CN220801650U

CN220801650U - Comfortable device capable of accurately controlling concentration of inhaled air and simultaneously detecting respiratory flow

Info

Publication number: CN220801650U
Application number: CN202320917411.1U
Authority: CN
Inventors: 梁珊凤; 罗英辉; 王璐; 罗远明
Original assignee: Individual
Current assignee: Individual
Priority date: 2023-04-22
Filing date: 2023-04-22
Publication date: 2024-04-19
Anticipated expiration: 2033-04-22

Abstract

The invention relates to a comfortable device capable of accurately controlling the concentration of inhaled air and simultaneously detecting the respiratory flow, which comprises a flow concentration controller, a mask and a flowmeter, wherein the flow concentration controller consists of an air flow generator, a medical air source and an air mixing assembly, and the flow concentration controller can output air with constant flow and concentration; the face guard includes face guard main part and near-end pad portion, and near-end pad portion texture is soft, can laminate with the face, and face guard main part near-end has the air inlet, and air inlet one side is equipped with a baffle, and the distal end of face guard main part is equipped with the flowmeter. The air flow with constant flow rate and concentration output by the flow concentration controller enters from the proximal end of the mask and flows out from the air outlet at the distal end of the mask through the flowmeter. The device can promote the discharge of the exhaled air, eliminate the retention of respiratory resistance and exhaled air CO ₂, provide the air with constant flow and concentration for the subjects, and accurately detect the respiratory flow including tidal volume and minute ventilation when various medical gases are inhaled.

Description

Comfortable device capable of accurately controlling concentration of inhaled air and simultaneously detecting respiratory flow

Technical field:

the invention relates to a device for detecting the inhalation and respiratory flow of medical gas with constant concentration

The background technology is as follows:

The quantification of respiratory airflow in a sleeping state is often realized by wearing a mask connected with a flow sensor, and the connecting mode can increase the dead space capacity and the respiratory resistance due to the lengthening of a pipeline, so that not only can the unsmooth breathing of a subject be caused and the sleeping be influenced, but also the pressure in the mask can be increased to cause the gas to enter and exit (leak) from the contact part of the mask and the face, thereby influencing the accuracy of gas flow measurement. "dead space volume" is a physiological term that refers to the inability of exhaled air to escape to the atmosphere, resulting in a portion of the inhaled air for the next respiratory cycle being exhaled air for the previous cycle. Because of the high content of exhaled CO ₂ and low oxygen concentration, the increased dead space volume can increase the concentration of CO ₂ in the body and exacerbate hypoxia, and can further exacerbate the illness state of patients with respiratory failure. In order to avoid the air leakage of the mask, the head band is usually tightened, the face is stressed, discomfort is caused, and the sleeping quality is affected. In addition, under the air conditioner or indoor cold environment, due to the high temperature of the exhaled air, water drops can be formed in the cavity of the mask after the exhaled air is cooled, so that the measurement of flow rate is affected, and the water drops can flow back to the face due to excessive accumulation of the water drops in the mask, so that discomfort of a subject is aggravated.

Inhalation of medical gases such as oxygen, carbon dioxide, hydrogen and the like is an important method for treating respiratory diseases, and in order to achieve the therapeutic effect when the medical gases are inhaled, the concentration of the inhaled gases is ensured, and the respiratory flow including tidal volume and minute ventilation volume under the inhaled gases is also required to be detected. When the nasal catheter is used for oxygen therapy, the nasal catheter influences the fit between the mask and the face, so that air leakage is caused, and the accurate measurement of respiratory airflow is influenced. Meanwhile, when the nasal catheter is used for oxygen therapy, the concentration of oxygen inhaled into the respiratory tract changes along with the breathing rhythm and the breathing depth, and the concentration of the inhaled air is difficult to accurately control. If the mask is provided with an additional hole for inputting medical gas, the concentration of inhaled gas still changes along with the breathing mode, and the preset treatment effect cannot be achieved. Clinically, a mask used in noninvasive ventilation is often provided with a small through hole, and is used for being connected with a central oxygen supply device in a hospital, a household oxygenerator or an oxygen bottle and other oxygen sources to realize oxygen therapy. CO ₂ can be input from the through hole to supplement CO ₂ reduction caused by excessive ventilation, so that the concentration of CO ₂ in blood can be increased. However, when oxygen therapy or CO ₂ gas replenishment is performed through the small through-holes, if the respiratory rate increases, the concentration of gas in the mask decreases, and the exhalation phase increases, gas in the mask accumulates, the concentration of inhaled gas increases, and if the patient pauses breathing, the concentration of inhaled gas may further increase. When CO ₂ is input, if too high a concentration of CO ₂ is inhaled, arousal may occur, compromising sleep quality. In addition, the flow rate often does not exceed 5 liters/minute when medical gas is directly delivered from the nasal cavity due to stimulation by the gas flow.

If a sufficient flow of gas is continuously fed from the proximal end of the mask and mixed well, and discharged through the distal end of the mask, a constant concentration of inhaled gas is ensured. If a flow meter is connected to the distal end of the mask, accurate measurement of respiratory airflow, including tidal volume and minute ventilation, is ensured at a constant inhaled gas concentration. We have earlier devised an oxygen therapy related device (ZL 2018 0388945.3) comprising a mask with a large aperture at the distal end. By feeding the high flow rate gas which has been uniformly mixed from the proximal end of the mask, the patient is supplied with inspiration, the excess gas is discharged through the distal end of the mask, and the high flow rate gas fed to the mask during expiration is discharged through the flowmeter together with the expired gas through the distal exhaust port. The inner pressure of the face mask is always zero and no respiratory resistance exists because the far end is provided with a large exhaust port communicated with the atmosphere. However, a high flow of air that is uniformly mixed is input from the proximal end of the mask, and the air can impinge on the face and nose and mouth, especially in environments where the air flow is large or cold, and the subject can feel cold discomfort or even be intolerable.

Disclosure of Invention

To overcome the above problems, we have invented a device that can accurately control the concentration of inhaled gas and accurately measure the flow of respiratory gas, and is comfortable to wear.

In order to achieve the above purpose, the invention is realized by the following scheme:

A comfortable device capable of accurately controlling the concentration of inhaled air and simultaneously detecting the respiratory flow comprises a flow concentration controller, a mask and a flowmeter, wherein the flow concentration controller can be used for accurately controlling the concentration of inhaled air. The flow concentration controller consists of a constant flow generator, a medical air source and an air mixing component, and can output air flow with constant flow rate and concentration; the near end of the mask is provided with an air inlet, the inner side of the mask is provided with a baffle plate, and the baffle plate is connected with an air inlet pipeline joint inserted into the air inlet; the medical air source is connected with the air outlet of the constant flow generator through a three-way pipe, and a third interface of the three-way pipe is connected with the air mixing assembly; or the medical air source is connected with the air inlet of the constant flow generator through a three-way pipe, and the air outlet of the constant flow generator is connected with the air mixing component.

The medical gas source is provided with a medical gas, which may be oxygen, carbon dioxide, nitrogen, helium or hydrogen.

The gas mixing assembly comprises a straight pipeline or a bent pipeline or a pipeline with gradually smaller pipe diameter.

The flow concentration controller consists of an air flow generator, a medical air source (which can be oxygen, CO ₂, hydrogen or the like) and a gas mixing component, and comprises a flow control component and a gas concentration control component. The principle is similar to that of an oxygen therapy related device invented earlier (patent license numbers are ZL 2018 1 0388945.3 respectively). Specifically, a constant air flow is generated by a blower, and is uniformly mixed with air (oxygen, CO ₂) from a medical air source and then is input into a mask. The air supply quantity can be monitored by a flow sensor built in the flow concentration controller and can be adjusted by manual feedback and automatic feedback or a combination of manual feedback and automatic feedback. The adjusting mode can be used for adjusting the rotating speed of the blower and controlling the size of the pipeline through the valve to adjust the flow. The gas concentration can be monitored by a concentration sensor arranged in the flow concentration controller, and the gas flow from the medical gas source can be regulated by manual feedback and automatic feedback or a combination mode of manual feedback and automatic feedback, so that the gas supply concentration can be regulated.

The mask is a gas container with an effective gas volume that can be set to any value between 50 and 1000m l, can be made of metal, plastic, silicone and other materials that can form a container, and can be cylindrical, rectangular, oval or any other shape. The face contacting end (proximal end) of the mask is the same as a conventional mask, and the proximal end of the mask is provided with a cushion of soft material. The material can be soft and light materials such as plastic, silica gel and the like so as to ensure the tight connection between the face and the face mask. The proximal end of the mask has one or more air inlets, the outside of which is connected to the air delivery conduit to receive a constant flow of air from the blower or a uniform mixture of medical gases at a constant flow and concentration. The inner side of the face mask is provided with a baffle which is connected with an air inlet pipeline joint inserted into the air inlet and is used for reducing or preventing the impact of air flow on the mouth, nose and face. The baffle may be vertical or may be angled, with the inward angle being toward the air inlet and the distal end of the mask, with the angle ranging from any value from 30 to 180. The distal end of the mask has a large orifice, and the exhaled air from the subject and air from the air delivery conduit are all exhausted from the large orifice at the distal end of the mask and its attached flow meter, such that the internal pressure of the mask is always zero.

The flowmeter can be a common differential pressure flowmeter, an electromagnetic flowmeter, an impeller flowmeter, an ultrasonic flowmeter, a mass flowmeter and the like, and also can be a flowmeter with an analog-to-digital conversion function or a detection and display function. The flow meter has a vent aperture large enough, 1cm ² or more in diameter, to ensure that the vent is clear and the internal pressure of the mask remains zero, and an ideal vent for adults is 3cm ² or even greater. 2-4 headband interfaces are provided outside the mask for securing the mask so that the mask is stably secured to the face.

The following is an example.

When the respiratory flow rate of the subject when inhaling the mixture gas having the hydrogen concentration of 2% is to be measured, the subject is put on a mask to which a flowmeter is attached. Assuming a mask gas volume of 500ml, a mask inlet gas flow of 60L/min and a gas flow of 2% H ₂ concentration was chosen. The high-pressure H ₂ gas cylinder was opened to output 100% pure hydrogen gas, the output flow of the blower was adjusted, and when the final output flow of the flow concentration controller was 60L/min and the H ₂ concentration was 2%, the flow from the blower was 58.8L/min, and the flow from the CO ₂ gas cylinder was 1.2L/min (output gas H ₂ concentration was 1.2×100%/(1.2+58.8) =2%). When the uniformly mixed gas is delivered to the mask, the gas flow diffuses around the baffle under the influence of the baffle, fills the mask and exits distally through the flow meter. Due to the baffle plate, the impact of the input air flow on the face and the mouth and nose of the patient is eliminated, and the patient has no uncomfortable feeling. When the subject inhales, the gas delivered to the mask from the flow concentration controller is inhaled, so that the gas flowing out of the flowmeter is reduced; during exhalation, the exhaled air of the subject is exhausted from the far end of the mask through the flowmeter together with the air flow output from the air flow concentration controller, so that the air flowing out through the flowmeter is increased. During an apnea, the flow of air exiting through the distal flow meter was equal to the flow of air input to the mask, i.e., 60L/min of base flow. The flow rate during respiration fluctuates up and down on the basis of 60L/min, so that the inspiration flow rate and the expiration flow rate are measured.

If the respiratory flow rate includes tidal volume and minute ventilation to be measured during certain conditions, such as exercise or sleep, the mask may be secured by the headgear and the flow meter connected by the adapter, and the flow concentration controller may be adjusted to output a predetermined flow of air to the mask, which may facilitate the removal of exhaled air due to the high flow rate of the air from the flow concentration controller. And the air flow output from the flow concentration controller continuously washes and replaces the air containing the exhaled air in the mask, so that the air at the near end of the mask does not contain the exhaled air during inhalation, and the repeated breathing of the traditional mask caused by dead space is avoided. If the subject's inspiratory flow rate is accidentally greater than the gas input to the mask, the subject may inhale the gas from the flow concentration controller that remains in the expiratory phase, the inhaled gas also being free of exhaled gas.

Compared with the prior art, the invention has the following advantages and beneficial effects:

1. The inner diameter of the flowmeter connected with the exhaust port at the far end of the mask is large, and the internal pressure of the mask is almost zero during breathing. Meanwhile, continuous high-flow air flow is input at the proximal end of the mask, so that extra air suction resistance can be eliminated; the high flow rate gas flows out of the far end flowmeter again, and the discharge of the exhaled air is promoted.

2. The high-flow air flow continuously input through the proximal end of the mask can flush and replace exhaled air, so that retention of carbon dioxide in the mask is eliminated, and repeated breathing and dead space ventilation are eliminated.

3. Because the mask exhaust port is large, the internal pressure is zero, and the head band is not required to be excessively tensioned when the mask is worn, the mask can be attached to the face to prevent air leakage, so that discomfort of wearing the mask is reduced, and the influence on sleeping is reduced.

4. Because continuous air flows pass through the mask and the flowmeter channels, the exhaled air is flushed, the formation that the exhaled air is converted into condensed water in a cold environment can be avoided, the measurement accuracy is ensured, and the stimulation of the condensed water to the face can be eliminated.

5. The air inlet in the mask of the device is provided with a baffle plate, so that direct impact of high-flow air flow from the air supply pipeline or cold air flow in a cold environment on the face and the mouth and nose can be eliminated, and the comfort of a subject is improved.

Drawings

Fig. 1 is a schematic diagram of a device capable of accurately controlling the concentration of inhaled air and simultaneously detecting the respiratory flow.

FIG. 2 is a schematic diagram of a first embodiment of the flow concentration controller of the present invention.

FIG. 3 is a schematic diagram of a second embodiment of the flow concentration controller of the present invention.

FIG. 4 is a schematic diagram of a third embodiment of a flow concentration controller according to the present invention.

Fig. 5 is a partial front view of a first embodiment of the mask of the present invention.

Figure 6 is a block diagram of a fixed or removable corner baffle assembly in a mask.

FIG. 7 is a schematic diagram of detecting respiratory tidal volume of a patient or subject.

FIG. 8 is a schematic diagram of detecting inspiratory tidal volume of a patient or subject.

Fig. 9 is a schematic diagram of a system for simulated flow detection of the device of the present invention.

FIG. 10 is a schematic illustration of simulated respiration at the 0.5L capacity site by pulling the pull rod 34 of the calibration cylinder 32 to the cartridge.

FIG. 11 is a schematic illustration of simulated respiration in a 1L capacity position by pulling the pull rod 34 of the calibration cylinder 32.

FIG. 12 is a schematic illustration of simulated respiration in a 1.5L capacity position by pulling the pull rod 34 of the calibration cylinder 32.

Fig. 13 is a schematic illustration of simulated respiration in a 2L capacity position pulling the pull rod 34 of the calibration cylinder 32 to the cartridge.

Detailed Description

The invention will be further described with reference to the drawings.

Fig. 1 is a schematic diagram of a device capable of accurately controlling the concentration of inhaled air and simultaneously detecting the respiratory flow. It is composed of a flow concentration controller 1, a mask 2 for detecting tidal volume and a flowmeter 3. The mask 2 is composed of a mask body 4, a cushion 5 which is attached to the face, and a baffle 6. The mask body 4 has a capacity of 50-1000m l, and the mask body 4 and the baffle 6 are mainly made of lightweight materials such as plastics, silica gel, metal, etc., and the material of the cushion 5 can be soft silica gel, gel or foam plastics, etc. The baffle 6 may be vertical or may be angled like an angle of refraction, with the angle of refraction being adjustable to any value in the range of 30-180 degrees toward the air inlet and the distal end of the mask. The air inlet pipeline joint 7 is used for connecting an air inlet of the face mask and the air output pipeline 8, and the air inlet pipeline joint 7 can be a joint which is straight-through, corner or can be made into a joint capable of rotating by 360 degrees through pipeline nesting, so that a subject can rotate the head at will after wearing the face mask, the joint between the face mask and the face is kept, and the air leakage of the face mask is avoided. The two outer sides of the face mask 2 are respectively provided with 1-2 head strap fixing bayonets 9. The exhaust port at the far end of the mask body is provided with a flowmeter. The flowmeter 3 can be a common differential pressure flowmeter, a flowmeter with an analog-to-digital conversion function or a flowmeter with a detection and display function, and can be connected with a biological signal processor through a connecting wire 11 for real-time monitoring. The medical air source (oxygen, CO ₂, hydrogen or nitrogen, etc.) is mixed with the air entering from the air inlet 13 through the air inlet 12 in the flow concentration controller. When the testee needs to detect the respiratory airflow and the tidal volume, after the testee wears the mask, the airflow with constant flow rate concentration output by the flow concentration controller enters the cavity of the mask through the gas output pipe 8 and the gas inlet pipe joint 7. When the patient inhales, the gas delivered to the mask 2 by the inflow concentration controller 1 is inhaled, so that the gas flowing out through the flowmeter 3 is reduced; during exhalation, the exhaled air is discharged from the mask distal end 10 through the flowmeter 3 together with the air flow outputted from the flow rate concentration controller 1, and the air flow outputted through the flowmeter is increased, thereby measuring the inhalation flow rate and the exhalation flow rate.

FIG. 2 is a schematic diagram of a first embodiment of the flow concentration controller of the present invention. An air flow generator 14 (e.g., a blower) is coupled to the air inlet 13 to generate a sufficient flow of air. The medical air source is passed from the air inlet 12 through a flow control valve 15 and is homogeneously mixed with the air flow from the blower 14 into the air mixing zone 16. The gas mixing zone 16 may be a straight conduit, a curved conduit, or any other shape of chamber. The uniformly mixed gas flows through the gas flow concentration sensor 17 and flows out of the gas flow output port 18, and the display 19 can display the gas flow and concentration of the output gas flow 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 to automatically adjust the output flow speed and concentration to set values, that is, the flow concentration controller 1 can continuously output the mixed gas flow with constant flow speed and concentration. The operator can also manually adjust the flow and the concentration through a knob or a touch panel arranged on the flow concentration controller 1.

FIG. 3 is a schematic diagram of a second embodiment of the flow concentration controller of the present invention. The medical gas passes through the flow control valve 15 from the gas inlet 12, mixes with the air entering from the gas inlet 13, and is further uniformly mixed by the blower.

FIG. 4 is a schematic diagram of a third embodiment of a flow concentration controller according to the present invention. The high-pressure air flows from the air inlet 13 through the flow control valve 22, is mixed with medical air from the air inlet 12 through the flow control valve 15, then enters the air mixing area 16 to realize uniform mixing of the air, the uniformly mixed air flows through the air flow concentration sensor 17, flows out of the air flow output port 18, is connected with a mask and a flowmeter through a pipeline, and the display 19 can display the air flow and concentration of the output air flow in real time. The signal detected by the gas flow and 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 flow speed and concentration to the set values.

Fig. 5 is a partial front view of a first embodiment of the mask of the present invention. It comprises a mask cushion inner face 5, a mask main body 4, a bevel baffle 6, an air inlet pipeline 7 and a mask far end 10 connected with a flowmeter.

Figure 6 is a block diagram of a fixed or removable corner baffle assembly in a mask. The angle baffle 6 consists of an air inlet pipeline connecting part 23, a first angle folding edge 24 connected with the connecting part 23 and a suspended second angle folding edge 25, wherein the inner angle is towards the air inlet and the far end of the face cover, and the angle range of the angle baffle is any value in 30-180 degrees. That is, the baffle 6 includes a connecting portion 23, a first corner edge 24, and a second corner edge 25, the second corner edge 25 is connected to the connecting portion 23 by the first corner edge 24, the second corner edge 25 is located above the connecting portion 23, the first corner edge 24 is parallel to the axis of the connecting portion 23, and the angle between the second corner edge 25 and the first corner edge 24 is any value from 30 ° to 180 °.

FIG. 7 is a schematic diagram of detecting respiratory tidal volume of a patient or subject. The patient wears the mask 2 through the headband fixing bayonet 9 and the connected headband 26, and the mask cushion 5 is attached to the face. The flow concentration controller delivers gas into the mask through the mask inlet 7 which is connected to the gas feed line, the direction of the gas flow through the gas feed line is shown by arrow 27, the direction of the gas flow after entering the mask is changed by the corner baffle 6 as shown by arrow 28 and flows to both sides of the mask to fill the mask, and the gas flow is discharged through the flow meter 3 as shown by arrow 29. When the subject holds his breath or apnea, the flow of gas through the flow meter 3 will coincide with the flow of gas 27 output by the flow concentration controller; when the subject exhales, the flow of exhaled air 30, together with the air 28 output by the flow concentration controller, forms an air flow 29 through the flow meter 3, when the amount of air flow through the flow meter 3 is equal to the sum of the flow of exhaled air 30 from the subject and the flow of air 27 from the air output device.

FIG. 8 is a schematic diagram of detecting inspiratory tidal volume of a patient or subject. The patient wears the mask 2 through the headband fixing bayonet 9 and the connected headband 26, and the mask cushion 5 is attached to the face. The flow concentration controller delivers gas into the mask through the mask inlet 7, which is connected to the gas supply line, the direction of the gas flow through the gas supply line is shown by arrow 27, and the direction of the gas flow is changed by the corner baffle 6 as shown by arrow 28 when it enters the mask, and flows to both sides of the mask to fill the mask. When the subject inhales, the flow of air 28, or air flowing on both sides of the mask, will enter the respiratory tract as indicated by arrow 31. When the subject inhalation flow rate is less than the flow rate outputted by the flow rate concentration controller, then the excess gas is discharged through the distal end of the flow meter 3 as indicated by arrow 29, and the flow rate of gas measured by the flow meter 3 is the difference between the flow rate 27 of gas and the patient inhalation flow rate 31.

In the following, an example of simulated flow rate detection is shown in fig. 9, in which breathing patterns of the subject, that is, tidal volumes of 0.5L, 1L, 1.5L, and 2L are simulated using a scale drum 32 provided with 0.5L, 1L, and 2L scales. The calibration cylinder 32 is tightly connected with the mask 2 through an adapter 33, and the flow concentration controller 1 is connected with the air inlet 7 of the mask 2 through a pipeline 8. The flow rate concentration controller 1 outputs an air flow rate of a constant flow rate (40L/min). When the air suction of the testee is simulated, the pull rod 34 of the calibration cylinder is pulled to the capacity positions of 0.5L, 1L, 1.5L and 2L of the air cylinder respectively, and the air flow rate curve is below the baseline flow, namely the flow detected by the flowmeter is smaller than the baseline flow; when the subject exhales, the piston of the calibration cylinder is pushed to fully discharge the gas in the cylinder, and the gas flow rate curve is above the baseline flow, namely, the flow detected by the flowmeter 3 is larger than the baseline flow, as shown in the curves of fig. 11, 12 and 13.

FIG. 10 is a schematic illustration of simulated respiration at the 0.5L capacity site by pulling the pull rod 34 of the calibration cylinder 32 to the cartridge. Graph a is a graph of respiratory flow rate curve generated by a 0.5L volume scale drum simulated respiration with a flow concentration controller outputting a 40L/min air flow, and a gas flow rate fluctuating up and down at a base flow rate (40L/min). Graph B shows that the base flow rate of 40L/min was set to the baseline flow rate (0L/min), and the suction capacity, i.e., the curve area at the baseline flow rate, was calculated using software to be 0.4981L, 0.4869L, 0.4916L, 0.4920L, 0.5069L, respectively, and the standard capacity error of 0.5L was less than 3%, which was substantially the same.

FIG. 11 is a schematic illustration of simulated respiration in a 1L capacity position by pulling the pull rod 34 of the calibration cylinder 32. Graph a is a graph of a breathing flow rate curve formed by a 1L volume scale drum simulating breathing with a flow concentration controller outputting a 40L/min air flow, and a gas flow rate fluctuating up and down at a base flow rate (40L/min). Graph B shows that the base flow rate 40L/min was set to the baseline flow rate (0L/min), and the suction capacity, i.e., the curve area at the baseline flow rate, was calculated using software to be 0.9903L, 0.9977L, 0.9773L, 0.9851L, 0.9759L, respectively, and the standard capacity error with 1L was less than 3%, which was substantially the same.

FIG. 12 is a schematic illustration of simulated respiration in a 1.5L capacity position by pulling the pull rod 34 of the calibration cylinder 32. Graph a is a graph of breathing flow rate curve generated by a 1.5L volume scale drum simulated breathing with a flow concentration controller outputting 40L/min air flow, and a gas flow rate fluctuating up and down at a base flow rate (40L/min). Graph B shows that the base flow rate of 40L/min was set to the baseline flow rate (0L/min), and the suction capacity, i.e., the curve area at the baseline flow rate, was calculated using software to be 1.4805L, 1.4717L, 1.4841L, 1.4755L, respectively, and the standard capacity error of 1.5L was less than 2%, which was substantially the same.

Fig. 13 is a schematic illustration of simulated respiration in a 2L capacity position pulling the pull rod 34 of the calibration cylinder 32 to the cartridge. Graph a is a graph of respiratory flow rate curve generated by a 2L volume calibration cylinder simulating respiration with a flow concentration controller outputting a 40L/min air flow, and a gas flow rate fluctuating up and down at a base flow rate (40L/min). Graph B shows that the base flow rate 40L/min was set to the baseline flow rate (0L/min), and the suction capacity, i.e., the curve area at the baseline flow rate, was calculated using software to be 1.9927L, 1.9627L, 1.9769L, 1.9915L, respectively, with a standard capacity error of less than 2% with 2L, and substantially identical.

The above embodiments are preferred embodiments of the present invention, and any accurate detection of respiratory flow from the proximal end of the mask through the baffled inlet to the open mask at a constant gas concentration and flow is within the scope of this patent.

Claims

1. The comfort device capable of accurately controlling the concentration of inhaled air and simultaneously detecting the respiratory flow is characterized in that: the device comprises a flow concentration controller, a mask and a flowmeter, wherein the flow concentration controller consists of a constant flow generator, a medical air source and an air mixing component, and can output air flow with constant flow rate and concentration; the near end of the mask is provided with an air inlet, the inner side of the mask is provided with a baffle plate, and the baffle plate is connected with an air inlet pipeline joint inserted into the air inlet; the medical air source is connected with the air outlet of the constant flow generator through a three-way pipe, and a third interface of the three-way pipe is connected with the air mixing assembly; or the medical air source is connected with the air inlet of the constant flow generator through a three-way pipe, and the air outlet of the constant flow generator is connected with the air mixing component.

2. The comfort device for accurately controlling the concentration of inhaled air and simultaneously detecting the flow of breathing according to claim 1, wherein: the medical gas source is provided with a medical gas, which may be oxygen, carbon dioxide, nitrogen, helium or hydrogen.

3. The comfort device for accurately controlling the concentration of inhaled air and simultaneously detecting the flow of breathing according to claim 1, wherein: the gas mixing assembly comprises a straight pipeline or a bent pipeline or a pipeline with gradually smaller pipe diameter.

4. The comfort device for accurately controlling the concentration of inhaled air and simultaneously detecting the flow of breathing according to claim 1, wherein: the number of air inlets may be 1 or more.

5. The comfort device for accurately controlling the concentration of inhaled air and simultaneously detecting the flow of breathing according to claim 1, wherein: the capacity of the mask is any value from 50 to 1000 ml.

6. The comfort device for accurately controlling the concentration of inhaled air and simultaneously detecting the flow of breathing according to claim 1, wherein: the caliber of the flowmeter arranged at the far end of the face mask is larger than 1cm ², so that the internal pressure of the face mask is ensured to be zero in the inspiration state and the expiration state.

7. The comfort device for accurately controlling the concentration of inhaled air and simultaneously detecting the flow of breathing according to claim 1, wherein: the proximal end of the mask is provided with a soft cushion made of soft material.

8. The comfort device for accurately controlling the concentration of inhaled air and simultaneously detecting the flow of breathing according to claim 1, wherein: the baffle comprises a connecting part, a first corner edge and a second corner edge, wherein the second corner edge is connected with the connecting part through the first corner edge, the second corner edge is positioned above the connecting part, the first corner edge is parallel to the axis of the connecting part, and the angle between the second corner edge and the first corner edge is any value of 30-180 degrees.

9. The comfort device for accurately controlling the concentration of inhaled air and simultaneously detecting the flow of breathing according to claim 1, wherein: the flowmeter can be any one of a common differential pressure flowmeter, an electromagnetic flowmeter, an impeller flowmeter, an ultrasonic flowmeter and a mass flowmeter.