Nose mask for sealing area from nose tip to upper lip

Abstract

A nasal mask for sealing the area from the nose tip to the upper lip of a user has a flexible portion curved toward the face of the user, the flexible portion having at least one protrusion and a chamber containing a gas, a first opening facing the face of the user and at least one second opening configured to receive a continuous positive pressure gas flow into the flexible portion, the flexible portion further comprises a sealing portion which, in use, surrounds the user at least including the nose tip and the first and second nostrils and abuts against the face around the nostrils, has at least one thin region and a support region thicker than the thin region, the nasal mask can be further provided with a rigid part with at least two connecting ports, an exhaust port with at least one hole opening and a spring structure with a foldable wall, the opening of the nasal mask can be adjusted according to the nose of the user through the design of the spring structure, and the sealing performance and comfort of the nasal mask are further improved.

Description

Technical Field

[0001] The present invention is a nasal mask for sealing the area from the tip of a user's nose to the upper lip, which is used to surround a part of the user's nose and send pressurized gas from a ventilator into the user's nasal airway for the treatment of obstructive sleep apnea. It mainly includes a rigid part, a flexible part, a spring structure, and an exhaust port. Background Art

[0002] Sleep is an absolute necessity for everyone and a need of life. At the same time, sleep is also a periodic physiological phenomenon. Nowadays, many people are in a sub-healthy state of the body, prone to fatigue. With the continuous increase in the number of overweight and obese people and the increasingly serious social problem of population aging, the number of people with sleep disorders is also increasing. As a result, the incidence of sleep apnea is a common problem globally, showing different incidences in different regions and populations. Sleep apnea includes various different types, and the most common type is Obstructive Sleep Apnea Hypopnea Syndrome (OSA). In research reports, from 2015 to 2019, the number of people suffering from sleep obstructive breathing disorders aged 30 - 69 worldwide increased from 980 million to 1.05 billion. It is expected that by 2024, the number of global obstructive sleep apnea patients will increase to about 1.15 billion, not including patients under 30 years old and over 69 years old. Obstructive sleep apnea syndrome, also known as obstructive sleep apnea, refers to the phenomenon that a user repeatedly experiences apnea and hypopnea during sleep. Clinically, it can be manifested as snoring, with a loud and irregular snoring sound, a sense of suffocation at night, sleep disorder, drowsiness during the day, memory decline, and in severe cases, cognitive function decline, behavioral abnormalities, etc. Thus, it can be seen that people's life rhythm is gradually affected by sleep apnea.

[0003] Continuous positive airway pressure therapy (CPAP) is a common treatment method for obstructive sleep apnea syndrome. That is, through positive pressure ventilation, the patency of the user's airway is maintained to reduce the user's apnea and snoring, etc., and improve the user's sleep quality and quality of life. It usually has components such as a ventilator, a hose, an elbow, a frame, and a patient interface device. The treatment process is generally that a ventilator for continuous positive airway pressure therapy generates a constant pressurized air flow, and the pressurized air flow is transported through the ventilator tube to the heating tube or hose and then through components such as the elbow and the frame to the patient interface device and finally to at least one airway of the user. During this process, the patient interface device is configured to directly contact the user's face and is a very important accessory that needs to consider various human feelings. There are also more key points to consider compared with components such as the elbow and the frame. The design of the patient interface device not only needs to consider the cooperation between components and whether it can accurately and stably seal the continuous positive pressure gas, but also needs to consider the user's comfort when contacting the user's face.

[0004] There are roughly two major types of patient interface devices on the existing market for sealing the user's nasal airway to meet the different preferences and needs of users, namely invasive nasal mask type patient interface devices and non-invasive nasal mask type patient interface devices. The invasive nasal mask patient interface device is a relatively small nasal mask with two small protrusions protruding to one side. Its material is usually silicone or rubber. When in use, the two small protrusions are inserted into the nostrils, and it will have relatively better sealing performance than the non-invasive nasal mask. However, since the two protruding parts at the air outlet enter the internal parts of the user's first nostril and second nostril entrances, some users will feel discomfort due to foreign objects in the nostrils when using it. Therefore, they are not very used to wearing such sleep apnea components. The invasive nasal mask also has relatively high requirements for the sealing formation structure and has many uncertainties that cannot guarantee its sealing. Therefore, for most users, the invasive nasal mask is not the best choice.

[0005] The non-invasive nasal mask reduces the user's sensory characteristics because a part of the nasal mask does not need to enter the user's nasal cavity, and the user will be relatively more comfortable when using it. However, it also has deficiencies compared with the invasive nasal mask. For example, the non-invasive nasal mask surrounds the outside of the user's nostrils and thus has a larger volume than the invasive nasal mask, which has a certain impact on the convenience of the nasal mask. Its weight will also be heavier than that of the invasive nasal mask. Compared with the invasive nasal mask, the pressure on the nose when the user wears it increases. Moreover, due to the difference in the straightness of different people's noses, the existing non-invasive nasal masks do not have corresponding sizes or flexible parts that can adapt to different nose straightness. As mentioned above, both invasive and non-invasive nasal masks have advantages and disadvantages, and there is no comprehensive nasal mask in the existing market that combines the advantages of invasive and non-invasive nasal masks and eliminates their respective disadvantages to provide better treatment comfort for patients with obstructive sleep apnea and thus achieve better treatment effects.

[0006] Based on the above findings, the present invention designs a nasal mask that seals the area from the tip of the nose to the upper lip, integrating the advantages of invasive nasal mask-type patient interface devices and non-invasive nasal masks. This nasal mask not only has advantages such as more comfortable wearing, small volume for easy carrying, light weight and small pressure feeling, but also has a spring structure that can be adjusted according to the different nose straightness of the user. This spring structure will improve the adaptability of the nasal mask and make the sealing performance of the whole nasal mask better. In addition, the nasal mask designed by the present invention can have two ways of adapting to one air inlet end and two air inlet ends to provide more options for the user. 。 Summary of the Invention

[0007] The present invention provides a new type of nasal mask that seals the area from the tip of the user's nose to the upper lip. Compared with the non-invasive nasal masks on the existing market, it has a larger adaptation range, better sealing performance, and a small volume for easy carrying. It is more comfortable than the invasive nasal mask and has less burden on the nostrils, overcoming the limitations of similar products in the prior art. Thus, it provides a more effective, more widely applicable scenario and space, and a more feasible treatment method to provide continuous treatment for patients with obstructive sleep apnea.

[0008] A nasal mask used in a pressure state for delivering continuous positive pressure gas to the nasal airway of a user to treat sleep apnea, the nasal mask comprising:

[0009] A flexible part having a first opening facing the user's face and a second opening away from the user's face, wherein the first opening is configured and arranged to surround at least the tip of the nose and the first and second nostril regions of the user and abut against the surface around the nostrils when in use, and

[0010] The flexible portion bends towards the side close to the user's face and forms at least one protrusion. The flexible portion has at least one thin region and a support region thicker than the thin region, jointly forming the wall of the flexible portion.

[0011] A rigid portion having at least two connection ports, one of the connection ports being configured to connect to the second opening of the flexible portion away from the user's face, sealing with the flexible portion and jointly forming a chamber for containing gas, and at least one connection port being configured as an air inlet for positive pressure air flow to enter the chamber, for receiving the positive pressure air flow entering the nasal mask.

[0012] In one embodiment, the wall thickness between the thin region and the support region of the sealing portion varies uniformly.

[0013] In one embodiment, the first opening of the rigid portion facing the user's face is larger than the second opening.

[0014] In one embodiment, the flexible portion is of a symmetric structure.

[0015] In one embodiment, the rigid portion has walls of unequal thickness.

[0016] The present invention also discloses a nasal mask for use under a pressure state according to an embodiment of the present application, for delivering continuous positive pressure gas to the nasal airway of a user to treat sleep apnea. The nasal mask includes:

[0017] A flexible portion that bends towards the side close to the user's face and forms at least one protrusion to form a chamber for containing gas, having a first opening facing the user's face and at least one second opening away from the user's face, wherein the second opening is configured and arranged as an air inlet to receive continuous positive pressure air flow into the flexible portion;

[0018] Wherein, the flexible portion includes a sealing portion, the sealing portion being configured as the wall formed by the protrusion extending at the first opening, arranged to surround the user at least including the nasal tip and the regions of the first nostril and the second nostril and abut against the surface around the nostrils during use, and

[0019] The sealing portion has at least one thin region and a support region thicker than the thin region, jointly forming the wall of the sealing portion.

[0020] In one embodiment, the second opening of the flexible portion away from the user's face has a rigid portion connected thereto, which is configured and constructed to form a connection with other sleep disorder treatment components.

[0021] In one embodiment, the support region of the sealing structure has more than one wall thickness.

[0022] In one embodiment, the wall thickness between the thin region and the support region of the sealing portion varies uniformly.

[0023] In one embodiment, the area of the support region of the portion is larger than the area of the thin region.

[0024] The present invention also discloses a nasal mask for use under pressure conditions provided by an embodiment of the present application, which is used to deliver continuous positive pressure gas to the nasal airway of a user to treat sleep apnea. The nasal mask includes:

[0025] A flexible portion that bends towards the side close to the user's face and forms at least one protrusion to form a chamber for accommodating gas, having a first opening facing the user's face and at least one second opening away from the user's face, wherein the second opening is configured and arranged as an air inlet to receive continuous positive pressure air flow into the flexible portion;

[0026] Wherein, the flexible portion includes a sealing portion, and the sealing portion is configured as a wall formed by the extension of the protrusion at the first opening, and is arranged to surround at least the tip of the nose, the first nostril, and the second nostril regions of the user and abut against the surface around the nostrils when in use;

[0027] An exhaust port having at least one hole opening for discharging the positive pressure gas in the chamber to the outside through the hole opening.

[0028] In one embodiment, the second opening of the flexible portion away from the user's face has a rigid portion connected thereto, which is configured and constructed to form a connection with other sleep disorder treatment components.

[0029] In one embodiment, the exhaust port is configured to be detachably engaged with the flexible portion.

[0030] In one embodiment, the support region of the sealing structure has more than one wall thickness.

[0031] In one embodiment, the first opening of the rigid portion facing the user's face is larger than the second opening.

[0032] The present invention also discloses a nasal mask for use under pressure conditions provided by an embodiment of the present application, which is used to deliver continuous positive pressure gas to the nasal airway of a user to treat sleep apnea. The nasal mask includes:

[0033] A flexible portion that bends towards the side close to the user's face and forms at least one protrusion to form a chamber for accommodating gas, having a first opening facing the user's face and at least one second opening away from the user's face, wherein the second opening is configured and arranged as an air inlet to receive continuous positive pressure air flow into the flexible portion;

[0034] Wherein, the flexible part includes a flexible part body and a sealing part, the sealing part is configured as a wall formed by the protrusion extending at the first opening, and is arranged to surround the user during use, including at least the nasal tip, the first nostril and the second nostril regions, and abut against the face around the nostrils, and

[0035] The sealing part has at least one thin area and a support area thicker than the thin area, jointly forming the wall of the sealing part;

[0036] A spring structure, having a foldable wall, is located between the flexible part body and the sealing part,

[0037] Wherein the spring structure has at least one of the following characteristics:

[0038] The height of the spring structure is between 5 - 30 mm;

[0039] The width of the spring structure is between 3 - 40 mm;

[0040] The wall thickness of the spring structure is less than 3 mm.

[0041] In one embodiment, the second opening of the flexible part away from the user's face has a rigid part connected thereto, which is configured and constructed to form a connection with other sleep disorder treatment components.

[0042] In one embodiment, a nasal mask for sealing the user's nasal tip to the upper lip area is characterized in that the uniform wall thickness of the flexible part body is greater than the uniform wall thickness of the sealing part.

[0043] In one embodiment, the sealing part is configured not to locate or abut against the columella nasi of the user when sealing with the user's face.

[0044] In one embodiment, the spring structure has a wall thickness different from that of the flexible part body and the sealing part.

[0045] The present invention also discloses a nasal mask used under a pressure state according to the embodiments of the present application, for delivering continuous positive pressure gas to the nasal airway of the user to treat sleep apnea, the nasal mask includes:

[0046] A flexible part, having a first opening facing the user's face and at least one second opening away from the user's face, the first opening is configured and arranged to surround the user during use, including at least the nasal tip, the first nostril and the second nostril regions, and abut against the face around the nostrils, and

[0047] The flexible portion bends towards one side of the user's face and forms at least one protrusion to form a chamber for accommodating gas. The flexible portion has at least one thin area and a support area thicker than the thin area, jointly forming the wall of the flexible portion.

[0048] A comfort layer portion is configured and arranged to be attached to at least a part of the flexible portion and engage the user's face.

[0049] In one embodiment, the material of the comfort layer portion can be sponge or cloth.

[0050] In one embodiment, the first opening of the rigid portion facing the user's face is larger than the second opening.

[0051] In one embodiment, the inner edge of the comfort layer portion is greater than or equal to the edge of the first opening of the flexible portion, and jointly defines an airtight flow of air into the user's nasal airway with the flexible portion during use.

[0052] In one embodiment, the inner edge of the comfort layer portion is smaller than the edge of the first opening of the flexible portion, and the comfort layer portion alone defines an airtight flow of air into the user's nasal airway during use.

[0053] A nasal mask for sealing the area from the user's nasal tip to the upper lip of the present invention has at least the following beneficial effects:

[0054] 1) Compared with the existing non-invasive nasal masks on the market that seal the area from below the nasal tip to the upper lip, the nasal mask designed by the present invention has better sealing performance. Since there are always differences in the size and height of people's noses, the existing non-invasive nasal masks often seal the user's face through two openings in contact with the plane where the nostrils are located to transmit continuous positive pressure air flow. Because of the differences in the height, size, etc. of people's noses, the two openings of the existing nasal masks cannot fully fit the nasal airways of most people, and there are easily problems such as air leakage. Therefore, the present invention designs a nasal mask for sealing the area from the nasal tip to the upper lip. The seal of this nasal mask includes a part of the nasal tip, and a spring structure is provided at the first opening where the continuous positive pressure air flow is output and in contact with the nasal tip. This spring structure helps to adjust according to the differences of different users' noses, solving the disadvantage that the non-invasive nasal mask is prone to air leakage due to poor sealing compared with the invasive nasal mask, resulting in poor treatment effect, that is, there will be no situation of gas leakage due to non-fitting with the user's nose. It not only achieves better sealing, but also reduces the discomfort or foreign body sensation that the user may feel inside the nostrils, improves the user's comfort during use, and reduces the situation of treatment interruption or the user not following the treatment plan due to the user's discomfort.

[0055] 2) When comparing with the nasal masks on the market that seal the nasal bridge area to the upper lip area, the nasal mask designed in the present invention is smaller in volume, lighter in weight, and more convenient. The nasal mask designed in the present invention adjusts the sealing area to seal the area from the user's nasal tip to the upper lip area, reducing the volume compared with existing similar nasal masks. A nasal mask with a smaller volume is easier for the user to wear and easier to adjust when the nasal mask is displaced, reducing the risk of gas leakage to a certain extent. And because of the smaller volume, the nasal mask of the present invention is more conducive to the user to carry and store when traveling, facilitating the continuity of treatment. At the same time, the comfort of wearing is improved due to the reduction of the contact area with the user. A smaller nasal mask usually does not block the user's vision compared with existing nasal masks. Therefore, it is easier for the user to perform activities such as reading when wearing.

[0056] 3) When comparing with invasive nasal masks, the nasal mask designed in the present invention is more comfortable, has less burden on the nostrils, and has stronger inclusiveness. Since the air outlet end of the nasal mask designed in the present invention does not enter the inside of the user's first nostril and second nostril entrances, it reduces the sensory interference to the user and is more suitable for most people to use, especially for those who are not used to wearing sleep apnea components, making it easier for such people to adapt to wearing the treatment device components. And it is difficult for the size of invasive nasal masks to match the nostril sizes of most users. In contrast, the non-invasive nasal mask designed in the present invention only needs to meet the size of the first opening to surround the user's nasal airway. The user feels more comfortable when using it, has less burden on the nostrils, has stronger inclusiveness, and has less sensory interference, making it easier for the user to fall asleep.

[0057] 4) The air inlet end of the nasal mask designed in the present invention can be designed in different air inlet end forms. The user can choose to intake air through two ports on both sides or one port in the middle. The user has a wide range of choices and can adapt to different forms, simplifying the product and reducing the production and R & D costs. The nasal mask shown in the present invention has flexibility for the air inlet of positive pressure airflow. The same flexible part in contact with the user's face can be adapted to different joint parts with one air inlet or joint parts with air inlets on both sides. It expands on the technical characteristics of existing products, facilitating the user to choose and replace according to their own needs or preferences, giving the user a greater choice space, enabling the design of the present invention to adapt to new demands and changing situations in the market. And independently developing and testing the flexible part in contact with the user's face reduces the complexity of the product and the risk level of the entire product compared with designing and developing the entire breathing accessory, making the production method and cost simpler and lower. Correspondingly, the present invention also reduces the R & D cost of the product. Description of the Drawings

[0058] Figure 1A three-dimensional schematic diagram of a nasal mask for sealing the area from the user's nasal tip to the upper lip in Embodiment 1 of the present invention;

[0059] Figure 2 A usage scenario diagram of a nasal mask for sealing the area from the user's nasal tip to the upper lip in Embodiment 1 of the present invention;

[0060] Figure 3 A diagram showing the sealing range of a nasal mask for sealing the area from the user's nasal tip to the upper lip in Embodiment 1 of the present invention;

[0061] Figure 4 A diagram showing the contact between a nasal mask for sealing the area from the user's nasal tip to the upper lip in Embodiment 1 of the present invention and the surface around the nostrils;

[0062] Figure 5 An exploded view of a nasal mask for sealing the area from the user's nasal tip to the upper lip in Embodiment 1 of the present invention;

[0063] Figure 6 A front view and an A-A sectional structure diagram of a nasal mask for sealing the area from the user's nasal tip to the upper lip in Embodiment 1 of the present invention;

[0064] Figure 7 A front view and a B-B sectional structure diagram of a nasal mask for sealing the area from the user's nasal tip to the upper lip in Embodiment 1 of the present invention;

[0065] Figure 8 A schematic diagram showing that the flexible part of a nasal mask for sealing the area from the user's nasal tip to the upper lip in Embodiment 1 of the present invention is a symmetric structure;

[0066] Figure 9 A sectional view showing different wall thicknesses of the sealing part of a nasal mask for sealing the area from the user's nasal tip to the upper lip in an embodiment;

[0067] Figure 10 A sectional view showing different wall thicknesses of the sealing part of another form of a nasal mask for sealing the area from the user's nasal tip to the upper lip in an embodiment;

[0068] Figure 11 A three-dimensional schematic diagram of a nasal mask with one air inlet for sealing the area from the user's nasal tip to the upper lip in another embodiment of Embodiment 1;

[0069] Figure 12 A three-dimensional schematic diagram of a nasal mask with a rigid part for sealing the area from the user's nasal tip to the upper lip in a form of Embodiment 2;

[0070] Figure 13 A three-dimensional schematic diagram of another form of a nasal mask with a rigid part for sealing the area from the user's nasal tip to the upper lip in Embodiment 2;

[0071] Figure 14 A three - dimensional schematic diagram of the nasal mask that seals the area from the user's nasal tip to the upper lip and has a ventilation opening in Embodiment 3;

[0072] Figure 15 A three - dimensional schematic diagram of another embodiment of the nasal mask that seals the area from the user's nasal tip to the upper lip and has a ventilation opening in Embodiment 3;

[0073] Figure 16 A diagram showing the positional relationship between the sealing formation structure and the exhaust port of the patient interface device in Embodiment 3 of the present invention;

[0074] Figure 17 A three - dimensional schematic diagram of the nasal mask that seals the area from the user's nasal tip to the upper lip and is provided with a spring structure in Embodiment 4;

[0075] Figure 18 A cross - sectional view of the extrusion of the nasal mask that seals the area from the user's nasal tip to the upper lip and is provided with a spring structure in Embodiment 4;

[0076] Figure 19 A three - dimensional schematic diagram of the nasal mask that seals the area from the user's nasal tip to the upper lip and has a comfort layer part in Embodiment 5;

[0077] Figure 20 A three - dimensional schematic diagram of the nasal mask that seals the area from the user's nasal tip to the upper lip and has a comfort layer part made of another material in Embodiment 5;

[0078] Figure 21 A three - dimensional schematic diagram of the nasal mask that seals the area from the user's nasal tip to the upper lip and has comfort layer parts in different forms in Embodiment 5. Detailed implementation manners

[0079] For the convenience of understanding the invention, the invention will be described more comprehensively below with reference to the relevant drawings. The typical embodiments of the invention are given 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.

[0080] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill 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.

[0081] The present invention has recognized that the adaptability of the invasive nasal mask 1 in the existing market has certain limitations for the population and a strong sense of interference to users, and that the non-invasive nasal mask 1 in the existing market also has disadvantages such as being too large in size and having poor sealing stability. In response to the above problems, the present invention designs a nasal mask 1 that seals the area from the user's nasal tip to the upper lip, and adds a spring structure 23 to the flexible part 2. The use of the spring structure 23 enables the nasal mask 1 of the present invention to be adjusted and adapted according to the user's nose, improving its sealing stability. Since it only needs to satisfy that the first opening 12 in contact with the user's face surrounds the user's nasal airway, it is suitable for almost all noses of different heights and sizes, and is small in size, facilitating the user to carry it out for continuous treatment and timely adjustment when displacement occurs. The innovative design of the present invention improves the flexibility of the product and has a positive impact on patients with obstructive sleep apnea.

[0082] The following describes several structures of a nasal mask that seals the area from the user's nasal tip to the upper lip according to the present invention with specific examples.

[0083] Embodiment 1

[0084] This embodiment provides a nasal mask 1 that seals the area from the user's nasal tip to the upper lip. This embodiment provides a three-dimensional schematic diagram, a usage scenario diagram, a sealing range display diagram, an exploded view, and a sectional structure diagram of a nasal mask that seals the area from the user's nasal tip to the upper lip. Refer to Figure 1-11 . The nasal mask 1 shown in this embodiment has a flexible part 2 that bends towards the side close to the user's face and forms at least one protrusion 22 to form a chamber 14 for accommodating gas, and has a first opening 12 facing the user's face and at least one second opening 13 away from the user's face. The second opening 13 is configured and arranged as an air inlet to receive continuous positive pressure airflow into the flexible part 2. Among them, the flexible part 2 includes a sealing part 21, and the sealing part 21 is configured as a wall formed by the protrusion 22 extending at the first opening 12, and is set to surround the user at least including the nasal tip and the areas of the first nostril and the second nostril and abut against the surface around the nostril during use (as Figure 3 , Figure 4As shown, this method has obvious advantages in the existing market. It is in a form between a nasal mask that seals from the tip of the user's nose to the upper lip and a nasal mask that only seals from below the tip of the user's nose to the upper lip. Since it surrounds the tip of the user's nose, there will be no situation where the nasal mask 1 does not fit well with the user's nose due to differences in the height and size of the noses of different people. The nasal mask 1 of the present invention only needs to ensure that the opening of the nasal mask 1 in contact with the user's face surrounds the user's nasal airway, without worrying about the opening being too large or too small or the opening not aligning with the user's nostrils and being prone to displacement. Among them, the present invention is different from the non-invasive nasal mask 1 in the existing market that seals the area from below the tip of the user's nose to the upper lip. In addition to sealing the area from the tip of the user's nose to the upper lip, its sealing part 21 is also constructed not to position or contact the columella of the user's nose when sealing with the user's face (as Figure 4 shown). This method increases the user's rapid adaptation to the nasal mask 1 by reducing the contact surface range of the sealing part 21 with the user's face. This method is non-invasive and reduces the foreign body sensation of the user when using the nasal mask 1 compared with the invasive nasal mask 1, making it more comfortable to use and thus increasing the patient's compliance with the treatment.

[0085] And the sealing part 21 has at least one thin area 212 and a support area 213 that is thicker than the thin area 212, jointly forming the wall of the sealing part 21. When in use, the sealing part 21 in the flexible part 2 contacts the user's face and forms a seal. To ensure the strength of the support of the sealing part 21 on the face and at the same time make it more comfortable for the user when the sealing part 21 contacts the face, a part of the wall at the sealing part 21 is thickened to form the support area 213, and the rest is used as the thin area 212 (as Figure 9 shown). In some nasal masks 1, the area of the support area 213 of the sealing part 21 is larger than the area of the thin area 212 to provide effective and stable support for the sealing part 21 of the nasal mask 1. In some forms of the nasal mask 1 in the embodiment, to ensure the appearance of the sealing part 21 of the nasal mask 1, the sealing part 21 can be set to have a uniformly varying wall thickness, gradually extending the thin area 212 from the thicker wall. The support area 213 of this sealing structure has more than one wall thickness (as Figure 10 shown).

[0086] In another embodiment, the nasal mask 1 is provided with an air inlet, and the nasal mask 1 can be matched with components such as elbows and frames, and is configured to receive continuous positive pressure air flow into the nasal mask 1 (as Figure 11 shown).

[0087] Embodiment 2

[0088] This embodiment provides a nasal mask 1 that seals the area from the tip of the user's nose to the upper lip, with reference to Figure 12-13 . This embodiment provides a three-dimensional schematic diagram of the patient interface device. In Figure 12-13In the embodiment of the present invention shown, the difference from the nasal mask 1 in the first embodiment is that the nasal mask 1 includes a rigid part 3, which is connected to the second opening 13 of the flexible part 2 away from the user's face, and is configured and constructed to form a connection with other sleep disorder treatment components. The rigid part 3 has at least two connection ports 31, one of the connection ports 31 is configured to connect to the second opening 13 of the flexible part 2 away from the user's face, and is sealed with the flexible part 2 to jointly form a chamber 14 for containing gas, and at least one connection port 31 is configured to be an air inlet for positive pressure air flow to enter the chamber 14, for receiving the positive pressure air flow entering the nasal mask 1. The rigid part 3 has two forms. One form is that two separate parts are respectively placed at the air inlet end of the nasal mask 1 for receiving continuous pressurized air flow as the connection port 31 for connecting between components. Since the connection port 31 of the rigid part 3 is generally connected to the components by a snap, in this case, the rigid part 3 has walls with unequal thickness for the connection between the snaps (as Figure 12 shown), and the other form is that it is hermetically connected to the second opening 13 of the flexible part 2 away from the user's face as a whole. It not only has a connection port 31 for connecting to the components, but also has a certain internal space for connecting with the flexible part 2 to jointly form a chamber 14 for storing gas (as Figure 13 shown). In this case, the first opening 12 of the rigid part 3 facing the user's face is larger than the second opening 13, where the second opening 13 is the opening for connecting the rigid part 3 and the flexible part 2. When the nasal mask 1 receives gas, the gas enters from the connection port 31 of the rigid part 3 and follows a part of the inner wall of the rigid part 3 as a path, and then enters the user's nasal airway through the flexible part 2.

[0089] Embodiment 3

[0090] This embodiment provides a nasal mask 1 for sealing the area from the user's nasal tip to the upper lip, as shown in reference Figure 14-16 . This embodiment provides a three-dimensional schematic diagram of the patient interface device and a diagram of the positional relationship between the sealing formation structure and the exhaust port 4. In Figure 14-16 the embodiment of the present invention shown, the difference from the nasal mask 1 in the first embodiment is that the nasal mask 1 is provided with an exhaust port 4, which has at least one hole opening for discharging the positive pressure gas in the chamber 14 to the outside through the hole opening, and the hole opening is arranged at the position of the nasal mask 1 facing the opening that is in contact with and sealed to the user's face (as Figure 16As shown in the figure, when the user wears the nasal mask 1 for exhaust, the gas first flows out from the user's airway to the sealing part 21. Since the exhaust port 4 is opposite to the sealing part 21, the waste gas can directly flow out to the external environment in an almost straight line. It can have two specific forms. One form is to directly open small holes with a certain distance from each other at this position. The holes can have a certain taper to disperse the airflow of the air about to be discharged to the outside, which has a certain degree of noise reduction effect. This form is relatively simple (as Figure 14 shown). Another form is to provide a large opening of a hole for installing an external exhaust component 41 at the position of the nasal mask 1 facing the opening that contacts and seals the user's face. The hole opening and the external exhaust component 41 can be connected by a clamping structure, or can be connected by other methods such as friction connection, adhesive connection or hot pressing. The external exhaust component 41 can be provided with a noise reduction material 42. When the user wears the nasal mask 1 for exhaust, the gas first flows out from the user's airway to the sealing part 21, and then is discharged to the external environment through the external exhaust component 41. The noise reduction effect of the nasal mask 1 is completed by the noise reduction material 42 in the external exhaust component 41. The noise reduction material 42 can be one or more of fiber-based, foam-based or particle-based materials (as Figure 15 shown).

[0091] Embodiment 4

[0092] This embodiment provides a nasal mask 1 that seals the area from the user's nasal tip to the upper lip. Refer to Figure 17-18 . This embodiment provides a three-dimensional schematic diagram of the patient interface device. In Figure 17-18In the embodiment of the present invention shown, the difference from the nose mask 1 in Embodiment 1 is that the nose mask 1 is provided with a spring structure 23 having a foldable wall, located between the flexible part 2 body and the sealing part 21, wherein the spring structure 23 has at least one of the following characteristics: 1. The height of the spring structure 23 is between 5 - 30 mm; 2. The width of the spring structure 23 is between 3 - 40 mm; 3. The wall thickness of the spring structure 23 is less than 3 mm. And the spring structure 23 has a wall thickness different from that of the flexible part 2 body and the sealing part 21. Since the sealing part 21 cannot be a completely soft wall and needs to have a certain thickness of the wall to maintain the shape of the support part for sealing the user's face, the flexible part 2 body is mainly for forming a chamber 14 for containing gas, and the wall of the spring structure 23 cannot be too thick to facilitate folding of the spring structure 23. Therefore, the wall thickness of the spring structure 23 should be thinner than that of the sealing part 21 and the flexible part 2 body. Because there are always differences in the size and height of people's noses, the presence of the spring structure 23 enables the nose mask 1 to adapt to the noses of users with different heights and sizes on the one hand, solving the problem that the two openings of the existing nose mask 1 cannot fully adapt to the nasal airways of most people and are prone to air leakage and other problems. On the other hand, since the tip of the nose is relatively higher than other places, the foldable wall of the spring structure 23 enables the nose mask 1 to have a certain buffer at the tip part during use. The setting of the spring structure 23 can relatively reduce the pressure of the sealing part 21 of the nose mask 1 at the tip of the nose, reducing the discomfort caused to the user by the excessive pressure of the nose mask 1 at the tip part during use.

[0093] Embodiment 5

[0094] This embodiment provides a nose mask 1 for sealing the area from the tip of the user's nose to the upper lip, referring to Figure 19-21 . This embodiment provides a three-dimensional schematic diagram of the patient interface device. In Figure 19-21In the embodiment of the present invention shown, the difference from the nasal mask 1 in the first embodiment is that the nasal mask 1 is provided with a comfort layer portion 5, which is configured and arranged to be attached to at least a part of the flexible portion 2 and engage the user's face. The use of the comfort layer portion 5 makes the nasal mask 1 both durable and comfortable. The part in contact with the face can be breathable, so that the skin will not have skin symptoms such as red marks due to long-term wearing, improving the user's compliance with the treatment. The material of the comfort layer portion 5 can be sponge or cloth. The comfort layer portion 5 and the sealing portion 21 can be directly or indirectly connected. The direct connection methods include silicone adhesives, hot pressing, molding, etc. There are two fitting methods between the comfort layer portion 5 and the sealing portion 21 of the nasal mask 1. Specifically, in one fitting method, the inner edge of the comfort layer portion 5 is greater than or equal to the edge of the first opening 12 of the flexible portion 2, and when in use, it jointly defines an airtight flow into the user's nasal airway with the flexible portion 2. In another fitting method, the inner edge of the comfort layer portion 5 is smaller than the edge of the first opening 12 of the flexible portion 2, and when in use, the comfort layer portion 5 alone defines an airtight flow into the user's nasal airway. The fitting between the nasal mask 1 and the comfort layer portion 5 includes, but is not limited to, detachable or non-detachable connections such as adhesives, hot melting, and welding.

[0095] In addition, the technical features in the above embodiments can be combined as needed to obtain a nasal mask that seals the user's nasal tip to the upper lip area and includes all or part of the above technical features.

[0096] Implementing a nasal mask that seals the user's nasal tip to the upper lip area of the present invention has at least the following beneficial effects:

[0097] 1) Comparing with the existing nasal mask 1 that non-invasively seals the area from below the tip of the nose to the upper lip in the market, the nasal mask 1 designed by the present invention has better sealing performance. Since there are always differences in the size and height of people's noses, the existing non-invasive nasal mask 1 usually seals the user's face through two openings that contact the plane where the nostrils are located to transmit continuous positive pressure air flow. Because of the differences in the height, size and other aspects of people's noses, the two openings of the existing nasal mask 1 cannot fully fit the nasal airways of most people, and air leakage and other problems are likely to occur. Therefore, the present invention designs a nasal mask 1 that seals the area from the tip of the nose to the upper lip. The seal of this nasal mask 1 includes a part of the tip of the nose, and a spring structure 23 is provided at the contact point between the first opening 12 that outputs continuous positive pressure air flow and the tip of the nose. This spring structure 23 helps to adjust according to the differences of different users' noses, solving the disadvantage that the non-invasive nasal mask 1 has poor sealing performance compared with the invasive nasal mask 1, which is likely to cause air leakage and poor treatment effect, that is, there will be no gas leakage due to the mismatch with the user's nose. It not only achieves better sealing, but also reduces the discomfort or foreign body sensation that the user may feel inside the nostrils, improves the comfort of the user during use, and reduces the situation of treatment interruption or the user not following the treatment plan due to the discomfort of the user.

[0098] 2) Comparing with the existing nasal mask 1 that seals the area from the nasal bridge to the upper lip in the market, the nasal mask 1 designed by the present invention has a smaller volume, lighter weight and better convenience. The nasal mask 1 designed by the present invention adjusts the sealed area to seal the area from the tip of the user's nose to the upper lip, reducing the volume compared with the existing similar nasal mask 1. A nasal mask 1 with a smaller volume is easier for the user to wear and easier to adjust when the nasal mask 1 is displaced. To a certain extent, it reduces the risk of gas leakage. And because of the smaller volume, the nasal mask 1 of the present invention is more conducive to the user to carry and store when traveling, facilitating the continuity of treatment. At the same time, because the contact area with the user is reduced, the wearing comfort is improved. A smaller nasal mask 1 usually does not block the user's vision compared with the existing nasal mask 1. Therefore, it is easier for the user to perform activities such as reading when wearing.

[0099] 3) Compared with the invasive nasal mask 1, the nasal mask 1 designed in the present invention is more comfortable, imposes less burden on the nostrils, and has stronger inclusiveness. Since the air outlet end of the nasal mask 1 designed in the present invention does not enter the interiors of the first nostril and the second nostril entrances of the user, it reduces the sensory interference to the user, is more suitable for most people to use, especially for those who are not used to wearing sleep apnea components, making it easier for such people to adapt to the wearing of the treatment device components. Moreover, it is difficult to make the size of the invasive nasal mask 1 match the nostril sizes of the vast majority of users. In contrast, the non-invasive nasal mask 1 designed in the present invention only needs to satisfy that the size of the first opening 12 surrounds the nasal airway of the user, which will make the user feel more comfortable during use, impose less burden on the nostrils, have stronger inclusiveness, have less sensory interference, and make it easier for the user to fall asleep.

[0100] 4) The air inlet end of the nasal mask 1 designed in the present invention can be designed in different air inlet end forms. The user can choose to intake air through two ports on both sides or one port in the middle. The user has a wide range of choices and can adapt to different forms, simplifying the product and reducing the production and R & D costs. The nasal mask 1 shown in the present invention has flexibility for the air inlet of the positive pressure air flow. The designed same flexible part 2 that contacts the user's face can be adapted to different joint parts with one air inlet or joint parts with air inlets on both sides. It expands on the technical characteristics of the existing products, facilitating the user to choose and replace according to their own needs or preferences, giving the user a larger choice space, enabling the design of the present invention to adapt to new demands and changing situations in the market. Moreover, independently developing and testing the flexible part 2 that contacts the user's face compared to designing and developing the entire breathing accessory as a whole reduces the complexity of the product and the degree of risk of the entire product, making the production method and cost simpler and lower. Correspondingly, the present invention also reduces the R & D cost of the product.

[0101] 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 nasal mask for use under pressure conditions, for delivering continuous positive pressure gas to the nasal airway of a user to treat sleep apnea, the nasal mask comprising: A flexible part having a first opening facing the user's face and a second opening facing away from the user's face, wherein the first opening is configured and arranged to surround the user during use and includes at least the tip of the nose and the first and second nostril regions and abut against the surface around the nostrils, and the flexible part bends towards the side closer to the user's face and forms at least one protrusion, the flexible part having at least one thin area and a support area thicker than the thin area, jointly forming the wall of the flexible part; A rigid part having at least two connection ports, one of the connection ports being configured to connect to the second opening of the flexible part facing away from the user's face, sealing with the flexible part and jointly forming a chamber for containing gas, wherein at least one connection port is configured as an air inlet for positive pressure air flow to enter the chamber, for receiving the positive pressure air flow entering the nasal mask.

2. The nasal mask according to claim 1, wherein, The wall thickness between the thin area and the support area of the sealing part changes uniformly.

3. The nasal mask according to claim 1, wherein, The first opening of the rigid part facing the user's face is larger than the second opening.

4. The nasal mask according to claim 1, wherein, The flexible part has a symmetric structure.

5. The nasal mask according to claim 1, wherein, The rigid part has walls of unequal thickness.

6. A nasal mask for use under pressure conditions, for delivering continuous positive pressure gas to the nasal airway of a user to treat sleep apnea, the nasal mask comprising: A flexible part bends towards the side closer to the user's face and forms at least one protrusion to form a chamber for containing gas, having a first opening facing the user's face and at least one second opening facing away from the user's face, wherein the second opening is configured and arranged as an air inlet to receive a continuous positive pressure air flow into the flexible part; wherein the flexible part includes a sealing part, the sealing part being configured as the wall formed by the extension of the protrusion at the first opening, arranged to surround the user during use and include at least the tip of the nose and the first and second nostril regions and abut against the surface around the nostrils, and the sealing part has at least one thin area and a support area thicker than the thin area, jointly forming the wall of the sealing part.

7. The nasal mask according to claim 6, wherein, The second opening of the flexible part facing away from the user's face has a rigid part connected thereto, which is configured and constructed to form a connection with other sleep disorder treatment components.

8. The nasal mask according to claim 6, wherein, The support area of the sealing structure has more than one wall thickness.

9. The nasal mask according to claim 6, wherein, The wall thickness between the thin area and the support area of the sealing part changes uniformly.

10. The nasal mask according to claim 6, wherein, The area of the support area of the part is larger than the area of the thin area.

11. A nasal mask for use under pressure conditions, for delivering continuous positive pressure gas to the nasal airway of a user to treat sleep apnea, the nasal mask comprising: A flexible part bends towards the side closer to the user's face and forms at least one protrusion to form a chamber for containing gas, having a first opening facing the user's face and at least one second opening facing away from the user's face, wherein the second opening is configured and arranged as an air inlet to receive a continuous positive pressure air flow into the flexible part; wherein the flexible part includes a sealing part, the sealing part being configured as the wall formed by the extension of the protrusion at the first opening, arranged to surround the user during use and include at least the tip of the nose and the first and second nostril regions and abut against the surface around the nostrils; An exhaust port having at least one hole opening for discharging the positive pressure gas in the chamber to the outside through the hole opening.

12. The nasal mask according to claim 11, wherein, The nasal mask includes a rigid part, and the second opening of the flexible part facing away from the user's face has a rigid part connected thereto, which is configured and constructed to form a connection with other sleep disorder treatment components.

13. The nasal mask according to claim 11, wherein, The exhaust port is configured to be detachably engaged with the flexible portion.

14. The nasal mask according to claim 11, wherein, The support region of the sealing structure has more than one wall thickness.

15. The nasal mask according to claim 11, wherein, The first opening of the rigid portion facing the user's face is larger than the second opening.

16. A nasal mask for use under pressure, for delivering continuous positive pressure gas to a user's nasal airway to treat sleep apnea, the nasal mask comprising: The flexible portion, which bends towards the side close to the user's face and forms at least one protrusion to form a chamber for accommodating gas, has a first opening facing the user's face and at least one second opening away from the user's face, wherein the second opening is configured and arranged as an air inlet to receive a continuous positive pressure air flow into the flexible portion; Wherein, the flexible portion includes a flexible portion body and a sealing portion, the sealing portion is configured as a wall formed by the extension of the protrusion at the first opening, and is arranged to surround the user at least including the nasal tip and the first and second nostril regions and abut against the surface around the nostrils during use, and The sealing portion has at least one thin region and a support region thicker than the thin region, jointly forming the wall of the sealing portion; A spring structure, having a collapsible wall, is located between the flexible portion body and the sealing portion, Wherein the spring structure has at least one of the following characteristics: The height of the spring structure is between 5 - 30 mm; The width of the spring structure is between 3 - 40 mm; The wall thickness of the spring structure is less than 3 mm.

17. The nasal mask according to claim 16, wherein, The second opening of the flexible portion away from the user's face has a rigid portion connected thereto, which is configured and constructed to form a connection with other sleep disorder treatment components.

18. The nasal mask according to claim 16, wherein, The uniform wall thickness of the flexible portion body is greater than the uniform wall thickness of the sealing portion.

19. The nasal mask according to claim 16, wherein, The sealing portion is configured not to be positioned or abut against the columella nasi of the user when sealing with the user's face.

20. The nasal mask according to claim 16, wherein, The spring structure has a wall thickness different from that of the flexible portion body and the sealing portion.

21. A nasal mask for use under pressure, for delivering continuous positive pressure gas to a user's nasal airway to treat sleep apnea, the nasal mask comprising: The flexible portion, having a first opening facing the user's face and at least one second opening away from the user's face, the first opening is configured and arranged to surround the user at least including the nasal tip and the first and second nostril regions and abut against the surface around the nostrils during use, and The flexible portion bends towards the user's face and forms at least one protrusion to form a chamber for accommodating gas, the flexible portion has at least one thin region and a support region thicker than the thin region, jointly forming the wall of the flexible portion; A comfort layer portion, which is configured and arranged to be attached to at least a part of the flexible portion and engage the user's face.

22. The nasal mask according to claim 21, wherein, The material of the comfort layer portion can be sponge or cloth.

23. The nasal mask according to claim 21, wherein, The first opening of the rigid portion facing the user's face is larger than the second opening.

24. The nasal mask according to claim 21, wherein, The inner edge of the comfort layer portion is greater than or equal to the edge of the first opening of the flexible portion, and jointly defines an air flow to seal into the user's nasal airway with the flexible portion during use.

25. The nasal mask according to claim 21, wherein, The inner edge of the comfort layer portion is less than the edge of the first opening of the flexible portion, and the comfort layer portion alone defines an air flow to seal into the user's nasal airway during use.

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