Liner assembly for user respiration assisting equipment and preparation method thereof

Abstract

The invention relates to a liner assembly for a user breathing assistance device and a preparation method thereof, the liner assembly comprises a sealing piece, a supporting piece and a non-detachable whole body formed by the sealing piece and the supporting piece, the supporting piece is provided with a first interface and a second interface, and the whole body and a contained user breathing organ form a pressurizable cavity when used; the sealing piece comprises a first end and a second end, and the second end is provided with a contour shape and a structure corresponding to the first interface so as to ensure the sealing joint with the first interface; the first end is provided with an opening, and the material, the elasticity and the structural shape of the opening part are arranged to be fit with the facial contour of a user; the elasticity of the material of the sealing piece is greater than or equal to that of the supporting piece; the face of a user is prevented from extruding the supporting piece during use, the use stability of the liner assembly is achieved, the liner assembly is attached to the face of the user, and the comfort degree of using the breathing auxiliary equipment is improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly relates to a gasket assembly for a user breathing assistance device and a preparation method thereof. Background Art

[0002] Obstructive sleep apnea refers to the situation where breathing is interrupted during sleep due to obstruction of the upper respiratory tract. The main causes of upper respiratory tract obstruction are: congenital narrowing of the upper respiratory tract, relaxation of pharyngeal soft tissues during sleep blocking the respiratory tract, and narrowing of the respiratory tract during sleep. The symptoms include snoring at night, daytime sleepiness, morning headache, etc. And in severe cases, it will cause chronic diseases and lead to damage to multiple organs and systems, such as hypertension, heart disease, diabetes, stroke, and arrhythmia. The treatment methods for obstructive sleep apnea are divided into surgical treatment and non-surgical treatment. Among them, non-surgical treatment includes oral appliances and airway positive pressure ventilation treatment. Airway positive pressure ventilation treatment is to wear a mask system during sleep, and blow pressurized indoor air into the upper respiratory tract through a tube connecting the machine and the mask system to help keep the airway open and prevent collapse during sleep. It is a safe and effective treatment method for obstructive sleep apnea at present. Since obstructive sleep apnea may occur in various age groups, there are extremely high requirements for the components of airway positive pressure ventilation treatment, especially the gasket assembly. It is required that the mask system can not only ensure the treatment effect (effective sealing) but also take into account the user experience (comfort). When the user uses an inappropriate or uncomfortable gasket assembly, problems such as air leakage, red nose bridge, and oral pain may occur during the treatment process. In order to provide a better experience for the user, various types of gasket assemblies have been developed for the mask system for the user to choose their favorite type, which can be mainly divided into: nasal mask (a small mask attached to the nose or inserted into the nostrils), and face mask (covering the mouth and nose). Not only is the gasket assembly diversified, but the frame, headband, elbow and other components matched with it also extend different forms. However, in the design process, the most important part is still the gasket assembly, more precisely, the seal in the gasket assembly that fits and seals with the face.

[0003] The gasket assembly needs to fit the human face for a long time, seal with the facial contour while ensuring comfort, avoid pressing the face, and needs to be suitable for most users. In the design process, it is necessary to consider the facial contours of different age groups, different groups, and different ethnic groups. After the initial design is completed, it is also necessary to collect the wearing conditions of volunteers and feedback information to modify the gasket assembly of the mask system, and repeated modifications are required to complete the entire design process. It can be seen that the complete design process of the gasket assembly is cumbersome and lengthy, so the design of the gasket assembly is the most important but also the most difficult part in the design of the mask system.

[0004] Therefore, there is a need for a new gasket assembly for a user's breathing assistance device and its preparation method to overcome the limitations of the prior art, meet different usage scenarios and requirements, increase the diversity of options for users to use the assistance device, and effectively compress the production cost and cycle of the product through standardized interface design. Summary of the Invention

[0005] The object of the present invention is to provide a gasket assembly and a preparation method for a user's breathing assistance device. By using this gasket assembly and its preparation method, on the premise of ensuring the sealing and comfort of the user when using the breathing assistance device, the production cost and cycle of the product can be effectively compressed through the standardized interface design of the present invention.

[0006] A gasket assembly for a user's breathing assistance device provided according to the present invention is characterized in that it includes an inseparable whole formed by a sealing member (1) for fitting the user's face and a support member (2) fixedly connected to the sealing member (1). The support member (2) has a first interface (21) connected to the sealing member (1) and a second interface (22) for receiving pressurized gas from the assistance device. The perimeter of the edge of the first interface (21) is greater than the perimeter of the edge of the second interface (22). When in use, the whole forms a pressurizable cavity with the user's respiratory organs accommodated therein. The sealing member (1) includes a first end (11) for contacting the user's face and a second end (12) for connecting to the support member (2). The second end (12) and the first end (11) are an integrated structure with a continuous curved surface. The second end (12) has a contour shape and structure corresponding to the first interface (21) to ensure a sealed engagement therewith. The first end (11) has an opening that can at least accommodate the user's nose to enter the pressurizable cavity. The material, elasticity, and structural shape of the opening part are set to ensure fitting the user's facial contour. The wall thickness of part of the material of the second end (12) is at least partially greater than the material thickness of the first end (11) to prevent the user's face from squeezing the support member (2) during use. The elasticity of the material of the sealing member (1) is greater than or equal to that of the support member (2).

[0007] Among them, for the gasket assemblies of different users or / and different breathing assistance devices, the fixed connection interface between the second end (12) of the sealing member (1) and the first interface (21) of the support member (2) is the same.

[0008] In the gasket assembly provided by the present invention, the sealing member (1) further includes at least one compliant zone to adapt to the part with a large change in facial contour, so as to closely fit the user's face. The compliant zone is provided in the bridge of the nose area or the chin area, and the wall thickness of the sealing member (1) in the compliant zone is 0.2 - 1 mm.

[0009] In the gasket assembly provided by the present invention, the seal (1) is made of a first material, and the first material includes at least one of polyamide, ABS, polycarbonate, PVC, polypropylene, and polyethylene. The hardness range of the first material is 10-70 on the Shore A scale.

[0010] In the gasket assembly provided by the present invention, the support (2) is made of a second material, and the second material has at least one of the following characteristics: 1. The density range is 0.8-1.8 g / m3; 2. The melting point is 130-300 °C; 3. The Young's modulus is 1-4 GPa.

[0011] In the gasket assembly provided by the present invention, the second interface (22) of the support (2) is circular, and the diameter range of the circular interface is 10-40 mm.

[0012] In the gasket assembly provided by the present invention, the fixed connection between the support (2) and the seal (1) includes physical connection, chemical connection, and through an intermediate layer. The physical connection includes molding, co-molding, welding, and snap-fastening. The chemical connection includes surfactant connection and gluing. Among them, any fixed connection interface is between the first interface (21) of the support (2) and the second end (12) of the seal (1).

[0013] In the gasket assembly provided by the present invention, the gasket assembly further includes a frame (4) for supporting the gasket assembly. The frame (4) includes a connecting portion (41) connected to the support (2) and a supporting portion (42) in contact with the user. The frame (4) has a connecting port, and the connecting port is located at the center of the connecting portion (41). The frame (4) is sleeved on the second interface (22) end of the support (2) through the connecting port. The support (2) is provided with a positioning assembly for realizing the connection and positioning between the frame (4) and the support (2).

[0014] A gasket assembly for a user breathing assistance device provided by the present invention is characterized in that it comprises an integral non-detachable unit formed by a seal (1) for fitting to the user's face and a support member (2) fixedly connected to the seal (1), so as to form a pressurizable cavity with the accommodated user's respiratory organs during use. The partial shape and size of the seal (1) depend on the user's facial size and contour, and the partial size and shape of the support member (2) depend on the breathing assistance device. The support member (2) has a first interface (21) connected to the seal (1) and a second interface (22) for receiving pressurized gas from the assistance device. The seal (1) includes a first end (11) for contacting the user's face and a second end (12) for connecting to the support member (2). The second end (12) has a contour shape corresponding to the first interface (21) and a structure to ensure a sealed engagement therewith. The gasket assemblies for different users or / and different breathing assistance devices have the same fixed connection interface between the second end (12) of the seal (1) and the first interface (21) of the support member (2). The fixed connection includes one of physical connection, chemical connection and intermediate layer connection;

[0015] The first end (11) has an opening that can at least accommodate the user's nose to enter the pressurizable cavity. In the static state, the opening edges of the first end (11) are at different horizontal levels to better fit the user's facial contour. The material, elasticity and structural shape of the opening part are set to ensure fitting to the user's facial contour; The wall thickness of part of the second end (12) is at least partially greater than the material thickness of the first end (11) to prevent the user's face from squeezing the support member (2) during use. The elasticity of the material of the seal (1) is greater than or equal to that of the support member (2); The perimeter of the edge of the first interface (21) is greater than that of the second interface (22) to buffer the pressurized gas from the breathing assistance device.

[0016] In the gasket assembly provided by the present invention, the seal (1) further includes at least one compliant zone to adapt to a part with a large change in facial contour, so as to closely fit the user's face. The compliant zone can be provided in the nasal bridge area or the chin area, and the wall thickness of the compliant zone is 0.2 - 1 mm.

[0017] In the gasket assembly provided by the present invention, the seal (1) is made of a first material, and the first material includes at least one of polyamide, ABS, polycarbonate, PVC, polypropylene, and polyethylene. The hardness range of the first material is 10 - 70 on the Shore A scale.

[0018] In the gasket assembly provided by the present invention, the support member (2) is made of a second material, and the second material has at least one of the following characteristics: 1. The density range is 0.8 - 1.8 g / m3; 2. The melting point is 130 - 300 °C; 3. The Young's modulus is 1 - 4 GPa.

[0019] In the gasket assembly provided by the present invention, the physical connection includes molding, co - molding, welding and snap - fitting, and the chemical connection includes surfactant connection and gluing.

[0020] In the gasket assembly provided by the present invention, the gasket assembly further includes a frame (4) for supporting the gasket assembly. The frame (4) includes a connecting portion (41) connected to the support member (2) and a supporting portion (42) in contact with the user. The frame (4) has a connection port, and the connection port is located at the center of the connecting portion (41). The frame (4) is sleeved on the second interface (22) end of the support member (2) through the connection port. A positioning assembly is provided on the support member (2) to realize the connection and positioning between the frame (4) and the support member (2).

[0021] A gasket assembly for a user breathing assistance device provided according to the present invention is characterized in that it comprises an integral non-detachable unit formed by a seal (1) for fitting to the user's face and a support member (2) fixedly connected to the seal (1), so as to form a pressurizable cavity with the accommodated user's respiratory organs during use. Part of the shape and size of the seal (1) depends on the user's facial size and contour, and part of the size and shape of the support member (2) depends on the breathing assistance device. The support member (2) has a first interface (21) connected to the seal (1) and a second interface (22) for receiving pressurized gas from the assistance device, and the peripheral circumference of the edge of the first interface (21) is greater than the peripheral circumference of the edge of the second interface (22); the seal (1) comprises a first end (11) for contacting the user's face and a second end (12) for connecting to the support member (2), and the second end (12) has a contour shape corresponding to the first interface (21) and a structure to ensure a sealed engagement therewith. For gasket assemblies of different users or / and different breathing assistance devices, there is the same fixed connection interface between the second end (12) of the seal (1) and the first interface (21) of the support member (2). The first end (11) has an opening that can at least accommodate the user's nose into the pressurizable cavity. When in a static state, the edges of the opening are at different horizontal planes to better fit the user's facial contour; the material, elasticity and structural shape of the opening part are set to ensure fitting to the user's facial contour; the wall thickness of part of the material of the second end (12) is at least partially greater than the material thickness of the first end (11) to prevent the user's face from squeezing the support member (2) during use. The elasticity of the material of the seal (1) is greater than or equal to that of the support member (2). The seal (1) further comprises a flexible clip (3), and the flexible clip (3) is arranged inside the opening of the second end (12) for engaging with the support member (2), and the first interface (21) is provided with an engaging portion meshing with the flexible clip (3).

[0022] In the gasket assembly provided by the present invention, the seal (1) further comprises at least one compliant zone to adapt to a part with a large change in facial contour, so as to closely fit the user's face. The compliant zone can be arranged in the nasal bridge area or the chin area, and the wall thickness of the compliant zone is 0.2 - 1 mm.

[0023] In the gasket assembly provided by the present invention, the seal (1) is made of a first material, and the first material is one of polyamide, ABS, polycarbonate, PVC, polypropylene, and polyethylene. The support (2) is made of a second material, and the second material is one of silica gel, rubber, and TPE. The hardness range of the first material is 10-70 on the Shore A scale. The wall thickness of the seal (1) is 0.2-1.5 mm. The second interface (22) is circular, and the diameter range of the circular interface is 10-40 mm.

[0024] In the gasket assembly provided by the present invention, the connection method between the support (2) and the seal (1) includes physical connection, chemical connection, or intermediate layer connection. The physical connection includes molding, co-molding, welding, or snap fitting. The chemical connection includes surfactant connection and gluing.

[0025] In the gasket assembly provided by the present invention, the second material has at least one of the following characteristics: 1. The density range is 0.8-1.8 g / m3; 2. The melting point is 130-300 °C; 3. The Young's modulus is 1-4 GPa.

[0026] In the gasket assembly provided by the present invention, the gasket assembly further includes a frame (4) for supporting the gasket assembly. The frame (4) includes a connecting portion (41) connected to the support (2) and a supporting portion (42) in contact with the user. The frame (4) has a connection port, and the connection port is located at the center of the connecting portion (41). The frame (4) is sleeved on the second interface (22) end of the support (2) through the connection port. A positioning assembly is provided on the support (2) to realize the connection positioning between the frame (4) and the support (2).

[0027] According to a preparation method of a gasket assembly for a user's breathing assistance device provided by the present invention, the gasket assembly is as described in claim 1. The feature is that the gasket assemblies for different users or / and different breathing assistance devices have the same fixed connection interface between the second end (12) of the seal (1) and the first interface (21) of the support (2). The preparation method includes the following steps:

[0028] Step S1, obtain a seal (1) with an opening meeting the requirements of the user's face, including a first end (11) and a second end (12);

[0029] Step S2: According to the dimensions and shape of the second end (12) of the seal (1) obtained, form the corresponding dimensions and shape of the first interface (21) of the support member (2), and determine the dimensions and shape of the second interface (22) of the support member (2) according to the requirements of the respiratory assistance device; prepare the support member (2) according to the dimensions and shape of the first interface (21) and the second interface (22).

[0030] Step S3: Fix and connect the seal (1) and the support member (2) into one body physically, chemically or by means of an intermediate member.

[0031] Wherein, the second end (12) and the first end (11) form a continuous curved surface, the wall thicknesses of the first end (11) and the second end (12) are uneven curved surfaces that vary, and the wall thickness of the second end (12) is at least partially greater than that of the first end (11).

[0032] In the gasket assembly provided by the present invention, Step S1 includes determining the opening dimensions and shape of at least one first end (11) of the seal (1) according to the ergonomic-related data obtained by statistical analysis, and determining the material of the seal (1) according to the requirements of comfort and airtightness.

[0033] According to a preparation method of a gasket assembly for a user's respiratory assistance device provided by the present invention, the gasket assembly is as described in Claim 1, characterized in that for the gasket assemblies of different users or / and different respiratory assistance devices, the fixed connection interface between the second end (12) of the seal (1) and the first interface (21) of the support member (2) is the same, and the preparation method includes the following steps:

[0034] Step S1: According to the requirements of the respiratory assistance device, determine the dimensions and shape of the support member (2), including the first interface (21) and the second interface (22), wherein the dimensions and shape of the second interface (22) meet the interface requirements of the respiratory assistance device.

[0035] Step S2: According to the dimensions and shape of the first interface (21) of the determined support member (2), form the corresponding dimensions and shape of the first end (11) of the seal (1), and determine the dimensions and shape of the second end (12) of the seal (1) according to the data of the user's respiratory organs and cheeks.

[0036] Step S3: Prepare the support member (2) according to the dimensions and shape of the first interface (21) and the second interface (22).

[0037] Step S4: Prepare the seal (1) according to the dimensions and shape of the first end (11) and the second end (12).

[0038] Step S4, fixedly connecting the seal (1) and the support (2) integrally in a physical, chemical or intermediate manner;

[0039] Wherein, the second end (12) and the first end (11) form a continuous curved surface, the wall thicknesses of the first end (11) and the second end (12) are non-uniform curved surfaces with variations, and the wall thickness of the second end (12) is at least partially greater than that of the first end (11).

[0040] A method for preparing the cushion assembly of the user breathing assistance device according to the present invention includes the following steps: Step S1, determining the size and shape of the support according to the requirements of the breathing assistance device, including a first interface and a second interface, wherein the size and shape of the second interface meet the interface requirements of the breathing assistance device; Step S2, forming the size and shape of the first end of the corresponding seal according to the size and shape of the first interface of the determined support, and determining the size and shape of the second end of the seal according to the data of the user's respiratory organs and cheeks; Step S3, preparing the support according to the sizes and shapes of the first interface and the second interface; Step S4, preparing the seal according to the sizes and shapes of the first end and the second end; Step S5, fixedly connecting the seal and the support integrally in a physical, chemical or intermediate manner; wherein, the second end and the first end form a continuous curved surface, the wall thicknesses of the first end and the second end are non-uniform curved surfaces with variations, and the wall thickness of the second end is at least partially greater than that of the first end.

[0041] A gasket assembly for a user breathing assistance device and a preparation method provided by the present invention. The gasket assembly forms an inseparable whole by a seal and a support, and this whole can form a pressurizable cavity with the user's face. When in use, the first end of the seal fits with the user's face to form a sealed pressurizable cavity, and the user's respiratory organs are accommodated in the pressurizable cavity through the opening at the first end. The second end of the seal is fixedly connected to the first interface of the support by physical, chemical or intermediate layer means. The second end of the seal corresponds to the first interface of the support in terms of size and shape, and the connection size between the seal and the support is maintained fixed, enabling the seal for cooperation with a nasal mask or a face mask to be connected to different supports to form multiple gasket assemblies with different supports, thereby meeting the needs of more users. Because during the R & D process, the seal requires more ergonomic-related data and a large number of comfort and airtightness tests, the R & D and production cycle of the seal is more complex than that of the support. By using the same seal to adapt to different supports, not only can the product development efficiency be improved, but also the R & D cycle of the gasket assembly can be effectively shortened. Moreover, the cost of the seal is relatively higher than that of the support. Using the same seal to prepare multiple different gasket assemblies can effectively reduce the production cost. Secondly, for the same seal, since the wall thickness, size, dimensions and structure are unchanged, the materials used are also the same. The seal part of different gasket assemblies can be prepared with the same material, which can avoid using multiple materials, save production resources, and different supports can meet different needs and markets, improving the application range of the gasket assembly. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] Figure 1 FIG. is a schematic structural diagram of a gasket assembly for a user breathing assistance device according to an embodiment of the present invention;

[0043] Figure 2 FIG. is an exploded view of a gasket assembly for a user breathing assistance device according to an embodiment of the present invention;

[0044] Figure 3 FIG. is a schematic diagram of the gasket assembly for a user breathing assistance device according to an embodiment of the present invention in cooperation with a nasal mask;

[0045] Figure 4 FIG. is a schematic diagram of the seal of the gasket assembly for a user breathing assistance device according to an embodiment of the present invention in cooperation with different supports;

[0046] Figure 5 FIG. is a schematic diagram of different side walls of the gasket assembly for a user breathing assistance device according to an embodiment of the present invention;

[0047] Figure 6Schematic diagram of physical connection for the gasket assembly of the user breathing assistance device in the embodiment of the present invention;

[0048] Figure 7 is Figure 6 Enlarged schematic diagram of the connection part of the connection method;

[0049] Figure 8 Another schematic diagram of physical connection for the gasket assembly of the user breathing assistance device in the embodiment of the present invention;

[0050] Figure 9 Schematic diagram of the gasket assembly of the user breathing assistance device in the embodiment of the present invention cooperating with a frame with a forehead support;

[0051] Figure 10 Another schematic diagram of the frame cooperation for the gasket assembly of the user breathing assistance device in the embodiment of the present invention;

[0052] Figure 11 Another schematic diagram of the frame cooperation for the gasket assembly in the embodiment of the present invention;

[0053] Figure 12 Schematic diagram of the gasket assembly with an exhaust hole structure in the embodiment of the present invention;

[0054] Figure 13 Schematic diagram of the gasket assembly with an oxygen interface structure in the embodiment of the present invention;

[0055] Figure 14 Schematic diagram of the preparation method of the gasket assembly for the user breathing assistance device in the embodiment of the present invention;

[0056] The unified description of the reference numerals in each figure is as follows:

[0057] 1. Seal; 11. First end; 12. Second end; 2. Support; 21. First interface; 22. Second interface; 23. Side wall; 3. Flexible clip; 4. Frame; 41. Connection part; 42. Support part; 43. Side strap; 5. Positioning part; 6. Exhaust hole; 7. Oxygen interface. Detailed implementation manners

[0058] To facilitate the understanding of 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.

[0059] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terms used in the description of the invention herein are for the purpose of describing specific embodiments only and are not intended to limit the invention.

[0060] Embodiment 1

[0061] This embodiment provides a cushion assembly for a user breathing assistance device, including a seal 1 and a support 2 that form an inseparable whole. The interior of the whole formed by the seal 1 and the support 2 has a pressurizable cavity for accommodating the user's respiratory organs, allowing pressurized gas to enter the user's respiratory organs. The seal 1 is used to fit the user's face and achieve a relatively sealed state with the user's face. The seal 1 is a tubular body with open ends at both ends. Refer to Figure 2, the seal 1 includes a first end 11 that fits against the user's face and a second end 12 that is fixedly connected to the support member 2. The seal 1 can be a single-layer wall or a double-layer wall. In order to ensure a tight fit between the seal 1 and the face, the wall thickness of the seal 1 is set between 0.2 - 3 mm. A seal 1 that is too thin has no supporting force on the face, which is likely to cause the collapse of the pressurizable cavity or be blown up and separated from the user's face under pressure. If the wall thickness of the seal 1 is too thick, it is likely to result in a smaller deformation distance of the seal 1, making it unable to better adapt to the changing curves of the face. Therefore, the optimal range of the wall thickness of the seal 1 is 0.3 - 1.5 mm. The seal 1 is made of a soft and elastic material, such as silicone, gel, rubber, TPE, etc. And in order to ensure the supporting force of the seal 1, the hardness of the seal 1 is in the range of 10 - 70 on the Shore A scale, and the optimal range is 40 - 60 degrees. The edge of the first end 11 of the seal 1 is a closed curve located at different horizontal planes and has an opening that can at least accommodate the user's nose to enter the pressurizable cavity. The user's nose enters the pressurizable cavity formed by the seal 1 and the support member 2 through this opening, and pressurized gas is delivered to the pressurizable cavity through an auxiliary device. The user absorbs the gas in the pressurizable cavity. Because the user's face is concave and convex at different horizontal planes, the contour shape of the first end 11 of the seal 1 and the structure of the seal 1 are obtained by fully considering ergonomic-related data and a large number of comfort and airtightness tests, so as to better improve the sealing effect of the seal 1 on the user and the comfort of using the gasket assembly; the second end 12 of the seal 1 and the first end 11 are of an integrated structure with a continuous curved surface. The integrated preparation can improve the production efficiency of the seal 1, and the continuous curved surface can better fit the concavities and convexities and changes of the user's face. The second end 12 of the seal 1 is used to be fixedly connected to the support member 2. Therefore, the wall thickness of part of the material of the second end 12 of the seal 1 is at least partially greater than the wall thickness of the material of the first end 11, to prevent the user's face from squeezing the support member 2 connected to the second end 12 when the first end 11 is in tight contact with the user's face, thus affecting the delivery of pressurized gas into the pressurizable cavity.

[0062] To ensure that the pressurizable cavity will not collapse or deform, the support member 2 is made of a material with a rigidity greater than that of the seal member 1, which can be polyamide (PA), ABS, polycarbonate (PC), PVC, polypropylene (PP), polyethylene (PE), or other materials with a hardness greater than that of the seal member 1. This can ensure that the wall of the support member 2 is less likely to deform than the seal member 1, thereby ensuring that the volume of the pressurizable cavity remains unchanged and realizing the stable delivery of pressurized gas to the user's respiratory organs. Specifically, the density range of the support member 2 is approximately 0.8 - 1.8 g / m3, the melting point range is between 130 - 300 °C, and the Young's modulus is between 1 - 4 GPa. The support member 2 includes a first interface 21 tightly connected to the second end 12 of the seal member 1, a second interface 22 connected to an external auxiliary device (such as an elbow or a gas delivery tube, which are components connecting the gas flow circuit), and a side wall 23 located between the first interface 21 and the second interface 22. The side wall 23 is designed with different shapes and specifications according to different product functions and application scenarios. Specifically, the thickness of the side wall 23 is between 0.5 - 3 mm. The first interface 21 and the second interface 22 are also integrally formed. The size of the first interface 21 of the support member 2 is determined according to the size of the second end 12 of the seal member 1, so as to achieve a tight connection between the first interface 21 and the second end 12 of the seal member 1, forming a stable and airtight pressurizable cavity. The second interface 22 of the support member 2 is connected to an external auxiliary device to deliver pressurized gas into the pressurizable cavity for the respiratory organs located inside the pressurizable cavity to absorb. Specifically, in this embodiment, the second interface 22 is a circular interface with a circular cross-section to facilitate connection with the gas delivery tube for delivering pressurized gas. Since an overly small opening for receiving pressurized gas may cause too small an air flow and affect the treatment effect, and an overly large opening will affect the connection effect with the external auxiliary device. Therefore, to ensure smooth reception of pressurized gas, the diameter range of the circular interface is set to 10 - 40 mm. To adapt to areas with a large variation in facial contour, the seal member 1 further includes at least one compliant zone, which is provided in the nasal bridge area or the area with a larger chin curvature. The wall thickness range of the compliant zone is between 0.2 - 1 mm. A smaller wall thickness has a greater deformation ability and can better adapt to the changes in the user's face to reduce the discomfort caused to the user's face. The gasket assembly for different users or / and different respiratory assistance devices has the same fixed connection interface between the second end (12) of the seal member (1) and the first interface (21) of the support member (2).

[0063] In other embodiments, such as Figure 3, the opening at the first end 11 of the seal 1 can be used to accommodate only the user's nose, that is, the gasket assembly is used in conjunction with the nasal mask. The opening at the first end 11 of the seal 1 can also be used to accommodate the user's nose and mouth, that is, the gasket assembly is used in conjunction with the face mask. The main difference between when the gasket assembly is used with the nasal mask and when it is used with the face mask lies in the size of the opening at the first end 11 of the seal 1, and the rest of the structure can remain the same. Figure 3 The structural differences of the two gasket assemblies shown in Figure 3 except for the first end 11 of the seal 1 are due to changes in different application scenarios or requirements, and are not related to the connection with the nasal mask or the face mask.

[0064] In other embodiments, such as Figure 4 , the gasket assembly can be composed of various forms. According to the needs of different users or changes in the usage scenario, the gasket assembly can be formed by connecting multiple identical seals 1 to different support members 2 to form multiple gasket assemblies with different functions. The seal 1 needs to be verified and adjusted according to ergonomic-related data, as well as a large number of comfort and airtightness tests. The preparatory work for production is relatively cumbersome and requires a large amount of manpower and material resources. Therefore, by using the same seal 1 in combination with different support members 2 to achieve different functions, not only can the development efficiency of the gasket assembly be improved, but also the time for long-term testing and adjustment can be effectively shortened, which can effectively shorten the product R & D cycle. Common support members 2 are usually made of plastic materials, and most seals 1 are produced using safe and stable liquid silicone. The raw material price of liquid silicone is higher than that of plastic raw materials, about 3 - 10 times that of plastic raw materials. Moreover, when producing liquid silicone, molds need to be developed. Usually, the mold production cycle of plastic molds is 1 - 2 months, while the mold production cycle of liquid silicone is as long as 2 - 6 months. Due to the complexity and production cycle of the molds, the mold development cost of liquid silicone is much higher than that of plastic molds. Therefore, by choosing the same seal 1 and preparing different gasket assemblies by replacing the support member 2, a large amount of production resources can be saved and production efficiency can be improved; such as Figure 5 , which is the combination of the same seal 1 and different support members 2. The main difference between the two support members 2 in the figure lies in the side wall 23 of the support member 2. The side wall 23 of the left support member 2 protrudes upward, and the side wall 23 of the right support member 2 is recessed downward. By changing the shape of the side wall 23, the overall volume of the gasket assembly and the volume of the pressurizable cavity of the gasket assembly can be changed, so as to meet the different needs of different users for the gasket assembly. The same seal 1 and different support members 2 can be connected by physical methods, chemical methods, and methods using an intermediate layer. Specifically, physical connections include, but are not limited to, molding, co-molding, welding, and snap-fitting, etc.; chemical connections include, but are not limited to, surfactant connections and adhesives.

[0065] In other embodiments, refer toFigure 6 Moreover, the seal 1 further includes a flexible clip 3 located inside the opening at the second end 12 of the seal 1. The flexible clip 3 is a number of protrusions densely distributed inside the second end 12 of the seal 1. The protrusions are evenly distributed inside the second end 12 of the seal 1 and are used to tightly engage with the support member 2. The first interface 21 of the support member 2 is provided with an engaging portion that meshes with the flexible clip 3. The engaging portion is provided with a number of grooves that cooperate with the protrusions. For example, Figure 7 As can be seen, the second end 12 of the seal 1 clamps the engaging portion of the first interface 21 of the support member 2, causing the protrusions and the grooves to abut against each other. While the protrusions and the grooves are abutting against each other, the edges of the seal 1 and the support member 2 are tightly fitted together, achieving a tight connection between the seal 1 and the support member 2. There are also other ways to arrange the flexible clip 3. For example, Figure 8 the flexible clip 3 is provided on the support member 2. A double-layer flexible clip 3 is provided at the engaging portion of the support member 2. There is a connection gap between the double-layer flexible clips 3 that is connected to the second end 12 of the seal 1. The second end 12 of the seal 1 is inserted into the connection gap of the flexible clip 3 of the support member 2 to achieve a tight abutment between the seal 1 and the support member 2. The method of connecting the seal 1 and the support member 2 through the flexible clip 3 is simple to operate and easy to implement, and can improve the installation efficiency of the seal 1 and the support member 2.

[0066] In other embodiments, the gasket assembly further includes a frame 4 for supporting the gasket assembly. The frame 4 includes a connecting portion 41 and a supporting portion 42 that are integrally connected. The connecting portion 41 has a connection port for connecting to the second interface 22 of the support member 2. The frame 4 is sleeved on the side wall 23 of the support member 2 through the connection port passing through the circular second interface 22. The second interface 22 is provided with a buckle for connecting to the frame 4. The connecting portion 41 is snapped with the buckle of the second interface 22 and is in contact with the side wall 23. According to different requirements, the gasket assembly can be connected to different frames 4. For example, Figure 9 as shown, the frame 4 includes a supporting portion 42 integrally connected for the gasket assembly to support the forehead. When the user uses the gasket assembly, the frame 4 is sleeved on the connection port of the gasket assembly, making the frame 4 tightly connected to the gasket assembly. The left arm and the right arm are also provided on both sides of the connecting portion 41 of the frame 4. The left arm and the right arm can be used to connect to the side straps 43 for fixing the gasket assembly to the user's face, fixing the gasket assembly to the user's face. When the gasket assembly is fixedly connected to the frame 4 and used on the user's face, the supporting portion 42 abuts against the user's forehead, achieving the support of the gasket assembly to the user's face, thereby improving the stability of the user using the gasket assembly. Figure 9 Two frames 4 with forehead support are shown. By changing the shape and structure of the connecting portion 41 and the supporting portion 42, a variety of frames 4 with forehead support functions are formed; the frame 4 can also be set in the form of a side strap 43 with a connection port. For example, Figure 10As shown, there are four side straps 43, which are symmetrically arranged on the left and right sides of the cushion assembly. The upper left and upper right side straps 43 extend between the user's eyes and ears respectively and conform to the contour of the user's face to ensure that the user's face will not be compressed during sleep; the lower left and lower right side straps 43 are in contact with the face at the user's chin, so as to realize the close connection between the cushion assembly and the user, and will not block the user's line of sight. The structure is simple, and the production and use are convenient; the frame 4 can also be set to a smaller and lighter structure, such as Figure 11 As shown, the connecting part 41 is set as an annular strip. The connecting part 41 is sleeved on the connection part of the seal 1 and the support 2. The support 2 is provided with a baffle plate that cooperates with the frame 4. The frame 4 is arranged on the cushion assembly and abuts against the baffle plate to realize the connection between the cushion assembly and the frame 4. Four side straps 43 for connecting with the user's face are symmetrically arranged on the left and right sides of the frame 4. Preferably, the entire frame 4 is integrally formed, which can improve the production efficiency of the frame 4 and save space; in other embodiments, the frame 4 can also be made in a split form.

[0067] In other embodiments, referring to Figure 12 , the cushion assembly further includes a positioning member 5 and an exhaust hole 6. The positioning member 5 is arranged on the support 2 and protrudes or recesses from the surface of the support 2 for realizing the positioning function with the frame 4. The frame 4 is simultaneously sleeved on the positioning member 5 and the second interface 22 to realize the tight connection between the frame 4 and the cushion assembly. Through the positioning member 5, the connection between the frame 4 and the support 2 can be initially positioned, improving the connection efficiency between the frame 4 and the support 2. At the same time, the surface of the support 2 is also densely provided with exhaust holes 6. The exhaust holes 6 include a plurality of small holes for discharging the waste gas exhaled by the user, realizing the gas exchange of the user's inhalation and exhalation. By opening the exhaust holes 6 on the surface of the support 2, the addition of an exhaust device on the cushion assembly can be reduced, and the exhaust function of the cushion assembly can be realized, improving the versatility of the exhaust assembly; in addition, the cushion assembly further includes an oxygen interface 7. Referring to Figure 13 , the oxygen interface 7 is arranged on the support 2 for connecting with an external oxygen delivery device to deliver oxygen to the user who needs oxygen supply, Figure 13 The example shown in is that there are two oxygen interfaces 7, and the two oxygen interfaces 7 are arranged in parallel below the second interface 22, which not only saves space occupancy but also does not affect the connection between the second interface 22 and the external breathing assistance device, realizing the versatility of the cushion assembly. In other embodiments, the oxygen interface 7 can also be set to other forms. There are anti-slip parts on both sides of the support 2, and the anti-slip parts protrude on both sides of the seal 1 to increase the contact area between the hand and the seal 1 part when using the cushion assembly, thereby improving the stability of holding the cushion assembly.

[0068] Referring to Figure 14, this embodiment provides a preparation method for a gasket assembly of a user breathing assistance device, including the following steps:

[0069] Step S1, according to ergonomic-related data and a large number of comfort and airtightness tests, obtain at least one specification of seal 1 with an opening that meets the requirements of the user's face. Each seal includes a first end 11 and a second end 12; the opening of the first end 11 can be used to accommodate only the user's nose, in which case the gasket assembly is used in conjunction with a nasal mask, or the opening of the first end 11 can also be used to accommodate both the user's nose and mouth, in which case the gasket assembly is used in conjunction with a face mask. Whether the opening of the first end 11 is used to accommodate the user's nose or both the user's nose and mouth, in the present invention, the dimensions, shapes, and other specifications of the second end 12 of each seal are the same. The second end 12 has an opening size and interface shape for fixedly connecting with the support member 2, that is, different users or / and gasket assemblies of different breathing assistance devices have the same fixed connection interface between the second end (12) of the seal (1) and the first interface (21) of the support member (2). On the other hand, to achieve a tight fit between the seal 1 and the user's face, the second end 12 and the first end 11 form a continuous curved surface corresponding to the user's face. To ensure the stability of the seal 1 and the part connected to the support member 2, the wall thicknesses of the first end 11 and the second end 12 are uneven curved surfaces that vary, and the wall thickness of the second end 12 is at least partially greater than that of the first end 11, so that when the gasket assembly is in use, the support member 2 is stably supported above the seal 1;

[0070] Step S2, according to the unified and fixed dimensions and shape of the second end 12 of all the obtained specifications of seals 1, form the corresponding dimensions and shape of the first interface 21 of the support member 2. According to the requirements of the breathing assistance device, determine the dimensions and shape of the second interface 22 of the support member 2. The second interface 22 is a fixed circular interface for connecting with an external assistance device. In other embodiments, it can also be other shapes. On this basis, prepare the required number of support members 2 that meet all the specification requirements according to the determined dimensions and shapes of the first interface 21 and the second interface 22;

[0071] Step S3, fixedly connect the second end 12 of the seal 1 and the first interface 21 of the support member 2 into one body by physical, chemical, or intermediate means; physical connections include, but are not limited to, molding, co-molding, welding, and snap-fitting, etc.; chemical connections include, but are not limited to, surfactant connections and adhesives.

[0072] By adopting the above preparation method, a gasket assembly that meets the ergonomic principle can be obtained. Since the curve radian of the seal 1 with different specifications fits the faces of different users, the comfort level when wearing the gasket assembly can be improved. Moreover, the second end 12 of the seal 1 and the first interface 21 of the support member 2 are standard fixed-size interfaces. The method of this embodiment is particularly beneficial for one or more existing specifications of seal designs or products. According to the unified size and shape of the first end 11 of the seal 1 and the requirements of the respiratory assistance device, the support member is designed, thereby greatly improving the product preparation process. It can quickly produce a gasket assembly that matches the seal of the existing nasal mask or face mask according to the actual needs of the respiratory assistance device at any time, reducing the production cost and production cycle.

[0073] In another embodiment, the method for preparing multiple different gasket assemblies provided by the present invention is applicable to a support member that meets the requirements of a respiratory assistance device. By preparing more than one specification of seals, multiple specifications of gasket assemblies are produced. Here, the support members that cooperate with multiple specifications of seals are the same and all have a first interface that cooperates with the second end of the seal, that is, different users or / and the gasket assemblies of different respiratory assistance devices have the same fixed connection interface between the second end (12) of the seal (1) and the first interface (21) of the support member (2). This method specifically includes the following steps:

[0074] Step S1, according to the requirements of the respiratory assistance device, determine the sizes and shapes of the first interface 21 and the second interface 22 of the support member 2, where the size and shape of the first interface 21 are fixed parameters, and the sizes and shapes of the second interface 22 meet the interface requirements of the respiratory assistance device; as Figure 14 shows different support members 2, but all have a common first interface 21. The support member can be set with different sizes and shapes of positioning members 5 according to the actual situation, and exhaust holes 6 can also be provided to meet the different functions of the gasket assemblies that support different respiratory assistance devices;

[0075] Step S2, according to the size and shape of the first interface 21 of the determined support member 2, form the corresponding size and shape of the first end 11 of the seal 1. According to the classification of the data of the user's respiratory organs and cheeks, determine at least one size and shape of the second end 12 of the seal 1; among them, the second end 12 and the first end 11 are continuous curved surfaces, the wall thicknesses of the first end 11 and the second end 12 are uneven curved surfaces that change, and the wall thickness of the second end 12 is at least partially greater than that of the first end 11;

[0076] Step S3, prepare the support member 2 according to the sizes and shapes of the first interface 21 and the second interface 22; the support member 2 can be Figure 14 two or more shapes in

[0077] Step S4: Prepare at least one specification of the seal 1 according to the sizes and shapes of the first end 11 and the second end 12. Commonly, there are three sizes: large, medium, and small, which are suitable for users with different cheek sizes. The different sizes only reflect the shape and size of the first end. All the second ends of the seals have the same size and shape and can support fixed connection with the support member;

[0078] Step S4: Fix the seal 1 and the support member 2 together in a physical, chemical, or intermediate member manner;

[0079] By adopting this preparation method, when the second interface 22 of the seal 1 is the same, it can be connected to different support members 2, thereby realizing the manufacture of different gasket assemblies. Because the research and development period and production cost of the seal 1 are relatively high compared to the production of the support member 2, on the premise of ensuring that the seal 1 remains unchanged, matching different support members 2 can reduce production costs, shorten the research and development cycle, and at the same time increase the scope of use of the gasket assembly.

[0080] The present invention provides a gasket assembly and a preparation method for a user's breathing assistance device, which can achieve at least the following beneficial effects:

[0081] 1. Reduce the research and development cycle cost: During the research and development process, the design of the seal is the most complex. It not only needs to consider a large amount of data related to ergonomics but also requires a large number of comfort and airtightness tests for verification and adjustment. Therefore, the modular gasket assembly uses the same seal, which can continue to use the seal that has been verified and has a higher user satisfaction to adapt to different support members. This not only improves the development efficiency but also effectively shortens the time for long-term design, testing, and adjustment of the seal, and can reduce the product research and development cycle.

[0082] 2. Improve product reusability: The modular gasket assembly has a common seal. At the production level, only the same type of seal needs to be manufactured. The production cost and cycle of the seal are much higher than those of the support member. In the case of the same number of product models, the present invention can save the mold development cost and production cost of the seal, improve reusability, and at the same time reduce the adverse impact of excessive industrial products on the environment.

[0083] 3. Diversify user choices: Moreover, the same seal can be adapted to different types of support members, which means that it can be adapted to different types of frames, elbows, and headbands, forming more product types and increasing the series design of the products. Users can try more products and have more diverse choices while ensuring the comfort and treatment effect of the gasket assembly remain unchanged, which can bring a bit of interesting experience to the long-term same treatment and improve the pleasure of daily treatment life.

[0084] 4. Saving raw material resources: For the same seal, since the wall thickness, size, and structure remain unchanged, the hardness of the first material used is also the same. The softness and hardness of the first material of the seal will not be affected by changes in the wall thickness structure, etc. Therefore, the modular gasket assembly seals use the same raw materials, which can avoid the use of multiple materials and save resources.

[0085] 5. Better user experience: Compared with the method of separately constructing clips on the seal and the support for connection, the gasket assembly in the present invention is an integral non-detachable unit, which can better ensure the airtightness of the product. At the same time, the number of components of the product is reduced, and the installation and disassembly by the user will be simpler and more convenient, resulting in a better user experience.

[0086] 6. Can meet different requirements and markets: The modular gasket assembly can achieve various scenario applications and multiple function changes by modifying the support that does not come into contact with the human body. For example, there may be certain differences between the mask systems used in the home environment and those in the medical environment. At this time, by modifying the support structure, the gasket assembly can be joined to frames / elbows with different functions to achieve the effect of modifying the mask system. Another example is that some users may have incomplete breathing or need oxygen supply. At this time, only by changing the support to be airless or adding an oxygen interface, the function of the gasket assembly can be modified to meet the needs of the user. The support can be changed by a modular method, and this modular method can quickly respond to market changes and user needs, which is of great benefit to both producers and users.

[0087] The embodiments of the invention have been described above in conjunction with the accompanying drawings. However, the invention is not limited to the above specific embodiments. The above specific embodiments are merely illustrative and not restrictive. Under the inspiration of the invention, those of ordinary skill in the art can also make many forms without departing from the spirit of the invention and the scope protected by the claims. These all fall within the protection scope of the invention.

Claims

1. A cushion assembly for a user breathing assistance device, characterized in that, An inseparable integral formed by a seal (1) for fitting to a user's face and a support member (2) fixedly connected to the seal (1), the support member (2) having a first interface (21) connected to the seal (1) and a second interface (22) for receiving pressurized gas from an auxiliary device, the peripheral circumference of the edge of the first interface (21) being greater than the peripheral circumference of the edge of the second interface (22), and the integral forming a pressurizable cavity with the user's respiratory organs when in use; the seal (1) includes a first end (11) for contacting the user's face and a second end (12) for connecting to the support member (2), and the second end (12) and the first end (11) are an integral structure with a continuous curved surface; the second end (12) has a contour shape corresponding to the first interface (21) and a structure to ensure a sealed engagement therewith; the first end (11) has an opening that can at least accommodate the user's nose to enter the pressurizable cavity, and the material, elasticity, and structural shape of the opening part are set to ensure a fit to the user's facial contour; the wall thickness of part of the material of the second end (12) is at least partially greater than the material thickness of the first end (11) to prevent the user's face from squeezing the support member (2) during use, and the elasticity of the material of the seal (1) is greater than or equal to that of the support member (2); Among them, gasket assemblies for different users or / and different respiratory assist devices have the same fixed connection interface between the second end (12) of the seal (1) and the first interface (21) of the support member (2).

2. The cushion assembly according to claim 1, characterized in that, The seal (1) further includes at least one compliant zone to adapt to parts with large facial contour changes, so as to closely fit the user's face. The compliant zone is provided in the nasal bridge area or the chin area, and the wall thickness of the seal (1) in the compliant zone is 0.2 - 1 mm.

3. The cushion assembly according to claim 1, characterized in that, The seal (1) is made of a first material, and the first material includes at least one of polyamide, ABS, polycarbonate, PVC, polypropylene, and polyethylene, and the hardness range of the first material is 10 - 70 on the Shore A scale.

4. The cushion assembly according to claim 1, characterized in that, The support member (2) is made of a second material, and the second material has at least one of the following characteristics:

1. The density range is 0.8 - 1.8 g / m3; 2. The melting point is 130 - 300 °C; 3. The Young's modulus is 1 - 4 GPa.

5. The cushion assembly according to claim 1, characterized in that, The second interface (22) of the support member (2) is circular, and the diameter range of the circular interface is 10 - 40 mm.

6. The cushion assembly according to claim 1, characterized in that, The fixed connection between the support member (2) and the seal (1) includes physical connection, chemical connection, and through an intermediate layer. The physical connection includes molding, co - molding, welding, and snap - fitting. The chemical connection includes surfactant connection and gluing. Among them, any fixed connection interface is between the first interface (21) of the support member (2) and the second end (12) of the seal (1).

7. The cushion assembly according to any one of claims 1-6, characterized in that, The gasket assembly further includes a frame (4) for supporting the gasket assembly. The frame (4) includes a connecting portion (41) connected to the support member (2) and a supporting portion (42) in contact with the user. The frame (4) has a connection port located at the center of the connecting portion (41). The frame (4) is sleeved on the second interface (22) end of the support member (2) through the connection port. A positioning assembly is provided on the support member (2) to achieve the connection and positioning between the frame (4) and the support member (2).

8. A cushion assembly for a user breathing assistance device, characterized in that, It includes an inseparable whole formed by a seal (1) for fitting the user's face and a support member (2) fixedly connected to the seal (1) to form a pressurizable cavity with the user's respiratory organs when in use. The partial shape and size of the seal (1) depend on the user's face size and contour, and the partial size and shape of the support member (2) depend on the respiratory assistance device. The support member (2) has a first interface (21) connected to the seal (1) and a second interface (22) for receiving pressurized gas from the assistance device. The seal (1) includes a first end (11) for contacting the user's face and a second end (12) for connecting to the support member (2). The second end (12) has a contour shape corresponding to the first interface (21) and a structure to ensure a sealed engagement therewith. The gasket assemblies for different users or / and different respiratory assistance devices have the same fixed connection interface between the second end (12) of the seal (1) and the first interface (21) of the support member (2). The fixed connection includes one of physical connection, chemical connection, and intermediate layer connection; the first end (11) has an opening that can at least accommodate the user's nose to enter the pressurizable cavity. When in a static state, the opening edges of the first end (11) are at different horizontal levels to better fit the user's face contour. The material, elasticity, and structural shape of the opening part are set to ensure a fit with the user's face contour; the wall thickness of part of the material of the second end (12) is at least partially greater than the material thickness of the first end (11) to prevent the user's face from squeezing the support member (2) during use. The elasticity of the material of the seal (1) is greater than or equal to that of the support member (2); the perimeter of the edge of the first interface (21) is greater than the perimeter of the edge of the second interface (22) to buffer the pressurized gas from the respiratory assistance device.

9. The cushion assembly according to claim 8, characterized in that, The seal (1) further includes at least one compliant zone to adapt to the part with a large change in face contour, so as to closely fit the user's face. The compliant zone can be provided in the nasal bridge area or the chin area, and the wall thickness of the compliant zone is 0.2 - 1 mm.

10. The cushion assembly according to claim 8, characterized in that, The seal (1) is made of a first material, and the first material includes at least one of polyamide, ABS, polycarbonate, PVC, polypropylene, and polyethylene. The hardness range of the first material is 10 - 70 on the Shore A scale.

11. The cushion assembly according to claim 8, characterized in that, The support member (2) is made of a second material having at least one of the following characteristics:

1. The density range is 0.8 - 1.8 g / m3; 2. The melting point is 130 - 300 °C; 3. The Young's modulus is 1 - 4 GPa.

12. The cushion assembly according to claim 8, characterized in that, The physical connections include molding, co - molding, welding, and snap - fitting, and the chemical connections include surfactant connection and gluing.

13. The cushion assembly according to any one of claims 8-12, characterized in that, The gasket assembly further includes a frame (4) for supporting the gasket assembly. The frame (4) includes a connecting portion (41) connected to the support member (2) and a supporting portion (42) in contact with the user. The frame (4) has a connection port located at the center of the connecting portion (41). The frame (4) is sleeved on the second interface (22) end of the support member (2) through the connection port. A positioning assembly is provided on the support member (2) for realizing the connection and positioning between the frame (4) and the support member (2).

14. A cushion assembly for a user breathing assistance device, characterized in that, It includes an integral non - detachable unit formed by a seal (1) for fitting the user's face and a support member (2) fixedly connected to the seal (1) to form a pressurizable cavity with the user's respiratory organs when in use. The partial shape and size of the seal (1) depend on the user's face size and contour, and the partial size and shape of the support member (2) depend on the respiratory assistance device. The support member (2) has a first interface (21) connected to the seal (1) and a second interface (22) for receiving pressurized gas from the assistance device. The edge perimeter of the first interface (21) is greater than the edge perimeter of the second interface (22). The seal (1) includes a first end (11) for contacting the user's face and a second end (12) for connecting to the support member (2). The second end (12) has a contour shape corresponding to the first interface (21) and a structure to ensure a sealed engagement therewith. The gasket assemblies for different users or / and different respiratory assistance devices have the same fixed connection interface between the second end (12) of the seal (1) and the first interface (21) of the support member (2). The first end (11) has an opening that can at least accommodate the user's nose into the pressurizable cavity. When in a static state, the edges of the opening are at different horizontal levels to better fit the user's face contour. The material, elasticity, and structural shape of the opening part are set to ensure a fit with the user's face contour. The wall thickness of the part of the second end (12) is at least partially greater than the material thickness of the first end (11) to prevent the user's face from squeezing the support member (2) during use. The elasticity of the material of the seal (1) is greater than or equal to that of the support member (2). The seal (1) further includes a flexible clip (3) provided inside the opening of the second end (12) for engaging with the support member (2). The first interface (21) is provided with an engaging portion for meshing with the flexible clip (3).

15. The cushion assembly according to claim 14, characterized in that, The seal (1) further includes at least one compliant zone to adapt to parts with large changes in facial contour, so as to closely fit with the user's face. The compliant zone can be provided in the nasal bridge area or the chin area, and the wall thickness of the compliant zone is 0.2 - 1 mm.

16. The cushion assembly according to claim 14, characterized in that, The seal (1) is made of a first material, which is one of polyamide, ABS, polycarbonate, PVC, polypropylene, and polyethylene. The support member (2) is made of a second material, which is one of silicone, rubber, and TPE. The hardness range of the first material is 10 - 70 on the Shore A scale. The wall thickness of the seal (1) is 0.2 - 1.5 mm. The second interface (22) is circular, and the diameter range of the circular interface is 10 - 40 mm.

17. The cushion assembly according to claim 14, characterized in that, The connection method between the support member (2) and the seal (1) includes physical connection, chemical connection, or intermediate layer connection. The physical connection includes molding, co - molding, welding, or snap - fitting. The chemical connection includes surfactant connection and gluing.

18. The cushion assembly according to claim 16, characterized in that, The second material has at least one of the following characteristics:

1. The density range is 0.8 - 1.8 g / m3; 2. The melting point is 130 - 300 °C; 3. The Young's modulus is 1 - 4 GPa.

19. The cushion assembly according to any one of claims 16-18, characterized in that, The gasket assembly further includes a frame (4) for supporting the gasket assembly. The frame (4) includes a connecting portion (41) connected to the support member (2) and a supporting portion (42) in contact with the user. The frame (4) has a connection port, and the connection port is located at the center of the connecting portion (41). The frame (4) is sleeved on the second interface (22) end of the support member (2) through the connection port. The support member (2) is provided with a positioning assembly for realizing the connection positioning between the frame (4) and the support member (2).

20. A method for preparing a gasket assembly for a user breathing assistance device, the gasket assembly being as described in claim 1, characterized in that, For gasket assemblies of different users or / and different respiratory assist devices, there is the same fixed connection interface between the second end (12) of the seal (1) and the first interface (21) of the support member (2). The preparation method includes the following steps: Step S1, obtain a seal (1) with an opening meeting the requirements of the user's face, including a first end (11) and a second end (12); Step S2, form the size and shape of the first interface (21) of the support member (2) corresponding to the size and shape of the second end (12) of the obtained seal (1). Determine the size and shape of the second interface (22) of the support member (2) according to the requirements of the respiratory assist device. Prepare the support member (2) according to the size and shape of the first interface (21) and the second interface (22); Step S3, fixedly connect the seal (1) and the support member (2) into one body in a physical, chemical, or intermediate - member manner; Wherein, the second end (12) and the first end (11) are in a continuous curved surface. The wall thicknesses of the first end (11) and the second end (12) are non - uniform curved surfaces with changes. The wall thickness of the second end (12) is at least partially greater than that of the first end (11).

21. The method according to claim 20, characterized in that, The step S1 includes determining the opening size and shape of the first end (11) of at least one seal (1) according to the statistically analyzed human engineering-related data, and determining the material of the seal (1) according to the comfort and airtightness requirements.

22. A method for preparing a gasket assembly for a user breathing assistance device, the gasket assembly being as described in claim 1, characterized in that, For different users or / and cushion assemblies of different respiratory assist devices, having the same fixed connection interface between the second end (12) of the seal (1) and the first interface (21) of the support member (2), the preparation method includes the following steps: Step S1, determining the size and shape of the support member (2) according to the requirements of the respiratory assist device, including the first interface (21) and the second interface (22), wherein the size and shape of the second interface (22) meet the interface requirements of the respiratory assist device; Step S2, forming the size and shape of the first end (11) of the corresponding seal (1) according to the determined size and shape of the first interface (21) of the support member (2), and determining the size and shape of the second end (12) of the seal (1) according to the data of the user's respiratory organs and cheeks; Step S3, preparing the support member (2) according to the size and shape of the first interface (21) and the second interface (22); Step S4, preparing the seal (1) according to the size and shape of the first end (11) and the second end (12); Step S4, fixedly connecting the seal (1) and the support member (2) into one body in a physical, chemical or intermediate member manner; Wherein, the second end (12) and the first end (11) are in a continuous curved surface, the wall thicknesses of the first end (11) and the second end (12) are non-uniform curved surfaces that change, and the wall thickness of the second end (12) is at least partially greater than that of the first end (11).

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