Nasal Seals, Masks and Respiratory Interface Assemblies

Abstract

To provide an improved respiratory interface.SOLUTION: A nasal seal, a mask or an interface assembly has a seal body defining a breathing chamber. A nasal port is provided in the seal body. The nasal port has a central portion straddled by a pair of lateral portions. The nasal port further has an upper edge and a lower edge. The upper edge defines an inwardly projecting portion within the central portion. The lower edge defines an inwardly protection portion within the central portion. Thus, the nasal port can be generally bean-shaped or bowtie-shaped. The mask can include a frame having a central portion that supports the seal and a pair of arm portions that extend backwardly of the seal and are configured to connect to headgear. The central portion can be more rigid than the arm portions. The mask can be configured to reduce noise transmitted through a bias flow vent.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] Priority application This application claims priority to U.S. Provisional Patent Application Nos. 62 / 381,496, filed August 30, 2016, 62 / 310,549, filed March 18, 2016, 62 / 300,578, filed February 26, 2016, and 62 / 217,656, filed September 11, 2015, the entire contents of which are incorporated herein by reference and form part of this disclosure.

[0002] The present disclosure generally relates to a nasal seal for a respiratory interface and an interface including a nasal seal, comprising either a mask or a mask and headgear. [Background technology]

[0003] Respiratory interfaces are used to provide one or more respiratory gases under positive pressure to a user, such as air in continuous positive airway pressure (CPAP) therapy. Nasal interfaces deliver the gases to the nose.

[0004] The seal of the indirect nasal interface contacts the upper lip, the face on either side of the nose, and the bridge of the nose, substantially sealing against the nose. The indirect nasal interface may be relatively large on the face and may exert pressure against the bridge of the nose, and the frame of the interface may include a T-piece that connects to headgear at the forehead of the wearer, which typically prevents the wearing of, for example, eyeglasses.

[0005] Direct nasal interfaces are typically smaller on the face, do not include a T-piece, and are therefore less obtrusive, however, they typically include nasal pillows or the like that enter the wearer's nostrils to ensure an effective seal. Summary of the Invention [Problem to be solved by the invention]

[0006] CPAP is a therapy for sleep apnea (e.g., obstructive sleep apnea). Patients being treated with CPAP for sleep apnea wear a face or nasal mask while sleeping. It is desirable for the respiratory interface to be comfortable to wear while maintaining a good seal between the respiratory interface and the user. [Means for solving the problem]

[0007] The systems, methods, and apparatus described herein have innovative aspects, none of which is essential or solely responsible for their desirable attributes. Without limiting the scope of the claims, some of the advantageous features will now be outlined.

[0008] In some configurations, the nasal seal includes a seal body defining a breathing chamber. The seal body includes a nasal port. The nasal port includes a central portion flanked by a pair of side portions. The nasal port further includes an upper edge and a lower edge. The upper edge defines an inwardly protruding portion within the central portion. The lower edge defines an inwardly protruding portion within the central portion.

[0009] In some configurations, the inwardly projecting portions of one or both of the upper and lower edges are curved.

[0010] In some configurations, the nasal ports are generally bean-shaped or bow-tie-shaped.

[0011] In some configurations, the nasal seal further comprises a thickened rim portion extending around part or all of the circumference of the nasal port, the thickened rim portion having a greater wall thickness than the portion of the seal adjacent the thickened rim portion.

[0012] In some configurations, the seal body comprises a central portion sandwiched between a pair of lateral portions, and in use, the seal body is configured such that the lateral portions move inward when pressure is applied to the central portion by a user.

[0013] In some configurations, the user-facing surface of the nasal seal comprises a thin-walled portion, hi some configurations, the thin-walled portion of the user-facing surface has or is equal to the minimum wall thickness of the seal body.

[0014] In some configurations, the seal further comprises a pair of thickened wall portions that contact the cheeks of a user in use, hi some configurations, the thickened wall portions have or are equal to the maximum wall thickness of the seal body.

[0015] In some configurations, the thick wall portions each include a groove therein that allows for decoupled movement of portions of the thick wall portion on either side of the groove.

[0016] In some configurations, the nasal seal further comprises a connector configured to enable the nasal seal to be coupled to the frame, the connector comprising a first portion within the seal body and a second portion exterior to the seal body, the first portion and the second portion being coupled to one another.

[0017] In some configurations, the first portion includes a flange and a hub, the hub extending through an aperture in the seal body, and the second portion coupled to the hub of the first portion.

[0018] In some configurations, the seal body includes a rim that extends partially or entirely around the aperture, the rim being captured between the first and second portions.

[0019] In some configurations, the rim has a generally T-shaped cross-section having a base, a first lobe extending from the base in a first direction, and a second lobe extending from the base in a second direction opposite the first direction.

[0020] In some configurations, the first and second portions of the connector each include a recess configured to receive the first and second lobes, respectively.

[0021] In some configurations, the seal and connector include an interference portion that inhibits or prevents relative rotation between the seal and connector.

[0022] In some configurations, the seal body has a first irregularity on a user-contacting side and a second irregularity on an opposite side, the second irregularity being different from the first irregularity.

[0023] In some configurations, the nasal mask comprises the nose seal of any of the preceding paragraphs and a frame, the frame comprising a central portion and a pair of arm portions extending rearwardly from the central portion, the arm portions configured to be connected to headgear.

[0024] In some configurations, the central portion of the frame is shaped to correspond to the side of the seal body facing the central portion.

[0025] In some configurations, the central portion is stiffer than the arm portions.

[0026] In some configurations, the pair of arm portions are overmolded onto the central portion.

[0027] In some configurations, each of the pair of arm portions includes a hinge portion that allows a rear end of the arm portion to bend relative to the central portion of the frame.

[0028] In some configurations, the central portion includes a seal connector portion configured to removably receive a seal.

[0029] In some configurations, the central portion comprises a conduit connector portion that supports the conduit connector.

[0030] In some configurations, the conduit connector comprises an elbow.

[0031] In some configurations, a bias flow exhaust is located at the conduit connector portion.

[0032] In some configurations, the nasal mask further comprises an extension within the flow path defined between the upstream end of the conduit connector portion and the breathing chamber of the seal body, the bias flow exhaust port being located upstream of the extension.

[0033] In some configurations, a mask tube is coupled to the conduit connector, the upstream end of the mask tube comprising a connector configured to connect to a gas supply conduit of an associated respiratory therapy system, the interior of the connector being the same size and shape as the interior of the mask tube.

[0034] In some configurations, the end of the connector abuts the upstream end of the mask tube, and the connector and mask tube are joined by a fitting sleeve, which in some configurations is overmolded onto the mask tube and connector.

[0035] In some configurations, a pad is disposed on the inwardly facing surface of each of the pair of arm portions.

[0036] In some configurations, the pad and arm portion are joined by an overmolding process.

[0037] In some configurations, the pad has a textured surface finish.

[0038] In some configurations, the pad includes a fabric outer layer.

[0039] In some configurations, the interface assembly comprises a nasal mask as described in any of the paragraphs above and headgear comprising a top strap, a rear strap and a strap extension that connects to the arm portions of the frame.

[0040] In some configurations, at least the top straps and front strap extensions are non-extensible. In some configurations, the rear straps are extensible.

[0041] In some configurations, the front strap extension and the arm portion are adjustably connected to one another.

[0042] In some configurations, the front strap extension and arm portion have multiple separate adjustment positions.

[0043] In some configurations, one of the forward strap extension and the arm portion includes a plurality of posts, and the other of the forward strap extension and the arm portion includes a plurality of openings, each configured to receive one of the posts.

[0044] In some configurations, the interface assembly includes a nasal mask, a frame attached to the nasal mask, a headgear, and a side arm connecting the frame and the headgear, the side arm being rigid in a vertical plane and movable in a horizontal plane relative to the user's face.

[0045] In some configurations, the side arm includes a hinge.

[0046] In some configurations, the side arms are formed from modular segments.

[0047] In some configurations, the side arm includes an accordion spring.

[0048] In some configurations, the side arms have notches in the surface of the side arms.

[0049] In some configurations, the end of the side arm has a hook connector that engages with a toothed post located on the frame.

[0050] In some configurations, the side arms include a leaf spring configured to bias the frame between the side arms.

[0051] In some configurations, a central portion is connected to the ends of the side arms and a channel is disposed in the frame, the central portion being disposed within the channel such that the frame is movably supported by the central portion.

[0052] In some configurations, the side arms are extensible.

[0053] In some configurations, the nasal seal further includes a seal body defining a breathing chamber and a nasal port disposed in the seal body. The nasal port includes a central portion flanked by a pair of side portions, and the nasal port further includes an upper edge and a lower edge. The nasal seal also includes a flange extending from the upper edge toward the breathing chamber, the flange configured to contact the user's nose when the user's nose is inserted into the nasal port.

[0054] In some configurations, the nasal seal further includes a through-hole disposed in the flange. Further provided are:

[0055] In some configurations, the nasal seal includes a seal body defining a breathing chamber, a nasal port disposed in the seal body, the nasal port further comprising an upper edge and a lower edge, and a nasal blocking member configured to contact the user's nose for insertion into the nasal port.

[0056] In some configurations, the nasal blocking member is positioned over the nasal port and includes a woven mesh attached to and spanning the nasal port.

[0057] In some configurations, the nasal blocking member is disposed over the nasal port and includes a through-hole extending through the nasal blocking member.

[0058] In some configurations, the nasal blocking member is positioned over the nasal port and includes a tether attached to the bottom of the breathing chamber.

[0059] In some configurations, the nasal blocking member extends from the bottom of the breathing chamber towards the nasal ports.

[0060] In some configurations, the distance between the upper and lower edges is narrowest at the midpoint along the width of the nasal port.

[0061] In some configurations, the nasal port includes a thickened bead disposed along the upper edge of the nasal port.

[0062] In some configurations, the nasal seal includes a seal body defining a breathing chamber and a nasal port disposed in the seal body. The nasal port further includes outer lateral portions and a central portion disposed between the outer lateral portions. The central portion of the nasal port is narrower than the outer lateral portions of the nasal port. The central portion is configured to contact a user's nose inserted into the nasal port.

[0063] In some configurations, the distance between the upper edge of the nasal port and the lower edge of said nasal port is narrowest at the lateral midpoint of the nasal port.

[0064] In some configurations, the outer lateral portions further comprise oval ports and the central portion further comprises a throat portion, the throat portion connecting the oval ports.

[0065] In some configurations, the oval ports are angled towards each other.

[0066] In some configurations, the throat is closer to the bottom edge of the oval port than to the top edge of the oval port.

[0067] In some configurations, the throat is closer to the uppermost edge of the oval port than to the lowermost edge of the oval port.

[0068] In some configurations, the nasal port is crescent shaped.

[0069] In some configurations, the nasal ports are kidney-shaped.

[0070] In some configurations, the outer lateral portions include oval ports separated by a central portion.

[0071] In some configurations, the upper portion of the nasal port and the lower portion of the nasal port overlap.

[0072] In some configurations, the upper portion has a recess and the lower portion has a protrusion, the protrusion being disposed within the recess.

[0073] In some configurations, the nasal seal includes a seal body defining a breathing chamber, a nasal port disposed in the seal body, and a marking disposed on the seal body configured to indicate the position of the user's nose over the nasal port.

[0074] In some configurations, the markings are printed on the seal body.

[0075] In some configurations, the marking is scented.

[0076] In some configurations, the markings are formed from matte silicone.

[0077] In some configurations, the markings are deformable.

[0078] In some configurations, the interface assembly includes a nasal mask, a frame attached to the nasal mask, a headgear, an upper connecting member rotatably connected to an upper portion of the frame and the headgear, and a lower connecting member connecting a lower portion of the frame and the headgear, wherein relative movement between the upper connecting member and the lower connecting member results in rotation of the frame.

[0079] In some configurations, the upper and lower connections are connected to the headgear by pulleys.

[0080] In some configurations, the nasal seal includes a seal body defining a breathing chamber and a downwardly deflectable upper portion that curls in a downward direction relative to the lower portion of the seal.

[0081] In some configurations, the nasal seal further includes an upwardly deflectable lower portion that curls in an upward direction relative to the lower portion of the seal.

[0082] In some configurations, the nasal seal includes a seal body defining a breathing chamber, a nasal port disposed in the seal body, and a deformable nasal interface portion formed above the nasal port, the deformable nasal interface portion deforming inwardly within the breathing chamber and expanding outwardly from the breathing chamber.

[0083] In some configurations, a reinforced region surrounds the nasal port, the reinforced region having a greater thickness than the deformable nasal interface portion.

[0084] In some configurations, the nasal seal includes a front wall having a rim circumferentially surrounding the gas inlet opening. The front wall extends proximally from the rim and joins with the rear wall to form a breathing chamber disposed therebetween. A central portion of the rear wall extends distally of the first and second lateral portions of the rear wall to form a recess. A nasal aperture in the recess communicates with the breathing chamber.

[0085] In some embodiments, the anterior wall has a first region having a first thickness and a second region having a second thickness, the first thickness being at least three times the second thickness. In some configurations, the anterior wall extends to the posterior wall without passing through an inflection point. In some embodiments, the nasal seal further comprises a connector secured to a rim of the anterior wall. In some configurations, the connector comprises an arm extending proximally along the anterior wall.

[0086] In some configurations, at least a portion of the nasal aperture is positioned closer to the distal-most point of the anterior wall than to the proximal-most point of the anterior wall, hi some embodiments, the entire nasal aperture is closer to said distal-most point of the anterior wall than to the proximal-most point of the anterior wall.

[0087] In some aspects, the nasal seal comprises a bottom wall extending from the gas inlet opening to the recess. The bottom wall has a front portion distal to a rear portion. The rear portion has a thickness greater than the thickness of the front portion. In some embodiments, the bottom wall further comprises a central portion interposed between the front and rear portions. The central portion has a thickness less than the thickness of the front portion.

[0088] In some embodiments, the posterior wall further comprises a thickened portion surrounding the nasal aperture. In some configurations, the thickened portion extends away from the nasal aperture by a maximum width that is less than three times the maximum thickness of the thickened portion. In some embodiments, the thickened portion extends away from the nasal aperture by a maximum width that is more than three times the maximum thickness of the thickened portion.

[0089] In some embodiments, the gas inlet aperture comprises a truncated region and a non-truncated region, and the distance between the center point of the aperture and the truncated region is less than the distance between the center point of the aperture and the non-truncated region.

[0090] Further aspects of the subject matter disclosed herein, which should be considered in all respects as novel, will become apparent to those skilled in the art upon reading the following description, which provides at least one example of a practical application of the invention.

[0091] Reference numerals may be reused throughout the drawings to indicate a general correspondence between referenced elements. The drawings are provided to illustrate example embodiments described herein and are not intended to limit the scope of the present disclosure. [Brief explanation of the drawings]

[0092] [Figure 1]FIG. 1 is a diagram of a breathing system including a flow generator, a humidifier, and a user interface. [Figure 2] FIG. 2 is a perspective view of a user interface including a mask and headgear suitable for use in the breathing system of FIG. 1; [Figure 3] FIG. 3 is another perspective view of the user interface of FIG. 2. [Figure 4] FIG. 3 is a perspective view of the mask of the user interface of FIG. 2, including the frame and seal. [Figure 5] 5 is a cross-sectional view of the mask of FIG. 4 taken along a vertical plane at the center of the mask. [Figure 6] FIG. 2 is a perspective view of a portion of a frame of a mask. [Figure 7] FIG. 7 is a top view of a portion of the frame of FIG. 6. [Figure 8] FIG. 8 is a perspective view of a mask with the portions shown in FIGS. 6 and 7 removed. [Figure 9] 9 is a cross-sectional view of the portion of the mask shown in FIG. 8 along a horizontal plane. [Figure 10] FIG. 1 is a front perspective view of a portion of a frame of a mask. [Figure 11] FIG. 11 is a rear perspective view of a portion of the frame of FIG. 10. [Figure 12] FIG. 10 is another perspective view of the mask showing the internal structure of the seal in dashed lines. [Figure 13] FIG. 10 is a perspective view of the seal separated from the frame. [Figure 14] 14 is a cross-sectional view of the seal taken along line 14-14 of FIG. 13. [Figure 15] 15 is a cross-sectional view of the seal taken along line 15-15 of FIG. 13. [Figure 16] 1 is a schematic diagram of an aperture in a seal. [Figure 17] FIG. 10 is a perspective view of a seal showing features of a connector configured to connect to a frame. [Figure 18] FIG. 1 is a perspective view of a seal with a portion of the connector removed. [Figure 19] FIG. 2 is a rear perspective view of a portion of the connector. [Figure 20] 20 is a front perspective view of another portion of a connector configured to connect to the portion of the connector of FIG. 19. [Figure 21] FIG. 1 is a perspective view of the seal with the connector removed. [Figure 22] FIG. 10 is a view of the seal with the connector removed, showing the upper portion of the seal's aperture. [Figure 23] FIG. 1 is a perspective view of the headgear separated from the mask. [Figure 24] FIG. 1 is a cross-sectional view of a conventional CPAP hose-mask connection. [Figure 25] FIG. 1 is a cross-sectional view of a CPAP hose-mask connection of the present disclosure. [Figure 26A-B] FIG. 10 is a velocity diagram of an expansion in a flow channel, with bias flow exhaust ports located before and after the expansion, respectively. [Figure 27A-B] FIG. 10 is a vector diagram of an expansion in a flow channel, with bias flow exhaust ports located before and after the expansion, respectively. [Figure 28A] 10A-10C are cross-sectional views of three different designs of a portion of an interface with a bias flow exhaust port. [Figure 28B] 10A-10C are cross-sectional views of three different designs of a portion of an interface with a bias flow exhaust port. [Figure 28C] 10A-10C are cross-sectional views of three different designs of a portion of an interface with a bias flow exhaust port. [Figure 29] 28A, 28B, and 28C are plots of noise level over time for the three designs of FIGS. 28A, 28B, and 28C. [Figure 30] FIG. 10 is a side view of an alternative connection configuration between the mask frame and the headgear. [Figure 31] FIG. 31 is a side view of the connection portion of FIG. 30 in a separated form. [Figure 32] FIG. 10 is a side view of another alternative connection between the mask frame and the headgear in a detached configuration. [Figure 33] FIG. 33 is a side view of the connection portion of FIG. 32 in a connected state. [Figure 34] FIG. 34 is a perspective view of the entire headgear of FIGS. 32 and 33. [Figure 35] 1A and 1B show horizontal and vertical planes across the user's face. [Figure 36A] FIG. 16 is a side perspective view of an interface with a side arm mechanism having a hinge with a concertina cover wrapped around it. [Figure 36B] FIG. 36B is an enlarged side perspective view of the hinge of the interface of FIG. 36A. [Figure 36C] 36B is a top view of the concertina cover of the interface of FIG. 36A shown in a bent position and an un-bent position. [Figure 36D] FIG. 36B is a perspective view of the accordion cover of the interface of FIG. 36A. [Figure 37A] FIG. 1 is a perspective view of an interface having a side arm mechanism with modular segments. [Figure 37B] FIG. 37B is an enlarged side perspective view of a modular segment of the interface of FIG. 37A. [Figure 37C] FIG. 37B is a top view of the interface of FIG. 37A showing articulation of the side arms. [Figure 38A] FIG. 1 is a perspective view of an interface having a spring-loaded side arm mechanism. [Figure 38B] FIG. 38B is an enlarged top view of the spring portion of the interface of FIG. 38A. [Figure 38C] FIG. 38B is a top view of the interface of FIG. 38A showing the side arms in an undeformed configuration. [Figure 38D] FIG. 38B is a top view of the interface of FIG. 38A showing articulation of the side arms. [Figure 39A] FIG. 10 is an enlarged side perspective view of an alternative spring-loaded side arm mechanism having a resilient segment and a rigid segment. [Figure 39B] FIG. 39B is a top view of the elastic and rigid segments of FIG. 39A. [Figure 40A] FIG. 1 is a perspective view of an interface having a side arm mechanism with a notch. [Figure 40B]FIG. 40B is a top view of the interface of FIG. 40A showing the side arms in an unbent and undeformed orientation. [Figure 40C] FIG. 40B is a top view of the interface of FIG. 40A showing maximum articulation of the side arms. [Figure 40D] FIG. 40B is an enlarged top view of the side arm cut of the interface of FIG. 40A. [Figure 40E] FIG. 40B is an enlarged top view of the interface of FIG. 40A showing articulation of the notch portion. [Figure 41A] FIG. 1 is a perspective view of an interface with a hook-and-post connector mechanism. [Figure 41B] FIG. 41B is an enlarged top view of the hook-and-post connector of FIG. 41A. [Figure 41C] FIG. 41B is an enlarged perspective view of the hook connector of FIG. 41A. [Figure 42A] FIG. 10 is a top view of an interface with a biased side arm mechanism. [Figure 42B] FIG. 42B is a top view of the interface of FIG. 42A showing the orientation of the side arms when the interface is placed on a user lying against a pillow. [Figure 42C] FIG. 42B is a top view of the interface of FIG. 42A showing the orientation of the side arms when the interface is placed on a user with a crooked nose. [Figure 42D] FIG. 42B is a top view of the interface of FIG. 42A showing a range of side arm positions. [Figure 43A] FIG. 1 is a perspective view of an interface having a sliding seal arrangement. [Figure 43B] FIG. 43B is a top view of the interface of FIG. 43A showing the orientation of the seal in an unobstructed position on the user. [Figure 43C] FIG. 43B is a top view of the interface of FIG. 43A showing the orientation of the seal when the interface is placed on a user lying against a pillow. [Figure 44A] FIG. 10 is a perspective cross-sectional view of a seal having a flange to indicate to the user that the seal is not installed correctly. [Figure 44B]FIG. 44B is a side cross-sectional view of the seal of FIG. 44A properly positioned on a user. [Figure 44C] FIG. 44B is a side cross-sectional view of the seal of FIG. 44A improperly positioned on a user. [Figure 44D] FIG. 10 is a perspective cross-sectional view of a seal having a flange with a vent to indicate to the user that the seal is not installed correctly. [Figure 44E] FIG. 44E is a side cross-sectional view of the seal of FIG. 44D properly positioned on a user. [Figure 44F] FIG. 44E is a side cross-sectional view of the seal of FIG. 44D improperly positioned on a user. [Figure 44G] FIG. 10 is a side cross-sectional view of an alternative flange configuration having a curved flange. [Figure 44H] FIG. 10 is a side cross-sectional view of an alternative flange configuration having a rounded edge. [Figure 44I] FIG. 10 is a perspective cross-sectional view of a seal having a flange with a recess to indicate to the user that the seal is not installed correctly. [Figure 45A] FIG. 10 is a perspective cross-sectional view of a seal configuration having a woven mesh over the aperture to physically prevent or discourage the user from applying the seal incorrectly. [Figure 45B] FIG. 10 is a perspective cross-sectional view of an alternative seal configuration having a woven mesh offset from the aperture to prevent direct skin contact. [Figure 45C] FIG. 45C is a side cross-sectional view of the seal of FIG. 45B. [Figure 45D] FIG. 10 is a perspective cross-sectional view of an alternative seal configuration having an aperture cover to physically prevent or deter a user from applying the seal incorrectly. [Figure 45E] 10 shows aperture covers with various hole arrangements. [Figure 46A] FIG. 10 is a perspective cross-sectional view of a seal arrangement having a tether to physically prevent or deter a user from applying the seal incorrectly. [Figure 46B] FIG. 46B is a side cross-sectional view of the seal arrangement of FIG. 46A. [Figure 46C] FIG. 46B is a cross-sectional side view of the seal of FIG. 46A showing the seal in an undeformed configuration. [Figure 46D] FIG. 46B is a side cross-sectional view of the seal of FIG. 46A showing the seal properly attached to the user. [Figure 46E] FIG. 10 is a perspective cross-sectional view of a seal arrangement having a bumper to physically prevent or discourage a user from applying the seal incorrectly. [Figure 46F] FIG. 46F is a side cross-sectional view of the seal of FIG. 46E showing the seal properly attached to the user. [Figure 46G] FIG. 46F is a side cross-sectional view of the seal of FIG. 46E showing the seal not properly attached to the user. [Figure 46H] 10 illustrates an alternative bumper configuration. [Figure 47A] 10 illustrates an alternative configuration of the sealing aperture to prevent or inhibit insertion of the user's nose into the aperture. [Figure 47B] 10 illustrates an alternative configuration of the sealing aperture to prevent or inhibit insertion of the user's nose into the aperture. [Figure 47C] 10 illustrates an alternative configuration of the sealing aperture to prevent or inhibit insertion of the user's nose into the aperture. [Figure 47D] 10 illustrates an alternative configuration of the sealing aperture to prevent or inhibit insertion of the user's nose into the aperture. [Figure 47E] 10 illustrates an alternative configuration of the sealing aperture to prevent or inhibit insertion of the user's nose into the aperture. [Figure 47F] 10 illustrates an alternative configuration of the sealing aperture to prevent or inhibit insertion of the user's nose into the aperture. [Figure 47G] FIG. 47F is a side cross-sectional view of the aperture arrangement of FIG. 47F. [Figure 48A] FIG. 10 is a rear view of a nose seal arrangement with visual markings to indicate correct nose position. [Figure 48B] 10 illustrates an alternative marking configuration. [Figure 48C]10 shows alternative marking combinations to indicate correct nose alignment and position. [Figure 48D] 10 shows alternative markings to indicate correct nose alignment and position. [Figure 48E] FIG. 10 is a rear view of an alternative marking configuration. [Figure 48F] FIG. 10 is a rear view of an alternative scented marking configuration. [Figure 48G] FIG. 10 is a rear view of a nose seal configuration with matte markings to visually indicate correct nose alignment and position. [Figure 48H] FIG. 10 is a rear view of a nose seal configuration with matte markings to visually indicate correct nostril position. [Figure 48I] 10 illustrates an alternative matte marking configuration. [Figure 49A] FIG. 10 is a rear view of a nose seal arrangement having a depressible depression to indicate correct nose position. [Figure 49B] FIG. 49B is a perspective cross-sectional view of the nose seal arrangement of FIG. 49A. [Figure 49C] 49B is a side cross-sectional view of multiple positions of the depressible depression of the nose seal arrangement of FIG. 49A. [Figure 50A] FIG. 1 is a perspective view of an interface device having a pivoting nasal seal. [Figure 50B] FIG. 50B is a side view of the interface device of FIG. 50A showing the range of rotation of the pivoting nasal seal. [Fig. 50C-D] 50B is a schematic side view illustrating the extended and retracted positions of the frame rails, which result in a pivoting of the frontal projection of the pivoting nasal seal of the interface device of FIG. 50A. FIG. [Figure 50E] FIG. 50B is a side cross-sectional view of the pivoting nose seal of FIG. 50A attached to a user with a positive nose angle. [Figure 50F] FIG. 50B is a side cross-sectional view of the pivoting nose seal of FIG. 50A attached to a user with a negative nose angle. [Figure 51A] FIG. 10 is a perspective view of an alternative interface device having a pulley that allows for rotation of the nasal seal. [Figure 51B]FIG. 51B is a side view of the alternative interface device of FIG. 51A showing rotation of the nasal seal. [Figure 51C] 51B is a side view of the alternative interface device of FIG. 51A showing various rotational positions of the nasal seal. [Figure 51D] 51B is a side view of the alternative interface device of FIG. 51A showing various rotational positions of the nasal seal. [Figure 51E] FIG. 10 is a side perspective view of a geared pulley for maintaining the rotational position of the nose seal. [Figure 51F] FIG. 1 is a side perspective view of a geared pulley having a knurled outer surface. [Figure 51G] FIG. 1 is a side perspective view of a geared pulley with a lever. [Figure 52A] FIG. 1 is a perspective view of a rolled nose seal. [Figure 52B] FIG. 52B is a side perspective cross-sectional view of the rolled nasal seal of FIG. 52A, showing an undeformed orientation. [Figure 52C] FIG. 52B is a side perspective cross-sectional view of the rolled nasal seal of FIG. 52A showing the rolled orientation. [Figure 53A] FIG. 12 is a perspective view of a rolled nose seal having upper and lower rolls. [Figure 53B] FIG. 1 is a schematic side view showing a user's nose angle and upper lip angle. [Figure 53C] FIG. 53B is a side view of the rolled nose seal of FIG. 53A showing an undeformed orientation. [Figure 53D] FIG. 53B is a side view of the rolled nose seal of FIG. 53A showing the rolled orientation. [Figure 53E] FIG. 10 is a perspective view of an alternative rolled nose seal with a spring steel section. [Figure 54A] FIG. 1 is a perspective view of a nose seal having a bellows-like region. [Figure 54B] FIG. 54B is a side perspective cross-sectional view of the nasal seal of FIG. 54A. [Figure 54C] 54B is a schematic side view showing the nose seal of FIG. 54A attached to a long-nosed user and a short-nosed user. FIG. [Figure 54D]FIG. 54B is a schematic side view showing the nose seal of FIG. 54A attached to a user with a long nose in a horizontal plane. [Figure 54E] FIG. 54B is a schematic side view showing the nose seal of FIG. 54A being fitted to a user with a long, downwardly angled nose. [Figure 54F] FIG. 54B is a schematic side view showing the nose seal of FIG. 54A being fitted to a user with a short, upwardly angled nose. [Figure 54G] FIG. 54B is a schematic side view showing the nose seal of FIG. 54A being fitted to a user with a short, downwardly angled nose. [Figure 55] FIG. 2 is a perspective view of a user interface including a patient interface and headgear suitable for use in the respiratory system of FIG. 1; [Figure 56] FIG. 10 is a perspective view of the seal and frame of the patient interface. [Figure 57] FIG. 57 is a rear perspective view of the frame of FIG. 56. [Figure 58A] FIG. 10 is a perspective view of an embodiment of a nasal seal. [Figure 58B] FIG. 10 is a perspective view of an embodiment of a nasal seal. [Figure 58C] FIG. 10 is a perspective view of an embodiment of a nasal seal. [Figure 59A] FIG. 58B is a front view of the nasal seal of FIG. 58A. [Figure 59B] FIG. 58C is a front view of the nasal seal of FIG. 58B. [Figure 59C] FIG. 58D is a front view of the nasal seal of FIG. 58C. [Figure 60A] FIG. 58B is a left side view of the nasal seal of FIG. 58A. [Figure 60B] FIG. 58C is a left side view of the nasal seal of FIG. 58B. [Figure 60C] FIG. 58D is a left side view of the nasal seal of FIG. 58C. [Figure 61A] FIG. 58B is a rear view of the nasal seal of FIG. 58A. [Figure 61B] FIG. 58C is a rear view of the nasal seal of FIG. 58B. [Figure 61C] FIG. 58D is a rear view of the nasal seal of FIG. 58C. [Figure 62A] FIG. 58B is a top view of the nasal seal of FIG. 58A. [Figure 62B] FIG. 58C is a top view of the nasal seal of FIG. 58B. [Figure 62C] FIG. 58D is a top view of the nasal seal of FIG. 58C. [Figure 63A] FIG. 58B is a left side view of the nasal seal of FIG. 58A in use. [Figure 63B] FIG. 58C is a left side view of the nasal seal of FIG. 58B in use. [Figure 63C] FIG. 58D is a left side view of the nasal seal of FIG. 58C in use. [Figure 64] FIG. 10 is a perspective view of an embodiment of a nasal seal. [Figure 65A] FIG. 58D is a partial cross-sectional view of the nasal seal of FIG. 58C. [Figure 65B] FIG. 58D is a partial cross-sectional view of the nasal seal of FIG. 58C. [Figure 66A] FIG. 58D is a partial rear view of the nose seal of FIG. 58C. [Figure 66B] FIG. 58D is a partial sagittal cross-sectional view of the nasal seal of FIG. 58C. [Figure 66C] FIG. 58D is a sagittal cross-sectional view of the nasal seal of FIG. 58C. [Figure 67A] FIG. 58B is a partial sagittal cross-sectional view of the nasal seal of FIG. 58A. [Figure 67B] FIG. 58C is a partial sagittal cross-sectional view of the nasal seal of FIG. 58B. [Figure 67C] FIG. 58D is a partial sagittal cross-sectional view of the nasal seal of FIG. 58C. [Figure 68] FIG. 10 is a rear view of an embodiment of a nasal seal. [Figure 69] FIG. 58C is a partial rear view of the nose seal of FIG. 58B. [Figure 70] FIG. 58D is a partial rear view of the nose seal of FIG. 58C. [Figure 71A] FIG. 58B is a rear view of the nasal seal of FIG. 58A. [Figure 71B] FIG. 58C is a rear view of the nasal seal of FIG. 58B. [Figure 71C] FIG. 58D is a rear view of the nasal seal of FIG. 58C. [Figure 72] FIG. 1 is a perspective view of an embodiment of a connector. [Figure 73]FIG. 73 is a perspective view of the connector of FIG. 72 on the nose seal. [Figure 74] FIG. 10 is a front perspective view of an embodiment of a connector attached to a nose seal. [Figure 75] FIG. 10 is a front perspective view of an embodiment of a connector attached to a nose seal. [Figure 76A] FIG. 10 is a front view of an embodiment of a nasal seal. [Figure 76B] FIG. 76B is a left side view of the nasal seal of FIG. 76A. [Figure 76C] FIG. 76B is a rear view of the nasal seal of FIG. 76A. [Figure 76D] FIG. 76B is a top view of the nasal seal of FIG. 76A. [Figure 76E] FIG. 76B is a bottom view of the nasal seal of FIG. 76A. [Figure 77] FIG. 16 is a perspective view of an embodiment of a medium size nose seal. [Figure 78] FIG. 16 is a perspective view of an embodiment of a wide sized nose seal. [Figure 79A] FIG. 76B is a left side view of the nasal seal of FIG. 76A. [Figure 79B] FIG. 76B is a left side view of the nasal seal of FIG. 76A. [Figure 80] FIG. 76B is a side view of the nose seal of FIG. 76A placed over a user's nose. [Figure 81] FIG. 76B is a front view of the nasal seal of FIG. 76A. [Figure 82A] FIG. 10 is a front perspective view of an embodiment of a nasal seal. [Figure 82B] FIG. 82B is a front perspective view of the nasal seal of FIG. 82A showing the location of areas of different wall thickness in the seal. [Figure 83] FIG. 10 is a partial cross-sectional view of an embodiment of a nasal seal. [Figure 84] FIG. 10 is a sagittal cross-sectional view of an embodiment of a nasal seal. [Figure 85] FIG. 10 is a front view of the inner surface of the rear wall of an embodiment of a nose seal showing the thickened portion surrounding the nasal aperture. [Figure 86] FIG. 13 is a bottom view of an embodiment of a nasal seal having a sub-nasal window. [Figure 87]FIG. 13 is a top cross-sectional view of an embodiment of a nasal seal having a sub-nasal window. [Figure 88] FIG. 10 is a bottom view of an embodiment of a nasal seal having a sub-nose window extending across the bottom wall of the seal. [Figure 89] FIG. 10 is a top cross-sectional view of an embodiment of a nasal seal having a sub-nose window extending across the bottom wall of the seal. [Figure 90] FIG. 13 is a rear perspective view of an embodiment of a nasal seal having a sub-nose window extending across the bottom wall of the seal. [Figure 91] FIG. 13 is a top cross-sectional view of an embodiment of a nasal seal having a partitioned sub-nasal window. [Figure 92A] FIG. 10 is a front perspective view of an embodiment of a front flange of a connector. [Figure 92B] FIG. 92B is a rear perspective view of the front flange of FIG. 92A. [Figure 92C] FIG. 92B is a front view of the front flange of FIG. 92A. [Figure 92D] FIG. 92B is a left side view of the front flange of FIG. 92A. [Figure 92E] FIG. 92B is a rear view of the front flange of FIG. 92A. [Figure 92F] FIG. 92B is a top view of the front flange of FIG. 92A. [Figure 92G] FIG. 92B is a bottom view of the front flange of FIG. 92A. [Figure 93A] FIG. 10 is a front perspective view of an embodiment of a rear flange of a connector. [Figure 93B] FIG. 93B is a rear perspective view of the rear flange of FIG. 93A. [Figure 93C] FIG. 93B is a front view of the rear flange of FIG. 93A. [Figure 93D] FIG. 93B is a left side view of the rear flange of FIG. 93A. [Figure 93E] FIG. 93B is a rear view of the rear flange of FIG. 93A. [Figure 93F] FIG. 93B is a top view of the rear flange of FIG. 93A. [Figure 93G] FIG. 93B is a bottom view of the rear flange of FIG. 93A. [Figure 94] FIG. 93B is a rear perspective view of the assembly of the front flange of FIG. 92A connected to the rear flange of FIG. 93A. [Figure 95] FIG. 10 is a sagittal cross-sectional view of an embodiment of a connector attached to a nasal seal. [Figure 96] FIG. 10 is a sagittal cross-sectional view of a portion of an embodiment of a connector attached to a nasal seal. [Figure 97] FIG. 10 is a sagittal cross-sectional view of a portion of another embodiment of a connector attached to a nasal seal. [Figure 98] FIG. 10 is a sagittal cross-sectional view of a portion of yet another embodiment of a connector attached to a nasal seal. [Figure 99] FIG. 10 is a sagittal cross-sectional view of a portion of yet another embodiment of a connector attached to a nasal seal. DETAILED DESCRIPTION OF THE INVENTION

[0093] Embodiments of systems, components, and methods of assembly and manufacturing will now be described with reference to the accompanying figures. Like numerals refer to like or similar elements throughout the drawings. While several embodiments, examples, and illustrations are disclosed below, those skilled in the art will understand that the invention described herein extends beyond the scope of the specifically disclosed embodiments, examples, and illustrations and can include other uses of the present invention and obvious modifications and equivalents thereof. The terminology used in the description provided herein is not intended to be construed as limiting or restrictive in any way, but is merely used in connection with the detailed description of several specific embodiments of the present invention. Furthermore, 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.

[0094] Certain terminology may be used in the following description for reference purposes only and, therefore, is not intended to be limiting. For example, the terms "upper" and "lower" refer to directions in the referenced drawings. Terms such as "front," "rear," "left," "right," "back," and "side" describe the orientation and / or location of a component or portion of an element within a consistent, but arbitrary, frame of reference that becomes apparent by reference to the text and associated drawings that describe the component or element being discussed. Furthermore, terms such as "first," "second," and "third" may be used to describe separate components. Such terminology may include the terms specifically mentioned above, derivatives thereof, and terms of similar import.

[0095] FIG. 1 is a schematic diagram of a positive pressure respiratory therapy system in the form of a continuous positive airway pressure (CPAP) system 10 that provides a heated and humidified airflow to a user U through an interface 110 worn by the user and connected to the CPAP system 10 by a conduit or tubing 12. A humidification chamber 14 has a thermally conductive base that contacts a heater plate 16 of a humidifier 17 to humidify the airflow. The conduit 12 is connected to an outlet 13 of the humidification chamber 14 to deliver the humidified air to the user interface 110. The humidifier 17 includes a controller 18, such as, for example, without limitation, a microprocessor-based controller that executes computer software commands stored in an associated memory. The controller 18 receives input commands from multiple input sources, including a user input interface 19, such as a dial or touch screen, that allows for setting predetermined values ​​for the humidity, temperature, or other characteristics of the humidified air provided to the user U. Controller 18 may also receive input from one or more other sources, such as, for example, temperature and / or flow rate sensors 20 and 21, and / or heater plate temperature sensor 23, connected through connector 22 to communicate with controller 18. Depending on the selected humidity or temperature value, controller 19 determines when and / or to what level heater plate 16 should be energized to suitably heat the water contained in humidification chamber 14.

[0096] As the water in the chamber heats, water vapor begins to fill the volume of the chamber above the surface of the water. The water vapor exits the humidification chamber through outlet 13 along with a flow of air provided from supply 25, such as blower 27, and entering humidification chamber 30 through inlet 26. Blower 27 may be a variable speed fan or may include a variable pressure regulator. Blower 27 draws air through inlet 28. The blower may be controlled, for example, by controller 29 or by controller 18. Controller 18 or 29 may control blower speed, regulated pressure, etc. according to any suitable criteria. For example, controller 29 may be responsive to input from controller 18 and user settings (e.g., preset values) for pressure and / or fan speed, which may be set on user interface 30 (e.g., dials).

[0097] The conduit 12 may be provided with a heater, such as a heater wire, that heats the walls of the conduit to reduce condensation of humidified gas within the conduit.

[0098] The seals and interfaces of the present disclosure may be used in CPAP systems as described above, whether humidified or not, or alternatively in other forms of breathing systems such as VPAP (variable positive airway pressure) systems, BiPAP (bilevel positive airway pressure) systems, or in conjunction with ventilators, and are generally described herein in relation to CPAP therapy by way of example only.

[0099] 2 and 3 are perspective views of an example interface assembly or interface 110 of system 10 of FIG. 1. Interface 110 includes a mask 112, which in some configurations includes a seal 114 and a frame assembly or frame 116. Interface 110 also includes headgear 118 for securing mask 112 to a user. In a preferred embodiment, interface 110 does not include a T-piece extending upward from frame 116 (when worn) to connect to headgear 118 at the forehead of the user. However, if desired, aspects, features, or components of the disclosed interface 110 can be utilized in designs incorporating a T-piece.

[0100] In some configurations, the interface 110 also includes a short, flexible supply conduit or tube 120 extending from the mask 112, such as from a central connection on the front of the mask 112, that connects to the supply conduit 12 of the CPAP system 10 or other respiratory system. The conduit 120 connects to the mask 112 directly or via a suitable connector, such as a hollow elbow 122. In some configurations, the elbow 122 can pivot relative to the mask 112 about one or more pivot axes, allowing the path of the conduit 120 relative to the positioning of the mask 112 on the user's face to adapt to the user's sleeping position. However, in other arrangements, the elbow 122 can be integral or integral with the mask 112. The end of the conduit 120 opposite the elbow 122 can include a suitable connector 124 that connects the conduit 120 to the supply conduit 12. In some configurations, the connector 124 may be or comprise a swivel connector that allows relative rotation between the conduit 120 and the supply conduit 12 .

[0101] The interface 110 preferably includes a restricted flow or bias flow vent 126 that allows gas to be washed out of the interface 110. In some configurations, the bias flow vent 126 is in the form of a collection of small apertures. The bias flow vent 126 can be located in the frame 116 as shown, in the elbow 122, or elsewhere in the interface 110.

[0102] As described above, the mask 112 can include a seal 114 and a frame 116. In some configurations, the frame 116 (and elbow 122, if desired) can be stiffer than at least a portion of the seal 114, such as the portion that defines the surface that contacts the user. In some configurations, the seal 114 is removably coupled to the frame 116 around a passageway from the interior of the elbow 122 through the frame 116. Thus, the seal 114 and the frame 116 together form a housing having a gas inlet from the CPAP system 10 and an aperture 128 through the seal 114 to the user.

[0103] In some configurations, the frame 116 includes side arms 130 that extend outward (away from each other), rearward, and upward at a shallow angle, past the left and right ends of the seal 114, along the user's left and right cheeks, particularly the cheekbones, and connect to the headgear 118 to hold the seal 114 against the user's face. These side arms 130 may be deep or thicker and longer, and may be resiliently flexibly connected to the frame and / or resiliently flexible along their length (laterally rather than vertically). In some configurations, the side arms 130 extend toward or to a position between the user's ears and eyes and / or to or near the temples of the user's head, where they connect to the headgear 118. In some configurations, the length of the side arms 130 is between about 100 mm and about 150 mm. The shape of the side arms 130 and / or the angle between them is such that the side arms 130 rest on the user's left and right cheeks, particularly the cheekbones, to help stabilize the interface 110 when worn against rotation about a horizontal axis.

[0104] The side arms can be resiliently flexible toward and away from the user's face in a generally horizontal plane (when worn) to accommodate different face sizes, but relatively inflexible in a generally vertical plane. The illustrated side arms 130 are solid, but can include one or more apertures or cutouts extending the length of the side arms to increase the resiliently flexibility of the side arms toward and away from the user's face, but remain relatively inflexible in a generally vertical plane (when worn).

[0105] In some configurations, the side arm 130 can include a softer material on at least part or all of the user-facing surface of the side arm 130, or completely around the periphery of the side arm 130, to soften contact of the side arm 130 with the user's face. If desired, the inner surface of the side arm 130 can include a pad 132 that faces and / or contacts the user's face, as shown in FIG. 3 . The pad 132 can be removable for cleaning or replacement. The pad 132 and side arm 130 can be connected by an overmolding or welding process. The pad 132 can have a textured and / or cloth outer surface. The textured surface can increase friction to keep the side arm 130 in place on the user's face, and the cloth material can promote comfort.

[0106] The side arms 130 include connector portions 134 at their outer or free ends that detachably connect the side arms 130 to the headgear 118. In some configurations, the connector portions 134 each include a recess or receiver 136 configured to receive a complementary connector 138 of the headgear 118. The connector 138 of the headgear 118 can be retained within the receiver 136 of the side arm 130 by any suitable mechanism, such as, for example, a snap-fit ​​mechanism. In some configurations, the connector 180 includes an orientation mechanism. In some configurations, the receiver 136 includes an orientation mechanism. The orientation mechanism can allow the left side of the headgear 118 to connect only to the left side arm 130 and the right side of the headgear 118 to connect only to the right side arm 130. In some configurations, the orientation mechanism may allow the left side of the headgear 118 to connect to the right side arm 130 and the right side of the headgear 118 to connect to the left side arm 130 only when the headgear 118 is turned inside out. In the illustrated arrangement, each connector portion 134 includes at least one protrusion or latch member 140, such as a pair of latch members 140, each disposed on either side of the receiver 136. The latch members 140 can retain the connector 138 within the receiver 136 in at least one direction, such as outwardly away from the connector portion 134 and rotationally. The latch members 140 can guide the connector 138 to a connected position, for example, when the connector 138 is inserted end-first. In some configurations, the connector portion 134 includes one or more additional retention elements, such as a protrusion or boss 142. In the illustrated arrangement, boss 142 extends outward from the outer surface of receiver 136 and engages a complementary opening in connector 138 of headgear 118 to retain connector 138 within receiver 136 in response to forces tending to move connector 138 rearward or longitudinally of side arm 130. In some configurations, boss 142 has a chamfer on one side (not shown in the drawings) to facilitate connector 138 staying in place.

[0107] In some configurations, the side arms 130 may be integrally formed with another portion or the remainder of the frame 116, for example, by injection molding from a plastic material. However, in the illustrated arrangement, the frame 116 includes a central or base portion (referred to herein as the “base”) 144 that supports the seal 114 and a connector portion or portions 146 that include the side arms 130. The base 144 and the connectors 146 may be permanently or removably coupled to one another. In some configurations, each of the side arms 130 may include its own connector 146 that may be separately attached to the base 144.

[0108] The illustrated connector 146 is a generally U-shaped member from the top, including side arms 130 and a central portion 148 that connects the two side arms together. In the illustrated arrangement, the central portion 148 passes under the elbows 122 and extends upward to each of the side arms 130 on each side. The central portion 148 can also be configured to connect to the base 144, such as via a snap-fit ​​connection. In the illustrated arrangement, the central portion 148 includes a pair of spaced-apart projections 150 that engage with a pair of complementary slots 152 in the base 144. In other configurations, the arrangement can be reversed, or other suitable connection mechanisms can be utilized. The central portion 148 can be detachable from the base 144; that is, the projections 150 can be detachable from the slots 152. In other configurations, the central portion 148 and / or the side arms 130 can be integral with the base 144, such as via a two-shot or overmolding process.

[0109] The central portion 148 includes an inner surface 154 that faces or abuts the base 144. In some configurations, the central portion 148 includes a shelf or shoulder 156 upon which the base 144 or another portion of the frame assembly 116 or seal 114 rests. In the illustrated arrangement, the lower edge of the base 144 rests on the shoulder 156, thereby disposing the portion of the connector 146 below the shoulder 156 below the base 144. The illustrated shoulder 156 is curved in shape, with its outer end lower than the central portion relative to the orientation of the mask 112 in use. In other arrangements, the shoulder 156 can have other shapes, such as being curved in the opposite direction (i.e., concave) or flat. Additionally, the front surface of the base 144 defines a recess 157 that accommodates the central portion 148 of the connector 146. The recess 157 can extend partially or entirely between the slots 152 in the base 144.

[0110] Laterally outer or rearward portions of a central portion 148 of the connector 138 connect to the side arms 130. In the arrangement shown, the side arms 130 are integrally formed with the central portion 148. However, in other arrangements, the side arms 130 can be separately formed using the same or a different material and coupled to the central portion 148, such as via mechanical fasteners, adhesives, a welding process, or by a two-shot molding process (e.g., overmolding).

[0111] In some configurations, the laterally outer or rearward portion of the central portion 148 can be configured to support the side arms 130 in a spaced-apart relationship relative to the base 144 and / or seal 114. In the illustrated arrangement, the laterally outer or rearward portion of the central portion 148 has a greater wall thickness in a direction perpendicular to the inner surface 154 than the center of the central portion 148. The wall thickness gradually increases in the anterior-posterior direction of the laterally outer or rearward portion of the central portion 148. As a result, the forward ends of the side arms 130 are spaced outward a distance 158 from the inner surface 154, the base 144, and / or the seal 114. The distance 158 can be, for example, 3 mm to 15 mm, 5 mm to 10 mm, or approximately 5 mm. The attachment point of the central portion 148 with the base 144, defined, for example, by the protrusion 150, can define a hinge or hinge point of a frame assembly that enhances flexibility of the side arms 130 relative to the central portion 148 and / or the base 144. The reduced thickness of the front ends of the side arms 130 relative to the relatively large wall thickness of the rearward portion of the central portion 148 may improve the flexibility of the side arms 130 relative to the central portion 148 and / or base 144.

[0112] In some configurations, the protrusions 150 are located at or near the ends of the laterally outer or rearward portions of the central portion 148. In such an arrangement, the central portion 148 of the connector 146 is coupled to the base 144, but the side arms 130 are not directly coupled to the base 144 and can move or flex freely relative to the base 144. In some configurations, the connector 146 is overmolded onto the base 144, or the connector 146 and base are otherwise joined by an overmolding process. In other arrangements, the connector 146 can be otherwise coupled to the base 144, preferably to the central portion 148, so that the side arms 130 can flex or move freely relative to the base 144. In some configurations, the base 144 is constructed from a material that is more rigid than the material of the connector 146, or at least more rigid than the side arms 130 of the connector 146. Additionally or alternatively, side arms 130 may be otherwise configured to be less rigid than base 144, such as by reduced material thickness, hinges, cutouts, or other suitable mechanisms. In some configurations, central portion 148 terminates forward of the trailing edge of one or both of base 144 and seal 114 on each side of mask 112. Thus, the portions of side arms 130 forward of the trailing edge of one or both of base 144 and seal 114 can move or flex relative to base 144 and / or seal 114.

[0113] In some configurations, the termination points of the central portion 148 are spaced a distance 160 from the rear edge of the base 144 and a distance 162 from the rear edge of the seal 114 on each side of the mask 112, as measured along a central axis 164 of the mask 112 that extends in the anterior-posterior direction and intersects the mask 112. The distance 160 may be between ¼ and ½ of the total length 166 of the mask 112, as measured along the central axis 164. In some configurations, the distance 160 may be between ⅓ and ⅜ of the total length 166 of the mask 112. The distance 162 may be between ⅓ and ⅝ of the total length 166, or between ⅔ and 9 / 16 of the total length 166. In some configurations, the length 168 of the side arms 130 may be at least as long as, at least 1.5 times longer than, or at least twice the total length 166 of the mask 112, as measured along the central axis 164, depending on where the front ends of the side arms 130 are located relative to the mask 112. Such an arrangement provides a desired level of support for the base 144 and seal 114 while also allowing a desired level of movement of the side arms 130 to accommodate a variety of facial shapes.

[0114] In an alternative arrangement, instead of side arms 130 as shown (or including shorter side arms), the ends of the headgear 118 can be attached to the mask frame 116 (or shorter side arms) on both (left and right) sides via stiffer strap ends that terminate at the mask 112 by an attachment mechanism that allows movement in a generally horizontal plane, but not in a generally vertical plane, such as hooks that engage in vertical upstanding slots (e.g., slots 152) in the mask frame 116 (e.g., base 144).

[0115] As described above, in some configurations, the seal 114 is removably coupled to the frame 116. The seal 114 can be configured to enclose a passageway from the interior of the elbow 122 through the frame 116. Thus, the seal 114 and / or the frame 116 can form a chamber having a gas inlet from the CPAP system 10 and an aperture 128 through the seal 114 to the user. In the illustrated arrangement, the base 144 of the frame 116 defines a generally U-shaped configuration when viewed from above. A central portion of the base 144 defines an aperture 170 through which gas can flow. A first annular wall surrounds the aperture 170 and projects rearward to define a support or connector 172 for the seal 114. A second annular wall surrounds the aperture and projects forward to define a support or connector 174 for the elbow 122.

[0116] The seal 114 defines an aperture 175 configured to receive the connector 172 of the base 144. The seal 114 and the base 144 may be removably coupled by any suitable mechanism, such as, for example, a friction fit or a snap fit. In the illustrated arrangement, the connector 172 includes one or more recesses 176 configured to receive corresponding protrusions 178 of the seal 114 to provide a snap-fit ​​engagement between the seal 114 and the base 144. However, this arrangement may be reversed. Furthermore, the entire arrangement between the seal 114 and the base 144 may be reversed in that the seal 114 may include a male connector portion and the base 144 may include a corresponding female connector portion.

[0117] Preferably, the seal 114 and base 144 include an alignment or keying feature so that the seal 114 and base 144 can only be assembled in the correct orientation relative to one another. Any suitable feature can be used. In the illustrated arrangement, the seal connector 172 includes a recess 180 configured to receive a key or protrusion 182 ( FIG. 17 ) on the seal 114. While the illustrated recess 180 and protrusion 182 are located in the top central portion of the aperture 170, other locations around the circumference of the aperture 170 can also be used. This arrangement can also be reversed. Other suitable arrangements can also be used, such as, for example, non-circular shapes for the connector 172 and aperture 176.

[0118] The elbow 122 can be connected to the elbow connector 174 in any suitable manner. In the illustrated arrangement, the elbow 122 is removably connected to the elbow connector 174 so that it can be removed, for example, for cleaning. In the illustrated arrangement, the elbow 122 and the elbow connector 174 are coupled by a snap-fit ​​connection, although other suitable connections (e.g., friction fit) can be used. In some configurations, the elbow connector 174 includes a recess 184 configured to receive a protrusion 186 of the elbow 122. In the illustrated arrangement, the recess 184 is an annular recess extending around the entire circumference of the elbow connector 174 such that the elbow 122 is rotatable relative to the frame 116 at the elbow connector 174. The protrusion 186 of the elbow 122 can be annular or intermittent around the circumference of the elbow 122. This arrangement can also be reversed. In an alternative arrangement, the connection of the elbow 122 to the frame 116 can allow both rotation and pivoting of the elbow 122 relative to the frame 116. For example, the connection can include a ball-joint connection such that the elbow 122 can pivot about axes parallel and perpendicular to its connection to the frame 116. The elbow 122 can include a ball end that snaps into a socket opening in the frame 116. The elbow 122 preferably defines an angle between the flow in the conduit 120 and the flow through the aperture 170 of between 0° and 90° or between 30° and 60°. Alternatively, as described above, the elbow 122 can be formed integrally or integrally with the frame 116. In other configurations, the elbow 122 can be omitted entirely, and the tubing 120 or other breathing circuit can be connected directly to the frame 116.

[0119] In the illustrated arrangement, bias flow exhaust 126 is defined by frame 116. In particular, bias flow exhaust 126 is defined by elbow connector 174 on base 144 of frame 116. The illustrated elbow connector 174 includes an enlarged portion of base 144 nearest the U-shaped body defining a surface, or shoulder 188, facing or contacting the end face of elbow 122. Bias flow exhaust 126 includes a plurality of openings or vent holes 190 extending generally radially through the enlarged portion of elbow connector 174. Thus, when elbow 122 is connected to base 144, the vent holes 190 do not cover the vent holes 190, and the vent holes 190 are located between elbow 122 and the U-shaped body of base 144. In the illustrated arrangement, the longitudinal axis of each exhaust hole 190 is tilted or angled forward as one travels along the axis from the interior of the elbow connector 174 toward the exterior of the elbow connector 174. This arrangement can direct the flow of exhaust gases away from the user's face. Alternatively, the bias flow exhaust port 126 can be located on the elbow 122, on the frame 116, or in another suitable location.

[0120] 12-15 illustrate features that enable the mask 112 to transfer forces from the seal 114 to the frame 116. The illustrated mask 112 includes a seal support, which may be, for example, a base, housing, shell, or connector 202. The seal 114 is attached to the connector 202 such that the connector 202 provides some support for the seal 114. The connector 202 enables the mask 112 to be connected to the frame 116. The illustrated connector 202 is generally annular in shape and, at least in some configurations, does not cover a substantial portion of the forward-facing surface of the seal 114.

[0121] The connector 202 can be constructed from a relatively rigid, semi-rigid, or rigid material, such as, for example, polycarbonate. Thus, in at least some configurations, the connector 202 is more rigid than the seal 114. The material forming at least the thin-walled, flexible central portion of the seal 114 can be, for example, a soft, stretchable material, such as a silicone material or a TPE (thermoplastic elastomer). In some configurations, the seal 114 is an integral component of all of the described parts, portions of which are integrally formed, for example, by injection molding. However, in alternative arrangements, only the wearer side of the seal 114 may be formed from such a material and may be bonded to a more rigid shell (rather than the connector 202) that is coupled to or integrally formed with the frame 116 of the interface. Alternatively or additionally, the seal 114 may be a foam or gel-filled seal.

[0122] The illustrated mask 112 has a hollow interior that, in use, is filled with air under positive pressure and is configured to fit along a portion of the face extending laterally to the nose, along the user's upper lip, and seal under the user's nose. The mask 112 advantageously does not need to contact the bridge of the user's nose. In the illustrated configuration, the mask 112 does not extend over the bridge of the user's nose. More specifically, the illustrated mask 112 does not contact the bridge of the user's nose.

[0123] The mask 112 may or may not extend over the tip of the user's nose. Thus, in some configurations, the mask 112 covers the tip of the nose. In some configurations, the seal 114 of the mask 112 covers the tip of the nose. In some configurations, the illustrated mask 112 preferably does not obscure the tip of the user's nose. In some configurations or for some face shapes, the tip of the user's nose extends over an adjacent portion of the mask 112. In some configurations, the frame 116 and other portions of the mask 112 can accommodate biasing of the seal 114 by some portions of the user's nose (e.g., the tip of the nose) so that the interface can accommodate various nose lengths.

[0124] As shown, the mask 112 is preferably adapted to extend around and seal on the alae of the nose, which flares to form a curved ridge around the nostrils. The illustrated mask 112 is adapted to seal around the surface defining the opening to the nostrils, which may include part or all of the outer end of the thick nasal septum, sometimes referred to as the columella. In some configurations, the mask 112 is adapted to extend upward to seal along at least a portion of the left and right dorsal sidewalls of the user's nose. In some configurations, the mask 112 is adapted to extend upward along at least a portion of the left and right dorsal sidewalls of the user's nose without extending upward to the area of ​​the user's nasal bridge. In some configurations, the primary sealing surface of the mask 112 contacts the underside of the user's nose, the upper lip, and / or the transition area between the underside and upper lip. The secondary sealing surface of the mask can contact the sides of the user's nose, and possibly the cheeks near the nose. Although such primary and secondary sealing surfaces may not contact every user's face, such an arrangement can provide a suitable seal with a relatively wide range of face shapes.

[0125] As mentioned above, the seal 114 includes at least one nasal opening or aperture 128. In some configurations, the seal 114 can include two or more nasal apertures 128. In some configurations, the seal 114 can include apertures 128 defined in the upper structure, such as pillows, prongs, etc. In some configurations, the nasal apertures 128 can be defined by nasal cushions or inserts, which can be overmolded or otherwise secured to the underlying structure of the seal 114. Examples of suitable arrangements for the seal 114 are disclosed in commonly assigned WO 2014 / 077708, the entire contents of which are incorporated herein by reference.

[0126] The seal 114 includes an inward- or rearward-facing central portion 204 that faces or contacts the user during use of the mask 112. The seal 114 also includes a pair of opposing inner side portions 206 and a pair of opposing outer side portions 208. The inner side portions 206 are configured to contact the sides of the nose and / or portions of the user's face on either side of the nose. The inner side portions 206 can include both an inward-facing surface and a rearward-facing surface. That is, each of the inner side portions 206 can wrap from the inner-facing surface of the seal 114 toward or to the rearward-facing surface of the seal 114. The outer side portions 208 can include both a rearward-facing surface and an outward-facing surface. The rearward-facing surface of the outer side portions 208 can contact the user's face during use of the mask 112. The seal 114 may also include nasal opening supports or thickened rims 210 that partially or completely surround and provide support to the nasal aperture 128. Preferably, the outer lateral portions 208 are not connected to the frame 116, allowing the outer lateral portions 208 and / or inner lateral portions 206 to move inward in response to pressure exerted by the user on the central portion 204 of the seal 114. This arrangement allows the side portions of the seal 114 to move inward to facilitate a seal with the user's face.

[0127] The seal 114 can have regions of varying thickness to provide the seal 114 with different properties or characteristics in different regions. For example, the central portion 204 can have a relatively small thickness to allow it to conform to a user's particular facial shape. In some configurations, the relatively small thickness can allow the central portion 204 to stretch. In some configurations, the central portion 204 can have a thickness of 0.3 mm to 0.5 mm or 0.6 mm. In some configurations, the central portion 204 is 0.3 mm thick. If desired, the central portion 204 can have a thickness as small as 0.15 mm. However, smaller thicknesses may increase the likelihood of wrinkling or creasing for some facial shapes and / or under some operating gas pressures. Maintaining a thickness of 0.3 mm or greater throughout a substantial portion or the entire central portion 204 can reduce the occurrence of wrinkling over a substantial range of operating pressures, which may include the entire range of normal operating pressures.

[0128] The inner lateral portions 206 can have a thickness greater than that of the central portion 204. In some configurations, the thickness of the inner lateral portions 206 can be 0.4 mm to 0.6 mm. In some configurations, the thickness of the inner lateral portions 206 is 0.5 mm. The nasal opening support 210 can have a thickness greater than one or both of the central portion 204 and the inner lateral portions 206. The relatively greater thickness can protect the seal 114 from tearing at the nasal aperture 128 and can help maintain the nasal aperture 128 in an open configuration. In some configurations, the thickness of the nasal opening support 210 is 1 mm to 2.5 mm. In some configurations, the thickness of the nasal opening support 210 is 1.2 mm. The thickness can be constant or vary within any of the central portion 204, inner lateral portions 206, or nasal opening support 210.

[0129] The side portions 212 of the mask 112, including some or all of the inner side portions 206 and outer side portions 208, may be referred to herein as paddles. Paddles 212 may refer to any portion of the interface seal that is placed along the user's nose during use of the interface. Although paddles 212 are disclosed herein in connection with under-the-nose interfaces, they may be utilized with other types of interfaces, including those that contact, cover, or seal against the bridge of the user's nose, unless otherwise indicated.

[0130] The outer lateral portions 208 may include features that help maintain the shape of the seal 114. In some configurations, the outer lateral portions 208 include regions of increased thickness, stiffness, or rigidity, referred to herein as support structures 214, that help maintain the shape of the seal 114. The support structures 214 of the mask 112 may inhibit or prevent over-extension or unwanted expansion of the lateral end portions of the seal 114, which may result in leakage and / or undesirable pressure being applied to the user's nose by the central portion 204 of the seal 114. The support structures 214 may also inhibit or prevent collapse of at least some portions of the mask seal 112 when engaged with the nose during use. For example, the support structures 214 may inhibit or prevent collapse of the nose region or the central portion 204 of the mask seal 112.

[0131] The support structure 214 can also transmit forces from one portion of the seal 114 to another portion of the seal 114. For example, the support structure 214 can transmit a force applied to a rear portion of the seal 114 to a front portion of the seal 114. In some configurations, the support structure 214 can transmit a force that a user's face applies to a rearward-facing surface of the seal 114 to another portion of the seal 114, which can withstand some or all of the transmitted force. In some configurations, the support structure 214 transmits a force from the rearward-facing or user-contacting surface of the seal 114 to the frame 116 or other structure (e.g., connector 202) that supports the seal 114. Thus, in some configurations, the support structure 214 extends between the rearward-facing surface of the seal 114 and a surface of the seal 114 that contacts or overlaps the frame 116 or other support structure for the seal 114. Preferably, the support structure extends from the rearward-facing surface to the surface that the frame 116 or other support structure overlaps. However, as discussed above, the support structure 214 can provide structure to the seal 114 and can be utilized to provide such support without necessarily transmitting force.

[0132] In some configurations, the frame 116 includes a central portion and a side portion on each side of the central portion. The side portions may function to provide support to the support structure 214 of the seal 114 and may be referred to herein as paddle covers 216. The side portions or paddle covers 216 may align with or overlap the portion of the seal 114 that includes the support structure 214, thereby allowing the support structure 214 to transfer loads to the side portions 216 of the frame 116.

[0133] The supports 214 can extend generally in a direction from the rear or user-contacting surface of the seal 114 toward its respective side portion of the cover 216 of the frame 116. In some configurations, each of the supports 214 extends generally or substantially in a longitudinal direction of the seal 114. The supports 214 can extend generally parallel to one another or can be closer together at the front end compared to the rear end. In other words, the supports 214 can converge in a direction proceeding from the rear or user-contacting surface of the seal 114 toward the front portion of the seal 114. However, in other configurations, the supports 214 can expand from the rear to the front.

[0134] In the illustrated arrangement, each support structure 214 is shaped or otherwise configured to follow part or all of the periphery of the associated outer lateral portion 208. Each support structure 214 may have a generally C-shape (or an inverted C-shape) when the seal 114 is viewed from the side, including a rearward portion 218 and upper and lower extensions or legs 220 and 222 extending forward from the rearward portion 218. In the illustrated arrangement, the support structures 214 are thickened regions of the seal 114, each of which projects inward into the interior space of the seal 114. One or both of the extensions 220, 222 may extend to and / or contact the connector 202. In the illustrated configuration, only the lower extension 220 extends to the connector 202, and the upper extension is spaced rearward from the connector 202. However, in other configurations, this arrangement may be reversed.

[0135] Each of the illustrated support structures 214 includes a cutout or relief 224 that provides an area of ​​reduced thickness, stiffness, or rigidity within the support structure 214. In the illustrated arrangement, the relief 224 is an area of ​​reduced thickness relative to the remainder of the support structure 214. The illustrated relief 224 also has a generally C-shape (or an inverted C-shape) when the seal 114 is viewed from the side. In some configurations, the relief 224 also follows part or all of the periphery of the associated outer lateral portion 208. Preferably, however, the relief 224 is spaced inward from the periphery of the outer lateral portion 208. In at least some configurations, the relief 224 is completely contained within the support structure 214. The relief 224 can allow portions of the support structure 214 to move relative to one another. Thus, the relief 224 can allow corresponding portions of the seal 114 to move relative to one another. Thus, the rearward portion of the relief 224 of the support structure 214 and seal 114 can move toward the forward portion of the relief 224 of the support structure 214 and seal 114 .

[0136] The support structure 214 may be of variable thickness to provide different levels of support for the seal 114. For example, the upper extension 220 and / or the lower extension 222 may have a thickness that is less than the thickness of at least a portion of the rearward portion 218. In some configurations, the portion of the rearward portion 218 rearward of the relief 224 and / or located at or adjacent to the rear face of the seal 114 has a thickness that is greater than the portion of the rearward portion 218 forward of the relief 224. The relief 224 may have a thickness that is less than both the portion of the rearward portion 218 forward of the relief 224 and the portion of the rearward portion 218 rearward of the relief 224. Furthermore, a portion of the outer lateral portion 208 on the outside (e.g., forward) of the support structure 214 may have a thickness that is less than the thickness of any portion of the support structure 214. In some configurations, the thickness of the portion of the outer lateral portion 208 on the outside of the support structure 214 is equal to or substantially equal to the thickness of the relief 224.

[0137] In some configurations, the portion of the rear portion 218 rearward of the relief 224 and / or located at or adjacent the rear face of the seal 114 has a thickness of 2 mm to 5 mm. In some configurations, the thickness is 4 mm. In some configurations, the portion of the rear portion 218 forward of the relief 224 has a thickness of 1.5 mm to 3 mm. In some configurations, the thickness is 2 mm. In some configurations, the relief 224 has a thickness of 0.3 mm to 0.6 mm. In some configurations, the thickness is 0.5 mm. In some configurations, the portion of the outer lateral portion 208 outside the support structure 214 can have a thickness of 0.3 mm to 0.6 mm. In some configurations, the thickness is 0.5 mm. The seal 114 can also have thicknesses proportional to those disclosed herein without having any or all of the specific thicknesses disclosed.

[0138] As described, the face-contacting or wearer-side of seal 114 includes a flexible, lower-nose-receiving, concave central portion shaped to receive and seal against the tip, underside, and base of the nose and the upper lip to form a seal on the wearer's face and position apertures 128 for gas flow directly below the wearer's nares. As shown in Figures 5 and 16, the lower-nose-receiving flexible central portion includes an upper wall portion 230 that contacts the tip of the wearer's nose, a lower wall portion 232 that contacts the upper lip below the wearer's nose, and left and right wall portions defined by the aforementioned inner lateral portions 206 that contact the left and right lower sides of the wearer's nose. Lower wall portion 232 below exit aperture 128 is positioned rearward of, or closer to, the left and right rearmost ends of seal 114 than upper wall portion 230.

[0139] The left and right side wall portions defined by the inner lateral portions 206 extend away from each other from the aperture 128. The angle between the left and right side wall portions 206 can be, for example, about 20 degrees to about 60 degrees, or about 30 degrees to about 50 degrees. Typically, the seal 114 has a width dimension greater than its height dimension. In at least some embodiments, the seal 114 can have an overall width of 5 cm to 10 cm, or 6 cm to 8 cm. In at least some embodiments, the seal 114 can have an overall height of less than 5 cm, less than 4.5 cm, or less than 4 cm. The seal 114 can have a first texture on the user-contacting side and a second texture on the opposite side that is different from the first texture. For example, the texture on the user-contacting side can promote a seal with, friction against, or comfort against the user's face. The opposing asperities can be configured to interact with the base 144 of the frame 116 to increase friction to prevent relative movement between the seal 114 and the frame 116, reduce friction to facilitate relative movement between the seal 114 and the frame 116, or reduce adhesion between the seal 114 and the frame 116 so that the lateral portions of the seal 114 are free to move away from and no longer contact the frame 116.

[0140] Aperture 128 may be elongated across the width of seal 114. Aperture 128 may be somewhat bean- or bow-tie-shaped when viewed from the rear. In the illustrated configuration, a central portion of aperture 128 has a height that is less than the side portions of aperture 128. Furthermore, because lower wall portion 232 is positioned rearward of upper wall portion 230, a lower edge 236 of aperture 128 is spaced rearward across the depth of seal 114 from an upper edge 234 of aperture 128 when seal 114 is oriented as worn by a user with the user's head upright.

[0141] 5 shows a cross-sectional view of the mask 112 along a vertical central plane of the mask 112. The portion of the upper wall portion 230 above and adjacent to the aperture 128 can define a line 240 that lies in the central plane. Similarly, the portion of the lower wall portion 232 below and adjacent to the aperture 128 can define a line 242 that lies in the central plane. Lines 240 and 242 define an angle 244 therebetween. In some configurations, angle 244 is greater than or equal to 90 degrees and less than 180 degrees. In some configurations, angle 244 is between 120 degrees and 150 degrees. In some configurations, angle 244 is 135 degrees.

[0142] The seal 114 may also define a line 246 that lies in the central plane and extends through a point on the lower edge 236 of the aperture and a point on the upper edge 234 of the aperture 128. FIG. 16A shows the aperture 128 from the rear of the seal 114 perpendicular to the line 246. As described above, the aperture 128 may have a bean or bowtie shape, with the central portion 250 having a height 252 that is less than the heights 254 of the side portions 256. The aperture 128 may be symmetrical about a central vertical axis. In the illustrated arrangement, each side portion 256 is generally elliptical in shape, with the major axes of the elliptical shapes angled inward or toward each other in a direction from the lower edge 236 to the upper edge 234. The central portion 250 defines a curved, concave transition between the elliptical shapes of the side portions 256 at each of the lower edge 236 and upper edge 234.

[0143] Each side portion 256 defines an uppermost point 260 and a lowermost point 262. The uppermost points 260 of the side portions 256 are closer to each other and to the central axis than the lowermost points 262. The uppermost points 260 define a horizontal distance or width 264 between them that is less than the horizontal distance or width 266 between the lowermost points 262. Each of the distances 264, 266 can be greater than or equal to ½ and less than or equal to ¾ of the overall width 268 of the aperture 128. In some configurations, the distance 264 is between ⅓ and ⅔ of the width 268, or ½ of the width 268. In some configurations, the distance 266 is between ½ and 7 / 8 of the width 268, or ¾ of the width 268.

[0144] The upper edge 234 of the aperture 128 defines a vertical distance 270 between an uppermost point 260 and a lowermost point 272 of the upper edge 234 within the central portion 250, which may be located on the central axis. The vertical distance 270 may also be referred to as the depth of the central portion 250 at the upper edge 234. Similarly, the lower edge 236 of the aperture 128 defines a vertical distance 274 between an uppermost point 262 and an uppermost point 276 of the lower edge 236 within the central portion 250, which may be located on the central axis. The vertical distance 274 may also be referred to as the depth of the central portion 250 at the lower edge 236. In some configurations, the vertical distances 270 and 274 may differ from one another. In some configurations, the vertical distance 270 is less than the vertical distance 274. In some configurations, the vertical distance 270 is between one-third and two-thirds of the vertical distance 274, or is approximately one-half of the vertical distance 274. In some configurations, vertical distance 270 is less than height 252 of central portion 250 and / or height 252 of central portion 250 is equal to or less than vertical distance 274 .

[0145] In some configurations, the overall width 268 of the aperture 128 is 20 mm to 25 mm, 21 mm to 23 mm, or approximately 22 mm. In some configurations, the overall height 254 of the aperture 128 is 10 mm to 14 mm, 11 mm to 13 mm, or approximately 12 mm. In some configurations, the height 252 of the central portion 250 of the aperture 128 is 4 mm to 6 mm, or approximately 5 mm. In some configurations, the distance 270 is 1.5 mm to 2.5 mm, or approximately 2 mm. In some configurations, the distance 274 is 4 mm to 6 mm, or approximately 5 mm. In some configurations, the distance 264 between the uppermost points 260 of the upper edges 234 is 8 mm to 12 mm, 9 mm to 11 mm, or approximately 10 mm. In some configurations, the distance 266 between the lowest points 262 of the lower edges 236 is between 15 mm and 20 mm, between 16 mm and 18 mm, or about 17 mm.

[0146] 5, 10, and 17-22, as described above, the illustrated mask 112 includes a connector 202 that couples the seal 114 to the frame 116. The connector 202 includes a first portion 300 and a second portion 302 that capture the seal 114 therebetween. The first portion 300 and the second portion 302 can be coupled to one another to hold the seal 114 between the first portion 300 and the second portion 302. In some configurations, the first portion 300 can be connected to the second portion 302 by a snap-fit ​​mechanism, which can be a permanent or removable connection.

[0147] In the illustrated arrangement, the first portion 300 of the connector 202 includes a hub portion 304 and a flange portion 306. The hub portion 304 includes an axially extending annular wall and defines an aperture 175 that receives the connector 172 on the base 144 portion of the frame 116. The flange portion 306 includes an annular wall that extends outwardly from the hub portion 304. In some configurations, the flange portion 306 extends radially and is therefore perpendicular to the hub portion 304. In the illustrated arrangement, the second portion 302 is an annular member sized and shaped to fit over the hub portion 304 of the first portion 300.

[0148] As described above, the first and second portions 300, 302 of the connector 202 are configured to axially interlock. In the illustrated arrangement, the outer surface of the end portion of the hub portion 304 of the first portion 300 defines a recess 308 that extends partially or completely circumferentially around the hub portion 304. The inner surface of the second portion 302 defines a protrusion 310 that extends partially or completely circumferentially around the second portion 302 and is configured to be received by the recess 308 of the first portion 300. In other configurations, this arrangement can be reversed, such that the protrusion 310 can be on the first portion 300 and the recess 308 can be on the second portion 302.

[0149] The first and second portions 300, 302 can also be secured to one another to ensure that the first and second portions 300, 302 can only be connected to one another in a single rotational orientation and / or to inhibit or prevent relative rotation once connected. In some configurations, one of the first and second portions 300, 302 includes a key or protrusion, and the other of the first and second portions 300, 302 includes a slot or recess configured to receive the key or protrusion. In the illustrated arrangement, the hub portion 304 of the first portion 300 includes a slot or recess 312, and the second portion 302 includes a key or protrusion 314 configured to engage with the slot or recess 312. At least an end of the slot or recess 312 is semi-cylindrical in shape, and the key or protrusion 314 includes a complementary semi-cylindrical shape. In the illustrated arrangement, the slots 312 and protrusions 314 are located in the upper portions of the first and second portions 300, 302 of the connector 202. However, in other configurations, this location can be varied. Additionally, the locations of the recesses 312 and protrusions 314 can be reversed between the first and second portions 300, 302 of the connector 202 from the locations shown.

[0150] The seal 114 defines an aperture 316 that receives the first and second portions 300, 302 of the connector 202. When the connector 202 is assembled to the seal 114, the flange portion 306 of the first portion 300 is disposed within the seal 114, and the hub portion 304 extends through the aperture 316. The second portion 302 of the connector 202 is disposed on the exterior of the seal 114. The seal 114 may include an annular rim 318 that surrounds the aperture 316 and is configured to be captured by the first and second portions 300, 302 of the connector 202. In particular, the rim 318 has a generally T-shaped cross-section having a narrow base 320, a first lobe 322 extending from the base 320 in a first axial direction, and a second lobe 324 extending from the base 320 in a second axial direction opposite the first axial direction. First portion 300 defines an annular recess 326 configured to receive first lobe 322, and second portion 302 defines an annular recess 328 configured to receive second lobe 324. Base 320 extends between first portion 300 and second portion 302 toward the main portion of seal 114.

[0151] In the illustrated arrangement, the connector 202 and the seal 114 include an interference fit configured to inhibit or prevent rotational movement between the seal 114 and the connector 202. In particular, the hub portion 304 of the first part 300 includes a first protrusion 330, and the second part 302 includes a second protrusion 332. The first protrusion 330 and the second protrusion 332 face each other with a space therebetween configured to receive a portion of the annular rim 318. That portion of the annular rim 318 defines a first recess 334 and a second recess 336 configured to receive the first protrusion 330 and the second protrusion 332, respectively. In the illustrated arrangement, each of the protrusions 330, 332 and the recesses 334, 336 has a generally rectangular parallelepiped shape. The protrusions 330, 332 and the recesses 334, 336 are located in lower portions of the first part 300 and the second part 302 of the connector 202. However, in other configurations, these positions may be varied.

[0152] In some configurations, connector 202 and seal 114 also include a second set of interference-fit portions configured to inhibit or prevent relative movement between seal 114 and connector 202. In particular, first portion 300 includes third protrusion 338, and seal 114 includes third recess 340 and fourth recess 342. Third recess 340 is configured to receive third protrusion 338. In the illustrated configuration, a portion of key or protrusion 314 extends into fourth recess 342. Third protrusion 338, third recess 340, and fourth recess 342 are located on upper portions of connector 202 and seal 114, respectively, and / or opposite protrusions 330, 332 and recesses 334, 336. However, in other configurations, third protrusion 338, third recess 340, and fourth recess 342 can be located in different locations.

[0153] 3 and 23 , in the illustrated arrangement, the headgear 118 can include a bifurcated headgear arrangement having a top or upper strap portion 350 and a rear strap portion 352. The upper strap portion 350 is configured to span from one side to the other over the top of the user's head. In some configurations, the upper strap portion 350 is a crown strap that sits on or near the parietal bone or the junction between the parietal bone and the frontal bone. In other configurations, the upper strap portion 350 can include a front strap that sits on the user's frontal bone. The rear strap portion 352 passes around the back of the user's head and, in some configurations, sits on the user's occipital bone. However, in other configurations, the rear strap portion 352 can be positioned higher or lower on the user's head and / or neck. In the illustrated arrangement, the upper strap portion 350 and the rear strap portion 352 join together at joints 354 on both sides of the headgear 118. A pair of forward extension straps 356 each extend forward from joint 354 toward and connect to a respective one of side arms 130 of frame 116 .

[0154] In some configurations, at least some portions of the headgear 118 are rigid, semi-rigid, inelastic, or substantially inextensible in response to normal or expected forces acting on the headgear 118, while other portions of the headgear 118 are elastic or extensible in response to normal or expected forces. In some configurations, one or more of the upper strap portion 350, the junction 354, and the forward extension strap 356 are rigid, semi-rigid, inelastic, or substantially inextensible. In the illustrated configuration, each of the upper strap portion 350, the junction 354, and the forward extension strap 356 is rigid, semi-rigid, inelastic, or substantially inextensible. In the illustrated configuration, the rear strap portion 352 is elastic or extensible. This arrangement allows the rear strap portion 352 to stretch to adjust the circumferential length of the headgear 118. The amount of stretch of the rear strap portion 352 can be limited, and therefore the rear strap portion 352 may also be adjustable in length. In some configurations, it is preferable for circumferential length adjustment to occur at the back of the user's head, which is less likely to lengthen in response to blowing forces. The rigid, semi-rigid, inelastic, or substantially inextensible nature of the joints 354 and forward extension straps 356 located at the sides and front of the user's head helps maintain the desired circumferential length of the headgear 118 despite the elastic nature of the rear strap portions 352. In some cases, frictional forces between some portions of the headgear 118 and the sides and front of the user's head prevent the headgear 118 from moving or lengthening in response to blowing forces. However, in other arrangements, the rear strap portions 352 can be rigid, semi-rigid, inelastic, or substantially inextensible, and in such cases, may be adjustable in length.

[0155] The upper strap portion 350 can include a length adjustment mechanism. In the illustrated arrangement, the upper strap portion 350 includes a first portion 358 and a second portion 360, which are separate from one another and can be adjustably connected to one another. The free end of the first portion 358 includes a loop 362 through which the second portion 360 can pass. Thus, the first portion 358 and the second portion 360 can slide relative to one another to change the overlapping distance of the first portion 358, 360 and thus the length of the upper strap portion 350. The second portion 360 can be coupled to the first portion 358 to secure the upper strap portion 350 at a desired adjusted length. In the illustrated arrangement, the inner surface of the second portion 360 can include a hook portion of a hook-and-loop fastener, and the outer surface of the first portion 358 can include a loop portion of a hook-and-loop fastener. This arrangement can also be reversed. In some configurations, the material of the upper strap portion 350 can define the loop portion of the hook-and-loop fastener. In other words, the loop portion may not be a separate element of the upper strap portion 350 .

[0156] In the above-described arrangement, the upper strap portion 350 can be adjusted to an appropriate length for a particular user so that the joints 354 and / or forward extension straps 356 are positioned above the user's ears. Once adjusted, the upper strap portion 350 can be maintained in the adjusted position while donning or doffing the headgear 118 and associated interface 110. In other words, the user preferably does not need to separate the first and second portions 358, 360 from one another to don or doff the interface 110. Rather, the headgear 118 ("like a cap") holds the frame 116 at or near the seal 114 (so as to hold the cap by its top as it is lifted or repositioned on the head) and allows the interface 110 to be donned by moving the rear strap portion 352 over and to the back of the user's head. The elastic or stretchable rear strap portion 352 can facilitate passing the headgear 118 over the user's head without releasing the headgear 118 by separating portions 358, 360 of the upper strap portion 350 or by separating one or both ends of the rear strap portion 352 from the remainder of the headgear 118. The headgear 118 can be removed or doffed in the reverse motion.

[0157] In the illustrated configuration, rear strap portion 352 is connected to each of joints 354 by an end of rear strap portion 352 that is threaded through loops 364 supported by joints 354 and then folded back. The ends of rear strap portion 352 may be joined to a relatively central portion of rear strap portion 352 by a suitable fastener, such as, for example, a hook-and-loop fastener. Rear strap portion 352 may be adjustable at one or both ends.

[0158] In some configurations, the rigid, semi-rigid, inelastic, or substantially inextensible portion of the headgear 118 can be constructed by introducing a molten plastic material into a space defined by a textile or fabric outer cover, allowing the temperature to drop to form a plastic core. The plastic material can adhere or bond to the textile or fabric material to form a unitary structure. The textile or fabric material can be, for example, a tubular structure or a separate layer of material. Headgear structures having a plastic core and an outer textile or fabric cover, and methods of manufacturing such headgear structures, are disclosed in commonly assigned U.S. Provisional Patent Applications Nos. 62 / 050,925, 62 / 159,857, and 62 / 198,104, which are incorporated by reference in their entireties and form a part of this disclosure. In some configurations, the connector 138 and some or all of the loops 362, 264 are formed as a unitary structure with the plastic core of the headgear 118.

[0159] The seals and masks disclosed herein can be used with other forms of headgear, such as headgear with two straps attached to each side of the mask, i.e., headgear with left and right upper and lower straps. The frame of such interface embodiments may or may not include side arms as described above. The left and right upper straps can pass downward between the wearer's eyes and ears (when the headgear is worn), and the left and right lower straps can extend from the back of the head below the ears to the mask (attached to the mask on each side below the upper strap). Alternatively, the upper and lower straps can be joined, for example, before attachment to the mask frame or in a more rigid yoke that is integral with the mask frame. Such headgear can have buckles and tongues, loops and tongues, or other adjustment devices on the upper or lower straps or on both sides, partway along their length, or at the connection of the straps to the mask. In a less preferred embodiment, the upper strap can be attached to the top of a T-piece that extends upward from the frame to the wearer's forehead. In another embodiment, again, the headgear can include a single strap that spans or loops around the back of the head from the mask on one side and back to the mask on the other side. Such headgear straps can be elastic or elastically stretchable and / or can have length adjustment devices (e.g., buckles and tongues, loops and tongues, etc.) at the back, or at the sides, or at one or both sides where the headgear connects to the mask. Variations of such headgear can also include a crown strap.

[0160] Other suitable materials or configurations for the headgear 118 can also be used. For example, in some configurations, the headgear can be formed at least in part from a soft, flexible material, which can be, for example, a fabric-covered foam material such as a BREATH-O-PRENE material. The headgear 118 can be formed by cutting the headgear 118 to shape from a sheet of material, for example, by blade cutting or radio frequency cutting. In one embodiment, the edges of the headgear are thermoformed, i.e., compressed under heat, to form the curved edges. That is, heat and pressure are applied along the edges of the headgear to compress opposing outer surfaces of the headgear material toward each other at the edges and heat-seal them together. This can be done simultaneously or with the same equipment as cutting and shaping the headgear, for example, by cutting the outline of the headgear shape in the sheet material in one operation and thermoforming to define the curved headgear edges, or alternatively, by first cutting and shaping the headgear and then curving the edges in a second operation. The rounded edges or any joints in the headgear may alternatively be formed by ultrasonic or radio frequency welding, for example.

[0161] As described above, the mask 112 includes a bias flow exhaust 126 that allows exhaled gases from the user to exit the interface 110. In the illustrated arrangement, the bias flow exhaust 126 is defined by the frame 116. In particular, the bias flow exhaust 126 is defined by the elbow connector 174 in the base 144 of the frame 116. The bias flow exhaust vent 190 extends generally radially through the elbow connector 174 between the elbow 122 and the U-shaped body of the base 144. The location of the vent 190 can reduce noise generated by the interface 110. Additionally, other features of the interface 110 can facilitate noise reduction. Examples of such features and locations are disclosed with particular reference to FIGS. 24-29.

[0162] Inspiratory noise can be defined as the increased level of noise resulting from the inhalation or inspiration of a user wearing a CPAP mask. Inspiratory noise is common in CPAP masks, especially small nasal masks or nasal pillow masks. Static bias noise can be defined as the constant noise when no flow is generated by the patient's breathing and is generally related to the bias hole shape and can be reduced through a number of different hole shapes, patterns, and configurations. Dynamic inspiratory noise (generally louder during inspiration) can be caused by shapes other than the bias hole. However, this inspiratory noise is transmitted or heard through the bias hole and is therefore closely related to the bias flow. When a patient breathes into a CPAP machine, the flow in the CPAP tubing increases during inhalation, maintaining a roughly constant pressure within the mask. As a result, the bias flow during inhalation and exhalation is roughly constant, and therefore the flow through the bias hole is determined solely by pressure.

[0163] Dynamic noise, particularly inspiratory noise, occurs when the patient is inhaling, and therefore when flow from the CPAP is at its highest. It is therefore believed that increased flow contributes to inspiratory noise. Methods for minimizing noise generated during inspiration are discussed below. The noise is caused by a constriction in the breathing circuit upstream of the bias flow. This constriction creates increased velocity and turbulence, which in turn creates noise. The noise is heard through the bias hole. It has been determined that having a diameter less than approximately 15 mm in the breathing circuit can contribute to significant inspiratory noise. Therefore, when possible or practical, given other factors, it may be desirable to maintain a diameter greater than approximately 15 mm in the breathing circuit when designing a mask system that reduces, minimizes, or eliminates inspiratory noise issues.

[0164] In addition to maintaining a minimum diameter or cross-sectional area within the breathing circuit, another factor is the consideration of turbulence. Turbulence generated by the airflow itself results in noise, which is subsequently heard by the patient. A sudden expansion in the pipe results in a change in velocity within the pipe, turbulence, and therefore noise. The expansion can be either a sudden expansion (expansion angle equal to 180 degrees) or a more gradual expansion (expansion angle greater than 0 degrees and less than 180 degrees). To reduce noise, the rate at which the fluid is decelerating can be reduced (i.e., a shallower, gradual expansion can be utilized) or the velocity at which the air is moving can be reduced. To reduce head loss, the expansion should preferably have an angle of θ<30°, or alternatively, 120°θ<180° or 150°θ<180°.

[0165] In practice, noise can be reduced by designing the cross section to reduce or minimize peak air velocity and / or by designing the shape to reduce or eliminate abrupt changes in shape that cause turbulence and, therefore, noise. In some configurations, noise reduction can be achieved by carefully considering the diameter of the tubing and connections within the breathing circuit. For example, FIG. 24 shows a conventional CPAP hose-mask tubing connection. The actual CPAP hole or breathing circuit is not shown in FIG. 24 (but see conduit 12 in FIG. 1 ), but is coupled to the upstream end of a CPAP hole adapter 400. The CPAP hose adapter 400 is coupled to the connector 124 of the mask tubing 120. The illustrated connector 124 of the mask tubing 120 is a swivel connector comprising a male swivel portion 402 and a female swivel portion 404. The male swivel portion 402 is coupled to the mask tubing 120, and the female swivel portion 404 is coupled to the CPAP hose adapter 400. In Figure 24, it can be seen that there are several constrictions and one expansion within the illustrated CPAP hose-mask tubing connection. The constrictions increase the velocity of the air, thereby increasing turbulence as the air passes through the expansion. The constrictions are a result of several male-female connections between the swivels 402, 404 and the tubing or hose.

[0166] Referring to FIG. 25 , an improved CPAP hose-to-mask tube connection reduces one or more of the constrictions by reducing or minimizing the wall thickness of the swivel components, modifying the manner in which the male swivel 402 is joined to the mask tube 120, and the like. Notably, in the configuration illustrated in FIG. 25 , the male swivel 402 does not extend inside the mask tube 120. Rather, the male swivel 402 has a minimum diameter that is equal to or substantially equal to the inner diameter of the mask tube 120. In some configurations, this is achieved by using a fitting sleeve 406 or other suitable fitting to couple the male swivel 402 to the mask tube 120. The fitting sleeve 406 can be formed, for example, by overmolding a material that chemically bonds to the male swivel 402 and mask tube 120 over portions of both the swivel 402 and the tube 120. Such an arrangement reduces the size of the constriction within the male swivel 402 and also eliminates or substantially eliminates the extension from the male swivel 402 to the mask tube 120. In the arrangement shown, the diameters of the various components are labeled and can be as follows: Approximate diameter: D1≒22mm D2≒D3≒19mm D4≒17mm D5≒D6≒15mm In other configurations, the diameters may vary from the values ​​recited above, but the ratio between two or more of the diameters may be the same or substantially the same. Additionally, the difference between two or more of the diameters may be the same, substantially the same, or less than the values ​​recited above.

[0167] In some applications, or at some locations within a CPAP system, such as interface 110, it may be difficult or impractical to avoid abrupt changes in shape. For example, small wall angles (e.g., less than 30°) are desirable to prevent abrupt transitions in cross-sectional area. These small wall angles require the transition between diameters or cross-sectional areas to occur over a greater length compared to more abrupt transitions, which may increase the overall size of the mask. In many cases, it is desirable for the mask to be as small and unobtrusive as possible or practical for the comfort of the user. Therefore, abrupt transitions may be desirable with respect to the smaller mask shapes they allow.

[0168] To reduce noise across the unavoidable transition from small diameter to large diameter (expansion), the location of the bias outlet can be selected to reduce the flow rate across the transition. Bias flow, which is generally associated with noise generation, can actually be used to reduce noise. Having bias flow on the side of the expansion with the smallest cross-sectional area (before the expansion) can reduce intake noise as the flow rate across the expansion, and therefore the velocity, is reduced here. This arrangement reduces turbulence, as shown in Figures 26 and 27. Figures 26A and 27A show the flow in the expansion when the bias flow outlet is located before or upstream of the expansion. Figure 26A is a velocity plot, and Figure 27A is a vector plot. Figures 26B and 27B show the flow in the expansion when the bias flow outlet is located after the expansion. Again, Figure 26B is a velocity plot, and Figure 27B is a vector plot. Comparing Figures 26A and 26B, it is clear that the velocity at the extension is lower when the bias-flow outlet is located before the extension (Figure 26A) relative to the velocity at the extension when the bias-flow outlet is located after the extension (Figure 26B). The dark areas in the relatively upstream part of the flow represent areas of relatively higher velocity. Therefore, the bias-flow outlet located before the extension has lower velocity and therefore lower noise. Figures 27A and 27B also show that there is less recirculation flow when the bias-flow outlet is located before the extension (Figure 27A) compared to the situation when the bias-flow outlet is located after the extension (Figure 27B). Less recirculation flow means less turbulence, which means less noise.

[0169] Figures 28A, 28B, and 28C show different design options (A, B, and C) that illustrate how this principle can be implemented in a mask 112. The sound levels for each design option are generated over three breaths, as shown in the plot in Figure 29. Design C has the lowest peak inhalation noise, Design A has the highest peak inhalation noise, and Design B has a peak inhalation noise between Designs C and A. Each sample has the same minimum inner diameter D. In the illustrated design, the bias flow outlet 126 is implemented within the elbow connector 174, but in other arrangements, the bias flow outlet 126 can be in other locations as well. For example, in some configurations, the bias flow outlet 126 can be within the elbow 122, among other possible locations.

[0170] In design A, the exhaust hole 190 of the bias flow exhaust port 126 is located after an abrupt change in shape. As a result, on inspiration, there is a high flow rate of air across the abrupt expansion, which causes turbulence and noise.

[0171] In Design B, the exhaust hole 190 of the bias flow exhaust port 126 is located after the gradual transition in the shape. The angle of the gradual transition in the shape is greater than 30°. As a result, during inspiration, the high flow rate across the gradual expansion causes some separation of the flow from the walls of the flow passage. This separation of the flow causes turbulence and, therefore, noise.

[0172] In Design C, the vent holes 190 of the bias-flow vent 126 are located before or upstream of the abrupt change in geometry. This reduces the flow rate and, therefore, the velocity of the air passing through the abrupt expansion. Because head loss or pressure loss is proportional to the square of the velocity, it is clear that velocity is a significant factor in the amount of head loss, turbulence, and therefore noise, generated as a fluid flows through a change in cross section. This illustrates the effect the location of the bias-flow vent 126 has on the noise and turbulence generated. Due to the reduced velocity through the expansion, the turbulence, and therefore the noise, is significantly lower in Design C than that observed in Design A.

[0173] In an alternative arrangement, the principles shown in Design C can be applied to Design B by placing the bias flow outlet 126 before or at the beginning of the gradual expansion. Similar results are expected as in Design C due to the reduction in flow across the gradual expansion.

[0174] The location of the bias flow exhaust port 126's exhaust hole 190 relative to the steep expansion has a greater impact on noise than reducing the wall angle in the expansion. This is desirable because using a desired (small) angle may not be practical for optimizing the expansion angle in an actual mask, as it would require an increased transition length to achieve the change in cross-sectional area, potentially making the mask overly large. To reduce dynamic (inhalation) noise, turbulence introduced into the air delivery flow path can be reduced or minimized by avoiding, reducing, or minimizing possible or practical constrictions in the flow path from the CPAP machine to the patient. Additionally or alternatively, the inner diameter (or cross-sectional area) of swivels, elbows, and / or other portions of the flow path can be increased, maximized, or as close as possible or practical to the inner diameter (or cross-sectional area) of the air delivery (CPAP) hose. Such an arrangement keeps flow velocity, and therefore turbulence, to a minimum, resulting in reduced noise generation. The design of the transition from the smaller cross section to the larger cross section, if necessary or desirable, is preferably located between the bias flow outlet and the patient (after the bias flow), thereby reducing the volumetric flow rate across the transition. The design of the transition from the smaller cross section to the larger cross section, if necessary or desirable, is preferably such that the flow head loss across the transition is minimized. The flow path from the smaller cross section to the larger cross section is preferably a gradual expansion, with a wall angle of less than 30 degrees. If such an arrangement is impractical, a sharp transition with 180° angled walls is preferred.

[0175] 30 and 31 show alternative connection mechanisms between the headgear 118 and the frame 116 (or other portions of the mask 112). In the arrangement shown, the forward extension straps 356 of the headgear 118 overlap the side arms 130 of the frame 116. In the arrangement shown, the forward extension straps 356 can be positioned inside the side arms 130, but in other arrangements, this arrangement can be reversed and the forward extension straps 356 can be positioned outside the side arms 130.

[0176] In some configurations, the position of the headgear 118 relative to the frame 116 is adjustable, thereby adjusting the amount of overlap between the forward extension straps 356. Such adjustment changes the effective circumference of the interface 110. In some configurations, the headgear 118 and the frame 116 are adjustable to a selected one of two or more distinct adjustment positions. Any suitable coupling mechanism between the headgear 118 and the frame 116 can be used. In the illustrated arrangement, the headgear 118 includes one or more posts 410 located on the forward extension straps 356, and the frame 116 includes one or more corresponding openings 412 located on the side arms 130 and configured to removably receive the posts 410. In the illustrated arrangement, the headgear 118 includes two posts 410 on each side, and each side arm 130 of the frame 116 includes three openings 412. Thus, the headgear 118 and the frame 116 have two different length adjustment positions. However, in other arrangements, other numbers of adjustment portions can be provided.

[0177] The posts 410 and openings 412 are similar in structure and function to baseball cap-style size adjustment mechanisms. Each post 410 includes a stem 414 and a head or cap 416. While the illustrated posts 410 are generally T-shaped, other shapes, such as a cylindrical stem 414 and a disk-shaped or spherical head 416, can also be used. The openings 412 are sized, shaped, and / or otherwise configured to allow the head 416 of the post 410 to pass therethrough and to retain the post 410 once it has passed through the opening 412, at least in response to normal or expected forces. However, the post 410 can be intentionally removed from the opening 412 to allow separation of the headgear 118 and the frame 116. Passing the post 410 through the opening 412 can be achieved by deformation of one or both of the post 410 and the opening 412. That is, the head 416 of the post 410 may bend or otherwise deform, and the opening 412 may stretch or enlarge to facilitate passage of the head 416 of the post 410 therethrough.

[0178] In the illustrated arrangement, the openings 412 are elongated and each include a recessed flange 418 spaced inwardly from the outer surface of the side arm 130 of the frame 116. The recessed flange 418 can extend partially or entirely around the periphery of the opening 412. The recessed flange 418 can be continuous or intermittent. For example, the recessed flange 418 can include multiple portions at each end of the elongated opening 412, the portions being distinct from one another. The recessed flange 418 can be configured to contact and retain the head 416 of the associated post 410.

[0179] The posts 410 may be formed or connected to the headgear 118 by any suitable mechanism. For example, the posts 410 may be integrally formed with the base member 420 that is coupled to the headgear 118 by stitching, RF welding, adhesive, or another suitable coupling mechanism, etc. In some configurations, the posts 410 may be integrally formed with the plastic core of the headgear 118.

[0180] 32 and 33 show yet another alternative connection mechanism between the headgear 118 and the frame 116 (or other portion of the mask 112). In the arrangement shown, the forward extension straps 356 of the headgear 118 overlap the side arms 130 of the frame 116. In the arrangement shown, the forward extension straps 356 can be positioned inside the side arms 130, although in other arrangements, this arrangement can be reversed and the forward extension straps 356 can be positioned outside the side arms 130.

[0181] In the illustrated configuration, the position of the headgear 118 relative to the frame 116 is fixed or non-adjustable when the frame 116 is connected to the headgear 118. In an alternative arrangement, the position of the headgear 118 relative to the frame 116 may be adjustable so that the effective circumference of the interface 110 can be adjusted. Any suitable coupling mechanism between the headgear 118 and the frame 116 can be used. In the illustrated arrangement, the headgear 118 includes one or more posts 410 located on the forward extension straps 356, and the frame 116 includes one or more corresponding openings 412 located on the side arms 130 and configured to removably receive the posts 410. In the illustrated arrangement, the headgear 118 includes two posts 410a, 410b on each side, and each side arm 130 of the frame 116 includes two complementary openings 412a, 412b. In some configurations, the two posts 410a and 410b differ from each other at least in shape. Similarly, the two openings 412a and 412b differ from one another at least in shape. In the illustrated arrangement, the rear post 410a is generally triangular in shape and the front post 410b is generally circular in shape. Similarly, the rear opening 412a is generally triangular in shape and the front post 412b is generally circular in shape. However, other suitable shapes can be used. Furthermore, the shapes of the different posts and / or openings can be the same or different.

[0182] Similar to the arrangements of FIGS. 30 and 31 , the posts 410 a, 410 b and openings 412 a, 412 b in FIGS. 32 and 33 are similar in structure and function to baseball cap-style size adjustment mechanisms. Each of the posts 410 a, 410 b includes a stem (not shown, but similar to the stem 414 in FIGS. 30 and 31 ) and a head or cap (the visible portion of the post 410, 410 b). The openings 412 a, 412 b are sized, shaped, and / or otherwise configured to allow the head of the post 410 a, 410 b to pass through and, at least in response to normal or expected forces, retain the post 410 a, 410 b once it has passed through the openings 412 a, 412 b. However, the posts 410 a, 410 b can be intentionally removed from the openings 412 a, 412 b to allow separation of the headgear 118 and the frame 116. Passing the posts 410a, 410b through the openings 412a, 412b can be achieved by deformation of one or both of the posts 410a, 410b and the openings 412a, 412b, i.e., the heads of the posts 410a, 410b can bend or otherwise deform, and the openings 412a, 412b can stretch or expand to facilitate passage of the posts 410a, 410b.

[0183] In some configurations, the openings 412a, 412b can each include a recessed flange spaced inward from the outer surface of the side arm 130 of the frame 116. The recessed flange can extend partially or entirely around the periphery of the openings 412a, 412b. The recessed flange can be continuous or intermittent. For example, the recessed flange 418 can include multiple portions at each end of the elongated openings 412a, 412b, and the portions are distinct from one another. The recessed flanges can be configured to contact and retain the heads of the associated posts 410a, 410b. In other configurations, the heads of the posts 410a, 410b can abut the outer surface of the side arm 130 (or other portions of the frame 116) adjacent the openings 412a, 412b instead of the recessed flanges.

[0184] The posts 410a, 410b may be formed or connected to the headgear 118 by any suitable mechanism. For example, the posts 410a, 410b may be integrally formed with a base member that is coupled to the headgear 118 by stitching, RF welding, adhesive, or another suitable coupling mechanism, etc. In some configurations, the posts 410, 410b may be integrally formed with a plastic core of the headgear 118.

[0185] FIG. 34 illustrates an alternative arrangement of headgear 118 that may be similar in many respects to the headgear 118 of FIGS. 3 and 23 . Accordingly, aspects of headgear 118 not specifically described below can be assumed to be the same or similar to the headgear 118 of FIGS. 2 and 23 , or may be of any other suitable configuration. In the arrangement of FIG. 34 , headgear 118 comprises a bifurcated headgear arrangement having a top or upper strap portion 350 and a rear strap portion 352. Upper strap portion 350 is configured to span the top of a user's head from one side to the other. In some configurations, upper strap portion 350 is a parietal strap that sits over the parietal bone or at or near the junction between the parietal and frontal bones. In other configurations, upper strap portion 350 may comprise a forehead strap that sits over the user's frontal bone.

[0186] The rear strap portion 352 wraps around the back of the user's head and, in some configurations, rests above the user's occipital bone. However, in other configurations, the rear strap portion 352 can be positioned higher or lower on the user's head and / or neck. In the illustrated arrangement, the top strap portion 350 and the rear strap portion 352 join together at a joint 354 on each side of the headgear 118. A pair of forward extension straps 356 each extend forward from the joint 354 toward and connect to a respective one of the side arms 130 of the frame 116.

[0187] In some configurations, at least some portions of the headgear 118 are rigid, semi-rigid, inelastic, or substantially inextensible in response to normal or expected forces acting on the headgear 118, while other portions of the headgear 118 are elastic or extensible in response to normal or expected forces. In some configurations, one or more of the upper strap portion 350, the junction 354, and the forward extension strap 356 are rigid, semi-rigid, inelastic, or substantially inextensible. In the illustrated configuration, each of the upper strap 350, the junction 354, and the forward extension strap 356 is rigid, semi-rigid, inelastic, or substantially inextensible. In the illustrated configuration, the rear strap portion 352 is elastic or extensible. This arrangement allows the rear strap portion 352 to stretch to adjust the circumferential length of the headgear 118. The amount of stretch of the rear strap portion 352 can be limited.

[0188] In some configurations, the rear strap portion 352 may also be adjustable in length. In some configurations, the circumferential length adjustment preferably occurs at the back of the user's head, which is less likely to lengthen in response to blowing forces. The rigid, semi-rigid, inelastic, or substantially inextensible nature of the joints 354 and forward extension straps 356 located at the sides and front of the user's head helps maintain the desired circumferential length of the headgear 118 despite the elastic nature of the rear strap portion 352. In some cases, frictional forces between some portions of the headgear 118 and the sides and front of the user's head prevent the headgear 118 from moving or lengthening in response to blowing forces. However, in other arrangements, the rear strap portion 352 may be rigid, semi-rigid, inelastic, or substantially inextensible, and in such cases, may be adjustable in length.

[0189] The upper strap portion 350 can include a length adjustment mechanism. In the illustrated arrangement, the upper strap portion 350 includes a first portion 358 and a second portion 360, which are separate from one another and can be adjustably connected to one another. The free end of the first portion 358 includes a loop 362 through which the second portion 360 can pass. Thus, the first portion 358 and the second portion 360 can slide relative to one another to change the overlapping distance of the first and second portions 358, 360 and thus the length of the upper strap portion 350. The second portion 360 can be coupled to the first portion 358 to secure the upper strap portion 350 at a desired adjusted length. In the illustrated arrangement, the inner surface of the second portion 360 can include at least one protrusion (not shown), which can be similar to any of the posts 410, and the outer surface of the first portion 358 can include multiple openings 370 configured to removably receive the protrusion to provide multiple discrete adjustment positions. This arrangement can also be reversed.

[0190] In the above-described arrangement, the upper strap portion 350 can be adjusted to an appropriate length for a particular user so that the joints 354 and / or forward extension straps 356 are positioned above the user's ears. Once adjusted, the upper strap portion 350 can be maintained in the adjusted position while donning or doffing the headgear 118 and associated interface 110. In other words, the user preferably does not need to separate the first and second portions 358, 360 from one another to don or doff the interface 110. Rather, the headgear 118 ("like a cap") holds the frame 116 at or near the seal 114 (so as to hold the cap by its top as it is lifted or repositioned on the head) and allows the interface 110 to be donned by moving the rear strap portion 352 over and to the back of the user's head. The elastic or stretchable rear strap portion 352 can facilitate threading of the headgear 118 over the user's head without opening the headgear 118 by separating portions 358, 360 of the upper strap portion 350 or by separating one or both ends of the rear strap portion 352 from the remainder of the headgear 118. The headgear 118 can be removed or doffed in the reverse motion.

[0191] In the illustrated configuration, rear strap portion 352 is connected to each of joints 354 by an end of rear strap portion 352 that is threaded through loops 364 supported by joints 354 and then folded back. The ends of rear strap portion 352 may be joined to a relatively central portion of rear strap portion 352 by a suitable fastener, such as, for example, a hook-and-loop fastener. Rear strap portion 352 may be adjustable at one or both ends.

[0192] 36A-40C illustrate interface devices with alternative side arm mechanisms that are rotatable or highly compliant along a horizontal plane (i.e., horizontally across the user's face) and substantially rigid along a vertical plane (i.e., vertically across the user's face). FIG. 35 illustrates the horizontal and vertical planes across the user's face. By providing side arms that are highly compliant along the horizontal plane, when a horizontal external force is applied to the side arms, for example, when the user sleeps in a recumbent position (e.g., a pillow contacts and applies a force to the side arms), the side arms can conform to and / or change shape with the user's face without disturbing the position of the seal. Furthermore, by providing side arms that are highly compliant along the horizontal plane, the seal can be separated from the side arms and frame, allowing the seal to be properly positioned on the user's face and not move with movement of the side arms. That is, external forces are not directly transmitted to the seal, thereby maintaining the seal in its correct operating position. The following example interface devices provide side arms that are substantially rigid across the vertical plane to resist or prevent pivoting or rocking of the side arms, headgear, and seal relative to the user's face caused by blowing forces, thereby ensuring a seal against the user's nose. Additionally, the side arm features in FIGS. 36A-40C also limit or prevent twisting of the side arms, thereby limiting or preventing rotation of the interface device relative to the user's face (i.e., along an axis that is generally parallel to a plane perpendicular to both the horizontal and vertical planes, as shown in FIG. 35). More specifically, each side arm can be substantially rigid so that it resists torsional bending along its length (i.e., about an axis defined by the longitudinal direction of the side arm).In some configurations, the side arms can allow for limiting the range of twisting or rotation of the interface device relative to the user's face to ensure that the interface seals against the user's face while providing an amount of compliance that can improve user comfort.

[0193] 36A-36D illustrate an interface 500 having a side arm mechanism with a hinge 510 that allows the side arm 130 to rotate along a horizontal plane while remaining substantially rigid (i.e., resisting bending caused by vertical forces) along a vertical plane. The side arm 130 may be formed from an injection-molded plastic material and is shown as having a rectangular cross-sectional shape. The rectangular cross-sectional shape of the side arm 130 has a height that is substantially greater than its thickness, such that resistance to bending in a direction parallel to the height direction is substantially greater than resistance to bending in a direction parallel to the thickness direction. Thus, in the illustrated configuration and orientation of the side arm 130 in FIGS. 36A-36D, the side arm 130 is substantially rigid along a vertical plane relative to the user and semi-rigid along a horizontal plane relative to the user (i.e., due to the rectangular cross-sectional shape). In some configurations, the side arm 130 may be rigid in both the vertical and horizontal planes relative to the user. Additionally, the shape, cross-sectional shape and type of material used to form the side arms may be configured to limit or prevent twisting of the side arms so that rotation of the interface device relative to the user's face is limited or prevented.

[0194] As shown in FIGS. 36A and 36B , the side arm 130 has a two-piece design, in which a seal connection portion 130A of the side arm 130 is connected to a headgear connection portion 130B of the side arm 130 by a hinge 510. The seal connection portion 130A is connected to the frame 116 of the seal 114, and the headgear connection portion 130B is connected to the headgear (not shown). The seal connection portion 130A can be permanently or removably coupled to the frame 116, such that the seal 114 is fixedly attached to the seal connection portion 130A. With this arrangement, the seal 114 is unlikely to rotate or rock relative to the seal connection portion 130A. The seal connection portions 130A on both the left and right sides of the seal 114 can be formed with the frame 116 as a single, unitary component. The seal 114 can be connected to the frame 116 using any of the seal and frame connection arrangements previously disclosed. Similarly, headgear connection portion 130B may be permanently or removably coupled to headgear using any of the side arm and headgear connection mechanisms previously disclosed.

[0195] As shown in FIG. 36B , hinge 510 includes a pin 512 extending through a hole 514 in the ends of seal connecting portion 130A and headgear connecting portion 130B. The end of headgear connecting portion 130B has a female connecting portion 530 including outer knuckles 532 defining a slot 516 therebetween. Seal connecting portion 130A has a male connecting portion 520 including an inner knuckle 522 disposed in slot 516 between outer knuckles 532. As shown in FIG. 36A , pin 512 and hole 514 are aligned in the height direction of the rectangular cross-section of side arm 130, which direction is also substantially aligned with a vertical plane relative to the user. Thus, seal connecting portion 130A and headgear connecting portion 130B rotate relative to each other about pin 512. In other words, seal connecting portion 130A and headgear connecting portion 130B can rotate horizontally across the user's face.

[0196] The hinge 510 and a portion of the side arm 130 are covered by a concertina cover 550. In some configurations, the concertina cover 550 provides resistance to rotation, thereby allowing the seal connection portion 130A and the headgear connection portion 130B to maintain their relative rotational positions. The concertina cover 550 is formed from a semi-rigid plastic and has a deformable, accordion-like shape with ridges and bellows formed along its length. The concertina cover 550 can have a length that covers the portion between the seal connection portion 130A and the headgear connection portion 130B. The concertina cover 550 has an internal cavity 552 through which the side arm 130 extends. The concertina cover 550 can have a size, shape, and geometry similar to that of the side arm 130, such that the concertina cover 550 is tightly wrapped over the hinge 510 and around the side arm 130. Internal ridge 554 of internal cavity 552 can have a tight or interference fit with side arm 130 such that it contacts and is tightly wrapped around the outer surface of side arm 130. Thus, by having concertina cover 550 wrapped around side arm 130 and positioned over hinge 510, concertina cover 550 resists rotation between seal connecting portion 130A and headgear connecting portion 130B until a predetermined threshold amount of force is applied to side arm 130, at which point concertina cover 550 flexes and deforms, allowing seal connecting portion 130A and headgear connecting portion 130B to rotate relative to one another.

[0197] Hinge 510 is shown as a butt or mortise hinge having inner knuckles 512 disposed between outer knuckles 514. However, one skilled in the art would know that hinge 510 could include different knuckles and / or hinge mechanisms. Furthermore, one skilled in the art would know that the illustrated arrangement is not limited to a single hinge, but could include multiple hinges and concertina covers. Furthermore, the illustrated arrangement is not limited to a hinge mechanism having a pin. Other hinge mechanisms, such as a protrusion that engages and rotates about a receiver, could be used.

[0198] 37A-37C illustrate an interface 600 having a side arm mechanism with a side arm 130 formed from modular segments 610A, 610B, 610C that interlock similarly to a watch band. Similar to the side arm mechanism in FIGS. 36A-36D, the multiple interlocking modular segments 610A, 610B, 610C allow the side arm 130 to rotate along a horizontal plane while remaining substantially rigid along a vertical plane. More specifically, the segments 610A, 610B, 610C allow the side arm 130 to gradually articulate and conform to the contours of a user's face when a horizontal external force is applied, as shown in FIG. 37C. Additionally, the multiple segments 610A, 610B, 610C allow for localized shape changes to the side arm 130 so that the side arm 130 conforms to facial features or landmarks on the user's face. Similar to interface 500, segments 610A, 610B, 610C of side arm 130 resist pivoting or rocking of seal 114 caused by normal forces (e.g., blowing forces) acting on seal 114. Segments 610A, 610B, 610C may be formed from an injection-molded plastic material and have a rectangular cross-sectional shape similar to side arm 130 in Figures 36A-36D.

[0199] As shown in FIG. 37A , segment 610A can be permanently or removably coupled at one end to the connector portion or connector 146 of seal frame 116. Segment 610A has a male connecting portion 620 including an inner knuckle 622 located at an opposite end of frame 116. Similarly, segment 610B can be permanently or removably coupled at one end to headgear 118 and has a female connecting portion 630 at its opposite end from headgear 118 including an outer knuckle 632 defining a slot 616 therebetween. In some configurations, segments 610A and 610B are connected to one another by one or a series of segments 610C. Each segment 610C has a male connecting portion 620 at one end and a female connecting portion 630 at the opposite longitudinal end of segment 610C. The inner knuckle 622 of the male connecting portion 620 of each segment 610A, 610C is disposed in a slot 616 between the outer knuckles 632 of the female connecting portion 630 of each segment 610B, 610C. The male connecting portion 620 and the female connecting portion 630 are connected by a pin 612 fitted into a through hole 614 extending through the male connecting portion 620 and the female connecting portion 630. As shown in FIG. 37B , the pin 612 and the hole 614 are aligned in the height direction of the rectangular cross section of the side arm 130, which is also aligned substantially in a plane vertical to the user.

[0200] Similar to a watch band, pin 612 may be removable to allow segments 610C to be added or removed so that the length of side arm 130 can be adjusted. Those skilled in the art will know that the segments are not limited to male and female connection portions 620, 630 having pins inserted through inner and outer knuckles 611, 632, but can include alternative modular interlocking connection mechanisms.

[0201] 38A-38D show an interface 700 with a side arm mechanism having a spring-loaded side arm 130 that deforms or deflects to provide a temporary shape change when a momentary horizontal external force is applied to the side arm 130. When the momentary horizontal external force is removed, the side arm 130 returns to or toward its undeformed shape. Additionally, the spring-loaded side arm 130 is extensible to expand and contract, allowing the interface 700 to accommodate a wider range of face shapes and account for blow-out forces within the mask. The side arm 130 has a spring portion 710 disposed between the seal connecting portion 130A and the headgear connecting portion 130B. The seal connecting portion 130A can be permanently or removably coupled to the frame 116, thereby rigidly attaching the seal 114 to the seal connecting portion 130A so that it does not rotate or rock relative to the seal connecting portion 130A. Similarly, the headgear connecting portion 130B can be permanently or removably coupled to the headgear. The seal connecting portion 130A, the headgear connecting portion 130B, and the spring portion 710 can be integrally formed as a one-piece, unitary side arm. The side arm 130 can be formed from an injection-molded plastic material and is shown as having a rectangular cross-sectional shape similar to the side arm features in Figures 36A-36D and 37A-37C.

[0202] As shown in FIG. 38B , spring portion 710 is shown as a linear accordion leaf spring that is compressible, extensible, and horizontally rotatable. Spring portion 710 is formed as a series of straight segments 712 connected by bends 714. The bends 714 can form acute angles between the straight segments 712 to allow spring portion 710 to bend, shorten, or lengthen. FIGS. 38C and 38D show spring portion 710 bending, shortening, and lengthening along a horizontal plane to allow side arm 130 to move relative to seal 114 when an instantaneous horizontal external force is applied to side arm 130. Spring portion 710 absorbs at least a portion of the instantaneous horizontal external force against seal 114 and does not transmit it in its entirety, thereby keeping the position of seal 114 on the user's face undisturbed or less disturbed than with other frame designs. The spring portion 710 can have an undeformed shape (i.e., when no momentary horizontal external force is applied) in which the seal connection portion 130A and the headgear connection portion 130B are, on average, substantially straight or parallel in the length direction. However, the spring portion 710 can be formed to have, on average, a curved or non-linear undeformed shape in the length direction.

[0203] Similar to FIGS. 38A-38D, FIGS. 39A and 39B show an alternative spring-loaded side arm mechanism that similarly deforms to allow temporary shape changes when a momentary horizontal external force is applied to the side arm 130. However, in contrast to the side arm 130 in FIGS. 38A-38D, the seal-connecting portion 130A and the headgear-connecting portion 130B are connected to a resilient segment 810, which provides a spring-loading effect similar to that of the spring portion 710. The resilient segment 810 may be formed from rubber or thermoplastic polyurethane (TPU). The resilient segment 810 is disposed between the seal-connecting portion 130A and the headgear-connecting portion 130B and is separated by a rigid segment 812. The seal-connecting portion 130A and the headgear-connecting portion 130B are also rigid. Thus, the resilient segment 810 bends and deforms such that the side arm 130 can be highly compliant in the horizontal plane, allowing the side arm 130 to move relative to the seal 114 when a momentary horizontal external force is applied. That is, the resilient segments 810 absorb at least a portion of the momentary external horizontal force on the seal 114, but do not transmit it in its entirety, so that the position of the seal 114 on the user's face remains undisturbed, or is disturbed less than with other frame designs. Furthermore, when the momentary external horizontal force is removed, the resilient segments 810 return to their neutral, undeformed shape.

[0204] As shown in FIG. 39B , the elastic segment 810 has a male connecting portion 820 at each end, and the rigid segment 812 has a female connecting portion 830 at each end. The elastic segment 810 is connected to the rigid segment 812 by placing the male connecting portion 820 within the female connecting portion 830. The male connecting portion 820 has a shape and size corresponding to the female segment portion 830 so that the male connecting portion 820 and the female connecting portion 830 are connected by a tight or interference fit. The seal connecting portion 130A and the headgear connecting portion 130B each have a female connecting portion 830 located at the end facing the rigid segment 812. The rigid segment 812 has female connecting portions 830 located at both ends. In some configurations, additional elastic segments 810 and rigid segments 812 can be added or removed to adjust the length of the side arm 130. Furthermore, the male connecting portion 820 is shown as a cylindrical post, and the female connecting portion 830 is shown as a cylindrical slot. Those skilled in the art should understand that male connecting portion 820 and female connecting portion 830 are not limited to cylindrical posts and slots, but can include alternative connecting mechanisms.

[0205] 40A-40E show an interface 900 having a side arm mechanism with a flexible side arm 130 that remains substantially rigid along a vertical plane while deforming to allow for a temporary shape change when a momentary external horizontal force is applied to the side arm 130. The side arm 130 has one or both of an outer cut 910 and an inner cut 920 along the length of the side arm 130. The outer cut 910 is located on the outer surface of the side arm 130 (i.e., facing away from the user) and is located closest to the seal 114. The inner cut 910 is located on the inner surface of the side arm 130 (i.e., facing towards the user) and is located closest to the headgear 118. The side arm 130 is formed from an injection-molded plastic material, and the cuts 910, 920 may be integrally and unitarily formed with the side arm 130. Alternatively, the cuts 910, 920 may be formed by cutting, molding, or otherwise providing vertical slots in the side arm 130. As shown, the side arm 130 has a rectangular cross-sectional shape similar to the side arm features in FIGS. 36A-36D and 37A-37D. Cheek pads 950 may be attached over the inner cuts 920 of the side arm 30 so that the inner cuts 920 do not contact the user's face. The cheek pads 950 may be formed from a soft padding material.

[0206] As shown in FIGS. 40D and 40E , the cuts 910, 920 consist of a series of live hinges or slots 930 recessed into the side arm 130 along its thickness. The slots 930 extend across the entire width of the side arm 130. Thus, the thickness of the side arm 130 is thinner at the portion having the slots 930 than at the portions between the slots 930. As a result, the side arm 130 can bend and rotate about the slots 930 when a momentary horizontal external force is applied to the side arm 130. Furthermore, the cuts 910, 920 allow the side arm 130 to return to or toward its undeformed shape when the momentary horizontal external force is removed. As shown in FIG. 40D , the slots 930 have a depth X, a width Y, and are spaced apart by a separation distance Z. The return force (i.e., the amount of resistance to bending) for biasing the side arm 130 back to or toward its undeformed neutral shape is controlled, at least in part, or primarily, by the depth X of the slot 930 (i.e., relative to the thickness of the side arm 130). The greater the depth X of the slot 930, the thinner the side arm 130 will be at the location where the slot 930 is located. As a result, the thinner thickness T provides less resistance to bending and less return force for returning the side arm 130 to its undeformed shape compared to a slot 930 having a smaller depth X. The maximum amount of bending provided by the slot 930 is controlled, at least in part, or primarily, by the width Y of the slot 930. Generally, a slot 930 having a greater width Y allows a greater amount of bending of the side arm 130 about the slot 930. The maximum amount of bending allowed by the slot 930 occurs when the width of the slot 930 narrows until the side walls 932 of the slot 930 contact each other, as shown in FIG. 40E. Thus, by providing a slot 930 with a larger width Y, the distance between the side walls 932 is increased. However, the amount of bending can be limited to prevent the side arms 130 from contacting the user's face or becoming dislodged from the headgear 118.FIG. 40C shows the maximum amount of bending provided by both the outer cuts 910 and the inner cuts 920 relative to the undeformed shape shown in FIG. 40B. The bending rate (i.e., gradual bending or sharp bending) of the side arms 130 is controlled, at least in part or primarily, by the spacing Z and amount of the slots 930. Closely spaced slots 930 with a narrow spacing Z allow a greater bending rate of the side arms 130 than more widely spaced slots 930 with a wider spacing Z. Thus, the amount and rate of bending of the side arms 130 is determined by the depth X, width Y, and spacing Z of the slots 930. Furthermore, although the side arms 130 are shown as having slots 930 with identical shapes, in some configurations, the slots 930 can have depths X, widths Y, and spacing Z that vary along the length of the side arms 130, thereby causing the side arms 130 to have a variable amount and rate of bending and return force along their length. Furthermore, the slot 930 is not limited to a rectangular shape, but can include a variety of shapes, such as a trapezoidal shape, a curved shape, or a semicircular shape.

[0207] FIGS. 41A-41C show an interface 1000 having a hook-and-post connector mechanism that allows rotation and maintains a rotated position between the seal 114 and the side arms 130 of the headgear 118. In the illustrated configuration, the headgear 118 is separable from the seal 114. The headgear 118 has a hook-like connector 1020 at each end of the side arms 130. The hook-like connectors 1020 may be integrally formed with the side arms 130. The side arms 130 and hook-like connectors 1020 may be formed from an injection-molded plastic material and are shown as having a rectangular cross-sectional shape similar to the side arm mechanism in FIGS. 36A-36D and 37A-37D. The connector 146 of the frame 114 has a post 1010 at each end. The seal 114 connects to the headgear 118 by attaching the hook-like connectors 1020 to the posts 1010. The hook-like connector 1020 has a cavity 1022 that receives the post 1010 such that it wraps over and around the post 1010. In other words, the post 1010 is disposed within the cavity 1022. In the configuration shown, the connector 146 has an opening 1012 adjacent the post 1010 through which the hook-like connector 1020 extends to wrap around the post 1010.

[0208] As shown in FIG. 41B , the post 1010 has teeth 1014 extending radially outward from the post 1010. The hook-like connector 1020 has pawls 1024 extending in a direction toward the cavity 1022. The pawls 1024 engage valleys 1016 between adjacent teeth 1014, such that rotation of the post 1010 within the cavity (i.e., rotation between the post 1010 and the hook-like connector 1020) is blocked or prevented by the pawls 1024. The pawls 1024 are semi-rigid and deflectable to allow rotation of the hook-like connector 1020 around the post 1010 (i.e., including rotation of the side arm 130 in a horizontal plane) when a horizontal external force is applied to the side arm 130. That is, if the horizontal external force applied to the side arm 130 exceeds the yield strength of the pawl 1024, the pawl 1024 will deform and slide upward from the valley 1016 to the tooth 1014 as the hook-like connector 1020 rotates about the post 1010. The pawl 1024 will slide upward and over the tooth 1014 and down the adjacent valley 1016. The shape, thickness, and geometry of the tooth 1014 and pawl 1024 can be varied to customize the force profile to enable rotation of the post 1010 relative to the hook-like connector 1020. Furthermore, because the tooth 1014 extends radially outward from the post 1010, the hook-like connector 1020 can rotate clockwise or counterclockwise relative to the post 1010. In the configuration shown, the teeth 1014 are formed only on the side or portion of the post 1010 that faces the headgear 118, thereby providing the post 1010 with a smooth, mating surface that contacts the inner surface of the hook-like connector 1020. In an alternative configuration, the teeth 1014 can be formed completely around the periphery of the post 1010. The hook-and-post connector mechanism provides rotational resistance between the post 1010 and the hook-like connector 1020, allowing a user to don or remove the interface using conventional break-and-loop donning and doffing methods.Additionally, the hook and post connector mechanism can also allow for alternative types of donning and doffing, such as a swing-fit donning and doffing mechanism, where one end of the headgear / frame connects to the mask and the other end of the headgear / frame wraps around the headgear and connects to the mask. The hook and post connector mechanism accommodates various donning and doffing methods to improve the usability of the interface.

[0209] 42A-42D show an alternative interface assembly or interface 1100 having a seal 1114 that pivots horizontally (i.e., across the user's face) relative to the side arms 1130 and is biased by a leaf spring 1140 to a pivot center position between the side arms 1130. The pivoting seal 1114 and leaf spring 1140 enable the interface 1100 to absorb horizontal external forces and inhibit or prevent the seal 1114 from slipping out from under the user's nose, for example, when the user is sleeping in a side-lying position and a pillow contacts the interface 1100, as shown in FIG. 42B. Furthermore, the pivoting seal 1114 enables the interface 1100 to accommodate users with crooked noses, as shown in FIG. 42C. Similar to the interfaces disclosed above, the interface 1100 prevents or prevents the seal 1114 from pivoting along a vertical plane (i.e., vertically across the user's face). Additionally, the leaf spring 1140 centers the seal 1114 when the horizontal external force is removed.

[0210] 1-11 , the interface includes a seal 1114 attached to a frame assembly or frame 1116. The frame 1116 supports the seal 1114. A connector portion or connector 1146 including side arms 1130 is attached to the frame 1116. The frame 1116 and connector 1146 may be formed from a relatively rigid, semi-rigid, or rigid material, such as, for example, polycarbonate. Thus, in at least some configurations, the frame 1116 and connector 1146 are more rigid than the seal 1114.

[0211] Similar to the connector 146 in FIGS. 1-11 , the connector 1146 is a generally U-shaped member when viewed from above, including side arms 1130 and a central portion 1148 that connects the two side arms 1130 together. That is, the side arms 1130 can be integrally formed as a one-piece unit with the connector 1146, thereby allowing for greater vertical stability (i.e., resistance to movement of the seal vertically across the user's face). In contrast to the connector 146 in FIGS. 1-11 , the connector 1146 is pivotally attached to the frame 1116, allowing the frame 1116 to rotate relative to the connector 1146 about a vertical axis, thereby rotating the frame 1116 along a horizontal plane. The connector 1146 can be pivotally connected to the frame 1116 by a pivot mechanism, such as a cylindrical post positioned vertically within a socket.

[0212] As shown, the side arms 1130 extend outward (away from each other), rearward, and upward at a shallow angle, past the left and right ends of the seal 1114, and along the user's left and right cheeks, particularly the cheekbones, to connect to headgear (not shown) to hold the seal 1114 on the user's face. The side arms 1130 include connector portions 1134 at their outer or free ends that detachably connect the side arms 1130 to the headgear (not shown). The side arms 1130 are relatively inflexible (when worn) in the horizontal and vertical planes.

[0213] As shown in FIG. 42A , each side arm 1130 has a leaf spring 1140 attached to and extending from an inner surface 1132 of the side arm 1130. The leaf springs 1140 extend some distance toward the frame 1116 so as to be in sliding contact with the outer surface 1118 of the frame 1116 when the frame 1116 is centered between the side arms. The leaf springs 1140 are positioned along the inner surface 1132 so that when the frame 1118 is pivotally centered between the side arms 1130, both leaf springs 1140 are in contact with the outer surface 1118 of the frame 1116. The leaf springs 1140 act as cantilever springs, biasing the frame 1116 away from the side arms 1130. In other words, the leaf springs 1140 bias the frame 1116 so that the seal 1114 is pivotally centered relative to the connector 1146. 42D (center) shows the neutral position of the frame 1116 relative to the side arms 1130, maintained by the leaf springs 1140. When the frame 1116 is centered between the side arms 1130, the leaf springs 1140 may be in slight contact with the frame 1116 so that the load is relieved. However, in some configurations, when the frame 1116 is centered between the side arms 1130 or slightly biased toward one of the side arms 1130, both leaf springs 1140 may be preloaded.

[0214] As the seal 1114 and frame 1116 pivot off-center relative to the connector 1146, the leaf spring 1140 provides a return force to center the seal 1114 and frame 1116. FIG. 42D (left, right) shows the seal 1114 and frame 1116 pivoted off-center relative to the connector 1146. The leaf spring 1140 deflects as the frame 1116 pivots toward it, exerting a return force to center the seal 1114 and frame 1116. In the configuration shown, the leaf spring 1140 is merely in sliding contact with the frame 1116; that is, the leaf spring 1140 is not fixed to the frame 1116. Thus, the leaf spring 1140 does not contact the frame 1116 and remains undeflected as the frame 1116 pivots away from it. In some configurations, the leaf springs 1140 can be attached to both the connector 1146 and the frame 1116 such that both leaf springs 1140 apply a return force to the frame 1116 to center the frame 1116 relative to the connector 1146. The leaf springs 1140 can have a smooth curved shape and sliding surfaces to reduce sliding friction between the leaf springs 1140 and the frame 1116. Furthermore, the leaf springs 1140 can be curved or include fillets or buttresses at their connections with the inner surface 1132 of the side arms 1130 to reinforce the connection between the side arms 1130 and the leaf springs 1140. Furthermore, the shape and geometry of the leaf springs 1140 can be modified to provide different force profiles to bias the frame 1116. Furthermore, one skilled in the art will understand that a variety of spring types can be used to absorb forces and bias the frame 1116. In other words, the interface 1100 is not limited to using only leaf springs 1140, but may employ alternative biasing arrangements such as coil springs or elastically deformable cushions, airbags, pads, etc.

[0215] 43A-43C show an alternative interface assembly or interface 2100 having a seal 2114 that slides horizontally or laterally (i.e., across the user's face) between side arms 2130. In contrast to interface 1100 in FIGS. 42A-42D, seal 2114 slides horizontally or laterally across the user's face, as opposed to pivoting horizontally about an axis across the user's face. By sliding seal 2114 horizontally between side arms 2130, interface 2100 can absorb and accommodate horizontal external forces to inhibit or prevent seal 2114 from dislodging from under the user's nose, for example, when a user is sleeping in a side-lying position and a pillow contacts interface 2100, as shown in FIGS. 43B and 43C. Similar to the interfaces disclosed above, the interface 2100 prevents or inhibits the seal 1114 from rotating or bending along a vertical plane (ie, perpendicularly across the user's face).

[0216] As shown in FIG. 43A , the side arms 2130 are connected to one another by a bridge or central portion 2148. That is, each side arm 2130 is connected at its end to the central portion 2148, thereby forming a closed loop with the headgear 2118. The side arms 2130 may be permanently or removably coupled to the headgear 2118. The side arms 2130 may be integrally formed as a one-piece unit with the connector 2146 from a material such as polycarbonate so that the side arms 2130 and central portion 2148 are rigid. Similar to the interfaces disclosed above, the side arms 2130 and central portion 2148 have elongated cross-sections with heights that are substantially greater than their thicknesses, thereby resisting vertical rotation (i.e., vertically across the user's face). The side arms 2130 and central portion 2148 are connected to the frame 2116 by connector portions or connectors 2146. Connector 2146 has a channel 2150 through which central portion 2148 slides. Channel 2150 has a shape and size that corresponds to side arms 2130 and central portion 2148, allowing side arms 2130 and central portion 2148 to slide and move within and through channel 2150. In operation, when a user is sleeping in a recumbent position and a pillow contacts interface 2100 and exerts a force on side arms 2130, side arms 2130 and central portion 2148 move and are pushed through channel 2150 in connector 2146, thereby not moving seal 2114 and disturbing its position on the user's nose.

[0217] In some configurations, the range of movement between the side arms 2130 can be limited by modifying the cross-sectional size and shape of the central portion 2148 or the side arms 2130 so that the enlarged area of ​​the central portion 2148 or the side arms 2130 cannot enter the connector 2146. For example, the height and / or thickness of the ends of the central portion 2148 can be increased so that the ends of the central portion 2148 are greater than the height and / or width of the channel 2150. Thus, the range of movement of the frame 2116 is limited between the ends of the central portion 2148. In alternative configurations, protrusions extending from the surfaces of the central portion 2148 or the side arms 2130 can also be used to prevent the central portion 2148 or the side arms 2130 from entering the connector 2146 so that the range of movement is limited.

[0218] Figures 44A-49C show nose seals with features that discourage or preferably prevent incorrect installation of the nose seal and indicate to the user that the seal is not properly installed. A common installation error is when a user inserts their nose into the seal's nose port. As a result, the seal does not seal properly around the user's nose and the mask may not function properly. Furthermore, the mask may be uncomfortable to wear, which may discourage the user from continuing to wear the mask. The nose seal features in Figures 42A-49C indicate to the user that the nose seal is not properly installed, preventing or discouraging the user from installing the nose seal incorrectly, or providing guidance to the user on how to properly install the nose seal.

[0219] The illustrated configuration in Figures 44A-44D shows a nasal seal 114 that provides physical feedback to indicate to the user that the seal 114 is not properly installed, discouraging the user from continuing to wear the seal improperly. The nasal seal 114 is similar to the seal shown in Figures 1-22, and therefore, a redundant discussion of similar structures will largely be omitted. The seal 114 has an inward- or rearward-facing central portion 204 that faces or contacts the user during use of the seal 114. The central portion 204 has a nasal opening or aperture 128 defined by an upper edge 234, a lower edge 236, and side edges 238. As shown, the seal 114 has a thickened flange 1210, such that the flange 1210 is stiffer than the central portion 204 of the seal 114. The flange 1210 is formed along an upper portion of the aperture 128 to define an upper edge 234 of the aperture 128 and extends toward the interior or dead space 228 of the seal 114 when the seal is not worn and is not deformed by a user. The ends of the flange 1210 can extend to connect to side edges 238, which can also increase the stiffness of the flange 1210. In some configurations, the flange 1210 can extend to include the lower edge 236 to substantially or completely surround the nasal aperture 128. The flange 1210 has a relatively greater thickness along the central portion 204 of the seal 114 such that the flange is stiffer or more rigid than the central portion 204. Although the flange 1210 is shown as having a constant thickness, the thickness of the flange 1210 can vary along its length. The flange 1210 can be integrally formed with the seal 114. The flange 1210 extends downwardly into the dead space 228 of the seal 114. In some configurations, the nasal aperture 128 has a rim that includes a thickened bead at the upper edge 234 of the nasal aperture 128.

[0220] 44B shows seal 114 properly attached to a user. As shown, the user's nose is positioned at the top of seal 114, aperture 128 is positioned below the user's nostrils, and the tip of the user's nose is in contact with central portion 204 of the seal. Furthermore, when seal 114 is properly attached to a user, flange 1210 is not in contact with the user. More specifically, flange 1210 is positioned below the nostrils of the user's nose and extends away from the nose and into seal 114.

[0221] FIG. 44C shows seal 114 improperly attached to a user. In contrast to FIG. 42B , the user's nose extends through aperture 128 and is positioned inside seal 114. With the user's nose extending through aperture 128, flange 1210 is positioned on the tip of the user's nose, with bottom edge 1212 of flange 1210 pressing against the tip, top, or bridge of the user's nose. The rigidity of flange 1210 (i.e., due to its thickness and having ends attached to side edges 238 of aperture 128) prevents flange 1210 from deforming or collapsing inwardly within seal 114 due to the force of the user's nose pushing into aperture 128. Thus, the user physically feels flange 1210 pressing against their nose and causing discomfort, which provides tactile feedback or indication to the user that the seal is improperly attached. In other words, any discomfort felt by the user caused by the flange 1210 is perceived as an indication that the seal 114 is not properly installed. The flange 1210 also prevents blowouts because it is formed from a thicker silicone and is therefore stiffer and able to better hold its shape when a blowout force is applied.

[0222] 44D-44F show an alternative flange configuration comprising a flange 1210 having through-holes or vents 1214 extending therethrough. The vents 1214 provide a path for pressurized air to escape from the inside of the seal to the outside of the seal. Similar to FIG. 44B, when the seal 114 is properly attached to the user as shown in FIG. 44E, the user's nose is positioned on top of the seal 114, and the flange 1210 does not contact the user when the seal is properly attached to the user. As shown in FIG. 44F, when the seal 114 is not properly attached to the user, the user's nose is forced into the aperture 128, causing the bottom edge 1212 of the flange 1210 to exert pressure on the user's nose, similar to FIG. 44C. In operation, when the seal 114 is filled with air under positive pressure, pressurized air flows through the vents 1214. The flange 1210 and vent 1214 are positioned slightly above the user's nose, such that the user feels the stream of pressurized air blowing out through the vent 1214. Thus, in addition to the uncomfortable feeling of the flange 1210 pressing against the user's nose, the user will also feel the stream of air leaking out of the seal just above their nose. In some configurations, the vent may be positioned and / or angled to direct the stream of pressurized air toward the user's eyes. Additionally, the size and shape of the vent 1214 may be adjusted to provide an audible sound to provide an audible indication to the user when the seal 114 is not properly seated. Those skilled in the art will appreciate that the vent 1214 is not limited to a circular cross-section and may be formed in a variety of cross-sectional shapes and sizes.

[0223] FIGS. 44G and 44H show an alternative flange configuration comprising a flange 1210 with a rounded bottom edge 1212. Similar to the flanges in FIGS. 44A-44F, when a user's nose is pressed into aperture 128, flange 1210 exerts pressure on the user's nose, and vents 1214 direct pressurized air toward the user's eyes, indicating to the user that seal 114 is not properly installed. However, in contrast to flange 1210 in FIGS. 44A-44F, rounded bottom edge 1212 can provide a wider, more rounded surface that contacts the user's nose without leaving marks or indentations on the user's nose. FIG. 44G shows flange 1210 with a semicircular cross-section. FIG. 44H shows flange 1210 with an upper portion that is rectangular in cross-section but a rounded bottom portion. The rectangular upper portion allows the flange 1210 to flex, thereby distributing the amount of force that is pressed by the flange 1210 onto the user's nose over a wider area so as not to leave marks or indentations on the user's nose.

[0224] Figure 441 shows an alternative flange configuration with a flange 1210 that includes a recess 1216 instead of the vent 1214 in Figures 44D-44F. The recess 1216 can be formed in the bottom edge 1212 of the flange 1210 so that when a user's nose is pressed into the aperture 128 and the seal 114 is pressurized (i.e., the seal 114 is not properly attached to the user), pressurized air will flow through the recess 1216.

[0225] The illustrated configuration in Figures 45A-45C shows a nasal seal 114 that physically prevents or discourages a user from wearing the seal 114 incorrectly. More specifically, the seal 114 prevents the user's nose from being inserted into the seal 114 through the aperture 128. The nasal seal 114 is similar to the seals shown in Figures 1-22 and 44A-44I, and therefore, a redundant discussion of similar structures will largely be omitted. As shown in Figure 45A, the seal 114 has a woven mesh 1310 that is overmolded or otherwise attached onto the upper edge 234, lower edge 236, and side edges 238 of the aperture 128 so as to be flush with the sealing surface of the seal 114. The woven mesh 1310 extends across and covers the aperture 128. The woven mesh 1310 allows air to flow through the aperture 128 while preventing or inhibiting a user from inserting their nose into the opening 128. The woven mesh 1310 may be overmolded onto the aperture 128 from a silicone material. The woven mesh 1310 may be elastic so that it conforms to the shape of the aperture 128 and deforms with the seal 114. However, the woven mesh 1310 may also be taut so that it prevents or inhibits the user's nose from entering the seal 114. Furthermore, the strand width and coarseness or fineness of the woven mesh 1310 can be varied to provide strength to withstand the force of pushing the user's nose into the aperture 128 while minimizing any pressure drop caused by the woven mesh 1310 restricting the flow of air through the aperture 128.

[0226] 45B and 45C show an alternative configuration of the nasal seal 114 having a woven mesh 1310 that is offset inwardly within the seal 114 by an offset flange 1320. As shown in FIG. 45C , the outer edge of the offset flange 1320 can be attached to the upper edge 234, lower edge 236, and side edge 238 of the aperture 128, with the offset flange 1320 extending inwardly toward the interior of the seal 114. The inner edge of the offset flange 1320 is attached to the woven mesh 1310. The offset flange 1320 positions the folded mesh 1310 away from the sealing surface so that the user's nose does not make direct skin contact with the woven mesh 1310 when positioned over the aperture 128.

[0227] 45D and 45E show an alternative configuration of nose seal 114 that prevents insertion of a user's nose through aperture 128 into seal 114. In contrast to woven mesh 1310 of FIGS. 45A-45C, seal 114 has an aperture cover 1410 with an array of holes 1420 extending through the aperture cover. Similar to woven mesh 1310, aperture cover 1410 prevents insertion of a user's nose through aperture 128 into seal 114. Aperture cover 1410 is attached over upper edge 234, lower edge 236, and side edges 238 of aperture 128 so as to be flush with the sealing surface of seal 114. Aperture cover 1410 may be integrally or integrally formed with seal 114. The holes 1420 extend through and are uniformly distributed across aperture cover 1410. The holes 1420 allow air to flow through the aperture cover 1410 while preventing or discouraging a user from inserting their nose into the aperture 128. The diameter and spacing of the holes 1420 can be configured to minimize noise and pressure drop. One skilled in the art will appreciate that the holes 1420 can include a non-limiting combination of holes having various shapes, sizes, and arrangements. FIG. 45E shows examples of holes 1420 arranged on the aperture cover 1410, such as a combination of large and small holes, polygonal holes, wide holes that span across the aperture, holes arranged in a fan configuration across the aperture, etc.

[0228] 46A-46D also show an alternative configuration of nose seal 114 that prevents a user's nose from being inserted through aperture 128 and into seal 114. In contrast to woven mesh 1310 of FIGS. 45A-45C and aperture cover 1410 of FIGS. 45D-45E, aperture 128 has a series of tethers 1510 attached to the periphery of aperture 128 along the top edge 234, bottom edge 236, and side edges 238 of aperture 128. When a user attempts to insert their nose into aperture 128, the user's nose will come into contact with one or more of tethers 1510, which indicates to the user that seal 114 is not properly attached. If the user continues to insert their nose into aperture 128, tethers 1510 will obstruct or prevent the user from pushing further into aperture 128.

[0229] Tether 1510 extends downwardly within seal 114 and is attached to the inner surface 1520 of the seal's bottom wall. Tether 1510 is formed from a thin, cord-like strand of silicone that is bonded to or integrally molded with a component of seal 114 or seal 114 itself. Tether 1510 is evenly spaced around the perimeter of aperture 128.

[0230] As shown in FIG. 46C , when the seal 114 is not deformed (i.e., the seal 114 is not attached to a user), the tether 1510 is taut (i.e., there is tension within the tether 1510). As a result, the tether 1510 anchors the central portion 204 of the seal 114 to the inner surface 1520 at the bottom of the seal 114, allowing the seal 114 to maintain its undeformed shape. This allows the undeformed position of the edge of the aperture 128 to be controlled and maintained. As shown in FIG. 46D , when the seal 114 is properly attached to a user, the tether 1510 is slack (i.e., there is no tension within the tether 1510). That is, when the seal 114 is donned by a user, the seal 114 is compressed such that the distance between the aperture 128 and the inner surface 1520 at the bottom of the seal 114 is reduced. As a result, the tether 1510 is compressed and slack.

[0231] 46E-46H show another alternative configuration of nose seal 114 that prevents a user's nose from being inserted into seal 114 through aperture 128. In contrast to tether 1510 of FIGS. 46A-46D, seal 114 has a bumper 1610 that is attached to an inner surface 1620 at the bottom of seal 114 and is positioned directly below aperture 128. As shown in FIG. 46F, if a user attempts to insert their nose into aperture 128, seal 114 will compress and their nose will contact bumper 1610. Upon contacting bumper 1610, the user is provided with feedback so that they know their nose should not be inserted into aperture 128 and will attempt to reinstall seal 114 with their nose positioned outside aperture 128.

[0232] The bumper includes a vertical post 1612 and a transverse beam 1614. The post 1612 is positioned below the aperture 128 and is attached to an inner surface 1620 at the bottom of the seal 114. The post 1612 extends vertically upward toward the aperture 128. The upper end of the post 1612 is attached to the beam 1614. The beam 1614 has an elongated shape that extends transversely across the width of the aperture 128.

[0233] The posts 1612 have a height such that when the seal 114 is properly attached to the user, the beam 1614 is spaced below the aperture 128, as shown in FIG. 46C . In other words, when the seal 114 is properly attached to the user, the beam 1614 does not contact the user's nose. The seal 114 may be slightly compressed due to the force required to provide an airtight seal around the user's nose. However, the posts 1612 have a height such that the beam 1614 does not contact the user's nose even when the seal 114 is compressed. The posts 1612 and beam 1614 may be formed from a silicone material so that the posts 1612 and beam 1614 are flexible and do not cause pain or injury when in contact with the user's nose. The posts 1612 and beam 1614 may be bonded to or integrally molded with components of the seal 114 or the seal 114 itself. Additionally, the struts 1612 may have a curved shape such that the shape can provide an amount of flexibility such that the struts 1612 deform when in contact with the user's nose.

[0234] The beam 1614 is shown as having a straight, elongated cylindrical shape. However, one skilled in the art will understand that the beam 1614 can be one of a variety of shapes that will prevent a user's nose or other object from passing through the aperture 128 and further down into the seal 114. Additionally, in some configurations, the seal 114 can have a post 1612 without a beam 1614 attached to the upper end of the post 1612. Figure 46H shows an example of a post mechanism with a post 1612 without a beam.

[0235] 47A-47G show an alternative configuration of aperture 128 for a seal (not shown) that inhibits or prevents insertion of the user's nose into aperture 128 by providing separate locations for the user's left and right nostrils over aperture 128. As shown, upper and lower edges 234, 236 of aperture 128 narrow at a lateral midpoint of aperture 128 to form a narrow central portion 1710 of aperture 128 that is disposed between left and right nostrils 1712. The widest distance between upper and lower edges 234, 236 of aperture 128 in narrow central region 1710 is substantially narrower than the widest distance between the upper and lower edges 234, 236 of left and right nostrils 1712, 1712. As a result, the narrow central portion 1710 defines separate left and right nostrils 1712, allowing a user to intuitively and unmistakably recognize that their nostrils should be positioned over the left and right nostrils 1712 because they will recognize that the aperture 128 is too narrow to insert their nose in the narrow central portion 1710. Furthermore, when a user attempts to insert their nose into the aperture 128, portions of the seal 114 around the narrow central portion 1710 contact the user's nasal tip or septum, preventing or obstructing insertion into the aperture 128. The left and right nostrils 1712 may be oval in shape. The aperture 128 may be formed in a variety of shapes, including, but not limited to, a kidney shape ( FIGS. 47A-47D ) or a crescent shape ( FIG. 47E ). The left and right nostrils 1712, 1712 can be angled toward each other such that the top edges of the left and right nostrils 1712, 1712 are closer to each other than the bottom edges of the left and right nostrils 1712, 1712. In some configurations, the left and right nostrils 1712, 1712 can be angled away from the narrow central region 1710. Each of the left and right nostrils 1712, 1712 can have a shape such that the width of the top portion of the left and right nostrils 1712, 1712 is narrower than the width of the bottom portion of the left and right nostrils 1712, 1712.In some configurations, the narrow central region 1710 can be positioned closer to the upper edge 234 of the aperture 128, as shown in Figures 47A, 47C, and 47D. In other configurations, the narrow central region 1710 can be positioned closer to the lower edge 236 of the aperture 128, as shown in Figure 47B.

[0236] As shown in FIGS. 47A-47F, the position, shape, and size of the narrow central region 1710 can be varied between the upper edge 234 and lower edge 236 of the aperture 128 according to the size and shape of the user's nose and nostrils. Similarly, the size and shape of the left nostril 1712 and right nostril 1712 can also be varied according to the size and shape of the user's nose and nostrils. FIGS. 47F and 47G show an aperture 128 having overlapping upper and lower edges 234 and 236. As shown, the lower edge 236 extends above the upper edge 234 such that the left and right nostrils 1712 and 1712 are completely separated. The separate left and right nostrils 1712 and 1712 provide distinctly separate positions for positioning the user's left and right nostrils over the aperture 128.

[0237] In some configurations, the seal 114 can be configured such that the aperture 128, having overlapping upper and lower edges 234, 236, provides a flush seating surface against which the user's nose rests. As shown in FIG. 47G , the upper portion 1730 of the seal 114 can have a recess 1732 that receives the lower portion 1740 of the seal 114, such that the seating surface at the intersection of the upper and lower portions 1730, 1740 is substantially flat. The substantially flat seating surface at the intersection of the upper and lower portions 1730, 1740 inhibits or prevents a portion of the user's nose from becoming pinched between the upper and lower portions 1730, 1740. The lower portion 1740 can also have a protrusion 1742 having a shape corresponding to the recess 1732, such that the upper and lower portions 1730, 1740 interlock and provide a substantially flat seating surface when the seal 114 is attached to the user.

[0238] 48A-48D show alternative configurations of the nose seal 114 that provide a user with visual guidance as to how the seal 114 should be properly attached to their nose. As shown in FIG. 48A, the seal 114 has markings 1810 that visually indicate to the user where the user's nose should be positioned over the aperture 128. The markings 1810 are shown as circular targets with a central "bull's-eye" mark. The markings 1810 are located on the central portion 204 of the seal 114 where the tip of the user's nose should be positioned. The markings 1810 can be printed with ink on the interior or exterior surface of the seal 114. In some configurations, the ink can be a water-based, washable ink that can be removed with water, allowing the user to remove the markings 1810 once they have learned how the seal 114 should be properly attached. In other configurations, the markings 1810 can be stickers adhesively applied to the seal 114 or to the inner surface of the seal 114 within the dead space, so that the markings 1810 are visible through the surface of the seal 114. FIG. 48B shows an alternative target-type marking 1810. FIG. 48C shows a combination of markings including marking 1810A indicating alignment of the user's nose on the seal 114 and marking 1810B indicating the position of the underside of the user's nose over the aperture 128. FIG. 48D shows marking 1810 showing the outline of the user's nose to indicate both the alignment of the user's nose on the seal 114 and the position of the user's nose over the aperture 128.

[0239] In contrast to a clear image indicating the correct location, placement, and / or alignment of the user's nose, the marking 1810 can include a fun or comical image that indicates the position of the seal 114 on the user's face. FIG. 48E shows a mustache-shaped marking 1810 printed on the central portion 204 of the seal 114, which is positioned below the aperture 128 and below the user's upper lip. The mustache image provided by the marking 1810 indicates to the user where their upper lip should be positioned. Similarly, FIG. 48F shows a flower-shaped marking 1810 printed on the central portion 204 of the seal 114, which is positioned above the aperture 128 and below the user's nose. In some configurations, the marking 1810 can also be scented (e.g., floral) to further indicate how the seal 114 should be attached. In other configurations, the marking 1810 can be a sticker that is applied with an adhesive onto the seal 114. In other configurations, the markings 1810 can be applied using temperature-sensitive ink or stickers such that areas of the seal 114 can change color (e.g., red or green) when the seal 114 is incorrectly or correctly installed. The color change can provide positive or negative feedback regarding the user's behavior.

[0240] In contrast to the printed markings 1810, FIGS. 48G-48I show markings 1910 formed of matte silicone. The markings 1910 may be integrally and integrally molded into the seal 114 to provide the matte silicone markings 1910 with an opaque appearance that contrasts with the translucent appearance of the remainder of the seal 114. Similar to FIG. 48D, FIG. 48G shows matte silicone markings 1910 that indicate both the position and alignment of the user's nose on the seal 114 and the position of the user's nostrils in the aperture 128. FIG. 48H shows matte silicone markings 1910 that indicate the position of the user's nostrils in the aperture 128 by outlining the shape of the user's nostrils in the matte silicone. Similar to FIG. 48A, FIG. 48I shows target-shaped markings 1910 in the matte silicone that can indicate where the tip of the user's nose should be placed on the seal 114.

[0241] As another alternative to printed markings, FIGS. 49A-49C show a deformable marking or depressible indentation 2010 that deforms to indicate that the seal 114 is properly attached to the user. Similar to the marking 1810 in the shape of a target or "bull's-eye," the indentation 2010 is located in the center portion 204 of the seal 114 at the location where the tip of the user's nose should be placed. As shown in FIG. 49C, when the indentation 2010 is pressed, it deforms inward toward the internal cavity or dead space of the seal 114. Thus, when the tip of the user's nose is placed over the indentation 2010, the indentation 2010 deforms inward, providing the user with tactile positive feedback that the seal 114 is properly placed. The indentation 2010 can also produce an audible "popping" sound when the indentation 2010 deforms inward. Indentation 2010 can be reset to extend outward (i.e., away from the interior or dead space of seal 114) when seal 114 is removed from the user's face, thereby resetting indentation 2010 for the next installation. Indentation 2010 provides an easily recognizable mechanism indicating where the user's nose should be placed on seal 114, as deformable indentations are also used in consumer products (e.g., take-out coffee lids).

[0242] Indentation 2010 can also be used to indicate whether seal 114 is sufficiently tight on a user. For example, a force profile or threshold amount of force required to deform indentation 2010 can be determined based on proper tightening of seal 114 against the user's nose or face. Thus, indentation 2010 will not deform unless a threshold force is applied, indicating to the user whether seal 114 is sufficiently tight against the user's nose or face.

[0243] 50A-50F show alternative configurations of the interface 3110 that adjust the angle of the nose seal 3114 according to the user's nose angle to comfortably fit the user's nose within a wide range of upward or downward angles and minimize the amount of force applied to the user's under-nose region. Generally, the user's under-nose region is sensitive to the upward force applied by the seal. However, to inhibit or prevent the seal from leaking, the seal must apply an upward force to the user's nose that is greater than the blowing force. The blowing force varies depending on the upward or downward angle of the user's nose. Thus, a seal that fits comfortably (i.e., by applying a minimal amount of force to the user's under-nose region) on a user with an upwardly angled nose may be uncomfortable on a user with a downwardly angled nose because the seal will not be aligned with the blowing force, thereby applying more force to the user's under-nose region. Thus, to reduce or minimize the amount of force applied to the under-nose area, the interface 3110 provides a seal 3114 that is rotatable depending on the upward or downward angle of the user's nose to provide a sealing force that is aligned with and directly opposed to the user's blowing force, reducing or minimizing the amount of force applied to the under-nose area of ​​the user.

[0244] In FIG. 50A , the interface 3110 includes a seal 3114 attached to a frame 3116. The seal 3114 and frame 3116 are similar to the seal 114 and frame 116 described in FIGS. 1-22 , and therefore, a redundant discussion of similar structures will largely be omitted. The frame 3116 is pivotally attached to an upper frame rail 3122 at an upper connection portion 3152 and to a lower frame rail 3124 at a lower connection portion 3154. That is, the frame 3116 pivots relative to the upper frame rail 3122 about the upper connection portion 3152, and the frame 3116 also pivots relative to the lower frame rail 3124 about the lower connection portion 3154. The upper frame rail 3122 and the lower frame rail 3124 can be formed from a relatively rigid, semi-rigid, or rigid material, such as, for example, polycarbonate. The ends of the upper and lower frame rails 3122, 3124 are attached to front straps 3140 of the headgear 3118. That is, the ends of the upper frame rails 3122 are attached to upper headgear straps 3142, and the ends of the lower frame rails 3124 are attached to lower headgear straps 3144. Thus, the seal 3114 is supported by the headgear 3118 at the upper and lower connecting portions 3152, 3154.

[0245] The upper and lower frame rails 3122, 3124 can be attached to the upper and lower headgear straps 3142, 3144 by connection mechanisms 3160, which allow the upper and lower frame rails 3122, 3124 to extend or retract relative to the headgear 3118, as shown in FIG. 50B. More specifically, extension or retraction of the upper and lower frame rails 3122, 3124 changes the relative positions of the upper and lower connecting portions 3152, 3154, thereby causing rotation of the seal 3114 and enabling rotational adjustability of the seal 3114 within a range of angular rotation. The rotated positions of the seal 3114 are shown in dashed lines in FIG. 50B.

[0246] For illustrative purposes, FIGS. 50C and 50D are schematic side views of the upper and lower frame rails 3122, 3124 to show the changes to the upper and lower connection portions 3152, 3154, respectively, as the upper and lower frame rails 3122, 3124 extend or retract from the upper and lower headgear straps 3142, 3144. As shown, length L1 is measured as the distance between the upper connection portion 3152 and the end of the upper headgear strap 3142. Similarly, length L2 is measured as the distance between the lower connection portion 3154 and the end of the lower headgear strap 3144. Thus, extending or retracting the upper and lower frame rails 3122, 3124 relative to the upper and lower connection portions 3152, 3154 changes lengths L1, L2. To further illustrate the effect of extending and retracting the upper and lower headgear straps 3142, 3144, a front projection line FP defined by the upper and lower connecting portions 3152, 3154 represents the front of the frame 3116. Thus, the angle of the front projection line FP varies depending on the lengths L1, L2 of the upper and lower frame rails 3122, 3124.

[0247] Comparing FIGS. 50C and 50D, the length L1 does not change between FIGS. 50C and 50D. However, the length L2 increases from FIG. 50C to FIG. 50D. That is, the length L2 in FIG. 50D is greater than in FIG. 50C. As a result, the lower connection portion 3154 is positioned further away from the headgear 3118 than in FIG. 50C, which causes the seal 3114 to pivot downward, as indicated by the clockwise rotation of the front projection line FP in FIG. 50D. Similarly, although not shown, extension of the upper frame rail 3122 and retraction of the lower frame rail 3124 causes the seal 3114 to pivot upward and the front projection line FP to pivot counterclockwise. The range of angular rotation provided by the upper and lower frame rails 3122, 3124 may depend on the amount or range of extension and retraction provided by the upper and lower frame rails 3122, 3124 via both connection mechanisms 3160. Thus, rotation of the seal 3114 within a range of angular rotation allows the seal 3114 to comfortably conform to the user's nose within a wide range of positive or negative nose positions to minimize the amount of force applied to the user's under-nose area.

[0248] To illustrate the effect of the pivotal adjustability of the seal 3114 provided by the interface 3110, FIG. 50E shows a cross-sectional view of the seal 3114 attached to a user's nose with a positive nose angle, and FIG. 50F shows a cross-sectional view of the seal 3114 attached to a user's nose with a negative nose angle. The nose angle is determined based on the angle σ between the bottom surface BP of the user's nose and a horizontal reference plane H. A positive nose angle is defined as an angle σ above the horizontal reference plane H. A negative nose angle is defined as an angle σ below the horizontal reference plane H. FIGS. 50E and 50F also show the blowing force vector BOF for both the positive and negative nose angles. As shown, the blowing force vector BOF for the positive nose angle is angled closer to the horizontal plane than the blowing force vector BOF for the negative nose angle. 50E and 50F also show a front projection line FP defined by the upper and lower connecting portions 3152, 3154, shown in FIGS. 50A-50D, and representing the front surface of the frame 3116. The interface 3110 accommodates the varying angles of the blowing force vector B0F caused by positive and negative nose angles by allowing the seal 3114 to rotate according to the nose angle so that the front projection line FP is perpendicular to the blowing force vector B0F. Aligning the front projection line FP to be perpendicular to the blowing force vector B0F minimizes the amount of force applied to the user's under-nose area.

[0249] As shown in FIG. 50E, the seal 3114 fitted at a positive nose angle rotates clockwise compared to the seal 3114 fitted at a negative nose angle (FIG. 50F), such that the front projection line FP is perpendicular to the blowing force. As a result, the amount of force applied to the user's under-nose area to seal against the user's nose is minimized. In FIG. 50F, the seal 3114 fitted at a negative nose angle rotates counterclockwise compared to the seal 3114 fitted at a positive nose angle in FIG. 50E, such that the front projection line FP is also perpendicular to the blowing force. As a result, the amount of force applied to the user's under-nose area to seal against the user's nose is minimized. To further illustrate the difference in the rotation angle of the front projection line FP, an angle θ is shown between the front projection line FP and a vertical reference plane V. As shown, the angle θ of the front projection line FP for the seal 3114 fitted to a positive nose angle in FIG. 50E is less than the angle θ of the front projection line FP for the seal 3114 fitted to a negative nose angle in FIG. 50F.

[0250] The seal 3114 can be pivotally attached to the upper and lower frame rails 3122, 3124 by any connection mechanism that allows for rotation of the frame 3116. In other words, the upper and lower connecting portions 3152, 3154 can include any of a variety of connection mechanisms that allow for rotation of the frame 3116. In some configurations, the frame 3116 can have loops or through-holes located at a front portion of the frame 3116 through which the upper and lower frame rails 3122, 3124 pass, thereby allowing the frame 3116 to pivot about the upper and lower frame rails 3122, 3124.

[0251] The connection mechanism 3160 can include any connection mechanism arrangement between the headgear 3118 and the upper and lower frame rails 3122, 3124 that provides for extension and retraction of the upper and lower frame rails 3122, 3124 so that the seal 3114 is rotatable through a range of angular rotation. The connection mechanism 3160 can include a stiffness adjustment mechanism as described in U.S. Provisional Patent Application No. 61 / 261,715, which is incorporated herein by reference.

[0252] 51A-51G illustrate an alternative connection mechanism that allows the seal 3114 to rotate through a range of angular rotation. FIGS. 51A and 51B illustrate a connection mechanism 3260 that includes an endless or closed-loop cable 3220 and a pulley 3230. The closed-loop cable 3220 has an upper loop portion 3222 and a lower loop portion 3224. Similar to the upper and lower frame rails 3122, 3124, the closed-loop cable 3220 connects to the frame 3116 at upper and lower connection portions 3152, 3154. The upper and lower connection portions 3152, 3154 may include loops or through-holes at the front of the frame 3116 through which the closed-loop cable 3220 passes, allowing the frame 3116 to rotate about the upper and lower frame rails 3222, 3224.

[0253] 51A and 51B, the closed-loop cable 3220 is wrapped around a pulley 3230. The pulley 3230 is attached to a front strap 3240 of the headgear 3118. The pulley 3230 can be rotated clockwise or counterclockwise to allow the upper and lower loop portions 3222, 3224 to increase or decrease in length, such that the seal 3114 rotates. That is, rotation of the pulley 3230 pulls the upper and lower connecting portions 3152, 3154 closer to the headgear 3118. Thus, a user can rotate the pulley 3230 to rotate and adjust the seal 3114 until it is comfortably fitted.

[0254] In some configurations, the pulley 3230 can have a recessed groove therearound that receives the closed-loop cable 3220. Furthermore, a user can attach or detach the seal 3114 by disconnecting the closed-loop cable 3220 from the pulley 3230. Furthermore, the pulley 3230 can be adjustably attached to a front strap 3240 of the headgear 3118 to allow the slack in the closed-loop cable 3220, and therefore the tightness of the seal 3114 against the user's face, to be adjusted. More specifically, the position of the pulley 3230 can be moved along the front strap 3240 (i.e., closer to or further from the frame 3114) to allow the tightness of the seal 3114 against the user's face to be adjusted. Alternatively, closed-loop cables 3220 can be provided having different lengths to allow the tightness of the seal 3114 against the user's face to be adjusted.

[0255] 51C and 51D show an alternative connection mechanism comprising an upper yoke 3322 and a lower yoke 3324 attached to a pulley 3330. In contrast to the closed-loop cable 3220, the upper yoke 3322 and the lower yoke 3324 have a fixed length and can be rigid or semi-rigid in structure. As a result, the upper yoke 3322 and the lower yoke 3324 can be rigid enough to resist yielding to a normal force, such as the normal component of a blowing force. The upper yoke 3322 and the lower yoke 3324 are rotatably attached to the pulley 3230 such that the upper yoke 3322 and the lower yoke 3324 can rotate relative to the pulley 3230. As shown, a user can rotate the pulley 3230 to rotate the seal 3114 in a clockwise or counterclockwise direction. More specifically, rotation of the pulley 3230 can push or pull the upper yoke 3322 and the lower yoke 3324, which in turn pushes or pulls the upper connecting portion 3152 and the lower connecting portion 3154 further away or closer to the headgear 3118. As a result, the seal 3114 rotates upward or downward.

[0256] 51E, the pulley 3430 can have a gear 3460 located on the side of the pulley 3430. The gear 3460 can engage with teeth 3462 attached to the headgear 3118. The teeth 3462 engage with teeth on the gear 3460 to inhibit or prevent rotation of the pulley 3430 so that the rotational orientation of the seal 3114 is maintained. In some configurations, the pulley 3460 can have a toothed periphery. The pulley 3430 and teeth 3462 can be formed from a plastic such as thermoplastic polyurethane (TPU).

[0257] FIG. 51F shows a pulley 3430 having a notched periphery 3470. The irregularities provided by the notched periphery 3270 allow a user to increase their grip to overcome the holding force of the teeth 3462 and rotate the pulley 3430. Similarly, FIG. 51G shows a pulley 3430 having a lever 3480 extending radially outward from the periphery of the pulley 3430. Thus, the pulley 3430 can be rotated by turning the lever 3480.

[0258] 52A-52C show an alternative configuration of a curling seal 4114 that deforms to comfortably fit a user's nose within a wide range of upward or downward angles to minimize the amount of force applied to the user's under-nose area. In contrast to mechanisms that rotate the seal up or down to align with the angle of the user's nose, the seal 4114 deforms and curls downward upon itself, allowing the seal 4114 to conform to the shape and angle of the user's nose. More specifically, the seal 4114 has regions of varying thickness or stiffness, which can control and accommodate deformation of the seal 4114 in predetermined areas of the seal 4114 when force is applied to the seal 4114, thereby minimizing the amount of force applied to the user's under-nose area. When the seal 4114 is removed, the upper perimeter region 4250 returns to its undeformed shape.

[0259] The seal 4114 has an aperture 4128 surrounded by an inward- or rearward-facing central portion 4204 that faces or contacts a lower portion of the user's nose when the seal 4114 is in use. The central portion 4204 is connected to an upper periphery region 4250 that surrounds the central portion 4204 and extends along lateral portions of the periphery of the seal 4114. A lower periphery region 4252 is disposed below the upper periphery region 4250 and also extends along a lower lateral portion of the periphery of the seal 4114. The upper periphery region 4250 is connected to an inner upper edge of the lower periphery region 4252 adjacent the dead space 4206 of the seal 4114. A sealing port 4172 can be formed in a central midpoint area of ​​the lower periphery region 4252.

[0260] FIG. 52B shows a vertical cross section of the seal 4114. As shown, the thickness of the lower perimeter region 4252 (i.e., the wall thickness of the seal 4114 at the lower perimeter region 4252) is much greater than the thickness of the upper perimeter region 4250. Thus, the lower perimeter region 4252 has significantly greater stiffness and rigidity than the upper perimeter region 4250. In some configurations, the lower perimeter region 4252 can be formed from a rigid plastic material onto which the silicone portion of the seal 4114 is overmolded. As a result, when a downward force is applied to the central portion 4204 of the seal 4114 (i.e., when a user has a downwardly angled nose), the upper perimeter region 4250 curls inward and downward onto itself and / or the lower perimeter region 4252, as shown in FIG. 52C. More specifically, the central portion 4204 moves downward and / or inward into the dead space 4206 of the seal 4114 in response to the applied force, causing the upper perimeter region 4250 to collapse and curl inward within the dead space 4206 of the seal 4114 and downward onto itself and / or the lower perimeter region 4252. The curling of the upper perimeter region 4250 causes the seal 4114 to move downward and / or inward, thereby conforming to the shape and angle of the bottom of the user's nose so as to reduce the force applied to the user's under-nose area. Furthermore, by adjusting the thickness and stiffness of the upper perimeter region 4250, the force required to cause the upper perimeter region 4250 to curl can be controlled, thereby controlling the force applied against the user's nose. For example, a gradual change in thickness or stiffness can provide gradual or ungradual resistance to curling of the upper perimeter region 4250 over a range of movement.

[0261] The seal 4114 may include a reinforcement portion or thickened band 4240 disposed between the upper perimeter region 4250 and the central portion 4204. The band 4240 may extend along the upper outer edge of the central portion 4204 of the inner wall of the seal 4114. The band 4240 reduces expansion spread and provides additional structure between the upper perimeter region 4250 and the central portion 4204 that inhibits or prevents curling of the central portion 4204 and encourages curling of the upper perimeter region 4250. The band 4240 may be a component formed from a material that is stiffer than or characterized by increased stiffness relative to the silicone or other material that forms the seal 4114.

[0262] The seal 4114 may also include a thickened or reinforced aperture region 4242 around the aperture 4128. The reinforced aperture region 4242 may extend around or surround the aperture 4128 and inhibit or prevent the edges of the aperture 4128 from deforming and collapsing into the dead space 4206 of the seal 4114. Additionally, the reinforced aperture region 4242 may also help transmit downward forces exerted by the user's nose to the upper perimeter region 4250. Like the band 4240, the reinforced aperture region 4242 may be a component formed from a material that is stiffer than or characterized by increased stiffness relative to the silicone or other material that forms the seal 4114.

[0263] In the illustrated configuration, the thickness of the upper perimeter region 4250 may be similar in thickness compared to the central portion 4204 and other regions of the seal 4114, except for the lower perimeter region 4252, which is significantly thicker. However, in such cases, the central portion 4204 is reinforced by a thickened band 4240 to inhibit or prevent crushing or curling of the central portion 4204. In some configurations, the thickness of the seal 4114 along the upper perimeter region 4250 may be thinner than all other portions of the seal 4114, providing a region of reduced stiffness relative to all other regions of the seal 4114, thereby limiting deformation and curling to only the upper perimeter region 4250.

[0264] While the illustrated configuration uses regions of varying thickness, other methods of providing regions of varying stiffness to induce curling of the seal 4114 can also be used. For example, the material of the seal 4114 can be configured to have regions of relatively increased or decreased stiffness through material selection or material properties. Additionally, composites of materials can be used to provide regions of varying stiffness or stiffness. Additionally, any suitable combination of techniques can be used. Nevertheless, the upper perimeter region 4250 configured with a reduced thickness provides a simple method of achieving regions of increased stiffness.

[0265] 53A-53D show an alternative configuration of a rolled seal 5114 that adjusts by deforming to accommodate users with a wide range of nose-down angles, which is a combination of the user's nose angle and upper lip angle. Similar to the seal 4114 in FIGS. 52A-52C, the seal 5114 has an upper perimeter region 5250 that rolls downward on itself to accommodate users with negative nose angles. However, the seal 5114 also has a lower perimeter region 5252 that rolls upward on itself to accommodate users with protruding upper lip angles. That is, the upper perimeter region 5250 and the lower perimeter region 5252 roll downward and upward, respectively, causing the seal 4114 to compress and fit between the space between the user's nose and upper lip. When the seal 4114 is removed from the space between the user's nose and upper lip, the upper perimeter region 5250 and the lower perimeter region 5252 return to their undeformed shapes.

[0266] The upper and lower perimeter regions 5250, 5252 can be separated by a rigid frame portion 5260. The rigid frame portion 5260 can be formed from thick silicone so as to be substantially inflexible. Alternatively, the rigid frame portion 5260 can be formed from a rigid plastic material onto which the upper and lower perimeter regions 5250, 5252 can be overmolded from a flexible material, such as silicone. A sealing port 5172 can be formed in a central midpoint area of ​​the front region of the rigid frame portion 5260. The rigid frame portion 5260 is shown as recessed inward relative to the outer lateral perimeters of the upper and lower perimeter regions 5250, 5252. However, one skilled in the art will understand that in some configurations, the rigid frame portion 5260 can be flush with or protrude from the upper and / or lower perimeter regions 5250, 5252.

[0267] The seal 5114, with its rounded upper and lower perimeter regions 5250, 5252, accommodates users with a wide range of inferior nasal angles (i.e., combinations of nasal angles and upper lip angles). FIG. 53B is a comparative diagram showing the profile profile of a user with a positive inferior nasal angle and a shallow upper lip angle superimposed on the profile profile of a user with a negative nasal angle and a protruding upper lip angle. The inferior nasal angle is measured between the inferior nasal region and the upper lip. A user with a positive nasal angle and a shallow upper lip angle will have a θ MAX A user with a negative nose angle and a protruding upper lip angle is shown as having a θ MIN In other words, the nose down angle is larger for a user with a positive nose angle and a shallow upper lip angle than for a user with a negative nose angle and a protruding upper lip angle.

[0268] The seal 5114 is MIN From θ MAX FIG. 53C shows the nose-down angle θ MAX1 is a side view of the seal 5114 configured to fit a user having a nose-down angle θ . As shown, the upper perimeter region 5250 and the lower perimeter region 5252 are undeformed, thereby allowing the seal 5114 to fit a user having a nose-down angle θ . MAX 53D shows the nose-under angle θ MIN 1 is a side view of the seal 5114 configured to fit a user having an under-the-nose angle θ 1 . In contrast, the upper perimeter region 5250 and the lower perimeter region 5252 deform and curl upon themselves, thereby allowing the seal 5114 to fit a user having an under-the-nose angle θ 1 . MIN The nosepiece conforms to the user's nose and seals against the user's nose.

[0269] The upper perimeter region 5250 and the lower perimeter region 5252 can be substantially similar in structure to the upper perimeter region 4250 and to each other. Thus, the upper perimeter region 5250 and the lower perimeter region 5252 can deform similarly under similar forces. Thus, the sealing port 5172 is balanced between the upper perimeter region 5250 and the lower perimeter region 5252. Furthermore, sustained normal external forces are absorbed by the upper perimeter region 5250 and the lower perimeter region 5252 as they curl and equalize in a new position. For example, a temporary normal external force caused by accidental hose pulling is absorbed by the upper perimeter region 5250 and the lower perimeter region 5252, causing the upper perimeter region 5250 and the lower perimeter region 5252 to return toward or to their equalized position. In some configurations, the upper perimeter region 5250 and the lower perimeter region 5252 can have different sizes, shapes, and / or structures, such that the upper perimeter region 5250 can provide a different force profile than the lower perimeter region 5252.

[0270] Similar to the seal 4114, a reinforcement portion or thickened band 5240 extends around the outer top edge of the upper periphery region 5250 and the outer bottom edge of the lower periphery region 5252 on the inner wall of the seal 5114. Additionally, the seal 5114 may also include a thickened or reinforced aperture region 5242 around the aperture 5128. The band 5240 and reinforced aperture region 5242 help transfer forces applied by the user's nose and upper lip to the upper periphery region 5250 and lower periphery region 5252. FIG. 53E shows an alternative configuration for the reinforcement band 5240. As shown, the seal 5114 may have a spring steel strip 5340 overmolded to the upper periphery region 5250 and lower periphery region 5252. The spring steel strip 5340 promotes curling of the upper periphery region 4250 by inhibiting or preventing curling in other regions of the seal 5114.

[0271] 54A-54G show an alternative configuration of the seal 6114 having a bellows-like region 6202 that allows the seal 6114 to be adjusted to fit a wide range of nose lengths. The bellows-like region 6202 is a deformable region of the seal 6114 that deforms to accommodate the user's nose and adapt to the length and shape of the user's nose, bellowing outward and / or upward to cushion and reduce the amount of force acting against the user's nose. As shown in FIGS. 54A and 54B, the bellows-like region 6202 is a flexible region formed from a thin-walled portion of the seal 6114. The bellows-like region 6202 can have the thinnest wall thickness compared to all other portions of the seal 6114, such that deformation occurs only in the bellows-like region 6202. The thin wall thickness provides flexibility, allowing the bellows-like region 6202 to change shape by deforming inward and expanding outward. The bellows-like region 6202 may include a central portion 6204 that surrounds the aperture 6128. Additionally, the bellows-like region 6202 may extend to include portions of the upper perimeter region 6250. The seal 6114 may also include a thickened or reinforced aperture region 6242 around the aperture 6128. That is, the aperture 6128 may have a thickened or reinforced aperture region 6242 formed from thicker silicone (i.e., relative to other portions of the seal 6114), such that the aperture 6128 is reinforced and strengthened to inhibit or prevent collapse of the seal 6114 around the aperture 6128. Thus, the reinforced aperture region 6242 may ensure that the bellows-like region 6202 of the seal 6114 deforms as opposed to the region around the aperture 6128 when the seal 6114 is attached by a user.

[0272] FIG. 54C is a comparative diagram showing a cross-sectional side view of the seal 6114 fitted to a user with a long nose superimposed on a cross-sectional side view of the seal 6114 fitted to a user with a short nose at an upward angle. As shown, a longer nose extends deeper into the seal 6114 compared to a shorter nose. As a result, the bellows-like region 6202L deforms inward to accommodate the longer nose. Furthermore, the bellows-like region 6202L protrudes outward in a forward and upward direction to increase the volume within the seal 6114, thereby minimizing pressure buildup inside the seal 6114. As a result, the amount of force acting on a long nose is reduced, thereby improving the comfort of the seal 6114. Furthermore, the thin surface provided by the bellows-like region 6202L extending above the user's nose improves the comfort of the seal 6114 because the amount of force is distributed over a larger contact area with the nose. In contrast, the bellows-like region 6202S expands or extends toward the user to accommodate a short nose, which does not extend as deeply into the seal 6114. Thus, the bellows-like region 6202S does not protrude outward in the forward and upward direction as the bellows-like region 6202L.

[0273] FIG. 54D shows the seal 6114 fitted to a user with a long nose and a horizontal plane nose angle. FIG. 54E shows the seal 6114 fitted to a user with a long nose and a negative nose angle. As shown, the bellows-like region 6202 of the seal 6114 protrudes outward in a forward and upward direction to accommodate both nose angles. Similarly, FIG. 54F shows the seal 6114 fitted to a user with a short nose and a positive nose angle. FIG. 54G shows the seal 6114 fitted to a user with a short nose and a negative nose angle. As shown, the bellows-like region 6202 of the seal 6114 extends in an upward direction to accommodate both nose angles. In some configurations, the thickness and stiffness along the bellows-like region 6202 can be varied so that the seal 6114 can initially bellow or protrude upward along the user's nose, improving the comfort of the seal 6114 against the user's nose. After a threshold pressure or force is applied, the bellows-like region 6202 can bellow or protrude forward to relieve pressure within the seal 6114 .

[0274] The comfort of a nasal pillow seal can be improved by avoiding the nasal seal from protruding into the user's nostrils. A nasal seal that does not protrude into the user's nostrils can form a seal with the user by having a surface that compresses against the lower portion of the user's nose and upper lip. This can impart a larger profile to the nasal seal compared to a seal that protrudes into the patient's nostrils. A problem with a large profile nasal pillow seal is that the seal may become dislodged if it comes into contact with another surface, for example, when the user changes position to a side-lying position. Reducing the profile of the nasal seal can reduce the perceived unsightliness of the seal and reduce the adverse effects experienced while sleeping in a side-lying position. Because a low-profile respiratory interface is smaller, it is less likely to come into contact with a pillow or other sleep-related surface, which could push the respiratory interface aside and break the seal on the patient's nose. However, a low-profile respiratory interface can have a smaller surface area that forms a seal with the user's skin. The respiratory interfaces disclosed herein provide a low-profile nasal seal that is comfortable to wear and maintains an excellent seal between the interface and the user.

[0275] FIG. 55 is a perspective view of another example of an interface assembly or respiratory mask system 110 that can be used with or incorporated into the system 10 of FIG. 1. The mask system 110 can be similar to at least some of the mask systems 110 of FIGS. 2-22 and will be described with reference to differences relative to the earlier mask systems 110. Components or features of the present mask system 110 not discussed in detail can be the same or similar to corresponding components or features of the earlier mask systems 110, or can be in another suitable arrangement. Thus, in some cases, the same reference numerals will be used to refer to the same, corresponding, or similar components or features. The respiratory mask system 110 includes a mask 112 that, in some configurations, includes a seal 114 and a frame assembly or frame 116. The seal 114 can be connected to the frame 116 by a connector 7222. The respiratory mask system 110 also includes headgear 118 for securing the patient interface 112 to a user. The headgear 118 can include a yoke 127 extending along the front of the patient interface 112. The yoke 127 can be formed integrally with the headgear 118. In some embodiments, the yoke 127 is removably connected to the frame 116. In some variations, the yoke 127 is integral with the frame 116. In the illustrated embodiment, the headgear 118 forms a closed loop from the back of the user's head to the front of the frame 116 and / or from the front of the frame 116 to the crown of the user's head. In a preferred embodiment, the respiratory mask system 110 does not include a T-piece from the frame 116 that extends upward (when worn) to connect to the headgear 118 at the forehead of the user. However, if desired, aspects, features, or components of the disclosed respiratory mask system 110 can be utilized in designs that incorporate a T-piece. The seal 114 does not rest on the bridge of the nose, thereby reducing the size and profile of the seal and making it less obtrusive. Additionally, by not resting on the bridge of the nose, the seal 114 is adapted to reduce any chance of pressure injury to the sensitive bridge of the nose area.

[0276] In some configurations, the respiratory mask system 110 also includes a short flexible tube or gas delivery conduit 120, which provides fluid communication with the interior of the seal 114 and connects to the supply conduit 12 of the CPAP system 10 or other respiratory system. The gas delivery conduit 120 connects to the mask 112 directly or via a suitable connector, such as a hollow connector 122, which may be of any desired or suitable shape, such as curved or bent (e.g., elbow) or straight. In some configurations, the connector 122 can pivot relative to the mask 112 about one or more pivot axes, thereby allowing the path of the gas delivery conduit 120 relative to the positioning of the mask on the user's face to adapt to the user's sleeping position. However, in other arrangements, the connector 122 may be integral with or separate from the mask 112. In the illustrated embodiment, the connector 122 is absent, and the gas delivery conduit 120 is fixedly connected to the frame 116. The end of the gas delivery conduit 120 opposite the connector 122 may include a suitable connector 124 for connecting the gas delivery conduit 120 to the supply conduit 12. In some configurations, the connector 124 may be or include a swivel connector that allows for relative rotation between the gas delivery conduit 120 and the supply conduit 12.

[0277] The respiratory mask system 110 preferably includes a restricted flow or bias flow outlet 126 that provides gas washout from the respiratory mask system 110. In some configurations, the bias flow outlet 126 is in the form of a collection of small apertures. The bias flow outlet 126 can be located in the frame 116 as shown, in the connector 122, or elsewhere in the respiratory mask system 110.

[0278] In some configurations, the mask 112 can include a seal 114, a frame 116, and a connector 122. In some configurations, the frame 116 (and connector 122, if desired) can be more rigid than at least a portion of the seal 114, such as the portion defining the user-contacting surface. In some configurations, the seal 114 is removably coupled to the frame 116 around a passageway from the interior of the connector 122 through the frame 116. In the illustrated embodiment, the frame 116 acts as a hub or connector between the seal 114, the gas delivery conduit 120, and the headgear 118. The frame 116 also provides rigid support for the seal 114 and / or connector 122. The frame 116 is preferably rigid or semi-rigid and can be formed from thick silicone or other plastic material. Thus, the seal 114 and frame 116 together can form a housing having a gas inlet from the CPAP system 10 and an aperture 7128 (see, eg, FIG. 58A) through the seal 114 to the user.

[0279] In some configurations, the headgear 118 includes side arms 130 that extend outward (away from each other), backward, and upward at a shallow angle, past the left and right ends of the seal 114, along the user's left and right cheeks, particularly the cheekbones, and connect to the headgear 118 to hold the seal 114 on the user's face. These side arms 130 can be deep or thicker or longer, and can be resiliently flexibly connected to the frame and / or resiliently flexible along their length (widthwise, but not heightwise). In some configurations, the side arms 130 extend toward or to a position between the user's ears and eyes and / or to or near the temples of the user. In some embodiments, the side arms 130 extend upward along the cheeks toward the crown of the head to form a closed-loop headgear 118.

[0280] FIG. 56 illustrates an embodiment of the seal 114 and frame 116. For clarity, the yoke 127 retention structure is not shown. The yoke 127 extends across the front or distal-facing surface of the frame 116. In the illustrated arrangement, the frame 116 defines a general U-shape when viewed from above. As described below, a connector 7222 can connect the seal 114 to the frame 116. The connector 7222 can function to provide support to the seal 114 and can resist deformation of the seal 114 when a positive pressure is applied to the seal 114 in use.

[0281] FIG. 57 illustrates a non-limiting embodiment of the frame 116. FIGS. 58A-58C illustrate non-limiting embodiments of the seal 114. Referring to FIG. 57, a central portion of the frame 116 defines an aperture 7170 through which gas can flow. A first annular wall surrounds the aperture 7170 and projects in a rearward direction to define a support or connector 7172 for the seal 114. A second annular wall of the frame 116 (which includes the bias flow exhaust port 126 and is shown in FIG. 56) surrounds the aperture 7170 and projects in a forward direction to define a support for the connector 122. Referring to FIGS. 58A-58C, the seal 114 defines a gas inlet aperture 7175 configured to receive the connector 7172 of the frame 116. The seal 114 and frame 116 can be removably coupled by any suitable mechanism, such as, for example, a friction fit or a snap fit. In the illustrated arrangement, the connector 7172 includes one or more recesses 7176 configured to receive corresponding protrusions (not shown) on the seal 114 to provide a snap-fit ​​engagement between the seal 114 and the frame 116. However, this arrangement can also be reversed. Furthermore, the entire arrangement can be reversed between the seal 114 and the frame 116, in that the seal 114 can include a male connector portion and the frame 116 can include a corresponding female connector portion. In some configurations, the seal 114 can include a connector 7222, as shown in FIGS. 72 and 73, formed around the gas inlet aperture 7175 of the seal 114. The connector 7222 can be formed from a rigid plastic (e.g., polycarbonate). The connector 7222 can be formed as part of the seal 114. For example, the seal 114 can be overmolded over the connector 7222. In some embodiments, the connector 7222 is adhered to the seal 114 with an adhesive or connected to the seal 114 by a fitting or fastener. In some configurations, the connector 7222 includes multiple parts that capture the seal 114 therebetween. The connector 7222 allows for a connection between the frame 116 and the seal 114.In some embodiments, the frame 116 does not provide structural support for the seal 114. Rather, the frame 116 acts as a manifold that allows the headgear 118, gas delivery conduit 120, and seal 114 to be coupled into a single respiratory mask system 110 in combination with the connector 7222. Structural support for the seal 114 is provided by the connector 7222 on the distal surface of the seal 114.

[0282] Preferably, the seal 114 and frame 116 include an alignment or keying feature so that the seal 114 and frame 116 can only be assembled in the correct orientation relative to one another. Any suitable feature can be used. For example, the seal connector 7172 can include a recess 7180 configured to receive a key or protrusion (not shown) on the seal 114. The recess 7180 and protrusion can be located in the upper central portion of the aperture 7170 and / or at other locations along the periphery of the aperture 7170. This arrangement can also be reversed. Furthermore, other suitable arrangements can be used, such as, for example, non-circular shapes for the connector 7172 and the gas inlet aperture 7175. In some embodiments, the gas inlet aperture 7175 can have a generally D-shape, with the bottom portion of the gas inlet aperture 7175 being flattened or closer to the center point of the gas inlet aperture 7175 than other portions of the gas inlet aperture 7175. The frame 116 may include a D-shaped seal connector 7172 that mates with the D-shaped gas inlet aperture 7175 to ensure proper alignment and prevent rotation of the seal 114 relative to the frame 116. The D-shaped or non-circular gas inlet aperture 7175 may also reduce the overall height of the respiratory mask system 110, making the respiratory mask system 110 less obtrusive and more desirable to use.

[0283] In the embodiment of FIG. 58A, the gas inlet aperture 7175a of the seal 114a is primarily circular in shape with a diameter of approximately 29.7 mm to accommodate circular gas delivery conduits. In some variations, the gas inlet aperture 7175a is 28 mm to 34 mm. In the embodiment of FIG. 58B, the gas inlet aperture 7175b is primarily circular in shape with a diameter of approximately 26.5 mm, but the lower edge of the gas inlet aperture 7175b includes a truncated portion 7177 having a slightly reduced diameter (FIG. 59B). This truncated portion 7177 can provide an intuitive indication of the orientation of the seal connector (FIGS. 72 and 73), described below. The truncated portion 7177 can be located on either or both edges of the gas inlet aperture 7175, the top edge, or anywhere around the perimeter of the gas inlet aperture 7175. In some variations, gas inlet aperture 7175b is between 26 mm and 30 mm. In the embodiment of FIG. 58C, gas inlet aperture 7175c is primarily circular in shape with a diameter of approximately 28.4 mm. The lower edge of gas inlet aperture 7175c includes truncated portion 7177 as described above. In some variations, gas inlet aperture 7175c is between 28 mm and 32 mm.

[0284] The seal 114 has a hollow interior that is configured to fill with air under positive pressure in use and seal under the user's nose, along the portion of the face extending laterally relative to the nose, and along the user's upper lip (FIGS. 63A-63C). FIGS. 58A-58C show non-limiting embodiments of the seal 114. The seal 114 includes at least one nasal opening or aperture 7128. The nasal aperture 7128 communicates between the hollow interior of the seal 114 and the rear wall 7202 of the seal 114 (FIGS. 66A-66C). A gas inlet aperture 7175 provides an opening between the hollow interior of the seal 114 and the front wall 7212 of the seal 114. In some configurations, the seal 114 can include two or more nasal apertures 7128. In some configurations, the seal 114 can include an aperture 7128 defined in an upper structure, such as a pillow, prong, or the like. In some configurations, the nasal aperture 7128 may be defined by a nasal cushion or insert that may be overmolded or otherwise secured to the underlying structure of the seal 114. Examples of suitable arrangements for the seal 114 are disclosed in commonly owned WO 2014 / 077708, the entire contents of which are incorporated herein by reference.

[0285] As described in more detail below, seal 114 can be designed to have a low profile and maintain good sealing characteristics under positive pressures of 18 mm H2O to 22 mm H2O or less. The profile of seal 114 can be characterized by the distance that seal 114 extends beyond the user's nose. Generally, seal 114 in FIG. 58C has a low profile compared to seal 114 in FIG. 58A. The profile of seal 114 in FIG. 58B is intermediate between the profiles of the seals in FIGS. 58A and 58C.

[0286] FIGS. 59A-59C show a front view of the seal 114 shown in FIGS. 58A-58C. The seal 114 can have an overall height 7140 and an overall width 7142, as shown in FIGS. 59A-59C. FIGS. 60A-60C show a left side view of the seal 114 of FIGS. 59A-59C. The seal 114 can have an overall depth 7144, as shown in FIGS. 60A-60C. In some embodiments, the profile of the seal 7144 can be reduced by reducing one or more of the overall height 7140, overall width 7142, and / or overall depth 7144 of the seal 114. While specific dimensions are discussed herein, ratios of specific dimensions to one another are also considered within the scope of this disclosure. For example, a disclosure of height and depth includes a disclosure of the ratio of height to depth.

[0287] In the illustrated embodiment of FIGS. 59A and 60A, the overall height 7140a is 42.1 mm, the overall width 7142a is 75.8 mm, and the overall depth 7144a is 45.6 mm. In some configurations, the overall height 7140a is 37 mm to 47 mm, 40 mm to 44 mm, or approximately 42 mm. In some configurations, the overall width 7142a of the seal 114a is 72 mm to 82 mm, 75 mm to 77 mm, or approximately 76 mm. In some embodiments, the overall depth 7144a is 40 mm to 50 mm, 44 mm to 48 mm, or approximately 46 mm.

[0288] In the illustrated embodiment of FIGS. 59B and 60B, the overall height 7140b is 41.0 mm, the overall width 7142b is 59.0 mm, and the overall depth 7144b is 43.0 mm. In some configurations, the overall height 7140a is 36 mm to 46 mm, 39 mm to 43 mm, or about 41 mm. In some configurations, the overall width 7142b of the seal 114b is 54 mm to 64 mm, 57 mm to 61 mm, or about 59 mm. In some embodiments, the overall depth 7144 is 38 mm to 48 mm, 41 mm to 45 mm, or about 43 mm.

[0289] In the illustrated embodiment of FIGS. 59C and 60C, the overall height 7140c is 35.6 mm, the overall width 7142c is 59.0 mm, and the overall depth 7144c is 43.2 mm. In some configurations, the overall height 7140c is 30 mm to 40 mm, 33 mm to 37 mm, or approximately 35 mm. In some configurations, the overall width 7142c of the seal 114c is 54 mm to 64 mm, 57 mm to 61 mm, or approximately 59 mm. In some embodiments, the overall depth 7144c is 38 mm to 48 mm, 41 mm to 45 mm, or approximately 43 mm.

[0290] In some configurations, the seal 114 is sized to accommodate different nasal structures. For example, the seal 114 can be provided in small, medium, large, and wide models. In some embodiments, the seal 114 can be sized to accommodate nasal structures of different ethnicities (e.g., Caucasian, Asian, African American). The ranges of overall height 7140, overall width 7142, and overall depth 7144 described above may be representative of the medium models of the various embodiments shown in FIGS. 59A-59C. For the embodiment shown in FIG. 59C, the overall width 7142c may range from approximately 45 mm for the small model to approximately 80 mm for the large model. The large model of the embodiment in FIG. 59C can have a height 7140c and a depth 7144c similar to those of the medium model shown in FIG. 59C. In some variations, the large model of the embodiment in FIG. 59C has a greater height 7140c and / or depth 7144c compared to the medium model shown in FIG. 59C. The small model of the embodiment in FIG. 59C can have a width 7142c similar to the medium model shown in FIG. 59C. In some variations, the small model has a smaller width 7142c, height 140c, and / or depth 7144c compared to the medium model shown in FIG. 6C. The wide model of the embodiment in FIG. 59C can have a width 7142c of 70 mm to 80 mm, 73 mm to 77 mm, or about 75 mm. The wide model of the embodiment in FIG. 59C can have a larger height 7140c and / or depth 7144c similar to that of the medium model shown in FIG. 59C.

[0291] 60A-60C, when the bottom wall of seal 114 is horizontal, uppermost point 7182 of gas inlet aperture 7175 can be located distal to lowermost point 7184 of gas inlet aperture 7175. As shown, a line passing through uppermost point 7182 and lowermost point 7184 of gas inlet aperture 7175 can form an angle 7186 with a vertical line passing through lowermost point 7184. This angle 7186 can be referred to as gas inlet angle 7186. In the embodiment of FIG. 60A, gas inlet angle 7186a is 8.75°, and uppermost point 7182a is 4.65 mm distal to lowermost point 7184a. In the embodiment of FIG. 60B, gas inlet angle 7186b is 13.2°, and uppermost point 7182b is 7.1 mm distal to lowermost point 7184b. In the embodiment of FIG. 60C, gas inlet angle 7186c is 15.5° and the highest point 7182c is 8.1 mm distal to the lowest point 7184c.

[0292] In some configurations, the gas inlet angle 7186 can range from 5° to 30°, 7° to 20°, or 8° to 16°. In some variations, the gas inlet angle 7186 can be selected to reduce the volume within the hollow interior space of the seal 114. Reducing the volume within the hollow interior space of the seal 114 can reduce the unsightly appearance of the seal 114. The volume within the hollow interior of the seal 114 can also be known as dead space. Reducing dead space can facilitate flushing of exhaled air and carbon dioxide. The gas inlet angle 7186 can be selected to angle the gas inlet aperture 7175 (and the gas delivery conduit projecting therefrom) toward a horizontal axis. Angling the gas delivery conduit projecting from the mask 112 toward a horizontal axis allows the gas delivery conduit 120 to be connected to the supply conduit 12 without the use of an elbow connector. Angling the gas delivery conduit 120 toward a horizontal axis can reduce hose strain.

[0293] In addition to reducing the overall height 7140, width 7142, and depth 7144 dimensions of the seal 114, the profile of the seal 114 can be reduced by changing its shape. FIGS. 61A-61C are rear views of the seal 114 shown in FIGS. 58A-58C. Referring to FIGS. 61A-61C, the rear wall 7202c of the embodiment in FIG. 61C has a more triangular shape compared to the rear surfaces 7202a, 7202b of the embodiment in FIGS. 61A and 61B. As shown in FIGS. 61A-61C, the rearward protrusion of the rear wall 7202 can define an outer perimeter that circumferentially surrounds the nasal aperture 7128. This outer perimeter can be referred to as the rear perimeter. The seal 114 shown in FIG. 61C has a smaller rear perimeter than the seal shown in FIG. 61A. In some variations, the profile of the seal 114 is reduced by reducing the rear perimeter of the seal 114.

[0294] The nasal aperture 7128 of the seal 114 is disposed in a central portion of the posterior wall 7202. The central portion of the posterior wall 7202 is distal to the lateral portions of the posterior wall 7202, thereby forming a nasal recess 7214. In use, the nasal recess 7214 receives the tip of the user's nose. The seal 114 has a bottom wall 7216 that extends proximally upward to meet the posterior wall 7202. In the embodiment of FIGS. 61B and 61C, the bottom walls 7216b, 7216c and the posterior walls 7202b, 7202c meet to form shelves 7218b, 7218c near the bottom of the nasal recess 7214. The seal shown in FIG. 61A does not have as distinct a shelf. As described below, a more defined ledge 7218 can reduce the profile of seal 114 by allowing the bottom portion of seal 114 to slope closer to the user's face, as shown in FIGS. 63A-63C. The defined ledge 7218 can reduce the volume of the hollow interior of seal 114, thereby reducing the profile of seal 114. The ledge 7218 can also improve the stability of seal 114, thereby allowing the size of seal 114 to be reduced while maintaining good performance (e.g., sealing) of seal 114.

[0295] 62A-62C are top views of the seal 114 shown in FIGS. 58A-58C. Referring to FIGS. 62A-62C, the rear wall 7202c of the embodiment of FIG. 62C extends further distally than the rear surfaces 7202a, 7202b of the embodiment of FIGS. 62A and 62B. When the seal 114 is viewed from the top, the aperture 7128c of the seal 114c shown in FIG. 62C is closer to the distal-most point 7230c of the seal 114c than to the proximal-most point 7232c of the seal 114c. In the embodiment of FIG. 62A, the aperture 7128a is closer to the proximal-most point 7232a of the seal 114a than to the distal-most point 7230a of the seal 114a. In the embodiment shown in FIG. 62A , the anterior wall 7212a flares out as it extends in a posterior direction compared to the anterior faces 7212b, 7212c of the seals 114b, 114c shown in FIGS. 62B and 62C . The anterior faces 7212b, 7212c maintain a parabolic shape as they extend in a posterior direction, and in some configurations, can curve continuously in one direction without an inflection point. In contrast, as shown in FIG. 62A , the anterior wall 7212a of the seal 114a has an inflection point 7201. In some configurations, the proximal-most point of the posterior face 7202c is located within the distal half of the seal 114c or less than halfway from the distal-most point 7230c to the nearest point 7232a in the anterior-posterior direction of the seal 114c. In some configurations, the most proximal point of the posterior surface 7202c is located at about 30% to 50%, or about 40%, of the distance from the most distal point 7230c to the most proximal point 7232a.

[0296] 63A-63C are side views of the seal 114 of FIGS. 58A-58C positioned on a user's face during use. The seal 114 advantageously does not need to contact the bridge of the user's nose. In the configuration shown, the seal 114 does not extend over the bridge of the user's nose. More particularly, the illustrated seal 114 does not contact the bridge of the user's nose.

[0297] Continuing with reference to FIGS. 63A-63C, the seal 114 can be positioned along the base of the user's nose within the space between the user's nose and cheeks, thereby providing a low profile. In the embodiment of FIG. 63C, the side portions of seal 114c are pushed further into the space between the user's cheeks and nose than the side portions of the embodiments of seals 114a, 114b shown in FIGS. 63A and 63B. Additionally or alternatively, the lower portions of seals 114b and 114c are positioned closer to the user's face (e.g., upper lip) during use than the lower portion of seal 114a (the lower portion of seal 114c is closer than the lower portion of seal 114b). Such an arrangement can provide advantageous orientations or angles of the gas delivery tube or conduit and / or frame or headgear. The orientation of the gas inlet aperture 7175 can be characterized by an angle 7240, also referred to as the angle of use 7240. The use angle 7240 is the angle between the horizontal axis and a line perpendicular to a line extending between the uppermost point 7182 and the lowermost point 7184 of the gas inlet aperture 7175 when the nasal aperture 7128 is directed toward the user's nasal passages. In the embodiment of seal 114a in FIG. 63A , the use angle 7240a is 30.0°. In other arrangements, such as the embodiments in FIGS. 63B and 63C , the use angles 7240b, 7240c are greater than about 35° or greater than about 40°. In the embodiment of FIG. 63B , the use angle 7240b is about 43.7°. In the embodiment of FIG. 63C , the use angle 7240c is about 45.6°. Due to variations in nose shape among the human population, the use angle 7240 can vary significantly for a given seal. For example, the use angle 7240 can vary from about 0° to about 70°. However, to reduce the adverse effects of hose tension, it may be advantageous to have a relatively large use angle 7240. In some variations, use angle 7240 may range from about 70° to about 90°.

[0298] The seal 114 can have an effective taper ratio, defined as the ratio of the depth 7144 (FIGS. 60A-60C) of the seal 114, when viewed from the side, to the protruding area of ​​the lateral portions of the front wall 7212. In calculating the effective taper ratio, the front wall 7212 is considered to extend to a line extending between the uppermost point 7182 and the lowest point 7184 of the gas inlet aperture 7175. In the embodiment of FIG. 63A, the effective taper ratio has a value of about 0.37. In the embodiment of FIG. 63C, the effective taper ratio has a value of about 0.39. In some variations, the profile of the seal 114 is reduced by increasing the use angle 7240 and / or by increasing the effective taper ratio of the seal 114.

[0299] 64 , the seal 114 can have a variable wall thickness. The thickened wall portions can be designed to provide a support structure that helps the seal 114 maintain contact with the user's skin when the seal 114 is in use. In some variations, the thickened wall portions help the seal 114 resist deformation when the seal 114 is in use. The thickened wall portions can reduce the material used to make the seal 114, thereby reducing the profile of the seal 114. The thickened wall portions can extend within the hollow interior of the seal. For example, the thickened wall portions can extend proximally from the front wall 7212 and / or distally from the rear wall 7202.

[0300] The seal 114 can have regions of varying thickness. For example, each lateral side of the seal 114 can have a top region 7302, a back region 7304, a front region 7306, and a center region 7308. Only one side has the regions identified in FIG. 11 . The regions on the other sides can be mirror images of the illustrated sides. The back region 7304 can have a thickness greater than the thickness of all other regions. The top region 7302 and / or the center region 7308 can have a thickness less than the thickness of all other regions. In the illustrated embodiment, the top region 7302 and the center region 7308 have a thickness of approximately 0.3 mm, the front region 7306 has a thickness of approximately 2.6 mm, and the back region 7304 has a thickness of approximately 3.9 mm.

[0301] FIGS. 65A and 65B illustrate thickened wall portions or regions of the embodiment of seal 114c shown in FIG. 58C. The regions shown in FIGS. 65A and 65B can be the same or similar to the regions shown in FIG. 64. The thickened wall portions extend into the hollow interior of seal 114c. In FIG. 65A, the outline of seal 114c is shown for clarity. Top region 7302c and center region 7308c have a thickness of approximately 0.3 mm, and front region 7306c has a thickness of approximately 1.0 mm. Rear region 7304c has a variable thickness, with a maximum thickness of approximately 1.45 mm. In some variations, the thickness of top region 7302c and center region 7308c is between approximately 0.2 mm and approximately 0.4 mm. The thickness of front region 7306c is between approximately 0.7 mm and approximately 1.3 mm. The maximum thickness of rear region 7304c is between approximately 1.2 mm and approximately 1.7 mm.

[0302] As shown in FIGS. 65A and 65B, the posterior region 7304c is "U" shaped, with the bottom of the "U" located near the proximal-most point of the anterior wall 7212. The anterior region 7306 extends across the top of the "U"-shaped structure formed by the posterior region 7304c. The central region 7308c is surrounded by the anterior region 7302c and the posterior region 7304c. The apex region 7302c extends from the posterior region 7304c away from the central region 7308c.

[0303] The thickness of the thickened wall portions in seal 114c shown in Figure 58C is reduced compared to the thickness of seal 114a shown in Figure 58A. Reducing the thickness of the wall portions helps reduce the weight and / or obscurity of seal 114. The thickness of the thickened wall portions can be increased to increase stiffness and friction between seal 114 and frame 116. In some variations, the thickness of the thickened wall portions is increased to improve the vertical stability of seal 114.

[0304] FIGS. 66A-66C show sagittal cross-sectional views of seal 114. In particular, FIGS. 66A-66C show seal 114c, although some features may be found in other seal 114 configurations, such as seals 114a and 114b. For comparison, FIGS. 67A-67C show seals 114a, 114b, and 114c. The thickness of a bottom wall 7216 of seal 114 may vary. The bottom wall 7216 may have a distal thickness 7316 near the anterior wall 7212. The bottom wall 7216 may have a proximal wall 7318 near the posterior wall 7202. The bottom wall 7216 may have a central thickness 7320 disposed within a longitudinally central portion of the bottom wall 7216. In some configurations, two or more of the distal thickness 7316, the proximal thickness 7318, and the central thickness 7320 vary relative to one another.

[0305] Figures 67A-67C show sagittal cross sections of the seal embodiment shown in Figures 58A-58C. Seal 114a shown in Figure 67A has a distal thickness 7316a of about 1.5 mm and a central thickness 7320a of about 0.3 mm. Seal 114b shown in Figure 67B has a distal thickness 7316b of about 2.4 mm, a central thickness 7320b of about 0.5 mm, and a proximal thickness 7318b of about 2.9 mm. Seal 114c shown in Figure 67C has a distal thickness 7316c of about 1.35 mm, a central thickness 7320b of about 0.5 mm, and a proximal thickness 7318c of about 3.1 mm. As noted above, the seals 144b, 144c shown in Figures 67B and 67C have a clear distinction between the bottom wall 7216 and the rear wall 7202, forming a shelf 7218 in the form of a curved edge proximal to the bottom wall 7216. The seal 144a in Figure 67A has a curved bottom wall 7216a without a clear interface with the rear wall 7202a.

[0306] 67A-67C , the rear wall 7202 can have a thickened portion 7330 that surrounds the nasal aperture 7128. The thickened portion 7330 can extend distally from a distal-facing surface of the rear wall 7202 and can have a maximum thickness 7332. The thickened portion 7330 can be adapted to prevent the edges of the aperture 7128 from deforming (e.g., being “blown off”) when pressure is applied to the seal 114 during use. Deformation of the aperture 7128 can reduce the effectiveness of the seal 114 and increase discomfort to the user. The thickened portion 7330 can improve the effectiveness of the seal 114.

[0307] Seal 114a in Figure 67A has an oval, pad-like thickened portion 7330a. Thickened portion 7330a has a maximum thickness 7332a of approximately 1.5 mm. Thickened portion 7330a gradually tapers as it extends away from nasal aperture 7128. Seal 114b in Figure 67B has a thickened portion 7330b similar to thickened portion 7330a of seal 114a shown in Figure 67A.

[0308] Referring to FIG. 68 , seal 114b can include a thickened ridge 7340 extending distally approximately 1.0 mm from the distally-facing surface of rear wall 7202b. The ridge 7340 can be disposed between the interface of thickened portion 7330b and the top region 7302b of seal 114b. In some variations, the ridge 7340 reinforces seal 114b to prevent seal 114b from wrinkling when air pressure builds up within the hollow interior of seal 114b. In some embodiments, the thickened portion 7330 can contribute to some deformation of seal 114b as it expands. The ridge 7340 allows seal 114b to expand smoothly. In some embodiments, a seal 114 having a thickened portion 7330 can expand smoothly without a seal 114 having a ridge 7340. In some variations, a seal 114c having a thickened portion 7330c that closely conforms to the nasal aperture 7128 may expand smoothly without a seal 114c having a ridge 7340.

[0309] Figure 69 shows the thickened portion 7330b of the seal 114b in Figure 14B in more detail. The thickened portion 7330b extends a maximum distance 7334b of approximately 7.9 mm from the edge of the nasal aperture 7128. The thickened portion extends a maximum thickness 7332b of approximately 1.5 mm from the distal-facing surface of the posterior wall 7202.

[0310] FIG. 70 shows a detailed front view of thickened portion 7330c of seal 114c shown in FIG. 67C. Thickened portion 7330c conforms to the periphery of nasal aperture 7128 more closely than thickened portions 7330a, 7330b shown in FIGS. 67A and 67B. Thickened portion 7330c extends distally from posterior wall 7202c into the hollow interior of seal 114c. Thickened portion 7330c has a maximum width of approximately 3.3 mm.

[0311] In many embodiments, the surface portion of the seal 114 surrounding or defining the nasal aperture 7128 does not directly contact the user's nose. Instead, a volume of air separates the surface portion of the seal 114 surrounding or defining the nasal aperture 7128 from the portion of the user's nose within the nasal recess 7214 of the seal 114. The separation between the seal 114 and the user's nose allows the area of ​​the nasal aperture 7128 to be reduced without the user experiencing a restriction in flow through the aperture 7128. With reference to FIGS. 71A-71C, the area of ​​the nasal aperture 7128 can be evaluated by comparing the area of ​​the rearward protrusion of the nasal aperture 7128. The rearward protrusion of the nasal aperture 7128 can have a minimum height 7342, a maximum height 7344, and an overall width 7346. Seal 144a in FIG. 71A has a minimum height 7342a of about 4.0 mm, a maximum height 7344a of about 12.0 mm, and an overall width 7346a of about 18.8 mm. Seal 144b in FIG. 72B has a minimum height 7342b of about 4.0 mm, a maximum height 7344b of about 11.0 mm, and an overall width 7346b of about 17.1 mm. Seal 144c in FIG. 71C has a minimum height 7342c of about 4.5 mm, a maximum height 7344c of about 11.0 mm, and an overall width 7346c of about 16.9 mm. Each of these above-mentioned minimum heights 7342, maximum heights 7344, and overall widths 7346 can be increased or decreased by at least 20% in some variations.

[0312] Another way to compare the reduction in size of nasal aperture 7128 for seal 114 shown in Figures 71A-71C is by comparing the change in surface area of ​​aperture 7128a shown in Figure 71A with the change in surface area of ​​aperture 7128c shown in Figure 71C. The surface area of ​​aperture 7128 can be measured along the curved surface of nasal recess 7214 to obtain a more accurate measurement than that obtained from the two-dimensional posterior projection data described above. For seal 114a in Figure 71A, the surface area of ​​aperture 7128a along the curved surface of nasal recess 7214a is approximately 161 mm 2In seal 114c in FIG. 71C, the surface area of ​​aperture 7128c along the curved surface of nasal recess 7214c is approximately 141 mm 2 In some configurations, the surface area of ​​the aperture 7128 is approximately 160 mm 2 Below, approximately 150mm 2 Less than or about 141mm 2 or less, or 140mm 2 is.

[0313] 72 and 73 , the seal 114 can include a connector 7222 (also referred to as a seal clip) that couples to the seal 114. In some embodiments, the connector 7222 can be a part of the frame 116. For example, the connector 7222 can be a part of the frame 116 that is permanently integrated into the seal 114 (e.g., the seal 114 is overmolded over the connector 7222 portion of the frame 116). In some embodiments, the connector 7222 includes a clip portion that allows connection to another frame 116 or to the yoke 127 or headgear 118. The connector 7222 can be configured to provide lateral support to the seal 114. The connector 7222 can have a front flange 7224, a rear flange 7226, and a hub portion 7228 disposed between the front flange 7224 and the rear flange 7226. The connector 7222 can be configured to capture a portion of the seal 114 between the front flange 7224 and the rear flange 7226. In some embodiments, the connector 7222 is overmolded onto the seal 114. In some embodiments, the seal 114 is overmolded onto the connector 7222. In some configurations, the front flange 7224 can be connected to the rear flange 7226 by a snap fit mechanism, which can be a permanent connection or a removable connection.

[0314] When the connector 7222 is assembled to the seal 114, the rear flange 7226 is disposed inside the seal 114 and the hub portion 7228 extends through the gas inlet aperture 7175 of the seal 114. The front flange 7224 of the connector 7222 is disposed outside the seal. The seal 114 can include an annular rim that surrounds the gas inlet aperture 7175 and is configured to be captured by the front flange 7224 and rear flange 7226 of the connector 7222.

[0315] The connector 7222 can have a central opening 7250 that aligns with the gas inlet opening 7175 of the seal 114 when attached to the seal 114. The central opening 7250 can be configured to couple to the frame 116, the gas delivery conduit 120, the elbow connector 122, or other suitable means for connecting the connector 7222 to a CPAP system.

[0316] The connector 7222 can have side arms 7252 extending proximally and laterally from the central opening 7250. The side arms 7252 can be configured to be more resistant to lateral deformation than the seal 114. The side arms 7252 can provide lateral support for the seal 114. The connector 7222 can ensure that the seal 114 maintains its shape under pressure, allowing the seal 114 to effectively encircle the patient's nose. In some variations, the front wall 7212 of the seal 114 can include a recess that receives the side arms 7252 of the connector 7222. By positioning the side arms 7252 so that they rest within the recess in the front wall 7212 of the seal 114, the profile of the seal 114 can be reduced. In some embodiments, the side arms 7252 can be overmolded, chemically bonded, or otherwise attached to the seal 114. The side arms 7252 prevent the seal 114 from overexpanding and losing its seal with the patient's nose. The side arms 7252 may prevent the seal 114 from deforming too much due to expansion from pressure from gas flowing through the patient interface 112 .

[0317] FIG. 74 illustrates another embodiment of seal 114d, similar to seals 114, 144a, 114b, and 114c, except as otherwise noted below. Features of seal 114d may be combined with or included in seal 114 or any other embodiment discussed herein. The illustrated embodiment includes a connector 7222d attached to seal 114d. Connector 7222d is similar to connector 7222, except as otherwise noted below. As noted above, connector 7222d includes side arms 7252d that extend proximally and laterally from central opening 7250d to provide lateral support to seal 114d. Connector 7222d includes a rear flange 7226d disposed within seal 114d. In the illustrated embodiment, rear flange 7226d is blue and is visible through translucent seal 114. The color of the rear flange 7226d can help guide a user to more appropriately connect the seal 114 to another component of the interface (e.g., the gas delivery conduit 120). For example, the color of the rear flange 7226d can match the color of a portion of the gas delivery conduit 120, making it intuitive for a user to connect the gas delivery conduit 120 to the connector 7222d. In some embodiments, the coloring is intended to be used as an indication of the components in the seal 114. For example, the front flange 7224d can be completely transparent, and the rear flange 7226d can be colored a transparent blue.

[0318] 75 shows another embodiment of a connector 7222e attached to a seal 114e. The seal 114e is similar to the seal 114 or any other embodiment discussed herein, except as otherwise noted below. The connector 7222e is similar to the connector 7222 or any other embodiment discussed herein, except as otherwise noted below. Features of the seal 114e and the connector 7222e can be combined or included with the seal 114 or the connector 7222, or any other embodiment discussed herein. In the illustrated embodiment, the front wall 7254e of the connector 7222e is substantially flush with the front wall 7212e of the seal 114e. In some embodiments, at least a portion of the front wall 7254e of the connector 7222e can protrude laterally and / or distally beyond the front wall 7212e of the seal 114e. In some embodiments, at least a portion of the front wall 7212e of the seal 114e can protrude laterally and / or distally beyond the front wall 7254e of the connector 7222e.

[0319] As described above, the seals 114 can be made in different sizes to allow at least some of the seals 114 to fit a wider variety of nasal structures. For example, the seals 114 can be made in four different sizes: small, medium, large, and wide. The four sizes of the seals 114 can be configured so that one or more of the available seals 114 may be suitable for a wide variety of users. In some configurations, the four seal sizes can allow the seals 114 to be viable for a substantial portion or the largest portion of the human population. The seals 114 can be made in five or more different sizes (e.g., extra large, medium wide, extra small).

[0320] FIGS. 76A-76E show various views of the medium-sized seal 114e shown in FIG. 75. FIG. 76A is a front view of the seal 114e, similar to the views shown in FIGS. 59A-59C for the seals 114a-114c. FIG. 76B is a left side view of the seal 114e, similar to the views shown in FIGS. 60A-60C for the seals 114a-114c. FIG. 76C is a rear view of the seal 114e, similar to the views shown in FIGS. 61A-61C for the seals 114a-114c. FIG. 76D is a top view of the seal 114e, similar to the views shown in FIGS. 62A-62C for the seals 114a-114c. FIG. 76E is a bottom view of the seal 114e.

[0321] As shown in FIG. 76A , the seal 114e can be symmetrical about a vertical axis 7256. The vertical axis 7256 passes through the midline of the seal 114e and is aligned with a sagittal plane extending from the front of the seal to the back of the seal 114e. As described above, the front wall 7212e of the seal 114e can have a recessed portion 7258e. The recessed portion 7258e can be configured to receive a portion of the connector 7222e. For example, the recessed portion 7258e can receive the front flange 7224 of the connector 7222. Referring to FIGS. 76A and 76B , the seal 114e can have an overall height 7140e, an overall width 7142e, and an overall width 7144e similar to those described for the seals 114a-114c shown in FIGS. 59A-7C above. Table 1 below shows example approximate dimensions of overall height 7140, overall width 7142, and overall depth 7144 for different sizes of seal 114 (e.g., small, medium, large, wide). In some embodiments, one or more of the dimensions of seal 114 can vary by ±10% of the dimensions listed in Table 1. The present disclosure includes ratios that can be derived from the dimensions disclosed herein. For example, the present disclosure includes not only the disclosed overall widths of the small and large seals, but also the ratio of the width of the small seal to the width of the large seal and any other ratios that can be derived from the dimensions disclosed herein.

[0322] [Table 1]

[0323] In some embodiments, the small and medium seals 114 are designed to fit approximately the same nose width (also referred to herein as transverse width) and are adapted to be empirically sized according to the subnasal to pronasal dimension. For example, the small seal 114 has a wider width than the medium seal 114 because users of the small seal 114 tend to have noses similar to or wider than users of the medium seal 114. However, in the embodiment presented in Table 1, the difference in overall width 7142 between the small seal 114 and the medium seal 114 is minimal (0.4 mm).

[0324] FIG. 77 shows a perspective view of the medium size seal 114e shown in FIG. 76A . FIG. 78 shows a perspective view of an embodiment of the wide size seal 114f. As shown in FIGS. 77 and 78 , the recessed portion 7258e of the medium size seal 114e may have a shallower angle compared to the recessed portion 7258f of the wide size seal. For example, in the illustrated embodiment, the recessed portion 7258e of the medium size seal 114e and the recessed portion 7258f of the wide size seal 114f can be said to have height dimensions measured parallel to the vertical axis 7256. Compared to the height dimension of the medium size seal 114e, the height dimension of the wide size seal 114f decreases more gradually toward the side 7260e of the recessed portion 7258e and the side 7260f of the recessed portion 7258f.

[0325] 79A and 79B are left side views of the medium seal 114e shown in FIG. 77. Referring to FIG. 79A, as described above with respect to FIGS. 60A-60C, when the bottom wall 7216e is aligned approximately horizontally, a gas inlet angle 7186e can be formed by the vertical axis 7256 and a line passing through the topmost point 7182e and the bottommost point 7184e of the gas inlet aperture 7175e. Because the bottom wall 7216e is curved, the entire bottom wall 7216e is not aligned horizontally, and neither is the entire forward portion of the bottom wall 7216e aligned horizontally. In the illustrated embodiment, the gas inlet angle 7186e is 14.0°. In some embodiments, the gas inlet angle 7186e can be an angle other than 14.0°. A front wall distal displacement 7261e can be defined as the distance from the vertical axis 7256 to the distal-most point of the seal 114e (which corresponds to the uppermost point 7182e in the illustrated arrangement). In the illustrated embodiment, the front wall distal displacement 7261e is 7.9 mm. In some embodiments, the front wall distal displacement 7261e can be a value other than 7.9 mm. Angling the gas inlet aperture 7175 downward helps to resist strong pulling on the hose when the seal 114 is in use. For example, angling the gas inlet aperture 7175 downward can reduce strong pulling from the gas delivery conduit 120 connected to the seal 114.

[0326] FIG. 79B shows another way of characterizing the size or shape of seal 114 relative to gas inlet aperture 7175. In FIG. 79B, seal 114e has been rotated along vertical axis 7256 to align top-most point 7182e and bottom-most point 7184e of gas inlet aperture 7175e. Vertical distance 7262e (or another way of characterizing the depth of seal 114e) can be defined as the distance of proximal-most point 7232e of seal 114e from vertical axis 7256. In the illustrated embodiment, vertical distance 7262e is 35.2 mm. In some embodiments, vertical distance 7262e can be a value other than 35.2 mm.

[0327] Table 2 shows a comparison of approximate vertical distances 7262 for seals 114 of different sizes (e.g., small, medium, large, wide). In some embodiments, one or more of the dimensions of the seal 114 can vary by ±10% of the dimensions listed in Table 2. As noted above, the present disclosure includes ratios that can be derived from the dimensions disclosed herein. Similar to Table 1 above, a medium size seal 114 can have a slightly smaller vertical distance 7262 compared to that of a small size seal 114 depending on the anthropometric data set applied.

[0328] [Table 2]

[0329] FIG. 80 shows a side view of seal 114e positioned on a user's face during use. As discussed above with respect to FIGS. 63A-63C, the orientation of gas inlet aperture 7175e can be characterized by a use angle 7240e. Use angle 7240e can characterize the angle at which seal 114 lies over the user's nose with respect to a cross-section of the user's head. In the illustrated embodiment, use angle 7240e is approximately 45°. In other embodiments, gas inlet aperture 7175e can be oriented differently. In some variations, the orientation of gas inlet aperture 7175e can depend on the size and physical characteristics of the user's nose.

[0330] FIG. 81 shows a front view of the seal 114e shown in FIG. 76A. The orientation of the front view shown in FIG. 81 differs from the front view of the seal 114e shown in FIG. 76A because the view shown in FIG. 81 is aligned in a plane perpendicular to the axial direction of the gas inlet aperture 7175e. As will be discussed in more detail, the seal 114e can include a connector engaging structure or connector retention structure 7262e surrounding the gas inlet aperture 7175e. Other embodiments of the seal 114 disclosed herein can also include a connector retention structure 7262 similar to the connector retention structure 7262e described below. The connector retention structure 7262e defines the gas inlet aperture 7175e and provides a structure that allows the connector 7222 (shown in FIG. 72) to be connected to the body of the seal 114.

[0331] The gas inlet aperture 7175e can include a truncated portion 7177e as described with respect to Figures 59B and 59C. The truncated portion 7177e can provide an intuitive indication of the orientation of the connector 7222 of the seal 114. In the illustrated embodiment, the truncated portion 7177e is located at the bottom edge of the connector retention structure 7262e. In some embodiments, the truncated portion 7177e can be located at the top edge of the connector retention structure 7262e, at either or both of the side edges of the connector retention structure 7262e, or any combination thereof.

[0332] The truncated portion 7177e of the connector retention structure 7262e allows the gas inlet aperture 7175e to have a vertical dimension 7264e that is different from the lateral dimension 7266e of the gas inlet aperture 7175e. For example, in FIG. 81 , the truncated portion 7177e is located at the bottom edge of the connector retention structure 7262e, causing the vertical dimension 7264e of the gas inlet aperture 7175e to be smaller than the lateral dimension 7266e of the gas inlet aperture 7175e. In the illustrated embodiment, the gas inlet aperture 7175e has a vertical dimension 7264e that is 26.5 mm and a lateral dimension 7266e that is 31.17 mm. However, these dimensions are merely exemplary and are not intended to be limiting. In some embodiments, the vertical dimension 7264e has a value other than 26.5 mm and the lateral dimension 7266e has a value other than 31.17 mm.

[0333] The seal 114e can have regions of different thicknesses, as described above with respect to FIG. 64 . FIG. 82A shows an isometric view of the seal 114e. FIG. 82B shows that the seal 114e can have an apex region 7268e, a core region 7270e, and an intermediate region 7272e disposed between the apex region 7268e and the core region 7270e. The apex region 7268e of the seal 114e can have a thickness of approximately 0.3 mm. In the illustrated embodiment, the thickness of the apex region 7268e is reduced compared to that of other embodiments of the seal 114 (e.g., the seal 114 of FIG. 64 ). In the illustrated embodiment, the reduced thickness of the apex region 7268e increases the extent to which the seal 114e can bend and compress during use. The reduced thickness of the apex region 7268e can reduce the force exerted by the seal 114 on the user's face when the seal 114 is in use.

[0334] 82B , the thickness of intermediate region 7272e can be non-uniform. In some embodiments, the thickness of intermediate region 7272e can increase non-linearly as seal 114e traverses seal 114e along intermediate region 7272e from a first point 7276e near the top of seal 114e to a second point 7278e near the bottom of seal 114e. In the illustrated embodiment, the thickness of intermediate region 7272e is approximately 0.3 mm at first point 7276e and approximately 3.4 mm at second point 7278e. In some embodiments, the thickness of intermediate region 7272e can simply vary from approximately 0.3 mm to approximately 3.8 mm at various locations along the contour of intermediate region 7272e (e.g., increasing and decreasing multiple times along the path between first point 7276e and second point 7278e). In the illustrated embodiment, core region 7270e corresponds to recessed portion 7258e of front wall 7212e and has a wall thickness of approximately 1.00 mm. The thicknesses noted above are seal thicknesses measured in a direction perpendicular to the surface of seal 114e. In some embodiments, one or more of the thicknesses noted above may vary ±10% of these indicated values.

[0335] FIG. 83 shows a left side view of a cross section of a lateral portion of seal 114e. In FIG. 83, the front portion of seal 114e is shown in light shading to indicate the location of the selected cross section relative to the remainder of seal 114e. FIG. 83 shows the inner surface 7274e of the front wall 7212e of seal 114e. The inner surface 7274e faces the hollow interior space of seal 7114e. The different thicknesses of the apex region 7268e, core region 7270e, and intermediate region 7272e are visible in the cross section of the front wall 7212e. The illustrated thickness profile of the front wall 7212e of seal 114e allows seal 114e to function better in use, as described below. The thinner areas of seal 114e allow seal 114e to deform where needed to better fit the user's nose. The thickened areas of the seal 114e provide and transmit a stiffening force that prevents the seal 114e from being blown away when the seal 114e is under pressure in use.

[0336] Figure 84 shows a left side view in sagittal section of seal 114e, as described above with respect to Figures 66A-67C. Seal 114e can include a thickened portion 7330e surrounding nasal aperture 7128e, as described above with respect to Figures 69 and 70.

[0337] 85 shows a front view of the inner surface of the rear wall of seal 114e. In the illustrated embodiment, thickened portion 7330e can closely approximate the contours of nasal aperture 7128e at the lateral edges of nasal aperture 7128e and extend further away from nasal aperture 7128e at a central portion of nasal aperture 7128e. As discussed above, thickened portion 7330e can help prevent seal 114e from blowing off when pressure is applied to seal 114e during use.

[0338] 84, the maximum thickness of the increased portion 7330e in the illustrated embodiment is 1.8 mm and is located adjacent the nasal aperture 7128e at the central axis of the seal 114e. In some embodiments, the maximum thickness of the increased portion 7330e is greater than 1.8 mm. In some embodiments, the maximum thickness of the increased portion 7330e is less than 1.8 mm. The ratio of the maximum thickness of the increased portion 7330e to the adjacent portion of the posterior wall 7202e can be 1.8:0.3 or 6:1.

[0339] With continued reference to FIG. 84 , the bottom wall 7216e of the seal 114e has a forward portion 7280e, a rear portion 7282e, and a central portion 7284e interposed between the forward portion 7280e and the rear portion 7282e. The forward portion 7280e is characterized by a region of relatively greater thickness adjacent the connector retention structure 7262e. As described below, at least a portion of the central portion 7284e may be characterized by a region of relatively less thickness. The region of the central portion 7284e characterized by a region of relatively less thickness is referred to herein as the sub-nose window 7285e (shown in FIG. 87 ). The rear portion 7282e is again characterized by a region of relatively greater thickness relative to the central portion 7284e. In the illustrated embodiment, the rear portion 7282e forms a clear distinction between the bottom wall 7216e and the rear wall 7202e. In the illustrated embodiment, the thickness of the anterior portion 7280e is 2.7 mm, the thickness of the central portion 7284e is 0.3 mm, and the thickness of the posterior portion 7282e is 2.7 mm, the thicknesses being measured along a direction perpendicular to the outer surface of the bottom wall 7216e. In some embodiments, one or more of the above-mentioned thicknesses may vary ±10% of these indicated values.

[0340] The under-nose window 7285e (shown in FIG. 87) of the central portion 7284e can be described as a concave surface on the inner surface of the bottom wall 7216e. In some embodiments, the central portion 7284e can include a band of reduced thickness along a portion of the surface of the bottom wall 7216e that faces the hollow interior of the seal 114e. In the illustrated embodiment, the central portion 7284e is recessed approximately 2.4 mm relative to the anterior and posterior portions 7280e and 7282e at the central axis of the seal 114e. In some embodiments, the entire central portion 7284e can be recessed a consistent distance relative to the anterior and posterior portions 7280e and 7282e.

[0341] Reducing the thickness of the central portion 7284e can improve the comfort of the seal 114e during extended use. A problem that can be encountered with nasal seal designs or by users is discomfort under the nose after extended periods of use. Reducing the thickness of the central portion 7284e of the bottom wall 7216e has been found to improve the comfort of the seal 114e. As described above, reducing the thickness of the central portion 7284e creates an under-nose window 7285e between the thickened anterior portion 7280e and posterior portion 7282e of the bottom wall 7216e. The under-nose window 7285e allows for increased deformation of the bottom wall 7216e of the seal 114e during use without compromising the effectiveness of the seal 114e. Increasing the thickness of the anterior portion 7280e and posterior portion 7282e of the bottom wall 7216e improves the structural integrity of the seal 114e, enabling it to form a nearly airtight seal with the user's face. A rear portion 7282e of the bottom wall 7216e helps to form this airtight seal against the user's lips and / or under-the-nose area.

[0342] In some variations, the degree to which the central portion 7284e is concave can vary. For example, the central portion 7284e can be concave by a maximum amount at the central axis (shown in cross section in FIG. 84 ) and by a minimum amount at the lateral ends of the central portion 7284e. In some embodiments, the central portion 7284e can include a combination of adjacent regions of increasing or decreasing thickness, thereby resulting in multiple regions of differing degrees of concavity relative to the anterior portion 7280e and posterior portion 7283e. The boundary between these adjacent regions can resemble a step function (e.g., an abrupt change in thickness). The boundary between adjacent regions can be a smooth curve that continuously transitions from one level of concavity to another. In some embodiments, the central portion 7284e can have an undulating thickness as it extends laterally away from the central axis. In another example, the central portion 7284e can include multiple raised ridges that extend parallel to each other laterally away from the central axis.

[0343] FIG. 86 shows a bottom view of an embodiment of seal 114g that is similar to seal 114 or any other embodiment discussed herein, except as otherwise noted below. The subnasal window 7285g of seal 114g can have a proximal dimension 7286g extending along the medial plane of seal 114g from the distal-most point of the subnasal window 7285g to the proximal-most point of the subnasal window 7285g, as shown in FIG. 86. The subnasal window 7285g can have a lateral dimension 7288g extending from the right-most point of the subnasal window 7285g to the left-most point of the subnasal window 7285g, as shown in FIG. 86. In the illustrated embodiment, seal 114g has a subnasal window 7285g with a proximal dimension 7286g of approximately 15.72 mm and a lateral dimension 7288g of approximately 32.45 mm. The overall depth 7144g of the seal 114e is 41.2 mm, resulting in a ratio of 1:2.6 between the proximal dimension 7286g and the overall depth 7144g in the illustrated embodiment. The proximal dimension 7286g constitutes approximately 38% of the overall depth 7144g of the seal 114g. The overall width 7142g of the seal 114g is 58.6 mm, resulting in a ratio of 1:1.8 between the lateral dimension 7288g and the overall width 7142g in the illustrated embodiment. The lateral dimension 7288g constitutes approximately 55% of the overall width 7142g of the seal 114g. These dimensions are exemplary and not intended to be limiting. In some embodiments, the dimensions and ratios may vary depending on the size of the seal 114.

[0344] FIG. 87 illustrates a top view of the cross section of the seal 114e shown in FIG. 76A. The top view is along a plane perpendicular to the sagittal plane. Thus, in FIG. 87, the surface of the bottom wall 7216e facing the hollow interior of the seal 114e is visible. As shown, the sub-nose window 7285e can have a first width 7290e that is a measurement of the length of the sub-nose window 7285e intersecting a proximal axis 7292 that extends along the midline of the seal 114e from the anterior wall 7212e to the posterior wall 7202e of the seal 114e. As shown in FIG. 87, a reference line 7296e can be defined that is perpendicular to the proximal axis 7292 and passes through the aft-most point of the sub-nose window 7285e located on the proximal axis 7292. 87 , the subnasal window 7285e can have a second width 7294e that is a measurement of the width of the subnasal window 7285e at the lateral-most point of the subnasal window 7285e located at the reference line 7296e, with the second width 7294e aligned as close as possible across the subnasal window 7285e. In the illustrated embodiment, the first width 7290e is approximately 5.9 mm and the second width 7294e is approximately 7.1 mm, resulting in a ratio of the first width 7290e to the second width 7294e of 1.0:1.2. These dimensions correspond to a medium-sized seal 114 and are intended to be exemplary and non-limiting. In some embodiments, the dimensions and ratios can vary depending on the size of the seal 114 (e.g., small, medium, large, wide).

[0345] In some embodiments, the second width 7294e can be the maximum width of the subnasal window 7285e. As described above, the second width 7294e can be measured at a point on the subnasal window 7285e that is displaced laterally from the proximal axis 7292. In some embodiments, the subnasal window 7285e can maintain approximately the same width as it extends laterally away from the proximal axis 7292.

[0346] FIG. 88 shows a bottom view of an embodiment of a seal 114h that is similar to the seal 114 or any other embodiment discussed herein, except as otherwise noted below. The illustrated embodiment is a wide-size seal 114h. In the seal 114h shown in FIG. 88, the sub-nose window 7285h spans the bottom wall 7216h of the seal 114h. Having the sub-nose window 7285h extend across the entire length of the bottom wall 7216h can be beneficial, compared to a sub-nose window 7285 that only partially spans the length of the bottom wall 7216h (e.g., the sub-nose window 7285e shown in FIG. 87), because the longer lateral profile of the sub-nose window 7285h allows a longer length of the seal 114h to be compressed when in use. This can therefore help further reduce potential sub-nose discomfort.

[0347] FIG. 89 shows a cross-sectional top view of an embodiment of wide size seal 114i. The top view is along a plane perpendicular to the sagittal plane. Thus, in FIG. 89, the surface of bottom wall 7216i facing the hollow interior of seal 114i is visible. The first width 7290i of seal 114i shown in FIG. 89 is larger than the first width 7290e of seal 114e shown in FIG. 87. In the illustrated embodiment, first width 7290i may be approximately 6.9 mm. As shown in FIG. 89, under-nose window 7285i spans the length of bottom wall 7216i. Except as otherwise noted below, seal 114i is similar to seal 114e or any other embodiment discussed herein. Features of seal 114i can be combined with or included in seal 114e or any other embodiment discussed herein. Thus, the sub-nasal window 7285i can have similar absolute dimensions and / or ratios and / or configurations as those described for the sub-nasal window 7285e or any other embodiment discussed herein.

[0348] Figure 90 shows a rear perspective view of an embodiment of the medium-sized seal 114j. The sub-nose window 7285j shown in Figure 90 is similar to the sub-nose window 7285h shown in Figure 89 in that the sub-nose window 7285j spans the length of the bottom wall 7216j. A recessed portion 7285j of the central portion 7284j (also referred to herein as the sub-nose window 7285j) is shown extending laterally along the bottom wall 7216j and into the region between the front wall 7212j and the rear wall 7202j of the seal 114j. Thus, the sub-nose window 7285j can be said to extend laterally beyond what can strictly be referred to as the bottom wall 7216j of the seal 114j.

[0349] FIG. 91 shows a cross-sectional top view of an embodiment of seal 114k. The top view is taken along a plane substantially perpendicular to the sagittal plane. Thus, FIG. 91 shows the surface of bottom wall 7216k facing the hollow interior of seal 114k. In the illustrated embodiment, central portion 7284k includes three sub-nose windows 7285k characterized by reduced wall thickness in the bottom wall 7216k of seal 114k. In the illustrated embodiment, the three sub-nose windows 7285k are separated by two struts 7287k characterized by regions of increased thickness. The separated sub-nose windows 7285k can improve the behavior of seal 114k when it is compressed. The reduced-thickness sub-nose windows 7285k can compress when seal 114k is worn, thereby reducing pressure on the user's upper lip. The thickened portion, strut 7287k, can improve the seal 114k's ability to retain its shape as it deforms around the user's nose in the distal-to-proximal direction. In the illustrated embodiment, the strut 7287k has the same wall thickness as the adjacent anterior portion 7280k and posterior portion 7282k. In some embodiments, the strut 7287k can have a wall thickness that is different from the wall thickness of the adjacent anterior portion 7280k and posterior portion 7282k. For example, the strut 7287k can have a wall thickness that is greater or less than the wall thickness of the adjacent anterior portion 7280k and posterior portion 7282k. In some embodiments, the wall thickness of the subnasal window 7285k can vary across the subnasal window 7285k. For example, the wall thickness of the subnasal window 7285k can gradually increase over the length of the subnasal window 7285k, such that the region of the subnasal window 7285k adjacent to the strut 7287k has the same wall thickness as the strut 7287k. Thus, the transition in wall thickness between the sub-nose windows 7285k and the struts 7287k may be gradual over the length of the bottom wall 7216k, rather than stepped as shown in the embodiment of Figure 91. The illustrated embodiment has three sub-nose windows 7285k. However, some embodiments may have four or more sub-nose windows 7285k.Additionally, the struts 7287k in the illustrated embodiment are of approximately constant width (e.g., the dimension of the struts 7287k adjacent the front wall 7212k of the seal 114k is approximately the same as the dimension of the struts 7287k adjacent the rear wall 7202k of the seal 114k). In some embodiments, the width of the struts 7287k may remain approximately constant. For example, the dimension of the struts 7287k adjacent the front wall 7212k of the seal 114k may be smaller than the dimension of the struts 7287k adjacent the rear wall 7202k of the seal 114k (e.g., the width of the struts 7287k increases as you transition from the front wall 7212k to the rear wall 7202k of the seal 114k along the bottom wall 7216k of the seal 114k). In some embodiments, the opposite may be true (eg, the width of the strut 7287k decreases when transitioning from the front wall 7212k to the rear wall 7202k of the seal 114k along the bottom wall 7216k of the seal 114k).

[0350] 55 , the seal 114 can be attached to a connector 7222 that helps provide structure to the seal 114 when pressure is applied to the seal 114 during use. Additionally, the connector 7222 can provide a means for connecting the seal 114 to the frame 116 of the mask 112. As shown in FIG. 72 , the connector 7222 can include a front flange 7224 and a rear flange 7226. The front flange 7224 and the rear flange 7226 can include cooperating structures that hold the connector retention structure 7262 of the seal 114 therebetween.

[0351] 92A-92G show different views of the embodiment of front flange 7224e shown in FIG. 75. Front flange 7224e is similar to front flange 7224 except as noted below. Features of front flange 7224e can be combined with or included in front flange 7224 or any other embodiment discussed herein. FIG. 92A shows a front perspective view of front flange 7224e. FIG. 92B shows a rear perspective view of front flange 7224e shown in FIG. 92A.

[0352] As shown in FIG. 92A , the front flange 7224e can include a front surface 7350e, a rear surface 7352e, a central opening 7250e, and side arms 7252e extending proximally and laterally away from the central opening 7250e. In the illustrated embodiment, the front flange 7224e is symmetrical about a sagittal plane of the front flange 7224e. As shown in FIG. 98B , the front flange 7224e can include a first clip retaining protrusion 7354e and a second clip retaining protrusion 7356e. In the illustrated embodiment, the first clip retaining protrusion 7354e and the second clip retaining protrusion 7356e have semicircular shapes and are located on the rear surface 7352e adjacent to the central opening 7250e of the front flange 7224e. The first clip retaining protrusion 7354e is vertically spaced from the second clip retaining protrusion 7356a. The rear surfaces 7352e of the side arms 7252e are configured to cooperate with the recessed portions 7258e of the seal 114e. As shown, each of the side arms 7252e is slightly twisted as it extends proximally, away from the central opening 7250e. The twist of the side arms 7252e is configured to match the contour of the recessed portions 7258e of the seal 114e. As described above, the side arms 7252e of the front flange 7224e act to provide rigidity and a form of structural integrity to the seal 114e.

[0353] Figure 92C is a front view of the front flange 7224e. Figure 92D is a left side view of the front flange 7224e. Figure 92E is a rear view of the front flange 7224e. As shown in Figure 92E, the front flange 7224e can include a rim 360e surrounding a central opening 7250e in the front flange 7224e. Figure 92F is a top view of the front flange 7224e. Figure 92G is a bottom view of the front flange 7224e.

[0354] 93A-93G show different views of an embodiment of rear flange 7226e. Rear flange 7226e is similar to rear flange 7226 except as otherwise noted below. Features of rear flange 7226e can be combined with or included in rear flange 7226 or any other embodiment discussed herein. FIG. 93A shows a front perspective view of rear flange 7226e. FIG. 93B shows a rear perspective view of rear flange 7226e shown in FIG. 93A.

[0355] 93A and 93B, the rear flange 7226e can include a collar 7362e, a first clip retaining recess 7364e, a second clip retaining recess 7336e, a plurality of positioning features 7368e, a plurality of frame retaining members 7370e, and a rim 7372e for securing the seal 114e. In the illustrated embodiment, the positioning features 7368e are similarly sized. However, this need not be the case. In some embodiments, the positioning features 7368e are different shapes from one another. In some embodiments, certain features 7368e can be different shapes from one another to reduce material used in manufacturing. The first clip retaining recess 7364e and the second clip retaining recess 7336e are adapted to cooperate with the first clip retaining protrusion 7354e and the second clip retaining protrusion 7356e, respectively, to enable the front flange 7224e and the rear flange 7226e to be aligned and secured together with a precise spacing between the front flange 7224e and the rear flange 7226e. The front flange 7224e and the rear flange 7226e can then be welded to one another. In some embodiments, the first clip retaining protrusion 7354e is a different size than the second clip retaining protrusion 7356e to prevent inverted or upside-down positioning of the rear flange 7226e relative to the front flange 7224e.

[0356] The orientation of one or more of the clip retaining projections and recesses can be reversed so that one or more of the projections are disposed on the rear flange 7226e and one or more of the recesses are disposed on the front flange 7224e. In some embodiments, the rear flange 7226e can include a retaining projection instead of a retaining recess, and the front flange 7224e can include a cooperating retaining recess. In some variations, there can be fewer than two corresponding recesses and projections to secure the front flanges 7224e and 7226e.

[0357] The frame retaining member 7370e can secure the frame 116 (shown in FIG. 55 ) to the connector 7222e and seal 114e via a push-fit or interference fit system. The front flange 7224e and the rear flange 7226e can close together, thereby securing the connector retaining structure 7262e of the seal 114e within the connector 7222e, as described below. In at least one embodiment, the rear flange 7226e can include only one frame retaining member 7370e. In some embodiments, the rear flange 7226e can include three or more frame retaining members 7370e.

[0358] The positioning features 7368e aid in the manufacture of the finished seal 114e and frame 116. The positioning features 7368e fit into corresponding recesses adjacent the outer periphery of the gas inlet aperture 7175e of the seal 114e. The presence of these cooperating features facilitates alignment of the aft flange 7226e and the seal 114e relative to one another. In at least one embodiment, the aft flange 7226e can include two or fewer positioning features 7368e. In some embodiments, the aft flange 7226e can include four or more positioning features 7368e.

[0359] In at least one embodiment, after the rear flange 7226e, seal 114e, and front flange 7224e are secured together, the rear flange 7226e can be glued to the front flange 7224e, thereby making the connector 7222e and seal 114e configuration substantially difficult to disassemble. The rear flange 7226e and the front flange 7224e can be joined together by any suitable means (e.g., RF welding, adhesive bonding, etc.).

[0360] Figure 93C is a front view of the rear flange 7226e. Figure 93D is a left side view of the rear flange 7226e. Figure 93E is a rear view of the rear flange 7226e. Figure 93F ...

Claims

1. 1. A nose seal comprising a gas inlet opening, a bottom wall, a front wall, and a rear wall, the front wall includes a rim circumferentially surrounding the gas inlet opening, the front wall extending proximally from the rim relative to a user to join the rear wall; the rear wall comprises a central portion, a first lateral portion, and a second lateral portion, the central portion extending distally of the first lateral portion and the second lateral portion with respect to the user to form a recess for receiving the tip of the user's nose; the bottom wall extends distally to the front wall and proximally to the rear wall, the front wall and the rear wall being adjacent to the bottom wall; the nose seal also includes a sub-nasal window extending laterally along and beyond the bottom wall to an area between the anterior and posterior walls of the nose seal, the sub-nasal window being divided by a strut at the bottom wall; A nose seal wherein the sub-nasal window is defined by an area of ​​reduced thickness in the bottom wall, and the struts are areas of increased thickness in the bottom wall between the sub-nasal windows.

2. The nasal seal of claim 1 , wherein the struts have a wall thickness that is different from the wall thicknesses of the adjacent anterior and posterior walls.

3. 3. A nasal seal according to claim 1 or 2, wherein the struts are of approximately constant width.

4. A nose seal according to any one of claims 1 to 3, wherein the nose seal comprises three sub-nasal windows separated by two struts.

5. A nasal seal according to any preceding claim, further comprising a connector secured to the rim of the front wall.

6. 4. The nose seal of claim 1, further comprising a connector configured to allow the nose seal to be coupled to a frame, the connector comprising a first portion within the nose seal and a second portion outside the nose seal, the first portion and the second portion being coupled to one another.

7. 7. The nasal seal of claim 6, wherein the first portion comprises a flange and a hub, the hub extending through an aperture in the nasal seal, and the second portion is coupled to the hub of the first portion.

8. 8. The nasal seal of claim 7, wherein the rim extends partially or completely around the aperture, the rim being captured between the first and second portions.

9. 9. The nasal seal of claim 8, wherein the rim comprises a T-shaped cross-section having a base, a first lobe extending from the base in a first direction, and a second lobe extending from the base in a second direction opposite the first direction.

10. 10. The nasal seal of claim 9, wherein the first and second portions of the connector each include a recess configured to receive a respective one of the first and second lobes.

11. A nasal seal according to any one of claims 5 to 10, wherein the nasal seal and the connector comprise interference portions that inhibit or prevent relative rotation between the nasal seal and the connector.

12. 11. The nasal seal of any one of claims 1 to 10, wherein the nasal seal has a first texture on the rear wall and a second texture on the front wall, the second texture being different from the first texture.

13. A nasal seal according to any preceding claim, wherein the rim has a greater wall thickness than the portion of the front wall adjacent the rim.

14. 14. A nasal seal according to any one of claims 1 to 13, wherein the nasal seal comprises a pair of thickened wall sections that, in use, contact the cheeks of a user, each of the thickened wall sections comprising a sub-nasal window within the respective thickened wall section.

15. 7. A nasal seal according to claim 5 or 6, wherein the front wall of the nasal seal comprises a recessed portion configured to receive a portion of the connector.

16. 7. A nasal seal according to claim 5 or 6, wherein the connector comprises a side arm, and the front wall of the nasal seal comprises a recess configured to receive the side arm of the connector.

Images