Device and method capable of manually adjusting contact rigidity to improve mask comfort

Abstract

The invention discloses a device and method capable of manually adjusting contact rigidity to improve mask comfort, and relates to the technical field of medical appliances, the device comprises multiple groups of gas control assemblies and a mask body, the mask body comprises a shell, a middle transition layer and a flexible inner contact layer, the middle transition layer is arranged between the flexible contact layer and the shell, and the flexible inner contact layer is arranged between the middle transition layer and the shell; the middle transition layer is formed by laminating a plurality of material layers with different rigidities, and each material layer is connected with a group of gas control components. According to the device and method capable of manually adjusting the contact rigidity to improve the comfort of the mask, real-time rigidity transition between levels with huge rigidity difference between the inner side and the outer side of the mask is achieved, oppression and discomfort caused by the fact that the appearance of the mask is not matched with the face of a wearer are effectively relieved, and the comfort of the mask is remarkably improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a device and method for manually adjusting contact stiffness to improve the comfort of a face mask. Background Art

[0002] The comfort problem caused by long-term wearing of a breathing face mask is a technical problem of medical devices that urgently needs to be solved at present. Due to the differences in human facial features, problems such as discomfort during wearing and uneven facial pressure faced by patients during treatment are an additional burden on patients, and are also likely to cause patients to be resistant to treatment, greatly reducing their treatment experience and quality of life. Especially for critically ill patients who need to wear a breathing face mask for a long time, long-term wearing of the breathing face mask can lead to the appearance of skin erythema, and in severe cases, it can cause damage to deep tissues such as muscle tissue and bones. These facial pressure injuries further cause unnecessary harm to patients and increase their pain during treatment. Currently, there are two main types of methods to improve the comfort of the face mask. One is to make the side of the breathing face mask close to the patient flexible to reduce the pressure of the face mask on the patient's face, and the other is to manufacture a special breathing face mask that can highly fit the patient's face through facial scanning and 3D printing technology. However, both of these methods have significant drawbacks. The former cannot fundamentally solve the compression problem caused by the mismatch between the face mask and the patient's face, and the latter is too costly to be widely applied.

[0003] The outer shell of the face mask is often made of hard rigid materials, with an elastic modulus between 103 and 106 MPa, while the elastic moduli of the human facial skin and muscles are 0.9 MPa and 10 - 20 MPa respectively, creating a huge gap between them. Moreover, the shapes of most face masks are single and cannot fit the patient's face, causing great compression 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 face mask and the patient's skin. Therefore, a device and method for manually adjusting contact stiffness to improve the comfort of a face mask are proposed. Summary of the Invention

[0005] The purpose of the present invention is to provide a device and method for manually adjusting contact stiffness to improve the comfort of a face mask, so as to solve the problems of the traditional face mask having a single shape, being difficult to adapt to different patient facial conditions, and having poor comfort.

[0006] To achieve the above object, the present invention provides a device for manually adjusting contact stiffness to improve the comfort of a face mask, which includes multiple groups of gas control components and a face mask body. The face mask body includes a housing, an intermediate transition layer, and a flexible inner contact layer. The intermediate transition layer is disposed between the flexible contact layer and the housing and is made by laminating multiple materials with different stiffnesses, and each material layer is connected to a group of gas control components.

[0007] Preferably, the outside of each material layer is hermetically coated with an airtight film, and a connection hole is provided on one side of the airtight film.

[0008] Preferably, the intermediate transition layer includes a high stiffness transition layer, a sub-high stiffness transition layer, a medium stiffness transition layer, a sub-low stiffness transition layer, and a low stiffness transition layer arranged in sequence. The low stiffness transition layer is disposed close to the flexible inner contact layer, and the high stiffness transition layer is disposed close to the housing.

[0009] Preferably, the gas control component includes an air delivery hose with one end passing through the connection hole. The other end of the air delivery hose is communicated with one end of a gas storage cylinder. A threaded through hole is provided at the other end of the gas storage cylinder, and a bolt-driven push rod is connected therein by threading. A spiral knob is provided at the outer end of the bolt-driven push rod, and the other end of the bolt-driven push rod is connected to a piston. The piston is disposed inside the gas storage cylinder and is in close fit with the inner wall of the gas storage cylinder.

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

[0011] Preferably, the material of the housing is a rigid-plastic material.

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

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

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

[0015] Step S1: Wear the face mask on the face and adjust the flexible inner contact layer of the face mask to make it fit closely with the face.

[0016] Step S2: Hold the housing of the face mask with the hand and lift it to a predetermined facial position. Rotate the spiral knob, and by adjusting the gas control component, change the air inflation amount in the intermediate transition layer to make its stiffness change to adapt to the stiffness change from the housing to the flexible inner contact layer.

[0017] Step S3: If discomfort is felt during wearing, repeat the above process to perform stiffness adaptation again to adjust the comfort of the face mask.

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

[0019] Rotate the screw knob in one direction, driving the bolt-driven push rod to move towards the side close to the air storage cylinder, and then driving the piston to move inward, so as to input the filling gas stored in the air storage cylinder into the transition material layer through the air delivery hose;

[0020] Rotate the screw knob in the opposite direction, driving the bolt-driven push rod to move away from the side of the air storage cylinder, and then driving the piston to move outward, so as to extract the filling gas in the transition material layer into the air storage cylinder for storage.

[0021] Therefore, the present invention adopts the above-mentioned device and method for manually adjusting the contact stiffness to improve the comfort of the face mask. By introducing a controllable continuous variable stiffness functionally graded material into the intermediate transition layer between the rigid outer shell and the flexible inner surface of the face mask device, through the controllable stiffness transition design of the intermediate transition layer, the real-time stiffness transition between the levels with a huge difference in rigidity between the inside and outside of the face mask is realized, effectively reducing the rigid compression and discomfort caused by the mismatch between the shape of the face mask and the wearer's face, and significantly improving the comfort of the face mask.

[0022] Next, through the drawings and embodiments, the technical solutions of the present invention will be further described in detail. Description of the Drawings

[0023] Figure 1 It is a schematic diagram of the face mask wearing of the embodiment of the device and method for manually adjusting the contact stiffness to improve the comfort of the face mask of the present invention;

[0024] Figure 2 It is a schematic structural diagram of the embodiment of the device and method for manually adjusting the contact stiffness to improve the comfort of the face mask of the present invention;

[0025] Figure 3 It 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 face mask of the present invention;

[0026] Reference numerals: 1, contact area between the face mask and the wearer's face; 2, outer shell; 3, flexible inner contact layer; 4, intermediate transition layer; 5, high stiffness transition layer; 6, sub-high stiffness transition layer; 7, medium stiffness transition layer; 8, sub-low stiffness transition layer; 9, low stiffness transition layer; 10, gas control component; 11, air delivery hose; 12, air storage cylinder; 13, piston; 14, bolt-driven push rod; 15, screw knob. Detailed Embodiments

[0027] The following further illustrates the technical solutions of the present invention through the drawings and embodiments.

[0028] Unless otherwise defined, the technical terms or scientific terms used in the present invention shall have the ordinary meanings understood by those of ordinary skill in the field to which the present invention pertains. The "first", "second" and similar terms used in the present invention do not denote any order, quantity or importance, but are only used to distinguish different components. Words such as "comprising" or "including" mean that the elements or items appearing before this word cover the elements or items listed after this word and their equivalents, without excluding other elements or items. Words such as "connected" or "coupled" are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. "Upper", "lower", "left", "right", etc. are only used to indicate relative position relationships. When the absolute position of the object being described changes, the relative position relationship may also change accordingly.

[0029] Embodiment

[0030] Please refer to Figures 1-3 , the present invention provides a device for manually adjusting contact stiffness to improve the comfort of a face mask, which includes multiple groups of gas control components 10 and a face mask body. The face mask body includes a housing 2, an intermediate transition layer 4 and a flexible inner contact layer 3. The material of the flexible inner contact layer 3 is a flexible silicone material. The flexible silicone material has good conformability and sealing performance, 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 during long-term wearing. As Figure 1 shown, the figure shows the contact area 1 between the face mask and the wearer's face and the housing 2.

[0031] The material of the housing 2 is a rigid-plastic material. The rigid-plastic material is polycarbonate, polyethylene or other engineering plastics with relatively high strength and stiffness, and has good plasticity. During wearing, it can be forced to undergo plastic shape changes by external forces to meet the requirements of the face mask drainage design; after wearing is completed, the shape of the face mask will no longer change without strong external forces 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 continuously variable stiffness functionally gradient material. The controllable continuously variable stiffness functionally gradient material gradually changes its stiffness along the thickness direction, with a larger stiffness on the outside and a smaller stiffness on the inside. And when its adjacent layer deforms, it can dynamically adjust its own stiffness according to the deformation of the adjacent layer. The controllable continuously variable stiffness functionally gradient material is made with a porous foam material as the substrate, having different initial stiffnesses and initial porosities. The material layer with a greater stiffness requirement has a higher initial stiffness; the material layer with a larger controllable stiffness range also has a higher initial porosity (meaning a larger total initial pore volume). The stiffness of the intermediate transition layer 4 increases layer by layer from the inside to the outside. The side close to the patient's face has a smaller stiffness, approaching the stiffness of the patient's face, and the part far from the patient's face and close to the mask outer shell 2 has a larger stiffness, approaching the stiffness of the outer shell 2. And when the inner contact layer connected to the transition layer deforms, its stiffness can be adjusted by manually adjusting the gas control component 10.

[0033] The intermediate transition layer 4 is made by laminating multiple material layers with different stiffnesses. Each material layer is connected to a set of gas control components 10. Gas can be pressed into the sealed material layer to fill the pores of the material layer, and 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 sub-high stiffness transition layer 6, a medium stiffness transition layer 7, a sub-low stiffness transition layer 8, and a low stiffness transition layer 9 arranged in sequence from the outside to the 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. The above layers have different stiffness magnitudes and adjustable ranges, and can realize the design of gradual transition of stiffness. The outside of each of the above material layers is hermetically coated with an airtight film. One side of the airtight film is provided with a connection hole for connecting to the air supply hose 11, and the connection part is sealed to prevent leakage.

[0034] The gas control component 10 includes an air supply hose 11 with one end passing through the connection hole. The other end of the air supply hose 11 is communicated with one end of a gas storage cylinder 12. The other end of the gas storage cylinder 12 is provided with a threaded through hole, and a bolt-driven push rod 14 is connected in the threaded through hole by threads. The outer end of the bolt-driven push rod 14 is provided with a spiral knob 15, and a groove is provided on the spiral knob 15 for rotation in one direction. The other end of the bolt-driven push rod 14 is connected to a piston 13. The piston 13 is arranged inside the gas storage cylinder 12 and is in close fit with the inner wall of the gas storage cylinder 12. The gas control component is indirectly connected to the intermediate transition layer 4 of the mask through the air supply hose 11, and has the function of controlling the inflow / outflow of the filling gas into / from the intermediate transition layer 4 to adjust the stiffness adaptation of the intermediate transition layer 4.

[0035] A method for a device that can manually adjust the contact stiffness to improve the comfort of a mask includes the following steps:

[0036] Step S1: Wear the face mask on the face and adjust the flexible inner contact layer 3 of the face mask to make it fit tightly with the face.

[0037] Step S2: Hold the outer shell 2 of the face mask with your hand, lift it to a predetermined facial position, and rotate the screw knob 15. By adjusting the gas control component 10, change the inflation amount in the intermediate transition layer 4, so that its stiffness changes to adapt to the stiffness change between the outer shell 2 and the flexible inner contact layer 3.

[0038] The method of adjusting the gas control component 10 specifically includes:

[0039] Rotate the screw knob 15 in one direction, drive the bolt transmission push rod 14 to move towards the side close to the air storage cylinder 12, and then drive the piston 13 to move inward, and input the filling gas stored in the air storage cylinder 12 into the transition material layer through the air delivery hose 11;

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

[0041] Step S3: If you feel discomfort during wearing, repeat the above process to perform stiffness adaptation again to adjust the comfort of the face mask.

[0042] Therefore, the present invention adopts the above-mentioned device and method for manually adjusting the contact stiffness to improve the comfort of the face mask. A controllable continuous variable stiffness functionally gradient material is introduced into the intermediate transition layer between the rigid outer shell and the flexible inner surface of the face mask device. Through the controllable stiffness transition design of the intermediate transition layer, the rigid pressing force brought by the outer shell of the face mask is alleviated, and the comfort of the face mask is improved.

[0043] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit them. Although the present invention has been described in detail with reference to the preferred embodiments, those of ordinary skill in the art should understand that they can still modify or equivalently replace the technical solutions of the present invention, 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 invention.

Claims

1. A device for improving mask comfort by manually adjusting contact stiffness, characterized in that: The invention 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. The intermediate transition layer is made by stacking a plurality of material layers with different stiffnesses. Each material layer is connected to a group of gas control components.

2. A 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. A device for improving mask comfort with manually adjustable contact stiffness according to claim 2, characterized in that: The intermediate transition layer includes a high stiffness transition layer, a second highest stiffness transition layer, a medium stiffness transition layer, a second lowest 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.

4. A device for improving mask comfort with manually adjustable contact stiffness according to claim 3, characterized in that: The gas control assembly includes a gas delivery hose with one end passing through a connecting hole, the other end of the gas delivery 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 in the threaded through hole, a spiral knob is provided at the outer end of the bolt transmission push rod, a piston is connected to the other end of the bolt transmission push rod, the piston is provided inside the gas cylinder and fits tightly with the inner wall of the gas cylinder.

5. A device for improving mask comfort with manually adjustable contact stiffness according to claim 4, characterized in that: The spiral knob is provided with grooves.

6. A device for improving mask comfort with manually adjustable contact stiffness according to claim 5, characterized in that: The shell is made of rigid-plastic material.

7. A device for improving mask comfort with manually adjustable contact stiffness according to claim 6, characterized in that: The material of the flexible inner contact layer is flexible silicone material.

8. The device for improving mask comfort by manually adjusting contact stiffness according to claim 7, characterized in that: The material of the middle 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.

9. A method for using the device for improving mask comfort with manually adjustable contact stiffness as described in any one of claims 1 to 8, characterized in that: The following steps are involved: Step S1, wearing the mask on the face, adjusting the flexible inner contact layer of the mask to make it fit closely to the face; Step S2, lift the outer shell of the mask by hand to a predetermined facial position, turn the spiral knob, and change the amount of gas in the middle transition layer by adjusting the gas control component to change 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.

10. A method for improving mask comfort by manually adjusting contact stiffness according to claim 9, 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 toward the side close to the gas reservoir, thereby driving the piston to move inward, and inputting the filling gas stored in the gas reservoir into the transition material layer through the gas delivery hose; Turning the spiral knob in the opposite direction drives the bolt drive push rod to move away from the gas reservoir, thereby driving the piston to move outward, and extracting the filling gas in the transition material layer into the gas reservoir for storage.

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