WO2024221648A1 - Comfortable device capable of accurately controlling concentration of inhaled gas and simultaneously measuring breath flow - Google Patents
Comfortable device capable of accurately controlling concentration of inhaled gas and simultaneously measuring breath flow Download PDFInfo
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- WO2024221648A1 WO2024221648A1 PCT/CN2023/112674 CN2023112674W WO2024221648A1 WO 2024221648 A1 WO2024221648 A1 WO 2024221648A1 CN 2023112674 W CN2023112674 W CN 2023112674W WO 2024221648 A1 WO2024221648 A1 WO 2024221648A1
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- Prior art keywords
- flow
- gas
- mask
- concentration
- flow rate
- Prior art date
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- 239000007789 gas Substances 0.000 claims abstract description 125
- 230000000241 respiratory effect Effects 0.000 claims description 23
- 238000000034 method Methods 0.000 claims description 6
- 239000001257 hydrogen Substances 0.000 claims description 5
- 229910052739 hydrogen Inorganic materials 0.000 claims description 5
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 claims description 4
- 238000001514 detection method Methods 0.000 claims description 4
- 238000006243 chemical reaction Methods 0.000 claims description 3
- UBAZGMLMVVQSCD-UHFFFAOYSA-N carbon dioxide;molecular oxygen Chemical compound O=O.O=C=O UBAZGMLMVVQSCD-UHFFFAOYSA-N 0.000 claims description 2
- 229910052757 nitrogen Inorganic materials 0.000 claims description 2
- 239000001307 helium Substances 0.000 claims 1
- 229910052734 helium Inorganic materials 0.000 claims 1
- SWQJXJOGLNCZEY-UHFFFAOYSA-N helium atom Chemical compound [He] SWQJXJOGLNCZEY-UHFFFAOYSA-N 0.000 claims 1
- 125000004435 hydrogen atom Chemical class [H]* 0.000 claims 1
- 230000029058 respiratory gaseous exchange Effects 0.000 abstract description 26
- 238000009423 ventilation Methods 0.000 abstract description 7
- 229940075473 medical gases Drugs 0.000 abstract description 4
- 230000014759 maintenance of location Effects 0.000 abstract description 2
- 230000000903 blocking effect Effects 0.000 abstract 1
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 description 22
- 238000010586 diagram Methods 0.000 description 12
- 229910002092 carbon dioxide Inorganic materials 0.000 description 11
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 10
- 230000003434 inspiratory effect Effects 0.000 description 10
- 239000001301 oxygen Substances 0.000 description 10
- 229910052760 oxygen Inorganic materials 0.000 description 10
- UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 description 4
- 239000000463 material Substances 0.000 description 4
- 238000005259 measurement Methods 0.000 description 4
- 210000001331 nose Anatomy 0.000 description 4
- 238000002640 oxygen therapy Methods 0.000 description 4
- 229920001296 polysiloxane Polymers 0.000 description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 4
- 239000002184 metal Substances 0.000 description 2
- 210000002345 respiratory system Anatomy 0.000 description 2
- 230000003860 sleep quality Effects 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- 206010013975 Dyspnoeas Diseases 0.000 description 1
- 206010021143 Hypoxia Diseases 0.000 description 1
- 208000004756 Respiratory Insufficiency Diseases 0.000 description 1
- 238000009825 accumulation Methods 0.000 description 1
- 238000004378 air conditioning Methods 0.000 description 1
- 238000013475 authorization Methods 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 239000001569 carbon dioxide Substances 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 239000006260 foam Substances 0.000 description 1
- 210000003128 head Anatomy 0.000 description 1
- 150000002431 hydrogen Chemical class 0.000 description 1
- 230000007954 hypoxia Effects 0.000 description 1
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- 239000003562 lightweight material Substances 0.000 description 1
- 210000003928 nasal cavity Anatomy 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 238000011002 quantification Methods 0.000 description 1
- 201000004193 respiratory failure Diseases 0.000 description 1
- 230000036387 respiratory rate Effects 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
- A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
- A61M16/0057—Pumps therefor
- A61M16/0066—Blowers or centrifugal pumps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
- A61M16/021—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes operated by electrical means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
- A61M16/021—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes operated by electrical means
- A61M16/022—Control means therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
- A61M16/06—Respiratory or anaesthetic masks
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
- A61M16/20—Valves specially adapted to medical respiratory devices
- A61M16/201—Controlled valves
- A61M16/202—Controlled valves electrically actuated
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
- A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
- A61M2016/003—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter
- A61M2016/0033—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M2230/00—Measuring parameters of the user
- A61M2230/40—Respiratory characteristics
Definitions
- the invention relates to a device for detecting the inhalation and breathing flow of medical gas with a constant concentration.
- Quantification of respiratory airflow during sleep is often achieved by wearing a mask connected to a flow sensor.
- This connection method increases the "dead space capacity" and respiratory resistance due to the lengthened pipe, which can cause the subject to have difficulty breathing and affect sleep. It can also cause an increase in pressure inside the mask, resulting in gas entering and exiting the part of the mask in contact with the face (leakage), thereby affecting the accuracy of gas flow measurement.
- "Dead space capacity" is a physiological term, which refers to the inability of exhaled air to be discharged into the atmosphere, resulting in part of the gas inhaled in the next respiratory cycle being the exhaled air of the previous cycle.
- Inhalation of medical gases such as oxygen, carbon dioxide, and hydrogen is an important method for treating respiratory diseases.
- medical gases such as oxygen, carbon dioxide, and hydrogen
- the nasal cannula affects the fit between the mask and the face, causing air leakage, which affects the accurate measurement of the respiratory airflow.
- oxygen is delivered through a nasal cannula
- the concentration of inhaled respiratory tract oxygen varies with the respiratory rhythm and depth of breathing, making it difficult to accurately control the concentration of the inhaled gas.
- the mask used for non-invasive ventilation is often provided with a small through hole for connecting to the central oxygen supply device in the hospital, the oxygen concentrator for home use or the oxygen cylinder to achieve oxygen therapy.
- CO2 can also be input through the through hole to supplement the CO2 of patients with overventilation and increase the blood CO2 concentration.
- the concentration of the inhaled gas can be kept constant. If the distal end of the mask is connected to a flowmeter, the inhaled gas flow can be accurately measured under a constant inhaled gas concentration.
- an oxygen therapy-related device (patent number ZL 2018 1 0388945.3) earlier, which includes a mask with a large hole at the distal end. By inputting evenly mixed high-flow gas from the proximal end of the mask, the patient inhales, and the excess gas is discharged through the distal end of the mask.
- the high-flow gas input into the mask is discharged from the distal exhaust port and flowmeter together with the exhaled gas. Since there is a large exhaust port at the distal end that is connected to the atmosphere, the internal pressure of the mask is always zero and there is no breathing resistance. However, the evenly mixed high-flow airflow is input from the proximal end of the mask, and the airflow can impact the face and mouth and nose. Especially in a large airflow or cold environment, the subject may feel cold and uncomfortable, or even unbearable.
- the present invention is implemented by the following scheme:
- the invention discloses a comfortable device which can accurately control the concentration of inhaled gas and detect the breathing flow simultaneously, comprising a flow concentration controller which can be used to accurately control the concentration of inhaled gas, a mask and a flow meter.
- the flow concentration controller consists of an air flow generator, a medical gas source (which can be oxygen, CO 2 or hydrogen, etc.) and a gas mixing component. Its principle is similar to an oxygen therapy-related device invented by us earlier (the patent authorization number is ZL 2018 1 0388945.3). Specifically, a constant airflow is generated by a blower, which is mixed evenly with the gas (oxygen, CO 2 ) from the medical gas source and then input into the mask.
- the air supply volume can be monitored by the flow sensor built into the flow concentration controller and adjusted by manual, automatic feedback, or a combination of manual and automatic feedback.
- the adjustment method can be adjusted by adjusting the speed of the blower or by controlling the size of the pipeline through a valve.
- the gas concentration can be monitored by the concentration sensor built into the flow concentration controller and the gas volume from the medical gas source can be adjusted by manual, automatic feedback, or a combination of manual and automatic feedback to adjust the air supply concentration.
- the mask is a gas container, and its effective gas capacity can be set to any value between 50-1000ml. It can be made of metal, plastic, silicone and other materials that can form a container, and the shape can be cylindrical, rectangular, elliptical or other arbitrary shapes.
- the face contact end (proximal end) of the mask is the same as that of a conventional mask, and its material can be made of soft and thin materials such as plastic and silicone to ensure that the face and the mask are tightly connected.
- a baffle is provided on the inner side of the mask at the air inlet to reduce or prevent the impact of the air flow on the mouth, nose and face.
- the baffle can be vertical or angled, with the inner angle facing the air inlet and the far end of the mask, and the angle range is any value between 30° and 180°.
- the flow meter can be a common differential pressure flow meter, an electromagnetic flow meter, an impeller flow meter, an ultrasonic flow meter, a mass flow meter, etc. It can also be a flow meter with an analog-to-digital conversion function or a flow meter with both detection and display functions.
- the ventilation aperture of the flow meter is large enough, with a diameter of more than 1 cm2 , to ensure smooth exhaust and zero pressure inside the mask. For adults, the ideal ventilation aperture is 3 cm2 or even larger. There are 2-4 headband interfaces outside the mask for fixing the mask so that the mask can be stably fixed on the face.
- the air flow diffuses around the baffle under the action of the baffle, fills the mask and flows to the far end to be discharged through the flowmeter. Due to the effect of the baffle, the impact of the input air flow on the patient's face and mouth and nose is eliminated, and the patient does not feel uncomfortable.
- the subject inhales, he inhales the gas delivered to the mask from the flow concentration controller, which reduces the gas flowing out of the flow meter; when exhaling, the subject's exhaled gas is discharged from the far end of the mask through the flow meter together with the airflow output from the gas flow concentration controller, which increases the gas flowing out of the flow meter.
- the airflow discharged through the far end flow meter is equal to the airflow input to the mask, that is, the basic flow of 60L/min.
- the flow during breathing fluctuates up and down on the basis of 60L/min, so as to measure the inspiratory flow and expiratory flow.
- the mask Under certain conditions, such as during exercise or sleep, if you want to measure the respiratory flow including tidal volume and minute ventilation when breathing air, you can fix the mask with a headband, connect the flowmeter with an adapter, and adjust the flow concentration controller to output a predetermined flow of air to the mask. Since the airflow velocity output from the flow concentration controller is large, it can promote the discharge of exhaled air. Moreover, the airflow output from the flow concentration controller continuously flushes and replaces the gas containing exhaled air in the mask, so that the gas near the mask does not contain exhaled air during inhalation, avoiding repeated breathing caused by the dead space of traditional masks. If the subject's inspiratory flow rate is accidentally greater than the gas input to the mask, the subject can inhale the gas from the flow concentration controller left in the exhalation phase, and the inhaled gas also does not contain exhaled air.
- the present invention has the following advantages and beneficial effects:
- the flow meter connected to the exhaust port at the far end of the mask has a large inner diameter, and the pressure inside the mask is almost zero during inhalation and exhalation. At the same time, continuous high-flow airflow is input at the near end of the mask to eliminate additional inhalation resistance; the high-flow airflow then flows out from the flow meter at the far end to promote the discharge of exhaled air.
- the high-flow airflow continuously input through the proximal end of the mask can flush and replace the exhaled air, eliminating the retention of carbon dioxide in the mask, and eliminating repeated breathing and dead space ventilation.
- the mask Since the mask has a large exhaust port and its internal pressure is zero, there is no need to over-tighten the headband when wearing the mask. You only need to fit the mask to your face to prevent air leakage, thereby reducing the discomfort of wearing the mask and reducing the impact on sleep.
- the air inlet of the mask of this device has a baffle to eliminate the direct impact of high-flow air from the air supply pipe or cold air in a cold environment on the face, mouth and nose, thereby increasing the comfort of the subject.
- FIG. 1 is a schematic diagram of a device that can accurately control the concentration of inhaled gas and detect the respiratory flow rate at the same time. It is composed of a flow concentration controller 1, a mask 2 for detecting tidal volume, and a flow meter 3.
- the mask 2 is composed of a mask body 4, a cushion 5 that fits the face, and a baffle 6.
- the capacity of the mask body 4 is 50-1000 ml.
- the mask body 4 and the baffle 6 are mainly made of lightweight materials such as plastic, silicone, metal, etc.
- the material of the cushion 5 can be soft silicone, gel or foam plastic, etc.
- the baffle 6 can be vertical or angled, with the inner angle facing the air inlet and the far end of the mask, and the angle range can be adjusted to any value in the range of 30-180°.
- the air inlet pipe joint 7 is used to connect the mask air inlet and the gas output pipe 8.
- the air inlet pipe joint 7 can be a straight-through, angled, or 360-degree rotatable joint made by overlapping the pipes, so that the subject can turn his head at will after wearing the mask, and keep the mask in close contact with the face to avoid air leakage.
- a flow meter 3 is provided at the far end 10 of the mask body 4.
- the flow meter 3 can be a common differential pressure flow meter, a flow meter with analog-to-digital conversion function, or a flow meter with both detection and display functions. It can be connected to the biological signal processor through a connecting line 11 to monitor, store and analyze data in real time.
- the medical gas source oxygen, CO2 , hydrogen or nitrogen, etc.
- the flow concentration controller is mixed evenly in the flow concentration controller with the air entering from the air inlet 13 through the air inlet 12.
- the gas delivered to the mask 2 by the flow concentration controller 1 is inhaled, which reduces the gas flowing out through the flow meter 3; when the patient exhales, the exhaled gas is discharged from the far end 10 of the mask through the flow meter 3 together with the airflow output by the flow concentration controller 1, which increases the gas flowing out through the flow meter, thereby measuring the inspiratory flow and expiratory flow.
- Fig. 2 is a schematic diagram of the first embodiment of the flow concentration controller of the present invention.
- An air flow generator 14 (such as a blower) is connected to the air inlet 13 to generate an air flow with a sufficient flow rate.
- the medical gas source passes through the flow control valve 15 from the air inlet 12 and enters the gas mixing area 16 to be evenly mixed with the air flow generated by the blower 14.
- the gas mixing area 16 can be a straight pipe, a curved pipe or a chamber of any other shape.
- the evenly mixed airflow flows through the gas flow concentration sensor 17 and flows out from the air flow output port 18.
- the display 19 can display the gas flow and concentration of the output airflow in real time.
- the signal detected by the gas flow concentration sensor 17 can be automatically transmitted to the controller 20, and the controller 20 controls the blower control component 21 and the flow control valve 15 so that the output airflow velocity and concentration are automatically adjusted to the set value, that is, the flow concentration controller 1 can continuously output a mixed airflow with a constant flow rate concentration.
- the operator can also manually adjust the flow and concentration through the knob or touch panel set by the flow concentration controller 1.
- Fig. 3 is a schematic diagram of the second embodiment of the flow concentration controller of the present invention.
- the medical gas passes through the flow control valve 15 from the air inlet 12, mixes with the air entering from the air inlet 13, and is further evenly mixed by the blower.
- Fig. 4 is a schematic diagram of the third embodiment of the flow concentration controller of the present invention.
- the high-pressure air flows from the air inlet 13 through the flow control valve 22, mixes with the medical gas from the air inlet 12 through the flow control valve 15, and then enters the gas mixing area 16 to achieve uniform mixing of the gas.
- the uniformly mixed airflow flows through the gas flow concentration sensor 17, flows out from the airflow output port 18, and is connected to the mask and the flow meter through the pipeline.
- the display 19 can display the gas flow and concentration of the output airflow in real time.
- the signal detected by the gas flow concentration sensor 17 can be transmitted to the controller 20, and the controller 20 controls the valves 15 and 22 to automatically adjust the output airflow velocity and concentration to the set values.
- FIG5 is a partial front view of the first embodiment of the face mask of the present invention. It includes a face mask cushion inner surface 5, a face mask body 4, Angle baffle 6, air inlet duct 7 and mask distal end 10 connected to flow meter.
- Fig. 6 is a structural diagram of a fixed or detachable angled baffle assembly in a mask.
- the angled baffle 6 is composed of an air intake duct connection portion 23, an angled edge 24 connected to the connection portion 23, and a suspended angled edge 25, with the inner angle facing the air intake port and the far end of the mask, and the angle range of the angled baffle is any value between 30 and 180 degrees.
- FIG7 is a schematic diagram of detecting the tidal volume of the patient's or subject's breathing.
- the patient wears the mask 2 through the headband fixing bayonet 9 and the connected headband 26, so that the mask cushion 5 fits the face.
- the flow concentration controller delivers gas to the mask through the mask air inlet 7 connected to the air supply pipeline.
- the airflow direction through the air inlet pipeline is shown by arrow 27. After the airflow enters the mask, under the action of the angle baffle 6, the direction is changed as shown by arrow 28 and flows to both sides of the mask to fill the mask, and is discharged through the flow meter 3 in the direction shown by arrow 29.
- the gas flow through the flow meter 3 will be consistent with the flow of gas 27 output by the flow concentration controller; when the subject exhales, the exhaled gas flow 30 and the gas 28 output by the flow concentration controller together form the gas flow 29 through the flow meter 3. At this time, the gas flow through the flow meter 3 is equal to the sum of the flow of the subject's exhaled gas 30 and the flow of gas 27 of the gas output device.
- Fig. 8 is a schematic diagram of detecting the inspiratory tidal volume of a patient or a subject.
- the patient wears the mask 2 through the headband fixing bayonet 9 and the connected headband 26, so that the mask cushion 5 fits the face.
- the flow concentration controller delivers gas to the mask through the mask air inlet 7 connected to the air supply pipeline.
- the air flow direction in the air inlet pipeline is shown by arrow 27.
- the air flow enters the mask the direction is changed as shown by arrow 28 under the action of the angle baffle 6, and flows to both sides of the mask to fill the mask.
- the air flow 28 or the air flow flowing to both sides of the mask will enter the respiratory tract as shown by arrow 31.
- the excess gas is discharged through the far end of the flow meter 3 as shown by arrow 29.
- the gas flow measured by the flow meter 3 is the difference between the air flow 27 and the patient's inspiratory flow 31.
- a calibration cylinder 32 with a scale of 0.5 L, 1 L, and 2 L is used to simulate the breathing pattern of the subject, that is, the tidal volume is 0.5 L, 1 L, 1.5 L, and 2 L.
- the calibration cylinder 32 is rotated
- the connector 33 is closely connected to the mask 2
- the flow concentration controller 1 is connected to the air inlet 7 of the mask 2 through the pipe 8.
- the flow concentration controller 1 outputs an air flow at a constant flow rate (40L/min).
- the pull rod 34 of the calibration cylinder When the simulated subject inhales, the pull rod 34 of the calibration cylinder is pulled to the 0.5L, 1L, 1.5L, and 2L capacity positions of the cylinder respectively, and the gas flow rate curve is below the baseline flow rate, that is, the flow rate detected by the flowmeter is less than the baseline flow rate; when the simulated subject exhales, the piston of the calibration cylinder is pushed to discharge all the gas in the cylinder, and the gas flow rate curve is above the baseline flow rate, that is, the flow rate detected by the flowmeter 3 is greater than the baseline flow rate, as shown in the curves of Figures 11, 12, 13, and 14.
- FIG10 is a schematic diagram of simulating breathing by pulling the pull rod 34 of the calibration cylinder 32 to the 0.5L capacity position of the gas cylinder.
- FIGA shows that a 0.5L capacity calibration cylinder is used to simulate breathing when the flow concentration controller outputs an air flow of 40L/min, and the gas flow rate fluctuates around the base flow rate (40L/min) to form a breathing flow rate curve.
- FIGB shows that the base flow rate of 40L/min is set as the baseline flow rate (0L/min), and the software is used to calculate the inspiratory capacity, i.e., the curve area under the baseline flow rate, which are 0.4981L, 0.4869L, 0.4916L, 0.4920L, and 0.5069L, respectively, which is less than 3% of the standard capacity error of 0.5L, which is basically consistent.
- the inspiratory capacity i.e., the curve area under the baseline flow rate, which are 0.4981L, 0.4869L, 0.4916L, 0.4920L, and 0.5069L, respectively, which is less than 3% of the standard capacity error of 0.5L, which is basically consistent.
- Fig. 11 is a schematic diagram of simulating breathing by pulling the pull rod 34 of the calibration cylinder 32 to the 1L capacity position of the gas cylinder.
- Fig. A shows that a 1L capacity calibration cylinder is used to simulate breathing when the flow concentration controller outputs 40L/min of air flow, and the gas flow rate fluctuates around the base flow rate (40L/min) to form a breathing flow rate curve.
- the base flow rate of 40L/min is set as the baseline flow rate (0L/min), and the software is used to calculate the inspiratory capacity, i.e., the curve area under the baseline flow rate, which are 0.9903L, 0.9977L, 0.9773L, 0.9851L, and 0.9759L, respectively, which is less than 3% of the standard capacity error of 1L, which is basically consistent.
- Fig. 12 is a schematic diagram of simulating breathing by pulling the pull rod 34 of the calibration cylinder 32 to the 1.5L capacity position of the gas cylinder.
- Fig. A shows that a 1.5L capacity calibration cylinder is used to simulate breathing when the flow concentration controller outputs 40L/min air flow, and the gas flow rate fluctuates around the base flow rate (40L/min) to form a breathing flow rate curve.
- the base flow rate of 40L/min is set as the baseline flow rate (0L/min), and the software is used to calculate the inspiratory capacity, i.e., the curve area under the baseline flow rate, which are 1.4805L, 1.4717L, 1.4841L, and 1.4755L, respectively, which is less than 2% of the standard capacity error of 1.5L, which is basically consistent.
- Figure 13 is a schematic diagram of pulling the rod 34 of the calibration cylinder 32 to the 2L capacity position of the cylinder to simulate breathing.
- Figure A shows that when the flow concentration controller outputs 40L/min air flow, a 2L capacity calibration cylinder is used to simulate breathing, and the gas flow rate is The basic flow rate (40L/min) fluctuates up and down to form a respiratory flow rate curve.
- Figure B sets the basic flow rate of 40L/min as the baseline flow rate (0L/min), and uses software to calculate the inspiratory capacity, that is, the curve area under the baseline flow rate, which are 1.9927L, 1.9627L, 1.9769L, and 1.9915L, respectively, with an error of less than 2% with the standard capacity of 2L, which is basically consistent.
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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)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
Abstract
The present invention relates to a comfortable device capable of accurately controlling the concentration of an inhaled gas and simultaneously measuring a breath flow, comprising a flow and concentration controller, a mask, and a flow meter. The flow and concentration controller consists of an airflow generator (such as an air blower), a medical gas source and a gas mixing assembly, and the flow and concentration controller can output a gas having constant flow and concentration; the mask has a capacity of 50-1000 ml, and comprises a mask body and a proximal pad portion, wherein the proximal pad portion is soft and can fit a face, a gas inlet is formed in the proximal end of the mask body, a blocking plate used for eliminating the impact of airflow on the face is provided on one side of the gas inlet, and the flow meter is arranged at the distal end of the mask body. Airflow having constant flow and concentration output by the flow and concentration controller enters from the proximal end of the mask and then flows out of an exhaust port at the distal end of the mask through the flow meter. The device can promote the discharge of an exhaled gas, eliminate the breathing resistance and the retention of the exhaled gas CO2, can provide a gas having constant flow and concentration for a subject, and can accurately measure the breath flow comprising a tidal volume and minute ventilation when various medical gases are inhaled.
Description
本发明涉及恒定浓度医用气体的吸入和呼吸流量检测装置。The invention relates to a device for detecting the inhalation and breathing flow of medical gas with a constant concentration.
睡眠状态下呼吸气流的量化常常通过佩戴连接有流量传感器的面罩实现,这一连接方式因管道变长,增加“死腔容量”和呼吸阻力,既可造成受试者呼吸不畅,影响睡眠,也可引起面罩内压力的增加导致气体从面罩与脸面接触部分进出(漏气),从而影响气体流量测量的准确度。“死腔容量”是一生理述语,它指呼出气不能排到大气中,造成下一个呼吸周期吸入的气体的一部分为前一周期的呼出气。由于呼出气CO2含量高,氧气浓度较低,死腔容量增大可增加体内CO2浓度和加重缺氧,可进一步加重呼吸衰竭病人的病情。为了避免漏气,通常要勒紧头带,加重脸面受压,造成不适,影响睡眠质量。另外,在空调或室内寒冷环境下,由于呼出气的温度高,遇冷后可在面罩腔内形成水滴,既影响流量的测定,也可因面罩内水滴的过多积聚,反流回脸部,加重受试者的不适。Quantification of respiratory airflow during sleep is often achieved by wearing a mask connected to a flow sensor. This connection method increases the "dead space capacity" and respiratory resistance due to the lengthened pipe, which can cause the subject to have difficulty breathing and affect sleep. It can also cause an increase in pressure inside the mask, resulting in gas entering and exiting the part of the mask in contact with the face (leakage), thereby affecting the accuracy of gas flow measurement. "Dead space capacity" is a physiological term, which refers to the inability of exhaled air to be discharged into the atmosphere, resulting in part of the gas inhaled in the next respiratory cycle being the exhaled air of the previous cycle. Due to the high CO2 content and low oxygen concentration in exhaled air, an increase in dead space capacity can increase the CO2 concentration in the body and aggravate hypoxia, which can further aggravate the condition of patients with respiratory failure. In order to avoid air leakage, the headband is usually tightened, which increases the pressure on the face, causes discomfort, and affects sleep quality. In addition, in air-conditioning or cold indoor environments, due to the high temperature of the exhaled air, water droplets may form in the mask cavity when it encounters cold, which not only affects the measurement of the flow rate, but also may cause excessive accumulation of water droplets in the mask, which may flow back to the face and aggravate the subject's discomfort.
吸入医用气体如氧气、二氧化碳、氢气等是治疗呼吸疾病的重要方法,为了达到吸入医用气体时的治疗效果,既要保证吸入气体的浓度,也需要检测吸入气体下呼吸流量包括潮气量和每分通气量。鼻导管输氧时,由于鼻导管影响面罩与脸面部之间贴合,造成漏气,影响呼吸气流量的准确测量。同时鼻导管输氧时,吸入呼吸道氧气浓度随呼吸节律和呼吸深度而变,难于准确控制吸入气浓度。如果在面罩上设置额外的孔输入医用气体,吸入气体浓度仍然会随呼吸的方式而变化,无法达到预设的治疗效果。临床上,
无创通气时所用的面罩常设置有小的通孔,用于连接医院内的中心供氧装置、家庭用的制氧机或氧气瓶实现氧疗。也可从通孔输入CO2以补充存在过度通气病人的CO2,提高血CO2浓度。然而,通过小通孔进行氧疗或者补充CO2气体时,如果呼吸频率增快,则面罩内气体浓度下降,而呼气相延长,则面罩内气体蓄积,吸入气体浓度增高,如果病人暂停呼吸则可造成吸入气体浓度进一步增高。当输入的是CO2时,如果吸入过高浓度的CO2可造成觉醒,损害睡眠质量。另外,由于气流的刺激,直接从鼻腔输入医用气体时流量常常不超过5升/分。Inhalation of medical gases such as oxygen, carbon dioxide, and hydrogen is an important method for treating respiratory diseases. In order to achieve the therapeutic effect when inhaling medical gases, it is necessary to ensure the concentration of the inhaled gas and detect the respiratory flow under the inhaled gas, including tidal volume and minute ventilation. When oxygen is delivered through a nasal cannula, the nasal cannula affects the fit between the mask and the face, causing air leakage, which affects the accurate measurement of the respiratory airflow. At the same time, when oxygen is delivered through a nasal cannula, the concentration of inhaled respiratory tract oxygen varies with the respiratory rhythm and depth of breathing, making it difficult to accurately control the concentration of the inhaled gas. If additional holes are set on the mask to input medical gases, the concentration of the inhaled gas will still vary with the breathing pattern, and the preset therapeutic effect cannot be achieved. Clinically, The mask used for non-invasive ventilation is often provided with a small through hole for connecting to the central oxygen supply device in the hospital, the oxygen concentrator for home use or the oxygen cylinder to achieve oxygen therapy. CO2 can also be input through the through hole to supplement the CO2 of patients with overventilation and increase the blood CO2 concentration. However, when oxygen therapy or CO2 gas supplementation is performed through the small through hole, if the respiratory rate increases, the gas concentration in the mask decreases, and the expiratory phase is prolonged, the gas accumulates in the mask, the concentration of the inhaled gas increases, and if the patient stops breathing, the concentration of the inhaled gas may further increase. When CO2 is input, inhaling too high a concentration of CO2 may cause awakening and impair sleep quality. In addition, due to the stimulation of airflow, the flow rate when medical gas is directly input from the nasal cavity often does not exceed 5 liters/minute.
如果能从面罩近端持续输入足够流量且混合均匀的气体,并经面罩的远端排出,则可保证吸入气体浓度恒定。如果,面罩的远端与流量计连接则可保证在吸入气体浓度恒定下,准确测量吸入气流量。我们早期发明了一种氧疗相关装置(专利号ZL 2018 1 0388945.3),它包含一个远端有大孔的面罩。通过从面罩近端输入已经均匀混合的高流量气体,供给病人吸气,多余的气体则经面罩的远端排出,呼气时则输入到面罩的高流量气体与呼出气一起从远端排气口及流量计排出。由于远端有一个与大气相通的大排气口,使面罩内压总是为零,且无呼吸阻力。然而均匀混合的高流量气流从面罩近端输入,气流可冲击脸面及口鼻,特别是在气流量大或者寒冷环境下,受试者可感到寒冷不适,甚至难于忍受。If a sufficient flow of evenly mixed gas can be continuously input from the proximal end of the mask and discharged through the distal end of the mask, the concentration of the inhaled gas can be kept constant. If the distal end of the mask is connected to a flowmeter, the inhaled gas flow can be accurately measured under a constant inhaled gas concentration. We invented an oxygen therapy-related device (patent number ZL 2018 1 0388945.3) earlier, which includes a mask with a large hole at the distal end. By inputting evenly mixed high-flow gas from the proximal end of the mask, the patient inhales, and the excess gas is discharged through the distal end of the mask. When exhaling, the high-flow gas input into the mask is discharged from the distal exhaust port and flowmeter together with the exhaled gas. Since there is a large exhaust port at the distal end that is connected to the atmosphere, the internal pressure of the mask is always zero and there is no breathing resistance. However, the evenly mixed high-flow airflow is input from the proximal end of the mask, and the airflow can impact the face and mouth and nose. Especially in a large airflow or cold environment, the subject may feel cold and uncomfortable, or even unbearable.
发明内容Summary of the invention
为了克服上述问题,我们发明了既可精确控制吸入气体浓度又可准确测量呼吸气流,且佩戴舒适的装置。To overcome the above problems, we invented a device that can precisely control the inhaled gas concentration, accurately measure the respiratory airflow, and is comfortable to wear.
为达到上述目的,本发明通过如下方案实现:To achieve the above object, the present invention is implemented by the following scheme:
一种可准确控制吸入气浓度并可同时检测呼吸流量的舒适装置,包括可用于准确控制吸入气浓度的流量浓度控制器、面罩和流量计三部分。
The invention discloses a comfortable device which can accurately control the concentration of inhaled gas and detect the breathing flow simultaneously, comprising a flow concentration controller which can be used to accurately control the concentration of inhaled gas, a mask and a flow meter.
流量浓度控制器由空气气流产生器、医用气源(它们可以是氧气、CO2或氢气等)和气体混合组件组成。其原理与我们早期发明的一种氧疗相关装置类似(专利授权号分别为ZL 2018 1 0388945.3)。具体的说,就是通过鼓风机产生恒定的气流,与来自医用气源的气体(氧气,CO2)混合均匀后输入面罩。送气量可通过内置于流量浓度控制器的流量传感器监测并通过人工、自动反馈,或者人工与自动反馈相结合调节。调节方式既可通过调节鼓风机的转速,也可通过阀门控制管道大小调节流量。气体浓度则可通过内置于流量浓度控制器的浓度传感器监测并通过人工、自动反馈,或者人工与自动反馈相结合调节来自医用气源的气体量从而调节送气浓度。The flow concentration controller consists of an air flow generator, a medical gas source (which can be oxygen, CO 2 or hydrogen, etc.) and a gas mixing component. Its principle is similar to an oxygen therapy-related device invented by us earlier (the patent authorization number is ZL 2018 1 0388945.3). Specifically, a constant airflow is generated by a blower, which is mixed evenly with the gas (oxygen, CO 2 ) from the medical gas source and then input into the mask. The air supply volume can be monitored by the flow sensor built into the flow concentration controller and adjusted by manual, automatic feedback, or a combination of manual and automatic feedback. The adjustment method can be adjusted by adjusting the speed of the blower or by controlling the size of the pipeline through a valve. The gas concentration can be monitored by the concentration sensor built into the flow concentration controller and the gas volume from the medical gas source can be adjusted by manual, automatic feedback, or a combination of manual and automatic feedback to adjust the air supply concentration.
面罩是一个气体容器,其有效气体容量可设置为在50-1000ml之间的任意值,可由金属、塑料、硅胶及其它能形成容器的材料制成,而形状可为筒状、长方体、椭圆形或其他任意形状。面罩的脸面接触端(近端)与常规面罩一样,其材料可为塑料、硅胶等柔软轻薄材料制成以保证脸面与面罩紧密连接。面罩的近端有一个或多个进气口,进气口的外侧与送气管道相接,接受来自鼓风机产生的恒定流速的空气或均匀混合后的恒定流速及浓度的医用气体。进气口的面罩内侧设有一挡板,用于减少或防止气流对口鼻和脸部的冲击。挡板可以垂直也可以像折角,内折角朝向进气口和面罩远端,角度范围在30°-180°中的任意值。面罩的远端有一个或数个大孔,受试者的呼出气和来自送气管道的气体全部从面罩远端的大孔及其连接的流量计排出,使面罩内压总是为零。The mask is a gas container, and its effective gas capacity can be set to any value between 50-1000ml. It can be made of metal, plastic, silicone and other materials that can form a container, and the shape can be cylindrical, rectangular, elliptical or other arbitrary shapes. The face contact end (proximal end) of the mask is the same as that of a conventional mask, and its material can be made of soft and thin materials such as plastic and silicone to ensure that the face and the mask are tightly connected. There are one or more air inlets at the proximal end of the mask, and the outer side of the air inlet is connected to the air supply pipe to receive the air with a constant flow rate generated by the blower or the medical gas with a constant flow rate and concentration after uniform mixing. A baffle is provided on the inner side of the mask at the air inlet to reduce or prevent the impact of the air flow on the mouth, nose and face. The baffle can be vertical or angled, with the inner angle facing the air inlet and the far end of the mask, and the angle range is any value between 30° and 180°. There is one or more large holes at the far end of the mask. The exhaled air of the subject and the gas from the air supply pipe are all discharged from the large holes at the far end of the mask and the flow meter connected to it, so that the pressure inside the mask is always zero.
流量计可以是普通压差式流量计,电磁流量计,叶轮流量计,超声波流量计,质量流量计等,也可以是带有模数转换功能或者同时具有检测与显示功能的流量计。流量计的通气口径足够大,其直径1cm2以上,以保证排气通畅且面罩内压保持为零,对于成人来说理想的通气口是3cm2甚至更大。面罩外有2-4个头带接口用于固定面罩,以使面罩稳定地固定在脸部。The flow meter can be a common differential pressure flow meter, an electromagnetic flow meter, an impeller flow meter, an ultrasonic flow meter, a mass flow meter, etc. It can also be a flow meter with an analog-to-digital conversion function or a flow meter with both detection and display functions. The ventilation aperture of the flow meter is large enough, with a diameter of more than 1 cm2 , to ensure smooth exhaust and zero pressure inside the mask. For adults, the ideal ventilation aperture is 3 cm2 or even larger. There are 2-4 headband interfaces outside the mask for fixing the mask so that the mask can be stably fixed on the face.
下面举例说明。
The following example illustrates this.
当要测量受试者在吸入氢气浓度为2%的混合气体时的呼吸流量时,让受试者佩戴好接有流量计的面罩。假设,选择面罩的气体容量为500ml,面罩进气口气体流量60L/分,H2浓度为2%的气流。打开高压H2气瓶让其输出100%的纯氢气气体,调节鼓风机的输出流量,当流量浓度控制器的最终输出流量为60L/分,H2浓度为2%时,这时来自鼓风机的气流为58.8升/分,来自CO2气瓶的流量为1.2升/分(输出气体H2浓度为1.2*100%/(1.2+58.8)=2%)。当气体输送到面罩时,气流在挡板的作用下向挡板周围扩散,填充面罩并流向远端通过流量计排出。由于挡板的作用,消除了输入气流对病人脸面及口鼻的冲击,病人无不适感。受试者吸气时,吸入来自流量浓度控制器输送至面罩的气体,使经流量计流出的气体减少;呼气时,受试者的呼出气与来自气体流量浓度控制器输出的气流一起从面罩远端经流量计排出,使经流量计流出的气体增多。当呼吸暂停时,经远端流量计排出的气流等于输入到面罩的气流,即60L/分的基础流量。呼吸时的流量在60L/分的基础上,来回上下波动,从而测出吸气流量和呼气流量。When measuring the respiratory flow of the subject when inhaling a mixed gas with a hydrogen concentration of 2%, let the subject wear a mask connected to a flowmeter. Assume that the gas capacity of the mask is 500ml, the gas flow rate at the mask inlet is 60L/min, and the H2 concentration is 2%. Open the high-pressure H2 gas cylinder to allow it to output 100% pure hydrogen gas, adjust the output flow of the blower, when the final output flow of the flow concentration controller is 60L/min, and the H2 concentration is 2%, then the air flow from the blower is 58.8 liters/min, and the flow from the CO2 gas cylinder is 1.2 liters/min (the output gas H2 concentration is 1.2*100%/(1.2+58.8)=2%). When the gas is delivered to the mask, the air flow diffuses around the baffle under the action of the baffle, fills the mask and flows to the far end to be discharged through the flowmeter. Due to the effect of the baffle, the impact of the input air flow on the patient's face and mouth and nose is eliminated, and the patient does not feel uncomfortable. When the subject inhales, he inhales the gas delivered to the mask from the flow concentration controller, which reduces the gas flowing out of the flow meter; when exhaling, the subject's exhaled gas is discharged from the far end of the mask through the flow meter together with the airflow output from the gas flow concentration controller, which increases the gas flowing out of the flow meter. When breathing stops, the airflow discharged through the far end flow meter is equal to the airflow input to the mask, that is, the basic flow of 60L/min. The flow during breathing fluctuates up and down on the basis of 60L/min, so as to measure the inspiratory flow and expiratory flow.
在一些特定条件下如运动或者睡眠状态下,如果要测量呼吸空气时的呼吸流量包括潮气量和每分通气量,则可通过头带固定面罩,并通过转接头连接流量计,调节流量浓度控制器使其输出预定流量的空气到面罩,由于来自流量浓度控制器输出的气流流速大,可以促进呼出气的排出。而且来自流量浓度控制器输出的气流持续不断地冲洗替代面罩内含有呼出气的气体,使得吸气时面罩近端的气体不含呼出气,避免了传统面罩因死腔所致的重复呼吸。如果受试者的吸气流速偶然大于输入到面罩的气体,受试者则可通过吸入呼气相所留下的来自流量浓度控制器的气体,吸入的气体同样不含呼出气。Under certain conditions, such as during exercise or sleep, if you want to measure the respiratory flow including tidal volume and minute ventilation when breathing air, you can fix the mask with a headband, connect the flowmeter with an adapter, and adjust the flow concentration controller to output a predetermined flow of air to the mask. Since the airflow velocity output from the flow concentration controller is large, it can promote the discharge of exhaled air. Moreover, the airflow output from the flow concentration controller continuously flushes and replaces the gas containing exhaled air in the mask, so that the gas near the mask does not contain exhaled air during inhalation, avoiding repeated breathing caused by the dead space of traditional masks. If the subject's inspiratory flow rate is accidentally greater than the gas input to the mask, the subject can inhale the gas from the flow concentration controller left in the exhalation phase, and the inhaled gas also does not contain exhaled air.
本发明相对于现有技术,具有如下优点与有益效果:Compared with the prior art, the present invention has the following advantages and beneficial effects:
1.面罩远端排气口连接的流量计内径大,吸呼时面罩内压均几乎为零。同时在面罩近端输入持续的高流量气流,可消除额外的吸气阻力;高流量气流再从远端的流量计流出,促进呼出气的排出。
1. The flow meter connected to the exhaust port at the far end of the mask has a large inner diameter, and the pressure inside the mask is almost zero during inhalation and exhalation. At the same time, continuous high-flow airflow is input at the near end of the mask to eliminate additional inhalation resistance; the high-flow airflow then flows out from the flow meter at the far end to promote the discharge of exhaled air.
2.通过面罩近端持续输入的高流量气流可冲洗替换呼出气,消除了面罩内二氧化碳的潴留,消除了重复呼吸和死腔通气。2. The high-flow airflow continuously input through the proximal end of the mask can flush and replace the exhaled air, eliminating the retention of carbon dioxide in the mask, and eliminating repeated breathing and dead space ventilation.
3.由于面罩排气口大,其内压为零,佩戴面罩时不必过度拉紧头带,只需将面罩与脸面贴合即可防止漏气,从而减小了佩戴面罩的不适,减少对睡眠的影响。3. Since the mask has a large exhaust port and its internal pressure is zero, there is no need to over-tighten the headband when wearing the mask. You only need to fit the mask to your face to prevent air leakage, thereby reducing the discomfort of wearing the mask and reducing the impact on sleep.
4.由于面罩和流量计通道中有持续的气流通过,冲洗呼出气,可避免寒冷环境下呼出气转为冷凝水的形成,既保证测量的准确性,也可消除冷凝水对脸面的刺激。4. As there is continuous airflow passing through the mask and flow meter channels to flush the exhaled air, it can prevent the exhaled air from turning into condensed water in a cold environment, which not only ensures the accuracy of the measurement, but also eliminates the irritation of condensed water to the face.
5.这一装置面罩内进气口有一挡板可消除来自送气管道的高流量气流或寒冷环境下的寒冷气流对脸面及口鼻的直接冲击,增加受试者的舒适感。5. The air inlet of the mask of this device has a baffle to eliminate the direct impact of high-flow air from the air supply pipe or cold air in a cold environment on the face, mouth and nose, thereby increasing the comfort of the subject.
下面结合实施图对本发明进行进一步说明。The present invention will be further described below in conjunction with the implementation diagram.
图1是可准确控制吸入气浓度并可同时检测呼吸流量的装置的结构示意图。它由流量浓度控制器1、检测潮气量的面罩2和流量计3组成。面罩2由面罩主体4、贴合脸面的软垫5和挡板6组成。面罩主体4容量为50-1000ml,面罩主体4和挡板6主要由轻便材料如塑料、硅胶,金属等制成,软垫5的材料可为柔软的硅胶、凝胶或泡沫塑料等。挡板6可以垂直也可以像折角,内折角朝向进气口和面罩远端,角度范围在30-180°中的任意值可调节。进气管道接头7用于连接面罩进气口和气体输出管道8,进气管道接头7可以是直通、转角或是通过管道套叠做成可360度旋转的接头,使受试者在佩戴面罩后可随意转动头部,并保持面罩与脸面的贴合,避免面罩漏气。面罩2两外侧各有1-2个头带固定卡口9。面罩体4远端10设有流量计3。流量计3可以是普通压差式流量计、带有模数转换功能的流量计或者同时具有检测与显示功能的流量计,其可通过连接线11与生物信号处理器连接进行实时监测、存储并分析数据。医用气源(氧气、CO2、氢气或氮气等)通过进气口12与由进气口13进入的空气在流量浓度控制器中混合均匀。当受试者
需检测呼吸气流及潮气量时,受试者佩戴好面罩后,来自流量浓度控制器输出的恒定流速浓度的气流通过气体输出管道8、进气管道接头7进入到面罩腔。病人吸气时,吸入流量浓度控制器1输送至面罩2的气体,使经流量计3流出的气体减少;呼气时,呼出气与来自流量浓度控制器1输出的气流一起从面罩远端10经流量计3排出,使经流量计流出的气体增多,从而测出吸气流量和呼气流量。FIG. 1 is a schematic diagram of a device that can accurately control the concentration of inhaled gas and detect the respiratory flow rate at the same time. It is composed of a flow concentration controller 1, a mask 2 for detecting tidal volume, and a flow meter 3. The mask 2 is composed of a mask body 4, a cushion 5 that fits the face, and a baffle 6. The capacity of the mask body 4 is 50-1000 ml. The mask body 4 and the baffle 6 are mainly made of lightweight materials such as plastic, silicone, metal, etc. The material of the cushion 5 can be soft silicone, gel or foam plastic, etc. The baffle 6 can be vertical or angled, with the inner angle facing the air inlet and the far end of the mask, and the angle range can be adjusted to any value in the range of 30-180°. The air inlet pipe joint 7 is used to connect the mask air inlet and the gas output pipe 8. The air inlet pipe joint 7 can be a straight-through, angled, or 360-degree rotatable joint made by overlapping the pipes, so that the subject can turn his head at will after wearing the mask, and keep the mask in close contact with the face to avoid air leakage. There are 1-2 headband fixing clips 9 on both sides of the mask 2. A flow meter 3 is provided at the far end 10 of the mask body 4. The flow meter 3 can be a common differential pressure flow meter, a flow meter with analog-to-digital conversion function, or a flow meter with both detection and display functions. It can be connected to the biological signal processor through a connecting line 11 to monitor, store and analyze data in real time. The medical gas source (oxygen, CO2 , hydrogen or nitrogen, etc.) is mixed evenly in the flow concentration controller with the air entering from the air inlet 13 through the air inlet 12. When the subject When it is necessary to detect the respiratory airflow and tidal volume, after the subject wears the mask, the airflow with a constant flow rate and concentration output by the flow concentration controller enters the mask cavity through the gas output pipe 8 and the air inlet pipe joint 7. When the patient inhales, the gas delivered to the mask 2 by the flow concentration controller 1 is inhaled, which reduces the gas flowing out through the flow meter 3; when the patient exhales, the exhaled gas is discharged from the far end 10 of the mask through the flow meter 3 together with the airflow output by the flow concentration controller 1, which increases the gas flowing out through the flow meter, thereby measuring the inspiratory flow and expiratory flow.
图2是本发明流量浓度控制器第一实施结构示意图。空气流产生器14(如鼓风机)与进气口13连接,可产生足够流量的空气气流。医用气源从进气口12经过流量控制阀门15,与来自鼓风机14产生的空气气流进入气体混合区域16均匀混合。气体混合区域16可以是直管道、弯曲管道或其他任意形状的室腔。均匀混合的气流流经气体流量浓度传感器17,从气流输出口18流出,显示器19可实时显示输出气流的气体流量及浓度。气体流量浓度传感器17检测的信号可自动传输至控制器20,由控制器20控制鼓风机控制组件21及流量控制阀门15,使输出的气流流速及浓度自动调节至设定的数值,即流量浓度控制器1可持续输出恒定流速浓度的混合气流。操作者也可通过流量浓度控制器1设置的旋钮或触控面板手动调节流量及浓度。Fig. 2 is a schematic diagram of the first embodiment of the flow concentration controller of the present invention. An air flow generator 14 (such as a blower) is connected to the air inlet 13 to generate an air flow with a sufficient flow rate. The medical gas source passes through the flow control valve 15 from the air inlet 12 and enters the gas mixing area 16 to be evenly mixed with the air flow generated by the blower 14. The gas mixing area 16 can be a straight pipe, a curved pipe or a chamber of any other shape. The evenly mixed airflow flows through the gas flow concentration sensor 17 and flows out from the air flow output port 18. The display 19 can display the gas flow and concentration of the output airflow in real time. The signal detected by the gas flow concentration sensor 17 can be automatically transmitted to the controller 20, and the controller 20 controls the blower control component 21 and the flow control valve 15 so that the output airflow velocity and concentration are automatically adjusted to the set value, that is, the flow concentration controller 1 can continuously output a mixed airflow with a constant flow rate concentration. The operator can also manually adjust the flow and concentration through the knob or touch panel set by the flow concentration controller 1.
图3是本发明流量浓度控制器第二实施结构示意图。医用气体从进气口12经过流量控制阀门15,与从进气口13进入的空气混合,并通过鼓风机进一步均匀混合。Fig. 3 is a schematic diagram of the second embodiment of the flow concentration controller of the present invention. The medical gas passes through the flow control valve 15 from the air inlet 12, mixes with the air entering from the air inlet 13, and is further evenly mixed by the blower.
图4是本发明流量浓度控制器第三实施结构示意图。高压空气流从进气口13经过流量控制阀门22,与从进气口12经过流量控制阀门15的医用气体混合,再进入气体混合区域16实现气体的均匀混合,均匀混合的气流流经气体流量浓度传感器17,从气流输出口18流出,并通过管道与面罩和流量计相连,显示器19可实时显示输出气流的气体流量及浓度。气体流量浓度传感器17检测的信号可传输至控制器20,由控制器20控制阀门15和22,使输出的气流流速及浓度自动调节至设定的数值。Fig. 4 is a schematic diagram of the third embodiment of the flow concentration controller of the present invention. The high-pressure air flows from the air inlet 13 through the flow control valve 22, mixes with the medical gas from the air inlet 12 through the flow control valve 15, and then enters the gas mixing area 16 to achieve uniform mixing of the gas. The uniformly mixed airflow flows through the gas flow concentration sensor 17, flows out from the airflow output port 18, and is connected to the mask and the flow meter through the pipeline. The display 19 can display the gas flow and concentration of the output airflow in real time. The signal detected by the gas flow concentration sensor 17 can be transmitted to the controller 20, and the controller 20 controls the valves 15 and 22 to automatically adjust the output airflow velocity and concentration to the set values.
图5是本发明面罩第一实施结构的部分前视图。它包括面罩软垫内面5、面罩主体4、
折角挡板6、进气管道7和连接流量计的面罩远端10。FIG5 is a partial front view of the first embodiment of the face mask of the present invention. It includes a face mask cushion inner surface 5, a face mask body 4, Angle baffle 6, air inlet duct 7 and mask distal end 10 connected to flow meter.
图6是面罩中一个固定或可拆卸的折角挡板组件结构图。折角挡板6由进气管道连接部23、与连接部23相连的折角边24和悬空的折角边25组成,内折角朝向进气口和面罩远端,折角挡板的角度范围在30-180°中的任意值。Fig. 6 is a structural diagram of a fixed or detachable angled baffle assembly in a mask. The angled baffle 6 is composed of an air intake duct connection portion 23, an angled edge 24 connected to the connection portion 23, and a suspended angled edge 25, with the inner angle facing the air intake port and the far end of the mask, and the angle range of the angled baffle is any value between 30 and 180 degrees.
图7是检测病人或受试者呼吸气潮气量示意图。病人通过头带固定卡口9及连接的头带26佩戴好面罩2,使面罩软垫5与脸面部贴合。流量浓度控制器通过与送气管道相连的面罩进气口7输送气体到面罩内,通过进气管道内的气流方向如箭头27所示,气流进入面罩内后在折角挡板6的作用下,方向被改变如箭头28所示并向面罩两侧流动填充面罩,并如箭头29所示的方向通过流量计3排出。当受检者屏住呼吸或呼吸暂停时,通过流量计3的气体流量将与流量浓度控制器输出的气体27的流量一致;当受检者呼气时,呼出气流30与流量浓度控制器输出的气体28一起形成气流29通过流量计3,此时通过流量计3的气流量等于受检者呼出气体30的流量与气体输出设备的气体27的流量之和。FIG7 is a schematic diagram of detecting the tidal volume of the patient's or subject's breathing. The patient wears the mask 2 through the headband fixing bayonet 9 and the connected headband 26, so that the mask cushion 5 fits the face. The flow concentration controller delivers gas to the mask through the mask air inlet 7 connected to the air supply pipeline. The airflow direction through the air inlet pipeline is shown by arrow 27. After the airflow enters the mask, under the action of the angle baffle 6, the direction is changed as shown by arrow 28 and flows to both sides of the mask to fill the mask, and is discharged through the flow meter 3 in the direction shown by arrow 29. When the subject holds his breath or stops breathing, the gas flow through the flow meter 3 will be consistent with the flow of gas 27 output by the flow concentration controller; when the subject exhales, the exhaled gas flow 30 and the gas 28 output by the flow concentration controller together form the gas flow 29 through the flow meter 3. At this time, the gas flow through the flow meter 3 is equal to the sum of the flow of the subject's exhaled gas 30 and the flow of gas 27 of the gas output device.
图8是检测病人或受试者吸气潮气量示意图。病人通过头带固定卡口9及连接的头带26佩戴好面罩2,使面罩软垫5与脸面部贴合。流量浓度控制器通过与送气管道相连的面罩进气口7输送气体到面罩内,通过进气管道内的气流方向如箭头27所示,气流进入面罩时在折角挡板6的作用下,方向被改变如箭头28所示,并向面罩两侧流动填充面罩。当受试者吸气时,气流28或向面罩两侧流动的气流将如箭头31所示进入呼吸道。当受试者吸气流量小于流量浓度控制器输出的气流量时,则多余的气体如箭头29所示经过流量计3的远端排出,此时流量计3所测得的气体流量为气流量27与病人吸气流量31之差。Fig. 8 is a schematic diagram of detecting the inspiratory tidal volume of a patient or a subject. The patient wears the mask 2 through the headband fixing bayonet 9 and the connected headband 26, so that the mask cushion 5 fits the face. The flow concentration controller delivers gas to the mask through the mask air inlet 7 connected to the air supply pipeline. The air flow direction in the air inlet pipeline is shown by arrow 27. When the air flow enters the mask, the direction is changed as shown by arrow 28 under the action of the angle baffle 6, and flows to both sides of the mask to fill the mask. When the subject inhales, the air flow 28 or the air flow flowing to both sides of the mask will enter the respiratory tract as shown by arrow 31. When the subject's inspiratory flow is less than the air flow output by the flow concentration controller, the excess gas is discharged through the far end of the flow meter 3 as shown by arrow 29. At this time, the gas flow measured by the flow meter 3 is the difference between the air flow 27 and the patient's inspiratory flow 31.
下面举一个流量模拟检测例子,如图9所示,使用设有容量为0.5L、1L、2L标尺的定标筒32模拟受检者的呼吸模式,即潮气量为0.5L、1L、1.5L、2L。定标筒32通过转
接器33与面罩2紧密相连,流量浓度控制器1通过管道8与面罩2的进气口7连接。流量浓度控制器1输出恒定流速(40L/min)的空气流量。当模拟受检者吸气时,分别拉动定标筒的拉杆34至气筒0.5L、1L、1.5L、2L容量位,气体流速曲线在基线流量下方,即流量计所检测的流量小于基线流量;当模拟受检者呼气时,推动定标筒的活塞将气筒内气体全部排出,气体流速曲线在基线流量上方,即流量计3所检测的流量大于基线流量,如图11、12、13、14的曲线所示。The following is an example of flow simulation detection. As shown in FIG9 , a calibration cylinder 32 with a scale of 0.5 L, 1 L, and 2 L is used to simulate the breathing pattern of the subject, that is, the tidal volume is 0.5 L, 1 L, 1.5 L, and 2 L. The calibration cylinder 32 is rotated The connector 33 is closely connected to the mask 2, and the flow concentration controller 1 is connected to the air inlet 7 of the mask 2 through the pipe 8. The flow concentration controller 1 outputs an air flow at a constant flow rate (40L/min). When the simulated subject inhales, the pull rod 34 of the calibration cylinder is pulled to the 0.5L, 1L, 1.5L, and 2L capacity positions of the cylinder respectively, and the gas flow rate curve is below the baseline flow rate, that is, the flow rate detected by the flowmeter is less than the baseline flow rate; when the simulated subject exhales, the piston of the calibration cylinder is pushed to discharge all the gas in the cylinder, and the gas flow rate curve is above the baseline flow rate, that is, the flow rate detected by the flowmeter 3 is greater than the baseline flow rate, as shown in the curves of Figures 11, 12, 13, and 14.
图10是拉动定标筒32的拉杆34至气筒的0.5L容量位模拟呼吸的示意图。图A是流量浓度控制器输出40L/min空气流的情况下,使用0.5L的容量定标筒模拟呼吸,气体流速在基础流速(40L/min)上下波动形成呼吸流速曲线。图B是将基础流速40L/min设定为基线流量(0L/min),使用软件计算吸气容量,即基线流量下的曲线面积,分别为0.4981L、0.4869L、0.4916L、0.4920L、0.5069L,与0.5L的标准容量误差小于3%,基本一致。FIG10 is a schematic diagram of simulating breathing by pulling the pull rod 34 of the calibration cylinder 32 to the 0.5L capacity position of the gas cylinder. FIGA shows that a 0.5L capacity calibration cylinder is used to simulate breathing when the flow concentration controller outputs an air flow of 40L/min, and the gas flow rate fluctuates around the base flow rate (40L/min) to form a breathing flow rate curve. FIGB shows that the base flow rate of 40L/min is set as the baseline flow rate (0L/min), and the software is used to calculate the inspiratory capacity, i.e., the curve area under the baseline flow rate, which are 0.4981L, 0.4869L, 0.4916L, 0.4920L, and 0.5069L, respectively, which is less than 3% of the standard capacity error of 0.5L, which is basically consistent.
图11是拉动定标筒32的拉杆34至气筒的1L容量位模拟呼吸的示意图。图A是流量浓度控制器输出40L/min空气流的情况下,使用1L的容量定标筒模拟呼吸,气体流速在基础流速(40L/min)上下波动形成呼吸流速曲线。图B是将基础流速40L/min设定为基线流量(0L/min),使用软件计算吸气容量,即基线流量下的曲线面积,分别为0.9903L、0.9977L、0.9773L、0.9851L、0.9759L,与1L的标准容量误差小于3%,基本一致。Fig. 11 is a schematic diagram of simulating breathing by pulling the pull rod 34 of the calibration cylinder 32 to the 1L capacity position of the gas cylinder. Fig. A shows that a 1L capacity calibration cylinder is used to simulate breathing when the flow concentration controller outputs 40L/min of air flow, and the gas flow rate fluctuates around the base flow rate (40L/min) to form a breathing flow rate curve. Fig. B shows that the base flow rate of 40L/min is set as the baseline flow rate (0L/min), and the software is used to calculate the inspiratory capacity, i.e., the curve area under the baseline flow rate, which are 0.9903L, 0.9977L, 0.9773L, 0.9851L, and 0.9759L, respectively, which is less than 3% of the standard capacity error of 1L, which is basically consistent.
图12是拉动定标筒32的拉杆34至气筒的1.5L容量位模拟呼吸的示意图。图A是流量浓度控制器输出40L/min空气流的情况下,使用1.5L的容量定标筒模拟呼吸,气体流速在基础流速(40L/min)上下波动形成呼吸流速曲线。图B是将基础流速40L/min设定为基线流量(0L/min),使用软件计算吸气容量,即基线流量下的曲线面积,分别为1.4805L、1.4717L、1.4841L、1.4755L,与1.5L的标准容量误差小于2%,基本一致。Fig. 12 is a schematic diagram of simulating breathing by pulling the pull rod 34 of the calibration cylinder 32 to the 1.5L capacity position of the gas cylinder. Fig. A shows that a 1.5L capacity calibration cylinder is used to simulate breathing when the flow concentration controller outputs 40L/min air flow, and the gas flow rate fluctuates around the base flow rate (40L/min) to form a breathing flow rate curve. Fig. B shows that the base flow rate of 40L/min is set as the baseline flow rate (0L/min), and the software is used to calculate the inspiratory capacity, i.e., the curve area under the baseline flow rate, which are 1.4805L, 1.4717L, 1.4841L, and 1.4755L, respectively, which is less than 2% of the standard capacity error of 1.5L, which is basically consistent.
图13是拉动定标筒32的拉杆34至气筒的2L容量位模拟呼吸的示意图。图A是流量浓度控制器输出40L/min空气流的情况下,使用2L的容量定标筒模拟呼吸,气体流速在
基础流速(40L/min)上下波动形成呼吸流速曲线。图B是将基础流速40L/min设定为基线流量(0L/min),使用软件计算吸气容量,即基线流量下的曲线面积,分别为1.9927L、1.9627L、1.9769L、1.9915L,与2L的标准容量误差小于2%,基本一致。Figure 13 is a schematic diagram of pulling the rod 34 of the calibration cylinder 32 to the 2L capacity position of the cylinder to simulate breathing. Figure A shows that when the flow concentration controller outputs 40L/min air flow, a 2L capacity calibration cylinder is used to simulate breathing, and the gas flow rate is The basic flow rate (40L/min) fluctuates up and down to form a respiratory flow rate curve. Figure B sets the basic flow rate of 40L/min as the baseline flow rate (0L/min), and uses software to calculate the inspiratory capacity, that is, the curve area under the baseline flow rate, which are 1.9927L, 1.9627L, 1.9769L, and 1.9915L, respectively, with an error of less than 2% with the standard capacity of 2L, which is basically consistent.
上述具体实施方式为本发明的优选实施例,任何以恒定气体浓度和流量从面罩近端通过带挡板的入口输入开放式面罩,准确检测呼吸流量,均为这一专利的保护范围。
The above specific implementation is a preferred embodiment of the present invention. Any method of accurately detecting respiratory flow by inputting a constant gas concentration and flow from the proximal end of the mask through an inlet with a baffle into an open mask is within the protection scope of this patent.
Claims (10)
- 一种可准确控制吸入气浓度并可同时检测呼吸流量的舒适装置,其特征在于:包括流量浓度控制器、面罩和流量计,所述流量浓度控制器由恒流产生器(如鼓风机)、医用气源和气体混合组件组成,这一流量浓度控制器可输出恒定流速和浓度的气流;所述面罩近端设有进气口,进气口的面罩内侧设有一个气流挡板,面罩主体的远端设有大口径的流量计。A comfortable device that can accurately control the concentration of inhaled gas and simultaneously detect the respiratory flow, characterized in that it includes a flow concentration controller, a mask and a flow meter, the flow concentration controller is composed of a constant flow generator (such as a blower), a medical gas source and a gas mixing component, and this flow concentration controller can output an airflow with a constant flow rate and concentration; an air inlet is provided at the proximal end of the mask, an air flow baffle is provided on the inner side of the mask at the air inlet, and a large-caliber flow meter is provided at the distal end of the mask body.
- 根据权利要求1所述的一种可准确控制吸入气浓度并可同时检测呼吸流量的舒适装置,其特征在于:所述医用气体可为氧气、二氧化碳、氮气、氦气、氢气,或者混合气体等。According to claim 1, a comfortable device that can accurately control the concentration of inhaled gas and simultaneously detect the respiratory flow rate is characterized in that the medical gas can be oxygen, carbon dioxide, nitrogen, helium, hydrogen, or a mixed gas.
- 根据权利要求1所述的一种可准确控制吸入气浓度并可同时检测呼吸流量的舒适装置,其特征在于:所述气体混合方法可为气体混合后经过的弯曲管道区、增大缩小的管道区,或者医用气体接入鼓风机的进气管道。According to claim 1, a comfort device that can accurately control the concentration of inhaled gas and simultaneously detect the respiratory flow rate is characterized in that the gas mixing method can be a curved pipe area, an enlarged and reduced pipe area, or an air intake pipe for the medical gas to be connected to the blower after the gas is mixed.
- 根据权利要求1所述的一种可准确控制吸入气浓度并可同时检测呼吸流量的舒适装置,其特征在于:面罩主体的近端具有进气口,所述进气口可为一个或多个接收来自流量浓度控制器的气流。According to claim 1, a comfort device that can accurately control the concentration of inhaled gas and simultaneously detect the respiratory flow rate is characterized in that the proximal end of the mask body has an air inlet, and the air inlet can be one or more airflows received from the flow concentration controller.
- 根据权利要求1所述的一种可准确控制吸入气浓度并可同时检测呼吸流量的舒适装置,其特征在于:所述面罩容量为50-1000ml的任意值。According to claim 1, a comfort device that can accurately control the concentration of inhaled gas and simultaneously detect the respiratory flow rate is characterized in that the mask capacity is an arbitrary value of 50-1000ml.
- 根据权利要求1所述的一种可准确控制吸入气浓度并可同时 检测呼吸流量的舒适装置,其特征在于:面罩主体远端的流量计口径大于1cm2,面罩内压几乎保持为零。According to claim 1, a method for accurately controlling the concentration of inhaled gas and simultaneously A comfortable device for detecting respiratory flow, characterized in that the flow meter aperture at the far end of the mask body is larger than 1 cm 2 , and the pressure inside the mask is kept almost zero.
- 根据权利要求1所述的一种可准确控制吸入气浓度并可同时检测呼吸流量的舒适装置,其特征在于:面罩近端垫部与脸面部轻轻贴合,无需勒紧头带和过度加压,即可避免漏气。According to claim 1, a comfortable device that can accurately control the concentration of inhaled gas and simultaneously detect the respiratory flow rate is characterized in that the proximal cushion of the mask fits lightly against the face, and air leakage can be avoided without tightening the headband or applying excessive pressure.
- 根据权利要求1所述的一种可准确控制吸入气浓度并可同时检测呼吸流量的舒适装置,其特征在于:挡板可以垂直也可以形成折角,内折角朝向进气口和面罩远端,角度范围在30-180°中的任意值。According to claim 1, a comfort device that can accurately control the concentration of inhaled gas and simultaneously detect the respiratory flow rate is characterized in that the baffle can be vertical or can form an angle, the inner angle is toward the air inlet and the far end of the mask, and the angle range is any value between 30-180°.
- 根据权利要求1所述的一种可准确控制吸入气浓度并可同时检测呼吸流量的舒适装置,其特征在于:所述流量计可以是普通压差式流量计,也可以是其他类型的流量计如电磁流量计,叶轮流量计,超声波流量计,质量流量计等,也可以是带有模数转换功能或者同时具有检测与显示功能的流量计。According to claim 1, a comfort device that can accurately control the inhaled gas concentration and simultaneously detect the respiratory flow rate is characterized in that: the flow meter can be a common differential pressure flow meter, or other types of flow meters such as electromagnetic flow meters, impeller flow meters, ultrasonic flow meters, mass flow meters, etc., or a flow meter with analog-to-digital conversion function or with both detection and display functions.
- 根据权利要求1所述的一种可准确控制吸入气浓度并可同时检测呼吸流量的舒适装置,其特征在于:输入到面罩内的气体流量为10-300升/分之间的任意值。 According to claim 1, a comfort device that can accurately control the concentration of inhaled gas and simultaneously detect the respiratory flow rate is characterized in that the gas flow rate input into the mask is any value between 10-300 liters/minute.
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CN202310435937.0A CN116271378A (en) | 2023-04-22 | 2023-04-22 | Comfortable device capable of accurately controlling concentration of inhaled air and simultaneously detecting respiratory flow |
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