Patient interface device

Abstract

A patient interface device used for conveying continuous positive pressure gas output by a breathing machine to a nasal airway of a user comprises an anterior cavity part, a seal forming structure, a ventilation assembly and a positioning stabilizing structure. The front cavity part is bent towards one side of the face of a user to form a main body cavity and is provided with at least one opening for mounting the ventilation assembly, and the sealing forming structure is provided with two shaped single-layer wall bulges and is communicated with the main body cavity of the front cavity part; the ventilation assembly is composed of a noise reduction material, a ventilation assembly body and a port cover, and the positioning and stabilizing structure is configured to provide connection with components at the two ends of the front cavity part so as to fix the patient interface device. During use, continuous positive pressure gas enters the patient interface device through the inlet ends located on the two sides of the front cavity part, and waste gas exhaled by a user is output to the external environment through the sealing forming structure and the ventilation assembly opposite to the sealing forming structure.

Description

Technical Field

[0001] The present invention is a patient interface device that seals with the nasal airway of a user, and includes a front cavity part, a sealing formation structure, a ventilation component, and a positioning and stabilizing structure, providing a comfortable wearing experience for the user while ensuring the sealed delivery of pressurized gas from a ventilator. Background Art

[0002] With the continuous increase in the number of overweight and obese people worldwide and the increasingly serious social problems such as population aging, the number of sleep apnea patients worldwide is also increasing. In the research report in 2022, relevant professionals predicted that the number of people suffering from sleep apnea globally will increase to about 1.15 billion by 2024, excluding patients under 30 years old and over 69 years old. Thus, it can be seen that sleep apnea has gradually developed into a very serious social problem with a very high prevalence rate and a rising trend. The incidence rate in men is generally higher than that in women, and obstructive sleep apnea syndrome (OSAS) is the most common type of sleep apnea disease. People suffering from obstructive sleep apnea syndrome are characterized by apnea and hypopnea caused by pharyngeal cavity stenosis during sleep, with a certain potential fatality rate and complication incidence rate. The pathogenesis of obstructive sleep apnea syndrome is a clinical syndrome with chronic intermittent hypoxia and sleep fragmentation, accompanied by a series of physiological changes such as hypoxemia and hypercapnia, and is also prone to cause multi-system damage throughout the body, leading to other serious symptoms in multiple organs and systems such as coronary heart disease, hypertension, and diabetes.

[0003] Continuous positive airway pressure therapy (CPAP) is a common treatment method for obstructive sleep apnea syndrome. Generally, moderate or severe sleep apnea patients need ventilator-assisted treatment. Continuous positive airway pressure therapy is achieved by the coordinated use of various components such as hoses, elbows, frames, and patient interface devices to deliver the continuously pressurized gas exhaled by the ventilator to the nasal airway or mouth airway of the patient in an invasive or non-invasive manner for treatment. Continuous positive airway pressure therapy is currently the most mainstream and recommended method for treating obstructive sleep apnea syndrome. Among components such as elbows and frames, the patient interface device has more considerations. Its design not only needs to consider the cooperation with other components and the ability to accurately and stably seal the continuous positive pressure gas, but also needs to consider the comfort of the user when contacting the user's face. Among the patient interface devices on the market, the patient interface device that only seals the nasal airway of the patient is the smallest and lightest type of patient interface device, and its main types are roughly divided into two types: invasive or non-invasive.

[0004] With the growing market of continuous positive airway pressure (CPAP) therapy components, several nasal masks or nasal pillows with noise reduction functions have been introduced on the market. The noise reduction function of nasal masks or nasal pillows was first achieved by dispersing the airflow through conical ventilation holes similar to those used in mask noise reduction, thereby reducing noise. As users have used this type of nasal mask for a longer time, more users have put forward higher requirements for the nasal mask. Therefore, an invasive nasal mask with a detachable noise reduction ventilation component has been introduced on the market. This invasive nasal mask has two protrusions that penetrate deep into the user's nostrils during use to seal the user's nasal airway. However, this method has too high requirements for sealing the patient's nasal airway. Therefore, in the design, the structure is made more complex to ensure the stability of its seal, which causes many inconveniences in various aspects during the subsequent use by users.

[0005] Moreover, although the existing noise reduction ventilation components on the market provide a relatively good method for gas discharge through corresponding structures, there are still areas for improvement in terms of simplicity and cleanliness. Therefore, the present invention has noticed this point, optimized and improved the nasal mask sealing formation structure in the existing market, and innovatively developed a more concise and easier-to-clean ventilation component. Combining the process of continuous pressurized gas entering the patient's nasal airway from the intake end and the patient's exhaled gas passing through the nasal mask and then discharging from the ventilation component, a patient interface device that is more effective, more convenient, and more hygienic for patients to use has been designed. This design significantly improves some disadvantages of the existing patient interface devices on the market and has a positive impact on users and production. Summary of the Invention

[0006] The objective of the present invention is to provide a new type of patient interface device with better sealing performance, more conducive to cleaning and drying, more comfortable to use, and overcoming the limitations of existing similar products in the art. Thus, it provides a more effective, more widely applicable, and more feasible treatment method to seal and deliver the pressurized gas output by the ventilator to the user's nasal airway for the treatment of sleep apnea.

[0007] A patient interface device for sealingly delivering continuous positive pressure gas to a user's nasal airway to treat sleep apnea, the patient interface device comprising:

[0008] A front cavity portion having a main cavity formed by a continuous wall and inlet ends of the front cavity portion on both sides, and the main cavity is curved towards the side close to the user's face to form a cavity with a certain curvature and a non-user contact structure.

[0009] A sealing formation structure, having a single-layer wall, is configured as two shaped protrusions and communicates with the main chamber of the front chamber portion. When in use, at least a part of it contacts a part of the user's nose and allows gas to enter at least one inlet inside the nostril through the outlet end to complete the delivery of pressurized gas and seal the user's nasal airway, wherein the two shaped protrusions are symmetric with each other;

[0010] There is at least one opening on the front chamber portion, and a ventilation assembly is located on an opening of the front chamber portion. The ventilation assembly includes:

[0011] Noise reduction material and a ventilation assembly body having two openings. The noise reduction material and one of the openings of the ventilation assembly body form an inseparable whole. The noise reduction material is connected to the body without a gap. When the airflow discharges from the front chamber portion, it is first divided into small airflows by the noise reduction material and then flows out to the outside through the opening of the ventilation assembly body away from the noise reduction material;

[0012] A positioning and stabilizing structure is provided and configured at both ends of the front chamber portion to provide a connection with components to fix the patient interface device to the user's face.

[0013] In one embodiment, the ventilation assembly has a port cover connected to the opening at the end of the ventilation assembly body away from the noise reduction material. The dispersed airflow of the ventilation assembly flows out to the outside through the gap between the periphery of the port cover and the opening of the ventilation assembly.

[0014] In one embodiment, the noise reduction material and the ventilation assembly body can be of the same or different materials.

[0015] In one embodiment, the two protrusions are symmetric by themselves.

[0016] In one embodiment, the sealing formation structure has a non-uniform wall thickness.

[0017] The present invention also discloses a patient interface device for sealingly delivering continuous positive pressure gas to a user's nasal airway to treat sleep apnea. The patient interface device includes:

[0018] A front chamber portion, having a main chamber formed by a continuous wall and inlet ends of the front chamber portion on both sides. The main chamber bends towards the side close to the user's face to form a chamber with a certain curvature and a non-user-contact structure;

[0019] A sealing formation structure is configured to communicate with the main chamber of the front chamber portion. When in use, at least a part of it contacts a part of the user's nose and allows gas to enter at least one inlet inside the nostril through the outlet end to complete the delivery of pressurized gas and seal the user's nasal airway;

[0020] The front cavity part has at least one opening, and the ventilation component is located on one opening of the front cavity part. The ventilation component includes:

[0021] A noise reduction material, a ventilation component body having two openings, and a port cover. The noise reduction material is integrally formed with one of the openings of the ventilation component body to form an inseparable whole. The port cover is arranged at the opening of the ventilation component body away from the noise reduction material. When the air flow discharges from the front cavity part, it first disperses the air flow through the pores of the noise reduction material. Among them, there is a certain distance between the port cover and the noise reduction material, and this distance is configured to gather the air flow dispersed by the noise reduction material relatively gently and then discharge it to the outside to further reduce the generation of noise.

[0022] Among them, there is a gap with a certain distance between the periphery of the port cover and the opening of the ventilation component, which is configured and arranged to guide the air flow direction passing through the noise reduction material and facilitate disassembly. The presence of the port cover makes the inlet and outlet structures of the ventilation component different;

[0023] A positioning and stabilizing structure, which is arranged and configured to provide connections with components at both ends of the front cavity part to fix the patient interface device to the user's face.

[0024] In one embodiment, the noise reduction material and the ventilation component body can be of the same or different materials.

[0025] In one embodiment, the sealing formation structure is configured not to position or contact the columella nasi of the user when sealing with the user's face.

[0026] In one embodiment, the positioning and stabilizing structure has a greater thickness than the wall of the front cavity part.

[0027] In one embodiment, the port cover and the ventilation component body are connected by a snap connection.

[0028] The present invention also discloses a patient interface device for sealingly delivering continuous positive pressure gas to the nasal airway of a user to treat sleep apnea. The patient interface device includes:

[0029] A front cavity part, having a main cavity formed by a continuous wall and inlet ends of the front cavity part on both sides, and the main cavity bends towards the side close to the user's face to form a cavity with a certain arc and a non-user-contact structure;

[0030] A sealing formation structure, which is configured to communicate with the main chamber of the front chamber part, and at least a part of which contacts a part of the user's nose during use and enables gas to enter at least one inlet inside the nostril through the outlet end to complete the delivery of pressurized gas and seal the user's nasal airway;

[0031] There is at least one opening on the front chamber part, and a ventilation assembly is located on an opening of the front chamber part. The ventilation assembly includes:

[0032] Noise reduction material and a ventilation assembly main body having two openings. The noise reduction material and one of the openings of the ventilation assembly main body form an inseparable whole. There is a gapless connection between the noise reduction material and the main body. When the airflow discharges from the front chamber part, it is first divided into small airflows by the noise reduction material and then flows out to the outside through the opening of the ventilation assembly main body away from the noise reduction material;

[0033] A positioning and stabilizing structure, which is arranged and configured to provide connections with components at both ends of the front chamber part to fix the patient interface device to the user's face.

[0034] In one embodiment, the ventilation assembly has a port cover connected to the opening at the end of the ventilation assembly main body away from the noise reduction material. The dispersed airflow of the ventilation assembly flows out to the outside through the gap between the periphery of the port cover and the opening of the ventilation assembly.

[0035] In one embodiment, the ventilation assembly forms a detachable connection with respect to the opening of the front chamber part.

[0036] In one embodiment, the positioning and stabilizing structure extends along the opening direction on the openings at both ends of the front chamber part without bending itself.

[0037] In one embodiment, the sealing formation structure has a tendency to converge towards a central point.

[0038] The present invention also discloses a patient interface device for sealingly delivering continuous positive pressure gas to a user's nasal airway to treat sleep apnea, which includes:

[0039] A front chamber part, which has a main chamber formed by a continuous wall and inlet ends of the front chamber part located on both sides. The main chamber bends towards the side close to the user's face to form a chamber with a certain arc and a non-user-contact structure;

[0040] A sealing formation structure, which is configured to communicate with the main chamber of the front chamber part, and at least a part of which contacts a part of the user's nose during use and enables gas to enter at least one inlet inside the nostril through the outlet end to complete the delivery of pressurized gas and seal the user's nasal airway;

[0041] There is at least one opening in the front cavity part, and the ventilation component is located on one opening of the front cavity part. The ventilation component includes:

[0042] A noise reduction material and a ventilation component main body having two openings. The noise reduction material and one of the openings of the ventilation component main body form an inseparable whole. There is a gapless connection between the noise reduction material and the main body. When the air flow discharges from the front cavity part, it is first divided into small air flows by the noise reduction material, and then flows out to the outside through the opening of the ventilation component main body far from the noise reduction material;

[0043] A positioning and stabilizing structure, which is arranged and configured to provide connections with components at both ends of the front cavity part to fix the patient interface device to the user's face;

[0044] Wherein the ratio of the opening area of the front cavity part for installing the ventilation component to the outer wall area of the front cavity part is at least 1:9, and the ratio of the opening area of the front cavity part to the area of the noise reduction material is at least 5:1;

[0045] Wherein the noise reduction material has at least one of the following characteristics:

[0046] The noise reduction material is a fiber material

[0047] The thickness of the noise reduction material is in the range of 0.2 - 5 mm

[0048] The surface area of one side of the noise reduction material is at least 50 mm 2 .

[0049] In one embodiment, the ventilation component has a port cover connected to the opening at the end of the ventilation component main body far from the noise reduction material, and the dispersed air flow of the ventilation component flows out to the outside through the gap between the periphery of the port cover and the opening of the ventilation component.

[0050] In one embodiment, the periphery of the ventilation component has a clamping structure for connecting with the front cavity part.

[0051] In one embodiment, the shape of the noise reduction material is similar to the shape of the opening of the ventilation component main body connected to the noise reduction material.

[0052] In one embodiment, the opening of the ventilation component main body connected to the noise reduction material is not larger than the opening of the ventilation component connected to the port cover.

[0053] The present invention also discloses a patient interface device for sealingly delivering continuous positive pressure gas to the nasal airway of a user to treat sleep apnea. The patient interface device includes:

[0054] The front cavity part has a main cavity formed by a continuous wall and inlet ends of the front cavity part located on both sides. The main cavity bends towards the side close to the user's face to form a cavity with a certain arc as a non-user contact structure;

[0055] The sealing formation structure has a single-layer wall, is configured as two shaped protrusions and communicates with the main cavity of the front cavity part. When in use, at least a part of it contacts at least a part of the user's nose and enables the gas outlet end to enter at least one inlet inside the nostril to complete the delivery of pressurized gas and seal the user's nasal airway, and the two shaped protrusions are symmetrical to each other;

[0056] There is at least one opening on the front cavity part, and a ventilation component is located on one opening of the front cavity part. The ventilation component includes:

[0057] Noise reduction material and a ventilation component main body with two openings. The noise reduction material and one of the openings of the ventilation component main body form an inseparable whole. There is a gapless connection between the noise reduction material and the main body. When the airflow discharges from the front cavity part, it is first divided into small airflows by the noise reduction material and then flows out to the outside through the opening of the ventilation component main body away from the noise reduction material;

[0058] The positioning and stabilizing structure is arranged and configured to provide connections with components at both ends of the front cavity part to fix the patient interface device on the user's face;

[0059] Wherein the ratio of the opening area of the front cavity part where the ventilation component is installed to the outer wall area of the front cavity part is at least 1:9, and the ratio of the opening area of the front cavity part to the area of the noise reduction material is at least 5:1;

[0060] Wherein the noise reduction material has at least one of the following characteristics:

[0061] The noise reduction material is one of foam and granular materials;

[0062] The thickness of the noise reduction material is in the range of 0.5 - 7 mm;

[0063] The surface area of one side of the noise reduction material is at least 50 mm 2 .

[0064] In one embodiment, the ventilation component has a port cover connected to the opening at the end of the ventilation component main body away from the noise reduction material, and the dispersed airflow of the ventilation component flows out to the outside through the gap between the periphery of the port cover and the opening of the ventilation component.

[0065] In one embodiment, any mutually parallel cross-sections are taken in the main cavity, and the cross-sections can be the same or different.

[0066] In one embodiment, the protrusion of the seal forming structure extends normally from a certain position of the front cavity part.

[0067] In one embodiment, the distances from the centers of the two gas outlets where the seal forming structure contacts the patient's face to the center of the noise reduction material are equal.

[0068] The patient interface device implementing the present invention has at least the following beneficial effects:

[0069] 1) Optimized the existing design, not prone to air leakage and more comfortable to use. Among the patient interface devices of the publicly disclosed technical inventions in the existing market, it is difficult to make the gas enter the nasal airway of the user in a sealed manner. And some patient interface devices set the sealing formation structure of the patient interface device as a double wall to ensure the stability of the formed shape. However, the use of the double wall also brings many problems to the user. For example, when the patient interface device contacts the nasal airway of the user, it is easy to cause discomfort and affect the subsequent treatment of the user. Moreover, the double wall relatively reduces the size of the outlet opening of the patient interface device, making it easy for the user to inhale an insufficient air flow. In addition, the double wall is prone to dirt accumulation and has an adverse impact on the health of the user. In the market, a patient interface device in the form of a small nasal mask similar to a face mask has been introduced, which seals the area from the user's nose bridge to the upper lip. However, it still has the disadvantages of large volume, being relatively bulky and prone to displacement during wearing, resulting in unsealing. The present invention has noticed these several disadvantages and has improved the existing patient interface device in view of the disadvantages of the existing sealing formation structure of the patient interface device. a. In order to provide a more comfortable use experience for the user, the present invention changes the double wall of the existing sealing formation structure to a single wall. However, to ensure the sealing of the gas and the stability of the sealing formation structure, through experimental tests, the size of the gas outlet opening where the gas flows out of the patient interface device is enlarged, its wall thickness is modified to be a non-uniform wall thickness, and the sealing formation structure is adjusted to a symmetric form. The above adjustments not only ensure the sealing performance of the patient interface device, but also solve the drawbacks of the existing patient interface device and bring many advantages. For example, the single wall has less impact on the user, reducing the discomfort or foreign body sensation that the user may feel inside the nostrils, improving the comfort of use for the user, reducing the situation of treatment interruption or the user not complying with the treatment plan due to the discomfort of the user. Moreover, the single wall is relatively lighter, making the pressure of the patient interface device on the user's face smaller and making the wearing more comfortable. Since there is no gap reserved between the double wall thicknesses, the enlargement of the gas outlet opening enables the user to breathe more smoothly, and the user will not feel that the air flow is too small. To ensure that the single-layer structure has the same stability as the double-layer structure, the non-uniform wall thickness of the sealing formation structure also makes the relatively soft wall more comfortable when contacting the user. The advantage of its symmetric form is that when the outlet port of the sealing formation structure enters the inside of the user's nostril, the structure around the nostril is squeezed with the same thickness at 360°, making the pressure on the periphery of the nostril more uniform, and the user will feel more comfortable during the use process, improving the compliance of the user with the treatment process.b. One form of the sealing formation structure of the patient interface device seals the area from the tip of the user's nose to the upper lip with the same structure. It only needs to meet the requirement that the size of the first opening surrounds the user's nasal airway. And a spring structure is provided at the contact point of the first opening that outputs continuous positive pressure airflow with the tip of the nose, which helps to adjust according to the differences of different users' noses. Therefore, it can match the nostril sizes of almost all users and is less likely to leak air. Moreover, compared with the existing invasive nasal mask patient interface device, since it does not enter the user's nasal cavity, 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, it makes it easier for such people to adapt to wearing the treatment device components. And compared with the existing patient interface device of a small nasal mask with a similar mask shape, it reduces the volume, making it easier for the user to wear and easier to adjust when the nasal mask is displaced. To a certain extent, it reduces the risk of gas leakage, which is beneficial for the user to carry and store when traveling, facilitating the realization of continuous treatment.

[0070] 2) Use an innovative noise reduction method. The ventilation component designed in the present invention innovatively attaches the noise reduction material closely to the opening of the ventilation component to disperse the airflow. And the designed distance between the noise reduction material and the port cover makes the airflow flow out more smoothly to the outside. In the patient interface devices existing on the market, the way of using the noise reduction material is to place a piece of noise reduction cotton between the two ends of the ventilation component. Although the airflow is dispersed by the noise reduction cotton, due to the relatively small gap between the noise reduction cotton and the two ends, the airflow is relatively turbulent at both the inlet and outlet ends of the ventilation component, which is not conducive to the user's use. And the way of designing the noise reduction cotton between the two ends of the ventilation component in a non-detachable manner is very inconvenient for the user to clean. The present invention innovatively designs the noise reduction material, including the noise reduction net, at the inlet end where the gas enters the ventilation component, so that there is a certain distance gap between the noise reduction material and the second end of the ventilation component, that is, the position of the port cover. When the airflow flows from the front cavity part through the ventilation component to the outside, the airflow first passes through the noise reduction material for dispersion, and then through the gap between the noise reduction material and the port cover to change the dispersed turbulent airflow into a relatively smooth airflow, and then flows out to the outside through the gap between the port cover and the ventilation component. This process is relatively more obvious in noise reduction for the patient interface device and makes the airflow flow to the user in a non-frontal direction, reducing the possibility of the airflow blowing onto the user's face. In summary, the ventilation component of the present invention is superior to the ventilation component of the user interface of the prior art in many aspects.

[0071] 3) Modular design increases the user's choice range. The present invention modularizes the ventilation component. Compared with the existing design, the ventilation component of the present invention can replace the port cover and the noise reduction material. Users can replace the appropriate noise reduction material and the port cover of an easy-to-use type according to their own preferences and needs to adapt to the main body of the ventilation component. This method provides users with diverse choices. a. The port cover of the ventilation component designed by the present invention is detachably connected to the ventilation component. Moreover, the noise reduction material is integrally and inseparably connected to the main body of the ventilation component instead of being placed in the middle of the ventilation component. Therefore, the presence or absence of the port cover will not cause the noise reduction material to fall due to no obstruction, and will not affect the noise reduction effect in a large range. The main function of the port cover of the present invention is to leave a certain gap between the port cover and the noise reduction material so that the turbulent air flow passing through the noise reduction material becomes gentle and flows out to the outside. However, in the case where the port cover is not provided, the air flow in the front cavity part will still pass through the noise reduction material for air flow dispersion to achieve the noise reduction effect. Although the case of setting the port cover has certain advantages, the port cover is not the main component providing the noise reduction effect. Therefore, users can choose to use or not use the port cover, and noise reduction can be achieved, providing a way for users not to use the noise reduction material when they accept it. b. In the case of using the port cover, the detachable port cover also enables users to choose the port cover they like and its connection method design. There are designed, for example, fully detachable port covers or flip-type port covers. Different port covers and connection methods have different advantages and disadvantages. Users can choose the fully detachable port cover for easy and detailed cleaning of the inside of the ventilation component, or choose the flip-type port cover which is more convenient for users to fasten and is not easy to fall off, and there will be no situation where the port cover cannot be found. Both types of port covers are more conducive to the cleaning and drying of the noise reduction material compared with the closed port cover. c. The present invention also designs the noise reduction material to be replaceable. Since the noise reduction material is inseparable from the main body of the ventilation component, the open end of the ventilation component is provided with a detachable port cover. The ventilation component composed of only two parts is more convenient for modular design of the ventilation component. Therefore, this design can be connected to the noise reduction material and the main body of the ventilation component not only for one type or ventilation port form. Users can choose the ventilation component with different types or ventilation port forms of noise reduction materials to meet the different ventilation needs of users. This method makes the entire patient interface device product more flexible. The replaceable module can adapt to the different needs and preferences of users, reducing the complexity of the ventilation component.

[0072] 4) The present invention makes cleaning more thorough and hygienic. Because the product will directly contact the user's face and communicate with the user's airway, maintaining the hygiene of the respiratory tract is crucial to the user's physical health and can effectively reduce the risk of infection through ingestion. a. The port cover at the air outlet of the patient interface device currently on the market is usually an inseparable whole formed with the ventilation assembly. Placing the noise reduction material inside the ventilation assembly on the inner side of the port cover is very inconvenient for the user to clean the ventilation assembly. When the user cleans the internal noise reduction material, i.e., the noise reduction cotton, or the noise reduction cotton has accumulated moisture after being used for a long time, due to the indivisibility of the port cover, the ventilation assembly has only a small gap for drying the noise reduction cotton, which can easily cause incomplete drying and the breeding of bacteria. The present invention designs the port cover to be detachable, which can be opened by The port cover directly cleans the noise reduction material to make the cleaning more thorough and clean. The port cover can also be opened for drying and ventilation. Compared with existing products, it has higher hygiene standards and can effectively reduce the risk of ingestion infection. The ventilation component of the present invention has two layers, namely one end of the noise reduction material and one end of the port cover and a chamber in the middle for smoothing the airflow. Compared with the three-layer form of the noise reduction material in the market, which is set in the middle of the ventilation component, this design is more concise as a whole, and it is convenient to clean and disinfect the whole and details of the ventilation component without having narrow gaps that cannot be cleaned. b. In addition, the noise reduction material used in the present invention can be a noise reduction net. The noise reduction cotton used in the existing market is not easy to clean and dry because the port cover cannot be opened, and it is easy to absorb exhaled moisture, thereby causing bacteria and mold to grow. The noise reduction net material does not have the above problems. It does not absorb moisture and can also open the port cover to repeatedly brush it with a brush, making the product ventilation component more durable. The noise reduction net used in the present invention can withstand repeated cleaning without being damaged, which provides more protection for the health of users. c. The double-layer wall of the existing technology on the market is easy to harbor dirt and is not easy to clean. Over time, users are easily infected by bacteria and other microorganisms and are at risk of getting sick. The present invention improves the product foundation as described above, so that the sealing structure is changed from the double-layer wall on the market to a single-layer wall structure. It not only has advantages in use, but also has a simpler structure than the multi-layer wall in terms of cleaning. Users can clean more easily without the internal slits in the multi-layer wall or areas that are difficult for cleaning tools to reach, making cleaning faster and more effective.

[0073] 5) It reduces processes, has lower costs, reduces the defect rate, and is environmentally friendly. The patient interface device designed in the present invention has differences from the prior art products in both the sealing formation part and the ventilation component part. With the innovative improvement of the present invention, in addition to the above advantages, the product also reduces the production processes, lowers the production cost and defect rate of the product, and reduces the material usage of the product through technological improvements, which also has a beneficial impact on the environment. a. Through the above formula for improving the product technology of the present invention, the sealing formation structure changes from a double-layer wall in the market to a single-layer wall structure, which is cheaper to manufacture than a multi-layer wall because a multi-layer wall requires more materials and relatively more complex production processes and mold costs, making the production process of the single-layer wall more economical and efficient. This method also saves the raw materials used to manufacture the user interface, and saving material usage means reducing the demand for materials such as plastics, polyesters, and silicones, which can lead to less carbon emissions. Continuously adopting this green design approach will have a positive impact on a larger scale and further advance the process of carbon neutrality. b. The present invention integrally forms the noise reduction material and the first opening where the air flow enters the ventilation component main body from the front cavity part, rather than the form of separately producing and assembling the components and the noise reduction material in the existing patient interface devices on the market. Simplifying the production process and using the method of manufacturing a whole product without assembly will be faster than the manufacturing and assembly steps of the existing products. Therefore, it reduces production time, labor costs, production processes, and equipment requirements. The integrally formed connection form also improves the structural strength of the ventilation component to a certain extent. Since the components are manufactured and connected in one operation, the possibility of assembly errors is reduced. This method improves the product quality and reliability, makes the product more durable, and further realizes the environmentally friendly design. BRIEF DESCRIPTION OF THE DRAWINGS

[0074] Figure 1 FIG. 3 is a three-dimensional schematic diagram of a patient interface device in Embodiment 1 of the present invention;

[0075] Figure 2 FIG. 4 is a three-dimensional schematic diagram of a ventilation component of a patient interface device in Embodiment 1 of the present invention;

[0076] Figure 3 FIG. 5 is an exploded view of a patient interface device in Embodiment 1 of the present invention;

[0077] Figure 4 FIG. 6 is a front view and a schematic cross-sectional structure diagram along line A-A of a patient interface device in Embodiment 1 of the present invention;

[0078] Figure 5 FIG. 7 is a front view and a schematic cross-sectional structure diagram along line B-B of a patient interface device in Embodiment 1 of the present invention;

[0079] Figure 6Front view and C-C cross-sectional structure diagram of the ventilation component in Embodiment 1 of the present invention;

[0080] Figure 7 Airflow path diagram of the airflow discharging from the ventilation component through the noise reduction net in Embodiment 1 of the present invention;

[0081] Figure 8 Airflow path diagram of the airflow discharging from the ventilation component through the noise reduction cotton in Embodiment 1 of the present invention;

[0082] Figure 9 Airflow path diagram of the airflow entering and discharging from the patient interface device in Embodiment 1 of the present invention;

[0083] Figure 10 Position relationship diagram between the seal formation structure of the patient interface device and the ventilation component in the embodiment of the present invention;

[0084] Figure 11 Wall thickness cross-sectional diagram of the seal formation structure of the patient interface device in the embodiment of the present invention;

[0085] Figure 12 Wall thickness cross-sectional diagram of the seal formation structure of the patient interface device in another implementation manner in the embodiment of the present invention;

[0086] Figure 13 Diagram showing the seal formation structure as a symmetric structure and symmetry with each other in the embodiment of the present invention;

[0087] Figure 14 Cleaning diagram of the ventilation component in the embodiment of the present invention;

[0088] Figure 15 Cleaning diagram of the seal formation structure in the embodiment of the present invention;

[0089] Figure 16 Mold cross-sectional diagram of the patient interface device in Embodiment 1 of the present invention;

[0090] Figure 17 Three-dimensional schematic diagram of the patient structure device with different seal formation structures in Embodiment 2 of the present invention;

[0091] Figure 18 Three-dimensional schematic diagram of the patient structure device in another embodiment in Embodiment 2 of the present invention;

[0092] Figure 19 Three-dimensional schematic diagram of the patient interface device using different noise reduction materials in Embodiment 3 of the present invention;

[0093] Figure 20 Three-dimensional schematic diagram of the patient interface device without a port cover in Embodiment 4 of the present invention;

[0094] Figure 21 3D schematic diagram of the patient interface device with different forms of port covers in Embodiment 5 of the present invention. Detailed implementation manners

[0095] 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 so that the disclosure of the invention is thorough and complete.

[0096] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the technical field to which the invention belongs. The terms used in the description of the invention herein are for the purpose of describing specific embodiments only and are not intended to limit the invention.

[0097] In view of the problems that the existing patient interface devices on the market for delivering gas to the nasal airway of users are not easy to clean, not conducive to the comfort of users, the ventilation components are too complex, the production difficulty is high and the cost is too high, etc., the present invention provides a patient interface device with a simpler structure and a comfortable wearing experience for users. The patient interface device designed by the present invention not only optimizes the disadvantages of the existing design, but also provides several different structures of patient interface devices for users to choose according to their respective needs and preferences. It is a better technical 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.

[0098] The following describes several structures of a patient interface device of the present invention with specific examples.

[0099] Embodiment 1

[0100] This embodiment provides a patient interface device 1 for sealing with the nasal airway of a user. This embodiment provides 3D views, exploded views, front views, sectional structure diagrams, airflow path diagrams, positional relationship diagrams, cleaning display diagrams, and mold sectional diagrams of the patient interface device 1, as shown in Figure 1-16。The patient interface device 1 shown in the embodiment includes a front cavity portion 2, a ventilation component 4, a seal-forming structure 3, and a positioning and stabilizing structure 5, configured to seal the area from below the user's nasal tip to the upper lip region and deliver continuous positive pressure gas to the user's nasal airway in a sealed manner to treat obstructive sleep apnea symptoms. The patient interface device 1 is provided with a front cavity portion 2 having a main cavity 21 formed by a continuous wall and inlet ends of the front cavity portion 2 on both sides. The main cavity 21 is curved toward the side close to the user's face to form a cavity with a certain arc as a non-user contact structure. When the patient uses the patient interface device 1 for treatment, the continuous pressurized gas output from the ventilator first enters the patient interface device 1 from the inlet ends of the front cavity portion 2 at both ends, and then part of the gas is stored in the main cavity 21.

[0101] The patient interface device 1 further includes a seal-forming structure 3 having a single-layer wall, which is configured as two shaped protrusions 31 and communicates with the main cavity 21 of the front cavity portion 2. During use, at least a part of it contacts a part of the user's nose and allows gas to enter at least one inlet inside the nostril through the outlet end to complete the delivery of the pressurized gas and seal the user's nasal airway. The two shaped protrusions 31 are symmetric with each other (as Figure 13 shown). Since there are many differences in the height of the noses and the sizes of the nostrils of different users, the existing patient interface device 1 designs the wall of the seal-forming structure 3 as a double-layer wall to ensure the airtightness of its gas flow. Although this design improves the airtightness of the patient interface device 1 to a certain extent, it also brings more disadvantages to the patient interface device 1 due to the formation of the double-layer wall. In the present invention, due to testing and design, the seal-forming structure 3 is changed to a single-layer wall and the structure of the ventilation component 4. Because of the single-layer wall design, the sealing function of the double-layer wall is achieved, and there is no need for the structure in which the seal-forming structure 3 of the existing patient interface device 1 in the market is designed asymmetrically to improve the airtightness. Therefore, the two protrusions 31 designed in the present invention are symmetric with each other (as Figure 13 shown). Considering the comfort of the seal-forming structure 3 on the patient's nose during wearing, the distance from the center of the two gas outlets where the seal-forming structure 3 contacts the patient's face to the center of the noise reduction material 42 is equal. The protrusions 31 of the seal-forming structure 3 are formed by normal extension from a certain position of the front cavity portion 2 until they contact and seal the part of the user's nose to transmit the pressurized gas. Since the double-layer seal-forming structure 3 in the existing market also has a supporting function, although the present invention designs to replace the function of the double-layer wall with a single-layer wall and enlarges the outlet end where the pressurized gas flows out, the input and exhaled airflows can be smoother when the user wears and uses it. However, for the shape stability design, the seal-forming structure 3 has a non-uniform wall thickness, which has at least one thin region and a non-thin region slightly thicker than the thin region as a support region. Specifically, a partial region of the seal-forming part is a thickened wall as a support region and the other parts are thin regions (as Figure 11as shown), in addition, the mold development cost of the single-layer wall is relatively lower than that of the double-layer wall and is easier to implement (as Figure 16 shown) ， its mold will be simpler, without considering the difficult demolding situation after the formation of the double-layer wall due to the two layers at the outlet end, and the patient interface device with a single-layer wall is easier to clean (as Figure 15 shown). The present invention also designs that the sealing formation structure 3 is configured not to position or contact the columella nasi of the user when sealing with the user's face, so that the treatment process of the user is more comfortable and the user does not feel that there is a foreign object contacting the nose of the user.

[0102] There is at least one opening on the front cavity part 2 of the patient interface device 1, and the ventilation component 4 is located on an opening of the front cavity part 2. The ventilation component 4 includes: a noise reduction material 42 and a ventilation component main body 41 with two ends. The noise reduction material 42 and the opening at one end of the ventilation component main body 41 form an inseparable whole. The noise reduction material 42 and the main body are connected without a gap. When the air flow discharges from the front cavity part 2, it is first divided into small air flows by the noise reduction material 42, and then flows out to the outside through the end of the ventilation component main body 41 far from the noise reduction material 42. A clamping structure can be arranged around the ventilation component 4 for detachable connection with the front cavity part 2, or the ventilation component 4 and the front cavity part 2 can be arranged for non-detachable connection. In one embodiment, the ventilation component 4 has a port cover 43 connected to the opening at the end of the ventilation component main body 41 far from the noise reduction material 42. The dispersed air flow of the ventilation component 4 flows out to the outside through the gap between the periphery of the port cover 43 and the opening of the ventilation component 4. The port cover 43 and the ventilation component main body 41 can be detachably or semi-detachably connected by a buckle or other means. Both methods are different from and superior to the existing ventilation components. The ventilation component 4 has only two layers, so it has the advantages of simple structure and easy cleaning compared with the three layers of the existing ventilation components (as Figure 12 , Figure 14 shown). It is designed that the noise reduction material 42 and the ventilation component main body 41 can be made of the same or different materials, providing more diverse choices for patients. To ensure the smoothness of the air flow of the patient interface device 1, the present invention has made certain restrictions on the following data. Among them, the ratio of the opening area of the front cavity part 2 where the ventilation component 4 is installed to the outer wall area of the front cavity part 2 is at least 1:9, and the ratio of the opening area of the front cavity part 2 to the area of the noise reduction material 42 is at least 5:1. In one embodiment, the noise reduction material 42 has at least one of the following characteristics: 1. The noise reduction material 42 is a fibrous material (such as polyester fiber cotton, glass fiber cotton); 2. The thickness of the noise reduction material 42 is in the range of 0.2-5 mm; 3. The surface area of one side of the noise reduction material 42 is at least 50 mm 2。The patient interface device 1 of this embodiment is further provided with a positioning and stabilizing structure 5, which is arranged and configured to provide connections with components at both ends of the front cavity part 2 to fix the patient interface device 1 to the user's face. The positioning and stabilizing structure 5 is designed to extend along the opening direction at the openings at both ends of the front cavity part 2 without bending itself and is harder than the front cavity part 2, for engaging with other components for treating sleep apnea symptoms. The positioning and stabilizing structure 5 can be made of rigid or non-rigid materials.

[0103] During use, the airflow first flows from the inlet ends of the front cavity parts 2 on both sides along the front cavity parts 2 into the interior of the patient interface device 1 through the cavity that bends towards the side close to the user's face, and then flows into the patient's nasal airway through the sealing formation structure 3. The process of the user exhaling waste gas is that the waste gas exhaled by the user first passes through the sealing formation structure 3 and is discharged to the external environment along an almost straight line through the ventilation component 4 (as Figure 9 shown). Specifically, the waste gas first passes through the noise reduction material 42 in the ventilation component 4 to disperse and reduce the noise of the airflow, and then passes through the chamber between the noise reduction material 42 and the other end opening of the ventilation component main body 41 to gradually slow down the turbulent airflow. In the case of having a port cover 43, it can finally flow out to the outside through the gap between the periphery of the port cover 43 and the opening of the ventilation component main body 41 away from the noise reduction material (as Figure 7 、 Figure 8 shown). The airflow slowed down by the chamber between the noise reduction material 42 and the other end opening of the ventilation component main body 41 helps to reduce the possibility of the airflow blowing onto the user's face, so that the airflow does not flow towards the user's face directly and further reduces noise, improving the noise reduction effect. Since the ventilation component 4 is designed on the central opening of the front cavity part 2, in this way, when the positive pressure airflow flows in through the two side inlet ends, the ventilation component 4 is on the airflow path, so that the positive pressure airflow will not or less likely be discharged to the external environment through the ventilation component 4. And the position of the ventilation component 4 happens to be directly opposite to the sealing formation structure 3, and the center points of both of them are located on the axis of symmetry of the patient interface device 1. Therefore, when exhausting, the waste gas can flow out to the outside through the chamber with a shorter path and accurate position, facilitating the ventilation of the patient (as Figure 10 shown).

[0104] In another embodiment, the wall thickness of the sealing formation structure 3 of the patient interface device 1 can also vary uniformly, where the thicker bottom layer area serves as the support area and the thinner upper area is the thin area (as Figure 12 shown).

[0105] Embodiment 2

[0106] This embodiment provides a patient interface device 1 that seals with the user's nasal airway. Refer to as Figure 17-18。This embodiment provides a three-dimensional schematic diagram of the patient interface device 1. In Figure 17-18 In the embodiment of the present invention shown, the difference from the patient interface device 1 in the first embodiment is that: the sealing formation structure 3 of the patient interface device 1 is arranged to seal the area from the tip of the user's nose to the upper lip, and both its front cavity part 2 and the sealing formation structure 3 have forms different from those in the first embodiment. When in use, it is configured to non-invasively surround the patient including at least the tip of the nose and the areas of the first nostril and the second nostril and abut against the surface around the nostrils. Since there are always differences in the size and height of the noses of different people, the patient interface device 1 in this embodiment only needs to satisfy that the size of the first opening surrounds the nasal airway of the patient, solving the problem of air leakage caused by the inability to perfectly fit 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, and improves the comfort of use for the patient.

[0107] In another embodiment, the front cavity part 2 of the patient interface device 1 is made of a rigid material, and the sealing formation structure 3 is configured to non-invasively surround the user excluding the tip of the nose area (as Figure 18 shown).

[0108] Embodiment 3

[0109] This embodiment provides a patient interface device 1 for sealing with the nasal airway of a user, with reference to Figure 19 。This embodiment provides a gas flow path diagram of the gas discharged from the ventilation component 4 and a three-dimensional schematic diagram of the patient interface device 1. In Figure 8 、 Figure 19 In the embodiment of the present invention shown, the difference from the patient interface device 1 in the first embodiment is that: in the ventilation component 4 of the patient interface device 1 in this embodiment, the ventilation component main body 41 and the noise reduction material 42 form a seamless and inseparable connection. The noise reduction material 42 has at least one of the following characteristics: 1. The noise reduction material 42 is one of foam and granular materials (such as polyurethane foam, foam metal); 2. The thickness of the noise reduction material 42 is in the range of 0.5 - 7 mm; 3. The surface area of one side of the noise reduction material 42 is at least 50 mm 2, the patient interface device 1 may have different noise reduction materials 42 sized and fitted to engage and form a connection with one end of the ventilation component body 41 away from the port cover 43. The noise reduction materials 42 can be fixed to the ventilation component body 41 by injection molding, ultrasonic pressing, hot pressing, etc., or by pasting with adhesives such as glue, tape, etc., or by snap-fitting, knobs, clips, etc., or can be assisted in connection by a third component (ties, clips), ultimately forming an inseparable whole. The various ways of connecting the multiple noise reduction materials 42 to the ventilation component body 41 to form different ventilation components 4 provide users with more diverse choices, and users can choose a more suitable ventilation component 4 to facilitate the persistence of sleep disorders.

[0110] Embodiment 4

[0111] This embodiment provides a patient interface device 1 that seals with the nasal airway of the user. Refer to Figure 20 . This embodiment provides a three-dimensional schematic diagram of the patient interface device 1. In Figure 20 the embodiment of the present invention shown, the difference from the patient interface device 1 in Embodiment 1 is that the ventilation component 4 of the patient interface device 1 does not have a port cover 43. In the ventilation component 4 designed in the present invention, the noise reduction material 42 and the ventilation component body 41 are integrally formed and inseparably connected, rather than being placed in the middle of the ventilation component 4. Therefore, the presence or absence of the port cover 43 will not cause the noise reduction material 42 to fall due to no obstruction and affect the use of the patient interface device 1. Moreover, the noise reduction effect of the ventilation component 4 is mainly achieved by the noise reduction material 42 rather than the port cover 43. The absence of the port cover 43 will not affect the noise reduction effect in a large range. In the case of no port cover 43, the airflow in the front cavity part 2 will still pass through the noise reduction material 42 to disperse the airflow, thereby achieving the noise reduction effect. The process of the user exhaling waste gas is still that the waste gas exhaled by the user first passes through the sealing structure 3 and is discharged to the external environment along an almost straight line through the ventilation component 4. Specifically, the waste gas first passes through the noise reduction material 42 in the ventilation component 4 to disperse and reduce the noise of the airflow, and then passes through the chamber between the noise reduction material 42 and the opening at one end of the ventilation component body 41 to gradually slow down the turbulent airflow and then directly discharge it to the external environment.

[0112] Embodiment 5

[0113] This embodiment provides a patient interface device 1 that seals with the nasal airway of the user. Refer to Figure 21 . This embodiment provides a three-dimensional schematic diagram of the patient interface device 1. In Figure 21In the embodiment of the present invention shown, the difference from the patient interface device 1 in the first embodiment is that the port cover 43 of the ventilation component 4 of the patient interface device 1 is provided and configured as a semi-detachable flip structure. The invention shown in this embodiment enables the user to select the port cover 43 and its connection method design according to their preference. Different port covers 43 and connection methods have different advantages and disadvantages. The semi-detachable flip design is more convenient for the user to clean and dry the noise reduction material 42 and the internal details of the ventilation component 4 compared to the sealed port cover 43 design. Although it is not as convenient as the fully detachable port cover 43 for cleaning, it is not easy to fall off compared to the fully detachable port cover 43. Since the fully detachable port cover 43 needs to be removed for each cleaning, and the port cover 43 is small in volume and not easy to be found, the ventilation component 4 is designed as a semi-detachable flip port cover 43 to avoid this problem. This semi-detachable flip port cover 43 design also provides multiple selectable types for users.

[0114] The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above 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.

[0115] The patient interface device 1 implementing the present invention has at least the following beneficial effects:

[0116] 1) Optimized the existing design, not easily leaking air and providing a more comfortable use. The patient interface device 1 of the publicly disclosed technology inventions in the existing market has a double-layer wall for the sealing formation structure 3 in order to make the gas enter the nasal airway of the user in a sealed manner and ensure the stability of the formed shape. However, the use of the double-layer wall also brings many problems to the user. For example, when the patient interface device 1 contacts the nasal airway of the user, it is easy to cause discomfort and affect the subsequent treatment of the user. Moreover, the double-layer wall relatively reduces the size of the opening at the gas outlet end of the patient interface device 1, making it easy for the user to inhale less required air flow. In addition, the double-layer wall is prone to dirt and scale, which also has an adverse impact on the health of the user. In the market, a patient interface device 1 in the form of a small nasal mask similar to a face mask has been introduced, which seals the area from the user's nose bridge to the upper lip. However, it still has the disadvantages of being relatively large in size, heavy, and prone to displacement during wearing, resulting in non-sealing. The present invention has noticed these pain points and improved the existing patient interface device 1 in view of the disadvantages of the existing sealing formation structure 3 of the patient interface device 1. a. In order to provide a more comfortable use experience for the user, the present invention changes the double-layer wall of the existing sealing formation structure 3 to a single-layer wall. However, to ensure the sealing of the gas and the stability of the sealing formation structure 3, through experimental testing, the opening size of the gas outlet end 32 where the gas flows out of the patient interface device 1 is enlarged, its wall thickness is modified to be a non-uniform wall thickness, and the sealing formation structure 3 is adjusted to a symmetrical form. The above adjustments not only ensure the sealing performance of the patient interface device 1, but also solve the drawbacks of the existing patient interface device 1 and bring many advantages. For example, the single-layer wall has less impact on the user, reducing the discomfort or foreign body sensation that the user may feel inside the nostrils, improving the comfort of use for the user, reducing the situation of treatment interruption or the user not following the treatment plan due to the discomfort of the user. Moreover, the single-layer wall is relatively lighter, making the pressure of the patient interface device 1 on the user's face smaller and the wearing more comfortable. Since there is no gap reserved between the double-layer wall thicknesses, the enlargement of the opening of the gas outlet end 32 enables the user to breathe more smoothly, and the user will not feel that the air flow is too small. To ensure that the single-layer structure has the same stability as the double-layer structure, the non-uniform wall thickness of the sealing formation structure 3 also makes the relatively soft wall more comfortable when contacting the user. The advantage of its symmetrical form is that when the air outlet port of the sealing formation structure 3 enters the inside of the user's nostril, the structure around the nostril is squeezed with the same thickness in a 360° manner, making the pressure on the surrounding of the nostril more uniform, and the user will feel more comfortable during the use process, improving the compliance of the user with the treatment process.b. One form of the sealing structure 3 of the patient interface device 1 seals the area from the tip of the user's nose to the upper lip with the same structure. It only needs to meet the requirement that the size of the first opening surrounds the user's nasal airway. And a spring structure is provided at the contact point of the first opening that outputs continuous positive pressure air flow with the tip of the nose, which helps to adjust according to the differences of different users' noses. Therefore, it can match the nostril sizes of almost all users and is less likely to leak air. Moreover, compared with the existing invasive nasal mask, the patient interface device 1 does not enter the inside of the user's nostrils, thus reducing the sensory interference to the user and being more suitable for most people to use. Especially for those who are not used to wearing sleep apnea components, it makes it easier for such people to adapt to wearing the treatment device components. And compared with the existing small nasal mask with a similar mask shape, the patient interface device 1 reduces the volume, making it easier for the user to wear and easier to adjust when the nasal mask is displaced. To a certain extent, it reduces the risk of gas leakage, which is beneficial for the user to carry and store when traveling, facilitating the realization of the continuity of treatment.

[0117] 2) Design an innovative noise reduction method. The ventilation component 4 designed in the present invention innovatively adheres the noise reduction material 42 closely to the opening of the ventilation component 4 to disperse the air flow. And the designed distance between the noise reduction material 42 and the port cover 43 makes the air flow flow out more smoothly to the outside. In the existing patient interface device 1 on the market, the way of using the noise reduction material 42 is to place a piece of noise reduction cotton between the two ends of the ventilation component 4. Although the air flow is dispersed by the noise reduction cotton, due to the relatively small gap between the noise reduction cotton and the two ends, the air flow is relatively turbulent at both the inlet and outlet ends of the ventilation component 4, which is not conducive to the user's use. And the way of designing the noise reduction cotton between the two ends of the ventilation component 4 and being non-detachable is very inconvenient for the user to clean. The present invention innovatively includes the noise reduction material 42, such as a noise reduction net, at the inlet end where the gas enters the ventilation component 4, so that there is a certain distance gap between the noise reduction material 42 and the second end of the ventilation component 4, that is, the port cover 43. When the air flow flows from the front cavity part 2 through the ventilation component 4 to the outside, the air flow is first dispersed by the noise reduction material 42, and then the dispersed turbulent air flow is changed into a relatively smooth air flow through the gap between the noise reduction material 42 and the port cover 43, and then flows out to the outside through the gap between the port cover 43 and the ventilation component 4. This process is relatively more obvious in noise reduction for the patient interface device 1 and makes the air flow flow to the user in a non-frontal direction, reducing the possibility of the air flow blowing onto the user's face. In summary, the ventilation component 4 of the present invention is superior to the ventilation component 4 of the existing user interface in many aspects.

[0118] 3) Modular design increases the user's choice range. The present invention modularizes the ventilation component 4. Compared with the existing design, the ventilation component 4 of the present invention can replace the port cover 43 and the noise reduction material 42. Users can replace the appropriate noise reduction material 42 and the port cover 43 of an easy-to-use type according to their own preferences and needs to adapt to the ventilation component body 41. This method provides users with diverse choices. a. The port cover 43 of the ventilation component 4 designed by the present invention is detachably connected to the ventilation component 4. Moreover, the noise reduction material 42 and the ventilation component body 41 are integrally and inseparably connected instead of being placed in the middle of the ventilation component 4. Therefore, the setting of the port cover 43 or not will not cause the noise reduction material 42 to fall due to no obstruction, and will not affect the noise reduction effect in a large range. The main function of the port cover 43 of the present invention is to leave a certain gap between the port cover 43 and the noise reduction material 42 so that the turbulent air flow passing through the noise reduction material 42 becomes gentle and flows out to the outside. However, in the case where the port cover 43 is not provided, the air flow in the front cavity part 2 will still pass through the noise reduction material 42 to disperse the air flow so as to achieve the noise reduction effect. Although the case of setting the port cover 43 has certain advantages, the port cover 43 is not the main component providing the noise reduction effect. Therefore, users can choose to use or not use the port cover 43, and noise reduction can be achieved, providing a way for users not to use the noise reduction material 42 under their own acceptance. b. In the case of using the port cover 43, the detachable port cover 43 also enables users to choose the port cover 43 they like and its connection method design. There are designs such as a fully detachable port cover 43 or a flip-type port cover 43. Different port covers 43 and connection methods have different advantages and disadvantages. Users can choose the fully detachable port cover 43 to facilitate a detailed cleaning of the inside of the ventilation component 4, or choose the flip-type port cover 43 which is more convenient for users to buckle and is not easy to fall off, and the situation of losing the port cover 43 will not occur. Both types of port covers 43 are more conducive to the cleaning and drying of the noise reduction material 42 compared with the closed port cover 43. c. The present invention also designs the noise reduction material 42 to be replaceable. Since the noise reduction material 42 and the ventilation component body 41 are inseparable, the opening end of the ventilation component 4 is provided with a detachable port cover 43. The ventilation component 4 composed of only two parts is more convenient for modular design of the ventilation component 4. Therefore, this design can be connected to the noise reduction material 42 and the ventilation component body 41 not only for one type or ventilation port form. Users can choose the ventilation component 4 with different types or ventilation port forms of the noise reduction material 42 to meet the different ventilation needs of users. This method makes the entire patient interface device 1 product more flexible. The replaceable module can adapt to the different needs and preferences of users, reducing the complexity of the ventilation component 4.

[0119] 4) The present invention makes cleaning more thorough and hygienic. Because the product will directly contact the user's face and communicate with the user's airway, maintaining the hygiene of the respiratory tract is crucial to the user's health and can effectively reduce the risk of infection through ingestion. a. The port cover 43 at the air outlet of the patient interface device 1 currently on the market is usually an inseparable whole formed with the ventilation component 4. Placing the noise reduction material 42 inside the ventilation component 4 on the inner side of the port cover 43 is very inconvenient for the user to clean the ventilation component 4. When the user cleans the internal noise reduction material 42, i.e., the noise reduction cotton, or the noise reduction cotton has accumulated moisture after being used for a long time, due to the indivisibility of the port cover 43, the ventilation component 4 has only a small gap for drying the noise reduction cotton, which can easily cause incomplete drying and the breeding of bacteria. The present invention designs the port cover 43 to be detachable, which can be opened by opening the port cover 43. The port cover 43 can be opened to directly clean the noise reduction material 42, making the cleaning more thorough and clean. The port cover 43 can also be opened for drying and ventilation. Compared with existing products, it has higher hygiene standards and can effectively reduce the risk of infection by ingestion. The ventilation component 4 of the present invention has two layers, namely one end of the noise reduction material 42 and one end of the port cover 43 and a chamber in the middle for smoothing the airflow. Compared with the market design in which the noise reduction material 42 is set in the middle of the ventilation component 4 and has a three-layer form, this design is more concise as a whole, and it is convenient to clean and disinfect the ventilation component 4 as a whole and in details without the existence of narrow gaps that cannot be cleaned. b. In addition, the noise reduction material 42 used in the present invention can be a noise reduction net. The noise reduction cotton used in the existing market is difficult to clean and dry because the port cover 43 cannot be opened, and it is easy to absorb exhaled moisture, thereby causing bacteria and mold to grow. However, the noise reduction net material does not have the above problems. It does not absorb moisture and can open the port cover 43 and use a brush to repeatedly brush it, making the product ventilation component 4 more durable. The noise reduction net used in the present invention can withstand repeated cleaning without being easily damaged, which provides more protection for the health of users. c. The double-layer wall of the existing technology on the market is easy to hide dirt and is not easy to clean. Over time, users are easily infected by bacteria and other microorganisms and have the risk of illness. The present invention, through the above-mentioned improvement on the product foundation, changes the sealing forming structure 3 from the double-layer wall on the market to a single-layer wall structure, which not only has advantages in use, but also has a simpler structure in terms of cleaning compared to the multi-layer wall. Users can clean more easily, and there will be no internal slits or areas that are difficult for cleaning tools to reach in the multi-layer wall, making cleaning faster and more effective.

[0120] 5) The number of processes is reduced, the cost is lower, the defective rate is decreased, and it is environmentally friendly. The patient interface device 1 designed in the present invention has differences from the prior art products in both the sealing formation part and the ventilation component 4 part. With the innovative improvement of the present invention, in addition to the above advantages, the product also reduces the production processes, the production cost and the defective rate of the product, and through the improvement of the technology, the material usage of the product is reduced, which also has a beneficial impact on the environment. a. Through the above improvement of the product technology, the sealing formation structure 3 of the present invention changes from a double-layer wall in the market to a single-layer wall structure, which is cheaper to manufacture than a multi-layer wall. Because a multi-layer wall requires more materials and relatively more complex production processes and die costs, the production process of the single-layer wall becomes more economical and efficient. This method also saves the raw materials used to manufacture the user interface, and saving the material usage means reducing the demand for materials such as plastics, polyesters, and silicones, which can lead to less carbon emissions. Continuously adopting this green design approach will have a positive impact on a larger scale and further promote the process of carbon neutrality. b. The present invention integrally forms the noise reduction material 42 with the first opening where the air flow flows from the front cavity part 2 into the ventilation component main body 41, rather than the form in which the components and the noise reduction material 42 are separately produced and assembled in the existing patient interface devices in the market. This simplifies the production process. Using the method of manufacturing a whole product without assembly will be faster than the manufacturing and assembly steps of the existing products. Therefore, the production time, labor cost, production processes and equipment requirements are reduced. The integrally formed connection form also improves the structural strength of the ventilation component 4 to a certain extent. Since the components are manufactured and connected in one operation, the possibility of assembly errors is reduced. This method improves the product quality and reliability, makes the product more durable, and further realizes the environmentally friendly design.

[0121] 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. All of these are within the protection scope of the invention.

Claims

1. A patient interface device for sealingly delivering continuous positive airway pressure gas to a user's nasal airway to treat sleep disordered breathing, the patient interface device comprising: The front cavity part has a main cavity formed by a continuous wall and inlet ends of the front cavity part located on both sides. The main cavity bends towards the side close to the user's face to form a cavity with a certain curvature and a non-user-contact structure. The sealing formation structure has a single-layer wall and is configured as two shaped protrusions that communicate with the main cavity of the front cavity part. During use, at least a part of it contacts at least a part of the user's nose, allowing gas to enter at least one inlet inside the nostril through the outlet end to complete the delivery of pressurized gas and seal the user's nasal airway. The two shaped protrusions are symmetrical to each other. There is at least one opening on the front cavity part, and a ventilation component is located on one opening of the front cavity part. The ventilation component includes: Noise reduction material and a ventilation component body with two ends. The noise reduction material and one end of the ventilation component body form an inseparable whole. There is a gapless connection between the noise reduction material and the body. When the airflow discharges from the front cavity part, it is first divided into small airflows by the noise reduction material and then flows out to the outside through the opening of the ventilation component body away from the noise reduction material. The positioning and stabilizing structure is arranged and configured to provide connections with components at both ends of the front cavity part to fix the patient interface device to the user's face.

2. The patient interface device according to claim 1, wherein, The ventilation component has a port cover connected to the opening of the ventilation component body away from the noise reduction material. The dispersed airflow of the ventilation component flows out to the outside through the gap between the periphery of the port cover and the opening of the ventilation component.

3. The patient interface device according to claim 1, wherein, The noise reduction material and the ventilation component body are made of the same or different materials.

4. The patient interface device according to claim 1, wherein, The two protrusions are symmetrical by themselves.

5. The patient interface device according to claim 1, wherein, The sealing formation structure has a non-uniform wall thickness.

6. A patient interface device for sealingly delivering continuous positive airway pressure gas to a user's nasal airway to treat sleep disordered breathing, the patient interface device comprising: The front cavity part has a main cavity formed by a continuous wall and inlet ends of the front cavity part located on both sides. The main cavity bends towards the side close to the user's face to form a cavity with a certain curvature and a non-user-contact structure. The sealing formation structure is configured to communicate with the main cavity of the front cavity part. During use, at least a part of it contacts at least a part of the user's nose, allowing gas to enter at least one inlet inside the nostril through the outlet end to complete the delivery of pressurized gas and seal the user's nasal airway. There is at least one opening on the front cavity part, and a ventilation component is located on one opening of the front cavity part. The ventilation component includes: Noise reduction material, a ventilation component body with two ends, and a port cover. The noise reduction material and one end of the ventilation component body are integrally formed into an inseparable whole. The port cover is arranged at the other end of the ventilation component body away from the noise reduction material. When the airflow discharges from the front cavity part, it first disperses the airflow through the pores of the noise reduction material. Among them, there is a certain distance between the port cover and the noise reduction material, and this distance is configured to gather the airflow dispersed by the noise reduction material relatively gently and then discharge it to the outside to further reduce the generation of noise. Wherein, there is a gap with a certain distance between the periphery of the port cover and the opening of the ventilation component, which is configured and arranged to guide the airflow direction through the noise reduction material and facilitate disassembly. The presence of the port cover makes the inlet and outlet structures of the ventilation component different; A positioning and stabilizing structure, which is provided and configured to provide connections with components at both ends of the front cavity part to fix the patient interface device to the user's face.

7. The patient interface device according to claim 6, wherein, The noise reduction material and the ventilation component body are made of the same or different materials.

8. The patient interface device according to claim 6, wherein, The positioning and stabilizing structure is harder than the wall of the front cavity part.

9. The patient interface device according to claim 6, wherein, The port cover and the ventilation component body are connected by a buckle.

10. A patient interface device for sealingly delivering continuous positive airway pressure gas to a user's nasal airway to treat sleep disordered breathing, the patient interface device comprising: A front cavity part, having a main cavity formed by a continuous wall and inlet ends of the front cavity part on both sides, and the main cavity bends towards the side close to the user's face to form a cavity with a certain arc and a non-user contact structure; A sealing and forming structure, which is configured to communicate with the main cavity of the front cavity part, and at least a part of it contacts at least a part of the user's nose during use and enables gas to enter at least one inlet inside the nostril through the outlet end to complete the delivery of pressurized gas and seal the user's nasal airway; There is at least one opening on the front cavity part, and the ventilation component is located on one opening of the front cavity part. The ventilation component includes: Noise reduction material and a ventilation component body with two ends. The noise reduction material and one end of the ventilation component body form an inseparable whole. There is no gap connection between the noise reduction material and the body. When the airflow discharges from the front cavity part, it is first divided into small airflows by the noise reduction material, and then flows out to the outside through the opening of the ventilation component body far from the noise reduction material; A positioning and stabilizing structure, which is provided and configured to provide connections with components at both ends of the front cavity part to fix the patient interface device to the user's face.

11. The patient interface device according to claim 10, wherein, The ventilation component has a port cover connected to the opening at the end of the ventilation component body far from the noise reduction material. The dispersed airflow of the ventilation component flows out to the outside through the gap between the periphery of the port cover and the opening of the ventilation component.

12. The patient interface device according to claim 10, wherein The ventilation component forms a detachable connection with respect to the opening of the front cavity part.

13. The patient interface device according to claim 10, wherein The positioning and stabilizing structure extends along the opening direction at the openings at both ends of the front cavity part without bending itself.

14. The patient interface device according to claim 10, wherein The sealing and forming structure has a tendency to converge towards a central point.

15. A patient interface device for sealingly delivering continuous positive airway pressure gas to a user's nasal airway to treat sleep disordered breathing, the patient interface device comprising: A front cavity part, having a main cavity formed by a continuous wall and inlet ends of the front cavity part on both sides, and the main cavity bends towards the side close to the user's face to form a cavity with a certain arc and a non-user contact structure; A sealing and forming structure, which is configured to communicate with the main cavity of the front cavity part, and at least a part of it contacts at least a part of the user's nose during use and enables gas to enter at least one inlet inside the nostril through the outlet end to complete the delivery of pressurized gas and seal the user's nasal airway; There is at least one opening on the front cavity part, and the ventilation component is located on one opening of the front cavity part. The ventilation component includes: A noise reduction material and a ventilation component body having two ends. The noise reduction material and one end of the ventilation component body form an inseparable whole. There is a gapless connection between the noise reduction material and the body. When the air flow discharges from the front cavity part, it is first divided into small air flows by the noise reduction material, and then flows out to the outside through the opening of the ventilation component body away from the noise reduction material; A positioning and stabilizing structure, which is arranged and configured to provide connections with components at both ends of the front cavity part to fix the patient interface device to the user's face; Wherein the ratio of the opening area of the front cavity part for installing the ventilation component to the outer wall area of the front cavity part is at least 1:9, and the ratio of the opening area of the front cavity part to the area of the noise reduction material is at least 5:1; Wherein the noise reduction material has at least one of the following characteristics: The noise reduction material is a fiber material; The thickness of the noise reduction material is in the range of 0.2 - 5 mm; The surface area of one side of the noise reduction material is at least 50 mm 2 .

16. The patient interface device according to claim 15, wherein The ventilation component has a port cover connected to the opening at the end of the ventilation component body away from the noise reduction material. The dispersed air flow of the ventilation component flows out to the outside through the gap between the periphery of the port cover and the opening of the ventilation component; 17. The patient interface device according to claim 15, wherein The periphery of the ventilation component has a clamping structure for connecting with the front cavity part; 18. The patient interface device according to claim 15, wherein The shape of the noise reduction material is similar to the shape of the opening of the ventilation component body where it is connected to the noise reduction material; 19. The patient interface device according to claim 16, wherein The opening of the ventilation component body connected to the noise reduction material is not larger than the opening of the ventilation component connected to the port cover; 20. A patient interface device for sealingly delivering continuous positive airway pressure gas to a user's nasal airway to treat sleep disordered breathing, the patient interface device comprising: The front cavity part has a main chamber formed by a continuous wall and the inlet ends of the front cavity part on both sides. The main chamber bends towards the side close to the user's face to form a chamber with a certain arc and a non-user contact structure; A sealing and forming structure, having a single-layer wall, which is configured as two shaped protrusions and communicates with the main chamber of the front cavity part. During use, at least a part contacts at least a part of the user's nose and enables the gas outlet end to enter at least one inlet inside the nostril to complete the delivery of pressurized gas and seal the user's nasal airway, and the two shaped protrusions are symmetric to each other; There is at least one opening on the front cavity part. The ventilation component is located on one opening of the front cavity part. The ventilation component includes: A noise reduction material and a ventilation component body having two ends. The noise reduction material and one end of the ventilation component body form an inseparable whole. There is a gapless connection between the noise reduction material and the body. When the air flow discharges from the front cavity part, it is first divided into small air flows by the noise reduction material, and then flows out to the outside through the opening of the ventilation component body away from the noise reduction material; A positioning and stabilizing structure, which is arranged and configured to provide connections with components at both ends of the front cavity part to fix the patient interface device to the user's face; Wherein the ratio of the opening area of the front cavity part for installing the ventilation component to the outer wall area of the front cavity part is at least 1:9, and the ratio of the opening area of the front cavity part to the area of the noise reduction material is at least 5:1; Wherein the noise reduction material has at least one of the following characteristics: The noise reduction material is one of foam materials and granular materials; The thickness of the noise reduction material is in the range of 0.5 - 7 mm; The surface area of one side of the noise reduction material is at least 50 mm 2 .

21. The patient interface device according to claim 20, wherein, The ventilation component has a port cover connected to an opening at one end of the ventilation component body away from the noise reduction material, and the dispersed airflow of the ventilation component flows out to the outside through a gap between the periphery of the port cover and the opening of the ventilation component.

22. The patient interface device according to claim 20, wherein, Among them, any mutually parallel cross-sections are taken in the main body chamber, and the cross-sections are the same or different.

23. The patient interface device according to claim 20, wherein, Among them, the protrusion of the sealing formation structure is formed by normal extension from a certain position in the front chamber part.

24. The patient interface device according to claim 20, wherein, The distances from the centers of the two gas outlets where the sealing formation structure contacts the patient's face to the center of the noise reduction material are equal.

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