Oxygen mask and intermittent normal-pressure high-concentration oxygen intelligent regulation and control system

Abstract

The invention relates to the technical field of medical instruments, and provides an oxygen mask and an intermittent normal-pressure high-concentration oxygen intelligent regulation and control system.The oxygen mask comprises a mask body and a connecting unit which corresponds to the nose and the mouth of a patient and is connected with the mask body; the baffling component is connected with the mask body to enable the mask body to form an oxygen supply area and an oxygen uptake area, the oxygen supply area is communicated with the oxygen uptake area, the connecting unit comprises an air inlet channel communicated with the oxygen supply area and an expiration channel communicated with the oxygen uptake area, and air is delivered to the oxygen supply area or the oxygen uptake area through the air inlet channel for oxygen uptake of a patient. Gas exhaled by the patient is discharged to the outside through the expiration channel. When a patient is subjected to intermittent normal-pressure high-concentration oxygen treatment, multiple physiological parameters of the patient are detected, the parameters of the oxygen generator can be intelligently regulated and controlled on the basis of monitoring data, and the treatment effect is further improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, specifically an oxygen mask and an intelligent regulation system for intermittent normobaric high-concentration oxygen. Background Art

[0002] Stroke is a major disease that seriously endangers human health and life safety. Currently, it is the main cause of death and disability among adults in China, imposing a heavy economic and social burden. Among them, ischemic stroke is caused by the stenosis or occlusion of cerebral arteries, resulting in the interruption of cerebral blood supply and the ischemic hypoxia necrosis of brain tissue. Reperfusion therapy, including intravenous thrombolysis and mechanical thrombectomy, to quickly open the occluded blood vessels and restore cerebral blood flow as soon as possible is the preferred treatment method for ischemic stroke at present. And brain protection treatment based on reperfusion therapy is an important means to improve the prognosis of stroke.

[0003] Normobaric high-concentration oxygen therapy (41 - 90% oxygen, 10 L / min) enables stroke patients to inhale high-concentration oxygen, and through the diffusion of oxygen, the oxygen concentration in brain tissue is increased, blocking the downstream damage cascade reaction of cerebral hypoxia. The results of multiple clinical trials show that normobaric high-concentration oxygen therapy based on reperfusion therapy can improve the prognosis of ischemic stroke. It is a simple, accessible, and early-implementable brain protection method. And intermittent normobaric high-concentration oxygen therapy, using the method of intermittent oxygen inhalation, also has a brain protection effect and can avoid the potential risks of continuous high-concentration oxygen inhalation, such as oxygen toxicity, carbon dioxide retention, cerebral excitotoxicity, etc., and has the value of popularization and application.

[0004] Hypothermia treatment refers to reducing body temperature to a certain level through physical or drug methods to achieve the treatment purpose. Clinical studies have shown that whole-body mild hypothermia (32 - 34°C) treatment improves the neurological function of patients with cardiac arrest and neonatal ischemic hypoxic encephalopathy, showing a brain protection effect. However, whole-body mild hypothermia has side effects such as shivering, infection, and abnormal coagulation function, which limit its application in stroke treatment. And local brain hypothermia has the advantages of small impact on core body temperature and small side effects while reducing brain temperature and playing a protective role.

[0005] At present, when a patient undergoes intermittent normobaric hyperoxic therapy, a dedicated person is required to be responsible for timing, and the mask body needs to be manually removed and worn multiple times by medical staff. In an emergency treatment environment, it is extremely difficult for medical staff who are performing a large number of treatments and examinations to remove and re-wear the mask body frequently, resulting in treatment interruption or delay, and greatly increasing the workload of medical staff. In addition, the method of intermittent normobaric hyperoxic therapy uses a traditional mask body to supply oxygen to the patient. When the oxygen generator supplies oxygen intermittently, the high-speed flowing oxygen directly impacts the patient's face and nose, causing discomfort symptoms such as restlessness and dry nasal mucosa in the patient, exacerbating the patient's sense of tension and fear, and causing the patient to be unable to use the mask according to the treatment requirements, thus affecting the patient's treatment compliance. In addition, intermittent oxygen supply makes the oxygen stay in the mask for a short time, resulting in insufficient oxygen inhalation by the patient, which may lead to the patient's asphyxiation or even death. Therefore, there is a need for improvement and development in view of the above problems. Summary of the Invention

[0006] The present invention provides an oxygen mask and an intelligent control system for intermittent normobaric hyperoxic therapy. When a patient undergoes intermittent normobaric hyperoxic therapy, multiple physiological parameters related to brain function of the patient are detected. Based on the monitoring data, the parameters of the oxygen generator can be intelligently controlled to achieve a better treatment effect. The specific implementation is as follows: The mask body includes a mask body and a connection unit corresponding to the patient's nose and mouth and connected to the mask body. A baffle member is provided on the mask body. The baffle member is connected to the mask body to form an oxygen supply area and an oxygen inhalation area on the mask body. The oxygen supply area and the oxygen inhalation area are communicated with each other. The connection unit includes an air inlet channel communicated with the oxygen supply area and an exhalation channel communicated with the oxygen inhalation area. Gas is delivered to the oxygen supply area or the oxygen inhalation area through the air inlet channel for the patient to inhale oxygen, and the gas exhaled by the patient is discharged to the outside through the exhalation channel.

[0007] As a further solution of the present invention, the baffle member forms a bulging portion for accommodating the mouth and nose, and the protruding portion of the bulging portion is arranged facing the air inlet channel to form an oxygen supply area for gas circulation.

[0008] As a further solution of the present invention, the edge of the mask body adheres to the facial contour of the patient, and the edge of the baffle member is adjacent to the patient's face and connected to the inner wall of the mask body.

[0009] As a further solution of the present invention, the baffle member is provided with an orifice, and the orifice is arranged corresponding to the air inlet channel to communicate the oxygen supply area and the oxygen inhalation area.

[0010] As a further solution of the present invention, at least a part of the baffle member is provided as a flexible body, the flexible body is arranged adjacent to the exhalation passage, an adjusting member is movably provided on the mask body, the adjusting member is connected to the flexible body and is used to cause the flexible body to deform, so as to reduce the space of the oxygen supply area.

[0011] As a further solution of the present invention, the mask body is formed with a connecting passage, the adjusting member is sleeved on the connecting passage, and a dynamic sealing member is provided between the connecting passage and the adjusting member, so that the adjusting member is hermetically connected to the mask body.

[0012] As a further solution of the present invention, the dynamic sealing member includes a sealing bowl and a sealing boss connected and matched therewith, the sealing bowl is provided on the adjusting member, and the sealing boss is provided on the connecting passage.

[0013] As a further solution of the present invention, the sealing boss is formed with a groove, the edge of the sealing bowl is sleeved on the groove, at least part of the area of the sealing bowl is provided as an elastic structure, and the adjusting member moves under the action of an external force, and the elastic structure deforms under the drive of the adjusting member.

[0014] As a further solution of the present invention, a sealing ring is provided on the sealing boss, the inner wall of the sealing ring abuts against the sealing boss, and the outer wall of the sealing ring abuts against the sealing bowl.

[0015] In addition, the present invention also provides an intermittent normal pressure high-concentration oxygen intelligent control system, which includes the above-mentioned mask body, and also includes an oxygen generator, a physiological parameter monitoring module, a terminal module, and a remote control module. The oxygen generator is used to prepare high-concentration oxygen and perform sub-low temperature treatment on the high-concentration oxygen, and transport the high-concentration oxygen after sub-low temperature treatment to the mask body. The physiological parameter monitoring module is used to collect a plurality of physiological information parameters of the patient and transmit the physiological information parameters of the patient to the remote control module. The remote control module is connected to the oxygen generator and the physiological parameter monitoring module through the terminal module, generates the brain function state of the patient based on a plurality of physiological information parameters of the patient, and controls the setting parameters of the oxygen generator and the physiological parameter monitoring module based on the brain function state of the patient.

[0016] Due to the adoption of the above technical solutions, the beneficial technical effects of the present invention are: 1. When the patient undergoes intermittent normal pressure high-concentration oxygen therapy, the present invention detects a plurality of physiological parameters related to brain function of the patient, and can intelligently control the parameters of the oxygen generator based on the monitoring data, further improving the treatment effect; 2. The present invention is provided with a baffle member on the mask body, which divides the mask body into an oxygen supply area and an oxygen inhalation area. In the case of intermittent oxygen supply by the oxygen generation equipment, it ensures the effective storage and utilization of oxygen, effectively prolongs the residence time of oxygen in the mask body, and achieves the purpose of providing sufficient oxygen for the patient in a short time; 3. The present invention can be applied in a variety of clinical scenarios, especially during the emergency rescue and transportation of critically ill patients. By combining the functions of preparing high-concentration oxygen and subjecting high-concentration oxygen to mild hypothermia treatment, a composite non-invasive brain protection function is formed. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 It is a schematic structural diagram of an oxygen mask in a specific embodiment of the present invention; Figure 2 It is a sectional view of an oxygen mask in a specific embodiment of the present invention; Figure 3 It is a partial schematic structural diagram of an oxygen mask in a specific embodiment of the present invention; Figure 4 It is a partial sectional view of an oxygen mask in a specific embodiment of the present invention; Figure 5 It is a sectional view of an oxygen delivery tube and an oxygen dispersion structure in a specific embodiment of the present invention; Figure 6 It is a sectional view of an oxygen delivery tube in a specific embodiment of the present invention; Figure 7 It is a schematic structural diagram of an oxygen dispersion structure in a specific embodiment of the present invention; Figure 8 It is a sectional view of a connecting tube and an adjusting member in a specific embodiment of the present invention; Figure 9 For the present invention Figure 8 The enlarged structural view of part A; Figure 10 It is a partial enlarged view of a connecting tube and an adjusting member in a specific embodiment of the present invention; Figure 11 It is a working principle diagram of an intermittent normal pressure high-concentration oxygen intelligent regulation system in a specific embodiment of the present invention; Figure 12 It is a control data analysis diagram of a continuous normal pressure high-concentration oxygen group and an intermittent normal pressure high-concentration oxygen group in a specific embodiment of the present invention; Figure 13 It is a cerebral infarction volume data analysis diagram in a specific embodiment of the present invention.

[0018] Description of the reference numerals: 1. Mask body, 2. Baffle member, 3. Oxygen supply chamber, 4. Oxygen delivery tube, 5. Adjusting member, 6. Pull ring, 7. Exhalation tube, 8. Fixing band, 9. Sealing ring, 11. Air inlet, 12. Connector, 13. Connection channel, 14. Step groove, 15. Sealing boss, 16. Projection, 17. Groove, 21. Flexible body, 22. Orifice, 23. Exhalation port, 41. Tube body, 42. Spring, 43. Oxygen dispersion member, 411. Oxygen delivery pipe, 412. Clamping end 431. Flared end, 432. Limiting part, 433. Wedge block 51. Outer sleeve, 52. Slot, 53. Sealing bowl 531. First connecting part, 532. Elastic structure, 533. Second connecting part Detailed implementation mode

[0019] The following describes the specific implementation mode of the present invention in conjunction with the accompanying drawings and embodiments: It should be noted that the structures, ratios, sizes, etc. shown in the drawings of this specification are only used to cooperate with the content disclosed in the specification for those familiar with this technology to understand and read, and are not used to limit the implementation conditions of the present invention. Any modification of the structure, change of the proportional relationship or adjustment of the size, without affecting the efficacy and purpose that the present invention can achieve, should still fall within the scope that the technical content disclosed by the present invention can cover.

[0020] At the same time, the terms such as "upper", "lower", "left", "right", "middle" and "one" cited in this specification are only for the convenience of clear narration, and are not used to limit the scope of implementation of the present invention. The change or adjustment of their relative relationship, without substantial change of the technical content, should also be regarded as the scope that the present invention can implement.

[0021] Example 1, in combination with Figures 1 to 10 As shown, this embodiment provides an oxygen mask, including a mask body 1 and a connection unit corresponding to the patient's nose and mouth and connected to the mask body 1. The edge of the mask body 1 closely fits the facial contour of the patient and forms a receiving space for accommodating the patient's mouth and nose. When in use, the mask body 1 is fixed on the patient's head through the fixing strap 8 on the mask body 1. The top edge of the mask body 1 fits the face above the patient's nose, and the bottom edge of the mask body 1 fits the face on the patient's lower jaw. The mask body 1 can be made of a relatively soft semi-rigid plastic material. The semi-rigid plastic material can be selected from plastic materials such as thermoplastic polyurethane and polyvinyl chloride. The semi-rigid plastic material has good biocompatibility, certain flexibility and strength, so as to provide sufficient rigidity to maintain the basic shape during normal use and ensure the comfort and safety of the patient.

[0022] Specifically, in combination with Figure 2As shown, a baffle member 2 is provided on the mask body 1. The baffle member 2 is connected to the mask body 1 to form an oxygen supply area and an oxygen inhalation area on the mask body 1. The oxygen supply area is communicated with the oxygen inhalation area. The connection unit includes an air inlet channel communicated with the oxygen supply area and an exhalation channel communicated with the oxygen inhalation area. Through the air inlet channel, gas is delivered into the oxygen supply area or the oxygen inhalation area for the patient to inhale oxygen, and the gas exhaled by the patient is discharged to the outside through the exhalation channel. The oxygen transported through the air inlet channel flows in the accommodation space of the mask body 1 to provide sufficient oxygen inhalation space for the patient. The baffle member 2 divides the accommodation space of the mask body 1 into an oxygen supply area and an oxygen inhalation area. The oxygen inhalation area faces the patient's face, and the oxygen supply area is an oxygen supply chamber 3 for storing incoming oxygen. In the case of intermittent oxygen supply by an external oxygen generation device, the oxygen transported through the air inlet channel is distributed to the oxygen supply chamber 3 and the oxygen inhalation area. The oxygen flows in the oxygen supply chamber 3 and the oxygen inhalation area respectively, and the oxygen is effectively stored through the oxygen supply chamber 3, so that the residence time of oxygen in the mask body 1 is extended, thereby achieving the purpose of providing sufficient oxygen for the patient in a short time.

[0023] In this embodiment, the baffle member 2 forms a bulged portion for accommodating the mouth and nose. The protruding portion of the bulged portion is arranged facing the air inlet channel to form an oxygen supply area for gas to flow through. The bulged portion of the baffle member 2 faces the protruding portion of the mask body 1 to form an accommodation space for accommodating the patient's nose and mouth, and this accommodation space is the above-mentioned oxygen inhalation area. Gas is transported from the air inlet channel into the mask body 1 and is distributed into the oxygen supply chamber 3 and the oxygen inhalation area. The oxygen flowing in the oxygen inhalation area is actively inhaled by the patient.

[0024] In this embodiment, the edge of the mask body 1 adheres to the facial contour of the patient, and the edge of the baffle member 2 is adjacent to the patient's face and is connected to the inner wall of the mask body 1. The baffle member 2 and the mask body 1 can also be made of a relatively soft semi-rigid plastic material. The baffle member 2 is arranged in the accommodation space of the mask body 1 and is integrally connected to the mask body 1. The edge of the baffle member 2 is adjacent to the patient's face but does not fit, so that the mask body 1 forms a sufficient double-layer accommodation space for oxygen to flow through.

[0025] In this embodiment, an orifice 22 is formed on the baffle member 2. The orifice 22 is arranged corresponding to the air inlet channel to communicate the oxygen supply area and the oxygen inhalation area. Oxygen enters the oxygen supply chamber 3 through the air inlet channel and then overflows into the oxygen inhalation area through the orifice 22. Since the orifice 22 is arranged corresponding to the air inlet channel, the air flow direction is relatively horizontal towards the patient's nose and then is actively inhaled by the patient.

[0026] In this embodiment, in combination with Figure 3As shown, at least a part of the baffle member 2 is provided as a flexible body 21. The flexible body 21 is arranged adjacent to the exhalation channel. A regulating member 5 is movably provided on the mask body 1. The regulating member 5 is connected to the flexible body 21 and is used to cause the flexible body 21 to deform, so as to reduce the space of the oxygen supply area. The flexible body 21 can be made of medical silica gel, which has good elasticity, so that the regulating member 5 drives the flexible body 21 to deform. The flexible body 21 is arranged between the orifice 22 and the exhalation channel. The driving device drives the regulating member 5 to move, so as to drive the flexible body 21 to move into the oxygen supply cavity 3, reduce the volume space of the oxygen supply cavity 3, so that the oxygen in the oxygen supply cavity 3 flows in the direction of the oxygen inhalation area, so that the patient can inhale enough oxygen.

[0027] In this embodiment, in order to prevent gas leakage from occurring in the mask body 1 during the process of the regulating member 5 driving the flexible body 21 to move, a dynamic seal connection is used between the regulating member 5 and the mask body 1. Specifically: As shown in Figure 8 the mask body 1 is formed with a connection channel 13. The regulating member 5 is sleeved on the connection channel 13. A dynamic seal member is provided between the connection channel 13 and the regulating member 5, so that the regulating member 5 is hermetically connected to the mask body 1. The first end of the regulating member 5 is made of a material with a certain hardness, so that the connecting part of the regulating member 5 and the connection channel 13 has sufficient support strength. The connection channel 13 is a tubular structure. The outer wall of the regulating member 5 fits with the inner wall of the connection channel 13. In addition, the connection channel 13 includes an outer sleeve 51. A slot 52 is formed between the outer sleeve 51 and the inner wall of the regulating member 5. The end of the connection channel 13 is inserted into the slot 52, and the connection channel 13 and the regulating member 5 are hermetically connected through a dynamic seal member. The regulating member 5 can be driven to move by a driving device or manually operated by a medical staff. For the convenience of manual operation by the medical staff, a pull ring 6 is provided at the end of the regulating member 5.

[0028] In this embodiment, the dynamic seal member includes a seal bowl 53 and a sealing boss 15 that is connected and cooperates with it. The seal bowl 53 is provided on the regulating member 5, and the sealing boss 15 is provided on the connection channel 13. The end of the connection channel 13 is inserted into the slot 52 and forms an installation cavity for installing the dynamic seal member with the slot 52. Both the seal bowl 53 and the sealing boss 15 are annular structures. Through the cooperation of the seal bowl 53 and the sealing boss 15, the sealing connection between the connection channel 13 and the regulating member 5 is realized. In addition, a sealing ring 9 is provided at the connection between the seal bowl 53 and the sealing boss 15. The sealing ring 9 can further improve the sealing effect between the connection channel 13 and the regulating member 5.

[0029] In this embodiment, as shown in Figure 9As shown, the sealing boss 15 is formed with a groove 17, the edge of the sealing bowl 53 is sleeved on the groove 17, at least part of the area of the sealing bowl 53 is set as an elastic structure 532, the adjusting member 5 moves under the action of an external force, and the elastic structure 532 deforms under the drive of the adjusting member 5. The elastic structure 532 is a "Z"-shaped bending structure and has the function of returning to its original shape after being deformed by an external force. Under the action of the adjusting member 5, the elastic structure 532 is driven to deform. After the external force on the adjusting member 5 is removed, the elastic structure 532 returns to its original state and drives the adjusting member 5 to reset, so that during the process of the adjusting member 5 driving the flexible body 21 to move, the connection sealing performance between the connection channel 13 and the adjusting member 5 can also be ensured. The elastic structure 532 can be made of an elastic plastic material, such as a shape memory polymer, an engineering plastic reinforced composite material, etc., which has the characteristic of returning to its original shape after the material deforms.

[0030] In this embodiment, the sealing boss 15 has a protrusion 16, a groove 17 is formed between the protrusion 16 and the inner wall of the connection channel 13. The sealing bowl 53 includes a first connection portion 531 connected to the adjusting member 5, and an elastic structure 532 and a second connection portion 533 that are sequentially connected to the first connection portion 531. The second connection portion 533 is disposed in the groove 17, and the sealing ring 9 is located between the groove wall of the groove 17 and the second connection portion 533. When the adjusting member 5 moves, it drives the first connection portion 531 to move, causing the elastic structure 532 to deform and extend in the moving direction of the adjusting member 5. Since the second connection portion 533 is connected to the groove 17, during the process of the adjusting member 5 driving the flexible body 21 to move, the connection sealing performance between the connection channel 13 and the adjusting member 5 will not change.

[0031] Preferably, to further improve the connection sealing performance between the connection channel 13 and the adjusting member 5, a sealing ring 9 is provided on the sealing boss 15. The inner wall of the sealing ring 9 abuts against the sealing boss 15, and the outer wall of the sealing ring 9 abuts against the sealing bowl 53. In this embodiment, two sealing rings 9 are provided, and the two sealing rings 9 are arranged along the groove depth of the groove 17.

[0032] In this embodiment, in combination with Figure 2 and Figure 4As shown, the connection unit includes an oxygen delivery tube 4 and an exhalation tube 7. A connector 12 is provided on the mask body 1. The oxygen delivery tube 4 is provided with a clamping end 412 corresponding to the connector 12 for mating connection. The connection between the oxygen delivery tube 4 and the mask body 1 is achieved through the sealed clamping connection between the clamping end 412 and the connector 12. The mask body 1 forms an air inlet 11, and the air inlet 11 is communicated with the oxygen delivery tube 4 to form an air inlet passage. The exhalation tube 7 penetrates through the mask body 1 and is connected to the baffle member 2. The baffle member 2 forms an exhalation port 23, and the exhalation port 23 is arranged corresponding to the patient's mouth. The exhalation tube 7 is connected to the exhalation port 23 so that the exhalation tube 7 is communicated with the oxygen inhalation area. The external oxygen generation device prepares oxygen and delivers the oxygen to the oxygen delivery tube 4. The oxygen flows towards the patient's nose relative to the horizontal direction for the patient to inhale sufficient oxygen. The patient exhales air from the mouth and discharges it to the outside through the exhalation tube 7. An exhalation valve (not shown in the figure) is provided on the exhalation tube 7 so that the exhaled gas can be discharged more easily, avoiding the accumulation of carbon dioxide in the oxygen inhalation area and keeping an appropriate oxygen concentration in the mask body 1.

[0033] In this embodiment, combined with Figure 5 As shown, when high-flow oxygen directly blows towards the patient, it will cause discomfort in the patient's respiratory tract, and even cause dryness or irritation in the nasal cavity and throat areas, resulting in discomfort for the patient or increasing the breathing resistance. To slow down the rate of oxygen delivered into the oxygen delivery tube 4, it is necessary to disperse the oxygen flow delivered into the mask body 1. The oxygen delivery tube 4 is tubular, and its inner diameter gradually increases from the input end to the output end of the oxygen delivery tube 4, so as to diffuse the oxygen flow delivered into the mask body 1, so that the oxygen is dispersed during the process of the oxygen delivery tube 4 delivering oxygen, thereby achieving the purpose of slowing down the oxygen flow rate.

[0034] In this embodiment, the oxygen delivery pipeline 411 includes a pipe body 41. The pipe body 41 forms the oxygen delivery pipeline 411. A oxygen-dispersing member 43 is provided in the pipe body 41. The oxygen-dispersing member 43 is movably arranged in the pipe body 41. The oxygen-dispersing member 43 includes a horn-shaped cylinder body. The top and bottom ends of the cylinder body are both flared ends 431. The cylinder body forms an air flow channel, and the air flow channel communicates with the flared ends 431. The inner diameter of the flared end 431 of the cylinder body facing the input end of the oxygen delivery tube 4 is smaller than the inner diameter of the flared end 431 facing the output end of the oxygen delivery tube 4. The oxygen flow rate can be effectively reduced through its gradually expanding channel, and the oxygen flow can also be smoothed to reduce the discomfort caused by the direct impact of high-speed oxygen on the patient's face or respiratory tract.

[0035] In this embodiment, the oxygen diffuser 43 is movably disposed in the pipe body 41 through the spring 42. The two ends of the spring 42 are respectively connected to the outer wall of the oxygen diffuser 43 and the inner wall of the pipe body 41. There are four groups of springs 42, and the four groups of springs 42 are arranged at equal intervals along the circumferential direction of the oxygen diffuser 43. The connection of the springs 42 can play a buffering role to a certain extent, weaken the vibration caused by the impact of the oxygen flow on the oxygen diffuser 43, thereby avoiding the influence on the mask body 1 caused by the vibration or movement of the oxygen delivery pipe 4, and thus playing a role in stabilizing the mask body 1.

[0036] In this embodiment, in order to make the oxygen diffuser 43 reciprocate linearly along the oxygen delivery pipe 411, a limiting member is provided between the oxygen delivery pipe 411 and the oxygen diffuser 43. There are multiple limiting members, and the multiple limiting members are arranged at equal intervals along the circumferential direction of the oxygen diffuser 43 and are disposed between adjacent two groups of springs 42. The limiting member includes a limiting portion 432 provided on the oxygen diffuser 43 and a wedge-shaped block 433 provided on the limiting portion 432. The pipe body 41 is provided with a sliding groove matching with the limiting portion 432 and the wedge-shaped block 433. The sliding groove is of a T-shaped structure and is arranged along the pipe direction of the pipe body 41. The limiting portion 432 and the wedge-shaped block 433 are slidably disposed in the sliding groove. During the process that the oxygen diffuser 43 is impacted by the oxygen flow, the oxygen diffuser 43 is driven to move, so as to drive the spring 42 to deform. At the same time, the limiting portion 432 and the wedge-shaped block 433 slide along the sliding groove, so that the oxygen diffuser 43 is stably connected in the pipe body 41 and the purpose of diffusing the oxygen flow is achieved, and further the oxygen is dispersed more evenly before reaching the patient's nose.

[0037] Embodiment 2, in combination with Figure 11 As shown, this embodiment provides an intermittent normal pressure high-concentration oxygen intelligent regulation system. Using the mask body 1 of the above Embodiment 1, it further includes an oxygen generator, a physiological parameter monitoring module, a terminal module, and a remote regulation module. The oxygen generator is used to prepare high-concentration oxygen, perform sub-low temperature treatment on the high-concentration oxygen, and deliver the high-concentration oxygen after sub-low temperature treatment to the mask body 1. The physiological parameter monitoring module is used to collect multiple physiological information parameters of the patient and transmit the physiological information parameters of the patient to the remote regulation module. The remote regulation module is connected to the oxygen generator and the physiological parameter monitoring module through the terminal module, generates the brain function state of the patient based on multiple physiological information parameters of the patient, and regulates the setting parameters of the oxygen generator and the physiological parameter monitoring module based on the brain function state of the patient.

[0038] In this embodiment, the oxygen generator is the external oxygen generation device described in Embodiment 1 above. The oxygen generator includes a refrigeration mechanism, where oxygen is subjected to pressure and temperature treatment and stored for use. The oxygen generator further includes a nitrogen refrigeration mechanism, which includes a nitrogen collection tank and a nitrogen storage tank connected to the nitrogen collection tank. The nitrogen storage tank is connected to the refrigeration mechanism through a pipeline, and functional devices such as a flow control valve and a pressure pump are provided on the pipeline. The nitrogen storage tank discharges nitrogen into the refrigeration mechanism to perform pressure and low-temperature treatment on oxygen, and then the pressure pump extracts and compresses the nitrogen in the refrigeration mechanism into the nitrogen collection tank, thereby realizing the recycling of nitrogen. The refrigeration mechanism is connected to the mask body 1 through an oxygen delivery tube 4. To avoid the impact of excessive oxygen concentration on patients, a blower for diluting oxygen and a mixing box for mixing oxygen and air are provided in the oxygen generator. An air tube is connected to the blower, and the air in the air tube is mixed with the oxygen delivered by the refrigeration mechanism in the mixing box and then delivered to the mask body 1 through the oxygen delivery tube 4, so as to achieve the purpose of oxygen pressure and temperature treatment.

[0039] In this embodiment, the oxygen generator is also provided with a flow control valve for controlling the oxygen flow rate, as well as a temperature sensor and a pressure sensor for respectively monitoring the oxygen temperature and pressure. The flow control valve, the temperature sensor, and the pressure sensor are all connected to the remote control module through the terminal module.

[0040] In this embodiment, the physiological parameter monitoring module includes a blood oxygen detection module, a cerebral oxygen detection module, a blood pressure detection module, and an electrocardiogram detection module, which are used to realize the real-time monitoring of physiological parameters such as the patient's blood oxygen, cerebral oxygen, blood pressure, heart rate, electrocardiogram, and respiration, and send them to the terminal module to realize the feedback adjustment of multiple physiological information parameters and the alarm of abnormal signals.

[0041] In this embodiment, the terminal module includes a central processing unit. The physiological parameter monitoring module and the oxygen generator are both connected to the remote control module through the central processing unit. The central processing unit is respectively connected to the physiological parameter monitoring module and the oxygen generator through a Bluetooth communication module to realize connection and data exchange, so as to send instructions or control signals to the oxygen generator and the physiological parameter monitoring module. A desktop computer or a laptop can be used as the application in the terminal module.

[0042] The terminal module is connected to the remote control module through a GSM communication module to realize network connection. Using the GSM communication module ensures stable transmission of patient information, oxygen inhalation plans, and multiple physiological information parameters even in the absence of Wi-Fi. The terminal module collects the patient's physiological information, and after preliminary processing, sends it to the remote control module. The remote control module receives the data from the terminal module, adjusts the oxygen supply parameters according to the preset oxygen inhalation plan, and the remote control module is also responsible for uploading the collected data to the cloud server for further analysis. The remote control module collects and stores a large amount of patient data transmitted from each terminal module, thereby helping medical staff better understand the patient's condition and make corresponding decisions.

[0043] Based on the above intermittent normal - pressure high - concentration oxygen intelligent regulation system, here, data control groups of a continuous normal - pressure high - concentration oxygen group (NBO group) and an intermittent normal - pressure high - concentration oxygen group (iNBO group) are provided for acute ischemic stroke patients who received intravenous thrombolysis within 4.5 hours of onset.

[0044] A total of 16 acute stroke patients who had an onset within 4.5 hours and received intravenous thrombolysis from December 2023 to December 2024 were included. Among them, there were 8 patients in the NBO group and 8 patients in the iNBO group. The average age was 66 (55.5, 74.5) years old, and 10 were male (62.5%). Both groups of patients received blood gas analysis before and after treatment, and the final cerebral infarction volume of the two groups of patients was evaluated through cranial MRI images to clarify the treatment effect.

[0045] Group 1: Patients in the NBO group were given continuous oxygen inhalation (reservoir mask, 10 L / min, for 4 hours) on the basis of intravenous thrombolysis. Group 2: Patients in the iNBO group would receive intermittent high - concentration oxygen therapy. During the oxygen inhalation stage, 10 L / min of oxygen was provided through the mask body 1 for 20 minutes, then the oxygen generator was stopped from providing oxygen to the mask body 1, and after a 20 - minute interval, oxygen was continued to be provided to the mask body 1 for 20 minutes, with a total of 4 hours of circulation.

[0046] The results showed that, as Figure 12 shown, there were no statistically significant differences in the partial pressure of oxygen and partial pressure of carbon dioxide in the arterial blood gas before treatment between the two groups of patients (P > 0.05).

[0047] The partial pressure of oxygen in the NBO group was 113.5 (95.3 - 200.3) mmHg; the partial pressure of oxygen in the iNBO group was 164 (98.8 - 219.3) mmHg. The partial pressure of oxygen in the iNBO group was higher than that in the NBO group, but there was no statistically significant difference between the two groups (P = 0.505).

[0048] The partial pressure of carbon dioxide in the NBO group was 41.5 (38.3 - 42.8) mmHg, and the partial pressure of carbon dioxide in the iNBO group was 39.5 (36.0 - 41.0) mmHg. There was no statistically significant difference between the two groups (P = 0.234).

[0049] From Figure 12 it can be seen that in the continuous normal - pressure high - concentration oxygen group (NBO group), due to the long - term high - flow oxygen inhalation into the patient's body, patients will have nasal discomfort, dryness of the respiratory tract, and accidental extubation caused by patient discomfort, etc., and the patient compliance is poor.

[0050] In clinical practice, the final cerebral infarction volume of the two groups of patients was analyzed by cranial magnetic resonance imaging diffusion-weighted imaging (DWI) and apparent diffusion coefficient (ADC). The area with high DWI signal and low ADC signal was defined as the final infarction area, and the infarction volume = slice thickness x (S1 + S2 +... + Sn). From Figure 13 it can be seen that the final infarction volume of the NBO group was 0.86 (0.21 - 1.68) mL, and that of the iNBO group was 0.32 (0 - 1.68) mL. There was no statistical difference between the two groups, but iNBO treatment had a tendency to reduce the final cerebral infarction volume of patients (P = 0.382). Based on the above data, it was concluded that iNBO treatment had a tendency to reduce the cerebral infarction volume of patients.

[0051] In summary, the intermittent normal pressure high-concentration oxygen intelligent regulation system and oxygen mask proposed in this study can not only implement the treatment method of intermittent oxygen supply to patients, but also ensure the effective storage and utilization of oxygen, effectively extend the residence time of oxygen in the mask body 1, and achieve the purpose of providing sufficient oxygen to patients in a short time.

[0052] Many other changes and modifications can be made without departing from the spirit and scope of the present invention. It should be understood that the present invention is not limited to the specific embodiments, and the scope of the present invention is defined by the appended claims.

Claims

1. Oxygen mask, comprising a mask body (1) and a connecting unit corresponding to the patient's nose and mouth and connected to the mask body (1), characterized in that, A baffle member (2) is provided on the mask body (1). The baffle member (2) is connected to the mask body (1) so that the mask body (1) forms an oxygen supply area and an oxygen inhalation area. The oxygen supply area is communicated with the oxygen inhalation area. The connection unit includes an air inlet passage communicated with the oxygen supply area and an exhalation passage communicated with the oxygen inhalation area. Gas is delivered to the oxygen supply area or the oxygen inhalation area through the air inlet passage for the patient to inhale oxygen, and the gas exhaled by the patient is discharged to the outside through the exhalation passage.

2. The oxygen mask according to claim 1, characterized in that, The baffle member (2) forms a bulging part for accommodating the mouth and nose, and the protruding part of the bulging part is arranged facing the air inlet passage to form an oxygen supply area for gas to flow through.

3. The oxygen mask according to claim 1, characterized in that, The edge of the mask body (1) adheres to the facial contour of the patient, and the edge of the baffle member (2) is adjacent to the patient's face and connected to the inner wall of the mask body (1).

4. The oxygen mask according to claim 1, characterized in that, An orifice (22) is formed on the baffle member (2), and the orifice (22) is arranged corresponding to the air inlet passage so that the oxygen supply area and the oxygen inhalation area are communicated.

5. The oxygen mask according to claim 1, characterized in that, At least a part of the baffle member (2) is set as a flexible body (21). The flexible body (21) is arranged adjacent to the exhalation passage. An adjusting member (5) is movably provided on the mask body (1). The adjusting member (5) is connected to the flexible body (21) and is used to cause the flexible body (21) to deform so as to reduce the space of the oxygen supply area.

6. The oxygen mask according to claim 5, characterized in that, The mask body (1) forms a connection passage (13). The adjusting member (5) is sleeved on the connection passage (13). A dynamic sealing member is provided between the connection passage (13) and the adjusting member (5) so that the adjusting member (5) is hermetically connected to the mask body (1).

7. The oxygen mask according to claim 6, wherein, The dynamic sealing member includes a sealing bowl (53) and a sealing boss (15) connected in cooperation therewith. The sealing bowl (53) is provided on the adjusting member (5), and the sealing boss (15) is provided on the connection passage (13).

8. The oxygen mask according to claim 7, characterized in that, The sealing boss (15) forms a groove (17). The edge of the sealing bowl (53) is sleeved on the groove (17). At least a part of the sealing bowl (53) is set as an elastic structure (532). When the adjusting member (5) moves under the action of an external force, the elastic structure (532) deforms under the drive of the adjusting member (5).

9. The oxygen mask according to claim 7, wherein A sealing ring (9) is provided on the sealing boss (15). The inner wall of the sealing ring (9) abuts against the sealing boss (15), and the outer wall of the sealing ring (9) abuts against the sealing bowl (53).

10. Intermittent normal pressure high-concentration oxygen intelligent regulation system, characterized in that, It includes the mask body (1) described in any one of claims 1-9, and further includes an oxygen generator, a physiological parameter monitoring module, a terminal module, and a remote control module. The oxygen generator is used to prepare high-concentration oxygen, perform sub-low-temperature treatment on the high-concentration oxygen, and deliver the high-concentration oxygen after sub-low-temperature treatment to the mask body (1). The physiological parameter monitoring module is used to collect multiple physiological information parameters of the patient and transmit the physiological information parameters of the patient to the remote control module. The remote control module is connected to the oxygen generator and the physiological parameter monitoring module through the terminal module, generates the brain function state of the patient based on multiple physiological information parameters of the patient, and regulates the setting parameters of the oxygen generator and the physiological parameter monitoring module based on the brain function state of the patient.

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