A test device and test method for CO2 rebreathing of sleep apnea treatment mask

Abstract

The present invention discloses a test device for CO2 rebreathing of a sleep apnea treatment mask, which relates to the technical field of medical device detection. The structure of the present invention includes an equipment cabinet, a human head model, a gas delivery device, two driving devices, and a carbon dioxide gas source; the human head model is installed at the upper end of the equipment cabinet; the gas delivery device and the two driving devices are installed inside the equipment cabinet, and the two driving devices drive the gas delivery device to simulate the normal breathing process; the gas delivery device is communicated with the mouth and nose of the human head model; the carbon dioxide gas source transports carbon dioxide through a carbon dioxide pipeline and a CO2 air pump. The present invention can not only comprehensively and accurately evaluate the performance of the treatment mask, but also has the advantages of simple operation, safety and reliability, etc.; it helps manufacturers design safer and more effective masks, and at the same time enables clinicians to better monitor and adjust treatment plans, ultimately improving the treatment effect and quality of life of patients.

Description

Technical Field

[0001] The invention belongs to the technical field of medical equipment detection, and in particular relates to a testing device suitable for CO2 rebreathing of a sleep apnea treatment mask. Background Art

[0002] Sleep apnea is a common sleep disorder characterized by repeated pauses in breathing or shallow breathing during sleep. This condition not only affects sleep quality, but can also lead to a range of health problems, such as daytime fatigue, heart disease, and decreased brain function. In order to effectively treat sleep apnea, specialized treatment equipment is usually required, the most common of which is a continuous positive airway pressure (CPAP) machine with a dedicated mask.

[0003] The design and function of masks are critical during treatment, as they must be able to deliver breathing gases effectively while ensuring patient comfort and a tight seal. An important function of the mask is to remove exhaled carbon dioxide (CO2) through passive exhaust when the active exhaust valve fails, thereby reducing rebreathing of CO2. Rebreathing too high a level of CO2 may cause the patient to inhale too much of their own exhaled air, which may pose a risk to the patient's health in some cases.

[0004] The experimental devices currently used to test respiratory equipment on the market are usually unable to accurately simulate the CO2 ratio in human exhaled gas, making it difficult to fully evaluate the effectiveness of masks in dealing with CO2 rebreathing. Existing test methods focus more on the determination of pressure and flow characteristics, but fail to directly measure the effect of CO2 treatment during actual breathing. This limitation makes the evaluation of mask design incomplete and poses certain safety risks.

[0005] Due to the lack of equipment that can accurately simulate the breathing process including CO2 management, the current evaluation of mask performance mainly relies on theoretical models and limited experimental data under non-realistic breathing conditions. This not only limits the optimization of mask design, but also affects the comprehensive evaluation of patient treatment effects. Therefore, it is very necessary to develop a test device that can accurately simulate CO2 rebreathing conditions and evaluate the performance of therapeutic masks. Summary of the invention

[0006] The purpose of the present invention is to provide a testing device and a testing method for CO2 rebreathing of a sleep apnea treatment mask, which can not only comprehensively and accurately evaluate the performance of the treatment mask, but also has the advantages of simple operation, safety and reliability, etc., providing strong technical support for the development and testing of medical equipment.

[0007] In order to solve the above technical problems, the present invention is achieved through the following technical solutions:

[0008] On the one hand, the present invention provides a test device for CO2 rebreathing of a sleep apnea treatment mask, the structure of which includes an equipment cabinet, a human head model, a gas delivery device, two driving devices and a carbon dioxide gas source; the human head model is installed on the upper end of the equipment cabinet; the gas delivery device and the two driving devices are installed inside the equipment cabinet, and the two driving devices drive the gas delivery device through a mechanical linkage mechanism to simulate a normal breathing process; the gas delivery device is connected to the mouth and nose of the human head model; the carbon dioxide gas source delivers carbon dioxide through a carbon dioxide pipeline and a CO2 air pump.

[0009] As a preferred technical solution of the present invention, the equipment cabinet includes three grid racks arranged vertically and in parallel; the three grid racks are connected as a whole through four columns, a plurality of tripods and bolts; a flat plate is fixed on the top surface of the upper and lower grid racks respectively; the driving device is installed on the middle grid rack; and the human head model is installed on the upper flat plate.

[0010] As a preferred technical solution of the present invention, the gas delivery device includes a CO2 cylinder, an air cylinder, and a Y-shaped hose; the CO2 cylinder and the air cylinder are respectively fixed on the lower flat plate; a piston driven and connected to the driving device is respectively installed in the CO2 cylinder and the air cylinder; a unidirectional air inlet valve and an air outlet valve are installed at the lower end of the side wall of the CO2 cylinder; the carbon dioxide pipeline is connected to the air inlet valve; a straight-through gas connector is installed at the lower end of the side wall of the air cylinder; and the three ends of the Y-shaped hose are respectively connected to the human head model, the air outlet valve and the straight-through gas connector.

[0011] As a preferred technical solution of the present invention, the driving device includes a motor, a short shaft, a cam, a first gear and a second gear; the motor is installed on the middle grid frame through a motor mounting seat; the short shaft is installed on the middle grid frame through two seat bearings; the first gear is installed on the motor shaft end; the cam and the second gear are respectively installed on the short shaft; the first gear and the second gear are meshed for transmission; a cam-shaped guide groove is provided on one side of the cam along the cam profile; an inverted L-shaped rod is fixed to the free end of the piston rod body; a bearing that matches the groove wall of the cam-shaped guide groove is installed on the horizontal rod end of the L-shaped rod.

[0012] As a preferred technical solution of the present invention, the carbon dioxide gas source is a carbon dioxide cylinder storing liquid carbon dioxide, and a pressure reducing valve is installed at the output end of the carbon dioxide cylinder, and the carbon dioxide pipeline is connected to the pressure reducing valve.

[0013] As a preferred technical solution of the present invention, a temperature control device is installed on the outer wall of the CO2 cylinder and the outer wall of the air cylinder respectively.

[0014] As a preferred technical solution of the present invention, the temperature control device includes a temperature controller, an electric heating belt and a temperature sensor; the electric heating belt and the temperature sensor are electrically connected to the temperature controller respectively; the electric heating belt is wound around the outer wall of the cylinder body; the temperature sensor is adhered to the outer wall of the cylinder body using heat-resistant tape.

[0015] In another aspect, the present invention further provides a method for testing a test device for a sleep apnea treatment mask CO2 rebreathing test device, comprising the following steps:

[0016] S1, start adjusting to simulate the normal breathing process, turn on the CO2 air pump, perform a simulated breathing experiment by synchronously controlling the two motors, use a carbon dioxide detector to detect the carbon dioxide concentration at the mouth and nose of the human head model, and comprehensively adjust the carbon dioxide flow delivered to the gas delivery device by adjusting the output pressure of the pressure reducing valve and adjusting the power of the CO2 air pump. Each adjustment interval is more than two minutes. When the carbon dioxide concentration detected by the carbon dioxide detector is stable at 5%, the simulation of the normal breathing process is completed. At this time, the end-tidal carbon dioxide concentration is recorded as Q1.

[0017] S2, put the treatment mask on the human head model to simulate normal use, confirm that the mask is completely sealed against the face of the simulated patient, adjust the flow source delivered to the treatment mask so that the pressure detected by the pressure sensor in the mask reaches the minimum rated pressure, and continue the detection for four minutes or more. After the carbon dioxide reading stabilizes, record the carbon dioxide concentration Q2 at this time, and use Q2 minus Q1 and divide by Q1 to obtain the increased concentration percentage P1 of the increased carbon dioxide gas.

[0018] S3, on the basis of step S2, adjust the flow source of the treatment mask so that the pressure sensor in the mask detects a pressure of 5hPa, and continue to detect for four minutes or more. After the carbon dioxide reading stabilizes, record the carbon dioxide concentration Q3 at this time, and use Q3 minus Q1 and divide it by Q1 to obtain the increased concentration percentage P2 of the increased carbon dioxide gas.

[0019] S4, on the basis of step S3, by adjusting the flow source of the treatment mask so that the pressure sensor in the mask detects a pressure of 10hPa, the detection is continued for four minutes or more. After the carbon dioxide reading is stable, the carbon dioxide concentration Q4 at this time is recorded, and Q4 is subtracted from Q1 and divided by Q1 to obtain the increased concentration percentage P3 of the carbon dioxide gas.

[0020] S5, judging whether the treatment mask meets the requirements. When P1, P2 and P3 are all less than 20%, the treatment mask is judged to meet the requirements, otherwise the treatment mask does not meet the requirements.

[0021] As a preferred technical solution of the present invention, the following steps are also included:

[0022] S11, start adjusting to simulate the normal breathing process, turn on the CO2 air pump, perform a simulated breathing experiment by synchronously controlling the two motors, use a carbon dioxide detector to detect the carbon dioxide concentration at the mouth and nose of the human head model, and comprehensively adjust the carbon dioxide flow delivered to the gas delivery device by adjusting the output pressure of the pressure reducing valve and adjusting the power of the CO2 air pump. Each adjustment interval is more than two minutes. When the carbon dioxide concentration detected by the carbon dioxide detector is stable at 5%, the simulation of the normal breathing process is completed. At this time, the end-tidal carbon dioxide concentration is recorded as Q1.

[0023] S12, simulates blockage of the breathing circuit by blocking the patient connection port, and continues to detect for four minutes or more. After the carbon dioxide reading stabilizes, record the carbon dioxide concentration Q5 at this time, subtract Q1 from Q5 and divide by Q1 to get the increased carbon dioxide gas concentration percentage P4.

[0024] S13, judging whether the treatment mask meets the requirements, when P4 is less than 60%, it is determined that the treatment mask meets the requirements, otherwise the treatment mask does not meet the requirements.

[0025] As a preferred technical solution of the present invention, the following steps are also included:

[0026] S111, start adjusting to simulate the normal breathing process, turn on the CO2 air pump, perform a simulated breathing experiment by synchronously controlling the two motors, use a carbon dioxide detector to detect the carbon dioxide concentration at the mouth and nose of the human head model, and comprehensively adjust the carbon dioxide flow delivered to the gas delivery device by adjusting the output pressure of the pressure reducing valve and adjusting the power of the CO2 air pump. Each adjustment interval is more than two minutes. When the carbon dioxide concentration detected by the carbon dioxide detector is stable at 5%, the simulation of the normal breathing process is completed. At this time, the end-tidal carbon dioxide concentration is recorded as Q1.

[0027] S112, simulate the failure of the air intake flow source of the treatment mask, turn off the air intake flow source of the treatment mask, and continue to detect for four minutes or more. After the carbon dioxide reading stabilizes, record the carbon dioxide concentration Q6 at this time, subtract Q1 from Q6 and divide it by Q1 to obtain the increased carbon dioxide gas concentration percentage P5.

[0028] S113, judging whether the treatment mask meets the requirements, when P5 is less than 60%, it is determined that the treatment mask meets the requirements, otherwise, the treatment mask does not meet the requirements.

[0029] The present invention has the following beneficial effects:

[0030] 1. The gas delivery device driven by the motor and cam mechanism of the present invention can accurately control the inhalation / exhalation ratio, so that the test device can accurately simulate the normal human breathing process, including different breathing waveforms and frequencies.

[0031] 2. The design of the CO2 cylinder and the air cylinder allows the volume of a single breath to be changed by replacing cylinders of different diameters and pistons of corresponding sizes, thereby simulating people with different lung capacities. At the same time, this design can also adjust the proportion of carbon dioxide output to ensure the diversity and adaptability of test conditions.

[0032] 3. The testing device of the present invention can not only evaluate the performance of the therapeutic mask under normal conditions, but also detect the protective effectiveness of the mask under simulated single fault conditions (such as breathing circuit blockage or air intake flow source failure), ensuring that the mask can provide adequate protection under various conditions.

[0033] 4. The entire test process of the present invention is designed with clear logic and clear steps, which is convenient for operators to quickly learn and master. At the same time, liquid carbon dioxide cylinders are used as CO2 sources, and the output is stable through a pressure reducing valve, which increases the safety and stability of the test process.

[0034] 5. By comparing the increased percentage of carbon dioxide concentration (P value), the testing method of the present invention can quickly and effectively determine whether the treatment mask meets the requirements in a normal state and a single fault state, thereby improving the testing efficiency and accuracy.

[0035] 6. The addition of the temperature control device of the present invention can heat the cylinder wall to body temperature, more accurately simulating the normal human breathing environment, and providing the possibility for studying the effect of temperature on gas exchange efficiency during breathing.

[0036] Of course, any product implementing the present invention does not necessarily need to achieve all of the advantages described above at the same time. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings required for describing the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other accompanying drawings can be obtained based on these accompanying drawings without paying creative work.

[0038] Figure 1 The present invention is a schematic structural diagram of a test device for CO2 rebreathing through a sleep apnea treatment mask.

[0039] Figure 2 It is a schematic diagram of the local structure of a human head model wearing a treatment mask during the implementation of the present invention.

[0040] Figure 3 This is a structural diagram of the equipment cabinet.

[0041] Figure 4 It is a schematic diagram of the structure of the human head model and the gas delivery device.

[0042] Figure 5 It is a schematic diagram of the structure of two driving devices, CO2 cylinder and air cylinder.

[0043] Figure 6 It is a structural schematic diagram of the connection state of the cam and the piston.

[0044] In the accompanying drawings, the components represented by the reference numerals are listed as follows:

[0045] 1-equipment cabinet, 2-human head model, 3-gas delivery device, 4-driving device, 5-carbon dioxide gas source, 6-carbon dioxide pipeline, 7-CO2 air pump, 8-pressure reducing valve, 9-treatment mask, 11-grid frame, 12-column, 13-plate, 31-CO2 cylinder, 32-air cylinder, 33-Y-shaped hose, 34-piston, 341-L-shaped rod, 342-bearing, 41-motor, 42-short shaft, 43-cam, 44-first gear, 45-second gear, 46-seat bearing, 431-cam-shaped guide groove. DETAILED DESCRIPTION

[0046] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention. Specific embodiment one:

[0048] See also Figure 1-6 As shown, the present invention is a test device for CO2 rebreathing of a sleep apnea treatment mask, including a test device for CO2 rebreathing of a sleep apnea treatment mask, including an equipment cabinet 1, a human head model 2, a gas delivery device 3, two drive devices 4 and a carbon dioxide gas source 5. The human head model 2 is installed at the upper end of the equipment cabinet 1. The gas delivery device 3 and the two drive devices 4 are installed inside the equipment cabinet 1, and the two drive devices 4 drive the gas delivery device 3 through a mechanical linkage mechanism to simulate a normal breathing process. The gas delivery device 3 is connected to the mouth and nose of the human head model 2. The carbon dioxide gas source 5 delivers carbon dioxide through a carbon dioxide pipeline 6 and a CO2 air pump 7.

[0049] The equipment cabinet 1 includes three grid frames 11 arranged vertically and arranged in parallel. The three grid frames 11 are connected as a whole through four columns 12 and a plurality of tripods and bolts. A flat plate 13 is fixed to the top surface of the upper and lower grid frames 11 respectively. The driving device 4 is installed on the middle grid frame 11. The human head model 2 is installed on the upper flat plate 13. The grid frame 11, columns 12 and tripods of the equipment cabinet 1 are all made of aluminum profiles, which are easy to disassemble as a whole, have a simple structure and are compactly arranged.

[0050] The gas delivery device 3 specifically includes a CO2 cylinder 31, an air cylinder 32, and a Y-shaped hose 33. The CO2 cylinder 31 and the air cylinder 32 are respectively fixed on the lower flat plate 13. A piston 34 connected to the driving device 4 is installed in the CO2 cylinder 31 and the air cylinder 32 respectively. A one-way inlet valve and an outlet valve are installed at the lower end of the side wall of the CO2 cylinder 31. The carbon dioxide pipeline 6 is connected to the inlet valve. A straight-through gas connection head is installed at the lower end of the side wall of the air cylinder 32. The three ends of the Y-shaped hose 33 are respectively connected to the human head model 2, the outlet valve and the straight-through gas connection head. The CO2 cylinder 31 and the air cylinder 32 can be replaced with specifications of different diameters when in use, and are equipped with pistons 34 of corresponding sizes. The cylinder diameter is changed to change the gas volume of a single breath while the piston stroke remains unchanged, which can simulate people with different vital capacities. At the same time, changing the diameter of the CO2 cylinder 31 also adjusts the proportion when changing the CO2 output. The CO2 cylinder 31 can only take in the carbon dioxide gas from the carbon dioxide pipeline 6, and the air cylinder 32 inhales and exhausts gas from the Y-shaped hose 33. When the CO2 cylinder 31 and the air cylinder 32 are synchronously driven and output by the two driving devices 4, the air in the air cylinder 32 and the carbon dioxide gas in the CO2 cylinder 31 are mixed in the Y-shaped hose 33, and the synchronous output ensures the stability of the carbon dioxide ratio of the output gas at the end of the Y-shaped hose 33.

[0051] Wherein, the driving device 4 includes a motor 41, a short shaft 42, a cam 43, a first gear 44 and a second gear 45. The motor 41 is mounted on the middle grid frame 11 through a motor mounting seat. The short shaft 42 is mounted on the middle grid frame 11 through two seat bearings 46. The first gear 44 is mounted on the shaft end of the motor 41. The cam 43 and the second gear 45 are respectively mounted on the short shaft 42. The first gear 44 and the second gear 45 are meshed and transmitted. The motor 41 drives the short shaft 42 and the cam 43 thereon to rotate through the meshing transmission of the first gear 44 and the second gear 45. The speed of the cam 43 can be conveniently adjusted by changing the transmission ratio of the gear set without changing the speed of the motor 41, that is, adjusting the frequency of the simulated breathing. In addition, by setting the gear set, the low-torque motor 41 can be used to indirectly adjust the movement frequency of the cam 43 driving the piston 34, which can effectively reduce the load of the motor 41.

[0052] A cam-shaped guide groove 431 is provided on one side of the cam 43 along the cam profile. An inverted L-shaped rod 341 is fixed to the free end of the piston 34 rod body. A bearing 342 that matches the groove wall of the cam-shaped guide groove 431 is installed at the horizontal rod end of the L-shaped rod 341. By replacing the cam 43 with different outer profiles, the gas can be exhaled in various waveforms to meet the needs of various experiments. Through the cam 43 mechanism, the inhalation / exhalation ratio can be accurately controlled, the stability of the test system can be improved, and the reliability of the test data can be ensured.

[0053] In order to facilitate the experiment, the carbon dioxide gas source 5 is a carbon dioxide gas cylinder storing liquid carbon dioxide. In addition, in order to ensure the stable output of the carbon dioxide gas cylinder, a pressure reducing valve 8 is installed at the output end of the carbon dioxide gas cylinder, and the carbon dioxide pipeline 6 is connected to the pressure reducing valve 8.

[0054] Among them, a temperature control device is installed on the outer wall of the CO2 cylinder 31 and the outer wall of the air cylinder 32 respectively. The temperature control device specifically includes a temperature controller, an electric heating belt and a temperature sensor. The electric heating belt and the temperature sensor are electrically connected to the temperature controller respectively. The electric heating belt is wound around the outer wall of the cylinder body. The temperature sensor is attached to the outer wall of the cylinder body using a heat-resistant tape. The temperature sensor sets the temperature of the cylinder body to body temperature by the electric heating belt, which can more accurately simulate the normal human breathing environment and physiological conditions. This heating function enables the test device to be used not only for conventional breathing curve simulation and carbon dioxide concentration detection, but also to further study the influence of temperature on gas exchange efficiency during breathing, which is of positive significance for the development and testing of medical equipment.

[0055] Secondly, this embodiment also provides a testing method for a testing device for a sleep apnea treatment mask CO2 rebreathing tester.

[0056] The mask detection for treating rebreathing under normal conditions includes the following steps:

[0057] S1, start to adjust and simulate the normal breathing process, turn on the CO2 air pump 7, and perform a simulated breathing experiment by synchronously controlling the two motors 41. Use a carbon dioxide detector to detect the carbon dioxide concentration at the mouth and nose of the human head model 2, and adjust the carbon dioxide flow delivered to the gas delivery device 3 by adjusting the output pressure of the pressure reducing valve 8 and the power of the CO2 air pump 7. Each adjustment interval is more than two minutes. When the carbon dioxide concentration detected by the carbon dioxide detector is stable at 5%, the simulation of the normal breathing process is completed. At this time, the end-tidal carbon dioxide concentration is recorded as Q1.

[0058] S2, put the treatment mask 9 on the human head model 2 to simulate normal use, confirm that the mask is completely sealed against the face of the simulated patient, adjust the flow source delivered to the treatment mask 9 so that the pressure detected by the pressure sensor in the mask reaches the minimum rated pressure, and continue the detection for four minutes or more. After the carbon dioxide reading stabilizes, record the carbon dioxide concentration Q2 at this time, and use Q2 minus Q1 and divide by Q1 to obtain the increased concentration percentage P1 of the carbon dioxide gas.

[0059] S3, on the basis of step S2, by adjusting the flow source of the treatment mask 9 so that the pressure sensor in the mask detects a pressure of 5hPa, the detection is continued for four minutes or more, and after the carbon dioxide reading is stable, the carbon dioxide concentration Q3 at this time is recorded, and Q3 is subtracted from Q1 and divided by Q1 to obtain the increased concentration percentage P2 of the increased carbon dioxide gas.

[0060] S4, on the basis of step S3, by adjusting the flow source of the treatment mask 9 so that the pressure sensor in the mask detects a pressure of 10hPa, the detection is continued for four minutes or more. After the carbon dioxide reading is stable, the carbon dioxide concentration Q4 at this time is recorded, and Q4 is subtracted from Q1 and divided by Q1 to obtain the increased concentration percentage P3 of the carbon dioxide gas.

[0061] S5, judging whether the treatment mask 9 meets the requirements. When P1, P2 and P3 are all less than 20%, it is determined that the treatment mask 9 meets the requirements; otherwise, the treatment mask 9 does not meet the requirements.

[0062] The single fault condition mask detection for treating rebreathing includes the following steps:

[0063] S11, start adjusting to simulate the normal breathing process, turn on the CO2 air pump 7, perform a simulated breathing experiment by synchronously controlling the two motors 41, use a carbon dioxide detector to detect the carbon dioxide concentration at the mouth and nose of the human head model 2, and comprehensively adjust the carbon dioxide flow delivered to the gas delivery device 3 by adjusting the output pressure of the pressure reducing valve 8 and adjusting the power of the CO2 air pump 7. Each adjustment interval is more than two minutes. When the carbon dioxide concentration detected by the carbon dioxide detector is stable at 5%, the simulation of the normal breathing process is completed. At this time, the end-tidal carbon dioxide concentration is recorded as Q1.

[0064] S12, simulates blockage of the breathing circuit by blocking the patient connection port, and continues to detect for four minutes or more. After the carbon dioxide reading stabilizes, record the carbon dioxide concentration Q5 at this time, subtract Q1 from Q5 and divide by Q1 to get the increased carbon dioxide gas concentration percentage P4.

[0065] S13, judging whether the treatment mask 9 meets the requirements, when P4 is less than 60%, it is judged that the treatment mask 9 meets the requirements, otherwise the treatment mask 9 does not meet the requirements.

[0066] The single fault condition mask detection for treating rebreathing also includes the following steps:

[0067] S111, start adjusting to simulate the normal breathing process, turn on the CO2 air pump 7, perform a simulated breathing experiment by synchronously controlling the two motors 41, use a carbon dioxide detector to detect the carbon dioxide concentration coming out of the mouth and nose of the human head model 2, and comprehensively adjust the carbon dioxide flow delivered to the gas delivery device 3 by adjusting the output pressure of the pressure reducing valve 8 and adjusting the power of the CO2 air pump 7. Each adjustment interval is more than two minutes. When the carbon dioxide concentration detected by the carbon dioxide detector is stable at 5%, the simulation of the normal breathing process is completed. At this time, the end-tidal carbon dioxide concentration is recorded as Q1.

[0068] S112, simulate the failure of the air intake flow source of the treatment mask 9, turn off the air intake flow source of the treatment mask 9, and continue to detect for four minutes or more. After the carbon dioxide reading stabilizes, record the carbon dioxide concentration Q6 at this time, subtract Q1 from Q6 and divide it by Q1 to get the increased carbon dioxide gas concentration percentage P5.

[0069] S113, judging whether the treatment mask 9 meets the requirements, when P5 is less than 60%, it is judged that the treatment mask 9 meets the requirements, otherwise the treatment mask 9 does not meet the requirements.

[0070] Through the above test, it can be quickly tested whether the protection of the treatment mask 9 in the normal state and the protection in the single fault state are qualified, and the test process is safe and reliable.

[0071] In the description of this specification, the description with reference to the terms "one embodiment", "example", "specific example", etc. means that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic representation of the above terms does not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described can be combined in any one or more embodiments or examples in a suitable manner.

[0072] The preferred embodiments of the present invention disclosed above are only used to help illustrate the present invention. The preferred embodiments do not describe all the details in detail, nor do they limit the invention to the specific implementation methods described. Obviously, many modifications and changes can be made according to the content of this specification. This specification selects and specifically describes these embodiments in order to better explain the principles and practical applications of the present invention, so that those skilled in the art can understand and use the present invention well. The present invention is limited only by the claims and their full scope and equivalents.

Claims

1. A test device for CO2 rebreathing of a sleep apnea treatment mask, characterized in that: It comprises an equipment cabinet (1), a human head model (2), a gas delivery device (3), two drive devices (4) and a carbon dioxide gas source (5); The human head model (2) is installed at the upper end of the equipment cabinet (1); the gas delivery device (3) and the two drive devices (4) are installed inside the equipment cabinet (1), and the two drive devices (4) drive the gas delivery device (3) through a mechanical linkage mechanism to simulate a normal breathing process; The gas delivery device (3) is connected to the mouth and nose of the human head model (2); The carbon dioxide gas source (5) delivers carbon dioxide via a carbon dioxide pipeline (6) and a CO2 gas pump (7); The driving device (4) comprises a motor (41), a short shaft (42), a cam (43), a first gear (44) and a second gear (45); the motor (41) is mounted on the middle grid frame (11) via a motor mounting seat; the short shaft (42) is mounted on the middle grid frame (11) via two seat bearings (46); the first gear (44) is mounted on the shaft end of the motor (41); the cam (43) and the second gear (45) are respectively mounted on the short shaft (42); the first gear (44) and the second gear (45) are meshed for transmission; a cam-shaped guide groove (431) is provided on one side of the cam (43) along the cam profile; The gas delivery device (3) comprises a CO2 cylinder (31), an air cylinder (32), and a Y-shaped hose (33); the CO2 cylinder (31) and the air cylinder (32) are respectively fixed on a lower flat plate (13); and a piston (34) is respectively installed in the CO2 cylinder (31) and the air cylinder (32) and is drivably connected to the drive device (4).

2. The test device for sleep apnea treatment mask CO2 rebreathing according to claim 1, characterized in that: The equipment cabinet (1) comprises three grid frames (11) arranged vertically and arranged in parallel; the three grid frames (11) are connected as a whole via four columns (12) and a plurality of tripods and bolts; a flat plate (13) is fixed to the top surface of the upper and lower grid frames (11) respectively; the driving device (4) is mounted on the middle grid frame (11); and the human head model (2) is mounted on the upper flat plate (13).

3. The test device for sleep apnea treatment mask CO2 rebreathing according to claim 2, characterized in that: A unidirectional air inlet valve and an air outlet valve are installed at the lower end of the side wall of the CO2 cylinder (31); the carbon dioxide pipeline (6) is connected to the air inlet valve; a straight-through air connector is installed at the lower end of the side wall of the air cylinder (32); and the three ends of the Y-shaped hose (33) are respectively connected to the human head model (2), the air outlet valve and the straight-through air connector.

4. The test device for sleep apnea treatment mask CO2 rebreathing according to claim 3, characterized in that: An inverted L-shaped rod (341) is fixed to the free end of the rod body of the piston (34); a bearing (342) that cooperates with the groove wall of the cam-shaped guide groove (431) is installed at the horizontal rod end of the L-shaped rod (341).

5. The test device for sleep apnea treatment mask CO2 rebreathing according to claim 4, characterized in that: The carbon dioxide gas source (5) is a carbon dioxide gas cylinder storing liquid carbon dioxide, and a pressure reducing valve (8) is installed at the output end of the carbon dioxide gas cylinder, and the carbon dioxide pipeline (6) is connected to the pressure reducing valve (8).

6. The test device for sleep apnea treatment mask CO2 rebreathing according to claim 5, characterized in that: A temperature control device is respectively installed on the outer wall of the CO2 cylinder (31) and the outer wall of the air cylinder (32).

7. The test device for sleep apnea treatment mask CO2 rebreathing according to claim 6, characterized in that: The temperature control device includes a temperature controller, an electric heating belt and a temperature sensor; the electric heating belt and the temperature sensor are electrically connected to the temperature controller respectively; the electric heating belt is wound around the outer wall of the cylinder body; the temperature sensor is adhered to the outer wall of the cylinder body using a heat-resistant tape.

8. A method for testing a test device for a sleep apnea treatment mask CO2 rebreathing test device, the test device being the test device according to any one of claims 5 to 7, characterized in that: The following steps are involved: S1, start adjusting to simulate the normal breathing process, turn on the CO2 air pump (7), perform a simulated breathing experiment by synchronously controlling the two motors (41), use a carbon dioxide detector to detect the carbon dioxide concentration at the mouth and nose of the human head model (2), and comprehensively adjust the carbon dioxide flow delivered to the gas delivery device (3) by adjusting the output pressure of the pressure reducing valve (8) and adjusting the power of the CO2 air pump (7). Each adjustment interval is more than two minutes. When the carbon dioxide concentration detected by the carbon dioxide detector is stable at 5%, the simulation of the normal breathing process is completed. At this time, the end-tidal carbon dioxide concentration is recorded as Q1; S2, putting the treatment mask (9) on the human head model (2) to simulate normal use, confirming that the mask is completely sealed against the face of the simulated patient, adjusting the flow source delivered to the treatment mask (9) so that the pressure detected by the pressure sensor in the mask reaches the minimum rated pressure, and continuing the detection for four minutes or more. After the carbon dioxide reading is stable, record the carbon dioxide concentration Q2 at this time, and use Q2 minus Q1 and divide by Q1 to obtain the increased concentration percentage P1 of the carbon dioxide gas; S3, based on step S2, by adjusting the flow source of the treatment mask (9) so that the pressure sensor in the mask detects a pressure of 5 hPa, the detection is continued for four minutes or more, and after the carbon dioxide reading is stable, the carbon dioxide concentration Q3 at this time is recorded, and the percentage of carbon dioxide gas increase P2 is obtained by subtracting Q1 from Q3 and dividing by Q1; S4, based on step S3, by adjusting the flow source of the treatment mask (9) so that the pressure sensor in the mask detects a pressure of 10 hPa, the detection is continued for four minutes or more, and after the carbon dioxide reading is stable, the carbon dioxide concentration Q4 at this time is recorded, and the concentration percentage P3 of the increased carbon dioxide gas is obtained by subtracting Q1 from Q4 and dividing it by Q1; S5, judging whether the treatment mask (9) meets the requirements. When P1, P2 and P3 are all less than 20%, it is judged that the treatment mask (9) meets the requirements; otherwise, the treatment mask (9) does not meet the requirements.

9. The testing method according to claim 8, characterized in that: The following steps are involved: S11, start adjusting to simulate the normal breathing process, turn on the CO2 air pump (7), perform a simulated breathing experiment by synchronously controlling the two motors (41), use a carbon dioxide detector to detect the carbon dioxide concentration at the mouth and nose of the human head model (2), and comprehensively adjust the carbon dioxide flow delivered to the gas delivery device (3) by adjusting the output pressure of the pressure reducing valve (8) and adjusting the power of the CO2 air pump (7). Each adjustment interval is more than two minutes. When the carbon dioxide concentration detected by the carbon dioxide detector stabilizes at 5%, the simulation of the normal breathing process is completed. At this time, the end-tidal carbon dioxide concentration is recorded as Q1; S12, simulates blockage of the breathing circuit by blocking the patient connection port, and continues to test for four minutes or more. After the carbon dioxide reading stabilizes, record the carbon dioxide concentration Q5 at this time, and use Q5 to subtract Q1 and divide it by Q1 to get the increased carbon dioxide gas concentration percentage P4; S13, judging whether the treatment mask (9) meets the requirements. When P4 is less than 60%, it is judged that the treatment mask (9) meets the requirements; otherwise, the treatment mask (9) does not meet the requirements.

10. The testing method according to claim 8 or 9, characterized in that: The following steps are involved: S111, start adjusting to simulate a normal breathing process, start the CO2 air pump (7), perform a simulated breathing experiment by synchronously controlling the two motors (41), use a carbon dioxide detector to detect the carbon dioxide concentration at the mouth and nose of the human head model (2), and comprehensively adjust the carbon dioxide flow delivered to the gas delivery device (3) by adjusting the output pressure of the pressure reducing valve (8) and adjusting the power of the CO2 air pump (7). Each adjustment interval is more than two minutes. When the carbon dioxide concentration detected by the carbon dioxide detector is stable at 5%, the simulation of a normal breathing process is completed. At this time, the end-tidal carbon dioxide concentration is recorded as Q1; S112, simulating that the air intake flow source of the treatment mask (9) fails, turning off the air intake flow source of the treatment mask (9), and continuing to detect for four minutes or more. After the carbon dioxide reading is stable, the carbon dioxide concentration Q6 at this time is recorded, and the concentration percentage P5 of the increased carbon dioxide gas is obtained by subtracting Q1 from Q6 and dividing it by Q1; S113, judging whether the treatment mask (9) meets the requirements. When P5 is less than 60%, it is judged that the treatment mask (9) meets the requirements; otherwise, the treatment mask (9) does not meet the requirements.

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