Respiratory Mask System

Abstract

To provide an improved respiratory mask system.SOLUTION: A respiratory mask system includes a mask interface and a headgear assembly. The headgear assembly is adjustable and comprised of an elastic portion, a non-elastic portion, and a restriction mechanism configured to provide force resisting movement of the non-elastic portion when the elastic portion is extended. There is a support beam coupled to the non-elastic portion and extending along a portion of the headgear that is curved along its longitudinal extension. In this way, particular seal modules can be comfortably fitted to a user and any blow off force is mitigated. A particular example of the respiratory mask system includes provision for removable attachment between the seal and a mask frame, between the mask frame and a yoke of the headgear, and between a conduit and the mask frame.SELECTED DRAWING: Figure 74

Description

[Technical Field]

[0001] The present disclosure relates generally to a respiratory mask system for delivering respiratory therapy to a patient. In particular, the present disclosure relates to various components of the respiratory mask system. [Background technology]

[0002] Respiratory masks are used to provide 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.

[0003] 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. Repetitive and frequent apneas can result in the patient only rarely achieving a sufficient night's restorative sleep.

[0004] CPAP therapy involves delivering a supply of continuous positive air pressure to a patient's airway via a breathing mask, which acts as a splint within the patient's airway, holding it in an open position so that the patient can breathe and sleep uninterrupted.

[0005] Respiratory masks typically include a patient interface and headgear, with the patient interface configured to deliver a supply of continuous positive air pressure to the patient's airway via a seal or cushion that forms an airtight seal in or around the patient's nose and / or mouth. Respiratory masks are available in a variety of styles, including full-face, nasal, direct nasal, and oral masks, and 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 to 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 other therapies, including NIV and NIV in combination with nasal high flow.

[0006] The seal of a partial nasal interface or nasal mask contacts the upper lip, the face on either side of the nose, and the bridge of the nose, substantially surrounding the nose. Such nasal interfaces are often secured to the user's head with headgear. Nasal mask assemblies often include a T-piece frame for connecting to the headgear, which includes a pair of upper and lower side straps that extend generally horizontally across the sides of the user's head. The upper straps extend over the user's ears and connect to the upper part of the T-piece frame in the user's forehead region, while the lower straps extend below the user's ears and connect to the lower part of the T-piece frame at or toward the nasal interface or from the nasal interface itself. While such headgear tends to provide a user with a relatively stable fixation of the nasal interface, it can be cumbersome or uncomfortable during use. Less bulky, single-strap headgear is known, but tends to lack stability in securing the nasal interface in sealing engagement during use.

[0007] Where patent specifications, other external documents or other sources of information are referenced herein, this is generally for the purpose of providing such information in the context of discussing features of the present invention. Unless otherwise expressly stated, the reference to such external documents should not be construed as an admission that such documents or such sources are prior art in any jurisdiction or form part of the common general knowledge in the art. Summary of the Invention [Means for solving the problem]

[0008] The systems and devices described herein have innovative aspects, no single aspect of which is essential or solely responsible for their desirable attributes. Without limiting the scope of the claims, some of the advantageous features are summarized here. However, additional combinations of features are possible even if not expressly set forth as examples herein.

[0009] In one embodiment, the adjustable headgear is comprised of an elastic portion, an inelastic portion, and a restraining mechanism configured to provide a force resisting movement of the inelastic portion when the elastic portion is extended. A support beam is coupled to the inelastic portion and extends along a portion of the headgear. The support beam is curved along its longitudinal extension.

[0010] The first portion of the support beam may be connected to the inelastic portion, the first portion configured to extend along a first axis. The second portion may be connected to the top and / or rear straps of the headgear, the second portion configured to extend along a second axis substantially parallel to the first axis. The transition portion may extend along a curve between the first and second portions. The transition portion may extend downward from the second portion, and the first portion may extend from the transition portion toward the mask connected to the headgear. The second portion may also be connected to the top and / or rear straps above the user's ears.

[0011] In one form, the first and second axes are spaced apart by 20 to 60 mm, preferably 30 to 50 mm, preferably about 40 mm, and the width of the support beam may be substantially constant along its longitudinal extension. Preferably, the width is 1 to 15 mm, preferably less than 10 mm, preferably less than 7 mm, preferably less than 5 mm, preferably about 3 mm. While the thickness of the support beam may be substantially constant along its longitudinal extension, the thickness may be 0.5 to 1 mm, preferably about 0.8 mm.

[0012] In one form, the second portion connects to halo straps that provide the top and back straps of the headgear. The elastic portion and support beam may comprise side straps of the headgear.

[0013] In a further example, the nasal mask interface assembly includes a seal housing, a flexible nasal seal connected or connectable to the seal housing to define a mask cavity, the nasal seal extending between the face-contacting side and an exterior. The nasal seal may include an under-nose support fixedly connected to the nasal seal and configured to extend into the mask cavity, the under-nose support having a contact surface oriented to contact at least a portion of a user's under-nose surface. There may also be a mask frame removably attachable to the seal housing, and a yoke for headgear removably attachable to the mask frame.

[0014] The mask frame may include a collar for removably attaching the conduit, the collar of the mask frame including a plurality of bias flow holes.

[0015] In one example, the mask frame may include a recessed area extending longitudinally across the mask frame at its front wall, and two overhangs extending forward from the wall to form an upper boundary of the recessed area, the two overhangs being separated from each other by a gap, and the yoke is configured to be at least partially disposed in the recessed area.

[0016] The nasal mask interface assembly may further include adjustable headgear extending from the yoke. The adjustable headgear may include a head engaging portion and an adjustable length adjustment mechanism configured to couple the head engaging portion to the mask frame via the yoke. The adjustment mechanism may include an elastic portion configured to provide a retraction force, an inelastic filament that is relatively inelastic compared to the elastic portion, a limiting mechanism configured to provide a force resisting movement of the inelastic filament when the elastic portion is stretched in the direction of its longitudinal axis, and a core disposed within the elastic portion and coupled to the inelastic filament.

[0017] In one form, the elastic portion may include an elastic braid. The core may be relatively stiffer than inelastic filaments. Preferably, the core is curved and forms curved side straps with the elastic portion, extending from the yoke to the head-engaging portion at a location above the user's ears. The seal housing and flexible nose seal may be connected by an overmolded portion. The seal housing is occupied by the overmolded material of the overmolded portion and includes channels that allow the seal housing to be permanently attached to the seal.

[0018] In some further examples, the respiratory mask system includes a mask frame and a yoke. The mask frame includes an inlet collar defining an opening and configured to be coupled to a gas conduit during use, an outlet collar defining an outlet opening, a gas pathway formed through the mask frame between the inlet and outlet openings, a wall disposed between the inlet and outlet collars, a recessed area extending longitudinally across the mask frame at a front surface of the wall, and two overhangs extending forward from the wall and forming an upper boundary of the recessed area, the two overhangs being separated from each other by a gap. The yoke is configured to be at least partially disposed in the recessed area.

[0019] The yoke may include yoke positioning features that protrude upward and rearward from the upper and rear surfaces of the yoke. The yoke positioning features are configured to be disposed within the gap between the two overhangs when the yoke and the mask frame are coupled together. The upper surfaces of the yoke positioning features may form a continuous surface with the upper surfaces of the overhangs when the yoke and the mask frame are coupled together. The yoke positioning features may be curved.

[0020] The mask frame may include at least two protrusions, at least one of which extends from a lower wall of the recessed region into the recessed region and at least one of which extends from at least one of the overhanging portions into the recessed region, and the yoke may include at least two recesses, at least one of which is disposed on an upper surface of the yoke and at least one of which is disposed on a lower surface of the yoke, each of the at least two protrusions being configured to be disposed in a respective recess when the yoke and the mask frame are coupled together.

[0021] The mask frame may include two protrusions extending from the lower wall of the recessed region and a protrusion extending from each of the overhanging portions, and the yoke may include two recesses on the upper surface of the yoke and two recesses disposed on the lower surface of the yoke. The distance between the two recesses on the upper surface of the yoke may be greater than the distance between the two recesses on the lower surface of the yoke. The distance between the protrusions extending from the overhanging portions may be greater than the distance between the protrusions extending from the lower wall of the recessed region. The distance between the overhanging portions may be greater than the distance between the protrusions extending from the lower wall of the recessed region.

[0022] The overhang may extend upward from the wall. The overhang may have a concave inner surface. The lower wall of the recessed region may be upwardly convex along the longitudinal axis of the recessed region and concave in the anterior-posterior direction. In the anterior-posterior or depth direction of the recessed region, the lower wall may be upwardly concave. The recessed region may be convex facing forward along the longitudinal axis of the recessed region and have a surface extending in a plane between the overhang and the lower wall of the recessed region. The height of the recessed region may be greater than the depth of the recessed region.

[0023] In some examples, a yoke configured to be coupled to a mask frame of the respiratory mask system includes a front yoke portion extending from a first lateral end to a second lateral end and a rear yoke portion extending from the first lateral end to the second lateral end, the front yoke portion and the rear yoke portion being coupled to each other and defining an internal cavity therebetween; and a filament splitter disposed within the cavity, the filament splitter at least partially defining a first line path configured to receive a first filament of the self-adjusting headgear mechanism and a second line path configured to receive a second filament of the self-adjusting headgear mechanism, the first line path being at least partially defined by the front of the filament splitter and the front yoke, and the second line path being at least partially defined by the rear of the filament splitter and the rear yoke.

[0024] The front yoke portion may include at least one protrusion and the rear yoke portion may include at least one recess, and the at least one protrusion may be received in the at least one recess when the front yoke portion and the rear yoke portion are joined together.

[0025] The yoke may include a first lock disposed in a cavity adjacent or near the first lateral end and acting on the first filament, and a second lock disposed in a cavity adjacent or near the second lateral end and acting on the second filament. The first lock may be disposed in a first washer housing, and the second lock may be disposed in a second washer housing, and the first and second washer housings may be oriented in the same direction. The yoke may further include first end caps coupled to the first lateral ends of the front and rear yoke sections and second end caps coupled to the second lateral ends of the front and rear yoke sections, the first end cap including an opening configured to receive the first filament, and the second end cap including an opening configured to receive the second filament. The rear yoke may include a protrusion adjacent each lateral end, and each end cap may include a recess, and the protrusion may be received in the recess when the end cap is coupled to the rear yoke.

[0026] The filament splitter may be a separate component from the front and rear yokes. The first line path may extend from the upper right portion of the yoke at an angle relative to the longitudinal axis of the yoke. The first line path may diverge as the first line path extends from the upper right portion. The second line path may extend from the upper left portion of the yoke at an angle relative to the longitudinal axis of the yoke. The second line path may diverge as the second line path extends from the upper left portion. The first and second line paths may extend laterally beyond the first and second lateral ends of the front and rear yokes.

[0027] In some examples, a yoke configured to be coupled to a mask frame of a respiratory mask system includes a front yoke section extending from a first lateral end to a second lateral end and a rear yoke section extending from the first lateral end to the second lateral end, the front yoke section and the rear yoke section extending from the first lateral end to the second lateral end, the front yoke section and the rear yoke section being coupled to each other and defining an internal cavity therebetween, a first line path configured to receive a first filament of a self-adjusting headgear mechanism, and a second line path configured to receive a second filament of the self-adjusting headgear mechanism, the first and second line paths being positioned between the front yoke section and the rear yoke section such that the first line path is forward of the second line path.

[0028] The first and second line paths may be separated by a wall. The wall may be formed in the front or rear of the yoke. The yoke may include a divider disposed between the front and rear of the yoke, the divider defining the wall separating the first and second line paths. The divider may at least partially define the first and second line paths.

[0029] In some examples, adjustable headgear for a respiratory mask includes a head-engaging portion and an adjustable length adjustment mechanism. The adjustment mechanism is configured to couple the head-engaging portion to the respiratory mask. The adjustment mechanism may include a first elongated member, a second elongated member slidably engaged with the first elongated member, a limiting mechanism, and a retraction means. The first elongated member and the second elongated member are configured to allow adjustment of the length of the adjustment mechanism by varying the amount of overlap between the first elongated member and the second elongated member. The limiting mechanism is configured to provide resistance to a decrease in the amount of overlap between the first elongated member and the second elongated member. The retraction means is configured to apply a retraction force to the first elongated member that increases the amount of overlap between the first elongated member and the second elongated member.

[0030] In some examples, the first elongated member is an inner member and the second elongated member is an outer member, with the first elongated member telescopically sliding within the second elongated member. In some embodiments, the first elongated member includes at least one outer rail and the second elongated member includes at least one inner rail. In some embodiments, the first elongated member includes at least one inner rail and the second elongated member includes at least one outer rail. In some embodiments, the retraction means includes a portion of elastic material. In some embodiments, the portion of elastic material is coupled to an inelastic filament extending through the restricting mechanism and coupled to the first elongated member. In some embodiments, the retraction means includes an elastic tube surrounding the first and second elongated members.

[0031] In some examples, adjustable headgear for a respiratory mask includes a head-engaging portion and an adjustable length adjustment mechanism. The adjustment mechanism is configured to couple the head-engaging portion to the respiratory mask. The adjustment mechanism may include a first elongated member, a second elongated member slidably engaged with the first elongated member, a limiting mechanism, and a biasing element. The first elongated member and the second elongated member are configured to allow adjustment of the length of the adjustment mechanism by varying the amount of overlap between the first elongated member and the second elongated member. The limiting mechanism is configured to provide resistance to a decrease in the amount of overlap between the first elongated member and the second elongated member. The biasing element is configured to apply a retraction force to the first elongated member that increases the amount of overlap between the first elongated member and the second elongated member.

[0032] In some examples, adjustable headgear for respiratory masks includes an elastic portion having a longitudinal axis, a non-elastic portion, a restraining mechanism, and a support beam. The non-elastic portion is relatively inelastic compared to the elastic portion and has a longitudinal axis aligned with the longitudinal axis of the elastic portion. The elastic portion is configured to provide a retraction force to the non-elastic portion in the direction of the longitudinal axis of the elastic portion. The restraining mechanism is configured to provide a force resisting movement of the non-elastic portion when the elastic portion is urged in the direction of its longitudinal axis. The support beam is coupled to the non-elastic portion and extends along a portion of the headgear. The support beam exhibits greater resistance to buckling in a direction perpendicular to the length of the support beam than the non-elastic portion in a direction perpendicular to the longitudinal axis of the non-elastic portion.

[0033] In some examples, the resistance to buckling is greater in the superior-inferior direction than in the medial-lateral direction during use. In some embodiments, the elastic portion comprises a tube and the support beam is disposed within the tube. In some embodiments, the support beam comprises interengaging rails. In some examples, the support beam comprises telescoping inner and outer members. In some examples, the elastic portion comprises an elastic braid and the support beam comprises a body disposed within the elastic braid. In some examples, the inelastic portion extends from the body and extends partially within the elastic braid when the elastic braid is stretched in the direction of its longitudinal axis. In some examples, the body is tapered. In some examples, the end of the body coupled to the inelastic portion is narrower than the opposite end of the body.

[0034] In some examples, adjustable headgear for respiratory masks includes an elastic portion configured to provide a retraction force, an inelastic filament, a restraining mechanism, and a core. The inelastic filament is relatively inelastic compared to the elastic portion. The restraining mechanism is configured to provide a force resisting movement of the inelastic filament when the elastic portion is stretched along its longitudinal axis. The core is disposed within the elastic portion and coupled to the inelastic filament. The core is configured to limit buckling of the inelastic filament under the retraction force of the elastic portion.

[0035] In some examples, the elastic portion comprises an elastic braid. In some embodiments, the core is relatively stiffer than the inelastic filaments. In some embodiments, the core is tapered. In some embodiments, the end of the core that is coupled to the inelastic filaments is narrower than the opposite end of the core.

[0036] In some examples, adjustable headgear for respiratory masks includes an elastic portion having a longitudinal axis, a non-elastic component, and a restricting mechanism. The elastic portion is configured to provide a retraction force in the direction of the longitudinal axis. The non-elastic component is relatively inelastic compared to the elastic portion. The non-elastic component has first and second portions, the second portion being wider than the first portion. The restricting mechanism is configured to provide a force resisting movement of the non-elastic component when the elastic portion is stretched in the direction of the longitudinal axis.

[0037] In some examples, the second portion is substantially contained within the elastic portion when the elastic portion is stretched along its longitudinal axis, and the first portion moves partially within the elastic portion when the elastic portion is stretched along its longitudinal axis. In some examples, the second portion is joined to the first portion. In some embodiments, the second portion is joined to the first portion by overmolding. In some embodiments, the first and second portions are a single body. In some embodiments, the first portion is a filament and the second portion is a body.

[0038] Examples of assembly and manufacturing systems, components, and methods will now be 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 understand that the invention described herein goes beyond the specifically disclosed embodiments, examples, and illustrations and may include other applications of the invention and obvious modifications thereof, as well as their equivalents. 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 include several novel features, and no single feature is solely responsible for its desirable attributes or is essential to practicing the invention described herein.

[0039] Certain terminology may be used in the following description for purposes of reference 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.

[0040] 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, yet arbitrary, frame of reference that becomes apparent 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]

[0041] [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 perspective exploded view of the mask assembly of FIG. 1. [Figure 3] FIG. 2 is a perspective view of the headgear assembly of FIG. 1. [Figure 4] FIG. 4 is a front view of the headgear assembly of FIG. 3. [Figure 5] FIG. 4 is a rear view of the headgear assembly of FIG. 3. [Figure 6] FIG. 4 is a side view of the headgear assembly of FIG. 3. [Figure 7] FIG. 4 is a detailed view of the joint between the halo strap and the side strap of the headgear assembly of FIG. 3. [Figure 8] FIG. 10 is a detailed view of a portion of a halo strap including a burst-through protrusion that helps form the joint between the halo strap and the side strap. [Figure 9] 10 shows a portion of an overmolding tool for forming the joint between the halo strap and the side strap. [Figure 10] 10 shows the halo strap and burst-through projection of FIG. 8 positioned in the overmold tool of FIG. 9. [Figure 11] 4 shows the braided core of the side straps of the headgear assembly of FIG. 3. [Figure 12] Shows side straps connected to end caps. [Figure 13] 1 shows a detailed view of one end of a side strap. [Figure 14] 10 shows the halo straps and side straps positioned on the overmold tool of FIG. 9. [Figure 15] 10 shows the halo strap and side straps positioned in the overmolding tool after overmolding to form a joint between the halo strap and the side strap. [Figure 16] FIG. 4 is a perspective view of a yoke of the headgear assembly of FIG. 3. [Figure 17] FIG. 17 is a front view of the yoke of FIG. 16. [Figure 18] FIG. 17 is a rear view of the yoke of FIG. 16. [Figure 19] FIG. 17 is a top view of the yoke of FIG. 16. [Figure 20] FIG. 17 is a bottom view of the yoke of FIG. 16. [Figure 21] FIG. 2 is a front view of the frame of the mask assembly of FIG. 1. [Figure 22] FIG. 22 is a side view of the frame of FIG. 21. [Figure 23] FIG. 22 is a rear view of the frame of FIG. 21. [Figure 24] FIG. 22 is a rear perspective view of the frame of FIG. 21. [Figure 25] FIG. 22 is a front perspective view of the frame of FIG. 21. [Figure 26] FIG. 22 is a side cross-sectional view of the frame of FIG. 21. [Figure 27] FIG. 2 is a front perspective view of a portion of the mask assembly of FIG. 1 showing the connection of the yoke to the frame. [Figure 28] FIG. 17 is an exploded view of the yoke of FIG. 16. [Figure 28B] 10 shows an example of a filament extending through a washer housing of a yoke. [Figure 28C] 1 shows a cross-sectional view of a filament extending through an example locking washer disposed within a washer housing, with the locked position of the washer indicated by a dotted line. [Figure 28D] 1 shows a cross-sectional view of a filament extending through an example locking washer disposed within a washer housing, with the locked position of the washer indicated by a dotted line. [Figure 28E] 1 shows a cross-sectional view of a filament extending through an example locking washer disposed within a washer housing, with the locked position of the washer indicated by a dotted line. [Figure 29] FIG. 17 is a front view of a filament splitting insert of the yoke of FIG. 16. [Figure 30] FIG. 30 is a rear view of the filament splitting insert of FIG. 29. [Figure 31] FIG. 17 is a front view of the rear portion of the yoke of FIG. 16. [Figure 32] FIG. 32 is a rear view of the rear part of the yoke in FIG. 31. [Figure 33] FIG. 17 is a rear view of the front portion of the yoke of FIG. 16. [Figure 34] FIG. 34 is a rear view of the front part of the yoke of FIG. 33. [Figure 35] FIG. 17 is a perspective view of an end cap of the yoke of FIG. 16. [Figure 36] FIG. 36 is a cross-sectional view of the end cap of FIG. 35. [Figure 37] FIG. 17 is a cross-sectional view of the yoke of FIG. 16. [Figure 38] FIG. 2 is a perspective view of a conduit of the mask assembly of FIG. 1. [Figure 39] FIG. 39 is a perspective view of a swivel connector of the conduit of FIG. 38. [Figure 40] FIG. 40 is an exploded view of the swivel connector of FIG. 39. [Figure 41] FIG. 40 is a cross-sectional view of the swivel connector of FIG. 39. [Figure 42] FIG. 39 is a perspective view of a conduit frame connector of the conduit of FIG. 38. [Figure 43] 2 is a perspective view of a seal assembly of the mask assembly of FIG. 1 including a seal and a seal clip having two seal clip portions. [Figure 44] FIG. 44 is an exploded view of the seal assembly of FIG. 43. [Figure 45] FIG. 44 is a side cross-sectional view of the seal assembly of FIG. 43. [Figure 46] FIG. 44 is a cross-sectional side view of the mask assembly of FIG. 1 showing the seal assembly of FIG. 43 coupled to the headgear, frame and conduit of the mask assembly. [Figure 47] FIG. 44 is a front view of the seal of FIG. 43. [Figure 48] FIG. 48 is a rear view of the seal of FIG. 47. [Figure 49] FIG. 48 is a side view of the seal of FIG. 47. [Figure 50] FIG. 48 is a top view of the seal of FIG. 47. [Figure 51] FIG. 48 is a side cross-sectional view of the seal of FIG. 47. [Figure 52] FIG. 1 is a perspective view of a mask assembly including a headgear assembly having a textured surface, a seal assembly, and a frame assembly. [Figure 53] FIG. 53 is a partial front view of the mask assembly of FIG. 52. [Figure 54] FIG. 1 is a perspective view of a mask assembly including a headgear assembly having a textured surface, a seal assembly, and a frame assembly. [Figure 55] FIG. 55 is a partial front view of the mask assembly of FIG. 54. [Figure 56] FIG. 1 is a perspective view of a mask assembly including a headgear assembly having a textured surface, a seal assembly, and a frame assembly. [Figure 57] 57 shows the inside of the rear of the headgear assembly of FIG. 56. [Figure 58] 10 shows a portion of a headgear assembly having a color change. [Figure 59] FIG. 10 is a front perspective view of an alternative embodiment of the frame and yoke. [Figure 60] FIG. 60 is a rear perspective view of the frame and yoke of FIG. 59. [Figure 61] FIG. 60 is a side cross-sectional view of the frame and yoke of FIG. 59. [Figure 62] FIG. 10 is a front perspective view of an alternative frame and yoke. [Figure 63] FIG. 63 is an exploded view of the frame and yoke of FIG. 62. [Figure 64] FIG. 63 is a side cross-sectional view of the frame and yoke of FIG. 62. [Figure 65] 63 shows a detailed view of the interaction between the yoke and frame of FIG. 62. [Figure 66] FIG. 10 is a front perspective view of an alternative frame and yoke. [Figure 67] FIG. 67 is an exploded view of the frame and yoke of FIG. 66. [Figure 68] FIG. 67 is a top view of the frame and yoke of FIG. 66. [Figure 69] FIG. 67 is a side cross-sectional view of the frame and yoke of FIG. 66. [Figure 70] FIG. 67 is a detailed exploded view of the frame and yoke of FIG. 66. [Figure 71] FIG. 10 is a front perspective view of an alternative frame and yoke. [Figure 72] FIG. 72 is a rear perspective view of the frame and yoke of FIG. 71. [Figure 73] FIG. 72 is a side cross-sectional view of the frame and yoke of FIG. 71. [Figure 74] FIG. 1 is a perspective view of a mask assembly including a headgear assembly, a seal assembly, and a frame assembly. [Figure 75A] 1 is a partial schematic side view of an exemplary embodiment of an adjustment mechanism for self-adjusting headgear. FIG. [Figure 75B] FIG. 75B is a partial longitudinal cross-sectional view of the adjustment mechanism of FIG. 75A. [Figure 75C] FIG. 75B is a perspective view of the adjustment mechanism of FIG. 75A. [Figure 76A] FIG. 75B is a transverse cross-sectional view of the adjustment mechanism of FIG. 75A. [Figure 76B] FIG. 75B is a perspective view of a portion of the adjustment mechanism of FIG. 75A. [Figure 77A] FIG. 75B is a schematic diagram showing the adjustment mechanism of FIG. 75A in a neutral position. [Figure 77B] FIG. 75B is a schematic diagram showing the adjustment mechanism of FIG. 75A at its maximum length during extension. [Figure 77C] FIG. 75B is a schematic diagram showing the adjustment mechanism of FIG. 75A during retraction. [Figure 78A] FIG. 10 is a transverse cross-sectional view of another exemplary embodiment of an adjustment mechanism. [Figure 78B] FIG. 78B is a perspective view of the adjustment mechanism of FIG. 78A. [Figure 78C] FIG. 78B is a perspective view of the adjustment mechanism of FIG. 78A in a neutral position. [Figure 78D] FIG. 78B is a perspective view of the adjustment mechanism of FIG. 78A at its maximum extended length. [Figure 79A] FIG. 78B is a schematic diagram showing the adjustment mechanism of FIG. 78A in a neutral position. [Figure 79B] FIG. 78B is a schematic diagram showing the adjustment mechanism of FIG. 78A at its maximum length during extension. [Figure 79C] FIG. 78B is a schematic diagram showing the adjustment mechanism of FIG. 78A during retraction. [Figure 80A] FIG. 10 is a perspective view of another exemplary embodiment of an adjustment mechanism. [Figure 80B] FIG. 80B is a transverse cross-sectional view of the adjustment mechanism of FIG. 80A. [Figure 80C] FIG. 80B is a perspective view of the adjustment mechanism of FIG. 80A in a neutral position. [Figure 80D] FIG. 80B is a perspective view of the adjustment mechanism of FIG. 80A at its maximum extended length. [Figure 81A] FIG. 80B is a schematic diagram showing the adjustment mechanism of FIG. 80A in a neutral position. [Figure 81B] FIG. 80B is a schematic diagram showing the adjustment mechanism of FIG. 80A at its maximum length during extension. [Figure 81C] FIG. 80B is a schematic diagram showing the adjustment mechanism of FIG. 80A during retraction. [Figure 82A] 13 illustrates another exemplary embodiment of an adjustment mechanism during extension. [Figure 82B] 82B shows the adjustment mechanism of FIG. 82A with the filament kinking during retraction. [Figure 83A] 10 illustrates another exemplary embodiment of an adjustment mechanism in a neutral position. [Figure 83B] 83B shows the adjustment mechanism of FIG. 83A at its maximum extended length. [Figure 83C] 83B shows the adjustment mechanism of FIG. 83A in retraction. [Figure 84A] FIG. 83B is a top view of an exemplary embodiment of the braided core of the adjustment mechanism of FIG. 83A. [Figure 84B] FIG. 84B is a side view of the braided core of FIG. 84A. [Figure 85A] 1A-1C are top views of an exemplary embodiment of a braided core during manufacture. [Figure 85B] FIG. 85B is a side view of the braided core of FIG. 85A during manufacture. [Figure 86A] FIG. 10 is a side view of another exemplary embodiment of a braided core. [Figure 86B] FIG. 86B is a top view of the braided core of FIG. 86A. [Figure 87] 10 illustrates another exemplary embodiment of an adjustment mechanism. [Figure 88] FIG. 1 is a front view from the face-contacting side (i.e., wearer's side) of the nasal seal of the nasal mask interface of the first embodiment. [Figure 89]FIG. 10 is a rear view from the outside of the nasal seal of the first embodiment. [Figure 90] FIG. 1 is a top view of the nasal seal of the first embodiment. [Figure 91] FIG. 10 is an underside view of the nose seal of the first embodiment. [Figure 92] FIG. 10 is a first rear underside perspective view from the exterior of the nasal seal of the first embodiment. [Figure 93] FIG. 10 is a second rear top perspective view from the exterior of the nasal seal of the first embodiment. [Figure 94] FIG. 1 is a first top perspective view from the face-contacting side of the nose seal of the first embodiment. [Figure 95] FIG. 10 is a second underside perspective view from the face-contacting side of the nose seal of the first embodiment. [Figure 96] FIG. 1 is a side view of the nose seal of the first embodiment. [Figure 97] 14 is a cross-sectional view of the nasal seal of the first embodiment taken through centerline AA of FIG. 13. [Figure 98] FIG. 10 is a view of the front or face-contacting side of the nasal seal of the nasal mask interface of the fourth embodiment. [Figure 99] FIG. 10 is a rear view of the nasal seal of the nasal mask interface of the fourth embodiment. [Figure 100] FIG. 10 is an external underside perspective view of the nasal seal of the fourth embodiment of the nasal mask interface. [Figure 101] FIG. 10 is a top perspective view from the outside of the nasal seal of the nasal mask interface of the fourth embodiment. [Figure 102] FIG. 10 is a side view of the nasal seal of the nasal mask interface of the fourth embodiment. [Figure 103] FIG. 10 is a top view of the nasal seal of the nasal mask interface of the fourth embodiment. [Figure 104] FIG. 10 is an underside view of the nasal seal of the nasal mask interface of the fourth embodiment. [Figure 105] FIG. 104 is a cross-sectional view of the nasal seal of the nasal mask interface of the fourth embodiment taken through line AB of FIG. 103. [Figure 106]FIG. 99 is a perspective cross-sectional view of the nasal seal of the fourth embodiment of the nasal mask interface taken through line AC of FIG. 98. [Figure 107] FIG. 99 is a cross-sectional view of the nasal seal of the nasal mask interface of the fourth embodiment taken through line AC of FIG. 98. [Figure 108] FIG. 99 is a cross-sectional view of the nasal seal of the fourth embodiment of the nasal mask interface taken through line AG of FIG. 98. [Figure 109] FIG. 108 is a close-up view of region AD of FIG. 107, particularly showing the angular dimension profile of a portion of the under-the-nose support of the nasal seal of the nasal mask interface of the fourth embodiment. [Figure 110] FIG. 10 is a close-up rear view of the under-nose support of the fourth embodiment nasal mask interface for the small-medium size seal configuration, particularly showing the radius of curvature of the central portion of the under-nose support. [Figure 111] FIG. 10 is a close-up rear view of the under-nose support of the fourth embodiment nasal mask interface for a medium-large size seal configuration, particularly showing the radius of curvature of the central portion of the under-nose support. [Figure 112] Figure 10 shows a close up rear view of an alternative configuration of the under-nose support of the fourth embodiment nasal mask interface, the under-nose support having an improved alternative generally rectangular shape. [Figure 113] 10 shows a close-up top perspective view of a central region of the under-nose support of the nasal seal of the fourth embodiment of a nasal mask interface, particularly identifying the width dimension of a portion of the under-nose support for the small-medium size seal configuration. [Figure 114] 10 shows a close-up top perspective view of a central region of the under-nose support of the nasal seal of the fourth embodiment of the nasal mask interface, particularly identifying the width dimension of a portion of the under-nose support for a medium-large size seal configuration. [Figure 115] FIG. 10 shows a close up cross-sectional view of a portion of the central connection portion of the under-nose support of the nasal seal of the fourth embodiment of the nasal mask interface, particularly showing the angular dimensions of the central connection portion for the small-medium size seal configuration. [Figure 116]FIG. 10 shows a close up cross-sectional view of a portion of the central connection portion of the under-nose support of the nasal seal of the fourth embodiment of the nasal mask interface, particularly the angular dimensions of the central connection portion for a medium-large size seal configuration. [Figure 117] FIG. 10 shows a close-up top view of the nasal bridge region of the nasal seal of the nasal mask interface of the fourth embodiment, particularly the valley region of the contact surface for the small-medium size seal configuration. [Figure 118] FIG. 10 shows a close-up top view of the nasal bridge region of the nasal seal of the fourth embodiment of the nasal mask interface, particularly the valley region of the contact surface for the medium-large size seal configuration. [Figure 119] FIG. 1 shows a perspective view of a mask assembly including a headgear assembly, a seal assembly, and a frame assembly. [Figure 120] 120 shows a more detailed view of the seal and frame assembly from FIG. 119. [Figure 121] 120 shows a side view of a mask assembly including the headgear assembly, seal assembly and frame assembly of FIG. 119. [Figure 122] A more detailed side view of the headgear assembly is shown. [Figure 123] FIG. 10 is a side view of a curved connecting member in a side strap of a headgear assembly. [Figure 124A] 1 shows a perspective view of an example including straight side straps. [Figure 124B] 1 shows a perspective view of an example including curved side straps. [Figure 125A] FIG. 2 shows a rear perspective view of the size guide device. [Figure 125B] FIG. 2 shows a front perspective view of a size guide device. [Figure 125C] FIG. 1 shows a pictorial perspective view of a size guide device. [Figure 126A] 1 shows a partial cutaway view of the seal module and mask frame. [Figure 126B] 10 shows a further partial cutaway view of the seal module and mask frame. [Figure 127]1 shows a perspective view of a modular seal component prior to assembly into a seal module. [Figure 128A] FIG. 1 shows a front perspective view of a section of a seal module. [Figure 128B] FIG. 1 shows a front perspective view of the assembled seal module. DETAILED DESCRIPTION OF THE INVENTION

[0042] Embodiments of assembly and manufacturing systems, components, and methods will now be 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 understand that the invention described herein goes beyond the specifically disclosed embodiments, examples, and illustrations and may include other applications of the invention and obvious modifications thereof, as well as their equivalents. 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 include several novel features, and no single feature is solely responsible for its desirable attributes or is essential to practicing the invention described herein.

[0043] The present disclosure relates to a respiratory mask system or mask assembly 100 for the delivery of respiratory therapy to a patient. For example, Figures 1 and 2 show an exemplary embodiment of the mask assembly 100 including a mask interface 102, such as a seal and frame assembly, and a headgear assembly 200. The mask interface 102 includes a seal or cushion 104 that seals around a user's nose and / or mouth and / or inside the user's nares during use, and a frame 106 that supports the seal 104 and couples it to the headgear 200 and / or gas delivery conduit 110. The seal 104 can be removably coupled to the frame 106 during use. The headgear 200 supports the mask interface 102 in the appropriate position on the user's face during use.

[0044] In the illustrated example, seal 104 is a nasal mask, specifically a pillow mask that seals against the inside of the patient's nostrils during use. In the illustrated configuration, seal 104 includes a secondary subnasal or subnasal seal portion that seals against the underside of the patient / user's nose. Seal 104 is configured to form a secondary seal below the patient / user's nose, along portions of the face extending laterally to the nose, and along the user's upper lip.

[0045] The headgear 200 includes a halo portion or halo strap 204 ( FIG. 3 ) configured to wrap around the back and top of a user's head during use, a pair of front or side straps 208 configured to extend along one of the user's cheeks during use, and a yoke or collector 202. A first end of each front strap 208 is attached to the halo strap 204. In the illustrated example, each front strap 208 is attached to the halo strap 204 at and / or through a joint 207. A second, opposite end of each front strap 208 extends from and / or is coupled to one end of the yoke 202. The yoke 202 couples, e.g., removably couples, to the frame 106 to couple the headgear 200 to the mask interface 102, such as in a manner described in more detail herein.

[0046] The headgear 200 may be automatically adjustable and / or may incorporate one or more directional locks that allow the headgear to shorten in length with relatively little resistance and resist increases in headgear length with greater resistance. Preferably, the directional locks are configured to resist at least the blow-off force generated by the mask assembly 100, and in some configurations may also resist some hose pull force. In some configurations, the locking force of the directional locks can be overcome to lengthen the headgear for donning / dosing the interface assembly. In some forms, the yoke 202 may form a collector for filaments used in an automatically adjustable headgear system. The filaments may extend within the side arms 208. The side arms 208, or portions thereof, may form or include a braided element of the automatic headgear adjustment mechanism, and the filaments may extend within the braided element. One or more elastic elements (or other suitable biasing structures) may be provided and configured to apply a retraction force to the headgear 200, which tends to shorten the circumference of the headgear 200 or shorten the length of a portion of the headgear 200, such as a braided element. In some configurations, the elastic elements are incorporated into the braided element. The yoke 202 may incorporate one or more directional locks, each of which may include one or more locking members. Each locking member is generally in the form of a washer and may be referred to herein as a "locking washer" or "washer." That is, a locking washer may be a relatively flat member that defines an opening through which the filament passes. The locking washer may be configured to frictionally engage the filament during headgear extension, but allow for reduced or relatively frictionless movement during headgear retraction. The directional lock or washer mechanism may be incorporated into the end of the yoke / collector 202, and the body of the yoke / collector 202 may be substantially hollow to accommodate the filament 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, U.S. Patent Application Publication No. 14 / 856,193, filed September 16, 2015, and PCT Publication No. WO 2016 / 043603, the entire contents of which are incorporated herein by reference.

[0047] As shown in FIG. 3 , the halo strap 204 includes an upper portion 205 and a rear portion 206. The boundary 203 between the upper portion 205 and the rear portion 206 can be, for example, generally parallel or can extend through a joint 207 along the longitudinal axis of the side straps 208 as shown. In the illustrated arrangement, the upper portion 205 extends over the top of the user's head during use. The rear portion 206 extends across the back of the user's head during use. The upper portion 205 and the rear portion 206 are integrally formed to form a continuous (loop) strap. The side straps 208 extend along the user's cheeks above the user's ears to the yoke 202 during use. The side straps 208 pass under the user's eyes during use. In the illustrated embodiment, the side straps 208 are permanently connected to the halo strap 204.

[0048] The width of the rear portion 206 of the halo strap 204 increases toward the centerline 201 of the headgear 200 (when viewed from the front (as shown in FIG. 4) or from the rear of the headgear 200), as shown in FIG. 4. The width Wr of the rear portion 206 extending along or parallel to the centerline 201 (in other words, the distal-most or rear-most point of the rear portion 206 that contacts the rear of the user's head when the headgear 200 is placed on the user's head during use) is therefore the maximum width of the rear portion 206 and is greater than the width of the rear portion 206 adjacent the joint 207. The wider width toward the rear of the user's head advantageously provides a larger contact area between the halo strap 204 and the user's head, helping to secure the headgear 200 to the user's head during use and may provide increased comfort compared to narrower straps. The increasing width towards the back of the user's head may also or alternatively provide a gripping location that is easier and / or more intuitive for the user to grasp when donning and / or doffing the mask assembly 100. The function and aesthetics of the gripping location may be further improved by adding an additional layer of material to provide tactile feedback.

[0049] Each side strap 208 may include a braided core 210, as shown in FIG. 11 . A first end of the braided core 210 is coupled to one of the filaments 220 of the automatically adjustable headgear system. A second, opposite end of the braided core 210 includes a positioning feature 212 positioned and designed to assist in positioning the side strap 208 within the overmold tool 300, as described in more detail herein. The second end of the braided core 210, including the positioning feature 212, is coupled to the halo strap 204, as described in more detail herein. The braided core 210 may include an expansion region 214 adjacent the second end and / or the positioning feature 212, as shown. The expansion region 214 may provide a location for connecting a braided element 216 of the automatically adjustable headgear system to the braided core 210.

[0050] The braided core 210 can function as a support beam for the side straps 208. The braided core 210 is flexible but may be relatively more rigid than the filaments 220. This may be because, for example, the braided core 210 is made of or includes a material that is relatively harder or stiffer than the filaments 220 and / or because of the relative dimensions of the braided core 210 and the filaments 220 (e.g., the braided core 210 may be thicker than the filaments 220, which may impart greater stiffness to the braided core 210 compared to the filaments 220). The braided core 210 advantageously improves the stability of the adjustment mechanism by providing additional structure over at least a portion of the adjustment length of the adjustment mechanism compared to the filaments 220 alone. For example, the braided core 220 provides structure and support to the braided element 216, improving the ability of the braided element 216 to transfer loads applied to the mask interface 102 through the yoke 202 to the headgear 200, thereby improving the stability of the mask on the user's face. Reducing filament buckling can help shorten or minimize the working length of the adjustment mechanism. Additional details regarding the braided core 210 can be found in applicant's U.S. Provisional Patent Application No. 62 / 525,643, the entire contents of which are incorporated herein by reference.

[0051] As shown in FIGS. 12 and 13 , the illustrated braided element 216 is tubular in shape and surrounds the braid core 210 (except for the positioning feature 212). The braided element 216 may also surround a portion of the filament 220. The braided element 216 is connected, e.g., permanently connected, to the braided core 210. In the illustrated embodiment, a first end of the braided element 216 is connected to the braided core 210 at the expansion region 214. The braided element 216 is not connected to the remainder of the braided core 210 or the filament 220, allowing the braided element 216 to stretch and therefore translate relative to the remainder of the braided core 210 and the filament 220. As shown in FIG. 12 , a second end of the braided element 216, opposite the first end connected to the braided core 210 at the expansion region 214, is connected, e.g., overmolded, to an end cap 250 of the yoke 202.

[0052] In the illustrated example, as shown in FIG. 7 , the joint 207 between the halo strap 204 and the side strap 208 is formed by or includes an overmolded portion that permanently connects the side strap 208 to the halo strap 204. The halo strap 204 can be formed via an intramolding process, an example of which is described in applicant's PCT Publication WO 2016 / 043603, which is incorporated herein in its entirety. "Intramolding" involves forming a component as a plastic core and textile casing as a unitary structure by applying molten plastic to a textile casing. An "intramolded" strap or any other component is a component formed by applying molten plastic to a textile casing. As shown in FIG. 8 , a burst-through projection 260 is formed during the intramolding process and extends from the halo strap 204 at or near the boundary 203 between the top 205 and rear 206 portions of the halo strap 204. "Burst-through molding" is described in applicant's PCT Publication No. WO 2017 / 158476, the entirety of which is incorporated herein by reference. Burst-through molding is a variation of the intramolding process described above. The burst-through molding process involves introducing molten plastic into a textile casing and forcing the molten plastic through a portion of the textile casing. A component formed by a burst-through molding process includes a single plastic core integrally formed with the textile casing, with the single plastic core having a portion extending through the textile casing. Each of the burst-through projections 260 includes a positioning feature 262 positioned and designed to assist in positioning the halo strap 204 within the overmold tool 300.

[0053] As shown in FIG. 9 , the overmold tool 300 includes two positioning features 302, 304. The first positioning feature 302 engages, interlocks, or interacts with the positioning feature 262 of the halo strap 204, as shown in FIGS. 10 and 14 . The second positioning feature 304 engages, interlocks, or interacts with the positioning feature 212 of the braided core 210 of the side strap 208, as shown in FIG. 14 . Once the halo strap 204 and side strap 208 are properly positioned in the overmold tool 300, the end of the braided core 210 of the side strap 208, including the burst-through projection 260 and the positioning feature 212, is overmolded to form the joint 207, as shown in FIG. 15 . The overmold material of the joint 207 can cover the portion of the braided element 216 connected to the extension 214 of the braided core 210, as shown, to further secure the braided element 216 to the braided core 210. Instead, the overmolded material at the junction 207 may be the only or primary connection of the braided element 216 to the braided core 210. The overmolding forms a permanent connection between the halo strap 204 and the side strap 208, thereby preventing the two from being separated. As shown in FIGS. 6-7 and 15, the overmolded junction 207 is asymmetrical. The lower edge of the junction 207 (i.e., the edge of the junction 207 positioned toward and facing the rear 206 of the halo strap 204) may be curved or contoured, as shown, to encourage the user to position the junction 207 above the user's ear. In the illustrated embodiment, the lower edge of the junction 207 is longer than the upper edge on the opposite side of the junction. The lower edge has a larger radius of curvature than the upper edge. The edge of the joint 207 that extends along or adjacent to the halo strap 204 extends further along the rear 206 of the halo strap 204 than it extends along the top 205 .

[0054] The yoke 202 couples, e.g., removably couples, to the frame 106 during use. In the illustrated example, the yoke 202 has a curved or forward-facing convex profile. As shown in FIGS. 16-20 , the yoke 202 includes a yoke positioning feature 254. The yoke positioning feature 254 is designed to align with a corresponding feature on the frame 106 and helps guide and / or indicate proper alignment of the frame 106 and the yoke 202 during use. The interaction between the yoke positioning feature 254 and the corresponding feature on the frame 106 can also, or instead, help secure the yoke 202 to the frame 106 by resisting relative lateral forces between the yoke 202 and the frame 106. In the illustrated example, the yoke positioning feature 254 extends along the upper rear surface or edge of the yoke 202. The yoke 202 may include connection recesses 256 that align with and interact with corresponding yoke connection protrusions 160 (shown in FIGS. 21-25) on the frame 106 to removably connect the yoke 202 to the frame 106. In the illustrated example, the yoke 202 includes four connection recesses 256 (two on the top or upper surface of the yoke 202 and two on the bottom or lower surface of the yoke 202). In the illustrated example, the distance between the connection recesses 256 on the upper surface of the yoke 202 is greater than the distance between the connection recesses 256 on the lower surface of the yoke 202.

[0055] 17 and 18 , the bottom surface of the yoke 202 has a curved profile such that the central portion of the bottom surface is concave. In other words, the yoke 202 has a reduced-height region 258 in the center or middle portion of the yoke 202, such that the height of the yoke 202 (measured from the top to the bottom) at the centerline of the yoke 202 is less than the height of the yoke 202 at its lateral ends (i.e., at and / or adjacent to the end caps 250). The asymmetrical height of the yoke 202 may help indicate the correct orientation of the yoke 202 for connection to the frame 106 and / or may provide aesthetic appeal. The reduced-height region 258 may also accommodate the frame 106, particularly the portion of the frame 106 that connects to the gas delivery conduit 110. As shown in Figures 19-20, the thickness of yoke 202 (measured from the front to the rear) is substantially uniform or constant throughout the length of yoke 202 (measured from one lateral end to the other lateral end), such that thickness T1 near the lateral ends is equal to or approximately equal to thickness T2 along the centerline of yoke 202.

[0056] As shown in FIGS. 21-26 , the frame 106 includes a main body 134 and a protruding or radial structure 135 extending from the main body. The protruding structure 135 can be in the form of a flange, skirt, or wall, such as a peripheral wall, that can partially or completely circumferentially surround the frame body. The protruding structure 135 has a front surface 112 and a rear surface 114. The frame includes an inlet collar 108 and an outlet collar 140. The inlet and outlet collars at least partially define the frame body. The inlet collar 108 protrudes from the front surface 112, and the outlet collar 140 protrudes from the rear surface 114. Thus, the wall 135 extends generally or substantially radially relative to the inlet collar 108 and / or the outlet collar 140. The inlet collar 108 defines an inlet opening 109, and the outlet collar 140 defines an outlet opening 142. During use, the conduit 110 is coupled to the inlet collar 108, and the seal 104 is coupled to the outlet collar 140. The inlet and outlet collars are in the form of tubes in fluid communication. Gas supplied by the conduit 110 to the frame 106 through the inlet opening 109 passes through the frame 106 from the inlet collar 108 to the outlet collar 140 and is supplied to the seal 104 through the outlet opening 142 for delivery to the user. The inlet and outlet collars have different cross-sectional shapes. The inlet and outlet collars extend along respective longitudinal axes that are angled relative to one another. Thus, the frame body is provided with a curved tube configuration. The front surface 112 includes a recessed region 154 extending laterally across the front surface 112. The recessed region 154 receives the yoke 202 when the yoke 202 is coupled to the frame 106. In the illustrated embodiment, the recessed region 154 is positioned above the inlet collar 108. Thus, the yoke 202 contacts the frame 106 above the inlet collar 108 when the yoke 202 is coupled to the frame 106 .

[0057] In the illustrated example, the frame 106 includes two clips or overhangs 156 formed as part of the wall 135 that extend upward from the recessed area 154 and then curve forward to overhang the recessed area 154. The overhangs 156 form the upper boundary of the recessed area 154 that receives the yoke 202. To couple the yoke 202 to the frame 106, the yoke 202 can be clipped or snapped horizontally, i.e., in a front-to-back direction, into the recessed area 154. In some examples, to remove the yoke 202 from the frame 106, the yoke can be rotated or pivoted out of the recessed area 154 following a bottom edge of the yoke 202. Alternatively, the yoke 202 can be pivoted or pulled out of the recessed area 154 following one lateral end of the yoke 202. In the illustrated configuration, the overhangs 156 are separated by a gap 158. When the yoke 202 is received in the recessed area 154, the yoke positioning feature 254 is received in the gap 158, as shown in FIG. 27 . In some configurations, the yoke positioning feature 254 is closely received in the gap 158, which may help to properly align the yoke 202 with the frame 106 and / or help to couple the yoke 202 to the frame 106. As shown, the yoke positioning feature 254 and the overhang 156 are sized and shaped such that when the yoke 202 is coupled to the frame 106, the yoke positioning feature 254 is flush with the overhang 156 along the top, rear, and / or front surfaces of the yoke positioning feature 254 and the overhang 156. The overhang 156 may help inhibit or limit relative lateral movement between the yoke 202 and the frame 106 due to the positioning of the yoke positioning feature 254 within the gap 158.

[0058] Each overhang 156 includes a yoke connection protrusion 160 that protrudes toward the recessed region 154 from the underside of the forwardly curved portion of the overhang 156. The frame 106 includes two additional yoke connection protrusions 160 that extend into the recessed region 154 from the bottom wall or boundary of the recessed region 154. When the yoke 202 is received in the recessed region 154, the yoke connection protrusions 160 of the frame 106 are received in the connection recesses 256 of the yoke 202. In the illustrated example, the distance between the yoke connection protrusions 160 extending from the overhang 156 is greater than the distance between the yoke connection protrusions 160 extending from the bottom wall of the recessed region 154. The spacing between the yoke connection protrusions 160 extending from the overhang 156 and the yoke connection protrusions 160 extending from the bottom wall of the recessed region 154 corresponds to the spacing between the connection recesses 256 on the top surface of the yoke 202 and the connection recesses 256 on the bottom surface of the yoke 202, respectively. The yoke connection protrusions 160 of the overhang 156 are received in connection recesses 256 on the top surface of the yoke 202, and the yoke connection protrusions 160 positioned along the bottom wall or boundary of the recessed area 154 are received in connection recesses 256 on the bottom surface of the yoke 202. The engagement between the yoke connection protrusions 160 and the connection recesses 256 enables a detachable connection between the yoke 202 and the frame 106. In other examples, the frame, e.g., the overhang 156 and the bottom wall of the recessed area 154, can include connection recesses, and the yoke 202 can include connection protrusions.

[0059] In the illustrated form, the inlet collar 108 extends diagonally downward from the front surface 112, rather than directly or perpendicularly outward. Such a configuration causes the conduit 110 to point somewhat downward (when the user's head is in an upright position) rather than directly outward, which may help reduce potential drag of the hose from the conduit 110 on the frame 106. Such a configuration may also or alternatively provide a less obtrusive feeling to the patient, as the downward angle allows the conduit 110 to be somewhat out of the patient's sight during use. The inlet collar 108 includes a protrusion 116 that retains and / or enables connection of the conduit 110 to the inlet collar 108. In the illustrated example, the protrusion 116 protrudes inward from an inner surface of the inlet collar 108 near or adjacent to an edge of the inlet collar 108 (i.e., the edge located away from the wall 135). The protrusions 116 can extend circumferentially around the entire circumference of the inner surface, or can extend only partially around the inner surface in one or more segments. The conduit 110 can be coupled to the collar 108 via or using the protrusions 116, e.g., irreversibly or permanently coupled. The inlet collar 108 can include multiple bias vents 118. In the illustrated example, the multiple bias vents 118 are positioned around the circumference of the inlet collar 108, but do not extend the entire circumference of the inlet collar 108. The bias vents 118 may not extend around the bottom of the inlet collar 108 or may be omitted. This arrangement can help prevent or reduce flow through the bias vents 118 from being directed toward the user. If flow were directed toward the user, the downward angle of the inlet collar 108, and therefore the conduit 110, could cause discomfort during use.

[0060] The outlet collar 140 includes one or more connection features 144, such as recesses, that facilitate connecting and retaining the seal 104 (or seal clip described herein) to the outlet collar 140. The seal 104 or seal clip may be coupled to the outlet collar 140 via the connection features 144 and / or an interference fit. When the seal 104 or seal clip is pressed against the outlet collar 140, the wall 135 acts as a stop for the seal 104 or seal clip and indicates to a user that the seal 104 or seal clip is fully coupled to the frame 106, for example, by providing a tactile and / or visual cue.

[0061] As described herein, the yoke 202 couples the headgear 200 to the frame 106 and can function as a collector or housing for the filaments 220 of the automatically adjustable headgear system. As shown in FIGS. 28-37 , the yoke 202 includes a front yoke section 230, a rear yoke section 232, a filament splitting insert 240, two washer housings 270, and two end caps 250, one at each lateral end of the yoke 202. The front yoke section 230 and the rear yoke section 232 can have a generally C-shaped cross-section, where the front yoke section 230 is concave facing rearward and the rear yoke section 232 is concave facing forward, as shown in FIG. 37 , for example, and form a space between them when coupled. In the illustrated example, the lateral end of the rear yoke section 232 includes or is formed by an end cap insert 238. Each end cap insert 238 includes an end cap connecting projection 239 projecting from the rear surface of the end cap insert 238, as shown in FIG. 32 . In the illustrated example, the yoke rear portion 232 includes a yoke positioning feature 254 and a connecting recess 256, as shown in Figures 31-32.

[0062] The front yoke section 230 and the rear yoke section 232 may be coupled to one another via, for example, an interference fit or a snap fit. In the illustrated example, the front yoke section 230 includes a protrusion 234 that protrudes downward from the inner surface of the top wall of the front yoke section 230 and a protrusion 234 that protrudes upward from the inner surface of the bottom wall of the front yoke section 230, as shown in FIG. 34 . The protrusion 234 may extend along part or the entire length of the front yoke section 230. The rear yoke section 232 includes a recess 236 on the outer surface of the top wall of the rear yoke section 232, as shown in FIG. 37 , and a recess 236 on the outer surface of the bottom wall of the rear yoke section 232. Also as shown in FIG. 37 , when the front yoke section 230 and the rear yoke section 232 are coupled together, the protrusion 234 of the front yoke section 230 is received in the recess 236 of the rear yoke section 232 to secure the front yoke section 230 and the rear yoke section 232 together.

[0063] Each washer housing 270 houses one or more washers 272 that function as part of the locking mechanism of the automatically adjustable headgear system, as shown in FIGS. 28B, 28C, 28D, and 28E. The filament 220 extends through the washers 272 as shown. The washers 272 may be the same (FIGS. 28D and E) or different (FIG. 28C). When the washer 272 is in the position shown in solid lines, with the axis of the washer opening aligned or more closely aligned with the longitudinal axis of the filament 220, the filament 220 can move through the opening of the washer 272 with a relatively low amount of resistance in a direction from right to left in FIG. 28C, D, or E, or in a direction that tends to shorten the circumference of the associated headgear or the length of the headgear portion. This may be referred to as the released or unlocked position of the washer 272 or directional lock. In response to movement of the filament 220 in the opposite direction (from left to right in FIGS. 28C, D, or E, or in a direction tending to increase the circumference of the associated headgear or length of the headgear portion), the washer 272 moves with the filament 220 to or toward a position shown by the dotted line where resistance to movement is relatively greater than in the released position as a result of frictional contact between the washer 272 and the filament 220. This can be referred to as the locked position of the washer 272 or directional lock. Preferably, the resistance to movement of the filament 220 in the locked position is sufficient to resist the blow-off force generated by the pressurized gas within the interface for a given treatment, taking into account the overall configuration of the headgear (e.g., the number of directional locks employed). Other variations of the illustrated directional locks or other types of directional locks can also be employed. Examples of such locking mechanisms are shown and described in PCT Publication No. WO 2017 / 158544 and U.S. Patent Application Publication No. 2016 / 0082217, the entire contents of which are incorporated herein by reference.

[0064] The end caps 250 may help secure the front yoke section 230 and the rear yoke section 232 to one another, connect the side straps 208 to the yoke 202, and / or provide an entrance for the filament 220 into the yoke 202. As shown in FIGS. 35-36 , the inner surface of the rear wall of each end cap 250 includes a connection recess 252. The connection recess 252 receives the end cap connection protrusion 239 when the end cap 250 is coupled to the end cap insert 238 to help secure the end cap 250 to the end cap insert 238. The inner edge of the rear wall of each end cap 250 (i.e., the edge of the end cap 250 that is positioned inward relative to the rest of the end cap 250 when the end cap 250 is coupled to the front yoke section 230 and / or the rear yoke 232) may include a recessed leading edge 253 that helps guide the end cap 250 into place so that the connection recess 252 receives the end cap connection protrusion 239 of the end cap insert 238. In the illustrated embodiment, the recessed leading edge 253 is positioned along the corner between the inner end and the inner surface of the rear wall of the end cap 250. The lateral end or wall of each end cap 250 (i.e., the end or wall of the end cap 250 that forms the lateral end of the yoke 202 when the end cap 250 is coupled to the yoke 202) includes openings 280, as shown in FIG. 36. Each opening 280 receives one of the filaments 220, allowing the filament 220 to pass from the side strap 208, through the end cap 250, and into the yoke 202.

[0065] To assemble the yoke 202, the filament splitting insert 240 and two washer housings 270 are placed in the rear yoke section 232, and the front yoke section 230 is coupled to the rear yoke section 232. Each end cap 250 can be coupled to one of the end cap inserts 238. When the front yoke section 230 and the rear yoke section 232 are coupled to each other, the filament splitting insert 240 and two washer housings 270 are positioned and secured between the front yoke section 230 and the rear yoke section 232.

[0066] The filament 220 from each side strap 208 extends into the yoke 202 such that two filaments 220 pass through the yoke 202. The filament splitting insert 240 separates the interior of the yoke 202 to create separate line paths for the two filaments 220. As shown in FIGS. 29-30 , a first line path 282 is defined at least in part by the front of the filament splitting insert 240 and the front yoke section 230, and a second line path 284 is defined at least in part by the rear of the filament splitting insert 240 and the rear yoke section 232. Thus, one filament 220 is in the first line path 282 in front of the filament splitting insert 240, and the other filament 220 is in the second line path 284 behind the filament splitting insert 240. The first filament 220 passes through the first end cap 250 and the washer of the first washer housing 270 and enters the first line path 282. The second filament 220 passes through the second end cap 250 and the second washer housing 270 into the second line path 284 .

[0067] 29-39 , the first and second line paths 282, 284 have a greater height or width at the ends where the filament 220 enters the line paths. This can advantageously help prevent or inhibit sharp bends in the filament 220 immediately or shortly after it exits the washer housing 270, and can facilitate proper engagement of the washer with the filament 220. This can also, or alternatively, help prevent or inhibit the filament 220 from catching on the interior features of the yoke 202 during retraction of the filament 220 and headgear.

[0068] The separated line paths prevent or inhibit interference between the two filaments 220. Because the line paths 282, 284 are separated in the front-to-back direction, both the washer housing 270 and the washer housed therein can be oriented in the same direction, as shown in FIG. 28 . Orienting the washer housing 270 and washer in the same direction advantageously helps provide consistency between the operation of the two side straps 208. If the line paths were not separated in the front-to-back direction and both washer housings 270 were oriented in the same direction, the two filaments 220 could interfere with each other, causing, for example, bucking, jamming, and / or tangling, which could disrupt smooth operation of the automatically adjustable headgear mechanism. Reversing the orientation of the washer housing 270 and washer (e.g., one upside down relative to the other) could allow the line paths to be separated in the front-to-back direction, potentially resulting in uneven operation and / or wear between the side straps 208 and / or directional locks.

[0069] 38-42 show an exemplary embodiment of a conduit 110 that can be coupled to the frame 106. A conduit frame connector 190 is coupled, e.g., overmolded, to a first end of the conduit 110, as shown in FIG. 42. The conduit frame connector 190 couples, e.g., permanently couples, the conduit 110 to the frame 106. The conduit frame connector 190 can be coupled to the frame 106 via an interference fit. A swivel connector 192 is coupled, e.g., overmolded, to a second, opposite end of the conduit 110. The swivel connector 192 couples the conduit 110 to a swivel 194 that allows for rotatable and removable connection to a CPAP hose or other gas delivery tube. In the illustrated example, the swivel connector 192 includes an expansion ring 191 and a protrusion 193 extending distally (away from the conduit 110) from the expansion ring 191. The swivel 194 is coupled to the protrusion 193. The swivel 194 can be coupled to the swivel connector 192 by pressing the swivel 194 against the protrusion 193 until the swivel 194 abuts the expansion ring 191 .

[0070] The swivel 194 can at least partially decouple the CPAP hose or other gas delivery tube from the frame 106 and the seal 104. As shown in FIG. 40 , the swivel 194 can be separated from the swivel connector 192 and the conduit 110 to remove the frame 106 and seal 104 from the CPAP hose or gas delivery tube. The swivel 194 can include a grip 196, such as a scalloped protrusion, to provide a user with an improved grip and / or tactile feedback as to where to grip the swivel 196 to separate it from the swivel connector 192 and the conduit 110. The swivel 194 can pivot relative to the swivel connector 192, which can facilitate decoupling forces on the CPAP hose or gas delivery tube from the conduit 110.

[0071] As shown in FIGS. 43-51 , the mask interface 102 can include a seal assembly including a seal 104 and a seal clip assembly or seal clip 122. In the illustrated configuration, the seal clip 122 includes a pair of seal clip members 122a, 122b. The seal assembly is attached to an outlet collar 140 of the frame 106. The seal 104 includes a gas inlet opening 120 surrounded by a base portion 121 of the seal 104, as shown in FIG. 51 . The seal 104 can be formed from a stretchable, resilient material, such as an elastomer, silicone, or rubber, that can stretch under tension but substantially return to its original shape when the tension is removed. The seal clip 122 can provide a rigid component that enables or assists in coupling the seal 104 to the frame 106. Alternatively, the base portion 121 of the seal 104 may be configured to extend around the outlet collar 140 of the frame 106 such that the inside of the base portion 121 (or another suitable seal structure) substantially surrounds and forms a seal with the outer surface of the outlet collar 140. The clip may also be formed from an elastomer (preferably stiffer than the seal) configured to stretch over the outlet collar.

[0072] As described herein, the outer surface of the outlet collar 140 may include one or more connecting features 144, such as recesses. The seal clip 122 may include one or more corresponding connecting features 124, such as corresponding protrusions shown in FIGS. 43 and 45 , that help to couple and secure the seal 104 to the outlet collar 140 via the seal clip 122. When the seal 104 and / or seal clip 122 are pressed against the outlet collar 140, the corresponding connecting features 144, 124 may engage with one another and help prevent the seal and / or seal clip 122 from being pulled out of and / or rotating relative to the outlet collar 140. The outlet collar 140 and the seal 104 and / or seal clip 122 may have asymmetric shapes, which may help to prevent or inhibit the seal 104 and seal clip 122 from rotating on or relative to the outlet collar 140.

[0073] As shown in FIG. 44 , in the illustrated example, the seal assembly includes a seal 104, an inner clip portion or member 122a, and an outer clip portion or member 122b. The inner clip member 122a and the outer clip member 122b may form a collar or ring that defines an opening that forms the gas inlet 120. The gas inlet 120 may be substantially the same shape (e.g., non-circular) and dimensions as an outlet collar 140 of the frame 106. The inner clip member 122a may include an inner surface configured to substantially surround and seal with the outer surface of the outlet collar 140. The inner clip member 122a may be positioned within an internal cavity of the seal 104, for example, around the inner periphery of the base portion 121. The outer clip member 122b may be positioned on the outer surface of the seal, for example, around the outer periphery of the base portion 121. When the inner and outer clip members 122a, 122b are connected to one another, for example via an interference fit connection 123, the seal 104, for example the base portion 121, is thus clamped between the inner and outer clip members 122a, 122b, as shown in FIG. 45. The seal 104 may include alignment features 126 that aid in proper alignment and positioning of the clip 122 relative to the seal 104. As shown in FIG. 51, the alignment features 126 may be positioned along the interior of the base portion 121.

[0074] As mentioned above, in the illustrated example, the seal 104 is a pillow mask that seals inside the patient's nares during use and includes a secondary subnasal or subnasal portion that seals against the underside of the patient / user's nose. The seal 104 is configured to form an airtight seal below the patient / user's nose, along portions of the face extending laterally relative to the nose, and along the user's upper lip. The seal 104 includes protrusions or nasal pillows that substantially seal against the inside of the patient / user's nares. The remaining portions of the seal 104 inflate and conform around the user's nose to properly position or position the seal 104, support the seal 104, and / or serve to act as a secondary seal in case the seal between the nasal pillows and the user's nares leaks during movement. Additional information regarding the seals described herein and / or usable in the mask assemblies described herein can be found in applicant's PCT Publication No. WO 2017 / 160166, which is hereby incorporated by reference.

[0075] As described herein, headgear 200 may be automatically adjustable. To don and / or doff mask assembly 100, a user can pull halo straps 204 away from or relative to yoke 202, frame 106, and seal 104. This stretches braided elements 216 of side straps 208 and allows filaments 220 (secured to halo straps 204 via braided core 210 and joints 207) to slide within and relative to yoke 202, increasing the overall length or size of headgear 200. Once mask assembly 100 is positioned on the user's head and face, the user releases halo straps 204, causing the overall length or size of headgear 200 to decrease or contract, allowing it to automatically adjust or size to the user's head. To help encourage and guide the user to grasp and pull the rear 206 of the halo strap 204, rather than the side straps 208, to don the mask assembly 100, the halo strap 204 may include a textured inner surface 290, as shown in FIGS. 52 and 53. In this example, the textured inner surface 290 extends around the entire halo strap 204. FIGS. 54 and 55 show a variation in which the textured inner surface 290 covers only a portion of the inner surface of the halo strap 204. In this example, the textured inner surface 290 is located on only a portion of the rear 206 of the halo strap 204. In this example, there is a relatively sharp boundary between the textured portion 290 and the non-textured portion of the halo strap 204. FIGS. 56 and 57 show another variation in which the textured inner surface 290 covers only a portion of the inner surface of the halo strap 204, for example, only a portion of the rear 206 of the halo strap 204 as shown. However, in this example, the portions of the textured surface 290 have gradually decreasing edges. In other words, the textured surface 290 or pattern fades out slowly or gradually and blends into the non-textured portions such that the portions of the textured surface 290 do not have sharply defined edges or distinct transition points.The textured surface 290, whether extending around the entire inner surface of the halo strap 204 or only a portion thereof, may include one or more of dimples (as shown), ribs, crosses, spirals, and / or other designs or textures.

[0076] The top 205 and back 206 of the halo strap 204 can be different colors, as shown in FIG. 58, for example. The side straps 208 can be the same color as the back 206. Having the side straps 208 and back 206 the same color can help emphasize the correct orientation of the headgear 200 on the user, as the same-colored side straps 208 and back 206 form a loop from the yoke 202 around the back of the user's head. In some examples, the top 205 and back 206 can be knitted, knitted in one piece, and / or otherwise configured so that the two colors fade or blend into each other, as shown.

[0077] 59-61 illustrate variations of the yoke 202 and frame 106. As described above, the illustrated yoke 202 includes a yoke positioning feature 254. The frame 106 includes two overhangs 156 separated by a gap. When the yoke 202 is coupled to the frame 106, the frame positioning feature 254 is disposed in the gap between the overhangs 156. The frame positioning feature 254 and the overhang 156 are sized and shaped such that the yoke positioning feature 254 is flush with the overhang 156 along the top and rear surfaces of the yoke positioning feature 254 and the overhang 156. In this example, the yoke positioning feature 254 is relatively larger or longer than the yoke positioning feature 254 in the example of FIG. 27, and the overhang 156 is relatively smaller or shorter than the overhang 156 in the example of FIG. 27.

[0078] FIGS. 62-65 show another variation of the yoke 202 and frame 106. In this example, the yoke 202 includes a central portion 354 and two lateral portions 356 extending from each lateral end of the central portion 354. The lateral portions 356 have a greater thickness and height than the central portion 354. Each lateral portion 356 includes a recess 358 on its inner end or surface, rearward or behind the central portion 354, as shown in FIG. 63. The frame 106 includes two lateral protrusions 155, each extending outward or laterally from each lateral end or edge of the recessed region 154 that receives the yoke 202. When the yoke 202 is coupled to the frame 106, the lateral protrusions 155 are received in the recesses 358 in the lateral portions 356 of the yoke 202, securing the yoke 202 to the frame 106, as shown in FIGS. 64-65.

[0079] Figures 66-70 show another variation of the yoke 202 and frame 106. In this example, the frame 106 includes two lateral protrusions 155, as in the example of Figures 62-65. The yoke 202 includes two recesses or openings 368. In the illustrated example, each recess or opening 368 is formed in or by a loop 366 that protrudes from the rear surface of the yoke, as shown in Figure 67. When the yoke 202 is coupled to the frame 106, the lateral protrusions 155 are received in the recesses 368 of the yoke 202, as shown in Figures 66 and 68-69, securing the yoke 202 to the frame 106.

[0080] 71-73 show another variation of the yoke 202 and frame 106. In this example, the frame 106 includes two upper overhangs 157 and two lower overhangs 159 extending forward from the frame 106. The upper overhangs 157 are concave downward, and the upper overhangs 159 are concave upward. The yoke 202 is received in the area between the upper overhangs 157 and the lower overhangs 159. An interference fit between the yoke 202 and the upper and lower overhangs 157 and 159 holds the yoke 202 in place. The yoke 202 and / or the frame 106 can include one or more positioning features (e.g., yoke positioning feature 254) to facilitate properly centering the yoke 202 relative to the frame 106.

[0081] 74 shows a further example of a respiratory mask system or mask assembly 2100 for delivering respiratory therapy to a patient. Any of the features of this system may be substituted for features described above or below, resulting in new combinations not explicitly shown.

[0082] The mask system may include a mask interface, such as a seal and frame assembly 2102, and a headgear assembly 2200. The mask interface 2102 and headgear assembly 2200 may include a connection system that attaches the headgear 2200 to the mask interface 2102. Various forms of connection system may be used to attach the headgear 2200 to the mask interface 2102. The mask interface 2102 may be used with various types of headgear. The headgear 2200 may be used with various mask interfaces.

[0083] The mask interface or seal and frame assembly 2102 can include a seal 2104 for sealing around and / or under the patient's mouth and / or nose, and a frame 2106 for supporting the seal 2104 and attaching the seal 2104 to the headgear 2200. The frame 2106 can include a gas inlet configured to attach to a gas conduit 2110 for delivering gas to the patient through the mask interface 2102.

[0084] The headgear 2200 of the respiratory mask system holds the mask interface 2102 against the patient's face during use. The headgear 2200 is typically attached to the mask interface 2102 and wraps around the back of the patient's head to seal the mask interface 2102 against the patient's face.

[0085] In some examples, the headgear assembly 2200 includes a yoke or collector 2202 configured to attach to the mask interface 2102. In some examples, the mask interface 2102 includes a recessed area that receives at least a portion of the yoke 2202 when the yoke 2202 and the mask interface 2102 are attached together.

[0086] The yoke 2202 can be attached to straps of the headgear 2200. In the example shown in FIG. 74 , the headgear 2200 includes a strap assembly including a rear strap 2204 configured to wrap around the back of the patient's head, an upper strap 2206 configured to wrap over the top of the patient's head, and a pair of front straps 2208 configured to extend along the patient's cheeks during use. In some examples, each front strap 2208 is attached by a rear connector 2205 to a rear strap 2204 of the headgear assembly 2200, such as to a free end 2207 of the rear strap 2204 or a connector coupled to the free end 2207. Each front strap 2208 can include a free end to which a connector can be attached. Each connector can engage with a complementary strap connector located on the yoke 2202. The connection between the front straps 2208 and the yoke 2202 can be any suitable form of connection, such as a snap-fit ​​connection, a screw-and-screw type connection, or a hook connection. In some examples, the yoke 2202 includes an end cap 2203 at each lateral end of the yoke 2202. Each end cap 2203 can function as a connector and can be coupled to one of the front straps 2208 as shown in FIG.

[0087] In some examples, the headgear can be automatically adjustable and / or incorporate one or more directional locks that allow the headgear to shorten in length with relatively little resistance and resist increases in headgear length. In some configurations, the locking force of the directional locks can be overcome to lengthen the headgear for donning and doffing the interface assembly. In some examples, the yoke 2202 forms a collector for filaments used in an automatically adjustable headgear system.

[0088] In some examples, as shown in FIG. 74 , for example, each front strap 2208 includes a filament 2300, which may be inelastic and extend within and / or be covered by an elastic covering 2302, such as an elastic braid. As shown, the longitudinal axis of the filament 2300 may be aligned (e.g., parallel or coaxial) with the longitudinal axis of the elastic braid. The elastic braid may function as a retraction means or biasing element to retract the headgear after stretching or increasing its length or to shorten the length of the headgear. Other retraction means or biasing elements may be used instead of or in addition to the elastic braid, such as an elastic filament or other member, any suitable type of spring, a recoil mechanism, or any other suitable biasing element, including, but not limited to, any of those described herein. In some examples, an end cap 2203 is overmolded onto the end of the elastic braid 2302. The yoke 2202 or another portion of the headgear can incorporate one or more limiting mechanisms or directional locks, each of which can include a washer mechanism 2312 (e.g., shown in FIG. 75A ), which can be configured to frictionally engage the filament 2300 during headgear extension, but allow relatively frictionless movement during headgear retraction. The washer mechanism can be incorporated into an end of the yoke / collector 2202, such as the end cap 2203 or a portion of the yoke / collector 2202 adjacent or near the end cap 2203. The body of the yoke / collector 2202 can be substantially hollow to receive the filament 2300 therein. In some examples, the yoke 2202 includes upper and lower line tracks 2201 for accommodating the filament 2300 extending into the yoke 2202 from either side of the headgear, as shown in FIG. 83A .

[0089] Each washer mechanism 2312 can include a cylindrical shaft 2314 and an arm 2316 extending from the shaft (as shown in FIG. 75A ). The cylindrical shaft 2314 can be substantially the same width as the washer housing 2310 in which the washer mechanism 2312 can be housed, and the arm 2316 is narrower. In the illustrated configuration, the arm 2316 includes a first section 2316 a and a second section 2316 b, where the first section 2316 a extends radially or perpendicularly from the cylindrical shaft 2314 and the second section 2316 b extends at an obtuse angle from the end of the first section 2316 a. The second section 2316 b of the arm 2316 includes a centrally located opening configured to receive the filament 2300. Applying tension to the filament 2300 causes the washer 2312 to pivot back and forth between a locked position and / or an open position. For example, FIGS. 77B, 79B, and 81B show the directional lock in a locked configuration where a force is applied to the filament 2300 in a direction toward the left side of the figure. The force applied to the filament 2300 in this configuration causes the washer 2312 to pivot, resulting in a non-linear or tortuous path for the filament 2300 through the directional lock, restricting movement of the filament. FIGS. 77C, 79C, and 81C show the directional lock in an open configuration where a force is applied to the filament 2300 in a direction toward the right side of the figure. In this configuration, the washer 2312 is pivoted such that the path of the filament 2300 is substantially straight. This provides a smooth path for the filament 2300 to be pulled substantially freely through the directional lock. 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, U.S. Patent Application Publication No. 14 / 856,193, filed September 16, 2015, and PCT Publication No. WO 2016 / 043603, the entire contents of which are incorporated herein by reference.

[0090] In some examples, the frame 2106 and / or headgear 2200 according to the present disclosure includes one or more features, such as support beams, that help to stabilize the joint or connection between the headgear 2200 and the mask interface 2102 and / or frame 2106, which may help to stabilize the seal of the mask against the patient's face during use.

[0091] For example, FIGS. 75A-77C show examples in which support beams in the form of elongated interengaging members or arms can provide structure and support to the automatically adjustable headgear system, which can help resist rotation of the seal 2104 relative to the user's face. In the illustrated example, the interengaging members or arms include an inner rail 2420 and an outer rail 2410 that can telescope relative to one another to change the length of the entire assembly of the inner rail 2420 and outer rail 2410 (and thus the length of the associated headgear). As shown in FIGS. 76A-76B, the outer rail 2410 and inner rail 2420 interlock with one another. In some examples, the inner rail 2420 and / or outer rail 2410 are semi-rigid. The inner rail 2420 and outer rail 2410 can be incorporated into the frame or side arms 2105 of the mask interface 2102, such as the frame 2106, the yoke 2202, and / or extensions of the frame 2106 and / or the yoke 2202, which extend over the cheeks of the user during use. In the illustrated example, the outer rail 2410 extends from and / or is coupled to the side arms 2105. In the illustrated example, the inner rail 2420 extends from and / or is coupled to the headgear 2200, such as the rear straps 2204. In other examples, the inner rail 2420 can extend from and / or be coupled to the side arms 2105, and the outer rail 2410 can extend from and / or be coupled to the headgear 2200, such as at the rear straps 2204. The inner rails 2420 and outer rails 410 can be included in, function as part of, or replace the front straps 2208 of the headgear 2200. The headgear 2200 includes two sets of inner rails 2420 and outer rails 2410, one on each side of the user's face during use.

[0092] As shown in FIG. 76A , the inner rail 2420 includes two elongated protrusions 2424 that protrude perpendicularly or substantially perpendicularly from an elongated base portion 2422. The protrusions 2424 are spaced apart from one another. The outer rail 2410 includes two elongated protrusions 2414 that protrude perpendicularly or substantially perpendicularly from an elongated base portion 2412. The protrusions 2414 of the outer rail 2410 are spaced apart from one another by a distance that is wider or greater than the spacing between the protrusions 2424 of the inner rail 2420. The protrusions 2424 of the inner rail 2420 are positioned inwardly of or between the protrusions 2414 of the outer rail 2410. In the illustrated example, the outer and inner rails 2410, 2420 include flanges 2416, 2426 at the end of each protrusion 2414, 2424 opposite the base portion 2412, 2422. A flange 2426 of the inner rail 2420 projects outward, and a flange 2416 of the outer rail 2410 projects inward. As shown in FIG. 76A , the flange 2416 of the outer rail 2410 engages or contacts the flange 2426 of the inner rail 2420. The engagement or contact of the flanges 2416, 2426 forms a retention feature that helps secure the inner rail 2420 and the outer rail 2410 together. The inner rail 2420 and the outer rail 2410 can slide relative to one another (e.g., longitudinally, toward and away from one another, and / or along an axis extending parallel to the longitudinal axis of the base portions 2412, 2422) during use.

[0093] A washer housing 2310, which can house a limiting or washer mechanism 2312, can be coupled to the inner rail 2420 or the outer rail 2410. In the example shown, a washer housing 2310 is secured to each end of the inner rail 2420 (i.e., one on each side of the user's face during use). In the example shown, the self-adjusting mechanism includes an inelastic filament 2300 and a reaction elastic 2304. One end 2301 of the filament 2300 can be fixed or fastened to the inner rail 2420 or the outer rail 2410. The opposite end of the inelastic filament 2300 can be joined to the reaction elastic 2304 by, for example, a crimp or a shuttle 2306, as shown in FIG. 75B. The longitudinal axis of the inelastic filament 2300 can be aligned (e.g., parallel or coaxial) with the longitudinal axis of the reaction elastic 2304. At least a portion of the inelastic filament 2300, recoil elastic 2304, and / or shuttle 2306 can be contained within and / or slide within a housing or tube 2308. The tube 2308 provides a low or relatively low friction housing for the filament 2300 and recoil elastic 2304 to slide within. The tube 2308 helps protect the filament 2300 and recoil elastic 2304 from interference from external forces, such as contact with a pillow, that may degrade the function of the self-adjusting mechanism.

[0094] 77A-77C illustrate the operation of the headgear 2200, including the inner rail 2420 and outer rail 2410, during use. As shown in FIG. 77A, in the neutral position, the inner rail 2420 and outer rail 2410 overlap completely or to a maximum extent, and the headgear is at its minimum size or length. The headgear 2200 can be stretched or elongated, for example, for donning and / or doffing, by pulling the mask interface 2102 away from the headgear 2200, thereby applying a stretching force. As the mask interface 2102 is pulled away from the headgear 2200, the inner rail 2420 and outer rail 2410 slide relative to each other, reducing the overlap between the inner rail 2420 and outer rail 2410 and increasing the length of the headgear 2200. As the inner rail 2420 and outer rail 2410 slide away from each other, the filament 2300 is pulled through the washer housing 2310, and the washer 2312 engages and resists the extension, causing the recoil elastic 2304 to stretch and be placed under tension, as shown in FIG. 77B. When the extension force is released, the headgear 2200 automatically retracts, as shown in FIG. 77C. The internal force of the recoil elastic 2304 causes the recoil elastic 2304 to recoil and / or retract. The recoil force provided by the recoil elastic 2304 pulls the filament 2300 back through the washer housing 2310 (in the opposite direction to that during extension), which releases the washer 2312 and reduces or minimizes the resistance to the filament 2300 moving through the washer housing 2310. When the filament 2300 is pulled back through the washer housing 2310, the outer rail 2410 and inner rail 2420 are pulled back toward each other, shortening the length of the headgear 2200.

[0095] 78A-79C show another exemplary embodiment of an automatic headgear adjustment mechanism including support beams in the form of inner and outer rails 2420 and 2410 and an inelastic filament 2300. The headgear can include two such adjustment mechanisms, one on each side of the user's face during use. In the illustrated example, the outer rail 2410 extends from, is coupled to, and / or is positioned relatively closer to the frame 2106, and the inner rail 2420 extends from, is coupled to, and / or is positioned relatively closer to the headgear or washer housing 2310. In other examples, the inner rail 2420 extends from, is coupled to, and / or is positioned relatively closer to the frame 2106, and the outer rail 2410 extends from, is coupled to, and / or is positioned relatively closer to the headgear or washer housing 2310. 78A-79C also includes an elastic tube 2324 surrounding the inner rail 2420, the outer rail 2410, and the washer housing 2310. The elastic tube 2324 can be made from or include, for example, a fabric such as a knitted or braided material, silicone, or a TPE (thermoplastic elastomer). In the illustrated example, a first end of the elastic tube 2324 is secured to the outer rail 2410 and the other end of the elastic tube 2324 is secured to the washer housing 2310 or another headgear component. In examples where the inner rail 2420 and outer rail 2410 are reversed, the first end of the elastic tube 2324 is secured to the inner rail 2420. One end of the filament 2300 can be secured or fastened to either the inner rail 2420 or the outer rail 2410. The opposite end of the inelastic filament 2300 forms or includes an end stop 2303. The longitudinal axis of the inelastic filament 2300 can be aligned (eg, parallel or coaxial) with the longitudinal axis of the elastic tube 2324.

[0096] 78C and 79A show the headgear in a neutral position, where the inner rail 2420 and outer rail 2410 overlap to their maximum or greatest extent and the headgear is at its minimum size or length. As the headgear 2200 is stretched or extended, for example to put on and / or take off, the inner rail 2420 and outer rail 2410 slide away from each other along an axis extending parallel to the longitudinal axes of the inner rail 2420 and outer rail 2410, thereby reducing the overlap therebetween, as shown in FIGS. 78D and 79B, and the filament 2300 is pulled through the washer housing 2310, with the washer 2312 engaging the filament and providing resistance to elongation, causing the elastic tube 2324, which resists elongation, to be stretched and placed under tension. The end stop 2303 provides a stop or limit to the amount the elastic tube 2324 can stretch. The washer housing 2310 contacts the end stop 2303 when the headgear reaches its maximum length during extension, and the end stop 2303 prevents, inhibits, or reduces the possibility of further movement or displacement of the washer housing 2310 and filament 2300 relative to one another. When the extension force is released, the headgear 2200 automatically retracts toward a fitting position, which may be a balanced fit position that may match or substantially match the circumference of the user's head, as shown in FIG. 79C. A balanced fit position may be a headgear position or length (size) where the headgear's holding force balances treatment-induced forces (e.g., blow-off forces) and / or other forces (e.g., hose pulling forces) tending to extend the headgear. The internal force of the elastic tube 2324 causes the elastic tube 2324 to recoil and / or retract. The retraction force provided by the elastic tube 2324 pushes the outer rail 2410 back toward the washer housing 2310 and / or pushes the filament 2300 back (in the opposite direction to that during extension) through the washer housing 2310 and washer 2312, thereby releasing the washer 2312 and reducing or minimizing resistance to the filament 2300 moving through the washer housing 2310.

[0097] 80A-81C show an exemplary embodiment of an automatic headgear adjustment mechanism including a telescoping member. The headgear can include two such adjustment mechanisms, one on each side of the user's head during use. As shown, the adjustment mechanism includes an outer member 2430, an inner member 2432, an inelastic filament 2300, a washer housing 2310, and an elastic tube 2438. The inner member 2432 is disposed within the outer member 2430, and the inner member 2432 and outer member 2430 can slide relative to one another. The telescoping inner member 2432 and outer member 2430 can act as a support beam. The elastic tube 2438 surrounds the inner member 2432, outer member 2430, and washer housing 2310. In the illustrated example, the outer member 2430 is coupled to the washer housing 2310, a first end of the elastic tube 2438 is secured to the inner member 2432, and the other end of the elastic tube 2438 is secured to the washer housing 2310 or another headgear component. In other examples, the inner member 2432 can be coupled to the washer housing 2310, and the first end of the elastic tube 2438 can be secured to the outer member 2430. The elastic tube 2438 can be made from or include, for example, a fabric such as a knitted or braided material, silicone, or a TPE (thermoplastic elastomer). One end of the filament 2300 can be secured or fastened to the inner member 2432 or the outer member 2430. The opposite end of the inelastic filament 2300 forms or includes an end stop 2303. The longitudinal axis of the filament 2300 can be aligned (e.g., parallel or coaxial) with the longitudinal axis of the elastic tube 2438.

[0098] 80C and 81A, the inner member 2432 and outer member 2430 overlap to their full or maximum extent, and the headgear is at its minimum size or length. As the headgear 2200 is stretched or elongated, for example to put on and / or take off, the inner member 2432 and outer member 2430 slide relative to one another to reduce the overlap therebetween, and the filament 2300 is pulled through the washer housing 2310, with the washer 2312 engaging the filament to provide resistance to elongation, causing the elongation-resistant elastic tube 2438 to stretch and be placed under tension, as shown in FIGS. 80D and 81B. The end stop 2303 can provide a stop or limit to the sliding of the inner member 2432 and outer member 2430 relative to one another and / or the amount the elastic tube 2438 is allowed to stretch. The washer housing 2310 contacts the end stop 2303 when the headgear reaches its maximum length during extension, and the end stop 2303 prevents, inhibits, or reduces the possibility of further movement or displacement of the washer housing 2310 and filament 2300 relative to one another. When the extension force is released, the headgear 2200 automatically retracts, as shown in FIG. 81C . The internal force of the elastic tube 2438 causes the elastic tube 2438 to recoil and / or retract. The retraction force provided by the elastic tube 2438 pushes the outer member 2430 and inner member 2432 back toward one another so that the overlap between them increases, and / or pushes the filament 2300 back through the washer housing 2310 (in the opposite direction as during extension), thereby releasing the washer and reducing or minimizing resistance to the filament 2300 moving through the washer housing 2310.

[0099] In some circumstances, the filament of an automatically adjustable headgear mechanism may buckle or bend during retraction. This may prevent, inhibit, or reduce the ability of the adjustment mechanism and / or headgear to smoothly retract to a smaller size to fit the user, which may compromise the seal between the mask interface and the user's face and / or reduce user comfort. If the force required to bend or buckle the filament is less than the resistive force applied to the filament by the washer mechanism, the filament may buckle. The filament may then bend or buckle before entering the washer housing and washer. For example, FIGS. 82A-82B show an example automatically adjustable headgear mechanism including an inelastic filament 2300 disposed within and extending through an elastic braid 2302. One end of the braid 2302 is connected to the end of the yoke 2202, and the other end of the braid 2302 is connected to the rear strap 2204 of the headgear. FIG. 82B shows the filament 2300 in a buckled state. The issue of potentially bending or buckling filaments may be accentuated in embodiments where the braid 2302 has an increased neutral or minimum length to provide a wider range of sizing.

[0100] To address this issue, in some examples, as shown in FIGS. 83A-83C , the automatically adjustable headgear mechanism includes a support beam in the form of a braided core 2440 that slides within the braid 2302. The filament 2300 can be permanently bonded to the braided core 2440, for example, by overmolding. The braided core 2440 can be integrally formed with the plastic headgear or headgear component and / or can be permanently bonded to the headgear straps, such as the rear straps 2204, for example, by intramolding as described above. Examples of intramolding processes and intramolded products are described in PCT Publication No. WO 2016 / 043603 and U.S. Patent Application Publication No. 2016 / 0074614, which are hereby incorporated by reference. Intramolded headgear straps in some embodiments include a tube of fabric with an integrated plastic core. The braided core in these embodiments can include an extension of the plastic core beyond the fabric layer. That is, the braided core comprises plastic without an integrated fabric layer. The braided core 2440 may be flexible, but may be relatively more flexible than the filament 2300, for example, because the braided core 2440 is made of or comprises a material that is relatively harder or stiffer than the filament 2300 and / or due to the relative dimensions of the braided core 2440 and the filament 2300 (e.g., the braided core 2440 may be thicker than the filament 2300, which may provide greater stiffness to the braided core 2440 compared to the filament 2300). The elastic braid 2302 may have a minimum length X1 substantially equal to the length of the braided core 2440. The braided core 2440 advantageously increases the stability of the adjustment mechanism by providing additional structure to at least a portion of the adjustment length of the adjustment mechanism compared to the filament 2300 alone. For example, the braided core 2440 provides structure and support to the braid 2302, improving the ability of the braid 2302 to transfer loads applied to the mask interface 2102 via the yoke 2202 to the headgear 2200, thereby improving the stability of the mask on the user's face.Reducing filament buckling can help shorten or minimize the working length of the adjustment mechanism. In the illustrated example, a washer housing 2310 is included in the yoke 2202 that couples to the mask interface during use, and the filament 2300 extends through the washer housing 2310 to a line track 2201 in the yoke 2202. The headgear can include two such adjustment mechanisms, one on each side of the user's head during use.

[0101] For example, in the neutral position shown in FIG. 83A, the braided core 2440 abuts either the end cap 2203 (e.g., as shown) or the washer housing 2310 (e.g., by extending through the end cap 2203 as shown in FIG. 87 and described in more detail herein or in examples not including a yoke 202 and / or shown in FIGS. 75A-81C). As the headgear 2200 is stretched or elongated, for example to don and / or doff, the elastic braid 2302 is stretched, the braided core 2440 and inelastic filament 2300 slide within the elastic braid 2302, and the filament 2300 is pulled through the washer housing 2310, with the washer engaging to provide resistance to the elongation, as shown in FIG. 83B. The elastic braid 2302 has a maximum extended length X2. As the elastic braid 2302 is stretched, it is partially supported by the braid core 2440, and a length of the elastic braid 2302 is supported only by the filament 2300. When the elastic braid 2302 is stretched to its maximum or full extent and maximum length, the length Y of the elastic braid 2302 not supported by the braid core 2440 is equal to the difference between X2 and X1. When the stretching force is released, the headgear 2200 automatically retracts, as shown in FIG. 83C. The internal force of the elastic braid 2302 causes the elastic braid 2302 to recoil and / or retract. The retraction force provided by the elastic braid 2302 pushes the filament 2300 back through the washer housing 2310 (in the opposite direction to that during stretching), which causes the washer to release and reduce or minimize resistance to the filament 2300 moving through the washer housing 2310. Once the headgear is fitted to the user, the headgear stabilizes at a balanced fit length, as shown in FIG. 83C. The balanced fit length can match or substantially match the circumference of the user's head. At the balanced fit length, the elastic braid 2302 can have a minimum length X1 to a maximum length X2, depending on the size of the user's head, and the length Z of the elastic braid 2302 not supported by the braid core 2440 can be less than Y.

[0102] 84A-84B illustrate an exemplary embodiment of a braided core 2440. The filament 2300 can be permanently joined to the free end 2442 of the braided core 2440, for example, by overmolding. The fixed end 2444 of the braided core 2440 can be permanently joined to a headgear strap, such as the rear strap 2204, for example, by overmolding or intramolding. A portion of the braided core 2440 adjacent to or near the fixed end 2444 can include a feature 2448 designed to help improve the strength of the mechanical connection between the braided core 2440 and the headgear strap. The feature 2448 can include a ribbed edge and / or an opening, as shown. Any other suitable shape can be used. The opening can facilitate the formation of a mechanical bond between the overmolded material of the headgear strap and the braided core 440.

[0103] In the illustrated example, the braided core 2440 is curved, which may allow the braided core 2440 to follow the curvature of a user's head during use. The curvature of the braided core 2440 may also or alternatively help keep the headgear 2200 open when not in use and / or during donning and doffing (e.g., so that the headgear 2200 retains or maintains its hoop-like structure or shape), which may help improve easy attachment of the headgear 2200 to a user. The braided core 2440 may help prevent, inhibit, or reduce the possibility of the headgear straps or braid becoming tangled or entangled with themselves and / or other portions of the headgear. The curvature of the braided core 2440 may help guide the filament 2300 into the washer housing 2310 in the correct direction, which may help reduce or minimize twisting of the filament 2300, which may prevent the adjustment mechanism from functioning effectively.

[0104] The braided core 2440 has a width W that is narrower or smaller than the width of the braid 2302 when the braid 2302 is fully extended as shown in FIG. 83B . This width difference may help reduce or prevent friction between the braided core 2440 and the braid 2302 from limiting the elongation of the braid 2302. The width W of the braided core 2440 is greater than the thickness T of the braided core 2440. The smaller thickness T compared to the width W may allow the braided core 2440 to flex in the direction of the thickness T and / or curvature, thereby allowing the headgear to more easily conform to the shape of the user's head. The increased width W compared to the thickness T helps provide stability of the mask interface 2102 in the up and down direction to the user during use. The width of the braided core 2440 may taper toward the free end 2442 (i.e., so that the free end 2442 is narrower than the portion of the braided core 2440 near the fixed end 2444). The tapered width can help prevent, inhibit, or reduce the possibility of the free end 2442 getting caught or caught inside the elastic braid 2302 when the headgear is shrunk in size. The tapered width can allow for even distribution of forces along the length of the braided core 2440. The tapered width makes the free end 2442 more flexible than the fixed end 2444, which can reduce the difference in flexibility between the free end 2442 and the filament 2300. Alternatively, if the braided core 2440 is significantly stiffer than the filament 2300, a hinge point may form at or near the junction between the filament 2300 and the braided core 2440. Thus, the filament 2300 may be more likely to bend or twist at the hinge point as a result of the force applied by the restricting mechanism, which can reduce the functionality of the adjustment mechanism. In some examples, the braided core 2440 includes a notch 2450, i.e., a region of reduced thickness, as shown in FIG. 85A . The notch 2450 can be positioned near the free end 2442 or relatively closer to the free end 2442 than the fixed end 2444. The notch 2450 can provide increased flexibility near the filament 2300, which can help guide the filament 2300 into the washer housing 2310.The notch 2450 can help prevent, inhibit, or reduce the likelihood that the junction between the braided core 2440 and the filament 2300 will become a hinge point at which the filament 2300 will bend or twist as a result of a sudden change in stiffness.

[0105] In some instances, for example as shown in Figures 85A and 85B, two braided cores 2440 can be formed in a single injection molding process shot, which can improve ease and efficiency of manufacturing.

[0106] FIGS. 86A-86B show another exemplary embodiment of a braided core 2440. The width W of the braided core 2440 in FIGS. 86A-86B has an increased taper toward the free end 2442 compared to the example in FIGS. 84A-84B. The taper may facilitate more even distribution of loads applied to the filament 2300 along the length of the braided core 2440. A portion of the braided core 2440 adjacent to or near the fixed end 2444 may include an engineered shape 2448 that helps improve the strength of the mechanical connection between the braided core 2440 and the headgear strap. The shape 2448 may help improve alignment with an overmolding tool. In the illustrated example, the shape 2448 includes an end A that is overmolded into the headgear strap, e.g., the end of an intramolded headgear strap. The end A may include an opening 2452 that forms part of the mechanical joint between the braided core 2440 and the headgear strap. In the illustrated example, end A is rectangular, but end A can be any suitable shape and / or include notches, ridges, and / or other features that provide strength to the overmolded joint formed with the headgear strap. Portion B of braided core 2440 can help align braided core 2440 within an overmolding tool. As shown, portion B can be adjacent to end A. Portion B can include openings 2454 that receive protrusions of the overmolding tool to prevent, inhibit, or reduce the possibility of movement of braided core 2440 when material is injected into the overmolding tool. In some embodiments, portion B has an increased thickness T2 compared to thicknesses T1 and T3 of end A and remaining portion C of braided core 2440 (e.g., the portion extending from portion B to free end 442), as shown in FIG. 86B . The increased thickness T2 advantageously allows the outer surface of the braided core 2440 to abut against the inner surface of the mold cavity in the overmolding tool, which can help improve alignment and positioning of the braided core 2440 within the tool.

[0107] In some examples, the braid core 2440 can have a width W that is wider or larger than the width of the braid 2302 when the braid 2302 is fully extended. This may allow the braid core 2440 and the braid 2302 to provide a soft stop for the adjustment mechanism, minimizing or preventing further elongation of the adjustment mechanism, and therefore the headgear size, when the braid 2302 is extended to reduce its width to the same width as the width of the braid core 2440. Once the braid 2302 is extended so that its width matches the width of the braid core 2440, friction between the braid core 2440 and the braid 2302 limits further elongation of the braid 2302. This soft stop may prevent, inhibit, or reduce the possibility of the filament 2300 becoming disengaged from contact with the washer. Disengagement may prevent, inhibit, or reduce the possibility of the adjustment mechanism functioning properly. In some examples, the thickness of the braided core 2440 can be greater than the width of the braided core 2440. This arrangement can provide increased radial stiffness to the user's head during use and / or can help reduce side-to-side movement of the mask on the user's face.

[0108] In some examples, as shown in FIG. 87 , for example, when the headgear is in a neutral (minimum length) position, the braided core 2440 can extend into the end cap 2203 or the end of the yoke 2202. This configuration can enhance the engagement between the braided core 2440 and the yoke 2202, which can help improve the stability of the mask. This configuration can also, or alternatively, help prevent, inhibit, or reduce the possibility of the braid 2302 twisting and / or the yoke 2202 and / or interface 2102 inverting relative to the headgear 2200 when not in use. The greater the distance that the free end 2442 extends into the end cap 2203 or yoke 2202, the greater the likelihood that the braided core 2440 will engage the yoke 2202 when the headgear is attached to a user.

[0109] 88-97, the nasal seal component 3102 of a further example of the nasal mask interface 3100 will be described in further detail. The nasal seal 3102 is flexible and soft and may be formed from a silicone material or other suitable material.

[0110] Referring to the face-contacting, or wearer-side, side of the nose seal 3102 shown in FIG. 88 , a contact surface generally designated 3120 is configured to seal around the user's nose, including over the bridge of the user's nose. In this example, the contact surface 3120 surrounds the nose and seals around the user's nose. In this embodiment, the contact surface portion of the nose seal includes an upper lip region generally designated 3121 configured to contact the upper lip region of the user's face, such as at a location above the vermilion lip and below the nostrils. The contact surface 3120 also includes left and right cheek, or side, regions 3123 extending between the upper lip region 3121 at the bottom of the seal 3102 and a region 3125 at the top of the seal 3102 corresponding to or proximal to the bridge of the nose region. The cheek regions 3123 of the contact surface 3120 are configured to contact the user's inner cheek surfaces and / or lateral nasal surfaces of the user on either side of the nose. The nasal bridge region 3125 of the contact surface 3120 is configured to extend over the nose and contact the nasal bridge region of the user's nose, connecting the two cheek regions 3123. The overall shape and configuration of the contact surface 3120 is configured to closely conform to and engage the contours of the user's face around the nose when secured to the user's head via the headgear and when the nasal mask interface receives a flow of gas. The nasal seal 3102 can be considered to be inflatable because, under pressure, the seal presses the face contact surface 3120 against the user's face and deforms to form a substantial seal with the contours of the user's face, including one or more of the upper lip, inner cheeks, lateral nose, and bridge of the nose.

[0111] The contact surface 3120 of the nasal seal 3102 terminates in an inner peripheral edge 3122 that defines a nasal receiving opening to the mask cavity when the seal 3102 is assembled to the seal housing 3104 .

[0112] 96 and 97, the nasal seal 3102 is substantially defined by a face-contacting surface portion 3120 and a sidewall portion 3126 which extends rearwardly from the contacting surface 3120 around the periphery of the seal and terminates at a connecting edge, generally indicated at 3127, on the exterior or outside of the seal which is mated to or connectable to an opening 3140 in the seal housing 3104. As mentioned above, in this example the nasal seal 3102 is releasably connectable to the seal housing, and the terminal edge of the sidewall 3126 includes a peripheral channel 3128 configured to engage with a complementary peripheral ridge or extension provided on the opening 3140 in the seal housing 3104. As mentioned above, in alternative embodiments the flexible nasal seal 3102 can be permanently or semi-permanently connected or bonded to the seal housing 3104, such as via overmolding, welding or other connecting methods. In a further alternative, the interface may be provided with a semi-rigid or rigid clip component that is molded to correspond to the connecting edge 3127 on the exterior or outside of the nasal seal. In such an example, the connecting edge 3127 of the seal may be overmolded or otherwise permanently connected to the rigid clip component to provide a rigid edge or portion on the exterior of the seal. The rigid clip component may be configured to couple the nasal seal to the base or housing by engaging or otherwise connecting with a complementary base or housing component.

[0113] 97, the face-contacting surface 3120 of the nose seal forms a flange that curves or extends inward from the side wall 3126 portion of the nose seal. In this embodiment, the area at or towards the terminal edge 3127 of the side wall 3126 may be a thickened area relative to the remainder of the side wall and the contact surface portion of the nose seal to accommodate the connecting channel 3128 or otherwise provide external stability to the overall shape of the nose seal.

[0114] As discussed, the nose seal 3102 is formed from a flexible, soft material such that the nose seal 3102 is flexible relative to the rigid housing 3104. By way of example, the seal 3102 may be formed from a silicone material or the like.

[0115] The nasal seal 3102 includes an under-nose support 3124 (or nasal mask sling) that, when the nasal seal 3102 is assembled to the seal housing 3104, at least extends or hangs laterally between each side of the seal and across the nasal seal within the mask cavity 3106. The under-nose support 3124 is configured to contact at least a portion of the under-nose surface of the user's nose to counteract the resulting lifting forces generated when the nasal mask is donned and used as described above.

[0116] In this example, the under-nose support extends at least laterally across the nose seal between opposite left and right sides of the nose seal. As shown, the under-nose support is disposed or positioned behind or posterior to the nose seal opening 3106. The under-nose support 3124 is fixedly connected to the nose seal in that it is non-removable. In one form, the under-nose support 3124 is integrally molded into the nose seal. It will be appreciated that in alternative forms, the under-nose support portion or portion of the nose seal 3102 can be formed separately and then fixedly coupled into the nose seal via adhesive, welding, or the like, or it can be connected to the seal housing.

[0117] In this example, the under nose support arrangement 3124 includes an elongated main lateral portion or band 3129 that extends across and into the nose seal, such as suspended between opposing sides of the seal. Referring to FIGS. 89, 92, and 97, the main lateral portion 3129 of the under nose support connects to or extends from the nose seal at a location that is spaced apart or displaced from at least the peripheral opening edge 3122 of the contact surface 3120, but in this example is completely separated or displaced from the contact surface 3120 such that the lateral portion 3129 does not inhibit or reduce sealing engagement or deformability of the contact surface 3120 with the user's face in the cheek and / or lateral nose regions 3123. In this example, the main lateral portion 3129 extends or is connected to a location 3131 on the inner surface of the opposing sidewall 3126 portions of the nose seal rearward of the contact surface 3120. In this example, the connection location 3131 coincides with or includes the terminal edge 3127 of the side wall 3126, although this is not required.

[0118] In this example, the under nose support 3124 further includes a central extension 3132 extending centrally from the main lateral portion 3129 and coupled or connected to the opening edge 3122 of the contact surface 3120 in the upper lip region 3121. In alternative examples, the central extension 3132 may instead be connected to a lower portion of the upper lip region 3121 of the contact surface 3120 below the opening edge 3122 of the seal, or may be connected at a location at least partially or wholly displaced or spaced apart from the contact surface 3121, such as connected to a lower portion of the side wall 3126 of the nose seal posterior to the contact surface 3120.

[0119] The under-nose support 3124, including the main lateral portions 3129 and the central extension 3132, provides a contact surface configured and / or oriented to contact at least a portion of the under-nose surface of the user's nose during use. In this configuration, the primary contact surface of the main lateral portions 3129 is configured to engage at least a portion of the tip of the under-nose surface of the user's nose, which may include, for example, the tip of the post and a portion of the alar rim toward the tip of the nose. The central extension 3132 is configured to contact the post region of the under-nose surface of the user's nose or at least a portion of the post between the tip and base of the nose, but preferably the majority of the post extending from the base. The final contact surface area of ​​the under-nose support depends on the shape and size of the user's nose. The configuration of the under-nose support is designed to contact one or more maximum portions of the under-nose surface without substantially obstructing the user's nostrils, which tend to align with the open spaces 3134 on either side of the central extension 3132. Depending on the size and shape of the user's nose, the under-nose support 3124 is generally configured to, in best case, avoid completely blocking the user's nostrils, but, in worst case, only partially block one or both nostrils.

[0120] As shown, the contact surface of the under-nose support 3124 is generally oriented and configured relative to the nose seal to engage the under-nose surface of the user's nose. In this example, a portion of the under-nose support 3124 is an integral narrow web or strip of the nose seal formed during molding of the seal. For example, the thickness of the under-nose support perpendicular to its contact surface is significantly less than the corresponding width of the contact surface at any location on the under-nose support. In one configuration, the thickness of the under-nose support portion can be substantially similar to the thickness of the seal in the region of the nose seal contact surface 3120.

[0121] In this example, the width of the major lateral portions 3129 of the under nose support 3124 may vary along its length between opposing sides of the nose seal. In this example, the width W1 of the major lateral portions 3129 may gradually increase from the center of the nose seal toward each side. In this example, the width W2 of the central extension 3132 of the under nose support 3124 gradually increases as it extends from the major lateral portions 3129 to the contact surface 3120. It will be understood that in alternative examples, the widths of either or both of the major lateral portions or central extensions may be uniform along their lengths or may have alternative width profiles along their lengths.

[0122] 97, a central seal axis BB is defined as extending tangentially between the outer uppermost and lowermost contact points at the center of the contact surface 3120 when in a relaxed state (e.g., not in use). As shown in FIG. 97, at least a portion of the contact surface of the under-nose support 3124 in the central region of the under-nose support (e.g., indicated by axis CC extending coincident with the contact surface of the under-nose support in the central region) extends at an angle θ relative to the seal axis BB such that the contact surface of the under-nose support is not parallel to or aligned with the seal axis BB. In this example, the contact surface in the central region of the under-nose support 3124 is oriented at an angle offset from the seal axis BB by an angle ranging from approximately 30 to approximately 90 degrees, more preferably from approximately 45 to approximately 75 degrees, and more preferably approximately 60 degrees. This angular orientation of at least the primary nose-contacting portion or surface of the under-nose support in the central region is configured to substantially align with the general or typical angular orientation of the under-nose surface of a user's nose when the nose is within the nose seal.

[0123] As explained above, the under-nose support 3124 is fixedly connected to or is an integral component of the nasal seal 3102. The accompanying drawings show the nasal seal and its under-nose support 3124 in a resting state, i.e., when not in use. Like the contact surface 3120 of the nasal seal, the under-nose support 3124 is also configured to be soft, flexible, or pliable so that its shape and position can conform to the under-nose surface of the user's nose with a sling-like effect when the nasal mask interface is secured to the user's face or otherwise worn in use. Typically, the under-nose support is non-elastic in any direction, but in alternative examples it may have some elasticity.

[0124] 98-118, the nasal seal 3202 of the nasal mask interface 3200 will be described in further detail. The nasal seal 3202 is flexible and soft and may be formed from a silicone material or other suitable material as will be understood by those skilled in the art.

[0125] Referring to the face-contacting, or wearer-side, side of the nose seal 3202 shown in FIG. 98 , the contact surface is generally designated 3220 and is configured to seal around the user's nose, including over the bridge of the user's nose. In this example, the contact surface 3220 surrounds at least a portion of the nose and seals around that portion of the user's nose. The contact surface 3220 of the nose seal includes an upper lip region, generally designated 3221, configured to contact the upper lip region of the user's face, such as above the vermilion lip and below the nostrils. The contact surface 3220 also includes left and right cheek, or side, regions 3223 extending between the upper lip region 3221 at the bottom of the seal and an upper region 3225 corresponding to or proximal to the nasal bridge region at the top of the nose seal 3202. The cheek regions 3223 of the contact surface 3220 are configured to contact the user's inner cheek surfaces and / or lateral nasal surfaces on either side of the nose. The nasal bridge region 3225 of the contact surface 3220 is configured to extend over the nose, contact the nasal bridge region of the user's nose, and connect the two cheek regions 3223. As described in more detail below, in this example, the nasal seal 3202 includes a lower profile height dimension than a conventional nasal mask, such that the nasal bridge region 3225 of the contact surface is configured to contact the bridge of the user's nose in a central region of the bridge, at a location on the bridge between the lower tip of the user's nose between the user's eyes and the higher tip of the bridge. In this example, the nasal bridge region 3225 of the contact surface 3220 is configured to contact the bridge of the user's nose in a region of the bridge below the user's eyes. In one example, the nasal bridge region 3225 of the nasal seal is configured to contact the bridge of the user's nose in a region defined between the nostrils and the center of the bridge. In one example, the nasal bridge region 3225 of the nasal seal is configured to contact the lower half of the user's nose.

[0126] 103, in this example, the nasal bridge region 3225 of the contact surface 3220 includes a central valley region or portion, designated 3245, that is recessed relative to the remainder of the contact surface. The valley region 3245 is configured to engage the bridge of the user's nose and is shaped to substantially conform to the bridge of the user's nose.

[0127] The overall shape and configuration of the contacting surface 3220 is configured to sealingly conform to and sealingly engage the contours of the user's face about the nose when secured to the user's head via the headgear and when the nasal mask interface is subjected to a flow of gas. In this example, the nasal seal can be considered to be inflatable because under pressure the seal deforms to press the face contacting surface 3220 against the user's face and form a substantial seal against the contours of the user's face, including one or more of the upper lip, inner cheeks, lateral nose, and bridge of the nose.

[0128] The contact surface 3220 of the nose seal 3202 terminates in an inner periphery 3222 that defines a nose receiving opening or nasal mask opening 3206 that leads to the mask cavity. The mask cavity is defined or formed when the nose seal 3202 is assembled or connected to the seal housing 3204. Referring to FIG. 99, the outside of the nose seal opposite the face contacting side of FIG. 98 is shown. The outside of the nose seal 3202 connects to the seal housing 3204. In this example, the outside of the nose seal 3202 terminates in a connecting edge 3227 that defines an outside or housing opening 3228 for receiving or connecting with the seal housing 3204.

[0129] Referring to Figure 102, the outer connecting edge 3227 of the nasal seal 3202 does not coincide with a single plane or extends within a single plane. Referring to Figures 99 and 102, the outer connecting edge 3227 of the nasal seal includes an upper edge 3227A, a lower edge 3227B, and lateral side edges 3227C, 3227D extending between the upper edge 3227A and the lower edge 3227B. The upper edge 3227A protrudes rearward from the lateral side edges 3227C, 3227D. At least a central portion of the lower edge 3227B may protrude rearward from the lateral edges 3227. At least a central portion of the upper connecting edge 3227A protrudes rearward beyond both the lateral edges 3227C, 3227D and the lower edge 3227B. As shown in FIG. 104, the upper edge 3227A projects or bulges outward to a peak in the center of the nose seal.

[0130] The nasal mask opening 3206 formed on the face-contacting side of the nose seal 3202 is generally or semi-triangular in shape to match the natural geometry of the human nose. The housing opening 3228 on the exterior of the nose seal 3202 is generally or semi-rectangular in shape.

[0131] 98 and 99, the under nose support 3224 can be seen, and is generally concave or U-shaped with three connection or attachment points to or within the nose seal 3202. As shown, the under nose support 3224 is suspended like a sling or hammock between two upper connection points 3231 located at opposite upper lateral positions or surfaces within the nose seal 3202. In particular, the upper lateral connections 3231 are disposed on the inner surface of the nose seal 3202, one on each side of the central apex region of the nasal opening 3206. The lateral connections 3231 of the under nose support 3224 are configured or arranged vertically such that the inner surfaces or contacting surfaces of the under nose support 3224 are substantially face-to-face or opposed at or towards the lateral connection points 3231. In particular, the lateral contacting surfaces of the under nose support 3224 may be substantially parallel to each other at or towards the lateral connection points 3231. The under nose support 3224 further includes a third connection at or toward the bottom center of the nose seal. A bottom central connection point 3232 joins or joins at the bottom center region of the edge 3222 of the contact surface 3220 of the nose seal that defines the nasal opening 206. The under nose support 3224 and its connections are described in more detail below.

[0132] 102-104, the nose seal 3202 is substantially defined by a face-contacting surface portion 3220 (shown in FIG. 98) and a sidewall portion 3226 (shown in FIG. 102) that extends rearward from the contacting surface around the periphery of the seal and terminates at a connecting edge 3227 on the exterior or outside of the seal where it joins or is connected to the seal housing 3204. The nose seal 3202 may include a variable thickness profile or region that extends from the nasal opening edge 3222 on the face-contacting side of the nose seal to the connecting edge 3227 on the exterior of the nose seal.

[0133] The nose seal 3202 includes at least a first front region generally designated 3233 extending from the nasal opening edge 3222 to an intermediate peripheral boundary 3235 located at the side wall portion 3226, and a second rear region 3234 extending from the intermediate peripheral transition boundary 3235 to a connecting edge 3227 on the outside of the seal.

[0134] The front region 3233 includes the contact surface 3220 and at least a portion of the side wall portion 3226 of the nose seal adjacent the contact surface 3220. The rear region 3234 includes the remaining portion of the side wall portion 3226 extending rearward from the transition boundary 3235 to the connecting edge 3227.

[0135] 107 , the front region 3233 of the nasal seal, which includes the contact surface, is thinner, or has a reduced thickness, on average, compared to the rear region 3234 of the nasal seal. The nasal seal further includes an additional, third thickness region 3236 within the front region 3233. In particular, the front region 3233 transitions to a thinner edge region 3236 adjacent the nasal opening edge 3222. The edge region 3236 is thinner than the remainder of the front region 3233. The edge region 3236 is a small portion of the front region 3233.

[0136] The described thickness profile provides stability to the nasal seal 3202 and enhances sealing engagement with the user's nose. In particular, the thicker posterior region 3234 provides stability to the overall shape of the nasal seal, while the reduced thickness of the anterior region 3233, including the contact surface 3220, facilitates conformance of the nasal seal with the user's nose. Furthermore, the edge region 3236 around the nasal opening edge 3222 is the thinnest portion of the contact surface 3220, improving user comfort and seal conformance. It will be understood that the thicknesses of the posterior region 3234, anterior region 3233, and edge region 3236 may be uniform within each region or may have varying thicknesses within the regions. For example, the posterior region 3234 gradually decreases in thickness from the contact edge 3227 to the intermediate transition boundary 3235. The anterior region 3233 is substantially uniform in thickness throughout the majority and slightly thinner edge 3236, with the edge 3236 having a reduced uniform thickness compared to the majority of the anterior region. The majority of the front region 3233 gradually transitions into a thinner edge region 3236, as shown in the body transition region 3237 in FIG. 107. As shown in FIG. 107, the face-contacting surface 3220 of the nose seal forms a flange that curves or extends inwardly from the sidewall portion 3226 of the nose seal, the flange including the thinned edge 3236.

[0137] The under-nose support 3224 of the nasal seal 3202 is in the form of a nasal sling or hammock that extends across or laterally hangs at least a central portion of the nasal seal within the mask cavity, and is configured to contact at least a portion of the under-nose surface of the user's nose so as to counteract any lifting forces that arise when the nasal mask is donned and caused by the pressurized gas flowing as described above during use.

[0138] The under nose support 3224 is completely defined or enclosed within the outer envelope of the nose seal, i.e., it does not protrude or extend beyond the connecting edge 3227 on the outside of the nose seal where it connects to the seal housing and the contacting surface edge 3222 of the nasal opening 3206. However, it will be appreciated that in alternative examples, at least a portion of the under nose support 3224 may protrude beyond the housing opening defined by the connecting edge 3227.

[0139] The under-nose support 3224 hangs laterally across a central region of the nose seal 3203 between the left and right sides of the nose seal. As shown, the under-nose support is disposed or positioned behind or posterior to the nasal opening or aperture 3206 on the face-contacting side of the nose seal. The under-nose support 3224 is fixedly connected to the nose seal in that it is not removable in this embodiment. In one form, the under-nose support is integrally molded into the nose seal. In an alternative form, the under-nose support or portion of the nose seal can be formed separately and then fixedly coupled into the nose seal via adhesive, welding, or the like, or it can be connected to the seal housing.

[0140] The under nose support arrangement 3224 includes an elongated main lateral portion or band 3229 that extends laterally within the nose seal across at least a portion of the nose seal. Referring to FIGS. 98-99, 105-107, and 108, the main lateral portions 3229 of the under nose support 3224 are suspended or connected at each opposite end to respective upper connection points 3231 located on the upper inner surface of the nose seal on either side of the seal relative to the apex region of the nasal opening 3206. The distal ends of the main lateral portions 3229 of the under nose support 3224 are connected to the inner surface of the nose seal via respective reinforcing portions or regions in the form of, for example, ribs 3241. The ribs 3241 extend substantially perpendicularly from an upper lateral location within the inner surface of the nose seal and extend to or connect to the distal ends of each of the main lateral portions 3229 at the connection locations 3231. The ribs 3241 are integrally molded with the main lateral portions 3229 of the under nose support 3224. It will also be understood that the ribs 3241 at the ends of the main lateral portion 3229 may be considered part of the under-nose support and the main lateral portion 3229. In other words, the reinforcement portion or region 3241 may be considered an extension of the main lateral portion or simply the end of the main lateral portion. Alternatively, the reinforcement portion or region may be considered a separate component or structure that is connected to or integrally formed with the end of the main lateral portion. The function and effect of the reinforcement portion or rib 3241 remains substantially the same in either interpretation.

[0141] 106, the ribs 3241 are part of a peripheral edge that is joined to or extends from an area of ​​the inner surface of the nasal seal, including the posterior region 3234 and a portion of the anterior region 3233. The ribs extend across a portion of the posterior region 3234 and a majority of the anterior region 3233, including the contact surface, but excluding the thinned edge region 3236 adjacent the nasal opening. However, it will be understood that in alternative examples, the ribs 3241 may extend from, contact, or extend into at least a portion of the thinned edge region 3236. The major lateral portions 3229 of the under-nose support connect to the respective ribs 3241 at the portions of the ribs that extend with or coincide with the thicker posterior region 3234 of the nasal seal wall. The ribs 3241 provide a rigid connection within the nasal seal to the major lateral portions 3229 of the under-nose support 3224, and also provide the dual function of structural support to the nasal seal by increasing the rigidity of the areas or regions of the nasal seal that contact the patient on either side of the nose. In particular, the ribs 3241 are located or disposed on either side of an upper valley region 3245 of the contact surface 3220 (see FIG. 103 ) that is associated with the nasal bridge region of the contact surface 3220. In particular, the ribs or panels 3241 prevent the nasal seal from collapsing under excessive compressive forces, while also allowing a secure connection between the under-nose support and the inner surface of the nasal seal.

[0142] In some forms, the ribs can also function, directly or indirectly, to provide feedback to the user when the mask is overtightened. As described further below, the buckling of the ribs can be configured to, for example, compress the user's nose under increased compression of the nose seal due to tightening of the headgear, and / or to deform or change the shape of the under-nose support so that portions of the contact surface adjacent to or associated with the ribs gradually press tighter against the sides of the nose. In other words, the buckling of the ribs initially provides an increased / improved seal with the interface, minimizing leakage in that area, but once the headgear is tightened beyond its intended limits, the buckling ribs provide further compression while providing feedback indicating that the headgear is too tight.

[0143] 106, a recessed region or zone 3243 is provided or formed between the front portion 3242a of the rib 3241 and the rear portion 3242b where it connects to the major lateral portion 3229 of the under-nose support 3224. This recessed region 3243 forms a buckling zone or axis 3242 in each rib 3241. The buckling axis 3242 extends from and toward the thickness region transition boundary 3235 and the apex of the recessed region 3243.

[0144] In some configurations, the buckling axis 3242 allows the rib 3241 to buckle outwardly toward the adjacent inner surface of the associated side wall of the nose seal during use when the nose seal is compressed in its depth dimension when worn by a user. This buckling of the rib allows the front region 3242a of the rib 3241 to bend or compress inward toward the user's nose, strengthening the seal formed during use and may also lift the under-nose support against the surface under the user's nose.

[0145] In another configuration, the buckling axis 3242 allows the ribs 3241 to buckle inwardly toward one another during use when the nose seal is compressed in its depth dimension when worn by a user. This inward buckling of the ribs tightens or closes up the under-nose support 3224 in at least the lateral direction, which acts to cause the under-nose support to press or clamp against the surface of the user's nose. In other words, the inward buckling of the ribs causes the contact surfaces of the lateral regions of the major lateral portions of the under-nose support to move toward one another, effectively narrowing or tightening the U-shape of the under-nose support to press against the user's nose.

[0146] The recessed region 3243 may be an area or zone of the rib 3241 where the depth (i.e., the distance from the edge of the rib connected to the inner surface of the seal to the free periphery of the rib) or surface area is reduced relative to the rest of the rib.

[0147] Referring to FIG. 99 , the upper connection locations 3231 of the under-nose support are located at the lateral ends or side boundaries of the nose seal. In particular, the vertical connecting ribs 3241 and connection points 3231 are offset relative to the outer lateral width of the nose seal on each side. The distance between the connection locations 3231 is generally equal to or less than the outermost width of the nasal opening, as indicated by 3242A in FIGS. 98 and 99 . In particular, the connection points 3231 of the main lateral portion 3229 of the under-nose support are located within a zone co-width with the nasal opening 3206 in relation to the nose seal. The connecting ribs 3241 extend from the contact surface 3220 of the upper lateral cheek regions 3223 of the contact surface at a location that engages the user's cheeks and / or outer or lateral nose surfaces against the bridge of the nose.

[0148] 108, the major lateral portion 3229 of the under-nose support 3224 is positioned to extend laterally across the nasal seal 3202 at approximately the middle or central depth of the overall depth profile of the nasal seal in the dimension extending from the contact surface 3220 to the outermost portion of the nasal seal's outer connecting edge 3227. However, in alternative forms, the major lateral portion can be positioned to extend laterally across the nasal seal at other depths, whether closer to or further from the contact surface, and can also have portions that extend or protrude beyond the nasal seal's outer connecting edge 3227 or main envelope.

[0149] In addition to the two upper lateral connections 3231, the under nose support 3224 also includes a third connection to the nose seal. The under nose support is connected to a central lower or bottom portion of the nose seal as shown at 3232. The lower central connection of the under nose support 3224 is in the form of a central extension or connection 3232 that extends centrally from the main lateral portion 3229 and is joined or connected to the nasal opening edge 3222 of the contact surface 3220 in the upper lip region 3221 of the nose seal. The central connection 3232 has a generally hourglass-width profile. Notably, the width dimension of the central connection 3232 at both the nasal opening edge 3222 and its interface with the main lateral band 3229 is greater than the width dimension of the central connection 3232 in the center or central region. For example, the central connecting portion 3232 is an elongated portion extending from a first end 3232A joined or integrally formed with the nasal opening edge 3222 of the contact surface 3220 to a second end 3232B joined or integrally formed with the main lateral band 3229 of the under-nose support 3224 (see FIGS. 99, 100, and 105). The width dimension of the central connecting portion 3232 gradually decreases from each of its ends 3232A, 3232B toward a center or central region of reduced width, providing a generally hourglass-width dimensional profile.

[0150] 106 and 107 , the central connecting portion 3232 of the under-nose support includes a thickness profile that varies across the contact surface of the connecting portion 3232. The thickness of the central connecting portion 3232 tapers, i.e., decreases in width, from the second end 3232B of the main lateral portion 3229 to the first end 3232A of the nasal opening edge 3222. For example, the thickness of the central connecting portion 3232 at the second end 3232B is substantially equal to or uniform to the thickness of the main lateral portion or band 3229 in that region, and the thickness tapers, i.e., decreases, from the second end 3232B or at a point in the central region of the connecting portion 3232 to a reduced thickness at the first end 3232A of the nasal opening edge 3222. The reduced thickness at the first end 3232A is substantially equal to or uniform to the thickness of the nasal opening edge 3222 at the contact surface. For example, the thickness of the central connecting portion 3232 at its first end 3232A can be substantially equal to the thickness of the thinned edge region 3236 of the contact surface 3220 of the nasal seal.

[0151] 98-99 and 105, the under-nose support 3224 is configured with a curved profile across the lateral width of the under-nose support between the upper lateral connections 3231. The curved profile may vary across the lateral width of the under-nose support in some configurations, or may instead have a uniform curvature. As shown, the curved profile varies. The contact surface of the major lateral portions 3229 of the under-nose support 3224 has a steeper curved profile in a central or central region 3235 relative to a flatter curved profile in the remaining lateral or outer regions 3236 extending to the upper lateral connections 3231. For example, in the central region designated 3235, the major lateral portions 3229 are provided with a first radius of curvature that is substantially uniform within the central region 3235. The radii of curvature of the remaining lateral portions 3236 on either side of the central region 3235 can be constant or vary, but generally have a larger radius of curvature than the first radius of curvature of the central region 3235, resulting in an overall flatter curvature. The main lateral portion 3229 is or includes a curved contact surface profile across its entire lateral width without any flat regions.

[0152] The width of the contact surface of the major lateral portion 3229 of the under nose support 3224 can vary along its length between opposing sides of the nose seal. The major lateral portion 3229 includes a substantially uniform width indicated at 3238 in the central region 3235, which gradually increases in the outer lateral regions 3236 toward the connection point 3231.

[0153] 107, a central seal axis AG is defined as extending tangentially between the outermost upper and lower contact points of the central region of the contact surface 3220 when the nose seal is in a relaxed state (e.g., not in use). As shown in FIG. 107, at least a portion of the contact surface of the under-nose support in the central region is indicated by axis AH and extends at an angle defined or indicated at 3239 relative to the seal axis AG, such that the contact surface of the under-nose support is not parallel or aligned with the seal axis AG. The contact surface of the central region of the under-nose support 3224 is oriented at an angle offset from the seal axis AG in the range of approximately 40° to approximately 80°, more preferably approximately 45° to approximately 75°, even more preferably approximately 50° to approximately 70°, and even more preferably approximately 55° to approximately 65°. As shown, at least a portion of the central connecting portions 3232 also have a corresponding or aligned angular offset.

[0154] As explained above, the under-nose support 3224 is fixedly connected to or is an integral component of the nasal seal 3202. The figures show the nasal seal 3202 and its under-nose support 3224 in a resting state, i.e., when not in use. Like the nasal seal contact surface 3220, the under-nose support 3224 is configured to be soft and flexible so that its shape and position can conform like a sling or hammock to the under-nose surface of the user when the nasal mask interface is secured to or worn on the user's face. The under-nose support is not stretchable in any direction, although in alternative forms it may have some stretchability in the same directions.

[0155] The main lateral portion 3229 or band of the under nose support 3224 is generally U-shaped with some curvature across the lateral width of the under nose support. In alternative forms, the under nose support may have flat sections or portions or an overall more rectangular or square shape. For example, with reference to FIG. 112 , the under nose support shown at 3224A may have a substantially flat central horizontal portion 3229A and two substantially vertical or upstanding portions 3229B extending upwardly from each end of the central horizontal portion 3229A, each connecting at connection points 3229C to the inner surface of each upper side of the nose seal, either directly or via a rib as in the previous example.

[0156] The ratio of overall height to overall width of the nose seal 3202 ranges from about 1:1 to about 1:1.4, and in this example is about 1:1.2. The ratio of overall height to overall width to overall depth of the nose seal ranges from about 1:1:0.6 to about 1:1.4:1, and in this example is about 1:1.2:0.8.

[0157] By way of example and to provide a sense of scale, the major dimensions of one embodiment of the nose seal configuration are listed. Referring to FIG. 98, the height of the nose opening defined by the contact surface edge 3222 in the central region, indicated at 3242B, ranges from approximately 8 mm to approximately 43 mm, preferably approximately 23 mm, and the outermost width of the nose opening, indicated at 3242A, ranges from approximately 24 mm to approximately 49 mm, preferably approximately 34 mm. The overall height of the nose seal, indicated at 3242D, ranges from approximately 22 mm to approximately 72 mm, preferably approximately 47 mm, and the overall width, indicated at 3242C, ranges from approximately 47 mm to approximately 87 mm, preferably approximately 57 mm. The width of the central connection portion 3232 in the reduced-width central region, indicated at 3242E, ranges from approximately 2 mm to approximately 15 mm, preferably approximately 3 mm. Referring to FIG. 103, the overall depth of the nose seal, indicated at 3243A, ranges from approximately 29 mm to approximately 49 mm, preferably approximately 39 mm. The depth of the nose seal between the lateral contact surface 3243B and the lateral edge of the housing opening ranges from approximately 21 mm to approximately 36 mm, preferably approximately 31 mm. The depth of the nose seal between the central nasal bridge valley 3245 of the contact surface 3220 and the corresponding central housing opening edge 3227 ranges from approximately 18 mm to approximately 33 mm, preferably approximately 28 mm. The lateral width of the nose seal between the outer lateral points of the outer connecting edge 3227 of the nose seal ranges from approximately 40 mm to approximately 50 mm, preferably approximately 49 mm. Referring to FIG. 105, the height of the nose seal between the bottom edge 3222 of the nasal opening 3206 and the bottom surface of the nose seal 3202 ranges from approximately 5 mm to approximately 20 mm.

[0158] 109, the thickness of the major lateral portion 3229 of the under nose support 3224, in a direction transverse to the contact surface of the major lateral portion, designated 3244A, is from approximately 0.2 mm to approximately 3 mm, preferably approximately 1.1 mm. A central connection portion 3232 extending from the center of the major lateral portion 3229 begins with a similar thickness and then transitions to a thinner thickness as it connects to the nasal opening edge 3222 of the contact surface 3220, as shown. In this exemplary embodiment, the thickness of the edge region 3236 of the contact surface is approximately 0.2 mm.

[0159] The dimensions of various aspects of the nasal seal may be varied to accommodate patients of different sizes. The nasal seal and interface may be provided in a number of different sizes, such as small, medium, large, or multiple size categories. The nasal seal may be provided in two sizes, such as a small-medium size and a medium-large size. By way of example, with reference to FIGS. 110-118, an exemplary dimensional aspect of a small-medium nasal seal compared to a medium-large nasal seal is provided. With reference to FIGS. 110 and 111, the radius of curvature R of the central region 3235 of the major lateral band 3229 of the under-nose support ranges from approximately 8 mm to approximately 18 mm, and is preferably approximately 12.5 mm for the small-medium nasal seal, while for the medium-large nasal seal, the central region 3235 is longer and includes a substantially constant, larger radius of curvature of approximately 14 mm. Referring to FIGS. 113 and 114, the width of the central connection 3232 of the central thin region is approximately 2.9 mm in the small-medium size configuration and approximately 4.12 mm in the medium-large size configuration. Referring to FIGS. 115 and 116, the angular offset, indicated at 3239, between the axis AH of the central region of the major lateral portion 3229 and the seal tangential axis AG is approximately 64° in the small-medium size configuration and approximately 58° in the medium-large size configuration. Referring to FIGS. 117 and 118, the nasal bridge region of the contact surface of the nose seal includes a recessed valley portion 3245 as previously described. In this example, the depth of valley region 3245, indicated at 3245B, is approximately 7 mm in both the small-medium and medium-large configurations. The width of valley region 3245A, indicated at 3245A, ranges from approximately 7 mm to approximately 17 mm, and is preferably approximately 13.8 mm in the small-medium size configuration and approximately 14.1 mm in the medium-large size configuration.

[0160] As described, the nose seal is configured to have a generally rectangular shape overall, dimensionally and / or when viewed from the outside as shown in FIG. 99 and from the front or face-contacting side as shown in FIG. 98.

[0161] 119-128 describe further embodiments of a respiratory mask system adapted from the prior examples described above. However, features from the prior examples may be combined in new combinations with this embodiment, and indeed combinations may exist between the prior examples as already described.

[0162] FIG. 119 shows a schematic featuring a mask assembly 4100 for delivery of respiratory therapy to a patient. The assembly includes a mask interface 4102, such as a seal module 4104 and a frame assembly 4106, and a headgear assembly 4200. During use, a seal or cushion 4123 seals around a user's nose and / or mouth or inside the user's nares. The frame 4106 supports the seal module 4104 and operatively couples the seal 4123 to the headgear 4200 and / or gas delivery conduit 4110. During use, the seal module 4104 can be removably coupled to the frame 4106 by a yoke 4202. The seal has an under-the-nose sling and is similar in shape to the seals shown and described with respect to FIGS. 88-118.

[0163] The connection features between the yoke 4202 and the frame 4106 that further support / connect the seal 4104 are similar to the features discussed with respect to any of the prior examples, either alone or in various combinations. Additionally, the headgear 4200 preferentially includes the adjustability features outlined above with reference to at least FIGS. 11-15, 28, and 74-83. As previously mentioned, the headgear's side straps may employ elastic portions, such as elastic braids 4302, that, after being stretched in combination with the inelastic filament 4300 and washer arrangement, as described above, function as a retraction means or biasing element to retract the headgear or shorten its length. A clip arrangement 4122 (FIGS. 128A and 128B) removably connects the seal module 4104 to the frame 4106 in a manner similar to that described above with reference to the prior examples, for example.

[0164] The difference from the previous example is the use of curved support beams or linking members 4444 within the braid of the side straps 4302 to direct forces into the headgear and move the straps away from the patient's eyes. As an example, a curved support beam 4444 is used instead of a straight support beam 210 as shown in Figure 11. The support beam or linking members act as the core of the braid that is the elastic portion of the headgear adjustment mechanism.

[0165] The braid functions as the elastic portion, while the filaments are the inelastic portion extending therethrough. A washer configuration or equivalent configuration functions as the restraining mechanism. A curved support beam or beams are coupled to the inelastic portion and extend along a portion of the headgear. As previously mentioned, at least a portion of the support beam is curved along its longitudinal extension. The support beam and elastic portion configuration preferably form the side straps of the headgear. However, other configurations are conceivable that provide an adjustable halo portion configuration, such as restraining mechanisms located at the intersections between the headgear side straps and the rear halo strap.

[0166] 120, an enlarged perspective view of the seal module 4104, frame 4106, yoke 4202, and side strap 4302 portion of the headgear is shown. Particularly visible are the end caps 4250 of the yoke 4202, similar to the arrangement shown in FIGS. 12 and 28, for example, where a washer housing 270 is disposed at each distal end of the yoke 4202 and receives a filament 4220 (FIG. 122) associated with adjusting the headgear. This mechanism is described in detail above with reference to the previous example.

[0167] Also detailed with reference to the previous examples is a yoke 4202 that is removably connected to the mask frame 4106, thereby allowing the headgear arrangement 4250 to be separated from the mask frame 4106 and the seal module 4104. The seal module 4104 is also removable from the opposite side of the mask frame 4106 via a seal clip arrangement, alternatives of which have been described above.

[0168] The two removable connection aspects allow the assembly to be broken down into three main components: the mask frame 4106, the seal module 4104 and the headgear 4200. A biased vent 4445 is visible on the mask frame 4106 adjacent to the conduit connection.

[0169] 121 and 122 show side views of the mask and headgear assembly, with FIG. 122 showing an overlay of the curved support beam 4444 on the braided side strap 4102 (showing its position within the side strap 4102). The support beam is bonded to the overmolded connections 4207 of the headgear and headgear straps, a process that was previously described with reference to FIGS. 8-15.

[0170] Also, as previously mentioned, the automatic adjustment mechanism and orientation lock are configured to resist at least the blow-off force generated by the mask assembly during use, and in some configurations may also resist some hose pulling force.

[0171] FIG. 122 shows the approximate location of the connecting member 4444 within the side strap 4302. In use, the support beam 4444 is placed inside the strap as a braided core and is connected to the headgear strap at one end 4447 via an overmold. Small holes 4446 in the end 4447 aid in positioning the curved support beam within the mold assembly. The lower end 4458 of the support beam is connected to the headgear adjustment filament 4220, in some embodiments, via an overmold.

[0172] The lower end of the support beam 4444 extends along a first axis 4501 and serves as a first portion 4458 configured to be connected to an inelastic portion, such as the filament 4220, while the headgear connection end 4447 extends along a second axis 4502 and serves as a second portion configured to be connected to the top and / or rear straps. Preferably, the second axis 4502 is substantially parallel to the first axis 4501.

[0173] The support beam 4444 includes a transition portion 4459 that extends along a curve between the first portion 4458 and the second portion 4447. The transition portion 4459 extends downwardly from the second portion 4447 when in position on the user's head. The first portion 4458 preferably extends from the transition portion towards the mask.

[0174] As best seen in Fig. 122, the second portion 4447 connects to the headgear 4200 above the location of the user's ears. Preferably, the second portion 4447 connects to halo straps that provide top and back straps.

[0175] The support beam is somewhat flexible laterally relative to the contours of the user's face in use, but retains its curved shape longitudinally within the plane of the drawing, thereby ensuring that forces are directed between the headgear and the seal during use while simultaneously directing the side straps away from the user's eyes. In other words, the support beam exhibits greater resistance to buckling perpendicular to the length of the support beam than the inelastic portion in a direction perpendicular to the longitudinal axis of the inelastic portion.

[0176] The support beam 4444 may be characterized by an overall vertical drop of approximately 40 mm, e.g., the distance between the axes of the first and second portions, respectively, where the horizontal length is approximately 75 mm. The curved support beam 4444 has a height of about 3 mm with a thickness of approximately 0.8 mm. It will be apparent that the curvature smoothly reverses during use from its rear connection end 4447, through the transition portion 4459, towards the substantially horizontal first portion 4458. As noted above, the axes of the first portion 4458 and second portion 4447 are substantially parallel, although alternative configurations may be envisaged depending on the force distribution, such as the second portion following the axis of the transition portion 4459 or curving backward.

[0177] Figures 124A and 124B show a comparison of a straight support beam (e.g., of the type depicted in Figure 11) compared to the curved support beam 4444 of this embodiment. The modification of the headgear force vector provided by the embodiment of Figure 124B serves to stabilize the patient interface while aligning the blow-off forces with the headgear retention forces.

[0178] By considering the internal curve and subsequent shape of the support beam, seals having different blow-off force vectors can be used with headgear such as those described with reference to the previous examples. For example, the seal referenced in FIG. 43 may have a different blow-off force vector and different stability issues compared to other seal configurations, such as those depicted in FIGS. 126-128. Varying the shape of the side straps and / or support beams allows a common headgear type to be used with multiple seal configurations.

[0179] Although presently preferred embodiments are outlined above, the support beam can have a range of possible dimensions, such as a vertical drop of 20-60 mm, a horizontal length of 50-100 mm, a height of 1-15 mm, and / or a thickness of 0.5-1 mm. Preferably, the width of the support beam is substantially constant along its length, e.g., at least in transition portion 4459. Preferably, the thickness of the support beam is substantially constant along its length, e.g., at least in transition portion 4459.

[0180] The curved side straps of Figure 124B compared to Figure 124A provide an angular change that affects the headgear force vectors suitable for certain nasal seals that rely on an under-the-nose sling / hammock for a significant portion of the seal's vertical support on the user's face, such as the seals shown in Figures 88-118. However, curved members and / or curved side strap configurations can be implemented and configured in combination with any of the examples described herein.

[0181] Figures 125A-125C show a user sizing guide. A sizing guide is a peripheral device that a user or advisor can use to provide recommendations for the optimal seal module size for a particular individual, i.e., to assist in the selection of an appropriate seal module of the type shown in Figures 88 et seq. Such a user interface (i.e., the seal component that contacts the patient's face) has two different measurement points for size selection: the seal transverse (width) and hammock (sling) angle, which can lead to more complex decisions related to the best seal module to select. The photographic sizing guide can measure both aspects simultaneously, simplifying the decision-making process.

[0182] During use, an upper lip contact portion 4448 in the form of a silicone guard is placed against the user's upper lip. The guard 4448 protrudes from a base 4449 that should preferably be maintained in a perpendicular orientation relative to the user's face. A first (lateral) measurement panel 4450 extends perpendicularly from the base 4448 but is disposed within a flexible holder 4451 that acts as a hinge to allow the lateral width measurement panel 4450 to fold and pivot when in contact with the user's nose, as shown in FIG. 125C .

[0183] The lateral width of the user's nose is determined by covering measurement markings 4452 etched into the surface of panel 4450. The recommended measurement is the marking that remains visible while the user's nose covers panel 4450. At the same time, the pivot angle of the displaced lateral width measurement panel 4450 can be obtained by side panel 4453, which acts as a protractor (or may be more commonly referred to as an "angle reader"). This angle offset measurement can assist the user or advisor in selecting specific sling characteristics for the seal, such as a high sling or a low sling, while the general width of the seal is determined from lateral width measurement markings 4452.

[0184] Thus, the size guide device can be described as comprising a displaceable upright face-contact panel hinged to a base at a predetermined distance from the user's face. Upon contact with the user's nose, the upright panel is angularly displaceable from its upright position. The angular displacement is preferably measured by markings on a second, fixed upright wall positioned perpendicular to the edge of the displaceable panel. Furthermore, markings on the displaceable panel, such as width markings, can be aligned with the user's nose to determine specific dimensional characteristics. The nose width dimensions can be grouped into small, medium, and large categories corresponding to the sizes of the seal modules. Preferably, the sizing device is made of a partially or entirely transparent material, particularly so that the displacement of the width measurement panel is visible through the wall of the protractor.

[0185] 126A and 126B show cutaway views of a seal module with an interface clip 4122a (e.g., similar in structure to FIG. 45) and a mask frame 4106. This embodiment details a seal module 4104 in the form of a three-piece structure comprised of a seal 4123, an inner clip rigid member 4122a, and an outer clip rigid member 4122b connected to one another, e.g., via an interference fit connection, with an annular flange 4123a of the seal 4123 clamped therebetween. Connecting the inner and outer clips together is a one-time operation resulting in the completion of the seal module 4104. Both clip members are of a relatively rigid material compared to the soft material of the seal 4123. Members 4122a and 4122b may be of a different density or hardness than the seal. The clip members may have secondary benefits, such as aesthetic improvements and added support.

[0186] Figure 127 shows a seal 4123 forming intermediate where the sling portion 4129 is located on the outside of the seal during forming. The forming intermediate is an intermediate product that will ultimately be formed into a seal structure similar to, for example, Figures 88 and 89. In the forming intermediate, the sling is connected to the edge of the seal by its central extension and the sling arms are not connected.

[0187] To form the shaped intermediate into a seal structure, the sling arms 4129 can be pulled through the opening where their edges connect with the central extension 4132. The sling arms are then attached in place, e.g., over the seal's inner surface and / or an internal feature of the seal 4123, by suitable means such as overmolding, adhesives, buttons, clips, magnets, welding, or other chemical and / or mechanical processes. By forming the sling 4129 on the outside of the seal body, the resulting structure allows for multiple attachment points; therefore, the sling angle can be selected from a range of available angles, requiring only one tool. FIG. 127 shows possible attachment points 4455 for the sling arms, which, when pulled through the seal opening, can be positioned in one of multiple locations 4456. In other words, sling characteristics, such as the angle of the nose support, can be tailored for a particular seal size.

[0188] The seal 4123 of FIG. 127 can be overmolded onto the seal housing without requiring additional manufacturing steps. By externally molding the sling, the tool core can be removed by deforming the seal (e.g., silicone) enough to slide the core through the main opening. In an alternative scenario where the sling is molded in place, removing the tool core becomes complicated and the seal cannot be directly overmolded onto the seal housing.

[0189] Figures 128A and 128B provide details of a three-piece seal module assembly according to one embodiment. The assembly includes a seal 4104, a seal housing 4122, and an overmolded connection 4454. This embodiment provides an overmolded shape that bonds the seal cushion 4123 to the rigid substrate (i.e., housing 4122) via mechanical adhesion. In particular, as seen in Figure 128A, a channel 4457 having multiple openings is located below the overmolded connection 4454 in the final form of Figure 128B. The channel 4457 is occupied by the overmolded material, permanently attaching the seal housing 4122 to the seal 4123.

[0190] Due to the seal's unique geometry, which requires an internal sling, it can be difficult to use traditional overmolding methods, where the seal is molded in a straight line onto the seal housing, because the sling / hammock presents a challenge in removing the seal / housing from the tool. Creating the seal assembly in a multi-step process can reduce or eliminate this complication. Essentially, the seal and seal housing are molded separately, then the seal and seal housing are placed in an overmolding tool and locked into place, after which a separate overmolding material is injected into the cavity between the seal and seal housing, permanently joining the two components.

[0191] While the present disclosure has been described in connection with specific embodiments and examples, those skilled in the art will recognize that the present disclosure extends to other alternatives and / or uses beyond the specifically disclosed examples, as well as obvious modifications and equivalents. Additionally, while certain variations have been shown and described in detail, other modifications that are within the scope of the present disclosure will be readily apparent to those skilled in the art. It is also contemplated that various combinations or subcombinations of specific features and aspects of the embodiments can be made and still fall within the scope of the present disclosure. For example, a feature described above in connection with one example can be used with a different example described herein, and the combination will still fall within the scope of the present disclosure. It should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another to form various modes of embodiments of the present disclosure. Therefore, it is not intended that the scope of the disclosure herein should be limited by the specific embodiments described above. Thus, unless otherwise specified or clearly contradicted, each embodiment of the present invention may include, in addition to its essential features described herein, one or more features described herein from each other embodiment of the present invention disclosed herein.

[0192] It should be understood that features, materials, properties, or groups described in connection with a particular aspect, embodiment, or example are applicable to other aspects, embodiments, or examples described in this section or elsewhere in this specification, to the extent not inconsistent. All features disclosed herein (including the accompanying claims, abstract, and drawings) and / or all steps of methods or processes so disclosed may be combined in any combination, except combinations in which at least some of such features and / or steps are mutually exclusive. Protection is not limited to the details of the foregoing embodiments. Protection extends to novel or novel combinations of features disclosed herein (including the accompanying claims, abstract, and drawings) or novel or novel combinations of steps of methods or processes so disclosed.

[0193] Furthermore, certain features that are described in this disclosure in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations individually or in any suitable subcombination. Furthermore, while features may be described above as functioning in a particular combination, one or more features from a claimed combination can optionally be deleted from that combination, and the combination can be claimed as a subcombination or a variation of the subcombination.

[0194] Unless the context clearly requires otherwise, throughout the description and claims, words like "comprise," "comprising," and the like should be interpreted in an inclusive sense, i.e., "including, but not limited to," rather than an exclusive or exhaustive sense. Conditional language used herein, particularly words like "may," "could," "might," "could," "for example," and the like, is generally intended to convey that certain embodiments include certain features, elements, and / or conditions, but not other embodiments, 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 in any way required by one or more embodiments, nor is it intended to imply 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.

[0195] 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 may be approximated and / or larger or smaller, as appropriate, to reflect tolerances, conversion factors, rounding, measurement error, etc., and other factors known to those of ordinary skill in the art. Enumerations of quantities, dimensions, sizes, formulas, parameters, shapes, and other characteristics should 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 characteristic, parameter, or value need not be exactly achieved, and deviations or variations may occur, including, for example, tolerances, measurement error, limitations in measurement precision, and other factors known to those of ordinary skill in the art, taking into account the impact the characteristic is intended to provide.

[0196] 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 that 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 breadth of the range or characteristic being described.

[0197] 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 effectively equivalent to any other member of the same list solely based on their presence in a common grouping, unless the content to the contrary indicates. 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 "instead" refers to a selection 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.

[0198] The reference in this specification 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.

[0199] In the above description, when reference is made to integers or components that have known equivalents thereof, those integers are incorporated herein as if individually set forth.

[0200] The invention may be broadly considered to include any combination of two or more of the parts, elements and features referred to or illustrated in the specification of this application, individually or collectively.

[0201] It should be noted that various changes and modifications to the preferred embodiments described herein will be 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 as needed. 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.

Claims

1. 1. Headgear for a respiratory mask, comprising: Hello strap and side straps connected to the halo straps, the side straps having an elastic portion, an inelastic portion, and a support beam; the resilient portion has a longitudinal axis; the inelastic portion is relatively inelastic compared to the elastic portion and has a longitudinal axis aligned with the longitudinal axis of the elastic portion; the elastic portion is configured to provide a retraction force on the inelastic portion in the direction of the longitudinal axis of the elastic portion; a limiting mechanism configured to provide a force resisting movement of the inelastic portion when the elastic portion is stretched in the direction of the longitudinal axis of the elastic portion; the support beam is coupled to the inelastic portion and the halo strap and extends along a portion of the headgear; the support beam has a width in a direction perpendicular to the longitudinal direction of the support beam and parallel to the surface of the user's face when the headgear is in use, the inelastic portion has a width in a direction perpendicular to the longitudinal direction of the inelastic portion and parallel to the surface of the user's face when the headgear is in use, the width of the support beam being greater than the width of the inelastic portion, the support beam exhibits a greater resistance to buckling in a direction perpendicular to the length of the support beam than the inelastic portion in a direction perpendicular to the longitudinal axis of the inelastic portion; The headgear, wherein the elastic portion includes a tube, the support beam is disposed within the tube, and at least a portion of the support beam is curved along its longitudinal extension.

2. 2. The headgear of claim 1, wherein the support beam includes a first portion connected to the inelastic portion, a second portion connected to a top and / or rear strap of the headgear, and a transition portion extending along the curvature of the support beam between the first and second portions.

3. 3. The headgear of claim 2, wherein the second portion is connected to the top and / or rear straps at a location above the user's ears.

4. The headgear of claim 2 , wherein the transition portion extends downwardly from the second portion.

5. The headgear of claim 2 , wherein the first portion extends from the transition portion toward a mask connected to the headgear.

6. Headgear as described in claim 1, wherein the width of the support beam is substantially constant along its longitudinal extension.

7. Headgear according to claim 6, wherein the width is between 1 and 15 mm, preferably less than 10 mm, preferably less than 7 mm, preferably less than 5 mm, preferably about 3 mm.

8. 2. The headgear of claim 1, wherein the support beam has a thickness in a direction perpendicular to a surface of a user's face when the headgear is in use, the thickness of the support beam being substantially constant along its longitudinal extension.

9. Headgear according to claim 8, wherein the thickness is between 0.5 and 1 mm, preferably about 0.8 mm.

10. The headgear of claim 2 , wherein the second portion connects to a halo strap that provides the top and rear straps of the headgear.

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