Patient interface

Abstract

A patient interface includes a cushion assembly, a headgear assembly, an elbow assembly, a transition ring structure, and a headgear fixation assembly. The cushion assembly, the elbow assembly, and the headgear fixation assembly are assembled together by the transition ring structure. The cushion assembly forms a seal with a patient's face in use. The headgear fixation assembly is for the headgear assembly to connect to in order to secure the patient interface to the patient's face in use. A cylindrical wall for delivering a flow of air is provided on the cushion assembly, which projects in two opposite directions along an axis of its opening in order to create a split flow guidance effect on the flow of air in the breathing cavity. In this way, the patient interface can be comfortably and conveniently worn and used.

Description

[Technical Field]

[0001] This invention relates to a patient interface, and more specifically, to a patient interface for a continuous positive airway pressure (CPAP) ventilator. [Background Technology]

[0002] A continuous positive pressure ventilator is a device used to treat obstructive sleep apnea (OSA). It uses a patient interface that covers the user's nose, or simultaneously the patient's mouth and nose, to continuously supply air or other breathable gases to the patient and maintain a continuous positive pressure to open the patient's obstructed airway, maintain airway patency, and thus achieve the purpose of treating obstructive sleep apnea.

[0003] During use, the breathing gas is generated by a fluid generator, delivered to the patient interface via a delivery tube, and then supplied to the patient. The patient's exhaled air is also expelled through the patient interface. The patient interface contains both the airflow from the fluid generator and the patient's exhaled air, and must also provide exhaust functionality for the exhaled air. Therefore, airflow turbulence is prone to occur within the patient interface, which not only easily generates noise but also makes it difficult for carbon dioxide in the patient's exhaled air to be expelled smoothly. [Summary of the Invention]

[0004] One of the objectives of this invention is to enable patients using continuous positive pressure ventilators or users of other breathing air supply devices to wear and use them comfortably and conveniently through a patient interface.

[0005] Another objective of this invention is to reduce the noise level generated by airflow when the patient wears the patient interface and uses a continuous positive pressure ventilator, thereby further improving comfort.

[0006] To achieve the above and other objectives, the present invention provides a patient interface for delivering an airflow within a therapeutic pressure range of 2-30 cm H2O generated by an airflow generator at a continuously positive pressure relative to ambient air pressure to a patient's airway. The patient interface comprises: a cushion assembly, a headband assembly, a frame assembly, and an elbow tube assembly. The cushion assembly includes: a shield, a cylindrical wall, and a soft seal. The shield has an opening constructed at a first end of the cushion assembly and an annular structure projecting from the opening toward the first end of the cushion assembly in one direction. The cylindrical wall is provided at the opening by a plurality of support structures concentric with the opening, wherein the cylindrical wall projects in two opposite directions along the axis of the opening. The soft seal is provided at the shield of the cushion assembly to form a breathing cavity together, and the soft seal is adapted to airtightly abut against at least a portion of the patient's face. The frame assembly is adapted to engage with the cushion assembly, and the frame assembly includes a plurality of slots adapted to attach to corresponding plurality of bands during use, wherein the frame assembly does not have forehead support. The elbow tube assembly is adapted to connect to an air delivery tube connected to a fluid generator to deliver airflow to a patient's airway during use, wherein the elbow tube assembly is non-removably disposed within the frame assembly. Furthermore, the frame assembly and the pad assembly are rotatable when attached.

[0007] According to one embodiment of the present invention, a cushion assembly includes: a hollow structure, a cylindrical wall, and a sealing assembly. The hollow structure may have a central opening configured at a first end of the cushion assembly to deliver airflow in use, and a convex ring structure projecting from the central opening toward the first end of the cushion assembly in one direction. The cylindrical wall is disposed at the central opening, the cylindrical wall being configured as a circle substantially concentric with the central opening, wherein the cylindrical wall projects toward the first end of the cushion assembly by a first distance with the same diameter, and the cylindrical wall projects toward a second end of the cushion assembly opposite to the first end by a second distance with a different diameter, the first distance being longer than the second distance. The sealing assembly is disposed at the hollow structure of the cushion assembly to form a breathing cavity together, the sealing assembly being adapted to seal the patient's face in response to a patient wearing the cushion and to prevent the hollow structure from contacting the patient's face.

[0008] According to one embodiment of the present invention, the frame assembly includes a transition ring structure and a headband fixation assembly. The transition ring structure is rigidly connected to the pad assembly and has one end for mounting an elbow tube assembly and allowing the elbow tube assembly to rotate 360 ​​degrees. The headband fixation assembly is adapted to engage the transition ring structure and has a central opening for receiving the elbow tube assembly. The headband fixation assembly includes a pair of headband clip attachment portions adapted to engage with a corresponding pair of headband clips to attach to a corresponding lower band body. The headband fixation assembly includes a pair of upper openings adapted to attach to a corresponding upper band body to secure the headband assembly to the patient's head during use. The headband fixation assembly does not have forehead support.

[0009] According to one embodiment of the present invention, the pad assembly includes a hollow structure and a cylindrical wall. It further includes a sealing forming component configured to form a seal with the patient's nose and / or mouth. Furthermore, the sealing forming component, together with the hollow structure, forms an inflatable chamber pressurizable to the therapeutic pressure. A first support region and a second support region of the sealing forming component jointly prevent the hollow structure from contacting the patient's face. The thickness of the first support region is substantially greater than the thickness of the second support region, and the thickness of the first support region gradually decreases towards the second support region. A boundary is formed between the first support region and the second support region on the sealing forming component, and the thickness of the sealing forming component at the boundary is substantially constant.

[0010] According to an embodiment of the present invention, a headband assembly includes a plurality of upper bands, a plurality of lower bands, and a rear band assembly. The plurality of upper bands are configured to extend above the patient's ears during use. The plurality of lower bands are configured to extend below the patient's ears during use. The rear band assembly is configured to be disposed on the plurality of upper bands and the plurality of lower bands. The rear band assembly includes a top, a plurality of sides, and a bottom, wherein the top is disposed between the plurality of sides, the bottom is disposed between the plurality of sides and the plurality of lower bands, and the plurality of upper bands are disposed on corresponding sides. A first band distance between the intersection point of each side and the top may be less than a second band distance between the intersection point of each side and the bottom, but the first band distance may be greater than a third band distance between the intersection point of each side and each upper band.

[0011] According to an embodiment of the present invention, an elbow tube assembly is disposed on a transition ring structure and is rotatable 360 ​​degrees. The elbow tube assembly includes: a first end, a second end, and a body. The first end has a curved peripheral structure. The second end is adapted to be disposed on an air delivery tube connected to a fluid generator to deliver airflow to a patient's airway during use. The curved peripheral structure of the first end and at least a portion of the transition ring structure together form an air passage in a non-releasable manner during use, wherein most of the intake airflow delivered from the fluid generator to the breathing chamber passes through the air passage of the duct and the inner surface of the cylindrical wall of the cushion assembly, respectively; and most of the outflow airflow discharged from the breathing chamber to the surrounding environment passes through the space between the outer surface of the cylindrical wall of the cushion assembly and the inner surface of the convex ring structure, and the curved peripheral structure of the first end and at least a portion of the transition ring structure are used to form the air passage during use.

[0012] According to one embodiment of the present invention, the transition ring structure (or connecting ring structure) and the pad assembly can be configured to be attached to each other in a manner that does not impede movement.

[0013] According to one embodiment of the present invention, the hollow structure (or shielding component) and the sealing component (or sealing forming component, soft seal) can be integrated.

[0014] According to one embodiment of the present invention, any part of the seal forming component (or soft seal, sealing component) may not include a double-layer structure.

[0015] According to one embodiment of the present invention, the pad assembly, elbow tube assembly and headband fixing assembly may not have direct physical contact / engagement during use.

[0016] Accordingly, each embodiment achieves a good synergistic effect, allowing the patient interface to be comfortably and stably fixed on the patient's face, and effectively reducing the level of noise. [Attached Image Description]

[0017] Figure 1 This is a perspective view of a patient interface according to an embodiment of the present invention;

[0018] Figure 2 A three-dimensional schematic diagram of a patient interface worn on a patient's head according to an embodiment of the present invention;

[0019] Figure 3 A perspective view of a frame assembly joined to a pad assembly according to an embodiment of the present invention;

[0020] Figure 4 for Figure 3 A three-dimensional schematic diagram of the frame components from another perspective;

[0021] Figure 5 A perspective view of a frame assembly joined to a pad assembly according to another embodiment of the present invention;

[0022] Figure 6 This is a perspective view of a gasket assembly disposed on a sealing forming assembly according to an embodiment of the present invention;

[0023] Figure 7 This is a front view of a sealing forming assembly according to an embodiment of the present invention;

[0024] Figure 8 for Figure 7 A schematic diagram of a cross-section below the AA section line;

[0025] Figure 9 for Figure 7 A cross-sectional diagram below the BB section line;

[0026] Figure 10 for Figure 7 A schematic diagram of a cross-section below the CC section line;

[0027] Figure 11 This is a perspective view of the pad assembly in an exploded state according to another embodiment of the present invention;

[0028] Figure 12 for Figure 11 A cross-sectional schematic diagram of the pad assembly in its assembled state;

[0029] Figure 13 This is a perspective view of a pad assembly according to another embodiment of the present invention;

[0030] Figure 14 for Figure 13 A cross-sectional schematic diagram of the cushion assembly;

[0031] Figure 15 This is a cross-sectional schematic diagram of a pad assembly according to another embodiment of the present invention;

[0032] Figure 16 This is a perspective view of a headband assembly according to an embodiment of the present invention;

[0033] Figure 17 for Figure 16 A diagram illustrating the headband assembly being worn on the patient's head;

[0034] Figure 18 This is a perspective view of a headband assembly according to another embodiment of the present invention;

[0035] Figure 19 This is a three-dimensional schematic diagram of the elbow tube assembly and transition ring structure in an exploded state according to an embodiment of the present invention.

[0036] Figure 20 for Figure 19 A cross-sectional schematic diagram of the elbow tube assembly and transition ring structure in the combined state.

[0037] Figure 21 for Figure 19 A three-dimensional schematic diagram of the elbow tube assembly and transition ring structure in their combined state and from another perspective;

[0038] Figure 22 This is a cross-sectional schematic diagram of the patient interface according to another embodiment of the present invention;

[0039] Figure 23 for Figure 22 A three-dimensional diagram of the patient interface from another perspective;

[0040] Figure 24 This is a perspective view of a headband fixing assembly according to another embodiment of the present invention;

[0041] Figure 25 This is a perspective view of a patient interface according to another embodiment of the present invention;

[0042] Figure 26 This is a three-dimensional schematic diagram of a connecting ring structure according to an embodiment of the present invention;

[0043] Figure 27 for Figure 26 A cross-sectional schematic diagram of the connecting ring structure in use;

[0044] Figure 28 for Figure 26 A three-dimensional schematic diagram of the connecting ring structure in use;

[0045] Figure 29 This is a cross-sectional schematic diagram of the cylindrical wall of a pad assembly according to an embodiment of the present invention;

[0046] Figure 30 This is a flow field analysis diagram according to an embodiment disclosed in the present invention;

[0047] Figure 31 This is a flow field analysis diagram according to another embodiment disclosed in the present invention;

[0048] Figure 32 This is a flow field analysis diagram under another embodiment disclosed in the present invention.

Detailed Implementation Methods

[0049] To fully understand the purpose, features, and effects of the present invention, the present invention will now be described in detail with reference to the following specific embodiments and accompanying drawings:

[0050] In this application, the terms "a" or "an" are used to describe units, components, structures, devices, modules, systems, parts, or regions, etc. This is used merely for ease of explanation and to provide a general meaning for the scope of the invention. Therefore, unless it is obvious otherwise, this description should be understood to include one or at least one, and the singular also includes the plural.

[0051] In this application, the terms "comprising," "including," "having," or any other similar terms used are not limited to the elements listed in this application, but may include other elements not expressly listed but which are typically inherent in the unit, component, structure, device, module, system, part, or region.

[0052] In this application, the ordinal terms such as "first" or "second" are used to distinguish or refer to elements, structures, parts, or regions that are related to the same or similar entities, and do not necessarily imply a spatial order of these elements, structures, parts, or regions. It should be understood that in certain situations or configurations, ordinal terms may be used interchangeably without affecting the implementation of the invention.

[0053] The patient interface disclosed in the following embodiments relates to the delivery of airflow generated by a fluid generator to the airway of a patient (or any other wearer), thereby constructing a treatment system. The fluid generator can be used to apply a therapeutic pressure to the patient's airway or its inlet, including, for example, at least the nasal inlet and / or oral inlet. The therapeutic pressure can be defined as a continuous positive pressure relative to the ambient air pressure, for example, a continuous positive pressure within the range of 2 cmH2O to 30 cmH2O. This therapeutic pressure can improve breathing difficulties such as sleep apnea.

[0054] 1. Overall patient interface and treatment system

[0055] Please refer to the following at the same time Figure 1 and Figure 2 , Figure 1 This is a perspective view of a patient interface according to an embodiment of the present invention. Figure 2 This is a three-dimensional schematic diagram of a patient interface worn on a patient's head according to an embodiment of the present invention. Figure 2 As shown, the patient interface in the treatment system is a fixed interface on the patient's head, which is used to deliver the airflow generated by the fluid generator to the patient's airway or the entrance of the patient's airway.

[0056] Regarding stability and comfort when worn by patients, this patient interface is designed so that even without forehead support, the various components can be stably fixed in the appropriate position on the patient's head, and a smooth flow field can be formed between the airflow delivered to the patient and the airflow exhaled by the patient, allowing the patient or wearer to receive positive pressure therapy in a stable and comfortable treatment environment.

[0057] like Figure 1 and Figure 2 In the illustrated embodiment, the patient interface 1 includes: a pad assembly 10, a headband assembly 20, a headband clip 30, an elbow tube assembly 40, and a frame assembly 50. The frame assembly 50, through adjustment of the headband assembly 20 during wear and the pad assembly 10 engaged with one end of the frame assembly 50, stably fixes the patient interface 1 to a suitable position on the patient's face. A breathing chamber is defined between the pad assembly 10 and the patient's face. The breathing chamber receives positive pressure airflow from the elbow tube assembly 40 for input into the patient's airway, while the elbow tube assembly 40 also receives the patient's exhaled airflow for output to the surrounding environment.

[0058] The other end of the frame assembly 50 is provided with an elbow tube assembly 40, allowing airflow from the self-flow generator (not shown) via the air delivery tube 60 to be guided by the elbow tube assembly 40, then flow through the frame assembly 50 and into the breathing chamber. The frame assembly 50, through direct and / or indirect attachment points to the headband assembly 20, allows the headband assembly 20 to be wrapped around a predetermined area of ​​the patient's head, avoiding unsuitable areas for restraint (e.g., the ears). Figure 1 and Figure 2 In the illustrated embodiment, the frame assembly 50 and part of the headband assembly 20 can be indirectly attached via the headband clip 30.

[0059] 2. Structure of headband fixing component / frame component

[0060] Please refer to Figure 3 and Figure 4 , Figure 3 This is a perspective view of a frame assembly joined to a pad assembly according to an embodiment of the present invention. Figure 4 for Figure 3 Another perspective view of the frame assembly shows a three-dimensional schematic diagram. Multiple slots 501 are included on the two opposite side edges of the frame assembly 50. These slots 501 can be used for direct and / or indirect attachment to the headband assembly 20. (The aforementioned...) Figure 1 and Figure 2The example illustrates attachment in two ways (direct and indirect). The two upper slots 501 of the frame assembly 50 provide direct attachment to the corresponding straps in the headband assembly 20, while the two lower slots 501 provide indirect attachment to the corresponding straps in the headband assembly 20 via a pair of headband clips 30. The indirect attachment method of the lower part of the frame assembly 50 further enhances patient or wearer comfort and ease of wearing or removing the headband. For example, the headband clips 30 are easier to operate for attachment to or removal from the slots 501, and the interchangeable headband clips 30 provide flexibility in matching, allowing for different attachment angles when the headband assembly 20 is attached to the frame assembly 50.

[0061] like Figure 3 and Figure 4 As shown, the pad assembly 10 includes a shield 101, a cylindrical wall 102, and a sealing assembly 103. The shield 101 has an opening constructed on a first end of the pad assembly 10, and an annular structure 1011 protruding in one direction toward the first end of the pad assembly 10 around the periphery of the opening. The cylindrical wall 102 is provided at the opening by a plurality of support structures 1021 and is concentric with the opening. The sealing assembly 103 is a softer component than the shield 101, and may also be referred to as a soft seal. The sealing assembly 103 is disposed on the shield 101. The combination of the sealing assembly 103 and the shield 101 forms a breathing cavity in the space defined between the sealing assembly 103 and the patient's face. The sealing assembly 103 is adapted to airtightly abut against at least a portion of the patient's face.

[0062] Furthermore, the upper edge of the annular structure 1011 of the pad assembly 10 may also be provided with a rotation limiting protrusion 1012, and correspondingly, a rotation limiting recess 503 is provided at the opening 502 of the frame assembly 50. The rotation limiting recess 503 is formed, for example, at the notch of the limiting wall 5031 to achieve a limiting function. The rotation limiting protrusion 1012 can be stopped by the rotation limiting recess 503, thereby achieving rotational capability but with limited extent. The limiting wall 5031 is constructed on the end of the frame assembly 50 facing the pad assembly 10, and the limiting wall 5031 is a wall structure that protrudes toward the pad assembly 10 in one direction.

[0063] Furthermore, an alignment guide 1013 may be provided on the shielding member 101, and a corresponding alignment indicator 504 may be provided on the frame assembly 50, providing guidance for the user when loading the pad assembly 10 onto the frame assembly 50. Simultaneously, based on the combination of the alignment guide 1013 and the alignment indicator 504, the relative displacement between the pad assembly 10 and the frame assembly 50 can also be indicated after loading, allowing the user or patient to interpret the information.

[0064] Please refer to Figure 5 This is a perspective view of a frame assembly according to another embodiment of the present invention. The frame assembly 50 includes a transition ring structure 510 and a headband fixing assembly 520. One end of the transition ring structure 510 is used to provide engagement with the pad assembly 10, and the other end is used to provide engagement with the headband fixing assembly 520. In one embodiment of this invention, the headband fixing assembly 520 and the pad assembly 10 can be engaged on the outer surfaces of the two end edges of the transition ring structure 510, so that there is no direct physical contact / engagement between the headband fixing assembly 520 and the pad assembly 10. In this embodiment, the transition ring structure 510 serves as a connection medium between the headband fixing assembly 520 and the pad assembly 10, and can also be considered as a connecting ring structure.

[0065] like Figure 5 As shown, the headband fixing assembly 520 has: a pair of upper openings 521, a pair of headband clip attachment portions 522, and a central opening 523. The central opening 523 is used to receive the elbow tube assembly 40, the pair of headband clip attachment portions 522 are used for attachment of corresponding headband clips 30, and the pair of upper openings 521 are used for attachment of the strap body of the corresponding headband assembly 20. In this embodiment, the elbow tube assembly 40 is fixed in the central opening 523 by engaging with the inner surface of the transition ring structure 510. The elbow tube assembly 40 may be further provided in a non-removable manner in the transition ring structure 510.

[0066] Furthermore, in one embodiment of this example, since the headband fixing assembly 520 and the pad assembly 10 are engaged on the outer surfaces of the two end edges of the transition ring structure 510, and the elbow tube assembly 40 is engaged on the inner surface of the transition ring structure 510, the pad assembly 10, the elbow tube assembly 40 and the headband assembly 520 do not have direct physical contact / engagement in the used state after engagement.

[0067] 3. Structure of the cushion assembly

[0068] Please refer to Figure 6 This is a perspective view of a pad assembly disposed on a sealing forming assembly according to an embodiment of the present invention. The pad assembly 10' is engaged with the sealing forming assembly 140 via a joint 143. The engagement method may be, for example, injection molding. The sealing forming assembly 140 is adapted to seal the patient's face in response to the patient's wearing, so that the pad assembly 10' and the sealing forming assembly 140 can together form an inflatable chamber pressurizable to therapeutic pressure on the patient's face.

[0069] like Figure 6As shown, the sealing forming assembly 140 includes a first support region 141 and a second support region 142. The first support region 141 is disposed on the end portion 104 of the second end of the pad assembly 10'. The end portion 104 is a joining portion for engaging (e.g., injection molding) with the first support region 141. The second support region 142 is disposed on the first support region 141, allowing the support region to extend to different degrees. A boundary 144 exists between the first support region 141 and the second support region 142, which is demarcated by the degree of thickness variation. Alternatively, the boundary between the first support region 141 and the end portion 104 can also be referred to as the first boundary, and the boundary between the first support region 141 and the second support region 142 can be referred to as the second boundary.

[0070] To improve patient comfort, no part of the sealing forming component 140 includes a double-layer structure, and the second support area 142 contacts at least the patient's nasal bridge area and / or chin area. Figure 6 In one embodiment, the first support region 141 and the second support region 142 can be used together to prevent specific portions of the pad assembly 10' from contacting the patient's face. The specific portion refers to the portion extending from end 104 of the pad assembly 10' in a direction opposite to the first end of the second end.

[0071] In one embodiment of this invention, the thickness of the first support region 141 is substantially greater than the thickness of the second support region 142, and the thickness of the first support region 141 gradually decreases and thins in the direction toward the second support region 142. Furthermore, the thickness at the boundary 144 of the dissimilar support regions formed on the sealing forming assembly 140 can be set to be substantially constant.

[0072] Please refer to Figures 7 to 10 , Figure 7 This is a front view of a sealing forming assembly according to an embodiment of the present invention. Figure 8 for Figure 7 A schematic diagram of a cross-section below section AA. Figure 9 for Figure 7 A cross-sectional diagram below the BB section line. Figure 10 for Figure 7 A cross-sectional diagram below the CC section line. Figures 7 to 10 This example illustrates a situation where the thickness of the sealing forming component 140 varies in different directions (the length of the variation). Figures 8 to 10 The component symbol 144 marked in the diagram (specifically indicated in the cross-sectional position) corresponds to the boundary between the aforementioned first support area 141 and second support area 142. Figure 8 The boundary 144 is closest to the joint 143. Figure 10 The position of the boundary 144 is next to that of the joint 143. Figure 9The boundary 144 is furthest from the joint 143. Figures 8 to 10 The element symbol 144 marked in the figure can be seen as the thickness of the sealing forming assembly 140 gradually thins from the joint 143 until it becomes substantially constant at the boundary 144.

[0073] Accordingly, the thickness within the first support region 141 varies, while the second support region 142 maintains approximately the same thickness. Furthermore, at the end of the second support region 142 in the direction away from the first support region 141, a thickened end edge 1421 can be configured for edging. Additionally, the positions of each point on the joint 143 of the sealing forming assembly 140 are each perpendicularly distanced from the boundary 144, wherein, among the formed perpendicular distances, the perpendicular distances of the sealing forming assembly 140 to the cheek and cheekbone area when used by the patient are all longer than the perpendicular distances of the sealing forming assembly 140 to the nose and chin area when used by the patient. Since the joint 143 and the boundary 144 have curved shapes, the vertical distance is, for example, the distance formed between all points of all line segments on the joint 143 and all points of all line segments on the boundary 144 along the surface of the sealing forming component 140 between these two tangent points, wherein the line connecting these two tangent points is perpendicular to the corresponding tangent segment on the joint 143 and the corresponding tangent segment on the boundary 144.

[0074] In other embodiments, a boundary 144 is defined at a position extending from the first support region 141 and gradually thinning to a predetermined thickness. When the predetermined thickness is selectable from any value between 0.50 and 0.70 (mm), it has a further positive effect on improving the wearer's comfort. Any value between 0.50 and 0.70 (mm) is, for example, any value of 0.5, 0.51, 0.52, 0.53, 0.54, 0.55, 0.56, 0.57, 0.58, 0.59, 0.6, 0.61, 0.62, 0.63, 0.64, 0.65, 0.66, 0.67, 0.68, 0.69, or 0.7, or values ​​with more decimal places are also applicable (e.g., 0.651, 0.652, etc.).

[0075] In other embodiments, the sealing forming component 140 may also have a longitudinally extending groove 145 on the inner surface of the two inner edges corresponding to the wearer's cheek (adjacent to the air chamber). The width of the groove 145 may be approximately wider at the top and narrower at the bottom, or conical (the base of the conical shape corresponds to the wearer's nose). The thickness of the groove 145 may be independent of the aforementioned thickness variation rules, and the thickness of the groove 145 may be thinner than any adjacent area, thereby providing a more comfortable fit on the wearer's cheek.

[0076] 4. Cylindrical walls, hollow structure, and sealing components of the pad assembly.

[0077] Please refer to Figure 11 and Figure 12 , Figure 11 This is a perspective view of the pad assembly in an exploded state according to another embodiment of the present invention. Figure 12 for Figure 11 A cross-sectional schematic diagram of the pad assembly in its assembled state. In this embodiment, the pad assembly 10 includes: a hollow structure 110, a cylindrical wall 120, and a sealing assembly 103'.

[0078] The hollow structure 110 has a central aperture 111 and a convex ring structure 112. The central aperture 111 is configured at the first end P1 of the pad assembly 10 and can be used to provide a path for airflow when the patient interface is used. The convex ring structure 112 is configured to protrude from the central aperture 111 in one direction toward the first end P1 of the pad assembly 10.

[0079] A cylindrical wall 120 is provided at the central opening 111. The cylindrical wall 120 is constructed as a circle substantially concentric with the central opening 111. The cylindrical wall 120 protrudes a first distance PD1 toward the first end P1 of the pad assembly 10 with the same diameter, and protrudes a second distance PD2 toward the second end P2 of the pad assembly 10 opposite to the first end P1 with a different diameter.

[0080] For example, the diameter change within the second distance PD2 can be a substantially decreasing diameter in the direction towards the second end P2; in contrast, the diameter change within the first distance PD1 can be a substantially constant diameter in the direction towards the first end P1. Furthermore, in other embodiments, the first distance PD1 can be longer than the second distance PD2.

[0081] like Figure 11 As shown and compared Figure 12 On the eaves 1201, which tapers in diameter towards the second end P2 of the cylindrical wall 120, it can be disposed only on a portion of the end of the cylindrical wall 120, thus forming a partially wraparound eaves 1201 of less than 360 degrees. It can also be simultaneously... Figure 12 From a vantage point of view, along the vertical section line of the partially encircling eaves 1201, a portion of the area below the cylindrical wall 120 does not have an eaves 1201; however, when using another vertical line... Figure 12 When the section line is shown (not shown in the figure), the eaves on both the upper and lower sides of the cylindrical wall 120 can appear simultaneously. Figure 12 The example shown is a roof with an eaves that wraps around the end of the cylindrical wall 120 by 270 degrees.

[0082] Please refer to Figure 13 and Figure 14 , Figure 13This is a perspective view of a pad assembly according to another embodiment of the present invention. Figure 14 for Figure 13 A cross-sectional schematic diagram of the pad assembly. In this embodiment, the pad assembly 10 includes: a hollow structure 110, a cylindrical wall 120, and a sealing assembly 103'.

[0083] The hollow structure 110 has a cylindrical orifice 111' and a first convex ring structure 112'. The cylindrical orifice 111' is constructed at the first end P1 of the pad assembly 10 and can be used to supply airflow when the patient interface is used. The first convex ring structure 112' is constructed to protrude from the cylindrical orifice 111' in one direction toward the first end P1 of the pad assembly 10.

[0084] A cylindrical wall 120 is provided at the cylindrical opening 111'. The cylindrical wall 120 is constructed as a circle substantially concentric with the cylindrical opening 111'. The cylindrical wall 120 has a second convex ring structure 122 and a third convex ring structure 123. The second convex ring structure 122 protrudes toward the first end P1 of the pad assembly 10, and the third convex ring structure 123 protrudes toward the second end P2 of the pad assembly 10 opposite to the first end P1.

[0085] like Figure 14 In the embodiment shown, the first convex ring structure 112' and the second convex ring structure 122 are concentric. The diameter D2 of the second convex ring structure 122 is smaller than the diameter D1 of the first convex ring structure 112'. Figure 14 (Taking the inner diameter as an example). Furthermore, the third convex ring structure 123 has a first portion 1231 and a second portion 1232. The first portion 1231 is in the form of a rod, and the second portion 1232 is in the form of a head supported by the first portion 1231. The rod-shaped first portion 1231 is disposed on the cylindrical wall 120 and is in fluid communication with the cylindrical orifice 111'. The head of the second portion 1232 is substantially truncated hollow cone-shaped, having a relatively narrow apex extending into the hollow structure 110.

[0086] In addition, compared to Figure 12 For the 270-degree partial wraparound eaves 1201 example, Figure 13 and Figure 14 The illustrated embodiment is a 360-degree wraparound eaves section in the shape of a truncated hollow cone. The second portion 1232, which is in the shape of a truncated hollow cone, has a diameter smaller than the diameter D2 of the second convex ring structure 122. Figure 14 (Taking the inner diameter as an example). The aforementioned first to third convex ring structures, based on structural features, can also be correspondingly referred to as first to third protruding structures, wherein the hollow structure 110 can be constructed from a single material. On the other hand, the sealing assembly 103' can be configured to have a softer material relative to the hollow structure 110.

[0087] like Figure 13 and Figure 14 As shown, the first part 1231 in the form of a rod can be regarded as a support structure, thereby enabling the cylindrical wall 120 to be provided at the opening (cylindrical orifice 111') of the hollow structure 110 and concentric with the opening (cylindrical orifice 111').

[0088] Please refer to Figure 15 , Figure 15 This is a cross-sectional schematic diagram of a pad assembly according to another embodiment of the present invention. The inner diameter of the cylindrical wall 120 before the change is the initial diameter D21, and the inner diameter of the cylindrical wall 120 after the change is the reduced diameter D22. The extent to which the cylindrical wall 120 extends into the hollow structure 110 is a depth of D4. Figure 15 The cylindrical wall 120 in the example has a relatively long distance from its initial diameter D21 to its reduced diameter D22, and therefore can extend more deeply into the hollow structure 110. Accordingly, compared to Figure 14 The example cylindrical wall is 120. Figure 15 The cylindrical wall 120 of the example has a relatively gentle change in diameter and extends deeply into the hollow structure 110, so that the inner wall surface of the cylindrical wall 120 can present a relatively gentle curve or slope in the direction toward the second end P2 of the pad assembly 10.

[0089] 5. Structure of the headband assembly

[0090] Please refer to Figure 16 and Figure 17 And at the same time refer to Figure 2 , Figure 16 This is a perspective view of a headband assembly according to an embodiment of the present invention. Figure 17 for Figure 16 A diagram illustrating the headband component being worn on the patient's head.

[0091] The headband assembly 20 includes multiple straps that can be used to adjust the position of the patient interface when the patient wears it, so that the patient interface is stably and comfortably secured to the patient's head, forming an airflow space, breathing cavity, or inflation chamber on the patient's face to apply therapeutic pressure to the patient's airway. These straps include multiple upper straps 210, multiple lower straps 220, and a rear portion configured to reach at least a portion of the occipital bone of the patient's head during use, referred to as the rear strap assembly 230.

[0092] Multiple upper bands 210 include bands that extend above the patient's ear when in use, and multiple lower bands 220 include bands that extend below the patient's ear when in use (see reference). Figure 17 The rear belt assembly 230 includes a top 231, multiple sides 232, and a bottom 233. See also... Figure 2 and Figure 3 The frame assembly 50 is adapted to be attached to the corresponding upper strap 210, for example, by slots 501 on the frame assembly 50 located at the upper edges of both sides. Furthermore, the frame assembly 50 is also adapted to be attached to the corresponding lower strap 220, for example, by a headband clip 30 engaging with the slots 501 at the lower edges of both sides of the frame assembly 50.

[0093] like Figure 16 and Figure 17 As shown, the top 231 of the rear strap assembly 230 is located between multiple side portions 232, and the bottom 233 of the rear strap assembly 230 is located between the multiple side portions 232 and multiple lower strap bodies 220. The bottom 233 of the rear strap assembly 230 can simultaneously connect to the side portions 232 and the lower strap bodies 220, and the connection method can be integral molding of the same fabric or splicing of different fabrics. Multiple upper strap bodies 210 are located on the sides of the corresponding side portions 232. Each of the multiple upper strap bodies 210 has an upper strap attachment portion 211 on the end opposite to the end connected to the corresponding side portion 232, and each of the multiple lower strap bodies 220 has a lower strap attachment portion 221 on the end opposite to the end connected to the corresponding lower portion 233. The upper strap attachment portions 211 and lower strap attachment portions 221 are used to fix to the frame assembly 50 and / or to the headband clip 30 by attachment. The upper belt attachment portion 211 and the lower belt attachment portion 221 are, for example, components with a felting effect, such as: hook belts (used to hook onto the surface of the upper belt body 210 or the lower belt body 220).

[0094] like Figure 16 As shown, each side portion 232 has an intersection point f. The intersection point f of each side portion 232 has a first belt distance d1 with the top 231, a second belt distance d2 with the lower portion 233, and a third belt distance d3 with the upper belt 210. In one embodiment, the first belt distance d1 is less than the second belt distance d2; in another embodiment, the first belt distance d1 is greater than the third belt distance d3.

[0095] The intersection point f of each side portion 232 is the geometric center of the side portion 232. In a preferred embodiment, each side portion 232 has a connecting edge with the top 231, the upper band 210, and the lower portion 233. The three vertical line segments from the intersection point f to each connecting edge can converge at the intersection point f. Under the configuration condition that can form the intersection point f, it helps to properly distribute the pressure of the headband assembly 20 on the wearer's or patient's head, improving wearing comfort and stability.

[0096] Please refer to Figure 18This is a perspective view of a headband assembly according to another embodiment of the present invention. The headband assembly 20 includes a plurality of straps that can be used to adjust the position of the patient interface when the patient wears it. These straps include a plurality of upper straps 210, a plurality of lower straps 220, and a rear portion 230' configured to reach at least a portion of the occipital bone of the patient's head during use.

[0097] The rear portion 230' has a top 231, multiple sides 232, and a bottom 233. The top 230 is disposed between the multiple sides 232, the bottom 233 is disposed between the multiple sides 232 and multiple lower belt bodies 220, and multiple upper belt bodies 210 are disposed on corresponding sides 232. Each side 232 has a first joint line L1 between itself and the top 231, each upper belt body 210 has a second joint line L2 between itself and its corresponding side 232, and each side 232 has a third joint line L3 between itself and the bottom 233.

[0098] The distance between the center points of the two first bonding lines L1 is the first strip spacing d1'. The distance between the center points of the two second bonding lines L2 is the second strip spacing d2'. The distance between the center points of the two third bonding lines L3 is the third strip spacing d3'. In one embodiment, the first strip spacing d1' is less than the second strip spacing d2' and greater than the third strip spacing d3'.

[0099] 6. Structure of the elbow tube assembly

[0100] Please refer to Figure 19 and Figure 20 , Figure 19 This is a three-dimensional schematic diagram of the elbow tube assembly and transition ring structure in an exploded state according to an embodiment of the present invention. Figure 20 for Figure 19 This is a cross-sectional view of the elbow tube assembly and transition ring structure in their combined state. The elbow tube assembly 40 is disposed on the transition ring structure 510, and the elbow tube assembly 40 is capable of rotating 360 degrees relative to the transition ring structure 510. The elbow tube assembly 40 includes: a first end 41, a second end 42, and a main body 43.

[0101] The main body 43 of the elbow assembly 40 has a conduit airpath that allows for adjustable airflow direction. The main body 43 defines the conduit airpath through its tortuous inner wall, creating a turning effect on the delivered airflow, thereby adjusting the path of the airflow passing through the elbow assembly 40. Therefore, the airflow delivered from the fluid generator (not shown) through the air delivery pipe 60 (see reference...) Figure 1The air enters the elbow tube assembly 40 through the second end 42, and after passing through the duct air channel in the main body 43 of the elbow tube assembly 40 to change the airflow direction, it flows out from the first end 41 to form an airflow path to the aforementioned airflow space, breathing chamber or inflation chamber.

[0102] 7. Structure of the vent assembly

[0103] Please refer to Figure 19 and Figure 21 , Figure 21 for Figure 19 This is a three-dimensional schematic diagram of the elbow tube assembly and transition ring structure in their combined state, viewed from another perspective. The curved peripheral structure of the first end 41 of the elbow tube assembly 40 can form multiple concavities 411 on the outer surface of the first end 41. When the elbow tube assembly 40 and the transition ring structure 510 are in their combined state, these concavities 411 and at least a portion of the transition ring structure 510 can together form an air passage 44 (or exhaust passage). Figure 21 As shown, the depression 411 and the inner wall of the transition ring structure 510 together form a channel through which gas can pass. These channels connect the aforementioned airflow space, breathing chamber or inflation chamber, so that the gas exhaled by the patient can be discharged into the surrounding environment through these channels.

[0104] like Figure 19 As shown, the outer surface of the first end 41 of the elbow assembly 40 may further have an annular groove 412 and a stop portion 413. The annular groove 412 is structured to surround the outer surface of the first end 41 and span across the recess 411. The annular groove 412 is configured to match the inner wall surface of the transition ring structure 510. The annular groove 412 is used to allow the elbow assembly 40 to rotate relative to the transition ring structure 510 in a plane after it is non-removably assembled to the transition ring structure 510. In addition, the stop portion 413 may be provided at both the upper and lower ends of the first end 41 of the elbow assembly 40. At least one stop portion 413 can prevent the elbow assembly 40 from detaching from the transition ring structure 510 after it is assembled to the transition ring structure 510, forming a non-releasable assembly.

[0105] Please refer to Figure 22 and Figure 23 , Figure 22 This is a schematic diagram of a patient interface according to another embodiment of the present invention. Figure 23 for Figure 22A three-dimensional schematic diagram of the patient interface from another perspective. A cylindrical wall 120 is disposed within a cylindrical opening 111' of the pad assembly 10 via multiple support structures 1021, wherein the multiple support structures 1021 are in fluid communication with the cylindrical opening 111'. One end of each support structure 1021 is connected to the outer surface of the cylindrical wall 120, and the other end of each support structure 1021 is connected to the inner surface of the cylindrical opening 111' (see also...). Figure 13 and Figure 14 ).

[0106] like Figure 23 As shown, the multiple support structures 1021 are arranged asymmetrically with respect to the axis of the cylindrical wall 120, such as the central axis of the cylindrical wall 120 (a vertical line perpendicular to this plane). Another example of this asymmetrical arrangement is two adjacent support structures 1021 with the shortest spacing along the outer surface of the cylindrical wall 120, which corresponds to the nasal position when the patient wears the device.

[0107] like Figure 22 As shown, the transition ring structure 510 provides attachment for the headband fixation assembly 520, the elbow tube assembly 40, and the pad assembly 10, and allows for a non-direct engagement between the fixation assembly 520, the elbow tube assembly 40, and the pad assembly 10. Furthermore, through the transition ring structure 510, the port portion of the elbow tube assembly 40, where the first end 41 for gas delivery is output, can mate with one end of the cylindrical wall 120 of the pad assembly 10 to form a gas flow channel for airflow to the rear end. The patient's exhaled air can be guided to an air passage 44 for gas wash-out (see reference). Figure 23 This creates a flow field splitting state of airflow.

[0108] Because the airflow deflects and turns within the main body 43 of the elbow assembly 40, a region of relatively dense airflow forms at the turning point during the airflow process. For example... Figure 22 As shown, the elbow tube assembly 40 defines a conduit air passage in the upper part of the duct through its tortuous inner wall, causing most of the delivered airflow g to be concentrated. Most of the intake airflow delivered from the fluid generator to the breathing chamber can pass through the conduit air passage and the inner surface of the cylindrical wall 120 of the cushion assembly 10, respectively. The eaves-like structure at the other end of the cylindrical wall 120 further guides the airflow field. Specifically, the eaves-like structure of the cylindrical wall 120 (the portion protruding towards the second end of the cushion assembly 10) alters the exit airflow direction of the airflow delivered from the elbow tube assembly 40, causing the exit airflow direction to be adjusted downwards.

[0109] Therefore, the eaves-like structure of the cylindrical wall 120 allows most of the main airflow concentrated in the upper part of the duct air channel to flow out of the cylindrical wall 120 in an outlet direction not parallel to the axis of the cylindrical wall 120. In this way, the impact of the outflowing airflow on the patient's mouth and nose can be reduced, and the airflow exhaled by the patient during use can flow smoothly to the upper part of the aforementioned airflow space, breathing chamber or inflation chamber, and then be discharged into the surrounding environment through the air channel (exhaust duct) 44.

[0110] 8. Engagement and position of the headband assembly and the headband fixing assembly

[0111] like Figure 5 As shown, the headband assembly 20 is secured to the patient interface by the headband fixing assembly 520 and the headband clip 30. The headband clip attachment portion 522 of the headband fixing assembly 520 is used for attaching the corresponding headband clip 30, and the corresponding strap of the headband assembly 20 is then secured to the headband fixing assembly 520 by the headband clip 30. The upper opening 521 of the headband fixing assembly 520 is used for attaching the corresponding strap of the headband assembly 20.

[0112] Further, please refer to Figure 24 This is a perspective view of a headband fixing assembly according to another embodiment of the present invention. The headband clip attachment portion 522 has an attachment post 5221, which allows for attachment of a corresponding headband clip 30. The central axis of the attachment post 5221 can form an angle θ1 with respect to the opening plane formed by the central opening 523 of the headband fixing assembly 520. The angle θ1 is... Figure 23 The angle between the opening plane formed by the central opening 523 and the clockwise direction can be between 18 and 22 degrees, and is preferably configured at an angle of approximately 20.5 to 20.7 degrees.

[0113] Please refer to Figure 25 This is a perspective view of a patient interface according to another embodiment of the present invention. The headband fixing assembly 520 extends a top cover 525 in a direction extending obliquely rearward from the central opening 523. The top cover 525 is raised, and the degree of raising is such that the angle θ2 formed between the tangent line T on the top cover 525 and the central axis X of the central opening 523 can be between 42 and 48 degrees, preferably configured at an angle with an error of approximately 45 degrees plus or minus 0.5 degrees.

[0114] 9. Engagement and sealing of the pad assembly, elbow tube assembly, and headband fixing assembly.

[0115] Please refer to Figure 26 , Figure 27 and Figure 28 , Figure 26This is a three-dimensional schematic diagram of a connecting ring structure according to an embodiment of the present invention. Figure 27 for Figure 26 A cross-sectional schematic diagram of the connecting ring structure in use. Figure 28 for Figure 26 A three-dimensional schematic diagram of the connecting ring structure in use. The connecting ring structure 510' (or transition ring structure) has a first annular portion 511 and a second annular portion 512. The inner diameter of the first annular portion 511 is larger than the inner diameter of the second annular portion 512. The outer diameter of the first annular portion 511 is also larger than the outer diameter of the second annular portion 512.

[0116] The second annular portion 512 is accommodated in the central opening 523 of the headband fixing assembly 520. The end edge of the second annular portion 512 has a radially convex interference structure 513. The outer diameter of the second annular portion 512 at the location of the interference structure 513 is slightly larger than the diameter of the central opening 523 of the headband fixing assembly 520, while the outer diameter of the middle section of the second annular portion 512 is slightly smaller than the diameter of the central opening 523 of the headband fixing assembly 520, thereby allowing the connecting ring structure 510' to be snapped onto the headband fixing assembly 520.

[0117] The connecting ring structure 510' has a first limiting portion 514, which corresponds to and interferes with a second limiting portion 524 on the headband fixing assembly 520. The width of the first limiting portion 514 is slightly larger than the width of the second limiting portion 524, allowing the headband fixing assembly 520 and the connecting ring structure 510' to rotate relative to each other within a limited range. The headband fixing assembly 520 is held onto the connecting ring structure 510' by the interference structure 513, the bottom edge of the first limiting portion 514, and the transition surface 515 between the first annular portion 511 and the second annular portion 512. The transition surface 515, for example, is an inclined surface that matches the inner surface of the headband fixing assembly 520, thereby causing the headband fixing assembly 520 to be pressed against the transition surface 515 and the interference structure 513.

[0118] A groove 516 extends from the outer circumferential surface of the first annular portion 511. The groove 516 allows the stop 1014 on the annular structure 1011 of the pad assembly 10 to engage. This allows the first annular portion 511 and the pad assembly 10 to be engaged via a snap-fit ​​connection. Figure 27 As shown, the stop portion 1014 can be, for example, a protrusion adjacent to the first end of the pad assembly 10. When the connecting ring structure 510' engages with the pad assembly 10, the stop portion 1014 can be correspondingly positioned in the groove 516 of the first annular portion 511. The protrusion can rotate and move along the path of the groove in the groove 516, thereby allowing the pad assembly 10 to have a certain degree of rotation relative to the connecting ring structure 510' after the pad assembly 10 engages with the connecting ring structure 510'.

[0119] In one embodiment, the outer diameter of the first annular portion 511 gradually decreases from the junction of the first annular portion 511 and the second annular portion 512 toward the pad assembly 10, such that the wall thickness of the first annular portion 511 gradually decreases from the connecting ring structure 510' toward the pad assembly 10. This allows the first annular portion 511 to provide slight deformation during the engagement of the pad assembly 10, facilitating the access of the stop portion 1014 on the annular structure 1011 of the pad assembly 10 to the groove 516 on the first annular portion 511.

[0120] Elbow tube assembly 40 and headband fixing assembly 520 are respectively attached to the inner and outer sides of connecting ring structure 510'. In other words, the second annular portion 512 is positioned between headband fixing assembly 520 and elbow tube assembly 40 during use. After assembly, there is no physical contact between elbow tube assembly 40 and headband fixing assembly 520.

[0121] The inner side of the second annular portion 512 may additionally have a radially inwardly convex inner flange 517. At the engagement of the elbow assembly 40 and the connecting ring structure 510', the inner flange 517 can be accommodated in the annular groove 412 on the elbow assembly 40. This allows the elbow assembly 40 to be rotatably attached to the connecting ring structure 510'. Preferably, the elbow assembly 40 is non-removably disposed on the connecting ring structure 510'.

[0122] Due to the change in inner diameter, a stepped portion 518 can be formed at the junction of the first annular portion 511 and the second annular portion 512. One end of the elbow tube assembly 40 may have a stop portion 413. In use, the stop portion 413 stops at the stepped portion 518 at the junction of the first annular portion 511 and the second annular portion 512 to provide a locking function, thereby making the elbow tube assembly 40 more stable when rotating. The locking function prevents the elbow tube assembly 40 from being disassembled from the outer self-connecting ring structure 510'.

[0123] 10. Functionality of the cushion assembly in intake / exhaust

[0124] Please refer to Figure 29 This is a schematic cross-sectional view of the cylindrical wall of a cushion assembly according to an embodiment of the present invention. The structural shape of the cylindrical wall 120 within the cushion assembly 10 can guide the flowing air, thereby causing the airflow exiting the cylindrical wall 120 to change its exit direction. This is particularly relevant for airflow from sources such as... Figure 21 The airflow that flows through the elbow tube assembly 40 and is deflected is shown, and the structural shape of the cylindrical wall 120 can play a good guiding role.

[0125] In one embodiment, the diameter of the cylindrical wall 120 within the pad assembly 10 is reduced towards one end of the pad assembly 10 according to a reduction rate. Figure 29 Taking the inner diameter of the cylindrical wall 120 as an example, the inner diameter of the cylindrical wall 120 before the change is the initial diameter D21, and the inner diameter of the cylindrical wall 120 after the change is the reduced diameter D22. The change segment D3 refers to the length of the cylindrical wall 120 along the central axis X, where the diameter is reduced. The reduction rate refers to the reduction of the diameter of the cylindrical wall 120 from the initial diameter D21 to the reduced diameter D22 within the length of the change segment D3, and the length of the change segment D3 does not exceed 10 mm. In one preferred embodiment, the reduction rate is 7.5-22.5% for a length of 8 mm in the change segment D3. In another preferred embodiment, the reduction rate is 10-20% for a length of 6 mm in the change segment D3.

[0126] In another embodiment, the ratio between the opening area of ​​the airflow inlet end of the cylindrical wall 120 and the opening area of ​​the airflow outlet end of the cylindrical wall 120 is between 0.5 and 0.95. The opening area of ​​the airflow inlet end of the cylindrical wall 120 is based on the size of the initial diameter D21, and the opening area of ​​the airflow outlet end of the cylindrical wall 120 is based on the size of the reduced diameter D22. The cylindrical wall 120 has a protruding section D4 protruding from the end edge of the annular structure 1011 of the pad assembly 10 in a direction parallel to the central axis X. The distance of the protruding section D4 is preferably 1-10 (mm). The protruding section D4 substantially extends into the aforementioned airflow space, breathing chamber, or inflation chamber.

[0127] In this way, the cylindrical wall 120, which provides guidance, can reduce the impact of the outflowing air on the patient's mouth and nose. Furthermore, it simultaneously achieves a flow separation effect between the inlet and outlet air fields, allowing the patient's exhaled air to flow more smoothly within the aforementioned airflow space, breathing cavity, or inflation chamber, and to pass smoothly through... Figure 21 and Figure 23 The air passage (exhaust duct) 44 shown is for discharging into the surrounding environment.

[0128] Please refer to Figure 30 , Figure 31 and Figure 32 , Figure 30 This is a flow field analysis diagram according to an embodiment disclosed in the present invention. Figure 31 This is a flow field analysis diagram according to another embodiment disclosed in the present invention. Figure 32 This is a flow field analysis diagram under another embodiment disclosed in the present invention.

[0129] Figure 30-32 This shows the airflow field flowing in the aforementioned airflow space, breathing chamber, or inflation chamber. Figure 30 The flow field analysis diagram shown depicts the cylindrical wall of the patient interface with a 60-degree roof-like extension at the end (see also reference). Figure 12 The example shown has an eaves that wrap around 270 degrees. Figure 31 The flow field analysis diagram shown is a cylindrical wall of the patient interface with an eaves that wrap around 270 degrees at the ends. Figure 32 The flow field analysis diagram shown is a cylindrical wall of the patient interface with an eaves that wrap around 360 degrees at the ends.

[0130] exist Figure 30 Within the breathing chamber, a clear flow field is observed along the inner wall of the hollow structure and sealing components. Furthermore, a significant guiding airflow is also generated in the upper part of the breathing chamber, directing airflow towards the air passage (exhaust duct). Figure 31 In the middle, the guiding airflow to the air passage (exhaust passage) in the upper part of the breathing cavity is more significant. And... Figure 32 Furthermore, the airflow guiding the air to the air passage (exhaust duct) is enhanced. Therefore, when using a patient interface with a cushion assembly having cylindrical walls, the separation effect between the inlet and outlet airflow fields is highlighted, and the smooth flow field further improves noise reduction.

[0131] 11. Sealing position, fixation, and stability

[0132] like Figure 6 The sealing-forming component 140 shown is adapted to seal the patient's face in response to the patient's wearing. The distribution of the support area within the sealing-forming component 140 further enhances the wearer's comfort and the stability of the device on the patient's face. Furthermore, as... Figure 16 and Figure 18 The example headband component 20 has a good synergistic effect in terms of comfortably and stably securing the patient interface to the patient's face.

[0133] Preferred embodiments have been disclosed above. However, those skilled in the art should understand that these embodiments are merely illustrative and should not be construed as limiting the scope of the invention. It should be noted that all equivalent variations and substitutions to the embodiments are to be understood as falling within the scope of this invention. Therefore, the scope of protection of this invention is determined by the scope of the claims.

[0134] [Attached image labels]

[0135] 10 cushion components

[0136] 10' cushion assembly

[0137] 101 shielding

[0138] 1011 ring structure

[0139] 1012 Rotary limiting protrusion

[0140] 1013 Alignment Guidance Unit

[0141] 1014 Stop Section

[0142] 102 cylindrical wall

[0143] 1021 Support Structure

[0144] 103 Sealing Assembly

[0145] 103' sealing assembly

[0146] The end of the second end of the 104 pad assembly

[0147] 110 hollow structure

[0148] 111 Central Orifice

[0149] 111' Cylindrical orifice

[0150] 112 convex ring structure

[0151] 112' First convex ring structure

[0152] 120 cylindrical wall

[0153] 1201 Eaves

[0154] 122 Second convex ring structure

[0155] 123 Third convex ring structure

[0156] 1231 Part 1 (Pole Form)

[0157] 1232 Part Two (Head Form)

[0158] 140 sealing forming assembly

[0159] 141 First Support Zone

[0160] 142 Second Support Zone

[0161] 1421 edge

[0162] 143 Sealing of the joint of the component

[0163] 144 Boundary between the first support zone and the second support zone

[0164] 145 ditch

[0165] 20 headband components

[0166] 210 upper belt body

[0167] 220 with body

[0168] 230 with components

[0169] 230' rear

[0170] 231 top

[0171] 232 side

[0172] 233 bottom

[0173] 30-head clip

[0174] 40 elbow tube assembly

[0175] 41 First end

[0176] 411 Depression (Curved Outer Structure)

[0177] 412 Annular Groove

[0178] 413 Stop

[0179] 42 Second End

[0180] 43 main bodies

[0181] 44. Air passage (exhaust duct)

[0182] 50 framework components

[0183] 501 slot

[0184] Openings in the 502 frame component

[0185] 503 Rotary limiting notch

[0186] 5031 limiting wall

[0187] 504 Alignment Indicator

[0188] 510 transition ring structure

[0189] 510' connecting ring structure

[0190] 511 First Circular Section

[0191] 512 Second Annular Section

[0192] 513 interference structure

[0193] 514 First Limiting Part

[0194] 515 transition surface

[0195] 516 trench

[0196] 517 inner flange

[0197] 518 steps

[0198] 520 headband fixing components

[0199] 521 Opening

[0200] 522 Headband Clip Attachment

[0201] 5221 Attachment Column

[0202] 523 Central Opening

[0203] 524 Second Limiting Part

[0204] 525 top cover

[0205] 60 air delivery pipe

[0206] D1 Diameter of the first convex ring structure

[0207] The diameter of the second convex ring structure of D2

[0208] D21 Initial Diameter

[0209] D22 reduced diameter

[0210] D3 Change Section

[0211] D4 extends into the hollow structure / protrusion segment

[0212] L1 First junction line

[0213] L2 Second Joint Line

[0214] L3 Third Junction Line

[0215] The first end of P1 pad assembly

[0216] The second end of the P2 pad assembly

[0217] PD1 first distance

[0218] PD2 second distance

[0219] T-tangent

[0220] The central axis of the X-cylindrical wall

[0221] d1 First belt distance

[0222] d2 Second belt distance

[0223] d3 third zone distance

[0224] d1' First zone interval

[0225] d2' Second band spacer

[0226] d3' third zone body spacer

[0227] f Intersection point

[0228] g is mostly concentrated in the upper part of the airflow.

[0229] θ1 Inclination angle

[0230] θ2 angle

Claims

1. A patient interface for CPAP therapy, the patient interface comprising: A cushion assembly, which further includes: A shielding member having an opening formed on a first end of the pad assembly and an annular structure protruding from the opening toward the first end of the pad assembly in a direction; A cylindrical wall, provided by a plurality of supporting structures concentrically with the opening, wherein the cylindrical wall protrudes in two opposite directions along an axis of the opening with different diameters; and A sealing assembly, disposed on the shield of the pad assembly to together form a breathing chamber, the sealing assembly being adapted to seal the patient's face. The cylindrical wall protrudes from the end edge of the annular structure of the pad assembly with a gradually decreasing diameter protrusion. The protrusion extends into the breathing cavity and has an inner wall surface that is curved or inclined, so as to separate the inlet airflow field from the outlet airflow field. A headband assembly includes multiple bands for securing the patient interface during use; An elbow tube assembly adapted to connect to an air delivery tube connected to a fluid generator to deliver airflow through the cylindrical wall to the breathing chamber during use; A connecting ring structure, one end of which is connected to the pad assembly, and the other end of which is non-detachably disposed in the elbow tube assembly; and A headband securing assembly adapted to engage with the connecting ring structure, the headband securing assembly including a plurality of slots adapted to attach to a corresponding band body in use, wherein the headband securing assembly does not have forehead support.

2. The patient interface as described in claim 1, wherein, The cylindrical wall protrudes a first distance toward the first end with the same diameter, and the cylindrical wall protrudes a second distance toward a second end opposite to the first end with a decreasing diameter, the first distance being longer than the second distance.

3. The patient interface as described in claim 2, wherein, The cylindrical wall protrudes toward the second end in a manner that reduces its diameter to form a head that is substantially truncated hollow cone-shaped, the head having a relatively narrow apex portion for access to the shield.

4. The patient interface as described in claim 1, wherein, When attached, the connecting ring structure is rotatable from the pad assembly.

5. The patient interface as described in claim 1, wherein, The shielding component and the sealing assembly are integrally formed.

6. The patient interface as described in claim 1, wherein, The pad assembly, the elbow tube assembly, and the headband fixing assembly do not have direct physical contact or physical engagement during use.

7. The patient interface as described in claim 1, wherein, The plurality of support structures are constructed in the form of rods, with one end of each support structure connected to the outer surface of the cylindrical wall and the other end connected to the inner surface of the opening of the shielding member; The plurality of support structures are asymmetrical with respect to one axis of the cylindrical wall.

8. The patient interface as described in claim 7, wherein, The elbow tube assembly has a plurality of recesses on the outer surface of a first end of the elbow tube assembly. The plurality of recesses are configured such that when the first end of the elbow tube assembly is engaged with the connecting ring structure, a plurality of exhaust channels are formed on the inner surface corresponding to the connecting ring structure. The plurality of exhaust channels are for allowing outflowing air from the breathing cavity to the surrounding environment to pass through. The plurality of support structures are in fluid communication with the plurality of exhaust channels. The adjacent two of the plurality of support structures with the shortest spacing along the outer surface of the cylindrical wall correspond to the nose when worn by the patient.

9. The patient interface as described in claim 8, wherein, The elbow tube assembly has a main body that defines a conduit air channel through a convoluted inner wall, whereby most of the delivered airflow is concentrated in the upper part. A portion of the cylindrical wall protruding from a second end opposite to the first end of the cushion assembly is used to alter the direction of the airflow delivered from the elbow tube assembly, so that the main airflow concentrated in the upper part of the conduit air channel flows out of the cylindrical wall in an outlet direction not parallel to an axis of the cylindrical wall. This reduces the impact of the outflowing airflow on the patient's mouth and nose, and allows the airflow exhaled by the patient to flow smoothly to the upper part of the respiratory cavity and then be discharged into the surrounding environment through the multiple exhaust ducts.

10. The patient interface as claimed in claim 1, wherein, The cylindrical wall is reduced in diameter toward a second end of the pad assembly opposite to the first end according to a reduction rate, the reduction rate being 5-25% over a length of 5 mm to 10 mm.

11. The patient interface as claimed in claim 1, wherein, The ratio between the opening area of ​​the opening at the first end of the cylindrical wall facing the cushion assembly and the opening area of ​​the opening at a second end of the cylindrical wall facing the cushion assembly opposite to the first end is 0.5-0.95, and the portion of the cylindrical wall protruding at the second end of the cushion assembly extends into the breathing cavity by more than 1 mm in a direction parallel to an axis of the cylindrical wall.

12. The patient interface as claimed in claim 1, wherein, The connecting ring structure has a first annular portion and a second annular portion. The inner diameter of the first annular portion is larger than the inner diameter of the second annular portion. The first annular portion is engaged with the pad assembly by a snap-fit ​​connection. The second annular portion is configured to be disposed between the headband fixing assembly and the elbow tube assembly during use. The connecting ring structure ensures that the pad assembly and the elbow tube assembly do not have direct physical contact or physical engagement during use.

13. The patient interface as described in claim 12, wherein, The first annular portion has an extending groove for engaging a stop on the annular structure of the pad assembly. The second annular portion has an outwardly projecting interference structure at its end edge, which engages the connecting ring structure with a central opening of the headband fixing assembly. The inner side of the second annular portion has an inwardly projecting inner flange, configured to be received in an annular groove on the elbow tube assembly during use. One end of the elbow tube assembly has a stop. The stop portion is configured to stop at the junction of the first annular portion and the second annular portion during use. The connecting ring structure has a first limiting portion configured to correspond to and interfere with a second limiting portion on the headband fixing assembly during use. The width of the first limiting portion is slightly larger than the width of the second limiting portion, so that there is a degree of rotation between the headband fixing assembly and the pad assembly. The outer diameter of the first annular portion gradually decreases from the junction of the first annular portion and the second annular portion toward a second end of the pad assembly opposite to the first end.

14. The patient interface as claimed in claim 1, wherein, The sealing assembly has a first support area disposed on the shield and a second support area extending from the first support area, a boundary being formed between the first support area and the second support area. The boundary is defined at a position where the sealing assembly extends from the junction of the shield and the first support area and gradually thins to a predetermined thickness, the predetermined thickness being any value selected between 0.50 and 0.70 mm.

15. The patient interface as claimed in claim 1, wherein, The sealing assembly has a first support area disposed on the shield and a second support area extending from the first support area. A first boundary is formed between the shield and the first support area, and a second boundary is formed between the first support area and the second support area. The second boundary is defined at a position where the sealing assembly extends from the first boundary and gradually thins to a predetermined thickness. Each point on the first boundary has a vertical distance from the second boundary. Among the plurality of vertical distances, the vertical distances of the sealing assembly to the cheek and cheekbone area when used by the patient are all longer than the vertical distances of the sealing assembly to the nose and chin area when used by the patient.

16. The patient interface as claimed in claim 1, wherein, The plurality of straps includes a plurality of upper straps and a plurality of lower straps configured for position adjustment when worn by a patient, and a rear portion configured to reach at least a portion of the occipital bone of the patient's head during use. The rear portion has a top, two side portions, and a bottom. The top is located between the two side portions, the bottom is located between the two side portions and the plurality of lower straps, and the plurality of upper straps are located on corresponding side portions. Two first joint lines are formed between the two side portions and the top, two second joint lines are formed between each upper strap and its corresponding side portion, and two third joint lines are formed between the two side portions and the bottom. The distance between the center points of the two first joint lines is a first strap interval, the distance between the center points of the two second joint lines is a second strap interval, and the distance between the center points of the two third joint lines is a third strap interval. The first strap interval is smaller than the second strap interval but larger than the third strap interval.

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