Respiratory mask system

Abstract

The present invention relates to a breathing mask system. The breathing mask system includes a mask interface, which includes a frame for a headgear assembly. The frame includes a body, which includes a first surface and a generally opposite second surface. The body also includes a gas inlet and an optional gas outlet. The gas inlet can be generally elliptical in shape. The frame can include a recessed area for receiving a yoke of the headgear assembly to attach the headgear to the mask interface. The breathing mask system can also include a yoke for attaching to the frame.

Description

[0001] This application is a divisional application of a patent application with an international application date of March 15, 2017, application number 201780029845.5 (PCT / NZ2017 / 050025), and invention name “Breathing Mask System”. Technical Field

[0002] The present disclosure generally relates to respiratory mask systems for delivering respiratory therapy to a patient. More specifically, the present disclosure relates to various components of a respiratory mask system. Background Art

[0003] Respiratory masks are used to provide respiratory therapy to the airways of people suffering from a variety of respiratory diseases or conditions. Such therapy may include, but is not limited to, continuous positive airway pressure (CPAP) therapy and non-invasive ventilation (NIV) therapy.

[0004] CPAP therapy can be used to treat obstructive sleep apnea (OSA), a condition in which a person's airway intermittently collapses during sleep, preventing the person from breathing for periods of time. The stops in breathing, or apneas, cause the person to wake up. Repeated and frequent apneas can cause the person to rarely get a full and restorative night's sleep.

[0005] CPAP therapy involves delivering continuous positive air pressure to a patient's airway via a breathing mask. The continuous positive air pressure acts as a splint within the patient's airway, securing the airway in an open position so that the patient's breathing and sleep are not interrupted.

[0006] A respiratory mask typically includes a patient interface and a headgear, wherein the patient interface is configured to deliver continuous positive air pressure to the patient's airway via a seal or cushion that forms an airtight seal in or around the patient's nose and / or mouth. Respiratory masks are available in a variety of styles, including full-face masks, nasal masks, and direct oronasal masks that form an airtight seal with the nose and / or mouth. The seal or cushion is held in place on the patient's face by a headband. In order to maintain an airtight seal, the headband should provide support for the patient interface so that it remains in a stable position relative to the patient's face during use. Such respiratory masks can also be used to deliver NIV and other treatments. Summary of the invention

[0007] The systems and devices described herein have innovative aspects, no single one of which is essential or solely responsible for their desired value.Without limiting the scope of the claims, some advantageous features will now be summarized.

[0008] In a first aspect, the present invention provides a respiratory mask system comprising a mask interface, the mask interface comprising a frame for a headgear assembly, wherein the frame comprises a body, the body of the frame comprising a first surface and a substantially opposite second surface; and wherein the body of the frame also comprises a gas inlet and a gas outlet.

[0009] In one embodiment, the frame is configured such that the gas inlet forms an angle of about 10° to 45° with the vertical.

[0010] The gas inlet may have a generally oval shape, wherein the gas inlet is located generally longitudinally along the length of the frame.

[0011] In one implementation, the frame may include an opening defined by a substantially continuous edge provided by a sealing flange projecting from a rear surface of the frame.

[0012] The gas inlet may be of generally elliptical shape.Preferably, the generally elliptical gas inlet extends longitudinally between the left and right sides of the frame.

[0013] The mask interface may also include a seal configured to be attached to the frame. The seal may include a front surface and a rear surface and an air inlet that may substantially correspond to the air inlet of the frame. The air inlet of the seal may include a substantially continuous lip configured to be attached to the sealing flange.

[0014] In one embodiment, the gas inlet of the frame includes a separator extending between two generally opposite points on the continuous edge to divide the opening into a gas inlet and a gas outlet.

[0015] Optionally, the seal forms part of a sealing assembly, the sealing assembly also including an inner clamp and an outer clamp, each of the inner clamp and the outer clamp including a collar, the collar including an air inlet, wherein the inner clamp also includes a partition, the partition spanning the air inlet of the inner clamp to divide the opening into an air inlet orifice and a vent orifice.

[0016] The inner clamp may be attached to the sealing flange of the frame such that the air inlet aperture is substantially aligned with the gas inlet of the frame and the vent aperture is substantially aligned with the vent aperture of the frame.Preferably, the sealing flange comprises one or more recesses into which a portion of the inner clamp may be retained.

[0017] In one implementation, the inner clamp includes a hooked flange extending around at least a portion of its outer periphery, and the outer clamp also includes a hooked flange extending around at least a portion of its periphery. The inner and outer clamps can be attached together so that the hooked flanges of each clamp face each other and form a sealing channel therebetween. The seal can include a substantially continuous lip configured to remain within the sealing channel.

[0018] In one embodiment, when the frame is in use, the gas outlet may be located above the gas inlet. In another embodiment, when the frame is in use, the gas outlet may be located below the gas inlet.

[0019] Optionally, the gas inlet and outlet are located substantially centrally along the length of the frame.

[0020] Preferably, a diffuser is located within the air outlet.

[0021] In one implementation, the respiratory mask system further includes a headgear assembly including a yoke configured to be attached to the frame. The frame may include a recessed area within which the yoke may be retained.

[0022] In a second aspect, the present invention provides a respiratory mask system comprising a mask interface, the mask interface comprising a frame for a headgear assembly, wherein the frame includes a body, the body of the frame including a front surface and a generally opposite rear surface, wherein the front surface of the body includes a recessed area, and a yoke of the headgear assembly can be positioned in the recessed area.

[0023] In one implementation, the recessed area may include a channel extending substantially through the length of the frame. Preferably, the channel is configured to extend substantially horizontally through the frame when the frame is in use. The channel may include: two side regions, each side region is located at an opposite end of the channel; and a substantially central region located between the two side regions.

[0024] In one implementation, the channel may include extension members extending from either side of the body of the frame.

[0025] Preferably, the frame comprises a gas inlet.The gas inlet may comprise a generally elliptical shape, wherein the gas inlet is located generally longitudinally along the length of the frame.

[0026] Preferably, the frame further comprises an air outlet. In one embodiment, at least a portion of the air outlet may be located within the channel. Alternatively, the entire air outlet may be located within the channel. The air outlet may comprise a diffuser.

[0027] Preferably, the frame is generally curved outwards from left to right. In one implementation, the front surface of the frame is generally curved outwards from top to bottom.

[0028] In one embodiment, the channel may include a first wall forming an upper surface, a second wall forming a lower surface substantially opposite to the first wall, and a channel floor forming a rear surface extending between the first wall and the second wall. In another embodiment, the channel consists of a rear surface and a lower surface.

[0029] Preferably, the lower surface of the channel comprises a recessed area.The recessed area may be located substantially adjacent to the air outlet.

[0030] In one implementation, the upper surface of the channel may include a recessed area. The recessed area of ​​the upper surface may be positioned substantially adjacent to the air outlet.

[0031] In one embodiment, the lower surface of the channel may be angled inwardly toward the rear surface of the channel.

[0032] In one embodiment, the upper surface of the channel may be angled inwardly toward the rear surface of the channel.

[0033] In one implementation, the height of the rear surface of the channel may be substantially defined by the distance between the upper and lower surfaces of the channel.Preferably, the height of the rear surface of the channel at its central region is less than the height of the channel at one or both side regions.

[0034] In one implementation, the lower surface of the channel may have a depth defined approximately by the distance between the rear surface of the channel and the distal end of the second edge.Preferably, the lower surface has a greater depth in a central region of the channel than at a side region.

[0035] In one implementation, the frame may include at least one attachment feature for attaching the headgear yoke to the frame. In one implementation, the at least one attachment feature may include an attachment aperture, a magnet, or an attachment tab. In one implementation, the at least one attachment feature may be located on a rear surface of the channel.

[0036] In one implementation, the at least one attachment feature may be an attachment aperture located on the rear surface of the channel. In one implementation, the attachment aperture may be located at each side region of the rear surface of the channel. The at least one attachment aperture may be configured to receive a protruding attachment feature of the headgear yoke to attach the headgear yoke to the frame.

[0037] In one embodiment, at least one attachment feature includes at least one magnet located in a channel of the frame. Preferably, the at least one magnet is located on the rear surface of the channel. In one embodiment, a plurality of magnets are located on the rear surface of the channel. Preferably, the magnets are spaced equidistantly from one another. The magnets may be positioned along a centerline extending along the length of the channel. Alternatively, the magnets may be positioned to one side of the centerline extending along the length of the channel. In one embodiment, the magnets may be closer to the upper surface of the channel than to the lower surface of the channel. Optionally, the channel may include one or more recesses in which one or more protruding flanges may be located.

[0038] In one embodiment, the at least one attachment feature comprises at least one attachment tab extending through at least a portion of the channel. Preferably, the at least one attachment tab extends from an upper surface or a lower surface of the channel and protrudes toward a substantially opposite channel surface. In one embodiment, the attachment protrusion protrudes from the upper surface of the channel, and the recess is disposed between a rear surface of the attachment tab and a rear surface of the channel.

[0039] In one implementation, the at least one attachment feature comprises a latch extending through the entire height of the channel from the upper surface to the lower surface of the channel. In one implementation, the at least one latch may be removable. Optionally, the at least one latch may be configured to attach to a lock disposed on the frame. In one implementation, the at least one attachment tab may be configured to attach to the lock in a snap-fit ​​arrangement. In other implementations, the at least one latch may be configured to attach to a lock disposed on a yoke. Preferably, the at least one latch is hingedly attached to the frame.

[0040] In a third aspect, the present invention provides a respiratory mask system comprising a yoke for a headgear assembly, wherein the yoke includes a body, the body of the yoke including: a front surface, the width of the front surface is defined by the distance between the top surface and the bottom surface of the yoke, and the yoke length of the front surface is defined by the distance between the opposite ends of the yoke; a middle portion located between two side portions, the side portions are located at or near the ends of the yoke, wherein the width of the yoke at the middle portion is less than the width of the yoke at the side portions.

[0041] In one implementation, a middle portion of the top surface of the yoke may be curved inwardly.

[0042] In one implementation, a middle portion of the bottom surface of the yoke may be curved inwardly. In another implementation, the bottom surface of the yoke may lie in substantially the same plane along the length of the yoke.

[0043] In one implementation, the front surface of the middle portion of the yoke may slope rearwardly from the top surface to the rear surface.

[0044] In one implementation, the front surface of the side portion of the yoke may be inclined forward from the top surface to the bottom surface. Alternatively, the front surface of the side portion may be substantially perpendicular to the bottom surface and / or the top surface.

[0045] In one implementation, the middle portion of the yoke tapers from the front surface to the rear surface.

[0046] In one implementation, the top surface of the middle portion slopes downward from the rear surface to the front surface.

[0047] In one implementation, the bottom surface of the middle portion slopes upward from the front surface to the rear surface.

[0048] In one embodiment, at least a portion of the yoke body may be covered in a fabric cover. Preferably, the fabric cover is a woven fabric that is substantially extensible in at least one direction. Preferably, the yoke is injection molded into the fabric cover.

[0049] In one embodiment, the yoke body may include a rear surface including a pair of locating features. Each locating feature may be located on a side portion of the yoke.

[0050] In one implementation, each locating feature projects from a rear surface of the yoke and includes an alignment surface that slopes outwardly from the rear surface toward an end of the yoke.

[0051] In one implementation, each alignment surface may be oriented at an angle such that the alignment surfaces are closer together near the bottom surface than near the top surface of the yoke.

[0052] In one implementation, the at least one positioning feature may include a generally curved protrusion formed at or near an end of the yoke and may protrude from a rear surface of the yoke.

[0053] Preferably, at least one locating member is formed integrally with the yoke body.

[0054] In one implementation, one or more locating features may be formed from an overmould located at or near each end of the yoke.

[0055] In one embodiment, one positioning component may include a hook and the other positioning component may include a post.

[0056] In one implementation, the tongue may protrude from the top surface of the yoke. Preferably, the tongue protrudes from a mid-portion of the yoke. Optionally, the tongue comprises a flange protruding from the top surface and generally along the length of the yoke.

[0057] In one embodiment, one or more magnets may be located on the rear surface of the yoke. The rear surface may include one or more recesses in which one or more magnets may be retained. The magnets may be equally spaced. The magnets may be positioned along a centerline extending along the length of the yoke. In another embodiment, a flange may protrude from the top surface of the yoke such that the height of the yoke is defined by the distance between the bottom surface and the distal edge of the flange, wherein the magnets may be closer to the bottom surface of the yoke than to the distal edge of the flange.

[0058] In one implementation, the yoke body may include a material that is generally extensible along its length, and the yoke may include one or more attachment features for engaging with one or more complementary attachment features provided on the frame of the respiratory mask system to attach the yoke to the frame.

[0059] In one implementation, the malleable yoke body may include at least one attachment feature including a hook configured to engage with a corresponding hook, recess, or opening of the frame to attach the yoke to the frame.

[0060] In one embodiment, the yoke may include a collection member for one or more filaments, the yoke forming part of an automatically adjustable headgear assembly.

[0061] In a fourth aspect, the present invention provides a respiratory mask system comprising a frame according to the first or second aspect of the invention and a yoke according to the third aspect of the invention. The frame and the yoke may comprise any feature or combination of features as described above with respect to the first, second and third aspects of the invention.

[0062] In some embodiments, a respiratory mask system includes a mask frame and a yoke. The mask frame includes an inlet configured to be connected to a gas conduit during use, a yoke channel, and a retaining ridge. The yoke channel extends longitudinally through the mask frame and is defined by an upper wall, a rear wall, and a lower wall. The retaining ridge protrudes downward from the upper wall into the yoke channel. The yoke is configured to be at least partially disposed in the yoke channel. The yoke includes a retaining notch located in an upper surface of the yoke. The retaining ridge is configured to snap fit into the retaining notch when the yoke and the mask frame are coupled together.

[0063] The retaining notch can be located along a corner between a front wall and a top wall of the yoke. The yoke can include a yoke front and a yoke rear attached to the yoke front. The yoke front can include the retaining notch.

[0064] In some embodiments, a respiratory mask system includes a mask frame and a yoke. The mask frame includes an inlet configured to be connected to a gas conduit in use, a yoke channel, and an anti-rotation groove. The yoke channel extends longitudinally through the mask frame and is defined by an upper wall, a rear wall, and a lower wall. The anti-rotation groove is recessed into the rear wall and extends along the length of the yoke channel. The yoke is configured to be at least partially arranged in the yoke channel. The yoke includes a tongue protruding rearwardly from the yoke. The tongue is configured to be arranged in the anti-rotation groove when the yoke and the mask frame are attached together. The interaction between the anti-rotation groove and the tongue is configured to prohibit the yoke from rotating away from the mask frame.

[0065] The yoke can include a yoke front portion coupled to a yoke rear portion. The tongue can include a front tongue extending from the yoke front portion and a rear tongue extending from the yoke rear portion. The front tongue can be disposed below the rear tongue such that an upper surface of the front tongue abuts a lower surface of the rear tongue.

[0066] In some embodiments, a yoke configured to be coupled to a mask frame of a respiratory mask system includes: a front wall extending from a first lateral end to a second lateral end; a rear wall extending from the first lateral end to the second lateral end, an inner chamber formed between the front wall and the rear wall; a first end cap coupled to the first lateral end of the front wall and the rear wall and a second end cap coupled to the second lateral end of the front wall and the rear wall, each end cap including a filament entry hole configured to receive a filament of a self-adjusting headgear mechanism; and a line rail divider that separates the inner chamber into an upper line rail and a lower line rail. The yoke can also include: a first gasket housing disposed between the front wall and the rear wall adjacent to the first end cap; and a second gasket housing disposed between the front wall and the rear wall adjacent to the second end cap. In some embodiments, the upper line rail extends from the first gasket housing to the second end cap above the second gasket housing, and the lower line rail extends from the second gasket housing to the first end cap below the first gasket housing.

[0067] The yoke can include: a yoke front portion including a front wall; and a yoke rear portion including a rear wall and coupled to the yoke front portion. The upper track can be at least partially defined by the upper wall of the yoke front portion and the track divider, and the lower track can be at least partially defined by the lower wall of the yoke front portion and the track divider.

[0068] In some configurations, a nasal seal for a respiratory mask system includes a body portion that defines an inlet and at least partially defines a user contacting surface of the nasal seal. A pair of nasal cannulas are supported by the body portion and configured to engage with nostrils of a user. The body portion includes a bridge portion extending laterally between the pair of nasal cannulas on an upper portion of the seal. The bridge portion defines a bridge depth between a front surface and a rear surface of the nasal seal, wherein the bridge depth is less than half of the total depth of the nasal seal.

[0069] In some configurations, the posterior-most point of the nasal seal is located posterior to the posterior-most surface of the pair of nasal cannulas.

[0070] In some configurations, the bridge depth is less than or equal to two fifths of the total depth.

[0071] In some configurations, the bridge depth is one third of the total depth.

[0072] In some configurations, the bridge depth is equal to or less than 15 mm, 13.5 mm, or 11 mm.

[0073] In some configurations, the overall depth is equal to or less than 35 mm, 32.5 mm, or 30 mm.

[0074] In some configurations, the wall thickness equal to or greater than 1 mm is limited to the front wall or the outer side wall of the nasal seal.

[0075] In some configurations, the transition between the upper wall and the outer side wall or the transition between the lower wall and the outer side wall is less than 1 mm.

[0076] In some configurations, the minimum wall thickness of the user contacting surface defined by the body portion of the nasal seal is equal to or greater than 0.3 mm.

[0077] In some configurations, the minimum wall thickness of the user contacting surface defined by the body portion of the nasal seal is equal to or greater than 0.45 mm.

[0078] In some configurations, the overall width of the nasal seal is equal to or equal to 65 mm.

[0079] In some configurations, the overall width is equal to or less than 61 mm or 58.5 mm.

[0080] In some configurations, the overall height of the nasal seal is equal to or less than 40 mm.

[0081] In some configurations, the overall height is equal to or less than 35.5 or 35.2 mm.

[0082] In some configurations, the sealing area of ​​the nose seal is equal to or less than 1000 mm 2 .

[0083] In some configurations, the sealing area is equal to or less than 907 mm 2 or 883mm 2 .

[0084] In some configurations, the inlet is generally D-shaped.

[0085] In some configurations, a clip assembly is secured to an inlet of the seal body, wherein the clip assembly is configured to allow the nasal seal to be removably connected to the frame.

[0086] In some configurations, the clamp assembly defines an air inlet and an air outlet.

[0087] In some configurations, the air outlet includes a diffuser.

[0088] In some configurations, the air outlet is defined by the clamping member.

[0089] In some configurations, the clamping member of the air outlet is removable.

[0090] In some configurations, the maximum height of the air inlet is between 12 mm and 16 mm or is 14 mm.

[0091] In some configurations, the maximum width of the air inlet is between 25 mm and 30 mm or is 27 mm.

[0092] In some configurations, the nose seal is combined with the frame. The seal and frame assembly can also include a headgear arrangement.

[0093] In some configurations, the headgear arrangement is self-adjusting or includes one or more directional locks.

[0094] In some embodiments, a respiratory mask system includes a mask frame and a yoke. The mask frame includes an inlet configured to be connected to a gas conduit in use, and a yoke channel. The yoke channel extends longitudinally through the mask frame and is defined by an upper wall, a rear wall, and a lower wall. The mask frame also includes at least one recess in at least one of the upper wall and the lower wall of the yoke channel. The yoke is configured to be at least partially disposed in the yoke channel. The yoke includes at least one protrusion that protrudes rearwardly from the yoke and is configured to be disposed in the at least one recess when the yoke is disposed in the yoke channel.

[0095] The at least one recess and the at least one projection can have a rectangular profile.

[0096] In some embodiments, a yoke configured to be coupled to a mask frame of a respiratory mask system includes: a yoke front portion including a first central connector and a yoke rear portion including a second central connector. The first central connector and the second central connector are configured to be coupled together to at least partially secure the yoke front portion and the yoke rear portion together.

[0097] In some embodiments, the first central connector is or includes a protrusion protruding rearward from the yoke front, the second central connector is or includes an aperture in the yoke rear, and the protrusion is configured to be received in the aperture. In some embodiments, the first central connector is or includes a protrusion protruding rearward from the yoke front, the second central connector is or includes a recess in the front surface of the yoke rear, and the protrusion is configured to be received in the recess. In some embodiments, the yoke front includes an upper alignment groove recessed into the rear surface of the yoke front and extending along the length of the yoke front adjacent to the upper edge of the yoke front, the yoke rear includes an upper alignment bead protruding forward from the front surface of the yoke rear, and the upper alignment bead is configured to be received in the upper alignment groove when the yoke front and yoke rear are coupled together. In some embodiments, the yoke front portion includes a lower alignment groove that is recessed into the rear surface of the yoke front portion and extends along the length of the yoke front portion adjacent to the lower edge of the yoke front portion, the yoke rear portion includes a lower alignment bead protruding forward from the front surface of the yoke rear portion, and the lower alignment bead is configured to be received in the lower alignment groove when the yoke front portion and the yoke rear portion are connected together.

[0098] In some embodiments, a yoke configured to be coupled to a mask frame of a respiratory mask system includes: a yoke front portion extending from a first lateral end to a second lateral end; a yoke rear portion extending from the first lateral end to the second lateral end, the yoke front portion and the yoke rear portion being coupled together and defining an internal chamber therebetween; a first end cap coupled to the first lateral end of the yoke front portion and the yoke rear portion and a second end cap coupled to the second lateral end of the yoke front portion and the yoke rear portion, each end cap including a filament access hole configured to receive a filament of a self-adjusting headgear mechanism; and a line rail divider that separates the internal chamber into an upper line rail and a lower line rail. The yoke can also include: a first gasket housing disposed between the front wall and the rear wall adjacent to the first end cap and a second gasket housing disposed between the front wall and the rear wall adjacent to the second end cap. In some embodiments, the upper line rail extends from the first gasket housing to the second end cap above the second gasket housing, and the lower line rail extends from the second gasket housing to the first end cap below the first gasket housing.

[0099] In some embodiments, the upper wire rail extends into the second end cap and the lower wire rail extends into the first end cap. In some embodiments, the first end cap and the second end cap are configured to be hinged to the first and second lateral ends of the front and rear walls, respectively, during assembly. In some such embodiments, the yoke rear portion includes a first retaining protrusion extending rearwardly from the yoke rear portion adjacent to the first lateral end of the yoke rear portion, the yoke front portion includes a second retaining protrusion extending forwardly from the yoke front portion adjacent to the first lateral end of the yoke front portion, the first retaining protrusion has a greater length than the second retaining protrusion, the first end cap includes: a retaining hole on one side of the end cap, the retaining hole configured to receive the first retaining feature; and a notch on an opposite side of the end cap, the notch configured to receive the second retaining protrusion; and during assembly, the first retaining protrusion engages with the retaining hole, and then the first end cap pivots on the first lateral ends of the yoke front and yoke rear portions to engage the second retaining protrusion with the notch. In some embodiments, the first gasket housing and the second gasket housing are U-shaped. In some such embodiments, the second gasket housing is oriented in an upwardly facing U-shape and the first gasket housing is oriented in a downwardly facing U-shape.

[0100] In some embodiments, a respiratory mask system includes a mask frame and a yoke. The mask frame includes an inlet configured to be connected to a gas conduit during use, and a yoke channel extending longitudinally through the mask frame and defined by an upper wall, a rear wall, and a lower wall. The yoke is configured to be at least partially disposed in the yoke channel.

[0101] Embodiments of systems, components, and methods of assembly and manufacture will now be described with reference to the accompanying drawings, wherein like reference numerals always represent like or similar elements. Although several embodiments, embodiments, and examples are disclosed below, it will be understood by those of ordinary skill in the art that the invention described herein extends beyond the specifically disclosed embodiments, embodiments, and examples, and may include other uses of the invention, obvious modifications, and equivalent technical solutions of the invention. The terms used in this specification appearing herein are not intended to be interpreted in any limited or restrictive manner, but only because they are used in conjunction with a detailed description of certain specific embodiments of the invention. In addition, embodiments of the present invention may include multiple novel features and no single feature is solely responsible for its expected value or is essential to the implementation of the invention described herein.

[0102] Certain terms may be used in the following description for reference purposes only and are not intended to be limiting. For example, terms such as "above" and "below" refer to directions in the drawings to which reference is made.

[0103] Terms such as "top", "bottom", "upper", "lower", "front", "back", "left", "right", "rear" and "side" describe the orientation and / or position of parts of components or elements within a consistent but arbitrary reference system, which is clearly explained by reference to the text and related drawings describing the component or element in question. In addition, terms such as "first", "second", "third", etc. may be used to describe separate components. Such terms may include the words specifically mentioned above, their derivatives and words of similar meaning. BRIEF DESCRIPTION OF THE DRAWINGS

[0104] Figure 1 is a perspective view of a mask assembly including a headgear assembly, a seal assembly and a frame assembly;

[0105] Figures 2 to 4 They are Figure 1 Front, side and rear perspective views of a mask assembly;

[0106] Figure 5 is an exploded view of a front portion of a seal assembly, a frame assembly, and a headgear assembly;

[0107] Figure 6 is an exploded view of an implementation form of a headgear assembly;

[0108] Figure 7 is a bottom view of an embodiment of a frame having a vent hole;

[0109] Figure 8 yes Figure 7 A top view of the frame;

[0110] Fig. 9 yes Figure 7 A rear view of the frame;

[0111] Fig.10 is an exploded view of one embodiment of a sealing assembly and a frame assembly;

[0112] Fig.11 is a rear perspective view of an implementation form of the frame;

[0113] Fig.12 yes Fig.11 A rear view of the frame;

[0114] Fig.13 yes Fig.11 A top view of the frame;

[0115] Fig.14 is a cutaway exploded rear perspective view of one embodiment of a frame and sealing clamp assembly, the frame having a vent opening;

[0116] Fig.15 yes Fig.14 A cutaway exploded front perspective view of the frame and the sealing clamp assembly;

[0117] Fig.16 is a cut-away side view of the frame and seal clamp assembly when assembled together;

[0118] Fig.17 is a perspective view of an embodiment of a sealing assembly, the sealing assembly comprising a sealing clamp having a vent hole;

[0119] Fig.18 yes Fig.17 A front view of a sealing assembly;

[0120] Fig.19 is a perspective view of another embodiment of a sealing assembly, the sealing assembly including a sealing clamp having a vent opening and a diffuser;

[0121] Fig. 20 yes Fig.19 A front view of a sealing assembly;

[0122] Fig.21 is an exploded perspective view of one embodiment of a frame and a diffuser;

[0123] Fig. 22 yes Fig.21 A front view of the frame;

[0124] Fig.23 yes Fig.21 Left side view of the frame, right side view is a mirror image;

[0125] Figure 24 to Figure 26 A top view, a front view and a side view of another embodiment of the frame are shown respectively;

[0126] Fig. 27 is a perspective view of one implementation of a yoke and, in some embodiments, a collector for a headgear assembly;

[0127] Fig.28 yes Fig. 27 A top view of the yoke;

[0128] Fig.29 This is a bottom view of the yoke;

[0129] Fig.30 It is the front view of the yoke;

[0130] Fig.31 It is the rear view of the yoke;

[0131] Fig.32 It is a right side view of the yoke;

[0132] Fig.33 is an exploded view of the yoke and yoke cover;

[0133] Figures 34 to 38 They are the front, top, bottom, rear and left side views of the assembled yoke and frame;

[0134] Fig.39 is a schematic diagram of the yoke-frame connection;

[0135] Fig.40A is a rear perspective view of the assembled yoke and frame;

[0136] FIG. 40B to FIG. 40D is a cross-sectional view of the assembled yoke and frame;

[0137] Fig.41A is a rear perspective view from above showing the frame and yoke attached together;

[0138] Fig.41B yes Fig.41A A partial bottom view of the frame and yoke combination;

[0139] Fig.41C It is shown from below Fig.41A A partial rear perspective view of the frame and yoke;

[0140] Fig.42A is a rear perspective view of another embodiment of a frame and yoke attached together using a hook and post arrangement;

[0141] Fig.42B is shown from above how the yoke can be attached to the frame Fig.42AA schematic diagram of the configuration;

[0142] FIG. 43A to FIG. 43C is shown from above how the yoke can be attached to the frame Fig.42A A further schematic diagram of the configuration of;

[0143] Fig.44 yes Fig.42A Another rear perspective view of the frame and yoke configuration;

[0144] Fig.45 is a front perspective view from below showing another embodiment of the frame and yoke arrangement;

[0145] Fig.46A When attached together Fig.45 A front view of the frame and yoke configuration;

[0146] Fig.46B It is along Fig.46A A cross-sectional view of the frame and yoke configuration along line 46B-46B;

[0147] FIG. 47A to FIG. 47C yes Fig.45 A front perspective view of a configuration of and illustrating a method of positioning the yoke within a channel of the frame;

[0148] FIG. 48A to FIG. 49C is a front perspective view of another configuration of a frame and yoke and illustrates a method of positioning the yoke within a channel of the frame;

[0149] FIG. 50A to FIG. 50C yes Fig.48A A side view of a configuration of and illustrating a method of positioning the yoke within a channel of the frame;

[0150] Fig.51A yes Fig.48A Another front perspective view of the configuration and illustrating a method of positioning the yoke in the channel of the frame;

[0151] Fig.51B It shows Fig.51A an enlarged front view of a portion of a front surface of the frame body;

[0152] Fig.51C are attached together Fig.51A A front perspective view of the frame and yoke;

[0153] Fig.52A and Fig.52B is a front perspective view of yet another frame and yoke configuration using an attachment clip or latch;

[0154] Fig.53Ais a front perspective view showing a frame and yoke configuration including magnets and showing a method of positioning the yoke within a channel of the frame;

[0155] Fig.53B When joined together Fig.53A A front view of the frame and yoke configuration;

[0156] Fig.54A yes Fig.53A a rear perspective view of the frame and yoke configuration;

[0157] Fig.54B yes Fig.53A Another rear perspective view of the frame and yoke configuration;

[0158] Fig.55A and Fig.55B is a front perspective view of another embodiment of the frame and yoke configuration;

[0159] Fig.56 When attached together Fig.55A a cut-away side view of the frame and yoke;

[0160] FIG. 57A to FIG. 57C as well as Fig.58 yes Fig.55A A cut-away side view of a frame and yoke of FIG. 1 and illustrating a method of positioning the yoke within a channel of the frame;

[0161] Fig.59A is an exploded front perspective view of another embodiment of a frame and yoke arrangement and illustrates a method of positioning the yoke within a channel of the frame;

[0162] Fig.59B When attached together Fig.59A Front view of the frame and yoke;

[0163] Fig.60 is a perspective view of an exemplary embodiment of an assembled frame, pad, and yoke;

[0164] Fig.61A yes Fig.60 A side view of an assembly of , showing the connection plane between the components shown;

[0165] Fig.61B yes Figures 60 to 61A a side cross-sectional view of the assembly of , showing the connection plane;

[0166] Fig.62 yes Fig.60 A side view of an assembly including a portion of a headgear strap illustrating forces that may be applied to or by the headgear strap in use;

[0167] Fig.63 yes Fig.60 A front view of the frame;

[0168] Fig.64 yes Fig.63 A side view of the frame;

[0169] Fig.65 yes Figure 63 to Figure 64 a side cross-sectional view of a frame;

[0170] Fig.66 yes Fig.60 A top view of the yoke;

[0171] Fig.67 yes Fig.66 Rear view of the yoke;

[0172] Fig.68 yes Fig.66 Bottom view of the yoke;

[0173] Fig.69 yes Fig.66 Front view of the yoke;

[0174] Fig.70 yes Fig.66 A side view of the yoke;

[0175] Fig.71 yes Fig.66 A side cross-sectional view of a yoke;

[0176] Fig.72 yes Fig.66 a rear view of the front portion of the yoke including the gasket housing and the end cap;

[0177] Fig.73A is a rear view of the front of the yoke with the gasket housing and end cap removed;

[0178] Fig.73B Yes Fig.73A a close rear view of the lateral end of the front portion of the yoke shown;

[0179] Fig.74 yes Fig.66 a front view of a rear portion of the yoke including a gasket housing and an end cap;

[0180] Fig.75 is a front view of the rear portion of the yoke with the gasket housing and end cap removed;

[0181] Fig.76 It is a rear view of the bottom half of the rear portion of the yoke;

[0182] Fig.77 It is along Fig.76A cross-sectional view taken along line 77-77 of ;

[0183] Fig.78 is the rear or interior view of one lateral half of the front portion of the yoke;

[0184] Fig.79 is a cross-section of the side portion of the front of the yoke;

[0185] Fig.80 is a front view of the yoke assembled to the frame;

[0186] Fig.81 It is along Fig.80 A cross-sectional view of the yoke and frame taken along line 81-81 in FIG.

[0187] Fig.82 is a schematic partial cross-sectional view of a yoke coupled to a frame;

[0188] Fig.83 is a cross-sectional view of a side portion of an alternative embodiment of a yoke;

[0189] Fig.84 yes Fig.83 A front view of the rear portion of the yoke;

[0190] Fig.85 is a cross-sectional view of a side portion of an alternative embodiment of a yoke showing a front portion of the yoke;

[0191] Fig.86 The rear of the yoke is shown Fig.85 A partial cross-sectional view of the yoke;

[0192] Fig.87 yes Figure 85 to Figure 86 A front view of the rear portion of the yoke;

[0193] Fig.88 is a rear view of an alternative embodiment of the yoke showing the front portion of the yoke and including the washer housing;

[0194] Fig.89 The gasket housing is removed Fig.88 Rear view of the front part of the yoke;

[0195] Fig.90 yes Figure 88 to Figure 89 A lateral end view of the front portion of the yoke;

[0196] Fig.91 is a rear view of an alternative embodiment of the yoke;

[0197] Fig.92 yes Fig.91 An end perspective view of the yoke;

[0198] Fig.93yes Fig.91 A schematic cross-sectional view of a yoke;

[0199] Fig.94 yes Fig.91 Schematic diagram of the interior of the yoke;

[0200] Fig.95A and Fig.95B shows front and rear perspective views of a mask assembly including a headgear assembly, a seal assembly, and a frame assembly;

[0201] Fig.96 Shows Fig.95A and Fig.95B A rear perspective view of a seal (right) and a prior art nose seal (left);

[0202] Fig.97 Shows Fig.96 A rear view of the seal;

[0203] Fig.98 Shows overlapping Fig.96 A rear view of the seal;

[0204] Fig.99 yes Fig.98 an enlarged view of a portion of an overlapping seal;

[0205] Fig.100 Shows Fig.96 A front view of a seal;

[0206] Fig.101 Shows Fig.96 A top view of a seal;

[0207] Fig.102 yes Fig.98 A cross-sectional view of overlapping seals;

[0208] Fig.103 Shows Fig.96 A front view of a seal showing regions of varying thickness;

[0209] Fig.104 Shows Fig.96 A top view of a seal showing regions of different thicknesses;

[0210] Fig.105 Shows Fig.96 A rear view of the seal;

[0211] Fig.106 Shows Fig.96 A cross-sectional view of a seal;

[0212] Fig.107 Shows Fig.96 A top view of a seal;

[0213] Fig.108 A front view of a first seal (left), a second seal (middle), and a seal of the prior art (right) is shown; the first seal and the seal of the prior art can be Fig.96 The respective seals are identical or substantially similar;

[0214] Fig.109 Shows Fig.108 A top view of a seal;

[0215] Fig.110 shows a comparison of some depth dimensions Fig.108 A top view of a seal;

[0216] Fig.111 Shows a comparison of some sealing areas Fig.108 A rear view of the seal;

[0217] Fig.112 Shows Fig.108 A bottom view of the seal;

[0218] Fig.113 overlap with each other Fig.108 A side view of a seal;

[0219] Fig.114 overlap with each other Fig.108 A side view of a second seal and a seal of the prior art;

[0220] Fig.115 yes Fig.113 A vertical cross-sectional view of overlapping seals;

[0221] Fig.116 yes Fig.114 A vertical cross-sectional view of overlapping seals;

[0222] Fig.117 yes Fig.113 A horizontal cross-section of overlapping seals;

[0223] Fig.118 yes Fig.108 a horizontal cross-sectional view of the overlapping seal of the first and second seals;

[0224] Fig.119 is included Fig.108 A front view of a sealing assembly having a second sealing member; the sealing assembly may alternatively be combined with Fig.108 a first seal;

[0225] Fig.120 yes Fig.119A vertical cross-sectional view of a sealing assembly;

[0226] Fig.121 yes Fig.119 A front view of an alternative embodiment of a sealing assembly;

[0227] Fig.122 yes Fig.121 A front perspective view of a sealing assembly;

[0228] Figures 123 to 132 Additional views showing a first seal, a second seal, and a prior art seal;

[0229] Fig.133 is a front view of one embodiment of an assembled frame, pad and yoke;

[0230] Fig.134 Is disconnected from the framework Fig.133 A partial perspective view of the yoke;

[0231] Fig.135 is along Fig.133 a cross-sectional view of the assembled frame and yoke taken along line 135-135 in;

[0232] Fig.136A yes Fig.133 A rear view of the rear portion of the yoke of the yoke;

[0233] Fig.136B yes Fig.136A A front view of the rear portion of the yoke;

[0234] Fig.136C yes Fig.133 A rear view of the front portion of the yoke of the yoke;

[0235] Fig.137 It is along Fig.133 The line 137-137 in Fig.133 a cross-sectional view of the assembled frame and yoke;

[0236] Fig.138 It is along Fig.133 The line 138-138 in Fig.133 a cross-sectional view of the assembled frame and yoke;

[0237] Fig.139 yes Fig.133 A cross-sectional view of a liner;

[0238] Fig.140 is a partial cross-sectional view of an alternative embodiment of a yoke showing components of a headgear adjustment mechanism;

[0239] Fig.141A method of coupling an end cap to an end of a yoke is shown;

[0240] Fig.142 yes Fig.141 A partial rear perspective view of the assembled end cap and yoke;

[0241] Fig.143 yes Fig.133 an end view of a yoke end of a yoke;

[0242] Fig.144 yes Fig.143 A top view of the yoke;

[0243] Fig.145 It is along Fig.143 A cross-sectional view of the end cap coupled to the end of the yoke taken along line 145-145 in FIG.

[0244] Fig.146 yes Fig.145 A cross-sectional view of an end cap;

[0245] Fig.147 yes Fig.133 and Figures 141 to 145 Rear view of the yoke;

[0246] Fig.148 is a front view of an alternative embodiment of the rear portion of the yoke;

[0247] Fig.149 is configured to connect to Fig.148 A rear view of an alternative embodiment of a yoke rear portion and a yoke front portion of the yoke; and

[0248] Fig.150 It is along Fig.147 The lines 150-150 are cut and assembled together Fig.148 The rear part of the yoke and Fig.149 A cross-sectional view of the front portion of the yoke. DETAILED DESCRIPTION

[0249] Embodiments of assembly and manufacturing systems, components, and methods will now be described with reference to the accompanying drawings, wherein like reference numerals represent like or similar elements throughout. Although several embodiments, embodiments, and examples are disclosed below, it will be understood by those of ordinary skill in the art that the invention described herein extends beyond the specifically disclosed embodiments, embodiments, and examples, and may include other uses of the invention, obvious modifications, and equivalent technical solutions of the invention. The terms used in this specification appearing herein are not intended to be interpreted in any limited or restrictive manner, but only because they are used in conjunction with a detailed description of certain specific embodiments of the invention. In addition, embodiments of the present invention may include multiple novel features and no single feature is solely responsible for its expected value or is essential to the implementation of the invention described herein.

[0250] Certain terms may be used in the following description for reference purposes only and are not intended to be limiting. For example, terms such as "upper" and "lower" refer to directions referenced in the accompanying drawings. Terms such as "front", "back", "left", "right", "rear", and "side" describe the orientation and / or position of parts of a component or element within a consistent but arbitrary reference system, which is clearly illustrated by reference to the text and related drawings describing the component or element in question. In addition, terms such as "first", "second", "third", etc. may be used to describe separate components. Such terms may include the words specifically mentioned above, derivatives of the words, and words of similar meaning.

[0251] Reference Figures 1 to 6 , the present disclosure is directed to a respiratory mask system or mask assembly 100 for delivering respiratory therapy to a patient. The mask system may include a mask interface, such as a seal and frame assembly 102 and a headgear assembly 200. The mask interface 102 and the headgear assembly 200 may include a connection system that attaches the headgear 200 to the mask interface 102. Various forms of connection systems may be used to attach the headgear 200 to the mask interface 102. Similarly, the mask interface 102 may be coupled to at least one and possibly multiple different types of headgear.

[0252] The mask interface or seal and frame assembly 102 may include a seal 104 for sealing around and / or under the patient's mouth and / or nose, and a frame 106 for supporting the seal 104 and attaching the seal 104 to the headgear 200. The frame 106 may also include a gas inlet 108 configured to attach to a gas conduit 110 for delivering gas to the patient via the mask interface 102.

[0253] The headgear 200 of the respiratory mask system is used to hold the mask interface 102 to the patient's face. The headgear 200 is generally attached to the mask interface 102 and wrapped around the back of the patient's head to seal the mask interface 102 against the patient's face.

[0254] In one implementation, the headgear assembly 200 can include a yoke or collection piece 202 that is configured to attach to a mask interface 102, as will be described later in this specification.

[0255] The yoke 202 can be configured as a strap that is attached to the headgear 200. Figure 5 In the illustrated embodiment, the headgear 200 includes a strap assembly including: a rear strap 204 configured to wrap around the back of the patient's head; an upper strap 206 configured to wrap over the top of the patient's head; and a pair of front straps 208 configured to extend along the patient's cheeks during use. In one implementation, each front strap 208 is attached to the rear strap 204 of the headgear assembly 200 by a rear connector 205, such as to the front end 207 of the rear strap 204 or to a connector coupled to the free end 207. In another implementation, the rear strap 204 includes side extensions that form the front straps to extend along the patient's cheeks during use.

[0256] In one embodiment, the headgear can be automatically adjusted and / or can be combined with one or more directional locks, which allow the headgear to reduce length with relatively low resistance and resist the increase of headgear length. In some configurations, the locking force of the directional lock can be overcome to allow the headgear to be extended for wearing the interface assembly. In some embodiments, the yoke can form a collection piece for the filaments used in the automatically adjustable headgear system. In this embodiment, the yoke can be combined with one or more directional locks, each of which can include a washer mechanism, which can be configured to frictionally engage with the filaments during the extension of the headgear, but allow relatively frictionless movement during the retraction of the headgear process. The washer mechanism can be incorporated into the end of the yoke / collection piece and the body of the yoke / collection piece can be roughly hollow to receive the filaments into the body. The headgear or any portion thereof can be configured according to any embodiment disclosed in the following documents: Applicant's U.S. Publication No. 2016 / 0082217, U.S. Application No. 14 / 856,193 filed on September 16, 2015, and PCT Publication No. WO2016 / 043603, the entire contents of which are incorporated herein by reference.

[0257] Each front strap 208 may include a free end to which a connector 209 may be attached. Each connector 209 may engage with a complementary strap connector 203 located on the yoke 202. Preferably, the yoke 202 is generally elongated and includes a strap connector 203 located at or near each end of the yoke 202.

[0258] The connection between the front strap 208 and the yoke 202 can be any type of connection, such as a snap fit connection, a screw and thread type connection, or a hook connection. Figure 6 As shown, each strap connector 203 includes a cover 210 located at each end of the yoke 202. Each cover 210 can include an opening, such as an aperture or recess, configured to receive a connector 209 of the front strap 208 in a snap-fit ​​arrangement to attach the yoke 202 to the front strap 208 of the headgear assembly 200.

[0259] As described above, the yoke 202 can also be configured to attach to the frame 106 of the mask interface 102. In one implementation, the frame 106 can include a recessed area configured to receive at least a portion of the yoke 202 therein when the yoke 202 and the frame 106 are attached together.

[0260] Reference Figures 7 to 26 , various implementations of the mask interface 102 will now be described in more detail.

[0261] The mask interface 102 can include a frame 106 having a body including a first or front surface 112 and a generally opposing second or rear surface 114. The frame 106 can also include an air inlet 108 for attachment to a gas conduit and an air outlet 140.

[0262] In one implementation, the frame 106 is configured such that the gas inlet 108 forms an angle of about 10° to 45° with the vertical direction. In this configuration, the gas conduit 110 can be comfortably away from the patient's chin, but not too far to generate enough torque to pull the mask interface away from the patient's face.

[0263] The mask interface 102 may include a seal 104 having a front or distal surface and a rear or proximal surface. The rear surface of the seal may be configured to seal roughly against the patient's face during use. The seal may be configured to fit over the patient's mouth, nose, or both. In one embodiment, the seal includes nasal pillows that seal roughly around the patient's nostrils. The seal 104 may also include an air inlet 118 that roughly corresponds to the air inlet 108 of the frame 106. The frame 106 and the seal 104 may be assembled together so that the air inlets of each component are roughly aligned with each other to provide a mask interface with a gas inlet. In another embodiment, the mask interface is a non-sealed mask interface, such as a nasal cannula configured for high flow therapy.

[0264] In one implementation, the air inlet 108 of the frame 106 may be defined by a substantially continuous edge. The edge may be provided by a sealing flange 120 protruding from a rear surface of the frame 106. The seal 104 or seal assembly may be configured to seal against the sealing flange 120 to attach the seal to the frame.

[0265] In one implementation, a seal assembly including a seal 104 and one or more seal clips 122 is configured to be attached to a sealing flange 120 of a frame. Fig.10 In the illustrated embodiment, the seal assembly includes a seal having an air inlet defined by a generally continuous lip 124. The lip may extend around the entire air inlet, or one or more gaps may be formed in the lip so that the lip forms a generally continuous flange or series of flanges. A channel 126 may be formed between the lip 124 and a front surface 128 of the seal 104. The seal may be formed of a stretchable elastic material, such as silicon or rubber, that can stretch under the action of a tensioning force but will generally return to its original shape after the tensioning force is removed. The lip 124 of the air inlet 108 of the seal may be configured to stretch around the sealing flange 120 of the frame 106 so that the inner surface of the air inlet 108 generally surrounds and seals against the outer surface of the sealing flange 120. The seal assembly may also include a ductile but secure seal clamp or ring 122 that may be positioned within the channel 126 of the lip to clamp the seal against the sealing flange.

[0266] Optionally, the sealing flange 120 and / or the seal 104 include one or more attachment features to help position and / or attach the seal 104 to the frame 106. For example, the frame 106 may include one or more protrusions configured to remain in one or more recesses disposed in the seal to help prevent the seal from rotating relative to the frame and to help prevent the seal from slipping out of the sealing flange. Typically, the one or more protrusions are disposed on the sealing flange and the one or more corresponding recesses are disposed on the inner surface of the air inlet of the seal. Alternatively, the recess may be positioned on the frame and the protrusion may be positioned on the seal. In yet another embodiment, one or more recesses may be disposed on the outer surface of the sealing flange and the lip of the seal may be configured to rest in the recess to help prevent the seal from accidentally slipping out of the sealing flange. It is contemplated that other suitable embodiments of attaching the seal to the frame may be used without departing from the scope of protection of the present disclosure.

[0267] In another embodiment, the sealing assembly can include a seal 104, an inner clamp 122a, and an outer clamp 122b. The inner and outer clamps can form a collar or ring defining an opening forming a gas inlet 108. The shape and size of the gas inlet 108 can be substantially the same as the shape and size of the frame. The inner clamp 122a can include an inner surface configured to substantially surround and seal against the outer surface of the sealing flange 120.

[0268] In one embodiment, one or more protrusions (e.g., as shown in Fig.15 The inner retainer 122a is positioned on a substantially opposite side of the inner surface of the inner retainer and is configured to be received in a snap recess of the sealing flange (e.g., similar to the protrusion 130 of the inner retainer) when the inner retainer 122a is pushed against the sealing flange. Fig.13 In other embodiments, the outer surface of the sealing flange may include one or more protrusions configured to be received in one or more recesses located on the inner surface of the inner clamp or seal. The inner clamp 122a may be made of a ductile material or a semi-ductile material to facilitate pushing the tightened inner clamp 122a onto the sealing flange 120.

[0269] The inner clamp 122a may include a seal locator for attaching the seal 104 to the inner clamp 122a and thus to the frame 106. The seal locator may include one or more hooks, flanges or other protrusions that can engage with one or more hooks, flanges or other protrusions, openings or recesses on the seal to attach the seal and the inner clamp together. It is contemplated that alternative attachment forms may also be suitable.

[0270] like Figures 14 to 16As shown, the outer clamp 122b can be engaged with the inner clamp 122a to form a sealing locator including a channel 134, in which a portion of the seal 104 can be retained to attach the seal 104 to the clamps 122a, 122b and thus to the frame 106. For example, the outer surface of the inner clamp can include a hook flange 136 extending around at least a portion of the outer periphery of the inner clamp. Preferably, the hook flange extends around the entire outer periphery of the inner clamp 122a. The hook flange 138 can also extend around at least a portion of the outer clamp 122b or preferably around the entire outer periphery of the outer clamp. The inner and outer clamps can be configured to be engaged together so that the hook flanges of each clamp face each other and form a sealing channel 134 between each other. The sealing channel can be roughly shaped like an inverted "T". The seal can include an inlet / outlet opening defined by a generally continuous lip. The sealing lip can form a "T" shape when viewed in cross section and can be sized to fit into the sealing channel by pushing the seal onto the clamp assembly. In this way, the frame and the seal assembly can be attached together to form a gas inlet extending between the frame and the seal. Optionally, the mask frame includes an air outlet 140 formed in the body of the frame, such as formed on the front surface of the frame, such as Figure 7 as shown, or formed in a recessed area of ​​the frame, such as Fig.24 As shown and described below in this specification.

[0271] In one implementation form, Figures 11 to 20 As shown, the mask interface may include an air outlet 140 located near or adjacent to the gas inlet 108. For example, the frame may include a flange that protrudes from a rear surface of the frame and provides a generally continuous edge to define an opening in the frame. A separator 142 may extend between two generally opposite points on the generally continuous edge of the opening to divide the opening into a gas inlet or inlet orifice 108 and an adjacent air outlet or vent orifice 140.

[0272] The portion of the flange adjacent to the gas inlet 108 may protrude further from the rear surface of the frame (i.e., may be deeper) than the portion of the flange adjacent to the gas outlet. The separator 142 may also protrude from the rear surface of the frame and may engage with the flange that protrudes further, so that the separator 142 and the flange together form a sealing flange 144. The sealing flange 144 provides a generally continuous edge around the gas inlet 108. The portion of the sealing flange formed by the separator 142 is referred to herein as the upper sealing flange 143, as shown in FIG. Figures 11 to 13 The area of ​​the protruding flange adjacent to the air outlet 140 is referred to herein as the vent flange 146 .

[0273] Optionally, the sealing flange 144 and / or the vent flange 146 include one or more attachment features configured to facilitate positioning the seal on the frame and / or attaching the seal to the frame. In one embodiment, the attachment features may include one or more recesses and / or protrusions configured to engage with one or more corresponding protrusions and / or recesses provided on the seal or seal assembly. For example, the sealing flange 144 may include a snap-fit ​​recess 132 positioned on a substantially opposite side of the outer surface of the sealing flange 144, such as Fig.13 Each snap recess 144 is configured to receive one or more protrusions (e.g., from the inner surface of the seal or seal assembly (e.g., from the seal clamp 122 or the inner clamp 122a, as shown) extending from the inner surface of the seal or seal assembly. Fig.15 A protrusion 130 is shown to help hold the seal or seal assembly in place against the sealing flange.

[0274] The seal or seal assembly may be attached to the frame by sealing against the sealing protrusion 120 .

[0275] In one embodiment, the sealing assembly includes a seal 104, an inner clamp 122a, and an outer clamp 122b, as described above. In this embodiment, the inner clamp and the outer clamp each include a collar or ring having an opening, but the inner clamp may also include a divider 148 that spans the opening of the inner clamp to divide the opening into an inlet aperture 118 and a vent aperture 150. The inlet aperture 118 and the vent aperture 150 may have substantially the same shape and size as the gas inlet 108 and the outlet 140 of the frame 106. The inner clamp 122a may include an inner surface configured to substantially surround the outer surfaces of both the sealing flange 144 and the vent flange 146. In this position, the divider 148 of the inner clamp 122a may extend through the upper sealing flange 143, as shown in FIG. Fig.16 As best shown. The inner clamp 122a is configured so that it can be pushed onto the sealing flange 144 to form an outer surface against the sealing flange 144. The other portion of the inner clamp 122a surrounding the air outlet 140 can be sealed against the air outlet 140 of the frame 106 or can simply abut the air outlet 140. There is no need to form a seal between the vent aperture 150 and the air outlet 140. Therefore, the assembly of the sealing assembly to the frame is simplified. In addition, the depth of the vent flange 146 does not need to be as large as the depth of the sealing flange 144, and therefore the volume of the frame can be minimized or reduced.

[0276] One or more protrusions 130 may be located on generally opposite sides of the inner surface of the inner clamp 122a and configured to be received in snap recesses 132 of the sealing flange 144 when the inner clamp 122a is pushed against the sealing flange 144 and the vent flange 146. In other embodiments, the outer surface of the sealing flange 144 and / or the vent flange 146 may include one or more recesses configured to be received on the inner surface of the inner clamp 122a or the seal 104.

[0277] In at least one embodiment, the inner clamp 122a can be connected to the sealing flange 144 by a tapered fit. The sealing flange 144 tapers as it extends rearwardly away from the gas inlet 108. The inner clamp 122a can include a corresponding oppositely oriented taper such that the distal opening of the inner clamp 122a is larger than the proximal opening of the inner clamp 122a.

[0278] In another embodiment, the inner clamp 122a may be formed of a malleable or semi-malleable material to facilitate a push-fit fit of the inner clamp 122a onto the sealing flange 144 and the vent flange 146 of the frame 106 .

[0279] The inner clamp 122a may include a seal locator for attaching the seal 104 to the inner clamp 122 and, therefore, to the frame 106. The seal locator may include one or more hooks, flanges, or other protrusions that may engage with one or more hooks, flanges, or other protrusions, openings, or recesses on the seal to attach the seal 104 and the inner clamp 122a together. It is contemplated that alternative attachment implementations may also be suitable.

[0280] As described above, the outer clamp 122b can be joined with the inner clamp 122a to form a seal retainer including a channel 134, in which a portion of the seal 104 can be retained to attach the seal 104 to the clamps 122a, 122b and thus to the frame 106. For example, the outer surface of the inner clamp 122a can include a hook flange 136 extending around at least a portion of the outer periphery of the inner clamp 122a. Preferably, the hook flange extends around the entire outer periphery of the inner clamp 122a. The hook flange 138 can also extend around at least a portion of the outer periphery of the outer clamp 122b or preferably around the entire outer periphery of the outer clamp. The inner clamp 122a and the outer clamp 122b can be configured to be joined together so that the hook flanges 136, 138 of each clamp face each other and form a sealing channel 134 between each other. The sealing channel 134 can be a generally inverted "T" shape. The seal may include an inlet opening / exhaust opening defined by a substantially continuous lip. The sealing lip may form a "T" shape when viewed in cross section and may be sized to fit within the sealing channel 134 by pushing the seal 104 onto the clamp assembly. In this way, the frame 106 and the seal assembly may be attached together to form a gas inlet and outlet extending between the frame and the seal.

[0281] In one implementation, the mask interface 102 may also include a diffuser 152. The diffuser 152 may be permanently or removably positioned in the air outlet 140. When the seal assembly includes a vent opening 150 within which the diffuser 152 may be positioned, the diffuser may be positioned within the frame 106 or within the seal assembly, such as Fig.19 and Fig. 20 By positioning the diffuser 152 in the seal assembly, the diffuser 152 can be easily cleaned each time the seal assembly is removed from the frame 106 and cleaned. If the mask interface is used with a respiratory mask system for treating sleep apnea, it is possible that the seal assembly and diffuser 152 can be cleaned as frequently as once per morning, while other mask components are cleaned less frequently.

[0282] Furthermore, by positioning the diffuser 152 in the sealing assembly, the exhausted air is diffused as it leaves the breathing chamber of the sealing assembly, and before the exhausted air contacts any other mask components or has a chance to generate noise or join ambient air. In this way, the exhausted air can then be exhausted further through or around other frame components with less noise, airflow / mist, and / or jets. In at least some embodiments, the exhaust arrangement can be hidden, thus providing a more desirable mask aesthetic.

[0283] In one implementation, the gas inlet 108 is generally oval in shape. The gas inlet 108 may extend longitudinally between the left and right sides of the frame 106 such that the width of the gas inlet 108 is greater than its height. When the frame 106 is in use, the gas outlet 140 may be positioned above the gas inlet 108. In another implementation, when the frame 106 is in use, the gas outlet 140 may be positioned below the gas inlet 108. The gas inlet 108 and the gas outlet 140 may be positioned approximately centrally along the length of the frame 106.

[0284] Reference now Figures 21 to 59A and Fig.59B , various implementations of the frame and yoke connection system will now be described.

[0285] In one embodiment, the frame 106 includes a body having: a first surface or front surface 112; a second surface or rear surface 114; and a gas inlet 108. In one embodiment, the front surface 112 of the frame 106 can be angled downward toward the bottom edge of the frame 106 and the gas inlet 108 is formed in the angled front surface. The frame 106 can also optionally include a gas outlet 140. In some embodiments, the gas outlet 140 can include a diffuser 152. In some embodiments, the frame 106 can include a diffuser 152. Figures 1 to 20 The embodiments shown in FIG. 1 and 10 may be configured to be attached to the seal 106 or seal assembly as described above.

[0286] The front surface of the frame 106 includes a recessed area configured to receive at least a portion of the yoke 202 of the headgear assembly 200 therein. In one implementation, the recessed area includes a channel 154 extending from left to right across the length of the front surface of the frame 106. The channel 154 may include extensions 156 protruding from both sides of the frame body.

[0287] The channel 154 can be defined by a first wall forming an upper surface 158, a second wall forming a lower surface 160 generally opposite the first wall, and a channel floor 162 forming a rear surface extending between the first wall and the second wall. The channel 154 can include: two side regions or channel extensions 156, each side region is located at an opposite end of the channel; and a central region or middle portion 164 is located generally centrally between the two side regions 156.

[0288] In one embodiment, the height of the rear surface 162 of the channel 154 can be substantially defined by the distance between the first wall and the second wall of the channel. At its central region 164, the height of the rear surface 162 of the channel 154 can be less than the height of the channel 154 at one or both side regions 156. For example, the second wall or lower surface 160 can be bent or angled toward the first wall or upper surface 158 to form a Fig. 22 Peak 166 is shown. Preferably, peak 166 is located at a central point along the length of channel 154.

[0289] In one implementation, the lower surface 160 of the channel 154 may be angled inwardly toward a rear surface 162 of the channel 154 .

[0290] In one implementation, the upper surface 158 of the channel 154 may be angled inwardly toward the rear surface 162 of the channel 154 .

[0291] In one implementation, the lower surface 160 of the channel 154 can have a depth generally defined by the distance between the rear surface 162 of the channel 154 and the front surface 112 of the frame 106. The depth of the lower surface 160 in the central region 164 of the channel 154 can be greater than the depth at the side regions 156 or ends of the channel 154. For example, the lower surface 160 can taper toward the ends 156 of the channel 154.

[0292] The frame 106 and the channel 154 can be roughly curved from left to right to conform to the arc around the patient's nose or mouth to a certain extent.Alternatively or additionally, the frame 106 can be tilted or curved downward from top to bottom.

[0293] In one implementation, the frame 106 may include an air outlet 140 located below a central region 164 of the channel 154 (e.g., Fig. 22 154). In another embodiment, at least a portion of the air outlet 140 can be positioned within the channel 154. In yet another embodiment, the entire air outlet 140 can be positioned within the channel 154, such as within the rear surface 162 of the channel 154. The air outlet 140 can include a single orifice formed in the frame 106 and / or the channel 154, or the air outlet 140 can include multiple orifices. In one embodiment, the air outlet 140 includes multiple small localized orifices. In another embodiment, the air outlet 140 includes an orifice in the form of a slot.

[0294] In one embodiment, the lower surface 160 of the channel 154 may include a recessed area 168 such as Fig.24As shown. The recessed area 168 can be located at a substantially central area of ​​the lower surface 160. For example, the recessed area 168 can be formed by a downward bend, by downwardly inclined surfaces converging at a point, or by a stepped descending area. The stepped descending area can include a substantially vertical transition edge or an inclined transition edge 170 between the recessed and non-recessed areas of the lower surface. The recessed area 168 can be substantially adjacent to the air outlet 140. Alternatively or additionally, the upper surface 158 of the channel 154 can include a recessed area that can be substantially adjacent to the air outlet 140. The recessed areas in the upper and / or lower surfaces of the channel can provide a fluid flow path from the air outlet 140 formed in the channel 154 to the atmosphere. This feature will be discussed in detail later in this specification.

[0295] To attach the headgear assembly 200 to the mask interface, at least a portion of the yoke 202 for the headgear assembly 200 may be retained within the channel 154 of the frame 106 .

[0296] Figures 27 to 33 One embodiment of a yoke 202 is shown, which can be used to attach a headgear assembly 200 to a frame 106. The yoke 202 can be used to attach any suitable closed loop headgear 200 to a frame. For example, in some embodiments, the yoke 202 can form a collector for a filament or other core element used in an automatically adjustable or self-adjusting headgear system. In this embodiment, the yoke 202 can include a washer mechanism that can be configured to frictionally engage with the filament during the extension of the headgear, but allow for relatively frictionless movement during the retraction of the headgear. The washer mechanism can be incorporated into the end of the yoke / collector and the body of the yoke / collector can be substantially hollow to receive the filament within the body.

[0297] In one implementation, the yoke 202 can include a generally elongated body having a distal end. The yoke 202 can be angled or curved along its length and can include a middle portion 212 located between two side portions 213. In one implementation, the side portions 213 include a pair of arms extending from the middle portion 212 and terminating at the distal end of the yoke 202.

[0298] The yoke 202 may include a front surface 214 , a rear surface 216 , a top surface 218 , and a bottom surface 220 .

[0299] The front surface 214 may have a width defined by the distance between the top surface 218 and the bottom surface 220 of the yoke 202 , and may have a length defined by the distance between opposing ends of the yoke 202 .

[0300] The cross-section of the yoke 202 can vary along the length of the yoke. For example, in one implementation, the width of the middle portion 212 of the yoke 202 is less than the width of the side portions 213 of the yoke to produce a yoke 202 with a thinner center area and flared ends. By providing a yoke 202 with a thinner center area, the height of the rear surface 162 of the channel 154 of the frame 106 can be smaller, which provides additional space on the frame body where the larger gas inlet 108 and optionally the gas outlet 140 are also located.

[0301] In another implementation, the top surface 218 of the intermediate portion 212 of the yoke 202 is curved inwardly toward the bottom surface 220 .

[0302] In yet another embodiment, the bottom surface 220 of the yoke 202 may be curved inwardly toward the top surface 218 (e.g., as shown in FIG. Fig.30 ) or the bottom surface 220 can be located substantially in the same plane along the length of the yoke 202.

[0303] In one implementation, the front surface 214 of the yoke 202 or the distal surface of the intermediate portion 212 of the yoke may slope rearwardly from the top surface 218 of the yoke to a bottom surface 220 of the yoke 202 .

[0304] In one implementation, the front surface 214 of the side portion 213 of the yoke 202 may slope forward from a top surface 218 of the yoke to a bottom surface 220 of the yoke.

[0305] In another implementation, the front surface 214 of the side portion 213 may be substantially perpendicular to the bottom surface 220 of the yoke 202 and / or the top surface 218 of the yoke.

[0306] In one implementation, the top surface 218 and / or the bottom surface 220 of the side portion 213 of the yoke can be configured to lie in a generally horizontal plane when the yoke 202 is positioned in the frame 106 during use. In this configuration, the side portion 213 can provide a useful gripping area by which a user can hold and manipulate the yoke 202.

[0307] In one implementation, the top surface 218 of the middle portion 212 of the yoke 202 can slope downward from the rear surface 216 to the front surface 214. In one implementation, the bottom surface 220 of the middle portion 212 of the yoke 202 can slope upward from the front surface 214 to the rear surface 216. When both of these implementations of the yoke 202 are combined, the body of the yoke tapers toward its rear surface.

[0308] At least a portion of the yoke body may be covered with a fabric cover 222, such as Fig.33202 and 21. Preferably, the fabric cover 222 is a woven fabric that is generally extensible in at least one direction. Also preferably, the woven fabric does not wrinkle. The fabric cover 222 can help provide a snap fit between the yoke 202 and the frame 106 without requiring high tolerance manufacturing, which may be required in certain embodiments where the yoke 202 and the frame 106 include hard surfaces that engage with each other to attach the yoke 202 to the frame 106.

[0309] The fabric cover 222 may be any suitable cover, such as a sheath, a fabric cover, or a fabric covering that fits over the yoke 202. In one implementation, the yoke 202 may be injection molded within the fabric cover 222.

[0310] The yoke 202 can be configured to provide one or more alignment surfaces 224 that abut the frame 106 to properly position the yoke 202 on the frame 106. In one implementation, the yoke 202 can include a pair of alignment surfaces 224, each alignment surface 224 located on or near a side portion of the yoke 202 and configured to abut a corresponding alignment surface on the left and right sides of the frame 106.

[0311] The alignment surface 224 of the yoke 202 may protrude from the rear surface 216 of the yoke 202, the top surface 218 of the yoke 202, the bottom surface 220 of the yoke 202, or any two or more of the rear surface 216, the top surface 218, and the bottom surface 220. In one embodiment, the top surface 218, the rear surface 216, and the bottom surface 220 of at least one side portion 213 of the yoke 202 extend beyond the top surface 218, the rear surface 216, and the bottom surface 220 of the middle portion 212 of the yoke 202. Each transition surface formed between the top surface, the rear surface, and the bottom surface of the middle portion 212 and the side portions 213 of the yoke 202 includes an alignment surface 224. In this embodiment, the middle portion 212 of the yoke 202 may be positioned within the channel 154 of the frame 106, and the alignment surface 224 may abut a corresponding alignment surface disposed on the frame, such as Figures 34 to 40D In one embodiment, the outer edge of the channel 154 forms a corresponding alignment surface of the frame 106.

[0312] In one embodiment, as described above, the air outlet 140 is disposed in the rear surface 162 of the channel 154, and the recessed area 168 is disposed in the lower surface 160 of the channel 154. In this embodiment, when the yoke 202 is retained within the channel 154, a gap is formed between the yoke 202 and the recessed lower surface 168 of the channel 154. The air outlet 140 and the adjacent gap form a fluid flow path through which gas can exit the mask interface. Additionally or alternatively, a gap can be disposed between the yoke 202 and the upper surface of the channel 154 to form a second or alternative fluid flow path through which gas can exit the mask interface.

[0313] By providing an air outlet 140 within the attachment channel 154 of the frame 106, the size of the frame can be kept relatively small. In addition, if these embodiments also include an oval-shaped air inlet 108 extending longitudinally from one side of the frame 106 to the other side, the height of the frame 106 can be minimized or reduced to provide a more compact, relatively low-profile mask interface.

[0314] There are many different options for attaching the yoke 202 to the frame 106. For example, the yoke 202 and the channel 154 of the frame 106 can be configured so that at least a portion of the yoke 202, such as the middle portion 212, can be simply pushed into the channel 154 and can be snugly held within the channel 154 due to friction and / or clamping forces between the yoke 202 and the frame 106. Where the yoke 202 includes a fabric cover 222, the fabric cover 222 can help fill any gaps 172 between the yoke 202 and the walls of the channel 154 (e.g., due to the height H of the channel 154). C Than the height H of the yoke 202 Y Large), such as Fig.39 As shown, the yoke 202 is held snugly within the channel 154. The fabric cover 222 can also increase the friction holding the yoke 202 in place.

[0315] FIG. 40A to FIG. 40D is a cross-sectional view of the assembled yoke 202 and frame 106 according to at least one embodiment. Fig.40A The yoke 202 is shown retained in the proper position within the channel 154 of the frame 106 . FIG. 40B to FIG. 40D 2 shows how the cross-section of the yoke 202 (and the channel 154) may vary along its length. For example, the side portion 213 of the yoke 202 may have a generally rectangular cross-section, such as Fig.40B As shown, the cross-section of the yoke 202 can be changed to become closer to a trapezoidal shape at the middle portion 212 of the yoke 202, such as Fig.40DIn other words, as the yoke 202 moves from the end to the middle portion 212, the body of the yoke 202 tapers toward the rear surface 162 until it reaches its maximum taper at the middle portion 212 of the yoke 202. This configuration helps position the yoke 202 in the channel 154 of the frame 106 and centers the yoke in the channel of the frame. The shape of the channel 154 can follow a similar transition between the side regions and the center region of the channel 154.

[0316] exist FIG. 40A to FIG. 40D In this embodiment shown, the height of the rear surface 216 of the yoke 202 is lowest at the middle portion 212 and highest at or near the ends of the yoke. The height of the rear surface 216 is also lower than the height of the front surface 214 at the middle portion 212 of the yoke 202, while the front surface 214 and the rear surface 216 are approximately the same height at or near the ends of the yoke 202. The front surface 214 of the yoke 202 may also be angled downward and rearward at the middle portion 214 and may be generally vertical at the side portions 213. This gradually curved front surface 214 of the yoke 202 helps to hold the yoke 202 in place within the channel 154 of the frame 106.

[0317] Optionally, the height of the middle portion 212 of the yoke 202 is less than the height of the side portions 213. In this embodiment, when the yoke 202 is placed in a channel 154 having an air outlet 140 formed therein, a gap is provided between the middle portion 212 and the upper surface 158 and / or lower surface 160 of the channel 154. The gap provides a fluid flow path through which gas can pass through the air outlet 140 and exit the mask interface between the yoke 202 and the channel wall.

[0318] The yoke 202 may be covered with a fabric cover 222, as described above. The friction created between the fabric cover 222 and the frame 106 and the slightly compressible nature of the fabric cover 222 may help retain the yoke 202 within the channel 154 of the frame 106.

[0319] Figures 41A to 59B Various implementations of connection systems between the yoke 202 and the frame 106 are shown. In each connection system, the yoke and / or the frame may include one or more attachment features to help retain and / or position the yoke within a channel of the frame.

[0320] In one implementation form, FIG. 41A to FIG. 41CAs shown, the yoke body may include one or more attachment features in the form of locating members. The locating members may help position the yoke 202 within the channel 154 of the frame 106. The locating members may also be configured to help ensure that the yoke 202 is properly oriented (i.e., the correct way) within the frame 106. Preferably, the yoke body includes a pair of locating members, one of which is positioned on each side portion 213 of the yoke 202. Each locating member may be in the form of a protrusion 226 protruding from the rear surface 216 of the yoke 202. Each locating member may include an alignment surface configured to abut a corresponding alignment surface of the frame to guide the yoke 202 to be positioned on the frame 106.

[0321] In one implementation, a pair of locating features may protrude from the rear surface 216 or proximal surface of the yoke 202. The alignment surface of at least one of the locating features may be generally perpendicular to the portion of the rear surface 216 of the yoke 202 from which the locating feature protrudes. Alternatively, the alignment surface may be angled outwardly from the rear surface 216 in a direction away from the middle portion 212 of the yoke 202. In one implementation, the locating features and their alignment surfaces may be oriented at an angle to the bottom surface 220 of the yoke 202. For example, in a position where the pair of generally opposed locating features are oriented in this manner, the alignment surfaces of the locating features are closer together near the bottom surface of the yoke than near the top surface of the yoke 202. In this implementation, the ends of the body or channel 154 of the frame 106 may be angled at a generally corresponding angle so that the frame 106 abuts the alignment surface when the yoke 202 is retained within the channel 154 of the frame 106.

[0322] In one implementation, the at least one positioning feature may include a generally curved protrusion formed at or near an end of the yoke 202 and may protrude from the rear surface 216 of the yoke 202. The curved protrusion may include an alignment surface configured to abut a corresponding alignment surface of the frame 106 when the yoke 202 is retained within the channel 154 of the frame 106. For example, the frame 106 may include a cut-out area in which the curved protrusion may be located when the yoke 202 is positioned on the frame 106.

[0323] At least one locating feature may be integrally formed with the yoke body.

[0324] In one embodiment, each locating feature can be formed by an overmold located at or near each end or side portion 213 of the yoke 202. One or more edges of the overmold can form one or more alignment surfaces. Optionally, the alignment surfaces are angled outwardly from the middle portion 212 of the yoke toward the side portions 213. In this embodiment, the outer edges of the frame body can be angled accordingly so that the frame 106 fits snugly between the portions of the overmold of the yoke 202.

[0325] In one embodiment, one positioning component may include hook 228, while the other positioning component may include post 230. FIG. 42A to FIG. 44 As shown, the hook 228 may protrude from the rear surface 216 of one side portion 213 of the yoke 202, while the post 230 may protrude from the rear surface 216 of the other side portion 213. The post aperture 232 may be disposed in the channel 154 of the frame 106.

[0326] To attach the yoke 202 to the frame 106, one edge of the frame 106 is slid under the hook 228 to attach one end of the yoke 202 to the frame 106. The yoke 202 is manipulated so that the post 230 is aligned with the post aperture 232. The free end of the yoke 202 is then pushed into the channel 154 of the frame 106 to cause the post 230 to protrude through the post aperture 232.

[0327] The post 230 may also include a protrusion 234 toward the hook 228. In this embodiment, after the yoke 202 is pushed into the channel 154 as described above, the yoke 202 may be pushed toward the hook 228 so that the post protrusion 234 is hooked on the rear surface of the frame 106.

[0328] In another embodiment of the frame 106 and yoke 202 connection system, the yoke body can include a material that is generally extensible along its length, and the yoke 202 can include one or more attachment features for engaging with one or more corresponding attachment features disposed on the frame 106 of the respiratory mask system. For example, the extensible yoke body can include at least one attachment feature that includes a hook configured to engage with a corresponding hook, recess, or opening disposed on the frame 106.

[0329] In another implementation, the frame 106 and the yoke 202 may include male and female attachment components configured to engage one another to help retain and / or position the yoke 202 within the channel 154 of the frame 106. For example, the yoke 202 may include a male component in the form of a protrusion configured to be retained in a female component in the form of an aperture or recess provided on the frame 106. Additionally or alternatively, the male component may be provided on the frame 106 and the female component may be provided on the yoke 202.

[0330] In one implementation, the rear surface 216 of the yoke 202 may include a pair of male attachment features in the form of protrusions configured to protrude through a pair of corresponding female attachment apertures or recesses provided on the rear surface 162 of the channel 154 of the frame 106. Preferably, the yoke 202 includes a pair of protrusions, one on each side (e.g., on each side portion 213) of a virtual centerline passing perpendicularly through the frame 106. In this implementation, one attachment aperture may be located at each side region of the rear surface 162 of the channel 154.

[0331] Figures 45 to 47C One embodiment of a frame 106 and yoke 202 connection system using male and female attachment components is shown. In this implementation, the yoke 202 can include a male attachment component in the form of a tab or flange 234 that protrudes from the top surface 218 of the yoke. Preferably, the tab 234 protrudes from the middle portion 212 of the yoke 202. In one implementation, the protruding tab 234 can extend substantially along the length of the yoke 202.

[0332] The upper surface 158 of the channel 154 may include a recess or aperture 236 configured to receive the tongue therein. FIG. 47A to FIG. 47C As shown, the yoke 202 is pushed upward into the channel 154 so that the tongue 234 is pushed into the recess 236. The yoke 202 can then be pushed rearward so that the rear surface 216 of the yoke 202 generally abuts the rear surface 162 of the channel 154. Fig.46B As shown, a gap 173 may exist between the bottom surface of the yoke and the lower surface of the channel 154. Optionally, the yoke 202 also includes a locating feature having an alignment surface that abuts a corresponding surface of the frame 106.

[0333] Figures 48A to 51CAnother embodiment of the frame 106 and yoke 202 connection system is shown. In this embodiment, the frame 106 includes a tab 238 that protrudes downward to partially cover the central area of ​​the channel 154. The front surface 112 of the frame body below the channel 154 may include an undulating surface 240 that tapers toward the sides of the frame 106. The lower surface 160 of the channel 154 may also taper toward the end of the channel 154. As shown, the tapered lower surface 242 may extend from the concave lower surface 168 to the lateral edges of the frame 106 and / or the channel 154. In order to assemble the yoke 202 and the frame 106 together, the yoke 202 is bent at an angle into the channel 154 so that the body of the yoke 202 is located within the channel 154 and behind the tab 238. In this configuration, the tab 238 covers a portion of the front surface 214 of the yoke 202 and holds the yoke 202 in place within the channel 154. The tapered undulating surface 240 and the lower surface 160 of the channel 154 help provide space for the curved or angled body of the yoke 202 to be maneuvered from below into the channel 154. In addition, the yoke 202 can include alignment surfaces to help position the yoke 202 on the frame 106.

[0334] Fig.52A and Fig.52B Yet another embodiment of the frame 106 and yoke 202 connection system is shown. In this embodiment, one or more latches or clamps 244 can be used to attach the yoke 202 to the frame 106. Each latch 244 can be fixedly or removably attached to the frame 106 and can be hinged between an open position and a closed position. In the open position, one end of the latch 244 is attached to the frame 106 and the channel 154 of the frame 106 is open. The yoke 202 can be pushed into place in the channel 154 and the latch 244 can then be closed on the yoke 202 and the channel 154. In the closed position, the latch 244 extends through the channel 154 and the yoke 202 in the channel. The free end of each latch 244 engages with a lock provided on the frame 106 to hold the latch 244 in the closed position.

[0335] In one implementation, the latch 244 is hinged from an upper portion of the hinged frame body above the channel 154 and is configured to extend through the channel 154 to engage a lock disposed on a lower portion of the frame body below the channel 154. In an alternative configuration, the latch 244 is hinged to a lower portion of the frame 106 and extends through the channel 154 to engage a lock on an upper portion of the frame 106.

[0336] The latch 244 may include a locking member, which may be in the form of a protrusion 246, configured to engage with a lock, which may be in the form of a latch engagement recess 248, to hold the latch 244 in the closed position. Preferably, a pair of latches 244 are provided, one latch 244 being located on one side of the central region 212 of the channel 154.

[0337] In another embodiment, the lock is disposed on the front surface 214 of the yoke 202. In this embodiment, one end of the latch 244 is hinged to the frame 106, and the other end engages with the lock disposed on the yoke 202 to hold the yoke 202 in the channel 154.

[0338] Figures 53A to 58 Another implementation of a frame 106 and yoke 202 connection system using an attachment feature in the form of a magnet is shown. The term "magnet" should be interpreted as including a magnetic region including a ferromagnetic material where appropriate. In other words, the frame 106 and yoke 202 can be attached to each other with both components including magnets, or with one component including a magnet and the other component including a magnetic region including a ferromagnetic material.

[0339] In one implementation form, FIG. 53A to FIG. 54B As shown, the rear surface 162 of the channel 154 includes one or more magnets configured to be attached to one or more magnets disposed on the rear surface of the yoke 202. In one embodiment, a plurality of magnets are located on the rear surface 162 of the channel 154. The magnets may be spaced apart from each other at equal intervals. Each channel magnet may be located on a centerline extending from one end of the channel 154 to the other end. Similarly, each yoke magnet may be located on a centerline extending from one end of the yoke 202 to the other end. Optionally, each magnet may be embedded in a recess 250 formed in the channel 154 or the yoke 202, as the case may be. In this embodiment, the yoke 202 may be placed in the channel 154 of the frame 106 and the magnetic attraction between the magnets on each component holds the yoke 202 in place within the channel 154.

[0340] In another embodiment, Figures 55A to 58 As shown, the upper surface 158 of the channel 154 may include a tab 252 that protrudes through a portion of the channel 154. The height of the opening of the channel 154 is defined by the distance between the distal end of the protruding tab 252 and the lower surface 160 of the channel 154. The recess 254 is formed between the rear portion of the tab 252 and the rear surface 162 of the channel 154, as shown in FIG. Figure 56 to Figure 58162 of the channel 154 such that each magnet 251 is closer to the upper surface of the channel 154 than to the lower surface. The yoke 202 may include a protrusion, such as a flange 256, protruding from its top surface. The height of the yoke body is defined by the distance between the bottom surface of the yoke 202 and the free upper edge of the protruding flange 256. The height of the yoke body is less than the height of the channel opening. The one or more magnets 249 disposed on the rear surface of the yoke 202 are closer to the bottom surface of the yoke 202 than to the free upper edge of the protruding flange 256. In this arrangement, when the yoke 202 is placed within the channel 154 of the frame 106, the magnetic attraction between the frame 106 and the magnets 251, 249 of the yoke 202 causes the yoke 202 to be pulled upwardly so that the protruding flange 256 of the yoke 202 is located in the recess 254 behind the protruding tab 252 of the frame 106. In this way, the tab 252 and the magnets 251, 249 hold the yoke 202 in place on the frame 106. Because the magnets 251, 249 pull the yoke 202 upwardly in the channel 154, a gap 258 is formed between the bottom surface 220 of the yoke 202 and the lower surface 160 of the channel 154. In one embodiment, the gas outlet 140 can be located on the rear surface 162 of the channel 154 and the gap 258 disposed below the yoke 202 forms a fluid flow path through which gas can escape from the gas outlet 140.

[0341] In another embodiment, Fig.59A and Fig.59BAs shown, the frame 106 may include a recessed area forming a channel, which includes only a rear surface and a lower wall including a lower surface. The channel may extend from the left side to the right side through the body of the frame. The yoke may be configured to be positioned in the channel. The yoke and the frame may include one or more attachment features to hold the yoke in place. For example, the bottom surface of the yoke may include one or more protruding tongues or protrusions 260 configured to engage with one or more corresponding engagement recesses 262 formed in the lower surface 160 of the channel 154. Alternatively or additionally, one or more tongues or protrusions may protrude from the lower surface of the channel and may be configured to engage with one or more corresponding engagement recesses formed in the bottom surface of the yoke. In one embodiment, the lower surface of the channel includes a recessed area 264, and the bottom surface of the yoke includes a protruding area 266 configured to be located within the recessed area when the yoke is located in the channel of the frame. Optionally, the rear surface of the channel 154 and the yoke 202 may each include one or more attachment features in the form of magnets for attaching the yoke and the frame together. The channel magnets can be positioned eccentrically from a centerline extending along the length of the channel so that the magnets are closer to the lower surface of the channel. Similarly, the yoke 202 can include one or more magnets that can be positioned eccentrically from a centerline extending along the length of the yoke 202 so that the magnets are closer to the top surface of the yoke 202 than to the bottom surface. In this configuration, when the yoke 202 is located within the channel 154, the magnetic attraction between the yoke 202 and the frame 106 causes the yoke 202 to be pulled downward so that the bottom surface of the yoke 202 abuts the lower surface of the channel 154. Because the bottom surface of the yoke 202 abuts the lower surface 160 of the channel 154, any protrusions protruding from the bottom surface of the yoke are received in corresponding recesses formed in the lower surface of the channel. Similarly, any protrusions protruding from the lower surface of the channel are received in corresponding recesses formed in the bottom surface of the yoke.

[0342] Fig.60 Another embodiment of a yoke 400 and a pad 302 attached to a frame 300 is shown. Figure 63 to Figure 65 As shown, the frame 300 includes an inlet 308 , a gasket connection flange 314 , and a yoke channel 316 .

[0343] A tube or gas conduit can be coupled to the inlet 308 via a tube overmold 318 coupled to the inlet 308. In some embodiments, the inlet 308 has an oval shape. In some embodiments, the inlet includes a biasing vent 320. In the embodiment shown, the biasing vent 320 includes a plurality of holes extending through the wall of the inlet 308. The holes of the biasing vent 320 can extend around a portion of the perimeter or the entire perimeter of the inlet 308. The holes can be laser drilled through the inlet wall.

[0344] The cushion connection flange 314 protrudes rearward from the frame 300. For ease of use, the cushion 302 is coupled to the cushion connection flange 314 to secure the cushion 302 to the frame 300. In some embodiments, the cushion 302 includes a cushion clip 304 or is coupled to a cushion clip, such as Figure 60 to Figure 62 As shown, the liner clip 304 is coupled to the liner connection flange 314 in use to secure the liner 302 to the frame 300. In some embodiments, when the liner 302 is coupled to the frame 300, the liner connection flange 314 protrudes slightly into the liner 302. The shape or profile of the liner connection flange 314 can match or correspond to the shape or profile of the inlet of the liner 302.

[0345] like Figure 63 to Figure 65 As shown, the yoke channel 316 is formed or defined by an upper wall 322, a rear wall 324, and a lower wall 326. In the illustrated embodiment, the yoke channel 316 extends generally horizontally through the frame 300. In the illustrated embodiment, the yoke channel 316 is positioned above the inlet 308. The yoke channel 316 is configured to receive the yoke 400 in use. The shape, profile, and / or geometry of the yoke channel 316 matches or corresponds to the shape, profile, and / or geometry of the yoke 400.

[0346] As described herein, the yoke 400 connects the headgear to the frame 300 and the cushion 302. The yoke 400 can also accommodate a core element, such as a filament 442, of a one-way friction, automatically adjustable or self-adjusting headgear adjustment mechanism as described herein. In the illustrated embodiment, the yoke 400 is generally C-shaped when viewed from the top or bottom. In the illustrated embodiment, the height of the yoke 400 is greater at the lateral ends (e.g., adjacent to and / or at the end caps 406) than at the center. Such a configuration can advantageously help minimize or reduce the size of the mask overall.

[0347] like Figures 66 to 71 As shown, in the illustrated embodiment, the yoke 400 includes a yoke front portion 402, a yoke rear portion 404, and two end caps 406, one at each lateral end of the yoke 400. In the illustrated embodiment, the yoke front portion 402 and the yoke rear portion 404 are formed as separate components that are coupled together. In the illustrated embodiment, the yoke front portion 402 includes a top wall 408, a front wall 409, and a bottom wall 410. The outer side or outer surface of the front wall 409 can be circular. The top wall 408 and the bottom wall 410 extend approximately perpendicularly from the upper edge and the lower edge of the front wall 409, respectively. The top wall 408 and the bottom wall 410 are therefore approximately parallel to each other. The yoke front portion 402 can form a D-shaped cross-sectional profile.

[0348] The yoke front portion 402 and the yoke rear portion 404 can be coupled together via a snap fit. Fig.71As shown, the yoke rear portion 404 snap fits between the top wall 408 and the bottom wall 410. In the illustrated embodiment, the yoke rear portion 404 includes snap fit ridges 412 positioned on upper and lower edges or upper and lower surfaces of the yoke rear portion 404. In some embodiments, the snap fit ridges 412 extend longitudinally between the lateral ends along a portion or the entire length of the yoke 400. Fig.71 As shown, the snap-fit ​​protrusions 412 fit into corresponding snap-fit ​​recesses 414 formed in the inner surfaces of the top wall 408 and the bottom wall 410 of the yoke front portion 412. In some embodiments, the yoke rear portion 404 may include only one snap-fit ​​protrusion 412, while the yoke front portion 402 may include only a corresponding snap-fit ​​recess 414. In some embodiments, the yoke front portion 402 includes the snap-fit ​​protrusion 412, while the yoke rear portion 404 includes the corresponding snap-fit ​​recess 414. A chamber or space is formed between the yoke front portion 402 and the yoke rear portion 404. In other words, the yoke 400 is hollow.

[0349] The end caps 406 can also help secure the yoke front portion 402 and the yoke rear portion 404 together by being clamped or snapped onto or onto the yoke front portion 402 and the yoke rear portion 404. FIG. 73A to FIG. 73B As shown, the lateral ends of the yoke front portion 402 include or are formed by end cap inserts 418. The end cap inserts 418 can be integrally formed with the lateral ends of the yoke front portion 402 or permanently or removably attached to the lateral ends of the yoke front portion. The end cap inserts 418 have walls that are offset inwardly from the top wall 408, the front wall 409, and the bottom wall 410 of the yoke front portion 402. As shown in FIG. Figure 74 to Figure 77 As shown, the lateral ends of the yoke rear portion 404 can include or be formed by end cap inserts 420. The end cap inserts 420 can be integrally formed with the lateral ends of the yoke rear portion 404 or permanently or removably attached to the lateral ends of the yoke rear portion. Figure 74 to Figure 77 As shown, each end cap insert 420 includes an alignment pin 422 that fits into a corresponding end cap insert 418 of the yoke front portion 402. In the illustrated embodiment, the alignment pin 422 of one end cap insert 420 (on one end of the yoke rear portion 404) is located adjacent to a top or upper surface of the yoke rear portion 404, while the other end cap insert 420 (on the other end of the yoke rear portion 404) is located adjacent to a bottom or lower surface of the yoke rear portion 404. When the yoke front portion 402 and the yoke rear portion 404 are coupled together, the alignment pin 422 fits into the end cap insert 418 of the yoke front portion 402.

[0350] When assembled, the end caps 406 snap onto and at least partially cover the end cap inserts 418, 420. The yoke front portion 402 can include end cap snap fit ridges 416 positioned on or near the lateral ends on the upper and / or lower edges or upper and / or lower surfaces of the yoke front portion 402. In the illustrated embodiment, the end cap snap fit ridges 416 extend transversely through a portion of the thickness or width of the yoke front portion 402 or the entire thickness or width of the yoke front portion. FIG. 73A to FIG. 73B As shown, the end cap snap-fit ​​ridges 416 can be positioned on the top and bottom surfaces of the end cap insert 418. Each end cap 406 can be connected to a front band of the headgear. In some embodiments, the end cap 406 can be overmolded onto the end of a braided element of an automatic headgear adjustment mechanism, such as the braided element shown and described in U.S. Provisional Patent Application No. 62 / 343,711, entitled "Directional Lock for Interface Headgear Arrangement," filed on May 31, 2016, and PCT Application No. PCT / NZ2014 / 000074, the entire contents of which are incorporated herein by reference. The core element or filament 442 can extend within the braided element. The end cap 406 can connect the braided element and therefore the headgear to the yoke 400 and create a closed loop headgear system.

[0351] like FIG. 61A to FIG. 61B As shown, the yoke 400 is assembled or coupled to the frame 300 in a plane (or along an axis) 401 that is different from a center plane (or axis) 309 extending through the inlet 308 and is also different from a plane (or axis) 303 along which the gasket 302 is coupled to the frame 300. In the embodiment shown, the inlet plane 309 is different from the gasket connection plane 303. Fig.61B As shown, the yoke plane 401 is aligned with or extends through the nasal cannula 310. When the mask system is placed on the face of a user, the alignment of the yoke plane 401 with the nasal cannula 310 advantageously allows the headgear to apply a force through the yoke 400 to pull the nasal cannula 310 toward the user's nostrils. In the illustrated embodiment, the cushion connection plane 303 and the inlet plane 309 are more closely aligned (or more closely aligned) with each other than each is with the yoke plane 401. This allows the cushion 302 to be coupled or attached to the frame 300 in an orientation that is close to being aligned with the inlet 308, which advantageously is intuitive to the user.

[0352] Due to the difference in angles between the cushion connection plane 303 and the yoke plane 401, the yoke 400 is coupled to the frame 300 in a different direction than the cushion 302 is coupled to the frame 300. This may be counter-intuitive to some users. If a user attempts to remove the yoke 400 from the frame 300 in the same direction as the cushion connection plane 303, the yoke 400 may bind or catch on the frame 300, increasing the removal force and making it more difficult to disconnect the yoke 400. Therefore, it may be beneficial if the yoke 400 is easier and requires minimal force to connect to and disconnect from the frame 300 while still maintaining an effective connection during use. During the process of putting on and taking off the mask, the headgear 312 can be pulled upward at an angle relative to the yoke plane 401, such as Fig.62 This can create a rotational force or torque on the connection between the yoke 400 and the frame 300. If the torque created is large enough, the yoke 400 can be undesirably disconnected from the frame 300, making it more difficult to put on and / or take off the mask. The various features described herein can help address these potential problems.

[0353] like Figure 63 to Figure 65 As shown, the frame 300 can include a retaining ridge 328. The retaining ridge 328 protrudes downward from the front bottom edge of the upper wall 322 toward the yoke channel 316 and / or protrudes downward into the yoke channel 316. In the illustrated embodiment, the retaining ridge 328 extends from a middle portion of the upper wall 322. The retaining ridge 328 forms a relatively narrow opening for a portion of the yoke channel 316. Fig.66 and Fig.69 As shown, the yoke 400 (in the illustrated embodiment, the yoke front portion 402) includes a retaining notch 424. In the illustrated embodiment, the retaining notch 424 is located at or near a corner formed between the top wall 408 and the front wall 409 of the yoke front portion 402. The retaining notch 424 can be formed with a scalloped area. In the illustrated embodiment, the retaining notch 424 is located at a middle portion of the yoke front portion 402. When the frame 300 and the yoke 400 are coupled together to form a snap-fit ​​connection between the frame 300 and the yoke 400, the retaining notch 424 is configured to receive the retaining ridge 328 of the frame 300. The width of the retaining ridge 328 and the retaining notch 424 may affect or at least partially determine the force required to connect and / or disconnect the yoke 400 and the frame 300. In the illustrated embodiment, the retention ridges 328 and retention notches 424 are narrower than the yoke channel 316 so that the force required to connect and / or disconnect the yoke 400 and frame 300 is small enough to allow for easy connection while still being effective in securing the yoke 400 to the frame 300 .

[0354] In some embodiments, for example, Fig.67 and Figure 71 to Figure 72 As shown, the yoke front portion 402 includes a lead-in chamber 426. The lead-in chamber 426 is a chamfered or rounded edge along the upper rear edge of the top wall 408. The lead-in chamber 426 can help guide the yoke 400 past the retention ridges 328 to help improve the ease of inserting the yoke 400 into the yoke channel 316. In some embodiments, the frame 300 and yoke 400 need not include retention ridges 328 and retention notches 424, respectively. Instead of or in addition to the snap fit between the retention ridges 328 and the retention notches, the tensioning force applied by the headgear to the yoke 400 and / or frame 300 can help secure the yoke 400 and frame 300 together.

[0355] The yoke channel 416 can include an anti-rotation groove 330 that is recessed into the rear wall 324 and extends along a portion or the entire length of the yoke channel 416, such as Figure 63 to Figure 65 In the illustrated embodiment, the anti-rotation groove 330 is positioned adjacent to the lower wall 326 of the frame 300. The yoke 400 includes a corresponding tongue 428 (at Figure 66 to Figure 68 ), the corresponding tongue is received in the anti-rotation groove 330 when the yoke 400 and the frame 300 are coupled together. Fig.71 As shown, the central region of the bottom wall 410 of the yoke front portion 402 extends deeper or projects rearward to a greater extent than the lateral ends of the yoke front portion 402 to form a front tongue 428a. Fig.71 and Fig.77 As shown, the central area of ​​the bottom of the yoke rear portion 404 extends rearward to a greater extent than the lateral ends of the yoke rear portion 404 to form a rear tongue 428b. The rear tongue 428b protrudes vertically from the central area of ​​the bottom of the yoke rear portion 404 to form an "L" shaped cross section. The front tongue 428a and the rear tongue 428b are aligned with each other and abut each other, so that the front tongue 428a is positioned below the rear tongue 428b, as shown in FIG. Fig.71 As shown. Having a tongue 428 formed of two parts (a front tongue 428a and a rear tongue 428b) can advantageously help improve the connection between the yoke front portion 402 and the yoke rear portion 404. The two-part configuration can allow rotational forces applied to the yoke 400 and / or the frame 300 to be applied to both the yoke front portion 402 and the yoke rear portion 404 simultaneously to help reduce or minimize twisting of the yoke front portion 402 and the yoke rear portion 404 relative to each other, which twisting may cause the yoke front portion 402 and the yoke rear portion 404 to become disconnected. During rotation, the front tongue 428a and the rear tongue 428b are squeezed together by contact with the anti-rotation groove 330 (as shown in FIG. 1 ). Fig.82 ), which helps to strengthen the connection between the yoke front portion 402 and the yoke rear portion 404.

[0356] When the tongue 428 is arranged in the anti-rotation groove 330, as shown in FIG. Figure 80 to Figure 82 As shown, if and when a rotational force is applied to the yoke 400, for example via a headgear rotational force, the interaction between the tongue 428 and the anti-rotation groove 330 helps prevent or inhibit the yoke 400 from rotating out of the yoke channel 416. In embodiments that include a retention ridge 328 and a retention notch 424, instead of or in addition to the interaction between the tongue 428 and the anti-rotation groove 330, the retention ridge 328 and the retention notch 424 can help resist the yoke 400 from rotating disconnected from the frame 300.

[0357] As described herein, in some embodiments, the yoke 400 can form a collection piece for a core element, such as a filament 442, that is used in an automatically adjustable or self-adjusting headgear system. Figures 71 to 73B As shown, the yoke front portion 402 includes an upper track 430 and a lower track 432. A track divider 434 protrudes rearward from the rear surface or inner surface of the front wall 409 of the yoke front portion 402. Figures 72 to 73A As shown, the track divider 434 generally extends diagonally across a portion of the length of the yoke front portion 402. In other words, one end of the track divider 434 is adjacent to the top wall 408, while the other opposite end of the track divider 434 is adjacent to the bottom wall 410. The upper track 430 is thus bounded and / or defined by the bottom surface of the top wall 408, the rear surface of the front wall 409, and the upper surface of the track divider 434. The lower track 432 is bounded and / or defined by the top surface of the bottom wall 408, the rear surface of the front wall 409, and the lower surface of the track divider 434.

[0358] The upper and lower wire rails 430, 432 receive the wires 442 of the automatically adjustable headgear system. The wires 442 extend from the portion of the headgear that is connected to the yoke 400 and / or adjacent to the yoke. Fig.67 and Fig.70 As shown, the end cap 406 includes a filament entry hole 444. The filament entry hole 444 helps guide the filament 442, for example, from the braided component of the headgear into the yoke 400. The filament 442 passes through the headgear, through the entry hole 444, and into the hollow yoke 400. Fig.72 and Fig.74 As shown, the yoke 400 includes a gasket housing 446 disposed adjacent to (and centered on) each end cap 406. Each gasket housing 446 can be assembled or disposed in a gasket housing pocket 448 formed by the yoke front portion 402, as shown in FIG. Fig.73A The gasket housing 446 accommodates one or more gaskets 450 (such as Fig.794, and the washer is used as part of a locking mechanism for an automatically adjustable headgear system. One embodiment of such a locking mechanism is shown and described in U.S. Provisional Patent Application No. 62 / 343,711, which is incorporated herein by reference. The first filament passes through the first end cap 406 and the washer 450 in the first washer housing 446 into the upper wire rail 430. The second filament passes through the washer 450 in the second end cap 406 and the second washer housing 446 into the lower wire rail 432.

[0359] like Figures 72 to 73A As shown, the upper track 430 widens toward the first end of the yoke front 402 and narrows toward the second end. The lower track 432 widens toward the second end of the yoke front 402 and narrows toward the first end. The upper track 430 and the lower track 432 have a greater height and width at the end where the filament 442 enters the track. This can advantageously help prevent or prohibit the formation of a sharp bend in the filament 442 immediately or shortly after the filament 442 leaves the gasket housing 446, which can help the gasket 450 to properly engage the filament. This can also or alternatively help prevent or prohibit the filament 442 from being caught on the internal geometry of the yoke 400 during the filament 442 and during the retraction of the headgear.

[0360] like Figure 78 to Figure 79 As shown, the end cap 406 and / or the filament entry hole 444 serve as a guide for the filament 442, which helps to improve the reliability of the operation of the adjustment mechanism. In use, if the filament 442 is bent at an acute angle near the point where the filament 442 exits the gasket housing 446 (for example, by the user), the gasket 450 may not properly engage with the filament 442 during the extension of the headgear, which may distort the force displacement distribution of the adjustment mechanism and prevent or prohibit the adjustment mechanism from operating correctly and / or effectively. Each end cap 406 provides an extension length or distance (in degrees) that the filament 442 extends within the yoke 400 before entering the gasket housing 446. Fig.78 and Fig.79 446). The filament 442 is prevented or prohibited from bending within the yoke 400 and the end cap 406. Once the filament 442 passes through the filament entry hole 444 and exits the end cap 406, the filament 442 can be bent by the user. However, the extension length X provided by the end cap 406 allows any bend formed in the filament 442 outside the yoke 400 to be offset or spaced apart to a greater extent from the gasket housing 446. This advantageously helps the filament 442 extend through the gasket housing 446 generally parallel to the walls of the gasket housing 446 and / or the end cap 406, which can help the gasket fully and properly engage the filament 442 during the adjustment process.

[0361] In the illustrated embodiment, the upper wire rail 430 extends above the washer housing 446 at the second end of the yoke 400 (the end opposite to where the filament 442 enters the upper wire rail 430), while the lower wire rail 432 extends below the washer housing 446 at the first end of the yoke 400 (the end opposite to where the filament 442 enters the lower wire rail 432). The extension of the upper wire rail 430 and the lower wire rail 432 above and below the opposing washer housings 446, respectively, advantageously allows a shorter yoke 400 to accommodate the same length of filament 442 (compared to a yoke 400 in which the upper wire rail 430 and the lower wire rail 432 are centered with respect to the washer housing 446). The shorter yoke 400 can advantageously prevent or inhibit the lateral ends of the yoke 400 from digging into the cheeks of a user during use. With this configuration (where the upper and lower wire rails 430, 432 extend above and below opposing gasket housings 446), the gasket housings 446 are vertically offset from one another, such as Fig.74 As shown, to allow the yoke 400 to be symmetrical.

[0362] like Figure 74 to Figure 75 As shown, the yoke rear portion 404 includes an upper rail insert 436 and a lower rail insert 438. The upper rail insert 436 and the lower rail insert 438 protrude forward from the front or inner surface of the yoke rear portion 404. The upper rail insert 436 is at least partially fitted within the upper rail 430 of the yoke front portion 402, and the lower rail insert 438 is at least partially fitted within the lower rail 432 of the yoke front portion 402. The upper rail insert 436 and the lower rail insert 438 can have shapes corresponding to the shapes of the upper rail 430 and the lower rail 432, respectively. For example, the upper rail insert 436 is wider adjacent a first end of the yoke rear portion 404, which is configured to be placed adjacent to a first end of the yoke front portion 402, while the lower rail insert 438 is wider adjacent a second end of the yoke rear portion 404, which is configured to be placed adjacent to a second end of the yoke front portion 402. A divider channel 440 extends longitudinally between and is defined by the upper rail insert 436 and the lower rail insert 438. The wall thickness of the yoke rear portion 404 in the area of ​​the divider channel 440 is reduced compared to the wall thickness in the area of ​​the upper rail insert 436 and the lower rail insert 438. The divider channel 440 receives the rail divider 434 of the yoke front portion 402. This can advantageously help to improve proper alignment of the yoke front portion 402 and the yoke rear portion 404 and / or can help to reduce or minimize the overall depth or thickness of the yoke 400.

[0363] The upper and lower rail inserts 436, 438 reduce the depth or height of the rails 430, 432. The reduced depth or height helps to better guide the wire 442 into the rails 430, 432. The upper and lower rail inserts 436, 438 can also or alternatively provide enhanced structure and increased rigidity to the yoke rear portion 404, which can help prevent or inhibit the yoke rear portion 404 from becoming disengaged from the yoke front portion 402 if the yoke 400 is bent. The interaction between the upper rail insert 436 and the upper rail 430 and the interaction between the lower rail insert 438 and the lower rail 432 can help align the yoke front portion 402 and the yoke rear portion 404 to help prevent or inhibit improper assembly.

[0364] Figure 83 to Figure 84 An alternative embodiment of the yoke rear portion 404 and the end cap 406 is shown. In the embodiment shown, the alignment pins 422 are aligned with Fig.45 The alignment pin 422 shown in the embodiment has an increased height (by Fig.84 406). The increased height of the alignment pin 422 reduces the space available within the end cap 406. The reduced space can help improve the ability to guide the filament 442 through the end cap insert 418. In the illustrated embodiment, the space within the end cap insert 418 for the filament 442 to pass over the alignment pin 422 is positioned above or above the opening in the first washer 450a through which the filament 442 extends. Fig.83 As shown, the filament 412 can thus bend over the filament pin 422, which increases the friction between the filament 442 and the first washer 450a. This can help ensure that the first washer 450a engages and pivots during the headgear extension and / or extension process. In this embodiment, the filament entry hole 444 can be extended (relative to, for example, Fig.67 442 within the yoke 400, less support is required for the filament 442 at the filament entry hole 444. An elongated slot rather than a circular hole for the filament entry hole 444 can allow the filament 442 to freely pass through the filament entry hole 444 without having to bend through a tortuous path. An elongated slot rather than a circular hole can also allow a single symmetrical end cap 406 to be used on both sides of the yoke 400.

[0365] Figure 85 to Figure 87Another alternative embodiment of the yoke rear portion 404 is shown. In the embodiment shown, the alignment pin 422 has a height H that is approximately the same as but slightly less than or smaller than the interior height of the yoke front portion 402 at the end cap insert 418, such that the alignment pin 422 abuts or nearly abuts the upper and lower interior surfaces of the end cap insert 418, as shown. Fig.85 The alignment pin 422 includes a filament slot 452 that allows the filament 442 to pass through the alignment pin 422 and reach the gasket housing 446. The alignment pin 422 and / or the filament slot 452 help guide the filament 442 through the end cap 406.

[0366] Figures 88 to 90 An alternative yoke 400 embodiment is shown that includes changes in the wire tracks 430, 432. As shown, the wire tracks 430, 432 overlap with the washer housing 446 to reduce the yoke length required for a given filament length, similar to the reference yoke 400 embodiment. Figures 72 to 73A The embodiments shown and described. Figures 88 to 90 In the embodiment of the present invention, each linear track 430, 432 passes in front of the relative gasket housing 446 rather than above or below the gasket housing 446. The linear tracks 430, 432 are cut or formed in the front wall 409 of the yoke front portion 402 (e.g., the end cap insert 418), wherein the linear tracks 430, 432 pass in front of the gasket housing 446, such as toward Fig.88 and Fig.90 The lateral end of Figures 72 to 73A This configuration allows the yoke height to be reduced compared to the embodiment of Fig.89 The reduced height H can help the mask appear smaller and / or less obtrusive overall. Figures 88 to 90 Compared with the implementation method, Figures 72 to 73A The embodiment may allow the depth of the yoke 400 to be reduced.

[0367] Figure 91 to Figure 94 Another alternative embodiment of the wire track is shown. Similar to the previously described embodiment, the wire track overlaps the washer housing 446 to reduce the yoke length required for a given filament length. Figure 91 to Figure 94 In an embodiment, the yoke is diagonally divided by a spiral wall that at least partially forms or defines a front linear track 460 and a rear linear track 462. The linear tracks 460, 462 overlap from front to back and then extend to terminate below the gasket housing 446. This arrangement allows the gasket housings 446 to be horizontally aligned with each other. This arrangement can help reduce or limit the increase in height of the yoke 400 caused by the linear tracks 460, 462 because the linear tracks 460, 462 pass through the gasket housing 446 instead of being as Fig.72As in the embodiment of the present invention, one passes under the gasket housing 446 and the other passes over the other gasket housing 446. Figure 91 to Figure 94 The yoke 400 is shown as being straight or linear, but has Figure 91 to Figure 94 The yoke 400 of the arrangement of rails 460, 462 shown in FIG. 4 may be curved in plan view, similar to the embodiments previously shown and described.

[0368] Figures 133 to 135 Another embodiment of a yoke 600 and a gasket or seal 502 coupled to a frame 500 is shown. The yoke 600, seal 502, and / or frame 500 can be similar in some respects to the yoke 400, gasket 302, and / or frame 300, respectively. The frame 500 includes a yoke channel 516 configured to receive the yoke 600 in use. The yoke channel 516 is formed or defined by an upper wall 522, a rear wall 524, and a lower wall 526. For example, compared to the yoke 400, the yoke 600 has an increased asymmetry between the upper and lower edges of the yoke 600. In the illustrated embodiment, the upper edge of the yoke 600 is straighter than the lower edge. The asymmetry advantageously provides an improved visual cue as to the correct orientation for assembling the yoke 600 to the frame 500 and helps inhibit incorrect assembly.

[0369] like Fig.134 As shown, the yoke channel 516 includes a connection recess 528 located in the upper wall 522 and the lower wall 526. In the embodiment shown, the connection recess 528 is located at each lateral end of the yoke channel 516, adjacent to or adjacent to each lateral end of the yoke channel. The connection recess 528 at least partially defines or forms a retaining lip 523 at or along the front edge of the yoke channel 516 (e.g., at or along the front edge of the inwardly facing surface of the upper wall 522 and the lower wall 526). The yoke 600 includes a connection protrusion 628 that protrudes rearwardly from the upper surface, lower surface, and / or rear surface of the yoke 600. In the embodiment shown, the yoke 600 includes a connection protrusion 628 on each side of the center of the yoke 600. In the illustrated embodiment, the yoke 600 includes a yoke front portion 602 and a yoke rear portion 604 that are coupled together, and as described in more detail herein, a connecting protrusion 628 is formed in the yoke rear portion 604. The connecting recess 528 is configured to receive the connecting protrusion 628 when the frame 500 and the yoke 600 are coupled together to form a snap-fit ​​connection between the frame 500 and the yoke 600. When the frame 500 and the yoke 600 are coupled together, the retaining lip 523 engages the yoke 600 in front of the connecting protrusion 628 to facilitate the snap-fit ​​connection and retain the yoke 600 in the yoke channel 516. In the illustrated embodiment, the connecting protrusion 628 and the connecting recess 528 have a square or rectangular profile, which prohibits the yoke 600 from being moved, for example, along the yoke channel 516. Fig.135 Rotate out of the yoke channel 516 in the direction indicated by the middle arrow.

[0370] In some embodiments, the yoke 600 has an elliptical or substantially elliptical cross-section, such as Fig.137 This shape advantageously reduces the size or volume of the yoke 600 and / or provides an improved aesthetic appearance. The gasket housing 646 discussed in more detail herein can have a D-shaped, substantially D-shaped, U-shaped, or substantially U-shaped cross-section, such as Figures 136A to 136C 646 to allow and / or facilitate an overall elliptical or substantially elliptical cross-section of the yoke 600. The gasket housings 646 can be oriented relative to each other. In other words, as Fig.136C One of the gasket housings 646 shown, such as the left gasket housing 646, can be oriented in an upwardly facing U-shape, while Fig.136C The other washer housing 646 shown, for example the right washer housing 646, can be oriented in a downward facing U-shape. This arrangement and orientation can advantageously help to allow the wire rails 630, 632 to extend above and below the left and right washer housings 646, respectively, as discussed in more detail herein. Fig.137 As shown, in the illustrated embodiment, the yoke 600 or the central portion of the yoke 600 has a depth D that is the same or similar or corresponds to the depth of the yoke channel 516, such that the yoke 600 does not protrude or substantially does not protrude from the yoke channel 516. This advantageously reduces the overall size of the frame 500 and yoke 600 assembly.

[0371] like Fig.136A and Fig.138 As shown, in the illustrated embodiment, the rear surface of the yoke 600 includes rearward steps on each side or lateral end of the central portion of the yoke 600 such that the yoke 600 has a stepped depth. In other words, when the yoke 600 is coupled to the frame 500, the lateral portions of the yoke 600 that are positioned laterally outside of the yoke channel 516 have a depth D that is greater than the depth D of the central portion of the yoke 600 that is positioned in the yoke channel 516 when the yoke 600 is coupled to the frame 500. The steps form or define frame abutment surfaces 605 at the transition between the central portion and the lateral portions of the yoke 600. When the yoke 600 is coupled to the frame 500, each frame abutment surface 605 abuts one of the lateral edges 505 of the frame 500 or is positioned adjacent to or proximate to one of the lateral edges of the frame, as shown. Fig.138Frame abutment surfaces 605 and lateral edges 505 assist in properly aligning yoke 600 with frame 500 during assembly. Frame abutment surfaces 605 and lateral edges 505 also or alternatively provide a more secure connection between yoke 600 and frame 500. The reduced depth of the central portion of yoke 600 advantageously reduces the overall size of the frame 500 and yoke 600 assembly.

[0372] like Figures 135 to 137 As shown, in the illustrated embodiment, the yoke 600 includes a yoke front portion 602 and a yoke rear portion 604. The yoke 600 can also include two end caps 606 (eg, Fig.140 ), there is an end cap at each lateral end of the yoke 600. In the illustrated embodiment, the yoke front portion 602 and the yoke rear portion 604 are formed by separate components that are coupled together. Figures 135 to 137 In the embodiment of the present invention, the joint line ( Fig.137 ) is centered or generally centered. This can improve ease of manufacturing.

[0373] The yoke front 602 and the yoke rear 604 can be coupled together via a snap fit. In the illustrated embodiment, the yoke front 602 includes a yoke fastener 613 that protrudes rearwardly from a rear surface of the yoke front 602. In the illustrated embodiment, the yoke fastener 613 is centrally or generally centrally located relative to the yoke front 602. The yoke rear 604 includes a fastener aperture 615 that is sized, shaped, and positioned to receive the yoke fastener 613 to form a snap fit connection when the yoke front 602 and the yoke rear 604 are coupled together. The central connection between the yoke front 602 and the yoke rear 604 via the yoke fastener 613 and the fastener aperture 615 provides greater robustness to the connection between the yoke front 602 and the yoke rear 604 and / or provides support to resist or inhibit twisting between the yoke front 602 and the yoke rear 604. In some embodiments, the yoke front portion 602 alternatively includes a fastener aperture 615, while the yoke rear portion 604 includes a yoke fastener 613. In some embodiments, the fastener aperture 615 includes one or more fastener protuberances 617 extending along (e.g., laterally along) the upper and / or lower edges of the fastener aperture 615 and protruding from the upper and / or lower edges into the fastener aperture 615. The yoke fastener 613 includes one or more corresponding notches 619 (e.g., extending along (e.g., laterally along) the upper and / or lower surfaces of the yoke fastener 613) Fig.137), the corresponding notches are sized, shaped and positioned to receive the fastener protuberances 617 to form a snap-fit ​​connection. In some embodiments, the fastener aperture 615 includes one or more notches 619 and the yoke fastener 613 includes one or more fastener protuberances 617.

[0374] Figures 148 to 150 A variation of the yoke 600 is shown in which the yoke rear portion 604 includes a fastener recess 615' in place of the fastener aperture 615. The fastener recess 615' does not extend completely through the thickness of the yoke rear portion 604. The yoke front portion 602 includes a yoke fastener 613' extending rearwardly. When the yoke front portion 602 and the yoke rear portion 604 are coupled together, the fastener recess 615' is sized, shaped, and positioned to receive the yoke fastener 613' to form a friction fit connection. In some such embodiments, the fastener recess 615' includes one or more interference ridges 617' on the upper and / or lower surface or upper and / or lower edge of the fastener recess 615'. In the illustrated embodiment, the interference ridges 617' are elongated and extend the entire depth of the fastener recess 615'. The interference ridges 617' influence and facilitate the friction fit between the fastener recesses 615' and the yoke fasteners 613' to help secure the yoke front 602 and yoke rear 604 together. This configuration can advantageously allow for easier manufacturing, provide a cleaner finish (no apertures in the yoke rear 604), and / or inhibit the ingress of dust or other debris into the linear rails 630, 632 (which allows the yoke 600 to be completely enclosed along its length due to the lack of apertures), which can help maintain operation of the automatic headgear adjustment mechanism.

[0375] exist Figures 135 to 137In an embodiment of the present invention, the yoke rear portion 604 includes: an upper alignment bead 612a that protrudes forward from the yoke rear portion 604 and extends along the length of the yoke rear portion 604, adjacent to or adjacent to the upper surface of the yoke rear portion 604; and / or a lower alignment bead 612b that protrudes forward from the yoke rear portion 604 and extends along the length of the yoke rear portion 604, adjacent to or adjacent to the lower surface of the yoke rear portion 604. The yoke front portion 602 includes: an upper alignment groove 614a in the rear surface of the yoke front portion 602, the upper alignment groove extending along the length of the yoke front portion 602, adjacent to or adjacent to the upper surface of the yoke front portion 602; and / or a lower alignment groove 614b in the rear surface of the yoke front portion 602, the lower alignment groove extending along the length of the yoke front portion 602, adjacent to or adjacent to the lower surface of the yoke front portion 602. When the yoke front portion 602 and the yoke rear portion 604 are coupled together, the upper and / or lower alignment grooves 614a, 614b receive the upper and / or lower alignment beads 612a, 612b, respectively. The alignment beads 612a, 612b and the alignment grooves 614a, 614b help to properly align the yoke front portion 602 and the yoke rear portion 604. The alignment beads 612a, 612b and the alignment grooves 614a, 614b can also or alternatively resist or support against twisting, for example, between the yoke front portion 602 and the yoke rear portion 604. In some embodiments, the alignment beads 612a, 612b and the alignment grooves 614a, 614b can positively engage with each other, such as in the form of a friction fit or snap fit connection.

[0376] The end caps 606 can help secure the yoke front 602 and yoke rear 604 together by clipping or snap-fitting over the lateral ends of or onto the yoke front 602 and yoke rear 604. The end caps 606 can also allow the front strap of the headgear to be connected to the yoke 600. In some embodiments, each end cap 606 is overmolded over a braided portion of the front strap.

[0377] like Figures 141 to 147 As shown, the lateral ends of the yoke front portion 602 and the yoke rear portion 604 include or are formed by end cap inserts 618. The end cap inserts 618 can be formed integrally with or attached to the lateral ends of the yoke front portion 602 and the yoke rear portion 604. The end cap inserts 618 have a reduced size or profile compared to the lateral portions of the yoke 600. The end cap 606 has an inner cavity 609 that receives the end cap insert 618. During assembly, the end cap 606 is hingedly connected to the end cap insert 618 or snapped onto the end cap insert, such as Fig.141 shown.

[0378] like Fig.146As shown, each end cap 606 includes a retention hole 605 on one side (e.g., the rear side in the illustrated embodiment) and a retention notch 607 on the opposite side (e.g., the front side in the illustrated embodiment). In other embodiments, the positions of the retention holes 605 and the retention notches 607 may be reversed. In the illustrated embodiment, the positioning of the retention holes 605 in the rear portion of the end cap 606 advantageously conceals the retention holes 605 during use, which provides an improved aesthetic appearance. The retention notches 607 extend forwardly from the end cap chamber 609 into the end cap 606. The end cap insert 618 includes a first retention feature 616 on one of the front and rear surfaces (e.g., extending rearwardly from the yoke rear 604 portion of the end cap insert 618 in the illustrated embodiment) and a second retention feature 617 on the opposite surface (e.g., extending forwardly from the yoke front 602 portion of the end cap insert 618 in the illustrated embodiment). To attach the end cap 606 to the yoke 600, such as to the end cap insert 618, the retaining hole 605 engages with the first retaining feature 616, such as Fig.141 The first retaining feature 616 then acts as a hinge or pivot point, and the end cap 606 is Fig.141 The hinged connection can be achieved by pivoting over the end cap insert 618 in the direction indicated by the arrow until the second retaining feature 617 and the retaining notch 607 engage in a ridge or snap-fit ​​connection, for example. Fig.144 606. The end cap 606 can thus be tapered more steeply. The reduced length of the end cap insert 618, the end cap 606, and / or the entire yoke 600 can advantageously reduce or minimize the digging of the yoke 600 into the patient's face.

[0379] In the illustrated embodiment, the first retention feature 616 is or comprises an oval or stadium-shaped cylinder extending rearwardly from the yoke rear portion 604. The length or depth of the first retention feature 616 is selected so that the outer or rearmost surface of the first retention feature 616 is flush or substantially flush with the rear surface of the yoke rear portion 604. This increases the contact area and interaction between the end cap 606 and the end cap insert 618 and increases the retention force. The connection between the end cap 606 and the end cap insert 618 can therefore resist greater torsional forces along the length of the yoke 600 and / or rotational forces about the joint.

[0380] In the illustrated embodiment, the second retention feature 617 is or includes a protruding tab extending forward from the yoke front portion 602. The second retention feature 617 has a reduced length or depth compared to the first retention feature 616, which allows the end cap 606 to straddle the second retention feature 617 during assembly. In the illustrated embodiment, the second retention feature 617 has a chamfered lead-in 617a on one edge, such as a lateral (relative to the yoke 600) edge in the illustrated embodiment, which allows the end cap 606 to be more easily hinged or pivoted on and / or hinged or pivoted to the second retention feature 617.

[0381] In some embodiments, the end cap 606 can be overmolded onto one end of a braided element of an automatic headgear adjustment mechanism, such as a braided element as shown and described in U.S. Provisional Patent Application No. 62 / 343,711, filed May 31, 2016, entitled "Directional Lock for Interface Headgear Arrangement," and PCT Application No. PCT / NZ2014 / 000074, the entire contents of which are incorporated herein by reference. The core element or filament 642 can extend within the braided element. The end cap 606 can connect the braided element and thus the headgear to the yoke 600 and create a closed loop headgear system.

[0382] As described herein, in some embodiments, the yoke 600 can form a collection piece for a core element, such as a filament 642, for use in an automatically adjustable or self-adjusting headgear system. Fig.136C As shown, the yoke front portion 602 includes an upper wire track 630 and a lower wire track 632. A wire track divider 634 projects rearwardly from a rear or inner surface of the yoke front portion 602. The wire track divider 634 generally extends diagonally across a portion of the length of the yoke front portion 602. In the illustrated embodiment, a divider wall 635 extends between each washer housing 646 and the opposing wire track. The divider wall 635 separates the opposing wire track from the washer housing 646 so that the free end of the filament 642 is inhibited from being caught in the opposing washer housing 646 during retraction. In the illustrated embodiment, due to the asymmetry of the upper and lower edges of the yoke 600, the wire tracks 630, 632 are not symmetrical mirror images.

[0383] Fig.140A variation of the yoke 600 is shown in which the wire tracks 630, 632 extend into and terminate in the end cap 606. The length of the wire tracks 630, 632 thus extends beyond the ends of the yoke front 602 and the yoke rear 604. This increases the length of the wire 642 that can be stored in the yoke 600, which increases the adjustment or variation range of the size of the headgear. The headgear assembly 200 defines a headgear loop that extends around the user's head during use. The wire 642 forms a part of an automatic headgear adjustment mechanism that allows the total length of the headgear loop to be extended during the process of putting on or taking off the mask system. In some such embodiments, the length of each of the wire tracks 630, 632 can be increased or extended by about 5 mm. In such embodiments, the total length of the headgear loop can therefore be increased by about 10 mm in the extended state.

[0384] Fig.139 An embodiment of a seal 502 is shown, such as a seal that can be used with a frame 500 and a yoke 600. In the illustrated embodiment, the seal 502 includes a lip pad 503 that protrudes outwardly from the seal grip 122 along the lower edge of the sealing surface to form a raised area that fills or cushions the seal grip 122. The lip pad 503 can minimize the bottoming out of the lower edge of the seal 502 against the seal grip 122 by providing additional cushioning, which can improve patient comfort, particularly in the upper lip area.

[0385] Fig.95A and Fig.95B A front view and a rear view of a nasal mask assembly 700 are shown, respectively, which includes a seal and frame assembly 702, a headgear assembly 704, and a gas conduit 706. The seal and frame assembly 702 includes a sealing cushion 708 supported by a frame 710. The sealing cushion 708 alone or in combination with the frame 710 defines a breathing chamber of the nasal mask assembly 700. The sealing cushion 708 can be in the form of a direct nasal cushion (e.g., a nasal pillow cushion). The gas conduit 706 transmits a respiratory gas flow from a gas source to the breathing chamber of the nasal mask assembly 700. The headgear assembly 704 supports the seal and frame assembly 702 in a desired position on the face of the user.

[0386] Figures 96 to 107 Shows Fig.95A and Fig.95BAn embodiment of a sealing liner or seal 708 of an interface or mask assembly of the present invention. An embodiment of the seal 78 is adjacent to a prior art nasal seal or reference seal 708R for comparison. As shown, the seal 708 is smaller than the prior art seal 708R. One aspect of the present disclosure relates to a seal (e.g., seal 708) having a smaller overall size / volume than the prior art seal 708R, while being well sealed on the user's face and stable on the user's face when incorporated in a mask assembly (e.g., mask assembly 700). In some embodiments, the seal 708 is used in conjunction with an automatically adjustable headgear or a headgear with orientation locking capability, as described above. Such a headgear allows the seal to remain in place with a reduced or minimal force that balances the blow-off or hose drag force that can be applied to the mask. The force applied to the user by the headgear without the mask assembly pressuring can be less than the force required to balance the blow-off force. The inventors have discovered that the reduced or minimal forces applied to the user's head by such a system allow the sealing surface of the seal to be reduced or minimized. This is because it is no longer necessary to spread the larger headgear forces over a larger sealing surface in order to reduce pressure points. The lower forces can be spread over a smaller sealing surface without a large number of pressure points occurring. This allows a smaller seal with a smaller contact surface to form an effective and comfortable seal with the user's face. Advantageously, the respiratory masks are as small or practical as possible, making them as unobtrusive as possible and avoiding a feeling of claustrophobia for the user. Because in some configurations of automatically adjustable headgear or headgear with directional locking capabilities, such as Fig.95A and Fig.95B The system is very flexible between the rear portion of the headgear and the mask frame, with the benefit that the seal is more stable on the face than the prior art seal 708R or other seals used in conjunction with other types of headgear. The inflatable nature of the prior art seal 708R allows it to rotate or roll about the user's nose.

[0387] Several factors limit how small a seal can be made. For example, typically, the minimum size of a seal is affected and limited by the access orifice and the sealing surface. The seal forms part of the air path and therefore must be connected to a gas conduit that delivers pressurized gas to the seal and the patient's airway. There are limitations on how small the diameter of the gas conduit can be while minimizing the pressure drop between the CPAP (blower or airflow generator) and the patient's interface / mask. In some embodiments, the inner diameter of the gas conduit used with the disclosed seal is equal to or greater than 15 mm.

[0388] Prior art masks use elbows to connect the gas conduit to the mask frame. The elbows add extra weight and bulk to the mask, which can cause instability in the mask. In at least some configurations of the currently disclosed interface, the elbows have been omitted in favor of a direct connection between the gas conduit and the mask frame (e.g., gas conduit 706 and frame 710). In use, the removal of the elbow shifts the center of gravity toward the user's face and, therefore, reduces rotational torque, improving the stability of the seal.

[0389] The bias flow or vent is typically located in an elbow for a direct nasal (e.g., nasal pillow) mask. If there is no elbow, the bias vent needs to be located elsewhere. The bias vent should be located within the air path of the mask and therefore the inlet orifice of the seal is preferably large enough to accommodate the path through which the exhausted air can exhaust. The inlet orifice of the seal is therefore preferably large enough to accommodate the gas inlet, the bias vent, and the clamping or other connecting structure that attaches the mask frame to the seal. The sealing surface of the seal should be large enough to form an airtight seal between the seal and a series of patient's nostrils.

[0390] refer to Fig.96 , a prior art nasal seal 708R is shown adjacent to the seal 708 of the present disclosure for comparison. The prior art seal 708R can be the same as or similar to the seal disclosed in applicant's PCT publication WO2015 / 009172, the entire contents of which are incorporated herein by reference. The prior art seal 708R cushion and the seal 708 cushion are generally similar in shape; however, in the illustrated arrangement, the overall size of the seal 708 cushion is smaller than the prior art seal 708R cushion. The seals 708, 708R cushions each include a pair of nasal cannulas or pillows 712, 712R, respectively, which are configured to engage with the user's nasal cavity and form a substantial seal with the user's nostrils so that a pressurized air supply can be delivered to the user's airway. In at least some configurations, the nasal cannula 712, 712R provides a primary sealing surface that provides primary contact between the nasal cavity and the seal 708, 708R cushion to provide a substantially airtight seal. The nasal cannula 712 of the seal 708 can be the same or substantially similar in shape to the nasal cannula 712R of the prior art seal 708R.

[0391] refer to Fig.97 , the prior art seal 708R includes a second sealing surface 714R surrounding and coupling the nasal cannula 712R. The second sealing surface 714R forms a secondary seal or a second seal with the lower nasal surface of the user's nose. The second sealing surface 714R is configured to trap air leakage that may occur between the nasal cannula 712R and the user's nasal cavity and substantially inhibit or prevent air from escaping outside the seal cushion.

[0392] The seal 708 cushion shown includes a second sealing surface 714 that is smaller than the second sealing surface 714R of the prior art. The second sealing surface 714 of the seal 708 extends primarily between the two nasal cannulas 712 and forms a connection between the two nasal cannulas without extending radially outward from the nasal cannulas 712. In some configurations, the second sealing surface 714 has an upper boundary at or above the uppermost portion of the nasal cannulas 712 and a lower boundary at or above the lowermost portion of the nasal cannulas 712. In some configurations, the second sealing surface 714 is defined by a concave portion of the user-facing surface of the seal 708 at or around the nasal cannulas 712. The second sealing surface or surrounding area 714 of the seal 708 can perform a smaller role than the second seal of the seal 708R of the prior art due to its smaller size. In some configurations, the second sealing surface 714 of the seal 708 can be configured to only trap leakage on the underside of the user's nose, without providing a substantial second seal on the outside edge of the user's nasal cavity for at least some users. However, in some configurations, the second sealing surface 714 of the seal 708 can be configured to provide a second seal around the entire perimeter of the seal cushion 708.

[0393] In some configurations, the profile of the second sealing surface 714 of the seal gasket 708 is substantially similar or identical to the profile of a corresponding portion of the second sealing surface of the prior art seal gasket 708R, such as by Fig.98 and Fig.99 As discussed above, the primary sealing surfaces of the nasal cannulas 712, 712R of both seals 708, 708R can also be substantially similar.

[0394] refer to Fig.99, the nasal cannula 712, 712R of both the seal liner 708, 708R include an outlet 716, 716R through which the pressurized air is supplied. The outlet 716, 716R includes an elliptical orifice formed at the truncated tip of the nasal cannula 712, 712R. The elliptical orifice 716, 716R has a major axis 718 and a minor axis 720. In the illustrated arrangement, the dimension along the major axis 718 of the outlet 716 of the seal 708 is longer than the corresponding dimension along the major axis 718 of the outlet 716R of the prior art. In at least some configurations, the difference exists only on the inner peripheral surface of the outlet 716, 716R. The dimension along the major axis 718 of the outlet 716, 716R is the same as the length on the outer peripheral surface of the outlet 716, 716R. This configuration provides a uniform wall thickness at the outlet 716 of the seal 708, which also provides uniform softness to improve the comfort and fit of the wearer. The dimensions of the outlets 716, 716R along the minor axis 720 of both the seal 708 and the prior art seal 708R are substantially the same.

[0395] refer to Fig.100 , the total height 722 of the seal 708 is less than the height 722R of the seal 708R of the prior art. Compared with the seal 708R of the prior art, the dimension in the direction of the height 722 of the seal 708 is reduced at both the top and the bottom. In the illustrated arrangement, the height 722 is mainly reduced at the top of the seal 708. This is shown by the difference of the height 722, 722R above the centerline 724, through which the nasal cannulas 712, 712R of the two seals 708, 708R are aligned. The reduced height 722 makes the seal 708 less prominent for the wearer. The reduced height 722 also means that the seal 708 is located below the nose of the wearer and may not cover the tip of the nose of the wearer in some cases. In some configurations, the height 722 can be equal to or less than about 38mm, 35mm or 33mm. In some configurations, the height 722 is equal to about 32mm (e.g., 32.2mm). For comparison, the prior art seal 708R is shown having a height 722R of 42.3 mm.

[0396] As shown, the inlet 726R of the prior art seal 708R includes a circular profile. The shape of the inlet 726 of the seal 708 is similar to a trapezoid that has been rounded. In other words, the inlet 726 of the seal 708 is generally "D-shaped" and slightly follows the outer contour of the seal 708 liner (when viewed from the front). The inlet 726 is configured to be clamped by a clamping mechanism (not shown, but capable of being engaged with the Figures 119 to 122The "D-shaped" inlet 726 of the seal 708 provides an alignment feature between the seal cushion 708 and the mask frame (e.g., mask frame 710) that prevents incorrect assembly and thus improves ease of use.

[0397] refer to Fig.101 , the total depth 730 of the seal 708 is less than the depth 730R of the seal 708R of the prior art. Compared with the seal 708R of the prior art, the depth 730 of the seal 708 is reduced at both the front and rear. The reduced depth 730 helps the seal 708 to be less prominent to the wearer and can help reduce the rotational movement of the seal 708 relative to the wearer's face (in the vertical plane around the lateral axis). The smaller depth 730 reduces the moment of the seal cushion 708 on the face by bringing the center of gravity closer to the face. As described above, this is beneficial when the seal 708 is used in combination with an automatically adjustable headgear or a headgear combined with one or more direction locks. In some configurations, the total depth 730 of the seal 708 is equal to or less than 40 mm, equal to or less than 38 mm, or about 35 mm (e.g., 35.7 mm), compared with the total depth 730R of 44.4 mm of the seal 708R of the prior art. In some configurations, the overall width 732 of the seal 708 is equal to or less than 60 mm or is approximately 57 mm (eg, 57.4 mm), compared to an overall width 732R of 68.1 mm for the prior art seal 708R.

[0398] refer to Fig.102 Due to the reduced height 722 and depth 730 of the seal cushion 708 relative to the prior art seal cushion 708R, in at least some configurations, the upper or rolling bridge portion 738 of the seal 708 is smaller (has a smaller depth or front-to-back dimension) than the upper or rolling bridge portion 738R of the prior art seal 708R. The rolling bridge 738R of the prior art seal 708R includes a thin-walled area or an area of ​​reduced wall thickness that is configured to roll or deform to allow the seal cushion 708R to accommodate a wider range of nasal geometries. By minimizing the amount of deformation in the seal cushion 708, the reduced size of the rolling bridge 738 of the seal 708 can reduce instability between the seal cushion 708 and the wearer's face.

[0399] When viewed from the side of the seal cushion 708, 708R, the inlet 726R of the prior art seal 708R and the inlet 726 of the seal 708 are both relatively flat. When the nasal cannulas 712, 712R are in the same position, the inlet 726 of the seal 708 is at a greater angle 740R to the horizontal plane ( Fig.102 In other words, when the nasal cannulas 712, 712R are in the same position, the inlet 726 of the seal 708 is closer to vertical than the inlet 726R of the prior art seal 708R. In addition, the inlet 726 of the seal 708 is offset toward the wearer's face (in use) compared to the inlet 726R of the prior art seal 708R.

[0400] Fig.103 and Fig.104 Thickness graphs of a prior art seal 708R and a comparative seal 708 are shown. Different shading patterns represent different thicknesses. Prior art seal 708R includes three thickness sections or regions 742R, 744R, 746R from thinnest to thickest. Seal 708 includes two thickness sections or regions 744, 746 from thinnest to thickest. Section or region 742R can have a thickness equal to or less than about 0.3 or 0.4 mm. Sections or regions 744, 744R can have a thickness between about 0.4 or 0.5 mm and about 0.8 or 1 mm. Sections or regions 746, 746R can have a thickness equal to or greater than 1 or 1.5 mm. The rolling bridge 738 of seal 708 has a smoother transition and increased wall thickness (e.g., 1.5 mm) in at least a portion thereof relative to the rolling bridge 738R of prior art seal 708R. Fig.102 This arrangement inhibits or prevents folds or creases from forming at abrupt thickness transitions and provides more uniform torsion under applied forces, which improves stability. Fig.103 As shown, the thickened side regions 746 of the seal 708 are limited to the side walls of the seal 708. That is, the thinner regions extend from the top and bottom walls through the transition regions and toward or onto the side walls. In some configurations, the thickened side regions 746 have a wall thickness equal to or greater than 1 mm, while the relatively thinner regions of the top and bottom walls have a wall thickness equal to or less than 1 mm. In the illustrated arrangement, the wall thickness greater than 1 mm is limited to the side walls 746, while the wall thickness less than 1 mm extends to the transition between the side walls and the top and bottom walls.

[0401] refer to Fig.105, the size and wall thickness of the outwardly protruding corners 748, 748R have been reduced in the seal 708 relative to the prior art seal 708R. The smaller size of the seal pad 708 means that the outwardly protruding corners 748 are less likely to contact the wearer's face to provide stability. In order to offset the reduction in stability provided by the outwardly protruding corners 748R in the prior art seal 708R, the seal pad 708 is made more stable by increasing the inner wall thickness and reducing the size of the rolling bridge 738, so that the outwardly protruding corners 748 are less important in providing stability. This means that the outwardly protruding corners 748 of the seal pad 708 do not need to contact the upper lip surface with as much force as possible to provide stability, and therefore can be smaller and have a thinner wall thickness. The reduced wall thickness of the outwardly protruding corners 748 can make them more compliant and able to bend to fit the wearer's facial geometry.

[0402] refer to Fig.106 , the primary sealing surfaces of the nasal cannula 712, 712R and the secondary sealing surfaces 714, 714R form the inner surfaces of the two seal pads 708, 708R, wherein the inner surfaces are adjacent to the wearer's face in use. The seal pad 708 has a greater wall thickness in the inner surface than the seal pad 708R of the prior art. In some configurations, the inner surface of the seal pad 708 has a wall thickness greater than 0.3 mm, greater than 0.4 mm, or approximately 0.45 mm, compared to the inner surface wall thickness of 0.25 mm of the prior art. Compared to the seal pad 708R of the prior art, the increased wall thickness of the inner surface of the seal pad 708 is less prone to deformation, which improves stability on the wearer's face. In some cases, this can improve manufacturability because it is easier to mold parts with thicker walls.

[0403] Fig.106Also shown is the depth 750 of the valley defined by the user contact surface of seal 708 and the depth 750R of the valley of the seal 708R of the prior art for comparison. The valley depth 750, 750R is defined as the maximum depth of the line defined by the last point of the upper and lower parts of the user contact surface of the seal, and this maximum depth appears along the vertical center plane of each seal 708, 708R shown. As shown, the valley depth 750 of seal 708 is significantly smaller than the valley depth 750R of the seal 708R of the prior art. In some configurations, the valley depth 750 of seal 708 is less than about 1.2mm. For example, the valley depth 750 of seal 708 can be between about 0.9mm and 1.2mm, or can be about 1.125mm. In comparison, the valley depth 750R of the seal 708R of the prior art is about 4.5-5mm. In the illustrated seals 708, 708R, at least a majority of the difference results from the larger rolling bridge portion 738R in the prior art seal 708R.

[0404] Fig.107 The prior art seal 708R is shown and used for comparison Figure 103 to Figure 105 A bottom-up thickness map of the seal 708 with the same shading. Fig.107 The seal 708 is shown to have a smoother thickness transition between the front wall and the bottom wall (eg Fig.102 and Fig.106 ). This arrangement inhibits or prevents folds or creases from forming at abrupt thickness transitions and provides more uniform torsion under applied forces, which improves stability.

[0405] Fig.108 A front view of a seal 708 is provided (left, which may be referred to herein as a "first seal"), a prior art seal 708R (right), and another embodiment of a nasal seal 708a referred to herein as a "second seal". The inlet openings 726, 726a, 726R of all illustrated seal cushions 708, 708a, 708R are configured to receive a seal clamp that connects the seal cushions 708, 708a, 708R to a mask frame. The inlet openings 726, 726a of the first seal 708 and the second seal 708a are sized to allow the gas inlet and the biasing vent to fit within the seal clamp. The lower edge of the inlet opening 726a of the second seal 708a is more curved than the lower edge of the inlet opening 726, and the maximum width of the inlet opening 726a is greater than the maximum width of the inlet opening 726. Furthermore, the front surface surrounding entry aperture 726a is more curved than the relatively flat front surface surrounding entry aperture 726 . Fig.108Also shown are the total relative heights 722, 722a, 722R and widths 732, 732a, 732R of the first seal 708, the second seal 708a, and the prior art seal 708R. The first and second seals 708, 708a can have a height 722, 722a less than or equal to 40 mm and a width 732, 732a less than or equal to 65 mm. The first seal 708 shown has a height 722 of about 35 mm (e.g., 35.2 mm) and a width 732 of about 58-60 mm (e.g., 58.5 mm). The second seal 708a shown has a height 722a of about 35-36 mm (e.g., 35.5 mm) and a width 732a of about 60-62 mm (e.g., 61 mm). The prior art seal 708R shown has a height 722R of 48.2 mm and a width 732R of 68 mm.

[0406] Fig.109 A top view of seal 708, secondary seal 708a, and prior art seal 708R is provided. The curved inlet 726a of secondary seal 708a allows for a reduced depth toward the lateral edges of secondary seal cushion 708a compared to seal cushion 708. This makes seal cushion 708a appear smaller and helps move the center of gravity of seal cushion 708a closer to the wearer's face during use. Fig.109 The total depths 730R, 730, 730a of the prior art seal 708R (left), seal 708 (right) and second seal 708a (middle) are shown, respectively. The seal 708 has a depth 730 of about 30 mm, the second seal 708a has a depth 730a of about 32-33 mm (e.g., 32.5 mm), and the prior art seal 708R has a depth 730R of about 38-40 mm (e.g., 38.2 mm).

[0407] refer to Fig.110 , the seals 708, 708a, 708R have a bridge depth 752, 752a, 752R defined as the depth of the top surface along the vertical center plane of the seals 708, 708a, 708R, respectively. The bridge depths 752, 752a in the seals 708 and second seals 708a have been reduced compared to the prior art seal 708R, which reduces or minimizes the instability and rolling of the seals 708, 708a on the user's nose. The bridge portions 738, 738a have a greater wall thickness in the seals 708 and second seals 708a, which also improves stability. Fig.104 The thickness graph of FIG. 708 shows the increased thickness and smoother thickness transition of seal 708. The second seal 708a can have a similar thickness and / or thickness transition as seal 708.

[0408] The bridge depths 752, 752a of the first and second seals 708, 708a can be less than or equal to 15 mm. In the illustrated arrangement, the bridge depth 752 of the seal 708 is 11 mm, the bridge depth 752a of the second seal 708a is 13.5 mm, and the bridge depth 752R of the prior art seal 708R is 21.7 mm. Thus, referring to Fig.109 , the bridge depth 752 of the seal 708 is less than half of the total depth 730 of the seal 708. In some configurations, the bridge depth 752 is about one-third of the total depth 730. The bridge depth 752a of the second seal 708a is less than half of the total depth 730a of the second seal 708a. In some configurations, the bridge depth 752a is about two-fifths of the total depth 730a. In contrast, the bridge depth 752R of the prior art seal 708R is greater than half of the total depth 730R of the prior art seal 708R. In particular, the bridge depth 752R of the prior art seal 708R is about four-fifths of the total depth 730R of the prior art seal 708R.

[0409] Seals 708, 708a, 708R also define internal cannula depths 754, 754a, 754R from the front surface to the inner portion of cannula 712, 712a, 712R and external cannula depths 756, 756a, 756R from the front surface to the outer portion of cannula 712, 712a, 712R, respectively. The internal cannula depths 754, 754a and external cannula depths 756, 756a of seals 708, 708a are both less than the corresponding internal cannula depths 754R and external cannula depths 756R of seal 708R, which can be partially or primarily due to the smaller bridge depths 752, 752a. In the illustrated seals 708, 708a, 708R, the inner cannula depths 754, 754a, 754R are 24.5 mm, 25.8 mm, and 29.8 mm, respectively, while the outer cannula depths are 27 mm, 28.9 mm, and 32.2 mm, respectively.

[0410] refer to Fig.111 , the geometry of the cannula 712a of the second seal 708a is more conical and less curvy than the geometry of the cannula 712 of the seal 708 and the geometry of the cannula 712R of the prior art seal 708R. The more conical and less curvy shape helps the cannula 712a seal with a wider range of nasal geometries without extending too far into larger nostrils.

[0411] Fig.111Also shown are the areas of the respective sealing surfaces 760, 760a, 760R (including the cannula 712, 712a, 712R and the second sealing surface 714, 714a, 714R) of each of the comparative seal 708, the second seal 708 and the prior art seal 708R. As shown, the sealing area 760R of the prior art seal 708R is greater than 1000 mm 2 , especially about 1100mm 2 (1102mm 2 In contrast, the sealing area 760, 760a of each of the seal 708 and the second seal 708a is less than 1000 mm 2 In particular, the sealing area 760 of the seal 708 is approximately 900 mm 2 (For example 907mm 2 ), and the sealing area 760a of the second sealing member 708a is approximately 880mm 2 (For example 883mm 2 ).

[0412] Fig.112 A bottom view of the seal 708, the second seal 708a, and the prior art seal 708R is provided for comparison. Fig.109 As shown, the second sealing member 708a includes a transversely curved inlet 726a. The sealing member 708 includes a planar inlet 726.

[0413] Fig.113 A side view of seal 708, second seal 708a, and prior art seal 708R are shown overlapping each other. Fig.114 A second seal 708a is shown superimposed on a prior art seal 708R. As described above, the seal 708 and the second seal 708a have a significantly smaller height and depth than the prior art seal 708R.

[0414] Fig.115 is a cross-sectional view along a vertical center plane of the seal 708, the second seal 708a, and the prior art seal 708R overlapping each other. Fig.115 The inner (user-facing) wall thickness of the first and second seals 708, 708a is shown to be greater than the inner wall thickness of the prior art seal 708R. Fig.116 708 and the second sealing member 708a are cross-sectional views overlapping each other. Fig.116 The laterally curved entry aperture 726a of the second seal 708a is shown compared to the planar entry aperture 726 of the seal 708 .

[0415] Fig.117A cross-sectional view along a center horizontal plane of the seal 708, the second seal 708a, and the prior art seal 708R overlapping each other is shown. Fig.117 It is shown that the wall thickness of both the first and second seal gaskets 708, 708a is reduced on the outer surface compared to the prior art seal gasket 708R.

[0416] Fig.118 is with Fig.117 Same cross-section, but with the prior art seal 708R omitted. Fig.118 The angle of the cannula tip is shown changing between the seal 708 and the second seal 708a. In the arrangement shown, the cannula angle 762 of the seal 708 is approximately 120 degrees, while the cannula angle 762a of the second seal is approximately 140 degrees. The increased angle 762a between the cannula tips of the second seal pad 708a is intended to reduce pressure on the user's septum and may make the cannula 712a less invasive.

[0417] refer to Fig.119 and Fig.120 , the second seal 708a includes a seal clamp 764a. The seal clamp 764a includes an inner clamp portion or inner clamp 766a and an outer clamp portion or outer clamp 768a, which are configured to clamp together so that they clamp the edge of the entry orifice 726a of the seal. In some configurations, the inner clamp 766a and the outer clamp 768a are permanently engaged with each other by snap-fit ​​geometry or any other suitable means (welding, gluing, etc.). The inner clamp 766a defines an air inlet 770a and a vent area 772a. The air inlet 770a has a larger area than the vent area 772a and is located below the vent area 772a.

[0418] The air inlet 770a is configured to receive and connect to a flange of a mask frame (e.g., frame 710). The connection between the flange and the inner clamp 766a is provided by a snap-fit ​​ridge 774a in the illustrated arrangement and is configured so that the seal 708a can be repeatedly connected to and disconnected from the frame. The flange is configured to surround the connection between the frame and the gas conduit. Thus, the air inlet 770a is sized according to the size of the gas conduit and the connection to the frame. In the illustrated arrangement, the air inlet 770a has a maximum width 776a of approximately 27 mm and a maximum height 778a of approximately 14 mm.

[0419] The vent area 772a is configured to receive and hold a diffuser clamp 780a, which holds the diffuser 782a within the vent area 772a such that all air / gas passing through the vent area 772a passes through the diffuser 782a. The diffuser clamp 780a can be permanently or temporarily connected to the inner clamp 766a by a snap-fit ​​connection or other suitable arrangement (e.g., welding).

[0420] Diffuser 782a includes a fabric through which air can pass. The area of ​​diffuser 782a combined with the density of diffuser 782a is configured to allow sufficient air to flow through ventilation area 772a to flush exhaled CO2 from a mask (e.g., mask 702) of which seal 708a is a part. In some embodiments, a flow rate of about 31 L / min may be desired.

[0421] In the arrangement shown, the diffuser 782a is permanently bonded to the diffuser holder 780a, such as by overmolding or welding. The diffuser holder 780a includes an orifice that is filled by the diffuser 782a.

[0422] The vent area 772a is limited at its lower limit by a pair of separators 784a extending inwardly from the inner periphery of the inner clamp 766a. The separators 784a extend partially in width so that they do not meet in the middle. The separators 784a are configured to support the diffuser clamp 780a within the inner clamp 766a.

[0423] refer to Fig.121 and Fig.122 A modified embodiment of the inner clamp 766a includes a single separator 784a that extends across the entire width of the inner clamp 766a to define a vent aperture 786a. The diffuser clamp 780a is permanently bonded to the inner clamp 766a within the vent aperture 786a. The diffuser clamp 780a can be bonded to the inner clamp 766a by overmolding, welding, bonding, etc.

[0424] Fig.123The outlet end of the cannula 712a of the second seal 708a and the end of the cannula 712R of the seal 708R of the prior art for comparison are shown. As shown, each outlet end of the cannula 712a, 712R defines a major axis 718a, 718R and a minor axis 720a, 720R. The outlet end of the cannula 712R is symmetrical about the major axis 718R and the minor axis 720R. The outlet end has a width 790R defined by the width 792R of the inner portion and the width 794R of the outer portion. The widths 792R, 794R are equal to each other. Each width 792R, 794R has a size of 2.90mm, so that the total width 790R has a size of 5.8mm. The outlet end has a height 796R defined by the height 798R of the upper portion and the height 800R of the lower portion. The heights 798R, 800R are equal to each other. Each height 798R, 800R has a size of 4.6mm, so that the total height 796R has a size of 9.2mm. In contrast, the outlet end of the cannula 712a is asymmetric about at least one of the primary axis 718a and the secondary axis 720a. In the illustrated arrangement, the width 790a is composed of the width 792a of the inner portion and the width 794a of the outer portion, wherein the width 794a is greater than the width 792a. In the illustrated arrangement, the width 792a is 2.6mm, the width 794a is 3.0mm, and the total width 790a is 5.6mm. The height 796a is composed of the height 798a of the upper portion and the height 800a of the lower portion, and the height of the upper portion and the height of the lower portion are equal to each other. In the illustrated arrangement, the height 798a and the height 800a each have a size of 4.25mm, so that the total height 796a has a size of 8.5mm.

[0425] Fig.124 is an exploded view of the second seal 708a, the seal holder 764a and the diffuser holder 780a. Fig.124 , the seal clamp 764a shows the inner clamp 766a and the outer clamp 768a clamped together separated from the seal 708a. The diffuser clamp 780a is also shown separated from the seal 708a and the seal clamp 764a.

[0426] Fig.125 and Fig.126 A top view and a side view, respectively, of a prior art seal cushion 708R are shown immediately adjacent to a first seal cushion 708 for comparison. As noted, the portion of the seal 708 surrounding the nasal cannula 712 is significantly smaller than the portion of the seal 708R surrounding the nasal cannula 712R for a given seal or nasal cannula size.

[0427] Figure 127 to Figure 129Several views of a prior art seal cushion 708R overlying a first seal cushion 708 are shown, with nasal cannulas 712R, 712 generally aligned with each other. Figure 127 to Figure 129 Differences in wall thickness in various portions of the seals 708, 708R, differences in attitude or angle of access openings 726, 726R, and differences in overall size and shape are shown.

[0428] Fig.130 Thickness plots of a prior art seal liner 708R and a first seal liner 708 are shown, with the seals 708, 708R in front and rear perspective views. Fig.130 Use the same shading pattern to indicate the combination of Figure 103 to Figure 105 and Fig.107 The wall thickness range described.

[0429] Fig.131 Top views of different combinations of seals 708, 708a, and 708R superimposed on each other are shown for comparison.

[0430] Fig.132 A cross-sectional view taken along a vertical lateral plane of seals 708 , 708 a , and 708R overlapping one another and seals 708 , 708 a overlapping one another for comparison is shown.

[0431] Unless the context clearly requires otherwise, throughout the specification and claims, the words "including," "comprising," and the like are to be interpreted in an inclusive sense, and not in an exclusive or exhaustive sense, that is, in the sense of "including, but not limited to." Unless otherwise noted, conditional language used herein, such as "can," "may," "possibly," "could," "for example," and the like, unless otherwise noted or otherwise understood in the context of use, is generally intended to express that certain embodiments include, while other embodiments do not include, certain features, elements, and / or states. Thus, such conditional language is generally not intended to indicate that such features, elements, and / or states are in any way essential to one or more embodiments, or that one or more embodiments must include logic for deciding, with or without author input or prompting, whether such features, elements, and / or states are included in any particular embodiment or are to be implemented in any embodiment.

[0432] The term "plurality" refers to two or more items. The description of quantity, dimension, size, formula, parameter, shape and other features should be interpreted as assuming that the term "about" or "approximately" is before the quantity, dimension, size, formula, parameter, shape or other features. The term "about" or "approximately" means that the quantity, dimension, size, formula, parameter, shape and other features do not need to be precise, but can be close and / or larger or smaller as needed, reflecting acceptable tolerances, conversion factors, rounding, measurement errors, etc. and other factors known to those skilled in the art. The description of quantity, dimension, size, formula, shape and other features should also be interpreted as assuming that the term "roughly" is before the quantity, dimension, size, formula, parameter, shape or other features. The term "roughly" means that the feature, parameter or value does not need to be precisely realized, but a deviation or change, including, for example, tolerance, measurement error, measurement accuracy limitations and other factors known to those skilled in the art, can occur in an amount that does not exclude the effect that the feature is intended to provide.

[0433] Numerical data can be expressed or presented in range format herein.It should be understood that such range format is only used for convenience and simplicity, and therefore should be flexibly interpreted as not only comprising the numerical value clearly listed as range limitation, but also interpreted as comprising all individual numerical values, or the sub-range included in the range, as if each numerical value and sub-range are clearly listed.As an example, the numerical range of "1 to 5" should be interpreted as not only comprising the value of about 1 to about 5 clearly listed, but also should be interpreted as being also included in the single value and sub-range in the indicated range.Therefore, included in the numerical range are single values ​​such as 2,3 and 4 and sub-ranges such as "1 to 3", "2 to 4" and "3 to 5" etc. The same principle is applicable to the scope of only listing a numerical value (e.g., "greater than 1"), and should be applicable regardless of the breadth of the scope or the described features.

[0434] For convenience, multiple items may be presented in a common list. However, such lists should be interpreted as if each member of the list was individually identified as a separate and unique member. Thus, no individual member of such a list should be interpreted as equivalent to any other member of the same list solely by virtue of its presentation in a common group without indication to the contrary. In addition, when the terms "and" and "or" are used in conjunction with a list of items, they should be interpreted broadly in that any one or more of the listed items may be used alone or in conjunction with the other listed items. The term "alternatively" refers to the selection of one of two or more alternatives and is not intended to limit the selection to only those listed alternatives or to only one of the listed alternatives at a time, unless the context clearly indicates otherwise.

[0435] The reference to any prior art in this specification is not and should not be taken as an acknowledgment or any form of suggestion that the prior art forms part of the common general knowledge in the field of endeavour in any country in the world.

[0436] Where in the foregoing description reference has been made to integers or components having known equivalents thereof, such integers are incorporated herein as if individually set forth.

[0437] The invention may also be broadly said to include the parts, elements and features mentioned or indicated in the specification of the present application, either individually or collectively, in any or all combinations of two or more parts, elements or features.

[0438] It should be noted that various changes and modifications of the presently preferred embodiments described herein will be apparent to those skilled in the art. These changes and modifications may be made without departing from the spirit and scope of the present invention, without diminishing the attendant advantages thereof. For example, various components may be repositioned as desired. Therefore, it is intended that these changes and modifications are included within the scope of the present invention. In addition, not all features, aspects, and advantages are necessary for implementing the present invention. Therefore, the scope of the present invention is limited only by the appended claims.

[0439] Incorporation by reference into any priority application

[0440] Any and all applications identifying foreign or domestic priority claims in the Application Data Sheet filed with the present application are incorporated herein by reference and made a part of the present disclosure.

[0441] The present invention relates to the following items.

[0442] 1. A respiratory mask system comprising a mask interface, the mask interface comprising a frame for a headgear assembly, wherein the frame comprises a body, the body of the frame comprising a first surface and a substantially opposite second surface; and wherein the body of the frame further comprises a gas inlet and a gas outlet.

[0443] 2. A respiratory mask system comprising a mask interface, the mask interface comprising a frame, wherein the frame comprises a body, the body of the frame comprising a front surface and a substantially opposite rear surface; wherein the front surface comprises a recessed area, and a yoke of the headgear assembly can be positioned within the recessed area.

[0444] 3. A respiratory mask system, the respiratory mask system comprising a yoke for a headgear assembly, wherein the yoke includes a body, the body of the yoke including: a front surface, the width of the front surface is defined by the distance between the top surface and the bottom surface of the yoke, the length of the front surface is defined by the distance between the opposite ends of the yoke; and a middle portion located between two side portions, the side portions are located at or near the ends of the yoke, wherein the width of the yoke at the middle portion is less than the width of the yoke at the side portions.

[0445] 4. A breathing mask system, the breathing mask system including a headgear assembly, wherein the breathing mask system includes a mask interface, the mask interface including a frame, the frame including a body, the body of the frame including: a first surface and a substantially opposite second surface; the body of the frame also includes a gas inlet and an outlet; and wherein the breathing mask system also includes a yoke for the headgear assembly, wherein the yoke includes a body, the body of the yoke including: a front surface, the width of the front surface is defined by the distance between the top surface and the bottom surface of the yoke, and the length of the front surface is defined by the distance between the opposite ends of the yoke; and a middle portion located between two side portions, the side portions are located at or near the ends of the yoke, wherein the width of the yoke at the middle portion is less than the width of the yoke at the side portions.

[0446] 5. A respiratory mask system, the respiratory mask system comprising a headgear assembly, wherein the respiratory mask system includes a mask interface, the mask interface including a frame, wherein the frame includes a body, the body of the frame including a front surface and a generally opposite rear surface, wherein the front surface includes a recessed area in which a yoke of the headgear assembly can be positioned; and wherein the respiratory mask system also includes a yoke for the headgear assembly, wherein the yoke includes a body, the body of the yoke includes: a front surface, the width of the front surface is defined by the distance between the top surface and the bottom surface of the yoke, and the length of the front surface is defined by the distance between opposite ends of the yoke; and a middle portion located between two side portions, the side portions being located at or near the ends of the yoke, wherein the width of the yoke at the middle portion is less than the width of the yoke at the side portions.

[0447] 6. A breathing mask system, comprising:

[0448] A mask frame, the mask frame comprising:

[0449] an inlet configured to be coupled to a gas conduit in use;

[0450] a yoke channel extending longitudinally through the mask frame, the yoke channel being defined by upper, rear and lower walls; and

[0451] a retaining ridge projecting downwardly from the upper wall into the yoke channel; and

[0452] a yoke configured to be at least partially disposed in the yoke channel, the yoke including a retaining notch in an upper surface of the yoke,

[0453] Wherein the retaining protrusion is configured to snap fit into the retaining notch when the yoke and the mask frame are coupled together.

[0454] 7. A respiratory mask system according to clause 6, wherein the retaining notch is located along a corner between a front wall and a top wall of the yoke.

[0455] 8. A respiratory mask system according to clause 6, wherein the yoke includes a yoke front portion and a yoke rear portion connected to the yoke front portion.

[0456] 9. A respiratory mask system according to clause 8, wherein the front portion of the yoke includes the retaining notch.

[0457] 10. A breathing mask system, comprising:

[0458] A mask frame, the mask frame comprising:

[0459] an inlet configured to be coupled to a gas conduit in use;

[0460] a yoke channel extending longitudinally through the mask frame, the yoke channel being defined by upper, rear and lower walls; and

[0461] an anti-rotation groove recessed into the rear wall and extending along the length of the yoke channel; and

[0462] a yoke configured to be at least partially disposed in the yoke channel, the yoke including a tongue projecting rearwardly from the yoke,

[0463] wherein the tongue is configured to be disposed in the anti-rotation groove when the yoke and the mask frame are coupled together, wherein the interaction between the anti-rotation groove and the tongue is configured to inhibit rotational disengagement of the yoke from the mask frame.

[0464] 11. A respiratory mask system according to clause 10, wherein the yoke includes a yoke front portion connected to a yoke rear portion.

[0465] 12. A respiratory mask system according to clause 11, wherein the tongue comprises a front tongue extending from the front of the yoke and a rear tongue extending from the rear of the yoke.

[0466] 13. A respiratory mask system according to clause 12, wherein the front tongue is arranged below the rear tongue such that an upper surface of the front tongue abuts a lower surface of the rear tongue.

[0467] 14. A yoke configured to be coupled to a mask frame of a respiratory mask system, the yoke comprising:

[0468] a front wall extending from a first lateral end to a second lateral end;

[0469] a rear wall extending from a first lateral end to a second lateral end, the front wall and the rear wall defining an interior chamber therebetween;

[0470] a first end cap coupled to first lateral ends of the front wall and the rear wall and a second end cap coupled to second lateral ends of the front wall and the rear wall, each end cap including a filament entry hole configured to receive a filament of a self-adjusting headgear mechanism;

[0471] a first gasket housing disposed between the front wall and the rear wall adjacent to the first end cap;

[0472] a second gasket housing disposed between the front wall and the rear wall adjacent the second end cap; and

[0473] A track divider that divides the inner chamber into an upper track and a lower track,

[0474] wherein the upper rail extends from the first gasket housing to the second end cap above the second gasket housing, and

[0475] Wherein, the lower rail extends from the second gasket housing to the first end cover below the first gasket housing.

[0476] 15. A yoke according to clause 14, wherein the yoke comprises: a yoke front portion, the yoke front portion including a front wall; and a yoke rear portion, the yoke rear portion including a rear wall, and the yoke front portion and the yoke rear portion are connected together.

[0477] 16. A yoke according to clause 15, wherein the upper track is at least partially defined by an upper wall of the yoke front portion and the track divider, and the lower track is at least partially defined by a lower wall of the yoke front portion and the track divider.

[0478] 17. A nasal seal for a respiratory mask system, the nasal seal comprising:

[0479] a body portion defining an inlet and at least partially defining a user contacting surface of the nasal seal;

[0480] a pair of nasal cannulas supported by the body portion and configured to engage the nostrils of a user;

[0481] wherein the main body portion includes a bridge portion extending laterally between the pair of nasal cannulas on an upper portion of the nasal seal, wherein the bridge portion defines a bridge depth between the front surface and the rear surface of the nasal seal, wherein the bridge depth is less than half of the total depth of the nasal seal.

[0482] 18. A nasal seal according to clause 17, wherein the rearmost point of the nasal seal is located behind the rearmost surface of the pair of nasal cannulas.

[0483] 19. A nasal seal according to clause 17 or 18, wherein the bridge depth is less than or equal to two-fifths of the total depth.

[0484] 20. The nasal seal of clause 19, wherein the bridge depth is one third of the total depth.

[0485] 21. A nasal seal according to any of clauses 17 to 20, wherein the bridge depth is equal to or less than 15 mm, 13.5 mm or 11 mm.

[0486] 22. A nasal seal according to any one of clauses 17 to 21, wherein the overall depth is equal to or less than 35 mm, 32.5 mm or 30 mm.

[0487] 23. A nasal seal according to any of clauses 17 to 22, wherein a wall thickness equal to or greater than 1 mm is limited to an outer side wall or anterior wall of the nasal seal.

[0488] 24. A nasal seal according to clause 23, wherein the transition between the upper wall and the outer side wall or the transition between the lower wall and the outer side wall is less than 1 mm.

[0489] 25. A nasal seal according to any of clauses 17 to 24, wherein the minimum wall thickness of the user contacting surface defined by the body portion of the nasal seal is equal to or greater than 0.3 mm.

[0490] 26. A nasal seal as described in clause 25, wherein the minimum wall thickness of the user contacting surface defined by the main body portion of the nasal seal is equal to or greater than 0.45 mm.

[0491] 27. A nasal seal according to any of clauses 17 to 26, wherein the overall width of the nasal seal is equal to or less than 65 mm.

[0492] 28. A nasal seal according to clause 27, wherein the overall width is equal to or less than 61 mm or 58.5 mm.

[0493] 29. A nasal seal according to any of clauses 17 to 28, wherein the overall height of the nasal seal is equal to or less than 40 mm.

[0494] 30. A nasal seal according to clause 29, wherein the overall height is equal to or less than 35.5 or 35.2 mm.

[0495] 31. A nasal seal according to any one of clauses 17 to 30, wherein the sealing area of ​​the nasal seal is equal to or less than 1000 mm 2 .

[0496] 32. A nasal seal according to clause 31, wherein the sealing area is equal to or less than 907 mm 2 or 883mm 2 .

[0497] 33. A nasal seal as described in any of clauses 17 to 32, wherein the inlet is generally D-shaped.

[0498] 34. The nasal seal of any one of clauses 17 to 33, further comprising a clip assembly secured to the inlet of the seal body, the clip assembly being configured to allow the nasal seal to be removably connected to a frame.

[0499] 35. The nasal seal of clause 34, wherein the clamp assembly defines an air inlet and an air outlet.

[0500] 36. The nasal seal of clause 35, wherein the air outlet comprises a diffuser.

[0501] 37. A nasal seal according to clause 36, wherein the air outlet is defined by a clamping member.

[0502] 38. A nasal seal according to clause 37, wherein the clamping member of the air outlet is removable.

[0503] 39. A nasal seal according to any of clauses 35 to 38, wherein the maximum height of the air inlet is between 12 mm and 16 mm or is 14 mm.

[0504] 40. A nasal seal according to clause 39, wherein the maximum width of the air inlet is between 25 mm and 30 mm or is 27 mm.

[0505] 41. A nasal seal according to any of clauses 17 to 40 in combination with a frame.

[0506] 42. The nasal seal and frame of clause 41 further comprising a headgear arrangement.

[0507] 43. A combination according to clause 42, wherein the headgear arrangement is self-adjusting or includes one or more directional locks.

[0508] 44. A breathing mask system, the breathing mask system comprising:

[0509] A mask frame, the mask frame comprising:

[0510] an inlet configured to be coupled to a gas conduit in use;

[0511] a yoke channel extending longitudinally through the mask frame, the yoke channel being defined by upper, rear and lower walls; and

[0512] at least one recess in at least one of the upper and lower walls of the yoke channel; and

[0513] A yoke is configured to be at least partially disposed in the yoke channel, the yoke comprising at least one protrusion projecting rearwardly from the yoke, wherein the at least one protrusion is configured to be disposed in the at least one recess when the yoke is disposed in the yoke channel.

[0514] 45. A respiratory mask system according to clause 44, wherein the at least one recess and the at least one protrusion have a rectangular profile.

[0515] 46. ​​A yoke configured to be coupled to a mask frame of a respiratory mask system, the yoke comprising:

[0516] a yoke front portion including a first central connecting member; and

[0517] a rear portion of the yoke including a second central connecting member,

[0518] Wherein, the first central connecting member and the second central connecting member are configured to be coupled together to at least partially fix the yoke front portion and the yoke rear portion together.

[0519] 47. An assembly according to clause 46, wherein the first central connector includes a protrusion projecting rearwardly from the front of the yoke, the second central connector includes an aperture in the rear of the yoke, and the protrusion is configured to be received in the aperture.

[0520] 48. An assembly according to clause 46, wherein the first central connector includes a protrusion protruding rearwardly from the front portion of the yoke, the second central connector includes a recess in the front surface of the rear portion of the yoke, and the protrusion is configured to be received in the recess.

[0521] 49. An assembly according to any one of clauses 46 to 48, wherein the yoke front portion includes an upper alignment groove that is recessed into the rear surface of the yoke front portion and extends along the length of the yoke front portion adjacent to the upper edge of the yoke front portion; the yoke rear portion includes an upper alignment bead protruding forward from the front surface of the yoke rear portion; and the upper alignment bead is configured to be received in the upper alignment groove when the yoke front portion and the yoke rear portion are connected together.

[0522] 50. An assembly according to any one of clauses 46 to 49, wherein the yoke front portion includes a lower alignment groove that is recessed into the rear surface of the yoke front portion and extends along the length of the yoke front portion adjacent to the lower edge of the yoke front portion; the yoke rear portion includes a lower alignment bead protruding forward from the front surface of the yoke rear portion; and the lower alignment bead is configured to be received in the lower alignment groove when the yoke front portion and the yoke rear portion are connected together.

[0523] 51. A yoke configured to be coupled to a mask frame of a respiratory mask system, the yoke comprising:

[0524] a yoke front portion extending from the first lateral end to the second lateral end;

[0525] a yoke rear portion extending from the first lateral end to the second lateral end, the yoke front portion and the yoke rear portion being coupled together and defining an interior chamber therebetween;

[0526] a first end cap coupled to first lateral ends of the yoke front and the yoke rear and a second end cap coupled to second lateral ends of the yoke front and the yoke rear, each end cap including a filament access hole configured to receive filaments of a self-adjusting headgear mechanism;

[0527] a first gasket housing disposed in the inner chamber adjacent to the first end cap;

[0528] a second gasket housing disposed within the interior chamber adjacent the second end cap; and

[0529] A track divider that divides the inner chamber into an upper track and a lower track,

[0530] wherein the upper rail extends from the first gasket housing to the second end cap above the second gasket housing, and

[0531] Wherein, the lower rail extends from the second gasket housing to the first end cover below the first gasket housing.

[0532] 52. The assembly of clause 51 , wherein the upper rail extends into the second end cap and the lower rail extends into the first end cap.

[0533] 53. An assembly according to clause 51 or 52, wherein the first and second end caps are configured to be hinged to the first and second lateral ends of the front and rear walls, respectively, during assembly.

[0534] 54. An assembly according to claim 53, wherein the yoke rear portion includes a first retaining protrusion extending rearwardly from the yoke rear portion adjacent to the first lateral end portion of the yoke rear portion, the yoke front portion includes a second retaining protrusion extending forwardly from the yoke front portion adjacent to the first lateral end portion of the yoke front portion, the first retaining protrusion having a greater length than the second retaining protrusion, and the first end cap includes: a retaining hole on one side of the first end cap, the retaining hole being configured to receive the first retaining feature; and a slot on an opposite side of the first end cap, the slot being configured to receive the second retaining protrusion; wherein, during assembly, the first retaining protrusion and the retaining hole are engaged, and then the first end cap is pivoted on the first lateral ends of the yoke front and the yoke rear portion to engage the second retaining protrusion and the slot.

[0535] 55. A combination according to any of clauses 51 to 54, wherein the first and second gasket shells are U-shaped.

[0536] 56. The assembly of clause 55, wherein the second gasket shell is oriented in an upward facing U-shape and the first gasket shell is oriented in a downward facing U-shape.

[0537] 57. A breathing mask system, the breathing mask system comprising:

[0538] A mask frame, the mask frame comprising:

[0539] an inlet configured to be coupled to a gas conduit in use; and

[0540] a yoke channel extending longitudinally through the mask frame, the yoke channel being defined by upper, rear and lower walls; and

[0541] A yoke is configured to be at least partially disposed in the yoke channel.

Claims

1. A breathing mask system, comprising: A mask frame, the mask frame comprising: an inlet configured to be coupled to a gas conduit in use; a yoke channel extending longitudinally through the mask frame, the yoke channel being defined by at least a rear wall and a lower wall; and one or more mask frame attachment features, the one or more mask frame attachment features comprising one of a male attachment feature and a female attachment feature; and a yoke configured to be at least partially disposed in the yoke channel, the yoke comprising one or more yoke attachment features complementary to the mask frame attachment features, the one or more yoke attachment features comprising the other of the male and female attachment features; wherein the male attachment feature comprises an attachment tab or protrusion extending from one of the yoke or the mask frame, and the female attachment feature comprises an attachment aperture in the other of the yoke or the mask frame; and Wherein the one or more yoke attachment features are configured to engage with the one or more mask frame attachment features to attach the yoke to the mask frame and resist rotation of the frame relative to the yoke.

2. The breathing mask system according to claim 1, wherein: The one or more mask frame attachment features are configured to engage with the one or more yoke attachment features when the yoke and the mask frame are coupled together.

3. The respiratory mask system of claim 1, wherein: The yoke channel is further defined by an upper wall.

4. A breathing mask system according to claim 3, wherein: The male attachment feature includes a retention protrusion that protrudes from the mask frame toward the yoke channel; and the female attachment feature includes a retention notch that is recessed into the yoke.

5. A breathing mask system according to claim 4, wherein: The retention protrusion is configured to snap fit into the retention notch when the yoke and the mask frame are coupled together.

6. A breathing mask system according to claim 5, wherein: The retention ridges and the retention notches are configured to resist rotational disconnection of the yoke from the frame.

7. The respiratory mask system of claim 4, wherein: The retaining ridge projects downwardly into the yoke channel from the upper wall of the yoke channel, and the retaining notch is recessed into the upper surface of the yoke.

8. A breathing mask system according to claim 7, wherein: The retaining notch is located along a corner between the front wall and the top wall of the yoke.

9. The respiratory mask system of claim 4, wherein: The yoke includes a yoke front portion and a yoke rear portion coupled to the yoke front portion, and the yoke front portion includes the retaining notch.

10. The respiratory mask system of claim 9, wherein: The retaining notch is located at a middle portion of the yoke front portion, and the retaining ridge extends from a middle portion of the upper wall of the yoke channel.

11. The respiratory mask system of claim 3, wherein: The male attachment feature includes a tongue protruding from the yoke, and the female attachment feature includes an anti-rotation groove recessed into the yoke channel.

12. A breathing mask system according to claim 11, wherein: The tongue is configured to be disposed in the anti-rotation groove when the yoke and the mask frame are coupled together.

13. A breathing mask system according to claim 12, wherein: The interaction between the anti-rotation groove and the tongue is configured to inhibit rotational disengagement of the yoke from the mask frame.

14. The respiratory mask system of claim 11, wherein: The tongue protrudes rearwardly from the yoke, and the anti-rotation groove is recessed into the rear wall and extends along the length of the yoke channel.

15. The respiratory mask system of claim 11, wherein: The yoke includes a yoke front portion and a yoke rear portion coupled to the yoke front portion, and the tongue includes a front tongue extending from the yoke front portion and a rear tongue extending from the yoke rear portion.

16. A breathing mask system according to claim 15, wherein: The front tongue is disposed below the rear tongue such that an upper surface of the front tongue abuts a lower surface of the rear tongue.

17. The respiratory mask system of claim 3, wherein: The male attachment feature comprises a tongue or protrusion protruding from the yoke, and the female attachment feature comprises an aperture or recess in the yoke channel.

18. The respiratory mask system of claim 6, wherein: The male attachment feature comprises a tongue or protrusion that protrudes from the yoke channel, and the female attachment feature comprises an aperture or recess in the yoke.

19. The respiratory mask system of claim 17, wherein: The tongue or protrusion projects rearwardly from the yoke and the apertures or recesses are recessed in the upper and lower walls of the yoke channel.

20. The respiratory mask system of claim 17, wherein: The tongue or protrusion projects rearwardly from the yoke and the aperture or recess is provided on the rear wall of the yoke channel.

21. The respiratory mask system of claim 17, wherein: The bottom surface of the yoke includes the tongue or protrusion, and the aperture or recess is formed in the lower wall of the yoke channel.

22. The respiratory mask system of claim 18, wherein: The tab or projection projects from the lower wall of the yoke channel and the aperture or recess is formed in a bottom surface of the yoke.

23. The respiratory mask system of claim 17, wherein: The tab or protrusion protrudes from an upper surface of the yoke, and the upper surface of the yoke channel includes the aperture or recess.

24. The respiratory mask system of claim 17, wherein: The tongue or the protrusion is configured to be disposed in the aperture or the recess when the yoke is disposed in the yoke channel.

25. The respiratory mask system of claim 17, wherein: The recessed portion and the protruding portion have a rectangular profile.

26. The respiratory mask system of claim 1, further comprising an air outlet disposed in the rear wall of the yoke channel.

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