, and a display unit 340 for displaying the analysis result on a display device.

Thus, by providing a function equivalent to the analysis unit 300 in FIG. 1 as a server, it is possible to provide a service for analyzing the respiratory function to more users. In addition, by maintaining the respiratory function database 350 in each terminal 500 and centrally managing it in the analysis server 400, maintenance and maintenance of updates and corrections on a data basis can be performed. Can be facilitated.

 FIGS. 41 (a), (b), (c), (d), and (e) show examples of use of the rehabilitation assistance device according to the embodiment. The rehabilitation assistance device has the same configuration as the measurement device 50 shown in FIG. 1, and uses the measurement unit 100 as a pressure unit and the sensing unit 110 as a pressure unit.

 FIG. 41 (a) shows a state in which the upper lobe of the lung of the subject is squeezed by the pressurizing unit 100. At this time, the pressurizing unit 110 is fixed so as to be positioned above the fourth rib, and a gas is introduced into the pressurizing unit 110 by the pressurizing pump until a predetermined pressure is reached, thereby pressing the sputum excretion site. FIGS. 41 (b) and 41 (c) show how the pressurizing unit 100 squeezes the middle lobe of the lungs of the subject. In FIG. 41 (b), the right side is squeezed, and in FIG. 41 (c), the left side is squeezed. FIG. 41 (d) shows a state in which the lower lobe of the subject is squeezed by the pressurizing unit 100. FIG. 41 (e) shows a state in which the pressurized unit 100 is used to squeeze the posterior segment of the lungs of the subject. In order to squeeze an appropriate position, a plurality of pressure units 100 may be mounted as necessary, or a plurality of pressure units 110 may be provided in the pressure unit 100. FIG. 42 shows a procedure of the rehabilitation assistance method according to the embodiment. First, as shown in FIG. 41, the pressurizing unit 100 is attached to the subject (S300). Subsequently, gas is introduced into the pressurizing unit 110 to compress the sputum site and squeeze (S 302). Yes (S304). While observing the breathing state of the subject, it is evaluated whether or not the pressure inside the pressurizing unit 110 is appropriate, and if necessary, the pressurized value is changed (S306). Until the rehabilitation is completed, proceed to N in S308 to perform the renovation steps. When the rehabilitation is completed (Y in S308), the pressure inside the pressurizing unit 110 is set to an appropriate initial pressure in order to measure the respiratory state of the subject (S310). Subsequently, the respiratory function is measured (S 312), and the effect of rehabilitation is evaluated (S 314).

As described above, the rehabilitation assisting device of the present embodiment also has a function as a measuring device, so that the rehabilitation assist device can be used during and after rehabilitation. Function can be measured to assess the effectiveness of rehabilitation. In the above description, squeezing was used as an example of physical therapy, but rehabilitation and respiratory function measurement can be performed in the same manner when other methods are used. The configuration and operation of the measurement system 10 have been described above. Subsequently, results of performing a respiratory function test on a plurality of subjects using the measurement system 10 of the present embodiment will be described.

 (Experiment conditions)

The respiratory function test was performed on 21 healthy subjects without respiratory dysfunction (12 males and 9 females) and 10 patients with respiratory dysfunction. At this time, measurements were also made with Spirome at the same time as measurements with this system, and both data were compared. Figure 9 shows the gender, age, height, weight, BMI, and body fat percentage of healthy subjects. Size of the fixed portion 120 is 14 Ommx 1 17 Omm, size 125mmx 230 mm sensing portion 1 10, the initial pressure was set at 2 OmmHg in 30 mmHg _N women in men. The respiratory waveform data was generated by adding the chest data and the abdominal data.

 (Experiment 1) Measurement of lung volume fraction

 FIG. 10 shows the time change of the internal pressure of the sensing unit 110 when the lung volume fraction of the subject 2 is measured. In the figure, the solid line is the chest data measured using the chest respiration measurement unit 100a, the thin solid line is the abdominal data measured using the abdominal respiration measurement unit 100b, and the thick solid line is the sum of the values. 2 shows waveform data. LV1 is the maximum expiratory level in the respiratory waveform data, LV2 is the resting expiratory position in the respiratory waveform data, LV3 is the resting inspiratory position in the respiratory waveform data, and LV4 is the maximum inspiratory level in the respiratory waveform data. Show.

 (Experiment 1-1) Measurement of vital capacity VC

The vital capacity VC is given by the difference between the maximum expiration level LV1 and the maximum inspiration level LV4. In this experiment, since the internal pressure of the sensing unit 110 was not converted to air volume, the amount calculated from the measurement results shown in FIG. 10 was not the vital capacity VC itself, but the index VC 1 for calculating the vital capacity. It is. In the case of subject 2, VC 1 uses only chest data It is calculated as 78.6 (mmHg) when used, 12.42 (mmHg) when using only abdominal data, and 88.32 (mmHg) when using respiratory waveform data. The spirometry VC was calculated to be 2.68 (1) based on the results of Spirome overnight measured at the same time.

 The same measurement was performed on 21 healthy subjects, and a comparison with the vital capacity VC measured by Spirome overnight was performed. Subjects with large disturbances in the measured data waveform were excluded from the evaluation. Figure 11 (a) shows the vital capacity VC1 calculated from the respiratory waveform data of each subject. FIG. 11 (b) is a diagram in which the measurement result VC1 by the measurement system 10 is plotted against the measurement result VC2 by spirometry. Regression by a straight line using the least squares method gave VC 1 = 40.382 XVC 2-39.646, and the correlation coefficient was a high value of 0.876. (Experiment 1-2) Preliminary expiratory volume measurement of ERV

 The pre-expiratory volume ERV is given by the difference between the maximum expiratory level LV1 and the resting expiratory level LV2. Fig. 12 (a) shows the measurement results calculated in the same manner as for the vital capacity VC, and Fig. 12 (b) shows the correlation with the measurement results by spirometry. The regression line was ERV1 = 8.3603XERV2 + 0.738, and the correlation coefficient was relatively high at 0.635.

 (Experiment 1-3) Preliminary intake volume measurement of IRV

 The preliminary intake amount I R V is given by the difference between the maximum intake level L V 4 and the resting intake position LV 3. Fig. 13 (a) shows the measurement results calculated in the same way as for the vital capacity VC, and Fig. 13 (b) shows the correlation with the measurement results by spirometry. The regression line was IRV1 = 44.662 x 1 RV2-6.2966, and its correlation coefficient was high at 0.756.

 (Experiment 1-4) Measurement of maximum inspiratory volume I C

The maximum inspiratory volume IC is given by the difference between the maximum inspiratory level LV4 and the resting expiratory position LV2. Fig. 14 (a) shows the measurement results calculated in the same manner as for the vital capacity VC, and Fig. 14 (b) shows the correlation with the measurement results obtained by using the spy mouth method. The regression line is I C1 = 4 5.736X I C2 — 13.977, with a high correlation coefficient of 0.770. The value was shown.

 (Experiment 1-5) Tidal volume TV measurement

 Tidal volume TV is given by the difference between the resting inspiratory position LV 3 and the resting expiratory position LV 2. Fig. 15 (a) shows the measurement results calculated in the same way as for the vital capacity VC, and Fig. 15 (b) shows the correlation with the measurement results by Spirome. The regression line was TV1 18.8.5 XTV2 + 12.745, and the correlation coefficient was 0.541, which was a relatively high value.

 From the above results, it was confirmed that the lung volume fraction can be measured by the measurement system 10 as in the case of Spirome overnight. Also, the absolute value of the lung volume fraction can be calculated from the measurement data of this system using the regression line equation. Similar measurements may be performed on more subjects, and a highly accurate conversion formula may be calculated.

 (Experiment 2) Measurement of effort call curve

 FIG. 16 shows a temporal change in the internal pressure of the sensing unit 110 when the effort call curve of the subject 2 is measured. In the figure, the solid line is the chest data measured with the chest respiration measurement unit 100a, the thin solid line is the abdominal data measured with the abdominal respiration measurement unit 100b, and the thick solid line is the sum of the data. 1 shows certain respiratory waveform data. FIGS. 17 (a), (b) and (c) are mouth-volume curves obtained by differentiating the effort calling curve of FIG. Fig. 17 (a) shows the flow volume curve obtained from the abdomen, and Fig. 17 (b) shows the flow volume curve obtained from the chest data.

 (C) shows a flow volume curve obtained from the respiratory waveform data. The fe flow volume curve measured with a spy mouth meter generally shows the air volume on the horizontal axis and the air speed on the vertical axis. In Fig. 17, the horizontal axis shows time. This is because the data analysis was performed without converting the measured data into the air volume, but it is considered that there is no effect on the calculation of the maximum expiratory flow rate PEFR.

 (Experiment 2-1) Forced vital capacity FVC measurement

Forced vital capacity FVC is calculated as shown in Figure 16. Figure 18 (a) shows the forced vital capacity index FVC1 calculated from the respiratory waveform data of each subject. Figure 18 (b) shows the measurement result FVC 1 by the measurement system 10 FIG. 11 is a diagram plotted with respect to FVC2. The regression line was FVC 1 = 33.874 XFVC 2-33.682, showing a high correlation coefficient of 0.831.

 (Experiment 2-2) 1 second amount FE Vi. Measurement

 The one second amount FEVi.0 is calculated as shown in Fig.16. 1-second volume index FEVi. Calculated from the respiratory waveform data of each subject. 1 is shown in Fig. 19 (a). FIG. 19B is a diagram in which the measurement result FEVi.01 by the measurement system 10 is plotted against the measurement result FEVi.02 by Spirome. The regression line was FEV 1.01 = 38. 438 x FEVi. O 2-39. 038, and the correlation coefficient showed a high value of 0 · 790.

 (Experiment 2-3) Measurement of PEFR

 Maximum expiratory flow rate PEFI is calculated as shown in Fig.17. Figure 20 (a) shows the maximum expiratory flow rate index PEFR1 calculated from the respiratory waveform data of each subject. FIG. 20 (b) is a diagram in which the measurement result PEFR1 by the measurement system 10 is plotted against the measurement result PEFR2 by spirometry. The regression line was PEFR 1 = 1.8788XPEFR2-5.7519, and the correlation coefficient was as high as 0.845.

 From the above results, it was confirmed that the measurement system 10 can measure the forced vital capacity, the amount of one second, the maximum expiratory flow rate, the forced expiratory curve, the flow volume curve, and the like, as in the case of Spirome. Also, as in the case of the lung volume fraction, the absolute value of the above amount can be obtained from the measurement data of this system using the regression line equation.

(Experiment 3) Measurement of resting ventilation

 FIG. 21 shows a temporal change in the internal pressure of the sensing unit 110 when the resting ventilation volume of the subject 2 is measured. In the figure, the solid line is the chest data measured with the chest respiratory measurement unit 100a, the thin solid line is the abdominal data measured with the abdominal respiration measurement unit 100b, and the thick solid line is the sum of each. It shows the respiratory waveform data overnight.

(Experiment 3-1) Measurement of Resting Ventilation Volume MV (Minutes Volume)-Resting Ventilation Volume MV represents 1 minute ventilation at rest, tidal volume TV and 1 minute It is calculated by the product of the number of breaths in between. Figure 22 (a) shows the resting ventilation index MV1 calculated from the respiratory waveform data of each subject. FIG. 22 (b) is a diagram in which the measurement result MV1 by the measurement system 10 is plotted against the measurement result MV2 by the spirometry. The regression line was MV1 35.675 XMV2 + 89.158, and the correlation coefficient was as high as 0.755.

 (Experiment 3-2) Tidal volume TV measurement

 Tidal volume TV is calculated by averaging the difference between peaks and valleys in the respiratory waveform at rest. Figure 23 (a) shows the tidal volume index TV1 calculated from the respiratory waveform data of each subject. FIG. 23 (b) is a diagram in which the measurement result TV1 by the measurement system 10 is plotted against the measurement result TV2 by spirome. The regression line was TV 1 = 35.01 XTV 2 + 5. 1348, and the correlation coefficient was as high as 0.649.

 (Experiment 3-3) Measurement of RR between peaks of waveform

 The peak-to-peak RR of the waveform is calculated by averaging between the peaks of the respiratory waveform at rest, but in this experiment, the reciprocal of the reciprocal is used to calculate the number of breaths per minute. FIG. 24A shows the peak-to-peak index R R1 of the waveform calculated from the respiratory waveform data of each subject. FIG. 24 (b) is a diagram in which the measurement result RR1 by the measurement system 10 is plotted against the measurement result RR2 by spirometry. Regression with a straight line using the least squares method gave RR 1 = 1.0003 XRR2-0.4108, and the correlation coefficient was 0.997, which was a high value.

 From the above results, it was confirmed that the measurement system 10 can measure the ventilation volume at rest, the tidal volume, the peak between waveforms, and the like, as in the case of Spirome. Also, as in the case of the lung volume fraction, the absolute value of the above amount can be obtained from the measurement data of this system using the equation of the regression line. Similar measurements may be performed on more subjects, and a highly accurate conversion formula may be calculated.

As described above, it was confirmed that this system can obtain data equivalent to that of Spirome. However, the advantage of this system is not limited to that, but there is a great advantage in that it is possible to measure Yonbe-de-evening and abdomen-de-night independently. Less than The relationship between the chest data and the abdomen is described below.

 (Experiment 4) Relationship between chest data and abdominal data

 The relationship between chest data and abdominal data in the above experiment was evaluated. The following shows the measurement data at rest and the measurement data at forced call.

 (Experiment 4-1) Relationship between resting chest and abdominal data

 Figure 25 shows the relationship between chest data and abdominal data when resting ventilation was measured in Experiment 3. In Fig. 25, chest data is shown on the horizontal axis, and abdominal data is shown on the vertical axis. When regression was performed with a straight line using the least squares method, (abdomen de night) = 0. It was 4.625X (chest chest night) + 4.5258, and the correlation coefficient was as high as 0.940. This indicates that the subject's breathing variation at rest was small, and that chest breathing and abdominal breathing were performed at a substantially constant ratio.

 (Experiment 4-2) Relationship between chest data and abdominal data at forced paging

 FIG. 26 shows the relationship between the chest data and the abdominal data when the effort call curve was measured in Experiment 2. In FIG. 26, the horizontal axis represents chest data and the vertical axis represents abdominal data. Regression with a straight line using the least squares method gives (abdomen de-night) = 0.14 6 2 X (chest de-night) + 1 2.6 14, and the correlation coefficient is 0.871. there were. Since the slope of the regression line is smaller than at rest, it can be seen that the superiority of chest respiration is greater during forced exhalation than at rest.

 As described above, similarly to the respisomnogram, the measurement system 10 of the present embodiment independently measures chest data and abdominal data, and evaluates the superiority of respiration and the abdominal contribution rate. It was confirmed that it was possible. Furthermore, in the respisomnogram, the reliability of the absolute value of the data was poor and a quantitative discussion could not be made.However, as can be seen from the explanations of Experiments 1 to 3, the quantitative You can get a strong de night. This makes it possible to quantitatively compare and evaluate the measurement of the same subject multiple times and the measurement of multiple subjects.

As described above, Experiments 1 to 4 show that the measurement system 10 of the present embodiment has functions equivalent to those of Spirome and Respisomnogram. In the measurement system 10 of the present embodiment, both functions of the spirome and respisomnograms are used. In addition to having information, it is possible to acquire information that had to be acquired separately for Spirome overnight and respisomnogram with a single measurement. In addition, independent measurements of chest data and abdominal data can provide findings that could not be obtained with conventional spy mouth and respisomnograms. For example, in a patient whose upper lobe of the lung was resected due to a disease such as emphysema, the respiratory muscles of the chest hardly contribute to breathing, and they breathe almost by abdominal breathing. Can not. In addition, respisomnograms show that abdominal respiration is superior, but quantitative evaluation is difficult due to poor reproducibility. However, according to the measurement system 10 of the present embodiment, since it is possible to independently obtain the respiratory and abdominal respiratory data independently with good reproducibility, it is possible to observe the progress after surgery, and to evaluate the rehabilitation drug. Quantitative evaluation, such as observing effects, can be performed. This is very medically significant.

 In addition, for a patient with amyotrophic lateral scleri'osis (ALS), the degree of progress of paralysis of respiratory muscles contributing to thoracic respiration is observed by the measurement system 10 of the present embodiment. be able to. This also makes it possible to perform quantitative evaluation with higher reproducibility and reliability than conventional respisommograms. (Experiment 5) Measurement with respiratory disease patients as subjects

As in Experiments 1 to 4, respiratory function was measured using this system and a spirometer on patients with respiratory disease. Five measurements were taken for 10 patients with respiratory disease. Measurement data with large waveform disturbances were excluded from the evaluation. The measurement results shown in FIGS. 27 to 36 were analyzed using the combined values of chest and abdomen, as in Experiments 1 to 3. The graph showing the correlation with Spirome overnight is drawn on the same scale as the graphs in Experiments 1 to 3 using healthy subjects as subjects. FIG. 27 (a) shows the measurement results of the vital capacity VC, and FIG. 27 (b) shows the correlation with Spirome overnight. FIG. 28 (a) shows the result of measurement of the pre-expired volume ERV, and FIG. 28 (b) shows the correlation with Spirome overnight. FIG. 29 (a) shows the measurement result of the preliminary intake air amount I: RV, and FIG. 29 (b) shows the correlation with Spirome overnight. Figure 30 (a) shows the measurement results of the maximum inspiratory flow IC, and Figure 30 (b) shows the spirometry Shows correlation with evening. Fig. 31 (a) shows the measurement results of tidal volume TV, and Fig. 31 (b) shows the correlation with Spirome overnight. FIG. 32 (a) shows the measurement results of forced vital capacity FVC, and FIG. 32 (b) shows the correlation with Spirome overnight. FIG. 33 (a) shows the measurement result of the maximum expiratory flow rate PEFR, and FIG. 33 (b) shows the correlation with the spirometry. FIG. 34 (a) shows the results of measurement of resting ventilation MV, and FIG. 34 (b) shows the correlation with Spirome overnight. Fig. 35 (a) shows the measurement result of tidal volume TV, and Fig. 35 (b) shows the correlation with Spirome overnight. Figure 36 (a) shows the measurement results between the peaks of the waveform, and Figure 36 (b) shows the correlation with the spy mouth meter.

 The above measurement results show that various types of respiratory function measurement can be performed by the measurement system of the present embodiment even for patients with respiratory diseases. In addition, multiple measurements were performed on each subject, and it was confirmed that highly reproducible measurement results could be obtained. FIG. 37 shows a time change of the internal pressure of the sensor 110 when a forced respiratory curve of a certain respiratory disease patient is measured. In the figure, the solid line is the chest data measured by the chest respiration measurement unit 100a, the thin solid line is the abdomen data measured by the abdominal respiration measurement unit 10 Ob, and the thick solid line is the respiratory waveform that is the sum of the data. Show data. After inhaling to the maximum, at the moment of forced exhalation, you can see that the internal pressure has risen sharply. This rapid increase in internal pressure is observed during the measurement of the effort expiratory curve, mainly in asthmatics, rarely seen in patients with bronchiectasis, and rapidly increasing at the moment of forced exhalation. It is considered that airway narrowing is the cause. That is, the internal pressure of the sensing unit 110 rises because the airflow was restricted at the narrowed part of the airway when trying to exhale at a stretch after inhalation, or because the respiratory muscles performed differently from the healthy person. It is thought that it was done.

This steep pressure increase is considered to be a hysteresis phenomenon that occurs when exhaled air passes through the peripheral airway, which tends to be spastic, while decaying. When the measurement was performed while auscultating the lungs, an abnormal breathing sound (with a wheezing sound) was observed at the same time as a sharp increase in pressure. This suggests that the steep pressure increase reflects airway conditions. Experiments have shown that the above-mentioned steep pressure increase appears only in the abdominal data and in some patients only in the chest data. When a patient with a narrowed or obstructed airway in the upper lobe of the lungs forcibly exhales, a sharp increase in chest data appears mainly due to the expansion of the chest, and the airway in the lower lobe of the lung is narrowed or obstructed. It is considered that when a patient who forcibly exhales, a sudden increase appears in the abdominal region, mainly due to swelling of the abdomen. From this, it can be seen that the present measurement system can determine the portion of the airway where stenosis or obstruction has occurred. In other words, when an increase in chest data is observed at the time of forced exhalation, the airway condition determination unit 331 determines that the airway in the upper lobe of the lung is narrowed or obstructed, and an increase in abdominal data is observed. If so, it may be determined that the airway of the lower lobe of the lung is narrowed or obstructed. Conventionally, it has been necessary to perform expensive and complicated measurements such as CT scans to identify the area where the airway is constricted.However, according to this measurement system, the stenotic area can be identified by low-cost and simple measurement. It is possible to make a judgment.

 FIG. 38 shows a flow volume curve measured for a patient with a respiratory disease. Unlike the flow volume curve of the healthy subject shown in Fig. 17, a large peak is observed in the positive direction. This is considered to reflect the rise in internal pressure at the time of forced expulsion described above.

 FIG. 39 is a diagram showing the relationship between the internal pressure rise value during forcible exhalation and the maximum expiratory flow rate: PEFI. The increase in internal pressure at the time of forced expiration, which was observed during the measurement of the forced expiratory curve in patients with respiratory disease, was negatively correlated with the maximum expiratory flow rate, PEFR. Or it is suggested that the degree of occlusion is reflected. The above measurement results show that this system is effective for diagnosing the condition of airway narrowing or obstruction.

FIG. 43 is a diagram showing the relationship between the internal pressure rise value at the time of a forced call and the amount per second. Similar to the relationship with the maximum expiratory flow rate PEFR shown in Fig. 39, the increase in internal pressure during forced exhalation has a negative correlation with the FEV i .0 per second. In general, if the amount per second is less than 70%, it is often determined that there is an obstructive disorder, but as can be seen from Fig. 40, even for subjects whose amount per second exceeds 70%, Internal pressure rise is observed at the time of forced call W

 31

There are cases. This suggests that the measurement by this system can be a more sensitive and more quantitative judgment of occlusive disorders than the one-second measurement by Spirome overnight. In the measurement during forced exhalation by this measurement system, it is possible to observe the pressure increase in the thorax and abdomen caused by airway obstruction and the pressure decrease when the obstruction is relieved, so that data reflecting the feeling of dyspnea was obtained. It can be said that. ,

 For subjects with higher internal pressure than the regression line, although obstructive disorders were observed, no decrease in respiratory muscles was observed, and it was considered that a higher pressure increase was observed because the power to exhale was not reduced. On the other hand, in subjects whose internal pressure rise value was lower than the regression line, the respiratory muscles were decreased, and it was considered that the ability to exhale was also reduced. In other words, the measurement of this system suggests that it is possible to not only detect the presence or absence of obstructive disorders, the degree of symptoms, etc. with high sensitivity and quantitatively, but also to grasp the state of respiratory muscles at the same time. The state of the respiratory muscles may be grasped quantitatively based on the degree of deviation from the regression line. '

 This increase in internal pressure is positively correlated with the resting ventilation MV and tidal volume TV.In the state of spasticity, not only during forced exhalation but also during resting breathing It turns out that the chest and abdominal wall pressure is higher, that is, more force is required for breathing. In other words, this system suggests the possibility of observing the condition of the respiratory tract and the state of the respiratory muscles from the measurement results at rest. In the past, measurement was performed by forcibly exhaling a patient who had impaired respiratory function.However, if it is possible to switch to measurement at rest, the burden on the patient can be greatly reduced, Always meaningful.

VC ヽ ERV 回 帰 The slope of the regression line indicating the relationship between the measurement results by this system and the measurement results by Spirome overnight when measuring IRV and IC is smaller in the patient group than in the healthy group . For example, for VC, the regression line is VC 1 = 40.382 XVC 2-39.646 in the healthy group, and the regression line is VC 1 = 14.997 XVC 2 + 10.47 in the patient group. . As can be seen from these formulas, when the chest and abdominal wall pressure is measured by this system for healthy subjects and patients with respiratory diseases who show the same VC value as measured by spirome overnight, the patient's chest and abdominal wall pressure is half that of a healthy person. Minutes or less. This suggests that the patient group may have lower respiratory muscle strength than the healthy group.

 In this experiment, since the age group of the healthy group and the patient group are different, the decrease in respiratory muscle strength due to aging is considered to be one of the causes. However, the effect of aging on respiratory muscle strength by Yoshihiro Nishimura et al. According to the Journal of the Japanese Society of Diseases, 29, 795-801, 1991, the PI max in the 60s with respect to the 30s was 78.9% for men and 74 for women. 5%. When the attenuation of chest and abdominal wall pressure in the respiratory disease patient group was estimated from the ratio of the slope of the regression line of VC, it was about 40% of the healthy subjects, which significantly exceeded the decrease in respiratory muscle strength due to aging. In other words, the reason why the results of measurement in the patient group are significantly lower than those in the healthy group is probably due to chronic fatigue of respiratory muscles due to respiratory dysfunction. Therefore, the magnitude of the deviation from the regression line in the healthy group suggests that it may be possible to obtain findings regarding the muscle strength of respiratory muscles.

 Similarly, in the measurement of the effort call curve, the slope of the regression line tends to be lower in the patient group than in the healthy group. As described in Fig. 37 to Fig. 39, when measuring the forced expiratory curve, a sudden increase in chest and abdominal wall pressure due to airway resistance is observed. It is thought to be related to lower chest and abdominal wall pressure. In other words, the magnitude of the deviation from the regression line in the healthy group suggests that it may be possible to obtain findings regarding airway stenosis.

No correlation was observed between the ventilation volume at rest and the measurement results at the time of lung volume fractionation and forced breathing in spy mouth meter measurements, and breathing at rest, active breathing, and breathing at forced breathing were not observed. Need to be grasped through separate measurements. However, in the measurement using this system, there is an item that shows a correlation between the ventilation volume at rest and the measurement results during lung volume fractionation and forced breathing. It is thought that this system monitors the performance of the bellows (bellows: compliance of the respiratory muscles, thorax, and lungs) that control breathing. It can be said that it is possible to observe the reflected parameters in the same way. Therefore, by measuring at rest, the state of airway stenosis and the state of respiratory muscles can be grasped, and these can be continuously observed over a long period of time. Hereinafter, the optimum measurement conditions of this system will be considered.

FIG. 44 is a diagram for explaining pressure related to the pulmonary-thoracic system. Atmospheric pressure! ¾ 、 Intra-alveolar pressure:? ^ 、 Intrathoracic pressure: Ppi, Transtracheal pressure! ¾, transpulmonary pressure Ptp, 絰 chest wall pressure Rt,

Is represented by Since the lung elastic contraction force of a normal lung is 10 cmH ₂₀ (= 9 mmHg), the preferred initial pressure is 10 cmH ₂₀ or more and 30 cmH ₂₀ or less. The higher the initial pressure, the higher the gain.Therefore, from the viewpoint of measurement sensitivity, it is preferable to increase the initial pressure.However, if the initial pressure is too high, the subject will feel oppressive, and in particular, respiratory dysfunction Since it may be a factor that inhibits respiration for patients who have this, the optimal initial pressure should be determined in consideration of both factors.

FIG. 45 is a diagram illustrating a relationship between the surface area of the sensing unit and the measurement sensitivity. Four types of sensing units 110 were prepared, and VC and FVC were measured for the same healthy person by a measurement system using them. Initial pressure at each measurement, and adjusted to the extent there is no feeling of pressure when the breathing motion was one row, the sample 1 (0. 450 mm ²⁾ and ² (0. 975mm 2) In 10 OmrnH gヽsample 3 (2.875 mm ²⁾ in 2 OmmHg, sample 4 (set to 10. 30 mm ²⁾ at 10 mmH g. As a result of the measurement, it was found that the measurement with sample 2 was the most sensitive for both VC and FVC. Therefore, the surface area of the sensing unit 110 is preferably 0.50 mm ² or more and 2.0 mm ² or less, more preferably 0.5 mm ² or more and 1.0 mm ² or less. The surface area of the sensing unit 110 in contact with the measurement site is preferably determined according to the surface area of the measurement site. That is, for a subject with a large body, the measurement may be performed by the large sensing unit 110, and for a subject with a small body, the measurement may be performed by the small sensing unit 110.

The frequency at which the waveform analysis is performed is preferably in the range of 0.112 to 1.0 Hz, centered at 0.25 Hz, which is close to the frequency characteristics of respiration. These measurement conditions may be controlled by the measurement control unit 250. These measurement conditions may be controlled independently, but it is considered that there is a correlation between the above three parameters, so the optimal parameters are considered in consideration of the relationship between each parameter. It is preferable to choose evening.

 The present invention has been described based on the embodiments. This embodiment is an exemplification, and it is understood by those skilled in the art that various modifications can be made to the combination of each component and each processing process, and that such modifications are also within the scope of the present invention. Where it is. Industrial applicability

 As described above, the present invention is applicable to a measurement system for measuring a respiratory function.

Claims

The scope of the claims

1, a measurement system for measuring respiratory function,

 A first measurement unit for detecting a change in the first measurement site of the subject due to a respiratory movement;

 A second measurement unit for detecting a change in the second measurement site of the subject due to respiratory movement;

 A control unit for obtaining outputs from the first measurement unit and the second measurement unit;

 An analysis unit for analyzing the output obtained by the control unit,

Including

 The first measurement unit and the second measurement unit are:

 A sensing unit for sensing a pressure change given from the measurement site,

 A fixing unit for disposing the sensing unit at the measurement site;

Each,

A measurement system, wherein a surface area of the sensing portion in contact with the measurement site is not less than 0.50 mm ^{2 and not} more than 2.0 mm ² .

2. A measuring system for measuring respiratory function,

 A first measurement unit for detecting a change in the first measurement site of the subject due to a respiratory movement;

 A second measurement unit for detecting a change in the second measurement site of the subject due to respiratory movement;

 A control unit for obtaining outputs from the first measurement unit and the second measurement unit;

 An analysis unit for analyzing the output obtained by the control unit;

The first measurement unit and the second measurement unit include: A sensing unit for sensing a pressure change given from the measurement site; and a fixing unit for disposing the sensing unit on the measurement site.

Respectively,

 The sensing unit has a cavity inside,

 The control unit includes an initial pressure adjusting unit for sending gas into the sensing unit to adjust the pressure to a predetermined initial pressure,

The initial pressure is, 1 0 c mH ₂ 0 or 3 0 c mH 2 0 measurement systems that feature to be adjusted in the following.

3. The measurement system according to claim 1, further comprising a measurement control unit that specifies a suitable combination of the surface area of the sensing unit and the initial pressure as a measurement condition.

4. The measurement system according to claim 3, wherein the measurement control unit further specifies a frequency at which the analysis unit analyzes a measurement result.

5. The measurement system according to claim 4, wherein the frequency is not less than 0.1 Hz and not more than 1.0 Hz.

6. A measurement system for measuring respiratory function,

 A first measurement unit for detecting a change in the first measurement site of the subject due to a respiratory movement;

 A second measurement unit for detecting a change in the second measurement site of the subject due to respiratory movement;

 A control unit for obtaining outputs from the first measurement unit and the second measurement unit;

An analysis unit for analyzing the output obtained by the control unit; and The first measurement unit and the second measurement unit are:

 A sensing unit for sensing a pressure change given from the measurement site,

 A fixing unit for disposing the sensing unit at the measurement site;

Respectively,

 A measurement system, characterized in that the analysis unit includes an airway condition judging unit that judges a condition of stenosis or obstruction of a subject's airway based on a measurement result at rest.

7. The measurement system according to claim 6, wherein the analysis unit further includes a respiratory muscle state determination unit that determines a state of a respiratory muscle of the subject.

8. The measurement system according to claim 7, wherein the respiratory muscle state determination unit determines a state of the respiratory muscle based on a measurement result at rest.

9. The measurement system according to claim 7, wherein the airway condition determination unit or the respiratory muscle state determination unit further refers to a measurement result by spirometry.