Patient interface assembly

Abstract

The invention relates to the technical field of breathing masks, in particular to a patient interface assembly capable of optimizing a connection mode and improving air tightness, the patient interface assembly, a gas conveying pipeline and a breathing machine form a complete channel for conveying positive pressure gas, and the assembly comprises a patient interface pad, a frame, an elbow assembly and a quick-release connecting piece. The patient interface pad is fixedly connected with one end of the elbow assembly, the frame is positioned between the elbow assembly and the patient interface pad (a positioning piece on the patient interface pad limits left-right rotation of the frame, and a baffle on the elbow assembly and the patient interface pad limit front-back displacement of the frame), and the other end of the elbow assembly is connected with the quick-release connecting piece. By reducing the connection steps between the components, the airtightness of the patient interface assembly is improved, and the patient interface assembly is adapted to various frames.

Description

Technical Field

[0001] The present invention mainly relates to a patient interface component, which is associated with the field of respiratory therapy, especially for the treatment field of sleep breathing disorders such as obstructive sleep apnea (OSA), and involves aspects such as connection, positioning, and modular matching between components. Background Art

[0002] Obstructive sleep apnea (OSA) is a potentially serious sleep disorder characterized by repeated collapse of the upper airway during sleep, causing obstructive apnea, hypopnea, or respiratory effort-related microarousals. OSA is the most common sleep-related breathing disorder. It is most common in older men, but can also occur in women and children. This sleep apnea occurs when the muscles at the back of the throat relax. These muscles support the soft palate, the triangular tissue (uvula) hanging from the soft palate, the tonsils, the side walls of the throat, and the tongue. If the muscles relax, the airway will narrow or close during inhalation, and the patient cannot obtain enough air. The oxygen content in the blood decreases, and the brain senses that the patient cannot breathe. It can only briefly wake up the patient to reopen the airway. This pattern repeats 5 - 30 times or more per hour, making it difficult for the patient to enter a peaceful deep sleep stage. This causes daytime sleepiness and morning headaches in most OSA patients. And there may be some adverse complications such as mental dysfunction, cardiovascular and cerebrovascular complications, pulmonary hypertension, or right heart failure, gastroesophageal reflux disease, etc. Due to the complexity of the causes of OSA and the individual differences in the anatomical characteristics of the upper airway, the severity of the patient's condition varies. Coupled with the uncertainty of the efficacy of different treatment methods, it determines the diversity of OSA treatment plans, and individualized treatment has become the development trend of OSA treatment. CPAP is the preferred treatment method for adult OSA patients. The patient wears a CPAP patient interface pad over the nose and mouth at night and is connected to a ventilator through a tube. Pressurized air is pumped into the patient's respiratory tract to keep it open during sleep. Even though this way of delivering air is effective, there are still problems with this treatment method in terms of comfort, ease of use, and compliance, resulting in up to 83% of patients not complying with ventilator treatment.

[0003] When patients choose component assemblies for sleep apnea treatment, they face various considerations, involving the following aspects: 1) Comfort of the patient interface component: The shape contours and dimensions of the components should fit the patient's facial contours or conform to the patient's facial curves, and through reasonable design and material selection, ensure that the patient interface component can fit the patient's face, making the overall component lighter, reducing the sense of foreign body and being more practical and aesthetically pleasing; 2) Airtightness of the system: Excluding the exhaust port and anti-asphyxiation valve, there are at least five leakage risks in the ventilator system between the patient's face and the patient interface pad, between the patient interface pad and the frame, between the frame and the elbow, between the elbow and the air delivery hose, and between the air delivery hose and the machine. Improving or simplifying the connection method between components can make the connection between components more stable, effectively prevent gas leakage, and improve the treatment effect; 3) Diversity of the frame: The weight of the frame, the length and number of the extension arms, etc. The frame can be in various shapes and sizes to adapt to different patients' facial features and personal preferences.

[0004] Most mask or nasal mask systems on the current market have the following phenomena: 1) By designing the structure of each interface and improving the application of sealing materials, the risk of air leakage in the system components is reduced. However, the commonly used sealing material silicone will be affected by aging during use, which may cause changes in its performance and appearance, and the airtightness will decrease accordingly; 2) The frame plays important roles such as support, positioning, and connection in the system components. However, due to different patient preferences, there are various requirements for its shape and size. But in the existing system components, the frame and the mask elbow are in a one-to-one matching relationship. Only through the one-to-one connection of the mask-frame-elbow can a complete component be achieved, resulting in most patients being unable to choose their favorite frame style due to considering the comfort of the mask, reducing the patient's satisfaction with the system components.

[0005] Therefore, we will design the connection method of each component in the patient interface component to improve the airtightness of the component and enable patients to have more frame combinations. This will make the entire patient interface component more user-friendly, easier to assemble, seal, clean, and maintain, and improve product performance. Summary of the Invention

[0006] Based on this, it is necessary to provide a patient interface component that is easy to assemble and has good sealing performance to address the above deficiencies.

[0007] A patient interface component 1 is configured to longitudinally contact the area between the patient's nose bridge and chin and form a seal for the patient's oral and nasal airways, or longitudinally contact the area between the patient's nose bridge and upper lip and form a seal for the patient's nasal airway, and connect a device that transmits positive pressure air or breathable gas and the patient's airway for medical treatment. The patient interface component 1 includes:

[0008] The patient interface pad 2 includes a front interface end 21, a rear interface end 22, a support member 23 that at least partially adheres to the side wall of the frame 4, a seal 24 having a buffer structure 241, and a positioning member 25 that contacts the frame 4. The front interface end 21 of the patient interface pad 2 is configured to be connected to the elbow assembly 3, and the rear interface end 22 is configured to at least seal one airway of the patient.

[0009] The elbow assembly 3 includes an elbow 31 having a first interface end 311, a second interface end 312, and an axially bent annular channel 313. A fixing structure 35 is provided on the elbow 31 and is configured to be connected to the front interface end 21 of the patient interface pad 2. A baffle 34 is provided on the elbow assembly 3 for restricting the front and rear displacement of the frame 4.

[0010] The frame 4 includes a positioning portion 42, at least one through opening 41, and support pieces 43 extending from the opening 41 in all directions. The positioning portion 42 is configured to position the frame 4 on the patient interface pad 2; and

[0011] An exhaust port 5 is provided on the patient interface pad 2 to allow the exhaled waste gas to flow from the inside of the patient interface pad 2 to the outside.

[0012] Wherein, the positioning member 25 has a contour shape that cooperates with the positioning portion 42 on the frame 4 and is configured to restrict the relative rotation of the frame 4 and the patient interface pad 2.

[0013] In one embodiment, the patient interface pad 2 can be a nasal mask or a face mask, and the rear interface of the patient interface pad 2 at least seals the nasal airway of the patient.

[0014] In one embodiment, the buffer structure 241 of the seal 24 can be a bellows shape or an air cushion.

[0015] In one embodiment, the baffle 34 on the elbow assembly 3 includes, but is not limited to, any continuous or discontinuous contour shapes such as circular, triangular, square, etc.

[0016] The present invention also discloses a patient interface assembly 1 configured to longitudinally contact the area between the patient's nose bridge and chin and form a seal for the patient's oral and nasal airways, or longitudinally contact the area between the patient's nose bridge and upper lip and form a seal for the patient's nasal airway, and connect a device for transmitting positive pressure air or breathable gas and the patient's airway for medical treatment. The patient interface assembly 1 includes:

[0017] The patient interface cushion 2 includes a front interface end 21, a rear interface end 22, a support member 23 that at least partially fits against the side wall of the frame 4, a seal 24 having a buffer structure 241, and a positioning member 25 that contacts the frame 4. The front interface end 21 of the patient interface cushion 2 is configured to be connected to the elbow assembly 3, and the rear interface end 22 is configured to at least seal one airway of the patient.

[0018] The elbow assembly 3 includes a connecting member 32 having a first end 321 and a second end 322, and an elbow 31 having a first interface end 311, a second interface end 312, and an axially curved annular channel 313. The first end 321 of the connecting member 32 is provided with a fixing structure 35 configured to be connected to the front interface end 21 of the patient interface cushion 2, and the second end 322 is configured to be connected to the first interface end 311 of the elbow 31. A baffle 34 is provided on the elbow assembly 3 to limit the forward and backward displacement of the frame 4.

[0019] The frame 4 includes a positioning portion 42, at least one through-opening 41, and support sheets 43 extending from the opening 41 in all directions. The positioning portion 42 is configured to position the frame 4 onto the patient interface cushion 2; and

[0020] An exhaust port 5 is provided on the elbow assembly 3 to allow the exhaled waste gas to be discharged from the elbow assembly 3 to the external environment.

[0021] Wherein the positioning member 25 has a contour shape that mates with the positioning portion 42 on the frame 4 and is configured to limit the relative rotation between the frame 4 and the patient interface cushion 2.

[0022] In one embodiment, the fixing structure 35 of the connecting member 32 of the elbow assembly 3 is one or more of a hinge, a ball-and-socket joint, a snap-fastener, and a magnet to connect with the front interface end 21 of the patient interface cushion 2.

[0023] In one embodiment, the connection manner between the connecting member 32 and the elbow 31 is one or more of a hinge, a ball-and-socket joint, a snap-fastener, and a magnet.

[0024] In one embodiment, the overall height range of the elbow assembly 3 is 30 - 80 mm.

[0025] The present invention also discloses a patient interface assembly 1 configured to longitudinally contact the area between the patient's nose bridge and chin and form a seal for the patient's oral and nasal airways, or longitudinally contact the area between the patient's nose bridge and upper lip and form a seal for the patient's nasal airway, and connect a device for transmitting positive pressure air or breathable gas and the patient's airway for medical treatment. The patient interface assembly 1 includes:

[0026] The patient interface pad 2 includes a front interface end 21, a rear interface end 22, a support member 23 that at least partially adheres to the side wall of the frame 4, a seal 24 having a buffer structure 241, and a positioning member 25 that contacts the frame 4. The front interface end 21 of the patient interface pad 2 is configured to be connected to the first interface end 311 of the elbow assembly 3, and the rear interface end 22 is configured to at least seal one airway of the patient;

[0027] The elbow assembly 3 includes an elbow 31 having a first interface end 311, a second interface end 312, and an axially bent annular channel 313. A fixing structure 35 is provided on the elbow 31 and is configured to be connected to the front interface end 21 of the patient interface pad 2. The second interface end 312 is configured to be rotatably connected to the quick-release connector 6. A baffle 34 is provided on the elbow assembly 3 to limit the front-back displacement of the frame 4;

[0028] The frame 4 includes a positioning portion 42, at least one through opening 41, and support pieces 43 extending from the opening 41 in all directions. The positioning portion 42 is configured to position the frame 4 on the patient interface pad 2;

[0029] The positioning member 25 has a contour shape that conforms to a part of the frame 4 and is configured to limit the relative rotation between the frame 4 and the patient interface pad 2;

[0030] The quick-release connector 6 has an upper end, a lower end, and a fixing member. The upper end is configured to be detachably directly connected to the second interface end 312 of the elbow assembly 3; and

[0031] An exhaust port 5 is provided on the patient interface pad 2 to allow the exhaled waste gas to flow from the inside of the patient interface pad 2 to the outside;

[0032] Wherein, without being subjected to external force, the force for connecting the patient interface pad 2 and the elbow assembly 3 is greater than the separating force.

[0033] In one embodiment, the fixing structure 35 on the elbow assembly 3 is one or more of a hinge, a ball and socket, a buckle, and a magnet.

[0034] In one embodiment, the form of the positioning member 25 can be a protrusion, a groove, a magnet, a contour, and the shape can be any shape such as a circle, a triangle, a square, etc.

[0035] In one embodiment, the positioning portion 42 on the frame 4 is any shape such as a circle, a triangle, a square, etc. that matches the positioning member 25.

[0036] The present invention also discloses a patient interface assembly 1, configured to longitudinally contact the area between the patient's nose bridge and chin to form a seal for the patient's oral and nasal airway, or longitudinally contact the area between the patient's nose bridge and upper lip to form a seal for the patient's nasal airway, and connect a device for transmitting positive pressure air or breathable gas and the patient's airway for medical treatment. The patient interface assembly 1 includes:

[0037] A patient interface pad 2, including a front interface end 21, a rear interface end 22, a support member 23 that at least partially adheres to the side wall of the frame 4, a seal 24 having a buffer structure 241, and a positioning member 25 that contacts the frame 4. The front interface end 21 of the patient interface pad 2 is configured to be rotatably and directly connected to the first interface end 311 of the elbow assembly 3, and the rear interface end 22 is configured to at least seal one airway of the patient;

[0038] An elbow assembly 3, having an elbow 31 with a first interface end 311, a second interface end 312, and an axially bent annular channel 313. A fixing structure 35 is provided on the elbow 31, configured to be connected to the front interface end 21 of the patient interface pad 2. The second interface end 312 is configured to be rotatably connected to a quick-release connector 6. A baffle 34 is provided on the elbow assembly 3 for restricting the front-back displacement of the frame 4;

[0039] A frame 4, including a positioning portion 42, at least one through-opening 41, and support sheets 43 extending from the opening 41 in all directions. The positioning portion 42 is configured to position the frame 4 onto the patient interface pad 2;

[0040] An exhaust port 5 is provided on the elbow assembly 3, allowing exhaled waste gas to flow from the inside of the patient interface pad 2 to the outside; and

[0041] A quick-release connector 6, having an upper end, a lower end, and a fixing member. The upper end is configured to be detachably and directly connected to the second interface end 312 of the elbow assembly 3;

[0042] Wherein, the positioning member 25 has a contour shape that cooperates with the positioning portion 42 on the frame 4, configured to restrict the relative rotation between the frame 4 and the patient interface pad 2.

[0043] In one embodiment, the support sheets 43 on the frame 4 are any contour extending from the periphery of the opening 41 towards the facial side.

[0044] In one embodiment, the form of the exhaust port 5 can be a through-opening or a mesh. When the exhaust port 5 is a mesh, the material of the exhaust port 5 is a noise-reducing material.

[0045] In one embodiment, the fixing member of the quick-release connector 6 is provided at the upper end of the quick-release connector 6, and the fixing member can be a clip, a buckle, or a magnet.

[0046] The present invention also discloses a patient interface assembly 1, configured to longitudinally contact the area between the patient's nose bridge and chin to form a seal for the patient's oral and nasal airways, or longitudinally contact the area between the patient's nose bridge and upper lip to form a seal for the patient's nasal airway, and connect a device for transmitting positive pressure air or breathable gas and the patient's airway for medical treatment. The patient interface assembly 1 includes:

[0047] A patient interface pad 2, including a front interface end 21, a rear interface end 22, a support member 23 that at least partially adheres to the side wall of the frame 4, a seal 24 having a buffer structure 241, and a positioning member 25 that contacts the frame 4. The front interface end 21 of the patient interface pad 2 is configured to be directly connected to the first interface end 311 of the elbow assembly 3, and the rear interface end 22 is configured to seal at least one airway of the patient. The front interface end 21 of the patient interface pad 2 has an outer opening 211, an inner opening 212, and an annular wall 213, and the diameter of the outer opening 211 is greater than the diameter of the inner opening 212;

[0048] An elbow assembly 3, including an elbow 31 having a first interface end 311, a second interface end 312, and an axially bent annular channel 313, and an anti-asphyxia valve 33 having a silicone sheet 332 and an anti-asphyxia valve 331. A fixing structure 35 is provided on the elbow 31 and is configured to be connected to the front interface end 21 of the patient interface pad 2. The anti-asphyxia valve 33 is configured to be provided on the elbow 31 at least one. A baffle 34 is provided on the elbow assembly 3 to limit the front and rear displacement of the frame 4;

[0049] A frame 4, including a positioning portion 42, at least one through opening 41, and support sheets 43 extending from the opening 41 in all directions. The positioning portion 42 is configured to position the frame 4 to the patient interface pad 2;

[0050] The positioning member 25 has a contour shape that cooperates with the positioning portion 42 on the frame 4 and is configured to limit the relative rotation of the frame 4 and the patient interface pad 2; and

[0051] An exhaust port 5 is provided on the elbow assembly 3 to allow the exhaled waste gas to be discharged from the elbow assembly 3 to the external environment;

[0052] Wherein, without being affected by external forces, the force for connecting the patient interface pad 2 and the elbow assembly 3 is greater than the separating force.

[0053] In one embodiment, the anti-asphyxia valve 331 can be any shape such as circular, oval, semi-circular, triangular, etc.

[0054] In one embodiment, the connection manner between the support member 23 and the seal 24 of the patient interface pad 2 can be one or more connection manners such as molding, adhesive, mechanical connection, etc.

[0055] In one embodiment, the form of the exhaust port 5 can be a through-opening or a mesh. When the exhaust port 5 is in the form of a hole, the exhaust port 5 can be used in conjunction with an external connector 7, and the external connector 7 includes an external connection buckle and a noise reduction material.

[0056] Implementing the breathing mask with a foam pad of the present invention has at least the following beneficial effects:

[0057] 1) Reducing the connection steps between components, reducing the failure points, lowering the failure rate during the operation of the entire product, and increasing the airtightness of the overall assembly. Most face masks or nasal mask systems in the market are assembled through the connection method of the patient interface pad 2 - frame 4 - elbow 31. This common method has two uncontrollable air leakage risks - between the patient interface pad 2 and the frame 4, and between the frame 4 and the elbow 31. Moreover, the complex and lengthy installation steps may increase the risk of operation errors, resulting in incorrect or incomplete assembly, thereby affecting the performance and reliability of the product, and causing problems such as poor product sealing, misalignment, and wear and tear. When patients are not familiar with the assembly process of the components, it is very likely that air leakage will occur after assembly. And there are at least 4 - 5 basic connections in the entire treatment system, which increases the difficulty for patients to troubleshoot the cause of air leakage. After long-term use by patients, since the patient interface component 1 needs to be frequently disassembled and cleaned, the connection seal is very likely to be damaged by the outside world, resulting in a decrease in airtightness. Connecting the patient interface pad 2 directly to the elbow component 3 and omitting the step of connecting the patient interface pad 2 to the frame 4 has the following advantages: a. The gas only needs to directly pass through one pipeline in the patient interface component 1, and there are fewer gaps when flowing through the pipeline, which can reduce the overall air leakage risk of the component; b. Simplifying the installation steps, when patients assemble the components, they do not need to install them one by one. They only need to position the frame 4 on the surface of the patient interface pad 2 and connect the elbow component 3 to the patient interface pad 2. An area for accommodating the frame 4 is automatically formed between the patient interface pad 2 and the elbow component 3 and can limit the relative displacement between the frame 4 and the two, making it easier for patients to assemble new products; c. Redesigning the installation steps, simplifying the connection points from two to one, making the overall structure of the entire breathing accessory simpler, which can reduce the chance of errors during installation, reduce the occurrence of poor or incorrect assembly. By designing a user-friendly installation interface and providing clear guidance, through an easy-to-operate assembly method, it is convenient for users to complete the assembly of the product more easily and reduce potential failure points during installation, thereby lowering the failure rate during the operation of the entire product.

[0058] 2) Modular configuration, more choices. Since the steps of installing the frame 4 are removed, the importance of the frame 4 in the installation steps is weakened. The frame 4 is limited to a certain extent through the groove formed by connecting the baffle 34 of the elbow component 3 with the patient interface pad 2. Therefore, the basic part of the frame 4 only needs to include the side walls that can accommodate part of the face mask, the through-opening 41 that allows the elbow component 3 to pass through and the patient interface pad 2, and the opening 41 that cooperates with the face mask positioning member 25 of the frame 4. Except for the basic part, the frame 4 can have more choices in terms of shape, and corresponding frames 4 can be provided for patients with different needs or preferences. There is no longer a need to design frames 4 with different connection methods for different elbows 31 and patient interface pads 2, and there is no need to consider the impact of the frame 4 on the overall airtightness of the components. Only the comfort of the patient's wearing needs to be focused on. In production, the basic connection structure between the patient interface pad 2 and the elbow component 3 is also simplified, and important functional structures such as the exhaust hole and the anti-asphyxia valve 33 do not need to be changed. The reduction of the processing steps of the overall connection structure means that on the premise that the connection structure between the elbow component 3 and the patient interface pad 2 is determined, only a frame 4 with a simple structure needs to be developed modularly, which greatly reduces the processing complexity and R & D cost of the patient interface component 1, and at the same time, diverse frame 4 configurations can be provided to meet various needs of users.

[0059] 3) The connection between components is more stable. Compared with the connection of the patient interface pad 2 - frame 4 - elbow 31, the connection method of the patient interface pad 2 - elbow component 3 is more stable. The direct connection design of the elbow component 3 and the patient interface pad 2 adds the radial support of the elbow component 3 to the frame 4 and the restriction and fixation of the frame 4 by the elbow component 3 through the baffle 34 on the basis of the original connection method. The connection points are also simplified from the original two to one and are not easy to loosen. Without applying external force, in the connection method of the patient interface pad 2 - frame 4 - elbow 31, the patient interface pad 2 is pulled by the gravity of both the frame 4 and the elbow 31; while in the connection method of the patient interface pad 2 - elbow component 3, the patient interface pad 2 is only pulled by the gravity of the elbow component 3. By comparing the two, the former assembly method increases the risk of the patient interface component 1 falling off under the action of tension, while the design of the latter assembly method reduces the risk of component detachment, is more stable and not easy to fall off.

[0060] 4) Compared with other products with quick-release elbows, it has fewer components and a lighter overall weight. Most existing products directly connect the elbow assembly 3 with a clip structure on both sides to the frame 4, and then the lower end of the elbow 31 is detachably connected to the gas transmission hose. At this time, the elbow assembly 3 adds weight to the patient interface system due to the quick-release connection structure. Therefore, the quick-release system on the elbow assembly 3 is separated independently and designed to be directly detachably connected between the elbow assembly 3 and the patient interface pad 2, achieving the purpose of reducing the overall weight of the patient interface assembly 1. The quick-release parts can be selected according to the patient's personal wearing preferences. When the patient interface assembly 1 is directly connected through the elbow 31, the overall components of the assembly are more portable and easier to use than the existing mask system. The weight is reduced by simplifying the structure of the elbow 31, and the components on the elbow 31 are reduced to achieve the reduction of the overall number of components.

[0061] 5) The structure of a single component is simplified, which can reduce costs, be easier to clean, and be more environmentally friendly: a) The connecting buckle structure is removed from the design of the frame 4, and the model structure is simpler, which can reduce the processing steps and complexity, and reduce the costs in the processing and manufacturing process; correspondingly, the mold making and mold opening methods are changed, reducing the investment and maintenance costs of equipment and molds; the simple component structure is easier to carry out quality inspection and control, reducing the generation of defective products and the inspection costs; the simplified structure brings a smaller volume and a lighter weight, and the components are easier to stack and place, reducing the transportation costs; when the frame 4 component is damaged, only a new frame 4 component needs to be replaced, and there are more choices without considering the connection problems between components, bringing more comfortable experiences to patients. The modular component combination can improve the service life of each component for production, helping to reduce energy consumption and waste in the production process. By reducing energy consumption and waste and recycling some components, the carbon emissions in production are reduced, protecting the environment. b) The model of the frame 4 is simplified, and the models of the patient interface pad 2 and the elbow assembly 3 can also be adjusted correspondingly to be simpler and easier to use. There are fewer connecting and fixing elements in the assembly, so it is easier to disassemble and clean when cleaning is required; the simple structure reduces the sanitary dead corners and complex concave and convex surfaces, reducing the chance of accumulation of impurities and dirt, making the cleaning process easier and more thorough; complex components may require more cleaning agents and tools to be cleaned thoroughly, while simple components only need less dosage to achieve the same effect, reducing the use of chemical cleaning agents, saving energy and time, and contributing to environmental protection. Description of the Drawings

[0062] Figure 1 Structural schematic diagram of the patient interface assembly in an embodiment of the present invention;

[0063] Figure 2 Exploded structural schematic diagram of the patient interface assembly in an embodiment of the present invention;

[0064] Figure 3 Explosion schematic diagram of the patient interface pad in an embodiment of the present invention;

[0065] Figure 4 Explosion schematic diagram of the elbow component in an embodiment of the present invention;

[0066] Figure 5 Schematic diagram of the exhaust port being arranged on the elbow component in the first embodiment of the present invention;

[0067] Figure 6 Schematic diagram of the exhaust port being arranged on the patient interface pad in the first embodiment of the present invention;

[0068] Figure 7 Schematic diagram of the exhaust port being provided with a noise reduction component in the first embodiment of the present invention;

[0069] Figure 8 Schematic diagram of the exhaust port being used in combination with a noise reduction member in the first embodiment of the present invention;

[0070] Figure 9 Cross-sectional view of the gap formed by the connection between the baffle of the elbow component and the patient interface pad in an embodiment of the present invention;

[0071] Figure 10 Schematic diagram of the fixing form of the quick-release connector in an embodiment of the present invention;

[0072] Figure 11 is Figure 10 Cross-sectional view of the fixing form of the quick-release connector;

[0073] Figure 12 Schematic diagram of the patient interface component matching different types of frames in an embodiment of the present invention;

[0074] Figure 13 Schematic diagram of the patient interface component matching different types of patient interface pads in an embodiment of the present invention;

[0075] Figure 14 Schematic diagram of different connection methods between the elbow component and the patient interface pad in the second embodiment of the present invention;

[0076] Figure 15 Schematic diagram of different connection methods between the connecting member and the elbow in the elbow component in the third embodiment of the present invention;

[0077] Figure 16 Schematic diagram of the elbow component being detachable or non-detachable from the frame in the fourth embodiment of the present invention;

[0078] Figure 17 Schematic diagram of the positioning method of the frame and the face mask in an embodiment of the present invention;

[0079] Figure 18 Schematic diagram of the contour shape of the baffle in Embodiment 1 of the present invention;

[0080] Figure 19 Schematic diagram of the buffer structure of the seal in an embodiment of the present invention. Detailed implementation manners

[0081] To make the above objects, features, and advantages of the present invention more obvious and understandable, the following will describe the detailed implementation manners of the present invention with reference to the accompanying drawings. Many specific details are set forth in the following description to fully understand the present invention. However, the present invention can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without departing from the connotation of the present invention. Therefore, the present invention is not limited by the specific embodiments disclosed below.

[0082] In view of the problem of inconvenient connection of components in the existing face mask system, the present invention provides a patient interface assembly 1 that simplifies the installation steps. The assembly includes a patient interface pad 2, a frame 4, an elbow assembly 3, and a quick-release connector 6. The patient interface pad 2 is fixedly connected to one end of the elbow assembly 3. As Figure 9 shown, the frame 4 is positioned between the elbow assembly 3 and the patient interface pad 2 (the positioning member 25 on the patient interface pad 2 restricts the left-right rotation of the frame 4, and the baffle 34 on the elbow assembly 3 and the patient interface pad 2 restrict the front-back displacement of the frame 4). The other end of the elbow assembly 3 is connected to the quick-release connector 6. The overall assembly forms a complete channel for delivering positive pressure gas with the air delivery pipe and the ventilator. By reducing the connection steps between components, the airtightness of the patient interface assembly 1 is improved, and various frames 4 are adapted to improve the satisfaction of patients with the use of the frame 4 assembly.

[0083] In addition, specifically, please refer to Figure 13 , the patient interface pad 2 of this embodiment can longitudinally contact the area between the patient's nose bridge and chin and form a seal for the patient's oral and nasal airways, or can longitudinally contact the area between the patient's nose bridge and upper lip and form a seal for the patient's nasal airway, and connect the device for delivering positive pressure air or breathable gas and the patient's airway for medical treatment.

[0084] Specifically, please refer to Figures 1 to 4, the patient interface component 1 of this embodiment includes a patient interface pad 2, an elbow component 3, a frame 4, a positioning member 25, and an exhaust port 5. Among them, the patient interface pad 2 includes a front interface end 21, a rear interface end 22, a support member 23 having at least a part that fits the contour of the side wall of the frame 4, a seal 24 having a buffer structure 241, and a positioning member 25 that contacts the frame 4; the front interface end 21 of the patient interface pad 2 is configured to be connected to the first interface end 311 of the elbow 31 in the elbow component 3 or the first end 321 of the connecting member 32 in the elbow component 3, and the rear interface end 22 is configured to at least seal one airway of the patient. The front interface end 21 includes an outer opening 211, an inner opening 212, and an annular wall 213. The diameter of the outer opening 211 is larger than that of the inner opening 212. The diameter of the outer opening 211 is approximately 10 - 45 mm, the length of the annular wall 213 is approximately 1 - 15 mm, the thickness of the annular wall 213 is approximately 0.5 - 5 mm, and the length of the fixed part of the patient interface pad 2 and the elbow component 3 is approximately 1 - 15 mm. The diameter size range of the front interface end 21 ensures that positive pressure gas can be smoothly delivered to the patient's airway and will not disperse the gas due to the too large size of the opening 41, resulting in a decrease in air pressure and the treatment failing to achieve the expected effect. The size of the annular wall 213 ensures that there is sufficient fixed area between the patient interface pad 2 and the elbow component 3. The connection method between the front interface end 21 and the elbow component 3 includes, but is not limited to, one or more of snap, clip, magnetic attraction, hinge, ball and socket, etc. After connection, the patient interface pad 2 and the elbow component 3 can rotate relative to each other; at least a part of the front interface end 21 is rigid and can produce slight deformation, and the materials include, but are not limited to, one or more of polyethylene, polypropylene, polyester, silicone, polycarbonate, thermoplastic, etc. The material of the support member 23 includes, but is not limited to, polycarbonate, polyethylene, polypropylene, polyester, etc.; the seal 24 has a buffer structure 241, and the buffer structure 241 can be on a part of the seal 24, or can be a circle around or covering the seal 24. The forms include, but are not limited to, accordion shape, air cushion, etc., and the materials include, but are not limited to, one or more of silicone, thermoplastic elastomer, nylon, cotton, natural fabric, etc.; the support member 23 and the seal 24 are in a connected state during use, and the connection methods include, but are not limited to, one or more of molding, adhesive, mechanical connection, etc. Further, please refer to Figure 17, at least one positioning member 25 is provided on the patient interface pad 2. The positioning member 25 includes a contour shape that cooperates with the positioning portion 42 on the frame 4, a contour shape that conforms to the inner surface of a part of the frame 4, or magnetic attraction. In one embodiment, the height of the positioning member 25 is approximately 0.1 - 8 mm; in another embodiment, the positioning member 25 is a partial shape contour of the support member 23 of the patient interface pad 2 that can be positioned to fit the contour of a part of the frame 4 to prevent relative rotation. The frame 4 is easily and quickly positioned on the outer surface of the patient interface pad 2 through the positioning member 25 to prevent relative left - right displacement between the two; the positioning member 25 includes, but is not limited to, protrusions and grooves, and the contour shape includes, but is not limited to, any regular shapes such as circles, triangles, squares, etc.; the positioning member 25 and the frame 4 can be in full contact or partial contact; the material of the positioning member 25 includes, but is not limited to, one or more of polyethylene, polypropylene, polycarbonate polyester, silica gel, thermoplastic elastomer, magnets, etc.

[0085] The elbow assembly 3 includes a connecting member 32 having a first end 321 and a second end 322, an elbow 31 having a first interface end 311, a second interface end 312, and an annular channel 313 with an axial bend (the axial bend means that there is a continuous force along the radial direction of the axis to form a bend, where the radial direction refers to the straight - line direction along the diameter or radius, or the straight - line direction perpendicular to the axis), an anti - asphyxiation valve 33 having a silica gel sheet 332 and an anti - asphyxiation valve 331, and a baffle 34. Further, as Figure 4 and Figure 15As shown, the elbow assembly 3 has two configurations: 1) When the patient uses the connecting piece 32, the first end 321 of the connecting piece 32 is configured to be directly connected to the front interface end 21 of the patient interface pad 2 through the fixing structure 35. The connection methods include, but are not limited to, one or more of snap, hinge, ball and socket, etc., and relative rotation can occur between the two; the second end 322 of the connecting piece 32 is configured to be connected to the first interface end 311 of the elbow 31. The connection methods include, but are not limited to, one or more of snap, clip, hinge, ball and socket, etc., and relative rotation can occur between the two; the second interface end 312 of the elbow 31 is configured to be connected to the quick-release connector 6 or the gas delivery pipe. 2) When the patient only uses the elbow 31, the first interface end of the elbow 31 is configured to be directly connected to the front interface end 21 of the patient interface pad 2 through the fixing structure 35. The connection methods include, but are not limited to, snap, hinge, ball and socket, etc., and relative rotation can occur between the two. At least one anti-asphyxia valve 33 is provided on the elbow 31. The anti-asphyxia valve 331 is configured to allow external gas to flow into the patient interface assembly 1, and the silicone sheet 332 is configured to prevent external gas from flowing into the assembly through the anti-asphyxia valve 331 when the CPAP machine is turned on. The materials of the elbow assembly 3 include, but are not limited to, one or more of polyethylene, polyamide, polypropylene, polycarbonate, polyester, silicone, thermoplastic elastomer, etc. The overall height range of the connecting piece 32 is 10 - 30 mm, and the overall height range of the elbow 31 is 30 - 80 mm. The wall thickness of both is approximately 0.5 - 5 mm; the outer diameter of the first end 321 of the connecting piece 32 is approximately 10 - 50 mm, and the outer diameter of the second end 322 is approximately 10 - 50 mm; the outer diameter of the first interface end 311 of the elbow 31 is approximately 10 - 50 mm, and the outer diameter of the second interface end 312 is approximately 10 - 50 mm. The length of the first interface end 311 of the elbow 31 is approximately 1 - 15 mm, and the length of the second interface end 312 of the elbow 31 is approximately 1 - 15 mm; the anti-asphyxia valve 331 can be any shape such as circular, oval, semi-circular, triangular, etc., and the area range is 25 - 256 mm 2 , ensuring that the patient can still breathe normally when the machine is powered off; the length and thickness ranges of the elbow assembly 3 ensure that each component will not be difficult for the user to assemble due to too small size or insufficient assembly area resulting in easy loosening of component connections, nor will the overall size of the assembly be too large and the weight be increased to press on the patient's face, affecting the use experience; the diameter size ensures the ventilation effect of the entire patient interface assembly 1; when the elbow 31 is connected to the patient interface pad 2, the first interface end 311 of the elbow 31 deforms, ensuring that the elbow 31 can be smoothly inserted into the front interface end 21 of the patient interface pad 2. Further, please refer to Figure 9 and Figure 18, at least one baffle 34 is provided on the elbow assembly 3. The baffle 34 can be continuous or discontinuous and can have any contour shape such as circular, triangular, square, etc. After the elbow assembly 3 is connected to the patient interface pad 2, the front-back displacement of the frame 4 can be restricted. The outer diameter of the baffle 34 is approximately 12 - 52 mm, and the thickness is approximately 0.5 - 5 mm. The material is consistent with the rigid part of the elbow assembly 3. Without the action of external force, the force when the patient interface pad 2 is connected to the elbow assembly 3 is greater than the force when they are separated. When the patient separates the elbow assembly 3 from the patient interface pad 2, a force greater than or equal to 35 N is required to separate the two, ensuring that the patient interface assembly 1 is not easily detached during normal use.

[0086] The frame 4 includes a positioning part 42, a through opening 41, and support pieces 43 extending around. The positioning part 42 is configured to be similar in contour shape to the positioning member 25 on the patient interface pad 2 or have a magnetic attraction function, and can be positioned on the outer surface of the patient interface pad 2 to restrict the rotation of the frame 4 and the patient interface pad 2. The diameter of the opening 41 of the frame 4 is approximately 10 - 50 mm, and is used to accommodate the front interface end 21 of the patient interface pad 2 or the elbow assembly 3, ensuring that the elbow assembly 3 can pass through but not larger than the baffle 34 on the elbow assembly 3 to prevent the frame 4 from falling. Further, please combine Figure 12 , the support pieces 43 are of any contour extending from around the opening 41 towards the facial side, and can conform to the user's facial curve, extend according to the user's needs and preferences, and have the functions of connection, positioning, and stability. At least part of the frame 4 is rigid, and the material includes but is not limited to one or more of polyethylene, polypropylene, polycarbonate, polyester, silica gel, thermoplastic elastomer, etc. In another embodiment, the elbow assembly 3 is used in cooperation with a nasal mask. In this embodiment, the elbow assembly 3 includes a connecting member 32 having a first end 321 and a second end 322, an elbow 31 having a first interface end 311, a second interface end 312, and an annular channel 313 with an axial bend (the axial bend means that the axis has a continuous force along the radial direction to form a bend, where the radial direction refers to the straight line direction along the diameter or radius, or the straight line direction perpendicular to the axis), and a baffle 34.

[0087] An exhaust port 5 is provided on the patient interface component 1, allowing the patient's exhaled waste gas to flow from the inside of the component to the outside. The exhaust port 5 can be provided on the patient interface pad 2 or the elbow component 3. The form of the exhaust port 5 can be a hole or a mesh; 1) When the exhaust port 5 is a hole, the outer diameter of the exhaust hole is greater than the inner diameter, and the diameter ratio of the two does not exceed 2.45. The ratio of the outer surface of the exhaust hole to the outer surface of the patient interface pad 2 or the elbow component 3 is approximately 5-50%. At this time, the material of the exhaust hole includes but is not limited to polyethylene, polypropylene, polycarbonate, polyester, silica gel, thermoplastic elastomer, etc.; 2) When the exhaust port 5 is a mesh, the form can be a mesh formed by a natural fabric or a mesh formed by a process. The ratio of the outer surface of the exhaust mesh to the outer surface of the patient interface pad 2 or the elbow component 3 is approximately 5-80%. At this time, the material of the exhaust mesh includes but is not limited to polyethylene, polypropylene, polyester, nylon, natural fabric, etc.; 3) When the exhaust hole is a hole, it can also be used in combination with an external connector 7. The external connector 7 includes an external connection buckle and a noise reduction material. The noise reduction material includes but is not limited to polyethylene, polypropylene, cotton, nylon, natural fabric, etc.

[0088] The quick-release connector 6 has an upper end, a lower end, and a fixing member. The upper end is configured to be connected to the elbow component 3, and mutual rotation between the quick-release connector 6 and the elbow component 3 can be achieved. The lower end is configured to be connected to the air supply pipeline. The upper end is provided with a fixing member for more quickly releasing the quick-release connector 6 and fixing it to the elbow component 3. Further, please refer to Figure 10 and Figure 11 The fixing member includes but is not limited to a clip, a buckle, and a magnet. The outer diameter of the upper end of the quick-release connector 6 is approximately 10-50 mm, the outer diameter of the lower end is approximately 15-27 mm, the overall height is approximately 10-45 mm, and the wall thickness is approximately 0.5-5 mm, ensuring that it can be connected to the second end of the elbow 31 and can be adapted to an air supply pipeline with an inner diameter of 15 mm or 22 mm. The material of the quick-release connector 6 can be polyethylene, polypropylene, polycarbonate, silica gel, thermoplastic elastomer, etc.

[0089] It should be noted that in this embodiment, the reason for directly connecting the elbow component 3 and the patient interface pad 2 is that there are many components in the mask system and the airtightness between components needs to be considered. When the patient assembles the mask system by himself, careful one-to-one installation is required to ensure the overall airtightness of the mask system. In this application, by directly connecting the elbow component 3 and the patient interface pad 2, the intermediate step of connecting the frame 4 is removed. By reducing the connection points, the possibility of air leakage in the patient interface component 1 is reduced. And the frame 4 only needs simple limitation by the positioning member 25 and the positioning part 42, without the need for one-to-one alignment, which can ensure the overall airtightness of the patient interface component 1, and the force received between components is reduced, the mutual connection is more stable, and the assembly process is more convenient; and the patient interface pad 2 can be a nasal mask or a face mask, providing diverse choices for the patient.

[0090] The main body of the frame 4 is designed to only require a through opening 41 so that the extension part of the frame 4 can be in various contour forms, which can meet the needs of different patients. And the frame 4 and the patient interface pad 2 are designed to be connected through the positioning member 25, making the user interface simpler and easier to understand. The frame 4 only needs to ensure that the opening 41 can accommodate the front interface end 21 of the patient interface pad 2 and the first interface end 311 of the elbow 31 in the elbow assembly 3 or the first end 321 of the connecting member 32. Most of the frame 4 components with complex and cumbersome structures have a one-to-one correspondence, that is, they need to be matched with corresponding sets to be used. Patients cannot choose their favorite type of frame 4 as much as possible to receive long-term treatment, and corresponding connections are also required to ensure the airtightness of the overall system. However, the simplified frame 4 components no longer need to correspond to the matching system. Patients can freely choose their preferred frame 4 and can replace the frame 4 separately according to their needs. Moreover, the simplified frame 4 can extend the service life of the components. There is no need for the frame 4 and other components to undergo multiple disassembly and wear, and it is also simpler in cleaning and manufacturing.

[0091] The following will illustrate several structures of the respiratory mask with a foam pad according to the present invention with specific examples.

[0092] Example 1

[0093] The patient interface assembly 1 of this embodiment is configured to longitudinally contact the area between the patient's nose bridge and chin and form a seal for the patient's oral and nasal airways, or longitudinally contact the area between the patient's nose bridge and upper lip and form a seal for the patient's nasal airway, and connect a device that transmits positive pressure air or breathable gas and the patient's airway for medical treatment. It includes a patient interface pad 2, a frame 4, an elbow assembly 3, and a quick-release connector 6. The patient interface pad 2 is provided with a front interface end 21 connected to the elbow assembly 3 and at least seals the rear interface end 22 of one of the patient's airways; the elbow assembly 3 is directly connected to the front interface end 21 of the patient interface pad 2 and can rotate relative to each other, and the quick-release connector 6 is connected to the elbow assembly 3 and can rotate relative to each other; an exhaust port 5 is provided on the patient interface assembly 1 to allow the patient's exhaled waste gas to flow from the inside of the assembly to the outside.

[0094] Such as Figure 5 and Figure 6As shown, the exhaust port 5 can be provided on the patient interface pad 2 or the elbow assembly 3. The exhaust port 5 is a through-opening. Its form can be a row of small-diameter openings arranged in a sheet or a circle with a contour shape, or a large-diameter opening connected to an exhaust net with a noise reduction function. When the exhaust port 5 is a sheet or a circle of exhaust holes, the outer diameter of the holes is larger than the inner diameter, which can reduce the noise of the air flow jet, allow the air flow to quickly pass through the small holes and be discharged, and avoid the formation of turbulence and eddy currents caused by blockage, thereby generating noise. When the exhaust port 5 is connected to a noise reduction net, the noise reduction net can be a net formed by natural fabric or a net formed by a process. Due to the material and structure of the noise reduction net, when the air flow passes through the exhaust port 5, it can be dispersed by the noise reduction net on the exhaust port 5 and flow to the outside, so as to achieve the purpose of reducing noise. Specifically, as Figure 5 shown, the exhaust port 5 is provided on the elbow assembly 3. The optimal effect of the exhaust port 5 is to be provided on the first end 321 of the connecting member 32 in the elbow assembly 3 or on the projection of the first interface end 311 of the elbow 31 onto the annular channel 313. This can enable the exhaled waste gas of the patient to flow out of the elbow assembly 3 in a straight line direction to the outside, prevent the exhaled waste of the patient from colliding with the positive pressure oxygen provided by the ventilator, maintain the patency of the airway, and the exhaust port 5 provided on the elbow assembly 3 is far from the patient's ear, which can reduce the overall noise of the patient interface assembly 1 by controlling the distance and is more friendly to patients with high requirements for the sleep environment. Further, as Figure 6 shown, the exhaust port 5 is provided on the patient interface pad 2, closer to the patient's oral and nasal airway, which can effectively discharge the carbon dioxide and waste gas exhaled by the patient, prevent the repeated inhalation of waste gas, and when the gas passes through the exhaust port 5 provided on the patient interface pad 2, the rushing air flow will appropriately lift the patient interface pad 2 upward, which can reduce the pressure of the patient interface pad 2 on the face and reduce the foreign body sensation of the patient using the patient interface assembly 1.

[0095] In another embodiment, as Figure 7 and Figure 8As shown, the exhaust port 5 can be used in conjunction with an external connector 7. The external connector 7 includes an external connection buckle and noise reduction material. The external connection buckle can be externally connected to the surface of the exhaust port 5. The outer edge of the external connection buckle is larger than the outer contour of the exhaust port 5, so that the exhaust port 5 is enclosed in the external connector 7; while the noise reduction material can be directly placed between the external connection buckle and the exhaust port 5, or can be connected to the external connection buckle. The connection methods can be hot pressing, gluing, etc.; the form of the noise reduction material can be natural fabric-like or industrially woven mesh-like, ensuring that there are enough gaps in the noise reduction material to discharge the exhaust gas, and the air flow can be dispersed through the gaps to achieve the purpose of noise reduction; the noise reduction material can be polyester fiber, glass fiber, polyethylene, polyurethane, rubber or porous material, etc. The patient can choose whether to wear the external connector 7 according to their own preference: for patients with a large exhaled gas flow rate, they can choose the patient interface component 1 with only noise reduction holes, which can help discharge the waste gas more quickly, while for patients with a small or normal exhaled gas flow rate, they can choose the patient interface component 1 with the external connector 7, which can help the patient create a more comfortable and quiet sleeping environment.

[0096] Example 2

[0097] The patient interface component 1 of this embodiment is configured to longitudinally contact the area between the patient's nose bridge and chin and form a seal for the patient's oral and nasal airways, or longitudinally contact the area between the patient's nose bridge and upper lip and form a seal for the patient's nasal airway, and connect a device that transmits positive pressure air or breathable gas and the patient's airway for medical treatment. It includes a patient interface pad 2, a frame 4, an elbow assembly 3, and a quick-release connector 6. The patient interface pad 2 is provided with a front interface end 21 connected to the first interface end 311 of the elbow 31 in the elbow assembly 3, and a rear interface end 22 that seals at least one airway of the patient; the elbow assembly 3 includes an elbow 31. The elbow 31 is provided with a first interface end 311 directly connected to the front interface end 21 of the patient interface pad 2, and the elbow 31 and the patient interface pad 2 can rotate relative to each other. The elbow 31 is connected to the quick-release connector 6 at a second interface end 312, and the two can rotate relative to each other; an exhaust port 5 is provided on the patient interface component 1, allowing the patient's exhaled waste gas to flow from the inside of the component to the outside.

[0098] As Figure 14 shown, the elbow assembly 3 and the patient interface pad 2 can be connected in various ways to achieve the purpose that the elbow assembly 3 can rotate relative to the patient interface pad 2 in at least one plane. Specifically, as Figure 14 -A shows, the elbow assembly 3 only includes an elbow 31 connected to the patient interface pad 2. The connection method between the elbow assembly 3 and the patient interface pad 2 can be a buckle, a snap button, etc., to achieve 360° rotation of the elbow assembly 3 in a plane parallel to the front interface end 21 of the patient interface pad 2. The exhaust port 5 can be provided on the patient interface pad 2 or the elbow 31; asFigure 14 As shown in -B, the elbow assembly 3 only includes an elbow 31 connected to the patient interface pad 2. The connection method between the elbow assembly 3 and the patient interface pad 2 can be one or more of hinge, ball and socket, snap, etc., so as to realize the rotation of the elbow assembly 3 in a plane perpendicular to the coronal plane of the patient interface pad 2. The exhaust port 5 can be arranged on the patient interface pad 2 or the elbow 31; For example Figure 14 As shown in -C, the elbow assembly 3 only includes an elbow 31 connected to the patient interface pad 2. The deformable material of the elbow 31 can be silicone, thermoplastic elastomer, etc. Due to the deformable material characteristics of the elbow 31, the elbow 31 can complete the engagement with the patient interface pad 2 through its own deformation, reducing the possibility of wear on the elbow 31 caused by the patient inserting and removing the elbow 31, and the deformable material can reinforce the sealing of the connection gap, improving the airtightness of the overall assembly.

[0099] Example 3

[0100] The patient interface assembly 1 of this embodiment is configured to longitudinally contact the area between the patient's nose bridge and chin and form a seal for the patient's oral and nasal airways, or longitudinally contact the area between the patient's nose bridge and upper lip and form a seal for the patient's nasal airway, and connect a device that transmits positive pressure air or breathable gas and the patient's airway for medical treatment. It includes a patient interface pad 2, a frame 4, an elbow assembly 3 and a quick-release connector 6. The patient interface pad 2 is provided with a front interface end 21 connected to the first interface end 311 of the elbow 31 in the elbow assembly 3, and at least seals the rear interface end 22 of one of the patient's airways; The elbow assembly 3 includes a connector 32 and an elbow 31. The connector 32 is provided with a first end 321 directly connected to the front interface end 21 of the patient interface pad 2 and the connector 32 can rotate relative to the patient interface pad 2, a second end 322 connected to the first interface end 311 of the elbow 31 and the connector 32 can rotate relative to the elbow 31. The elbow 31 is provided with a first interface end 311 directly connected to the front interface end 21 of the patient interface pad 2 or the second end 322 of the connector 32 and the elbow 31 can rotate relative to the patient interface pad 2 or the connector 32, and a second interface end 312 connected to the quick-release connector 6 and the elbow 31 can rotate relative to the quick-release connector 6; An exhaust port 5 is arranged on the patient interface assembly 1 to allow the patient's exhaled waste gas to flow from the inside of the assembly to the outside.

[0101] For example Figure 15As shown in -A, the elbow assembly 3 includes a connecting member 32 connected to the patient interface pad 2 and an elbow 31 connected thereto. The connecting member 32 can be connected to the patient interface pad 2 by means of snap fasteners, press buttons, etc., so as to enable the connecting member 32 to rotate 360° in a plane parallel to the front interface end 21 of the patient interface pad 2. The connection mode between the elbow 31 and the connecting member 32 can be one or more of hinge, ball and socket, snap fastener, etc., so as to enable the elbow 31 to rotate relative to the connecting member 32 in a plane perpendicular to the coronal plane of the patient interface pad 2. The elbow assembly 3 can rotate 360° relative to the patient interface pad 2 in a plane parallel to the front interface end 21 of the patient interface pad 2 and rotate relative to the patient interface pad 2 in a plane perpendicular to the coronal plane of the patient interface pad 2. As Figure 15 As shown in -A, the exhaust port 5 can be provided on the elbow 31, as Figure 15 As shown in -B, the exhaust port 5 can be used in combination with an external connecting member 7, as Figure 15 As shown in -D, the exhaust port 5 can be provided on the connecting member 32; as Figure 15 As shown in -C, the elbow assembly 3 includes a connecting member 32 connected to the patient interface pad 2 and an elbow 31 connected thereto. The connection mode between the connecting member 32 and the patient interface pad 2 can be one or more of ball and socket, hinge, etc., and rotate relative to the connecting member 32 in a plane perpendicular to the coronal plane of the patient interface pad 2. The connection mode between the elbow 31 and the connecting member 32 can be snap fasteners, press buttons, etc., so as to enable the connecting member 32 to rotate 360° in a plane parallel to the front interface end 21 of the patient interface pad 2. The elbow assembly 3 can rotate 360° relative to the patient interface pad 2 in a plane parallel to the front interface end 21 of the patient interface pad 2 and rotate relative to the patient interface pad 2 in a plane perpendicular to the coronal plane of the patient interface pad 2. The exhaust port 5 can be provided on the elbow assembly 3 or on the patient interface pad 2.

[0102] Example 4

[0103] The patient interface assembly 1 of this embodiment is configured to longitudinally contact the area between the patient's nose bridge and chin and form a seal for the patient's oral and nasal airways, or longitudinally contact the area between the patient's nose bridge and upper lip and form a seal for the patient's nasal airway, and connect a device for transmitting positive pressure air or breathable gas and the patient's airway for medical treatment, including a patient interface pad 2, a frame 4, an elbow assembly 3 and a quick-release connector 6. The patient interface pad 2 is provided with a front interface end 21 connected to the elbow assembly 3 and at least seals the rear interface end 22 of one airway of the patient; the elbow assembly 3 is directly connected to the front interface end 21 of the patient interface pad 2 and can rotate relatively, and the quick-release connector 6 is connected to the elbow assembly 3 and can rotate relative to each other; an exhaust port 5 is provided on the patient interface assembly 1 to allow the patient's exhaled waste gas to flow from the inside of the assembly to the outside.

[0104] As Figure 16As shown, the frame 4 and the elbow assembly 3 can be in two forms: 1) they are detachable, 2) they are non-detachable. When the patient interface assembly 1 has the form that the elbow assembly 3 and the frame 4 are detachable, it is convenient for the patient to easily disassemble, clean and maintain the assembly, avoiding dead corners where dirt and bacteria can hide, which helps to keep the assembly hygienic; when the patient interface assembly 1 has the form that the elbow assembly 3 and the frame 4 are non-detachable, it is more convenient for the patient to assemble, and the structure is more stable. The firm contact between the frame 4 and the elbow assembly 3 ensures that the product will not move or loosen during use, guaranteeing the usage experience of the overall assembly.

[0105] Implementing the breathing mask with a foam pad of the present invention has at least the following beneficial effects:

[0106] 1) Reducing the connection steps between components, reducing the failure points, lowering the failure rate during the operation of the entire product, and increasing the airtightness of the overall assembly. Most of the masks or nasal mask systems in the market are assembled through the connection method of the patient interface pad 2 - frame 4 - elbow 31. This common method contains two uncontrollable air leakage risks - between the patient interface pad 2 and the frame 4, and between the frame 4 and the elbow 31. And the complex and lengthy installation steps may increase the risk of operation errors, resulting in incorrect or incomplete assembly, thereby affecting the performance and reliability of the product, and problems such as poor product sealing, improper matching, and wear and tear may occur. When the patient is not familiar with the assembly process of the components, it is very likely that air leakage will occur after assembly. And there are at least 4 - 5 basic connections in the entire treatment system, increasing the difficulty for the patient to troubleshoot the cause of air leakage; after long-term use by the patient, since the patient interface assembly 1 needs to be frequently disassembled and cleaned, the seal of the connection is very likely to be damaged by the outside world, resulting in a decrease in airtightness. Connecting the patient interface pad 2 directly to the elbow assembly 3 and omitting the step of connecting the patient interface pad 2 to the frame 4 has the following advantages: a. The gas only needs to directly pass through one pipeline in the patient interface assembly 1, and there are fewer gaps when flowing through the pipeline, which can reduce the overall air leakage risk of the assembly; b. Simplifying the installation steps, when the patient assembles the components, there is no need to install them one by one. Just position the frame 4 on the surface of the patient interface pad 2 and connect the elbow assembly 3 to the patient interface pad 2. An area for accommodating the frame 4 will be automatically formed between the patient interface pad 2 and the elbow assembly 3 and can limit the relative displacement between the frame 4 and the two, making it easier for the patient to assemble the new product; c. Redesigning the installation steps, simplifying the connection points from two to one, making the overall structure of the entire breathing accessory simpler, which can reduce the chance of errors during installation, reduce the occurrence of poor or incorrect assembly. By designing a user-friendly installation interface and providing clear guidance, through an easy-to-operate assembly method, it is convenient for the user to more easily complete the assembly of the product and reduce potential failure points during installation, lowering the failure rate during the operation of the entire product.

[0107] 2) Modular configuration, more choices. Since the step of installing the frame 4 is removed, the importance of the frame 4 in the installation step is weakened. The frame 4 is limited to a certain extent by the groove formed by connecting the baffle 34 of the elbow assembly 3 with the patient interface pad 2. Therefore, the basic part of the frame 4 only needs to include a side wall that can accommodate part of the face mask, a through opening 41 that allows the elbow assembly 3 to pass through and the patient interface pad 2, and an opening 41 that cooperates with the face mask positioning member 25 of the frame 4. Excluding the basic part, the frame 4 can have more choices in terms of shape. Corresponding frames 4 can be provided for patients with different needs or preferences. There is no need to design frames 4 with different connection methods corresponding to different elbows 31 and patient interface pads 2, and there is no need to consider the impact of the frame 4 on the overall airtightness of the components. Only the comfort of the patient's wearing needs to be focused on. In production, the basic connection structure between the patient interface pad 2 and the elbow assembly 3 is also simplified. Important functional structures such as exhaust holes and anti-asphyxia valves 33 do not need to be changed. The reduction of the processing steps of the overall connection structure means that on the premise that the connection structure between the elbow assembly 3 and the patient interface pad 2 is determined, only a frame 4 with a simple structure needs to be developed modularly, which greatly reduces the processing complexity and R & D cost of the patient interface assembly 1, and at the same time, diverse frame 4 configurations can be provided to meet various needs of users.

[0108] 3) The connection between components is more stable. Compared with the connection of the patient interface pad 2 - frame 4 - elbow 31, the connection method of the patient interface pad 2 - elbow assembly 3 is more stable. The direct connection design of the elbow assembly 3 and the patient interface pad 2 adds radial support of the elbow assembly 3 to the frame 4 and the restriction and fixation of the frame 4 by the baffle 34 of the elbow assembly 3 on the original connection basis. The connection points are also simplified from two to one and are not easy to loosen. Without applying external force, in the connection method of the patient interface pad 2 - frame 4 - elbow 31, the patient interface pad 2 is pulled by the gravity of both the frame 4 and the elbow 31; while in the connection method of the patient interface pad 2 - elbow assembly 3, the patient interface pad 2 is only pulled by the gravity of the elbow assembly 3. Comparing the two, the former assembly method increases the risk of the patient interface assembly 1 falling off under the action of tension, while the design of the latter assembly method reduces the risk of component detachment, is more stable and not easy to fall off.

[0109] 4) Compared with other products with quick-release elbows 31, it has fewer components and a lighter overall weight. Most existing products are directly connected to the frame 4 through elbow assemblies 3 with clip structures on both sides, and the lower end of the elbow 31 is then detachably connected to the gas supply hose. At this time, the quick-release connection structure in the elbow assembly 3 increases the weight of the patient interface system. Therefore, the quick-release system on the elbow assembly 3 is independently separated and designed to be directly detachably connected between the elbow assembly 3 and the patient interface pad 2, achieving the purpose of reducing the overall weight of the patient interface assembly 1. The quick-release parts can be selected according to the patient's personal wearing preferences. When the patient interface assembly 1 is directly connected through the elbow 31, the overall components of the assembly are more lightweight and easier to use compared to the existing mask system. By simplifying the structure of the elbow 31 to reduce weight and reducing the components on the elbow 31 to achieve a reduction in the overall number of components.

[0110] The structure of a single component is simplified, which can reduce costs, and is easier to clean and more environmentally friendly: a) The connecting buckle structure is removed in the design of the frame 4, and the model structure is simpler, which can reduce the processing steps and complexity, and reduce the costs in the processing and manufacturing process; accordingly, the production of the mold and the way of mold opening are changed, reducing the investment and maintenance costs of the equipment and molds; the simple component structure is easier to conduct quality inspection and control, reducing the generation of defective products and the inspection costs; the simplified structure brings a smaller volume and a lighter weight, making it easier to stack and place the components, reducing the transportation costs; when the frame 4 component is damaged, only the new frame 4 component needs to be replaced, and there are more choices without considering the connection problems between components, bringing a more comfortable experience to the patient. The modular combination of components can, for production, improve the service life of each component, contribute to reducing energy consumption and waste in the production process. By reducing energy consumption and waste and recycling and reusing some components, the carbon emissions in production are reduced, protecting the environment. b) The model of the frame 4 is simplified, and the models of the patient interface pad 2 and the elbow assembly 3 can also be adjusted accordingly to be simpler and easier to use. There are fewer connecting and fixing elements in the assembly, so it is easier to disassemble and clean when cleaning; the simple structure reduces the sanitary dead corners and complex concave and convex surfaces, reducing the chance of accumulation of impurities and dirt, making the cleaning process easier and more thorough; complex components may require more cleaning agents and tools to be cleaned thoroughly, while simple components only need less dosage to achieve the same effect, reducing the use of chemical cleaning agents, saving energy and time, and contributing to environmental protection.

Claims

1. A patient interface component configured to longitudinally contact the area between the patient's nose bridge and chin and form a seal with the patient's oral and nasal airway, or longitudinally contact the area between the patient's nose bridge and upper lip and form a seal with the patient's nasal airway, and connect a device for delivering positive pressure air or breathable gas and the patient's airway for medical treatment, the patient interface component comprising: Patient interface pad, including a front interface end, a rear interface end, a support member at least partially fitting against the side wall of the frame, a seal with a buffer structure, and a positioning member in contact with the frame. The front interface end of the patient interface pad is configured to be connected to an elbow assembly, and the rear interface end is configured to at least seal one airway of the patient; Elbow assembly, having a first interface end, a second interface end, and an elbow with an axially curved annular channel. A fixing structure is provided on the elbow and is configured to be connected to the front interface end of the patient interface pad. A baffle is provided on the elbow assembly for restricting the front-back displacement of the frame; Frame, including a positioning portion, at least one through opening, and support pieces extending from the opening in all directions. The positioning portion is configured to position the frame onto the patient interface pad; And An exhaust port is provided on the patient interface pad, allowing exhaled waste gas to flow from the inside of the patient interface pad to the outside; Wherein, the positioning member has a contour shape that mates with the positioning portion on the frame and is configured to restrict the relative rotation between the frame and the patient interface pad.

2. The patient interface component according to claim 1, wherein, The patient interface pad can be a nasal mask or a face mask, and the rear interface of the patient interface pad at least seals the nasal airway of the patient.

3. The patient interface component according to claim 1, wherein, The buffer structure of the seal can be a bellows shape or an air cushion.

4. The patient interface component according to claim 1, wherein, The baffle on the elbow assembly includes, but is not limited to, any continuous or discontinuous contour shapes such as circular, triangular, square, etc.

5. A patient interface component configured to longitudinally contact the area between the patient's nose bridge and chin and form a seal with the patient's oral and nasal airway, or longitudinally contact the area between the patient's nose bridge and upper lip and form a seal with the patient's nasal airway, and connect a device for delivering positive pressure air or breathable gas and the patient's airway for medical treatment, the patient interface component comprising: Patient interface pad, including a front interface end, a rear interface end, a support member at least partially fitting against the side wall of the frame, a seal with a buffer structure, and a positioning member in contact with the frame. The front interface end of the patient interface pad is configured to be connected to an elbow assembly, and the rear interface end is configured to at least seal one airway of the patient; Elbow assembly, including a connecting member having a first end and a second end, an elbow having a first interface end, a second interface end, and an axially curved annular channel. The first end of the connecting member is provided with a fixing structure configured to be connected to the front interface end of the patient interface pad, and the second end is configured to be connected to the first interface end of the elbow. A baffle is provided on the elbow assembly for restricting the front-back displacement of the frame; Frame, including a positioning portion, at least one through opening, and support pieces extending from the opening in all directions. The positioning portion is configured to position the frame onto the patient interface pad; And An exhaust port is provided on the elbow assembly, allowing exhaled waste gas to be discharged from the elbow assembly to the external environment; Wherein the positioning member has a contour shape that mates with the positioning portion on the frame and is configured to restrict the relative rotation between the frame and the patient interface pad.

6. The patient interface component according to claim 5, wherein, The fixing structure of the connecting member of the elbow assembly is one or more of a hinge, a ball and socket, a snap, and a magnet for connecting to the front interface end of the patient interface pad.

7. The patient interface component according to claim 5, wherein, The connection manner between the connecting member and the elbow is one or more of a hinge, a ball and socket, a snap, and a magnet.

8. The patient interface component according to claim 5, wherein, The overall height range of the elbow assembly is 30 - 80 mm.

9. A patient interface component configured to longitudinally contact the area between the patient's nose bridge and chin and form a seal with the patient's oral and nasal airway, or longitudinally contact the area between the patient's nose bridge and upper lip and form a seal with the patient's nasal airway, and connect a device for delivering positive pressure air or breathable gas and the patient's airway for medical treatment, the patient interface component comprising: Patient interface pad, including a front interface end, a rear interface end, a support member at least partially conforming to the side wall of the frame, a seal with a buffer structure, and a positioning member in contact with the frame. The front interface end of the patient interface pad is configured to be connected to the first interface end of the elbow assembly, and the rear interface end is configured to at least seal one airway of the patient; Elbow assembly, having a first interface end, a second interface end, and an elbow with an axially curved annular channel. A fixing structure is provided on the elbow and is configured to be connected to the front interface end of the patient interface pad. The second interface end is configured to be rotatably connected to a quick-release connector. A baffle is provided on the elbow assembly to limit the front and rear displacement of the frame; Frame, including a positioning portion, at least one through opening, and support sheets extending from the opening in all directions. The positioning portion is configured to position the frame onto the patient interface pad; The positioning member has a contour shape conforming to the frame portion and is configured to limit the relative rotation between the frame and the patient interface pad; Quick-release connector, having an upper end, a lower end, and a fixing member. The upper end is configured to be detachably directly connected to the second interface end of the elbow assembly; and An exhaust port is provided on the patient interface pad to allow exhaled waste gas to flow from the inside of the patient interface pad to the outside; Wherein, without being subjected to external force, the force for connecting the patient interface pad and the elbow assembly is greater than the separating force.

10. The patient interface component according to claim 9, wherein, The fixing structure on the elbow assembly is one or more of a hinge, a ball socket, a buckle, and a magnet.

11. The patient interface component according to claim 9, wherein, The form of the positioning member can be a protrusion, a groove, a magnet, a contour, and the shape can be any shape such as a circle, a triangle, a square, etc.

12. The patient interface component according to claim 9, wherein, The positioning portion on the frame is any shape such as a circle, a triangle, a square, etc. that matches the positioning member.

13. A patient interface component configured to longitudinally contact an area between a patient's nose bridge and chin and form a seal with the patient's oral and nasal airways, or longitudinally contact an area between the patient's nose bridge and upper lip and form a seal with the patient's nasal airway, and connect a device for delivering positive pressure air or breathable gas and the patient's airway for medical treatment, the patient interface component comprising: Patient interface pad, including a front interface end, a rear interface end, a support member at least partially conforming to the side wall of the frame, a seal with a buffer structure, and a positioning member in contact with the frame. The front interface end of the patient interface pad is configured to be rotatably directly connected to the first interface end of the elbow assembly, and the rear interface end is configured to at least seal one airway of the patient; Elbow assembly, having a first interface end, a second interface end, and an elbow with an axially curved annular channel. A fixing structure is provided on the elbow and is configured to be connected to the front interface end of the patient interface pad. The second interface end is configured to be rotatably connected to a quick-release connector. A baffle is provided on the elbow assembly to limit the front and rear displacement of the frame; Frame, including a positioning portion, at least one through opening, and support sheets extending from the opening in all directions. The positioning portion is configured to position the frame onto the patient interface pad; An exhaust port is provided on the elbow assembly to allow exhaled waste gas to flow from the inside of the patient interface pad to the outside; and Quick-release connector, having an upper end, a lower end, and a fixing member. The upper end is configured to be detachably directly connected to the second interface end of the elbow assembly; Wherein, the positioning member has a contour shape cooperating with the positioning portion on the frame and is configured to limit the relative rotation between the frame and the patient interface pad.

14. The patient interface component according to claim 13, wherein, The support sheet on the frame is any contour extending from the periphery of the opening toward the side facing the face.

15. The patient interface component according to claim 13, wherein, The form of the exhaust port can be a through-opening or a mesh. When the exhaust port is a mesh, the material of the exhaust port is a noise-reducing material.

16. The patient interface component according to claim 13, wherein, The fixing member of the quick-release connector is provided at the upper end of the quick-release connector, and the fixing member can be a clip, a buckle, or a magnet.

17. A patient interface component configured to longitudinally contact an area between a patient's nose bridge and chin and form a seal with the patient's oral and nasal airways, or longitudinally contact an area between the patient's nose bridge and upper lip and form a seal with the patient's nasal airway, and connect a device for delivering positive pressure air or breathable gas and the patient's airway for medical treatment, the patient interface component comprising: The patient interface pad includes a front interface end, a rear interface end, a support member that at least partially adheres to the side wall of the frame, a seal with a buffer structure, and a positioning member that contacts the frame. The front interface end of the patient interface pad is configured to be directly connected to the first interface end of the elbow assembly, and the rear interface end is configured to at least seal one airway of the patient. The front interface end of the patient interface pad has an outer opening, an inner opening, and an annular wall, and the diameter of the outer opening is greater than the diameter of the inner opening. The elbow assembly includes an elbow having a first interface end, a second interface end, and an axially curved annular channel, and an anti-asphyxia valve having a silicone sheet and an anti-asphyxia valve. A fixing structure is provided on the elbow and is configured to be connected to the front interface end of the patient interface pad. At least one anti-asphyxia valve is configured to be provided on the elbow, and a baffle is provided on the elbow assembly to limit the front-rear displacement of the frame. The frame includes a positioning portion, at least one through-opening, and support sheets extending from the opening to the surroundings. The positioning portion is configured to position the frame to the patient interface pad. The positioning member has a contour shape that cooperates with the positioning portion on the frame and is configured to limit the relative rotation between the frame and the patient interface pad; and An exhaust port is provided on the elbow assembly to allow the exhaled waste gas to be discharged from the elbow assembly to the external environment; Wherein, without being acted upon by an external force, the force for connecting the patient interface pad and the elbow assembly is greater than the separating force.

18. The patient interface component according to claim 17, wherein The anti-asphyxia valve can be any shape such as circular, oval, semi-circular, triangular, etc.

19. The patient interface component according to claim 17, wherein The connection manner between the support member and the seal of the patient interface pad can be one or more connection manners such as molding, gluing, and mechanical connection.

20. The patient interface component according to claim 17, wherein The form of the exhaust port can be a through-opening or a mesh. When the exhaust port is a hole, the exhaust port can be used in combination with an external connector. The external connector includes an external connection buckle and a noise-reducing material.

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