WO2021112015A1

WO2021112015A1 - Respiratory apparatus

Info

Publication number: WO2021112015A1
Application number: PCT/JP2020/044322
Authority: WO
Inventors: 聡五十嵐
Original assignee: 帝人ファーマ株式会社
Priority date: 2019-12-05
Filing date: 2020-11-27
Publication date: 2021-06-10
Also published as: JPWO2021112015A1

Abstract

Provided is a respiratory apparatus whereby the airway is given patency by a pressure higher than atmospheric pressure being applied to the upper pharynx during exhalation, thereby reducing dyspnea. The respiratory apparatus is characterized by: being provided with a ventilation part communicating with the nostril of a user or a nasal mask for covering the nostril, a casing for forming a chamber for temporarily retaining exhaled air from the user, and an opening for discharging the exhaled air temporarily retained in the casing to the outside; comprising, before the opening within the casing, an exhaled air control valve provided with an elastic body that is pressure-deformable and has a hole through which exhaled air passes and with a wall surface part that makes contact with the rim of the hole when the elastic body is deformed by pressure toward the opening, thereby stopping the flow of exhaled air; and comprising a conductive part on at least the wall surface side of the elastic body and an electrode on the surface of the wall surface part which makes contact with the elastic body.

Description

Respiratory device

The present invention relates to a respiratory device for treating a patient with a respiratory disease.

There are various types of respiratory diseases such as bronchial asthma, chronic obstructive pulmonary disease, interstitial pneumonia, and obstructive sleep apnea. Among them, obstructive respiratory diseases such as chronic obstructive pulmonary disease and obstructive sleep. The number of patients with hourly asthma is increasing in recent years. Chronic obstructive pulmonary disease is a lifestyle-related disease of the lungs that makes it difficult to breathe due to damage to the bronchi and lungs that serve as air passages when breathing, and is closely related to smoking. For the diagnosis of chronic obstructive pulmonary disease, a spirometer that measures the state of ventilation function is generally used, and the presence or absence and degree of ventilation dysfunction are measured by measuring indicators such as vital capacity, forced vital capacity, forced expiratory volume in one second, and forced expiratory volume in one second. To diagnose.

Obstructive sleep apnea syndrome is caused by narrowing of the upper airway during sleep, and may obstruct the airway by lowering the base of the tongue and soft palate due to muscle relaxation, as well as fat deposition around the neck and throat and hypertrophy of the tonsils. It is considered to be the main cause. The symptom is that the breathing airflow of the mouth and nose stops for a certain period of time or drops to a certain amount or less during sleep multiple times, and when breathing stops for 10 seconds or more, apnea and ventilation amount The state in which the value is reduced to 50% or less of the normal level continues for 10 seconds or more is called hypopnea, and the apnea and hypopnea are diagnosed by the apnea-hypopnea index expressed by the number of times per hour. It is known that when this number is 30 times or more, it is evaluated as severe, excessive drowsiness frequently occurs during the day, and the risk of developing cardiovascular diseases such as hypertension, stroke, and myocardial infarction also increases. There is. Diagnosis of such obstructive sleep apnea syndrome is usually made by a simplified sleep apnea monitor, polysomnography, or the like.

Obstructive sleep apnea syndrome is a common illness, especially in obese middle-aged and older men, but patients often go unnoticed during nighttime sleep and are one of the causes of traffic accidents in recent years. It has become a social problem, and countermeasures are required.

While various treatment methods for obstructive sleep apnea syndrome have been proposed, nasal continuous positive airway pressure (CPAP therapy) is widely used. CPAP therapy prevents airway obstruction by continuously sending air to the airways, and at night, pressurized air is sent from the pressurized air generator (CPAP device) used for CPAP therapy to the airways via an air tube and a nasal mask. It keeps the airway patency by supplying it to the airway, preventing airway obstruction during sleep and preventing the occurrence of apnea.

Further, in Patent Document 1, a plunger that opens at a predetermined pressure or higher is provided, and by giving a high airflow resistance, a pressure higher than the atmospheric pressure is maintained in the nasopharynx, the airway is opened, and obstructive sleep apnea is absent. Techniques for reducing the symptoms of respiratory syndrome have been disclosed. Further, Patent Document 2 discloses a nasal breathing device capable of adhering a structure based on the technique of a one-sided valve around the nostril.

In addition, in Patent Document 3, the position of the tongue is monitored by a sensor in the oral cavity, and when it is detected that the tongue is not in a position where the airway is not obstructed, the tongue is electrically operated so as to move to a position where the tongue does not obstruct the airway. Stimulating techniques are disclosed.

U.S. Pat. No. 5,649,533 Japanese Patent No. 5230202 U.S. Pat. No. 8249723

The treatment of sleep apnea syndrome normally requires high airway pressure to open the airway only when the airway is obstructed during exhalation and an apnea condition occurs. However, in CPAP therapy, since air with a pressure higher than atmospheric pressure is constantly sent to the airway from the CPAP device, the patient may feel uncomfortable at the start of treatment and may exhibit symptoms such as sleeplessness. In addition, CPAP therapy may be interrupted due to the troublesome attachment and detachment.

Originally, a high airway pressure is required only when sleep apnea occurs, but like the devices described in Patent Document 1 and Patent Document 2, a pressure higher than the conventional atmospheric pressure is applied to the entire exhalation period. In the technique, during sleep, even if sleep apnea does not occur, exhalation that always has high airflow resistance is forced, and exhalation cannot be sufficiently exhaled. In Non-Patent Document 1, Patent Document 2 It has been reported that there were difficulty in calling, discomfort in the nose, dry mouth, headache, and sleep apnea as malfunctioning symptoms when the nasal breathing device using the above technology was used in clinical research. In particular, in the case of patients who are not accustomed to treatment using such a device, there are patients who cannot continue treatment because they feel suffocating. For these reasons, it is difficult to improve the therapeutic effect by applying a high pressure equivalent to the positive pressure used in CPAP therapy. Therefore, Non-Patent Document 2 reports that the nasal respiratory apparatus using the technique described in Patent Document 2 is effective for patients with a mild to moderate apnea-hypopnea index.

The device described in Patent Document 3 is effective for the subsidence of the base of the tongue among the causes of obstructive sleep apnea syndrome, but other fat deposits around the neck, soft palate subsidence, and tonsillar hypertrophy. Does not exert any effect on. Therefore, it is effective only for patients whose main cause is subsidence of the base of the tongue.

When the device described in Patent Document 1 or Patent Document 2 is used instead of the CPAP device for a patient with a high apnea-hypopnea index, it is confirmed whether the apnea-hypopnea index is lowered when actually used. It may be necessary to use it while confirming whether it is effective in reducing the apnea-hypopnea index. Alternatively, it is necessary to use other physical stimulation techniques such as Patent Document 3 in combination.

The present invention uses an exhalation control valve using an elastic body to apply a pressure higher than atmospheric pressure to the upper airway during exhalation to open the airway, but obstructive respiratory disease, more specifically, obstructive. It assists the breathing of patients with sleep apnea syndrome, reduces breathing difficulty during exhalation, monitors and records the respiratory state by using a conductive elastic body, and when respiratory depression is detected, It provides a breathing apparatus that generates a physical stimulus that stimulates breathing.

In the present invention, a nasal mask covering the user's nostrils or a ventilation portion communicating with the nostrils, a housing forming a chamber for temporarily holding the user's exhaled breath, and an exhaled air temporarily held in the housing are released to the outside. An elastic body that has an opening to be provided and has a hole through which exhaled air flows in the housing in front of the opening and is deformed by pressure, and the elastic body is in contact with the hole edge of the hole by being pressure-deformed toward the opening. It has a breath control valve provided with a wall surface portion that closes the flow of exhaled breath, and has a conductive portion at least on the wall surface side of the elastic body and an electrode on the surface of the wall surface portion in contact with the elastic body. Provide the device. As the elastic body, a conductive film is preferably used.

A measuring means for measuring a change in electrical characteristics due to contact or approach between the conductive portion of the elastic body and the electrode is provided, and a change in electrical characteristics generated between the conductive portion of the elastic body and the electrode can be obtained. By providing a plurality of electrodes on the surface of the wall surface in contact with the elastic body, changes in electrical characteristics that occur between the electrodes due to contact between the conductive portion of the elastic body and the electrodes, or a plurality of conductivitys on the elastic body. By providing the sex site, a breathing device provided with a measuring means for measuring a change in electrical characteristics occurring between the conductive sites is provided.

The measuring means is a means for measuring the presence or absence of exhalation or fluctuations in expiratory pressure, and further, based on the result measured by the measurement recording means, information on respiration such as the number and time of apnea or hypopnea is obtained. Provided is a breathing apparatus further provided with a recording means for recording and a physical stimulating means for stimulating to reduce apnea and hypopnea.

The present invention is a respiratory device for treating patients with chronic respiratory diseases, more specifically, patients with obstructive sleep apnea syndrome, which reduces the difficulty of breathing of the user and detects hypoventilation and apnea. When it is done, it can be recorded and physical stimulation based on the detection result can be performed to stimulate the user's breathing and suppress the occurrence of sleep apnea.

In the respiratory apparatus configuration according to the first embodiment of the present invention, a schematic view of a state when a patient inhales is shown. In the respiratory apparatus configuration according to the first embodiment of the present invention, a schematic view when a patient starts exhalation is shown. In the respiratory apparatus configuration according to the first embodiment of the present invention, a schematic view is shown when the patient is continuing to exhale. In the respiratory apparatus configuration according to the first embodiment of the present invention, a schematic view of a rotary screw type wall surface portion of a position adjusting mechanism in which an electrode material is arranged is shown. In the respiration device configuration according to the first embodiment of the present invention, a flow rate / pressure pattern using a respiration simulator is shown. In the respirator configuration according to the first embodiment of the present invention, a pressure / measured value pattern using a respiration simulator and a measurement circuit is shown. In the respiratory apparatus configuration according to the second embodiment of the present invention, a schematic view of a state when a patient inhales is shown. A schematic view of an elastic body having a conductive material used in the respiratory device configuration according to the second embodiment of the present invention is shown. In the respiratory apparatus configuration according to the third embodiment of the present invention, a schematic diagram of a state when a patient inhales is shown. A schematic view of an elastic body having a conductive material used in the respiratory device configuration according to the third embodiment of the present invention is shown. In the respiratory apparatus configuration according to the fourth embodiment of the present invention, a schematic view of a state when a patient inhales is shown.

The breathing device of the present invention controls the timing of exhalation of exhaled air accompanying the user's spontaneous breathing, expels exhaled air through an exhaust valve in the early stage of exhalation, and exhales to the outside of the system in the latter half of exhalation. It is a device that maintains high airway pressure by suppressing release and opens the airway. Specifically, a housing that forms a space for temporarily holding the user's exhaled breath and an exhaled air temporarily held inside the housing are released to the outside through a nasal mask that covers the nostrils or a ventilation portion that communicates with the nostrils. It is a breathing apparatus provided with a first opening to be operated and an exhalation control valve for controlling exhalation from the first opening according to the pressure inside the space.

Such an exhalation control valve is a valve that closes when the pressure inside the space exceeds a predetermined value while exhaling is released to the first opening side at the start of exhaling of the patient, and is a first hole through which exhaled air flows. It has a pressure-deformable elastic body provided with the above, and a wall surface portion where the elastic body is pressure-deformed toward the first opening side of the housing so that the edge of the first hole is in contact with the elastic body. Immediately after the start of exhalation, the exhaled air is discharged from the vent through the first hole of the elastic body and the first opening of the housing, and the first hole is formed by the contact between the hole edge and the wall surface. Close and stop the exhalation from the first opening. The first hole of the elastic body needs to be closed when the hole edge and the wall surface portion come into contact with each other so that the positions of the first hole and the first opening on the wall surface portion do not overlap. One opening is preferably located on the outer peripheral portion of the edge of the first hole of the elastic body. However, in order to adjust the airflow resistance, the two may be partially overlapped to the extent that the effect of increasing the airflow resistance is not reduced.

Further, the elastic body is made of a conductive member having at least a part of conductivity, and by providing an electrode on the surface of the wall surface portion in contact with the conductive member, the elastic body and the wall surface portion are brought into contact with each other or approach to each other. It is possible to detect changes in the electrical characteristics between the member and the electrodes, measure the presence or absence of exhalation of the user, fluctuations in expiratory pressure, and record the measurement results.

The shape of the elastic body is deformed by the pressure of the exhaled breath of the user taken into the inside of the housing, such as the bellows structure, the piston structure, and the elastic membrane, and at least one first hole is formed in the portion deformed by the pressure. Is provided. As the elastic body having conductivity, an elastic film having a conductive layer laminated by a sputtering method, a vapor deposition method, a coating, etc., a rubber film having a conductive polymer laminated, and a simple structure make it easy to miniaturize. Therefore, a conductive silicone film obtained by kneading carbon black or the like with silicone can be used.

Since the elastic body is deformed by the pressure of the exhaled breath of the user, the first hole needs to have a total opening area sufficient to give airflow resistance to the expiratory pressure. Therefore, the total opening area is preferably 1000 mm2 or less, more preferably 500 mm2 or less. More preferably, it is 300 mm2 or less.

When a conductive elastic film is used as the elastic body having conductivity, the thickness of the conductive elastic film depends on the elastic coefficient of the material of the conductive elastic film, but it is easily deformed by exhalation. From the viewpoint of the durability of the conductive elastic film, it is preferably 1000 μm or less and 10 μm or more. More preferably, it is 500 μm or less and 20 μm or more.

As the electrode, a conductive layer laminated by a sputtering method, a vapor deposition method, coating, etc., or a metal plate, a metal wire, a carbon material, a conductive polymer, or the like can be used.

[Device according to the first embodiment]
The configuration of the respirator according to the first embodiment of the present invention is shown in FIGS. 1 to 4. Such a breathing device includes an elastic body 105 composed of a ventilation portion 101 inserted into the user's nostril and a conductive elastic film having a first hole 104 inside a housing 103 having a first opening 102, and elastic. It is composed of a wall surface portion 106, an intake hole 108, an intake valve 109, a one-sided valve 110, and a second opening 111 that close the hole by contacting the edge of the first hole due to pressure deformation of the body. Further, by connecting the housing 103 and the wall surface portion 106 in a rotary screw type, a distance adjusting mechanism 112 capable of adjusting the distance between the elastic body 105 and the wall surface portion 106 is provided. Two electrodes 107 are arranged on the wall surface 106, and a measurement terminal A114 and a measurement terminal B115 are connected to the ends of the electrodes.

The ventilation portion 101 is a tubular member that is inserted into the nostril of the user and is in close contact with the nostril, and introduces the exhaled breath of the user into the housing 103. The venting portion 101 may have a shape that is sealed from the outside air and communicates with the user's nostril, and is not limited to the prong shape that is inserted and closely inserted into the user's nostril shown in FIG. 1, and is not limited to the conventional CPAP therapy. A nasal mask shape or a tube shape to be inserted into the nostril can also be used.

The first opening 102 is a portion having an opening provided in the housing 103 for discharging the exhaled breath of the user taken into the housing 103 to the outside of the housing 103, and the first opening 102 is shown in FIG. Although the embodiment in which six openings are provided is shown as the openings 102 of the above, there may be one or a plurality of openings. The size of the first opening 102 is preferably such that the total opening area is larger than the opening area of the nostrils. Further, since it is open to the outside, the first opening 102 can be made into a large number of micropores so that foreign matter does not enter from the outside, and a net-like filter is provided in the first opening 102. May be good.

On the other hand, the valve 110 is provided inside the housing 103 between the venting portion 101 and the elastic body 105 in order to suppress the re-inhalation of exhaled air. On the other hand, the valve 110 allows the flow of air from the ventilation portion side to the elastic body 105 side and blocks the flow of air in the opposite direction. Therefore, during the exhalation period, exhalation is introduced to the elastic body 105 side to increase the internal pressure of the housing 103, and at the time of inspiration, the high-pressure exhalation filled on the elastic body 105 side flows back and the user rebreathes. Can be suppressed. Since the one-sided valve 110 is closed during intake, external air is supplied from the intake hole 108 where the intake valve 109 is located. Therefore, it is preferable that the intake hole 108 is provided between the ventilation portion 101 and the elastic body 105, and is provided on the ventilation portion 101 side of the valve 110.

In the present embodiment, the wall surface portion 106, which is the surface of the housing 103 having the first opening 102, is configured to face the first hole 104. As shown in FIG. 3, the wall surface portion 106 is installed so that the hole edge of the first hole 104 comes into contact with the wall surface portion when the elastic body 105 is deformed during exhalation of the user.

As a distance adjusting mechanism 112 for adjusting the distance between the elastic body 105 and the wall surface portion 106, a female screw is provided on the inner wall of the housing 103, and a male screw is provided on the outer peripheral surface of the wall surface portion having the first opening, and is provided on the outer side of the wall surface portion 106. By rotating the adjustment knob 113 provided, the distance between the wall surface portion 106 and the elastic body 105 can be finely adjusted. Thereby, the position of the wall surface portion 106 can be adjusted according to the breathing strength of the patient, and when the patient's expiratory pressure is low and the airflow resistance of the exhaled air is desired to be increased, the wall surface portion 106 and the elastic body 105 can be adjusted. By shortening the distance between them, it is possible to suppress the expiratory discharge at an early stage and to exert the effect of increasing the airflow resistance of the exhaled breath.

The distance adjusting mechanism 112 has a screw-shaped connection structure, but the present invention is not limited to this. For example, a method of adjusting the distance between the elastic body 105 and the wall surface portion 106 by a structure supported via an O-ring or the like instead of a screw-shaped connection structure, or a plurality of methods in which the distance between the elastic body 105 and the wall surface portion 106 is different. The structure may be prepared and exchanged so as to have a desired distance between the elastic body 105 and the wall surface portion 106. However, in that case, disassembly and assembly work is required to adjust the distance between the elastic body 105 and the wall surface portion 106, and a large number of replacement distance adjustment mechanisms 112 are prepared for fine adjustment of the distance. There is a need to.

In the breathing apparatus according to the present embodiment, as shown by the broken line arrow in FIG. 1, the air that has flowed into the room of the housing 103 through the intake hole 108 at the time of intake is introduced into the nostril of the user through the ventilation portion 101. For convenience, the dashed arrow indicating the airflow in the figure is shown only in one of the two intake holes 108 and the ventilation part 101, but the airflow of intake air to the other intake hole 108 and the ventilation part 101 without the broken line arrow is also shown. Occurs. This illustrated method is the same in FIGS. 2 and later.

Next, as shown in FIG. 2, the elastic body 105 starts to be deformed by the start of exhalation of the user. The exhaled air is discharged from the first opening 102 until the elastic body 105 is sufficiently deformed from the start of exhalation until the hole edge of the first hole 104 and the wall surface portion 106 come into contact with each other. As the exhalation progresses, the hole edge of the first hole 104 and the wall surface portion 106 approach each other, so that the flow path area decreases, the expiratory airflow decreases, and the internal pressure of the housing 103 increases at the same time. Then, as shown in FIG. 3, in the latter half of the exhalation, the airflow resistance of the exhalation increases due to the contact of the hole edge of the first hole 104 with the wall surface portion 106 to close the exhalation, and the internal pressure applied to the nasopharynx of the user. The internal pressure in the room of the same housing 103 as above greatly increases. Therefore, it is possible to apply a pressure higher than the atmospheric pressure to the nasopharynx by lowering the airflow resistance of the exhaled breath at the start of exhalation and continuing the expiratory discharge. As a result, the airway of the user can be opened to reduce the symptoms of obstructive sleep apnea syndrome, and the pressure at the initial stage of exhalation can be reduced to reduce the suffocation of the user.

On the other hand, when the exhalation is finished, the pressurization in the housing 103 by the exhalation of the user is finished, and the elastic body 105 returns to the original shape. The exhaled air in the housing 103 that is pressurized and filled through the first hole 104 and the first opening 102 is discharged to the outside of the system. Then, when the intake air is restarted, the external air is introduced into the user's nostril from the ventilation portion 101 via the intake hole 108.

In the breathing apparatus of the first embodiment, carbon black having a thickness of 50 μm is kneaded as a conductive elastic body 105 between the ventilation portion 101 and the first opening 102 inside the housing 103. A conductive silicone rubber film is used.

Further, as shown in FIG. 4, the electrode 107 is provided with measurement terminals A114 and B115 on the opposite surfaces through two copper wires passing through the first opening 102 of the wall surface portion of the rotary screw type. An opening different from the first opening 102 can be provided in the wall surface 106 to embed a conductive member, or a part of the rotary screw type wall surface 106 can be made of a conductive material to form an electrode. is there.

When the hole edge of the first hole 104 comes into contact with the wall surface portion 106 due to the exhalation of the user, the elastic body 105 and the two electrodes 107 on the wall surface portion 106 are in a conductive state. This makes it possible to measure the change in electrical characteristics that occurs between the measurement terminal A114 and the measurement terminal B115. Here, the electrical characteristics are current, voltage, electrical resistance, capacitance, and electrical impedance that can be electrically measured, and include an elastic body 105 and electrodes made of a conductive elastic film that accompanies the user's breathing. The change in electrical characteristics between the wall surface portion 106 and the wall surface portion 106 can be measured. This makes it possible to measure and record the respiratory state of the user during sleep without using a special sensing device.

In addition, it is possible to detect the presence or absence of abnormalities in the respiratory state by performing a comparison calculation of the measurement data with preset conditions, and while the user is using the respiratory device of the present invention, apnea is possible. It is possible to record how often or hypopnea occurs. In addition, if the apnea or hypopnea state continues for a certain period of time, or if the apnea or hypopnea exceeds a certain frequency, an abnormality can be detected as a sleep apnea state, and an alarm is displayed and an alarm is issued. it can.

By linking the respiratory state detection circuit and the physical stimulator, when an abnormality such as apnea is detected, the physics for stimulating the user's breathing such as electrical stimulation, magnetic stimulation, and mechanical stimulation to the tongue muscle. By stimulating, the apnea state can be resolved. Patent Document 3 discloses a device capable of applying electrical stimulation to the tongue in response to a change in the position of the tongue detected by the sensor, but according to the present invention, a sensor that detects the position of the tongue is unnecessary. It is only necessary to place the stimulation electrode at the position where the electrode for electrical stimulation to the tongue comes into contact with the tongue in the oral cavity. In addition to the method of directly stimulating the user, indirect stimulus methods such as changing the inclination of pillows and bedding such as beds, adjusting the illuminance of lighting, and adjusting the acoustic environment can also be adopted.

As described above, in the breathing apparatus of the present invention, the conductive material 116 portion is added to at least the wall surface side of the elastic body 105 and the electrode 107 is provided on the surface of the wall surface portion 106 in contact with the elastic body, and a change in electrical characteristics is detected therein. It can be configured as a device provided with a detection circuit for performing, a device provided with recording means, and a physical stimulating means for stimulating respiration based on the detection result.

[Example 1]
In the respirator according to the first embodiment, the ventilation unit 101 was connected to the ASL5000 respiration simulator manufactured by INGMAR MEDICAL via a flow path imitating the inside of the nasopharynx of an adult, and was measured by artificially generated respiration. The flow rate / pressure pattern is shown in FIG. Breathing rate is 12 bpm, expiratory muscle pressure is 10 cmH2O, inspiratory muscle pressure is 10 cmH2O, inspiratory rise time is 10% of one breathing cycle, expiratory rise time is 15%, inspiratory release time is 10%, expiratory release time is 10%, expiratory retention It was set to be 55%.

As the conductive elastic membrane which is the elastic body 105 of the breathing device, conductive silicone rubber having a thickness of 50 μm, a volume resistivity of 3 Ω · cm, and a portion capable of elastic deformation having a diameter of 50 mm is used, and the diameter of the first hole 104 is 14 mm. The distance between the elastic body 105 and the wall surface portion 106 is set to 85 mm, and the first opening 102 is a hole having a diameter of 6 mm at a position where it does not overlap with the first hole 104 when viewed perpendicularly to the surface of the elastic body 105. 6 were provided. The total opening area of the intake hole 108 was 280 square mm, and the intake valve 109 was a membrane type on-off valve using a silicone rubber film having a thickness of 100 μm. The opening area of the second opening 111 was set to 0.8 square mm.

As this result shows, the expiratory airflow is generated at the initial stage of exhalation, but the effect that the expiratory airflow decreases in the middle of the expiratory time and the internal pressure of the housing increases at the same time can be confirmed. This indicates that it is possible to increase the expiratory pressure from the middle of exhalation and increase the pressure in the airway at the end of exhalation, which is effective for airway patency, while reducing the pain in the early stage of exhalation. This exhalation pattern varies depending on the exhalation intensity, but it should be variously designed according to the distance between the elastic body 105 and the wall surface 106, the size of the first hole 104, and the size of the second opening 111. Can be done.

In FIG. 6, a 5 V constant voltage power supply and a 5.1 kΩ resistor are connected in series between the measurement terminal A114 and the measurement terminal B115 so that the voltage between both terminals of the resistor can be measured. The pressure / voltage pattern when the internal pressure and the voltage between both terminals of the resistor can be measured simultaneously with a data logger is shown. Until time T, artificially generated respiration was given under the same conditions as in FIG. 5, and from time T, the expiratory muscle pressure was changed to 4 cmH2O and the inspiratory muscle pressure was changed to 4 cmH2O, and the measurement was continued.

As this result shows, when the expiratory pressure is sufficient and the elastic body 105 is in contact with the wall surface portion 106, the voltage between both terminals of the resistor rises, the expiratory pressure becomes weak, and the elastic body 105 reaches the wall surface portion 106. It was confirmed that the voltage between both terminals of the resistor did not change when it was deformed and became in contact with each other.

[Device according to the second embodiment]
FIG. 7 shows, in the breathing apparatus according to the first embodiment, the elastic body 105 is an elastic body 205 which is a non-conductive elastic film on which the conductive material 216 shown in FIG. The electrode material 207 was laminated.

In the present embodiment, the conductive material 216 laminated on the elastic body 205 needs to be thin enough not to significantly affect the elastic characteristics of the elastic body 205. Further, the conductive materials 216 are independently laminated so as to form two patterns, and measurement terminals A214 and B215 are provided at both ends of each. Also with this configuration, as in the breathing apparatus according to the first embodiment, the expiratory airflow is generated at the initial stage of exhalation, but the expiratory airflow decreases in the middle of the expiratory time, and the internal pressure of the housing 203 increases at the same time. And the effect that the measurement result of the change in the electrical characteristics generated according to the contact state between the elastic body 205 and the wall surface 206 can be obtained.

[Device according to the third embodiment]
FIG. 9 shows, in the breathing apparatus according to the first embodiment, the elastic body 105 is an elastic film on which the conductive material 316 shown in FIG. 10 is laminated, and one electrode material 307 is arranged on the rotary screw type wall surface portion 306. The elastic membrane and the electrodes were each provided with terminals. According to this configuration, since the conductive material 316 is concentrically laminated on the surface of the elastic body 305, the elastic characteristics in the radial direction from the center of the elastic body become uniform. In this case, the same conductive elastic film as the elastic body 105 used in the first embodiment can be used.

[Device according to the fourth embodiment]
FIG. 11 shows a mode in which the one-side valve 110 is omitted in the breathing apparatus according to the first embodiment. In this case, when the intake valve 409 is opened at the time of intake, a part of the exhaled air remaining inside the housing 403 is rebreathed together with the air from the outside flowing from the intake hole 408, but the structure is simplified. ..

As described above, in the present invention, in the technique of applying a pressure higher than atmospheric pressure to the nasopharynx at the time of exhalation to open the airway, obstructive breathing disease, more preferably obstructive sleep apnea, which reduces suffocation. Respiratory devices for treating patients with apnea syndrome can be provided.

101, 201, 301, 401:

Ventilation portions

102, 202, 302, 402: First openings 103, 203, 303, 403:

Housing

104, 204, 304, 404:

First holes

105, 205, 305 , 405:

Elastic bodies

106, 206, 306, 406:

Wall surface portions

107, 207, 307, 407:

Electrodes

108, 208, 308, 408: Intake holes 109, 209, 309, 409:

Intake valves

110, 210, 310: On the other hand,

valves

111, 211, 311, 411: Second opening 112, 212, 312, 412:

Position adjustment mechanism

113, 213, 313, 413:

Adjustment knob

114, 214, 314, 414: Measurement terminal A
115, 215, 315, 415: Measurement terminal B
116, 216, 316, 416: Conductive material

Claims

A nasal mask covering the user's nostrils or a ventilation part communicating with the nostrils, a housing forming a chamber for temporarily holding the user's exhaled breath, and an opening for discharging the exhaled air temporarily held in the housing to the outside. In the housing in front of the opening, an elastic body that has a hole through which exhaled air flows and is deformed by pressure, and an elastic body that is pressure-deformed toward the opening side and comes into contact with the hole edge of the hole to flow exhaled air. A breathing apparatus comprising an exhalation control valve provided with a wall surface portion for closing the wall surface, and having a conductive portion on at least the wall surface side of the elastic body and an electrode on the surface of the wall surface portion in contact with the elastic body.
The respirator according to claim 1, wherein the elastic body is a conductive membrane.
The breathing apparatus according to claim 1 or 2, further comprising a measuring means for measuring a change in electrical characteristics due to contact or approach between a conductive portion of the elastic body and the electrode.
A plurality of electrodes are provided on the surface of the wall surface in contact with the elastic body, and a measuring means for measuring changes in electrical characteristics that occur between the electrodes due to contact or approach between the conductive portion of the elastic body and the electrodes is provided. The respiratory device according to claim 2.
The second aspect of claim 2, further comprising a measuring means for measuring a change in electrical characteristics generated between the conductive portion of the elastic body and the electrode due to contact or approach between the conductive portion of the elastic body and the electrode. Breathing device.
The elastic body is provided with a plurality of conductive parts, and is provided with a measuring means for measuring a change in electrical characteristics generated between the conductive parts when the conductive parts of the elastic body and an electrode come into contact with each other or approach each other. The breathing apparatus according to claim 2.
The breathing apparatus according to any one of claims 1 to 6, wherein the means is a means for measuring the presence or absence of exhalation or fluctuations in expiratory pressure.
The respiratory device according to any one of claims 1 to 7, further comprising a recording means for recording information related to respiration from the measurement result of the measuring means.
The respiratory device according to any one of claims 1 to 8, further comprising a physical stimulating means for performing respiratory stimulation based on the measurement result of the measuring means.