Respiratory Mask System

Abstract

To provide an improved respiratory mask system for delivering a respiratory therapy to a patient.SOLUTION: A respiratory mask system 100 comprises a mask interface 102 comprising a frame for a headgear assembly 200. The frame comprises a body having a first surface and a substantially opposing second surface. The body further has a gas inlet and optionally an outlet vent. The gas inlet may be substantially elliptical in shape. The frame may comprise a recessed region for receiving a yoke of the headgear assembly 200 to attach the headgear to the mask interface. The respiratory mask system 100 may also comprise a yoke for attaching the frame.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] [Incorporation by reference of priority application]

[0001] Any application for which a foreign or domestic priority claim is identified in the Application Data Sheet filed hereby is incorporated herein by reference and forms a part of this disclosure.

[0002]

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

[0003] Respiratory masks are used to deliver respiratory therapy to the airways of individuals suffering from any of a number of respiratory diseases or conditions, including, but 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 patient's airway intermittently becomes blocked during sleep, preventing the patient from breathing for periods of time. The interruptions in breathing, or apneas, result in the patient waking up. As a result of the repetitive and frequent apneas, the patient is only occasionally able to achieve a sufficient, restorative night's sleep.

[0005] CPAP therapy involves delivering a supply of continuous positive airway pressure to a patient's airway via a breathing mask. The continuous positive airway pressure acts as a splint within the patient's airway, holding it in an open position so that the patient's breathing and sleep are uninterrupted.

[0006]

[0006] Respiratory masks typically include a patient interface and headgear, where the patient interface is configured to deliver a supply of continuous positive airway 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 range of styles, including full-face, nasal, and direct nose and mouth masks, which form an airtight seal with the nose and / or mouth. The seal or cushion is held in place on the patient's face by the headgear. To maintain an airtight seal, the headgear must provide support for the patient interface so that it is held in a stable position against the patient's face during use. Such respiratory masks can also be used to deliver NIV and other therapies. Summary of the Invention

[0007]

[0007] The systems and devices described herein have innovative aspects, but no single aspect is essential or solely responsible for the desirable attributes of such systems and devices. Without limiting the scope of the claims, some of the advantageous features are summarized below.

[0008]

[0008] In a first aspect, the present invention provides a respiratory mask system comprising a mask interface comprising a frame for a headgear assembly, the frame comprising a body having a first surface and a substantially opposite second surface, the body further comprising gas inlet and outlet ventilation holes.

[0009] In one form, the frame is configured so that the gas inlet is angled at about 10 to 45 degrees from the vertical.

[0010] The gas inlet may have a substantially oval shape, the gas inlet being positioned substantially longitudinally along the length of the frame.

[0011] In one form, 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 substantially oval in shape. Preferably, the substantially oval 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 back surface and a gas inlet opening that may be substantially aligned with the gas inlet opening of the frame. The gas inlet opening of the seal may include a substantially continuous lip configured to be attached to the seal flange.

[0014] In one form, the gas inlet of the frame includes a separator extending between two substantially opposite points on the continuous edge to separate the opening into a gas inlet and an outlet ventilation hole.

[0015]

[0015] Optionally, the seal forms part of a seal assembly, which further comprises an inner clip and an outer clip, each of which has a collar with a gas inlet opening, and the inner clip further comprises a divider that overlies the gas inlet opening of the inner clip and separates the opening into a gas inlet opening and a ventilation hole opening.

[0016] The inner clip can be attached to the sealing flange of the frame such that the gas inlet opening is substantially aligned with the gas inlet of the frame and the ventilation hole opening is substantially aligned with the outlet ventilation hole of the frame. The sealing flange preferably includes one or more recesses capable of retaining a portion of the inner clip within the recess.

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

[0018] In one form, the outlet ventilation holes can be located above the gas inlet when the frame is in use. In another form, the outlet ventilation holes can be located below the gas inlet when the frame is in use.

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

[0020]

[0020] A diffuser is preferably located within the outlet ventilation hole.

[0021] In one form, the respiratory mask system also includes a headgear assembly including a yoke configured to be attached to the frame, the frame can include a recessed area, and the yoke can be retained within the recessed area.

[0022]

[0022] In a second aspect, the present invention provides a respiratory mask system comprising a mask interface comprising a frame for a headgear assembly, the frame comprising a body having a front surface and a substantially opposite back surface, the front surface comprising a recessed area within which a yoke of the headgear assembly can be positioned.

[0023] In one form, the recessed region can comprise a channel extending substantially the length of the frame. The channel is preferably configured to lie substantially horizontally across the entire frame when the frame is in use. The channel can comprise two side regions, one at each end of the channel, with a substantially central region located between the two side regions.

[0024] In one form, the channel may comprise an extension member extending from either side of the body of the frame.

[0025]

[0025] The frame preferably comprises a gas inlet, which may have a substantially oval shape and is positioned substantially longitudinally along the length of the frame.

[0026] The frame also preferably includes outlet ventilation holes. In one form, at least a portion of the outlet ventilation holes can be located within the channel. Optionally, the entire outlet ventilation holes can be located within the channel. The outlet ventilation holes can include a diffuser.

[0027]

[0027] Preferably the frame is substantially curved outwardly from left to right, hi one form the front face of the frame is substantially curved outwardly from top to bottom.

[0028] In one form, the channel may comprise a first wall forming an upper surface, a second wall forming a lower surface substantially opposite the first wall, and a channel floor forming a back surface extending between the first and second walls. In another form, the channel comprises a back surface and a lower surface.

[0029]

[0029] The lower surface of the channel preferably comprises a recessed area, which may be located substantially adjacent to the outlet ventilation hole.

[0030] In one form, the upper surface of the channel may include a recessed area. The recessed area of ​​the upper surface may be located substantially adjacent to the outlet ventilation hole.

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

[0032] In one form, the top surface of the channel may be angled inwardly toward the back surface of the channel.

[0033] In one form, the height of the back surface of the channel can be substantially defined by the distance between the upper and lower surfaces of the channel, and the height of the back surface of the channel in its central region is preferably less than the height of the channel in one or both side regions.

[0034] In one form, the lower surface of the channel can have a depth substantially defined by the distance between the rear surface of the channel and the distal end of the second edge, and the depth of the lower surface is preferably greater in a central region of the channel than in side regions.

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

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

[0037]

[0037] In one form, the at least one mounting feature comprises at least one magnet located within a channel of the frame. Preferably, the at least one magnet is located on a rear surface of the channel. In one form, multiple magnets are located on a rear surface of the channel. Preferably, the magnets are spaced equidistant from one another. The magnet(s) may be located along a centerline extending along the length of the channel. Alternatively, the magnet(s) may be located on one side of a centerline extending along the length of the channel. In one form, the magnet(s) may be located closer to an upper surface of the channel than a lower surface of the channel. Optionally, the channel may comprise one or more recesses, and one or more magnets may be located within the recesses.

[0038] In one form, the at least one mounting feature comprises at least one mounting tab extending across at least a portion of the channel. Preferably, the at least one mounting tab extends from either the upper or lower surface of the channel and projects substantially toward the opposite channel surface. In one form, the mounting tab projects from the upper surface of the channel, and a recess is provided between a rear surface of the mounting tab and a rear surface of the channel.

[0039] In one form, the at least one mounting feature comprises a latch that extends the entire height of the channel from the upper surface to the lower surface of the channel. In one form, the at least one latch can be removable. Optionally, the at least one latch can be configured to attach to a lock provided on the frame. In one form, the at least one mounting tab can be configured to attach to the lock in a snap-fit ​​arrangement. In another form, the at least one latch can be configured to attach to a lock provided on the yoke. Preferably, the at least one latch is hingedly attached to the frame.

[0040]

[0040] In a third aspect, the present invention provides a respiratory mask system comprising a yoke for a headgear assembly, the yoke comprising a body having a front surface having a width defined by the distance between the top and bottom surfaces of the yoke and a length defined by the distance between opposite ends of the yoke, and an intermediate portion located between two side portions, the side portions being located at or near the ends of the yoke, the width of the yoke at the intermediate portion being less than the width of the yoke at the side portions.

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

[0042] In one form, an intermediate portion of the bottom surface of the yoke may be curved inwardly. In yet another form, the bottom surface of the yoke may lie in substantially the same plane along the length of the yoke.

[0043] In one form, the front surface of the intermediate portion of the yoke may be angled rearward from the top surface to the bottom surface.

[0044] In one form, the front faces of the side portions of the yoke may be angled forward from the top face to the bottom face. Alternatively, the front faces of the side portions may be substantially perpendicular to the bottom and / or top faces.

[0045] In one form, the intermediate portion of the yoke tapers from the front to the rear.

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

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

[0048] In one form, at least a portion of the yoke body can be covered within a fabric cover, preferably a knit fabric that is substantially stretchable in at least one direction, and the yoke is preferably injection molded into the fabric cover.

[0049] In one form, the yoke body may have a rear surface provided with a pair of locating members, each of which may be located on one side portion of the yoke.

[0050] In one form, each positioning member projects from the rear surface of the yoke and includes an alignment surface that slopes outwardly from the rear surface toward the end of the yoke.

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

[0052] In one form, the at least one positioning member may comprise a substantially curved protrusion, which may be formed at or near the end of the yoke and protrude from the back surface of the yoke.

[0053]

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

[0054] In one form, one or more positioning members may be formed from an overmold located at or near each end of the yoke.

[0055] In one form, one positioning member may comprise a hook and the other positioning member may comprise a post.

[0056] In one form, a tab may project from the top surface of the yoke. Preferably, the tab projects from a middle portion of the yoke. Optionally, the tab comprises a flange projecting from the top surface substantially along the length of the yoke.

[0057] In one form, one or more magnets can be located on a back surface of the yoke. The back surface can include one or more recesses that can hold one or more magnets within the recesses. The magnet(s) can be spaced equidistantly apart. The magnet(s) can be located along a centerline extending along the length of the yoke. In another form, a flange can 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, and the magnet(s) can be located closer to the bottom surface of the yoke than the distal edge of the flange.

[0058]

[0058] In one form, the yoke body may comprise a substantially elastic material along its length, and the yoke may comprise 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]

[0059] In one form, the elastic yoke body can include at least one attachment feature comprising a hook configured to engage with a corresponding hook, recess, or opening in the frame to attach the yoke to the frame.

[0060] In one form, the yoke may include a collector for one or more wires, 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 yoke may comprise any feature or combination of features described above in relation to the first, second and third aspects of the invention.

[0062]

[0062] In some embodiments, a respiratory mask system includes a mask frame and a yoke. The mask frame includes an inlet configured to be coupled to a gas conduit in use, a yoke channel, and a retention bump. The yoke channel extends longitudinally across the mask frame and is defined by a top wall, a back wall, and a bottom wall. The retention bump protrudes downwardly from the top wall into the yoke channel. The yoke is configured to be at least partially disposed within the yoke channel. The yoke includes a retention notch on an upper surface of the yoke. The retention bump is configured to snap into the retention notch when the yoke and mask frame are coupled together.

[0063] The retention notch can be positioned along a corner between the front wall and the top wall of the yoke. The yoke can include a front yoke portion and a rear yoke portion coupled to the front yoke portion. The front yoke portion can include the retention notch.

[0064] In some embodiments, the respiratory mask system includes a mask frame and a yoke. The mask frame includes an inlet configured to be coupled to a gas conduit during use, a yoke channel, and an anti-rotation groove. The yoke channel extends longitudinally across 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 disposed within the yoke channel. The yoke includes a tongue that protrudes rearwardly from the yoke. The tongue is configured to be disposed within the anti-rotation groove when the yoke and mask frame are coupled together. Interaction between the anti-rotation groove and the tongue is adapted to inhibit rotational disengagement of the yoke from the mask frame.

[0065]

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

[0066]

[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, the rear wall defining an interior cavity between the front and rear walls; a first end cap coupled to the first lateral ends of the front and rear walls; and a second end cap coupled to the second lateral ends of the front and rear walls, each end cap including a linear body inlet hole configured to receive a linear body of a self-adjusting headgear mechanism; and a line track divider dividing the interior cavity into an upper line track and a lower line track. The yoke may further include a first washer housing disposed between the front and rear walls adjacent to the first end cap, and a second washer housing disposed between the front and rear walls adjacent to the second end cap. In some embodiments, the upper line track extends from the first washer housing to a second end cap above the second washer housing, and the lower line track extends from the second washer housing to a first end cap below the first washer housing.

[0067] The yoke can include a front yoke portion including a front wall and a rear yoke portion including a back wall, the rear yoke portion being coupled to the front yoke portion. The upper line track can be at least partially defined by an upper wall of the front yoke portion and the line track divider, and the lower line track can be at least partially defined by a lower wall of the front yoke portion and the line 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 prongs are supported by the body portion and configured to engage the user's nares. The body portion includes a bridge portion extending laterally between the pair of nasal prongs at an upper portion of the seal. The bridge portion defines a bridge depth between a front surface and a back surface of the nasal seal, the bridge depth being less than one-half of the overall depth of the nasal seal.

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

[0070] In some configurations, the bridge depth is no more than two-fifths of the overall depth.

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

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

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

[0074] In some configurations, a wall thickness of 1 mm or more is limited to the outer or front wall of the nose seal.

[0075] In some configurations, the transition between the upper wall and the outer wall or the transition between the lower wall and the outer 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 nose seal is 0.3 mm or greater.

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

[0078] In some configurations, the overall width of the nose seal is 65 mm or less.

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

[0080] In some configurations, the overall height of the nose seal is 40mm or less.

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

[0082] In some configurations, the sealing area of ​​the nose seal is 1000 mm 2 The following is the result.

[0083] In some configurations, the sealing area is 907 mm 2 or 883 mm 2 The following is the result.

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

[0085]

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

[0086]

[0086] In some configurations, the clip assembly defines an inlet and a ventilation hole.

[0087]

[0087] In some configurations, the ventilation holes include a diffuser.

[0088]

[0088] In some configurations, the ventilation holes are defined by clip members.

[0089]

[0089] In some configurations, the ventilation hole clip member is removable.

[0090] In some configurations, the inlet has a maximum height of 12-16 mm or 14 mm.

[0091] In some configurations, the inlet has a maximum width of 25-30 mm or 27 mm.

[0092]

[0092] In some configurations, the nose seal is combined with a frame, and this seal and frame assembly may further comprise a headgear mechanism.

[0093]

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

[0094]

[0094] In some embodiments, the respiratory mask system includes a mask frame and a yoke. The mask frame includes an inlet configured to be coupled to a gas conduit in use and a yoke channel. The yoke channel extends longitudinally throughout the mask frame and is defined by an upper wall, a rear wall, and a lower wall. The mask frame further includes at least one recess in at least one of the upper and lower walls of the yoke channel. The yoke is configured to be at least partially disposed within the yoke channel. The yoke includes at least one protrusion protruding rearward from the yoke, the at least one protrusion configured to be disposed within the at least one recess when the yoke is disposed within the yoke channel.

[0095]

[0095] The at least one recess and the at least one protrusion may 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 front yoke portion including a first central connector and a rear yoke portion including a second central connector, the first and second central connectors configured to be coupled together to at least partially secure the front and rear yoke portions together.

[0097] In some embodiments, the first central connector is or includes a protrusion projecting rearward from the front yoke, and the second central connector is or includes an opening in the rear yoke, the protrusion being configured to be received in the opening. In some embodiments, the first central connector is or includes a protrusion projecting rearward from the front yoke, and the second central connector is or includes a recess in the front surface of the rear yoke, the protrusion being configured to be received in the recess. In some embodiments, the front yoke includes an upper alignment groove recessed into the rear surface of the front yoke and extending along the length of the front yoke near an upper edge of the front yoke, and the back yoke includes an upper alignment bead projecting forward from the front surface of the back yoke, the upper alignment bead being configured to be received in the upper alignment groove when the front and back yokes are joined together. In some embodiments, the front yoke includes a lower alignment groove recessed into the rear surface of the front yoke and extending along the length of the front yoke near the lower edge of the front yoke, and the back yoke includes a lower alignment bead protruding forward from the front surface of the back yoke, the lower alignment bead being configured to be received in the lower alignment groove when the front and back yokes are joined together.

[0098]

[0098] In some embodiments, a yoke configured to be coupled to a mask frame of a respiratory mask system includes a front yoke extending from a first lateral end to a second lateral end, and a back yoke extending from the first lateral end to the second lateral end, wherein the front and back yokes are coupled together and define an internal cavity between the front and back yokes, a first end cap coupled to the first lateral ends of the front and back yokes and a second end cap coupled to the second lateral ends of the front and back yokes, each end cap comprising a linear body inlet hole configured to receive a linear body of a self-adjusting headgear mechanism, and a line track divider dividing the internal cavity into an upper line track and a lower line track. The yoke may further include a first washer housing disposed between the front wall and the rear wall adjacent to the first end cap and a second washer housing disposed between the front wall and the rear wall adjacent to the second end cap. In some embodiments, an upper line track extends from the first washer housing to the second end cap above the second washer housing and a lower line track extends from the second washer housing to the first end cap below the first washer housing.

[0099] In some embodiments, the upper line track extends into the second end cap and the lower line track extends into the first end cap, hi some embodiments, the first and second end caps are configured to be hingedly attached to the first and second lateral ends of the front and back walls, respectively, during assembly. In some such embodiments, the yoke back includes a first retention protrusion extending rearwardly from the yoke back near the first lateral end thereof, the yoke front includes a second retention protrusion extending forwardly from the yoke front near the first lateral end thereof, the first retention protrusion having a length greater than the second retention protrusion, the first end cap includes a retention hole located on one side of the end cap and configured to receive the first retention feature and a notch located on the opposite side of the end cap and configured to receive the second retention protrusion, wherein during assembly, the first retention protrusion and retention hole engage and then the first end cap is pivoted onto the first lateral ends of the yoke front and yoke back to engage the second retention protrusion and notch. In some embodiments, the first and second washer housings are U-shaped. In some such embodiments, the second washer housing is oriented in an upward U-shape and the first washer housing is oriented in a downward 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 coupled to a gas conduit in use, and a yoke channel extending longitudinally throughout 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 within the yoke channel.

[0101]

[0101] Embodiments of assembly and manufacturing systems, components, and methods are now described with reference to the accompanying figures. Like numbers refer to like or similar elements throughout the figures. While several embodiments, examples, and illustrations are disclosed below, those skilled in the art will recognize that the invention described herein can go beyond the specifically disclosed embodiments, examples, and illustrations and can include other applications of the invention and obvious modifications thereof, as well as equivalents thereof. The terminology used in the description presented herein is not intended to be construed in any limiting or restrictive manner, merely because it is used in conjunction with the detailed description of certain specific embodiments of the invention. Additionally, embodiments of the present invention may comprise several novel features, and no single feature is solely responsible for its desirable attributes or is essential to practicing the invention described herein.

[0102]

[0102] In the following description, certain terminology may be used for reference purposes only and, therefore, such terminology is not intended to be limiting. For example, terms such as "top" and "bottom" refer to directions in the drawings to which reference is made.

[0103] Terms such as "top," "bottom," "upper," "lower," "front," "rear," "left," "right," "back," and "side" indicate the orientation and / or location of a component or portion of an element within a consistent but arbitrary frame of reference that becomes clear by reference to the text and associated drawings that describe the component or element under discussion. Additionally, terms such as "first," "second," and "third" may be used to describe separate components. Such terminology may include the terms specifically mentioned above, derivatives thereof, and terms of similar import. [Brief explanation of the drawings]

[0104] [Figure 1] FIG. 1 is a perspective view of a mask assembly including a headgear assembly, a seal assembly, and a frame assembly. [Figure 2] FIG. 2 is a front view of the mask assembly of FIG. 1. [Figure 3] FIG. 2 is a side view of the mask assembly of FIG. 1. [Figure 4] FIG. 2 is a rear perspective view of the mask assembly of FIG. 1. [Figure 5] FIG. 10 is an exploded view of the seal assembly, frame assembly, and front portion of the headgear assembly. [Figure 6] FIG. 1 is an exploded view of one form of headgear assembly. [Figure 7] FIG. 10 is a bottom view of one form of frame having ventilation hole openings. [Figure 8] FIG. 8 is a top view of the frame of FIG. 7. [Figure 9] FIG. 8 is a rear view of the frame of FIG. 7. [Figure 10] FIG. 1 is an exploded view of one embodiment of a seal assembly and a frame assembly. [Figure 11] FIG. 1 is a rear perspective view of one embodiment of a frame. [Figure 12] FIG. 12 is a rear view of the frame of FIG. 11. [Figure 13] FIG. 12 is a top view of the frame of FIG. [Figure 14] FIG. 10 is a cross-sectional exploded rear perspective view of one embodiment of a frame and seal clip assembly, the frame having ventilation hole openings. [Figure 15] 15 is a cross-sectional exploded front perspective view of the frame and seal clip assembly of FIG. 14. [Figure 16] FIG. 10 is a cross-sectional side view of the frame and seal clip assembly when installed together. [Figure 17] 1 is a perspective view of one form of a seal assembly including a seal clip having ventilation hole openings. FIG. [Figure 18] FIG. 18 is a front view of the seal assembly of FIG. 17. [Figure 19] 10 is a perspective view of another embodiment of a seal assembly including a seal clip having a ventilation opening and a diffuser. [Figure 20] FIG. 20 is a front view of the seal assembly of FIG. 19. [Figure 21] FIG. 1 is an exploded perspective view of one embodiment of a frame and diffuser. [Figure 22] FIG. 22 is a front view of the frame of FIG. 21. [Figure 23] FIG. 22 is a left side view of the frame of FIG. 21, with the right side being a mirror image. [Figure 24] FIG. 10 is a top perspective view of another embodiment of the frame. [Figure 25] FIG. 10 is a top elevational view of another embodiment of the frame. [Figure 26] FIG. 10 is a top side view of another embodiment of the frame. [Figure 27] FIG. 1 is a perspective view of one form of a yoke and, in some embodiments, a collector for a headgear assembly. [Figure 28] FIG. 28 is a top view of the yoke of FIG. 27. [Figure 29] FIG. [Figure 30] FIG. [Figure 31] FIG. [Figure 32] FIG. [Figure 33] FIG. 2 is an exploded view of the yoke and the yoke cover. [Figure 34] FIG. 1 is a front view of the assembled yoke and frame. [Figure 35] FIG. 10 is a top view of the assembled yoke and frame. [Figure 36] FIG. 10 is a bottom view of the assembled yoke and frame. [Figure 37] FIG. 10 is a rear view of the assembled yoke and frame. [Figure 38] FIG. 10 is a left side view of the assembled yoke and frame. [Figure 39] FIG. 1 is a schematic diagram of the connection between the yoke and the frame. [Figure 40A] FIG. 10 is a rear perspective view of the assembled yoke and frame. [Figure 40B] FIG. 1 is a cross-sectional view of the assembled yoke and frame. [Figure 40C] FIG. 1 is a cross-sectional view of the assembled yoke and frame. [Figure 40D] FIG. 1 is a cross-sectional view of the assembled yoke and frame. [Figure 41A] FIG. 10 is a top rear perspective view showing the frame and yoke attached together. [Figure 41B] FIG. 41B is a partial bottom view of the frame and yoke combination of FIG. 41A. [Figure 41C] FIG. 41B is a partial rear perspective view from below showing the frame and yoke combination of FIG. 41A. [Figure 42A] FIG. 10 is a rear perspective view of another form of frame and yoke attached together using a hook and post arrangement. [Figure 42B] FIG. 42B is a schematic diagram of the configuration of FIG. 42A from above, showing how the yoke can be attached to the frame. [Figure 43A] FIG. 42B is a further schematic view of FIG. 42A, seen from above, showing how the yoke can be attached to the frame. [Figure 43B] FIG. 42B is a further schematic view of FIG. 42A, seen from above, showing how the yoke can be attached to the frame. [Figure 43C] FIG. 42B is a further schematic view of FIG. 42A, seen from above, showing how the yoke can be attached to the frame. [Figure 44] FIG. 42B is another rear perspective view of the frame and yoke configuration of FIG. 42A. [Figure 45] FIG. 10 is a bottom front perspective view showing an alternative embodiment of the frame and yoke configuration. [Figure 46A] FIG. 46 is a front view of the frame and yoke arrangement of FIG. 45 when installed together. [Figure 46B] FIG. 46B is a cross-sectional view of the frame and yoke configuration taken along line 46B-46B of FIG. 46A. [Figure 47A] FIG. 46 is a front perspective view of the configuration of FIG. 45, showing one way of positioning the yoke within the channel of the frame. [Figure 47B]FIG. 46 is a front perspective view of the configuration of FIG. 45, showing one way of positioning the yoke within the channel of the frame. [Figure 47C] FIG. 46 is a front perspective view of the configuration of FIG. 45, showing one way of positioning the yoke within the channel of the frame. [Figure 48A] FIG. 10 is a front perspective view of another configuration of the frame and yoke, illustrating how the yoke is positioned within the channel of the frame. [Figure 48B] FIG. 10 is a front perspective view of another configuration of the frame and yoke, illustrating how the yoke is positioned within the channel of the frame. [Figure 48C] FIG. 10 is a front perspective view of another configuration of the frame and yoke, illustrating how the yoke is positioned within the channel of the frame. [Figure 49A] FIG. 10 is a front perspective view of another configuration of the frame and yoke, illustrating how the yoke is positioned within the channel of the frame. [Figure 49B] FIG. 10 is a front perspective view of another configuration of the frame and yoke, illustrating how the yoke is positioned within the channel of the frame. [Figure 49C] FIG. 10 is a front perspective view of another configuration of the frame and yoke, illustrating how the yoke is positioned within the channel of the frame. [Figure 50A] FIG. 48B is a side view of the configuration of FIG. 48A showing how the yoke is positioned within the channel of the frame. [Figure 50B] FIG. 48B is a side view of the configuration of FIG. 48A showing how the yoke is positioned within the channel of the frame. [Figure 50C] FIG. 48B is a side view of the configuration of FIG. 48A showing how the yoke is positioned within the channel of the frame. [Figure 51A] FIG. 48B is another front perspective view of the configuration of FIG. 48A demonstrating how the yoke is positioned within the channel of the frame. [Figure 51B] FIG. 51B is an enlarged front view showing a portion of the front surface of the frame main body of FIG. 51A. [Figure 51C] FIG. 51B is a front perspective view of the frame and yoke of FIG. 51A attached together. [Figure 52A]FIG. 10 is a front perspective view of yet another frame and yoke configuration using attachment clips or latches. [Figure 52B] FIG. 10 is a front perspective view of yet another frame and yoke configuration using attachment clips or latches. [Figure 53A] FIG. 10 is a front perspective view of a frame and yoke configuration with magnets demonstrating one method of placing the yoke within the channel of the frame. [Figure 53B] FIG. 53B is a front view of the frame and yoke arrangement of FIG. 53A when coupled together. [Figure 54A] FIG. 53B is a rear perspective view of the frame and yoke configuration of FIG. 53A. [Figure 54B] FIG. 53B is another rear perspective view of the frame and yoke configuration of FIG. 53A. [Figure 55A] FIG. 10 is a front perspective view of yet another form of frame and yoke configuration. [Figure 55B] FIG. 10 is a front perspective view of yet another form of frame and yoke configuration. [Figure 56] FIG. 55B is a cross-sectional side view of the frame and yoke of FIG. 55A when attached together. [Figure 57A] FIG. 55B is a cross-sectional side view of the frame and yoke of FIG. 55A demonstrating one method of placing the yoke within the channel of the frame. [Figure 57B] FIG. 55B is a cross-sectional side view of the frame and yoke of FIG. 55A demonstrating one method of placing the yoke within the channel of the frame. [Figure 57C] FIG. 55B is a cross-sectional side view of the frame and yoke of FIG. 55A demonstrating one method of placing the yoke within the channel of the frame. [Figure 58] FIG. 55B is a cross-sectional side view of the frame and yoke of FIG. 55A demonstrating one method of placing the yoke within the channel of the frame. [Figure 59A] FIG. 10 is an exploded front perspective view of another configuration of the frame and yoke, demonstrating one method of placing the yoke within the channel of the frame. [Figure 59B]FIG. 59B is a front view of the frame and yoke of FIG. 59A when attached together. [Figure 60] FIG. 1 is a perspective view of an exemplary embodiment of an assembled frame, cushion, and yoke. [Figure 61A] FIG. 61 is a side view of the assembly of FIG. 60 showing the connection planes between the components shown. [Figure 61B] FIG. 62 is a side cross-sectional view of the assembly of FIGS. 60-61A, showing the connection plane. [Figure 62] FIG. 61 is a side view of the assembly of FIG. 60 including a portion of the headgear straps, illustrating the forces that can be applied to or by the headgear straps in use. [Figure 63] FIG. 61 is a front view of the frame of FIG. 60. [Figure 64] FIG. 64 is a side view of the frame of FIG. 63. [Figure 65] FIG. 65 is a side cross-sectional view of the frame of FIGS. 63-64. [Figure 66] FIG. 61 is a top view of the yoke of FIG. 60. [Figure 67] FIG. 67 is a rear or back view of the yoke of FIG. 66. [Figure 68] FIG. 67 is a bottom view of the yoke of FIG. 66. [Figure 69] FIG. 67 is a front view of the yoke of FIG. 66. [Figure 70] FIG. 67 is a side view of the yoke of FIG. 66. [Figure 71] FIG. 67 is a side cross-sectional view of the yoke of FIG. 66. [Figure 72] FIG. 67 is a rear view of the yoke front portion of the yoke of FIG. 66, including the washer housing and end cap. [Figure 73] FIG. 73A is a rear view of the front yoke with the washer housing and end caps removed, and FIG. 73B is an enlarged rear view of the lateral end of the front yoke shown in FIG. 73A. [Figure 74] FIG. 67 is a front view of the rear portion of the yoke of FIG. 66, including the washer housing and end cap. [Figure 75]FIG. 10 is a front view of the rear of the yoke with the washer housing and end cap removed. [Figure 76] FIG. 10 is a rear view of the lower half of the rear part of the yoke. [Figure 77] FIG. 77 is a cross-sectional view taken along line 77-77 of FIG. 76. [Figure 78] A rear or interior view of one horizontal half of the front of the yoke. [Figure 79] FIG. 2 is a cross-sectional view of a lateral portion of the front of the yoke. [Figure 80] FIG. 1 is a front view of the yoke assembled to the frame. [Figure 81] 81 is a cross-sectional view of the yoke and frame taken along line 81-81 of FIG. 80. [Figure 82] FIG. 2 is a schematic partial cross-sectional view of a yoke coupled to a frame. [Figure 83] FIG. 10 is a cross-sectional view of a lateral portion of an alternative embodiment of a yoke. [Figure 84] FIG. 84 is a front view of the rear of the yoke in FIG. 83. [Figure 85] FIG. 10 is a cross-sectional view of a lateral portion of an alternative embodiment of a yoke showing the front of the yoke. [Figure 86] FIG. 86 is a partial cross-sectional view of the yoke of FIG. 85 showing the rear of the yoke. [Figure 87] FIG. 87 is a front view of the rear part of the yoke shown in FIGS. 85 and 86. [Figure 88] FIG. 10 is a rear view of an alternative embodiment of the yoke showing the front of the yoke, including the washer housing. [Figure 89] FIG. 89 is a rear view of the front of the yoke of FIG. 88 with the washer housing removed. [Figure 90] FIG. 81 is a side end view of the front part of the yoke of FIGS. 88-89. [Figure 91] FIG. 10 is a rear view of an alternative embodiment of the yoke. [Figure 92] FIG. 92 is an end perspective view of the yoke of FIG. 91. [Figure 93] FIG. 92 is a schematic cross-sectional view of the yoke of FIG. 91. [Figure 94] FIG. 92 is a schematic view of the interior of the yoke of FIG. 91. [Figure 95A] 1 is a front view of a mask assembly including a headgear assembly, a seal assembly, and a frame assembly. [Figure 95B] FIG. 1 is a rear perspective view of a mask assembly including a headgear assembly, a seal assembly, and a frame assembly. [Figure 96] FIG. 96 is a rear perspective view of the seal of FIG. 95 (right) and a prior art nasal seal (left). [Figure 97] FIG. 97 is a rear view of the seal of FIG. 96. [Figure 98] FIG. 97 is a rear view of the seals of FIG. 96 stacked on top of each other. [Figure 99] FIG. 99 is an enlarged view of a portion of the overlapped seal of FIG. 98. [Figure 100] FIG. 97 is a front view of the seal of FIG. 96. [Figure 101] FIG. 97 is a top view of the seal of FIG. 96. [Figure 102] FIG. 99 is a cross-sectional view of the overlapped seal of FIG. 98. [Figure 103] FIG. 97 is a front view of the seal of FIG. 96 showing areas of different thickness. [Figure 104] FIG. 97 is a top view of the seal of FIG. 96 showing areas of different thickness. [Figure 105] FIG. 97 is a rear view of the seal of FIG. 96. [Figure 106] FIG. 97 is a cross-sectional view of the seal of FIG. 96. [Figure 107] FIG. 97 is a top view of the seal of FIG. 96. [Figure 108] 96A and 96B are front views of a first seal (left), a second seal (middle), and a prior art seal (right), which may be the same as or substantially similar to the respective seals in FIG. [Figure 109] FIG. 109 is a top view of the seal of FIG. 108. [Figure 110] FIG. 109 is a top view of the seal of FIG. 108 comparing specific depth dimensions. [Figure 111] FIG. 109 is a rear view of the seal of FIG. 108 comparing specific sealing areas. [Figure 112] FIG. 109 is a bottom view of the seal of FIG. 108. [Figure 113] FIG. 109 is a side view of the seals of FIG. 108 stacked on top of each other. [Figure 114] FIG. 109 is a side view of the second seal of FIG. 108 and a prior art seal superimposed on one another. [Figure 115] FIG. 114 is a vertical cross-sectional view of the overlapped seal of FIG. 113. [Figure 116] FIG. 115 is a vertical cross-sectional view of the overlapped seal of FIG. 114. [Figure 117] FIG. 114 is a horizontal cross-sectional view of the overlapped seal of FIG. 113. [Figure 118] 109 is a horizontal cross-sectional view of the first and second seals of FIG. 108 superimposed on each other. [Figure 119] 109 is a front view of a seal assembly incorporating the second seal of FIG. 108; FIG. 109 is a front view of a seal assembly incorporating the second seal of FIG. 108; [Figure 120] FIG. 120 is a vertical cross-sectional view of the seal assembly of FIG. 119. [Figure 121] FIG. 120 is a front view of an alternative embodiment of the seal assembly of FIG. 119. [Figure 122] FIG. 122 is a front perspective view of the seal assembly of FIG. 121; [Figure 123] 1A-1C are additional views of the first seal, the second seal, and a prior art seal. [Figure 124] 1A-1C are additional views of the first seal, the second seal, and a prior art seal. [Figure 125] 1A-1C are additional views of the first seal, the second seal, and a prior art seal. [Figure 126] 1A-1C are additional views of the first seal, the second seal, and a prior art seal. [Figure 127] 1A-1C are additional views of the first seal, the second seal, and a prior art seal. [Figure 128] 1A-1C are additional views of the first seal, the second seal, and a prior art seal. [Figure 129]1A-1C are additional views of the first seal, the second seal, and a prior art seal. [Figure 130] 1A-1C are additional views of the first seal, the second seal, and a prior art seal. [Figure 131] 1A-1C are additional views of the first seal, the second seal, and a prior art seal. [Figure 132] 1A-1C are additional views of the first seal, the second seal, and a prior art seal. [Figure 133] FIG. 10 is a front view of an exemplary embodiment of an assembled frame, cushion, and yoke. [Figure 134] FIG. 134 is a partial perspective view of the yoke of FIG. 133 cut from the frame. [Figure 135] 135 is a cross-sectional view of the assembled frame and yoke taken along line 135-135 of FIG. 133. [Figure 136A] FIG. 134 is a rear view of the yoke back portion of the yoke of FIG. 133. [Figure 136B] FIG. 136B is a front view of the back portion of the yoke of FIG. 136A. [Figure 136C] FIG. 134 is a rear view of the front portion of the yoke of FIG. 133. [Figure 137] 137 is a cross-sectional view of the assembled frame and yoke of FIG. 133 taken along line 137-137 of FIG. 133. [Figure 138] 138 is a cross-sectional view of the assembled frame and yoke of FIG. 133 taken along line 138-138 of FIG. 133. [Figure 139] FIG. 134 is a cross-sectional view of the cushion of FIG. 133. [Figure 140] FIG. 10 is a partial cross-sectional view of an alternative embodiment of a yoke showing components of the headgear adjustment mechanism. [Figure 141] 10A-10C illustrate how the end caps are coupled to the ends of the yoke. [Figure 142] FIG. 142 is a partial rear perspective view of the assembled end cap and yoke of FIG. 141; [Figure 143] FIG. 134 is an end view of the yoke end of the yoke of FIG. 133. [Figure 144] FIG. 144 is a top view of the yoke end of FIG. 143. [Figure 145] 145 is a cross-sectional view of an end cap coupled to a yoke end taken along line 145-145 of FIG. 143. FIG. [Figure 146] FIG. 146 is a cross-sectional view of the end cap of FIG. 145; [Figure 147] FIG. 146 is a rear view of the yoke of FIG. 133 and FIGS. 141 to 145. [Figure 148] FIG. 10 is a front view of an alternative embodiment of the rear of the yoke. [Figure 149] FIG. 149 is a rear view of an alternative embodiment of a front yoke configured to be coupled to the rear yoke of FIG. 148. [Figure 150] 150 is a cross-sectional view of the rear yoke of FIG. 148 and the front yoke of FIG. 149 assembled together, taken along line 150-150 of FIG. 147. DETAILED DESCRIPTION OF THE INVENTION

[0105]

[0249] Embodiments of assembly and manufacturing systems, components, and methods are now described with reference to the accompanying figures. Like numbers refer to like or similar elements throughout the figures. While several embodiments, examples, and illustrations are disclosed below, those skilled in the art will appreciate that the invention described herein can go beyond the specifically disclosed embodiments, examples, and illustrations and can include other applications of the invention and obvious modifications thereof, as well as equivalents thereof. The terminology used in the description presented herein is not intended to be construed in any limiting or restrictive manner, merely because it is used in conjunction with the detailed description of certain specific embodiments of the invention. Additionally, embodiments of the present invention may comprise several novel features, and no single feature is solely responsible for its desirable attributes or is essential to practicing the invention described herein.

[0106]

[0250] Certain terminology may be used in the following description for reference purposes only and, therefore, is not intended to be limiting. For example, terms such as "top" and "bottom" refer to directions in the drawings to which they refer. Terms such as "front," "rear," "left," "right," "back," and "side" indicate the orientation and / or location of a component or portion of an element within a consistent but arbitrary frame of reference that becomes apparent by reference to the text and associated drawings that describe the component or element under discussion. Furthermore, terms such as "first," "second," and "third" may be used to describe separate components. Such terminology may include the terms specifically mentioned above, derivatives thereof, and terms of similar import.

[0107]

[0251] 1-6, the present disclosure relates to a respiratory mask system or mask assembly 100 for delivering respiratory therapy to a patient. The mask system may include a mask interface 102, such as a seal and frame assembly, and a headgear assembly 200. The mask interface 102 and headgear assembly 200 may include a connection system for attaching the headgear 200 to the mask interface 102. Various forms of connection system 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.

[0108]

[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 headgear 200. The frame 106 may also include a gas inlet 108 configured to be attached to a gas conduit 110 for delivering gas to the patient through the mask interface 102.

[0109]

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

[0110]

[0254] In one form, the headgear assembly 200 may include a yoke or collector 202 configured to attach to the mask interface 102, as described herein below.

[0111]

[0255] The yoke 202 can be configured to attach to straps of the headgear 200. In the embodiment shown in FIG. 5, the headgear 200 comprises a strap assembly including a back strap 204 configured to wrap around the back of the patient's head, a top strap 206 configured to wrap over the patient's head, and a pair of front straps 208 configured to extend along the patient's cheeks during use. In one form, each front strap 208 is attached to a back strap 204 of the headgear assembly 200 by a back connector 205, for example, to a free end 207 of the back strap 204 or a connector coupled to the free end 207. In another form, the back straps 204 comprise side extensions that form the front straps to extend along the patient's cheeks during use.

[0112]

[0256] In one form, the headgear can be automatically adjustable and / or incorporate one or more directional locks, which allow for a relatively small amount of resistance in reducing the length of the headgear and for resistance to increases in the length of the headgear. In some configurations, the locking force of the directional lock can be overcome to allow for lengthening of the headgear for donning the interface assembly. In some forms, the yoke can form a collector for a linear object used in an automatically adjustable headgear system. In this form, the yoke can incorporate one or more directional locks, each of which can include a washer mechanism that can be configured to frictionally engage the linear object during headgear extension but allow relatively frictionless movement during headgear retraction. 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 linear object therein. The headgear, or any portion thereof, may be configured according to any of the embodiments disclosed in applicant's U.S. Patent Application Publication No. 2016 / 0082217, filed September 16, 2015, U.S. Patent Application No. 14 / 856,193, and International Application No. WO2016 / 043603, all of which are incorporated herein by reference in their entireties.

[0113]

[0257] Each front strap 208 may have a free end to which a connector 209 may be attached. Each connector 209 may mate with a complementary strap connector 203 located on the yoke 202. The yoke 202 is preferably substantially elongated, with the strap connectors 203 located at or near each end of the yoke 202.

[0114]

[0258] The connection between the front straps 208 and the yoke 202 can be any suitable form of connection, such as a snap-fit ​​connection, a screw and thread type connection, or a hook-type connection. In one form, as shown in FIG. 6 , each strap connector 203 includes a cap 210 located at each end of the yoke 202. Each cap 210 can include an opening, such as an aperture or recess, configured to receive the 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.

[0115]

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

[0116]

[0260] Various forms of the mask interface 102 will now be described in further detail with reference to Figures 7-26.

[0117]

[0261] The mask interface 102 may comprise a frame 106 having a body with a first or front surface 112 and a substantially opposite second or back surface 114. The frame 106 may also comprise a gas inlet 108 that is open for attachment to a gas conduit and an outlet vent 140.

[0118]

[0262] In one form, the frame 106 is configured so that the gas inlet 108 is angled approximately 10-45 degrees from vertical. In this configuration, the gas conduit 110 can be positioned comfortably away from the patient's chin, but not too far away to create enough torque to pull the mask interface away from the patient's face.

[0119]

[0263] The mask interface 102 may include a seal 104 having a front or distal surface and a back or proximal surface. The back of the seal may be configured to substantially seal against the patient's face during use. The seal may be configured to cover the patient's mouth, nose, or both. In one form, the seal includes nasal pillows that substantially seal against the patient's nares. The seal 104 may also include a gas inlet opening 118 that substantially coincides with the gas inlet opening 108 of the frame 106. The frame 106 and seal 104 may mate together such that the gas inlet openings of each portion are substantially aligned with one another to provide a gas inlet to the mask interface. In another form, the mask interface is a non-sealing interface, such as a nasal cannula configured for high-flow therapy.

[0120]

[0264] In one form, the gas inlet opening 108 in the frame 106 can be defined by a substantially continuous edge. This edge can be provided by a sealing flange 120 that protrudes from the rear surface of the frame 106. The seal 104 or seal assembly can be configured to seal against the sealing flange 120 to attach the seal to the frame.

[0121]

[0265] In one form, a seal assembly including a seal 104 and one or more seal clips 122 is configured to mount to a seal flange 120 of the frame. In the embodiment shown in FIG. 10 , the seal assembly includes a seal having a gas inlet opening defined by a substantially continuous lip 124. The lip can extend around the entire gas inlet opening so that the lip forms a substantially continuous flange or series of flanges, or one or more gaps can be formed within the lip. A channel 126 can be formed between the lip 124 and a front surface 128 of the seal 104. The seal can be formed from a stretchable, resilient material, such as silicone or rubber, that can expand and contract under tension but substantially return to its original shape after the tension is removed. The lip 124 of the gas inlet opening 108 of the seal can be configured to expand and contract around the seal flange 120 of the frame 106, such that the inner surface of the gas inlet opening 108 substantially surrounds and seals against the outer surface of the seal flange 120. The seal assembly may also include a stretchable but tight-fitting seal clip or ring 122 that may be positioned within a channel 126 in the lip to clamp the seal against the seal flange.

[0122]

[0266] Optionally, the seal flange 120 and / or the seal 104 include one or more mounting features to aid in positioning and / or mounting the seal 104 to the frame 106. For example, the frame 106 can include one or more protrusions configured to be retained within one or more recesses provided in the seal to help prevent the seal from rotating relative to the frame and from being pulled off the seal flange. Typically, one or more protrusions are provided on the seal flange, with one or more corresponding recesses provided on the inner surface of the seal's gas inlet opening. Alternatively, the recesses can be located on the frame, and the protrusions can be located on the seal. In yet another form, one or more recesses can be provided on the outer surface of the seal flange, with a lip of the seal configured to rest within the recess(es) to help prevent the seal from being inadvertently pulled off the seal flange. It is contemplated that other suitable forms of mounting the seal to the frame can be used without departing from the scope of this disclosure.

[0123]

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

[0124]

[0268] In one form, one or more protrusions (e.g., similar to protrusion 130 shown in FIG. 15 ) are located on substantially opposing sides of the inner surface of the inner clip and are configured to be received within snap recesses (e.g., similar to snap recess 132 shown in FIG. 13 ) of the sealing flange when the inner clip 122 a is pressed onto the sealing flange. In other forms, the outer surface of the sealing flange can include one or more protrusions configured to be received within one or more recesses located on the inner surface of the inner clip or seal. The inner clip 122 a can be formed from a stretchable or semi-stretchable material to aid in pressing the tight-fitting inner clip 122 a onto the sealing flange 120.

[0125]

[0269] The inner clip 122a may include a seal locator for attaching the seal 104 to the inner clip 122a and thus 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 located on the seal to attach the seal and inner clip together. It is contemplated that alternative attachment configurations may be suitable.

[0126]

[0270] As shown in FIGS. 14-16 , the outer clip 122b can engage with the inner clip 122a to form a seal locator, which includes a channel 134 that can retain a portion of the seal 104 within the channel 134 to attach the seal 104 to the clips 122a, 122b, and thus to the frame 106. For example, the outer surface of the inner clip can include a hooked flange 136 that extends around at least a portion of the inner clip's outer periphery. The hooked flange preferably extends around the entire periphery of the inner clip 122a. Also, a hooked flange 138 can preferably extend around at least a portion of the outer clip 122b, or the entire periphery of the outer clip 122b. The inner and outer clips can be configured to interlock together such that the hooked flanges of each clip face each other, forming a seal channel 134 between them. The seal channel can be shaped substantially like an inverted “T.” The seal can include an inlet / outlet 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 by forcing the seal into the clip assembly. In this manner, the frame and seal assembly may be attached together to form a gas inlet extending between the frame and the seal. Optionally, the mask frame includes outlet ventilation holes 140 formed in the body of the frame, such as the front face of the frame as shown in FIG. 7, or in a recessed area of ​​the frame as shown in FIG. 24 and described later herein.

[0127]

[0271] 11-20, the mask interface can include an exit ventilation hole 140 located near or adjacent to the gas inlet 108. For example, the frame can include a flange projecting from a rear surface of the frame, the flange providing a substantially continuous edge to define an opening in the frame. A separator 142 can extend between two substantially opposite points of the substantially continuous edge of the opening to separate the opening into the gas inlet or inlet opening 108 and an adjacent exit ventilation hole or ventilation opening 140.

[0128]

[0272] The portion of the flange adjacent the gas inlet 108 can protrude further from the rear surface of the frame (i.e., can be deeper) than the portion of the flange adjacent the outlet ventilation holes. A separator 142 can also protrude from the rear surface of the frame and can be connected to the protruding flange, such that the separator 142 and flange together form a sealing flange 144. The sealing flange 144 provides a substantially 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 Figures 11-13. The area of ​​the protruding flange adjacent the outlet ventilation holes 140 is referred to herein as the ventilation hole flange 146.

[0129]

[0273] Optionally, the seal flange 144 and / or the vent flange 146 include one or more mounting features configured to aid in positioning the seal on the frame and / or attaching the seal to the frame. In one form, these mounting features may include one or more recesses and / or protrusions configured to engage with one or more corresponding protrusions and / or recesses on the seal or seal assembly. For example, the seal flange 144 may include snap recesses 132 located on substantially opposite sides of the outer surface of the seal flange 144, as shown in FIG. 13. Each snap recess 132 is configured to receive one or more protrusions (e.g., protrusion 130 shown in FIG. 15) extending from an inner surface of the seal or seal assembly (e.g., seal clip 122 or inner clip 122a, as shown) to help hold the seal or seal assembly in place relative to the seal flange.

[0130]

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

[0131]

[0275] In one form, the seal assembly includes the seal 104, inner clip 122a, and outer clip 122b, as described above. In this form, the inner and outer clips each include a collar or ring with an opening, but the inner clip can also include a divider 148 that spans the opening in the inner clip and separates it into a gas inlet opening 118 and a vent opening 150. The inlet opening 118 and the vent opening 150 can be substantially the same shape and size as the gas inlet 108 and the outlet vent 140 in the frame 106. The inner clip 122a can include an inner surface configured to substantially surround the outer surfaces of both the seal flange 144 and the vent flange 146. In this position, the divider 148 of the inner clip 122a can extend across the entire upper seal flange 143, as best shown in FIG. 16 . The inner clip 122a is configured to be pressable over the seal flange 144 to form a seal against the outer surface of the seal flange 144. The remaining portion of inner clip 122a surrounding ventilation hole opening 140 may seal off outlet ventilation hole 140 in frame 106, or may simply abut outlet ventilation hole 140. No seal needs to be formed between ventilation hole opening 150 and outlet ventilation hole 140. Thus, fitting of the seal assembly to the frame is simplified. Additionally, the depth of ventilation hole flange 146 does not need to be the same depth as seal flange 144, thereby minimizing or reducing the bulk of the frame.

[0132]

[0276] One or more protrusions 130 can be located on substantially opposite sides of the inner surface of inner clip 122a and configured to be received within snap recesses 132 of sealing flange 144 when inner clip 122a is pressed over sealing flange 144 and vent hole flange 146. In other forms, the outer surface of sealing flange 144 and / or vent hole flange 146 can include one or more protrusions configured to be received within one or more recesses located on the inner surface of inner clip 122a or seal 104.

[0133]

[0277] In at least one embodiment, inner clip 122a can connect to sealing flange 144 with a tapered fit. Sealing flange 144 tapers as sealing flange 144 extends rearward, away from inlet 108. Inner clip 122a can include a corresponding opposing taper such that a distal opening of inner clip 122a is larger than a proximal opening of inner clip 122a.

[0134]

[0278] In another embodiment, the inner clip 122a can be formed from a stretchable or semi-stretchable material to aid in forcing the tight-fitting inner clip 122a onto the sealing flange 144 and ventilation hole flange 146 of the frame 106.

[0135]

[0279] The inner clip 122a may include a seal locator for attaching the seal 104 to the inner clip 122a and thus 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 located on the seal to attach the seal 104 and inner clip 122a together. It is contemplated that alternative attachment configurations may be suitable.

[0136]

[0280] As described above, the outer clip 122b can engage with the inner clip 122a to form a seal locator that includes a channel 134 that can retain a portion of the seal 104 within the channel 134 to attach the seal 104 to the clips 122a, 122b, and thus to the frame 106. For example, the outer surface of the inner clip 122a can include a hooked flange 136 that extends around at least a portion of the outer circumference of the inner clip 122a. The hooked flange preferably extends around the entire outer circumference of the inner clip 122a. Also, a hooked flange 138 can preferably extend around at least a portion of the outer clip 122b or extend around the entire outer circumference of the outer clip 122b. The inner clip 122a and the outer clip 122b can be configured to interlock together such that the hooked flanges 136, 138 of each clip face toward each other to form the seal channel 134 between the flanges 136, 138. The seal channel 134 may be shaped substantially like an inverted "T." The seal may include an inlet / outlet opening defined by a substantially continuous lip. The seal lip may form a "T" shape when viewed in cross section and may be sized to fit within the seal channel 134 by pressing the seal 104 into the clip assembly. In this manner, the frame 106 and seal assembly may be attached together to form gas inlet and outlet ventilation holes extending between the frame and the seal.

[0137]

[0281] In one form, the mask interface 102 also includes a diffuser 152. The diffuser 152 can be permanently or removably located within the exit ventilation holes 140. The diffuser can be located within the frame 106 or the seal assembly; when the seal assembly includes ventilation hole openings 150, the diffuser 152 can be located within the ventilation hole openings 150, as shown in FIGS. 19 and 20 . By locating the diffuser 152 within 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 to treat sleep apnea, the seal assembly and diffuser 152 can be cleaned as frequently as every morning, while other mask components are likely to be cleaned less frequently.

[0138]

[0282] Additionally, by positioning the diffuser 152 within the seal assembly, the exhaust air is diffused as it exits the breathing chamber of the seal assembly before it comes into contact with any other mask components or has an opportunity to create noise or entrain ambient air. Thus, the exhaust air can then be further ventilated through or around other frame portions with less noise, drafts / entrainment, and / or jetting. In at least some embodiments, it is possible to conceal the exhaust arrangement, thus providing more desirable mask aesthetics.

[0139]

[0283] In one form, the gas inlet 108 is substantially oval in shape. The gas inlet 108 can extend longitudinally between the left and right sides of the frame 106, such that the gas inlet 108 is wider than it is tall. The outlet ventilation holes 140 can be located above the gas inlet 108 when the frame 106 is in use. In another form, the outlet ventilation holes 140 can be located below the gas inlet 108 when the frame 106 is in use. The gas inlet 108 and the outlet ventilation holes 140 can be substantially centered along the length of the frame 106.

[0140]

[0284] 21-59A and 59B, various configurations of frame and yoke connection systems will now be described.

[0141]

[0285] In one form, the frame 106 comprises a body having a first or front surface 112, a second or back surface 114, and a gas inlet 108. In one form, the front surface 112 of the frame 106 can be angled downwardly toward a lower edge of the frame 106, with the gas inlet 108 formed in the angled front surface. The frame 106 can also optionally comprise outlet ventilation holes 140. In some forms, the outlet ventilation holes 140 can comprise a diffuser 152. In some forms, the frame 106 can comprise the features described above in connection with the embodiment shown in FIGS. 1-20 and can be configured to attach to the seal 104 or seal assembly, as described above.

[0142]

[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. In one form, the recessed area includes a channel 154 that extends from left to right across the length of the front surface 112 of the frame 106. The channel 154 can include extension members 156 that protrude from either side of the frame body.

[0143]

[0287] The channel 154 may be defined by a first wall forming an upper surface 158, a second wall forming a lower surface 160 substantially opposite the first wall, and a channel floor 162 forming a back surface extending between the first and second walls. The channel 154 may include two side regions or channel extensions 156, one at each end of the channel, and a central region or intermediate portion 164 located substantially centered between the two side regions 156.

[0144]

[0288] In one form, the height of the back surface 162 of the channel 154 can be substantially defined by the distance between the first and second walls of the channel. At its central region 164, the height of the back 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 curved or angled toward the first wall or upper surface 158 to form a peak 166, as shown in FIG. 22 . The peak 166 is preferably located at a central point along the length of the channel 154.

[0145]

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

[0146]

[0290] In one form, the top surface 158 of the channel 154 may be angled inward toward the back surface 162 of the channel 154 .

[0147]

[0291] In one form, the lower surface 160 of the channel 154 can have a depth that is substantially 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 can be greater in a central region 164 of the channel 154 than in 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.

[0148]

[0292] The frame 106 and channel 154 may be substantially curved from left to right to somewhat conform to the curves around the patient's nose or mouth. Alternatively or additionally, the frame 106 may be sloped or curved downward from top to bottom.

[0149]

[0293] In one form, the frame 106 can include outlet ventilation holes 140 located below a central region 164 of the channel 154 (e.g., as shown in FIG. 22 ). In another form, at least a portion of the outlet ventilation holes 140 can be located within the channel 154. In yet another form, the entire outlet ventilation holes 140 can be located within the channel 154, such as within the back surface 162 of the channel 154. The outlet ventilation holes 140 can comprise a single opening formed in the frame 106 and / or the channel 154, or the outlet ventilation holes 140 can comprise multiple openings. In one form, the outlet ventilation holes 140 comprise multiple small, localized openings. In another form, the outlet ventilation holes 140 comprise openings in the form of slots.

[0150]

[0294] In one form, the lower surface 160 of the channel 154 can include a recessed region 168, as shown in FIG. 24 . The recessed region 168 can be located in a substantially central region of the lower surface 160. The recessed region 168 can be formed, for example, by a downward curve, by a downwardly sloping surface that meets at a single point, or by a stepped region. The stepped region can include a substantially perpendicular or sloped transition edge 170 between the recessed and non-recessed regions of the lower surface. The recessed region 168 can be located substantially adjacent to the outlet ventilation holes 140. Alternatively or additionally, the upper surface 158 of the channel 154 can include a recessed region, which can be located substantially adjacent to the outlet ventilation holes 140. The recessed regions on the upper and / or lower surfaces of the channel can provide a fluid flow path from the outlet ventilation holes 140 formed in the channel 154 to the atmosphere. This feature is discussed in more detail later in this specification.

[0151]

[0295] At least a portion of a yoke 202 for the headgear assembly 200 can be held within the channel 154 of the frame 106 to attach the headgear assembly 200 to the mask interface.

[0152]

[0296] 27-33 illustrate one form of a yoke 202 that can be used to attach the headgear assembly 202 to the frame 106. The yoke 202 can be used to attach any suitable closed-loop headgear 200 to the frame. For example, in some forms, the yoke 202 can form a collector for a linear body or other core element used in an auto-adjustable or self-adjusting headgear system. In this form, the yoke 202 can include a washer mechanism that can be configured to frictionally engage the linear body during headgear extension, but allow relatively frictionless movement during headgear retraction. 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 linear body within the body.

[0153]

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

[0154]

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

[0155]

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

[0156]

[0300] The cross-section of the yoke 202 can vary along its length. For example, in one form, the width of the middle portion 212 of the yoke 202 is less than the width of the side portions 213 of the yoke, resulting in the yoke 202 having a thinner center region and flared ends. By providing the yoke 202 with a thinner center region, the height of the back surface 162 of the channel 154 of the frame 106 can be made thinner, thereby providing additional space in the frame body within which the larger gas inlet 108 and, optionally, the outlet ventilation holes 140 can be located.

[0157]

[0301] In another form, the top surface 218 of the intermediate portion 212 of the yoke 202 may curve inwardly toward the bottom surface 220 .

[0158]

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

[0159]

[0303] In one form, the front surface 214 or distal surface of the intermediate portion 212 of the yoke 202 can be angled rearward from the top surface 218 to the bottom surface 220 of the yoke 202 .

[0160]

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

[0161]

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

[0162]

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

[0163]

[0307] In one form, 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 form, 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 forms of the yoke 202 are combined, the body of the yoke tapers toward its rear surface.

[0164]

[0308] At least a portion of the yoke body can be covered in a fabric cover 222, as shown in FIG. 33. The fabric cover 222 is preferably a knit fabric that has substantial stretch in at least one direction. The fabric is also preferably wrinkle-resistant. The fabric cover 222 can help provide a snug fit between the yoke 202 and the frame 106 without requiring high-precision manufacturing, which may be required in some configurations that include rigid surfaces where the yoke 202 and frame 106 engage with each other to attach the yoke 202 to the frame 106.

[0165]

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

[0166]

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

[0167]

[0311] The alignment surfaces 224 of the yoke 202 can protrude from the back 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 back surface 216, the top surface 218, and the bottom surface 220. In one configuration, the top surface 218, the back 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 back 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 back 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 configuration, as shown in FIGS. 34-40 , the middle portion 212 of the yoke 202 can be positioned within the channel 154 of the frame 106, and the alignment surfaces 224 can abut corresponding alignment surfaces provided on the frame. In one form, the outer edge of the channel 154 forms a corresponding alignment surface on the frame 106 .

[0168]

[0312] In one configuration, as described above, the rear surface 162 of the channel 154 is provided with the outlet ventilation holes 140, and the lower surface 160 of the channel 154 is provided with a recessed region 168. In this configuration, 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 outlet ventilation holes 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 provided 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.

[0169]

[0313] By providing the outlet ventilation holes 140 within the mounting channels 154 of the frame 106, the size of the frame can be kept relatively small. Furthermore, when these configurations also include a gas inlet 108 having an oval shape extending longitudinally from one side of the frame 106 to the other, the height of the frame 106 can be minimized or reduced to provide a more compact and substantially lower profile mask interface.

[0170]

[0314] Many different options exist 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 mid-portion 212, can be simply pressed into the channel 154 and held snugly within the channel 154 by friction and / or clamping forces between the yoke 202 and the frame 106. If the yoke 202 includes a fabric cover 222, the cover 222 may have some gap 172 between the walls of the yoke 202 and the walls of the channel 154 (e.g., when the channel 154 is positioned over the height H of the yoke 202), as shown in FIG. Y Larger height H C The fabric cover 222 can also increase the frictional force that holds the yoke 202 in place.

[0171]

[0315] 40A-40D are cross-sectional views of an assembled yoke 202 and frame 106 according to at least one embodiment. FIG. 40A shows the yoke 202 held in a precise position within the channel 154 of the frame 106. FIGS. 40B-40D illustrate how the cross-section of the yoke 202 (and channel 154) can vary along its length. For example, the side portions 213 of the yoke 202 can have a substantially rectangular cross-section, as shown in FIG. 40B, and the cross-section of the yoke 202 can change to a more trapezoidal shape at the middle portion 212 of the yoke 202, as shown in FIG. 40D. In other words, moving along the yoke 202 from the ends to the middle portion 212, the body of the yoke 202 gradually tapers toward the back surface 162, reaching its maximum taper at the middle portion 212 of the yoke 202. This configuration aids in locating and centering the yoke 202 within the channel 154 of the frame 106. The shape of the channel 154 may follow similar variations between the side and central regions of the channel 154 .

[0172]

[0316] 40A-40D, 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. At the middle portion 212 of the yoke 202, the rear surface 216 also has a lower height than the front surface 214, while at or near the ends of the yoke 202, the front surface 214 and the rear surface 216 are substantially the same height. The front surface 214 of the yoke 202 may also slope downward and rearward at the middle portion 212 and be substantially vertical at the side portions 213. This gradual twisting of the front surface 214 of the yoke 202 helps to hold the yoke 202 in place within the channel 154 of the frame 106.

[0173]

[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 configuration, when the yoke 202 is positioned within the channel 154 having the outlet ventilation holes 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. This gap provides a fluid flow path through which gas can exit the mask interface between the yoke 202 and the channel wall through the outlet ventilation holes 140.

[0174]

[0318] The yoke 202, as described above, may be covered in a fabric cover 222. The frictional forces 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.

[0175]

[0319] 41-59 illustrate various forms of connection systems between the yoke 202 and the frame 106. Within each connection system, the yoke and / or frame may include one or more attachment features to help retain and / or position the yoke within the channel in the frame.

[0176]

[0320] In one form, as shown in FIGS. 41A-41C , the yoke body can include one or more attachment features in the form of positioning members. The positioning members can help position the yoke 202 within the channel 154 of the frame 106. The positioning members can also be configured to help ensure that the yoke 202 is properly oriented (i.e., upside down) within the frame 106. The yoke body preferably includes a pair of positioning members, one on each side portion 213 of the yoke 202. Each positioning member can be in the form of a protrusion 226 extending from the rear surface 216 of the yoke 202. Each positioning member can include an alignment surface configured to abut a corresponding alignment surface on the frame 106 to guide the yoke 202 into position on the frame 106.

[0177]

[0321] In one form, a pair of positioning members may project from the rear surface 216 or proximal face of the yoke 202. At least one alignment surface of the positioning member may be substantially perpendicular to the portion of the rear surface 216 of the yoke 202 from which the positioning member projects. Alternatively, the alignment surface may be angled outward from the rear surface 216, away from the intermediate portion 212 of the yoke 202. In one form, the positioning member and its alignment surface may be oriented at an angle relative to the bottom surface 220 of the yoke 202. For example, with a pair of substantially opposed positioning members so oriented, the alignment surfaces of the positioning members are closer together at the bottom than near the top surface of the yoke 202. In this form, the ends of the body or channel 154 of the frame 106 may be angled at a substantially 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.

[0178]

[0322] In one form, at least one positioning member can comprise a substantially curved protrusion formed at or near an end of the yoke 202 and protruding from the back surface 216 of the yoke 202. The curved protrusion can comprise an alignment surface configured to abut a corresponding alignment surface of the frame 106 when the yoke 202 is retained in the channel 154 of the frame 106. For example, the frame 106 can include a cutout region, and the curved protrusion can be located within the cutout region when the yoke 202 is placed on the frame 106.

[0179]

[0323] The at least one positioning member may be integrally formed with the yoke body.

[0180]

[0324] In one form, each positioning member can be formed from an overmolding located at or near each end or side portion 213 of the yoke 202. One or more edges of the overmolding can form one or more alignment surfaces. Optionally, the alignment surfaces angle outward from the middle portion 212 toward the side portions 213 of the yoke. In this form, the outer edges of the frame body can be correspondingly angled so that the frame 106 fits snugly between the overmolded portions of the yoke 202.

[0181]

[0325] In one form, one positioning member can include a hook 228 and the other positioning member can include a post 230. For example, as shown in FIGS. 42A-44 , the hook 228 can protrude from the back surface 216 of one side portion 213 of the yoke 202, and the post 230 can protrude from the back surface 216 of the other side portion 213. A post opening 232 can be provided in the channel 154 of the frame 106.

[0182]

[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 opening 232. The free end of the yoke 202 is then pushed into the channel 154 of the frame 106, with the post 230 protruding through the post opening 232.

[0183]

[0327] The post 230 can also include an overhang 234 that faces toward the hook 228. In this configuration, after the yoke 202 is pushed into the channel 154, as described above, the yoke 202 can be pushed toward the hook 228, causing the post overhang 234 to hook onto the back surface of the frame 106.

[0184]

[0328] In another form of the frame 106 and yoke 202 connection system, the yoke body can comprise a substantially elastic material along its length, and the yoke 202 can include one or more attachment features for engaging one or more corresponding attachment features on the frame 106 of the respiratory mask system. For example, the elastic yoke body can include at least one attachment feature comprising a hook configured to engage a corresponding hook, recess, or opening on the frame 106.

[0185]

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

[0186]

[0330] In one form, the back surface 216 of the yoke 202 can include a pair of male mounting members in the form of protrusions configured to protrude through a pair of corresponding female mounting openings or recesses in the back surface 162 of the channel 154 of the frame 106. The yoke 202 preferably includes a pair of protrusions, one on either side of an imaginary centerline passing vertically through the frame 106, such as on each side portion 213. In this form, a mounting opening can be located on each side region of the back surface 162 of the channel 154.

[0187]

[0331] 45-47C show one example of a connection system between the frame 106 and the yoke 202 using male and female attachment members. In this configuration, the yoke 202 may include a male attachment member in the form of a tab or flange 234 that protrudes from the top surface 218 of the yoke. The tab 234 preferably protrudes from the middle portion 212 of the yoke 202. In one configuration, the protruding tab 234 may extend substantially along the length of the yoke 202.

[0188]

[0332] The top surface 158 of the channel 154 can include a recess or opening 236 configured to receive the tab 234. In this configuration, as shown in FIGS. 47A-47C, the yoke 202 can be pressed upward into the channel 154, causing the tab 234 to be pressed into the recess 236. The yoke 202 can then be pressed back so that the back surface 216 of the yoke 202 substantially abuts the back surface 162 of the channel 154. As shown in FIG. 46B, a gap 173 can exist between the bottom surface of the yoke and the lower surface of the channel 154. Optionally, the yoke 202 also includes a positioning member having an alignment surface that abuts a corresponding surface of the frame 106.

[0189]

[0333] 48A-51C show another configuration of the frame 106 and yoke 202 connection system. In this configuration, the frame 106 includes a tab 238 that protrudes downward to partially cover the central region of the channel 154. The front surface 112 of the frame body can include a relief surface 240 below the channel 154 that tapers toward the side of the frame 106. The lower surface 160 of the channel 154 can also taper toward the end of the channel 154. As shown, a tapered lower surface 242 can extend from the concave lower surface 168 to the lateral edges of the frame 106 and / or channel 154. To mate the yoke 202 and frame 106 together, the yoke 202 is angled into the channel 154 so that the body of the yoke 202 is positioned behind the tab 238 within the channel 154. In this configuration, tab 238 covers a portion of front surface 214 of yoke 202, holding yoke 202 in place within channel 154. Tapered flank 240 and underside 160 of channel 154 help provide space for the curved or angled body of yoke 202 to move into channel 154 from below. Again, yoke 202 may include alignment surfaces to help position yoke 202 in frame 106.

[0190]

[0334] 52A and 52B show yet another configuration of the connection system for the frame 106 and the yoke 202. In this configuration, one or more latches or clips 244 may be used to attach the yoke 202 to the frame 106. Each latch 244 may be fixedly or removably attached to the frame 106 and may 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 may be pushed into place within the channel 154, and the latch 244 may then close over the yoke 202 and channel 154. In the closed position, the latch 244 extends across the channel 154 and the yoke 202 therein. The free end of each latch 244 engages a lock on the frame 106 to hold the latch 244 in the closed position.

[0191]

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

[0192]

[0336] The latch 244 may include a locking member, which may be in the form of a protrusion 246 that is configured to engage a lock, which may be in the form of a latch-engaging recess 248, to hold the latch 244 in the closed position. A pair of latches 244 are provided, preferably one on either side of the central region 164 of the channel 154.

[0193]

[0337] In another configuration, the lock is located on the front surface 214 of the yoke 202. In this configuration, one end of the latch 244 hinges from the frame 106 and the other end engages a lock located on the yoke 202 to retain the yoke 202 in the channel 154.

[0194]

[0338] 53A-58 illustrate another form of connection system for the frame 106 and yoke 202 that uses attachment features in the form of magnets. The term "magnet" should be interpreted to include, where appropriate, a magnetic region comprising ferromagnetic material. In other words, the frame 106 and yoke 202 can be attached to one another when both portions include magnets, or when one portion includes a magnet and the other portion includes a magnetic region comprising ferromagnetic material.

[0195]

[0339] In one embodiment, as shown in FIGS. 53A-54B , the rear surface 162 of the channel 154 includes one or more magnets configured to attach to one or more magnets provided on the rear surface of the yoke 202. In one embodiment, multiple magnets are located on the rear surface 162 of the channel 154. The magnets can be equidistantly spaced from one another. Each channel magnet can be located on a centerline extending from one end of the channel 154 to the other. Similarly, each yoke magnet can be located on a centerline extending from one end of the yoke 202 to the other. Optionally, each magnet can be recessed within a recess 250 formed in the channel 154 or the yoke 202, as the case may be. In this embodiment, the yoke 202 can be placed within the channel 154 of the frame 106, and the magnetic attraction between the magnets in each portion holds the yoke 202 in place within the channel 154.

[0196]

[0340] In another form, as shown in FIGS. 55A-58 , the upper surface 158 of the channel 154 can include a tab 252 that protrudes over 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. As best seen in FIGS. 56-58 , a recess 254 is formed between the rear of the tab 252 and the back surface 162 of the channel 154. One or more magnets 251 can be positioned off-center on the back surface 162 of the channel 154, such that each magnet 251 is closer to the upper surface than to the lower surface of the channel 154. The yoke 202 can 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. One or more magnets 249 on the back surface of the yoke 202 can be positioned closer to the bottom surface of the yoke 202 than 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 magnets 251, 249 on the frame 106 and the yoke 202 pulls the yoke 202 upward, so that the protruding flange 256 of the yoke 202 is positioned within the recess 254 behind the protruding tab 252 of the frame 106. In this manner, the tab 252 and the magnets 251, 249 hold the yoke 202 in place on the frame 106. As the magnets 251, 249 pull the yoke 202 upward within 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 form, the outlet ventilation holes 140 can be located at the rear surface 162 of the channel 154, and a gap 258 provided under the yoke 202 provides a fluid flow path through which gas can escape from the outlet ventilation holes 140.

[0197]

[0341] In another form, as shown in FIGS. 59A and 59B , the frame 106 can include a recessed region forming a channel that includes only a back surface and a bottom wall with a lower surface. The channel can extend from left to right across the entire body of the frame. The yoke can be configured to be disposed within the channel. The yoke and frame can include one or more attachment features to hold the yoke in place. For example, the bottom surface of the yoke can include one or more protruding tabs or protrusions 260 configured to engage with one or more corresponding engagement recesses 262 formed in the bottom surface 160 of the channel 154. Alternatively or additionally, one or more tabs or protrusions can protrude from the bottom surface of the channel and be configured to engage with one or more corresponding engagement recesses formed in the bottom surface of the yoke. In one form, the bottom surface of the channel includes a recessed region 264, and the bottom surface of the yoke includes a protruding region 266 configured to reside within the recessed region when the yoke is positioned within the channel of the frame. Optionally, the channel 154 and the back surface of the yoke 202 may each include one or more mounting features in the form of magnets for attaching the yoke and frame together. The channel magnet(s) may be positioned off-center from a centerline extending along the length of the channel, resulting in the magnet(s) being closer to the bottom surface of the channel. Similarly, the yoke 202 may include one or more magnets that may be positioned off-center from a centerline extending along the length of the yoke 202, resulting in the magnet(s) being closer to the top surface of the yoke 202 than the bottom surface. In this configuration, when the yoke 202 is positioned within the channel 154, the magnetic attraction between the yoke 202 and the frame 106 pulls the yoke 202 downward, resulting in the bottom surface of the yoke 202 abutting the bottom surface of the channel 154. When the bottom surface of the yoke 202 abuts the bottom surface 160 of the channel 154, any protrusions protruding from the bottom surface of the yoke are received in corresponding recesses formed in the bottom surface of the channel. Similarly, any projections projecting from the lower surface of the channel are received within corresponding recesses formed in the bottom surface of the yoke.

[0198]

[0342] Figure 60 illustrates another exemplary embodiment of a yoke 400 and cushion 302 coupled to a frame 300. As shown in Figures 63-65, the frame 300 includes an inlet 308, a cushion connection flange 314, and a yoke channel 316.

[0199]

[0343] A pipe or gas conduit may be coupled to the inlet 308 via a pipe overmold 318 coupled to the inlet 308. In some embodiments, the inlet 308 has an oval shape. In some embodiments, the inlet includes bias ventilation holes 320. In the illustrated embodiment, the bias ventilation holes 320 include a plurality of holes that extend through the wall of the inlet 308. The holes in the bias ventilation holes 320 may extend around some or all of the circumference of the inlet 308. The holes may be laser drilled through the inlet wall.

[0200]

[0344] The cushion connection flange 314 protrudes rearward from the frame 300. In 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 or is coupled to a cushion clip 304, as shown in FIGS. 60-62 , for example, which is coupled to the cushion connection flange 314 in use to secure the cushion 302 to the frame 300. In some embodiments, the cushion connection flange 314 protrudes slightly into the cushion 302 when the cushion 302 is coupled to the frame 300. The cushion connection flange 314 can have a shape or profile that matches or corresponds to the shape or profile of an inlet of the cushion 302.

[0201]

[0345] As shown in Figures 63-65, yoke channel 316 is formed or defined by top wall 322, back wall 324, and bottom wall 326. In the illustrated embodiment, yoke channel 316 extends substantially horizontally across frame 300. In the illustrated embodiment, yoke channel 316 is disposed above inlet 308. Yoke channel 316 is configured to receive yoke 400 in use. Yoke channel 316 has a shape, profile, and / or geometry that matches or corresponds to the shape, profile, and / or geometry of yoke 400.

[0202]

[0346] As described herein, the yoke 400 connects the headgear to the frame 300 and cushion 302. The yoke 400 can also accommodate core elements, such as the wires 442 of the one-way friction, self-adjusting, or self-adjusting headgear adjustment mechanisms 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., at and / or near the end caps 406) than at the center. Advantageously, such a configuration can help minimize or reduce the size of the mask overall.

[0203]

[0347] As shown in FIGS. 66-71 , in the illustrated embodiment, the yoke 400 includes a front yoke section 402, a rear yoke section 404, and two end caps 406, one at each lateral end of the yoke 400. In the illustrated embodiment, the front yoke section 402 and the rear yoke section 404 are formed as separate components and joined together. In the illustrated embodiment, the front yoke section 402 includes a top wall 408, a front wall 409, and a bottom wall 410. The exterior or outer surface of the front wall 409 may be rounded. The top wall 408 and the bottom wall 410 extend substantially perpendicularly from the upper and lower edges of the front wall 409, respectively. Thus, the top wall 408 and the bottom wall 410 are substantially parallel to each other. The front yoke section 402 may form a D-shaped cross-sectional profile.

[0204]

[0348] The front yoke section 402 and the rear yoke section 404 can be coupled together via a snap fit. The rear yoke section 404 snaps into a top wall 408 and a bottom wall 410, as shown in FIG. 71 . In the illustrated embodiment, the rear yoke section 404 includes snap-fit ​​bumps 412 located on the upper edge or upper surface and lower edge or lower surface of the rear yoke section 404. In some embodiments, the snap-fit ​​bumps 412 extend longitudinally between the lateral ends along a portion or the entire length of the yoke 400. As shown in FIG. 71 , the snap-fit ​​bumps 412 fit into corresponding snap-fit ​​grooves 414 formed on the inner surfaces of the top wall 408 and bottom wall 410 of the front yoke section 402. In some embodiments, the rear yoke section 404 can include only one of the snap-fit ​​bumps 412, and the front yoke section 402 can include only the corresponding snap-fit ​​groove 414. In some embodiments, the front yoke portion 402 includes snap-fit ​​bump(s) 412 and the rear yoke portion 404 includes corresponding snap-fit ​​groove(s) 414. A cavity or space is formed between the front yoke portion 402 and the rear yoke portion 404. In other words, the yoke 400 is hollow.

[0205]

[0349] The end caps 406 can also help secure the front yoke section 402 and the rear yoke section 404 together by clipping or snapping onto the lateral ends of the front yoke section 402 and the rear yoke section 404. As shown in FIGS. 73A-73B, the lateral ends of the front yoke section 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 front yoke section 402 or can be permanently or removably attached to the lateral ends of the front yoke section 402. The end cap inserts 418 have walls that are offset inwardly from the top wall 408, front wall 409, and bottom wall 410 of the front yoke section 402. As shown in FIGS. 74-77, the lateral ends of the rear yoke section 404 can include or be formed by end cap inserts 420. The end cap inserts 420 may be integrally formed with the lateral ends of the aft yoke section 404, or may be permanently or removably attached to the lateral ends of the aft yoke section 404. As shown in FIGS. 74-77 , each end cap insert 420 includes an alignment peg 422 that fits within a corresponding end cap insert 418 of the front yoke section 402. In the illustrated embodiment, the alignment peg 422 of one end cap insert 420 (located at one end of the aft yoke section 404) is positioned near the top or upper surface of the aft yoke section 404, and the alignment peg 422 of the other end cap insert 420 (located at the other end of the aft yoke section 404) is positioned near the bottom or lower surface of the aft yoke section 404. When the front yoke section 402 and the aft yoke section 404 are joined together, the alignment peg 422 fits within the end cap insert 418 of the front yoke section 402.

[0206]

[0350] When assembled, the end cap 406 fits over and at least partially covers the end cap inserts 418, 420. The yoke front 402 may include end cap snap-fit ​​bump(s) 416 located at or near the lateral edges of the upper edge or surface and / or lower edge or surface of the yoke front 402. In the illustrated embodiment, the end cap snap-fit ​​bumps 416 extend laterally across a portion or the entire thickness or width of the yoke front 402. The end cap snap-fit ​​bumps 416 may be positioned on the top and bottom surfaces of the end cap insert 418, as shown in FIGS. 73A-73B. Each of the end caps 406 may be coupled to one of the front straps of the headgear. In some embodiments, the end caps 406 can be overmolded onto the ends of the braided elements of an automatic headgear adjustment mechanism, such as those 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 International Application No. PCT / NZ2014 / 000074, which are incorporated herein by reference in their entireties. A core element or wire 442 can extend within the braided elements. The end caps 406 can connect the braided elements, and thus the headgear, to the yoke 400, creating a closed-loop headgear system.

[0207]

[0351] As shown in FIGS. 61A-61B, the yoke 400 is assembled to or coupled to the frame 300 at a plane (or axis) 401 that is different from the central plane (or axis) 309 that extends through the inlet 308 and the plane (or axis) 303 at which the cushion 302 is coupled to the frame 300. In the illustrated embodiment, the inlet plane 309 is different from the cushion connection plane 303. As shown in FIG. 61B, the yoke plane 401 is aligned with or extends through the nasal prongs 310. Advantageously, when the mask system is placed on a user's face, the alignment of the yoke plane 401 with the nasal prongs 310 allows the headgear to apply a force through the yoke 400, pulling the nasal prongs 310 toward the user's nares. In the illustrated embodiment, the cushion connection plane 303 and the inlet plane 309 are more closely aligned (or nearly aligned) with each other than the yoke plane 401. This allows the cushion 302 to be coupled or attached to the frame 300 in an orientation that is generally aligned with the inlet 308, which may advantageously be intuitive to a user.

[0208]

[0352] Because of the difference in angle 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 counterintuitive to some users. If a user attempts to remove the yoke 400 from the frame 300 along the same direction as the cushion connection plane 303, the yoke 400 may get stuck or catch on the frame 300, thereby increasing the removal force and making the yoke 400 more difficult to disconnect. Therefore, it may be beneficial if the yoke 400 is relatively simple and requires minimal force to connect and disconnect from the frame 300, while still maintaining a substantial connection during use. During donning and doffing of the mask, the headgear 312 can be pulled upward at an angle relative to the yoke plane 401, as shown in FIG. 62 . This can create a rotational force or torque on the connection between the yoke 400 and the frame 300. If the torque generated is great enough, the yoke 400 may unintentionally disconnect from the frame 300, making the mask more difficult to don and doff. Various features described herein can help address these potential problems.

[0209]

[0353] As shown in FIGS. 63-65, the frame 300 may include a retention bump 328. The retention bump 328 projects downward from the front lower edge of the top wall 322 toward and / or into the yoke channel 316. In the illustrated embodiment, the retention bump 328 extends from a middle portion of the top wall 322. The retention bump 328 forms a relatively narrower opening for a portion of the yoke channel 316. As shown in FIGS. 66 and 69, the yoke 400 (in the illustrated embodiment, the yoke front portion 402) includes a retention notch 424. In the illustrated embodiment, the retention notch 424 is located at or near the corner formed between the top wall 408 and the front wall 409 of the yoke front portion 402. The retention notch 424 may form a scalloped region. In the illustrated embodiment, the retention notch 424 is located in a middle portion of the yoke front portion 402. The retention notch 424 is configured to receive the retention bump 328 of the frame 300 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 width of the retention bump 328 and the retention notch 424 can 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 bump 328 and the retention notch 424 are narrower than the yoke channel 316, and therefore the force required to connect and / or disconnect the yoke 400 and the frame 300 is small enough to allow for a simple connection that is still effective in securing the yoke 400 to the frame 300.

[0210]

[0354] In some embodiments, as shown, for example, in FIGS. 67 and 71-72 , the yoke front 402 includes a lead-in chamfer 426. The lead-in chamfer 426 is a chamfered or rounded edge along the rear upper edge of the top wall 408. The lead-in chamfer 426 can help guide the yoke 400 over the retention bump 328, improving ease of insertion of the yoke 400 into the yoke channel 316. In some embodiments, the frame 300 and yoke 400 need not include the retention bump 328 and retention notch 424, respectively. Tension applied to the yoke 400 and / or frame 300 by the headgear can help secure the yoke 400 and frame 300 together as an alternative to or in addition to a snap fit between the retention bump 328 and the retention notch 424.

[0211]

[0355] The yoke channel 316 may include an anti-rotation groove 330 recessed into the back wall 324 and extending along some or all of the length of the yoke channel 316, as shown in FIGS. 63-65. In the illustrated embodiment, the anti-rotation groove 330 is located adjacent the bottom wall 326 of the frame 300. The yoke 400 includes a corresponding tongue 428 (shown in FIGS. 66-68) that is received in the anti-rotation groove 330 when the yoke 400 and frame 300 are joined together. As shown in FIG. 71, a central region of the bottom wall 410 of the front yoke section 402 extends deeper and protrudes more rearward than the lateral ends of the front yoke section 402, forming a front tongue 428a. As shown in FIGS. 71 and 77, a central region of the bottom of the rear yoke section 404 extends more rearward than the lateral ends of the rear yoke section 404, forming a rear tongue 428b. The rear tongue 428b projects perpendicularly from a central region of the bottom of the rear yoke portion 404, forming an "L"-shaped cross section. The front tongue 428a and the rear tongue 428b are aligned and abut one another, with the front tongue 428a disposed below the rear tongue 428b, as shown in FIG. 71 . Forming the tongue 428 from two portions (the front tongue 428a and the rear tongue 428b) can advantageously help improve the connection between the front yoke portion 402 and the rear yoke portion 404. The two-part configuration can allow rotational forces applied to the yoke 400 and / or frame 300 to be applied to both the front yoke portion 402 and the rear yoke portion 404 simultaneously, helping to reduce or minimize distortion of the front yoke portion 402 and the rear yoke portion 404 relative to one another, which could cause the front yoke portion 402 and the rear yoke portion 404 to shear. During rotation, the front and rear tongues 428a, 428b can be pinched together by contacting the anti-rotation grooves 330 (shown in FIG. 82), thereby helping to reinforce the connection between the front yoke section 402 and the rear yoke section 404.

[0212]

[0356] 80-82 , when tongue 428 is disposed within anti-rotation groove 330, if and when a rotational force is applied to yoke 400, for example, via headgear, the interaction between tongue 428 and anti-rotation groove 330 helps prevent or inhibit yoke 400 from rotating out of yoke channel 316. In embodiments including retention bump 328 and retention notch 424, retention bump 328 and retention notch 424 can help resist rotational disconnection of yoke 400 from frame 300 as an alternative or in addition to the interaction between tongue 428 and anti-rotation groove 330.

[0213]

[0357] As described herein, in some embodiments, the yoke 400 can form a collector for core elements, such as wires 442, used in an automatic or self-adjusting headgear system. As shown in FIGS. 71-73B, the front yoke 402 includes an upper line track 430 and a lower line track 432. A line track divider 434 projects rearward from the rear or inner surface of the front wall 409 of the front yoke 402. As shown in FIGS. 72-73A, the line track divider 434 extends approximately diagonally across a portion of the length of the front yoke 402. In other words, one end of the line track divider 434 is located near the top wall 408, and the other, opposite end of the line track divider 434 is located near the bottom wall 410. Thus, the upper line track 430 is 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 line track divider 434. The lower line track 432 is bounded and / or defined by the top surface of the bottom wall 410 , the back surface of the front wall 409 , and the lower surface of the line track divider 434 .

[0214]

[0358] The upper line track 430 and the lower line track 432 receive a wire 442 of the automatically adjustable headgear system. The wire 442 extends from a portion of the headgear coupled to and / or adjacent to the yoke 400. As shown in FIGS. 67 and 70 , the end caps 406 include wire entry holes 444. The wire entry holes 444 help guide the wire 442 into the yoke 400, for example, from the braided component of the headgear. The wire 442 passes from the headgear through the entry holes 444 and into the hollow yoke 400. As shown in FIGS. 72 and 74 , the yoke 400 includes a washer housing 446 positioned adjacent to (between) each end cap 406. Each washer housing 446 can fit or be positioned within a washer housing pocket 448 formed by the yoke front 402, as shown in FIG. 73A . The washer housing 446 houses one or more washers 450 (shown in FIG. 79 ) that act as part of a locking mechanism for the automatically adjustable headgear system. An example 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. A first linear body passes through the end cap 406 and the first of the washer(s) 450 in the first washer housing 446 into the upper line track 430. A second linear body passes through the end cap 406 and the second of the washer(s) 450 in the second washer housing 446 into the lower line track 432.

[0215]

[0359] As shown in FIGS. 72-73A , the upper line track 430 is wider toward the first end of the front yoke 402 and narrows toward the second end. The lower line track 432 is wider toward the second end of the front yoke 402 and narrows toward the first end. The upper and lower line tracks 430, 432 have a greater height or width at the end where the linear body 442 enters the line track. This can advantageously help prevent or inhibit sharp bends from forming in the linear body 442 immediately or immediately after it exits the washer housing 446, thereby helping the washer(s) 450 properly engage the linear body 442. This can additionally or alternatively help prevent or inhibit the linear body 442 from getting caught on the interior geometry of the yoke 400 during retraction of the linear body 442 and headgear.

[0216]

[0360] As shown in FIGS. 78-79 , the end caps 406 and / or the linear entry holes 444 act as guides for the linear body 442, thereby helping to improve the reliability of the adjustment mechanism's function. In use, if the linear body 442 is bent (e.g., by a user) at an acute angle near where it exits the washer housing 446, the washer(s) 450 may be unable to properly engage the linear body 442 during headgear extension, distorting the force-displacement profile of the adjustment mechanism and potentially preventing or inhibiting the adjustment mechanism from functioning properly and / or effectively. Each end cap 406 provides an extension (indicated by X in FIGS. 78 and 79 ) of the linear body 442 into the yoke 400 before entering the washer housing 446. The linear body 442 is prevented or inhibited from bending within the yoke 400 and end caps 406. The wire 442 can be bent by the user after it exits the end cap 406 through the wire entry hole 444. However, the extension of length X provided by the end cap 406 allows any bend formed in the wire 442 outside of the yoke 400 to be more offset or spaced from the washer housing 446. This can advantageously help the wire 442 extend through the washer housing 446 substantially parallel to the walls of the washer housing 446 and / or end cap 406, thereby helping the washer(s) to fully and properly engage the wire 442 during adjustment.

[0217]

[0361] In the illustrated embodiment, the upper line track 430 extends above the washer housing 446 at the second end of the yoke 400 (the end opposite where the linear body 442 enters the upper line track 430), and the lower line track 432 extends below the washer housing 446 at the first end of the yoke 400 (the end opposite where the linear body 442 enters the lower line track 432). The extension of the upper and lower line tracks 430 and 432 above and below the washer housing 446 on opposite sides thereof advantageously allows a shorter yoke 400 to accommodate linear bodies 442 of the same length (compared to a yoke 400 in which the upper and lower line tracks 430 and 432 terminate midway relative to the washer housing 446). A shorter yoke 400 advantageously prevents or reduces the lateral edges of the yoke 400 from digging into the user's cheek during use. This configuration (upper line track 430 and lower line track 432 extending above and below opposite washer housings 446) allows the washer housings 446 to be vertically offset from one another, as shown in FIG. 74, making the yoke 400 symmetrical.

[0218]

[0362] As shown in FIGS. 74-75 , the rear yoke portion 404 includes an upper line track insert 436 and a lower line track insert 438. The upper line track insert 436 and the lower line track insert 438 protrude forward from the front or inner surface of the rear yoke portion 404. The upper line track insert 436 fits at least partially within the upper line track 430 of the front yoke portion 402, and the lower line track insert 438 fits at least partially within the lower line track 432 of the front yoke portion 402. The upper line track insert 436 and the lower line track insert 438 may have shapes corresponding to the shapes of the upper line track 430 and the lower line track 432, respectively. For example, the upper line track insert 436 is wider near a first end of the rear yoke portion 404 that is configured to be positioned adjacent to the first end of the front yoke portion 402, and the lower line track insert 438 is wider near a second end of the rear yoke portion 404 that is configured to be positioned adjacent to the second end of the front yoke portion 402. A divider channel 440 extends longitudinally between and is defined by the upper and lower line track inserts 436, 438. The wall thickness of the rear yoke portion 404 is reduced in the region of the divider channel 440 compared to in the region of the upper and lower line track inserts 436, 438. The divider channel 440 receives the line track divider 434 of the front yoke portion 402. This can advantageously help promote accurate alignment of the front yoke portion 402 and the rear yoke portion 404 and / or can help reduce or minimize the overall depth or thickness of the yoke 400.

[0219]

[0363] The upper and lower line track inserts 436, 438 reduce the depth or height of the line tracks 430, 432. The reduced depth or height helps to better guide the linear body 442 within the line tracks 430, 432. The upper and lower line track inserts 436, 438 can additionally or alternatively provide increased structure and rigidity to the rear yoke portion 404, which can help prevent or reduce the rear yoke portion 404 from being disconnected from the front yoke portion 402 when the yoke 400 is bent. The interaction between the upper and lower line track inserts 436, 438 and the upper and lower line tracks 430, 432, respectively, can help align the front and rear yoke portions 402, 404 and help prevent or reduce incorrect assembly.

[0220]

[0364] FIGS. 83-84 illustrate an alternative embodiment of the yoke rear section 404 and end cap 406. In the illustrated embodiment, the alignment peg 422 has an increased height (indicated by "H" in FIG. 84) relative to the alignment peg 422 shown in the embodiment of FIG. 45. The increased height of the alignment peg 422 reduces the available space within the end cap 406. The reduced space can help improve guiding the linear body 442 through the end cap insert 418. In the illustrated embodiment, the space within the end cap insert 418 through which the linear body 442 passes over the alignment peg 422 is positioned above or higher than the opening in the first washer 450a through which the linear body 442 extends. Thus, the linear body 442 can bend over the alignment peg 422, as shown in FIG. 83, thereby increasing friction between the linear body 442 and the first washer 450a. This can help ensure that the first washer 450a engages and pivots during extension and / or retraction of the headgear. In this embodiment, the linear body entry hole 444 can be elongated (e.g., relative to the embodiment of FIG. 67 ) to form an elongated slot having a height greater than its depth. The increased height of the alignment peg 422 provides additional guidance for the linear body 442 within the yoke 400, so that the linear body entry hole 444 requires less support for the linear body 442. An elongated slot rather than a circular hole for the linear body entry hole 444 can allow the linear body 442 to pass freely through the linear body 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.

[0221]

[0365] 85-87 illustrate another alternative embodiment of the rear yoke section 404. In the illustrated embodiment, the height H of the alignment peg 422 is approximately the same as, but slightly less than, the interior height of the end cap insert 418 of the front yoke section 402, so that the alignment peg 422 abuts or nearly abuts the upper and lower inner surfaces of the end cap insert 418, as shown in FIG. 85. The alignment peg 422 includes a linear body slot 452 that allows the linear body 442 to pass through the alignment peg 422 and into the washer housing 446. The alignment peg 422 and / or linear body slot 452 help guide the linear body 442 through the end cap 406.

[0222]

[0366] FIGS. 88-90 illustrate an alternative yoke 400 embodiment including variations in the line tracks 430, 432. As shown, the line tracks 430, 432 overlap the washer housing 446, similar to the embodiment shown and described with respect to FIGS. 72-73A, reducing the yoke length required for a given linear length. In the embodiment of FIGS. 88-90, the line tracks 430, 432 each pass in front of the washer housing 446 on opposite sides, rather than above or below the washer housing 446. The line tracks 430, 432 are cut or formed into the front wall 409 of the yoke front portion 402 (e.g., the end cap insert 418), and the line tracks 430, 432 pass in front of the washer housing 446, as shown in FIG. 90, looking toward the lateral end of FIG. 88. This configuration may allow for a reduced yoke height ("H" in FIG. 89) compared to the embodiment of FIGS. 72-73A. The reduced height H can help the mask appear smaller and / or less obtrusive overall, however, the embodiment of Figures 72-73A can allow for a reduced depth of yoke 400 compared to the embodiment of Figures 88-90.

[0223]

[0367] 91-94 show another alternative embodiment of the line track. As with the previously described embodiment, the line track overlaps the washer housing 446 to reduce the yoke length required for a given linear length. In the embodiment of FIGS. 91-94, the yoke is divided diagonally by a spiral wall that at least partially forms or defines a front line track 460 and a rear line track 462. The line tracks 460, 462 overlap front to back and then extend to terminate below the washer housing 446. This arrangement allows the washer housings 446 to be horizontally aligned with one another. This arrangement can help reduce or limit the increase in height of the yoke 400 caused by the line tracks 460, 462 because both line tracks 460, 462 pass under the washer housing 446, rather than one passing under and one over the other, as shown in the embodiment of FIG. 72. Although Figures 91-94 show the yoke 400 as straight or linear, the yoke 400 having the arrangement of line tracks 460, 462 shown in Figures 91-94 can be curved in a plane, similar to the embodiments shown and described above.

[0224]

[0368] 133-135 illustrate another exemplary embodiment of a yoke 600 and a cushion or seal 502 coupled to a frame 500. The yoke 600, seal 502, and / or frame 500 may be similar in some respects to the yoke 400, cushion 302, and / or frame 300, respectively. The frame 500 includes a yoke channel 516 configured to receive the yoke 600 during use. The yoke channel 516 is formed or defined by a top wall 522, a back wall 524, and a bottom wall 526. The yoke 600 exhibits increased asymmetry between the top and bottom edges of the yoke 600, as compared to, for example, the yoke 400. In the illustrated embodiment, the top edge of the yoke 600 is straighter than the bottom edge. Advantageously, the asymmetry provides an improved visual cue regarding the correct orientation for assembling the yoke 600 to the frame 500 and helps to discourage incorrect assembly.

[0225]

[0369] As shown in FIG. 134 , the yoke channel 516 includes connector recesses 528 in the upper and lower walls 522, 526. In the illustrated embodiment, a connector recess 528 is located at, adjacent to, or near each lateral end of the yoke channel 516. The connector recesses 528 at least partially define or form a retention lip 523 at or along the leading edge of the yoke channel 516 (e.g., at or along the leading edges of the inwardly facing surfaces of the upper and lower walls 522, 526). The yoke 600 includes connector protrusions 628 that protrude rearwardly from the top, bottom, and / or rear surface of the yoke 600. In the illustrated embodiment, the yoke 600 includes a connector protrusion 628 on each side of the center of the yoke 600. In the illustrated embodiment, the yoke 600 includes a front yoke section 602 and a rear yoke section 604 coupled together, as described in more detail herein, and the connector protrusions 628 are formed in the rear yoke section 604. The connector recess 528 is configured to receive the connector 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 retention lip 523 engages the yoke 600 in front of the connector protrusion 628 to contribute to the snap-fit ​​connection and retain the yoke 600 within the yoke channel 516. In the illustrated embodiment, the connector protrusion 628 and the connector recess 528 have a square or rectangular profile to inhibit the yoke 600 from rotating out of the yoke channel 516, for example, in the direction indicated by the arrow in FIG.

[0226]

[0370] In some embodiments, the yoke 600 has an elliptical or substantially elliptical cross-section, as shown, for example, in FIG. 137 . This shape may advantageously reduce the size or bulk of the yoke 600 and / or provide an improved aesthetic appearance. As discussed in more detail herein, the washer housing 646 may have a D-shaped, substantially D-shaped, U-shaped, or substantially U-shaped cross-section, as shown, for example, in FIGS. 136A-136C , and may enable and / or contribute to the overall elliptical or substantially elliptical cross-section of the yoke 600. The washer housings 646 may be oriented opposite one another. In other words, as shown in FIG. 136C , one of the washer housings 646, e.g., the left washer housing 646, may be oriented as an upward U-shape, and the other washer housing 646, e.g., the right washer housing 646 in FIG. 136C , may be oriented as a downward U-shape. This arrangement and orientation can advantageously help to allow the line tracks 630, 632 to extend above and below the left and right washer housings 646, respectively, as discussed in more detail herein. As shown in FIG. 137 , in the illustrated embodiment, the depth D of the yoke 600 or a central portion of the yoke 600 is the same as, similar to, 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.

[0227]

[0371] As shown in FIGS. 136A and 138 , in the illustrated embodiment, the back or rear face of the yoke 600 includes a rear step on each side or lateral end of a central portion of the yoke 600, such that the yoke 600 has a stepped depth. In other words, the depth of the lateral portions of the yoke 600 that are disposed laterally outboard of the yoke channel 516 when the yoke 600 is coupled to the frame 500 is greater than the depth D of the central portion of the yoke 600 that is disposed within the yoke channel 516 when the yoke 600 is coupled to the frame 500. The step forms or defines frame abutment surfaces 605 at the transition between the central and lateral portions of the yoke 600. When the yoke 600 is coupled to the frame 500, each of the frame abutment surfaces 605 abuts one of the lateral edges 505 of the frame 500 or is disposed adjacent to or near one of the lateral edges 505, as shown in FIG. 138 . The frame abutment surfaces 605 and lateral edges 505 aid in properly aligning the frame 500 and yoke 600 during assembly. The frame abutment surfaces 605 and lateral edges 505 additionally or alternatively provide a more secure connection between the yoke 600 and the frame 500. Advantageously, the reduced depth of the central portion of the yoke 600 reduces the overall size of the frame 500 and yoke 600 assembly.

[0228]

[0372] As shown in FIGS. 135-137, in the illustrated embodiment, the yoke 600 includes a front yoke section 602 and a rear yoke section 604. The yoke 600 may also include two end caps 606 (shown in FIG. 140), one end cap 606 at each lateral end of the yoke 600. In the illustrated embodiment, the front yoke section 602 and the rear yoke section 604 are formed as separate components that are joined together. In the embodiment of FIGS. 135-137, a parting line 603 (shown in FIG. 137) between the front yoke section 602 and the rear yoke section 604 is located at or near the center. This may improve manufacturability.

[0229]

[0373] The front yoke section 602 and the rear yoke section 604 can be coupled together via a snap fit. In the illustrated embodiment, the front yoke section 602 includes a yoke fastener 613 that protrudes rearward from the rear surface of the front yoke section 602. In the illustrated embodiment, the yoke fastener 613 is centrally or nearly centrally located with respect to the front yoke section 602. The rear yoke section 604 includes a fastener opening 615 that is sized, shaped, and positioned to receive the yoke fastener 613 and form a snap fit connection when the front yoke section 602 and the rear yoke section 604 are coupled together. The central connection between the front yoke section 602 and the rear yoke section 604 via the yoke fastener 613 and fastener opening 615 provides additional rigidity to the connection between the front yoke section 602 and the rear yoke section 604 and / or provides torsional support or restraint between the front yoke section 602 and the rear yoke section 604. In some embodiments, alternatively, the front yoke portion 602 includes the fastener opening 615 and the rear yoke portion 604 includes the yoke fastener 613. In some embodiments, the fastener opening 615 includes one or more fastener bumps 617 that extend along (e.g., laterally along) the top and / or bottom edges of the fastener opening 615 and project from the top and / or bottom edges into the fastener opening 615. The yoke fastener 613 includes one or more corresponding notches 619 (shown in FIG. 137 ) that extend along (e.g., laterally along) the top and / or bottom surfaces of the yoke fastener 613 that are sized, shaped, and positioned to receive the fastener bump(s) 617 to form a snap-fit ​​connection. In some embodiments, fastener opening 615 includes one or more notches 619 and yoke fastener 613 includes one or more fastener bumps 617 .

[0230]

[0374] 148-150 show a variation of a yoke 600 in which the rear yoke section 604 includes a fastener recess 615' rather than a fastener opening 615. The fastener recess 615' does not extend the entire thickness of the rear yoke section 604. The front yoke section 602 includes a rearwardly extending yoke fastener 613'. The fastener recess 615' is sized, shaped, and positioned to receive the yoke fastener 613' and form a friction-fit connection when the front yoke section 602 and the rear yoke section 604 are joined together. In some such embodiments, the fastener recess 615' includes one or more interference bumps 617' on the top surface or edge and / or the bottom surface or edge of the fastener recess 615'. In the illustrated embodiment, the interference bumps 617' are elongated and extend the entire depth of the fastener recess 615'. The interference bumps 617' interfere with the fastener recesses 615' and the yoke fasteners 613' and help create a friction fit between the fastener recesses 615' and the yoke fasteners 613' to help secure together the front yoke section 602 and the rear yoke section 604. Advantageously, this configuration may allow for easier manufacturing, provide a neater finish (no openings in the rear yoke section 604), and / or may inhibit the ingress of dirt or other debris into the line tracks 630, 632 (because the lack of openings allows the yoke 600 to be completely enclosed along its length), thereby helping to maintain the functionality of the automatic headgear adjustment mechanism.

[0231]

[0375] 135-137, the yoke rear portion 604 includes an upper alignment bead 612a projecting forward from the yoke rear portion 604 and extending along the length of the yoke rear portion 604 adjacent or adjacent to the upper surface of the yoke rear portion 604, and / or a lower alignment bead 612b projecting forward from the yoke rear portion 604 and extending along the length of the yoke rear portion 604 adjacent 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 back surface of the yoke front portion 602 extending along the length of the yoke front portion 602 adjacent or adjacent to the upper surface of the yoke front portion 602, and / or a lower alignment groove 614b in the back surface of the yoke front portion 602 extending along the length of the yoke front portion 602 adjacent or adjacent to the lower surface of the yoke front portion 602. The upper alignment groove 614a and / or the lower alignment groove 614b receive the upper alignment bead 612a and / or the lower alignment bead 612b, respectively, when the front yoke section 602 and the rear yoke section 604 are coupled together. The alignment beads 612a, 612b and the alignment grooves 614a, 614b help to precisely align the front yoke section 602 and the rear yoke section 604. The alignment beads 612a, 612b and the alignment grooves 614a, 614b may additionally or alternatively resist or support torsion, for example, between the front yoke section 602 and the rear yoke section 604. In some embodiments, the alignment beads 612a, 612b and the alignment grooves 614a, 614b may positively engage one another, for example, in the form of a friction-fit or snap-fit ​​connection.

[0232]

[0376] The end caps 606 can help secure the front yoke 602 and the rear yoke 604 together by clipping or snapping onto the lateral ends of the front yoke 602 and the rear yoke 604. The end caps 606 can also allow for connection of the front straps of the headgear to the yoke 600. In some embodiments, each end cap 606 is overmolded onto the braided portion of the front strap.

[0233]

[0377] As shown in FIGS. 141-147, the lateral ends of the front yoke section 602 and the rear yoke section 604 include or are formed by end cap inserts 618. The end cap inserts 618 may be integrally formed with or attached to the lateral ends of the front yoke section 602 and the rear yoke section 604. The end cap inserts 618 have a reduced size or profile compared to the lateral portions of the yoke 600. The end caps 606 have internal cavities 609 that receive the end cap inserts 618. During assembly, the end caps 606 are hingedly or snap-fit ​​onto the end cap inserts 618, as shown in FIG. 141.

[0234]

[0378] As shown in FIG. 146 , 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 retention notch 607 can be reversed. In the illustrated embodiment, positioning the retention holes 605 within the rear of the end cap 606 advantageously conceals the retention holes 605 during use and provides an improved aesthetic appearance. The retention notch 607 extends forward from the end cap cavity 609 into the end cap 606. The end cap insert 618 includes a first retention feature 616 located on one of the front and rear faces (e.g., in the illustrated embodiment, extending rearward from a portion of the yoke rear 604 of the end cap insert 618) and a second retention feature 617 located on the opposite face (e.g., in the illustrated embodiment, extending forward from a portion of the yoke front 602 of the end cap insert 618). To attach the end cap 606 to the yoke 600, for example, to an end cap insert 618, the retention hole 605 engages a first retention feature 616, as shown in FIG. 141 . The first retention feature 616 then acts as a hinge or pivot point, and the end cap 606 pivots onto the end cap insert 618 in the direction shown by the arrow in FIG. 141 until the second retention feature 617 and the retention notch 607 engage, for example, with a bump or snap-fit ​​connection. The hinged connection can provide a strong connection between the yoke 600 and the end cap 606 while reducing the length L (shown in FIG. 144) of the end cap insert 618. Thus, the end cap 606 can taper more steeply. Advantageously, reducing the length of the end cap insert 618, the end cap 606, and / or the overall yoke 600 can reduce or minimize digging of the yoke 600 into the patient's face.

[0235]

[0379] In the illustrated embodiment, the first retention feature 616 is or includes an oval or horseshoe-shaped post that extends rearward from the yoke aft section 604. The length or depth of the first retention feature 616 is selected so that the outer or final surface of the first retention feature 616 is flush or substantially flush with the rear surface of the yoke aft section 604. This increases the contact area and interaction between the end cap 606 and the end cap insert 618, increasing the retention force. Thus, the connection between the end cap 606 and the end cap insert 618 can withstand greater twisting forces along the length of the yoke 600 and / or rotational forces about the joint.

[0236]

[0380] In the illustrated embodiment, the second retention feature 617 is or includes a raised tab extending forward from the yoke front 602. The length or depth of the second retention feature 617 is reduced compared to the first retention feature 616, allowing the end cap 606 to slide over the second retention feature 617 during assembly. In the illustrated embodiment, the second retention feature 617 has a chamfered recess 617a on one edge, e.g., a lateral edge (relative to the yoke 600) in the illustrated embodiment, allowing the end cap 606 to be more easily hinged or pivoted onto the second retention feature 617.

[0237]

[0381] In some embodiments, the end caps 606 can be overmolded onto the ends of the braided elements of an automatic headgear adjustment mechanism, such as those 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 International Application No. PCT / NZ2014 / 000074, which are incorporated herein by reference in their entireties. A core element or wire 642 can extend within the braided elements. The end caps 606 can connect the braided elements, and thus the headgear, to the yoke 600, creating a closed-loop headgear system.

[0238]

[0382] As described herein, in some embodiments, the yoke 600 can form a collector for core elements, such as linear bodies 642, used in automatic or self-adjusting headgear systems. As shown in FIG. 136C , the front yoke 602 includes an upper line track 630 and a lower line track 632. A line track divider 634 projects rearward from the rear or inner surface of the front yoke 602. The line track divider 634 extends approximately diagonally across a portion of the length of the front yoke 602. In the illustrated embodiment, a divider wall 635 extends between each washer housing 646 and the opposing line track. The divider wall 635 separates the opposing line tracks from the washer housing 646, thereby preventing the free ends of the linear bodies 642 from getting caught in the opposing washer housing 646 during retraction. In the illustrated embodiment, the line tracks 630 , 632 are not mirror symmetrical due to the asymmetry of the top and bottom edges of the yoke 600 .

[0239]

[0383] FIG. 140 shows a variation of the yoke 600 in which the line tracks 630, 632 terminate within the yoke 600, extending into the end cap 606. Thus, the length of the line tracks 630, 632 extends beyond the ends of the front yoke 602 and rear yoke 604. This increases the length of the linear body 642 that can be stored within the yoke 600, thereby increasing the range or variability of headgear size adjustment. The headgear assembly 200 defines a headgear loop that extends around the user's head during use. The linear body 642 forms part of an automatic headgear adjustment mechanism that allows the total length of the headgear loop to be increased during donning and doffing of the mask system. In some such embodiments, the length of each of the line tracks 630, 632 can be increased or lengthened by approximately 5 mm. Thus, in such embodiments, the total length of the headgear loop can be increased by approximately 10 mm when extended.

[0240]

[0384] 139 shows an exemplary embodiment of a seal 502 that can be used, for example, with the frame 500 and yoke 600. In the illustrated embodiment, the seal 502 includes a lip pad 503 that projects outward from the seal clip 122 along the lower edge of the sealing surface to form a convex area that pads or cushions against the seal clip 122. By providing additional cushioning, the lip pad 503 can minimize the bottom edge of the seal 502 against the seal clip 122, thereby improving patient comfort, particularly in the upper lip area.

[0241]

[0385] 95A and 95B show front and rear views, respectively, of a nasal mask assembly 700 comprising a seal and frame assembly 702, a headgear assembly 704, and a gas conduit 706. The seal and frame assembly 702 comprises a seal cushion 708 supported by a frame 710. The seal cushion 708, alone or in combination with the frame 710, defines the breathing chamber of the nasal mask assembly 700. The seal cushion 708 may be in the form of a direct nasal cushion (e.g., a nasal pillow cushion). The gas conduit 706 delivers a flow of breathing gas 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 user's face.

[0242]

[0386] 96-107 illustrate one embodiment of the seal cushion or seal 708 of the interface or mask assembly of FIG. 95. For comparison, the seal 708 is shown next to an example of a prior art nose seal or reference seal 708R. As shown, the seal 708 is smaller than the prior art seal 708R. One aspect of the present disclosure involves a seal (e.g., seal 708) that has a smaller overall size / volume than the prior art seal 708R, yet provides a sufficient, stable seal against a user's face when incorporated into a mask assembly (e.g., mask assembly 700). In some configurations, the seal 708 is used in combination with auto-adjustable headgear or headgear with directional locking capabilities, as described above. Such headgear can reduce or minimize the force required to balance blow-out forces or hose drag that may be applied to the mask, thereby holding the seal in place. The force applied to the user by the headgear without pressurization of the mask assembly can be less than the force required to balance blow-out forces. The inventors have found that reducing or minimizing the force applied to the user's head by such a system allows the sealing surface of the seal to be reduced or minimized. This is because it is not necessary to distribute a stronger headgear force over a larger sealing surface to reduce pressure points. The smaller force can be distributed over a smaller sealing surface without creating significant pressure points. This allows a smaller seal with a smaller contact surface to form an effective and comfortable seal against the user's face. It is advantageous to make the respirator as small as possible or as practicable so as to be as unobtrusive as possible and to avoid a claustrophobic feeling for the user. In some configurations of headgear with automatic adjustable headgear or directional locking capabilities, such as the headgear of FIG. 95, the system has significant flexibility between the back portion of the headgear and the mask frame, thereby beneficially providing a more stable seal on the face than prior art seal 708R or other seals used in combination with other types of headgear.The expansile nature of the prior art seal 708R allows it to rotate or roll around the user's nose.

[0243]

[0387] Several factors limit how small a seal can be. For example, the minimum size of a seal is typically influenced or limited by the size of the inlet opening and sealing surface. The seal forms part of the airway and therefore must be connected to a gas conduit that delivers pressurized gas to the seal and the patient's airway. There are limits as to how small the diameter of the gas conduit can be while still minimizing the pressure drop between the CPAP (blower or flow generator) and the patient interface / mask. In some configurations, the inner diameter of the gas conduit used with the disclosed seal is 15 mm or larger.

[0244]

[0388] Some prior art masks use elbows to connect the gas conduit to the mask frame. The elbows add extra weight and bulk to the mask and can contribute to mask instability. At least some configurations of the presently disclosed interface omit the elbows in favor of a direct connection between the gas conduit and the mask frame (e.g., between the gas conduit 706 and the frame 710). Removing the elbows shifts the center of gravity toward the user's face during use, thus reducing rotational moments and improving seal stability.

[0245]

[0389] The bias flow or exhaust ventilation holes are typically located within an elbow to a direct nasal (e.g., pillow) mask. Absence of an elbow requires the bias ventilation holes to be located elsewhere. The bias ventilation holes should be located within the mask's airway, and therefore the seal's inlet opening is preferably large enough to accommodate a path through which the exhaust can be vented. Therefore, the seal's inlet opening is preferably large enough to accommodate the gas inlet, the bias ventilation holes, and clips or other connecting structure for attaching the mask frame to the seal. The seal's sealing surface should be large enough to form an airtight seal between the seal and the various patient nares.

[0246]

[0390] 96, for comparison, a prior art nasal seal 708R is shown next to the seal 708 of the present disclosure. The prior art seal 708R may be the same as or similar to the seal disclosed in applicant's International Application No. WO 2015 / 009172, the entire contents of which are incorporated herein by reference. The cushion of the prior art seal 708R and the cushion of the seal 708 are generally similar in shape, although in the illustrated arrangement, the cushion of the seal 708 is smaller in overall size than the cushion of the prior art seal 708R. Both seal cushions 708, 708R include a pair of nasal prongs or pillows 712, 712R, respectively, configured to engage and form a substantial seal against a user's nares so that a supply of pressurized air can be delivered to the user's airways. In at least some configurations, the nasal prongs 712, 712R provide a primary sealing surface that provides primary contact between the nostrils and the seal cushion 708, 708R to provide a substantially airtight seal. The nasal prongs 712 of the seal 708 can be shaped the same as or substantially similar to the nasal prongs 712R of the prior art seal 708R.

[0247]

[0391] 97, the prior art seal 708R includes a secondary sealing surface 714R that surrounds and interfaces with the nasal prongs 712R. The secondary sealing surface 714R forms a preliminary or secondary seal with the lower nasal surface of the user's nose. The secondary sealing surface 714R is configured to capture any air leakage that may occur between the nasal prongs 712R and the user's nares and substantially reduce or prevent it from escaping outside the seal cushion.

[0248]

[0392] The cushion of the illustrated seal 708 includes a secondary sealing surface 714 that is smaller than the secondary sealing surface 714R of the prior art. The secondary sealing surface 714 of the seal 708 extends primarily between the two nasal prongs 712, forming a link between them, rather than extending radially outward from the nasal prongs 712. In some configurations, the secondary sealing surface 714 has an upper boundary at or below the uppermost extent of the nasal prongs 712 and a lower boundary at or above the lowermost extent of the nasal prongs 712. In some configurations, the secondary sealing surface 714 is defined by a concave portion of the user-facing surface of the seal 708 between or around the nasal prongs 712. Due to its smaller size, the secondary sealing surface or peripheral region 714 of the seal 708 can perform a smaller role as a secondary seal compared to the prior art seal 708R. In some configurations, the secondary sealing surface 714 of the seal 708 may be configured only to capture leakage beneath the user's nose and may not provide a substantial secondary seal around the outer edges of the user's nares for at least some users. However, in some configurations, the secondary sealing surface 714 of the seal 708 may be configured to provide a secondary seal around the entire periphery of the seal cushion 708.

[0249]

[0393] In some configurations, the secondary sealing surface 714 of the seal cushion 708 has a contour that is substantially similar or identical to the corresponding portion of the secondary sealing surface of the prior art seal cushion 708R, as shown by the overlapping geometries in Figures 98 and 99. As discussed above, the primary sealing surfaces of the nasal prongs 712, 712R of both seals 708, 708R can likewise be substantially similar.

[0250]

[0394] Referring to FIG. 99, the nasal prongs 712, 712R of both seal cushions 708, 708R include outlets 716, 716R through which a supply of pressurized air passes. The outlets 716, 716R define oval openings formed at the truncated apexes of the nasal prongs 712, 712R. The oval openings 716, 716R have a major axis 718 and a minor axis 720. In the illustrated arrangement, the dimension of the outlet 716 of the seal 708 along the major axis 718 is longer than the corresponding dimension of the prior art outlet 716R along the major axis 718. In at least some configurations, this difference exists only at the inner periphery of the outlet 716, 716R. These dimensions of the outlet 716, 716R along the major axis 718 are the same length at the outer periphery of the outlet 716, 716R. This configuration provides a uniform wall thickness at the outlet 716 of the seal 708, thereby providing uniform flexibility and improving comfort and fit for 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.

[0251]

[0395] Referring to FIG. 100 , the overall height 722 of the seal 708 is smaller than the height 722R of the prior art seal 708R. The dimension along the height 722 of the seal 708 is reduced both at the top and bottom compared to the prior art seal 708R. In the illustrated arrangement, the height 722 is reduced primarily at the top of the seal 708. This is indicated by the difference in heights 722, 722R above the centerline 724 along which the nasal prongs 712, 712R of both seals 708, 708R are aligned. The reduced height 722 makes the seal 708 less noticeable to the wearer. The reduced height 722 also means that the seal 708 sits lower on the wearer's nose and may not cover the tip of the wearer's nose. In some configurations, the height 722 can be approximately 38 mm, 35 mm, or 33 mm or less. In some configurations, height 722 is equal to approximately 32 mm (e.g., 32.2 mm). For comparison, the prior art seal 708R shown has a height 722R of 42.3 mm.

[0252]

[0396] As shown, the inlet 726R of the prior art seal 708R has a circular profile. The inlet 726 of the seal 708 is shaped like a rounded trapezoid or trapezoid. In other words, the inlet 726 of the seal 708 is substantially "D-shaped" and somewhat follows the outer silhouette (when viewed from the front) of the cushion of the seal 708. The inlet 726 is configured to be surrounded by a clipping mechanism (not shown, but which can be the same as or similar to the clipping mechanism in FIGS. 119-122) configured to clip the seal cushion 708 to a mask frame (e.g., mask frame 710). The "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 therefore improves ease of use.

[0253]

[0397] Referring to FIG. 101 , the overall depth 730 of the seal 708 is less than the depth 730R of the prior art seal 708R. The depth 730 of the seal 708 is reduced both at the front and rear compared to the prior art seal 708R. The reduced depth 730 contributes to the seal 708 being less noticeable to the wearer and can help reduce rotational movement (in a vertical plane about a lateral axis) of the seal 708 relative to the wearer's face. The smaller depth 730 reduces the moment of the seal cushion 708 on the face by moving the center of gravity closer to the face. As mentioned above, this is beneficial when the seal 708 is used in combination with self-adjustable headgear or headgear incorporating one or more directional locks. In some configurations, the overall depth 730 of the seal 708 is 40 mm or less, 38 mm or less, or about 35 mm (e.g., 35.7 mm), compared to an overall depth 730R of 44.4 mm for the prior art seal 708R. In some configurations, the overall width 732 of the seal 708 is 60 mm or less, or about 57 mm (e.g., 57.4 mm), compared to an overall width 732R of 68.1 mm for the prior art seal 708R.

[0254]

[0398] 102 , the reduced height 722 and depth 730 of the sealing cushion 708 relative to the prior art sealing cushion 708R results in, at least in some configurations, the upper or rotating bridge portion 738 of the seal 708 being smaller (having a smaller depth or anterior-posterior dimension) than the upper or rotating bridge portion 738R of the prior art seal 708R. The rotating bridge 738R of the prior art seal 708R includes a thinned region or region of reduced wall thickness configured to rotate or deform to allow the sealing cushion 708R to accommodate a wider range of nasal geometries. Reducing the size of the rotating bridge 738 of the seal 708 may reduce instability between the sealing cushion 708 and the wearer's face by minimizing the amount of deformation of the sealing cushion 708.

[0255]

[0399] Both the inlet 726R of the prior art seal 708R and the inlet 726 of the seal 708 are relatively planar when viewed from the side of the seal cushions 708, 708R. The inlet 726 of the seal 708 is angled at a greater angle 740 relative to the horizontal plane than the angle 740R of the inlet 726R of the prior art seal 708R when the nasal prongs 712, 712R are in the same position ( FIG. 102 ). In other words, the inlet 726 of the seal 708 is closer to vertical than the inlet 726R of the prior art seal 708R when the nasal prongs 712, 712R are in the same position. Additionally, the inlet 726 of the seal 708 is offset toward the wearer's face (during use) compared to the inlet 726R of the prior art seal 708R.

[0256]

[0400] For comparison, FIGS. 103 and 104 show thickness maps of prior art seal 708R and seal 708. Different thicknesses are indicated by different hatching patterns. Prior art seal 708R includes three thickness sections or regions 742R, 744R, and 746R, from thinnest to thickest. Seal 708 includes two thickness sections or regions 744 and 746, from thinnest to thickest. Section or region 742R can have a thickness of about 0.3 or 0.4 mm or less. Sections or regions 744 and 744R can have a thickness of about 0.4 or 0.5 mm to about 0.8 or 1 mm. Section or region 746 and 746R can have a thickness of 1 or 1.5 mm or more. The rotating bridge 738 of the seal 708 has, at least in part, a smoother transition and increased wall thickness relative to the rotating bridge 738R of the prior art seal 708R (shown in FIG. 102). Such an arrangement reduces or prevents the formation of folds or creases at abrupt thickness transitions, provides more uniform strain under applied forces, and improves stability. As shown in FIG. 103, the thickened side regions 746 of the seal 708 are confined to the side walls of the seal 708. That is, thinner regions extend from the top and bottom walls through the transition regions toward or onto the side walls. In some configurations, the thickened side regions 746 have a wall thickness of 1 mm or more, while the relatively thinner regions of the top and bottom walls have a wall thickness of 1 mm or less. In the illustrated arrangement, wall thicknesses greater than 1 mm are confined to the side walls 746, and wall thicknesses less than 1 mm extend to the transitions between the side walls and the top and bottom walls.

[0257]

[0401] Referring 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 cushion 708 means that the outwardly protruding corners 748 are less likely to contact the wearer's face, providing stability. To counter the reduced stability provided by the outwardly protruding corners 748R in the prior art seal 708R, the seal cushion 708 is made more stable by increasing the inner wall thickness and reducing the size of the rotating 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 cushion 708 no longer need to contact the upper lip surface with a large force to provide stability and can therefore be smaller and have a thinner wall thickness. Reducing the wall thickness of the outwardly protruding corners 748 can make them more flexible and allow them to flex to match the geometry of the wearer's face.

[0258]

[0402] Referring to FIG. 106 , the primary and secondary sealing surfaces 714, 714R of the nasal prongs 712, 712R form the inner surfaces of both sealing cushions 708, 708R, which are adjacent to the wearer's face during use. The sealing cushion 708 has a greater wall thickness at its inner surface than the prior art sealing cushion 708R. In some configurations, the inner surface of the sealing cushion 708 has a wall thickness of greater than 0.3 mm, greater than 0.4 mm, or about 0.45 mm, compared to the prior art inner surface wall thickness of 0.25 mm. The increased wall thickness of the inner surface of the sealing cushion 708 is less susceptible to deformation than the inner surface of the prior art sealing cushion 708R, providing increased stability against the wearer's face. In some cases, this can improve manufacturability, as it is easier to mold parts with thicker walls.

[0259]

[0403] FIG. 106 also shows, for comparison, a valley depth 750 defined by the user-contacting surface of the seal 708 and a valley depth 750R of a prior art seal 708R. The valley depths 750, 750R are defined as the maximum depth relative to a line defined by the rearmost points of the upper and lower portions of the user-contacting surface of the seal, each occurring along the vertical center plane of the illustrated seals 708, 708R. As shown, the valley depth 750 of the seal 708 is significantly less than the valley depth 750R of the prior art seal 708R. In some configurations, the valley depth 750 of the seal 708 is less than approximately 1.2 mm. For example, the valley depth 750 of the seal 708 can be approximately 0.9 mm to 1.2 mm, or approximately 1.125 mm. By comparison, the valley depth 750R of the prior art seal 708R is approximately 4.5 mm to 5 mm. In the illustrated seals 708, 708R, this difference is at least in large part due to the larger rotating bridge portion 738R in the prior art seal 708R.

[0260]

[0404] For comparison, Figure 107 shows the bottom thickness map of prior art seal 708R and seal 708, using the same shading as Figures 103-105. Figure 107 shows that seal 708 has a smoother thickness transition between the front and bottom walls (as shown in Figures 102 and 106). Such an arrangement reduces or prevents folds or creases from forming at abrupt thickness transitions, provides more uniform strain under applied forces, and improves stability.

[0261]

[0405] FIG. 108 provides a front view of a seal 708 (left, which may be referred to herein as the "first seal"), a prior art seal 708R (right), and another embodiment of a nasal seal 708a, referred to herein as the "second seal." All of the inlet openings 726, 726a, 726R of the illustrated seal cushions 708, 708a, 708R are configured to receive seal clips that connect the seal cushions 708, 708a, 708R to the mask frame. The inlet openings 726, 726a of the first seal 708 and second seal 708a are sized to allow the gas inlet and bias ventilation holes to fit within the seal clips. 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. Additionally, the front surface surrounding the inlet opening 726a is curved rather than the relatively flat front surface surrounding the inlet opening 726. FIG. 108 also shows the overall 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 seal 708 and the second seal 708a can have heights 722, 722a of 40 mm or less and widths 732, 732a of 65 mm or less. The illustrated first seal 708 has a height 722 of approximately 35 mm (e.g., 35.2 mm) and a width 732 of approximately 58-60 mm (e.g., 58.5 mm). The illustrated second seal 708a 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 illustrated prior art seal 708R has a height 722R of 48.2 mm and a width 732R of 68 mm.

[0262]

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

[0263]

[0407] Referring to FIG. 110 , seals 708, 708a, and 708R have bridge depths 752, 752a, and 752R, respectively, defined as the depth of the top surface along the vertical center plane of seals 708, 708a, and 708R. Bridge depths 752, 752a are reduced in seal 708 and second seal 708a compared to prior art seal 708R, reducing or minimizing instability and rotation of seals 708, 708a on the user's nose. Bridge portions 738, 738a have larger wall thicknesses in seal 708 and second seal 708a, improving stability. The thickness map in FIG. 104 illustrates the increased thickness and smoother thickness transition of seal 708. Second seal 708a can have a similar thickness and / or thickness transition to seal 708.

[0264]

[0408] The bridge depths 752, 752a of the first seal 708 and the second seal 708a can be 15 mm or less. 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, with reference to the depths 730, 730a, 730R identified in FIG. 109 , the bridge depth 752 of the seal 708 is less than one-half the overall depth 730 of the seal 708. In some configurations, the bridge depth 752 is approximately one-third of the overall depth 730. The bridge depth 752a of the second seal 708a is less than one-half the overall depth 730a of the second seal 708a. In some configurations, the bridge depth 752a is approximately two-fifths of the overall depth 730a. In contrast, the bridge depth 752R of the prior art seal 708R is more than one-half of the overall depth 730R of the prior art seal 708R. In particular, the bridge depth 752R of the prior art seal 708R is approximately four-fifths of the overall depth 730R of the prior art seal 708R.

[0265]

[0409] Seals 708, 708a, 708R also define inner prong depths 754, 754a, 754R, respectively, from the front surface to the inner portions of prongs 712, 712a, 712R, and outer prong depths 756, 756a, 756R, respectively, from the front surface to the outer portions of prongs 712, 712a, 712R. Both inner prong depths 754, 754a and outer prong depths 756, 756a of seals 708, 708a are smaller than the respective inner prong depths 754R and outer prong depths 756R of seal 708R, which may be partially or primarily the result of the smaller bridge depths 752, 752a. For the illustrated seals 708, 708a, 708R, the inner prong depths 754, 754a, 754R are 24.5 mm, 25.8 mm, and 29.8 mm, respectively, and the outer prong depths are 27 mm, 28.9 mm, and 32.2 mm, respectively.

[0266]

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

[0267]

[0411] For comparison, Figure 111 also shows the areas of the sealing surfaces 760, 760a, 760R (including prongs 712, 712a, 712R and secondary sealing surfaces 714, 714a, 714R) of the seal 708, secondary seal 708a, and prior art seal 708R, respectively. As shown, the sealing area 760R of prior art seal 708R is 1000mm 2 Larger, especially around 1100mm 2 (1102mm 2 In contrast, the sealing areas 760, 760a of the seal 708 and the second seal 708a, respectively, are 1000 mm 2 In particular, the sealing area 760 of the seal 708 is approximately 900 mm 2 (For example, 907 mm 2 ) and the sealing area 760a of the second seal 708a is approximately 880 mm 2 (For example, 883 mm 2 )

[0268]

[0412] For comparison, Figure 112 provides bottom views of seal 708, second seal 708a, and prior art seal 708R. As described in connection with Figure 109, second seal 708a includes a laterally curved inlet 726a. Seal 708 includes a planar inlet 726.

[0269]

[0413] Fig. 113 shows a side view of the overlapping seal 708, second seal 708a, and prior art seal 708R. Fig. 114 shows the overlapping second seal 708a on the prior art seal 708R. As noted above, seal 708 and second seal 708a have significantly smaller heights and depths compared to prior art seal 708R.

[0270]

[0414] Figure 115 is a cross-sectional view along a central vertical plane of the stacked seal 708, second seal 708a, and prior art seal 708R. Figure 115 shows that the interior (user-facing) wall thickness of the first seal 708 and second seal 708a is greater than the interior wall thickness of the prior art seal 708R. Figure 116 is a cross-sectional view of the stacked seals 708 and second seal 708a. Figure 116 shows the laterally curved inlet opening 726a of the second seal 708a compared to the planar inlet 726 of the seal 708.

[0271]

[0415] Fig. 117 shows a cross-sectional view along a central horizontal plane of the stacked seal 708, second seal 708a, and prior art seal 708R. Fig. 117 shows that the wall thickness of both the first seal cushion 708 and the second seal cushion 708a is reduced at the outer surface compared to the prior art seal cushion 708R.

[0272]

[0416] Figure 118 is the same cross-sectional view as Figure 117, but omits prior art seal 708R. Figure 118 shows that the angle of the prong tips varies between seal 708 and second seal 708a. In the illustrated arrangement, prong angle 762 of seal 708 is approximately 120 degrees, and prong angle 762a of second seal 708a is approximately 140 degrees. The increased angle 762a between the prong tips of second seal cushion 708a is expected to reduce pressure on the user's diaphragm, allowing prong 712a to be less obtrusive.

[0273]

[0417] 119 and 120, the second seal 708a includes a seal clip 764a. The seal clip 764a comprises an inner clip portion or inner clip 766a and an outer clip portion or outer clip 768a configured to clip together to sandwich the edges of the seal's inlet opening 726a. In some configurations, the inner clip 766a and the outer clip 768a are permanently coupled to one another by a snap-fit ​​geometry or any other suitable means (welding, adhesive, etc.). The inner clip 766a defines a gas inlet opening 770a and a ventilation hole area 772a. The gas inlet opening 770a has a larger area than the ventilation hole area 772a and is disposed below the ventilation hole area 772a.

[0274]

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

[0275]

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

[0276]

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

[0277]

[0421] In the arrangement shown, the diffuser 782a is permanently joined to the diffuser clip 780a by means such as overmolding or welding. The diffuser clip 780a includes an opening that is filled by the diffuser 782a.

[0278]

[0422] The ventilation hole region 772a is bounded at its lower end by a pair of separators 784a that extend inward from the inner periphery of the inner clip 766a. The separators 784a extend partially across the width so as not to meet in the middle. The separators 784a are configured to support the diffuser clip 780a within the inner clip 766a.

[0279]

[0423] 121 and 122, a modified embodiment of the inner clip 766a includes a single separator 784a that extends across the entire width of the inner clip 766a and defines a ventilation hole opening 786a. A diffuser clip 780a is permanently bonded to the inner clip 766a within the ventilation hole opening 786a. The diffuser clip 780a can be bonded to the inner clip 766a by overmolding, welding, adhesive, or the like.

[0280]

[0424] For comparison, FIG. 123 shows the outlet end of the prong 712a of the second seal 708a, along with the end of the prong 712R of the prior art seal 708R. As shown, each outlet end of the prongs 712a, 712R defines a major axis 718a, 718R and a minor axis 720a, 720R. The outlet end of the prong 712R is symmetrical about the major axis 718R and the minor axis 720R. The outlet end has a width 790R defined by an inner portion width 792R and an outer portion width 794R. The widths 792R, 794R are equal to each other. Each width 792R, 794R measures 2.90 mm, resulting in an overall width 790R of 5.8 mm. The outlet end has a height 796R defined by an upper portion height 798R and a lower portion height 800R. Heights 798R, 800R are equal to one another. Each height 798R, 800R has a dimension of 4.6 mm, resulting in an overall height 796R of 9.2 mm. In contrast, the outlet end of prong 712a is asymmetrical about at least one of major axis 718a and minor axis 720a. In the illustrated configuration, width 790a is composed of an inner portion width 792a and an outer portion width 794a, with width 794a being larger than width 792a. In the illustrated configuration, width 792a is 2.6 mm, width 794a is 3.0 mm, resulting in an overall width 790a of 5.6 mm. Height 796a is composed of an upper portion height 798a and a lower portion height 800a, with heights 798a and 800a being equal to one another. In the illustrated arrangement, height 798a and height 800a each measure 4.25 mm, so that overall height 796a measures 8.5 mm.

[0281]

[0425] Figure 124 is an exploded view of the second seal 708a, seal clip 764a, and diffuser clip 780a. In Figure 124, seal clip 764a shows inner clip 766a and outer clip 768a clipped together separately from seal 708a. Diffuser clip 780a is also shown separately from seal 708a and seal clip 764a.

[0282]

[0426] For comparison, Figures 125 and 126 show a top view and a side view, respectively, of the prior art seal cushion 708R next to the first seal cushion 708. As noted above, the portion of the seal 708 that surrounds the nasal prongs 712 is substantially smaller than the portion of the seal 708R that surrounds the nasal prongs 712R for a given seal or nasal prong size.

[0283]

[0427] Figures 127-129 show several views of the prior art seal cushion 708R on top of the first seal cushion 708, with the nasal prongs 712R, 712 substantially aligned with one another. Figures 127-129 show, among other differences, differences in wall thickness of various portions of the seals 708, 708R, differences in the attitude or angle of the inlet openings 726, 726R, and differences in overall size and shape.

[0284]

[0428] FIG. 130 shows a thickness map of the prior art seal cushion 708R and first seal cushion 708, showing the seals 708, 708R in front and rear perspective views. FIG. 130 utilizes the same hatching pattern to indicate the wall thickness ranges discussed in connection with FIGS. 103-105 and 107.

[0285]

[0429] For comparison, FIG. 131 shows a top view of different combinations of overlapping seals 708, 708a, and 708R.

[0286]

[0430] FIG. 132 shows, for comparison, overlapping seals 708, 708a, and 708R, and a cross-sectional view taken along a vertical transverse plane of overlapping seals 708, 708a.

[0287]

[0431] Unless the context clearly requires otherwise, throughout the description and claims, words like "comprise," "comprising," and the like should be construed in an inclusive sense, i.e., "including, but not limited to," rather than an exclusive or exhaustive sense. Conditional language used herein, such as "can," "could," "might," "may," "e.g.," and the like, among others, is generally intended to convey that certain embodiments include certain features, elements, and / or conditions, while other embodiments do not, unless specifically indicated otherwise or understood otherwise by the context in which it is used. Thus, such conditional language is generally not intended to imply that features, elements, and / or conditions are somehow required by one or more embodiments, or that one or more embodiments necessarily include logic that determines whether those features, elements, and / or conditions are included or should be implemented in any particular embodiment, with or without author input or direction.

[0288]

[0432] The term "plurality" refers to two or more of an item. Enumerations of quantities, dimensions, sizes, formulas, parameters, shapes, and other characteristics should be interpreted in the same manner as if the term "about" or "approximately" were preceding the quantity, dimension, size, formula, parameter, shape, or other characteristic. The term "about" or "approximately" means that the quantity, dimension, size, formula, parameter, shape, and other characteristic need not be exact and can be approximated and / or larger or smaller, if desired, to reflect tolerances, conversion factors, rounding, measurement error, etc., and other factors known to those of skill in the art. Enumerations of quantities, dimensions, sizes, formulas, parameters, shapes, and other characteristics should also be interpreted in the same manner as if the term "substantially" were preceding the quantity, dimension, size, formula, parameter, shape, or other characteristic. The term "substantially" means that the recited feature, parameter, or value need not be exactly realized, and deviations or variations may occur, including, for example, tolerances, measurement errors, limitations in measurement accuracy, and other factors known to those skilled in the art, taking into consideration not the exclusion of the effect that the feature is intended to provide.

[0289]

[0433] Numerical data may be expressed or presented herein in a range format. It should be understood that such range format is used merely for convenience and brevity and, therefore, should be interpreted flexibly to include not only the numerical values ​​explicitly recited as the limits of the range, but also all of the individual numerical values ​​or subranges subsumed within that range, as if each numerical value and subrange were explicitly recited. As an example, a numerical range of "1 to 5" should be interpreted to include not only the explicitly recited values ​​of about 1 to about 5, but also each individual value and subrange within the stated range. Thus, within this numerical range, individual values ​​such as 2, 3, and 4 are included, as well as subranges such as "1 to 3," "2 to 4," and "3 to 5." This same principle should also apply to ranges reciting only a single numerical value (e.g., "greater than 1"), regardless of the broadness of the range or characteristic being described.

[0290]

[0434] For convenience, multiple items may be presented in a common list. However, these lists should be construed as if each member of the list were individually identified as a separate and unique member. Accordingly, individual members of such lists should not be construed as de facto equivalents of any other member of the same list solely based on their presence in a common grouping, unless indicated to the contrary. Furthermore, the terms "and" and "or," when used in conjunction with a list of items, should be construed broadly in that any one or more of the listed items may be used alone or in combination with other listed items. The term "alternatively" refers to the selection of one of two or more alternatives and is not intended to limit this selection to only those listed alternatives, or to only one of the listed alternatives at a time, unless the context clearly dictates otherwise.

[0291]

[0435] The reference herein to any prior art is not, and should not be construed as, an acknowledgment or any form of suggestion that that prior art forms part of the common general knowledge in any field of endeavor anywhere in the world.

[0292]

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

[0293]

[0437] The invention may also be broadly considered to consist of the parts, elements, and features referred to or illustrated herein in this application, individually or collectively, and any combination of two or more of said parts, elements, or features.

[0294]

[0438] It should be noted that various changes and modifications to the preferred embodiments described herein will become apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present invention and without diminishing the advantages attendant thereto. For example, the positions of various components can be rearranged, if desired. Accordingly, such changes and modifications are intended to be included within the scope of the present invention. Furthermore, not all features, aspects, and advantages are necessarily required to practice the present invention. Accordingly, the scope of the present invention is intended to be defined solely by the following claims.

[0295] The present invention includes the following aspects. 1. 1. A respiratory mask system comprising a mask interface having a frame for a headgear assembly, the frame comprising a body having a first surface and a substantially opposite second surface, the body further comprising gas inlet and outlet ventilation holes. 2. 1. A respiratory mask system comprising a mask interface having a frame, the frame comprising a body having a front surface and a substantially opposite back surface, the front surface comprising a recessed area within which a yoke of a headgear assembly can be positioned. 3. 1. A respiratory mask system comprising a yoke for a headgear assembly, the yoke comprising a body, the body comprising a front surface having a width defined by the distance between a top surface and a bottom surface of the yoke and a length defined by the distance between opposite ends of the yoke, and an intermediate portion located between two side portions, the side portions being located at or near the ends of the yoke, the width of the yoke at the intermediate portion being less than the width of the yoke at the side portions. 4. 1. A respiratory mask system comprising a headgear assembly, the system comprising a mask interface having a frame, the frame comprising a frame body having a first surface and a substantially opposite second surface, the frame body further comprising gas inlet and outlet ventilation holes, the respiratory mask system further comprising a yoke for the headgear assembly, the yoke comprising a yoke body, the yoke body comprising a front surface having a width defined by the distance between a top surface and a bottom surface of the yoke and a length defined by the distance between opposite ends of the yoke, and an intermediate portion located between two side portions, the side portions being located at or near the ends of the yoke, the width of the yoke at the intermediate portion being less than the width of the yoke at the side portions. 5. 1. A respiratory mask system comprising a headgear assembly, the system comprising a mask interface having a frame, the frame comprising a frame body having a front surface and a substantially opposite back surface, the front surface comprising a recessed area within which a yoke of a headgear assembly can be positioned, the system further comprising a yoke for the headgear assembly, the yoke comprising a yoke body, the yoke body comprising a front surface having a width defined by a distance between a top surface and a bottom surface of the yoke and a length defined by a distance between opposite ends of the yoke, and an intermediate portion located between two side portions, the side portions being located at or near the ends of the yoke, the width of the yoke at the intermediate portion being smaller than the width of the yoke at the side portions. 6. A respiratory mask system comprising a mask frame and a yoke, The mask frame is an inlet configured to be coupled to a gas conduit in use; a yoke channel extending longitudinally through the mask frame and defined by an upper wall, a rear wall, and a lower wall; a retention bump projecting downwardly from the top wall into the yoke channel; Equipped with the yoke is configured to be at least partially disposed within the yoke channel and includes a retention notch on an upper surface of the yoke; The respiratory mask system, wherein the retention bumps are configured to snap into the retention notches when the yoke and the mask frame are coupled together. 7. 7. The respiratory mask system of claim 6, wherein the retention notch is located along a corner between the front wall and the top wall of the yoke. 8. 7. The respiratory mask system of claim 6, wherein the yoke comprises a front yoke portion and a rear yoke portion coupled to the front yoke portion. 9. 9. The respiratory mask system of claim 8, wherein the front of the yoke includes the retention notch. 10. A respiratory mask system comprising a mask frame and a yoke, The mask frame is an inlet configured to be coupled to a gas conduit in use; a yoke channel extending longitudinally through the mask frame and defined by an upper wall, a rear wall, and a lower wall; an anti-rotation groove recessed into the back wall and extending along the length of the yoke channel; Equipped with the yoke is configured to be at least partially disposed within the yoke channel and includes a tongue projecting rearwardly from the yoke; the tongue is configured to be positioned within the anti-rotation groove when the yoke and the mask frame are coupled together, and interaction between the anti-rotation groove and the tongue inhibits rotational disengagement of the yoke from the mask frame. 11. 11. The respiratory mask system of claim 10, wherein the yoke comprises a front yoke portion coupled to a rear yoke portion. 12. 12. The respiratory mask system of claim 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. 13. 13. A respiratory mask system as described in claim 12, wherein the front tongue is positioned below the rear tongue such that an upper surface of the front tongue abuts a lower surface of the rear tongue. 14. 1. A yoke configured to be coupled to a mask frame of a respiratory mask system, comprising: 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, the rear wall defining an interior cavity 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 linear element entry hole configured to receive a linear element of a self-adjusting headgear mechanism; a first washer housing disposed adjacent to the first end cap and between the front wall and the rear wall; a second washer housing disposed adjacent to the second end cap and between the front wall and the rear wall; a line track divider for dividing the inner cavity into an upper line track and a lower line track; Equipped with the upper line track extends over the second washer housing from the first washer housing to the second end cap; The yoke, wherein the lower line track extends below the first washer housing from the second washer housing to the first end cap. 15. 15. The yoke of claim 14, wherein the yoke comprises a front yoke portion having the front wall and a rear yoke portion having the back wall, the front yoke portion and the rear yoke portion being joined to one another. 16. 16. The yoke of claim 15, wherein the upper line track is at least partially defined by an upper wall of the front of the yoke and the line track divider, and the lower line track is at least partially defined by a lower wall of the front of the yoke and the line track divider. 17. 1. A nose seal for a respiratory mask system, comprising: a body portion defining an inlet and at least partially defining a user-contacting surface of said nasal seal; a pair of nasal prongs supported by the body portion and configured to engage the nostrils of a user; 10. A nose seal, wherein the body portion includes a bridge portion extending laterally between the pair of nasal prongs at an upper portion of the seal, the bridge portion defining a bridge depth between a front surface and a rear surface of the nose seal, the bridge depth being less than one-half of the overall depth of the nose seal. 18. 18. A nasal seal as claimed in claim 17, wherein the dorsal most point of the nasal seal is located posterior to the dorsal most surface of the pair of nasal prongs. 19. 19. A nasal seal according to claim 17 or 18, wherein the bridge depth is no more than two-fifths of the overall depth. 20. 20. A nasal seal as described in claim 19, wherein the bridge depth is one-third of the overall depth. twenty one. 21. The nose seal according to any one of claims 17 to 20, wherein the bridge depth is 15mm or less, 13.5mm or less, or 11mm or less. twenty two. 22. A nose seal according to any one of claims 17 to 21, wherein the overall depth is 35mm or less, 32.5mm or less, or 30mm or less. twenty three. 23. A nasal seal according to any one of claims 17 to 22, wherein a wall thickness of 1 mm or more is limited within the outer or front wall of the nasal seal. twenty four. 24. A nasal seal as claimed in claim 23, wherein the transition between the upper wall and the outer wall or the transition between the lower wall and the outer wall is less than 1 mm. twenty five. 25. A nasal seal according to any one of claims 17 to 24, wherein the user-contacting surface defined by the body portion of the nasal seal has a minimum wall thickness of 0.3 mm or greater. 26. 26. The nasal seal of claim 25, wherein the minimum wall thickness of the user-contacting surface defined by the body portion of the nasal seal is 0.45 mm or greater. 27. 27. The nose seal according to any one of claims 17 to 26, wherein the nose seal has an overall width of 65mm or less. 28. 28. A nose seal as claimed in claim 27, wherein the overall width is 61mm or less or 58.5mm or less. 29. 29. The nose seal according to any one of claims 17 to 28, wherein the nose seal has an overall height of 40mm or less. 30. 30. A nasal seal as claimed in claim 29, wherein the overall height is 35.5mm or less or 35.2mm or less. 31. The sealing area of ​​the nose seal is 1000mm 2 31. The nose seal according to any one of claims 17 to 30, which is: 32. The sealing area is 907 mm 2 Less than or equal to 883mm 2 32. A nose seal as described in claim 31, which is: 33. 33. The nose seal according to any one of claims 17 to 32, wherein the inlet is generally D-shaped. 34. A nose seal as described in any one of claims 17 to 33, further comprising a clip assembly secured to the entrance of the main body portion, the clip assembly configured to enable the nose seal to be removably connected to a frame. 35. 35. A nasal seal as claimed in claim 34, wherein the clip assembly defines an inlet and a ventilation hole. 36. 36. A nasal seal as described in claim 35, wherein the ventilation holes comprise a diffuser. 37. 37. A nasal seal as described in claim 36, wherein the ventilation holes are defined by clip members. 38. 38. A nasal seal as claimed in claim 37, wherein the clip member of the ventilation hole is removable. 39. 39. A nasal seal according to any one of claims 35 to 38, wherein the inlet has a maximum height of 12 to 16 mm or 14 mm. 40. 40. A nose seal as claimed in claim 39, wherein the inlet has a maximum width of 25 to 30 mm or 27 mm. 41. 41. A nose seal according to any one of claims 17 to 40 in combination with a frame. 42. 42. The nose seal and frame of claim 41, further comprising a headgear mechanism. 43. 43. The assembly of claim 42, wherein the headgear mechanism is self-adjusting or includes one or more directional locks. 44. A respiratory mask system comprising a mask frame and a yoke, The mask frame is an inlet configured to be coupled to a gas conduit in use; a yoke channel extending longitudinally through the mask frame and defined by an upper wall, a rear wall, and a lower wall; at least one recess in at least one of the upper wall and the lower wall of the yoke channel; Equipped with the yoke is configured to be at least partially disposed within the yoke channel and includes at least one protrusion projecting rearwardly from the yoke, the at least one protrusion configured to be disposed within the at least one recess when the yoke is disposed within the yoke channel. 45. 45. The respiratory mask system of claim 44, wherein the at least one recess and the at least one protrusion have a rectangular profile. 46. 1. A yoke configured to be coupled to a mask frame of a respiratory mask system, comprising: a front yoke portion having a first central connector; a yoke back including a second central connector; The yoke, wherein the first central connector and the second central connector are configured to couple together to at least partially secure the yoke front and the yoke back to each other. 47. 47. The yoke of claim 46, wherein the first central connector comprises a protrusion projecting rearward from the front of the yoke, and the second central connector comprises an opening in the rear of the yoke, the protrusion being configured to be received in the opening. 48. 47. The yoke of claim 46, wherein the first central connector comprises a protrusion projecting rearward from the front of the yoke and the second central connector comprises a recess in the front surface of the back of the yoke, the protrusion being configured to be received in the recess. 49. 49. The yoke of any one of claims 46 to 48, wherein the front yoke portion includes an upper alignment groove recessed into a rear surface of the front yoke portion and extending along the length of the front yoke portion near an upper edge of the front yoke portion, and the back yoke portion includes an upper alignment bead protruding forward from the front surface of the back yoke portion, the upper alignment bead being configured to be received in the upper alignment groove when the front and back yoke portions are joined together. 50. 50. A yoke as described in any one of claims 46 to 49, wherein the front yoke section includes a lower alignment groove recessed into a rear surface of the front yoke section and extending along the length of the front yoke section near a lower edge of the front yoke section, and the back yoke section includes a lower alignment bead protruding forward from the front surface of the back yoke section, the lower alignment bead being configured to be received in the lower alignment groove when the front and back yoke sections are joined together. 51. 1. A yoke configured to be coupled to a mask frame of a respiratory mask system, comprising: a yoke front portion extending from a first lateral end to a second lateral end; a yoke back extending from a first lateral end to a second lateral end, the yoke front and the yoke back being coupled to one another to define an interior cavity between the yoke front and the yoke back; a first end cap coupled to the first lateral end of the front yoke and the back yoke, and a second end cap coupled to the second lateral end of the front yoke and the back yoke, each end cap including a linear element entry hole configured to receive a linear element of a self-adjusting headgear mechanism; a first washer housing disposed within the cavity adjacent to the first end cap; a second washer housing disposed within the cavity adjacent the second end cap; a line track divider for dividing the inner cavity into an upper line track and a lower line track; Equipped with the upper line track extends over the second washer housing from the first washer housing to the second end cap; The lower line track extends below the first washer housing from the second washer housing to the first end cap. 52. 52. The yoke of claim 51, wherein the upper line track extends into the second end cap and the lower line track extends into the first end cap. 53. 53. A yoke as described in claim 51 or 52, wherein the first and second end caps are configured to be hingedly attached to the first and second lateral ends of the front and rear walls, respectively, during assembly. 54. 54. The yoke of claim 53, wherein the yoke back includes a first retention protrusion extending rearwardly from the yoke back near the first lateral end thereof, the yoke front includes a second retention protrusion extending forwardly from the yoke front near the first lateral end thereof, the first retention protrusion having a length greater than that of the second retention protrusion, the first end cap includes a retention hole located on one side of the first end cap and configured to receive the first retention protrusion, and a notch located on the opposite side of the first end cap and configured to receive the second retention protrusion, wherein during assembly, the first retention protrusion and the retention hole engage with each other, and then the first end cap is pivoted onto the first lateral end of the yoke front and yoke back to engage the second retention protrusion and the notch. 55. 55. The yoke according to any one of claims 51 to 54, wherein the first and second washer housings are U-shaped. 56. 56. The yoke of claim 55, wherein the second washer housing is oriented in an upward U-shape and the first washer housing is oriented in a downward U-shape. 57. A respiratory mask system comprising a mask frame and a yoke, The mask frame is 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 an upper wall, a rear wall, and a lower wall; Equipped with The respiratory mask system, wherein the yoke is configured to be at least partially disposed within the yoke channel.

Claims

1. 1. A respiratory mask system comprising a mask frame and a single yoke, The mask frame is an inlet configured to be coupled to a gas conduit during use; a single yoke channel extending longitudinally of the mask frame, the single yoke channel being defined by at least a back wall, a lower wall, and an upper wall; one or more mask frame attachment features located within the yoke channel and having one of a male attachment feature or a female attachment feature; the single yoke is for attaching a headgear assembly to the mask frame and is configured to be at least partially disposed within the single yoke channel, the yoke having one or more yoke attachment features complementary to the mask frame attachment features, the one or more yoke attachment features having the other of the male attachment feature or the female attachment feature; the male mounting feature has a mounting tab or protrusion extending from one of the yoke or the mask frame, and the female mounting feature has a mounting opening or recess in the other of the yoke or the mask frame; 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; a) the male mounting feature has a retention bump that protrudes from the mask frame into the yoke channel and the female mounting feature has a retention notch recessed into the yoke; or b) the male mounting feature has a tongue protruding from the yoke and the female mounting feature has an anti-rotation groove recessed in the yoke channel; Respiratory mask system.

2. 10. The respiratory mask system of 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 during use.

3. A respiratory mask system as described in claim 1 or 2, wherein, when the retention bump and the retention notch are present, the retention bump is configured to snap into the retention notch when the yoke and the mask frame are joined.

4. A respiratory mask system as described in any one of claims 1 to 3, wherein the retention bump and the retention notch, when present, are configured to resist rotational separation of the yoke from the frame.

5. A respiratory mask system as described in any one of claims 1 to 4, wherein, when the retaining bump and the retaining notch are present, the retaining bump protrudes downwardly from the upper wall of the yoke channel into the yoke channel, and the retaining notch is recessed into the upper surface of the yoke.

6. 6. The respiratory mask system of claim 5, wherein the retention notch is located along a corner between the front and top walls of the yoke.

7. 7. The respiratory mask system of claim 1, wherein the yoke comprises a front yoke portion and a rear yoke portion coupled to the front yoke portion, the front yoke portion having the retention notch.

8. 8. The respiratory mask system of claim 7, wherein the retention notch is located in a medial portion of the front of the yoke and the retention bump extends from a medial portion of the top wall of the yoke channel.

9. A respiratory mask system as described in claim 1, wherein, when the tongue and anti-rotation groove are present, the tongue is configured to be positioned within the anti-rotation groove when the yoke and the mask frame are joined.

10. 10. The respiratory mask system of claim 9, wherein interaction of the anti-rotation groove and the tongue prevents rotational disengagement of the yoke from the mask frame.

11. A respiratory mask system as described in claim 1, 9 or 10, wherein, when the tongue and anti-rotation groove are present, the tongue protrudes rearward from the yoke and the anti-rotation groove is recessed in the back wall and extends along the length of the yoke channel.

12. 12. The respiratory mask system according to claim 9, wherein the yoke comprises a front yoke portion and a rear yoke portion connected to the front yoke portion, and the tongues include a front tongue extending from the front yoke portion and a rear tongue extending from the rear yoke portion.

13. 13. The respiratory mask system of claim 12, wherein the front tongue is positioned below the rear tongue such that an upper surface of the front tongue abuts a lower surface of the rear tongue.

14. 14. The respiratory mask system of claim 1, further comprising an outlet ventilation hole in the back wall of the yoke channel, wherein, in use, when the yoke is positioned within the yoke channel, a gap is formed between the yoke and the yoke channel.

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