Comfortable pad applied to CPAP frame

Abstract

The invention relates to the technical field of CPAP frames, and particularly discloses a comfortable pad applied to a CPAP frame, the comfortable pad is configured to be in contact with the face of a patient, the comfortable pad is of a bilaterally symmetrical structure, and the comfortable pad comprises a first surface connected with the frame, a second surface in contact with the patient, an upper side, a lower side, a left side and a right side opposite to the left side. The material of the comfortable pad can be a foam material, a cloth material or a combination of the foam material and the cloth material, and provides a comfortable contact surface for a patient.

Description

Technical Field

[0001] The present invention relates to the technical field of patient interface components. Specifically, the frame in the components relates to side straps or forehead supports, and more specifically to the form and usage of a comfort pad on a CPAP frame. Background Art

[0002] Sleep apnea is a potentially dangerous disease. In addition to causing patients to be listless, sleep apnea can also cause a series of complications. Therefore, sufficient attention should be paid to sleep apnea, and it can be treated by continuously maintaining positive airway pressure ventilation through a CPAP mask. At night, the patient wears a CPAP mask over the nose and mouth, and the mask is connected to a ventilator by a tube. The ventilator pumps pressurized air into the patient's respiratory tract, so that the collapsed respiratory tract of the patient remains open during sleep. However, since the comfort of each component in the patient interface component that contacts the patient's face is difficult to meet different patients, in actual use, up to [X]% of patients do not comply with ventilator treatment. In the patient interface component, part of the frame is designed to have side straps or a forehead support, aiming to disperse the pressure of the overall patient interface component on the patient's face and improve the patient's wearing experience. At the same time, the increase in the contact points also brings the problem of whether the contact points are comfortable to contact with the patient's face. To solve this problem, in the production of some patient interface components, the fabric is directly connected to the side strap of the frame by hot pressing or bonding, and the forehead support of some patient interface components is combined with a silicone pad, both aiming to provide a comfortable contact surface for the patient. The patient's face contacting the soft fabric or the elastic silicone pad can solve the indentation problem caused by 80% of the rigid material to the patient's skin. However, due to the limited deformation ability of the fabric or the airtightness of the silicone material, it is impossible to ensure that the patient's face is not compressed under long-term pressure or avoid skin damage caused by airtightness to the patient.

[0003] Therefore, the frame design in the patient interface component not only needs to consider whether its shape can disperse the pressure of the patient interface component on the patient's face, but also needs to consider the comfort of its contact with the patient's face to meet the comfort needs of different patients to the greatest extent. Summary of the Invention

[0004] Based on this, it is necessary to provide a comfort pad applied to a CPAP frame to address the above deficiencies.

[0005] A comfort pad applied to a CPAP frame, having symmetric left and right parts configured to contact the patient's face, the comfort pad comprising:

[0006] having a first surface 3 in contact with the side strap 10 and a second surface 4 in contact with the patient's face, an upper side 5 and a lower side 6;

[0007] Among them, the comfort pad has a first flexible material, which is configured as a foam material and is non-removably connected to the side strap 10;

[0008] Among them, the first surface 3 has a contour similar to the shape of the side strap 10 during use.

[0009] In one embodiment, the comfort pad has a left side 7 and a right side 8 opposite thereto, and the left side 7 and the right side 8 do not exceed the connection of the side strap 10 to other components, where the other components are a frame or a headband.

[0010] In one embodiment, the foam material can be connected to the side strap 10 by means of an adhesive 12, hot pressing, welding, ultrasonic, or sewing.

[0011] In one embodiment, the contour of the first surface 3 similar to the shape of the side strap 10 is any one of a straight line shape, a curved line shape, a Y shape, a V shape, and a T shape.

[0012] This embodiment also provides a comfort pad applied to a CPAP frame, which has symmetric left and right parts and is configured to contact the patient's face. The comfort pad includes:

[0013] A first surface 3 in contact with the side strap 10, a second surface 4 in contact with the patient's face, an upper side 5, and a lower side 6;

[0014] Among them, the comfort pad has a first flexible material, which is configured as a foam material and is removably connected to the side strap 10;

[0015] Among them, the first surface 3 has a contour similar to the shape of the side strap 10 during use.

[0016] In one embodiment, the comfort pad has a left side 7 and a right side 8 opposite thereto, and the left side 7 and the right side 8 do not exceed the connection of the side strap 10 to other components, where the other components are a frame or a headband.

[0017] In one embodiment, the connection method of the foam material to the side strap 10 is any one of double-sided tape, peelable glue, Velcro, flexible magnets, snap buttons, and straps.

[0018] In one embodiment, the contour of the first surface 3 similar to the shape of the side strap 10 is any one of a straight line shape, a curved line shape, a Y shape, a V shape, and a T shape.

[0019] This embodiment also provides a comfort pad applied to a CPAP frame, which has symmetric left and right parts and is configured to contact the patient's face. The comfort pad includes:

[0020] It has a first surface 3 in contact with the side strap 10, a second surface 4 in contact with the patient's face, an upper side 5 and a lower side 6;

[0021] Wherein, the comfort pad has a first flexible material, and the first flexible material is configured as a foam material;

[0022] Wherein, a partial contour of the comfort pad is larger than the contour of the side strap 10;

[0023] Wherein, the first surface 3 has a contour similar to the shape of the side strap 10 during use;

[0024] Wherein, the upper side 5 and the lower side 6 connecting the first surface 3 and the second surface 4 of the comfort pad have arc-shaped curved surfaces.

[0025] In one embodiment, the comfort pad has a left side 7 and an opposite right side 8, and the left side 7 and the right side 8 do not exceed the connection of the side strap 10 with other components, wherein the other components are a frame or a headband.

[0026] In one embodiment, the arc-shaped curved surfaces of the upper side 5 and the lower side 6 are rounded corners.

[0027] In one embodiment, the width of the part of the comfort pad that is larger than the contour of the side strap 10 does not exceed 10 mm.

[0028] This embodiment also provides a comfort pad applied to a CPAP frame, configured to contact the patient's face, and the comfort pad includes:

[0029] It has a first surface 3 in contact with the frame and a second surface 4 in contact with the patient's face, an upper side 5 and a lower side 6;

[0030] Wherein, the comfort pad has a first flexible material, and the first flexible material is configured as a foam material;

[0031] Wherein, the first surface 3 has a contour similar to the shape of the side strap 10 during use;

[0032] Wherein, the foam material has one or more of the following characteristics:

[0033] a. The thickness is 2 - 20 mm;

[0034] b. The density is at least 30 kg / m 3 ;

[0035] c. The tear force is at least 1.5 N / cm;

[0036] d. The tensile force is at least 5 N / cm 2 。

[0037] In one embodiment, the comfort pad has a left side 7 and an opposite right side 8, and the left side 7 and the right side 8 do not extend beyond the connection of the side strap 10 to other components, where the other components are the frame or the headband.

[0038] In one embodiment, the contour of the first surface 3 that is similar to the shape of the side strap 10 is any one of linear, curved, Y-shaped, V-shaped, and T-shaped.

[0039] In one embodiment, the part of the frame connected to the comfort pad is the side strap 10 or the forehead support 11.

[0040] This embodiment also provides a comfort pad applied to a CPAP frame and configured to contact a patient's face. The comfort pad includes:

[0041] A first surface 3 that contacts the frame and a second surface 4 that contacts the patient's face, an upper side 5 and a lower side 6;

[0042] Wherein, the comfort pad is configured to be detachably connected to the frame and has a first flexible material and a second flexible material, and the second flexible material is connected to the first flexible material;

[0043] Wherein, the first surface 3 has a contour similar to the shape of the side strap 10 during use.

[0044] In one embodiment, the comfort pad has a left side 7 and an opposite right side 8, and the left side 7 and the right side 8 do not extend beyond the connection of the side strap 10 to other components, where the other components are the frame or the headband.

[0045] In one embodiment, the first flexible material is a foam material and the second flexible material is a fabric 16.

[0046] In one embodiment, the contour of the first surface 3 that is similar to the shape of the side strap 10 is any one of linear, curved, Y-shaped, V-shaped, and T-shaped.

[0047] In one embodiment, the part of the frame connected to the comfort pad is the side strap 10 or the forehead support 11.

[0048] Implementing a comfort pad applied to a CPAP frame of the present invention has at least the following

[0049] Beneficial effects:

[0050] 1) Improved comfort: Some patient interface components on the market are designed in the form of a frame with side straps or forehead supports due to stability requirements; in order to provide a more stable connection for the frame, side straps and forehead supports usually prefer rigid materials such as polycarbonate and polyethylene. However, the rigid materials on the side straps can also cause discomfort to patients: patients usually wear them for a long time at night and cannot control their sleeping positions after falling asleep. It is very likely that lying on the side will cause the side straps to press on the face and form red marks or pressure sores. In response to this phenomenon, when some patient interface components are produced, the fabric is directly connected to the side straps of the frame by hot pressing or bonding. The forehead supports of some patient interface components are combined with silicone pads. The purpose is to provide a comfortable contact surface for patients. When the patient's face contacts the soft fabric or the elastic silicone pad, it can solve the indentation problem caused by 80% of the rigid materials to the patient's skin. However, due to the limited deformation ability of the fabric or the airtightness of the silicone material, it cannot ensure that the patient's face is not compressed under long-term pressure or avoid the skin damage caused by airtightness to the patient. According to market data analysis, 1 / 2 of the users who purchase the side strap frame with fabric will choose to purchase an additional pair of comfort covers for superimposed use. Therefore, in the present invention, a foam material with stronger deformation ability and better air permeability than the fabric is selected to be connected to the side strap 10 and the forehead support 11 of the frame; a. The foam material has elasticity, and the pore structure of the foam expands when it is subjected to external pressure, dispersing the pressure to a wider area to reduce the sense of compression in the areas of the side strap 10 and the forehead support 11, and can better disperse the pressure; b. The soft material of the foam material enables it to better adapt to the three-dimensional curve of the human face, and air can circulate in the pores, making the foam material body fluffy and not pressing on the face, and also avoiding skin allergies such as pressure sores and red marks caused by the airtightness of the rigid materials; c. When the patient does not use it during the day, the foam material will return to its most original form due to its own resilience characteristics, providing for the patient's next use; d. Due to the pore spaces and surface tension of the foam material, the pore spaces can accommodate gas and liquid molecules. When sweat and oil adhere to the foam material, the gas or liquid molecules will be inhaled to keep the patient's face dry and comfortable all night, avoiding the relative displacement between the side strap 10 and the patient's face due to the sweat or oil secreted by the patient; e. Since the patient's face is connected to the frame through the foam material and does not directly contact the frame, it can effectively avoid damage to the side strap 10 caused by the patient's facial oil stains and other secretions or friction, and improve the service life of the frame.

[0051] 2) The process is simpler: For some frames on the market, the side straps use fabric composite foam materials to improve the overall deformability. Usually, the composite steps are rather cumbersome and complex: a. Select the base material to be a foam body and prepare the fabric; b. Cut the foam material into pieces to the required thickness; c. Clean the surfaces of the foam material and the fabric; d. Select a suitable adhesive (ensure that the adhesive is compatible with the materials to be bonded); e. Bond (apply the adhesive on the surface of one of the materials, ensure tight bonding of the two, place the composite material in a press or fixture to apply pressure, and finally dry and cure); f. Inspect and trim (check whether the composite is complete, whether there are bubbles or loose parts); g. Cut into the required shape; Since the composite material is usually composed of two or more different materials with different textures and properties, some composite materials also involve edge wrapping processes to prevent delamination, peeling or wear during reuse of the composite material, and improve the durability and lifespan of the product; After obtaining the comfortable pad with the composite material, the composite material is then attached by hot pressing or pasting. The preparation steps of the comfortable pad material in the present invention are relatively simple (only the steps of preparing the foam material or fabric material are required): a. Select the base material to be a foam body; b. Cut into pieces to the required thickness; c. Cut into a circular shape as required, or involve sewing and cutting of the fabric 16. After obtaining the comfortable pad of the required shape, it is then connected to the frame by other means such as the adhesive 12, double-sided tape, etc., greatly reducing the difficulty in manufacturing the comfortable pad.

[0052] 3) Detachable and replaceable: All frames with side straps and fabric composite foam materials on the market are in non-detachable forms. Patients can only remove surface stains by cleaning, but because the foam material has many tiny pores and fiber structures, it can firmly adsorb liquids inside by capillary action and is not easily completely separated under the action of water or cleaning agents. Therefore, even if it looks clean on the surface, there may still be residual oil stains. The comfortable pad of the present invention combines the easy availability of the foam material and provides a detachable function for the comfortable pad. The foam material is detachably connected to the side strap 10 and the forehead support 11 of the frame through double-sided tape, peelable glue, Velcro, etc. or through structural design; or the fabric 16 is sewn into a form that can accommodate the foam material and is detachably connected to the side strap 10 and the forehead support 11 of the frame; The detachable and replaceable comfortable pad can ensure the cleanliness and hygiene of the side strap 10 and the forehead support 11, avoid the uncomfortable experience brought by the accumulation of oil stains to patients, and the detachable replacement comfortable pad is more environmentally friendly. Patients only need to remove and discard the foam material without replacing the entire frame, reducing the increase in carbon emissions caused by waste. Description of the Drawings

[0053] Figure 1 Schematic structural diagram of the comfortable pad on the side strap in Embodiment 1 of the present invention;

[0054] Figure 2Schematic diagram of the structure of the comfort pad on the forehead support in Embodiment 1 of the present invention;

[0055] Figure 3 Schematic diagram of the area of the comfort pad in Embodiment 1 of the present invention;

[0056] Figure 4 Schematic diagram of the planar area of the comfort pad in Embodiment 1 of the present invention;

[0057] Figure 5 Schematic diagrams of different forms of the comfort pad (corresponding side strap) in Embodiment 1 of the present invention;

[0058] Figure 6 Schematic diagrams of different forms of the comfort pad (corresponding forehead support) in Embodiment 1 of the present invention;

[0059] Figure 7 Schematic diagram of the non-detachable connection method of the comfort pad in Embodiment 1 of the present invention;

[0060] Figure 8 Schematic diagrams of different forms of the upper side 5 and the lower side 6 of the comfort pad in Embodiment 1 of the present invention;

[0061] Figure 9 Planar schematic diagram of the distance that the comfort pad extends beyond the frame in Embodiment 1 of the present invention;

[0062] Figure 10 Schematic diagrams of cross-sections of different forms of the comfort pad in Embodiment 1 of the present invention;

[0063] Figure 11 Schematic diagram of the detachable connection method of the comfort pad in Embodiment 2 of the present invention;

[0064] Figure 12 Schematic diagram of the detachable structure of the comfort pad in Embodiment 2 of the present invention;

[0065] Figure 13 Schematic diagram of the cross-sectional structure of the comfort pad in Embodiment 3 of the present invention;

[0066] Figure 14 Schematic diagram of the detachable structure of the comfort pad in Embodiment 3 of the present invention;

[0067] Figure 15 Schematic diagram of the connection between the first flexible material and the second flexible material of the comfort pad in Embodiment 3 of the present invention;

[0068] Figure 16 Schematic diagram of another connection method between the first flexible material and the second flexible material of the comfort pad in Embodiment 3 of the present invention;

[0069] Figure 17Regional division diagram of the left and right parts in multiple embodiments of the present invention. Detailed implementation manners

[0070] To make the above objects, features and advantages of the present invention more obvious and understandable, the following will describe the detailed implementation manners of the present invention in conjunction with the accompanying drawings. Many specific details are set forth in the following description in order to fully understand the present invention. However, the present invention can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without departing from the connotation of the present invention. Therefore, the present invention is not limited by the specific embodiments disclosed below.

[0071] In order to solve the problems in the existing patient interface components, such as the lack of comfort of the side strap 10 or the forehead support 11 on the frame, which may cause the side strap to press on the face to form red marks and pressure sores when the patient lies on the side for a long time at night, and the silicone pad of the forehead support may cause the patient's forehead skin to become oily and sweaty and cannot be discharged in time due to the non-breathable material, resulting in damage, etc., and the frame in some patient interface components has a non-removable comfort pad, resulting in the patient being unable to replace the clean comfort pad in time, the present invention provides a comfort pad applied to the CPAP frame. This comfort pad is made of a material with stronger deformation ability and better air permeability, and realizes detachable or non-detachable connection with the frame through the design of its structure, providing more comfortable choices for patients; the frame with the comfort pad can deform partially according to the patient's facial contour, reducing the displacement with the patient's face, making the connection between the patient interface component and the patient's face more stable. At the same time, the frame with the side strap 10 or the forehead support 11 can disperse the pressure brought by the component to the patient's face through the comfort pad, making the patient's wearing experience more comfortable, relieving the patient's mentality during treatment, and bringing better compliance.

[0072] The following will illustrate several forms of the comfort pad of the present invention applied to the CPAP frame with specific examples.

[0073] Example 1

[0074] The purpose of the present invention is to provide a comfort pad applied to the CPAP frame, as Figure 1-2 and Figure 17 shown. This comfort pad is designed to have a symmetric left part and right part, configured to partially contact the patient's face and enhance the overall fixation of the patient interface component to the patient's face, and better disperse the pressure.

[0075] Specifically, as Figure 3 shown, the figure shows the front and back sides of the unilateral comfort pad. The comfort pad has a first surface 3 in contact with the side strap 10 or the forehead support 11, a second surface 4 in contact with the patient's face, and an upper side 5 and a lower side 6 (as Figure 4As shown, the upper side 5 and the lower side 6 are determined by the comfort pad itself. When the comfort pad is placed on the frame at the corresponding position, the upper side 5 is located above and the lower side 6 is located below according to the midline of the comfort pad. Among them, the comfort pad has a left side 7 and a right side 8 opposite thereto. The left side 7 and the right side 8 do not exceed the connection between the side strap 10 and other components (including the frame, headband, etc.); the first surface 3 of the comfort pad has a contour similar to the shape of the side strap 10 or the forehead support 11. As Figure 5 shown, the shape contour corresponding to the side strap 10 can be linear, curved, Y-shaped, V-shaped, T-shaped, etc. As Figure 6 shown, the shape contour corresponding to the forehead support 11 can be a symmetric shape such as circular, square, oval, etc. As Figure 10 shown, the shape of the cross-section of the comfort pad can be semicircular, wavy, triangular, etc. Among them, as Figure 9 shown, part of the contour of the comfort pad can be larger than the contour of the side strap 10, but the distance between the two contours does not exceed 10 mm to prevent the comfort pad from being prone to wrinkling or deformation due to the loss of the support of the side strap 10, which affects the wearing experience of the patient; as Figure 8 -A shown, the upper side 5 and the lower side 6 of the comfort pad have an arc-shaped curved surface. The form of the curved surface can be an isometric fillet or an unequal fillet, forming a smooth contact surface to provide a comfortable contact experience for the patient's face. The thickness of the comfort pad is about 2 - 20 mm to ensure sufficient deformation and support for the patient's face and fit. The comfort pad is made of a foam material with both deformation ability and breathability. The foam material can be made of wood cellulose or foamed plastic polymer, or synthetic sponge such as polyvinyl alcohol (a high water-absorbing material without obvious pores), polyester, polyurethane, etc.; in order to ensure the durability and comfort of the comfort pad made of the foam material, the foam material should have one or more of the following characteristics: a. The density of the foam material is about 30 kg / m 3 , b. The tear strength is at least 1.5 N / cm (tested according to the regulation ASTM D - 412), c. The tensile strength is at least 5 N / cm 2 (tested according to the regulation ASTM D - 624). In this embodiment, as Figure 7 shown, the connection method between the comfort pad and the frame is non-detachable connection, which can be direct connection such as adhesive 12, hot pressing, welding, ultrasonic, sewing, etc., or connection through a film 13 made of thermoplastic material. Among them, the adhesive 12 is usually selected as glue, and in order to ensure the performance among the foam material, the frame and the adhesive 12, and avoid the adhesive 12 from damaging the appearance and characteristics of the foam material or the frame, hardening or turning white after curing, the following several elements need to be noted when selecting the adhesive 12: a. The bonding strength, ensuring that the connection between the frame and the comfort pad is strong enough. The usage amount of the adhesive 12 is at least 0.03 g, and the density is about 0.3 - 3 g / cm3 , the temperature resistance range is approximately -55°C to 200°C, the tensile strength is greater than or equal to 0.5 MPa. Ensure that when there is no external force, the force between the frame and the comfort pad is greater than the gravity of the comfort pad itself, and there will be no detachment due to movement during sleep, nor will there be wrinkles causing air leakage; at the same time, the bonding strength should not be too strong to avoid glue residue during recycling and disassembly, or easy damage to the material. b. Material characteristics: The position where the adhesive 12 is located is close to the patient's respiratory tract and face when using the product, and should meet the basic characteristics of being non-toxic, odorless, etc., harmless to the human body. After curing, it is transparent or semi-transparent in color to avoid traces affecting the final appearance of the frame; ensure the compatibility and adaptability between the bonding materials to avoid delamination, damage to the material surface, or penetration during the bonding process; the adhesive 12 meets the requirements of being non-toxic, adaptable, etc., and complies with local regulations such as ISO 10993 regulations; the adhesive 12 is in a liquid or semi-flowing state when in use. After the adhesive 12 is cured and shaped, the hardness is greater than or equal to Shore A 15, and the tensile strength is greater than or equal to 2, to avoid excessive hardness exerting pressure on the user's face or making the user feel stiff and uncomfortable. c. Environmental protection: The adhesive 12 needs to be selected with a longer service life to avoid rapid aging of the product; for the environment, it is preferred to choose an adhesive 12 that is harmless to the environment and easily degradable, and comprehensive considerations need to be given to energy conservation, waste treatment, process optimization, etc. Glues of brands such as 3M, Loctite, and UHU can be selected.

[0076] In another embodiment, as Figure 8 shown in -B, the upper side 5 and the lower side 6 of the comfort pad are straight surfaces (or inclined surfaces).

[0077] Example 2

[0078] The object of the present invention is to provide a comfort pad applied to a CPAP frame. This comfort pad is designed to have a symmetric left part and right part, configured to partially contact the patient's face and improve the overall fixation of the patient interface component to the patient's face, and better disperse pressure. The comfort pad has a first surface 3 that contacts the side strap 10 or the forehead support 11, a second surface 4 that contacts the patient's face, as well as an upper side 5 and a lower side 6. The comfort pad has a left side 7 and an opposite right side 8. The difference between the comfort pad applied to the CPAP frame provided in this embodiment and the comfort pad in Embodiment 1 is that: the comfort pad and the frame are detachably connected. As Figure 11 shown, the detachable connection method can be double-sided tape, peelable glue, Velcro ( Figure 11 shown in -A), flexible magnet ( Figure 11 shown in -B), snap button, strap, etc. As Figure 12As shown in -A, it is also possible to design the shape profile of the comfort pad so that it can be detachably connected to the frame. Specifically, the comfort pad has a chamber 14 for receiving the side strap 10 or the forehead support 11 and a fixing portion 15. The fixing portion 15 contacts at least one surface of the side strap 10 and is configured to fix the comfort pad to the side strap 10; As Figure 12 As shown in -B, the comfort pad itself can be detachably connected to the frame. Specifically, the comfort pad has a chamber 14 for receiving the side strap 10 or the forehead support 11, and the comfort pad is directly connected to the side strap of the frame through a closed ring.

[0079] Example 3

[0080] The object of the present invention is to provide a comfort pad applied to a CPAP frame. This comfort pad is designed to have a symmetric left part and right part, configured to partially contact the patient's face and enhance the overall fixation of the patient interface component to the patient's face, and better disperse pressure. The comfort pad has a first surface 3 in contact with the side strap 10 or the forehead support 11 and a second surface 4 in contact with the patient's face, as well as an upper side 5 and a lower side 6. The comfort pad has a left side 7 and a right side 8 opposite thereto. The difference between the comfort pad applied to the CPAP frame provided in this embodiment and the comfort pad in Embodiment 1 is that: the constituent materials of the comfort pad are different, and the connection between the comfort pad and the frame is a detachable connection. As Figure 13As shown, the comfort pad is made of a first flexible material and a second flexible material. The second flexible material is connected to the first flexible material. The first flexible material can be a foam material, and the second flexible material can be fabric 16. Among them, the first flexible material has the same characteristics as the foam material in Embodiment 1. The second material is fabric 16 with water absorption and high breathability, which can effectively absorb the secretions on the patient's face at night, keep the patient's face dry and breathable, and improve the patient's compliance with the patient interface pad. The composition of fabric 16 includes one or more materials such as cotton, silk, flannelette, nylon, polyamide, spandex, polyester, etc. made in different proportions; some fabric 16 can also be made into different functional fabrics 16 together with metal fibers, such as antibacterial fabrics, antistatic fabrics, etc. Fabric 16 should meet the permeability between 1 - 30 CFM (obtained according to the air permeability test method in ASTM D737). In another embodiment, the air permeability is about 40 - 60 CFM, or 50 - 80 CFM, to ensure the comfort of the patient while avoiding excessive gas leakage; fabric 16 should have a water absorption time of less than 30 seconds, preferably less than 20 seconds, and more preferably less than 10 seconds to ensure that fabric 16 can absorb the sweat and oil on the patient's face; the count of fabric 16 is not less than 30 and not higher than 100, and the average roughness (Ra value) of the second surface 4 in contact with the patient's face should be 0.2 - 10 microns to ensure that fabric 16 provides a soft and comfortable surface for the patient and avoid excessive self-weight of fabric 16 pressing on the patient's face. To ensure the comfort effect of the patient interface pad, the thickness of fabric 16 is about 0.8 mm - 3.5 mm (too thin fabric 16 layers are prone to losing elasticity and softness, and too thick fabric 16 layers are prone to displacement and leakage). The thickness of the fabric 16 part can be uniform or variable. The fabric 16 part can be in a single-layer form or a multi-layer form. The combination method of multi-layer fabric 16 can be lamination, stitching, thermoplastic compounding, or hot melt compounding, film 13 compounding. The connection method between fabric 16 and the foam material can be composite connection or ordinary connection. Specifically, when fabric 16 and the foam material are in composite connection, the first surface 3 of the comfort pad in contact with the frame is the foam material, and the second surface 4 in contact with the patient is fabric 16; or by stitching fabric 16 to have a shape profile similar to the side strap 10 or forehead support 11 of the frame during use, the first surface 3 of the comfort pad in contact with the frame is fabric 16, and the second surface 4 in contact with the patient is fabric 16. Such as Figures 14-16As shown, when the fabric 16 is not connected to the foam material by an adhesive, the first surface 3 of the comfort pad in contact with the frame can be the fabric 16, and the second surface 4 in contact with the patient can be the fabric 16 or the foam material. Specifically, the fabric 16 can be cut and sewn to be designed with a chamber 17 for accommodating the foam material, and a fixing portion 18 connected to the side strap 10 (shown as a zipper form in the figure, and there can be other forms in other embodiments). Openings can be provided on the fabric 16 to expose the foam material to contact the patient's face; in this way, the foam material and the fabric 16 can be detachably connected to achieve the purpose of timely replacement.

[0081] Applying a comfort pad to a frame for CPAP according to the present invention has at least the following

[0082] Beneficial effects:

[0083] 1) Improved comfort: Some patient interface components on the market are designed in the form of a frame with side straps or forehead supports due to stability requirements; in order to provide a more stable connection for the frame, the side straps and forehead supports usually prefer rigid materials such as polycarbonate and polyethylene. However, the rigid materials on the side straps can also cause discomfort to patients: patients usually wear them for a long time at night and cannot control their sleeping positions after falling asleep. It is very likely that lying on the side will cause the side straps to press on the face and form red marks or pressure sores. In response to this phenomenon, some patient interface components directly connect the fabric to the side straps of the frame by hot pressing or bonding during production, and some forehead supports of patient interface components are combined with silicone pads, all aiming to provide a comfortable contact surface for patients. The patient's face contacting the soft fabric or the elastic silicone pad can solve the problem of indentation on the patient's skin caused by 80% of the rigid materials. However, due to the limited deformation ability of the fabric or the airtightness of the silicone material, it cannot be guaranteed that the patient's face will not be compressed under long-term pressure or avoid skin damage caused by airtightness to the patient. According to market data analysis, 1 / 2 of the users who purchase the side strap frame with fabric will choose to buy an extra pair of comfort covers and use them superimposed. Therefore, the present invention selects a foam material with stronger deformation ability and better air permeability than the fabric to connect with the side strap 10 and forehead support 11 of the frame; a. The foam material is elastic, and the pore structure of the foam expands when it is subjected to external pressure, dispersing the pressure to a wider area to reduce the sense of compression in the areas of the side strap 10 and forehead support 11, and can better disperse the pressure; b. The soft material of the foam material enables it to better adapt to the three-dimensional curve of the human face, and air can circulate in the pores, making the foam material body fluffy and not pressing on the face, and also avoiding skin allergies such as pressure sores and red marks caused by the airtightness of the rigid material; c. When the patient does not use it during the day, the foam material will return to its most original form due to its own resilience characteristics, providing it for the patient's next use; d. Due to the pore spaces and surface tension of the foam material, the pore spaces can accommodate gas and liquid molecules. When sweat and oil adhere to the foam material, the gas or liquid molecules will be inhaled to keep the patient's face dry and comfortable all night, and avoid the relative displacement of the side strap 10 with the face due to the sweat or oil secreted by the patient; e. Since the patient's face is connected to the frame through the foam material and does not directly contact the frame, it can effectively avoid damage to the side strap 10 caused by oil stains and other secretions or friction on the patient's face, and improve the service life of the frame.

[0084] 2) The process is simpler: For some frames on the market, the side straps adopt a fabric composite foam material to enhance the overall deformability. Usually, the composite steps are rather cumbersome and complex: a. Select the base material to be a foam body and prepare the fabric; b. Cut the foam material into pieces to the required thickness; c. Clean the surfaces of the foam material and the fabric; d. Select a suitable adhesive (ensure that the adhesive is compatible with the materials to be bonded); e. Bond (apply the adhesive on the surface of one of the materials, ensure tight bonding of the two, place the composite material in a press or fixture for pressure application, and finally dry and cure); f. Inspect and trim (check whether the composite is complete, whether there are bubbles or loose areas); g. Cut into the required shape; Since the composite material is usually composed of two or more different materials with different textures and properties, some composite materials also involve edge-binding processes to prevent delamination, peeling or wear during reuse of the composite material, and improve the durability and lifespan of the product; After obtaining the comfortable pad with the composite material, the composite material is then attached by hot pressing or pasting. The preparation steps of the comfortable pad material in the present invention are relatively simple (only the steps of preparing the foam material or the fabric material are required): a. Select the base material to be a foam body; b. Cut into pieces to the required thickness; c. Cut into a circular shape as required, or involve sewing and cutting of the fabric 16. After obtaining the comfortable pad of the required shape, it is then connected to the frame by other means such as the adhesive 12, double-sided tape, etc., greatly reducing the difficulty in manufacturing the comfortable pad.

[0085] 3) Detachable and replaceable: All frames with side straps and fabric composite foam materials on the market are in non-detachable forms. Patients can only remove the surface stains by cleaning, but due to the many tiny pores and fiber structures of the foam material, it can firmly adsorb liquids inside by capillary action and is not easily completely separated under the action of water or detergent. Therefore, even if it looks clean on the surface, there may still be residual oil stains. The comfortable pad of the present invention combines the characteristics of easy availability of the foam material and provides the detachable function of the comfortable pad. The foam material is detachably connected to the side strap 10 and the forehead support 11 of the frame through double-sided tape, peelable glue, Velcro, etc. or through structural design; or the fabric 16 is sewn into a form that can accommodate the foam material and is detachably connected to the side strap 10 and the forehead support 11 of the frame; The detachable and replaceable comfortable pad can ensure the cleanliness and hygiene of the side strap 10 and the forehead support 11, avoid the uncomfortable experience brought by the accumulation of oil stains to the patient, and the detachable replaceable comfortable pad is more environmentally friendly. The patient only needs to remove and discard the foam material without replacing the entire frame, reducing the increase in carbon emissions caused by waste.

[0086] The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered as the scope recorded in this specification.

[0087] The above-described embodiments merely represent several implementation manners of the present invention. The description is relatively specific and detailed, but it should not be construed as a limitation on the scope of the invention patent. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present invention, several modifications and improvements can still be made, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the present invention patent shall be subject to the appended claims.

Claims

1. A comfort pad applied to a CPAP frame, having symmetric left and right parts configured to contact a patient's face, characterized in that, The comfort pad includes: It has a first surface in contact with the side strap and a second surface in contact with the patient's face, an upper side and a lower side; Wherein, the comfort pad has a first flexible material, and the first flexible material is configured as a foam material and is non-removably connected to the side strap; Wherein, the first surface has a contour similar to the shape of the side strap during use.

2. The comfort pad according to claim 1, wherein The comfort pad has a left side and a right side opposite thereto, and the left side and the right side do not exceed the connection of the side strap to other components, wherein the other components are a frame or a headband.

3. The comfort pad according to claim 1, wherein The connection between the foam material and the side strap can be by means of adhesive, hot pressing, welding, ultrasonic, sewing.

4. The comfort pad according to claim 1, wherein The contour of the first surface similar to the shape of the side strap is any one of a straight line shape, a curved shape, a Y shape, a V shape, a T shape.

5. A comfort pad applied to a CPAP frame, having symmetric left and right parts configured to contact a patient's face, characterized in that, The comfort pad includes: It has a first surface in contact with the side strap and a second surface in contact with the patient's face, an upper side and a lower side; Wherein, the comfort pad has a first flexible material, and the first flexible material is configured as a foam material and is removably connected to the side strap; Wherein, the first surface has a contour similar to the shape of the side strap during use.

6. The comfort pad according to claim 5, characterized in that, The comfort pad has a left side and a right side opposite thereto, and the left side and the right side do not exceed the connection of the side strap to other components, wherein the other components are a frame or a headband.

7. The comfort pad according to claim 5, characterized in that, The connection between the foam material and the side strap is any one of double-sided tape, peelable glue, Velcro, flexible magnet, snap button, strap.

8. The comfort pad according to claim 5, characterized in that, The contour of the first surface similar to the shape of the side strap is any one of a straight line shape, a curved shape, a Y shape, a V shape, a T shape.

9. A comfort pad applied to a CPAP frame, having symmetric left and right parts configured to contact a patient's face, characterized in that, The comfort pad includes: It has a first surface in contact with the side strap and a second surface in contact with the patient's face, an upper side and a lower side; Wherein, the comfort pad has a first flexible material, and the first flexible material is configured as a foam material; Wherein, a part of the contour of the comfort pad is larger than the contour of the side strap; Wherein, the first surface has a contour similar to the shape of the side strap during use; Wherein, the upper side and the lower side connecting the first surface and the second surface of the comfort pad have an arc-shaped curved surface.

10. The comfort pad according to claim 9, characterized in that, The comfort pad has a left side and a right side opposite thereto, and the left side and the right side do not exceed the connection of the side strap to other components, wherein the other components are a frame or a headband.

11. The comfort pad according to claim 9, characterized in that, The arc-shaped curved surfaces of the upper side and the lower side are rounded corners.

12. The comfort pad according to claim 9, wherein The width of the part of the comfort pad larger than the contour of the side strap does not exceed 10 mm.

13. A comfort pad applied to a CPAP frame, configured to contact a patient's face, characterized in that, The comfort pad includes: It has a first surface in contact with the frame and a second surface in contact with the patient's face, an upper side and a lower side; Wherein, the comfort pad has a first flexible material, and the first flexible material is configured as a foam material; Wherein, the first surface has a contour similar to the shape of the side strap during use; Wherein, the foam material has one or more of the following characteristics: a. The thickness is 2 - 20 mm; b. The density is at least 30 kg / m 3 ; c. The tearing force is at least 1.5 N / cm; d. Tensile force is at least 5 N / cm 2 .

14. The comfort pad according to claim 13, characterized in that, The comfort pad has a left side and an opposite right side, and the left side and the right side do not extend beyond the connection of the side strap to other components, where the other components are the frame or the headband.

15. The comfort pad according to claim 13, wherein The contour of the first surface that is similar in shape to the side strap is any one of linear, curved, Y-shaped, V-shaped, and T-shaped.

16. The comfort pad according to claim 13, wherein, The part of the frame connected to the comfort pad is the side strap or the forehead support.

17. A comfort pad applied to a CPAP frame, configured to contact a patient's face, characterized in that, The comfort pad includes: a first surface in contact with the frame, a second surface in contact with the patient's face, an upper side, and a lower side; wherein the comfort pad is configured to be detachably connected to the frame, has a first flexible material and a second flexible material, and the second flexible material is connected to the first flexible material; wherein the first surface has a contour similar in shape to the side strap during use.

18. The comfort pad according to claim 17, characterized in that, The comfort pad has a left side and an opposite right side, and the left side and the right side do not extend beyond the connection of the side strap to other components, where the other components are the frame or the headband.

19. The comfort pad according to claim 17, wherein The first flexible material is a foam material, and the second flexible material is a fabric.

20. The comfort pad according to claim 17, characterized in that, The contour of the first surface that is similar in shape to the side strap is any one of linear, curved, Y-shaped, V-shaped, and T-shaped.

21. The comfort pad according to claim 17, characterized in that, The part of the frame connected to the comfort pad is the side strap or the forehead support.

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