CN106267505B - Mask liner assembly, manufacturing method thereof and breathing machine mask - Google Patents

Abstract

The embodiment of the invention provides a mask liner component, a manufacturing method thereof and a breathing machine mask, wherein the mask liner component is used for being installed on a mask main frame and comprises the following components: the outer layer of liner, the outer layer of liner adopts the fabric material to make, the outer layer of liner includes: the mask comprises a contact part matched with the contour of the face of a patient and a connecting part connected with the mask main frame, wherein a closed cavity structure is formed between the contact part and the connecting part; a cushion filling filled inside the cavity structure, the cushion filling being made of a soft elastic material to fit the mask cushion assembly to the patient's face; and a cushion stiffener located inside the cavity structure, the cushion stiffener being made of a stiff material to shape the mask cushion assembly. The embodiment of the invention can greatly reduce the processing cost of the mask liner component; and the comfort level of the outer layer of the liner made of the fabric material contacting with the face is higher, and the air permeability is better.

Description

A mask cushion assembly and its manufacturing method, a ventilator mask

technical field

The invention relates to the technical field of medical devices, in particular to a mask cushion assembly and a manufacturing method thereof, and a ventilator mask.

Background technique

CPAP (Continuous Positive Airway Pressure) ventilator mask is a product that needs to be worn by patients for a long time, and its wearing comfort has a great impact on the overall performance of the product. In practical applications, when the ventilator is working normally, it will output a positive pressure airflow, which is introduced into the patient's nose or mouth through the ventilator mask. Therefore, only the mask pad of the ventilator mask is in good contact with the patient's face. It can be ensured that there is no air leakage at the position where the face fits.

At present, in order to achieve the comfort and sealing of the face fitting position, most of the mask pads are made of silicone material. For example, an existing mask liner may specifically include: an inner liner and an outer liner, wherein the inner liner and the outer liner are both made of silicone materials, the outer liner mainly plays a sealing function, and the inner liner The pads mainly play a supporting role. Because the silicone material has good toughness and elasticity, the patient can achieve acceptable comfort after wearing the corresponding ventilator mask, and can achieve better sealing of the face fitting position, thereby avoiding air leakage at the face fitting position Phenomenon. However, silicone materials are expensive, resulting in higher processing costs for existing mask pads. In addition, due to the poor air permeability of silica gel, especially in hot weather, patients will feel uncomfortable wearing it, and many patients will also have skin allergy symptoms.

SUMMARY OF THE INVENTION

In view of the above problems, the purpose of the embodiments of the present invention is to provide a mask pad assembly and a manufacturing method thereof, and a ventilator mask, so as to solve the problems of air permeability and high processing cost of the existing mask pad.

An embodiment of the first aspect provides a mask cushion assembly for mounting on a mask main frame, comprising:

The outer layer of the cushion, the outer layer of the cushion is made of fabric material, the outer layer of the cushion comprises: a contact part adapted to the contour of the patient's face, and a connection part connected with the main frame of the mask, the A closed cavity structure is formed between the contact part and the connection part;

a cushion filling, which is filled inside the cavity structure, the cushion filling is made of a soft elastic material, so that the mask cushion assembly fits the patient's face; and

A cushion hard liner is located inside the cavity structure, and the cushion hard liner is made of a durometer material to shape the mask cushion assembly.

Optionally, the gasket filling is located inside the cavity structure on a side close to the contact portion.

Optionally, the liner hard lining is located inside the cavity structure on a side close to the connecting portion.

Optionally, the liner hard lining is distributed in whole or in part along the axial direction of the cavity structure.

Optionally, there is a detachable connection between the connecting portion and the main frame of the mask, or the connecting portion and the main frame of the mask are integrally formed.

Optionally, a plurality of hole structures are arranged on the pad filling, so as to facilitate the discharge of air flow.

Optionally, the composition of the fabric material includes: at least one of cotton, wool, linen and polyester.

Optionally, the soft elastic material includes: foam, fabric, soft silicone, soft thermoplastic elastomer or soft polyurethane.

Optionally, the hardness material includes: hard plastic, hard thermoplastic elastomer, hard polyurethane, or a memory material whose hardness is within the second hardness range.

Optionally, the mask cushion assembly is provided with a vent hole that opens outward, or the outer layer of the cushion is provided with a pre-distributed coating, or the fabric material, soft elastic material or The durometer material has a preset sparse density to achieve the discharge of the air flow.

A second aspect embodiment provides a ventilator mask comprising: a mask main frame and the aforementioned mask cushion assembly, the mask cushion assembly being connected to the mask main frame to allow the mask to cushion the mask when in use The pad assembly is in full contact with the patient's face.

Embodiments of the third aspect provide a method for manufacturing a mask cushion assembly, including:

A cushion outer layer with a cavity structure is made of fabric material; the cushion outer layer includes: a contact part adapted to the contour of the patient's face, and a connection part connected with the main frame of the mask, the contact part and the A closed cavity structure is formed between the connecting parts;

The padding is made of soft elastic material;

Hard lining is made of hard material;

The cushion filler and the cushion hardliner are assembled within the cavity structure, respectively, to obtain an assembled mask cushion assembly.

The embodiments of the present invention include the following advantages:

Compared with the mask pad made of silicone material in the existing solution, because the mask pad assembly of the embodiment of the present invention can be made of fabric material, soft elastic material and hardness material, and the fabric material, soft elastic material and hardness material The price is much lower than the price of silicone material, so it can greatly reduce the processing cost of the mask cushion assembly.

Secondly, compared with the mask liner made of silicone material in the existing solution, the outer layer of the liner made of the fabric material in the embodiment of the present invention has higher comfort in contact with the face and better air permeability.

Furthermore, the soft elastic material used for pad filling in the embodiment of the present invention is relatively soft and has good elasticity, so the mask pad assembly can be more easily fitted to the patient's face, and has a wider range of adaptation to different face shapes of patients. More comfort.

In addition, in the embodiment of the present invention, the liner hard liner made of a hardness material can shape the mask liner assembly, so as to maintain the preset shape of the mask liner assembly through the liner hard liner.

Moreover, in the existing solution, the mask liner made of silicone material needs to be provided with air vents on the mask frame and the elbow to meet the exhaust requirements; while in the embodiment of the present invention, the material of the outer layer of the liner is a fabric material, The material filled with the pad can be a soft elastic material with pores inside, such as foam, fabric, etc. Since the above-mentioned fabric material and soft elastic material have certain air permeability, the mask pad assembly itself can realize the vent hole. function, so the process cost required for the setting of the exhaust hole can be saved.

In addition, the molding process of the silicone material is complicated, which makes it difficult to manufacture the existing mask pad. However, the mask pad assembly of the embodiment of the present invention can be manufactured by using fabric materials, soft elastic materials, and hardness materials, while fabric materials, soft elastic materials, and hardness materials are used. The elastic material does not need a corresponding molding process. In addition, the pad hard liner made of a hardness material can be used to maintain the preset shape of the mask pad assembly. In practical applications, suitable materials such as hard plastic and hard thermoplastic elastomer can be used. Or a rigid polyurethane material to simplify the manufacturing process of the mask cushion assembly.

Description of drawings

Fig. 1 is the structural representation of a kind of ventilator mask provided by the present invention;

FIG. 2 is a partial cross-sectional view of the mask cushion assembly 2 shown in FIG. 1 along the direction A-A;

3 is a schematic diagram of the exhaust process of a ventilator mask of the present invention;

4 is a schematic diagram of the exhaust process of another ventilator mask of the present invention;

5 is a schematic diagram of the exhaust process of yet another ventilator mask of the present invention;

6 is a schematic diagram of the exhaust process of another ventilator mask of the present invention

7 is a flow chart of steps of an embodiment of a method for manufacturing a mask cushion assembly of the present invention;

In the figure, 1—mask main frame; 2—mask cushion assembly; 3—pad outer layer; 4—pad filling; 5—pad hard lining; 6—first exhaust hole; 7—air intake pipe; 8 - the second exhaust hole; 9 - the third exhaust hole; A-A - cutting direction; B - intake direction; C - exhaust direction.

Detailed ways

In order to make the above objects, features and advantages of the present invention more clearly understood, the present invention will be described in further detail below with reference to the accompanying drawings and specific embodiments.

The mask cushion assembly provided by the embodiment of the present invention can be used to be installed on the main frame of the mask, and specifically may include: a cushion outer layer, a cushion filling and a cushion hard lining, wherein the cushion outer layer It can be made of fabric material, and the outer layer of the pad can include: a contact part adapted to the contour of the patient's face, and a connection part connected with the main frame of the mask, the contact part and the connection part are formed between the contact part and the connection part. A closed cavity structure; the interior of the cavity structure can be filled with the above-mentioned cushion filling and cushion hard lining, and the cushion filling can be made of soft elastic material, so that the mask cushion assembly fits the patient's face; The pad fill is fabricated from a durometer material to shape the mask pad assembly. Wherein, the face in the embodiment of the present invention may specifically include: nasal cavity, oral cavity, or nasal cavity and oral cavity, and the embodiment of the present invention does not limit the specific facial position.

Compared with the mask pad made of silicone material in the existing solution, because the mask pad assembly of the embodiment of the present invention can be made of fabric material, soft elastic material and hardness material, and the fabric material, soft elastic material and hardness material The price is much lower than the price of silicone material, so it can greatly reduce the processing cost of the mask cushion assembly.

In practical applications, the components of the above-mentioned fabric materials may specifically include: at least one of cotton, wool, linen and polyester. Compared with the mask liner made of silicone material in the existing solution, the outer layer of the liner made of fabric material is more comfortable in contact with the face and has better air permeability.

The above-mentioned soft elastic material can be used to represent a material with a hardness within a first hardness range and good elasticity, wherein the first hardness range can be determined by those skilled in the art according to actual application requirements, for example, when using a Shore A durometer to measure In terms of hardness, the first hardness range may be 0 degrees to 40 degrees, and the embodiment of the present invention does not limit the specific first hardness range. Optionally, the soft elastic material may specifically include: foam, fabric, or other soft material with pores inside, or may include: soft silicone, soft TPE (thermoplastic elastomer, Thermoplastic Elastomer) or soft polyurethane (polyurethane). Ester, polyurethane) and other materials with hardness within the first hardness range and good elasticity. Since the cushion filling material is soft and has better elasticity, the mask cushion assembly can be more easily fitted to the patient's face, and has a wider range of adaptation to different face shapes of the patient, and higher comfort.

The above hardness materials can be used to represent materials whose hardness is within a second hardness range, wherein the second hardness range can be determined by those skilled in the art according to actual application requirements, for example, the second hardness range can be: hardness greater than 65 degrees, etc., It can be understood that the embodiment of the present invention does not limit the specific second hardness range. Optionally, the above-mentioned hardness material may specifically include: hard plastic, hard thermoplastic elastomer or hard polyurethane, and the hardness of the above-mentioned hard plastic, hard thermoplastic elastomer or hard polyurethane may be greater than 65 degrees. The use of a hard liner made of a durometer material can shape the mask cushion assembly, for example, can be determined according to the patient's preset face shape (eg, round face, square face, oval face, etc.) and/or preset nose bridge height The preset shape of the mask cushion assembly, which can be adapted to the preset face shape and/or the preset nose bridge height, so as to maintain the preset shape of the mask cushion assembly by the cushion hard liner.

In an optional embodiment of the present invention, the above-mentioned hardness material may include: a memory material whose hardness is within the second hardness range. Among them, the memory material has excellent characteristics such as memory, response, recovery, shock resistance and adaptability. In this way, the pad hard liner made of the memory material can automatically remember and match the patient's face shape in the working environment of the ventilator. shape so that the patient enjoys a consistent fit.

Embodiments of the present invention also provide a ventilator mask, which may specifically include: a mask main frame and the aforementioned mask cushion assembly, the mask cushion assembly being connected to the mask main frame, so as to connect the patient to the mask during use. spaced from the mask main frame.

A mask cushion assembly provided by an embodiment of the present invention is described in detail below through specific embodiments. For the convenience of description, the following description will be given as the application scenario of the mask cushion assembly of the embodiment of the present invention. Those skilled in the art can understand that in addition to the CPAP ventilator, other ventilators that require a mask, such as APAP (Automatic CPAP) , Auto-CPAP) and other ventilators are all within the scope of protection of the embodiments of the present invention.

Referring to FIG. 1, there is shown a schematic structural diagram of a ventilator mask provided by the present invention. The ventilator mask may specifically include: a mask main frame 1 and a mask cushion assembly 2, and the mask cushion assembly 2 can be used to be installed on the mask main frame. on the frame. Optionally, the mask cushion assembly 2 may be provided with a connecting part on the side close to the mask main frame 1, and a detachable connection may be provided between the connecting part and the mask main frame 1, or the connecting part and the mask main frame 1 may be detachably connected. The frame 1 may form a one-piece structure. In practical applications, the connection between the mask main frame 1 and the mask cushion assembly 2 can be various. For example, the mask main frame 1 can have a groove-like structure, and the mask cushion assembly can be directly placed in the groove. or, the mask main frame 1 may have a groove-like structure and a fixing structure, then when the mask cushion assembly 2 is placed in the groove-like structure, the groove-like structure can be fixed by the fixing structure of the mask main frame 1 at the same time. The inner mask cushion assembly is fixed, wherein the fixing structure may be a structure with a fixing function such as a clip structure. It can be understood that the embodiment of the present invention has no effect on the specific connection between the mask main frame 1 and the mask cushion assembly 2. be restricted. After the patient wears the ventilator mask shown in Figure 1, the mask cushion assembly 2 can achieve a good fit with the patient's face; further, the ventilator mask shown in Figure 1 has a good seal with the patient's face. On the other hand, the positive pressure airflow continuously provided by the ventilator can enter the ventilator mask according to the B direction in Figure 1, and the positive pressure airflow will enter the patient's nose or mouth, thereby achieving a therapeutic effect.

Referring to FIG. 2 , there is shown a partial cross-sectional view of the mask cushion assembly 2 shown in FIG. 1 along the A-A direction. The mask cushion assembly 2 may specifically include: a cushion outer layer 3 , a cushion filling 4 and a cushion hard liner 5 .

The pad outer layer 3 can be made of fabric material, which can include: a contact part (located on the side away from the main frame 1 of the mask, not shown in FIG. 1 ) adapted to the contour of the patient's face; The connecting part (located on the side close to the main frame 1 of the mask, not shown in FIG. 1 ) connected with the main frame of the mask, a closed cavity structure can be formed between the contact part and the connecting part, so that the pad is filled with 4 And the liner hard liner 5 is installed inside the cavity structure. Compared with the mask liner made of silicone material in the existing solution, the outer layer 3 of the liner made of fabric material is more comfortable in contact with the face and has better air permeability. Optionally, the cavity structure may be closed in the circumferential direction and leave an opening in the cross-sectional direction to facilitate the assembly of the cushion filling 4 and the cushion hard liner 5 through the opening.

The cushion filling 4 can be filled inside the cavity structure. Since the cushion filling 4 is made of soft elastic material, the mask cushion assembly 2 can be better fitted to the patient's face. In an optional embodiment of the present invention, the cushion filling 4 may be located inside the cavity structure on the side close to the above-mentioned contact part, so as to achieve better fit between the mask cushion assembly 2 and the patient's face at the same time , to improve the comfort of face contact. Further optionally, a plurality of hole structures may be provided on the pad filling 4 to facilitate the exclusion of airflow. It can be understood that those skilled in the art can set the above-mentioned hole structure according to the actual exhaust requirements, and the embodiment of the present invention does not limit the specific hole structure and its setting method.

The cushion hard liner 5 can be located inside the cavity structure, and the cushion filling 5 is made of a rigid material, so that the mask cushion assembly 2 can be shaped. Further, the above-mentioned pad hard lining 5 can also make the connection between the mask main frame 1 and the mask pad assembly 2 a rigid connection, which makes the disassembly and assembly between the mask main frame 1 and the mask pad assembly 2 more convenient, Improve the convenience of disassembly. In an optional embodiment of the present invention, the liner hard liner 5 may be located inside the cavity structure on the side close to the above-mentioned connecting portion, so that the liner filling 4 made of soft elastic material can increase the tightness of the fit and the comfort.

In practical applications, the cross-sectional shape of the cavity structure may be an ellipse, an approximate ellipse, etc. It can be understood that the specific cross-sectional shape of the cavity structure is not limited in the embodiment of the present invention.

The cross-section of the cavity structure shown in FIG. 2 may specifically include: a liner outer layer 3 , a liner filler 4 and a liner hard liner 5 surrounded by the liner outer layer. Optionally, the pad filling 4 and the pad hard liner 5 may be adjacent, and in practical applications, the pad filling 4 and the pad hard liner 5 may be close to each other or have a certain gap. It can be understood that the structural composition of the above-mentioned section is only an optional embodiment, and those skilled in the art can determine other structural composition of the cross-section according to actual application requirements.

In an optional embodiment of the present invention, the gasket filling 4 may be distributed in whole or in part along the axial direction of the cavity structure, wherein the above-mentioned A-A direction is an example of the axial direction of the cavity structure, then the gasket The filling 4 can be distributed in the above-mentioned A-A direction as a whole or in part, wherein, when the whole is distributed in the above-mentioned A-A direction, the cross section of the outer layer 3 of the liner can include the lining filling 4; when it is partially distributed in the above-mentioned A-A direction, the lining The cross-section of the pad outer layer 3 may not include the pad filling 4 .

In another optional embodiment of the present invention, the liner hard liner 5 may be distributed in whole or in part along the axial direction of the cavity structure, wherein the A-A direction is an example of the axial direction of the cavity structure, then The pad hard liner 5 can be distributed in the above-mentioned A-A direction in whole or in part, wherein, when the whole is distributed in the above-mentioned A-A direction, the section of the outer layer 3 of the pad can include the back pad hard liner 5; the main part is distributed in the above-mentioned A-A direction When applied, the cross section of the outer layer 3 of the pad may not include the pad hard liner 5 .

In practical applications, the connection between the pad filling 4 and the outer layer 3 of the pad can be various. For example, the pad filler 4 can be directly incorporated into the pad outer layer 3 . In an optional embodiment of the present invention, the connection between the pad filling 4 and the outer layer 3 of the pad may specifically include: bonding. It can be understood that any connection between the fabric material and the soft elastic material is within the protection scope of the connection between the pad filling 4 and the outer layer 3 of the pad according to the embodiment of the present invention.

In practical applications, there may be various ways of connecting the hard liner 5 and the outer layer 3 of the liner. In an optional embodiment of the present invention, the connection manner between the liner hard liner 5 and the liner outer layer 3 may specifically include: bonding, or thermocompression connection, and the like. It can be understood that any connection mode between the hard material and the soft elastic material is within the protection scope of the connection mode between the pad hard liner 5 and the pad outer layer 3 in the embodiment of the present invention.

When using the mask cushion assembly of the embodiments of the present invention, the embodiments of the present invention can provide the following ventilator mask exhaust methods to assist the patient to complete each breath:

Mode 1. The mask cushion assembly may be provided with an exhaust hole with an opening facing outwards, so as to realize the discharge of airflow. Referring to Fig. 3, a schematic diagram of the exhaust process of a ventilator mask of the present invention is shown, wherein the opening of the first exhaust hole 6 that can be provided on the mask cushion assembly faces the outside of the mask, so that the exhausted gas is discharged, so The exhaust gas can be prevented from blowing to the patient's face; in addition, the exhaust hole with the opening facing the outside of the mask is far away from the air intake pipe 7 of the ventilator, so the noise of the mask exhaust can be reduced to a certain extent.

Mode 2: According to the density of the manufacturing material of the mask cushion assembly, the discharge of the airflow is realized. Since the material of the outer layer 3 of the pad is a fabric material, and the material of the pad filling 4 can be a soft elastic material with pores inside, such as foam, fabric, etc., the above-mentioned fabric material and soft elastic material have certain air permeability, so It is possible that the mask cushion assembly itself can perform the function of the vent. Specifically, in order to meet the exhaust requirements, a production material with a preset sparse density can be used, that is, the function of the exhaust hole is realized by the production material with a relatively sparse density, and the production material with a relatively sparse density is placed in a preset position, and For other positions other than the preset positions, materials with relatively dense density can be used to make materials. It can be understood that those skilled in the art can use materials with suitable density according to actual exhaust requirements. The specific density of the fabrication material is not limited.

Mode 3: A pre-distributed coating may be provided on the outer layer of the liner to realize the discharge of airflow. Since the material of the outer layer 3 of the pad is a fabric material, and the material of the pad filling 4 can be a soft elastic material with pores inside, such as foam, fabric, etc., the above-mentioned fabric material and soft elastic material have certain air permeability, so The mask cushion assembly itself can realize the function of the vent hole, so that the pre-distributed coating provided on the outer layer of the cushion can achieve the desired vent effect. For example, the desired venting effect may include at least one of: allowing the vented gas to meet product venting requirements, not blowing the gas onto the patient's face, more dispersing the airflow, and reducing the noise of the mask venting lower. Wherein, the above-mentioned coating can be set by applying glue on the outer layer of the liner, and the above-mentioned preset distribution can be as follows: the positions close to the air intake pipe of the ventilator are densely distributed, and the positions far from the air intake pipe of the ventilator are sparsely distributed, etc., It can be understood that the embodiment of the present invention does not limit the specific preset distribution.

Referring to FIG. 4 , a schematic diagram of the exhaust process of another ventilator mask of the present invention is shown, wherein the mask cushion assembly may be distributed with a relatively sparse coating at a position far from the air intake pipe 7 of the ventilator, so that the The gas is expelled in direction C through the non-coated area.

Method 4. Set the vent hole on the main frame of the mask. Referring to FIG. 5 , a schematic diagram of the exhaust process of still another ventilator mask of the present invention is shown, wherein a second exhaust hole 8 may be provided on the main frame 1 of the mask, so that the gas is discharged through the second exhaust hole 8 .

Method 5. Set the exhaust hole on the intake pipe. Referring to FIG. 6 , a schematic diagram of the exhaust process of yet another ventilator mask of the present invention is shown, wherein a third exhaust hole 9 may be provided on the air intake pipe 7 so that the gas is discharged through the third exhaust hole 9 .

The exhaust mode of the ventilator mask has been introduced in detail through Mode 1 to Mode 5 above. It can be understood that those skilled in the art can adopt one or more of the above Mode 1 to Mode 4 according to actual application requirements. For example, Mode 1 or Mode 2 can be used to reduce the noise of the mask exhaust, and the embodiment of the present invention does not limit the specific exhaust mode of the ventilator mask.

To sum up, the mask cushion assembly and the ventilator mask of the embodiments of the present invention have the following advantages:

First of all, compared with the mask pad made of silicone material in the existing solution, because the mask pad assembly of the embodiment of the present invention can be made of fabric material, soft elastic material and hardness material, and the fabric material, soft elastic material and hardness material The price of the material is much lower than the price of the silicone material, which can greatly reduce the processing cost of the mask cushion assembly.

Secondly, compared with the mask liner made of silicone material in the existing solution, the outer layer of the liner made of the fabric material in the embodiment of the present invention has higher comfort in contact with the face and better air permeability.

Furthermore, the soft elastic material used for pad filling in the embodiment of the present invention is relatively soft and has good elasticity, so the mask pad assembly can be more easily fitted to the patient's face, and has a wider range of adaptation to different face shapes of patients. More comfort.

Moreover, in the existing solution, the mask liner made of silicone material needs to be provided with air vents on the mask frame and the elbow to meet the exhaust requirements; while in the embodiment of the present invention, the material of the outer layer of the liner is a fabric material, The material filled with the pad can be a soft elastic material with pores inside, such as foam, fabric, etc. Since the above-mentioned fabric material and soft elastic material have certain air permeability, the mask pad assembly itself can realize the vent hole. function, so the process cost required for the setting of the exhaust hole can be saved.

In addition, in the embodiment of the present invention, the liner hard liner made of a hardness material can shape the mask liner assembly, so as to maintain the preset shape of the mask liner assembly through the liner hard liner.

In addition, the molding process of the silicone material is complicated, which makes it difficult to manufacture the existing mask pad. However, the mask pad assembly of the embodiment of the present invention can be manufactured by using fabric materials, soft elastic materials, and hardness materials, while fabric materials, soft elastic materials, and hardness materials are used. The elastic material does not need a corresponding molding process. In addition, the pad hard liner made of a hardness material can be used to maintain the preset shape of the mask pad assembly. In practical applications, suitable materials such as hard plastic and hard thermoplastic elastomer can be used. Or a rigid polyurethane material to simplify the manufacturing process of the mask cushion assembly.

Embodiments of the present invention also provide a method for manufacturing a mask cushion assembly, so as to manufacture the mask cushion assembly through a relatively simple process.

Referring to FIG. 7 , there is shown a flow chart of steps of an embodiment of a method for manufacturing a mask cushion assembly of the present invention, which may specifically include the following steps:

Step 701: Use a fabric material to make an outer cushion layer with a cavity structure; the outer cushion layer may include: a contact part adapted to the contour of the patient's face, and a connection part connected to the main frame of the mask, so A closed cavity structure is formed between the contact portion and the connection portion;

Alternatively, a process such as sewing can be used to produce the outer padding layer with a cavity structure for fabric materials such as cotton, wool, linen and polyester. In addition, the specific size and shape of the outer layer of the liner can be determined according to actual application requirements, and the embodiment of the present invention does not limit the specific manufacturing process of the outer layer of the liner.

Step 702, using soft elastic material to make pad filling;

In practical applications, a process such as die-cutting can be used to make padding for soft elastic materials such as soft silicone, soft TPE or soft polyurethane. Among them, the specific size and shape of the padding can be determined according to the actual application requirements, so that the padding can be assembled into the outer layer of the padding, and the tightness and comfort of facial fit can be achieved through the padding. It is understood that the embodiments of the present invention do not limit the specific manufacturing process of the pad filling.

Step 703, using a hardness material to make a liner hard liner;

In practical applications, a process such as vulcanization can be used to make padding for hard materials such as hard plastics, hard thermoplastic elastomers, or hard polyurethanes. The specific size and shape of the hard liner can be determined according to the actual application requirements. For example, the mask can be determined according to the preset face shape of the patient (for example, round face, square face, oval face, etc.) and/or preset nose bridge height. The preset shape of the cushion assembly, the preset shape can be adapted to the preset face shape and/or the preset height of the nose bridge, so as to maintain the preset shape of the mask cushion assembly through the cushion hard lining, it can be understood that the implementation of the present invention For example, the specific manufacturing process of the liner hard liner is not limited.

It should be noted that this embodiment of the present invention does not limit the execution order of step 701 , step 702 and step 703 , that is, the execution order of the three steps can be any order, such as parallel order or sequential order.

Step 704 , assembling the cushion filling and the cushion hard liner in the cavity structure, respectively, to obtain an assembled mask cushion assembly.

The order of assembly of the cushion padding and the padding hardliner can be in any order, such as first-come, last-first, etc., or, after the padding padding and the padding hardliner are assembled in sequence, the padding filling is continued to cover the mask pad components to adjust, etc.

In practical applications, the connection between the pad filling and the outer layer of the pad can be various. In this way, the liner filling can be directly loaded into the liner outer layer, or an adhesive can be loaded between the liner filling and the liner outer layer to realize the bonding between the liner filling and the liner outer layer.

In practical applications, the connection between the hard liner and the outer layer of the liner can be various. In this way, the assembly of the pad hard liner can be realized by means of bonding, or thermocompression bonding. For example, an adhesive may be placed between the hard liner and the outer layer of the liner to achieve bonding between the hard liner and the outer layer of the liner. For another example, brazing filler metal or interlayer material may be placed between the hard liner and the outer layer of the liner to realize the thermocompression connection between the hard liner and the outer layer of the liner.

To sum up, the molding process of the silicone material is complicated, which makes it difficult to manufacture the existing mask pad. However, the mask pad assembly of the embodiment of the present invention can be made of fabric material, soft elastic material and hardness material, while the fabric material, The soft elastic material does not need a corresponding molding process. In addition, the liner hard liner made of a hard material can be used to maintain the preset shape of the mask liner assembly. In practical applications, suitable materials such as hard plastic, hard thermoplastic elastic Body or hard polyurethane hardness material to simplify the manufacturing process of the mask cushion assembly.

For the embodiment of the manufacturing method of the mask cushion assembly, since it is basically similar to the embodiment of the mask cushion assembly, the description is relatively simple.

The various embodiments in this specification are described in a progressive manner, and each embodiment focuses on the differences from other embodiments, and the same and similar parts between the various embodiments may be referred to each other.

Although preferred embodiments of the embodiments of the present invention have been described, additional changes and modifications to these embodiments may be made by those skilled in the art once the basic inventive concepts are known. Therefore, the appended claims are intended to be construed to include the preferred embodiments as well as all changes and modifications that fall within the scope of the embodiments of the present invention.

Finally, it should also be noted that in this document, relational terms such as first and second are used only to distinguish one entity or operation from another, and do not necessarily require or imply these entities or that there is any such actual relationship or sequence between operations. Moreover, the terms "comprising", "comprising" or any other variation thereof are intended to encompass non-exclusive inclusion, such that a process, method, article or terminal device comprising a list of elements includes not only those elements, but also a non-exclusive list of elements. other elements, or also include elements inherent to such a process, method, article or terminal equipment. Without further limitation, an element defined by the phrase "comprises a..." does not preclude the presence of additional identical elements in the process, method, article or terminal device comprising said element.

The above provides a detailed introduction to a mask cushion assembly, a manufacturing method thereof, and a ventilator mask provided by the present invention. Specific examples are used in this paper to illustrate the principles and implementations of the present invention. The description is only used to help understand the method of the present invention and its core idea; at the same time, for those skilled in the art, according to the idea of the present invention, there will be changes in the specific implementation and application scope. , the contents of this specification should not be construed as limiting the invention.

Claims (12)

1. A mask cushion assembly for being mounted on a mask main frame, comprising: The outer layer of the cushion, the outer layer of the cushion is made of fabric material, the outer layer of the cushion comprises: a contact part adapted to the contour of the patient's face, and a connection part connected with the main frame of the mask, the A closed cavity structure is formed between the contact part and the connection part; a cushion filling, which is filled inside the cavity structure, the cushion filling is made of a soft elastic material, so that the mask cushion assembly fits the patient's face; and a cushion hard liner, located inside the cavity structure, the cushion hard liner is made of a durometer material to shape the mask cushion assembly; Wherein, the soft elastic material has air permeability, and a pre-distributed coating is provided on the outer layer of the liner, and the coating is used to adjust the exhaust effect of the liner assembly. 2 . The mask cushion assembly of claim 1 , wherein the cushion filling is located inside the cavity structure on a side close to the contact portion. 3 . 3 . The mask cushion assembly of claim 1 , wherein the cushion hard liner is located inside the cavity structure on a side close to the connecting portion. 4 . 4 . The mask cushion assembly of claim 1 , wherein the cushion hard lining is distributed in whole or in part along the axial direction of the cavity structure. 5 . 5 . The mask cushion assembly according to claim 1 , wherein a detachable connection is provided between the connecting portion and the mask main frame, or the connecting portion and the mask main frame are integrally formed. 6 . 6. The mask cushion assembly according to any one of claims 1 to 5, wherein the cushion is filled with a plurality of hole structures to facilitate the exclusion of airflow. 7. The mask cushion assembly according to any one of claims 1 to 5, wherein the composition of the fabric material comprises: at least one of cotton, wool, linen and polyester. 8. The mask cushion assembly according to any one of claims 1 to 5, wherein the soft elastic material comprises: foam, fabric. 9. The mask cushion assembly of any one of claims 1 to 5, wherein the hardness material comprises: hard plastic, hard thermoplastic elastomer, hard polyurethane, or memory having a hardness within the second hardness range sexual material. 10. The mask cushion assembly according to any one of claims 1 to 5, wherein the mask cushion assembly is provided with a vent hole with an opening facing outward, or the fabric material, soft elastic material Or the durometer material has a preset sparse density to enable the discharge of the airflow. 11. A ventilator mask, comprising: a mask main frame and the mask cushion assembly of any one of the preceding claims 1 to 10, the mask cushion assembly being connected to the mask main frame to The mask cushion assembly is brought into full contact with the patient's face during use. 12. A method of manufacturing a mask cushion assembly, comprising: A cushion outer layer with a cavity structure is made of fabric material; the cushion outer layer includes: a contact part adapted to the contour of the patient's face, and a connection part connected with the main frame of the mask, the contact part and the A closed cavity structure is formed between the connecting parts; The padding is made of soft elastic material; Hard lining is made of hard material; assembling the cushion filler and the cushion hard liner in the cavity structure, respectively, to obtain an assembled mask cushion assembly; Wherein, the soft elastic material has air permeability, and a pre-distributed coating is provided on the outer layer of the liner, and the coating is used to adjust the exhaust effect of the liner assembly.

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