Frame assembly in forehead supporting field

Abstract

A frame assembly with a forehead support is used for fixing a patient interface cushion on the face of a patient and assisting in conveying continuous positive pressure gas output by a breathing machine to the airway of the patient and comprises an elbow, a forehead support frame, a cushion, an exhaust port and a fixing part. The forehead supporting frame is provided with a first connector, a second connector, a supporting rod and a forehead pad, the supporting rod extends upwards from the wall between the first connector and the second connector to the forehead of a patient, the forehead pad is connected with the supporting rod, and the first connector is detachably connected with an elbow. The two sides of the forehead supporting frame are further provided with connecting end portions which extend towards the side close to the face of the patient at a certain angle and are used for being connected with a fixing component, the magnetic buckles and the connecting end portions are used for being connected with a fixing headband, and the buffering cushion is arranged on a forehead cushion of the forehead supporting frame. The elbow is used for buffering the face of a patient to a certain extent during use, and an exhaust port can be formed in the elbow.

Description

Technical Field

[0001] The present invention is a frame component in the field of forehead support. The frame component in the field of forehead support is applicable to one or more of the diagnosis, treatment and improvement of respiratory diseases, and involves procedures for preventing respiratory diseases. It mainly includes an elbow, a forehead support frame, a buffer pad, an exhaust port and a fixing component. Background Art

[0002] Sleep apnea syndrome (SAS), also known as sleep apnea hypopnea syndrome, is a common sleep breathing disorder disease, generally divided into central type (CSAS), obstructive type (OSAS) and mixed type (MSAS). Among them, the main pathological site of obstructive sleep apnea is in the pharynx. During sleep, a person mainly relies on the contraction of the muscles around the pharyngeal cavity to adjust the size of the pharyngeal cavity. Factors such as thickening of the pharyngeal side wall, hypertrophy of the tonsils and tongue body, hypertrophy of the soft palate, posterior displacement of the mandible, and edema of the epiglottis can all lead to stenosis or occlusion of the pharyngeal cavity, thus causing obstructive sleep apnea. Usually, during 7 hours of sleep every night, if the number of repeated apnea and hypopnea is more than 30 times or the apnea hypopnea index ≥ 5 times / h, it is diagnosed as sleep apnea syndrome. Obstructive sleep apnea accounts for about 90% of snoring patients, mainly manifested as snoring during night sleep with irregular snoring sounds, repeated apnea and awakening, obvious daytime sleepiness, and memory decline. Obstructive sleep apnea is characterized by apnea and hypopnea caused by pharyngeal cavity stenosis or occlusion during sleep, with a high prevalence rate. It is a potentially lethal and complication-prone disease, and is likely to cause various diseases such as coronary heart disease, hypertension, diabetes, stroke, myocardial hypoxia, myocardial infarction, etc.

[0003] The treatment of obstructive sleep apnea mainly aims to increase the tension of the pharyngeal airway, expand the airway volume, and establish bypass ventilation to eliminate apnea and hypopnea. Generally, there are five treatment methods: improving living habits, drug treatment, airway positive pressure ventilation treatment (including continuous positive airway pressure ventilation, automatic continuous positive airway pressure ventilation and bilevel positive airway pressure ventilation), oral orthosis, and surgical treatment; among them, continuous positive airway pressure ventilation (CPAP) treatment is generally for patients with moderate to severe sleep apnea, and it is also a currently recommended treatment method for sleep apnea. It can immediately improve sleep quality and reduce the pain and sequelae caused by surgery. According to statistics, 60%-75% of patients are satisfied with the treatment effect of continuous positive airway pressure ventilation. However, after long-term follow-up, only 46% of patients use it regularly. And the beneficial effect of continuous positive airway pressure ventilation depends on long-term use, and the regular use frequency of the ventilator is more than 5 days a week and at least 4 hours every night to achieve the treatment effect.

[0004] Due to the long duration and long-term treatment characteristics of continuous positive airway pressure therapy, the comfort and convenience of the treatment components for obstructive sleep apnea must be a major consideration for patients. The treatment components for obstructive sleep apnea generally include patient interface pads, frames, air tubes, ventilators, elbows, headbands, etc. The present invention is a frame assembly in the field of forehead support, mainly involving a frame, an elbow, and a patient interface pad. During the treatment of obstructive sleep apnea, the frame is used to connect the elbow and the patient interface pad, and then provides support and ensures its stability for other components through the connected headband, so as to ensure that the mask fits correctly on the patient's face, and also helps to prevent air leakage caused by the movement or loosening of the patient interface pad at night, thereby improving the treatment effect. Frames with forehead support have been introduced in the market. Compared with the existing frames without forehead support, the stability is enhanced, and the forehead support frame shares the pressure of the treatment components on the face, weakening the concentrated pressure in the facial area and bringing a more stable, comfortable and effective treatment process to the patient.

[0005] Although there are many styles and types of forehead support frames in the existing market, none of them can truly meet the various needs of patients. Some forehead support frames use rigid materials to contact the patient's face, which is likely to cause discomfort to the patient. Some forehead support frames have weak adaptability, and the fixed combination is not the best for patients. There are also some forehead support frames with extremely complex structures, which are not conducive to production. The labor and material costs will increase, and it is easy to cause waste of materials, thus affecting the environment. For the forehead support frames with complex structures, although they have many functions, in case of emergencies, their supply chain is extremely likely to have major problems, resulting in out-of-stock for a long time. Without sacrificing the functions of the forehead support frame, the present invention simplifies the structure of the forehead support frame, adds quick-release magnetic buttons convenient for patients and buffer pads for comfortable use, and designs the elbow. A modular design method is used in all aspects, so that the user's choice range, cost, and comfort are all improved. Compared with various existing frame components in the field of forehead support, it has more advantages and marketability, and belongs to a more competitive product in the field of forehead support frames. Summary of the Invention

[0006] The object of the present invention is to provide a new type of frame assembly in the field of forehead support, which is modular, has good comprehensive performance, low cost, and simple structure, and overcomes the limitations of existing similar products in the prior art, so as to provide a treatment that is more effective than the prior art, has a wider application scenario and space, and in a more feasible processing method, fixes the patient interface pad and assists in sealing and delivering the pressurized gas output by the ventilator to the patient's airway to provide treatment for sleep breathing disorders.

[0007] A frame component in the field of forehead support, which is used to cooperate with other components that supply continuous pressurized breathing gas to a patient to jointly treat sleep apnea. The frame component in the field of forehead support includes:

[0008] A forehead support frame having a first joint that forms a detachable connection with an elbow, a second joint away from the elbow, a wall formed between the first joint and the second joint, and a support rod that extends upward from the wall between the first joint and the second joint to the patient's forehead and a forehead pad formed by connecting with the support rod, configured to disperse the pressure of the patient interface pad on the face to the patient's forehead during use, and

[0009] The forehead support frame also has connection ends on both sides thereof that extend at an angle toward the side close to the patient's face for connecting fixing components. The entire forehead support frame is made of the same material;

[0010] An elbow having a first interface with a clamping structure, wherein the elbow forms a detachable connection with the first joint of the forehead support frame through the clamping structure, and the elbow is also provided with an exhaust port configured to allow the gas exhaled by the patient to continuously flow to the external environment.

[0011] In one embodiment, the frame component in the field of forehead support further includes a buffer pad that forms a detachable connection with the forehead support frame.

[0012] In one embodiment, the angle between the straight line where the connection ends on both sides of the forehead support frame are located and the parallel line of the axis of the first joint of the forehead support frame is 5 - 90°.

[0013] In one embodiment, the angle between the straight line where the connection ends on both sides of the forehead support frame are located and the vertical line at its position is 0 - 85°.

[0014] In one embodiment, the wall formed between the first joint and the second joint of the forehead support frame has a buckle for connecting with the patient interface pad.

[0015] The present invention also discloses a frame component in the field of forehead support according to an embodiment of the present application, which is used to cooperate with other components that supply continuous pressurized breathing gas to a patient to jointly treat sleep apnea. The frame component in the field of forehead support includes:

[0016] A forehead support frame, having a first joint that forms a detachable connection with an elbow, a second joint away from the elbow, a wall formed between the first joint and the second joint, and a support rod extending upward from the wall between the first joint and the second joint to the patient's forehead and a forehead pad formed by connecting with the support rod, configured to disperse the pressure of the patient interface pad on the face to the patient's forehead when in use, and

[0017] On both sides of the forehead support frame, there are also connecting ends extending at an angle toward the side close to the patient's face for connecting fixing components;

[0018] A buffer pad, having a first end connected to the forehead pad and a second end in contact with the patient's face, is configured to give a certain buffer to the patient's face when in use;

[0019] A quick-release magnetic buckle, including a connection end and a magnetic attraction end connected to the forehead support frame, wherein the quick-release magnetic buckle is configured to have a protruding magnetic attraction structure to enable releasable connection and disconnection between the forehead support frame and the headband.

[0020] In one embodiment, a detachable connection is formed between the buffer pad and the forehead pad of the forehead support frame.

[0021] In one embodiment, the area of the buffer pad in contact with the patient's face is not less than 6 cm 2 .

[0022] In one embodiment, the thickness of the buffer pad is at least 3 mm.

[0023] In one embodiment, the material of the buffer pad is one or more of foam material and silicone material.

[0024] The present invention also discloses a frame assembly in the field of forehead support provided by the embodiments of the present application, which is used to cooperate with other components for supplying continuously pressurized breathing gas to the patient to jointly treat sleep apnea. The frame assembly in the field of forehead support includes:

[0025] A forehead support frame, having a first joint that forms a detachable connection with an elbow, a second joint away from the elbow, a wall formed between the first joint and the second joint, and a support rod extending upward from the wall between the first joint and the second joint to the patient's forehead and a forehead pad formed by connecting with the support rod, configured to disperse the pressure of the patient interface pad on the face to the patient's forehead when in use. There is at least one through opening on the forehead pad for receiving the headband to form a connection, and

[0026] On both sides of the forehead support frame, there are also connecting ends extending at an angle toward the side close to the patient's face for connecting fixing components;

[0027] The elbow has a first interface that forms a detachable connection with the first joint of the forehead support frame, a second interface connected to the air delivery pipe, and is configured to receive the ventilator air flow through the air delivery pipe into the patient interface pad.

[0028] In one embodiment, the frame assembly in the forehead support area further includes a buffer pad that forms a detachable connection with the forehead support frame.

[0029] In one embodiment, the second interface of the elbow is configured to be connected to the air delivery pipe.

[0030] In one embodiment, the height of the support rod is 3 - 12 cm.

[0031] In one embodiment, the angle between the line connecting the two ends of the support rod on the forehead support frame and the vertical line at its position is 3 - 45°.

[0032] The present invention also discloses a frame assembly in the forehead support area provided according to the embodiments of the present application, which is used to cooperate with other components that supply continuous pressurized breathing gas to the patient to jointly treat sleep apnea. The frame assembly in the forehead support area includes:

[0033] A forehead support frame having a first joint that forms a detachable connection with the elbow, a second joint away from the elbow, a wall formed between the first joint and the second joint, and a support rod extending upward from the wall between the first joint and the second joint to the patient's forehead and a forehead pad formed by connecting with the support rod, configured to disperse the pressure on the face by the patient interface pad on the patient's forehead when in use. The forehead pad has at least one through opening for receiving a headband to form a connection, and

[0034] The forehead support frame also has connection ends on both sides thereof that extend at a certain angle toward the side close to the patient's face for connecting fixing components;

[0035] A buffer pad having a first end connected to the forehead pad and a second end in contact with the patient's face, wherein there is a preset distance between the first end and the second end, and is configured to give a certain buffer to the patient's face when in use;

[0036] The area of the buffer pad in contact with the patient's face is not less than 6 cm 2 .

[0037] In one embodiment, a non - detachable connection is formed between the buffer pad and the forehead pad of the forehead support frame.

[0038] In one embodiment, the distance between the first end and the second end of the buffer pad is 1-5 cm.

[0039] In one embodiment, the angle between the straight line where the connecting ends on both sides of the forehead support frame are located and the parallel line of the axis of the second joint of the forehead support frame at its position is 5-90°.

[0040] In one embodiment, the forehead pad has an opening for stabilizing and accommodating a part of the buffer pad.

[0041] The present invention also discloses a frame assembly in the field of forehead support provided according to the embodiments of the present application, which is used to cooperate with other components for supplying continuous pressurized breathing gas to a patient to jointly treat sleep apnea. The frame assembly in the field of forehead support includes:

[0042] A forehead support frame, having a first joint detachably connected to an elbow, a second joint far from the elbow, a wall formed between the first joint and the second joint, and a support rod extending upward from the wall between the first joint and the second joint to the patient's forehead and a forehead pad formed by connecting with the support rod, configured to disperse the pressure of the patient interface pad on the face to the patient's forehead during use, and

[0043] The forehead support frame has at least three connection points for connecting with a headband, and two of the connection points are arranged on the connection ends extending at a certain angle towards the side close to the patient's face on both sides of the forehead support frame, and are configured and arranged to connect a fixing component or a headband;

[0044] An elbow, having a first interface with a clamping structure, wherein the elbow forms a detachable connection with the first joint of the forehead support frame through the clamping structure, and the elbow is further provided with an exhaust port, configured to allow the gas exhaled by the patient to continuously flow to the external environment.

[0045] In one embodiment, the frame assembly in the field of forehead support further includes a buffer pad detachably connected to the forehead support frame.

[0046] In one embodiment, the length of the connection ends on both sides of the forehead support frame is 1-5 cm.

[0047] In one embodiment, the area of the buffer pad in contact with the patient's face is not less than 6 cm 2 .

[0048] In one embodiment, the angle between the line connecting the two ends of the support rod on the forehead support frame and the vertical line at its position is 3-45°.

[0049] The frame component in the forehead support field for implementing the present invention has at least the following beneficial effects:

[0050] 1) For the frame field with forehead support, the present invention designs a more marketable forehead support frame, which has better highlights in all aspects compared with the existing forehead support frames in the market, and is more advantageous. It belongs to a more competitive frame component in the forehead support field. Referring to the design concept in the Tesla car design field, the present invention simplifies the frame and applies a large number of modular designs. The forehead support frame is used as a separate component to be more convenient and comfortable on the premise of ensuring and optimizing its functions. Specifically, a. Compared with the existing MirageActiva TM LT Nasal CPAP Mask, ComfortGel Blue, Ultra Mirage TMII Nasal CPAP Mask's forehead support frame needs to be connected to a larger patient interface pad, which appears bulky both visually and during wearing and use, exerts a stronger sense of pressure on the patient, is likely to cause discomfort to the patient, and the larger patient interface pad encloses a larger range of the patient's face, meaning a greater horizontal drop in the areas surrounding different parts of the face, making it easier for air leakage to occur and thus reducing the treatment effect. In contrast, the forehead support frame of the present invention is connected to a smaller patient interface pad, which is more user-friendly, less likely to have air leakage problems, uses less material, and is smaller in size, making it more convenient to carry and transport. The present invention also designs quick-release magnetic buttons at the connection ends where the two sides of the frame are connected to the headband, making the installation and disassembly of the frame simpler, providing a more convenient user experience for patients. The designed quick-release magnetic buttons are connected to the connection ends on both sides of the forehead support frame by a snap-fastening method. The magnetic buttons have protrusions for storing magnets and are connected to the other side by attracting with different magnetic poles when connected. Because they have protrusions connected to grooves on the corresponding other side and have baffles in the connection force direction, they are not easily dropped. When disassembling, just slightly pull one side vertically, and it can be easily disassembled; this method saves time and effort. Since the quick-release magnetic buttons are designed to be detachably connected to the connection ends on both sides of the forehead support frame, patients can choose to use different quick-release connectors or not use them according to their preferences or needs, providing multiple different selection methods for patients. If air leakage occurs in the frame components in the forehead support area, it is beneficial for patients to quickly adjust the frame components in the forehead support area through the quick-release design of the magnetic buttons. The design of the magnetic buttons also makes the disassembly and installation steps more concise and clear, which is beneficial for elderly patients or patients with clumsy hands to install and disassemble. The present invention saves at least half of the time for disassembly or installation compared to the disassembly or installation of the above-mentioned existing forehead support frames. For the overall forehead support frame, the designed forehead support frame of the present invention is more concise in form, mostly formed by smooth and clean walls, taking the forehead support frame as a simpler module, which is a more advantageous design method not only in terms of cleaning, patient use, and production. b. Comparison with the existing resmed Mirage TM FX, Eson TM Nasal CPAP Mask, Eson TMThe forehead support frame of the 2Nasal CPAP Mask is in rigid contact with the patient's forehead. Although the shape of its rigid part bends towards the facial side to fit the patient's forehead as much as possible, since the human forehead is not a completely smooth curve, it is impossible for its forehead pad to fit the patient's forehead perfectly to evenly disperse the force and make the patient use it more comfortably. Moreover, the protrusion degrees of different people's foreheads are different, and the existing forehead pads of the above-mentioned forehead support frames cannot adapt to the forehead protrusion degrees of all patients. When the pressure is concentrated on the forehead, some patients will feel very uncomfortable. In addition, the rigid part usually does not have the ability to absorb impact or extrusion. When the rigid part is in direct contact with the skin, any external force will be directly transmitted to the skin, and the rigid part is not breathable and is prone to moisture accumulation, making the patient's skin often feel uncomfortable. The present invention uses a buffer pad at the forehead pad part. On the one hand, it adapts to the curve or irregular shape of the forehead, evenly disperses the pressure brought by the headband fixation with a flexible material, prevents the pressure from concentrating in a specific area, such as a higher protrusion part of the forehead, so as to cause pain or discomfort, and then uses the flexible material to absorb a certain amount of force to reduce the pressure on the patient's forehead, and uses the gentle touch of the flexible material to provide a more comfortable wearing experience for the patient; and the present invention is provided with a quick-release magnetic buckle, which is more convenient, easy to disassemble and install, saving time and effort. c. Compare with the existing Mirage TM The FX forehead support frame has a complex structure. Although it is relatively convenient in function, its complex structure and process make the production and processing costs high. It is composed of secondary injection molding of silicone and rigid materials, and the position of its exhaust hole is set on the supporting patient interface pad. This production method determines its high defective rate and cost. In special cases, its supply will be relatively difficult, resulting in a continuous out-of-stock situation for a long time. The forehead support frame of the present invention is entirely composed of one material, with a simple structure while ensuring the function. It is mostly composed of smooth walls, and the frame assembly in the forehead support field of the present invention sets the exhaust hole on the elbow, and the elbow is detachably connected to the forehead support frame, reducing the defective rate and production cost of the frame assembly in the forehead support field, improving the product quality and the processing is simple without out-of-stock situation.

[0051] 2) On the premise of ensuring the functional integrity, the frame component in the forehead support field of the present invention simplifies the product structure, improves the efficiency of the supply chain, reduces production costs, reduces risks, and makes the frame component in the forehead support field of the present invention more competitive in the market. The forehead support frame shown in the present invention can be roughly divided into four parts, and the whole is integrally injection-molded from one kind of material. The four parts are respectively a central part for connecting the patient interface pad, composed of a first joint, a second joint and the wall connecting the two, a forehead pad part, a support rod part connecting the forehead pad and the central part, and connecting end parts on both sides. The outer walls of the four parts are all smooth and integral without complex structures such as protrusions and depressions, with a simple form and relatively small volume, making the mold simple and the production more simple and efficient. It can reduce the labor, equipment and energy costs in production. The reduction of costs and the improvement of efficiency make it easier to adjust to quickly respond to and meet the changes in market demand, and to introduce new products faster. The simple structure makes the production process easier to manage and control, and the product quality can be guaranteed. Moreover, the reduction of components and the use of modularization can effectively reduce the variety of inventories, reduce the risk of overstocked inventory and the complexity of material management. In summary, the present invention better meets the customer needs, improves the maintainability and life cycle value of the product, and improves the supply chain efficiency. At the same time, the simplification of the structure reduces the material consumption and the waste rate, having a positive impact on environmental protection and climate change.

[0052] 3) The present invention is provided with a quick-release elbow that forms a detachable connection with the forehead support pad, modularizing the elbow. Patients can choose different elbows to connect with the forehead support frame according to their preferences and needs, and can replace different elbows for different types of patients to adapt to different levels of airflow pressure and to cooperate with tubes of different diameters and lengths. According to some opinions from the CPAP forum and Amazon customer reviews, we have learned that different patients have different requirements for the pressure airflow entering the airway. Moreover, some patients will find that the 22-mm air tube is rather bulky and has a strong sense of compression for the nasal mask, and patients also have different requirements for the length of the tube. Therefore, in the frame assembly in the forehead support field of the present invention, the exhaust holes are arranged on the detachable elbow. If a patient cannot obtain the optimal airflow pressure that meets their needs through the ventilator, they can adjust the airflow pressure entering the patient's airway by replacing the elbow with different pore diameters or numbers of exhaust holes, so that the patient can choose an elbow with a different number of holes or pore size according to their own respiratory resistance. Some special patients with respiratory insufficiency and respiratory failure can also choose an elbow without holes for replacement; in addition to choosing an elbow with different pore diameters or numbers of exhaust holes, patients can also choose an elbow with or without noise reduction. Generally, the elbow with noise reduction and the elbow without noise reduction are two different elbows. The modular design provides diversity in the choice of elbows, and users who like noise reduction or not can purchase and replace them according to their preferences or needs; in addition, the second interface where the elbow is connected to the tube also has different sizes to connect tubes of different diameters or lengths, such as short tubes or air tubes, aiming to enable patients to independently choose a suitable elbow to make the continuous positive airway pressure treatment more comfortable.

[0053] 4) The frame assembly in the forehead support field of the present invention reduces the user cost in many aspects. Since the forehead support frame of the present invention has a simpler structure and the functions remain unchanged, due to the cost reduction, the purchase cost of patients will also be correspondingly reduced. Moreover, the detachable modular elbow design provides patients with the opportunity to purchase a suitable elbow separately, and there will be no situation where the frame assembly in the forehead support field is bundled with the elbow for purchase. The detachable quick-release magnetic buckle design also gives patients the opportunity to purchase different suitable fixing components. In this regard, the purchase and replacement costs of users are further saved. Since the parts are detachable and the forehead support frame is a combination of fewer components, the maintenance cost of users is also reduced. Description of the Drawings

[0054] Figure 1 is a three-dimensional schematic diagram of a frame assembly in the forehead support field in Embodiment 1 of the present invention;

[0055] Figure 2 is an exploded view of a frame assembly in the forehead support field in Embodiment 1 of the present invention;

[0056] Figure 3 Schematic cross-sectional structure diagram of a frame component in the field of forehead support in the first embodiment of the present invention;

[0057] Figure 4 Schematic diagram of the use of a frame component in the field of forehead support in the first embodiment of the present invention;

[0058] Figure 5 Schematic diagram of the contact between the buffer pad and the forehead when wearing a frame component in the field of forehead support in the first embodiment of the present invention;

[0059] Figure 6 Schematic diagram of the connection between the forehead pad and the buffer pad of a frame component in the field of forehead support in the first embodiment of the present invention;

[0060] Figure 7 Schematic diagram of the angle of the connection end of a frame component in the field of forehead support in the first embodiment of the present invention;

[0061] Figure 8 Schematic diagram of the angle of the support rod of a frame component in the field of forehead support in the first embodiment of the present invention;

[0062] Figure 9 Three-dimensional schematic diagram of the quick-release magnetic buckle of a frame component in the field of forehead support in the first embodiment of the present invention;

[0063] Figure 10 Schematic diagram of the disassembly of the quick-release magnetic buckle of a frame component in the field of forehead support in the first embodiment of the present invention;

[0064] Figure 11 Schematic diagram of the connection between the quick-release magnetic buckle and the forehead support frame in the first embodiment of the present invention;

[0065] Figure 12 Schematic diagram of the connection between a frame component in the field of forehead support and a face mask in another embodiment of the present invention;

[0066] Figure 13 Schematic diagram of a forehead support frame having three connection points in another embodiment of the present invention;

[0067] Figure 14 Schematic diagram of the non-detachable buffer pad in a frame component in the field of forehead support in another embodiment of the present invention;

[0068] Figure 15 Another connection form between the frame and the patient interface pad in another embodiment of the present invention;

[0069] Figure 16 Schematic diagram of the connection between different exhaust elbow bends and the forehead support frame in the second embodiment of the present invention;

[0070] Figure 17 Schematic diagram of the connection between the elbow with and without noise reduction and the forehead support frame in the second embodiment of the present invention;

[0071] Figure 18 Schematic diagram of the connection between the elbow and the forehead support frame after the elbow is connected to different forms of air ducts in the second embodiment of the present invention;

[0072] Figure 19 Schematic diagram of the exhaust port arranged on the frame in another implementation manner in the second embodiment of the present invention;

[0073] Figure 20 In the third embodiment of the present invention, other connection methods are used between the forehead support frame and the headband except for the quick-release magnetic buckle;

[0074] Figure 21 Schematic diagram of the elbow directly connected to the patient interface pad in the fourth embodiment of the present invention;

[0075] Figure 22 Schematic diagram of the adjustable support rod of the forehead support frame arranged in the fifth embodiment of the present invention;

[0076] Figure 23 Schematic diagram of the connection between the buffer pad and other comfort layers in the sixth embodiment of the present invention. Detailed implementation manners

[0077] To facilitate the understanding of the invention, the invention will be described more comprehensively below with reference to the relevant drawings. Typical embodiments of the invention are shown in the drawings. However, the invention can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, these embodiments are provided to make the disclosure of the invention more thorough and comprehensive.

[0078] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the technical field to which the invention belongs. The terms used in the description of the invention herein are only for the purpose of describing specific embodiments and are not intended to limit the invention.

[0079] The present invention provides a frame component in the forehead support field for fixing a patient interface device to a patient's face and assisting in transmitting gas to the patient's airway. The existing frame components in the market are complex in structure, lack comfort, are difficult to manufacture, and have high costs. The frame component in the forehead support field designed by the present invention has a simpler structure and provides a better comfortable wearing experience for patients. The frame component in the forehead support field designed by the present invention not only optimizes the disadvantages of the existing design, but also provides several different structures of frame components in the forehead support field for patients to choose according to their respective needs and preferences. It is a better technological invention for users, producers, and the market. The reduction of waste of materials in the present invention is also a sustainable and environmentally friendly design for the environment.

[0080] The following uses specific examples to illustrate several structures of the frame component in the forehead support field of the present invention.

[0081] Embodiment 1

[0082] This embodiment provides a frame component 1 in the forehead support field. This embodiment provides a three-dimensional schematic diagram, an exploded view, a front view, a sectional structure schematic diagram, a usage schematic diagram, and a detailed display diagram of the frame component 1 in the forehead support field. Refer to Figure 1-11 . The frame component 1 in the forehead support field shown in the embodiment mainly includes an elbow 3, a forehead support frame 2, a buffer pad 21, an exhaust port 34, and a quick-release magnetic buckle 4, and is configured to send pressurized gas from a ventilator into the patient's nasal airway for the treatment of obstructive sleep apnea.

[0083] The frame component 1 in the forehead support field includes a forehead support frame 2, which has a first joint 22 detachably connected to the elbow 3, a second joint 23 away from the elbow 3, a wall formed between the first joint 22 and the second joint 23, and a support rod 24 extending upward from the wall between the first joint 22 and the second joint 23 to the patient's forehead and a forehead pad 25 connected to the support rod 24. It is configured to disperse the pressure of the patient interface pad 5 on the face to the patient's forehead during use. The first joint 22 of the forehead support frame 2 may have a wall protruding inward or outward for connection with the elbow 3. During use, at least a part of the wall formed between the first joint 22 and the second joint 23 of the forehead support frame 2 contacts the outer wall of the patient interface pad 5. The wall formed between the first joint 22 and the second joint 23 of the forehead support frame 2 may have a buckle for connection with the patient interface pad 5. The connection between the forehead support frame 2 and the patient interface pad 5 is formed by the buckle. In addition, the two sides of the forehead support frame 2 also have connection ends 26 extending at a certain angle toward the side close to the patient's face for connecting fixing components, and at least one through opening is provided on the forehead pad 25 for receiving a headband to form a connection (such as Figure 4As shown, thus, the forehead support frame 2 has at least three connection points for connecting with the headband. In this embodiment, there are four connection points. Specifically, two of the connection points are provided on the connection ends 26 that extend at an angle towards the side close to the patient's face on both sides of the forehead support frame 2, and are configured and arranged to connect to the fixing member or the headband. The fixing member includes a quick-release magnetic buckle 4 and other components for connection and fixation; the other connection points are configured and arranged on the forehead pad, that is, the through openings for receiving the headband to form a connection are provided at both ends of the forehead pad 25. Since the forehead pad 25 is configured to form a detachable connection with the buffer pad 21, there are various ways to connect the forehead pad 25 and the buffer pad 21. In one of the connection methods, the forehead pad has an opening for stabilizing and accommodating a part of the buffer pad 21, and the buffer pad 21 is connected to the forehead support frame 2 by passing a part of itself through the opening on the forehead pad (as Figure 6 shown). The buffer pad 21 and the forehead support frame 2 can also be connected in other ways. Moreover, the entire forehead support frame 2 is made of the same material, and the process will be relatively simple during production and manufacturing without waste of extra materials. Since a part of the forehead support frame 2 needs to contact the patient's face, its structure and styling trend need to conform to various characteristics of the human face. For example, since the forehead support frame 2 is firmly fixed at the mouth and nose area, i.e., the lower middle part of the face, during use, to make it stable, the connection points of the forehead support frame 2 and the headband should be distributed vertically. Therefore, the connection ends 26 on both sides of the forehead support frame 2 are designed at the lower part of the wall between the first joint 22 and the second joint 23 and are set in a protruding form to facilitate the connection of the headband or the quick-release magnetic buckle 4. The length of the connection ends 26 on both sides of the forehead support frame 2 is 1 - 5 cm. To further enhance its stability, the angle between the straight line where the connection ends 26 on both sides of the forehead support frame 2 are located and the parallel line of the axis of the first joint 22 of the forehead support frame 2 is 5 - 90° (such as the angle α shown in Figure 7 ), and the wall between the first joint 22 and the second joint 23 is designed as an arc to fit the patient interface pad 5. The angle between the straight line where the connection ends 26 on both sides of the forehead support frame 2 are located and the vertical line at its position is 0 - 85° (such as the angle β shown in Figure 7 ). The distance range from the tip of the nose to the forehead of most people is fixed, and the line from the tip of the nose to the forehead is not a vertical plane but forms a certain angle. Therefore, in order to better adapt to the contour of the face, the height of the support rod 24 is 3 - 12 cm, and the angle between the line connecting both ends of the support rod 24 on the forehead support frame 2 and the vertical line at its position is 3 - 45° (such as the angle γ shown in Figure 8 ), so that the forehead pad 25 just fits tightly against the patient's forehead when in use.

[0084] The frame component 1 in the forehead support field further includes an elbow 3, which has a first interface 31 detachably connected to the first joint 22 of the forehead support frame 2, and a second interface 32 connected to the air delivery tube, and is configured to receive the ventilator air flow through the air delivery tube into the patient interface pad 5. In this embodiment, the elbow 3 is configured to have a first interface 31 with a clamping structure 33, wherein the elbow 3 forms a detachable connection with the first joint 22 of the forehead support frame 2 through the clamping structure 33, and the second interface 32 of the elbow 3 is configured to be connected to the air delivery tube. The elbow 3 may also be provided with an exhaust port 34, which is configured to allow the gas exhaled by the patient to continuously flow to the external environment. Since the connection between the elbow 3 and the forehead support frame 2 is detachable, different elbows 3 can be selected according to the patient's needs or preferences to match the forehead support frame 2 while keeping the forehead support frame 2 unchanged. The patient can select the exhaust pressure of the elbow 3, can also select the noise reduction function of the elbow 3, and can also select the air delivery tubes with different diameters and lengths connected to the second interface 32 end of the elbow 3. For example, by replacing the elbow 3 with different pore diameters or numbers of exhaust holes, the air flow pressure flowing into the patient's airway can be adjusted, so that the patient can select the elbow 3 with different numbers or pore diameters of holes according to the size of their own respiratory resistance. Some special patients with respiratory insufficiency and respiratory failure can also select an elbow 3 without holes for replacement, and can select an elbow 3 with or without noise reduction. The second interface 32 of the elbow 3 can be selected to be connected to a short tube or an air delivery tube (by changing the size of the second interface 32 of the elbow 3). The short tube will not cause the patient to feel a sense of oppression due to the overly large or heavy air delivery tube, while the air delivery tube has a larger gas storage capacity than the flexible tube, making the selection more flexible for the user. The aim is to allow the patient to independently select a suitable elbow 3 to make the continuous positive airway pressure ventilation treatment more comfortable. This method uses the same forehead support 2 frame to match different elbows, modularizing the frame component in the forehead support field.

[0085] The buffer pad 21 has a first end 211 connected to the forehead pad 25 and a second end 212 in contact with the patient's face, wherein there is a preset distance between the first end 211 and the second end 212, and is configured to give a certain buffer to the patient's face during use. During use, the buffer pad 21 is placed on the forehead (such as Figure 5As shown in the figure, when the headband is tightened and a certain force is transmitted to the forehead support frame 2, without the presence of the buffer pad 21, since the relatively hard frame will concentrate the pressure, the patient will feel uncomfortable. However, the presence of the buffer pad 21 can conform to the curve of the patient's forehead for uniform dispersion and absorption of part of the pressure, making it more comfortable to use. The distance between the first end 211 and the second end 212 of the buffer pad 21 is used to provide extra space for the buffer pad 21 to fit the forehead and disperse the pressure. Specifically, the distance a between the first end 211 and the second end 212 of the buffer pad 21 is 1 - 5 cm, and the area of the buffer pad 21 in contact with the patient's face is not less than 6 cm 2 to ensure that sufficient contact area and buffer distance are provided for the patient. The frame assembly in the forehead support area further includes that the buffer pad 21 and the forehead support frame 2 form a detachable connection, which is convenient for the patient to clean and replace. The thickness of the buffer pad 21 is at least 3 mm, and the material of the buffer pad 21 is one or more of foam material and silicone material.

[0086] The quick-release magnetic buckle 4 includes a connection end 41 and a magnetic attraction end 42 connected to the forehead support frame 2. The quick-release magnetic buckle 4 (fixed part) is configured to have a protruding magnetic attraction structure so that the forehead support frame 2 and the headband can be releasably connected and disassembled. The connection end 41 of the quick-release magnetic buckle 4 has a buckle structure and forms a detachable connection with the connection ends 26 on both sides of the forehead support frame 2. The specific usage method is that when connecting, bring half of the magnetic buckle close to the other half, and they will have an adsorption feeling due to different magnetic poles, making it easier to connect. Since the force for connecting the headband is roughly along the long side of the quick-release magnetic buckle 4, the magnetic attraction end 42 is designed with a protruding eaves, so that the force for connecting the headband will not easily split the quick-release magnetic buckle 4. When disassembling, just gently lift one side of the quick-release magnetic buckle 4 along the normal direction of the protrusion of the magnetic attraction end 42, and the magnetic buckle will be easily separated (as Figure 9-11 shown in the figure). The design of the quick-release magnetic buckle 4 makes disassembly and connection extremely simple, suitable for use by the elderly or those with inconvenient hands. It saves at least half of the time compared to the disassembly or connection of existing connecting components in the market, saving time and effort.

[0087] In another embodiment, the forehead support frame 2 in the frame assembly 1 in the forehead support area can be connected to the mask in addition to being connected to the nasal mask, which is beneficial to the modularization of the forehead support frame 2 (as Figure 12 shown in the figure).

[0088] In another embodiment, the forehead support frame 2 in the forehead support frame assembly 1 has three connection points (as Figure 13 shown in the figure).

[0089] In another embodiment, the cushion 21 in the frame component 1 in the forehead support field is configured to form an inseparable connection with the forehead support frame 2, such as ultrasonic connection, welding, molding, etc. (as Figure 14 shown).

[0090] In another embodiment, the forehead support frame 2 is in contact with a part of the patient interface pad 5, specifically, the elastic part of the patient interface pad forms a separable connection with the forehead support frame 2 through snap connection, glue, magnetic attraction, etc., jointly forming a combined form of the patient interface pad 5 and the frame. Figure 15 Shown is one of the snap connection methods. The specific form is to construct a flexible clip on the patient interface pad 5, and there is a wall corresponding to the flexible clip groove on the second joint 23 of the forehead support frame 2. By connecting the two correspondingly, the patient interface pad 5 is fixed on the forehead support frame 2.

[0091] Embodiment 2

[0092] This embodiment provides a frame component 1 in the forehead support field, with reference to Figure 16-18 as shown. This embodiment provides a three-dimensional schematic diagram of the frame component 1 of the forehead support. In Figure 16-18 the embodiment of the present invention shown, the difference from the frame component 1 of the forehead support in Embodiment 1 is that the elbow 3 is modularized, and elbows 3 of different forms are provided to connect with the forehead support frame 2. Among them, elbows 3 with different aperture diameters, numbers of holes, and hole shapes can be set, elbows 3 corresponding to different air pressures. According to feedback, different patients have different preferences and adaptabilities for the air flow pressure during continuous positive airway pressure treatment. Therefore, different types of elbows 3 are designed to provide patients with a variety of selection ranges. Patients can choose different types of elbows 3 according to their own needs and preferences to connect and use with the frame component 1 in the forehead support field. Some special patients with respiratory insufficiency and respiratory failure can also choose elbows 3 without holes for selection and replacement (as Figure 16 shown). In addition to choosing elbows 3 with different aperture diameters or numbers of exhaust holes, patients can also choose elbows 3 with or without noise reduction. With the same air pressure, different patients also have different preferences for the noise reduction function. Patients can also independently choose elbows 3 with or without noise reduction function (as Figure 17 shown). In addition, the selection of the elbow 3 is usually also related to the connection with the tracheal tube. The tracheal tube has different forms. A larger tracheal tube has a larger ventilation volume, but is more cumbersome and prone to cause a strong sense of compression on people. While a smaller tracheal tube (such as a short tube) is more portable, but the corresponding ventilation volume also becomes smaller. Therefore, patients can also select a suitable elbow 3 according to the matching with the tracheal tube, aiming to select an elbow 3 that is more suitable for the patient to make the continuous positive airway pressure treatment more comfortable and improve the patient's compliance with the treatment (as Figure 18As shown, Figure A shows the connection to the smaller gas pipeline, and Figure B shows the connection to the larger gas pipeline).

[0093] In another embodiment, the exhaust port 34 in the frame component 1 in the forehead support field can also be provided on the forehead support frame 2 (as Figure 19 shown).

[0094] Embodiment 3

[0095] This embodiment provides a frame component 1 in the forehead support field, with reference to Figure 20 . This embodiment provides a three-dimensional schematic diagram of the frame component 1 of the forehead support. In Figure 20 the embodiment of the present invention shown, the difference from the frame component 1 of the forehead support in Embodiment 1 is that the fixing component is not the quick-release magnetic buckle 4, that is, the connection between the connecting ends 26 on both sides of the forehead support frame 2 and the headgear is not carried out through the quick-release magnetic buckle 4. The connection between the connecting ends 26 on both sides of the forehead support frame 2 and the headband can be a component with a hook structure or directly use Velcro, etc. in addition to the quick-release magnetic buckle 4. The present invention sets the connection between the connecting ends 26 on both sides of the forehead support frame 2 and the quick-release magnetic buckle 4 as a detachable link, which means that the patient can replace the magnetic buckles on the connecting ends 26 on both sides of the forehead support frame 2 according to their own needs and preferences. Although the quick-release magnetic buckle 4 is relatively convenient, for some patients who are used to the direct connection method between the frame and the headband, and patients who cannot contact magnets (such as patients with metal implants), the quick-release magnetic buckle 4 is not the most suitable connection and disconnection method. The replaceability of product components further increases the user's choice range and provides a suitable solution for users who are not used to the quick-release magnetic buckle 4.

[0096] Embodiment 4

[0097] This embodiment provides a frame component 1 in the forehead support field, with reference to Figure 21 . This embodiment provides a three-dimensional schematic diagram of the frame component 1 of the forehead support. In Figure 21In the embodiment of the present invention shown, the difference from the forehead support frame component 1 in the first embodiment is as follows: An elbow 3 is provided to be directly connected to the patient interface pad 5, and the forehead support frame 2 is regarded as a modular component. The first joint and the second joint 23 of the forehead support frame 2 are both openings with smooth walls. When in use, the forehead support frame 2 is clamped between the elbow 3 and the patient interface pad 5 and restricted in the middle. The advantage of regarding the forehead support frame 2 as a modular component is that it can be adapted to and form more diverse combinations. The same forehead support frame 2 can be adapted to different elbows 3 and patient interface pads 5, which improves the patient's choice range, enables the forehead support frame 2 to circulate in the market for a longer time, simplifies the structure of the forehead support frame 2 further, and at the same time, there is no need to consider the cooperation between multiple components in production, simplifies the production process, saves production and time costs, and the modular forehead support frame 2 component can quickly adapt to the market, facilitating rapid product update and iteration following the market.

[0098] Embodiment 5

[0099] This embodiment provides a frame component 1 in the field of forehead support, as shown in Figure 22 . This embodiment provides a three-dimensional schematic diagram of the frame component 1 for forehead support. In Figure 22 the embodiment of the present invention shown, the difference from the forehead support frame component 1 in the first embodiment is as follows: The support rod 24 in the forehead support frame 2 is set in an adjustable form. Since the forehead heights and protrusion degrees of different patients are different, and the forehead support frame 2 is related to the cooperation with the patient's face, that is, the distances between the various parts of the forehead support frame 2 can only be calculated based on the standard distances of the human face, and this method cannot be adapted to all patients. Therefore, it is necessary to design an adjustable forehead support frame 2. The greatest uncertainty is the height and protrusion degree of the patient's forehead. Therefore, it is appropriate to set the adjustable part on the support rod 24 of the forehead support frame 2, and there can be various forms of adjustment methods; one form is that the support rod 24 and the forehead pad 25 are designed as an adjustable structure through structural design for mechanical adjustment (as shown in Figure 22 C), this method does not require multiple materials, but it will be relatively complex and difficult in manufacturing; another method is to adjust through the characteristics of the material or the special structure of the material. The entire support rod 24 or a section of it is made of a flexible material that can be stretched. When in use, it is necessary to manually stretch the distance between the forehead pad and the second joint 23 of the forehead support frame 2 to reach the appropriate range for the patient (as shown in Figure 22 A, 22B).

[0100] Embodiment 6

[0101] This embodiment provides a frame component 1 in the field of forehead support, as shown in Figure 23。This embodiment provides a three-dimensional schematic diagram of the forehead support frame component 1. In Figure 23 In the embodiment of the present invention shown, the difference from the forehead support frame component 1 in the first embodiment is that a comfort layer is provided on the buffer pad 21 in the forehead support frame 2 component 1. In some embodiments, the material of the buffer pad 21 is set to silica gel, and silica gel is relatively airtight. Also, when silica gel comes into contact with the patient's face, it is prone to slipping after the patient sweats, or some patients require a more comfortable buffer pad 21. Therefore, a layer of textile material or foam material can be provided on the silica gel for ventilation and moisture absorption. When the patient uses it, they will not feel stuffy or uncomfortable. The addition of the comfort layer also makes the buffer pad 21 softer and more comfortable, improving the comfort of treatment. The comfort layer also serves as a barrier, reducing the direct contact of the face with the buffer pad 21, avoiding potential irritation and skin abrasion for users with sensitive skin, allergic to silicone rubber, or those who dislike the existing buffer pad 21. Adding a comfort layer to the buffer pad 21 provides a more comfortable wearing experience for the patient. The comfort layer is a foam material (as shown in Figure 23 Figure A) or a textile material (as shown in Figure 23 Figure B) and other comfortable materials. At the same time, the addition of the comfort layer also makes it easier for the patient to clean the frame component 1 in the forehead support area, helping to maintain the cleanliness and hygiene of the frame component 1 in the forehead support area and ensuring the effectiveness of treatment.

[0102] 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 various technical features in the above 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 described in this specification.

[0103] Implementing the frame component 1 in the forehead support area of the present invention has at least the following beneficial effects:

[0104] 1) The present invention designs a more marketable forehead support frame for the field of frames with forehead support. In terms of comprehensiveness, it has more excellent highlights in all aspects compared to the existing forehead support frames in the market, and is more advantageous. It belongs to a more competitive frame component in the forehead support field. The present invention refers to the design concept in the Tesla automotive design field, simplifies the frame, and applies a large number of modular designs. The forehead support frame is used as a separate component to be more convenient and comfortable while ensuring and optimizing its functions. Specifically, a. Compared with the existing MirageActiva TM LT Nasal CPAP Mask, ComfortGel Blue, Ultra Mirage TMII The forehead support frame of the Nasal CPAP Mask needs to be connected to a larger patient interface pad, which appears visually and in use to be rather bulky, exerts a stronger sense of pressure on the patient, is likely to cause discomfort to the patient, and the larger patient interface pad encloses a larger area of the patient's face, meaning there is a greater horizontal drop in the areas enclosing different parts of the face, making it easier for gas leakage to occur and thus reducing the treatment effect. In contrast, the forehead support frame of the present invention is connected to a smaller patient interface pad, is more user-friendly to the patient, is less likely to have gas leakage problems, uses less material, and is smaller in size, making it more convenient to carry and transport. The present invention also designs quick-release magnetic buttons at the connection ends where the two sides of the frame are connected to the headband, making the installation and disassembly of the frame simpler, providing a more convenient user experience for the patient. The designed quick-release magnetic buttons are connected to the two connection ends on both sides of the forehead support frame by a snap-fastening method. The magnetic buttons have protrusions for storing magnets, and when connecting, they attract each other with different magnetic poles on the other side. Because they have protrusions connected to the grooves on the corresponding other side and have baffles in the connection force direction, they are not easily dropped. When disassembling, just slightly pull one side vertically, and it can be easily disassembled. This method saves time and effort. Because the design of the quick-release magnetic buttons is detachably connected to the two connection ends on both sides of the forehead support frame, the patient can choose to use different quick-release connectors or not use quick-release connectors according to their preferences or needs, providing the patient with a variety of different selection methods. If there is a gas leakage situation in the frame assembly in the forehead support field, it is beneficial for the patient to quickly adjust the frame assembly in the forehead support field through the quick-release design of the magnetic buttons. The design of the magnetic buttons also makes the disassembly and installation steps more concise and clear, which is beneficial for elderly patients or patients with clumsy hands to install and disassemble. The present invention saves at least half of the time for disassembly or installation compared to the disassembly or installation of the above-mentioned existing forehead support frames. For the overall forehead support frame, the designed forehead support frame of the present invention is more concise in form, mostly formed by smooth and tidy walls, taking the forehead support frame as a simpler module, which is a more advantageous design method not only in terms of cleaning, patient use, and production. b. Comparison with the existing resmed Mirage TM FX, Eson TM Nasal CPAP Mask, Eson TMThe forehead support frame of the 2Nasal CPAP Mask has a rigid part that contacts the patient's forehead. Although the shape of its rigid part bends towards the facial side to fit the patient's forehead as much as possible, since the human forehead is not a completely smooth curve, it is impossible for its forehead pad to fit the patient's forehead perfectly to evenly disperse the force and make the patient use it more comfortably. Moreover, the protrusion of the foreheads of different people is different, and the forehead pads of the existing forehead support frames cannot adapt to the forehead protrusion of all patients. When the pressure is concentrated on the forehead, some patients will feel very uncomfortable. In addition, the rigid part usually does not have the ability to absorb impacts or squeezes. When the rigid part directly contacts the skin, any external force will be directly transmitted to the skin, and the rigid part is not breathable and easily causes moisture accumulation, making the patient's skin often feel uncomfortable. In the present invention, a buffer pad is provided at the forehead pad part. On the one hand, it adapts to the curve or irregular shape of the forehead, evenly disperses the pressure brought by the headband fixation with a flexible material, and prevents the pressure from concentrating on a specific area, such as a higher protrusion of the forehead, which may cause pain or discomfort. Then, a certain amount of force is absorbed by the flexible material to reduce the pressure on the patient's forehead. On the other hand, the gentle touch of the flexible material provides a more comfortable wearing experience for the patient; and the present invention is provided with quick-release magnetic buttons, which are more convenient, easy to disassemble and install, saving time and effort. c. Compare with the existing Mirage TM The FX forehead support frame has a complex structure. Although it is relatively convenient in function, its complex structure and process make the production and processing costs high. It is composed of silicone and a rigid material connected by secondary injection molding, using more materials. Moreover, the position of its exhaust hole is set on the supporting patient interface pad. This production method determines that its defective rate and cost are relatively high. In special cases, its supply will be relatively difficult, resulting in continuous out-of-stock situations for a long time. The forehead support frame of the present invention is integrally composed of one material, with a simple structure while ensuring the function. It is mostly composed of smooth walls. And the frame assembly in the forehead support field of the present invention sets the exhaust hole on the elbow, and the elbow and the forehead support frame form a detachable connection, reducing the defective rate and production cost of the frame assembly in the forehead support field, improving the product quality and being simple to process without out-of-stock situations.

[0105] 2) On the premise of ensuring its functional integrity, the frame component in the forehead support field of the present invention simplifies the product structure, improves the efficiency of the supply chain, reduces production costs, reduces risks, and makes the frame component in the forehead support field of the present invention more competitive in the market. The forehead support frame shown in the present invention can be roughly divided into four parts, and its whole is integrally injection-molded from one kind of material. The four parts are respectively the central part for connecting the patient interface pad, which is composed of the first joint, the second joint and the wall connecting the two, the forehead pad part, the support rod part connecting the forehead pad and the central part, and the connecting end parts on both sides. The outer walls of the four parts are all smooth and integral without complex structures such as protrusions and depressions, with a simple form and relatively small volume, making the mold simple and the production more simple and efficient. It can reduce the labor, equipment and energy costs in production. The reduction of costs and the high efficiency are easier to adjust to quickly respond to and meet the changes in market demand, and to introduce new products faster. The simple structure makes the production process easier to manage and control, and the product quality can be guaranteed. Moreover, the reduction of components and the use of modularization can effectively reduce the variety of inventories, reduce the risk of overstocked inventory and the complexity of material management. In summary, the present invention better meets the customer needs, improves the maintainability and life cycle value of the product and improves the supply chain efficiency. At the same time, the simplification of the structure reduces the material consumption and the waste rate, which has a positive impact on environmental protection and climate change.

[0106] 3) The present invention is provided with a quick-release elbow that forms a detachable connection with the forehead support pad, modularizing the elbow. Patients can choose different elbows to connect with the forehead support frame according to their preferences and needs, and can replace different elbows for different types of patients to adapt to different levels of airflow pressure and match tubes of different diameters and lengths. According to some opinions from the CPAP forum and Amazon customer reviews, we learned that different patients have different requirements for the pressure airflow flowing into the airway. Moreover, some patients may think that the 22-mm air tube is rather bulky for the nasal mask and exerts a strong sense of compression on the patients. Patients also have different requirements for the length of the tube. Therefore, in the frame assembly in the forehead support field of the present invention, the exhaust holes are arranged on the detachable elbow. If a patient cannot obtain the optimal airflow pressure that meets their needs through the ventilator, they can adjust the airflow pressure flowing into the patient's airway by replacing the elbow with different aperture diameters or numbers of exhaust holes, enabling the patient to choose an elbow with a different number of holes or aperture size according to their own respiratory resistance. Some special patients with respiratory insufficiency and respiratory failure can also choose an elbow without holes for replacement. In addition to choosing an elbow with different aperture diameters or numbers of exhaust holes, patients can also choose an elbow with or without noise reduction. Generally, the noise reduction and non-noise reduction are two different elbows. The modular design provides a variety of choices for elbows, and users who prefer noise reduction or not can purchase and replace according to their preferences or needs. In addition, the second interface where the elbow is connected to the tube also has different sizes to connect tubes of different diameters or lengths, such as short tubes or air tubes, aiming to enable patients to independently choose a suitable elbow to make the continuous positive airway pressure treatment more comfortable.

[0107] 4) The frame assembly in the forehead support field of the present invention reduces the user cost in many aspects. Since the forehead support frame of the present invention has a simpler structure and the functions remain unchanged, due to the cost reduction, the purchase cost of patients will also be correspondingly reduced. Moreover, the detachable modular elbow design provides an opportunity for patients to purchase a suitable elbow separately, rather than having the situation of bundling the purchase of the frame assembly in the forehead support field and the elbow. The detachable quick-release magnetic buckle design also gives patients the opportunity to purchase different suitable quick-release parts. In this regard, the purchase and replacement costs of users are further saved. Since the parts are detachable and the forehead support frame is a combination of fewer components, the maintenance cost of users is also reduced.

[0108] The embodiments of the invention have been described above in conjunction with the accompanying drawings. However, the invention is not limited to the above specific embodiments. The above specific embodiments are merely illustrative and not restrictive. Under the inspiration of the invention, those of ordinary skill in the art can also make many forms without departing from the spirit of the invention and the scope protected by the claims. These all fall within the protection scope of the invention.

Claims

1. A frame component in the field of forehead support, which is used to cooperate with other components that supply continuous pressurized breathing gas to a patient to jointly treat sleep apnea, characterized in that, The frame assembly in the forehead support field includes: A forehead support frame having a first joint that forms a detachable connection with an elbow, a second joint away from the elbow, a wall formed between the first joint and the second joint, and a support rod that extends upward from the wall between the first joint and the second joint to the patient's forehead and a forehead pad formed by connecting with the support rod, configured to disperse the pressure of the patient interface pad on the face to the patient's forehead during use; And the forehead support frame also has connection ends on both sides thereof that extend at an angle toward the side close to the patient's face for connecting fixing components, and the entire forehead support frame is made of the same material; An elbow having a first interface with a clamping structure, wherein the elbow forms a detachable connection with the first joint of the forehead support frame through the clamping structure, and the elbow is also provided with an exhaust port configured to allow the gas exhaled by the patient to continuously flow to the external environment.

2. The frame component in the field of forehead support according to claim 1, characterized in that, The frame assembly in the forehead support field further includes a buffer pad that forms a detachable connection with the forehead support frame.

3. The frame component in the forehead support field according to claim 1, characterized in that, The angle between the straight line where the connection ends on both sides of the forehead support frame are located and the parallel line of the axis of the first joint of the forehead support frame is 5-90°.

4. The frame component in the field of forehead support according to claim 1, characterized in that, The angle between the straight line where the connection ends on both sides of the forehead support frame are located and the plumb line at its position is 0-85°.

5. The frame component in the forehead support field according to claim 1, characterized in that, The forehead support frame has a buckle for connecting with the patient interface pad on the wall formed between the first joint and the second joint.

6. A frame component in the field of forehead support, which is used to cooperate with other components that supply continuous pressurized breathing gas to a patient to jointly treat sleep apnea, characterized in that, The frame assembly in the forehead support field includes: A forehead support frame having a first joint that forms a detachable connection with an elbow, a second joint away from the elbow, a wall formed between the first joint and the second joint, and a support rod that extends upward from the wall between the first joint and the second joint to the patient's forehead and a forehead pad formed by connecting with the support rod, configured to disperse the pressure of the patient interface pad on the face to the patient's forehead during use; And the forehead support frame also has connection ends on both sides thereof that extend at an angle toward the side close to the patient's face for connecting fixing components; A buffer pad having a first end connected to the forehead pad and a second end in contact with the patient's face, configured to give a certain buffer to the patient's face during use; The fixing component is a quick-release magnetic buckle, including a connection end and a magnetic attraction end connected to the forehead support frame, wherein the quick-release magnetic buckle is configured to have a protruding magnetic attraction structure so that the forehead support frame and the headband can be releasably connected and detached.

7. The frame component in the forehead support field according to claim 6, characterized in that, The buffer pad forms a detachable connection with the forehead pad of the forehead support frame.

8. The frame component in the forehead support field according to claim 6, characterized in that, The area of the buffer pad in contact with the patient's face is not less than 6 cm 2 .

9. The frame component in the forehead support field according to claim 6, characterized in that, The thickness of the buffer pad is at least 3 mm.

10. The frame component in the forehead support field according to claim 6, characterized in that, The material of the buffer pad is one or more of foam material and silicone material.

11. A frame component in the field of forehead support, which is used to cooperate with other components that supply continuous pressurized breathing gas to a patient to jointly treat sleep apnea, characterized in that, The frame assembly in the forehead support field includes: A forehead support frame, having a first joint that forms a detachable connection with an elbow, a second joint away from the elbow, a wall formed between the first joint and the second joint, and a support rod extending upward from the wall between the first joint and the second joint to the patient's forehead and a forehead pad formed by connecting with the support rod, configured to disperse the pressure of the patient interface pad on the face to the patient's forehead when in use, and having at least one through opening on the forehead pad for receiving a headband to form a connection; And the forehead support frame also has connection ends extending at an angle toward the side close to the patient's face on both sides thereof for connecting fixing components; An elbow, configured to receive the ventilator airflow through an air delivery tube into the patient interface pad, having a first interface that forms a detachable connection with the first joint of the forehead support frame and a second interface connected to the air delivery tube.

12. The frame component in the field of forehead support according to claim 11, characterized in that, The frame assembly in the forehead support field further includes a buffer pad that forms a detachable connection with the forehead support frame.

13. The frame component in the forehead support field according to claim 11, characterized in that, The second interface of the elbow is configured to be connected to the air delivery tube.

14. The frame component in the forehead support field according to claim 11, characterized in that, The height of the support rod is 3 - 12 cm.

15. The frame component in the forehead support field according to claim 11, characterized in that The angle between the line connecting the two ends of the support rod on the forehead support frame and the plumb line at its position is 3 - 45°.

16. A frame component in the field of forehead support, which is used to cooperate with other components for supplying continuous pressurized breathing gas to a patient to jointly treat sleep apnea, characterized in that, The frame assembly in this forehead support field includes: A forehead support frame, having a first joint that forms a detachable connection with an elbow, a second joint away from the elbow, a wall formed between the first joint and the second joint, and a support rod extending upward from the wall between the first joint and the second joint to the patient's forehead and a forehead pad formed by connecting with the support rod, configured to disperse the pressure of the patient interface pad on the face to the patient's forehead when in use, and having at least one through opening on the forehead pad for receiving a headband to form a connection; And the forehead support frame also has connection ends extending at an angle toward the side close to the patient's face on both sides thereof for connecting fixing components; A buffer pad, having a first end connected to the forehead pad and a second end in contact with the patient's face, wherein there is a preset distance between the first end and the second end, and configured to give a certain buffer to the patient's face when in use; The area of the buffer pad in contact with the patient's face is not less than 6 cm 2 .

17. The frame component in the forehead support field according to claim 16, characterized in that, The buffer pad forms a non - detachable connection with the forehead pad of the forehead support frame.

18. The frame component in the field of forehead support according to claim 16, characterized in that, The distance between the first end and the second end of the buffer pad is 1 - 5 cm.

19. The frame component in the forehead support field according to claim 16, characterized in that, The angle between the straight line where the connection ends on both sides of the forehead support frame are located and the parallel line of the axis of the second joint of the forehead support frame at its position is 5 - 90°.

20. The frame component in the forehead support field according to claim 16, characterized in that, The forehead pad has an opening for stabilizing and accommodating a part of the buffer pad.

21. A frame component in the field of forehead support, which is used in cooperation with other components for supplying continuous pressurized breathing gas to a patient to jointly treat sleep apnea, characterized in that, The frame assembly in this forehead support field includes: A forehead support frame, having a first joint that forms a detachable connection with an elbow, a second joint away from the elbow, a wall formed between the first joint and the second joint, and a support rod extending upward from the wall between the first joint and the second joint to the patient's forehead and a forehead pad formed by connecting with the support rod, configured to disperse the pressure of the patient interface pad on the face to the patient's forehead when in use; and the forehead support frame has at least three connection points for connecting with the headband, wherein two connection points are arranged on the connection ends extending at an angle from both sides of the forehead support frame towards the side close to the patient's face, and are configured and arranged to connect the fixing member or the headband; The elbow has a first interface with a clamping structure, wherein the elbow forms a detachable connection with the first joint of the forehead support frame through the clamping structure, and the elbow is further provided with an exhaust port configured to allow the gas exhaled by the patient to continuously flow to the external environment.

22. The frame assembly in the forehead support field according to claim 21, characterized in that, The frame assembly in the forehead support field further includes a buffer pad that forms a detachable connection with the forehead support frame.

23. The frame component in the forehead support field according to claim 21, characterized in that, The lengths of the connection ends on both sides of the forehead support frame are 1-5 cm.

24. The frame assembly in the forehead support field according to claim 21, characterized in that, The area of the buffer pad in contact with the patient's face is not less than 6 cm 2 .

25. The frame component in the forehead support field according to claim 21, characterized in that, The angle between the line connecting the two ends of the support rod on the forehead support frame and the vertical line at its position is 3-45°.

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