A manually adjustable contact stiffness boosting face mask comfort device and method

Abstract

The application discloses a manually adjustable contact rigidity mask comfort improving device and method, and relates to the technical field of medical apparatuses.The device comprises a plurality of gas control components and a mask body.The mask body comprises an outer shell, an intermediate transition layer and a flexible inner contact layer.The intermediate transition layer is arranged between the flexible contact layer and the outer shell, and is made by laminating a plurality of material layers with different rigidities.Every material layer is connected with a group of gas control components.The device and method can realize real-time rigidity transition between layers with a large rigidity difference on the inner and outer sides of the mask, effectively reduce oppression and discomfort caused by the inadaptation of the mask shape and the wearer's face, and significantly improve the comfort of the mask.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a device and method for improving the comfort of a mask by manually adjusting the contact stiffness. BACKGROUND

[0002] The comfort problem caused by long-term wearing of a respiratory mask is a medical device technical problem that needs to be solved urgently. Due to the differences in human facial features, patients face the problems of wearing discomfort and uneven facial pressure during treatment, which is an additional burden for patients and can easily lead to their resistance to treatment, greatly reducing their treatment experience and quality of life. Especially for critically ill patients who need to wear a respiratory mask for a long time, long-term wearing of a respiratory mask can cause skin erythema, and in severe cases, it can cause damage to deep tissues such as muscle tissue and bone. These facial pressure injuries further harm patients and increase their suffering during treatment. Currently, there are two main methods to improve the comfort of a mask: one is to make the side of the respiratory mask close to the patient flexible to reduce the pressure of the mask on the patient's face; the other is to use facial scanning and 3D printing technology to manufacture a special respiratory mask that can closely fit the patient's face. However, both methods have significant drawbacks. The former cannot solve the problem of pressure caused by the mismatch between the mask and the patient's face, and the latter is too expensive to be widely used.

[0003] The shell of the mask is usually made of hard and rigid material, with an elastic modulus of 103-106MPa, while the elastic modulus of human facial skin and muscle is 0.9MPa and 10-20MPa, respectively, with a huge gap between them. Moreover, most masks have a single shape and cannot be adapted to the patient's face, causing great pressure and discomfort to the patient's face.

[0004] To solve this problem, there is an urgent need for a method that can effectively adapt to the patient's face to adjust the contact stiffness between the mask and the patient's skin, so a device and method for improving the comfort of a mask by manually adjusting the contact stiffness are proposed. SUMMARY

[0005] The purpose of the present application is to provide a device and method for improving the comfort of a mask by manually adjusting the contact stiffness, which solves the problem of traditional masks having a single shape and being difficult to adapt to different patient facial conditions, and poor comfort.

[0006] In order to achieve the above object, the present application provides a device for manually adjusting contact stiffness to improve the comfort of a mask, comprising a plurality of gas control assemblies and a mask body, the mask body comprising an outer shell, an intermediate transition layer and a flexible inner contact layer, the intermediate transition layer being arranged between the flexible contact layer and the outer shell, the intermediate transition layer being made by laminating a plurality of material layers with different stiffness, and each material layer being connected to a group of gas control assemblies.

[0007] Preferably, the outer part of each material layer is sealed and covered with an air-tight film, and one side of the air-tight film is provided with a connecting hole.

[0008] Preferably, the intermediate transition layer comprises a high-stiffness transition layer, a second-high-stiffness transition layer, a medium-stiffness transition layer, a second-low-stiffness transition layer and a low-stiffness transition layer arranged in sequence, the low-stiffness transition layer being arranged close to the flexible inner contact layer, and the high-stiffness transition layer being arranged close to the outer shell.

[0009] Preferably, the gas control assembly comprises a gas delivery hose penetrating through the connecting hole, one end of the gas delivery hose being in communication with one end of a gas cylinder, the other end of the gas cylinder being provided with a threaded through hole, a threaded bolt transmission push rod being threadedly connected in the threaded through hole, a spiral knob being arranged on the outer side of the threaded bolt transmission push rod, and a piston being connected to the other end of the threaded bolt transmission push rod, the piston being arranged inside the gas cylinder and being tightly attached to the inner wall of the gas cylinder.

[0010] Preferably, the spiral knob is provided with a notch.

[0011] Preferably, the material of the outer shell is a rigid plastic material.

[0012] Preferably, the material of the flexible inner contact layer is a flexible silica gel material.

[0013] Preferably, the material of the intermediate transition layer is a controllable continuous variable stiffness functionally graded material, and the controllable continuous variable stiffness functionally graded material is made of a porous foam material as a substrate.

[0014] A method for manually adjusting contact stiffness to improve the comfort of a mask, comprising the following steps:

[0015] Step S1, wearing the mask on the face, adjusting the flexible inner contact layer of the mask to tightly attach to the face;

[0016] Step S2, holding the outer shell of the mask with hands, lifting it to a predetermined position on the face, rotating the spiral knob, adjusting the gas control assembly to change the inflation amount in the intermediate transition layer, so that the stiffness changes to adapt to the stiffness change between the outer shell and the flexible inner contact layer;

[0017] Step S3, if discomfort is felt during wearing, repeating the above process to adjust the stiffness again to adjust the comfort of the mask.

[0018] Preferably, the method for adjusting the gas control assembly in step S2 specifically comprises:

[0019] Rotating the screw knob in one direction drives the bolt transmission push rod to move towards the side close to the gas cylinder, and in turn drives the piston to move inward, so as to input the filling gas stored in the gas cylinder into the transition material layer through the gas delivery hose;

[0020] Rotating the screw knob in the opposite direction drives the bolt transmission push rod to move away from the side of the gas cylinder, and in turn drives the piston to move outward, so as to extract the filling gas in the transition material layer into the gas cylinder for storage.

[0021] Therefore, the device and method for manually adjusting the contact stiffness to improve the comfort of the mask adopt the above-mentioned technology, introduce a controllable continuous variable stiffness function gradient material in the intermediate transition layer between the rigid shell and the flexible inner surface of the mask device, and realize real-time stiffness transition between the layers with a large difference in rigidity on the inside and outside of the mask through the controllable stiffness transition design of the intermediate transition layer, effectively reducing the rigid compression and discomfort caused by the mismatch between the shape of the mask and the wearer's face, and significantly improving the comfort of the mask.

[0022] The technical solutions of the present application will be further described in detail below with reference to the drawings and examples. BRIEF DESCRIPTION OF DRAWINGS

[0023] Figure 1 The figure is a schematic diagram of a mask worn by the embodiment of the device and method for manually adjusting the contact stiffness to improve the comfort of the mask.

[0024] Figure 2 The figure is a schematic diagram of the structure of the embodiment of the device and method for manually adjusting the contact stiffness to improve the comfort of the mask.

[0025] Figure 3 The figure is a single-layer function implementation diagram of the intermediate transition layer of the device and method for manually adjusting the contact stiffness to improve the comfort of the mask.

[0026] The figure is a single-layer function implementation diagram of the intermediate transition layer of the device and method for manually adjusting the contact stiffness to improve the comfort of the mask. DETAILED DESCRIPTION

[0027] The technical solutions of the present application will be further described in detail below with reference to the drawings and examples.

[0028] Unless otherwise defined, technical terms or scientific terms used in the present application shall have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. Unless otherwise defined, the terms "first", "second", and the like, used in the present application do not imply any order, quantity, or importance, but are used to distinguish different constituent parts. The terms "comprises", "comprising", "includes", "including" and the like are meant to encompass the elements listed thereafter, and equivalents thereof, without precluding other elements. The terms "connected", "coupled", and the like, are not limited to a direct or physical connection, but can include an electrical connection, whether direct or indirect. The terms "upper", "lower", "left", "right", and the like, are used only to indicate relative positional relationships, and when the absolute positions of the described objects are changed, the relative positional relationships can also be changed accordingly.

[0029] Embodiments

[0030] Referring to Figures 1-3 The present application provides a manually adjustable contact stiffness mask comfort device, which comprises a plurality of gas control components 10 and a mask body. The mask body comprises an outer shell 2, an intermediate transition layer 4, and a flexible inner contact layer 3. The flexible inner contact layer 3 is made of flexible silicone material, which has good adhesion and sealing properties, can adapt to different facial contours and provide a comfortable wearing experience, has good skin affinity, and will not cause irritation or allergic reactions to the skin when worn for a long time. Figure 1 As shown in the figure, the contact area 1 between the mask and the wearer's face and the outer shell 2 are shown.

[0031] The outer shell 2 is made of a rigid plastic material, which is polycarbonate, polyethylene, or other engineering plastics with high strength and rigidity, and has good plasticity. During wearing, external force can be used to force it to change its plastic shape to meet the needs of mask drainage design; after wearing, the shape of the mask will not change without strong external force, so as to maintain its original function.

[0032] The intermediate transition layer 4 is arranged between the flexible contact layer and the outer shell 2. The material of the intermediate transition layer 4 is a controllable continuous variable stiffness functionally graded material. The controllable continuous variable stiffness functionally graded material gradually changes in stiffness along the thickness direction. The outer stiffness is larger, and the inner stiffness is smaller. When the adjacent layers are deformed, the stiffness of the controllable continuous variable stiffness functionally graded material can be dynamically adjusted according to the deformation of the adjacent layers. The controllable continuous variable stiffness functionally graded material is made of a porous foam material as a substrate. The material has different initial stiffness and initial porosity. The higher the initial stiffness of the material layer, the higher the initial stiffness required. The greater the adjustable range of the stiffness, the higher the initial porosity of the material layer (which means the total initial pore volume is larger). The stiffness of the intermediate transition layer 4 gradually increases layer by layer from the inside to the outside. The stiffness near the patient's face is small, and the stiffness near the patient's face is large. The part far away from the patient's face near the mask shell 2 has a large stiffness, and the stiffness near the shell 2 is large. When the inner contact layer connected with the transition layer is deformed, the stiffness can be adjusted by manually adjusting the gas control assembly 10.

[0033] The intermediate transition layer 4 is made of a plurality of material layers with different stiffnesses. Each material layer is connected with a group of gas control assemblies 10. The gas can be pressed into the sealed material layer to fill the pores of the material layer. The stiffness of the material layer can be controlled by controlling the degree of gas filling into the material layer. The intermediate transition layer 4 specifically includes a high-stiffness transition layer 5, a second-high-stiffness transition layer 6, a medium-stiffness transition layer 7, a second-low-stiffness transition layer 8, and a low-stiffness transition layer 9 arranged from outside to inside. The low-stiffness transition layer is arranged close to the flexible inner contact layer 3, and the high-stiffness transition layer 5 is arranged close to the outer shell 2. Each layer has different stiffness and adjustable range, which can realize the gradual transition design of the stiffness. The outer part of each layer is sealed and covered with an air-tight film. One side of the air-tight film is provided with a connecting hole for connecting with the gas supply hose 11. The connecting part is sealed to prevent leakage.

[0034] The gas control assembly 10 includes a gas supply hose 11 penetrating through the connecting hole. The other end of the gas supply hose 11 is connected with one end of a gas cylinder 12. The other end of the gas cylinder 12 is provided with a threaded hole. A threaded bolt transmission push rod 14 is connected in the threaded hole. A spiral knob 15 is arranged on the outer side of the bolt transmission push rod 14. The spiral knob 15 is provided with a groove. The other end of the bolt transmission push rod 14 is connected with a piston 13. The piston 13 is arranged in the gas cylinder 12 and tightly contacts with the inner wall of the gas cylinder 12. The gas control assembly is indirectly connected with the intermediate transition layer 4 of the mask through the gas supply hose 11. The gas control assembly has the function of controlling the filling gas to flow into / out of the intermediate transition layer 4 to adjust the stiffness of the intermediate transition layer 4.

[0035] A method for manually adjusting the contact stiffness to improve the comfort of the mask device, comprising the following steps:

[0036] Step S1, wearing the mask on the face, adjusting the flexible inner contact layer 3 of the mask to make it closely contact with the face;

[0037] Step S2, holding the shell 2 of the mask with hands, lifting it to the predetermined facial position, rotating the screw knob 15, changing the amount of inflation in the intermediate transition layer 4 by adjusting the gas control assembly 10, so that the stiffness changes to adapt to the stiffness change between the shell 2 and the flexible inner contact layer 3.

[0038] The method for adjusting the gas control assembly 10 specifically includes:

[0039] Rotating the screw knob 15 in one direction, moving the bolt transmission push rod 14 to the side close to the gas cylinder 12, and then moving the piston 13 inward, inputting the filling gas stored in the gas cylinder 12 into the transition material layer through the gas hose 11;

[0040] Rotating the screw knob 15 in the opposite direction, moving the bolt transmission push rod 14 to the side away from the gas cylinder 12, and then moving the piston 13 outward, extracting the filling gas in the transition material layer into the gas cylinder 12 for storage.

[0041] Step S3, if discomfort occurs during wearing, repeat the above process to adjust the stiffness again to adjust the comfort of the mask.

[0042] Therefore, the application adopts the above-mentioned device and method for manually adjusting the contact stiffness to improve the comfort of the mask. The intermediate transition layer between the rigid shell and the flexible inner surface of the mask device introduces a controllable continuous variable stiffness function gradient material. Through the controllable stiffness transition design of the intermediate transition layer, the rigid compression force brought by the mask shell is relieved, and the comfort of the mask is improved.

[0043] Finally, it should be noted that: the above examples are only used to illustrate the technical solutions of the present application and not to limit them. Although the present application has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solutions of the present application can still be modified or replaced by equivalents, and these modifications or equivalent replacements cannot make the modified technical solutions deviate from the spirit and scope of the technical solutions of the present application.

Claims

1. A device for improving mask comfort by manually adjusting contact stiffness, characterized in that: The mask comprises multiple gas control components and a mask body, wherein the mask body comprises an outer shell, an intermediate transition layer and a flexible inner contact layer. The intermediate transition layer is arranged between the flexible contact layer and the outer shell, and is made by laminating multiple material layers with different stiffnesses, each material layer being connected to a group of gas control components. The intermediate transition layer includes a high stiffness transition layer, a second high stiffness transition layer, a medium stiffness transition layer, a second low stiffness transition layer and a low stiffness transition layer which are arranged in sequence. The low stiffness transition layer is arranged close to the flexible inner contact layer, and the high stiffness transition layer is arranged close to the outer shell. The gas control assembly includes a gas hose with one end passing through a connecting hole, the other end of the gas hose is connected to one end of a gas cylinder, a threaded through hole is provided at the other end of the gas cylinder, a bolt transmission push rod is threadedly connected to the threaded through hole, a spiral knob is provided at the outer end of the bolt transmission push rod, and a piston is connected to the other end of the bolt transmission push rod, which is provided inside the gas cylinder and fits tightly against the inner wall of the gas cylinder.

2. The device for improving mask comfort with manually adjustable contact stiffness according to claim 1, characterized in that: The outside of each material layer is sealed and covered with an airtight film, and a connecting hole is opened on one side of the airtight film.

3. The device for improving mask comfort with manually adjustable contact stiffness according to claim 2, characterized in that: The screw knob is provided with grooves.

4. The device for improving mask comfort with manually adjustable contact stiffness according to claim 3, characterized in that: The shell is made of rigid-plastic material.

5. The device for improving mask comfort with manually adjustable contact stiffness according to claim 4, characterized in that: The material of the flexible inner contact layer is flexible silicone material.

6. The device for improving mask comfort with manually adjustable contact stiffness according to claim 5, characterized in that: The material of the intermediate transition layer is an adjustable continuously variable stiffness functional gradient material, and the adjustable continuously variable stiffness functional gradient material is made of a porous foam material as a base.

7. A method for improving mask comfort using the device for manually adjusting contact stiffness according to any one of claims 1 to 6, characterized in that: The following steps are involved: Step S1: Wear the mask on your face and adjust the flexible inner contact layer of the mask to fit tightly against your face; Step S2: Lift the outer shell of the mask by hand to a predetermined facial position, turn the screw knob, and adjust the gas control assembly to change the amount of air in the intermediate transition layer, thereby changing its stiffness to adapt to the change in stiffness between the outer shell and the flexible inner contact layer; Step S3: If you feel uncomfortable during wearing, repeat the above process to perform stiffness adaptation again to adjust the comfort of the mask.

8. The method for improving mask comfort by manually adjusting contact stiffness according to claim 7, characterized in that: The method for adjusting the gas control component in step S2 specifically includes: Turn the spiral knob in one direction to drive the bolt drive push rod to move closer to the gas reservoir, which in turn drives the piston to move inward, and the filling gas stored in the gas reservoir is input into the transition material layer through the gas hose; Turning the spiral knob in the opposite direction drives the bolt drive push rod to move away from the air reservoir, thereby driving the piston to move outward, drawing out the filling gas in the transition material layer into the air reservoir for storage.

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