Patient interface

Abstract

The present application discloses a patient interface, which comprises a headgear and a frame assembly, the headgear is used to maintain the patient interface on the head of a patient; the frame assembly is used to connect the headgear, the frame assembly has a main frame and two side extension arms, the two side extension arms respectively extend from two sides of the main frame, wherein when the side extension arms are not stressed, the upper edge of the cheek contact section of the side extension arm is closer to the mask central axis of the patient interface than the lower edge, so that the patient interface makes the upper edge of the cheek contact section away from the vertex of the patient's malar bone when worn. The patient interface of the present application can better conform to the face by the shape of the two side extension arms conforming to the position of the upper half of the malar bone, and provides good support force, stability and weight pressure dispersion effect.

Description

Technical Field

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

[0002] A continuous positive airway pressure (CPAP) device is used to treat obstructive sleep apnea (OSA). It seals the user's nose or mouth and nose through a patient interface to continuously supply air or other breathable gases to the patient and maintain a continuous positive pressure to open the patient's obstructed airway and keep the airway open, thereby achieving the purpose of treating obstructive sleep apnea.

[0003] During use, the patient interface is held in place on the patient's head by a headband. The patient interface typically consists of a frame and a pad. The softer pad creates a positive-pressure air cavity around the nose and / or mouth, which is then sealed against the cheek or around the nostrils. Generally, the smaller the contact area between the patient interface and the patient's face, the less foreign body sensation the patient experiences, and the higher the comfort level. However, a reduced contact area also decreases the stability of the patient interface, potentially affecting treatment effectiveness. Therefore, a more rigid frame is needed to provide support. Taking a nasal pillow-type patient interface as an example, to ensure stable wear, the frame uses a tightened headband or highly elastic headband to create a strong headband restraint force, pressing the pad against the patient's nostrils. Part of the frame or headband rests against the cheek, extending below the cheekbone and above the ear. However, with prolonged wear, this strong headband restraint force can cause excessive pressure around the nostrils and cheeks, leading to discomfort. Furthermore, due to the weight of the patient interface itself or the overall airflow configuration, the center of gravity of the patient interface tends to be biased towards the front of the wearer. If part of the frame or headband extends only along the area below the cheekbone and merely rests against the patient's cheek, the patient interface is not easily supported by that part of the frame or headband. This also makes it easier for the padding, whose center of gravity is also biased towards the front of the wearer, to shift downwards, creating undue pressure on the wearer's philtrum and upper lip. This is a significant reason for poor comfort. In addition, when the patient sleeps on their side, the frame and headband are easily compressed and deformed or shifted, causing the padding to detach from the area around the nostrils and lose its sealing effect. All of these factors can reduce patient compliance when using the patient interface for OSA treatment, leading to less than expected treatment results. Therefore, there is a need to provide a stable patient interface that can appropriately distribute facial pressure. Summary of the Invention

[0004] One of the objectives of this invention is to provide a patient interface that improves wearing stability and can appropriately distribute the pressure applied to the face.

[0005] To achieve the above and other objectives, the present invention discloses a patient interface for supplying gas to a patient's airway. The patient interface may include a headband and a frame assembly. The headband is used to hold the patient interface on the patient's head. The frame assembly is used to connect the headband and may have a main frame and two side extension arms. The two side extension arms extend from both sides of the main frame, wherein, when the side extension arms are not under force, the upper edge of the cheek contact section of the side extension arm is closer to the central axis of the mask of the patient interface than the lower edge, so that when the patient interface is worn, the upper edge of the cheek contact section is away from the apex of the patient's cheekbone.

[0006] In one embodiment of the present invention, when the patient interface is worn, the upper edge of the cheek contact segment is closer to the patient's eye socket than the lower edge.

[0007] In one embodiment of the invention, when the patient interface is worn, the upper edge of the cheek contact segment is closer to the patient's median sagittal plane than the lower edge.

[0008] In one embodiment of the present invention, the patient interface may further include a cushion assembly, an elbow tube assembly, and an adapter; the cushion assembly is used to form an air cavity with a positive pressure environment near the inlet of the patient's airway; the elbow tube assembly is used to deliver gas generated by the fluid generator to the air cavity of the cushion assembly; the adapter is used to connect the frame assembly, the cushion assembly, and the elbow tube assembly, wherein the center of the air inlet of the elbow tube assembly and the center of the mounting hole of the adapter form the central axis of the mask.

[0009] In one embodiment of the present invention, when the patient interface is worn, the cheek contact segment can abut against the upper part of the cheekbone of the patient's cheek and be away from the lower part of the cheekbone of the patient's cheek.

[0010] In one embodiment of the invention, each side extension arm may have a first end close to the main frame and a second end away from the main frame, wherein the shortest distance between the upper and lower edges of the first end is less than the shortest distance between the upper and lower edges of the second end.

[0011] In one embodiment of the invention, each side extension arm may further include a frame connecting section and a bend; the frame connecting section is used to connect to the main frame; the bend is located between the frame connecting section and the cheek contact section, such that the cheek contact section extends away from the central axis of the mask on the patient interface along the length extension direction.

[0012] In one embodiment of the invention, each side extension arm is rotatably connected to the main frame.

[0013] In one embodiment of the invention, each side extension arm may further include a headband connecting section for connecting a headband.

[0014] In one embodiment of the present invention, the headband may include two side bands, a top band, and a back band. The top band is connected between the two side bands. Each side band is detachably attached to the headband connecting section of the two side extension arms. The top band can cross the top of the patient's head when worn, and the back band can be located at the occipital bone of the patient when worn.

[0015] In one embodiment of the present invention, the back band of the headband may have an elastic segment, the elongation of which may be greater than that of other parts of the back band.

[0016] In one embodiment of the present invention, in the headband, the width of the back band is wider in the middle and narrower on both sides.

[0017] In one embodiment of the present invention, in the headband, the width of the top band is wider in the middle and narrower on both sides.

[0018] To achieve the above and other objectives, the present invention provides a patient interface comprising a pad assembly and a pair of side extension arms. The pad assembly is used to form an air cavity with a positive pressure environment near the entrance of the patient's airway. The side extension arms are adjacent to both sides of the pad assembly, and each side extension arm may have a cheek contact segment. When worn, the cheek contact segment is located between the apex of the patient's cheekbone and the eye socket, and is adapted to the upper edge of the upper half of the left and right cheekbones of the patient, so as to avoid the apex and lower half of the patient's cheekbone.

[0019] In one embodiment of the invention, the upper edge of a portion of the cheek contact segment is closer to the patient's median sagittal plane than the lower edge.

[0020] In one embodiment of the invention, each side extension arm may be made of a flexible material.

[0021] In one embodiment of the invention, each side extension arm may have a bend between the patient's nose and cheekbone, the curvature of which is greater than the curvature of other parts of the side extension arm, suitable for supporting the patient near the nasal alae.

[0022] In one embodiment of the invention, the width of the turning portion may be greater than the width of other portions of the side extension arm.

[0023] In one embodiment of the present invention, the line connecting the upper and lower vertices of the turning portion may not be perpendicular to the tangent of the upper edge of the side extension arm, nor perpendicular to the tangent of the lower edge of the side extension arm.

[0024] In one embodiment of the invention, the pad assembly can be inserted into, sealed inside or near the patient's nostril.

[0025] Thus, the patient interface of this invention has two downwardly folding outward extension arms, allowing it to fit snugly against the upper half of the cheekbone, providing better support and preventing the mask from slipping or sagging. Therefore, the headband maintains a moderate restraint force, which is sufficient to stably support the patient interface and prevent excessive pressure around the nostrils and cheeks. Since the two extension arms rest against the upper part of the cheekbone, they distribute the pressure caused by the overall weight of the mask, while avoiding excessive pressure on the philtrum and upper lip, thus improving wearing comfort. In addition, when the patient sleeps on their side, the frame and headband are not easily squeezed, deformed, or displaced, ensuring the therapeutic effect of the patient wearing the interface. Attached Figure Description

[0026] Figure 1 This is a schematic diagram of the structure of a patient interface according to one embodiment; Figure 2 This is an exploded view of a patient interface according to one embodiment; Figure 3 This is a cross-sectional schematic diagram of a patient interface according to one embodiment; Figure 4 This is a schematic diagram of the structure of the frame components of a patient interface according to one embodiment; Figure 5 This is a top view of a patient interface according to one embodiment; Figure 6 (a) to (f) are six views of a side extension arm according to an embodiment, including front view, rear view, left view, right view, top view and bottom view. Figure 7 (a) to (e) are schematic diagrams showing the structure and shape of a side extension arm according to an embodiment; Figure 8 This is a schematic diagram of a patient interface being worn according to one embodiment; Figure 9 This is another schematic diagram of a patient interface being worn according to one embodiment; Figure 10 This is a schematic diagram of the human skull; Figure 11 This is a side view of a patient interface according to one embodiment; Figure 12 This is a partially exploded view of a patient interface according to one embodiment; Figure 13 This is a side view of the patient interface according to another embodiment; Figure 14 This is a side view of the patient interface according to yet another embodiment; Figure 15 This is a side view of the patient interface according to another embodiment; Figure 16 This is a side view of the patient interface according to another embodiment; Figure 17 This is a schematic diagram of the patient interface according to one embodiment where the headband has not yet been attached; Figure 18 This is a three-dimensional schematic diagram of the headband combined with the patient interface according to one embodiment. Detailed Implementation

[0027] 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:

[0028] In this application, the terms “comprising,” “including,” “having,” or any other similar terms are not intended to be limited to the such elements listed herein, but may include other elements not expressly listed but which are generally inherent in the unit, component, structure, device, system, part, or area.

[0029] In this application, the ordinal terms such as "first" or "second" are used to distinguish or refer to elements or structures that are related to the same or similar ones, and do not necessarily imply a spatial order of such elements, structures, parts, or regions. It should be understood that in some cases or configurations, ordinal terms may be used interchangeably without affecting the implementation of the invention.

[0030] In this application, the terms "a" or "an" are used to describe units, components, structures, devices, 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.

[0031] This invention primarily discloses a patient interface, which is a connection method for delivering 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 therapeutic pressure to the patient's airway or its inlet, such as at least the nasal inlet and / or oral inlet. This 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 to 40 cmH2O. This therapeutic pressure can improve breathing difficulties such as sleep apnea. The patient interface provided by this invention can also be used with another fluid generator, which can deliver supplemental gas, such as gas in the range of 0 to 6 liters per minute or gas in the range of 30 to 70 liters per minute, to patients who can breathe independently but require supplemental gas.

[0032] Please refer to Figures 1 to 3 This is a structural schematic diagram, an exploded schematic diagram, and a cross-sectional schematic diagram of a patient interface according to an embodiment of the present invention.

[0033] The patient interface 1 in this embodiment is an example of a nasal pillow-type patient interface. The patient interface 1 mainly includes a frame assembly 100, a cushion assembly 200, an adapter 300, an elbow tube assembly 400, and a headband 500. The frame assembly 100, the cushion assembly 200, and the elbow tube assembly 400 are individually attached to the adapter 300 and then assembled together. Preferably, the elbow tube assembly 400 does not need to be in substantial direct contact with the frame assembly 100. Preferably, the end of the adapter 300 connected to the cushion assembly 200 has a channel opening 310 for allowing airflow generated from a fluid generator (not shown) to pass through and be delivered to the cushion assembly 200, and the width of the channel opening 310 is substantially equal to the height of the opening. The frame assembly 100 can be used to connect the headband 500 so that the patient interface 1 is stably maintained in the appropriate position on the patient's head, while the cushion assembly 200 corresponds to the patient's nose, thereby creating a positive pressure environment near the nostrils to supply breathing gas. The patient interface in this embodiment uses a nasal pillow mask as an example. The pad assembly 200 is a nasal pillow in the corresponding example. The nasal pillow can be sealed inside the patient's nostrils or sealed near the nostrils. However, it is not limited to this. The patient interface can also be a nasal mask or a full-face mask, such as a nasal cradle mask that is not sealed to the bridge of the nose but is sealed near the nostrils, or a high-flow nasal cannula that is inserted into the patient's nostrils but is not sealed in the nostrils.

[0034] Please refer to the above as well. Figure 4 , Figure 4 This is a schematic diagram of the structure of a frame assembly for a patient interface according to an embodiment of the present invention. The frame assembly 100 has a main frame 110 and two side extension arms 120. The main frame 110 has a certain degree of rigidity, for example, it is made of polycarbonate (PC) material, to support the pad assembly 200, which has a lower rigidity than the frame, during wear. Each side extension arm 120 extends a certain length from both sides of the main frame 110 and can be divided into a frame connecting section 121, a cheek contact section 122, and a headband connecting section 123. One end of the frame connecting section 121 is rotatably or fixedly attached to the main frame 110. The cheek contact section 122 rests against the patient's face during wear. The headband connecting section 123 is used to connect to the headband 500. In this preferred embodiment, the headband connecting section 123 is an elongated hole, but this is not a limitation.

[0035] The side extension arms 120 are less rigid than the main frame 110 and are flexible, for example, made of a flat sheet of TPEE (THERMOPLASTIC POLYESTER ELASTOMER) material, allowing them to be more easily folded outwards or twisted for easy placement on the patient's face. It is particularly noteworthy that the degree to which the side extension arms 120 can be folded outwards or twisted is essentially directional. This advantage allows the side extension arms 120 to be more adaptable to different head shapes or skull features, making them more suitable for the patient's face shape near the upper part of the cheekbone, thus providing better adjustability and ease of use. To increase patient comfort, the side extension arms 120 can be fitted into a cloth cover (not shown), or a soft material, such as a pad, gel, or breathable foam, can be placed between the patient's face and the cheek contact section 122 on the side closest to the patient's face.

[0036] like Figures 4 to 7 As shown, the cheek contact segment 122 has an arc and a main body that basically conforms to the shape of the cheek near the upper half of the patient's cheekbone, and is generally flat. The cheek contact segment 122 has an upper edge 122A and a lower edge 122B, the curvature of the lower edge 122B being less than the curvature of the upper edge 122A. Figure 2 , 4 As shown in Figure 5, the patient interface 1 defines a mask central axis L, which is defined as a virtual extension line passing through the center of the air inlet of the elbow tube assembly 400 and the center of the mounting hole of the adapter 300. In this embodiment, when the side extension arm 120 is not under force, the upper edge 122A of the cheek contact section 122 is closer to the mask central axis L than the lower edge 122B. For example... Figure 4As shown, a reference point P11 on the upper edge 122A is closer to the central axis L of the mask than another reference point P12 on the lower edge 122B, which corresponds to the shortest distance D1 along the surface of the side extension arm 120. This is so that when the patient interface 1 is worn, the upper edge 122A of the cheek contact section 122 is away from the apex of the patient's cheekbone.

[0037] It is worth noting that the length of distance D1 can gradually increase or decrease along the direction of the central axis L of the mask, moving closer to or further away from the patient. For example, the distance D1 can be shortest at the point where the curvature change is greatest at the upper edge 122A, while the distance D1 extending to both sides of that point can gradually increase, and vice versa. In this embodiment, the example is that the shortest distance between the upper edge 122A and the lower edge 122B of the side extension arm 120 (or, in other words, the width of the cheek contact section 122 of the side extension arm 120) gradually increases towards the patient. Figure 4 and 6 As shown, the side extension arm 120 has a first end close to the main frame 110 and a second end far from the main frame 110, and the shortest distance between the upper edge 122A and the lower edge 122B of the first end of the side extension arm 120 is smaller than the shortest distance between the upper edge 122A and the lower edge 122B of the second end. Therefore, the closer to the second end of the side extension arm 120, the larger the contact area between the side extension arm 120 and the patient's cheek. This not only increases the stability of the wearing interface for the patient but also increases wearing comfort.

[0038] In this embodiment, a bend 124 is formed at the connection between the frame connecting section 121 and the cheek contact section 122. The bend 124 is the part with the greatest curvature change on the side of the main body of the side extension arm 120. When not worn or under no force, the frame connecting section 121 extends to both sides of the main frame 110, and its extension direction is substantially parallel to the central axis L of the mask. The cheek contact section 122 extends with length, and its extension direction is away from the central axis L of the mask, until the headband connecting section 123, which is the position farthest from the central axis L of the mask.

[0039] like Figure 7As shown in (a)-(e), as an example of the outward-folding configuration of the side extension arm 120, a configuration is implemented in which the length of the upper edge 121A of the frame connecting section 121 is greater than the length of the lower edge 121B, and the line connecting the upper and lower vertices of the turning portion 124 is not perpendicular to the tangent of the upper edge 121A or the lower edge 121B of the side extension arm 120. In other words, the turning portion 124 and the upper edge 121A of the frame connecting section 121 (or the upper edge 122A of the cheek contact section 122) are at intersection point P21. The lower edge 121B of the frame connecting section 121 (or the lower edge 122B of the cheek contact section 122) is the intersection point P22. The intersection point P21 is farther from the connection point (front end side 1211) of the main frame 110 and the side extension arm 120 than the intersection point P22. On the other hand, the width W1 of the turning portion 124 is greater than the width W2 of the frame connecting section 121, thereby resulting in the lower edge 122B of the cheek contact section 122 being farther away from the central axis L of the mask than the upper edge 122A. The curvature change of the upper edge 122A of the cheek contact section 122 is also different from that of the lower edge 122B, with the curve of the lower edge 122B being gentler than that of the upper edge 122A. In addition, when not affected by external forces, the surface extending from the upper edge 122A to the lower edge 122B of the cheek contact section 122 is preferably curved.

[0040] Figure 7 (b) Mark a plurality of reference points a1-a10 and b11-b19 on the upper and lower edges of the side extension arm 120, wherein reference points a1-a10 are located on the upper edge and are equidistantly distributed, and reference points b11-b19 are located on the lower edge and are equidistantly distributed. Figure 7 (c)-(e) are schematic diagrams showing the distribution of reference points a1-a10 and b11-b19 on the three projection planes (XY, XZ, YZ) to facilitate understanding of the shape of the side extension arm 120 body in this embodiment.

[0041] Please refer to Figures 8 to 10 , Figure 8 and Figure 9 These are, respectively, a perspective view and a top view of the patient interface when wearing the device in this embodiment. Figure 10 This is a schematic diagram of the human skull.

[0042] When the patient interface of this embodiment is worn, the frame connecting segment 121 of the lateral extension arm 120 extends approximately from the position connected to the main frame 110 towards the patient's face with the shortest distance, up to the bend 124 near the nostril. The bend 124 is supported near the patient's nostril to increase the stability of the main frame 110. From the bend 124, the cheek contact segment 122 of the lateral extension arm 120 extends towards both sides of the patient's face, and the cheek contact segment 122 has an outward folding shape (e.g., at least a portion folds towards the patient's chin) to conform to the shape of the upper half of the cheekbone. The cheek contact segment 122 is located between the apex T of the patient's cheekbone ZB and the orbit OB, but still maintains an appropriate distance from the eyes to avoid eye discomfort or obstruction of vision. The surface area of ​​the cheek contact segment 122 on the side closest to the patient's face is approximately 545 mm². 2 ±10%. The cheek contact segment 122 extends along the upper half of the cheekbone towards the temple and the corner of the eye, so that the headband connecting segment 123 is located between the temple and the corner of the eye and is connected to the headband 500.

[0043] The length of the frame connecting segment 121 is related to the depth of the main frame 110 accommodating the pad assembly 200 (the collapsible space of the pad assembly 200 in the main frame 110), the firmness of the pad assembly 200, the wearing angle of the pad assembly 200, and the depth of the nasal occipital portion of the pad assembly 200 into the nostril. In this preferred embodiment, the pad assembly 200 is made of silicone material and includes a base and two nasal occipitals with gas communication to the base. Each nasal occipital includes a head and a neck, wherein the head is a truncated hollow cone, and one end of the neck is connected to the base, and the other end is connected to the head. In other preferred embodiments, the pad assembly further includes two support portions, each of which is located on the outer side of the two nasal occipitals to abut against the sides of the nasal wings, such as the nasolabial folds near the nasal wings. Furthermore, at least a portion of the support is connected to the head of the nasal pillow, while the neck is located on the inner side of the nasal pillow. Therefore, when the head of the nasal pillow is inserted into the patient's nostril, the support can increase the wearing stability of the pad assembly, and the neck of the nasal pillow can change the angle between the heads of the two nasal pillows to reduce the pressure of the nasal pillow on the nostril. In another preferred embodiment, the pad assembly also has a base, two nasal pillows, and two support portions, but the nasal pillows only have heads and no necks. One side of the nasal pillow, for example, the outer side, is connected to the corresponding support portion, while the other side of the nasal pillow, for example, the inner side, is directly connected to the base. The head of the nasal pillow forms a protruding skirt that can extend into the nostril or fit against the outer periphery of the patient's nostril, and deforms to adapt to different patients' nose shapes / nostril angles to reduce the pressure of the nasal pillow on the nostril.

[0044] like Figure 10As shown, on the human skull, the zygomatic bone (ZB) is located below and outside the eye socket (OB), and is a relatively convex part of the facial contour. The apex (T) of the zygomatic bone (ZB) is the most prominent position of the zygomatic bone on the facial contour. The zygomatic bone (ZB) is distinguished by the position of its apex (T). The area extending from apex T towards the eye socket (OB) is defined as the upper half or upper part of the zygomatic bone, and the area extending from apex T towards the cheek is defined as the lower half or lower part of the zygomatic bone. Please refer to this information. Figures 8 to 10 When the patient interface of this embodiment is worn, the upper edge 122A of the cheek contact segment 122 is closer to the patient's eye socket OB than the lower edge 122B, thereby forming an outward folding shape of the lateral extension arm 120 towards the patient's chin, so that the cheek contact segment 122 conforms to the facial surface corresponding to the upper part of the zygomatic bone ZB.

[0045] The sagittal plane is anatomically defined as a longitudinal section that divides the human body into left and right parts. The sagittal plane that divides the torso into two equal or symmetrical parts (left and right) through the midline is defined as the median sagittal plane. In this embodiment, under normal wearing conditions or general circumstances, the central axis L of the mask is located on the median sagittal plane that divides the head into left and right parts. Accordingly, when the patient interface of this embodiment is worn, the upper edge 122A of the cheek contact section 122 is closer to the patient's median sagittal plane than the lower edge 122B, thereby forming the everted shape of the lateral extension arm 120.

[0046] In this embodiment, the patient interface can be fitted onto the upper half of the face corresponding to the left and right cheekbones ZB via two everted extension arms 120. Specifically, the cheek contact section 122 rests against the upper part of the cheekbone between the apex T of the cheekbone ZB and the orbit OB, and is far from the lower part of the cheekbone. The upper edge 122A and lower edge 122B of the cheek contact section 122 are both higher than the apex T of the patient's cheekbone ZB, allowing the overall weight of the patient interface to be transferred to the cheekbone ZB via the side extension arms 120. Compared to fixing a frame or headband to the apex T or lower part of the cheekbone ZB, which requires tightening the headband or highly elastic headband to create a strong headband restraint force to stably clamp the patient's head, the side extension arms 120 in this embodiment can be more effectively supported by the inherent structure of the upper half of the cheekbone ZB, rather than simply relying on the restraint force of the headband to press the frame or headband against the apex T or lower part of the cheekbone ZB, thus preventing the patient interface from slipping down. In this way, patients do not need to pull the headband too tight or use a highly elastic headband to stably fix the patient interface in the appropriate position on their face, thereby avoiding excessive pressure on the area around the patient's nostrils and cheeks.

[0047] Furthermore, since the side extension arm 120 is positioned above the ZB zygomatic bone when the patient interface is worn, avoiding the most prominent ZB apex T and the lower part of the zygomatic bone where it would touch the pillow when sleeping on one's side, patients wearing the patient interface of this embodiment are less likely to experience discomfort due to excessive pressure from the side extension arm 120 on their face when sleeping on their side. The reduced foreign body sensation when wearing the patient interface helps increase patient compliance.

[0048] Because the side extension arm 120 is a flat sheet made of flexible material, it can easily be flipped open or twisted to accommodate changes in the patient's facial shape. Therefore, the cheek contact section 122 of the side extension arm 120 better conforms to the contours of the upper half of the cheekbones on both sides, allowing the weight of the patient's face to be distributed across the cheekbones. This prevents the mask from sagging excessively due to gravity, thereby reducing discomfort caused by excessive pressure exerted on the philtrum and upper lip by the pad or nose pillow. The flexible material can be selected from thermoplastic materials (e.g., TPEE), polymer materials (e.g., silicone), colloids or foams, or composite materials containing any of the above materials, but is not limited thereto.

[0049] like Figure 8 and 9 As shown, the length of the cheek contact section 122 is greater than the length of the frame connecting section 121 and the headband connecting section 123, so that when worn, each side extension arm 120 extends across the patient's cheek, and the headband connecting section 123 is approximately located between the corner of the eye and the temple. Through the connection of the headband 500, the patient's face is maintained in a fixed position when worn, and the two side extension arms 120 are located on the upper part of the cheekbone.

[0050] In one embodiment of the present invention, the frame assembly 100 can be configured such that each extension arm 120 is rotatable, has limited rotation, or is non-rotatable relative to the main frame 110 in a plane parallel to the sagittal plane. Specifically, if the lateral extension arm 120 is rotatable relative to the main frame 110, the angle between the lateral extension arm 120 and the main frame 110 can be adjusted, allowing the lateral extension arm 120 to adapt to more different patient head shapes; if the lateral extension arm 120 is non-rotatable relative to the main frame 110, the overall stability of the patient interface can be increased.

[0051] Please refer to Figure 11 and 12 In this embodiment, the side extension arm 120 cannot swing up and down relative to the main frame 110, that is, the side extension arm 120 is not rotatable relative to the main frame 110 on a plane parallel to the sagittal plane.

[0052] For example, the frame connecting section 121 of each side extension arm 120 can be assembled with the main frame 110 by means of a snap-fit ​​structure 125. The snap-fit ​​structure 125 can be a separate fastener or a structure integrally formed with the side extension arm 120 or the main frame 110, and is not limited to this embodiment or the drawings. In other embodiments, the frame connecting section 121 of each side extension arm 120 and the main frame 110 can be integrally formed.

[0053] A first limiting part 111 may be provided on the main frame 110 at the position corresponding to the connection of the side extension arm 120, to limit the range of rotation of the side extension arm 120 about the snap-fit ​​structure 125 as the axis, such as Figure 10 and 11 As shown, the first limiting part 111 is a baffle wall that protrudes outward on the surface of the main frame 110. It forms a notch that is complementary to the shape of the front end side surface of the frame connecting section 121 of the side extension arm 120. The inner side wall 1111 of the first limiting part 111 and the front end side surface 1211 of the frame connecting section 121 of the side extension arm 120 abut against each other, thereby restricting the side extension wall 120.

[0054] The side extension wall 120 may have a second limiting portion 126, which is a stop formed on the front end side (upper / lower edge) of the frame connecting section 121, to abut against the end face 1101 of the main frame 110 and the first limiting portion 111, thereby creating interference between the second limiting portion 126 and the main frame 110 and preventing it from swinging up or down. In this embodiment, the surface of the second limiting portion 126 that abuts is approximately parallel to the end face surface of the first limiting portion 111.

[0055] In this embodiment, the limiting effect can be achieved by implementing at least one of the first limiting part 111 and the second limiting part 126.

[0056] Please refer to Figure 13 In this embodiment, the side extension arm 120' can swing upward relative to the main frame 110' within a limited angle range.

[0057] As shown in the figure, there is a gap 112 between the first limiting part 111' and the frame connecting section 121' of the side extension arm 120'. That is, the shape of the notch formed by the first limiting part 111' is not completely complementary to the shape of the front end side of the frame connecting section 121' of the side extension arm 120', so that the side extension arm 120' can swing upward within the swing angle range of θ1, and the range of θ1 can be 3-5 degrees.

[0058] In this embodiment, a second limiting part 126' is provided at the lower edge of the frame connecting section 121' of the side extension arm 120' to allow the side extension arm 120' to swing only upward.

[0059] Please refer to Figure 14 In this embodiment, the side extension arm 120” can swing up and down relative to the main frame 110” within a limited angle range.

[0060] As shown in the figure, there are gaps 112a and 112b between the first limiting part 111” and the frame connecting section 121” of the side extension arm 120”. That is, the notch shape formed by the first limiting part 111” is only partially complementary to the front end side shape of the frame connecting section 121” of the side extension arm 120”, so that the side extension arm 120” can swing up and down within the angle range of θ2. The range of θ2 can be 1-26 degrees, preferably 22-25 degrees.

[0061] As an example, the thickness of the cheek contact segment 122” can be between 0.5-1 mm, preferably 0.8 mm; to increase stability, the entire or partial thickness of the frame connecting segment 121” used to connect the main frame 110”, and the entire or partial thickness of the headband connecting segment 123” used to connect the headband, are thicker than the thickness of the cheek contact segment 122”. A longer and thinner cheek contact segment 122” allows the side extension arms 120” to be flexible, enabling them to open outwards when not fully worn, thus creating a larger angle between the two extension arms 120”, facilitating the wearing process and adapting to different face sizes; furthermore, the thickness of the cheek contact segment 122” can also be uniform or varied, for example… Figure 13 As shown, the cheek contact segment 122” may have a recessed portion 122C, so that the cheek contact segment 122” has a thinner thickness at the recessed position, thereby increasing flexibility.

[0062] like Figure 15 As shown, the side extension arm 120 may have an opening 127, which may be formed at or near the bend 124 to enhance the flexibility of the side extension arm 120, making it easier for the side extension arm 120 to flex outward (away from the central axis L of the face mask) or inward (towards the central axis L of the face mask). As an alternative embodiment, the opening may also be located only within the frame connection section, without being limited by the figures.

[0063] Furthermore, the side extension arm 120 may have a piece 128 at the bend 124. The piece 128 extends from the cheek contact section 122 and protrudes into the opening 127. The piece 128 connects to the cheek contact section 122 and together with the cheek contact section 122 forms a surface that contacts the cheek, thereby increasing the contact area of ​​the side extension arm 120 with the face. The thickness of the piece 128 may be the same as the thickness of the cheek contact section 122. In addition, since the piece 128 extends from the cheek contact section 122 and protrudes into the opening 127, it forms a hook-like structure at the bend 124. If the patient needs to put a cloth cover (not shown) on the side extension arm 120, one end of the cloth cover can be hooked onto the hook-like structure formed by the piece 128, making the cloth cover less likely to slip off.

[0064] Please refer to Figure 16 This is a schematic diagram of the patient interface according to another embodiment of the present invention. The frame assembly 100 can be configured such that each side extension arm 120 can be rotated and opened outward relative to the main frame 110, and the large angle formed between the two side extension arms 120 makes it easier for the side extension arms 120 to flex outward (away from the central axis L of the mask) or inward (towards the central axis L of the mask).

[0065] For example, the main frame 110 has a rotating support column 113 on each of its left and right sides, and the front end of the frame connecting section 121 of the side extension arm 120 has a fastener 129, which is correspondingly fastened to the rotating support column 113 so that the side extension arm 120 can rotate outward with the rotating support column 113 as the axis.

[0066] Please refer to Figure 17 and 18 And can be referenced at the same time. Figure 1 , 8 and 9, Figure 17 This is a schematic diagram of the patient interface in this embodiment where the headband 500 has not yet been assembled. Figure 18 This is a schematic diagram of the headband 500 combined in the patient interface of this embodiment.

[0067] In one embodiment of the invention, the headband 500 may include a plurality of 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 fixed 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 at least two side straps 510, a top strap 520, and a rear strap 530, with the top strap 520 connected between the two side straps 510. Each side strap 510 is detachably attached to a headband connecting section 123 of a corresponding side extension arm 120. The side straps 510 may pass through connecting holes on the headband connecting section 123 and may be secured by Velcro, buttons, or other means. The two side straps 510 and the top strap 520 can be integrated. Near the junction of the side straps 510 and the top strap 520, there is a connecting portion 540 (one on each side). This connecting portion 540 is used to connect to the back strap 530, for example, by sewing. When the patient interface is worn, the top strap 520 spans the top of the patient's head, and the back strap 530 is located at the occipital bone.

[0068] In this embodiment, the back strap 530 may have an elastic segment 531 in the middle. This elastic segment 531 may be, for example, an elastic webbing made of a blend of nylon and spandex. Other parts of the back strap 530 may be, for example, a composite fabric made of cloth and foam, providing sufficient support and preventing curling. The elastic segment 531 has greater elasticity than other parts of the back strap 530. When worn, the elastic segment 531 can elastically expand to conform to the shape of the patient's occipital bone.

[0069] As an example, the elongation of the elastic segment 531 is 200%, while the elongation of other parts of the rear band 530 is 100%.

[0070] As an example, the elastic segment 531 may account for 8.77%-26.32% of the total length of the rear belt body 530. Preferably, the elastic segment 531 may account for 17.54% of the total length of the rear belt body 530. In practice, the length of the elastic segment 531 may be 40 mm, and the length of the rear belt body 530 may be 228 mm.

[0071] The width of the back band 530 can be the same as or different from the width of the elastic segment 531. For example, the width of the back band 530 may be wider in the middle and narrower at both ends, while the elastic segment 531 may be at its widest point. The proportion of the narrower ends of the back band 530 to the total width of the elastic segment 531 can be 52%-68%, preferably 60%. The width of the back band 530 can vary continuously or discontinuously. By designing the elastic segment 531 in the middle of the back band 531 to be wider and more elastic, the comfort and stability of the patient's wearing experience can be improved. In practice, the length of the narrower ends of the back band 530 can be 12-20 mm, preferably 12 mm ± 1 mm, and the total width of the elastic segment 531 should be at least greater than 15 mm, preferably 20 mm ± 1 mm.

[0072] The width of the top band 520 itself can vary or remain constant. In this embodiment, the width of the top band 520 is wider in the middle and narrower at both ends, with the narrower ends (closer to the connecting portion 540) accounting for 53%-68% of the total width of the widest part in the middle. Preferably, the narrower ends (closer to the connecting portion 540) account for 60% of the total width of the widest part in the middle. The wider middle section of the top band 520 also improves the stability of the patient's wearing experience. In practice, the length of the narrower ends of the top band 520 can be 12-20 mm, preferably 12 mm ± 1 mm, and the widest part in the middle of the top band 520 is at least greater than 15 mm, preferably 20 mm ± 1 mm.

[0073] In this embodiment, after the rear strap 530 is attached to the connecting portion 540, the rear strap 530, side straps 510, and top strap 520 can form a headband 500. The connecting portion 540 extends from the junction of the side strap 510 and the top strap 520, and its extension direction is approximately parallel to the attached rear strap 530. The extension direction of the connecting portion 540 and the extension direction of the top strap 520 form a strap angle α. The strap angle α is an obtuse angle greater than 100 degrees and less than 180 degrees, preferably 150 degrees.

[0074] As described above, to avoid undue pressure on the patient's face and head from the patient interface, the two side extension arms 120 of the patient interface of this invention are located on the upper half of the left and right cheekbones. To ensure that the side extension arms 120 can stably remain on the upper half of the cheekbones, the patient interface of this invention can be paired with a headband 500, with at least a portion of the headband 500 located near the patient's occipital bone. For example, the top band 520 of the headband 500 is located on the parietal bone of the patient's head, while the back band 530 of the headband 500 is located on the occipital bone of the patient's head, and the extending direction of the connecting portion 540 of the headband 500 maintains an obtuse angle with the extending direction of the top band 520. This prevents the patient interface from slipping off the top of the head during sleep, making the overall wearing of the patient interface more stable. However, since the characteristics of the occipital bone of the head vary from person to person, in order to make the posterior band 530 conform to the shape of the occipital bone of different patients, the elastic segment 531 of the posterior band 530 has greater extensibility than the top band 520, so as to ensure the balance of the overall patient interface system when worn on the patient's head, and also to solve the problem of needing to make various headband sizes due to the poor extensibility of the headband 500.

[0075] Please refer to Figure 2 and Figure 4 To facilitate patient identification of the installation orientation of the frame assembly 100 and the pad assembly 200, the main frame 110 has a protrusion 114 on the side near the pad assembly 200 to correspond to the groove 201 of the pad assembly 200. However, this structure is not limited to this; the patient can also be guided by shape (e.g., triangle or trapezoid), indicator symbols, or text (e.g., indicating R for right, L for left). Additionally, please refer to... Figures 1 to 4 To enable patients to easily identify the wearing orientation of the patient interface 1 in low-light environments, the upper side of the main frame 110 has a sheet 115 that protrudes away from the pad assembly 200. In this way, patients do not need to rely entirely on vision; they can perceive the up / down and front / back directions of the patient interface 1 through touch to confirm the wearing orientation. Since the elbow tube assembly 400 of the patient interface 1 can typically rotate relative to the frame assembly 100 to accommodate the placement of the continuous positive pressure respirator, to facilitate patient identification of the wearing orientation of the patient interface 1, the elbow tube assembly 400 can be designed to rotate only within a limited angle relative to the frame assembly 100, such as 180 degrees to 359 degrees, but is not limited to this. Patients can also perceive the up / down direction of the patient interface 1 by rotating the elbow tube assembly 400, thereby determining the wearing orientation of the patient interface 1.

[0076] Thus, the patient interface of this embodiment of the invention has two downwardly folded outward extension arms, which can fit snugly against the upper part of the cheekbone, providing better support for the patient interface and preventing the mask from slipping or sagging. Therefore, the headband maintains a moderate binding force, which is sufficient to stably support the patient interface and prevent excessive pressure on the area around the patient's nostrils and cheeks. Since the two extension arms rest against the upper part of the cheekbone, the pressure caused by the overall weight of the mask is distributed, while avoiding excessive pressure on the philtrum and upper lip, thereby improving wearing comfort. In addition, when the patient sleeps on their side, the frame and headband are not easily squeezed, deformed, or displaced, ensuring the therapeutic effect of the patient wearing the patient interface.

[0077] Preferred embodiments have been disclosed above. However, those skilled in the art should understand that the embodiments described herein are for illustrative purposes only 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 should be understood to be covered within the scope of the invention. Therefore, the scope of protection of this invention is determined by the scope of the claims. Figure Labels

[0078] 1. Patient Interface 100 Framework Components 110,110',110” Main frame 1101 end face 111,111” First limit section 1111 Inner wall 112 gap 112a, 112b gap 113 Rotating support 114 bumps 115 pieces 120", 120", 120" Side extension arm 121,121',121” Frame connection segment 1211 Front end side 122,122” Cheek contact segment 122A Upper edge 122B Lower edge 123,123” Headband Connector Section 124 Turning point 125 snap-fit ​​structure 126 Second Limiting Part 127 Opening 128 pieces 200 cushion assembly 201 Groove 300 adapter 310 Channel Opening 400 elbow tube assembly 500 headband 510 Side girdle 520 Top band body 530 Backband 531 Elastic Segment 540 Connecting part L-shaped mask center axis OB eye socket ZB cheekbone T vertex a1-a10 reference points b11-b19 reference points P11 Reference Point P12 Reference Point P21 Intersection P22 Intersection

Claims

1. A patient interface for delivering gas to a patient's airway, the patient interface comprising: A headband is used to hold the patient interface on the patient's head; and A frame assembly for connecting the headband, the frame assembly having a main frame and two side extension arms extending from both sides of the main frame. in, When the side extension arm is not under force, the upper edge of the cheek contact segment of the side extension arm is closer to the central axis of the mask of the patient interface than the lower edge. The central axis of the mask is located on the midsagittal plane that divides the skull into left and right parts. When the patient interface is worn, the upper and lower edges of the cheek contact segment are higher than the apex of the patient's cheekbone, and the upper edge of the cheek contact segment is far away from the apex of the patient's cheekbone.

2. The patient interface as described in claim 1, wherein, When the patient interface is worn, the upper edge of the cheek contact segment is closer to the patient's eye socket than the lower edge.

3. The patient interface as described in claim 1, wherein, When the patient interface is worn, the upper edge of the cheek contact segment is closer to the patient's median sagittal plane than the lower edge.

4. The patient interface as described in claim 1, wherein, The patient interface also includes: A cushion assembly for creating an air cavity with a positive pressure environment near the entrance to the patient's airway; An elbow tube assembly for delivering gas generated by a fluid generator to the air cavity of the cushion assembly; and An adapter is provided for connecting the frame assembly, the pad assembly, and the elbow tube assembly, wherein the center of an air inlet of the elbow tube assembly and the center of a mounting hole of the adapter define the central axis of the mask.

5. The patient interface as described in claim 1, wherein, When the patient interface is worn, the cheek contact section rests against the upper part of the patient's cheekbone and is far away from the lower part of the patient's cheekbone.

6. The patient interface as described in claim 1, wherein, Each of the side extension arms has a first end close to the main frame and a second end away from the main frame, wherein the shortest distance between the upper and lower edges of the first end is less than the shortest distance between the upper and lower edges of the second end.

7. The patient interface as described in claim 1, wherein, Each of the said side extension arms further includes: A frame connection segment for connecting to the main frame; and A turning section is located between the frame connecting section and the cheek contact section, such that the cheek contact section extends away from the central axis of the mask on the patient interface along its length.

8. The patient interface as described in claim 1, wherein, Each side extension arm is rotatably connected to the main frame.

9. The patient interface as described in claim 1, wherein, Each of the said side extension arms further includes a headband connecting section for connecting the headband.

10. The patient interface as claimed in claim 1, wherein, The headband includes two side bands, a top band, and a back band. The top band is connected between the two side bands. Each side band is detachably attached to a headband connecting section of the two side extension arms. The top band crosses the top of the patient's head when worn, and the back band is located at the occipital bone of the patient when worn.

11. The patient interface as claimed in claim 10, wherein, In the headband, the rear band has an elastic segment with an elongation greater than that of other parts of the rear band.

12. The patient interface as described in claim 10, wherein, In the headband, the width of the back band is wider in the middle and narrower on both sides.

13. The patient interface as described in claim 10, wherein, In the headband, the width of the top band is wider in the middle and narrower on both sides.

14. The patient interface as described in claim 1, comprising: A cushion assembly for creating an air cavity with a positive pressure environment near the entrance to the patient's airway; in, The two extension arms are located adjacent to both sides of the pad assembly. When worn, the cheek contact section is located between the apex of the patient's cheekbone and the eye socket, and is adapted to the upper edge of the upper half of the patient's left and right cheekbones, so as to avoid the apex and lower half of the patient's cheekbone.

15. The patient interface as described in claim 14, wherein, The upper edge of a portion of the cheek contact segment is closer to the patient's median sagittal plane than the lower edge.

16. The patient interface as described in claim 14, wherein, Each of the aforementioned side extension arms is made of a flexible material.

17. The patient interface as described in claim 14, wherein, Each of the said lateral extension arms has a bend between the patient's nose and cheekbone, the curvature of which is greater than that of the other parts of the lateral extension arm, suitable for support near the patient's nasal alae.

18. The patient interface as described in claim 17, wherein, The width of the turning section is greater than the width of a frame connection segment of the side extension arm.

19. The patient interface as claimed in claim 17, wherein, The line connecting the upper and lower vertices of the turning section is not perpendicular to the tangent of the upper edge of the side extension arm, nor is it perpendicular to the tangent of the lower edge of the side extension arm.

20. The patient interface as described in claim 14, wherein, The pad assembly is inserted into, sealed inside or near the patient's nostril.

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