Elbow assembly directly connected with mask

Abstract

The invention discloses a ventilation elbow assembly directly connected with a mask, and mainly relates to an elbow, a connecting piece, a ventilation opening and a noise reduction device which are arranged on the elbow or the connecting piece, a hose, the mask, a frame and a quick-release connecting piece. The elbow is provided with a first connector directly connected with the mask, a second connector for receiving pressurized gas and an annular channel which is axially bent between the first connector and the second connector, at least one height difference exists at the first connector of the elbow and is used for connecting the mask and sealing the pressurized gas, and a baffle is further arranged at the first connector of the elbow; the frame is limited to move back and forth relative to the mask and the elbow; the elbow assembly is further provided with an anti-suffocation valve, and the anti-suffocation valve comprises an anti-suffocation valve opening and a silica gel sheet and is used for preventing the patient from suffocation when non-continuous positive air pressure enters the elbow. When the elbow assembly is provided with the connecting piece, the elbow can be firstly connected with the connecting piece and then connected with the mask through the connecting piece, and the movable range of the elbow assembly relative to the mask is increased.

Description

Technical Field

[0001] The present invention is a ventilation elbow assembly directly connected to a face mask, mainly involving an elbow, a connector, a ventilation port and a noise reduction device arranged on the elbow or the connector, and a quick-release connector, which is used to cooperate with a hose, a face mask, and a frame to send pressurized air from a ventilator into a patient's airway for treatment purposes. Background Art

[0002] Obstructive sleep apnea is a disease associated with a patient's respiratory system and sleep quality, and has a rather serious harm to different human organs and human states. Nowadays, there are various solutions and technologies in different fields for diagnosing, monitoring, and treating the conditions of sleep apnea patients. CPAP (Continuous Positive Airway Pressure) treatment is a commonly used treatment method at present. This treatment provides continuous positive pressure gas from a ventilator to the patient's airway, and keeps the upper airway of the patient unobstructed by increasing air pressure and reducing air resistance, thereby reducing the occurrence of apnea events. The treatment of obstructive apnea involves the coordinated use of various treatment components, and the cooperation between components is crucial for the patient, which involves the treatment effect and comfort of the patient as well as the patient's compliance with the treatment. Therefore, in addition to better control of the treatment principle process, improving the cooperation between components and the comfort of components during the treatment process is also a way to ensure the best treatment effect.

[0003] The ventilation elbow is one of the most important components in CPAP treatment. It is usually located at the outlet where the air flow passes through the breathing hose, and is used to guide the continuous positive pressure air flow to patient interfaces such as a face mask, a nasal mask, or a nasal cushion. In addition to guiding the continuous positive pressure air flow, some elbows are also responsible for discharging the exhaled waste gas of the patient to the outside to prevent the re-breathing of carbon dioxide. Compared with the combination of sleep apnea treatment accessories without an elbow, the positive pressure air flow output from the ventilator may be too intense. The presence of the elbow can reduce the effect of the air flow directly on the face mask or the patient's airway. The elbow can make the air flow more uniform, thereby reducing the discomfort of the patient. The elbow can also reduce noise and improve the direction of the air flow. However, at the same time, the elbow will increase the air flow resistance and reduce the air flow efficiency to a certain extent. Although this impact is usually small for the patient, it may affect the pressure setting of the ventilator in some cases. Moreover, the method of connecting the elbow to the frame and then connecting the frame to the face mask on the market will also cause loosening during use due to more connection points. Once this situation occurs, the patient needs to check and adjust the elbow and the entire breathing accessory combination, which is an extremely inconvenient way for the patient.

[0004] Most elbows on the market are similar in form, the most important and indispensable of which is the connection between the first end and the second end. Later, the elbows also added additional functions such as reducing noise through noise reduction materials or directly by noise reduction nets and being able to connect external parts. The first end of the elbow is generally a connecting frame, and the second end is generally a connecting breathing hose. The matching connection between the two ends of the elbow and the frame or the breathing hose must ensure that the continuous positive pressure airflow will not leak gas at the connection. The accuracy and stability of the sealing at the connection is still a difficult problem to be solved. In addition, because there are a large number of sleep apnea patients in the elderly group, the difficulty of connecting the two ends of the elbow with the matching parts is also an aspect that needs to be optimized. Simple connection is more conducive to patients wearing and adjusting the treatment accessory combination, making it easier to operate.

[0005] In the CPAP treatment process, in addition to the elbow, the frame is also a very important key point. Its main function is to support and fix the mask so that the mask can fit the patient's face tightly and ensure normal airflow transmission and treatment effect. In the sleep apnea medical component market, there are already many manufacturers who provide patients with different types of frames to meet different needs, and different frames may have different fits for the mask. The market requires the frame to be as light as possible and stable as possible, while also adapting to the needs of different patients as much as possible to provide better comfort and effect.

[0006] In summary, there are still many areas for improvement in the design of elbows on the current market. The air tightness of the elbow and the coordination between the elbow and the frame and the mask need to be optimized. With the emergence of more and more styles of masks on the market, there are more diverse choices for the frame used to stabilize the mask. However, the existing frame not only involves the connection and coordination with the mask but also involves the connection and coordination with the elbow. Therefore, when patients choose to buy, the first end and the second end of the mask connector must match the connection end of the patient's existing elbow and mask. It seems that the increase in mask styles has increased the patient's choice range, but in fact it has increased the difficulty of patients' choice. Therefore, we designed an elbow that is directly connected to the mask, which simplifies the coordination between the frame, the elbow and the mask, and also improves the stability of the seal at the elbow connection during treatment. Compared with the situation where the elbow is connected to the frame and then the frame is connected to the mask, the connection steps are simplified and it is less likely to loosen and leak. While ensuring the sealing is qualified, the functionality (such as noise reduction function and quick release function) is increased. This design significantly improves some disadvantages of the coordination of the elbow components and has a positive impact on patients. Summary of the invention

[0007] The object of the invention is to provide a new elbow component with better sealing performance and stability, which is simple to manufacture, has low R & D and manufacturing costs, overcomes the limitations of existing technologies in similar products, and thus provides a more effective and widely applicable matching usage scenario than existing technologies, bringing users a better wearing experience in a more feasible processing manner.

[0008] An elbow component directly connected to a face mask, used to provide continuous positive pressure gas to a patient's airway to improve sleep apnea. The elbow component includes:

[0009] An elbow, having a first interface directly connected to the face mask, a second interface for receiving pressurized gas, and an annular channel with an axial bend between the first interface and the second interface;

[0010] At least one height difference is provided at the first interface end of the elbow, which is configured and arranged to closely contact the inner wall of the extended interface at the center opening of the face mask when connected to the face mask, prevent the elbow from easily detaching when a force in the direction opposite to the patient's face is applied to the elbow, and enable mutual rotation between the elbow and the face mask;

[0011] A baffle is provided near the first interface of the elbow. The baffle is configured such that when the elbow is connected to the face mask, there is a gap at least large enough to accommodate the wall thickness of the frame between the inner surface facing the patient's face and the outer surface of the center opening of the face mask, for restricting the forward and backward movement of the frame relative to the face mask and the elbow;

[0012] The elbow component further includes: an anti-asphyxia valve, including an anti-asphyxia valve opening and a silicone sheet provided at its lower end. The anti-asphyxia valve opening is formed on the wall of the annular channel of the elbow, allowing the patient to breathe through the anti-asphyxia valve opening when there is no continuous positive air pressure entering the elbow to prevent patient asphyxia;

[0013] Wherein, the distance between the inner surface of the baffle at the first interface end of the elbow facing the patient's face and the first interface of the elbow is at least 2 mm.

[0014] In one embodiment, the edge of the first interface end is a non-planar circular ring with at least one notch to facilitate buckling connection of the port with the face mask.

[0015] In one embodiment, the baffle is a radially protruding part of the outer wall of the elbow or formed by the height difference on the elbow.

[0016] In one embodiment, the anti-asphyxia valve opening and the silicone sheet are symmetric about the axis at the second interface end of the elbow.

[0017] In one embodiment, the anti-asphyxia valve opening is configured to have one or more openings.

[0018] The present invention also discloses an elbow component directly connected to a face mask, which is used to provide continuous positive pressure gas to a patient's airway to improve sleep apnea. The elbow component includes:

[0019] An elbow having a first interface directly connected to the face mask, a second interface for receiving pressurized gas, and an annular channel with at least one section of shaft bending between the first interface and the second interface;

[0020] At the first interface end of the elbow, there is a spherical partial protrusion, and the outer wall near the first interface end is constructed and arranged to have two outward protrusions or inward grooves. When the elbow is connected to the face mask, the protrusions or grooves cooperate with the receiver on the inner wall of the central opening of the face mask to form a hinge connection, enabling the elbow to rotate relative to the face mask along the axis of the formed hinge. The spherical protrusion structure at the first interface end prevents air leakage when the elbow rotates;

[0021] The elbow component further includes an anti-asphyxia valve, which includes an anti-asphyxia valve opening and a silica gel sheet provided at its lower end. The anti-asphyxia valve opening is constructed on the wall of the annular channel of the elbow, allowing the patient to breathe through the anti-asphyxia valve opening when there is no continuous positive air pressure entering the elbow to prevent the patient from asphyxiating.

[0022] In one embodiment, a baffle is provided near the first interface of the elbow. The baffle is constructed such that when the elbow is connected to the face mask, there is a gap with a certain distance between the inner surface facing the patient's face and the outer surface of the central opening of the face mask, which is used to accommodate a frame and limit the front-back movement of the frame relative to the face mask and the elbow. The minimum gap is 0.5 mm, which is the thickness of the connection part of the accommodated frame.

[0023] In one embodiment, the distance from the first interface of the elbow to the inner surface of the baffle facing the patient's face is greater than the distance from the outer surface of the central opening of the face mask to the outermost end of the extension interface.

[0024] In one embodiment, the anti-asphyxia valve opening and the silica gel sheet are symmetric about the axis of the second interface end of the elbow.

[0025] The present invention also discloses an elbow component directly connected to a face mask, which is used to provide continuous positive pressure gas to a patient's airway to improve sleep apnea. The elbow component includes:

[0026] An elbow having a first interface directly connected to a connecting member, a second interface for receiving pressurized gas, and an annular channel with a shaft bend between the first interface and the second interface;

[0027] A connecting piece, having a first end connected to the elbow and a second end directly connected to the face mask. The second end is provided with at least one height difference and is configured and arranged to closely contact the extended interface at the center opening of the face mask when connected to the face mask, preventing a force in the direction opposite to the patient's face from being applied to the connecting piece and making the connecting piece easily detached;

[0028] The elbow assembly further includes: an anti-asphyxiation valve, including an anti-asphyxiation valve opening and a silica gel sheet provided at its lower end. The anti-asphyxiation valve opening is formed on the wall of the annular channel of the elbow, allowing the patient to breathe through the anti-asphyxiation valve opening when there is no continuous positive airway pressure entering the elbow to prevent the patient from asphyxiating;

[0029] Wherein, the connecting piece has a baffle, and the distance between the inner surface of the baffle facing the patient's face and the first interface of the elbow is at least 2 mm.

[0030] In one embodiment, the first end of the connecting piece connected to the elbow can be connected to the face mask in the form of a snap, ball and socket or hinge plus ball and socket.

[0031] In one embodiment, the connecting piece is composed of a second material that is not integrally formed with the elbow and the elbow together, and the vent allows the patient to discharge waste into the external environment.

[0032] In one embodiment, when the elastic modulus of the material is the same, the ratio of the uniform wall thickness of the part with a height difference near the first interface of the elbow to the area of the part where the first interface of the elbow contacts the extended interface of the face mask and the annular area formed by the two contacting parts is not equal to the value of the uniform wall thickness of the extended interface part of the face mask.

[0033] In one embodiment, the area of the silica gel sheet is larger than the total opening area of the anti-asphyxiation valve to prevent the silica gel sheet from being blown out.

[0034] The present invention also discloses an elbow assembly directly connected to a face mask for providing continuous positive pressure gas to a patient's airway to improve sleep apnea. The elbow assembly includes:

[0035] An elbow, having a first interface directly connected to the connecting piece, a second interface for receiving pressurized gas, and an annular channel with an axis bent between the first interface and the second interface;

[0036] A connecting piece, having a first end connected to the elbow and a second end directly connected to the face mask. The second end is provided with at least one height difference and is configured and arranged to closely contact the extended interface at the center opening of the face mask when connected to the face mask, preventing a force in the direction opposite to the patient's face from being applied to the connecting piece and making the connecting piece easily detached;

[0037] A vent with at least one ventilation hole that allows the exhaled waste gas of the patient to flow out to the outside;

[0038] The connecting piece is provided with a baffle, and the baffle is configured to leave a gap for at least accommodating the frame between the inner surface facing the patient's face and the outer surface of the central opening of the mask when the connecting piece is connected to the mask, so as to limit the front-back movement of the frame relative to the mask and the elbow;

[0039] The elbow assembly further includes: an anti-asphyxia valve, including an anti-asphyxia valve opening and a silica gel sheet provided at its lower end, and the anti-asphyxia valve opening is configured on the wall of the annular channel of the elbow, allowing the patient to breathe through the anti-asphyxia valve opening when there is no continuous positive air pressure entering the elbow to prevent the patient from suffocating.

[0040] In one embodiment, when the elbow is connected to the mask, the thickness between the outer surface of the central opening of the mask and the inner surface of the baffle facing the patient's face is greater than or equal to the wall thickness of the connection part of the accommodated frame.

[0041] In one embodiment, the baffle can be on the connecting piece.

[0042] In one embodiment, the vent includes noise reduction materials, and the noise reduction materials include noise reduction cotton and noise reduction net;

[0043] The noise reduction materials have one or more of the following characteristics:

[0044] The thickness is at most 9 mm;

[0045] The weight is at most 7 g.

[0046] In one embodiment, the noise reduction materials cover the vent, and the elbow assembly is at least provided with a port cover for engaging and setting on the outer wall of the annular channel in contact with the air to fix the noise reduction materials.

[0047] The present invention also discloses an elbow assembly directly connected to a mask for providing continuous positive pressure gas to a patient's airway to improve sleep disordered breathing. The elbow assembly includes:

[0048] An elbow, having a first interface directly connected to the mask, a second interface for receiving pressurized gas, and a curved annular channel between the first interface and the second interface;

[0049] The first interface end of the elbow is configured and arranged to closely contact the extended interface at the central opening of the mask when connected to the mask;

[0050] A baffle is provided near the first interface of the elbow. The baffle is configured such that when the elbow is connected to the face mask, there is a gap for at least accommodating the frame between the inner surface facing the patient's face and the outer surface of the central opening of the face mask, for restricting the front-back movement of the frame relative to the face mask and the elbow.

[0051] A quick-release connector, having a first end and a second end. The first end is configured to be detachably connected to the second interface end of the elbow, and the second end is configured to be connected to the breathing tube.

[0052] The elbow assembly further includes: an anti-asphyxia valve, including an anti-asphyxia valve opening and a silica gel sheet provided at its lower end. The anti-asphyxia valve opening is formed on the wall of the annular channel of the elbow, allowing the patient to breathe through the anti-asphyxia valve opening when there is no continuous positive air pressure entering the elbow to prevent the patient from asphyxiating.

[0053] In one embodiment, the second interface of the elbow can be connected to the quick-release connector. The quick-release connector is configured and arranged with connection parts for clamping and fastening integrally formed on both sides of its main body. After the quick-release connector is connected to the elbow, it can rotate relative to the elbow.

[0054] In one embodiment, when the elbow is connected to the face mask, the thickness between the outer surface of the central opening of the face mask and the inner surface of the baffle facing the patient's face is greater than or equal to the wall thickness of the connection part of the accommodated frame.

[0055] In one embodiment, the edge of the first interface end is a non-planar circular ring, which has at least one notch to facilitate the snap connection of the port to the face mask.

[0056] In one embodiment, the baffle is a radially protruding part of the outer wall of the elbow, which can be the height difference wall of the elbow itself relative to the first interface.

[0057] The baffle has at least one of the following characteristics:

[0058] Perpendicular to the interface axis connected to the face mask;

[0059] The distance from the face mask central opening outer surface during connection is at least equal to the frame connection part thickness;

[0060] The height is at least 2 mm;

[0061] The thickness is between 0.5 - 8 mm.

[0062] Implementing the elbow assembly directly connected to the face mask of the present invention has at least the following beneficial effects:

[0063] 1) The way that the elbow passes through the frame and is directly connected to the face mask reduces the seams at the joints between components. The continuous positive pressure airflow output by the ventilator passes through the breathing hose, through the elbow, and then enters the patient's airway through the patient interface. During this process, the airflow may leak out from the seams. The reduction of seams is to reduce the risk of airflow leakage, thereby improving the sealing performance of the entire respiratory therapy component system. In the previous installation method, two alignments were required. First, the frame was aligned and fixed to the face mask to be installed, and then the elbow was aligned and fixed to the frame after installation. The present invention simplifies the installation steps from three steps directly to two steps. It only needs to put the frame on the elbow before installation and then combine the elbow with the face mask. This optimization of the installation process not only reduces the installation error rate and saves time but also improves the user experience, making it easier for people with inflexible hands and feet to operate.

[0064] 2) During the installation and disassembly process of the present invention, the frame is only involved in passing through the first interface of the elbow. The fixing form of the frame to the face mask and the elbow is fixed by the shape of the face mask and the elbow baffle. Therefore, the most important and essential structure of the frame at the joint is the frame opening passing through the first interface end of the elbow. The present invention simplifies the connection of the frame directly to a frame opening with a smooth wall, modularizes the frame. For different patient needs, different frames only need to have the same-sized frame opening that can pass through the first interface end of the elbow to be connected and fixed to the elbow and the face mask. It is no longer a frame with different forms of connection ports corresponding to different face masks and elbow interfaces, nor do the face mask and elbow need to have different forms of connection ports corresponding to the frame design. The reduction of the processing steps of the connecting parts means that the processing complexity and R & D costs of the elbow, face mask, and frame are greatly reduced, simplifies the market's selectivity for the frame. On this basis, the reduction in structure and processing steps reduces the loss of raw materials, which is a very important step for carbon neutrality, better responds to reducing the burden on the environment and climate change, and promotes the goals of sustainable development and carbon neutrality.

[0065] 3) Compare the connection form where the frame is connected to the face mask and then to the elbow. The design of directly connecting the elbow to the face mask can, on the original basis, increase the radial support of the elbow for the frame and the restriction and fixation of the frame by the elbow through the baffle. Moreover, the connection position changes from two original places to one, making the connection between components more stable and less likely to loosen. And the overall structure composed of the entire breathing accessory becomes simpler, reducing the failure rate of the overall components. In the existing connection method, since the face mask is directly connected to the patient's face by a headband or other means, and the frame is connected to the face mask by a snap connection, the connection of the face mask to the frame is more stable and less likely to become loose. However, connecting the elbow to the frame will cause the frame to have an outward pulling force away from the patient's face, increasing the risk of the frame falling off under the action of the pulling force. But the design of directly connecting the elbow to the face mask avoids this kind of situation. As long as the face mask is tightly connected to the patient's head by a headband or other means, the connection of the elbow to the frame and the face mask will not cause the face mask to fall off relative to the patient's face.

[0066] 4) Compare the elbow that connects the frame through the clip structures on both sides of the existing elbow. The design of directly connecting the elbow to the face mask simplifies the overall structure of the elbow. The outer wall of the elbow is basically smooth and tidy except for the baffle, which simplifies the complexity of the mold in production and manufacturing, and relatively reduces the production cost of the elbow. And it does not contain other complex external connection structures with special designs. The reduction in the number of connection structures simplifies the manufacturing process and the assembly process. Since the reduction in component structures reduces the demand for corresponding materials, and at the same time, no second material other than the main material of the elbow is required, both the processing cost and the material cost are reduced. For the frame, the method of directly connecting the elbow with a baffle to the face mask makes it unnecessary to have extra fixing parts at the connection of the frame for fixing the frame. The connecting part of the frame only needs to be manufactured as a simple smooth-wall opening suitable for the elbow, which is a more simplified way for the mold of the frame production, greatly reducing the mold cost of the frame.

[0067] 5) For the components of obstructive sleep apnea treatment, cleaning is a very important link. Due to the frequent use, patients need to clean and maintain the components regularly. The connection parts between components are the most likely to accumulate dirt. If not cleaned for a long time or not cleaned thoroughly, dirt, grease, and secretions will block the channels, breeding microorganisms such as bacteria and viruses, causing problems such as allergies and skin infections. The simplification of the structure at the connection part between the elbow and the frame reduces the area where dirt accumulates, making it easier for patients to clean thoroughly, reducing the health risks of patients, ensuring the safety of patients, and improving the compliance of treatment. At the same time, the reduction in components will also correspondingly reduce the carbon emissions during the production and manufacturing process. BRIEF DESCRIPTION OF THE DRAWINGS

[0068] Figure 1 It is a schematic structural diagram of a snap-type elbow assembly in an embodiment of the present invention;

[0069] Figure 2 Front view of the snap - type elbow assembly in an embodiment of the present invention;

[0070] Figure 3 Schematic structural diagram of the ball - socket plus hinge type elbow assembly in an embodiment of the present invention;

[0071] Figure 4 Schematic structural diagram of the ball - socket plus hinge and then connected by a connecting member type elbow assembly in an embodiment of the present invention;

[0072] Figure 5 For Figure 2 Cross - sectional view in the A - A direction in;

[0073] Figure 6 Schematic diagram of the ventilation opening of the elbow assembly in an embodiment of the present invention;

[0074] Figure 7 Display diagram of the ratio of the inner and outer diameters of the exhaust hole of the elbow assembly in an embodiment of the present invention;

[0075] Figure 8 Co - usage diagram of the elbow assembly in an embodiment of the present invention;

[0076] Figure 9 Exploded structural schematic diagram of the elbow assembly in an embodiment of the present invention;

[0077] Figure 10 Schematic diagram of the air flow of the elbow assembly directly connected to the mask in an embodiment of the present invention;

[0078] Figure 11 Schematic diagram of the air flow when the elbow is connected to the frame and then to the mask;

[0079] Figure 12 Partially enlarged structural schematic diagram of the connection between the elbow and the mask of the elbow assembly in an embodiment of the present invention;

[0080] Figure 13 Force diagram of the frame in an embodiment of the present invention;

[0081] Figure 14 Diagram of different forms of the baffle of the elbow assembly in an embodiment of the present invention;

[0082] Figure 15 Diagram of different forms of the height difference of the elbow assembly in an embodiment of the present invention;

[0083] Figure 16 Diagram of different forms of the connection between the elbow assembly and the mask in an embodiment of the present invention;

[0084] Figure 17 Structural diagram of an elbow component with exhaust and noise reduction functions in an embodiment of the present invention;

[0085] Figure 18 Structural diagram of an elbow component directly reduced in noise by a noise reduction net in an embodiment of the present invention;

[0086] Figure 19 Schematic connection diagram with soft glue arranged at the connection between the elbow and the face mask in an embodiment of the present invention;

[0087] Figure 20 Schematic diagram of the connection between the elbow component and the nasal mask in an embodiment of the present invention;

[0088] Figure 21 Schematic diagram of an elbow component with a ventilation opening on the elbow / connector in an embodiment of the present invention. Detailed implementation manners

[0089] For the convenience of understanding the invention, the invention will be described more comprehensively below with reference to the relevant drawings. Typical embodiments of the invention are given in the drawings. However, the invention can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, these embodiments are provided to make the disclosure of the invention more thorough and comprehensive.

[0090] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the technical field to which the invention belongs. The terms used in the description of the invention herein are only for the purpose of describing specific embodiments and are not intended to limit the invention.

[0091] In view of the fact that in the market, traditional elbows need to first connect the face mask with a frame and then connect the elbow to the frame during use, resulting in multiple connection points in this connection method, and the connection points are prone to looseness and unstable sealing, and the wearing steps are cumbersome. The present invention provides an elbow component that directly passes through the frame and connects to the face mask. Now, the number of connection points is changed from two to one, reducing the failure rate of the treatment accessory combination and the possibility of unstable sealing between components. And the direct connection of the elbow to the face mask means that no auxiliary connection components such as clips are needed, making the elbow more convenient to use and saving costs in processing and other aspects. This connection method enables the frame to only have a smooth central hole for passing through the elbow, making the frame modular and increasing the adaptability of the frame, the face mask, and the elbow.

[0092] The following describes several structures of an elbow component directly connecting to a face mask according to the present invention with specific examples.

[0093] Embodiment 1

[0094] This embodiment provides an elbow assembly 1 directly connected to a face mask 72, which is used to provide continuous positive pressure gas to the patient's airway to improve sleep apnea. The elbow assembly 1 includes an elbow 73, an anti-asphyxia valve, and a quick-release connector 41. Refer to Figure 1-2 , Figure 5 , Figures 8-16 , Figure 20 . This embodiment provides a structural schematic diagram, a front view, a sectional view, a usage diagram, an exploded view, and an air flow direction diagram of the elbow assembly 1. The elbow assembly 1 shown in this embodiment has a first interface 12 and a second interface 13, and there is at least one axially bent annular channel 14 between the first interface 12 and the second interface 13. Axial bending means that the axis forms a bend due to a continuous force along the radial direction, where the radial direction refers to the direction along the diameter or radius, or the direction perpendicular to the axis. The annular channel 14 is used to guide and change the air flow direction and reduce the direct impact of the air flow on the patient. The angle formed by the axes of the first interface 12 and the second interface 13 of the elbow 73 constitutes the angle of the elbow 73. This angle ensures that the continuous positive pressure air flow entering the elbow 73 passes through the elbow 73 smoothly, and also determines the impact of the breathing hose 51 on the patient. If this angle is less than 90°, the air flow will hit the wall when passing through the elbow 73, resulting in non-smoothness, and the force for removing and installing the breathing hose will be directed towards the patient himself, which is not conducive to installation. Therefore, this angle should be greater than or equal to 90°. The second interface 13 of the elbow 73 is configured to receive the pressurized gas output by the ventilator. The second interface 13 of the elbow 73 can be connected to the quick-release connector 41. The quick-release connector 41 is constructed and arranged with connecting parts for clamping and fastening integrally formed or non-integrally formed with its main body on both sides. After the quick-release connector 41 is connected to the second interface 13 of the elbow 73, it can rotate relative to the elbow 73, expanding the flexibility of the treatment accessory combination and increasing the patient's range of motion.

[0095] The first interface 12 of the elbow 73 is directly connected to the face mask 72 through the central opening 21 on the face mask 72. There can be different connection methods between the elbow 73 and the face mask 72. In one of the connection methods, at least one height difference 122 is provided at the end of the first interface 12 of the elbow 73, which is constructed and arranged to closely contact the inner wall of the extended interface 22 at the central opening 21 of the face mask 72 when connected to the face mask 72, preventing the elbow 73 from easily detaching when a force in the direction opposite to the patient's face is applied to the elbow 73, and realizing the mutual rotation between the elbow 73 and the face mask 72. The height difference 122 causes a certain gap between the part at the first interface 12 and the extended interface 22 of the face mask 72 when the elbow 73 is buckled with the face mask 72, enabling the elbow 73 to achieve the rotation function and seal between the elbow 73 and the face mask 72. The height difference 122 at the end of the first interface 12 of the elbow 73 can have various forms (such as Figure 15As shown in the figure, it includes, but is not limited to, a form in which a protrusion is provided at the first interface 12 of the elbow 73 to engage with the extension interface 22 of the face mask 72, plus the cooperation of the protruding or recessed part on the outer wall of the end of the first interface 12 of the elbow 73 and the protruding or recessed part of the extension interface 22 of the face mask 72. It can also be a form of cooperation between the protruding or recessed part on the outer wall of the end of the first interface 12 of the elbow 73 and the protruding or recessed part of the extension interface 22 of the face mask 72. A height difference 122 of 1-3 mm is formed on the outer wall at the first interface 12 of the elbow 73. If it is too high, it is not conducive to the elbow 73 entering the extension interface 22 of the face mask 72. If it is too low, it cannot form an engagement with the extension interface 22 of the face mask 72, and the elbow 73 can be easily pulled out. Since the connection between the first interface 12 of the elbow 73 and the face mask 72 is due to the patient pushing the elbow 73 along the axis of the central opening 21 of the face mask 72, the thrust is transformed into the radial squeezing force of the extension interface 22 of the face mask 72 on the outer wall of the elbow 73 near the first interface 12 and the radial thrust of the elbow 73 on the extension interface 22 of the face mask 72, causing the end of the first interface 12 of the elbow 73 or the extension interface 22 of the face mask 72 to deform, so that the elbow 73 is engaged and rotated with the face mask 72 through the height difference 122 part at the end of the first interface 12. Once the insertion is completed, the end of the first interface 12 of the elbow 73 will return to its original state to maintain the stability of the connection. To make the end of the first interface 12 of the elbow 73 and the extension part of the face mask 72 receive the same radial force and cause greater deformation in one of the elbow 73 and the face mask 72. When the elastic modulus of the materials is the same, the ratio of the uniform wall thickness of the part with the height difference 122 near the first interface 12 of the elbow 73 to the area of the contact part between the first interface 12 of the elbow 73 and the extension interface 22 of the face mask 72 and the annular area 221 formed by the contact part of the two is not equal to the numerical value of the uniform wall thickness of the extension interface 22 of the face mask 72 (where when the first interface 12 of the elbow 73 is a complete ring without a notch, the ratio of the area of the contact part between the first interface 12 of the elbow 73 and the extension interface 22 of the face mask 72 to the annular area 221 formed by the contact part of the two is 1. When the first interface 12 of the elbow 73 is an incomplete ring with a notch, the ratio is not equal to 1; when there is a notch at the first interface 12 of the elbow 73, the annular area 221 formed by the contact part between the first interface 12 of the elbow 73 and the extension interface 22 of the face mask 72 is equivalent to the annular area of the contact part between the first interface 12 of the elbow 73 and the extension interface 22 of the face mask 72 after filling the notch) (as Figure 12 shown), and when the deformation of the elbow 73 is greater than the deformation of the extension interface 22 of the face mask 72 during connection, to ensure the firmness of the elbow 73, the uniform wall thickness of the part forming the height difference 122 at the end of the first interface 12 of the elbow 73 is less than the uniform wall thickness at the annular channel 14 of the elbow 73. In addition to changing the wall thickness, the edge of the end of the first interface 12 of the elbow 73 can also be a non-planar ring, which has at least one notch to facilitate the form of buckling the port with the face mask 72 (as Figure 16As shown). In addition, the first interface 12 of the elbow 73 is directly connected to the extension interface 22 of the face mask 72, so that the air flow channel at the connection between the elbow 73 and the face mask 72 does not involve the frame 74 and is only composed of the elbow 73 and the face mask 72. Compared with the connection form in which the frame 74 is connected to the face mask 72 and then the elbow 73 is connected to the frame 74, it is ensured that the air flow will not flow out from the gap at the connection between the elbow 73 and the frame 74, improving the sealing performance of this connection (as Figure 10 , Figure 11 shown).

[0096] A baffle 121 is provided at the end of the elbow assembly 1 close to the first interface 12. The baffle 121 is configured to leave a gap at least accommodating the wall thickness of the frame 74 between its inner surface facing the patient's face and the outer surface of the central opening 21 of the face mask 72 when the elbow 73 is connected to the face mask 72 (such as the gap a shown in Figure 12 ), for restricting the front-back movement of the frame 74 relative to the face mask 72 and the elbow 73. The baffle 121 can be an annular sheet or any arc-shaped sheet on the ring or any other form (such as shown in Figure 14 ). When the face mask 72, the frame 74, and the elbow 73 are connected, the inner surface of the baffle 121 facing the patient's face contacts the outer surface of the frame 74 where the opening 61 does not face the patient's face. The distance between the inner surface of the baffle 121 facing the patient's face and the outer surface of the central opening 21 of the face mask 72 is at least just enough to accommodate the frame 74, and this distance is at least equal to the thickness of 0.5 mm at the connection of the frame 74. Since the face mask 72, the frame 74, and the elbow 73 are connected by an axis and the outer surface of the frame 74 opening 61 is parallel to the outer surface of the central opening 21 of the face mask 72, the baffle 121 needs to be parallel to the outer surface of the frame 74 opening 61 to restrict the frame 74. Therefore, the baffle 121 is configured to be perpendicular to the axis of the interface connected to the face mask 72. The function of the baffle 121 to restrict the frame 74 is based on its certain radial height relative to the outer wall 145 of the annular channel of the elbow 73. So its height is at least 2 mm to restrict the frame 74 in the air duct. Because the baffle 121 has a radial height, it has a certain thickness and is not easily damaged. The thickness of the baffle 121 is between 0.5 - 8 mm. The baffle 121 can also be a wall formed by the height difference 122 of the elbow 73 itself relative to the first interface 12.

[0097] The elbow assembly 1 further includes: an anti-asphyxiation valve, including an anti-asphyxiation valve opening 141 and a silica gel sheet 142 disposed at its lower end. The anti-asphyxiation valve opening 141 is configured on the annular channel wall of the elbow 73, allowing the exhaled air flow of the patient to flow out through the anti-asphyxiation valve opening 141 when there is no continuous positive air pressure entering the elbow 73 to prevent the patient from asphyxiating. The anti-asphyxiation valve opening 141 has one or more openings. The function of the silica gel sheet 142 is to block the anti-asphyxiation valve opening 141 when the ventilator is in operation and open the anti-asphyxiation valve opening 141 when the ventilator is not in operation. The area of the silica gel sheet 142 is larger than the total opening area of the anti-asphyxiation valve to prevent the silica gel sheet 142 from being blown out. The silica gel sheet 142 can be disassembled and installed from the elbow 73 part through deformation, and at least a part of it is in contact with the external environment. To make the air flow through the anti-asphyxiation valve relatively smooth, the anti-asphyxiation valve and the silica gel sheet 142 arranged below it are symmetric about the axis of the second interface 13 end of the elbow 73.

[0098] In some other embodiments, the elbow assembly 1 can also be connected to a nasal mask (as Figure 20 shown).

[0099] Embodiment 2

[0100] This embodiment provides an elbow assembly 1 directly connected to a face mask 72 for providing continuous positive pressure gas to a patient's airway to improve sleep apnea. The elbow assembly 1 includes an elbow 73 and an anti-asphyxiation valve. The anti-asphyxiation valve includes an anti-asphyxiation valve opening 141 and a silica gel sheet 142 disposed at its lower end. Referring to Figure 3 , a structural schematic diagram of the elbow assembly 1 of this embodiment is provided. In Figure 3 the shown embodiment of the present invention, the difference from the elbow assembly 1 in the first embodiment is that: a spherical part protrusion is provided at the first interface 12 end of the elbow 73, and the outer wall near the first interface 12 end is configured and arranged to have two outward protrusions or inward grooves. When the elbow 73 is connected to the face mask 72, the protrusion or groove cooperates with the receiver 31 on the inner wall of the central opening 21 of the face mask 72 to form a hinge connection, enabling the elbow 73 to rotate relative to the face mask 72 along the axis of the formed hinge. The spherical protrusion 15 structure at the first interface 12 end is to prevent air leakage when the elbow 73 rotates and to achieve rotation of the elbow 73 within a certain angle up and down.

[0101] In another form, the elbow assembly 1 includes an elbow 73, an anti-asphyxia valve, and a quick-release connector 41. The anti-asphyxia valve includes an anti-asphyxia valve opening 141 and a silica gel sheet 142 disposed at its lower end. In the connection mode of the second embodiment, the elbow 73 realizes a rotational connection with the face mask 72 at a certain angle rather than 360°. The connection of the quick-release connector 41 to the second joint of the elbow 73 realizes a 360° rotation of the hose relative to the elbow 73, further increasing the range of motion for the patient on this basis.

[0102] Embodiment 3

[0103] This embodiment provides an elbow assembly 1 directly connected to the face mask 72 for providing continuous positive pressure gas to the patient's airway to improve sleep apnea. The elbow assembly 1 includes an elbow 73, an anti-asphyxia valve, and a connector 71. The anti-asphyxia valve includes an anti-asphyxia valve opening 141 and a silica gel sheet 142 disposed at its lower end. Refer to Figure 4 . This embodiment provides a schematic structural diagram of the elbow assembly 1. In Figure 4 the illustrated embodiment of the present invention, the difference from the elbow assembly 1 in the first embodiment is that: the elbow assembly 1 is provided with a connector 71 connected to the face mask 72. The connector 71 is configured to have a first end connected to the elbow 73 and a second end directly connected to the face mask 72. The second end is provided with at least one height difference 122, which is constructed and arranged to closely contact the extension interface 22 at the center opening 21 of the face mask 72 when connected to the face mask 72, preventing a force in the direction opposite to the patient's face from being applied to the connector 71 and making the connector 71 prone to detachment. The first end of the connector 71 connected to the elbow 73 can be connected to the face mask 72 in the form of a snap, ball and socket, or hinge plus ball and socket. The first end of the connector 71 can be set to be detachably or non-detachably connected to the elbow 73. The connector 71 can be made of the same material as the elbow 73 or a second material different from the elbow 73. A part of the protrusion at the first interface 12 end of the elbow 73 is spherical. A rotatable hinge structure is provided on the spherical protrusion 15. The spherical protrusion of the elbow 73 is connected to the connector 71. The structure of the first interface 12 end of the elbow 73 enables the elbow 73 to rotate relative to the face mask 72 along the axis of the hinge. The spherical protrusion 15 and the snap structure are used to seal the gas and fix the elbow 73. The connector 71 disposed at the first port of the elbow 73 enables the elbow 73 to rotate arbitrarily along the axis of the connection port relative to the face mask 72. In the connection mode of this structure, the elbow assembly 1 not only realizes the same function of rotating arbitrarily along the axis of the connection port as the elbow assembly 1 in the first embodiment through the connector 71 but also adds the function of rotating at a certain angle along the axis of the hinge, making the connection of the elbow assembly 1 more flexible compared to the first and second embodiments, with a smaller range of influence of patient movement on the overall components during wearing and improving the comfort of the patient.

[0104] Example 4

[0105] This embodiment provides an elbow assembly 1 directly connected to a face mask 72 for providing continuous positive pressure gas to a patient's airway to improve sleep apnea. The elbow assembly 1 includes an elbow 73, a connecting member 71, an anti-asphyxia valve, and a vent 143. The anti-asphyxia valve includes an anti-asphyxia valve opening 141 and a silica gel sheet 142 disposed at its lower end. Refer to Figures 6-7 , Figures 17-18 , Figure 21 . This embodiment provides a schematic structural diagram of the elbow assembly 1. In Figures 6-7 , Figures 17-18 , Figure 21 shown in the embodiments of the present invention, the difference from the elbow assembly 1 in Embodiment 1 is that the elbow assembly 1 is provided with a vent 143 having at least one ventilation hole to allow the patient's exhaled waste gas to flow out to the outside. The vent 143 can be disposed on the connecting member 71 (as shown in Figure 21 ), or can be disposed on the elbow 73 (as shown in Figure 17 ). The vent 143 can have a noise reduction function. The vent 143 is composed of a ventilation hole 1431 with a noise reduction material 144 or directly composed of a noise reduction net 1432 (as shown in Figure 18 ) for dispersing the patient's exhaled waste gas to the outside. The ventilation hole 1431 can be configured and arranged such that the outer aperture in contact with the air and the inner aperture opposite thereto form a certain taper (as shown in Figure 7 ), or can be arranged with equal outer and inner apertures. The shape of the vent 143 and the ventilation hole 1431 can be o-shaped, square, or other shapes. Since the noise reduction material 144 needs to cover the ventilation hole 1431, at least one port cover 16 (as shown in Figure 17 ) can be provided on the elbow 73 for engaging and setting to the outer wall of the annular channel in contact with the air to fix the noise reduction material 144. The port cover 16 can be composed of a second material that is not integrally formed with the elbow 73 or the same material as the elbow 73, or can be integrally formed by the connecting member 71.

[0106] The noise reduction material 144 includes, but is not limited to, noise reduction cotton and noise reduction net 1432. Fibrous sound-absorbing materials and foam sound-absorbing materials can be used, and they can be made of fabrics, nylon or other materials. The fixing method of the elbow 73 and the noise reduction material 144 can be injection molding, ultrasonic pressing, hot pressing, etc.; it can also be pasted through adhesives such as glue and tape; it can also be buckles, knobs, clips, etc. It can also be assisted by a third component for connection, such as the port cover 16. The port cover 16 is configured to press the noise reduction material 144 on the outer surface of the connector 71 that is in direct contact with the air. The noise reduction material 144 is sized and placed at the ventilation opening 143 of the elbow 73 and the middle part of the port cover of the elbow 73. The width of the noise reduction material 144 is smaller than the width of the port cover. It can be a combination of one part or multiple parts, and is attached to the outer surface of the ventilation opening 143 of the elbow 73 where the gas flows out to allow the exhaled gas of the patient to disperse and flow out to the outside. Its thickness is at most 9 mm and its weight is at most 7 g. The exhaust ventilation opening 143 and the increased noise reduction function increase the range of choices for the patient for the mask 72 and the frame 74 that cooperate with it. The patient can choose to use the mask 72 without the ventilation opening 143 in combination with the elbow 73 with the ventilation opening 143, or use the mask 72 and the elbow 73 without the ventilation opening 143 in combination with the connector with the ventilation opening 143, expanding the range of choices for the user.

[0107] Embodiment 5

[0108] This embodiment provides an elbow assembly 1 directly connected to the mask 72 for providing continuous positive pressure gas to the patient's airway to improve sleep apnea. The elbow assembly 1 includes an elbow 73, an anti-asphyxia valve, and a quick-release connector 41. The anti-asphyxia valve includes an anti-asphyxia valve opening 141 and a silicone sheet 142 provided at its lower end, as shown in Figure 19 . This embodiment provides a schematic structural diagram of the elbow assembly 1. In Figure 19In the embodiment of the present invention shown, the difference from the elbow component 1 in the first embodiment is that: the first interface 12 end of the elbow 73 is made of soft rubber, which is configured and arranged to extend in a circle of soft rubber on the inner side facing the patient's face or the outer side opposite thereto at the opening of the first interface 12 of the elbow 73. When the elbow 73 is connected to the mask 72, there is no height difference 122 at the first interface 12 of the elbow 73, and only the friction between the extended interface 22 of the mask 72 and the soft rubber at the first interface 12 of the elbow 73 is relied on for fixation, which simplifies the structure of the elbow 73 and reduces the production cost. Moreover, to a certain extent, the elbow 73 is modularized. Since the soft rubber has a certain elasticity, it is inclusive of the mask 72 with an extended interface 22 having a slightly different aperture, and weakens the influence of the structure at the extended interface 22 of the mask 72 on the selectivity of the elbow 73. The patient only needs to select an elbow 73 with a soft rubber circumference within a certain range to match the mask 72, without considering the correspondence of the structure at the interface. The soft rubber can also be arranged at the connection between the extended interface 22 of the mask 72 and the elbow 73.

[0109] In addition, the technical features in the above embodiments can be combined as needed to obtain an elbow component directly connected to the mask, including all or part of the above technical features.

[0110] The elbow component directly connected to the mask implementing the present invention has at least the following beneficial effects:

[0111] 1) The way that the elbow 73 passes through the frame 74 and is directly connected to the mask 72 reduces the seams at the connections between components. The continuous positive pressure airflow output by the ventilator passes through the breathing hose, through the elbow 73 and the patient interface, and then enters the patient's airway. During this process, the airflow may leak out from the seams, and the reduction of the seams is to reduce the risk of airflow leakage, thereby improving the sealing performance of the entire respiratory therapy component system. The previous installation method required aligning two places. First, the frame 74 was aligned to fix the mask 72, and then the elbow 73 was aligned to fix the frame 74 after the mask 72 was installed. The present invention directly simplifies the installation steps from three steps to two steps. It only needs to put the frame 74 on the elbow 73 before installation and then combine the elbow 73 and the mask. This optimization of the installation process not only reduces the installation error rate and saves time but also improves the user experience, and is more convenient for people with inflexible hands and feet to operate.

[0112] 2) During the installation and disassembly of the present invention, the frame 74 only passes through the first interface 12 of the elbow 73. The fixing form of the frame 74 with the face mask and the elbow 73 is fixed by the shape of the face mask and the baffle 121 of the elbow 73. Therefore, the most important and essential structure of the frame 74 at the connection is the opening 61 of the frame 74 passing through the end of the first interface 12 of the elbow 73. The present invention simplifies the connection of the frame 74 directly to a smooth-wall opening 61 of the frame 74, modularizes the frame 74. For different patient needs, as long as the frame 74 has an opening 61 of the same size that can pass through the end of the first interface 12 of the elbow 73, it can be connected and fixed to the elbow 73 and the face mask. It is no longer a frame 74 with different forms of connection ports corresponding to different face masks and elbow 73 interfaces, nor is it necessary to design face masks and elbows 73 with different forms of connection ports corresponding to the frame 74. The reduction of the processing steps of the connecting piece means that the processing complexity and R & D cost of the elbow 73, the face mask, and the frame 74 are greatly reduced, simplifies the market selectivity for the frame 74. On this basis, the reduction in structure and processing steps reduces the loss of raw materials, which is a very important step for carbon neutrality, better responds to reducing the burden on the environment and climate change, and promotes the goals of sustainable development and carbon neutrality.

[0113] 3) Comparing the connection form of the frame 74 connecting the face mask and then the elbow 73 connecting the frame 74, the design of the elbow 73 directly connecting the face mask can increase the radial support of the elbow 73 for the frame 74 and the restriction and fixation of the elbow 73 on the frame 74 through the baffle 121 on the basis of the original, and the connection position changes from two original places to one place, making the connection between components more stable and not easy to loosen. And the overall structure composed of the whole respiratory accessory becomes simpler, reducing the failure rate of the overall components. In the existing connection method, since the face mask is directly connected to the patient's face through a headband or other means, and the frame 74 is connected to the face mask by a snap-fit connection, the connection of the face mask to the frame 74 is more stable and not easy to come off. However, connecting the elbow 73 to the frame 74 will cause the frame 74 to have an outward pulling force away from the patient's face, increasing the risk of the frame 74 falling off under the action of the pulling force. But the design of the elbow 73 directly connecting the face mask avoids the occurrence of this kind of situation. As long as the face mask is tightly connected to the patient's head through a headband or other means, the connection of the elbow 73 to the frame 74 and the face mask will not cause the face mask to fall off relative to the patient's face.

[0114] 4) Comparing the elbow 73 that connects the frame 74 through the clip structures on both sides of the elbow 73 in the existing design, the design of the elbow 73 directly connecting the face mask simplifies the overall structure of the elbow 73. The outer wall of the elbow 73 is basically smooth and clean except for the baffle 121, which simplifies the complexity of the mold in production and manufacturing, and relatively reduces the production cost of the elbow 73. And it does not contain other complex external connection structures with special designs. The reduction in the number of connection structures simplifies the manufacturing process and the assembly process. Since the reduction in component structures also reduces the demand for corresponding materials, and there is no need for a second material other than the main material of the elbow 73, it reduces both the processing cost and the material cost. For the frame 74, the way that the elbow 73 with the baffle 121 directly connects to the face mask 72 makes it unnecessary to have extra fixing parts at the connection of the frame 74. The connecting part of the frame 74 only needs to be manufactured as a simple smooth wall opening suitable for the elbow 73, which is a more simplified way for the mold of the frame 74 production and greatly reduces the mold cost of the frame 74.

[0115] 5) For the components of obstructive sleep apnea treatment, cleaning is a very important step. Due to the frequent use, patients need to clean and maintain the components regularly. The connection parts between components are the most likely to accumulate dirt. If not cleaned for a long time or not cleaned thoroughly, dirt, grease, and secretions will clog the channels, breeding bacteria, viruses and other microorganisms, causing problems such as allergies and skin infections. The simplification of the connection structure between the elbow 73 and the frame 74 reduces the area where dirt accumulates, making it easier for patients to clean thoroughly, reducing the health risks of patients, ensuring the safety of patients and improving the compliance of treatment. At the same time, with the reduction of components, the carbon emissions in the production and manufacturing process will also be reduced accordingly.

[0116] The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered as the scope described in this specification.

[0117] The above-described embodiments only represent several implementation manners of the present invention. The description is relatively specific and detailed, but it should not be construed as a limitation on the scope of the invention patent. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present invention, several modifications and improvements can still be made, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the invention patent should be subject to the appended claims.

Claims

1. An elbow component directly connected to a face mask, for providing continuous positive pressure gas to a patient's airway to improve sleep apnea, the elbow component comprising: Elbow, having a first interface directly connected to the face mask, a second interface for receiving pressurized gas, and an annular channel with an axial bend between the first interface and the second interface; At least one height difference is provided at the first interface end of the elbow, which is configured and arranged to closely contact the inner wall of the extended interface at the center opening of the face mask when connected to the face mask, prevent the elbow from easily detaching when a force in the direction opposite to the patient's face is applied to the elbow, and enable mutual rotation between the elbow and the face mask; A baffle is provided near the first interface of the elbow. The baffle is configured such that when the elbow is connected to the face mask, a gap at least large enough to accommodate the wall thickness of the frame is left between its inner surface facing the patient's face and the outer surface of the center opening of the face mask, for restricting the front-back movement of the frame relative to the face mask and the elbow; The elbow assembly further includes: an anti-asphyxia valve, including an anti-asphyxia valve opening and a silicone sheet provided at its lower end. The anti-asphyxia valve opening is formed on the wall of the annular channel of the elbow, allowing the patient to breathe through the anti-asphyxia valve opening when there is no continuous positive air pressure entering the elbow to prevent patient asphyxia; Wherein, the distance between the inner surface of the baffle at the first interface end of the elbow facing the patient's face and the first interface of the elbow is at least 2 mm.

2. The elbow component directly connected to a face mask according to claim 1, characterized in that The edge of the first interface end is a non-planar circular ring, with at least one notch to facilitate snap connection of the port to the face mask.

3. The elbow component directly connected to a face mask according to claim 1, characterized in that The baffle is a radially protruding part of the outer wall of the elbow or is formed by the height difference on the elbow.

4. The elbow component directly connected to a face mask according to claim 1, characterized in that The anti-asphyxia valve opening and the silicone sheet are symmetric about the axis at the second interface end of the elbow.

5. The elbow component directly connected to a face mask according to claim 1, characterized in that The anti-asphyxia valve opening is configured to have one or more openings.

6. An elbow component directly connected to a face mask, for providing continuous positive pressure gas to a patient's airway to improve sleep apnea, the elbow component comprising: Elbow, having a first interface directly connected to the face mask, a second interface for receiving pressurized gas, and an annular channel with at least one section of axial bend between the first interface and the second interface; A spherical partial protrusion is provided at the first interface end of the elbow, and the outer wall near the first interface end is configured and arranged to have two outward protrusions or inward grooves. When the elbow is connected to the face mask, the protrusions or grooves cooperate with the receivers on the inner wall of the center opening of the face mask to form a hinge connection, enabling the elbow to rotate relative to the face mask along the axis of the formed hinge. The spherical protrusion structure at the first interface end ensures smooth rotation of the elbow and prevents air leakage during elbow rotation; The elbow assembly further includes: an anti-asphyxia valve, including an anti-asphyxia valve opening and a silicone sheet provided at its lower end. The anti-asphyxia valve opening is formed on the wall of the annular channel of the elbow, allowing the patient to breathe through the anti-asphyxia valve opening when there is no continuous positive air pressure entering the elbow to prevent patient asphyxia.

7. The elbow component directly connected to a face mask according to claim 6, characterized in that A baffle is provided near the first interface of the elbow. The baffle is configured such that when the elbow is connected to the face mask, a gap with a certain distance is left between its inner surface facing the patient's face and the outer surface of the center opening of the face mask, for accommodating the frame and restricting the front-back movement of the frame relative to the face mask and the elbow. The minimum gap is 0.5 mm, which is the thickness of the connection part of the accommodated frame.

8. The elbow component directly connected to a face mask according to claim 6, characterized in that The distance from the first interface of the elbow to the inner surface of the baffle facing the patient's face is greater than the distance from the outer surface of the central opening of the face mask to the outermost end of the extension interface.

9. The elbow component directly connected to a face mask according to claim 6, characterized in that The anti-asphyxia valve opening and the silica gel sheet are symmetrically arranged at the axis of the second interface end of the elbow.

10. An elbow component directly connected to a face mask, for providing continuous positive pressure gas to a patient's airway to improve sleep apnea, the elbow component comprising: An elbow having a first interface directly connected to a connector, a second interface for receiving pressurized gas, and an annular channel with an axis bent between the first interface and the second interface; A connector having a first end connected to the elbow and a second end directly connected to the face mask. The second end is provided with at least one height difference and is configured and arranged to closely contact the extension interface at the central opening of the face mask when connected to the face mask, preventing a force in the direction opposite to the patient's face from being applied to the connector and making the connector easily detached; The elbow assembly further includes: an anti-asphyxia valve including an anti-asphyxia valve opening and a silica gel sheet provided at its lower end. The anti-asphyxia valve opening is formed on the wall of the annular channel of the elbow, allowing the patient to breathe through the anti-asphyxia valve opening when there is no continuous positive air pressure entering the elbow to prevent the patient from suffocating; Wherein, the connector has a baffle, and the distance between the inner surface of the baffle facing the patient's face and the first interface of the elbow is at least 2 mm.

11. The elbow component directly connected to a face mask according to claim 10, characterized in that The first end of the connector connected to the elbow can be connected to the face mask in the form of a snap, ball and socket, or hinge plus ball and socket.

12. An elbow assembly directly connected to a face mask, characterized in that, The connector and the elbow are not integrally formed, and the vent allows the patient to discharge waste gas into the external environment.

13. An elbow assembly directly connected to a face mask, characterized in that, When the elastic modulus of the material is the same, the ratio of the uniform wall thickness of the part with a height difference near the first interface of the elbow to the ratio of the contact area between the first interface of the elbow and the extension interface of the face mask and the annular area formed by the two contact parts is not equal to the value of the uniform wall thickness of the extension interface part of the face mask.

14. An elbow assembly directly connected to a face mask, characterized in that, The area of the silica gel sheet is larger than the total opening area of the anti-asphyxia valve to prevent the silica gel sheet from being blown out.

15. An elbow assembly directly connected to a face mask for providing continuous positive pressure gas to a patient's airway to improve sleep apnea. The elbow assembly includes: An elbow having a first interface directly connected to a connector, a second interface for receiving pressurized gas, and an annular channel with an axis bent between the first interface and the second interface; A connector having a first end connected to the elbow and a second end directly connected to the face mask. The second end is provided with at least one height difference and is configured and arranged to closely contact the extension interface at the central opening of the face mask when connected to the face mask, preventing a force in the direction opposite to the patient's face from being applied to the connector and making the connector easily detached; A vent having at least one vent hole allowing the patient to exhale waste gas to flow to the outside; The connector is provided with a baffle, and the baffle is configured to leave a gap for at least accommodating the frame between the inner surface facing the patient's face and the outer surface of the central opening of the face mask when the connector is connected to the face mask, for restricting the front-back movement of the frame relative to the face mask and the elbow; The elbow assembly further includes: an anti-asphyxia valve including an anti-asphyxia valve opening and a silica gel sheet provided at its lower end. The anti-asphyxia valve opening is formed on the wall of the annular channel of the elbow, allowing the patient to breathe through the anti-asphyxia valve opening when there is no continuous positive air pressure entering the elbow to prevent the patient from suffocating.

16. An elbow assembly directly connected to a face mask, characterized in that, When the elbow is connected to the face mask, the thickness between the outer surface of the central opening of the face mask and the inner surface of the baffle facing the patient's face is greater than or equal to the wall thickness of the connection of the accommodated frame.

17. An elbow assembly directly connected to a face mask, characterized in that, The vent includes noise reduction material, and the noise reduction material includes noise reduction cotton and noise reduction net; The noise reduction material has one or more of the following characteristics: The thickness is at most 9 mm; The weight is at most 7 g.

18. An elbow assembly directly connected to a face mask according to claim 17, characterized in that, Wherein the noise reduction material covers the vent, and the elbow assembly is provided with at least one port cover for engaging the outer wall of the annular channel in contact with air to fix the noise reduction material.

19. An elbow assembly directly connected to a face mask for providing continuous positive pressure gas to a patient's airway to improve sleep apnea. The elbow assembly includes: An elbow, having a first interface directly connected to the face mask, a second interface for receiving pressurized gas, and a curved annular channel between the first interface and the second interface; The first interface end of the elbow is configured and arranged to be in close contact with the extended interface at the central opening of the face mask when connected to the face mask. A baffle is provided near the first interface of the elbow. The baffle is configured to leave a gap for at least accommodating the frame between the inner surface of the baffle facing the patient's face and the outer surface of the central opening of the face mask when the elbow is connected to the face mask, so as to limit the front-back movement of the frame relative to the face mask and the elbow. A quick-release connector, having a first end and a second end. The first end is configured to be detachably connected to the second interface end of the elbow, and the second end is configured to be connected to a breathing tube. The elbow assembly further includes: an anti-asphyxia valve, including an anti-asphyxia valve opening and a silica gel sheet provided at its lower end. The anti-asphyxia valve opening is formed on the wall of the annular channel of the elbow, allowing the patient to breathe through the anti-asphyxia valve opening when there is no continuous positive air pressure entering the elbow to prevent the patient from suffocating.

20. An elbow assembly directly connected to a face mask according to claim 18, characterized in that, The second interface of the elbow can be connected to the quick-release connector. The quick-release connector is configured and arranged to have connecting parts for clamping and fastening integrally formed on both sides of its main body. After the quick-release connector is connected to the elbow, it can rotate relative to the elbow.

21. An elbow assembly directly connected to a face mask according to claim 18, characterized in that, When the elbow is connected to the face mask, the thickness between the outer surface of the central opening of the face mask and the inner surface of the baffle facing the patient's face is greater than or equal to the wall thickness of the connection of the accommodated frame.

22. An elbow assembly directly connected to a face mask according to claim 18, characterized in that, The edge of the first interface end is a non-planar ring, which has at least one notch to facilitate the buckling connection between the port and the face mask.

23. An elbow component directly connected to a face mask according to claim 18, characterized in that, The baffle is a radially protruding part of the outer wall of the elbow, which can be the height difference wall of the elbow itself relative to the first interface; Wherein the baffle has at least one of the following characteristics: Perpendicular to the interface axis connected to the face mask; The distance from the outer surface of the central opening of the face mask during connection is at least equal to the thickness of the frame connection; The height is at least 2 mm; The thickness is between 0.5 - 8 mm.

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