CN120324730A

CN120324730A - A comfortable patient interface pad and preparation method thereof

Info

Publication number: CN120324730A
Application number: CN202410072319.9A
Authority: CN
Inventors: 罗大伟; 陈春卉
Original assignee: Shenzhen Sanyi Enterprise Technology Co ltd
Current assignee: Shenzhen Sanyi Enterprise Technology Co ltd
Priority date: 2024-01-18
Filing date: 2024-01-18
Publication date: 2025-07-18

Abstract

The invention relates to the technical field of patient interface pads, and particularly discloses a comfortable patient interface pad which is configured to supply pressurized gas to an airway of a patient, and comprises a supporting part, an elastic part and a comfortable part, wherein the supporting part and the elastic part form a complete patient interface pad together; the material of the comfort portion may be foam, cloth, or a composite of the two; the invention also discloses a manufacturing method of the comfortable patient interface pad, and the connection mode of the comfortable part and the patient interface pad is adhesive connection.

Description

Comfortable patient interface pad and preparation method thereof

Technical Field

The present invention relates to the field of patient interface pads, and in particular to a patient interface pad for sealing an airway of a patient, and more particularly to a comfortable patient interface pad and method of manufacture.

Background

Respiration is one of the key processes for maintaining vital signs, the main purpose of which is to achieve gas exchange through the action of the upper and lower respiratory tract. While some people repeatedly experience more than 30 times of apnea and hypopnea during 7 hours of night sleep, airway collapse renders them unable to perform normal gas exchange, and the lungs are unable to inhale sufficient oxygen and exhale carbon dioxide, a condition known as Sleep Apnea Syndrome (SAS), also known as sleep apnea hypopnea syndrome, and respiratory failure causes a series of diseases and disorders. One of the ways in which a home is treated for sleep apnea is CPAP therapy, in which the patient is required to wear a corresponding device (patient interface assembly), switch on a machine that provides positive pressure gas, and provide sufficient pressurized gas to breathe. The design of the patient interface pad contacting the face of the patient in the device has many challenges that the fluctuation of bones and soft tissues contained in the face of the human body has a complex three-dimensional shape, the structure, the size, the shape and the sensitivity degree of the patient interface pad are different from person to person, and in recent years, serious public health events occur, partial people are accompanied with dyspnea complications, the number of people suffering from sleep apnea increases, and the demand for the patient interface pad also increases.

Therefore, the design of the patient interface pad needs to consider not only the most basic tightness to the airway of the patient and wearing comfort, but also the adaptability and flexibility of the patient interface pad to different patients, and how to rapidly and massively produce different patient interface pads with comfort, so as to meet different patient demands to the greatest extent.

Disclosure of Invention

In view of the above, it is desirable to provide a comfortable patient interface pad and method of making the same.

A comfortable patient interface pad configured to sealingly deliver a flow of gas pressurized relative to ambient pressure to an entrance to an airway of a patient, comprising:

a support portion 2 comprising a first opening 21 and a second opening 22, wherein the second opening 22 is configured to be connected with the elastic portion;

An elastic portion 3 comprising a third opening 31 connected to said support portion 2, a fourth opening 32 opposite thereto, and a side wall 33 connecting said third opening 31 and said fourth opening 32 in a smooth manner, wherein part of said side wall 33 has a relatively gentle first surface 34, said first surface 34 being configured to be connected to a comfort portion 4;

The comfort portion 4 comprises a second surface 41 in contact with the elastic portion 3 and a third surface 42 in contact with the patient's face, wherein the comfort portion 4 is a foam material 6;

Wherein the first surface 34 of the elastic portion 3 and the second surface 41 of the foam material 6 are connected by an adhesive 8, the adhesive 8 having one or more of the following characteristics:

a. The amount of the adhesive 8 used is at least 0.05g;

b. The density range is 0.3-3g/cm ³;

c. The temperature resistant range is-55 ℃ to 200 ℃;

d. tensile strength is more than or equal to 0.5MPa;

e. The adhesive 8 application path is continuous and the path perimeter is not less than the perimeter of the fourth opening 32.

In one embodiment, the patient interface pad accommodates both the nasal and oral airways of a patient or only the nasal airways.

In one embodiment, the material of the support part 2 is polycarbonate, polypropylene, polyethylene or a thermoplastic elastomer with a hardness of Shore a 30-80, and the second opening 22 of the support part 2 is connected to the third opening 31 of the elastic part 3 by molding or co-molding.

In one embodiment, the first surface 34 of the resilient portion 3 and the second surface 41 of the comfort portion 4 have the same curvature when connected, and the third surface 42 of the comfort portion 4 conforms partially to the patient's facial curve when in use.

In one embodiment, the foam 6 is a continuous three-dimensional shape with a width to thickness ratio in the range of 0.1 to 30.

The present embodiment also provides a comfortable patient interface cushion configured to sealingly deliver a flow of gas pressurized relative to ambient air pressure to an entrance to an airway of a patient, comprising:

a support portion 2 including a first opening 21 and a second opening 22, wherein the second opening 22 is configured to be connected with the elastic portion;

the comfort portion 4 comprises a second surface 41 in contact with the elastic portion 3 and a third surface 42 in contact with the patient's face, wherein the comfort portion 4 is a cloth 5;

wherein the first surface 34 of the elastic portion 3 and the second surface 41 of the comfort portion 4 are connected by an adhesive 8, the adhesive 8 having one or more of the following characteristics:

a. The amount of the adhesive 8 used is at least 0.03g;

b. hardness is greater than or equal to Shore A15;

c. a density of at least 0.3g/cm ³;

d. the color after curing is transparent or semitransparent.

In one embodiment, the material of the support part 2 is polycarbonate, polypropylene, polyethylene or a thermoplastic elastomer with a hardness of Shore a 30-80, and the second opening 22 of the support part 2 is formed by moulding or co-moulding a connection with the third opening 31 of the elastic part 3.

In one embodiment, the cloth 5 has elasticity and changes in response to the change in curvature of the elastic portion 3 when subjected to pressure, and the second surface Ra of the cloth 5 ranges from 0.2 to 10 microns.

In one embodiment, the opening area of the inner edge of the cloth 5 is not smaller than 23mm ².

An elastic portion 3 comprising a third opening 31 connected to said support portion 2, a fourth opening 32 opposite thereto, and a side wall 33 connecting said third opening 31 and said fourth opening 32 in a smooth manner, wherein part of said side wall 33 has a relatively gentle first surface 34, said first surface 34 being configured to be connected to said comfort portion 4;

The comfort part 4 comprises a second surface 41 contacted with the elastic part 3 and a third surface 42 contacted with the face of the patient, wherein the comfort part 4 comprises a foam material 6 and a cloth 5, the second surface 41 of the comfort part 4 is the foam material 6, the third surface 42 is the cloth 5, and the foam material 6 and the cloth 5 are in a connection state;

a. The amount of the adhesive 8 used is at least 0.05g;

b. A density of at most 3g/cm ³;

c. The temperature resistant range is-55 ℃ to 200 ℃;

d. The adhesive 8 application path is continuous and the path perimeter is not less than the perimeter of the fourth opening 32.

In one embodiment, the cloth 5 has elasticity and changes in response to changes in the curvature of the foam material 6 when subjected to pressure, and the second surface Ra value of the cloth 5 is in the range of 0.2-10 microns.

In one embodiment, the foam material 6 is connected to the cloth 5 by means of an adhesive 8 or by means of an intermediate layer, wherein the intermediate layer is made of TPU.

The present embodiment also provides a method of manufacturing a comfortable patient interface pad having a support portion 2, a resilient portion 3 and a comfort portion 4, the comfort portion 4 being connected to the resilient portion 3 by an adhesive 8, the method comprising the steps of:

Step S1, acquiring an elastic part 3 connected with a supporting part 2 and a comfortable part 4 corresponding to the elastic part 3, and cleaning the elastic part 3 and the comfortable part 4;

Step S2, applying an adhesive 8 to a portion of the first surface 34 of the elastic portion 3, either manually or automatically;

step S3, connecting the elastic part 3 of the adhesive 8 with the comfort part 4 correspondingly, so that the adhesive 8 is positioned between the patient interface pad or the comfort part 4,

Step S4, standing the connected patient interface pad with the comfort part 4, waiting for the adhesive 8 to cure;

wherein the adhesive 8 has one or more of the following characteristics:

a. The amount of the adhesive 8 used is at least 0.03g;

b. hardness after curing is greater than or equal to Shore A15;

c. the perimeter of the path to which the adhesive 8 is applied is not smaller than the perimeter of the fourth opening 32 of the elastic portion 3;

d. The adhesive 8 is applied to a range not exceeding the second surface 41 of the comfort portion 4;

e. the state of the colloid before solidification is liquid or semi-flowing.

In one embodiment, the patient interface pad accommodates both the nasal and oral airways of a patient, or only the nasal airways.

In one embodiment, the comfort portion 4 comprises a foam material 6 and a cloth 5, the foam material 6 and the cloth 5 being connected by the adhesive 8 or by an intermediate layer, wherein the intermediate layer is a TPU material.

In one embodiment, the steps are accomplished by a first receptacle being a clamp 93 that secures the patient interface pad and a second receptacle being a clamp 94 that secures the comfort portion 4.

step S2, applying an adhesive 8 to a portion of the second surface 41 of the comfort portion 4, either manually or automatically;

Step S3, correspondingly connecting the elastic part 3 and the comfortable part 4, enabling the adhesive 8 to be positioned between the elastic part 3 or the comfortable part 4,

wherein the adhesive 8 has one or more of the following characteristics:

a. The amount of the adhesive 8 used is at least 0.03g;

b. hardness after curing is greater than or equal to Shore A15;

e. the state before the colloid is solidified is in a semi-flowing state.

A comfortable patient interface pad embodying the invention and a method of making the same have at least the following beneficial effects:

1) The development cycle is shortened, most of the patient interface pads on the market are used for providing more comfortable use feeling for patients, the curve radian of the elastic part is researched and designed to better conform to the curve of the face of the patient, a large amount of ergonomically related data is required to be referred to in the design process because the face of the human body has complex three-dimensional characteristics, and a large amount of comfort and air tightness test verification and adjustment are carried out, the production of the elastic part is generally longer due to the solidification requirement of materials compared with the production cycle of the supporting part, in the mode, a researcher needs to manufacture a three-dimensional model of the patient interface pad, then perform mold opening according to the established three-dimensional model (the process needs to be carried out for 30-50 days), the production of the elastic part can be started after the mold is obtained, b, because the elastic part is mainly used for thermoplastic elastomer materials, raw materials need to be prepared (usually supplied in the form of particles) during the production, the raw materials need to be subjected to pretreatment steps such as drying and mixing, so as to ensure the quality and stability of the materials), raw materials need to be injected (injection molding by the manufactured mold), cooling and solidification treatment (the time is generally longer than the production cycle of the supporting part, compared with the production cycle of the supporting part is longer than that the production cycle of the supporting part, a large amount of the patient interface pad needs to be subjected to the air tightness test by the research and development step and the production step is carried out repeatedly and the comfort test is carried out by the research and development step is more than the patient. The preparation method of the invention uses the same patient interface pad, different materials are connected on the elastic part of the patient interface pad, materials which are more easily obtained through research and design, such as foam materials 6 (foaming molding), cloth 5 (textile technology) and other materials which have comfortableness and can deform are used for shortening the design flow for optimizing the comfortableness of the patient interface pad, and a more comfortable use feeling is provided for a patient. The method can be used for producing the patient interface pad with different comfortableness, can eliminate the step of redesigning the production of the thermoplastic elastomer, can reduce the development time by three months or more, can rapidly design the novel comfortable part 4 according to market trend or user preference, can enable the patient interface pad to meet the demand of different patients on the comfort level of the patient interface pad, can be put on the market more rapidly and effectively, and can produce series products.

2) The modular manufacturing approach is that for the existing patient interface pad market, most patient interface pad designs are used with fixed frame assemblies to form a complete set of patient interface assemblies, but patient interface pads cannot meet the needs of different patients, and for the manufacturer, designing different patient interface pads in the same patient interface assembly is certainly wasteful in terms of cost, namely, a. The same function needs to be produced, but different support portions with different structures waste materials, b. The elastic portions are usually thermoplastic elastomers, and the materials such as plastics are usually slower in production and manufacture and have higher reject ratio, and the optimal design of the patient interface pad has higher requirements on material cost and time cost. In the preparation method, a modularized mode is adopted, and the comfort materials such as the foam material 6, the cloth 5 and the like are innovatively and fixedly connected with the patient interface pad, so that various patient interface pads with good comfort can be provided for the market. a. Because in this manufacturing mode, the relatively complex part in production is confirmed (the supporting part 2 and the elastic part 3), only the comfort part 4 of different types is required to be designed respectively to meet the requirements of patients, the quality control of the parts is easier, the quality control of the whole product can be in a stable position, the time of the whole production is saved, and the reject ratio is also greatly reduced. c. The support portion 2 and the resilient portion 3 serve as a base portion of the patient interface pad, which provides increased reusability and reduces the adverse environmental impact of excessive industrial products.

3) In the aspect of supply, common patient interface pads in the market at present are supplied, for a supply chain of products, a warehouse needs to be provided with different types of patient interface pads to meet the requirements of different patients for shipment, and high requirements are set for warehouse cost (material cost, site cost and the like). For suppliers of products, factories need to be provided with different types of patient interface pad production molds to prepare more complex patient interface pads, the mold cost and the material cost consumption are high, and in the face of serious public health events, great challenges are presented to the supply of medical supplies, the production cycle is short, the global shortage of respirators occurs, so that the situation of supply shortage commonly occurs in a plurality of respirator manufacturing companies, and the reasons are that materials and working procedures required in a respirator system are numerous, and most raw materials obstruct the supply shortage due to epidemic situations. The modular design mode is adopted, a producer only needs to prepare a model for producing the patient interface pad, a large number of the same patient interface pads are stored in a warehouse, the comfort part 4 is fixed on the elastic part 3 of the patient interface pad through the adhesive 8 according to the user requirement during the distribution, the patient interface pad can be rapidly delivered, the storage cost and the production cost are greatly reduced, the material waste is reduced, the flexibility of a production line is enhanced, and a simpler and easily obtained material is adopted, a large number of imported or special materials are not needed, so that the stability of a supply chain is ensured. b. Because in the manufacturing mode, the basic similar parts of the product are more, the same production process, tools and equipment can be adopted, the production and manufacturing cost is reduced, the components of different modules can be simultaneously produced and manufactured, and can be independently tested and checked, the components with problems can be quickly maintained, the quality of the components is easier to control, the quality control of the whole product can be in a stable position, the time of the whole production is saved, and the reject ratio is greatly reduced. c. The support portion 2 and the resilient portion 3 serve as a base portion of the patient interface pad, which provides increased reusability and reduces the adverse environmental impact of excessive industrial products. d. The foam 6, cloth 5, etc. materials are easier to obtain in the desired form than thermoplastic elastomers, allowing for faster iteration of the product in its supply.

4) The method not only can provide different types of patient interface pads for users, but also is more important, compared with the existing patient interface pad for sealing faces by singly using silica gel, the cloth 5, the foam material 6 or the compound 7 of the cloth is more breathable than the silica gel, can provide comfortable contact surfaces with different degrees, can adsorb grease or sweat generated by long-time use of a patient, can keep the face of the patient dry, avoid skin sensitivity problems, and can also reduce the condition that the silica gel contacts the sweat or the grease is displaced. b. The adhesive 8 adopted by the method is nontoxic and harmless, has moderate tensile strength, has moderate hardness after curing, and shows transparent or semitransparent color after curing, and the adhesive 8 can not damage the surface of the elastic part 3 or generate harmful wastes. c. Due to the lower production costs, the patient's purchase costs are also reduced, and the user purchases more affordable, being able to enjoy and experience more types of patient interface pads, choosing the most appropriate one.

Drawings

FIG. 1 is a schematic structural view of a comfort patient interface pad of example 1 of the present invention;

FIG. 2 is a schematic exploded view of a patient interface pad of example 1 of the present invention for comfort;

FIG. 3 is a schematic structural view of a comfort portion of a comfort patient interface pad of example 1 of the present invention;

FIG. 4 is a material schematic for the comfort portion of the comfort patient interface pad of example 1 of the present invention under various examples;

FIG. 5 is a schematic structural view of a comfort patient interface pad of example 2 of the present invention;

FIG. 6 is a schematic structural view of a comfort patient interface pad of example 3 of the present invention;

FIG. 7 is a schematic structural view of a comfort patient interface pad of example 4 of the present invention;

FIG. 8 is a schematic representation of the adhesive coated areas of the method of making a comfort patient interface pad of example 1of the present invention;

FIG. 9 is a schematic illustration of the path of adhesive application in the method of making a comfort patient interface pad of example 1of the present invention;

FIG. 10 is a schematic view of the adhesive bond sites in the method of making a comfort patient interface pad of example 1of the present invention;

FIG. 11 is a schematic view of the structure of a support member in the method of manufacturing a comfort patient interface pad of example 1 of the present invention;

FIG. 12 is a schematic view of the structure of the clamp in the method of manufacturing a comfort patient interface pad of example 1 of the present invention;

FIG. 13 is a schematic view of the structure of the clamp in the method of manufacturing a comfort patient interface pad of example 1 of the present invention;

FIG. 14 is a schematic view of the clip fit in the method of making a comfort patient interface pad of example 1 of the present invention;

FIG. 15 is a schematic view of a comfort portion of multiple embodiments of a comfort patient interface pad of embodiment 1 of the present invention;

FIG. 16 is a schematic diagram of steps S1 and S2 of a method of making a comfort patient interface pad of example 1 of the present invention;

FIG. 17 is a schematic diagram of a method step S3 of making a comfort patient interface pad of example 1 of the present invention;

FIG. 18 is a schematic diagram of a method step S4 of manufacturing a comfort patient interface pad of example 1 of the present invention;

FIG. 19 is a schematic diagram of a method step S5 of manufacturing a comfort patient interface pad of example 1 of the present invention;

FIG. 20 is a schematic diagram of a method step S6 of manufacturing a comfort patient interface pad of example 1 of the present invention;

FIG. 21 is a schematic diagram of a method step S7 of manufacturing a comfort patient interface pad of example 1 of the present invention;

FIG. 22 is a schematic illustration of the steps of an automated method of making a comfort patient interface pad of example 5 of the present invention;

FIG. 23 is a schematic diagram of an automated manufacturing method step S3 of a comfort patient interface pad of example 5 of the present invention;

FIG. 24 is a schematic diagram of an automated manufacturing method step S5 of a comfort patient interface pad of example 5 of the present invention;

Fig. 25 is a schematic diagram of an automated manufacturing method step S7 of a comfort patient interface pad in example 5 of the present invention.

Detailed Description

In order that the above objects, features and advantages of the invention will be readily understood, a more particular description of the invention will be rendered by reference to the appended drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. The present invention may be embodied in many other forms than described herein and similarly modified by those skilled in the art without departing from the spirit of the invention, whereby the invention is not limited to the specific embodiments disclosed below.

The invention provides a comfortable patient interface pad, which aims at solving the problems that the face is airtight, the face is easy to sweat and the displacement of the traditional patient interface pad affects sealing, the mask pad and the mask sleeve are easy to wrinkle and are not easy to wear, the face of a user is adhered by cloth 5, foam material 6 or compound 7, sweat and grease can be adsorbed, the pad is more breathable, the wearing feeling of the user is more comfortable, the bitter feeling of the user under treatment is relieved, the mood of the user under treatment is relieved, better compliance is brought, and the steps of a specific manufacturing method are provided for how to rapidly produce the comfortable patient interface pad.

Several structures of the comfort patient interface pad of the present invention and methods of making the same are described below in connection with specific examples.

Example 1

It is an object of the present invention to provide a comfortable patient interface cushion designed to deliver a relatively ambient pressure pressurized flow of gas to the entrance of the patient's airway. As shown in fig. 1, the patient interface pad is composed of a support portion 2, a resilient portion 3 and a comfort portion 4.

Specifically, as shown in FIG. 2, the support portion 2 is configured to support the flexible portion 3, and includes a first opening 21 and a second opening 22, the first opening 21 is configured to contact other components of the patient interface assembly (e.g., an elbow, a frame, etc.), the first opening 21 is configured to be more comfortable and flexible for patient use, is generally a fixed circular interface and has a diameter of about 10-45mm (in other embodiments, other shapes are possible), the second opening 22 is configured to connect with the flexible portion 3 to cooperatively form a chamber for receiving a pressurized air flow, the two are connected by a non-removable connection such as molding, co-molding, or a removable connection such as a snap, magnetic, etc., and the support portion 2 is preferably a rigid material such as polycarbonate, polyethylene, polypropylene, etc., or a thermoplastic elastomer having a hardness of Shore A30-80 for better supporting the flexible portion 3.

The elastic part 3 is used for connecting the support part 2 and providing attachment points for the comfort part 4, the elastic part 3 comprises a third opening 31 connected with the support part 2 and a fourth opening 32 opposite thereto, and a side wall 33 for smoothly connecting the third opening 31 and the fourth opening 32, wherein the fourth opening 32 is configured to surround the nasal airway and the oral airway of a patient, as shown in fig. 8, the elastic part 3 is provided with a relatively gentle first surface 34 for better attachment of the comfort part 4, and the first surface 34 is configured to be connected with the comfort part 4 by means of an adhesive 8. The elastic part 3 is softer, more deformable and can conform to the deformation of the face than the supporting part 2, is usually made of a flexible material with the hardness of Shore A30-70, can be thermoplastic elastomer such as silica gel, rubber, elastic plastic and the like, preferably adopts biocompatible material between Shore A35-50, and in order to make the patient interface pad 1 more comfortable and durable, the wall thickness of the elastic part 3 can be single-layer, multi-layer or uneven, generally, the connection part of the elastic part 3 and the supporting part 2 is thicker than other parts (the rest part of the connection part of the elastic part 3 is removed), the elastic part is stronger and is not easy to break, the fourth opening 32 can be thinner than other parts (the rest part of the fourth opening 32 is removed), and the elastic part has larger deformability to adapt to the contour curves of faces of different patients, better conforms to the skin and improves the overall air tightness of the patient interface pad 1.

Specifically, as shown in fig. 3, the comfort portion 4 includes a second surface 41 that contacts the elastic portion 3 and a third surface 42 that contacts the patient's face, the second surface 41 is fixedly connected to the first surface 34 of the elastic portion 3 by the adhesive 8, the second surface 41 of the comfort portion 4 and the first surface 34 of the elastic portion 3 may have the same curvature (i.e., shape, contour, and contour being the same) or may have different curvatures (i.e., the second surface 41 may be planar or have other curvatures) at the common contact portion, and the third surface 42 of the comfort portion 4 may be designed to have a three-dimensional contour with different features and contour partially conforming to the patient's face curve in order to achieve a more comfortable adaptation experience and to promote the overall tightness of the patient interface pad 1, depending on the breathing assistance requirements, and the user's needs. As shown in figure 4, the comfort portion 4 is more fluffy, soft, breathable than the elastic portion 3 and may be made of foam 6, cloth 5, or a composite 7 of the two. The comfort portion 4 is generally in the shape of a drop of water having an inner edge and an outer edge, the inner edge shape may be generally triangular, oval, drop of water, or other shape that may surround the patient's nasal and oral airways.

In other embodiments, the fourth opening 32 of the flexible portion 3 may be used to accommodate only the nasal airways of a patient, i.e. the comfort portion 4 is used in conjunction with a nasal mask.

In other embodiments, the support portion 2 and the resilient portion 3 may be of the same material, such as a less invasive nasal mask, each of which may be of a silicone, rubber or other thermoplastic elastomer having a durometer Shore A30-70.

The present embodiment provides a method for manufacturing a comfortable patient interface pad, specifically, as shown in fig. 11-21, including the following steps:

Step S1, obtaining a patient interface pad for connecting the elastic portion 3 of the support portion 2 (and the elastic portion 3 having an opening for satisfying the facial requirements of a patient) according to ergonomically relevant data and a plurality of comfort and tightness tests (the patient interface pad having only the support portion 2 and the elastic portion 3 at this time), the support portion 2 comprising a first opening 21 and a second opening 22, wherein the second opening 22 is configured to be connected to the elastic portion, both of which may be connected in a detachable or non-detachable manner, the first opening 21 being a fixed circular interface for connecting to external auxiliary devices (such as elbows, frames, etc.), and in other embodiments also other shapes;

Step S2, forming the size and shape of the second surface 41 of the comfort portion 4 corresponding to the acquired size and shape of the first surface 34 of the resilient portion 3 of the patient interface pad, and determining the size and shape of the comfort portion 4 of the third surface 42 in contact with the patient' S face according to breathing assistance device requirements. In the present invention, patient interface pads having the same support portion 2 and resilient portion 3 may be connected to different comfort portions 4 (the first surface 34 of the resilient portion 3 is configured to be connected to a comfort portion 4 of a different general contour shape or material than the third surface 42 by adhesive 8). On the other hand, in order to achieve a close fitting of the comfort portion 4 to the patient's face, the third surface 42 of the comfort portion 4 presents a continuous curved surface corresponding to the patient's face when connected, the first surface 34 of the elastic portion 3 and the second surface 41 of said comfort portion 4, when connected, have the same curvature, in order to satisfy the stability of the portion where the elastic portion 3 and the support portion 2 are connected, the wall thickness of the third opening 31 of the elastic portion 3 is at least partially greater than the wall thickness of the fourth opening 32;

step S3, cleaning pretreatment is carried out on the patient interface pad (the elastic part 3) and the foam material 6, so that the surface of the material to be bonded is clean and tidy, and no pollutants affecting the bonding quality such as dirt, dust, wrinkles and the like are generated;

In step S4, the support 9 is placed inside the patient interface pad after the cleaning pretreatment, and the patient interface pad and the support 9 are fixed in a first container, which may be a jig 93, and the first container includes a receiving portion 932 for placing the support portion 2 or/and the elastic portion 3 of the patient interface pad, and a positioning portion 931 connected to the second container. The supporting piece 9 is configured to provide support for the elastic part 3, the outline of the supporting piece 9 is the same as that of the elastic part 3, in order to realize more stable support, the material of the supporting piece 9 is harder than that of the elastic part 3, and the supporting piece 9 is provided with a hand-held part 91 which is convenient to assemble and take;

Step S5, fixing the comfort portion 4 having completed the cleaning pretreatment in a second container, wherein the second container may be a jig 94, and the second container includes a receiving portion 942 for receiving the comfort portion 4, and a positioning portion 941 connected to the first container;

in step S6, the adhesive 8 is applied to the portion of the first surface 34 of the elastic portion 3, either manually or automatically. Wherein the adhesive 8 is manually applied to the first surface 34 of the elastic portion 3 to partially or completely cover the first surface 34, as shown in fig. 9-10, the dispenser may be automatically applied according to a path by a design program, the dispensing path of the dispenser is a complete continuous loop, the number of paths is at least 1 according to the material of the adhesive 8, and the application area of the adhesive 8 does not exceed the area of the second surface 41 of the comfort portion 4;

Step S7, the first container and the second container are connected in a corresponding configuration, such that the adhesive 8 is between the patient interface pad or comfort portion 4, and allowed to stand for curing.

In another embodiment, step S6, adhesive 8 is applied to a portion of second surface 41 of comfort portion 4, either manually or automatically. Wherein the adhesive 8 is manually applied to the second surface 41 of the comfort portion 4 to partially or completely cover the second surface 41, or the dispenser may be automatically applied according to a path by a design program, the dispensing path of the dispenser is a complete continuous loop, the number of paths is at least 1 according to the material of the adhesive 8, and the application area of the adhesive 8 does not exceed the area of the second surface 41 of the comfort portion 4.

In another embodiment, as shown in fig. 11-B, 12-B, 13, the first container may be a clamp 93, the first container contacting the support portion 2 of the patient interface pad or/and the receiving portion 932 of the resilient portion 3, the second container may be a clamp 94, the second container including a receiving portion 942 contacting the comfort portion 4, a positioning portion 941 coupled to the support 9, the support 9 configured to provide support to the resilient portion 3 and to couple to the second container, the support 9 including a positioning portion 92 coupled to the second portion, the support 9 having a contour that is the same as the contour of the resilient portion 3, and the support 9 being of a material that is harder than the material of the resilient portion 3 for a more secure support.

The adhesive 8 is usually glue, in order to ensure the quality and performance of the bond between the foam material 6, the elastic portion 3 and the adhesive 8, to avoid the adhesive 8 from damaging the appearance and properties of the material of the foam material 6 and the adhesive 8 from hardening or whitening after curing, care is taken in the selection of the material of the adhesive 8, 1) the adhesive strength is to ensure that the connection between the elastic portion 3 and the comfort portion 4 is sufficiently firm, the amount of adhesive 8 used is at least 0.03g, to ensure that the force of connection between the comfort portion 4 and the elastic portion 3 is greater than the gravity of the comfort portion 4 itself without external forces, and to avoid occurrence of separation due to movement during sleep, and to avoid wrinkling resulting in air leakage. 2) The material characteristics are that the adhesive 8 is positioned close to the respiratory tract and the face of a patient when the product is used, and the characteristics of no toxicity, no smell and the like which are basically harmless to human bodies are satisfied, and the adhesive is transparent or semitransparent after being solidified, so that the influence of trace on the final appearance of the patient interface pad is avoided; ensuring compatibility and adaptability between the adhesive materials, avoiding delamination, damaging the surface of the materials, changing the material characteristics or penetration by chemical reaction during the bonding process, meeting the requirements of regulations in various places such as ISO 10993, meeting the requirements of non-toxicity, adaptability and the like, ensuring that the adhesive 8 is liquid or semi-trickle in use (in another embodiment, the adhesive 8 is manually or automatically applied to the second surface 41 of the comfort portion 4, and the adhesive 8 is semi-trickle in use), and taking into account whether the adhesive 8 penetrates the comfort portion 4 or not when the adhesive 8 is initially in a flowing state, particularly, ensuring that the adhesive 8 is cured and set according to the materials in contact with the adhesive, avoiding applying pressure to the face of a user, not having a hardness higher than that of the elastic portion 3, having a hardness greater than or equal to Shore A15 after curing, and not having sufficient stretchability to break or affect the deformation of the patient interface pad when the patient interface pad is deformed, and ensuring that the tensile strength of the adhesive 8 is greater than or equal to 2MPa after curing, if the adhesive 8 is cured, the adhesive 8 is required to penetrate the comfort portion 4 and if the comfort portion 4 is a third surface 42 and the comfort portion is uncomfortable to feel when the comfort portion is not affected by the user. 3) The environment-friendly adhesive 8 needs to be selected to have long service life, avoid rapid aging of products, is preferably harmless and easily degradable, is comprehensively considered in energy conservation, waste treatment, process optimization and the like, and can be selected to be 3M, loctite, UHU brands of glue. The glue selected in this example has the basic characteristics of a density of about 0.3-3g/cm ³, a temperature resistance in the range of about-55-200 ℃, and a tensile strength of 0.5MPa or more.

Example 2

A comfortable patient interface pad of the present embodiment is designed to deliver a flow of air pressurized relative to ambient air pressure to the entrance of the patient's airway. The patient interface pad consists of a comfort portion 4 comprising a first opening 21 for contacting other components in the patient interface assembly (e.g. elbows, frames, etc.) and a support portion 2 connected to the comfort portion 3, comprising a third opening 31 connected to the support portion 2, a fourth opening 32 opposite the third opening 31, a side wall 33 connecting the third opening 31 and the fourth opening 32 in a smooth manner, comprising a second surface 41 for contacting the elastic portion 3 and a third surface 42 for contacting the patient's face, wherein a portion of the side wall 33 of the elastic portion 3 has a relatively gentle first surface 34, the first surface 34 being configured to be connected to the comfort portion 4 by means of an adhesive 8, and the fourth opening 32 being configured to surround the patient's nasal airway and the oral airway or separately. The patient interface pad with comfort provided by this embodiment differs from the patient interface pad of embodiment 1 in that this embodiment defines the comfort portion 4 as a cloth 5 (fabric). As shown in fig. 5, the cloth 5 of the comfort portion 4 has the advantages of water absorption and high air permeability, can effectively absorb secretion of the face of a patient at night, keeps the face of the patient dry and breathable, and improves compliance of the patient to the patient interface pad. The cloth 5 can be made of one or more materials such as cotton, silk, flannelette, nylon, spandex, terylene and the like according to different proportions, and part of the cloth 5 can also be made into different functional cloths 5 together with metal fibers, such as antibacterial cloth, antistatic cloth and the like. The cloth 5 should meet a permeability of between 1 and 30CFM (as determined by the permeability test method in ASTM D737), in another embodiment the permeability is about 40-60CFM, or 50-80CFM, ensuring patient comfort while avoiding excessive gas leakage, the cloth 5 should have a water absorption time of less than 30 seconds, preferably less than 20 seconds, more preferably less than 10 seconds, ensuring that the cloth 5 is capable of absorbing sweat, grease, of the patient's face, the count of the cloth 5 is not less than 30 and not more than 100, the average roughness (Ra value) of the third surface 42 contacting the patient's face should be 0.2-10 microns, ensuring that the cloth 5 provides a soft comfort to the patient, and avoiding the cloth 5 from weighing too much to press the patient's face. The cloth 5 may be cut into an annular contour by laser, die cutting, ultrasonic wave, etc., and the inner and outer edges may be substantially triangular, oval, drop-shaped, circular, or any other shape that may cover the first surface 34 of the elastic portion 3, and the outer edge may have a contour similar to the inner edge or a general contour similar to the first surface 34, and the inner edge of the cloth 5 may have an open area of not less than 23mm ². The first surface 34 of the elastic portion 3 and the second surface 41 of the cloth 5 may have the same curvature or different curvatures at the common contact portion, and the third surface 42 of the cloth 5 may conform to the curve of the patient's face, wherein when the inner edge opening is smaller than or equal to the fourth opening 32 of the elastic portion 3, meaning that the user's face is completely sealed by at least a portion of the outer surface (contact area) of the cloth 5 at this time, and when the inner edge opening is larger than the fourth opening 32 of the elastic portion 3 or the outer edge is smaller than the first surface 34 of the elastic portion 3, meaning that the elastic portion 3 and at least a portion of the second surface 41 of the cloth 5 simultaneously seal the user's face. The cloth 5 part can be in a single-layer form or a multi-layer form, and the combination mode of the multi-layer cloth 5 can be pressing, stitching, thermoplastic compounding, hot melting compounding and film compounding. To ensure the sealing effect of the patient interface pad, the thickness of the cloth 5 is about 0.8mm-3.5mm (too thin a layer of cloth 5 is easily inelastic and flexible, too thick a layer of cloth 5 is easily displaced and leaked), and the thickness of the cloth 5 may be uniform or may be varied, for example, tapered at the outer edge portion to fit the elastic portion 3 or tapered at the inner edge portion to reduce the feeling of presence at the face.

This example provides a method of making a comfortable patient interface pad that differs from the patient interface pad of example 1 in the amount of adhesive 8 used. In order to ensure that the adhesive 8 does not completely penetrate the cloth 5 and can be tightly bonded to the elastic portion 3 at the time of production, the adhesive 8 is used in an amount of at least 0.03g.

Example 3

A comfortable patient interface pad of the present embodiment is designed to deliver a flow of air pressurized relative to ambient air pressure to the entrance of the patient's airway. The patient interface pad consists of a comfort portion 4 comprising a first opening 21 for contacting other components in the patient interface assembly (e.g. elbows, frames, etc.) and a support portion 2 connected to the comfort portion 3, comprising a third opening 31 connected to the support portion 2, a fourth opening 32 opposite the third opening 31, a side wall 33 connecting the third opening 31 and the fourth opening 32 in a smooth manner, comprising a second surface 41 for contacting the elastic portion 3 and a third surface 42 for contacting the patient's face, wherein a portion of the side wall 33 of the elastic portion 3 has a relatively gentle first surface 34, the first surface 34 being configured to be connected to the comfort portion 4 by means of an adhesive 8, and the fourth opening 32 being configured to surround the patient's nasal airway and the oral airway or separately. The patient interface pad of this embodiment provides comfort that differs from the patient interface pad of embodiment 1 in that the comfort portion 4 is defined as a foam material 6.

As shown in FIG. 6, the foam material 6 is a porous material including, but not limited to, a soft, resilient material such as polyurethane foam, EVA foam, latex, and the like, having a density of about 10-100kg/m ³. The permeability of the foam material 6 is less than 50L/min, ensuring that the patient interface pad to which the foam material 6 is bonded does not affect the overall air tightness. The foam material 6 has a three-dimensional shape with a width of about 3-30mm and a width to thickness ratio of about 0.1-30, the cross section of the foam material 6 may be approximately quadrangular, pentagonal, hexagonal, and for better comfort the edges of the first surface 34 will be rounded, and the third surface 42 contacting the patient's face will have an arc conforming to the patient's face, so that during wear the elastic portion 3 and the comfort portion 4 deform to different degrees following the contours of the face, approximately conforming to the shape of the face, dispersing the pressure of the face, achieving a more comfortable wearing effect.

This example provides a method of making a comfortable patient interface pad that differs from the patient interface pad of example 1 in the amount of adhesive 8 used. In order to ensure that the adhesive 8 does not completely penetrate the cloth 5 and can be tightly bonded to the elastic portion 3 at the time of production, the adhesive 8 is used in an amount of at least 0.05g.

Example 4

A comfortable patient interface pad of the present embodiment is designed to deliver a flow of air pressurized relative to ambient air pressure to the entrance of the patient's airway. The patient interface pad consists of a comfort portion 4 comprising a first opening 21 for contacting other components in the patient interface assembly (e.g. elbows, frames, etc.) and a support portion 2 connected to the comfort portion 3, comprising a third opening 31 connected to the support portion 2, a fourth opening 32 opposite the third opening 31, a side wall 33 connecting the third opening 31 and the fourth opening 32 in a smooth manner, comprising a second surface 41 for contacting the elastic portion 3 and a third surface 42 for contacting the patient's face, wherein a portion of the side wall 33 of the elastic portion 3 has a relatively gentle first surface 34, the first surface 34 being configured to be connected to the comfort portion 4 by means of an adhesive 8, and the fourth opening 32 being configured to surround the patient's nasal airway and the oral airway or separately. The patient interface pad of this embodiment provides comfort that differs from the patient interface pad of embodiment 1 by further defining the comfort portion 4 as a composite of foam material 6 and cloth 5. As shown in fig. 7, the comfort portion 4 includes a second surface 41 contacting the elastic portion 3 and a third surface 42 contacting the patient's face, wherein the comfort portion 4 is a composite of the foam material 6 and the cloth 5, the second surface 41 of the comfort portion 4 is the foam material 6, the third surface 42 is the cloth 5, and the foam material 6 and the cloth 5 are in a connected state. Foam 6 in this example has the same characteristics as in example 3 and cloth 5 has the same characteristics as in example 2. The foam material 6 and the cloth 5 can be bonded by an adhesive 8, hot melting and pressure, and can also be sewn, pressed and the like.

Example 5

A comfortable patient interface pad of the present embodiment is designed to deliver a flow of air pressurized relative to ambient air pressure to the entrance of the patient's airway. The patient interface pad consists of a comfort portion 4 comprising a first opening 21 for contacting other components in the patient interface assembly (e.g. elbows, frames, etc.) and a support portion 2 connected to the comfort portion 3, comprising a third opening 31 connected to the support portion 2, a fourth opening 32 opposite the third opening 31, a side wall 33 connecting the third opening 31 and the fourth opening 32 in a smooth manner, comprising a second surface 41 for contacting the elastic portion 3 and a third surface 42 for contacting the patient's face, wherein a portion of the side wall 33 of the elastic portion 3 has a relatively gentle first surface 34, the first surface 34 being configured to be connected to the comfort portion 4 by means of an adhesive 8, and the fourth opening 32 being configured to surround the patient's nasal airway and the oral airway or separately.

This embodiment provides a method of making a comfortable patient interface pad that differs from the method of making of embodiment 1 in that the adhesive 8 is applied in a fully automated manner, as shown in fig. 22-25.

Step S1, obtaining a patient interface pad for connecting the elastic portion 3 of the support portion 2 (and the elastic portion 3 having an opening for satisfying the patient' S face requirements) according to ergonomically relevant data and a plurality of comfort and tightness tests (the patient interface pad having only the support portion 2 and the elastic portion 3 at this time), the support portion 2 comprising a first opening 21 and a second opening 22, wherein the second opening 22 is configured to be connected to the elastic portion, both of which may be connected in a detachable or non-detachable manner, the first opening 21 being a fixed circular interface for connecting to external auxiliary devices (such as elbows, frames, etc.), and in other embodiments also other shapes;

Step S2, forming the size and shape of the second surface 41 of the comfort portion 4 corresponding to the acquired size and shape of the first surface 34 of the resilient portion 3 of the patient interface pad, and determining the size and shape of the comfort portion 4 of the third surface 42 in contact with the patient' S face according to breathing assistance device requirements. In the present invention, a patient interface pad having the same support portion 2 and comfort portion 4 may be connected to different comfort portions 4, i.e., the first surface 34 of the resilient portion 3 is configured to be connected to the comfort portion 4 by the adhesive 8. On the other hand, in order to achieve a close fitting of the comfort portion 4 to the patient's face, the second surface 41 and the third surface 42 of the comfort portion 4 are continuously curved surfaces corresponding to the patient's face, and in order to satisfy the stability of the connecting portion of the elastic portion 3 and the support portion 2, the wall thickness of the third opening 31 of the elastic portion 3 is at least partially larger than the wall thickness of the fourth opening 32;

Step S3, fixing the patient interface pad in a first container, wherein the first container may be a clamp 93, the first container comprising a receiving portion 932 for receiving the support portion 2 or/and the resilient portion 3 of the patient interface pad, a positioning portion 931 connected to the second container, a support pouch, wherein the support pouch is configured to automatically inflate the support resilient portion 3 after fixing the patient interface pad;

Step S4, cleaning pretreatment is carried out on the patient interface pad and the foam material 6, so that the surfaces of the materials are clean and tidy, and no pollutants affecting the bonding quality such as dirt, dust, wrinkles and the like are generated;

Step S6, moving the first container subjected to the cleaning pretreatment to a position below a glue releasing and positioning device, as shown in fig. 9-10, automatically applying the adhesive 8 to the first surface 34 of the elastic part 3 or completely covering the first surface 34 according to a designated path by a set program, wherein the glue releasing path of the glue releasing and positioning device is a complete continuous ring shape, the number of paths is selectable according to the material of the adhesive 8 and at least more than 1 path, and the application area of the adhesive 8 does not exceed the area of the second surface 41 of the comfort part 4;

step S7, the first container and the second container are connected in a corresponding configuration, such that the adhesive 8 is between the patient interface pad or comfort portion 4, and allowed to stand for curing. The completed patient interface pad 1 is removed from the first container and the remaining first container is returned to the supply tank.

In another embodiment, step S6, adhesive 8 is applied to a portion of second surface 41 of comfort portion 4. Wherein the adhesive 8 is applied to the second surface 41 of the comfort portion 4 by a design procedure such that the glue release and retainer are applied to the second surface 41 partially or completely over the second surface 41 in a path, the glue release and retainer application path being a complete continuous loop, the number of paths being selectable according to the material of the adhesive 8 therewith but at least 1 or more, the area of application of the adhesive 8 not exceeding the area of the second surface 41 of the comfort portion 4.

The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.

The above examples illustrate only a few embodiments of the invention, which are described in detail and are not to be construed as limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.

Claims

1. A comfortable patient interface cushion configured to deliver airflow pressurized relative to ambient air pressure to a patient's airway entrance in a sealed manner, characterized in that it comprises:

a support portion including a first opening and a second opening, wherein the second opening is configured to connect with the elastic portion;

an elastic portion, comprising a third opening connected to the support portion, a fourth opening opposite thereto, and a side wall smoothly connecting the third opening and the fourth opening, wherein a portion of the side wall has a relatively flat first surface, and the first surface is configured to be connected to the comfort portion;

The comfort portion comprises a second surface in contact with the elastic portion and a third surface in contact with the patient's face, wherein the comfort portion is a foam material;

Wherein, the first surface of the elastic part and the second surface of the foam material are connected by an adhesive, and the adhesive has one or more of the following characteristics:

a. The amount of adhesive used is at least 0.05g;

b. Density range is 0.3-3g/cm ³ ;

c. Temperature resistance range is -55℃-200℃;

d. Tensile strength is greater than or equal to 0.5MPa;

e. The adhesive coating path is continuous and the circumference of the path is not less than the circumference of the fourth opening.

2. The patient interface pad according to claim 1 is characterized in that the patient interface pad accommodates both the nasal and oral airways of the patient or only the nasal airway.

3. The patient interface pad according to claim 1 is characterized in that the material of the support part is polycarbonate, polypropylene, polyethylene or a thermoplastic elastomer with a hardness of Shore A 30-80, and the second opening of the support part and the third opening of the elastic part are connected by molding or co-molding.

4. The patient interface pad according to claim 1 is characterized in that the first surface of the elastic part and the second surface of the comfort part have the same curvature in the parts in common contact when connected, and the third surface of the comfort part partially conforms to the curve of the patient's face when in use.

5. The patient interface pad of claim 1, wherein the foam material is a continuous three-dimensional shape with a width-to-thickness ratio ranging from 0.1-30.

6. A comfortable patient interface cushion configured to deliver airflow pressurized relative to ambient air pressure to a patient's airway entrance in a sealed manner, comprising:

The comfort portion comprises a second surface in contact with the elastic portion and a third surface in contact with the patient's face, wherein the comfort portion is a cloth;

Wherein, the first surface of the elastic portion and the second surface of the comfort portion are connected by an adhesive, and the adhesive has one or more of the following characteristics:

a. The amount of adhesive used is at least 0.03g;

b.Hardness greater than or equal to Shore A 15;

c. Density of at least 0.3 g/cm ³ ;

d. The color after curing is transparent or translucent.

7. The patient interface cushion of claim 6, wherein the patient interface cushion accommodates both the nasal and oral airways of the patient or only the nasal airway.

8. The patient interface pad according to claim 6 is characterized in that the material of the support part is polycarbonate, polypropylene, polyethylene or a thermoplastic elastomer with a hardness of Shore A 30-80, and the second opening of the support part and the third opening of the elastic part are connected by molding or co-molding.

9. The patient interface pad according to claim 6 is characterized in that the fabric is elastic and changes in accordance with the curvature of the elastic portion when subjected to pressure, and the Ra value of the second surface of the fabric is in the range of 0.2-10 microns.

10. The patient interface pad of claim 6, wherein the opening area of the inner edge of the fabric is not less than 23 ^mm2 .

11. A comfortable patient interface cushion configured to deliver airflow pressurized relative to ambient air pressure to a patient's airway entrance in a sealed manner, comprising:

The comfort part comprises a second surface in contact with the elastic part and a third surface in contact with the patient's face, wherein the comfort part comprises a foam material and a cloth, the second surface of the comfort part is the foam material, the third surface is the cloth, and the foam material and the cloth are in a connected state;

a. The amount of adhesive used is at least 0.05g;

b. Density is at most 3g/cm ³ ;

c. Temperature resistance range is -55℃-200℃;

d. The adhesive coating path is continuous and the circumference of the path is not less than the circumference of the fourth opening.

12. The patient interface cushion of claim 11, wherein the patient interface cushion accommodates both the nasal and oral airways of the patient or only the nasal airway.

13. The patient interface pad according to claim 11 is characterized in that the material of the support part is polycarbonate, polypropylene, polyethylene or a thermoplastic elastomer with a hardness of Shore A 30-80, and the second opening of the support part and the third opening of the elastic part are connected by molding or co-molding.

14. The patient interface pad according to claim 11 is characterized in that the first surface of the elastic part and the second surface of the comfort part have the same curvature in the parts in common contact when connected, and the third surface of the comfort part partially conforms to the curve of the patient's face when in use.

15. The patient interface pad of claim 11, wherein the foam material is a continuous three-dimensional shape with a width to thickness ratio ranging from 0.1-30.

16. The patient interface pad according to claim 11, characterized in that the fabric is elastic and changes in accordance with the curvature of the foam material when subjected to pressure, and the Ra value of the second surface of the fabric is in the range of 0.2-10 microns.

17. The patient interface pad according to claim 11, characterized in that the foam material and the cloth are connected by an adhesive or by an intermediate layer, wherein the intermediate layer is made of TPU material.

18. A method for manufacturing a comfortable patient interface pad, the patient interface pad having a support portion, an elastic portion and a comfort portion, wherein the comfort portion and the elastic portion are connected by an adhesive, the steps of the manufacturing method are as follows:

Step S, obtaining the elastic part connected to the supporting part and the corresponding comfortable part, and cleaning the elastic part and the comfortable part;

Step S, applying adhesive to a portion of the first surface of the elastic portion manually or automatically;

Step S, connecting the elastic portion coated with adhesive to the comfort portion accordingly, so that the adhesive is located between the patient interface pad or the comfort portion,

Step S, leaving the connected patient interface pad with the comfort portion to stand, waiting for the adhesive to solidify;

Wherein, the adhesive has one or more of the following characteristics:

a. The amount of adhesive used is at least 0.03g;

b. After curing, the hardness is greater than or equal to Shore A 15;

c. The circumference of the adhesive coating path is not less than the circumference of the fourth opening of the elastic portion;

d. The adhesive coating does not exceed the second surface of the comfort portion;

e. The state of the colloid before solidification is liquid or semi-fluid.

19. The method for manufacturing a patient interface pad according to claim 18, wherein the patient interface pad accommodates both the nasal airway and the oral airway of the patient, or only accommodates the nasal airway.

20. The method for manufacturing a patient interface pad according to claim 18, characterized in that the comfort portion comprises a foam material and a cloth, and the foam material and the cloth are connected via the adhesive or via an intermediate layer, wherein the intermediate layer is made of TPU material.

21. The method for making a patient interface pad according to claim 18, characterized in that the step is completed by cooperation between a first container and a second container, wherein the first container is a clamp for fixing the patient interface pad, and the second container is a clamp for fixing the comfort part.

22. A method for manufacturing a comfortable patient interface pad, the patient interface pad having a support portion, an elastic portion and a comfort portion, wherein the comfort portion and the elastic portion are connected by an adhesive, the steps of the manufacturing method are as follows:

Step S, applying adhesive to a portion of the second surface of the comfort portion manually or automatically;

Step S, connecting the elastic part and the comfortable part correspondingly, so that the adhesive is between the elastic part or the comfortable part,

Wherein, the adhesive has one or more of the following characteristics:

a. The amount of adhesive used is at least 0.03g;

b. After curing, the hardness is greater than or equal to Shore A 15;

e. The state of the colloid before solidification is semi-fluid.

23. The method for making a patient interface pad according to claim 22, wherein the patient interface pad accommodates both the nasal airway and the oral airway of the patient, or only accommodates the nasal airway.

24. The method for manufacturing a patient interface pad according to claim 22, characterized in that the comfort part comprises a foam material and a cloth, and the foam material and the cloth are connected via the adhesive or via an intermediate layer, wherein the intermediate layer is made of TPU material.

25. The method for making a patient interface pad according to claim 22, characterized in that the step is completed by cooperation between a first container and a second container, wherein the first container is a clamp for fixing the patient interface pad, and the second container is a clamp for fixing the comfort part.