WO2022181459A1 - Breathing apparatus - Google Patents

Breathing apparatus Download PDF

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Publication number
WO2022181459A1
WO2022181459A1 PCT/JP2022/006518 JP2022006518W WO2022181459A1 WO 2022181459 A1 WO2022181459 A1 WO 2022181459A1 JP 2022006518 W JP2022006518 W JP 2022006518W WO 2022181459 A1 WO2022181459 A1 WO 2022181459A1
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WO
WIPO (PCT)
Prior art keywords
valve body
opening
valve
respiratory
exhalation
Prior art date
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PCT/JP2022/006518
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French (fr)
Japanese (ja)
Inventor
典彦 中尾
健司 中嶋
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帝人ファーマ株式会社
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Publication of WO2022181459A1 publication Critical patent/WO2022181459A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06Respiratory or anaesthetic masks
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/20Valves specially adapted to medical respiratory devices

Definitions

  • the present invention relates to a therapeutic device for treating patients with respiratory diseases.
  • bronchial asthma chronic obstructive pulmonary disease
  • interstitial pneumonia obstructive sleep apnea
  • obstructive sleep apnea obstructive sleep apnea
  • Obstructive sleep apnea syndrome occurs due to narrowing of the upper airway during sleep, and in addition to fatty deposits around the neck and throat, enlarged tonsils, and muscle relaxation, the airway may be obstructed due to the lowering of the base of the tongue and soft palate. considered to be the main cause.
  • the symptom is that the respiratory airflow in the mouth and nose stops for a certain period of time or the ventilation volume drops below a certain amount, which occurs multiple times during sleep.
  • Hypopnea is defined as a state in which the is decreased to 50% or less of the normal state for 10 seconds or more, and is diagnosed by the apnea-hypopnea index, which is expressed as the number of apnea and hypopnea per hour.
  • this number is 30 or more, it is evaluated as severe, and excessive daytime sleepiness occurs frequently, and it is known that the risk of cardiovascular diseases such as high blood pressure, stroke, and myocardial infarction increases.
  • cardiovascular diseases such as high blood pressure, stroke, and myocardial infarction increases.
  • Diagnosis of such obstructive sleep apnea syndrome is usually performed by a simplified sleep breathing monitor, polysomnography, or the like.
  • Obstructive sleep apnea syndrome is a disease that is particularly common in obese middle-aged and elderly men, but the patients themselves often do not notice the symptoms that occur during sleep at night, and in recent years it has become one of the causes of traffic accidents. It has become a social problem, and countermeasures are required.
  • CPAP therapy prevents airway obstruction by continuously supplying air to the respiratory tract.
  • pressurized air is supplied from a pressurized air generator (CPAP device) used for CPAP therapy through an air tube and a nasal mask to the respiratory tract. It keeps the airway open by supplying it to the airway, prevents airway obstruction during sleep, and prevents the occurrence of apnea.
  • CPAP device pressurized air generator
  • CPAP therapy In CPAP therapy, the CPAP device constantly sends air with pressure higher than the atmospheric pressure to the respiratory tract, so patients may experience discomfort and symptoms such as inability to sleep at the start of treatment. In addition, CPAP therapy may be interrupted due to the troublesomeness of putting on and taking off the nasal mask.
  • Patent Documents 1 and 2 as a device of the type inserted into the nostrils, it is possible to apply a pressure higher than atmospheric pressure with high airflow resistance during exhalation, while using a valve structure to apply atmospheric pressure to the nasopharynx during exhalation. Techniques have also been disclosed that apply a higher pressure to open the airway and alleviate the symptoms of sleep apnea syndrome, but the additional pressure during exhalation may cause suffocation.
  • the present invention relates to techniques disclosed in conventional Patent Documents 1 and 2 that reduce suffocation by enabling exhalation in the early stages of expiration.
  • the present invention controls the timing of exhalation of the user's exhalation to the outside of the system, exhaling the exhalation to the outside of the system in a state close to resting breathing in the early stage of exhalation, and suppressing exhalation to the outside of the system in the latter half of exhalation.
  • This provides a device that maintains a high airway pressure and keeps the airway open.
  • the present invention comprises a housing provided with a breathing passage for circulating the user's inhaled air and exhaled air, a ventilation part connected to the user's nostrils, and an opening serving as an exhalation outlet and an inhalation inlet for the exhaled air.
  • a valve element movable by the flow of exhaled air in the respiratory channel inside the housing, and an exhalation shut-off valve that closes the opening after a predetermined period of time from the start of exhalation.
  • the expiratory shut-off valve is characterized by comprising a valve body supporting portion that supports the valve body in the respiratory passage, and a guide portion that moves the valve body to the opening, wherein: 1) a doughnut-shaped disc shape; a valve body, a cross frame that supports the valve body in the respiratory channel, and a guide shaft that moves the valve body between the cross frame provided in the opening, 2)
  • a respiratory apparatus characterized by comprising a spherical or disk-shaped valve body, a support for supporting the valve body, and a guide part for moving the valve body on the inner surface of the housing between the support and the opening. I will provide a.
  • the present invention also provides a partition plate in which the expiratory stop valve comprises: 3) a partition plate that supports the valve body, partitions a part of the respiratory passage inside the housing, and has a hole through which part of the exhaled air can flow;
  • a breathing apparatus characterized by having a valve body movable by exhalation on the opening side of a partition plate, the valve body being moved by exhalation through a hole in a partition plate to close the opening.
  • the present invention is characterized by having a valve body movable between the partition plate and the opening, and a guide shaft or framework for guiding the movement of the valve body, wherein the guide shaft passes through the doughnut-shaped membrane valve body and its central hole. , or a valve having a spherical valve body and a guide frame for guiding it, wherein the guide shaft or the guide frame is between the partition plate and the opening and passes through the center of the vent and the housing
  • a respiratory apparatus characterized by being obliquely arranged with respect to.
  • the present invention changes the size of the holes in the partition plate, includes means for adjusting the ventilation rate of exhaled breath, and has a disk with a curved notch portion, or a plurality of holes with different sizes on the circumference.
  • a disk is arranged in close contact with the partition plate, and means for changing the size of a hole in the partition plate by rotating the disk, and the hole in the partition plate is a U-shaped notch.
  • the present invention provides a breathing apparatus having a pressure regulating hole in the housing for reducing part of the pressure increase that occurs when the opening is closed by the exhalation shutoff valve, and the exhalation shutoff valve abuts against the opening.
  • a breathing apparatus having a damping mechanism at the opening that reduces vibrations or sounds that occur during breathing.
  • a device smaller than the prior art which exhaled as well as normal in the early exhalation It is a device that makes it possible to exhale and creates high airflow resistance from the middle to the end of expiration to apply pressure higher than atmospheric pressure to the nasopharynx and open the airway. It is possible to provide a device that reduces suffocation during treatment.
  • FIG. 1 shows an external view of a first embodiment of the respiratory apparatus of the present invention
  • FIG. 1 shows a cross-sectional view of a first embodiment of the respiratory apparatus of the present invention
  • FIG. Figure 2 shows a cross-sectional view of a second embodiment of the respiratory apparatus of the present invention
  • Figure 3 shows a cross-sectional view of a third embodiment of the respiratory apparatus of the present invention
  • Fig. 3 shows an external view of a fourth embodiment of the respiratory apparatus of the present invention
  • Fig. 3 shows a cross-sectional perspective view of a fourth embodiment of the respiratory apparatus of the present invention
  • Fig. 3 shows a cross-sectional view of a fourth embodiment of the respiratory apparatus of the present invention
  • FIG. 1 shows an external view of a first embodiment of the respiratory apparatus of the present invention
  • FIG. 1 shows a cross-sectional view of a first embodiment of the respiratory apparatus of the present invention
  • FIG. Figure 2 shows a cross-sectional view of a second embodiment of the respiratory apparatus of the present invention
  • FIG. 3 shows a schematic diagram of the relationship between the respiratory airflow and the exhalation shut-off valve of the respiratory apparatus of the present invention
  • FIG. 11 illustrates flow variation when using the respiratory apparatus of the present invention
  • FIG. Figure 2 shows the variation in pressure when using the respiratory apparatus of the present invention
  • 1 shows an example of means for adjusting the aperture of the partition plate by combining the partition plate and the disc of the respiratory apparatus of the present invention.
  • Fig. 2 shows the difference in closing timing of the opening of the exhalation stop valve due to the difference in the size of the hole in the partition plate in the respiratory apparatus of the present invention.
  • FIG. 3 shows a schematic diagram of the operation of a buffer mechanism that reduces vibrations and sounds that occur when the valve body of the exhalation stop valve comes into contact with the opening in the respiratory apparatus of the present invention.
  • Fig. 1 shows an external view of a respiratory apparatus that is one embodiment of the present invention
  • Fig. 2 shows a cross-sectional perspective view of the embodiment when cut along the A-A' plane in Fig. 1.
  • 3 and 4 show cross-sectional perspective views of second and third embodiment respirators. The external views of the second and third embodiments are the same as FIG. 1 of the first embodiment.
  • the respiratory apparatus of the present invention includes a housing 2 having a respiratory channel for circulating the user's inhaled air and exhaled air, a ventilation part 1 connected to the user's nostrils, an exhaled air outlet and an inhaled air.
  • a respiratory apparatus with an opening 3;
  • a valve body 10 that is movable by the flow of exhalation in the respiratory passage inside the housing 2, and providing an exhalation closing valve 5 that closes the opening 3 after a predetermined time elapses after the start of exhalation, exhalation is started.
  • exhaled air is exhaled outside the system, and after the opening 3 is closed, the amount of exhaled exhaled air is suppressed to keep the pressure inside the housing 2, that is, the airway pressure high, thereby suppressing airway obstruction.
  • the expiratory stop valve 5 includes a valve body supporting portion 12 that supports the valve body 10 in the middle of the respiratory passage. Acting as a guide during movement, the valve body 10 is moved to the opening 3 by the flow of exhalation, and the valve body 10 is moved to the valve body support 12 by the flow of inhalation. A space between the valve body 10 and the inner wall of the housing 2 serves as a respiratory passage, and intake and exhaust are performed between the ventilation section 1 and the opening section 3 on the nostril side.
  • the valve body supporting portion 12 holds the valve body 10 of the exhalation shutoff valve 5 on the respiratory channel.
  • the valve body support portion 12 can be designed and used in various shapes such as a cross frame, a rib, and a mesh composition.
  • the guide portion 11 guides the movement of the valve body 10 between the valve body support portion 12 and the opening portion 3, and as shown in FIG.
  • ribs may be provided on the inner surface of the housing 2 between the opening 3 and the valve body support part 12, or a guide frame for movement of the valve body 10 may be provided.
  • a doughnut-shaped disk-shaped valve body is used, and a guide shaft 11' for moving the valve body 10 is provided between the cross frame supporting the valve body 10 and the cross frame of the opening 3, thereby achieving high accuracy.
  • the opening 3 can be opened and closed by the valve body 10 .
  • Figure 4 shows a third embodiment of the respiratory apparatus of the present invention.
  • the time from the start of exhalation by the user until the expiratory stop valve 5 closes the opening 3 depends on the movement distance of the valve body 10, the distance from the valve body support 12 to the opening 3, the size and weight of the valve body 10, etc. can be designed as appropriate by changing
  • the valve closing time can be adjusted by adjusting the amount of exhaled air hitting the valve body 10 .
  • the respiratory apparatus of FIG. 4 is provided with a rectifying plate 13 having an aperture through which a portion of exhaled air passes as a valve supporting portion 12 .
  • Figure 5 shows a fourth embodiment of the respiratory apparatus of the present invention.
  • Such a respiratory apparatus includes a ventilation part 1 which is inserted into and close to the user's nostrils, and a respiratory channel through which the user's inhalation and exhalation flow, and a housing 2 which forms a chamber for temporarily holding the user's exhalation. , and an opening 3 serving as an outlet for exhaled air and an inlet for inhaled air.
  • a respiratory channel through which exhaled air and intake air can flow
  • a partition plate 4 that partitions a part of the respiratory channel and has a hole through which a part of the exhaled air can flow
  • a partition On the open side of the plate is an expiratory shut-off valve 5 with a valve body 10 movable by respiratory inhalation and exhalation.
  • a buffer mechanism 6 that reduces vibrations and sounds generated when the valve body 10 of the exhalation stop valve contacts the opening 3, and an adjustment that reduces part of the pressure increase that occurs when the opening 3 is closed by the valve body 10.
  • a pressure hole 7 is provided.
  • the ventilation part 1 is a cylindrical member that is inserted into the nostrils of the user and is in close contact with the nostrils, and introduces the user's breath into the housing 2 .
  • the ventilation part 1 may have any shape as long as it is sealed from the outside air and communicates with the nostrils of the user.
  • the ventilation part is made of a flexible material different from the housing 2 in order to ensure close contact with the inner wall of the nasal cavity. 1 may be formed, preferably a cylindrical member made of silicone, for example.
  • the housing 2 is connected to the ventilation part 1 and installed between the user's nostrils and the upper lip, and has a size that fits between the nostrils and the upper lip so as not to disturb the user's sleep. length, preferably 15 mm or less. In addition, it is sufficient that the device is of a size that does not interfere with each other even if the devices are attached to both nostrils, and the width is preferably 20 mm or less. A circular or elliptical shape is preferable as long as the shape does not interfere with the skin even when worn in various directions of the nasal cavity.
  • the opening 3 discharges the user's exhaled air taken inside the housing 2 to the outside of the housing 2 during exhalation, and ventilates the outside air to the user through the housing 2 during inhalation. It is an opening provided.
  • the size of the opening 3 is desirably larger than the opening area of the nostrils in order to suppress breathing resistance. It has a fixed portion for supporting the guide shaft 11'.
  • the partition plate 4 is provided in the interior of the housing 2, partitions a part of the respiratory channel, has a hole through which part of the exhaled air can flow, and functions as the straightening plate 13 of the third embodiment. Fulfill.
  • the partition plate 4 is provided with a disc 8 for adjusting the size of the hole through which exhaled air passes.
  • the disc 8 has a curved notch shown in FIG.
  • a disc 8 is arranged in close contact with the partition plate 4, and by rotating the disc 8, the size of the hole 9 of the partition plate 4 can be adjusted. This makes it possible to adjust the closing time of the expiratory stop valve, which will be explained below.
  • one or more holes having a diameter of 0.8 mm or more may be provided on the extension line of the ventilation part 1 for efficient circulation of exhaled air from the nasal cavity of the user.
  • a slit with a width of 2 mm was used.
  • the expiratory stop valve 5 has a valve body 10 that acts as an expiratory flow path resistance movable between the center of the opening 3 and the partition plate 4, and a guide shaft 11' that supports it.
  • the valve body 10 is a membrane or spherical lightweight member that moves with the user's exhalation, and examples thereof include resin membranes made of polyurethane, polyethylene, polystyrene, polyvinyl chloride, polyethylene terephthalate, and lightweight resin balls. be done. More preferably, a resin thin film, which is a flexible member, can be used. In this embodiment, a polyurethane sheet with an outer diameter of 13 mm and a doughnut-shaped thin film with a thickness of 100 ⁇ m is used, and the valve body 10 is supported at the center. A guide shaft 11' is provided. In addition, moisture contained in exhaled air may increase the weight of the device and cause malfunction, so a water-repellent material is even better.
  • the guide shaft 11' that supports the valve body 10 of the expiratory stop valve 5 serves as a guide when the valve body 10 moves according to the flow of exhalation or inspiration.
  • a cylindrical structure is mentioned. Furthermore, it is preferable to use a round bar so that interference with the valve element 10 can be minimized regardless of the installation direction.
  • the guide shaft 11' is preferably arranged downwardly with an inclination of 1 to 45° from the partition plate 4 toward the opening 3, more preferably. are arranged with an inclination of 10 to 15°. In this embodiment, the inclination is 15°.
  • the pressure adjustment hole 7 is provided below the opening 3 in the direction of inclination of the guide shaft 11', and the pressure adjustment hole 7 is positioned downward. It is desirable to fit the nostrils in one orientation.
  • FIG. 8D is a schematic diagram of the relationship between the respiratory airflow and the expiratory stop valve 5.
  • the user's exhaled air passes through the nostrils, the ventilation part 1, the respiratory passage in the housing 2, and is discharged outside the system from the opening 3.
  • part of the exhaled air passes through the hole 9 provided in the partition plate 4 inside the housing 2 and hits the valve element 10 made of resin film of the exhalation stop valve 5, and guide shaft 11' supporting the valve element 10. , to the opening 3 side.
  • the valve body 10 of the expiratory stop valve abuts against the opening 3 to close the opening 3 .
  • expiratory discharge is suppressed and high airflow resistance is generated, which increases the airway pressure. Suppresses airway obstruction.
  • valve body 10 returns to the original position of the partition plate 4, and outside air passes through the respiratory passage in the housing 2 from the opening 3, and is inhaled from the user's nasal cavity through the vent 1.
  • the pressure regulating hole 7 is a hole provided in the housing 2 for discharging the user's exhaled air taken into the housing 2 after the opening 3 is closed by the exhalation shutoff valve 5 to the outside of the housing 2. be.
  • the size of the pressure adjusting hole 7 is desirably a micro hole, more preferably 2 mm or less in diameter, in order not to excessively reduce the internal pressure of the housing 2 that has increased after the opening 3 is closed by the exhalation stop valve 5 .
  • One pressure adjusting hole 7 may be provided, or a plurality of pressure adjusting holes may be provided so that the size of the opening can be selected according to the user's breathing ability.
  • two micro holes having a diameter of 1 mm or less are provided, and either or both of the micro holes can be used for exhaust.
  • the pressure adjusting hole 7 be arranged along the inner wall of the lower end of the housing 2 so that water droplets accumulated in the housing 2 due to condensation of exhaled air can be discharged.
  • the flow rate fluctuations (Fig. 9) and pressure fluctuations (Fig. 10) in the housing 2 when the respiratory apparatus of the present invention is attached to an oxygenator and used are shown.
  • the flow of exhalation and inhalation corresponding to the respiration generated by the artificial lung is generated, and the closing of the opening 3 by the exhalation shutoff valve 5 stops the flow of exhalation to the outside of the system, and the excess from the pressure regulation hole 7 Air is discharged, and the internal pressure of the housing 2 is maintained at a high level until the start of inspiration, although there is a slight decrease due to the outflow of exhaled air from the pressure regulating hole 7 .
  • FIG. 11 shows an embodiment of the partition plate 4 and the disk 8 for adjusting the size of the hole 9 in the partition plate 4 through which part of the exhaled air passes.
  • a circular partition plate 4 shown in 11A is provided with a U-shaped hole 9 through which part of exhaled air passes.
  • a disk 8 having a curved notch portion shown in (11B) is placed in close contact with the partition plate 4 on the ventilation part side of the partition plate 4. By rotating the disk 8, the hole of the partition plate 4 can be opened.
  • the size of 9 is adjustable. As a result, the amount of exhaled air passing through the hole 9 of the partition plate 4 can be adjusted. can be adjusted.
  • the apertures 9 of the partition plate are provided on the extension line of the ventilation part for efficient circulation of exhaled air from the nostrils of the user. Holes of various shapes such as circular, elliptical, and square can be selected. In this embodiment, the slit is 2 mm wide.
  • the disk 8 for adjusting the size of the hole 9 of the partition plate 4 the disk 8 having a curved notch portion is shown in 11B of FIG. It is possible to adopt a shape and a combination that can adjust the amount of exhaled air passing through the hole 9 of the partition plate 4, such as using an arranged adjusting disk 8.
  • the state in which the U-shaped hole 9 of the partition plate 4 is completely opened (11C) by the notch portion of the adjustment disk 8 is 75% open (11D).
  • the degree of opening of the hole 9 can be adjusted by rotating the disc 8 in the opened state as shown in FIG. 11E.
  • the closing time of the expiratory stop valve 5 of the respiratory apparatus of the present invention can be adjusted relative to the respiratory flow generated by the artificial lung.
  • FIG. 11 shows the mechanism for adjusting the holes 9 using the disk-like partition plate 4 as an example. It can be designed in various shapes, such as a semi-circle, depending on the size of the respiratory channel required, as well as matching the shape inside the body 2 .
  • a sound is generated when the valve body 10 of the exhalation shutoff valve 5 abuts against the opening 3 and stops exhalation of exhaled air to the outside of the system. Since noise is generated in synchronization with breathing during sleep, noise reduction is required.
  • a damping mechanism 6 for suppressing the generation of vibration and noise when the valve body 10 comes into contact with the opening 3 is attached to the joining portion of the guide shaft 11' of the valve body 10 of the opening 3. is preferably provided.
  • FIGS. 13 and 14 show a buffer mechanism 6 having an elastic four-branch structure provided at a fixed portion of a guide shaft 11' that supports the valve body 10 at the center of the opening 3.
  • FIG. Such a buffer mechanism 6 is a member that interferes with the generation of sound and impact due to contact with the housing 2 when the valve body 10 of the exhalation stop valve 5 pushed out by exhalation closes the opening 3, Any elastic thin film may be used.
  • the technique of applying pressure higher than atmospheric pressure to the epipharynx during exhalation to open the airway reduces suffocation, and treats patients with obstructive respiratory diseases, more preferably obstructive sleep apnea syndrome.
  • a therapeutic respiratory apparatus can be provided.
  • ventilation part 2 housing 3: opening 4: partition plate 5: expiratory stop valve 6: buffer mechanism 7: pressure adjustment hole 8: adjustment disk 9: partition plate hole 10: valve body 11: guide part , 11′: guide shaft 12: valve support portion 13: current plate

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  • Health & Medical Sciences (AREA)
  • Emergency Medicine (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
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Abstract

Provided is a breathing apparatus that is equipped with an expiration closing valve that is provided with, in a respiration flow passage inside a housing, a valve body capable of being moved by the flow of expiration, and that closes an opening after a prescribed period of time has elapsed since the beginning of expiration. As a result, the breathing apparatus controls the timing for discharge of a user's expiration out of the system so as to maintain the internal pressure in an airway during expiration and to make the airway open.

Description

呼吸装置breathing apparatus
  本発明は、呼吸疾患の患者を治療するための治療装置に関する。   The present invention relates to a therapeutic device for treating patients with respiratory diseases.
 呼吸器疾患には、気管支喘息や慢性閉塞性肺疾患、間質性肺炎、閉塞性睡眠時無呼吸症など各種存在し、その中でも閉塞性呼吸器疾患である慢性閉塞性肺疾患や閉塞性睡眠時無呼吸症の患者が近年増えている。 There are various types of respiratory diseases such as bronchial asthma, chronic obstructive pulmonary disease, interstitial pneumonia, and obstructive sleep apnea. The number of patients with apnea has increased in recent years.
 閉塞性睡眠時無呼吸症候群は、睡眠時に上気道が狭窄することにより発生し、首喉まわりの脂肪沈着や扁桃肥大の他、筋弛緩により舌根部や軟口蓋が下がることにより気道が閉塞することが主な原因とされている。その症状は、睡眠中に口、鼻の呼吸気流が一定時間停止あるいは一定量以下の換気量に低下することが複数回起こるものであり、10秒以上呼吸が停止する場合を無呼吸、換気量が通常の50%以下に低下した状態が10秒以上続く場合を低呼吸と呼び、この無呼吸および低呼吸の1時間当たりの回数で表される無呼吸低呼吸指数によって診断される。この回数が30回以上となると重症と評価され、日中に過剰な眠気が頻繁に発生し、さらには高血圧や脳卒中、心筋梗塞など心血管系疾患発生の危険性も高くなることが知られている。このような閉塞性睡眠時無呼吸症候群の診断は、通常、簡易型睡眠呼吸モニターやポリソムノグラフィーなどによって行われる。 Obstructive sleep apnea syndrome occurs due to narrowing of the upper airway during sleep, and in addition to fatty deposits around the neck and throat, enlarged tonsils, and muscle relaxation, the airway may be obstructed due to the lowering of the base of the tongue and soft palate. considered to be the main cause. The symptom is that the respiratory airflow in the mouth and nose stops for a certain period of time or the ventilation volume drops below a certain amount, which occurs multiple times during sleep. Hypopnea is defined as a state in which the is decreased to 50% or less of the normal state for 10 seconds or more, and is diagnosed by the apnea-hypopnea index, which is expressed as the number of apnea and hypopnea per hour. If this number is 30 or more, it is evaluated as severe, and excessive daytime sleepiness occurs frequently, and it is known that the risk of cardiovascular diseases such as high blood pressure, stroke, and myocardial infarction increases. there is Diagnosis of such obstructive sleep apnea syndrome is usually performed by a simplified sleep breathing monitor, polysomnography, or the like.
 閉塞性睡眠時無呼吸症候群は、特に肥満の中高年男性に多くみられる疾病であるが、患者自身は夜間の睡眠中に発生する症状に気が付かないことも多く、近年、交通事故発生の1つの原因として社会問題となっており、対策が求められている。 Obstructive sleep apnea syndrome is a disease that is particularly common in obese middle-aged and elderly men, but the patients themselves often do not notice the symptoms that occur during sleep at night, and in recent years it has become one of the causes of traffic accidents. It has become a social problem, and countermeasures are required.
 各種の閉塞性睡眠時無呼吸症候群の治療方法が提案されている中で、経鼻的持続陽圧呼吸療法(CPAP療法)が広く普及している。CPAP療法は気道に空気を送り続けることで気道閉塞を防止するものであり、夜間、CPAP療法に用いられる加圧空気発生装置(CPAP装置)から加圧空気をエアチューブ、鼻マスクを介して気道に供給することで気道を開存させておくものであり、睡眠時の気道閉塞を防止し、無呼吸の発生を予防している。 Among various treatment methods for obstructive sleep apnea syndrome that have been proposed, nasal continuous positive airway pressure therapy (CPAP therapy) is widely used. CPAP therapy prevents airway obstruction by continuously supplying air to the respiratory tract. At night, pressurized air is supplied from a pressurized air generator (CPAP device) used for CPAP therapy through an air tube and a nasal mask to the respiratory tract. It keeps the airway open by supplying it to the airway, prevents airway obstruction during sleep, and prevents the occurrence of apnea.
米国特許第7856979号明細書U.S. Pat. No. 7,856,979 米国特許第10751501号明細書U.S. Pat. No. 1,075,1501
 CPAP療法では、CPAP装置から大気圧よりも高い圧力の空気を常時気道に送られることから、治療開始時に患者は違和感を覚え、眠れないなどの症状を呈する場合がある。また、鼻マスクの装着や脱着の煩わしさからCPAP療法を中断してしまう場合もある。 In CPAP therapy, the CPAP device constantly sends air with pressure higher than the atmospheric pressure to the respiratory tract, so patients may experience discomfort and symptoms such as inability to sleep at the start of treatment. In addition, CPAP therapy may be interrupted due to the troublesomeness of putting on and taking off the nasal mask.
 また、従来の大気圧よりも高い圧力を呼気時に加える技術では、睡眠の間、睡眠時無呼吸が発生していなくても常に高い気流抵抗となる呼気が強いられることとなり、不具合症状として高い割合で頭痛や不快感を経験したとの報告もある。特に慣れない患者の場合には息苦しさを感じることから使用できない場合もある。また、これらの理由から、CPAP療法で用いられる陽圧と同等の高い圧力を加えて治療効果を向上させることが困難である。 In addition, with conventional technology that applies a pressure higher than the atmospheric pressure during exhalation, even if sleep apnea does not occur, exhalation with high airflow resistance is always forced during sleep, resulting in a high proportion of malfunction symptoms. Some have reported experiencing headaches and discomfort in Especially in the case of unaccustomed patients, it may not be possible to use it because they feel suffocation. 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.
 特許文献1および特許文献2では、鼻孔に挿入するタイプのデバイスとして、呼気時に高い気流抵抗で大気圧よりも高い圧力を加えることができる一方、弁構造を用いて呼気時に上咽頭部に大気圧よりも高い圧力を加え、気道を開存させて睡眠時無呼吸症候群の症状を軽減させる技術も開示されているが、呼気の間圧力が加わることから、息苦しさを訴える場合がある。 In Patent Documents 1 and 2, as a device of the type inserted into the nostrils, it is possible to apply a pressure higher than atmospheric pressure with high airflow resistance during exhalation, while using a valve structure to apply atmospheric pressure to the nasopharynx during exhalation. Techniques have also been disclosed that apply a higher pressure to open the airway and alleviate the symptoms of sleep apnea syndrome, but the additional pressure during exhalation may cause suffocation.
 本発明は、従来の特許文献1および特許文献2で開示される技術において、呼気初期の吐出しを可能とすることで息苦しさを低減するための技術に関するものである。 The present invention relates to techniques disclosed in conventional Patent Documents 1 and 2 that reduce suffocation by enabling exhalation in the early stages of expiration.
 本発明は、使用者の呼気の系外への排出のタイミングを制御し、呼気初期には安静呼吸に近い状態で呼気を系外に排出すると共に、呼気後半では系外への呼気放出を抑えることにより高い気道内圧を維持し、気道を開存させる装置を提供する。 The present invention controls the timing of exhalation of the user's exhalation to the outside of the system, exhaling the exhalation to the outside of the system in a state close to resting breathing in the early stage of exhalation, and suppressing exhalation to the outside of the system in the latter half of exhalation. This provides a device that maintains a high airway pressure and keeps the airway open.
 すなわち、本発明は、使用者の吸気および呼気を流通する呼吸流路を備えた筐体と、使用者の鼻孔と連結する通気部と、呼気の排出口および吸気の吸入口となる開口部とを備えた呼吸装置であり、前記筐体内部の呼吸流路内に、呼気の流れによって移動可能な弁体を備え、呼気開始の所定時間経過後に前記開口部を閉止する呼気閉止弁を備えることを特徴とする、呼吸装置を提供する。 That is, the present invention comprises a housing provided with a breathing passage for circulating the user's inhaled air and exhaled air, a ventilation part connected to the user's nostrils, and an opening serving as an exhalation outlet and an inhalation inlet for the exhaled air. comprising a valve element movable by the flow of exhaled air in the respiratory channel inside the housing, and an exhalation shut-off valve that closes the opening after a predetermined period of time from the start of exhalation. There is provided a respiratory apparatus characterized by:
 また本発明は、前記呼気閉止弁が、呼吸流路内で弁体を支持する弁体支持部と、弁体を開口部に移動させるガイド部を備えることを特徴とし、1)ドーナツ型円盤状の弁体と、呼吸流路内で弁体を支持する十字枠と、前記開口部に備えた十字枠との間で弁体を移動させるガイド軸とを備えたことを特徴とする呼吸装置、2)球状または円盤状の弁体と、弁体を支持する支持部と、支持部と開口部との間の筐体内面に弁体移動用のガイド部を備えたことを特徴とする呼吸装置を提供する。 Further, according to the present invention, the expiratory shut-off valve is characterized by comprising a valve body supporting portion that supports the valve body in the respiratory passage, and a guide portion that moves the valve body to the opening, wherein: 1) a doughnut-shaped disc shape; a valve body, a cross frame that supports the valve body in the respiratory channel, and a guide shaft that moves the valve body between the cross frame provided in the opening, 2) A respiratory apparatus characterized by comprising a spherical or disk-shaped valve body, a support for supporting the valve body, and a guide part for moving the valve body on the inner surface of the housing between the support and the opening. I will provide a.
 また本発明は、前記呼気閉止弁が、3)弁体を支持し且つ前記筐体内部の呼吸流路の一部を仕切ると共に呼気の一部が流通可能な孔を有する仕切板と、仕切板の開口部側に呼気によって移動可能な弁体を有すると共に、仕切板の孔からの呼気により弁体が移動し、前記開口部を閉止する弁であることを特徴とする呼吸装置を提供する。 The present invention also provides a partition plate in which the expiratory stop valve comprises: 3) a partition plate that supports the valve body, partitions a part of the respiratory passage inside the housing, and has a hole through which part of the exhaled air can flow; A breathing apparatus characterized by having a valve body movable by exhalation on the opening side of a partition plate, the valve body being moved by exhalation through a hole in a partition plate to close the opening.
 また本発明は。前記仕切板と前記開口部との間で移動可能な弁体と、弁体の移動を案内するガイド軸または枠組を有することを特徴とし、ドーナツ型膜の弁体とその中心孔を通るガイド軸、または球状の弁体とそれを案内するガイド枠を有する弁であり、前記ガイド軸またはガイド枠が、前記仕切板と前記開口部の間で、前記通気部と前記筐体の中心を通る軸に対して斜めに配置されていることを特徴とする呼吸装置を提供する。 Also, the present invention is characterized by having a valve body movable between the partition plate and the opening, and a guide shaft or framework for guiding the movement of the valve body, wherein the guide shaft passes through the doughnut-shaped membrane valve body and its central hole. , or a valve having a spherical valve body and a guide frame for guiding it, wherein the guide shaft or the guide frame is between the partition plate and the opening and passes through the center of the vent and the housing To provide a respiratory apparatus characterized by being obliquely arranged with respect to.
 また本発明は、前記仕切板の孔の大きさを変更し、呼気の通気量の調整手段を備え、曲線状の切り欠き部分を有する円盤、又は大きさが異なる複数孔を円周上に有する円盤が前記仕切板に密接して配置され、円盤を回転させることにより、仕切板の孔の大きさを変更する手段であり、前記仕切板の孔が、U字状の切り欠き部である呼吸装置を提供する。 In addition, the present invention changes the size of the holes in the partition plate, includes means for adjusting the ventilation rate of exhaled breath, and has a disk with a curved notch portion, or a plurality of holes with different sizes on the circumference. A disk is arranged in close contact with the partition plate, and means for changing the size of a hole in the partition plate by rotating the disk, and the hole in the partition plate is a U-shaped notch. Provide equipment.
 また本発明は、前記開口部が前記呼気閉止弁により閉止された時に生じる圧力上昇の一部を低減する調圧孔を前記筐体に有する呼吸装置、前記開口部に前記呼気閉止弁が当接する際に生じる振動または音を低減する緩衝機構を開口部に有する呼吸装置を提供する。 Further, the present invention provides a breathing apparatus having a pressure regulating hole in the housing for reducing part of the pressure increase that occurs when the opening is closed by the exhalation shutoff valve, and the exhalation shutoff valve abuts against the opening. To provide a breathing apparatus having a damping mechanism at the opening that reduces vibrations or sounds that occur during breathing.
 本発明によれば、呼吸疾患の患者、より具体的には閉塞性睡眠時無呼吸症候群の患者を治療するために、従来の技術よりも小型な装置で、呼気初期には通常呼吸同様に呼気を吐き出すことを可能とし、呼気中盤から終末時には高い気流抵抗を生じさせることで上咽頭部に大気圧よりも高い圧力を加え、気道を開存させる装置であって、装着や脱着の煩わしさや、治療中の息苦しさを低減した装置を提供することができる。 According to the present invention, for treating patients with respiratory disorders, more particularly obstructive sleep apnea syndrome, a device smaller than the prior art, which exhaled as well as normal in the early exhalation It is a device that makes it possible to exhale and creates high airflow resistance from the middle to the end of expiration to apply pressure higher than atmospheric pressure to the nasopharynx and open the airway. It is possible to provide a device that reduces suffocation during treatment.
本発明の呼吸装置の第1の実施態様の外観図を示す。1 shows an external view of a first embodiment of the respiratory apparatus of the present invention; FIG. 本発明の呼吸装置の第1の実施態様の断面図を示す。1 shows a cross-sectional view of a first embodiment of the respiratory apparatus of the present invention; FIG. 本発明の呼吸装置の第2の実施態様の断面図を示す。Figure 2 shows a cross-sectional view of a second embodiment of the respiratory apparatus of the present invention; 本発明の呼吸装置の第3の実施態様の断面図を示す。Figure 3 shows a cross-sectional view of a third embodiment of the respiratory apparatus of the present invention; 本発明の呼吸装置の第4の実施態様の外観図を示す。Fig. 3 shows an external view of a fourth embodiment of the respiratory apparatus of the present invention; 本発明の呼吸装置の第4の実施態様の断面斜視図を示す。Fig. 3 shows a cross-sectional perspective view of a fourth embodiment of the respiratory apparatus of the present invention; 本発明の呼吸装置の第4の実施態様の断面図を示す。Fig. 3 shows a cross-sectional view of a fourth embodiment of the respiratory apparatus of the present invention; 本発明の呼吸装置の呼吸気流と呼気閉止弁の関係の模式図を示す。FIG. 3 shows a schematic diagram of the relationship between the respiratory airflow and the exhalation shut-off valve of the respiratory apparatus of the present invention; 本発明の呼吸装置使用時の、流量の変動を示す。FIG. 11 illustrates flow variation when using the respiratory apparatus of the present invention; FIG. 本発明の呼吸装置使用時の、圧力の変動を示す。Figure 2 shows the variation in pressure when using the respiratory apparatus of the present invention; 本発明の呼吸装置の仕切板と円盤との組み合わせによる仕切板の孔の調整手段の一例を示す。1 shows an example of means for adjusting the aperture of the partition plate by combining the partition plate and the disc of the respiratory apparatus of the present invention. 本発明の呼吸装置において、仕切板の孔の大きさの違いによる呼気閉止弁での開口部の閉止のタイミングの違いを示す。Fig. 2 shows the difference in closing timing of the opening of the exhalation stop valve due to the difference in the size of the hole in the partition plate in the respiratory apparatus of the present invention. 本発明の呼吸装置において、開口部に呼気閉止弁の弁体が当接する際に生じる振動や音を低減する緩衝機構の一例を示す。In the breathing apparatus of the present invention, an example of a damping mechanism for reducing vibration and sound generated when the valve body of the exhalation stop valve comes into contact with the opening is shown. 本発明の呼吸装置において、開口部に呼気閉止弁の弁体が当接する際に生じる振動や音を低減する緩衝機構の動作模式図を示す。FIG. 3 shows a schematic diagram of the operation of a buffer mechanism that reduces vibrations and sounds that occur when the valve body of the exhalation stop valve comes into contact with the opening in the respiratory apparatus of the present invention.
 本発明の実施形態の一つである呼吸装置の外観図を図1に、図1のA-A’面で切断した時の実施態様の断面斜視図を図2に示す。また図3、図4に第2、第3の実施態様の呼吸装置の断面斜視図を示す。第2、第3の実施態様の外観図は第1の実施態様である図1と同じである。 Fig. 1 shows an external view of a respiratory apparatus that is one embodiment of the present invention, and Fig. 2 shows a cross-sectional perspective view of the embodiment when cut along the A-A' plane in Fig. 1. 3 and 4 show cross-sectional perspective views of second and third embodiment respirators. The external views of the second and third embodiments are the same as FIG. 1 of the first embodiment.
 本発明の呼吸装置は、使用者の吸気および呼気を流通する呼吸流路を備えた筐体2と、使用者の鼻孔と連結する通気部1と、呼気の排出口および吸気の吸入口となる開口部3とを備えた呼吸装置である。前記筐体2内部の呼吸流路内に、呼気の流れによって移動可能な弁体10を備え、呼気開始の所定時間経過後に前記開口部3を閉止する呼気閉止弁5を備えることで、呼気開始初期には呼気を系外に排出すると共に、開口部3の閉止後は呼気排出量を抑え、筐体2内圧力、即ち気道内圧力を高く維持することで気道閉塞を抑制する。 The respiratory apparatus of the present invention includes a housing 2 having a respiratory channel for circulating the user's inhaled air and exhaled air, a ventilation part 1 connected to the user's nostrils, an exhaled air outlet and an inhaled air. a respiratory apparatus with an opening 3; By providing a valve body 10 that is movable by the flow of exhalation in the respiratory passage inside the housing 2, and providing an exhalation closing valve 5 that closes the opening 3 after a predetermined time elapses after the start of exhalation, exhalation is started. Initially, exhaled air is exhaled outside the system, and after the opening 3 is closed, the amount of exhaled exhaled air is suppressed to keep the pressure inside the housing 2, that is, the airway pressure high, thereby suppressing airway obstruction.
 かかる呼気閉止弁5は、呼吸流路内の途中に弁体10を支持する弁体支持部12を備え、筐体2内壁が、弁体10が弁体支持部12と開口部3の間を移動する際のガイドとして働き、呼気の流れにより弁体10が開口部3に、吸気の流れにより弁体10が弁体支持部12に移動する。弁体10と筐体2内壁との間の空間が呼吸流路となり、鼻孔側の通気部1と開口部3との間で吸排気が行われる。 The expiratory stop valve 5 includes a valve body supporting portion 12 that supports the valve body 10 in the middle of the respiratory passage. Acting as a guide during movement, the valve body 10 is moved to the opening 3 by the flow of exhalation, and the valve body 10 is moved to the valve body support 12 by the flow of inhalation. A space between the valve body 10 and the inner wall of the housing 2 serves as a respiratory passage, and intake and exhaust are performed between the ventilation section 1 and the opening section 3 on the nostril side.
 弁体支持部12は呼気閉止弁5の弁体10を呼吸流路上に保持するものであり、図2の呼吸装置では、ドーナツ型円盤状の弁体10と、十字枠の弁体支持部12とを備える。筐体2および弁体10の形状により弁体支持部12は十字枠の他、リブ、メッシュ構図など各種の形状に設計使用が可能である。 The valve body supporting portion 12 holds the valve body 10 of the exhalation shutoff valve 5 on the respiratory channel. In the respiratory apparatus of FIG. and Depending on the shapes of the housing 2 and the valve body 10, the valve body support portion 12 can be designed and used in various shapes such as a cross frame, a rib, and a mesh composition.
 ガイド部11は、弁体10を弁体支持部12から開口部3との間での移動を案内するものであり、図2のように円筒状の筐体2の内面をそのまま弁体10の移動用のガイドとして利用することもできるが、開口部3と弁体支持部12との間の筐体2内面にリブを設ける、あるいは弁体10の移動用のガイド枠を設けたり、図3に示すように、ドーナツ型円盤状の弁体を用い、弁体10を支持する十字枠と開口部3の十字枠との間に弁体10を移動させるガイド軸11’を設けることで精度よく弁体10による開口部3の開閉を行うことができる。 The guide portion 11 guides the movement of the valve body 10 between the valve body support portion 12 and the opening portion 3, and as shown in FIG. Although it can be used as a guide for movement, ribs may be provided on the inner surface of the housing 2 between the opening 3 and the valve body support part 12, or a guide frame for movement of the valve body 10 may be provided. As shown in Fig. 2, a doughnut-shaped disk-shaped valve body is used, and a guide shaft 11' for moving the valve body 10 is provided between the cross frame supporting the valve body 10 and the cross frame of the opening 3, thereby achieving high accuracy. The opening 3 can be opened and closed by the valve body 10 .
 図4に本発明の呼吸装置の第3の実施態様を示す。  Figure 4 shows a third embodiment of the respiratory apparatus of the present invention.
 使用者の呼気開始時から呼気閉止弁5が開口部3を閉止するまでの時間は弁体10の移動距離、弁体支持部12から開口部3まで距離と弁体10の大きさ、重量等を変更することで適宜設計することができる。弁体10に当る呼気風量を調整することでかかる弁閉止時間を調整することができる。図4の呼吸装置には弁体支持部12として呼気の一部が通る開孔を備えた整流板13を備える。かかる整流板13の開孔の大きさ、数、配置を設計することで弁閉止時間を調整し、呼気排出量および閉止後の気道内圧を調整することができる。 The time from the start of exhalation by the user until the expiratory stop valve 5 closes the opening 3 depends on the movement distance of the valve body 10, the distance from the valve body support 12 to the opening 3, the size and weight of the valve body 10, etc. can be designed as appropriate by changing The valve closing time can be adjusted by adjusting the amount of exhaled air hitting the valve body 10 . The respiratory apparatus of FIG. 4 is provided with a rectifying plate 13 having an aperture through which a portion of exhaled air passes as a valve supporting portion 12 . By designing the size, number, and arrangement of the openings of the straightening plate 13, the valve closing time can be adjusted, and the expiratory volume and the airway pressure after closing can be adjusted.
 図5に本発明の呼吸装置の第4の実施態様を示す。  Figure 5 shows a fourth embodiment of the respiratory apparatus of the present invention.
 かかる呼吸装置は、使用者の鼻孔に挿入し密接する通気部1と、使用者の吸気および呼気を流通する呼吸流路を備えると共に、使用者の呼気を一時保持する室を形成する筐体2、呼気の排出口および吸気の吸入口となる開口部3とを備えた呼吸装置である。 Such a respiratory apparatus includes a ventilation part 1 which is inserted into and close to the user's nostrils, and a respiratory channel through which the user's inhalation and exhalation flow, and a housing 2 which forms a chamber for temporarily holding the user's exhalation. , and an opening 3 serving as an outlet for exhaled air and an inlet for inhaled air.
 筐体2の室内部には、呼吸の呼気および吸気が流通可能な呼吸流路と、呼吸流路の一部を仕切ると共に、呼気の一部が流通可能な孔を有する仕切板4と、仕切板の開口部側には、呼吸の吸気および排気によって移動可能な弁体10を備えた呼気閉止弁5を備える。開口部3に呼気閉止弁の弁体10が当接する際に生じる振動や音を低減する緩衝機構6と、開口部3が弁体10により閉止された時に生じる圧力上昇の一部を低減する調圧孔7を備える。 In the interior of the housing 2, there are a respiratory channel through which exhaled air and intake air can flow, a partition plate 4 that partitions a part of the respiratory channel and has a hole through which a part of the exhaled air can flow, and a partition. On the open side of the plate is an expiratory shut-off valve 5 with a valve body 10 movable by respiratory inhalation and exhalation. A buffer mechanism 6 that reduces vibrations and sounds generated when the valve body 10 of the exhalation stop valve contacts the opening 3, and an adjustment that reduces part of the pressure increase that occurs when the opening 3 is closed by the valve body 10. A pressure hole 7 is provided.
 通気部1は、使用者の鼻孔に挿入され、鼻孔内に密接する筒状の部材であって、筐体2内に使用者の呼気を導入する。なお、通気部1は外部の空気から密閉され使用者の鼻孔と連通している形状であればよい。第1~第3の実施態様の示した筐体2の端部を鼻腔に挿入するタイプの他、鼻腔内壁との密着性を確保するために筐体2とは別の柔軟な材質で通気部1を形成してもよく、例えばシリコーンで形成された筒状の部材を用いるのが好ましい。 The ventilation part 1 is a cylindrical member that is inserted into the nostrils of the user and is in close contact with the nostrils, and introduces the user's breath into the housing 2 . The ventilation part 1 may have any shape as long as it is sealed from the outside air and communicates with the nostrils of the user. In addition to the type in which the end of the housing 2 shown in the first to third embodiments is inserted into the nasal cavity, the ventilation part is made of a flexible material different from the housing 2 in order to ensure close contact with the inner wall of the nasal cavity. 1 may be formed, preferably a cylindrical member made of silicone, for example.
 筐体2は、通気部1に連結し使用者の鼻孔と上口唇との間に設置されるものであり、使用者の睡眠の妨げとならないよう鼻孔から上口唇の間に収まる大きさであればよく、好ましくは15mm以下の長さである。また、両鼻に本装置を装着しても互いに緩衝しない大きさであればよく、好ましくは20mm以下の幅である。様々な鼻腔の向きで装着した場合でも肌への干渉が少ない形状であればよく、円形もしくは楕円形が望ましい。 The housing 2 is connected to the ventilation part 1 and installed between the user's nostrils and the upper lip, and has a size that fits between the nostrils and the upper lip so as not to disturb the user's sleep. length, preferably 15 mm or less. In addition, it is sufficient that the device is of a size that does not interfere with each other even if the devices are attached to both nostrils, and the width is preferably 20 mm or less. A circular or elliptical shape is preferable as long as the shape does not interfere with the skin even when worn in various directions of the nasal cavity.
 開口部3は、呼気時には筐体2内部に取り込まれた使用者の呼気を筐体2外部に排出し、吸気時には筐体2内を介して使用者へ外気を通気するために筐体2に設けられた開口である。開口部3の大きさは、呼吸抵抗を抑えるために、その開口面積が鼻孔の開口面積より大きいことが望ましく、本実施形態では内径11mmの円形とし、中心に呼気閉止弁5の弁体10を支持するガイド軸11’の固定部を備える。 The opening 3 discharges the user's exhaled air taken inside the housing 2 to the outside of the housing 2 during exhalation, and ventilates the outside air to the user through the housing 2 during inhalation. It is an opening provided. The size of the opening 3 is desirably larger than the opening area of the nostrils in order to suppress breathing resistance. It has a fixed portion for supporting the guide shaft 11'.
 仕切板4は、筐体2の室内部に設けられ、呼吸流路の一部を仕切ると共に、呼気の一部を流通可能な孔を備え、第3の実施態様の整流板13としての機能を果たす。仕切板4には呼気を通す孔の大きさを調整する円盤8を備え、図10に示す曲線状の切り欠き部分を有する円盤8、または径が異なる複数孔を円周上に配置した調整用の円盤8が仕切板4に密接して配置され、円盤8を回転させることで、仕切板4の孔9の大きさを調整可能とする。これにより次に説明する呼気閉止弁の閉止時間を調整することが出来る。仕切板の孔9は、使用者の鼻腔からの呼気が効率的に流通するために通気部1の延長線上に径0.8mm以上の孔が1つ以上設けられていればよく、本実施形態では、幅2mmのスリットとした。 The partition plate 4 is provided in the interior of the housing 2, partitions a part of the respiratory channel, has a hole through which part of the exhaled air can flow, and functions as the straightening plate 13 of the third embodiment. Fulfill. The partition plate 4 is provided with a disc 8 for adjusting the size of the hole through which exhaled air passes. The disc 8 has a curved notch shown in FIG. A disc 8 is arranged in close contact with the partition plate 4, and by rotating the disc 8, the size of the hole 9 of the partition plate 4 can be adjusted. This makes it possible to adjust the closing time of the expiratory stop valve, which will be explained below. For the holes 9 of the partition plate, one or more holes having a diameter of 0.8 mm or more may be provided on the extension line of the ventilation part 1 for efficient circulation of exhaled air from the nasal cavity of the user. A slit with a width of 2 mm was used.
 呼気閉止弁5は、開口部3の中心と仕切板4との間で移動可能な呼気流路抵抗となる弁体10と、それを支持するガイド軸11’を有する。 The expiratory stop valve 5 has a valve body 10 that acts as an expiratory flow path resistance movable between the center of the opening 3 and the partition plate 4, and a guide shaft 11' that supports it.
 弁体10は、使用者の呼気によって移動する膜又は球状の軽量な部材であって、例えば、例えばポリウレタン、ポリエチレン、ポリスチレン、ポリ塩化ビニル、ポリエチレンテレフタラート製の樹脂膜や軽量の樹脂球が挙げられる。より好ましくは、柔軟性を備えた部材である樹脂薄膜を用いることができ、本実施形態では、外径13mmのポリウレタンシート100μm厚のドーナツ形状の薄膜を使用し、中心には弁体10を支持するガイド軸11’を設けた。さらに呼気中に含まれる湿気の付着によって重量が増して動作不良を生じる可能性があるので撥水材料であればなおよい。 The valve body 10 is a membrane or spherical lightweight member that moves with the user's exhalation, and examples thereof include resin membranes made of polyurethane, polyethylene, polystyrene, polyvinyl chloride, polyethylene terephthalate, and lightweight resin balls. be done. More preferably, a resin thin film, which is a flexible member, can be used. In this embodiment, a polyurethane sheet with an outer diameter of 13 mm and a doughnut-shaped thin film with a thickness of 100 μm is used, and the valve body 10 is supported at the center. A guide shaft 11' is provided. In addition, moisture contained in exhaled air may increase the weight of the device and cause malfunction, so a water-repellent material is even better.
 呼気閉止弁5の弁体10を支持するガイド軸11’は、呼気や吸気の流れに応じて弁体10が移動する際のガイドとなるため、捻じれや撓みがないものがよく、棒状や筒状の構造体が挙げられる。さらには、いかなる方向に設置した場合でも、弁体10との干渉を最低限に抑えられるよう丸棒を用いるのがよい。 The guide shaft 11' that supports the valve body 10 of the expiratory stop valve 5 serves as a guide when the valve body 10 moves according to the flow of exhalation or inspiration. A cylindrical structure is mentioned. Furthermore, it is preferable to use a round bar so that interference with the valve element 10 can be minimized regardless of the installation direction.
 本装置は、使用者が就寝中に使用者の鼻孔に挿入して使用されるものであり、呼気閉止弁5の弁体10が円滑に移動するために、使用者が仰臥位で就寝した際にガイド軸11’が床面に対して水平となるよう、ガイド軸11’は、仕切板4から開口部3に向けて1~45°の傾きをもって下降傾斜に配置するのがよく、より好ましくは10~15°の傾きをもって配置する。本実施形態では15°の傾きとした。使用者は、その向きを保つよう鼻孔に装着する必要があり、その目印として、調圧孔7をガイド軸11’の傾斜方向である開口部3の下方に設け、調圧孔7が下方にある向きで鼻孔へ装着することが望ましい。 This device is used by inserting it into the user's nostrils while the user is asleep. In order that the guide shaft 11' is horizontal with respect to the floor surface, the guide shaft 11' is preferably arranged downwardly with an inclination of 1 to 45° from the partition plate 4 toward the opening 3, more preferably. are arranged with an inclination of 10 to 15°. In this embodiment, the inclination is 15°. The user needs to wear it in the nostrils so as to keep its orientation. As a mark, the pressure adjustment hole 7 is provided below the opening 3 in the direction of inclination of the guide shaft 11', and the pressure adjustment hole 7 is positioned downward. It is desirable to fit the nostrils in one orientation.
 本装置の断面図(図7)を用い、図8に、使用者が呼吸装置を用いて呼吸した時の呼気開始時(8A)、呼気途中(8B)、呼気終末(8C)と、吸気時(8D)での、呼吸気流と呼気閉止弁5の関係の模式図で示す。 Using the cross-sectional view of this device (FIG. 7), FIG. (8D) is a schematic diagram of the relationship between the respiratory airflow and the expiratory stop valve 5. FIG.
 呼気開始時、使用者の呼気は鼻孔から通気部1、筐体2内の呼吸流路を通って開口部3から系外に排出される。その時、呼気の一部は、筐体2内の仕切板4に設けられた孔9を通って、呼気閉止弁5の樹脂薄膜製の弁体10に当たり、弁体10を支持するガイド軸11’に沿って開口部3側に移動する。 At the start of exhalation, the user's exhaled air passes through the nostrils, the ventilation part 1, the respiratory passage in the housing 2, and is discharged outside the system from the opening 3. At that time, part of the exhaled air passes through the hole 9 provided in the partition plate 4 inside the housing 2 and hits the valve element 10 made of resin film of the exhalation stop valve 5, and guide shaft 11' supporting the valve element 10. , to the opening 3 side.
 呼気終末時に呼気閉止弁の弁体10が開口部3に当接し、開口部3を閉止する。これによって呼気排出が抑えられ、高い気流抵抗が生じることで、気道内圧が上昇し、上咽頭部に大気圧よりも高い圧力が加わることで気道を開存させ、睡眠時無呼吸症候群患者などの気道閉塞を抑制する。 At the end of expiration, the valve body 10 of the expiratory stop valve abuts against the opening 3 to close the opening 3 . As a result, expiratory discharge is suppressed and high airflow resistance is generated, which increases the airway pressure. Suppresses airway obstruction.
 吸気開始時には、弁体10は元の仕切板4の位置に戻り、外気が開口部3から筐体2内の呼吸流路を通り、通気部1から使用者の鼻腔から吸気される。 At the start of inhalation, the valve body 10 returns to the original position of the partition plate 4, and outside air passes through the respiratory passage in the housing 2 from the opening 3, and is inhaled from the user's nasal cavity through the vent 1.
 調圧孔7は、開口部3が呼気閉止弁5によって閉止された後に筐体2内に取り込まれた使用者の呼気を筐体2外部に排出するために筐体2に設けられた孔である。調圧孔7の大きさは、開口部3が呼気閉止弁5で閉止された後に高まった筐体2内圧を過剰に下げないために微小孔が望ましく、より好ましくは径2mm以下である。調圧孔7は1つでもよく、使用者の呼吸能力に応じて開口の大きさを選択できるように複数設けてもよい。本実施形態では、径1mm以下の微小孔を2つ設けて、どちらかの微小孔あるいは両方の孔を用いて排気可能とする。また調圧孔7は、筐体2内で呼気が結露することによりに貯まった水滴を排出できるように、筐体2下端の内壁に沿わせた位置へ配置することが望ましい。 The pressure regulating hole 7 is a hole provided in the housing 2 for discharging the user's exhaled air taken into the housing 2 after the opening 3 is closed by the exhalation shutoff valve 5 to the outside of the housing 2. be. The size of the pressure adjusting hole 7 is desirably a micro hole, more preferably 2 mm or less in diameter, in order not to excessively reduce the internal pressure of the housing 2 that has increased after the opening 3 is closed by the exhalation stop valve 5 . One pressure adjusting hole 7 may be provided, or a plurality of pressure adjusting holes may be provided so that the size of the opening can be selected according to the user's breathing ability. In this embodiment, two micro holes having a diameter of 1 mm or less are provided, and either or both of the micro holes can be used for exhaust. Moreover, it is desirable that the pressure adjusting hole 7 be arranged along the inner wall of the lower end of the housing 2 so that water droplets accumulated in the housing 2 due to condensation of exhaled air can be discharged.
 本発明の呼吸装置を人工肺に装着して使用した時の筐体2内の流量の変動(図9)、圧力の変動(図10)を示す。人工肺で発生させた呼吸に応じた呼気、吸気の流れが発生すると共に、呼気閉止弁5による開口部3の閉鎖により、呼気の系外への流れが停止し、調圧孔7からの過剰空気の排出が認められ、筐体2内圧は調圧孔7からの呼気流出による若干の低下はあるものの高い圧力を吸気開始まで維持している。 The flow rate fluctuations (Fig. 9) and pressure fluctuations (Fig. 10) in the housing 2 when the respiratory apparatus of the present invention is attached to an oxygenator and used are shown. The flow of exhalation and inhalation corresponding to the respiration generated by the artificial lung is generated, and the closing of the opening 3 by the exhalation shutoff valve 5 stops the flow of exhalation to the outside of the system, and the excess from the pressure regulation hole 7 Air is discharged, and the internal pressure of the housing 2 is maintained at a high level until the start of inspiration, although there is a slight decrease due to the outflow of exhaled air from the pressure regulating hole 7 .
 図11に仕切板4と呼気の一部を通過させる仕切板4の孔9の大きさを調整する円盤8の実施態様例を示す。11Aに示す円形の仕切板4にはU字状の孔9を備え、呼気の一部がこの孔9を通過する。仕切板4の通気部側には、(11B)に示す曲線状の切り欠き部分を有する円盤8が、仕切板4に密接して配置され、円盤8を回転させることで、仕切板4の孔9の大きさを調整可能とする。これにより仕切板4の孔9を通過する呼気量を調整することができ、次に説明する呼気閉止弁5の弁体10の移動時間、すなわち、呼気閉止弁5による開口部3の閉止時間を調整することが出来る。 FIG. 11 shows an embodiment of the partition plate 4 and the disk 8 for adjusting the size of the hole 9 in the partition plate 4 through which part of the exhaled air passes. A circular partition plate 4 shown in 11A is provided with a U-shaped hole 9 through which part of exhaled air passes. A disk 8 having a curved notch portion shown in (11B) is placed in close contact with the partition plate 4 on the ventilation part side of the partition plate 4. By rotating the disk 8, the hole of the partition plate 4 can be opened. The size of 9 is adjustable. As a result, the amount of exhaled air passing through the hole 9 of the partition plate 4 can be adjusted. can be adjusted.
 仕切板の孔9は、使用者の鼻孔からの呼気が効率的に流通するために通気部の延長線上に設けられており、例えば、径0.8mm以上の円形の孔9が1つ以上設けられていればよく、形状は円形、楕円形、方形など各種形状の孔を選択することが可能である。本実施形態では、幅2mmのスリットとした。仕切板4の孔9の大きさを調整するための円盤8も、図11の11Bでは曲線状の切り欠き部分を有する円盤8を示したが、その他に径が異なる複数孔を円周上に配置した調整用の円盤8を用いるなど、仕切板4の孔9を通過する呼気量を調整可能な形状、組合せを採用することが出来る。 The apertures 9 of the partition plate are provided on the extension line of the ventilation part for efficient circulation of exhaled air from the nostrils of the user. Holes of various shapes such as circular, elliptical, and square can be selected. In this embodiment, the slit is 2 mm wide. As for the disk 8 for adjusting the size of the hole 9 of the partition plate 4, the disk 8 having a curved notch portion is shown in 11B of FIG. It is possible to adopt a shape and a combination that can adjust the amount of exhaled air passing through the hole 9 of the partition plate 4, such as using an arranged adjusting disk 8.
 本実施態様例の場合、調整用の円盤8の切り欠き分で仕切板4のU字状の孔9が完全に開く状態(11C)から、75%開いた状態の図(11D)、50%開いた状態に図(11E)など、円盤8を回転させることで孔9の開度を調整することができる。図12に示すように、人工肺で発生させた呼吸流量に対する本発明の呼吸装置の呼気閉止弁5の閉止時間を調整することができる。 In the case of this embodiment example, the state in which the U-shaped hole 9 of the partition plate 4 is completely opened (11C) by the notch portion of the adjustment disk 8 is 75% open (11D). The degree of opening of the hole 9 can be adjusted by rotating the disc 8 in the opened state as shown in FIG. 11E. As shown in FIG. 12, the closing time of the expiratory stop valve 5 of the respiratory apparatus of the present invention can be adjusted relative to the respiratory flow generated by the artificial lung.
 図11では真円形の円盤の仕切板4を例に孔9の調整機構を示したが、仕切板4は筐体2内に設置され、呼吸流路の一部を仕切る構造体であり、筐体2内の形状に合わせると共に、必要な呼吸流路の大きさに応じて、半円形など各種形状に設計可能である。 FIG. 11 shows the mechanism for adjusting the holes 9 using the disk-like partition plate 4 as an example. It can be designed in various shapes, such as a semi-circle, depending on the size of the respiratory channel required, as well as matching the shape inside the body 2 .
 呼気閉止弁5の弁体10が開口部3に当接し、呼気の系外への排出を停止する際に音が発生する。睡眠時に呼吸に同調して騒音が発生するため、静音化が求められる。本発明の呼吸装置では、開口部3の弁体10のガイド軸11’の接合部位に、弁体10が開口部3に当接した際の振動および騒音の発生を抑制するための緩衝機構6を設けるのが好ましい。 A sound is generated when the valve body 10 of the exhalation shutoff valve 5 abuts against the opening 3 and stops exhalation of exhaled air to the outside of the system. Since noise is generated in synchronization with breathing during sleep, noise reduction is required. In the breathing apparatus of the present invention, a damping mechanism 6 for suppressing the generation of vibration and noise when the valve body 10 comes into contact with the opening 3 is attached to the joining portion of the guide shaft 11' of the valve body 10 of the opening 3. is preferably provided.
 図13、図14に開口部3の中心の弁体10を支持するガイド軸11’の固定部に設けられた弾性作用のある四枝構造の緩衝機構6を示す。かかる緩衝機構6は、呼気によって押し出された呼気閉止弁5の弁体10が開口部3を閉止する際に筐体2との当接によって音と衝撃を発生するのを干渉させる部材であり、弾性体の薄膜であればよい。(14B)呼気により押し出された弁体10は開口部3の位置に届いた際に緩衝機構6で動きを緩衝され、筐体2に直接当たることによる振動および騒音発生を抑制すると共に、(14C)呼気圧に応じて緩衝機構6を押し下げ、(14D)開口部3の壁面に当接することで呼気流を完全に閉止する。 FIGS. 13 and 14 show a buffer mechanism 6 having an elastic four-branch structure provided at a fixed portion of a guide shaft 11' that supports the valve body 10 at the center of the opening 3. FIG. Such a buffer mechanism 6 is a member that interferes with the generation of sound and impact due to contact with the housing 2 when the valve body 10 of the exhalation stop valve 5 pushed out by exhalation closes the opening 3, Any elastic thin film may be used. (14B) When the valve body 10 pushed out by exhalation reaches the position of the opening 3, its movement is damped by the damping mechanism 6, suppressing the generation of vibration and noise due to direct contact with the housing 2, and (14C ) Push down the buffer mechanism 6 according to the expiratory pressure, and (14D) contact the wall surface of the opening 3 to completely close the expiratory flow.
 本発明においては呼気時に上咽頭部に大気圧よりも高い圧力を加え気道を開存させる技術において、息苦しさを低減する、閉塞性呼吸疾患、より好ましくは閉塞性睡眠時無呼吸症候群の患者を治療するための呼吸装置を提供することができる。 In the present invention, the technique of applying pressure higher than atmospheric pressure to the epipharynx during exhalation to open the airway reduces suffocation, and treats patients with obstructive respiratory diseases, more preferably obstructive sleep apnea syndrome. A therapeutic respiratory apparatus can be provided.
 1:通気部
 2:筐体
 3:開口部
 4:仕切板
 5:呼気閉止弁
 6:緩衝機構
 7:調圧孔
 8:調整用の円盤
 9:仕切板の孔
10:弁体
11:ガイド部、11’:ガイド軸
12:弁体支持部
13:整流板
1: ventilation part 2: housing 3: opening 4: partition plate 5: expiratory stop valve 6: buffer mechanism 7: pressure adjustment hole 8: adjustment disk 9: partition plate hole 10: valve body 11: guide part , 11′: guide shaft 12: valve support portion 13: current plate

Claims (14)

  1.  使用者の吸気および呼気を流通する呼吸流路を備えた筐体と、使用者の鼻孔と連結する通気部と、呼気の排出口および吸気の吸入口となる開口部とを備えた呼吸装置であり、
     前記筐体内部の呼吸流路内に、呼気の流れによって移動可能な弁体を備え、呼気開始の所定時間経過後に前記開口部を閉止する呼気閉止弁を備えることを特徴とする、呼吸装置。
    A respiratory apparatus comprising a housing having a respiratory passage through which a user's inhaled air and exhaled air circulate, a ventilation part connected to the user's nostrils, and an opening serving as an exhaled air outlet and an inhaled air inlet. can be,
    1. A respiratory apparatus, comprising: an exhalation shut-off valve that is provided in a respiratory passage inside said housing and that is movable by the flow of exhaled air, and which closes said opening after a predetermined time elapses from the start of exhalation.
  2.  前記呼気閉止弁が、呼吸流路内で弁体を支持する弁体支持部と、弁体を開口部に移動させるガイド部を備えることを特徴とする、請求項1記載の呼吸装置。  The respiratory apparatus according to claim 1, characterized in that the exhalation stop valve comprises a valve body supporting part that supports the valve body in the respiratory channel and a guide part that moves the valve body to the opening.
  3.  前記呼気閉止弁が、ドーナツ型円盤状の弁体と、呼吸流路内で弁体を支持する十字枠と、前記開口部に備えた十字枠との間で弁体を移動させるガイド軸とを備えたことを特徴とする、請求項2記載の呼吸装置。 The expiratory stop valve includes a doughnut-shaped disk-shaped valve body, a cross frame that supports the valve body in the respiratory channel, and a guide shaft that moves the valve body between the cross frame provided in the opening. 3. The respiratory apparatus of claim 2, comprising:
  4.  前記呼気閉止弁が、球状または円盤状の弁体と、弁体を支持する支持部と、支持部と開口部との間の筐体内面に弁体移動用のガイド部を備えたことを特徴とする、請求項2記載の呼吸装置。 The expiratory stop valve is characterized by comprising a spherical or disk-shaped valve body, a support for supporting the valve body, and a guide part for moving the valve body on the inner surface of the housing between the support and the opening. 3. The respiratory apparatus of claim 2, wherein:
  5.  前記呼気閉止弁の弁体に当る呼気流を制御する整流板を備えたことを特徴とする、請求項1~4の何れかに記載の呼吸装置。 The breathing apparatus according to any one of claims 1 to 4, characterized by comprising a rectifying plate for controlling an exhalation flow that hits the valve body of the exhalation stop valve.
  6.  前記呼気閉止弁が、弁体を支持し且つ前記筐体内部の呼吸流路の一部を仕切ると共に呼気の一部が流通可能な孔を有する仕切板と、仕切板の開口部側に呼気によって移動可能な弁体を有すると共に、仕切板の孔からの呼気により弁体が移動し、前記開口部を閉止する弁であることを特徴とする、請求項1記載の呼吸装置。 The expiratory shut-off valve includes a partition plate that supports a valve body, partitions a part of the respiratory channel inside the housing, and has a hole through which part of the expired air can flow; 2. The respiratory apparatus according to claim 1, wherein said breathing apparatus is a valve having a movable valve body, said valve body being moved by exhalation through a hole in said partition plate to close said opening.
  7.  前記呼気閉止弁が、前記仕切板と前記開口部との間で移動可能な弁体と、弁体の移動を案内するガイド軸または枠組を有することを特徴とする、請求項6記載の呼吸装置。 7. The respiratory apparatus according to claim 6, wherein the expiratory stop valve has a valve body movable between the partition plate and the opening, and a guide shaft or framework for guiding movement of the valve body. .
  8.  前記呼気閉止弁が、ドーナツ型膜の弁体とその中心孔を通るガイド軸、または球状の弁体とそれを案内するガイド枠を有する弁であることを特徴とする、請求項7記載の呼吸装置。 8. Breathing according to claim 7, characterized in that the expiratory stop valve is a valve having a donut-shaped membrane valve body and a guide shaft passing through its central hole, or a valve having a spherical valve body and a guide frame for guiding it. Device.
  9.  前記ガイド軸またはガイド枠が、前記仕切板と前記開口部の間で、前記通気部と前記筐体の中心を通る軸に対して斜めに配置されていることを特徴とする、請求項6に記載の呼吸装置。 7. The guide shaft or the guide frame is arranged between the partition plate and the opening at an angle to an axis passing through the center of the vent and the housing. Respirator as described.
  10.  前記仕切板の孔の大きさを変更し、呼気の通気量の調整手段を備えることを特徴とする、請求項6~9の何れかに記載の呼吸装置。 The breathing apparatus according to any one of claims 6 to 9, characterized in that it is provided with means for adjusting the amount of exhaled air by changing the size of the holes in the partition plate.
  11.  前記調整手段が、曲線状の切り欠き部分を有する円盤、又は大きさが異なる複数孔を円周上に有する円盤が前記仕切板に密接して配置され、円盤を回転させることにより、仕切板の孔の大きさを変更する手段である、請求項10に記載の呼吸装置。 A disk having a curved notch portion or a disk having a plurality of holes of different sizes on the circumference is arranged in close contact with the partition plate, and the partition plate is adjusted by rotating the disk. 11. The respiratory apparatus of claim 10, which is means for varying the pore size.
  12.  前記仕切板の孔が、U字状の切り欠き部である、請求項11に記載の呼吸装置。 The respiratory apparatus according to claim 11, wherein the aperture in the partition plate is a U-shaped notch.
  13.  前記開口部が前記呼気閉止弁により閉止された時に生じる圧力上昇の一部を低減する調圧孔を前記筐体に有する、請求項1~12の何れかに記載の呼吸装置。 The respiratory apparatus according to any one of claims 1 to 12, wherein the housing has a pressure regulating hole that reduces part of the pressure rise that occurs when the opening is closed by the expiratory stop valve.
  14.  前記開口部に前記呼気閉止弁が当接する際に生じる振動または音を低減する緩衝機構を開口部に有する、請求項1~13の何れかに記載の呼吸装置。 
     
     
    14. The respiratory apparatus according to any one of claims 1 to 13, wherein the opening has a damping mechanism for reducing vibration or sound generated when the exhalation stop valve contacts the opening.

PCT/JP2022/006518 2021-02-24 2022-02-18 Breathing apparatus WO2022181459A1 (en)

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JP2021027462 2021-02-24
JP2021-027462 2021-02-24

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6626179B1 (en) * 2000-09-29 2003-09-30 Philip Pedley Breathing valve for improving oxygen absorption
US20050279351A1 (en) * 2004-06-18 2005-12-22 Charles Lewis Medicine delivery interface system
US20180361108A1 (en) * 2014-08-21 2018-12-20 The Regents Of The University Of California Sleep apnea ball valve device with bleed for exhaling
GB2569145A (en) * 2017-12-06 2019-06-12 Oxtex Ltd A nasal device

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6626179B1 (en) * 2000-09-29 2003-09-30 Philip Pedley Breathing valve for improving oxygen absorption
US20050279351A1 (en) * 2004-06-18 2005-12-22 Charles Lewis Medicine delivery interface system
US20180361108A1 (en) * 2014-08-21 2018-12-20 The Regents Of The University Of California Sleep apnea ball valve device with bleed for exhaling
GB2569145A (en) * 2017-12-06 2019-06-12 Oxtex Ltd A nasal device

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