Patient interfaces

Abstract

To provide an interface assembly for respiratory therapy.SOLUTION: A mask assembly 2100 can include a mask seal 2104. In some configurations, the mask assembly can be positioned sufficiently lower than the nasal bridge of the nose of a user's face and configured to provide an exposed nasal bridge of the user's nose. The mask seal includes a nasal region including at least one nasal opening, a first paddle on a first side of the nasal region and a second paddle on a second side of the nasal region. The first paddle is configured to contact one side of the user's nose and the second paddle is configured to contact the other side of the user's nose.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 62 / 413,604, filed October 5, 2016, U.S. Provisional Patent Application No. 62 / 413,280, filed October 26, 2017, and U.S. Provisional Patent Application No. 62 / 404,341, filed October 27, 2016, each of which is incorporated by reference in its entirety.

[0002] The present disclosure relates to an interface assembly for respiratory therapy. In particular, the present disclosure relates to an under-nose interface assembly that does not cover the bridge of a user's nose. [Background technology]

[0003] In patients with obstructive sleep apnea (OSA), the muscles that normally keep the upper airway open relax during sleep to the extent that the airway is compressed or completely blocked, which manifests as snoring.If this occurs over a period of time, the patient's brain will generally recognize the risk of hypoxia and partially awaken the patient to resume normal breathing in order to open the airway.The patient may not be aware of these awakening episodes, which may occur hundreds of times per sleep session.This partial awakening state can significantly reduce the patient's sleep quality, and over time, can cause a variety of symptoms, including excessive daytime sleepiness, chronic fatigue, high heart rate, elevated blood pressure, weight gain, headaches, irritability, depression and anxiety.

[0004] Obstructive sleep apnea is commonly treated by administering positive airway pressure (PAP) therapy. PAP therapy involves delivering a flow of gas to a patient at a therapeutic pressure above atmospheric pressure, which reduces the frequency and / or duration of apneas, hypopneas, and / or flow limitation. This therapy is often implemented using a positive airway pressure device to deliver a pressurized flow of air through a conduit to the patient via a patient interface or mask positioned on the patient's face.

[0005] One common type of patient interface assembly used with PAP therapy or other respiratory therapy involving the administration of gases includes a seal that contacts the bridge of the nose of the user of the interface assembly. The bridge of the nose is sensitive to pressure exerted by the seal of the interface assembly. Recently, interface assemblies that do not contact the bridge of the nose have become available. Such interface assemblies may be referred to as "under-the-nose" interface assemblies. A need exists to provide an improved under-the-nose interface assembly with improved comfort and / or seal, or to provide the public with a useful option. Summary of the Invention [Means for solving the problem]

[0006] The systems, methods, and apparatus described herein have inventive aspects, no single one of which is essential or solely responsible for their desirable attributes. Without limiting the scope of the claims, some of the advantageous features are summarized below.

[0007] In some configurations, an interface for use in providing positive airway pressure therapy includes a mask assembly having a mask seal. The mask assembly is configured to be positioned sufficiently lower than the bridge of the nose on a user's face and to provide an exposed bridge of the nose. The mask seal includes a nasal region including at least one nasal opening. The mask seal includes a first paddle on a first side of the nasal region and a second paddle on a second side of the nasal region. The first paddle is configured to contact one side of the user's nose, and the second paddle is configured to contact the other side of the user's nose. The first paddle includes a first cutout region extending from a front side of the first paddle to a rear side of the first paddle. The second paddle includes a second cutout region extending from a front side of the second paddle to a rear side of the second paddle.

[0008] In some configurations, the mask seal further comprises a support structure configured to support the nasal region of the mask seal.

[0009] In some configurations, the mask seal includes a recessed front surface, including an upper recessed front surface configured to receive the frame paddle.

[0010] In some configurations, the first cutout region includes a reduced wall thickness.

[0011] In some configurations, the first cutout area includes a first recessed portion positioned along the length of the first cutout area, and the second cutout area includes a second recessed portion positioned along the length of the second cutout area.

[0012] In some configurations, the first concave portion is configured to allow the first cutout area to fold inward when a force is applied to the first paddle, and the second concave portion is configured to allow the second cutout area to fold inward when a force is applied to the second paddle.

[0013] In some configurations, the mask seal includes a concave region positioned along the outer periphery of the mask seal.

[0014] In some configurations, the first cutout region includes a first inner region and a first outer region. The first inner region is configured to compress toward the first outer region when a force is applied to the first inner region. The second cutout region includes a second inner region and a second outer region. The second inner region is configured to compress toward the second outer region when a force is applied to the second outer region.

[0015] In some configurations, the first cutout area extends across a portion of the rear side of the first paddle to at least the first side of the nasal opening.

[0016] In some configurations, an interface for use in providing positive airway pressure therapy includes a mask assembly having a mask seal. The mask assembly is configured to be positioned sufficiently lower than the bridge of the nose on a user's face and to provide an exposed bridge of the nose. The mask seal includes a nasal region including at least one nasal opening. The mask seal includes a first paddle at a first side of the nasal region and a second paddle at a second side of the nasal region. The first paddle is configured to contact one side of the user's nose, and the second paddle is configured to contact the other side of the user's nose. The mask assembly further includes a front upper portion. The front upper portion includes a recessed front portion. In some configurations, the mask assembly further includes a stepped transition between an upper periphery of the front upper portion and the recessed front portion.

[0017] In some configurations, the stepped transition follows the curvature of the periphery of the first paddle and the second paddle.

[0018] In some configurations, the stepped transition varies in depth.

[0019] In some configurations, the stepped transition is tapered so that the depth is smallest at the lower end of the stepped transition.

[0020] In some configurations, the depth of the stepped transition depends on the size of the mask seal.

[0021] In some configurations, the mask assembly further includes a frame, the recessed front portion configured to receive at least a portion of the frame.

[0022] In some configurations, the stepped transition has a maximum depth that is equal to or greater than the thickness of the frame.

[0023] In some configurations, the upper front surface further includes first and second upper corners formed on the front sides of the first and second paddles.

[0024] In some configurations, the stepped transition includes a depth that varies such that the depth of the stepped transition is greater at the first upper corner and the second upper corner than at an intermediate portion between the first upper corner and the second upper corner.

[0025] In some configurations, the interface includes a frame that is removably connectable to the mask assembly.

[0026] In some configurations, the frame includes a frame paddle.

[0027] In some configurations, the frame paddle is inserted into and / or positioned within the recessed front face when assembled into the mask assembly.

[0028] In some configurations, the outer surface of the frame paddle rests flush with the upper recessed surface.

[0029] In some configurations, the frame provides additional support to the nose region of the seal.

[0030] In some configurations, the frame provides additional rigidity to the front nose region of the seal.

[0031] In some configurations, the frame paddles provide support to the nose area.

[0032] In some configurations, the frame paddle helps prevent the seal paddle from deflecting away from the user's nose during use.

[0033] In some configurations, the frame paddles may help prevent the frame paddles from contacting or digging into the user's face if the mask seal is overly deformed.

[0034] In some configurations, the recessed front surface allows for the use of a single size frame with mask assemblies having a variety of sizes to be implemented.

[0035] According to some embodiments, an interface for use in providing positive airway pressure therapy may include a mask assembly and a frame. The mask assembly may include a mask seal. The mask assembly may be positioned sufficiently lower than the bridge of the nose of a user's face and provide an exposed bridge of the nose. The mask seal may include a nasal region. The nasal region may include at least one nasal opening. The mask seal may include a first paddle on a first side of the nasal region and a second paddle on a second side of the nasal region. The first paddle may contact one side of the user's nose, and the second paddle may contact the other side of the user's nose. The frame may be removably coupled to the mask assembly. The mask assembly may include a housing. The housing may include an inlet and a concave front surface surrounding the inlet. The inlet may define a flow path to an interior chamber of the mask assembly.

[0036] In some configurations, the interface includes an elbow that is connected to the frame by a connecting feature.

[0037] In some configurations, the connection features include a snap-fit ​​arrangement whereby the frame can be snapped into a slot in the elbow.

[0038] In some configurations, the connection features include a snap-fit ​​arrangement whereby the elbow includes a plurality of ribs extending outwardly from the elbow, which may form slots for receiving the frame.

[0039] In some configurations, the frame is shaped to at least partially receive the elbow.

[0040] In some configurations, the elbow includes a valve port configured to provide a flow path from the atmosphere to the interior volume of the elbow.

[0041] In some configurations, the orifice faces the concave front surface, and the orifice and the concave front surface define the flow path, whereby the area of ​​the orifice forms the smallest area of ​​the flow path.

[0042] In some configurations, the mask assembly may include a bias vent configured to exhaust air exhaled by the user.

[0043] In some configurations, an interface for use in providing positive airway pressure therapy includes a mask assembly having a mask seal. The mask assembly is configured to be positioned sufficiently lower than the bridge of the nose on a user's face and to provide an exposed bridge of the nose. The mask seal includes a nasal region including at least one nasal opening. The mask seal includes a first paddle on a first side of the nasal region and a second paddle on a second side of the nasal region. The first paddle is configured to contact one side of the user's nose, and the second paddle is configured to contact the other side of the user's nose. The mask assembly further includes a frame removably coupled to the mask assembly, the frame including a clip retention feature configured to connect to a headgear clip. The headgear clip includes upper strap slots, lower strap slots, a pull tab, and an aperture positioned between outer portions of the upper and lower strap slots and the pull tab.

[0044] In some configurations, the clip retention feature provides an opening configured to vent air exhaled by the user.

[0045] In some configurations, the headgear clip includes an insert whereby the pull tab forms at least a portion of the overmolded arrangement.

[0046] In some configurations, the frame includes keying ridges configured to engage corresponding keying notches in the headgear clips.

[0047] In some configurations, the keying ridge is positioned on one side of the first clip retaining feature, and the keying ridge is configured to indicate the proper orientation for connecting the headgear clip.

[0048] In some configurations, the frame includes at least two openings.

[0049] In some configurations, the headgear clip includes a finger grip and a thumb grip, which form an overmolded grip presented to the user, the finger grip being positioned laterally opposite the thumb grip along the outer concave surface of the headgear clip.

[0050] In some configurations, the headgear clips are positioned adjacent to the upper front of the mask seal, so that the headgear clips prevent the mask seal from bulging.

[0051] According to some embodiments, a respiratory mask may include a mask assembly and a frame. The mask assembly may include a seal and a housing. The seal may include a nose sealing portion and a mouth sealing portion. The seal may provide a flow of gas to a user's nose and mouth. The housing and seal may form a breathing chamber. The frame may be removably coupled to the mask assembly. The frame may include a body, an inlet opening through which a supply of pressurized air is provided to the mask assembly, and an anti-asphyxiation valve in fluid communication with the inlet opening. The body of the frame may define at least a portion of a gas flow path of the anti-asphyxiation valve.

[0052] In some configurations, the frame includes a tubing connector coupled to a body of the frame. The frame may connect to a breathing tube. The tubing connector may define an inlet opening.

[0053] In some configurations, the tubing connector may secure the valve member of the anti-asphyxiation valve to the body of the frame.

[0054] In some configurations, the frame may define a mask connector. The mask connector may secure the mask assembly to the frame. The mask connector may define a portion of the gas flow path. The mask connector may receive the flow of gas from the inlet opening and the anti-asphyxiation valve. The mask connector may deliver the flow of gas to the mask assembly.

[0055] In some configurations, the front wall of the frame may define a portion of the gas flow path of the respiratory mask.

[0056] In some configurations, the housing may define a recess that accommodates at least a portion of the frame including the anti-asphyxiation valve.

[0057] In some configurations, the nasal sealing portion may include a left nasal sealing surface and a right nasal sealing surface. An inner portion of each sealing surface closest to the nasal opening of the seal may be generally flat.

[0058] In some configurations, the outer portion of each of the sealing surfaces may be curved. The radius of curvature of the outer portion may decrease in the back-to-front direction of each of the outer portions.

[0059] In some configurations, the angle defined between the left and right sealing faces may increase in the rear-to-front direction.

[0060] In some configurations, the mask includes an inlet tube that defines a portion of the gas flow path and is fixed relative to the body of the frame.

[0061] In some configurations, the inlet opening is integrally formed with the body of the frame.

[0062] In some configurations, the inlet pipe extends downwardly from a bottom region of the front wall.

[0063] In some configurations, the inlet pipe includes a front surface that defines a continuous surface with the front surface of the front wall.

[0064] In some configurations, the inlet pipe is positioned at least partially rearward of the front wall.

[0065] In some configurations, the inlet pipe includes a rear inner surface and a front inner surface. The rear inner surface may extend away from the inlet and may be angled toward the front inner surface.

[0066] In some configurations, the recess accommodates the inlet tube.

[0067] In some configurations, the housing includes a bias vent positioned on a front surface of the housing opposite the inlet aperture and below the frame. The bias vent can exhaust air below the lower edge of the frame.

[0068] According to some embodiments, the respiratory mask may include a mask assembly and a frame. The mask assembly may include a full-face mask seal and a housing. The housing may include a bias vent. The frame may connect the mask assembly to a supply of pressurized air and may include a body defining at least one headgear connector. The bias vent may be positioned on a front surface of the housing opposite the inlet aperture and below the frame, and the bias vent may exhaust air below a lower edge of the frame. The frame may define at least a portion of a gas flow path of the anti-asphyxiation valve.

[0069] In some configurations, the frame may define at least one valve outlet of the anti-asphyxiation valve.

[0070] In some configurations, the frame includes a tubing connector coupled to a body of the frame. The frame may connect to a breathing tube. The tubing connector may define an inlet opening.

[0071] In some configurations, the tubing connector may secure the valve member of the anti-asphyxiation valve to the body of the frame.

[0072] In some configurations, the frame may define a mask connector. The mask connector may secure the mask assembly to the frame. The mask connector may define a portion of the gas flow path. The mask connector may receive the flow of gas from the inlet opening and the anti-asphyxiation valve. The mask connector may deliver the flow of gas to the mask assembly.

[0073] In some configurations, the front wall of the frame may define a portion of the gas flow path of the respiratory mask.

[0074] In some configurations, the housing may define a recess that accommodates at least a portion of the frame including the anti-asphyxiation valve.

[0075] In some configurations, the nasal sealing portion may include a left nasal sealing surface and a right nasal sealing surface. An inner portion of each sealing surface closest to the nasal opening of the seal may be generally flat.

[0076] In some configurations, the outer portion of each of the sealing surfaces may be curved. The radius of curvature of the outer portion may decrease in the back-to-front direction of each of the outer portions.

[0077] In some configurations, the angle defined between the left and right sealing faces may increase in the rear-to-front direction.

[0078] In some configurations, the mask includes an inlet tube that defines a portion of the gas flow path and is fixed relative to the body of the frame.

[0079] In some configurations, the inlet opening is integrally formed with the body of the frame.

[0080] In some configurations, the inlet pipe extends downwardly from a bottom region of the front wall.

[0081] In some configurations, the inlet pipe includes a front surface that defines a continuous surface with the front surface of the front wall.

[0082] In some configurations, the inlet pipe is positioned at least partially rearward of the front wall.

[0083] In some configurations, the inlet pipe includes a rear inner surface and a front inner surface. The rear inner surface may extend away from the inlet and may be angled toward the front inner surface.

[0084] In some configurations, the recess accommodates the inlet tube.

[0085] In some configurations, the housing includes a bias vent positioned on a front surface of the housing opposite the inlet aperture and below the frame. The bias vent can exhaust air below the lower edge of the frame.

[0086] According to some embodiments, a respiratory mask may include a mask assembly and a frame. The mask assembly may include a seal and a housing. The frame may be removably coupled to the mask assembly. The frame may include an inlet opening through which a supply of pressurized air is provided to the mask assembly, and an anti-asphyxiation valve in fluid communication with the inlet opening. The housing may include a valve recess that accommodates at least a portion of the frame, including the anti-asphyxiation valve.

[0087] In some configurations, the valve recess defines a concave area.

[0088] In some configurations, the concave area is positioned below the inlet.

[0089] In some configurations, the concave area is positioned adjacent the inlet.

[0090] In some configurations, the valve recess has a width that is less than the maximum width of the inlet.

[0091] In some configurations, the valve recess can receive at least a portion of the valve.

[0092] In some configurations, the valve recess can receive at least a posterior portion of the valve.

[0093] In some configurations, the valve recess may receive at least a portion of one or more valve outlets of the valve.

[0094] In some configurations, the valve recess has a curved surface that corresponds to the curvature of the posterior surface of the valve.

[0095] In some configurations, the valve recess is configured to allow the valve to be recessed and positioned within the seal.

[0096] In some configurations, the valve recess and valve are configured to reduce the overall depth of the mask assembly and make the mask assembly less noticeable to the user.

[0097] In some configurations, the valve recess and valve are configured to allow the valve to be positioned higher relative to the bottom edge of the seal.

[0098] In some configurations, the valve recess and the valve are configured to reduce the length of the inlet aperture.

[0099] Reference numerals may be reused throughout the drawings to indicate the general correspondence of referenced elements. The drawings are provided to illustrate the exemplary embodiments described herein and are not intended to limit the scope of the present disclosure. [Brief explanation of the drawings]

[0100] [Figure 1] FIG. 1 is a perspective front view of an interface assembly positioned on a user's head and having certain features, aspects, and advantages of the present disclosure. [Figure 2] FIG. 2 is a top view of the interface assembly of FIG. 1 positioned on a user's head. [Figure 3] 2 is a perspective rear view of the interface portion of the interface assembly of FIG. 1, separated from the user and without headgear. [Figure 4] FIG. 2 is a perspective front view of a mask assembly of the interface assembly of FIG. 1. [Figure 5] FIG. 5 is a rear view of the mask assembly of FIG. 4 showing the thickened area of ​​the mask seal of the mask assembly. [Figure 6] FIG. 5 is a side view of the mask assembly of FIG. 4 showing the thickened areas of the mask seal. [Figure 7]FIG. 10 is a rear view of the mask assembly showing the cut-out area of ​​the mask seal of the mask assembly. [Figure 8] FIG. 8 is a top view of the mask assembly of FIG. 7 showing the cutout area of ​​the mask seal. [Figures 9A-9D] Figure 9A is a front view of the mask assembly showing the cutout area of ​​the mask seal. Figure 9B is a cross-sectional view of the mask assembly taken along line AA in Figure 9A showing the cutout area of ​​the mask seal. Figure 9C is an enlarged view of the mask assembly of Figure 9A showing the cutout area of ​​Figure 9B. Figure 9D is a rear view of the mask assembly of Figure 9A showing the cutout area of ​​the mask seal. [Figure 10A] FIG. 10 is a partial top view of a mask assembly showing the cut-out area of ​​the mask seal of a generally uncompressed mask assembly. [Figure 10B] FIG. 10B is a top view of the mask assembly of FIG. 10A showing the cutout area of ​​the mask seal partially compressed. [Figure 10C] FIG. 10B is a top view of the mask assembly of FIG. 10A showing the cutout area of ​​the mask seal partially compressed. [Figure 11A] FIG. 10B is a perspective top view of the mask assembly of FIG. 10A showing the cutout area of ​​the generally uncompressed mask seal; [Figure 11B] FIG. 10B is a top view of the mask assembly of FIG. 10A showing the cutout area of ​​the mask seal partially compressed. [Figure 12] FIG. 10 is a rear view of the mask seal of the mask assembly showing the cutout area of ​​the mask seal. [Figure 13] FIG. 13 is a partial rear view of the mask assembly of FIG. 12 showing the cutout area of ​​the mask seal. [Figure 14] 13A and 13B are perspective views of the top and back of the mask assembly of FIG. 12, showing the cut-out area of ​​the mask seal. [Figure 15] FIG. 13 is a top view of the mask assembly of FIG. 12 showing the cutout area of ​​the mask seal. [Figure 16]FIG. 1 is a perspective front view of the mask assembly showing the recessed side of the mask assembly. [Figure 17] 17A and 17B are front and side perspective views of the mask assembly of FIG. 16, showing the recessed surface and frame of the mask assembly. [Figure 18A] FIG. 17 is a rear view of the mask assembly of FIG. 16 showing the recessed side of the mask assembly. [Figure 18B] FIG. 17 is a front view of the mask assembly of FIG. 16 showing the recessed side of the mask assembly. [Figure 19A] FIG. 10 is a front view of the mask assembly showing the recessed side of the mask assembly. [Figure 19B] 19B is a front and side perspective view of the mask assembly of FIG. 19A showing the recessed side of the mask assembly. [Figure 20] 19B is a front and side perspective view of the frame of the mask assembly of FIG. 19A. [Figure 21A] FIG. 19B is an exploded view of the mask assembly of FIG. 19A showing assembly of the mask assembly. [Figure 21B] FIG. 19B is an exploded view of the mask assembly of FIG. 19A showing assembly of the mask assembly. [Figure 22A] FIG. 10 is a front view of the mask assembly showing the assembly of the mask frame. [Figure 22B] FIG. 22B is a rear view of the mask assembly of FIG. 22A showing assembly of the mask frame. [Figure 23A] 1A and 1B are rear and side perspective views of the mask assembly showing the assembly of the mask frame. [Figure 23B] 23B is a rear and side perspective view of the mask assembly of FIG. 23A showing assembly of the mask frame. [Figure 24] FIG. 10 is a front view of the mask assembly showing the recessed side of the mask assembly. [Figure 25] FIG. 25 is a cross-sectional view of the mask assembly of FIG. 24 showing the recessed side of the mask assembly. [Figure 26]FIG. 10 is a partial cross-sectional view of a mask assembly showing a recessed surface of the mask assembly. [Figure 27] FIG. 10 is a bottom view of the mask assembly showing the recessed side of the mask assembly. [Figure 28] FIG. 27 is an exploded view of the mask assembly showing the elbow design of FIG. 26. [Figure 29] 1A-1C are front and side perspective views of a mask assembly showing headgear clips and clip retention features. [Figure 30A-30B] Figure 30A is a front and side perspective view of the mask assembly of Figure 29 showing the clip retention features, and Figure 30B is a front and side perspective view of the headgear clip of the mask assembly of Figure 29; [Figure 31A] FIG. 30 is a top view of the mask assembly of FIG. 29 showing the clip retention features. [Figure 31B] 30A and 30B are front and side perspective views of the mask assembly of FIG. 29 showing the clip retention features. [Figure 32A] FIG. 30 is a front view of the frame of the mask assembly of FIG. 29. [Figure 32B] FIG. 30 is a rear view of the frame of the mask assembly of FIG. 29. [Figure 33A] FIG. 30 is a front view of the headgear clip of the mask assembly of FIG. 29. [Figure 33B] 30A and 30B are rear and side perspective views of the headgear clip of the mask assembly of FIG. 29. [Figure 33C] FIG. 30 is a side view of the headgear clip of the mask assembly of FIG. 29, with a portion of the clip transparent to reveal the underlying structure. [Figure 33D] FIG. 30 is a front view of the headgear clip of the mask assembly of FIG. 29, with a portion of the clip transparent to reveal the underlying structure. [Figure 33E] 30 is a perspective view of the side and rear of the headgear clip of the mask assembly of FIG. 29, with a portion of the clip transparent to reveal the underlying structure. [Figure 34A]1A and 1B are front and side perspective views of a frame assembly of a mask assembly. [Figure 34B] FIG. 34B is a front view of the frame assembly of the mask assembly of FIG. 34A. [Figure 35A] FIG. 34B is a front view of the frame of the mask assembly of FIG. 34A. [Figure 35B] FIG. 34B is a rear view of the frame of the mask assembly of FIG. 34A. [Figure 36A] FIG. 34B is a front view of the first headgear clip of the mask assembly of FIG. 34A. [Figure 36B] FIG. 34B is a front view of a second headgear clip of the mask assembly of FIG. 34A. [Figure 37A] FIG. 34B is a side view of a first headgear clip of the mask assembly of FIG. 34A. [Figure 37B] FIG. 34B is a side view of a second headgear clip of the mask assembly of FIG. 34A. [Figure 37C] FIG. 34B is a rear view of the second headgear clip of the mask assembly of FIG. 34A. [Figure 37D] FIG. 34B is a rear view of the first headgear clip of the mask assembly of FIG. 34A. [Figure 38A] FIG. 34B is a side view of a first clip retaining feature of the mask assembly of FIG. 34A. [Figure 38B] FIG. 34B is a side view of a first headgear clip assembly of the mask assembly of FIG. 34A. [Figure 39A] FIG. 34B is a side view of a second headgear clip assembly of the mask assembly of FIG. 34A. [Figure 39B] FIG. 34B is an exterior side view of a second clip retention feature of the mask assembly of FIG. 34A. [Figure 39C] FIG. 34B is an interior side view of a second clip retaining feature of the mask assembly of FIG. 34A. [Figure 40] 34B is a cross-sectional view of the top of the frame assembly of the mask assembly of FIG. 34A. [Figure 41] FIG. 34B is a rear view of the frame assembly of the mask assembly of FIG. 34A. [Figure 42] 34B is a top and front perspective view of the frame assembly of the mask assembly of FIG. 34A. [Figure 43] 34B is a perspective view of the bottom and front of the frame assembly of the mask assembly of FIG. 34A. [Figure 44] FIG. 10 is a front view of the interface assembly showing the clip retention feature and the vent feature. [Figure 45] 45A and 45B are front and side perspective views of the interface assembly of FIG. 44, showing the clip retention feature and the vent feature. [Figure 46] FIG. 45 is a front view of the interface assembly of FIG. 44 showing the clip retention feature and the vent feature. [Figure 47] FIG. 45 is a cross-sectional view of the headgear clip of the interface assembly of FIG. 44. [Figure 48] FIG. 45 is a cross-sectional view of the headgear clip of the interface assembly of FIG. 44. [Figure 49] FIG. 1 is a front and top perspective view of an interface assembly. [Figure 50A] 1A-1C are front, top and side perspective views of a mask assembly including an air delivery conduit. [Figure 50B] 50B is a perspective close-up view of the rear, top, and side of the mask assembly of FIG. 50A. [Figure 51A] FIG. 50B is a front view of the frame of the mask assembly of FIG. 50A. [Figure 51B] FIG. 50B is a rear view of the frame of the mask assembly of FIG. 50A. [Figure 52] FIG. 50B is a side view of the frame of the mask assembly of FIG. 50A. [Figure 53] 53 is a cross-sectional view of the frame of the mask assembly of FIG. 50A taken along line 53-53 of FIG. 51A. [Figure 54] 54 is a cross-sectional view of the frame of the mask assembly of FIG. 50A taken along line 54-54 of FIG. 51A. [Figure 55]55 is a cross-sectional view of the front of the frame of the mask assembly of FIG. 50A taken along line 55-55 of FIG. 52. [Figure 56] FIG. 50B is a bottom view of the frame of the mask assembly of FIG. 50A. [Figure 57] 50B is a perspective exploded view of the front, bottom and side of the frame of the mask assembly of FIG. 50A. [Figure 58] FIG. 50B is a perspective exploded view of the rear, bottom and side of the frame of the mask assembly of FIG. 50A. [Figure 59] FIG. 50B is a cross-sectional view of the frame of the mask assembly of FIG. 50A showing the inlet axis and the cushion connector axis. [Figure 60] 50B is a front, top, and side perspective view of the mask seal of the mask assembly of FIG. 50A. [Figure 61] FIG. 50B is a rear view of the mask seal of the mask assembly of FIG. 50A. [Figure 62] FIG. 50B is a front view of the mask seal of the mask assembly of FIG. 50A. [Figure 63] FIG. 50B is a side view of the mask seal of the mask assembly of FIG. 50A. [Figure 64] FIG. 50B is a cross-sectional view of a mask seal of the mask assembly of FIG. 50A. [Figure 65] FIG. 50B is an enlarged view of the rear surface of a portion of the mask seal of the mask assembly of FIG. 50A. [Figure 66] FIG. 50B is a top view of the mask seal of the mask assembly of FIG. 50A. [Figure 67A] 67A is a cross-sectional view of the rear of the mask seal of the mask assembly of FIG. 50A taken along line 67A-67A of FIG. 66. [Figure 67B] 67B is a cross-sectional view of the rear of the mask seal of the mask assembly of FIG. 50A taken along line 67B-67B of FIG. 66. [Figure 67C] 67C is a cross-sectional view of the rear of the mask seal of the mask assembly of FIG. 50A taken along line 67C-67C of FIG. 66. [Figure 67D]67D is a cross-sectional view of the rear of the mask seal of the mask assembly of FIG. 50A taken along line 67D-67D of FIG. 66. [Figure 67E] 67E is a cross-sectional view of the rear of the mask seal of the mask assembly of FIG. 50A taken along line 67E-67E of FIG. 66. [Figure 67F] 67F is a cross-sectional view of the rear of the mask seal of the mask assembly of FIG. 50A taken along line 67F-67F of FIG. 66. [Figure 68] FIG. 50B is a side view of the mask assembly of FIG. 50A. [Figure 69] FIG. 50B is a cross-sectional view of the mask assembly of FIG. 50A. [Figure 70] FIG. 50B is a front view of the mask assembly of FIG. 50A. [Figure 71] FIG. 50B is a bottom view of the mask assembly of FIG. 50A. [Figure 72A] FIG. 50B is a cross-sectional view of the mask assembly of FIG. 50A from above. [Figure 72B] FIG. 50B is a bottom view of the mask assembly of FIG. 50A. [Figure 73] FIG. 10 is a side view of the interface assembly showing the headgear assembly. [Figure 74] FIG. 1 is a view of the exterior surface of the headgear assembly in a flat orientation. [Figure 75] FIG. 75 is a view of the interior surface of the headgear assembly of FIG. 74 in a flat orientation. DETAILED DESCRIPTION OF THE INVENTION

[0101] Embodiments of systems, components, and methods of assembly and manufacture are described below with reference to the accompanying drawings, in which like reference numerals indicate like or similar elements throughout. While several embodiments, examples, and descriptions are disclosed below, those skilled in the art will understand that the invention described herein may deviate from the specifically disclosed embodiments, examples, and descriptions and may include other uses of the invention as well as obvious modifications and their equivalents. The terminology used in the description presented herein is used solely in conjunction with the detailed description of several specific embodiments of the invention and should not be construed as limiting or restrictive in any way. Furthermore, embodiments of the invention may include several novel features, and no single feature is solely responsible for its desirable properties or is essential to practicing the invention described herein.

[0102] Certain terminology may be used in the following description for reference purposes only and is not intended to be limiting. For example, terms such as "top" and "bottom" refer to the direction in the drawings. Terms such as "front," "rear," "left," "right," "rearward," and "side" describe the orientation and / or location of a component or portion of an element within a consistent, yet arbitrary, coordinate system that is made clear by reference to the text and associated drawings describing the component or element under consideration. For example, as the context may dictate, the terms "front" and / or anterior may be used for components described herein that are positioned relatively or entirely distal to the face of a user when a mask assembly as described herein is worn by a user. As the context may dictate, the terms "rear" and / or "rear" may be used for components described herein that are positioned relatively or entirely proximal to the face of a user when a mask assembly as described herein is worn by a user and / or components that are anterior or in front of the mask assembly. Furthermore, terms such as "first," "second," "third," etc. may be used to describe separate components. Such terminology may include words specifically mentioned above, derivatives thereof and words of similar import.

[0103] One or more of the embodiments described herein address the sealing and conformance challenges of various facial (e.g., nasal) geometries that may be experienced with face masks. In particular, at least some of the embodiments relate to patient interfaces, e.g., face masks, that seal under the bridge of a user's nose and around the nostrils. However, the embodiments disclosed herein may also be adapted for other full face masks (e.g., those that partially cover and / or seal over the bridge of a user's nose).

[0104] One or more of the embodiments described herein address the challenge of creating a satisfactory seal with a nose-under seal across a variety of facial geometries. Compared to traditional nose masks or full-face masks that contact the bridge of the nose, nose-under masks or combined nose-and-mouth masks have a reduced footprint on the user's face, making them more difficult to maintain a seal with and can be configured to fit a variety of facial geometries. Sealing around and below the nose can be challenging due to variations in facial geometry between users. One or more of the embodiments described herein allow the nose portion of the mask seal to expand, for example, in response to fit on a particular user or in response to pressure within the mask seal. In some configurations, the nose portion of the mask seal can be configured to offer relatively low resistance to increasing in width. Such an arrangement allows a single mask seal to create a satisfactory seal with users with relatively narrow and wide noses. For example, when used with a user with a relatively narrow nose, the width of the nose portion may not expand or widen, or may only expand or widen slightly. The width of the nose portion may expand or widen significantly or to its fullest extent when used on a user with a relatively wide nose. However, in at least some configurations, even when expanded, the nose portion does not exert an uncomfortable level of pressure on the user's nose. Such an arrangement may advantageously maintain a satisfactory seal between the user's face and the mask seal.

[0105] 1-75 show a mask assembly 2100 and its components both in position on and away from a user's face. The illustrated mask assembly 2100 is a combined nose and mouth mask and may be referred to herein as a nose-mouth mask. The illustrated mask assembly 2100 is designed to seal against the underside of a user's nose, along a portion of the face extending laterally relative to the nose, and around the user's mouth. The mask assembly 2100 advantageously does not require contact with the bridge of the user's nose. In the illustrated configuration, the mask assembly 2100 does not extend over the upper side of the bridge of the user's nose. More specifically, the illustrated mask assembly 2100 does not contact the bridge of the user's nose. Even more specifically, the illustrated assembly 2100 does not contact the forward-facing portion of the bridge of the user's nose. In some configurations, the assembly 2100 does not contact the face in an area vertically higher than a generally horizontal plane extending along the lower edges of the user's eyes. The mask assembly 2100 may or may not extend above the tip of the user's nose. Thus, in some configurations, the mask assembly 2100 covers the tip of the nose. In some configurations, the seal of the mask assembly 2100 covers the tip of the nose. In some configurations, the illustrated mask assembly 2100 preferably does not obscure the tip of the user's nose. In some configurations, or according to some facial geometries, the tip of the user's nose extends above an adjacent portion of the mask assembly 2100.

[0106] As shown, the mask assembly 2100 is preferably adapted to extend around and seal above the alae or nostrils, which flare to form rounded ridges around the nostrils. The illustrated mask assembly 2100 is adapted to seal around the surfaces defining the openings to the nostrils, which may include part or all of the fleshy outer end of the nasal septum, sometimes referred to as the columella. In some configurations, the mask assembly 2100 is adapted to extend upward and seal along at least a portion of the left and right sidewalls of the dorsum of the user's nose. In some configurations, the mask assembly 2100 is adapted to extend upward along at least a portion of the left and right sidewalls of the dorsum without extending upward to the bridge region of the user's nose. In some configurations, the primary sealing surface of the mask assembly 2100 contacts the underside of the user's nose and, possibly, the upper lip and / or the transition region between the underside of the nose and the upper lip. The secondary sealing surface of the mask may contact the sides of the user's nose and possibly the cheeks adjacent to the nose. Such primary and secondary sealing surfaces may not contact all users' faces. However, such an arrangement may provide a suitable seal with a relatively wide range of facial geometries. The mask assembly 2100 preferably also seals around at least a portion of the user's mouth. The mask assembly 2100 may or may not be adapted to seal between the user's mouth and nose.

[0107] As shown, the mask assembly 2100 includes a mask support, such as, for example, a base, housing, or mask shell 2102 (see, e.g., FIG. 4). A mask seal or cushion 2104 is attached to the housing 2102, such that the housing 2102 may provide some amount of support to the mask seal 2104. However, in other configurations, the mask seal 2104 may not include a support and may be adapted to be assembled directly to another component of an associated interface assembly. In some configurations, the housing 2102 may be substantially smaller than the illustrated housing. For example, the housing 2102 may define an opening that allows the mask assembly 2100 to be attached to another component, such as a frame and / or a conduit connector (e.g., an elbow), and the housing 2102 may be localized to the opening without providing direct support to other portions of the mask assembly 2100.

[0108] The mask assembly 2100 may engage with or otherwise be supported by a frame 2178 that allows it to be connected to a head strap or headgear 2180 in any suitable arrangement. The mask assembly 2100 is adjustably secured to the frame 2178, allowing the assembly to be oriented only in the correct direction. In some configurations, the head strap or headgear 2180 is directly coupled to the mask assembly 2100, and the frame 2178 may be used for other purposes or may be omitted. The conduit connector 2106 may also be attached to the housing 2102, the frame 2178, or otherwise adapted to be supported against and in communication with the interior space of the mask assembly 2100. Together, the frame 2178 and headgear 2180 may support the mask assembly 2100 in place on the user's face. Collectively, the mask assembly 2100, the frame 2178, and the headgear 2180 may be referred to as an interface assembly. The mask assembly 2100 or the mask assembly 2100 in combination with the frame 2178 may be referred to as an interface.

[0109] The illustrated conduit connector 2106 may be connected to the frame 2178 and / or the housing 2102 in any suitable manner, including, but not limited to, any of the methods described elsewhere in this application. For example, but not limited to, the connector 2106 may be connected to the housing 2102 such that the connector 2106 can pivot, rotate, or pivot relative to the housing 2102 about a single axis or about multiple axes. In some configurations, the connector 2106 may define a portion of a ball-and-socket joint, for example, but not limited to, the frame 2178 and / or the housing 2102 defining other portions. The ball-and-socket joint may have any suitable configuration. The connector 2106 facilitates connection to a gas conduit, such as a supply conduit, for supplying pressurized breathing gas to the interior of the mask assembly 2100. Any suitable connector 2106 may be used, which may optionally include a swivel or rotary coupling that allows relative rotation between the connector 2106 and the gas conduit.

[0110] In the illustrated configuration, the connector 2106 includes an elbow that includes a vent, such as, but not limited to, a polycarbonate elbow. In the illustrated arrangement, the vent includes bias flow holes 2110. However, the vent may include other geometries or configurations, such as slots, or controlled leaks, for example, between components. The vent may also include a diffusing material to reduce noise and / or drafts. The bias flow holes 2110 are a collection of orifices that are configured to exhaust and flow CO2 to reduce the likelihood of rebreathing carbon dioxide exhaled by the user. Although the bias flow holes 2110 are shown exclusively on the connector 2106, in some configurations, the bias flow holes 2110 are provided in the housing 2102, the mask seal 2104, or any combination of the connector 2106, the housing 2102, and the seal 2104, or any other component of the interface assembly or associated breathing circuit. The bias flow holes 2110 can have any suitable cross-section and can be cylindrical, hourglass shaped, tapered in both directions, fully or partially tapered, fully or partially cylindrical and contoured to vary in cross-section, etc.

[0111] The housing 2102 provides some support structure to the mask assembly 2100 generally, and more specifically, to the mask seal 2104. The housing 2102 may be formed from any suitable material. In some configurations, the housing 2102 is formed from a fairly rigid material. In some configurations, the housing 2102 is formed from a plastic material, such as a polycarbonate material. In some configurations, the mask assembly 2100 may include a mask seal including a mask seal clip that is separate from but attachable to the housing. In such configurations, the mask seal clip connects the mask seal 2104 to the housing 2102. In such configurations, the mask seal and mask seal clip may be formed separately and secured together, or the mask seal and mask seal clip may be incorporated into a single component. In some configurations, the mask seal may be overmolded onto the mask seal clip, and in some configurations, the mask seal 2104 may be overmolded directly onto the housing 2102, which may include, for example, chemical and / or mechanical overmolding.

[0112] In some configurations, the housing 2102 comprises a substantial portion of the anterior wall of the mask assembly 2100. Such an arrangement provides an advantageous level of support for the mask seal 2104. For example, the housing 2102 comprises a substantial portion of the mouth portion of the anterior wall of the mask assembly 2100. In some configurations, the housing 2102 is entirely restricted to the mouth portion of the mask assembly 2100 and does not extend to the nose portion of the mask assembly 2100, at least to an extent that affects it. Such an arrangement may provide support for the mask seal 2104 while advantageously allowing movement or deformation of the nose portion of the mask seal 2104. In other arrangements, the housing 2102 may extend to the nose portion to provide additional support to the nose portion as needed. In the illustrated configuration, the housing 2102 extends rearward from a central portion 2112 toward opposing side portions 2116. The central portion 2112 includes an aperture 2114 for receiving the connector 2106. The housing 2102 may have an overall or substantially constant height throughout the central portion 2112 and the opposing side portions 2116. In other arrangements, the housing 2102 may vary in height, such as by forming a shape that generally mimics the shape of the front of the mask seal 2104. The height of the housing 2102 may be substantially equal to the height of the mouth portion of the mask seal 2104. The width of the housing 2102 may include a significant portion of the overall width of the mouth portion of the mask assembly 2100, such as at least about three-quarters of the overall width of the mouth portion of the mask assembly 2100. Such an arrangement of the housing 2102 may reinforce the center and lateral portions of the mask seal 2104. In some configurations, the housing 2102 may be minimal, such as, for example, an annular support ring or frame.

[0113] The mask seal 2104 is designed to seal against the face of a user. The mask seal 2104 is preferably formed of a soft material such as, for example, but not limited to, silicone. In some configurations, at least portions of the mask seal 2104 may be textured to enhance user comfort. For example, in some configurations, at least portions of the mold used to form the illustrated mask seal 2104 may be bead blasted to provide a surface texture at least in the area of ​​the mask seal 2104 that contacts the user's skin. Other techniques for texturing one or more surfaces of the mask seal 2104 may be used. In some configurations, it may be desirable to avoid surface texturing and provide a smooth surface texture on at least the face-contacting surface of the mask seal 2104, which may increase the grip of the mask seal 2104 on the user's face and improve sealing characteristics.

[0114] As mentioned above, the illustrated mask seal 2104 comprises a nose-mouth mask seal and, as such, includes at least one mouth opening 2122 and at least one nose opening 2124. In some configurations, the mask seal 2104 may include a combined mouth-nose opening. In some configurations, the mask seal 2104 may include two or more nose openings 2124. In some configurations, the mask seal 2104 may include nose openings 2124 defined in an upper structure, such as pillows, prongs, etc. In some configurations, the nose openings 2124 may be defined by nasal cushions or inserts that may be overmolded or otherwise secured to the base structure of the mask seal 2104. Examples of such arrangements are disclosed in applicant's publication WO 2014 / 062070, which is incorporated herein by reference in its entirety.

[0115] The at least one oral opening 2122 and the at least one nasal opening 2124 preferably communicate with a single chamber 2125 defined within the mask assembly 2100. The chamber 2125 of the illustrated mask assembly 2100 is defined at least in part by the housing 2102 and the mask seal 2104. The at least one oral opening 2122 is substantially opposite the aperture 2114 that receives or communicates with the connector 2106. The at least one nasal opening 2124 may be vertically above the at least one oral opening 2122. The at least one nasal opening 2124 may be positioned between the aperture 2114 for the connector 2106 and the at least one oral opening 2122 in the anterior-posterior direction of the mask assembly 2100. The at least one nasal opening has an axis that is oblique to the vertical and, in some arrangements, may extend entirely through the aperture 2114 for the connector 2106.

[0116] The mask seal 2104 preferably includes a pair of paddles 2126 extending upwardly above an upper surface 2130 (see, e.g., FIG. 7) of a central portion of the mask seal 2104. The upper surface 2130 may define a line lying along the central plane of the nasal surface of the mask seal 2104 in the anterior-posterior direction. Such a line generally extends along the nasal septum in a direction away from the user's face. The paddles 2126 are configured to extend parallel to the nares and, in some configurations, upwardly above the nares. The paddles 2126 may contact the edges of the nares and / or the sides of the nose. The paddles 2126 or portions of the mask seal 2104 between the paddles 2126 may or may not cover the tip of the user's nose. As described herein, preferably, the mask seal 2104 does not contact the bridge of the user's nose.

[0117] In some configurations, the paddles 2126 each include an air pocket that is in direct fluid communication with the air path through the mask assembly 2100 from the connector 2106 to the at least one nasal opening 2124 and the at least one mouth opening 2122. The paddles 2126 may be configured to expand in volume in response to an increase in pressure within the mask seal 2104 and / or to flex inward to conform to various facial and nasal geometries to assist in creating a sealing contact with the user's face. The expansion of the paddles 2126 may assist in sealing against the user's face, particularly along various contours at and around the user's nose. The inward flexing of the paddles 2126 may allow a central portion (e.g., upper surface 2130) to move downward with less constraint or stretching of the mask seal 2104 material, thereby allowing the mask seal 2104 to better conform to various nasal geometries. Similarly, as described in more detail below, the cutout area 2202 of the support structure 2163 may advantageously allow the mask seal 2104 to maintain sealing contact with the user's face in response to an increase in pressure within the mask seal 2104.

[0118] The height of the paddles 2126 above the upper surface 2130 may be selected to provide a desirable balance between stability of the mask seal 2104 on the user's face (e.g., vertical stability) and the ability to accommodate a range of nasal geometries or reduce visual collapse due to the paddles 2126. Generally, taller paddles 2126 tend to provide additional vertical stability to the mask assembly 2100, while shorter paddles 2126 tend to better accommodate a wider range of users and cause less visual collapse. In some configurations, the paddle height 2126 is about 10 mm to about 30 mm, or about 15 mm to about 25 mm. In some configurations, the paddle height 2126 is about 15 mm to about 22 mm, or about 18 mm to about 20 mm, including any value or subrange within the aforementioned ranges. In some configurations, the paddle height is about 18.5 mm.

[0119] The mask seal 2104 may also include support structures or supports 2163 for the paddles 2126, which may be in the form of suspension members or springs that provide mechanical rigidity and structure to retain the shape of the paddles 2126 when the mask seal 2104 is worn by a user. The supports 2163 may include thickened regions of seal material. The supports 2163 are preferably sized, shaped, and / or otherwise configured to transmit forces from the rear or user-contacting surface of the paddles 2126 toward or to the front surface of the paddles 2126. In some configurations, the interface may include a support portion or cover for the paddles 2126, and the supports 2163 may transmit forces from the rear surface of the paddles 2126 to the front surface or other portion of the paddles 2126 or mask seal 2104 that contacts or faces the support portion or cover. In some configurations, the supports 2163 may transmit force from the posterior face of the paddles 2126 toward or to another support portion (e.g., the housing 2102) or interface of the mask seal 2104. The supports 2163 may resist or prevent the paddles 2126 or other associated or adjacent portions of the mask seal 2104 from collapsing to facilitate donning and to provide feedback to the user, such as in response to applied force (e.g., headgear force). In some configurations, the supports 2163 may resist or prevent the paddles 2126 or other associated or adjacent portions of the mask seal 2104 from collapsing in the absence of significant internal gas pressure.

[0120] The support 2163 may, at least in response to forces experienced during normal use, help maintain the shape of the paddles 2126 of the mask seal 2104 and / or help maintain separation between the rear wall of the mask seal 2104 (which defines the face-contacting surface) and the front wall of the mask seal 2104. Additionally, the support 2163 may provide support to the nose region or nose seal portion 2168. In particular, the support 2163 may provide structure to the nose seal portion 2168 and / or the front upper portion 2150 and inhibit or prevent them from folding, wrinkling, or collapsing. As mentioned above, the nose region 2168 and / or front upper portion 2150 are preferably relatively thin, allowing these portions of the mask seal 2104 to conform to the user's nose. The relatively thin nose region 2168 and / or front upper portion 2150 may expand to seal around the user's nose. When a user engages the user's nose with the mask assembly 2100, the support 2163 provides a rigid portion or element of the seal 2104 adjacent to or near the relatively thin nose seal portion 2168 and / or front upper 2150 to inhibit or prevent collapse. The rear upper 2156 may assist in preventing collapse of the nose region 2168 and / or front upper 2150.

[0121] In some configurations, the supports 2163 serve to reduce the likelihood of wrinkles or creases forming in the face-contacting portion of the paddle 2126 during use, while allowing the laterally inner portions to be as thin as possible, as desired, within practical limits, as discussed above. The supports 2163 may inhibit or prevent collapse of the paddle 2126 or assist in maintaining a desired shape of the paddle 2126. For example, the supports 2163 may assist in maintaining a desired front-to-back shape of the paddle 2126 and / or a lateral or side-to-side shape of the paddle 2126. The level of support provided may be different in different directions. In some configurations, the supports 2163 may be formed as a separate piece or component from the seal material and may be the same or a different material. Such separate supports 2163 may be coupled to other portions of the paddle 2126 or mask seal 2104 as needed. The supports 2163 disclosed herein may be particularly useful in under-the-nose mask assemblies, including both nasal masks and combination nose-and-mouth masks. However, support 2163 may also be used with other types of mask assemblies or interfaces, including, for example and without limitation, those that cover, contact, or seal with the bridge of the user's nose and / or include a T-piece or other type of forehead support. Support 2163 may be used or modified for use at any point in the interface where support against collapse and / or support against overexpansion may be desired. Such points may be at or near the portion of the seal that contacts or extends with the user's nose, or may be at other points.

[0122] In the illustrated arrangement, at least a portion of the support 2163 extends generally in the anterior-posterior direction along the paddle 2126. In particular, the support 2163 may extend along the upper edge of the paddle 2126 or along a region or ridge along the upper edge of the paddle 2126 where the laterally outer surface portion and the laterally inner surface portion join. The support 2163 may extend along a portion of the side of the nasal region 2168. The support 2163 may include an overall thin, elongated shape. When viewed from above, the support 2163 may include a generally triangular shape, with the base of the triangle positioned posterior to the apex or point of the triangle. Other shapes are possible to achieve a desired level of support or for other design considerations, such as the desired shape of adjacent or nearby structures. The support 2163 may have additional portions to provide other levels of support or may provide support in other directions. For example, the supports 2163 may connect to each other, such as along one or both of the anterior or posterior sides of the nasal opening 2124. In some configurations, the support 2163 may extend completely through the paddle 2126, such as all the way to the housing 2102.

[0123] As shown in FIGS. 7-18B , the paddles 2126 (or, for example, the supports 2163) may each include a thinned and / or cutout region 2202. The cutout region 2202 extends posteriorly and is positioned below the nasal region of each paddle 2126. In some configurations, the cutout region 2202 extends posteriorly and is positioned adjacent the nasal region of each paddle 2126. However, in other configurations, the cutout region 2202 extends posteriorly and is positioned laterally offset from the nasal region of each paddle 2126. The cutout region 2202 may extend from the upper front portion 2150 of the mask seal 2104 to the upper rear portion 2151 of the mask seal 2104 such that the cutout region 2202 wraps around the outer portion 2210 of each paddle 2126. Thus, in some configurations, the cutout area 2202 is generally curved, straight, and / or has variable curvature. In some configurations, the cutout area 2202 may be sloped from the front upper 2150 to the back upper 2151 and / or from the back upper 2151 to the front upper 2150. In some other configurations, the cutout area 2202 is substantially flat or has minimal slope.

[0124] As shown in the illustrated configuration, the cutout region 2202 extends across at least a portion of the upper front portion 2150 and at least a portion of the upper rear portion 2151. For example, the cutout region 2202 extends around the outer portion 2110 of the mask seal 2104 and across the upper rear portion 2151 toward approximately the center of the upper rear portion above the mouth opening 2122. In some configurations, the cutout region 2202 extends across approximately 1 / 16, 1 / 8, 1 / 4, and / or 1 / 2 or more of the upper rear portion and / or upper front portion. In some configurations, the cutout region 2202 extends across the upper rear portion 2151 a distance that falls short of reaching the outer portions of the nasal openings 2124 of the nasal region 2200.

[0125] In the illustrated configuration, the cutout region 2202 is positioned below the nasal region of the paddle 2126. However, in other configurations, the cutout region 2202 may be positioned above and / or flush with the nasal region of the paddle 2126. For example, the cutout region 2202 may be positioned approximately 0.1-0.5 mm, 0.5-1 mm, 1-10 mm, 10-50 mm, 50 mm-1 cm, 1 cm-2 cm, and / or 2 cm-3 cm or more below the nasal region of the paddle 2126. In some configurations, the cutout region 2202 is positioned approximately adjacent above the mouth opening 2122. In yet other configurations, the cutout region 2202 is positioned above, below, and / or flush with the nasal opening 2124. However, in some configurations, the cutout region 2202 extends along the outer side of the paddle 2126. In such a configuration, the cutout area 2202 may not extend across a portion of the upper front portion 2150 and / or a portion of the upper back portion 2151 and may be limited to the paddle 2126 or terminate within the nose region 2200.

[0126] As shown in FIGS. 7-18B , the illustrated mask seal 2104 of the mask assembly 2100 includes a range and configuration of thicknesses. The thicknesses are varied to utilize or provide different characteristics in different regions of the illustrated mask seal 2104. For example, the thicknesses of various regions may be selected to address desired characteristics for that region and / or for the mask seal 2104 as a whole. Such characteristics may include, for example, allowing the mask seal 2104 to conform to the geometry of the user's face to enhance seal or comfort, lacking significant internal gas pressure to facilitate donning and / or maintaining the shape of the mask seal in response to internal gas pressure and / or external pressure (e.g., due to headgear forces), or providing strength or durability.

[0127] As mentioned above, the mask seal 2104 may include various regions of different thicknesses. Examples of such arrangements are described in applicant's publication WO 2015 / 193821, which is incorporated herein by reference in its entirety. Generally, the outer surface of the mask seal 2104 defines a relatively smoothly shaped or curved surface without abrupt changes in direction. The different thicknesses may result from changes in apparent wall thickness or from changes in the shape of the inner surface of the mask seal 2104.

[0128] The support 2163 can have a different thickness than the rest of the paddle 2126 and can be thicker than the rest of the paddle 2126. In some configurations, the support 2163 can have the greatest thickness or can be one of the greatest thicknesses of the mask seal 2104. In some configurations, the partial or total thickness of the support 2163 can be from about 1.5 mm to about 3.5 mm. In the illustrated configuration, the partial or total thickness of the support 2163 can be about 2.5 mm. The thickness of the support 2163 can be constant or variable.

[0129] In some configurations, the support structure 2163 for the paddles is thicker than the nasal region 2168 and the upper front surface 2150. In some configurations, a relatively abrupt transition in thickness occurs between the nasal region 2168 and the upper front surface 2150 and the paddles 2126. In contrast, the transition in thickness between the outer periphery 2162, the paddles 2126 and the upper rear surface 2151 is more gradual. Furthermore, in at least some configurations, the transition in thickness between the outer periphery 2162, the upper rear surface 2151 and the mouth opening 2122 is relatively gradual. The various portions of the mask seal 2104 are further described below.

[0130] To reduce the occurrence of wrinkles in at least some of the face-contacting regions of the mask seal 2104 during use, it has been found that the outer periphery 2162 of the mask seal 2104, generally adjacent some or all of the face-contacting portions of the mask seal 2104, provides the desired performance when the outer periphery 2162 is substantially stiff or relatively stiff compared to adjacent or other portions of the mask seal 2104. In the illustrated arrangement, the outer periphery 2162 extends along a generally vertically extending portion of the rear of the mask seal 2104 and wraps slightly inward at the bottom of the rear of the mask seal 2104. Additionally, the outer periphery 2162 wraps from the rear-facing side of the mask seal around at least a portion of the side-facing side of the mask seal 2104.

[0131] In the illustrated arrangement, the outer perimeter 2162 is disposed on each outer portion of the mouth opening 2122. In some configurations, the outer perimeter 2162 extends along the entire height of the mouth opening 2122. The upper end of the outer perimeter 2162 may extend at least to about the upper end of the mouth opening 2122. The lower end of the outer perimeter 2162 extends below the lower end of the mouth opening 2122. As mentioned above, in some configurations, the outer perimeter 2162 wraps inwardly below the mouth opening 2122 such that portions of the outer perimeter 2162 are positioned vertically below portions of the mouth opening 2122.

[0132] The relatively increased thickness of the outer periphery 2162 may help resist or prevent collapse of the mask seal 2104 in the absence of significant internal gas pressure to facilitate donning and provide feedback to the user, such as in response to applied forces (e.g., headgear forces). The outer periphery 2162 may help maintain the curved shape of the outer portion of the mask seal 2104 and / or may help maintain the separation between the rear wall of the mask seal 2104 (which defines the face-contacting surface) and the front wall of the mask seal 2104, at least in response to forces experienced during normal use. In some configurations, the partial or total thickness of the outer periphery 2162 may be between about 1.0 mm and about 2.0 mm. In the illustrated configuration, the partial or total thickness of the outer periphery 2162 is preferably about 1.5 mm. The thickness of the outer periphery 2162 may be consistent or vary within the boundaries of the outer periphery 2162.

[0133] In some configurations, the wall thickness of the cutout region 2202 is thin relative to the surrounding sealing surface (e.g., support structure 2163). For example, the wall thickness of some or all of the cutout region 2202 can be thin relative to the surrounding sealing surface, and in at least some embodiments, all or a portion of it can be defined by all or a portion of the support structure 2163. In some configurations, the wall thickness of the surrounding sealing surface is approximately 3 mm. As noted above, the thickness of some or all of the surrounding sealing surface, including the outer periphery 2162, can be from about 1.0 mm to about 2.0 mm. However, the cutout region 2202 of the support structure 2163 can have a wall thickness of, for example, about 0.1-0.2 mm, 0.2-0.3 mm, 0.3-0.4 mm, 0.4-0.5 mm, 0.5-0.6 mm, 0.6-0.7 mm, 0.7-0.8 mm, 0.8-0.9 mm, and / or 0.9-1.0 mm or more. In the illustrated configuration, part or all of the cutout area 2202 preferably has a wall thickness of about 0.3 mm. The thickness of the cutout area 2202 may be consistent or may vary within the boundaries of the cutout area 2202.

[0134] A thinner wall thickness of the cutout region 2202 relative to the surrounding sealing surface may desirably provide a region that is more deformable and / or compressible than the surrounding sealing surface. For example, the cutout region may be less rigid and / or more expandable than the surrounding sealing surface. This may be desirable when lateral forces are applied to the paddle 2126, such as by a wider nose. As such, the cutout region 2202 may be more easily compressible and better accommodate lateral forces applied to the nasal region of the paddle 2126 compared to a paddle 2126 without the cutout region 2202 and / or with or without the support structure 2163. Instead of remaining rigid, the cutout region 2202 allows the paddle 2126 to compress while maintaining the structural integrity of the mask seal assembly (see, e.g., FIGS. 10A-10C, 11A-11B). This configuration may be more comfortable for a patient wearing the mask seal assembly.

[0135] In some configurations, the cutout areas 2202 of the support structure 2163 of the mask seal 2104 include a concave contour 2204. For example, FIG. 8 shows that the cutout areas 2202 include a concave contour 2204 in the posterior portion 2160 of the cutout areas 2202. In the configuration shown, a relatively low point of the concave contour 2204 is positioned approximately in the center of the posterior portion 2160 of each cutout area 2202. However, in other configurations, the concave contour is positioned closer to one side. In still other configurations, the concave contour 2204 of the cutout area 2202 is positioned closer to the nasal region of the paddle 2126.

[0136] In some configurations, the cutout area 2202 includes a concave contour 2204 along a portion or the entire length of the cutout area 2202. In the configuration shown, a relatively low point of the concave contour 2204 is positioned approximately in the center of the width of the cutout area 2202. However, in other configurations, the concave contour 2204 is positioned closer to one side. In still other configurations, the concave contour 2204 of the cutout area 2202 is positioned closer to the nasal region of the paddle 2126. As shown in FIG. 8 , the concave contour 2204 transitions smoothly inward along the posterior portion 2160 of the cutout area 2202. In some configurations, the concave contour 2204 extends inward toward the upper front surface 2150 of the mask seal 2104 a relatively short distance. In some configurations, the concave contour 2204 extends inward toward the upper front surface 2150 of the mask seal 2104 a more substantial distance. In some configurations, the concave contour 2204 extends downwardly along the rear surface 2160 of the cutout area 2202 .

[0137] In general, the expansion of the paddles 2126 may assist in sealing against the user's face, particularly along the varying surface contour 2206 at and around the user's nose. For example, as shown in FIG. 8 , the nasal region 2168 includes a surface contour 2206. The surface contour 2206 may extend along the inner surface of the nasal region 2168. The surface contour 2206 may extend generally inward from the upper posterior surface of the mask seal 2104 toward the center of the upper anterior surface 2150 of the mask seal 2104. The surface contour 2206 desirably enhances patient comfort and helps ensure a seal is formed with the user's face, while allowing for outward movement of the nasal region 2168 as needed to accommodate a particular user.

[0138] 9A-9D show close-up views of the concave contour 2204 of the cutout region 2202 of the support structure 2163. As shown in the illustrated configuration, the concave contour 2204 may extend vertically downward (relative to the orientation shown in FIGS. 9A-9D) and inward toward the interior of the mask seal 2104. As such, the concave contour 2204 allows the cutout region 2202 to fold inward toward the interior of the mask seal 2104 when sufficient force is applied to the paddle 2126.

[0139] In general, the concave contour 2204, surface contour 2206, and / or thin wall thickness of the cutout region 2202 may contribute to reducing material, which may desirably reduce bulk and increase patient comfort. In some configurations, the concave contour 2204 may encourage the walls of the cutout region 2202 to fold inward toward the internal chamber 2125 of the mask seal assembly. This may advantageously reduce bulk as the mask seal 2104 folds against the patient's face. Similarly, the concave contour 2204 of the cutout region 2202 may help minimize leakage by providing a better seal with the user's face when the mask seal 2104 is worn by the user. For example, rather than expanding and / or bulging outward as the mask seal 2104 expands laterally, the cutout portion 2202 may advantageously fold inward to maintain engagement with the user's face and prevent the mask seal 2104 from shifting to an undesirable position.

[0140] In some configurations, the concave contour 2204 may allow the cutout area 2202 to better compress when a force is applied to the paddle 2126. As described above, the concave contour 2204 may allow the cutout area 2202 to fold laterally and / or vertically and inward when a lateral force is applied to the paddle 2126.

[0141] 10A-10C and 11A-11B show top views of a mask assembly showing the cutout region 2202 of the mask seal 2104. In this example, a constant lateral force 2400 is applied to the nasal region 2402 of the paddle 2126. In some configurations, the lateral force 2400 results from the user's nose being wider than the neutral width of the nasal region 2402 (e.g., when no or minimal lateral force is applied to the nasal region 2402). However, in other configurations not shown, the force may be applied in either direction and / or may be varied. As shown in the illustrated example, when force 2400 is applied to the paddle 2126, the cutout region 2202 may compress. FIG. 10A shows an exemplary configuration when no or little force is applied. As shown, the support structure 2163 includes an inner region 2404 and an outer region 2406, which cooperate to define the cutout region 2202. In such a configuration, the cutout region 2202 separates the inner region 2404 and the outer region 2406. When no or low force is applied to the paddle 2126, the outer ends of the inner region 2404 and the outer region 2406 are separated by a gap 2408. FIG. 10B illustrates the configuration of the mask seal 2104 when a lateral force 2400 is applied to the nasal region of the paddle 2126. As shown in the illustrated configuration, the inner region 2404 compresses toward the outer region 2406 of the cutout region 2202. In the illustrated configuration, the outer region 2406 remains relatively stationary when the lateral force 2400 is applied to the nasal region of the paddle 2126. 10B, the size of the gap 2408 decreases as the inner region 2404 of the cutout area 2202 is compressed. As the paddle 2126 is compressed, the inner region 2404 moves toward the outer region 2406. In some configurations, depending on the amount of force applied to the nose region, the inner region 2404 of the cutout area 2202 does not touch and / or overlap the outer region 2406. However, as shown in FIG. 10C, the inner region 2404 may touch and / or at least partially overlap the outer region 2406.

[0142] In some configurations, the mask seal 2104 provides flexibility to the nasal sealing surface to accommodate various user nasal geometries and different sized nasal regions, particularly various nose widths. In some such configurations, the seal 2104 described herein pinches inward on the outside of the user's nose to improve the seal with the user's lower nasal surface.

[0143] As shown in FIGS. 12-15 , the mask seal may include a narrower nose region width 2410 compared to other mask seals. A narrower nose region width 2410 may desirably provide a sense of increased secure engagement with the sides of the user's nose. For example, the nose region width 2410 may be approximately one-half the width of the top of the mask seal 2104. In some configurations, the nose region width 2410 is approximately one-quarter the width of the top of the mask seal 2104. In some configurations, the nose region width 2410 may extend outward from the center of the mask seal 2104 toward the outer periphery 2162 of the mask seal 2104 a distance less than the lateral width of the mouth opening 2122. In some configurations, the nose region width 2410 extends outward from the center of the mask seal 2104 toward the outer periphery 2162 of the mask seal 2104 a distance approximately equal to and / or greater than the lateral width of the mouth opening 2122. In some configurations, the nose region width 2410 extends outward from the center of the mask seal 2104 to the cutout region 2202.

[0144] In some configurations, the total nose region width 2412 is approximately 20 mm to 25 mm wide, 25 mm to 30 mm wide, 30 mm to 35 mm wide, 35 mm to 40 mm wide, 40 mm to 45 mm wide, 45 mm to 50 mm wide, and / or 50 mm or wider. Preferably, the total nose region width 2412 is approximately 40 mm wide.

[0145] In some configurations, a narrow overall nose region width 2412 may increase engagement with the sides of the user's nose during wear. As such, the mask seal 2104 may provide a better seal with the user's face, as described above. Such a configuration may allow the user to feel that the mask seal 2104 is correctly positioned and / or has a proper seal with the user's nose. In some configurations, the paddles 2126 of the mask seal 2104 may pinch inward on the user's nose, increasing the sealing force applied to the user's nose.

[0146] In some configurations, the mask assembly includes a front portion 2420. The front portion 2420 may include a recessed front surface 2430 and one or more scalloped outer portions 2440. For example, FIG. 16 shows an example of a mask assembly 2100 including a recessed front surface 2430 formed by the housing or mask shell 2102. The recessed surface 2430 may be positioned in front of the mask seal 2104 and may be configured to receive the frame 2178. The recessed front surface 2430 may be formed along part or all of the periphery of the housing or mask shell 2102 to which the seal 2104 is joined. In the illustrated example, the recessed front surface 2430 forms a step in the surface of the front portion 2420. The recessed front surface 2430 generally extends along the sides and bottom edge of the periphery of the housing 2102. In some configurations, the step tapers in depth along its length, with no or little step along the upper peripheral edge of the housing 2102, allowing the seal 2104 to be flush with the housing 2102 along the upper peripheral edge of the housing 2102.

[0147] The depth of the step may depend on the size of the seal 2104. For example, the seal 2104 may be provided in a range of sizes to accommodate users with a range of facial sizes and geometries. In some configurations, the seal 2104 is bonded to a single-sized housing 2102. In some configurations, the varying sizes of the seal 2104 relative to the housing 2102 determine the depth of the step. In some configurations, the recessed front surface 2430 is recessed to a constant or variable depth. For example, the depth of the recessed front surface 2430 may be constant throughout the entire surface of the recessed front surface 2430. However, in some configurations, the upper recessed surface 2432 (described in more detail below) is recessed to a depth that is less than and / or greater than the depth of the remaining areas of the recessed front surface 2430.

[0148] In some configurations, the front surface 2420 includes a top recessed surface 2432 formed in the seal 2104. The top recessed surface 2432 may be positioned on the front top 2150. In the configuration shown, the top recessed surface 2432 is positioned along the front side of the paddle 2126. The top recessed surface 2432 may extend along the outer periphery 2162 of the front side 2422 of the mask seal 2104. The top recessed surface 2432 may extend rearward around the side of the mask seal 2104. In some configurations, the top recessed surface 2432 substantially wraps around the outer periphery 2162 of the mask seal 2104. In some configurations, the top recessed surface 2432 is positioned on only a portion of the outer periphery 2162. For example, the upper recessed surface 2432 can extend down approximately half the height of the front side 2422 on either side of the seal 2104. In some configurations, the upper recessed surface 2432 extends down less than half the height of the front side 2422 and possibly about one-third of the height of the front side 2422.

[0149] In some configurations, the upper recessed surface 2432 forms a stepped transition between the upper periphery of the front upper portion 2420 or the upper edge of the paddle 2126 that extends along the curvature of the periphery. In some configurations, the stepped transition extends to a constant depth or a variable depth. For example, the depth of the stepped transition may be constant throughout the stepped transition between the upper periphery of the front upper portion 2420 and the recessed front surface 2430. However, in some configurations, the stepped transition varies. For example, the stepped transition may be tapered. In this arrangement, the depth may be smallest at the lower or lateral ends of the stepped transition. However, in some embodiments, the depth may be smallest at the upper end of the stepped transition.

[0150] The depth of the stepped transition may depend on a number of factors, including the size of the mask seal. For example, the depth of the taper of the stepped transition may be deeper for larger mask seals or shallower for smaller mask seals. In some configurations, the upper front surface 2420 includes multiple upper corners. For example, the upper front surface 2420 may include a first upper corner and / or a second upper corner. The multiple upper corners may be formed in the front portion of the paddle 2126. The multiple upper corners may define all or part of the perimeter of an upper recessed surface 2432 that extends along the perimeter of the upper front surface 2420.

[0151] In some configurations, the depth of the stepped transition and / or the taper of the stepped transition is greater at the corners compared to a central top positioned generally between the upper corners (e.g., between a first upper corner and a second upper corner).

[0152] In some configurations, the recessed front surface 2430 and / or the top recessed surface allow the frame 2178 to be inserted into the mask seal 2104. For example, the top recessed surface 2432 may receive all or a portion of the frame 2178. As such, in some configurations, the stepped transition of the top recessed surface 2432 has a maximum depth that is equal to or greater than the thickness of the frame. Similarly, the recessed front surface 2430 may receive all or a portion of the frame 2178. These configurations may advantageously provide a somewhat flatter finish, which is more aesthetically pleasing to the user. In some configurations, the visual size of the mask seal 2104 may be reduced and / or the amount of material used in the mask seal may be reduced. As such, in some configurations, the mask seal 2104 is less bulky and / or less noticeable to the user (see, e.g., FIG. 17 ).

[0153] In some configurations, the upper recessed surface 2432 may be provided only on some sealing cushion sizes. For example, the upper recessed surface 2432 may be provided only on some medium or large mask seals 2104. In some configurations, the upper recessed surface 2432 is provided on some small or medium size mask seals 2104. In some configurations, the upper recessed surface 2432 may be present on all sizes of mask seals 2104. The depth of the upper recessed surface 2432 may vary depending on the size of the mask seal 2104. In some configurations, the depth of the recessed upper portion may be substantially the same as the thickness of the frame 2178 for small and / or medium size mask seals 2104, and the depth may exceed the thickness of the frame 2178 for large mask seals 2104 (e.g., sizes larger than the small and / or medium size mask seals 2104). In such a configuration, this may result in the mask seal 2104 overhanging and / or extending beyond the frame 2178. In some configurations, the upper recessed surface 2432 is configured to allow a single size frame to be used with multiple mask seals 2104 of various sizes without the frame 2178 being too large or too small for the multiple mask seals 2104.

[0154] In some configurations, the upper recessed surface 2432 provides better support for the nasal sealing surface. For example, FIG. 17 shows a frame 2178 and a frame paddle 2179 inserted into and / or positioned within the upper recessed surface 2432. As shown in the illustrated configuration, the frame paddle 2179 can be positioned within the upper recessed surface 2432. In this configuration, the outer surface of the frame paddle 2179 rests flush with the upper recessed surface 2432. This arrangement can provide additional rigidity to the anterior side 2422 of the mask seal 2104 and the paddle 2126, thereby providing additional support for the nasal sealing surface. In some configurations, the frame paddle 2179 desirably supports the seal paddle 2126. In such a configuration, the frame paddle 2179 can help prevent the seal paddle 2126 from flexing away from the user's nose during use. In some configurations, this arrangement may help prevent the frame paddle 2179 from contacting or digging into the user's face if the mask seal 2104 is overly deformed. As such, in some configurations, the recessed front surface 2430 may advantageously allow the mask seal 2104 to maintain its structure over time and increase the durability of the mask seal 2104. In some configurations, the recessed front surface 2430 allows a single size frame 2178 to be used with mask seals 2104 having a variety of sizes. As such, in some configurations, the recessed front surface 2430 reduces the manufacturing costs of the mask assembly.

[0155] 18A and 18B show an example of a mask seal 2104 that includes a scalloped outer portion 2440. The scalloped outer portion 2440 may advantageously reduce the amount of material in the mask seal 2104 and may provide a more aesthetically pleasing or visually smaller mask seal 2104. As shown in the illustrated configuration, the outer wall of the mask seal 2104 transitions smoothly along the outer periphery 2162 of the mask seal 2104. However, in other configurations, the outer periphery 2162 may include at least three distinct sections (e.g., an upper portion, a central portion, and a lower portion), and the outer periphery 2162 may not transition smoothly between each section.

[0156] In the illustrated configuration, the scalloped outer portion 2440 forms a recessed portion along the side of the mask seal 2104. The scalloped outer portion 2440 may be positioned below the paddle 2126 along the outer periphery 2162 of the mask seal 2104. In some configurations, the scalloped outer portion 2440 is positioned at least partially overlapping the bottom of the paddle 2126. In some configurations, the scalloped outer portion 2440 is positioned entirely below the paddle 2126. In some configurations, the center 2442 of the recessed portion of the scalloped outer portion 2440 is approximately aligned with the top of the mouth opening 2122. In some configurations, the center 2442 of the recessed portion is positioned above the mouth opening 2122 but below the nasal region 2168. In some configurations, the center 2442 of the recessed portion is positioned above the nasal region 2168.

[0157] In some configurations, the scalloped outer portion 2440 extends along approximately one-half of the outer perimeter 2162 of the mask seal 2104. In some configurations, the scalloped outer portion 2440 extends along approximately one-eighth, one-quarter, one-third, three-quarters, or more of the outer perimeter 2162 of the mask seal 2104.

[0158] As shown in the illustrated configuration, the scalloped outer portion 2440 may provide additional vertical support to the nasal region 2168. For example, the scalloped outer portion 2440 may provide additional support when lateral forces are applied to the nasal region and / or when pressure increases within the mask seal 2104. For example, the scalloped outer portion 2440 may advantageously help transfer loads from the cheeks to the frame 2178 on the sides of the mask seal 2104, among other portions of the mask seal 2104, thereby helping to maintain engagement with the user's face. As such, the scalloped outer portion 2440 may improve the seal between the user's nose and the mask seal 2104.

[0159] 19A and 19B show an example of a mask assembly 2100 that includes a recessed front surface 2430 formed by the housing or mask shell 2102. The recessed front surface 2430 may be positioned in front of the mask seal 2104 and can accommodate various configurations of a frame 2178. For example, as shown in FIGS. 19A and 19B, the frame 2178 and frame paddle 2179 are inserted into and / or positioned within an upper recessed surface 2432 that may be defined in whole or in part by the seal 2104.

[0160] In some configurations, the housing 2102 may include a bias vent 2502. The bias vent 2502 may include multiple orifices configured to exhaust and flow CO2 to reduce the likelihood of rebreathing carbon dioxide exhaled by the user. While the orifices of the bias vent 2502 are shown exclusively on the housing 2102, in some configurations the bias vent 2502 may be located on the mask seal 2104, elbow 2520, or other conduit connector, or any combination of the housing 2102, mask seal 2104, elbow 2520, or any other component of the interface assembly or associated breathing circuit. The orifice may have any suitable cross-section and may be cylindrical, hourglass-shaped, tapered in both directions, fully or partially tapered, fully or partially cylindrical, contoured to vary in cross-section, etc. The cross-section of the orifice may increase or decrease exhaust airflow through the orifice.

[0161] In some configurations, the frame 2178 may have attached and / or otherwise include an elbow 2520. While FIGS. 19A and 19B show an example of a mask assembly 2100 in which the elbow 2520 is attached to the frame 2178, in some configurations the elbow is attached directly to the mask housing 2102 and / or the mask seal 2104, among other mask components. The elbow may be removably and / or permanently attached to the frame 2178 and / or the housing 2102. The elbow 2520 may form a non-horizontal connector. For example, the elbow 2520 may include a bend. In some configurations, the elbow 2520 bends at an angle of approximately 10-20 degrees, 20-30 degrees, 30-40 degrees, 40-50 degrees, 50-60 degrees, 60-70 degrees, 70-80 degrees, and / or 80-90 degrees, among other ranges. Such a configuration may desirably reduce the bulk of the mask assembly, save material, and / or redirect air flow in a desired direction. In some configurations, the elbow 2520 is horizontal, vertical, or straight.

[0162] The elbow 2520 may include an upper portion and a lower portion. The upper portion and lower portion may be separated by a bend as described above. The elbow 2520 may include various connection features, such as a frame connection slot 2532, a retention notch 2534, and an inlet connector 2530, among others. The inlet connector 2530 forms the upper portion of the elbow 2520 such that the inlet connector 2530 may connect with the inlet 2510 of the mask housing 2102. The inlet connector 2530 may removably connect the elbow 2520 to the inlet 2510 via a snap fit, press fit, interference fit, and / or other mating configuration. Thus, in some configurations, the elbow 2520 may be connected at one end (e.g., the bottom) to a gas supply conduit (not shown), and an inlet connector 2530 positioned at another end (e.g., the top) of the elbow 2520 provides a flow path through which a flow of pressurized gas is delivered to the user through the internal chamber 2125 of the mask seal 2104.

[0163] The frame connection slot 2532 may be formed by a slot or cutout in the elbow 2520. In some configurations, the frame connection slot 2532 may be formed by a plurality of protrusions, such as ribs, extending outward from adjacent surface portions of the elbow 2520. For example, as shown in FIGS. 26 and 28 , the elbow 2520 includes two ribs extending outward from the elbow 2520 to receive and / or retain the elbow connector 2516 of the frame 2178. As shown in FIGS. 21A and 21B , the frame connection slot 2532 may be positioned offset from the upper end of the elbow 2520. In some configurations, the frame connection slot 2532 is positioned at the bottom of the elbow 2520, on one side of the bend. The frame connection slot 2532 may wrap completely around the elbow 2520. In some configurations, the frame connection slot 2532 extends only partially around the elbow 2520, as shown.

[0164] In some configurations, the elbow 2520 may include an anti-asphyxiation (AA) valve 2522. The AA valve 2522 may provide a flow path that allows ambient air to enter the mask 2100. For example, in some cases, if the flow generator is unable to supply gas to the mask, the valve 2522 provides the user with access to ambient air.

[0165] The AA valve 2522 may include, among other components, a valve flap 2524, a valve seat or retainer 2526, and a valve orifice 2536. The valve orifice 2536 may include one or more openings to provide a path for air to flow from the atmosphere to the interior chamber 2125 of the mask seal 2104. The valve orifice 2536 may be positioned at one end of the elbow 2520. For example, the valve orifice 2536 may be positioned on the rear side 2540 of the lower portion of the elbow 2520 such that the valve orifice 2536 forms an opening that generally faces toward the mask seal 2104 or the concave front surface 2508 of the mask seal 2104 (as described below). In some configurations, the valve orifice 2536 is positioned below the inlet connector 2530 of the elbow 2520. In some configurations, the valve orifice 2536 is approximately parallel to the concave front surface 2508 of the mask seal 2104. In some configurations, the valve orifice 2536 is angled downwardly toward the concave anterior surface 2508 of the mask seal 2104 .

[0166] The valve flap 2524 may be positioned to fit within the elbow 2520 and / or at least a portion of the valve seat 2526. The valve flap 2524 may open or close the valve orifice 2536 to allow air to flow therethrough. For example, when the flow generator provides airflow to the user through the mask seal 2104, the valve flap 2524 is open against the valve seat 2526, thereby closing the valve orifice 2536. When the flow generator does not provide airflow to the mask seal 2104, the valve flap 2524 is closed against the valve seat 2526, and the valve orifice 2536 is open, allowing the user to inhale ambient air through the valve orifice 2536. The valve seat 2526 may support the valve flap 2524 in an operable position. In some configurations, the valve seat 2526 defines a stop that prevents the valve flap 2524 from inverting or extending downward from the elbow 2520. As described in more detail below, in some configurations, the elbow 2520, including the valve 2522, may be positioned forward of the concave front surface of the mask seal 2104.

[0167] 20 illustrates an exemplary frame 2178 that may be mounted to the mask assembly 2100 and connected to embodiments of the housing 2102 described herein. The frame 2178 may be attached to the housing 2102 by a variety of arrangements. For example, the frame 2178 may slide into the mask seal 2104 and / or may be attached to the mask seal 2104 by a snap fit or press fit, among other suitable attachment arrangements. As described above, the frame 2178 may fit into the recessed front surface 2430 of the mask seal 2104, including the upper recessed surface 2432. In some configurations, the frame 2178 is configured to be repeatedly removable from the mask seal 2104, allowing for replacement of one or both of the mask seal 2104 and the frame 2178. However, in some configurations, the frame 2178 may be permanently attached to the mask seal 2104.

[0168] In some configurations, the frame 2178 may include at least one headgear connector 2512, a ventilation aperture 2514, and / or an elbow connector 2516, among other features or components. The at least one headgear connector 2512 may connect to and / or receive headgear. In some configurations, the headgear connectors 2512 may be formed in the frame 2178. For example, the frame 2178 may include one, two, three, four, five, and / or six or more headgear connectors 2512. As shown in FIG. 20 , the illustrated frame 2178 includes a pair of opposing headgear connectors 2512 that form a slot that each receives at least a portion of the headgear, such as a connector clip of the headgear.

[0169] At least one headgear connector 2512 may be positioned along the front side of the frame 2178. For example, the at least one headgear connector 2512 may extend outward (e.g., forward and / or laterally outward) from the front side of the frame 2178 and at least partially define the perimeter of an aperture in the frame 2178 for connecting headgear. As shown in FIG. 20 , the headgear connector 2512 may extend along only a portion of the front side of the frame 2178 in the height and / or width direction. The headgear connector 2512 may extend vertically between the top side of the frame 2178 and the underside of the frame 2178 or may be angled. In the illustrated arrangement, the upper end of the headgear connector 2512 is positioned forward and / or inward relative to the lower end of the headgear connector 2512. The headgear connector 2512 may be positioned at least partially below each of the paddle 2126 and / or nose region of the frame 2178. In some configurations, the headgear connectors 2512 may be positioned on the housing 2102 or other components of the mask assembly 2100.

[0170] As shown in FIG. 20 , the frame 2178 may include a vent aperture 2514 shaped to accommodate or receive the bias vent 2502. Thus, in some configurations, the vent aperture 2514 aligns with the bias vent 2502. Some arrangements may advantageously allow exhaust air to pass through the frame 2178 to the atmosphere, as described above. For example, the bias vent 2502 is preferably provided in the housing 2102 and may communicate with or align with any openings in the frame 2178 and / or headgear. In some configurations, the bias vent 2502 is disposed within at least a portion of the housing 2102 not covered by the frame 2178 or within a space defined between the frame 2178 and the housing 2102. In some configurations, the bias vent 2502 may be at least partially covered by the frame 2178. Such an arrangement may affect the flow rate if the exhaust air contacts the frame 2178.

[0171] In some configurations, the bias vent 2502 may extend at least partially through the vent aperture 2514 of the frame 2178 when the frame 2178 is connected to the mask seal 2104 (see, for example, FIGS. 19A and 19B). In some configurations, the bias vent 2502 is positioned flush with the frame 2178 when the bias vent 2502 is positioned within the vent aperture 2514.

[0172] In some configurations, the frame 2178 can include an elbow connector 2516. The elbow connector 2516 can receive and / or connect to an elbow 2520, as shown in FIGS. 22A-23B. The elbow connector 2516 can be defined by or include a cutout located on a lower edge of the frame 2178, which can be configured to receive at least a portion of the elbow 2520. For example, the cutout portion of the elbow connector 2516 can connect to the elbow 2520 such that the frame 2178 fits into a frame connection slot 2532 of the elbow 2520.

[0173] In some configurations, the elbow connector 2516 may connect to the elbow 2520 via a snap fit, press fit, interference fit, and / or other mating configuration. For example, the elbow connector 2516 may preferably include a pair of retention ridges 2518. The retention ridges 2518 may be positioned opposite each other on the lower corners of the elbow connector 2516. The retention ridges 2518 may engage with corresponding connection features on the elbow 2520, such as a retention notch 2534. The retention notch 2534 may be positioned at the lower end of the frame connection slot 2532 on the elbow 2520. In some configurations, the frame 2178 may be permanently connected to the elbow 2520 by connection means such as welding, overmolding, and / or adhesives, among others.

[0174] As described above, the elbow 2520 may connect to the frame 2178. In some configurations, as shown in FIGS. 22A-23B , the elbow 2520 may connect to the frame 2178 before the frame 2178 is connected to the mask seal 2104. For example, the elbow may slide into a cutout in the elbow connector 2516 such that the elbow connector 2516 aligns with the frame connection slot 2532. As the elbow connector 2516 slides into the frame connection slot 2532, the retention ridges 2518 may align with corresponding retention notches 2534. Thus, the elbow 2520 may be retained by the frame 2178 to form a subassembly that may then be coupled to the mask seal 2104.

[0175] 21A and 21B , for example, the elbow 2520 connects directly to the inlet 2510 of the housing 2102 via the inlet connector 2530 of the elbow 2520. In some configurations, the elbow 2520 may connect to the housing 2102 before or after the frame 2178 is connected to the elbow 2520. However, in other configurations, the elbow 2520 must first be connected to the frame 2178, after which the elbow 2520 / frame 2178 subassembly may be connected to the housing 2102. In some configurations, the elbow 2520 may connect between the housing 2102 and the frame 2178. For example, in such configurations, the frame 2178 may not connect to the housing 2102 without the connection provided by the elbow 2520. In some configurations, the elbow connects to and / or disconnects from the housing 2102 in a direction angled downward from a plane 2506 that is approximately perpendicular to the sealing surface 2504 of the mask seal 2104. For example, the plane 2506 can be substantially perpendicular to the direction in which the elbow 2520 connects to the frame 2178. In some configurations, the plane 2506 can be substantially perpendicular to the direction in which the frame 2178 connects to the elbow 2520. The elbow 2520 can be removably attached to the housing 2102 by any number of connection arrangements, such as a snap-fit ​​arrangement.

[0176] When the elbow 2520 is connected to the housing 2102, the elbow 2520 may be non-rotatable. For example, when the frame 2178, elbow 2520, and housing 2102 are assembled, the frame 2178 may not be rotatable relative to the housing 2102. In some configurations, the connection arrangement between the housing 2102 and the elbow 2520 advantageously allows hose drag forces generated by the CPAP hose to be isolated from the mask. In such a configuration, a flexible conduit (not shown) may form an intermediate component connecting the CPAP hose to the elbow 2520. In some configurations, the connection arrangement between the housing 2102 and the elbow 2520 is desirably angled to provide a lower profile mask assembly 2100 that is less noticeable to a user for wear. As such, the elbow 2520 may not extend as far from a user's face when worn compared to conventional mask assemblies. Such a configuration may reduce the moment arm due to potential hose drag on the elbow 2520 and mask assembly 2100.

[0177] In some configurations, the housing 2102 includes a concave front surface 2508 that at least partially surrounds the inlet 2510 (see, e.g., FIGS. 21B and 24). For example, the concave front surface 2508 may be offset relative to the inlet 2510 such that the portion of the concave front surface 2508 below the inlet 2510 is wider than the portion of the concave front surface 2508 above the inlet 2510. In some configurations, the area of ​​the portion of the concave front surface 2508 below the lowest point of the inlet 2510 is at least two, three, four, and / or five times greater than the area of ​​the portion of the concave front surface 2508 above the center of the inlet 2510. In some configurations, the area of ​​the portion of the concave front surface below the inlet 2510 is greater than the portion of the concave front surface to the sides of the inlet 2510.

[0178] The concave front surface may advantageously aid in aligning the mask assembly 2100 such that the concave front surface orients the elbow 2520 and / or frame 2178 within the entrance 2510 of the housing 2102 during assembly.

[0179] When assembled, as shown in FIGS. 26-28 , for example, the concave surface 2508 is spaced from the rear side 2540 of the elbow 2520. Thus, a gap is formed between the rear side 2540 of the elbow 2520 or the inner surface of the frame 2178 on one side and the housing 2102 on the other side. In some configurations, the gap provides a flow path for air to flow in and out of the internal mask breathing chamber when the valve orifice 2536 is in the open position. As shown in FIGS. 26 and 27 , for example, the cross-sectional area of ​​the gap is larger than the area of ​​the valve orifice 2536. Thus, in some configurations, the flow path through the valve orifice 2536 defines the smallest area for a flow path from ambient air through the gap, the valve orifice 2536, and into the interior of the elbow 2520. This arrangement may desirably ensure unrestricted airflow through the AA valve. This arrangement may therefore allow sufficient ambient air to enter the internal mask breathing chamber and CO2 to be adequately flushed from the internal mask breathing chamber, thereby preventing airflow restriction.

[0180] In some configurations, the concave front surface 2508 may desirably diffuse the air flow from the valve orifice 2536 away from the user. For example, air may flow through the valve orifice 2536 towards the concave front surface 2508 and exit the gap formed between the elbow and the housing 2102 to the atmosphere so that the air dissipates laterally along and / or is reflected off the concave front surface 2508 away from the user.

[0181] In some configurations, this arrangement can position the elbow 2520 closer to the user's face during use than in a typical mask assembly. For example, the concave front surface 2508 can reduce the depth of the housing 2102 and position the inlet 2510 closer to the sealing surface 2504 of the mask seal 2104. At the same time, this arrangement can allow a sufficient amount of airflow through the valve orifice 2536.

[0182] Similarly, the elbow 2520 can be positioned at least partially within the space defined by the concave front surface 2508 of the housing 2102. Arrangements described herein can allow the elbow to include a wall (e.g., the rear side 2540) that is angled downward relative to the portion of the elbow 2520 that connects with the housing 2102 (e.g., the inlet connector 2530). Such an arrangement can therefore reduce the distance that the elbow 2520 extends outwardly away from the housing 2102.

[0183] By shortening or minimizing the distance that the elbow 2520 extends outwardly away from the housing 2102 compared to arrangements without the concave front surface 2508, the arrangements described herein may desirably reduce hose drag on the mask assembly 2100 caused by the CPAP hose, as discussed above. Excessive hose drag may unnecessarily cause the mask seal 2104 to disengage from the user's face during wear, resulting in partial or complete loss of therapy. Generally, hose drag forces can be counteracted by headgear, including headgear straps for maintaining engagement between the mask assembly 2100 and the user's face with a sufficient amount of force. However, if greater hose drag forces are caused by excessive material and an elbow extending too far from the mask housing 2102, the force exerted by the headgear straps may cause discomfort to the user. Thus, the arrangements described herein may advantageously reduce discomfort to the user by limiting excessive force exerted on the user by the headgear straps and / or by reducing or minimizing hose drag forces.

[0184] In some configurations, the arrangements described herein may, as discussed above, reduce the moment arm applied to the elbow 2520. Similarly, the concave front surface 2508 may minimize the overall size of the housing 2102 or mask assembly 2100 by providing a mask assembly that protrudes less.

[0185] As shown in at least FIGS. 21B-23B and 27 , the frame 2178 includes a shield surface 2181. The shield surface 2181 surrounds the elbow connector 2518 and forms a front boundary of the flow path formed between the frame 2178 and the concave front surface 2508 of the housing 2102. The shield surface 2181 may be formed by a truncated surface or a concave portion on the front surface of the frame 2178. In some configurations, the shield surface 2181 may be offset from the concave front surface 2508 of the housing 2102 when the frame 2178 is connected to the housing 2102. For example, the shield surface 2181 may be planar and positioned substantially parallel to the concave surface 2508 of the housing 2102 when the frame 2178 and the housing 2102 are assembled. Such an arrangement may advantageously reduce the overall size of the mask assembly 2100, making it less obtrusive to the user, and may provide adequate support for the elbow 2520. This arrangement may facilitate diffusion and / or direction of airflow through and / or exiting the valve orifice 2536.

[0186] 29-33E illustrate configurations of a mask assembly 2100. For example, the mask assembly 2100 may include a full face mask that forms a seal under at least a portion of a user's nose and / or around at least a portion of the user's mouth. As shown in FIGS. 29-33E, the mask assembly 2100 may include a mask seal 2104, a housing 2102, a frame 2178, at least one headgear clip 2600, and an elbow 2520 or other type of inlet conduit connector.

[0187] In some configurations, the mask seal 2104 may be permanently bonded or coupled to the housing 2102, for example by overmolding. The housing 2102 may be positioned in front of the mask seal 2104 and may alone or together with the seal 2104 define a breathing chamber around at least a portion of the user's mouth and / or nose (e.g., the user's nostrils). In some configurations, the housing 2102 may include a biased vent 2502 as described herein.

[0188] As mentioned above, the mask assembly 2100 may engage or otherwise be supported by the frame 2178, thereby enabling connection with head straps or headgear 2180 (see FIG. 1 ) in any suitable arrangement. In some configurations, the head straps or headgear 2180 may be directly coupled to at least a portion of the mask assembly 2100 and / or the frame 2178. For example, the frame 2178 may include at least one clip retaining feature 2550. Preferably, the frame 2178 may include a pair of clip retaining features 2550 positioned on opposite outer sides of the frame 2178. For example, the clip retaining features 2550 may be positioned laterally of a central portion of the frame 2178. The frame 2178 may include a frame paddle 2179 to support the paddle 2126 of the mask seal 2104. In some configurations, the frame 2178 may include a vent aperture 2514 through which the biased vent 2502 may vent exhaust air from the internal chamber 2125 (see FIG. 5).

[0189] In some configurations, the mask assembly 2100 includes at least one headgear clip 2600. Preferably, the mask assembly 2100 may include a pair of headgear clips 2600. The headgear clips 2600 may connect to clip retention features 2550 on opposite sides of the mask frame 2178. As described in more detail below, the headgear clips 2600 may provide a connection between at least a portion of the headgear 2180, such as a headgear strap, and the frame 2178.

[0190] In some configurations, the elbow 2520 may be attached to the housing 2102, the frame 2178, or otherwise supported and adapted to communicate with the internal chamber 2125 of the mask assembly 2100. As described herein, the elbow 2520 may connect to an air supply conduit to, for example, deliver a supply of pressurized air to the internal chamber 2125. The frame 2178 and headgear 2180 may cooperate to support the mask assembly 2100 in place of the user's face.

[0191] 30A and 30B show configurations of the mask assembly 2100 showing the clip retaining feature 2550 and the headgear clip 2600. In some configurations, as shown in FIGS. 30A and 30B, the headgear clip 2600 may be removably connected to the frame 2178. For example, the headgear clip 2600 may be removably clipped and / or snapped or otherwise attached to the clip retaining feature 2550 of the frame 2178. In some configurations, the headgear clip 2600 may be adjustably attached to the headgear 2180. For example, the headgear clip 2600 may include an aperture 2606 that may fit into a corresponding retaining feature 2550 of the frame 2178 and / or may slide rearward or toward the user's face when worn so that the clip retaining feature 2550 captures the headgear clip 2600.

[0192] For example, FIG. 30B shows an example of a headgear clip 2600. The headgear clip 2600 may include at least one strap slot, such as an upper strap slot 2602 and a lower strap slot 2604. The headgear 2180 may include at least one headgear strap for connecting to each of the upper and lower strap slots 2602, 2604. For example, the headgear 2180 (as shown in FIG. 1 ) may include an upper strap for connecting to the upper strap slot 2602 and a lower strap for connecting to the lower strap slot 2604. In some configurations, the headgear straps may be adjustably attached to the upper and lower strap slots 2602, 2604 of the headgear clip 2600.

[0193] 31A and 31B show additional examples of a mask assembly 2100 including a mask seal 2104 connected to a mask frame 2178 and an elbow 2520. Advantageously, the headgear clip 2600 of the mask assembly 2100 may connect to at least one and / or preferably two headgear straps in a single operation. This configuration allows for easy assembly and / or disassembly of the various components of the interface assembly, such as the frame 2178, headgear clip 2600, and headgear 2180. In such a configuration, a user's visibility may be limited and / or restricted when assembling and / or disassembling the interface assembly. In some configurations, the arrangements described herein allow a user to assemble and / or disassemble the interface assembly with one hand. As described herein, the headgear clip 2600 and / or the frame 2178 may provide various features for orienting the headgear 2180 to the frame 2178 to ensure that the headgear 2180 and / or the headgear clip 2600 are properly positioned within the interface assembly during assembly and / or to prevent the interface assembly from inadvertently detaching during use.

[0194] 32A and 32B show various configurations of the frame 2178 of the mask assembly 2100. As shown in FIGS. 32A and 32B, the frame 2178 may include a plurality of clip retaining features 2550 and a vent aperture 2514. The clip retaining features 2550 may be positioned along an outer portion of the frame 2178. For example, the clip retaining features 2550 may be positioned laterally offset from a central portion of the frame 2178. In some configurations, the clip retaining features 2550 are positioned along and / or extend from an outermost outer portion of the frame 2178. As shown in the illustrated configuration, the clip retaining features 2550 may be positioned at least partially below the paddles 2179 of the frame 2178.

[0195] 32A and 32B , the clip retaining feature 2550 may include a raised wall 2554 and at least one support 2552. The raised wall 2554 may be offset anteriorly or laterally from an adjacent portion of the mask frame 2178. For example, the raised wall 2554 provides a front surface of the clip retaining feature 2600 such that the raised wall 2554 is positioned anteriorly from an adjacent portion of the front surface 2560 of the frame 2178. In some configurations, the raised wall 2554 may follow the contour of the front surface 2560 of the frame 2178. For example, the raised wall 2554 may be substantially flat and / or curved to conform to the shape of the frame 2178. In such a configuration, the raised wall 2554 may extend substantially parallel to the mask frame 2178 and from an outer portion of the frame 2178 toward a central portion of the mask frame 2178. In some configurations, the raised wall 2554 extends from the bottom region of the paddle 2179 toward or to the lower region of the mask frame 2178. For example, in some configurations, the raised wall 2554 extends along the entire outer portion of the mask frame 2178 below the paddle 2179. If desired, the raised wall 2554 may extend along all or substantially all of the outer portion of the mask frame 2178.

[0196] In some configurations, the raised wall 2554 is connected to the frame 2178 by at least one support 2552. Preferably, each clip retaining feature 2550 may include at least two supports 2552 spaced apart from one another, for example, at the upper and lower edges of the raised wall 2554. The supports 2552 may connect the raised wall 2554 to the frame 2178 along the upper, lower, and / or outer sides of the raised wall 2554. In some configurations, the supports 2552 extend outward from the mask frame 2178 to connect the raised wall 2554 in a direction substantially perpendicular to the front surface 2560 of the frame 2178. As such, the supports 2552 may support the raised wall 2554 at a location offset forward of the front surface 2560 of the frame 2178. Thus, a gap 2558 may be formed within the clip retaining feature 2550 and the frame 2178. The gap 2558 may provide an aperture in the frame 2178 to receive at least a portion of the headgear 2180 and / or at least a portion of the headgear clip 2600. As shown in the illustrated configuration, the gap 2558 may be defined by the leading edge 2556 of the raised wall 2554, the support 2552, and the front surface 2560 of the frame 2178. In some configurations, the leading edge 2556 of the raised wall 2554 extends forward of the support 2552 to form a lip. The lip may desirably engage and / or retain the headgear clip 2600 during use.

[0197] 33A-33E show exemplary configurations of a headgear clip 2600. The headgear clip 2600 may include an upper strap slot 2602, a lower strap slot 2604, an aperture 2606, a step 2608, a pull tab 2630, and a front surface 2620. In some configurations, the headgear clip 2600 forms a substantially "D" shape. For example, the aperture 2606 may be centered within the headgear clip 2606. In some configurations, the aperture 2606 may be positioned laterally between the pull tab 2630 and the upper and lower strap slots 2602, 2604. In some configurations, the aperture 2606 may have a maximum height that exceeds the maximum width of the aperture 2606.

[0198] In such a configuration, the clip retaining feature 2550 may extend entirely through the aperture 2606 during assembly of the mask assembly 2100. For example, the aperture 2606 may be formed in at least a portion of the headgear clip 2600. In some configurations, the aperture 2606 is formed through an insert 2614 of the headgear clip 2600 (described in more detail below). In some configurations, the headgear clip 2600 may be clipped, attached, and / or snapped to a corresponding clip retaining feature 2550 of the frame 2178. For example, the aperture 2606 may receive at least a portion of the clip retaining feature 2550. When assembled, the aperture 2606 may slide rearward past the clip retaining feature 2550 of the frame 2178 and into a gap 2558 formed in the front side of the clip retaining feature 2550. In such a configuration, the forward portion of the perimeter formed by the aperture 2606 rests between the raised wall 2554 of the clip retaining feature 2550 and the front surface 2560 of the frame 2178. As such, the forward portion of the perimeter of the aperture 2606 can be retained beneath a lip formed on the leading edge 2556 of the clip retaining feature 2550.

[0199] 33C-33E, the headgear connector 2600 may include an overmolded arrangement. For example, the headgear connector 2600 may include an insert 2614. In some configurations, the insert 2614 may be formed of plastic. For example, the plastic of the insert 2614 may be substantially rigid. The insert 2614 may be overmolded with a relatively flexible and / or soft material, such as silicone or TPE. In some configurations, the overmolding may form a pull tab 2630.

[0200] In some configurations, the aperture 2606 and / or the upper and lower strap slots 2602, 2604 may be formed through and / or within the insert 2614. In some configurations, the insert 2614 may comprise structure on the headgear clip 2600. For example, the insert 2614 may provide a substantially rigid connection between the headgear straps of the headgear 2180 and the frame 2178. As shown in the illustrated example, the upper and lower strap slots 2602, 2604 may be spaced apart to allow the upper and lower headgear straps to be connected to the frame 2178. For example, the upper strap slot 2602 may be positioned offset above the lower strap slot 2604. When worn, this arrangement allows the upper straps of the headgear 2180 to pass over the user's ears and the lower straps of the headgear 2180 to pass below the user's ears. Such a configuration desirably improves stability of the mask when the interface assembly is worn on the user's face.

[0201] As shown in the illustrated arrangement, the overmold may surround at least a portion of the insert 2614. In some configurations, the overmold forms a perimeter around substantially the entire insert 2614 or the entire insert 2614. The overmold arrangement may desirably provide a surface that is soft to the touch and / or easily grippable by a user. For example, the overmold arrangement may provide flexibility to at least a portion of the headgear clip 2600 (e.g., the pull tab 2030). The overmold arrangement may provide at least some rigidity to support the connection between the frame 2178 and the headgear 2180.

[0202] In some configurations, the overmolding may form the pull tab 2630 and the rotation lock 2616. In some configurations, the rotation lock 2616 may include a protrusion extending rearward from the rear surface 2624 of the headgear clip 2600. In some configurations, the protrusion may be substantially L-shaped. However, in some configurations, the protrusion may form various shapes. The protrusion may extend along at least a portion of the rear and / or lower edge of the headgear clip 2600. For example, the protrusion may extend along at least a portion of the lower portion of the insert 2614. The protrusion may extend laterally beyond the side edge of the lower portion of the insert 2614. In some configurations, the protrusion extends vertically along the rear surface of the headgear clip 2600. In some configurations, the rear surface of the protrusion extends approximately parallel to the rear surface 2624 of the headgear clip 2600.

[0203] The rotation lock 2616 may abut and / or be positioned adjacent to the lower edge of the frame 2178. In some configurations, the rotation lock 2616 may abut and / or be positioned adjacent to the support 2552 of the clip retaining feature 2550. In the configurations described herein, the rotation lock 2616 may desirably prevent rotation of the headgear clip 2600 about an axis that extends approximately perpendicular to the raised wall 2554 of the clip retaining feature 2550.

[0204] In some configurations, the vertical portion of the rotation lock 2616 of the headgear clip 2600 may include upper and lower strap slots 2602, 2604 that form an aperture through which the protrusion passes. As shown in FIG. 33B , the upper and lower strap slots 2602, 2604 may include strap guides 2612. The strap guides 2612 may form cutouts in the rear edge 2622 of the rotation lock 2616. In some configurations, the strap guides 2612 may provide a smooth surface. For example, the strap guides 2612 may desirably align and / or orient the headgear straps in a proper alignment configuration within the upper and lower strap slots 2602, 2604 of the headgear connector 2600. Such a configuration may advantageously help reduce the bulk and / or depth of the headgear straps that connect to the headgear connector 2600 when assembled. For example, the strap guides 2612 allow the headgear straps to lie substantially flat against the headgear clip 2600 .

[0205] In some configurations, the rotation lock 2616 includes a keyed portion to indicate the proper positioning of the connection to the mask frame 2178. For example, the rotation lock 2616 may prevent the left headgear connector 2600 from connecting to the right clip retaining feature 2550 and / or the right headgear connector 2600 from connecting to the left clip retaining feature 2550. Similarly, the rotation lock 2616 may prevent the headgear connector 2600 from being positioned in an incorrect vertical alignment configuration.

[0206] In some configurations, the pull tab 2630 includes a front surface that can have a portion that extends above and / or below the aperture 2606 formed in the headgear clip 2600. The front surface of the pull tab 2630 can be raised and / or extend outward relative to the front surface of at least a portion of the headgear clip 2600. For example, the front surface of the pull tab 2630 can be raised and / or extend outward relative to the front surface of a portion of the headgear clip 2600 that surrounds and / or is adjacent to the aperture 2616.

[0207] As shown in FIG. 33A , for example, the raised front surface 2620 of the pull tab 2630 may form a step 2608. The step 2608 may form the front surface and may form at least a portion of the perimeter surrounding the aperture 2616. The step 2608 may desirably prevent the headgear clip 2600 from being incorrectly attached and / or aligned with the frame 2178 during assembly of the mask assembly 2100. For example, the step 2608 may prevent the headgear clip 2600 from being attached to the frame 2178 in the incorrect front-to-back orientation by providing a surface that is offset from the aperture 2616. That is, when the front side (shown in FIG. 33A ) is positioned inward against or adjacent the frame 2178 instead of the correct outward orientation, the step 2608 may prevent the clip 2600 from engaging the clip retaining feature 2550. Such a configuration may prevent the aperture 2616 from sliding under and / or receiving a corresponding clip retaining feature 2550 on the frame 2178.

[0208] In some configurations, the pull tab 2630 may be somewhat resilient and / or flexible. For example, the pull tab 2630 may be formed of a substantially flexible material that allows the pull tab 2630 to stretch and / or bend when a force is applied to the pull tab 2630. For example, the pull tab 2630 may stretch when pulled to detach the headgear clip 2600 from the corresponding clip retaining feature 2550. Such an arrangement may facilitate a peel-off type actuation to detach the headgear clip 2600 from the clip retaining feature 2550. Such an arrangement may ensure that a user properly detaches the clip 2600 from the clip retaining feature 2550. For example, such an arrangement may ensure that a user does not inadvertently remove and / or detach the clip 2600 from the clip retaining feature 2550 and / or may minimize the risk of the user doing so. In some configurations, the pull tab 2630 provides sufficient pulling force to allow only a portion of the headgear clip 2600 to bend laterally.

[0209] 33C-33E, for example, the overmold may not form the upper and lower strap slots 2602, 2604. For example, the upper and lower strap slots 2602, 2604 may be formed by a material that is thicker and / or more rigid than the surrounding surface, which in some configurations may be the insert 2614. Such an arrangement may provide a low-friction surface finish that allows the headgear straps to pass through, and be easily adjusted and / or slid within, the upper and lower strap slots 2602, 2604.

[0210] 34A-35B show a configuration of the mask assembly 2100. The mask assembly 2100 may include a frame 2178 and first and second headgear clips 2600A, 2600B. The first and second headgear clips 2600A, 2600B may be defined as the right and left headgear clips 2600A, 2600B from the perspective of a wearer of the mask assembly 2100. FIGS. 34A and 34B show an exemplary configuration of the first and second headgear clips 2600A, 2600B connected to the frame 2178.

[0211] As shown in FIGS. 35A and 35B , the frame 2178 may include at least one clip retaining feature 2550 and at least one vent aperture 2514. For example, the frame 2178 may include at least two vent apertures. In some configurations, the frame 2178 may include at least three openings. The clip retaining feature 2550 may at least partially form the vent aperture 2514 extending through the frame 2178. The vent aperture 2514 may provide an opening in the frame 2178 to receive at least a portion of the headgear clip 2600. The vent aperture 2514 may be substantially rectangular, circular, and / or oval in shape. For example, the vent aperture 2514 may include a top side, a bottom side, and at least one outer side. As shown in FIGS. 35A and 35B , the top and bottom sides of the vent aperture 2514 may be curved. In some configurations, the top and bottom sides of the vent aperture 2514 can be concave and can face a central portion of the frame 2178. For example, the concave top and bottom sides of the vent aperture 2514 face generally toward the apex of the elbow connector 2516.

[0212] In some embodiments, the connecting feature 2550 can include a raised edge 2572. The raised edge 2572 can be formed by an outermost portion of the aperture of the connecting feature 2550 being positioned closer to the outermost lateral portion of the frame 2178. For example, the raised edge 2572 can extend outside the contoured front surface 2560 of the frame 2178. The thickness of the raised edge 2572 can be increased compared to the portion of the frame 2178 surrounding the raised edge 2572.

[0213] In some configurations, the raised lip 2572 extends along the length of the side edge of the vent aperture 2514 and forms a connection point for the headgear clip 2600. For example, the raised lip 2572 may form a post 2576 for connecting to the hook 2654 of the headgear clip 2600 (see, e.g., FIG. 40 ). Such an arrangement may provide clearance for the hook 2654 of the headgear clip 2600 to pass through the aperture. Such a configuration allows the headgear clip 2600 to be easily aligned and / or connected to the frame 2178.

[0214] For example, the raised edge 2572 can form an alignment feature 2574 that properly aligns the headgear clip 2600 with the frame 2178 (see, e.g., FIG. 35B). Thus, the raised edge 2572 can form a stepped region and / or a recess in the rear surface of the frame 2178. In some configurations, the alignment feature 2574 can receive at least a portion of the hook 2654 of the headgear clip 2600. In some configurations, the alignment feature 2574 can have a variable wall thickness. For example, the wall thickness can be greater at the raised edge 2572, such as the post 2576, compared to the surface adjacent the post 2576 and the surrounding surface, including the outer peripheral surface of the rear surface of the frame 2178. In such a configuration, the alignment feature 2574 may abut the hook 2654 of the headgear clip 2600 to desirably minimize and / or prevent rotation about an axis that is substantially perpendicular to the front surface 2560 of the frame 2178 proximal to the clip retaining feature 2550. Such an arrangement may prevent the clip from being pushed off the clip retaining feature 2550 as a result of the headgear being pulled up, down, and / or away from the mask assembly 2100. The alignment feature 2574 desirably provides a non-sliding or anti-skid surface. As such, the alignment feature 2574 prevents the headgear clip 2600 from sliding along the post 2576 of the clip retaining feature 2550. Such an arrangement may provide a more secure connection between the headgear 2180 and the mask assembly 2100. Similarly, such an arrangement may provide greater stability to the connection between the headgear 2180 and the mask assembly 2100.

[0215] As shown in FIGS. 34A-35B , the frame 2178 may include a keying ridge 2570. In some configurations, the keying ridge 2570 may be formed on the frame 2178 adjacent to only one of the clip retaining features 2550. In some configurations, the keying ridge 2570 may be formed on the frame 2178 positioned adjacent to multiple clip retaining features 2550. For example, the keying ridge 2570 may allow the headgear clip 2600 to adjustably secure to the frame 2178, ensuring the assembly is only properly oriented. In some configurations, the keying ridge 2570 may extend outward from the front surface 2560 of the left lateral side of the frame 2178. The keying ridge 2570 may preferably be positioned laterally offset from the left clip retaining feature 2550 toward the outermost side edge of the frame 2178. The keying ridge 2570 may align with a corresponding keying notch 2650 on, for example, the second and / or left headgear clip 2600B. In some configurations, the keying ridge 2570 may desirably prevent the wrong headgear clip 2600 (in this example, the right headgear clip 2600A) from connecting with the left side of the frame 2178. In some configurations, the keying ridge 2570 desirably prevents the headgear 2180 from being attached to the frame 2178 in the wrong horizontal, vertical, and / or front-to-back orientation. As such, the keying ridge 2570 may enhance usability of the mask assembly 2100 and / or allow the mask assembly 2100 to be easily assembled and / or disassembled.

[0216] 36A-43 show configurations of first and second headgear clips 2600A, 2600B and / or the first and second headgear clips 2600A, 2600B connected to a frame 2178. The first and second headgear clips 2600A, 2600B may be similar or identical in many respects to other examples of the headgear clip 2600 described above. As shown in the illustrated configurations, the first and second headgear clips 2600A, 2600B include apertures that may clip onto and / or receive at least a portion (e.g., post 2576) of a corresponding clip retention feature 2550 of the frame 2178. In some configurations, the first and second headgear clips 2600A, 2600B are formed of a substantially rigid material such as nylon, polycarbonate, and / or polypropylene, among other materials. As such, the first and second headgear clips 2600A, 2600B may desirably support the headgear 2180 and / or maintain a connection between the headgear 2180 and the frame 2178.

[0217] The first and second headgear clips 2600A, 2600B may include an aperture 2606, a thumb grip 2640, a finger grip 2642, an upper strap slot 2602, a lower strap slot 2604, an overmolded grip 2644, a hook 2654, and a keying notch 2650. For example, the first and second headgear clips 2600A, 2600B may form a substantially arcuate loop that surrounds the aperture 2606. Thus, the aperture 2606 may be centrally positioned within the first and second headgear clips 2600A, 2600B. In some configurations, the aperture 2606 may receive at least a portion of the clip retention feature 2550 of the frame 2178 (e.g., a raised lip 2652). For example, when the first and second headgear clips 2600A, 2600B are connected to the frame 2178 via the clip retaining features 2550, the first and second headgear clips 2600A, 2600B can be placed substantially flush with the front surface 2560 of the frame 2178.

[0218] In some configurations, the first and second headgear clips 2600A, 2600B may include thumb grips 2640. The thumb grips 2640 may be defined by raised tabs positioned along the outer edges of the first and second headgear clips 2600A, 2600B relative to a central plane extending perpendicularly between the first and second headgear clips 2600A, 2600B. Such a configuration may desirably provide a grip for a user's thumb. For example, a user may rest their thumb on the thumb grip 2640. In some configurations, the thumb grip 2640 may be thicker than the surrounding portion of the thumb grip 2640. Such a configuration may desirably provide a larger contact area for the user's thumb to grasp, thereby allowing the user to easily connect and / or disconnect the first and second headgear clips 2600A, 2600B to and / or from the corresponding clip retention features 2550.

[0219] As shown in at least FIGS. 36A and 36B , the first and second headgear clips 2600A, 2600B form a concave surface along at least a portion of the first and second headgear clips 2600A, 2600B (e.g., along a portion of the outer edges of the first and second headgear clips 2600A, 2600B). For example, the thumb grips may be centrally positioned along the outer edges of the first and second headgear clips 2600A, 2600B. The concave surface of the thumb grip 2640 may provide a comfortable gripping surface for the user. In some configurations, the concave surface may provide a visual indicator that may indicate to the user which surface of the thumb grip 2640 needs to be gripped by the user.

[0220] In some configurations, the first and second headgear clips 2600A, 2600B include finger grips 2642. The finger grips 2642 may be defined by raised tabs positioned along the inner edges of the first and second headgear clips 2600A, 2600B. Such a configuration may desirably provide a grip for one or more of a user's fingers. For example, a user may place their fingers on the finger grips 2642. In some configurations, the finger grips 2642 may be thicker than the surrounding portions of the finger grips 2642. Such a configuration desirably increases the contact area for the user's fingers to grasp, thereby allowing the user to easily connect and / or disconnect the first and second headgear clips 2600A, 2600B from the corresponding clip retention features 2550.

[0221] As shown in at least FIGS. 36 and 36B , the finger grips 2642 of the first and second headgear clips 2600A, 2600B form a concave surface along at least a portion of the first and second headgear clips 2600A, 2600B (e.g., along a portion of the inner edges of the first and second headgear clips 2600A, 2600B). For example, the finger grips 2642 may be centrally positioned along the inner edges of the first and second headgear clips 2600A, 2600B. The concave surface of the finger grips 2642 may provide a comfortable gripping surface for a user. In some configurations, the concave surface may provide a visual indicator that may indicate to a user that the surface of the finger grips 2642 should be grasped by the user.

[0222] In some configurations, the finger grips 2642 may be positioned along the side edges of the first and second headgear clips 2600A, 2600B opposite the thumb grips 2640. For example, the finger grips 2642 and the thumb grips 2640 may be positioned on opposite sides of the aperture 2606. Such a configuration may encourage a user to grasp the first and second headgear clips 2600A, 2600B with the user's fingers toward the leading edge of the clips. Such a configuration may improve a user's control over the angle of the first and second headgear clips 2600A, 2600B during assembly and / or disassembly, thereby allowing the first and second headgear clips 2600A, 2600B to be more easily connected to the clip retaining features 2550. For example, the first and second headgear clips 2600A, 2600B may be more easily aligned with the clip retaining features 2550. In some configurations, the position and / or shape of the finger grips 2642 relative to the thumb grips 2640 may encourage the user to grasp the first and second outer surfaces of the first and second headgear clips 2600A, 2600B.

[0223] In some configurations, the first and second headgear clips 2600A, 2600B may include upper and lower strap slots 2602, 2604. The upper and lower strap slots 2602, 2604 may be similar or identical in many respects to the other examples of the upper and lower strap slots 2602, 2604 described above. As such, the upper and lower strap slots 2602, 2604 may receive corresponding upper and lower headgear straps of the headgear 2180.

[0224] In some configurations, the overmolded grips 2644 of the first and second headgear clips 2600A, 2600B may extend around at least a portion of the first and second headgear clips 2600A, 2600B. For example, the overmolded grips 2644 may extend around the first and second headgear clips 2600A, 2600B. As shown in FIGS. 36A and 36B , the overmolded grips 2644 may form at least a portion of the concave surfaces of the thumb grips 2640 and / or finger grips 2642. In some configurations, the overmolded grips 2644 may form the concave surfaces of the thumb grips 2640 and / or finger grips 2642.

[0225] In some configurations, the overmolded grip 2644 may include various materials, such as an elastomeric material. For example, the overmolded grip 2644 may include silicone and / or TPE, among other materials. The overmolded grip 2644 may provide a soft-touch finish that provides a more comfortable grip on the first and second headgear clips 2600A, 2600B. In some configurations, the overmolded grip 2644 may provide a grip for the user. In such configurations, the overmolded grip 2644 may have a coefficient of friction greater than the surrounding portions of the first and second headgear clips 2600A, 2600B.

[0226] As shown in FIGS. 37A and 37B , the first and second headgear clips 2600A, 2600B may include hooks 2654. The hooks 2654 may form tongues that protrude rearward and laterally from the rear surface of the finger grips 2642 toward the center of the aperture 2606. For example, the hooks 2654 may extend inward into the aperture 2606. In some configurations, the hooks 2654 may slide under at least a portion of the clip retaining feature 2550 (e.g., raised edge 2572) during assembly. In some configurations, the hooks 2654 may include a raised lip 2652. The raised lip 2652 may extend along an inner edge of the hooks 2654. The raised lip 2652 may engage with at least a portion of the clip retaining feature 2550 (e.g., post 2576). As such, the hooks 2654 can secure the first and second headgear clips 2600A, 2600B to the frame 2178.

[0227] In some configurations, at least one of the first and second headgear clips 2600A, 2600B includes a keying notch 2650. The keying notch 2650 may form a recess, for example, along an edge of at least one of the first and second headgear clips 2600A, 2600B. For example, the keying notch 2650 may be positioned along a rear surface of at least one of the first and second headgear clips 2600A, 2600B. The keying notch 2654 may correspond to and / or receive a keying ridge 2570 on the frame 2178 so that the headgear clip rests substantially flush with the front surface of the frame 2178 when the headgear clip is connected to the frame 2178. For example, as shown in FIG. 36B , the left headgear clip may include a keying notch 2650. The keying notch 2650 may correspond to a keying ridge 2570 positioned on the left outer side of the frame 2178. The keying notch 2650 may indicate to a user, for example, whether the headgear clip 2600 is a left headgear clip 2600B or a right headgear clip 2600A. In such a configuration, the keying notch 2650 may desirably prevent the headgear clip 2600 from connecting with the wrong clip retaining feature 2550.

[0228] 44-45 illustrate an embodiment of an interface assembly. As shown in FIGS. 44-45, the interface may include a headgear assembly 2180 and a mask assembly 2100. The mask assembly 2100 may include a mask seal 2104, a frame 2178, and an air delivery conduit 2520A. As shown in the illustrated example, the frame 2178 may include a conduit connection 2700. The conduit connection 2700 may directly connect between the frame 2178 and the air delivery conduit 2520A. For example, the conduit connection 2700 may form a substantial portion of the lower region of the housing 2102. For example, the conduit connection 2700 may extend substantially laterally between opposing clip retaining features 2550. In some configurations, the conduit connection 2700 may be angled downwardly away from the frame 2178.

[0229] 44-45, the frame may include at least one ventilation aperture 2514. For example, the ventilation aperture 2514 may preferably be provided in the mask assembly 2100 such that the ventilation aperture 2514 aligns with openings in the frame 2178 and / or between various components of the mask assembly 2100. For example, the ventilation aperture 2514 may be provided between the frame 2178 and the headgear clips 2600A, 2600B. In some configurations, the ventilation aperture 2514 may define an opening provided between the frame 2178 and the headgear clips 2600A, 2600B. In some configurations, the ventilation aperture 2514 may form at least a portion of the clip retention feature 2550 (e.g., at least a portion of an aperture of the clip retention feature 2550). For example, the ventilation aperture 2514 may define a portion of the aperture of the clip retention feature 2550 that is not covered by the headgear clip 2600 when the headgear clip 2600 is connected to the frame 2178. Such a configuration may desirably distribute exhaust air over a larger area and in at least two directions away from the user's face to reduce drafts against the user's face when worn.

[0230] In some arrangements, the ventilation apertures 2514 may advantageously allow exhaust air to pass through the frame 2178 to the atmosphere, as described above. In some configurations, the ventilation apertures 2514 may be positioned along the outer side of the mask frame 2178 and may be directed outward from a central portion of the frame 2178. For example, as shown in FIG. 45 , when a user is wearing the mask assembly 2100, exhaust air may pass through the frame 2178 and laterally away from the user. As described above, such a configuration may desirably distribute the exhaust air over a larger area and in at least two directions away from the user's face, reducing drafts against the user's face when worn.

[0231] 46-48 illustrate embodiments of interface assemblies that include similar or identical features and / or components to the interface assemblies described above. As shown in FIGS. 46-48, the vent aperture 2514 may be centrally positioned within the frame 2178, as described above. In some configurations, the vent aperture 2514 may be formed in at least a portion of the conduit connection 2700. For example, the vent aperture 2514 may be formed in an upper portion of the conduit connection 2700. As shown in FIG. 46, for example, the conduit connection 2700 may be integrally formed with the frame 2178. In some configurations, the conduit connection 2700 may be formed directly into the housing 2102.

[0232] In some configurations, as shown in FIG. 46 , the headgear clips 2600 may support the mask seal 2104. In such configurations, the frame 2178 may not support the paddles 2126 of the mask seal 2104. For example, the headgear clips 2600 may be provided on the front surface of the mask seal 2104 so that the headgear clips 2600 provide sufficient mechanical rigidity and structure to retain the shape of the mask seal 2104 when the mask seal 2104 is worn by a user. For example, the headgear clips 2600 may help prevent the mask seal 2104 from bulging. As shown in FIG. 46 , the headgear clips may extend vertically along the outer sides of the mask seal 2104. For example, the headgear clips 2600 may extend along a substantial portion of the outer sides of the mask seal 2104. When connected to the frame 2178, the headgear clips 2600 may extend upward along the front surface of the mask seal 2104 and cover at least a portion of the mask seal 2104. Such a configuration may desirably support the mask seal 2104 and reduce the overall size of the frame 2178. As such, such a configuration may reduce the bulkiness of the mask assembly 2100.

[0233] 47 and 48 show various configurations of the headgear clip 2600. In some configurations, the headgear clip 2600 may have a rounded and / or oval cross-section (see FIG. 48). In such configurations, the rounded surfaces of the headgear clip 2600 may provide an aesthetically pleasing appearance to the user. For example, the rounded surfaces of the headgear clip 2600 may make the headgear clip 2600 appear smaller to the user and / or may reduce the overall bulkiness of the headgear clip 2600. In some configurations, the headgear clip 2600 may include a square and / or substantially rectangular cross-section (see FIG. 47). In such configurations, the square surfaces of the headgear clip 2600 may provide an easier-to-grip surface compared to cross-sections of other shapes.

[0234] 49-75 illustrate embodiments of an interface assembly. As shown in FIG. 49, the interface assembly may include, among other possible components, a headgear assembly 2180, a frame 2178, a mask assembly 2100, and an air delivery conduit 2520A. The headgear assembly 2180 may include, among other possible components, straps, such as one or more upper side straps 2804, one or more lower side straps 2802, and / or a crown strap 2808 (see FIGS. 73-75). The mask assembly 2100 may include, among other possible components, a mask housing 2012 and a mask seal 2104, which form a breathing chamber. As shown in the illustrated example and described in more detail below, the frame 2178 may include an anti-asphyxiation (AA) valve assembly 2522B. In some configurations, the valve assembly 2522B may be received by a valve recess 2726, as described below. As described in more detail below, the valve assembly 2522B may include a valve housing 2522 (referred to herein as "valve 2522"). The valve 2522 may be integrally formed with the frame 2178. As described below, the valve assembly 2522B may include, among other possible components, at least a portion of the frame 2178, a valve 2522, a valve element or member, such as a valve flap 2524, and / or a tube connector 2711. The valve 2522 may be located within the frame 2178 adjacent to the air supply conduit 2520A. In some embodiments, the valve 2522 of the valve assembly 2522B may include an inlet tube 2522A. The inlet tube 2522A may be positioned aft of the front wall of the frame 2178. In some embodiments, the inlet tube 2522A may define at least a portion of the gas flow path. In some configurations, integration of the valve 2522 with the frame 2178 may allow the air delivery conduit 2520A to extend generally downward from the lower front of the frame 2178. Such a configuration may reduce the overall bulkiness of the patient interface. For example, in such a configuration, the conduit 2520A may be positioned closer to the user during use.The gas flow path is provided by gas supply conduit 2520A, valve assembly 2522B and cushion connector 2708. The gas flow path provides a passageway for pressurized gas to be delivered through mask assembly 2100 to the nose and / or mouth of the user.

[0235] 50A-50B show an example of a mask assembly 2100. As described above, the mask assembly 2100 may include a mask seal 2104 and a housing 2012, and is assembled to, among other components, a frame 2178 and / or an air delivery conduit 2520A. The frame 2178 may be generally curved in the lateral and / or vertical directions.

[0236] In some embodiments, the frame 2178 may be provided on the front side of the mask seal 2104. In some embodiments, the frame 2178 may cover a substantial portion of the front side of the mask seal 2104, for example, a substantial portion of the housing 2102 of the mask seal 2104. In some embodiments, the frame 2178 is centered laterally along the front side of the mask seal 2104. For example, the entire front side of the frame 2178 may be positioned forward of the mask seal 2104.

[0237] 51A-59 show embodiments of a frame 2178. In some embodiments, the frame 2178 can include a cushion connector 2708, an inlet or inlet opening 2706, a valve 2522, at least one upper strap connector 2702, at least one lower strap connector 2704, and / or a paddle 2179.

[0238] In some embodiments, the cushion connector 2708 may be positioned posterior to the frame 2178. In some embodiments, the cushion connector 2708 is unitary with the frame 2178 and extends posteriorly from the posterior surface of the anterior wall of the frame 2178. The cushion connector 2708 may provide a fluid connection between the inlet 2706 and the mask assembly 2100.

[0239] In some embodiments, the cushion connector 2708 may be shaped to fit within at least a portion of the mask assembly 2100 to connect the frame 2178 to the mask assembly 2100. For example, the cushion connector 2708 may fit within at least a receiving portion of the mask housing 2102 portion of the mask assembly 2100. The cushion connector 2708 may include a somewhat rounded "D" shape, a rounded trapezoidal shape, a circular shape, an elliptical shape, and / or an oval shape, among other possible shapes.

[0240] In some embodiments, the cushion connector 2708 is in the form of a protruding wall that forms a cuff or collar. The protruding wall may extend rearward and / or upward from the rear side of the front wall portion 2701 of the frame 2178. The cushion connector 2708 may be positioned above the AA valve 2522 along the rear side of the frame 2178. The cushion connector 2708 may be positioned adjacent to the AA valve 2522 along the rear side of the frame 2178. In some configurations, the inlet 2706, the AA valve 2522, and the cushion connector 2708 cooperate to form a gas flow path defined by the frame 2178. In the illustrated arrangement, each of the inlet 2706, the AA valve 2522, and the cushion connector 2708 includes a substantially enclosed space (except for specific and intended openings), thereby defining a portion of the overall gas flow path. In some configurations, the front wall portion 2701 of the frame 2178 defines at least a portion of the gas flow path. In the illustrated arrangement, the front wall portion 2701 of the frame 2178 defines a portion of the gas flow path to one or both of the AA valve 2522 and the cushion connector 2708. Such an arrangement allows the frame 2178 to have a shallower depth than designs in which the entire gas flow path is defined by a dedicated structure.

[0241] In some embodiments, the cushion connector 2708 may include an alignment feature such as an alignment notch 2710. The alignment notch 2710 may be formed in a portion of the cushion connector 2710. For example, the alignment notch 2710 may be formed in a top wall portion of the cushion connector 2708. The alignment notch 2710 may guide the connection between the frame 2178 and the mask assembly 2100. For example, the alignment notch 2710 may correspond to a feature on the mask assembly 2100 to allow the frame 2178 and mask assembly 2100 to be connected in the proper orientation. In some embodiments, the alignment notch 2710 has a generally trapezoidal, rectangular, and / or square shape, among other possible shapes. In some embodiments, the width of the alignment notch 2710 may be wider at the outer edge of the top wall of the cushion connector 2708 than the width of the alignment notch 2710 located closer to the rear of the frame 2178.

[0242] In some embodiments, the frame 2178 may include an inlet 2706. The inlet 2706 may be defined by a tubing connector 2711, which may be a separate structure coupled to the frame 2178. In some embodiments, the inlet 2706 provides a fluid or gas flow path through which pressurized air may be provided to the mask assembly 2100. In some embodiments, the pressurized air may be provided to the mask assembly 2100 through the inlet 2706 via or through the AA valve 2522. As described in more detail below, the AA valve 2522 may provide access to the atmosphere in the absence of a pressurized air source or when the pressure within the mask assembly 2100 otherwise drops below atmospheric pressure.

[0243] In some embodiments, the frame 2178 may include at least one upper strap connector 2702 and at least one lower strap connector 2704. In the illustrated arrangement, the frame 2178 includes a pair of upper strap connectors 2702 and a pair of lower strap connectors 2704. Each of the pair of upper and lower strap connectors 2702, 2704 may be positioned on opposite outer sides of the frame 2178. In some embodiments, the upper strap connectors 2702 may slidably receive corresponding upper headgear straps 2802 of the headgear 2180 (see, for example, FIG. 49 ). The upper headgear connector 2702 may include a post 2703A and an aperture 2703B. The post 2703A may be spaced from the front of the frame 2178. The post 2703A may be positioned approximately in the center of the aperture 2703B. In some embodiments, the post 2703A can be positioned offset from the center of the aperture 2703B. In some embodiments, the post 2703A can be positioned offset forward of the front wall of the frame 2178.

[0244] As shown in at least FIGS. 49 and 73 , the post 2703A can facilitate securing the upper side strap 2802 to the upper headgear connector 2702. In some embodiments, the post 2703A, together with the front of the frame 2178, can define a slot through which the corresponding upper side strap 2802 can pass. For example, the upper side strap 2802 can pass through a slot formed between the post 2703A and the aperture 2703B. Once the upper side strap 2802 passes through the slot, the upper side strap 2802 can wrap around the outside of the post 2703A and, for example, fold over itself. In some embodiments, the aperture 2703B can provide additional space, allowing the upper side strap 2802 to pass behind the post 2703A. In some configurations, the aperture 2703B facilitates shortening the distance between the post 2703A and the front of the frame 2178 necessary to accommodate the thickness of the strap 2802. In some embodiments, the upper strap connectors 2702 may secure, such as by removably securing, headgear clips that may be attached to the upper side straps 2802 .

[0245] In some embodiments, the lower strap connector 2704 may receive and / or secure the lower side strap 2802 and / or the lower headgear clip 2600 (see FIG. 49). As shown in at least FIGS. 51A-54, the lower strap connector 2704 may include a lower post 2705A. The lower post 2705A may be positioned along a side edge of the frame 2178. The lower post 2705A may be spaced from a portion of the frame 2178 to define an aperture 2705B. In some embodiments, the lower post 2705A forms a lower side edge of the frame 2178. In some embodiments, the aperture 2705B may be shaped to receive at least a portion of the lower headgear clip 2600. In some embodiments, the aperture 2705B may be substantially D-shaped, among other possible shapes. In some embodiments, the post 2705A may be received within and / or retain a portion of a corresponding lower headgear clip 2600, such as a hook portion of the clip 2600. The lower post 2705A may provide a removable connection between the lower side strap 2804 and the frame 2178 and / or between the lower headgear clip 2600 and the frame 2178.

[0246] In some embodiments, the frame 2178 may include a frame paddle 2179. As described above, the paddle 2179 may define an upper support member that, when assembled, supports a forward-facing outer portion (seal paddle 2126) of the nasal region 2168 of the mask seal 2104. The paddle 2179 may help minimize deflection of the mask seal 2104. In some embodiments, the paddle 2179 may help maintain contact between the nasal region 2168 and the user's nose. For example, the paddle 2179 may help prevent the nasal region 2168 and the seal paddle 2126 of the mask seal 2104 from expanding away from and / or disengaging from the user's nose.

[0247] 52-58 illustrate several portions of the valve 2522 in greater detail. As shown in at least FIGS. 52-54, the valve 2522 may include a valve element or member, such as a valve flap 2524. The valve 2522 may also include a tubing connector 2711, among other possible components. In some embodiments, the valve 2522 may include an air passage 2722 and / or an outlet 2720. As shown, at least a portion or several components of the valve 2522 may be integrally formed with the frame 2178. For example, a body portion defining one or more gas flow passages of the valve 2522 may be integrally formed with the frame 2178. Some configurations may desirably reduce assembly time and / or the number of components required to manufacture, clean, and / or replace. Some such configurations may desirably reduce the likelihood of pressurized air leaking from the assembly.

[0248] 53 and 54 show cross-sectional views of the frame 2178 taken along lines 53-53 and 54-54, respectively, shown in FIG. 51A. FIG. 55 shows a front cross-sectional view of the frame 2178 shown in FIG. 52. As shown, the frame 2178 can house the valve flap 2524. In some embodiments, the frame 2178 entirely surrounds the valve flap 2524. As such, the valve flap 2524 can be positioned to fit within the gas flow path of the valve 2522 of the frame 2178.

[0249] In some embodiments, the tubing connector 2711 may define an inlet opening 2706 that directs pressurized air through the valve 2522 and through the mask assembly 2100 to the user. In some embodiments, the tubing connector 2711 may be elliptical, circular, and / or oval, among other shapes. Preferably, the dimension of the inlet 2706 in the anterior-posterior direction is smaller than the dimension of the inlet 2706 in the lateral direction. Thus, extra space may be provided in the anterior-posterior direction to accommodate the valve 2522 without increasing the anterior-posterior dimension of the frame 2178 or moving the inlet 2706 further away from the user's face, as compared to a design in which the inlet 2706 is circular. The tubing connector 2711 may include a male component that is received by a corresponding female connector. The female connector may be attached to the conduit 2520A. In some embodiments, the tube connector 2711 allows for disconnection of the conduit 2520A by twisting the conduit 2520A relative to the frame 2178 and / or the tube connector 2711. In some embodiments, the conduit 2520A is connected to the tube connector 2711 via a snap-fit ​​arrangement, among other possible configurations. For example, the tube connector 2711 may include one or more tube connector notches 2712. The tube connector notches 2712 may engage corresponding features on the conduit 2520A via a snap-fit ​​arrangement.

[0250] In some embodiments, the valve flap 2524 may be secured within the frame 2178 by a tubing connector 2711. In some embodiments, the tubing connector 2711 may be permanently connected to a lower end of the frame 2178 defining the valve 2522 by various configurations, such as welding, adhesives, and / or snap-fit ​​configurations, among other possible configurations. In some embodiments, the tubing connector 2711 may surround and / or secure a tab of the valve flap 2524 between the lower end of the frame 2178 and a flange of the tubing connector 2711. In some embodiments, the valve flap 2524 may be positioned adjacent the inner end 2711A of the tubing connector 2711 of the frame 2178. In some embodiments, the valve flap 2524 may be constructed, in whole or in part, from a flexible elastomer such as silicone, among other materials.

[0251] The valve flap 2524 may open or close different flow paths within the valve 2522 to allow air to flow through desired ones of the different flow paths of the valve 2522. For example, when the flow generator supplies positive pressure air to a user through the mask assembly 2100, the valve flap 2524 may pivot about a hinge or otherwise move in response to pressurized air entering the inlet 2706. In this position, the valve flap 2524 is open to the inlet 2706 of the tubing connector 2711 and closed to the valve 2522 and / or the air passage 2722 of the valve 2522. Some configurations may facilitate ensuring that all or substantially all of the positive pressure air flow is directed to the user with little or no air flow leakage from the air passage 2722 of the valve 2522. When the flow generator does not provide air flow to the mask assembly 2100 or the pressure within the mask assembly 2100 otherwise drops below atmospheric pressure, the valve flap 2524 is closed to the inlet 2706 of the tube connector 2711 and the air passage 2722 of the AA valve 2522 is opened to allow the user to inhale ambient air through the valve 2522.

[0252] The tubing connector 2711 may support the valve flap 2524 in an operable position relative to the valve 2522 portion of the frame 2178. In some configurations, the tubing connector 2711 defines a stop that prevents the valve flap 2524 from inverting or extending downwardly from the inlet 2706 of the frame 2178 (see, e.g., FIG. 53). In some configurations, the tubing connector 2711 may include a flap support 2724. In some embodiments, the tubing connector 2711 may include at least three flap supports 2724 (see FIG. 56). In some embodiments, the tubing connector 2711 may include at least two, three, four, five, six, or more flap supports 2724. The flap supports 2724 may extend radially inward from the inner surface of the peripheral wall of the tubing connector 2711 to the inlet 2706 of the tubing connector 2711. In some embodiments, the flap support 2724 can be positioned adjacent the upper edge of the tubing connector 2711. In some configurations, the flap support 2724 can prevent the valve flap 2524 from inverting or extending downward into the inlet 2706.

[0253] 55 , the valve 2522 (alone or in combination with the frame 2178) may include various air passages and valve outlets to allow air to flow in or out of the mask assembly 2100 when the valve flap 2524 is in the closed position. For example, in some embodiments, a flow path is provided through the air passage 2722 and valve outlet 2720 of the valve assembly 2522B and the cushion connector 2708. In some embodiments, the valve 2522 may include at least two air passages 2722 and / or at least two lateral valve outlets 2720.

[0254] In some embodiments, the air passage 2722 may extend rearward, away from the inlet 2706, towards the outlet 2720. In some embodiments, the air passage 2722 may extend through the inner wall of the valve 2522 towards the outlet 2720. In some embodiments, the air passage 2722 may extend from the tube 2520A through the inner wall of the valve 2522 towards the outlet 2720. In some embodiments, the air passage 2722 may extend rearward and downward into the outlet 2720. In some embodiments, the central axis of the air passage 2722 forms an acute angle with the central axis 2706A of the inlet 2706 (as shown in FIG. 59 ).

[0255] In some embodiments, the outlet 2720 may define an opening to allow exhaust air to pass from the patient interface or allow inhaled air to enter the patient interface via the air passage 2722 when the valve flap 2524 is in the closed position. As shown in FIG. 54 , the valve 2522 may include a rear wall 2523 spaced rearward from the outlet of the air passage 2722 at the outlet 2720 and, together with the inner wall, define the outlet 2720. Such a configuration may provide space for directing the exhaust laterally, as indicated by the arrows shown in FIG. 51B . The rear wall of the valve 2522 may direct the exhaust away from the user. In some embodiments, the lateral orientation may help minimize contact between the exhaust and the user. Some configurations may help reduce discomfort caused to the patient by the exhaust. In some embodiments, the outlet 2720 may extend below the lower surface of the housing 2102 when assembled (see FIGS. 68-70 ). In such a configuration, the exhaust air may not be blocked by the housing 2102 .

[0256] 57 and 58 show exploded views of the frame 2178 showing portions of the valve 2522. In some embodiments, the valve flap 2524 may include a perimeter 2524A and an internal rib 2524B. The perimeter 2524A may include a lip. The lip may define a thickened region extending along the perimeter 2524A. In some embodiments, the rib 2524B may be positioned along the underside of the valve flap 2524. The rib 2524B may be positioned approximately along the central axis of the valve flap 2524. In some embodiments, the rib 2524B may define a thickened region along the center of the valve flap 2524. In some embodiments, the perimeter 2524A and / or the rib 2524B may provide rigidity to the valve flap 2524. The perimeter 2524A and / or ribs 2524B may help prevent the valve flap 2524 from bulging and / or deforming due to the flow of pressurized air during use. Some configurations may help provide an effective seal around the air passage 2722 when the valve 2522 is in the open position.

[0257] In some embodiments, the tubing connector 2711 includes an inlet 2706, by which a source of pressurized air may be directed through the valve 2522 and into the breathing chamber. The inlet 2706 may be angled downward during use. For example, as shown in FIG. 59 , the central axis 2706A of the inlet 2706 may form an angle with the central axis 2708A of the cushion connector 2708. In some embodiments, the angle is about 125 degrees. In some embodiments, the angle is greater than or less than 125 degrees. In some embodiments, the angle is about 124.4 degrees. In some embodiments, the angle is greater than or less than 124.4 degrees. Some configurations may facilitate keeping the conduit 2520A away from the user. Some configurations may desirably minimize bulkiness of the patient interface, such as at the front of the mask assembly 2100.

[0258] 60-72B show an embodiment of a mask assembly 2100 coupled to a frame 2178. As described herein above, the mask assembly 2100 may include a housing 2102 and a mask seal 2104. The housing 2102 may be located forward of the mask seal 2104. In some embodiments, the housing 2102 may be substantially rigid. In some embodiments, the housing 2102 may include a frame connector 2730, at least one bias vent 2502, and / or an AA valve recess 2726.

[0259] FIG. 62 shows a front view of the mask assembly 2100 showing the housing 2102. In some embodiments, the housing 2102 can include one, two, three, four, or five or more bias vents 2502. The bias vents 2502 can be positioned in a bottom region of the housing 2102. In some embodiments, the bias vents 2502 can be positioned on a generally forward-facing surface of the housing 2102. For example, the bias vents 2502 can be positioned adjacent a lower edge of the housing 2102. In some configurations, the bias vent 2502 openings can be positioned near and / or adjacent a lower edge of the frame 2178 when assembled. Preferably, the bias vents 2502 are positioned below the lower edge of the frame 2178. Such a configuration can minimize contact between the vents and the frame 2178. Such a configuration can help reduce noise and / or unwanted drafts or air leakage.

[0260] FIG. 62 shows an example of a housing 2102 including two bias vents 2502. The bias vents 2502 may include multiple holes. The multiple holes may be arranged in a generally triangular pattern, among other possible patterns. The bias vents 2502 may be positioned on opposite outer sides of the inlet 2732 and / or the valve recess 2726 of the mask seal 2104. In some embodiments, at least a portion of the bias vent 2502 is positioned below at least a portion of the inlet 2732, and at least a portion of the bias vent 2502 is positioned beyond a side of the inlet 2732. In such a configuration, only a portion of the bias vent 2502 is positioned laterally beyond the inlet 2732. In some embodiments, the bias vent 2502 is positioned entirely beyond a side of the inlet 2732. The bias vents 2502 may facilitate dispersing exhaust air. Such a configuration may reduce disturbances and / or noise, such as drafts caused by exhaust air, for the user and / or co-sleepers.

[0261] In some embodiments, the bias vent 2502 is positioned such that air is exhausted below the frame 2178 (see FIGS. 68-70). For example, the bias vent 2502 is positioned directly below and / or adjacent to the lower edge of the frame 2178. Such a configuration allows the air to pass through the frame 2178 with minimal disruption to the airflow. As discussed above, such a configuration may help disperse the exhaust air, reduce noise, and / or reduce disruption caused by the exhaust air to the user and / or co-sleeping companions.

[0262] In some embodiments, the housing 2102 includes a valve recess 2726. The valve recess 2726 may define a concave area. The concave area may be positioned below and / or adjacent to the inlet 2732. In some embodiments, the width of the valve recess 2726 may be less than the maximum width of the inlet 2732.

[0263] In some embodiments, the valve recess 2726 may receive at least a portion of the valve assembly 2522B, such as the rear surface of the valve 2522 and / or the valve outlet 2720. In some embodiments, the valve recess 2726 has a curved surface that includes a curvature that accommodates or matches the curvature of the rear surface / wall 2523 of the valve 2522. In at least some embodiments, the valve recess 2726 allows the valve 2522 to be recessed into the mask assembly 2100 and / or positioned below at least a portion of the mask seal 2104, such as the upper front portion and / or nasal region 2168 of the mask seal 2104. In at least some embodiments, the valve recess 2726 and / or the valve 2522 may desirably reduce the overall depth of the patient interface. This may reduce the visibility of the patient interface to a user and may help reduce hose strain. In at least some embodiments, the valve recess 2726 and / or the valve 2522 may position the valve 2522 higher than the bottom of the mask seal 2104 and / or may shorten the inlet 2732. This may facilitate reducing the overall size of the mask assembly 2100.

[0264] As described above, the housing 2102 may include a frame connector 2730. As shown in FIG. 60 , the frame connector 2730 may form a collar. The collar may protrude inward from the front of the housing 2102 toward or into the interior of the mask assembly 2100. The frame connector 2730 may extend around all or part of the periphery of the inlet 2730. In some embodiments, the frame connector 2730 may receive and / or retain the cushion connector 2708 of the frame 2178.

[0265] In some embodiments, the frame connector 2730 can include a securing feature for engaging the cushion connector 2708 of the frame 2178. For example, the frame connector 2730 can include at least one connector ridge 2734 (e.g., a pair of connector ridges 2734) or other retention or alignment feature. The connector ridge 2734 can be positioned along a portion of the interior surface of the frame connector 2730. The connector ridge 2734 can engage with a corresponding engagement feature 2715 of the cushion connector 2708. The engagement feature 2715 can include a notch, recess, or other engagement feature. The engagement feature 2715 can be positioned on the outer surface of the cushion connector 2708. In some embodiments, the connector ridge 2734 can engage with the engagement feature 2715 of the cushion connector 2708 via a snap-fit ​​arrangement, among other engagement arrangements. In some embodiments, the cushion connector 2708 includes a pair of laterally opposed recesses 2715 configured to receive and / or retain a corresponding pair of connector ridges 2734 on the frame connector 2730. Such a configuration may secure the frame 2178 to the mask seal 2104.

[0266] As shown in at least FIG. 61 , in some embodiments, the frame connector 2730 can include a lip 2738 (see FIG. 69 ). The lip 2738 can define an upper wall of the valve recess 2726. In some configurations, the lip 2738 can be recessed relative to the front side of the housing 2102. In some embodiments, the lip 2738 can form at least a portion of the frame connector 2730 and / or the inlet 2732. When assembled, the lip 2738 can be positioned above the valve outlet 2720.

[0267] In some embodiments, the frame connector 2730 may include an alignment feature 2714. An alignment feature 2739 may protrude radially into the inlet and / or forward of the trailing edge of the frame connector 2730. The alignment feature 2714 may engage with an alignment notch 2710 in the cushion connector 2708 of the frame 2178. Such a configuration may facilitate aligning and / or securing the frame 2178 with the mask seal 2104.

[0268] In some embodiments, the mask seal 2104 is substantially resilient. In some embodiments, the mask seal 2104 may include a nasal region 2168 and a mouth sealing portion. The nasal region 2168 may include a nasal opening 2124 and right and left nasal sealing surfaces 2124A, 2124B. The right and left nasal sealing surfaces 2124A, 2124B may extend outward from the nasal opening 2124. In some embodiments, the mouth sealing portion may include a mouth opening 2122 (see FIG. 61 ).

[0269] As shown in at least FIGS. 61-62 , the mask seal 2104 may include an inlet 2732. The inlet 2732 may form an opening in the mask seal 2104 to allow air to flow in and out of the breathing chamber. In some embodiments, the inlet 2732 may include a non-circular perimeter. In some embodiments, the perimeter of the inlet 2732 may have a generally oval, elliptical, square, and / or rectangular shape, among other shapes. In some embodiments, the inlet 2732 includes a generally rounded "D" shape and / or a rounded trapezoidal shape, among other shapes. An inlet 2732 having a non-circular perimeter may desirably facilitate easier assembly and / or alignment of the frame 2178 and the mask seal 2104. Such a configuration may facilitate preventing incorrect assembly of the seal 2104 to the frame 2178. Such a configuration may facilitate preventing or limiting rotation of the frame 2178 relative to the seal 2104 once assembled. In some embodiments, the non-circular perimeter of the inlet 2732 allows at least a portion of the valve 2522 to be positioned closer to the center of the inlet 2732 than in designs with a circular inlet 2732. Such a non-circular configuration may desirably create additional space for the valve 2522, thereby reducing the overall dimensions (e.g., height) of the mask assembly 2100 when assembled compared to a mask with a circular inlet.

[0270] As described above, the mask seal 2104 may include a nasal region 2168. The nasal region 2168 may include left and right sealing surfaces 2124B, 2124A. In some embodiments, each of the left and right sealing surfaces 2124B, 2124A may define a convex region. As described herein above, the left and right sealing surfaces 2124B, 2124A may cooperate to define a concave region configured to receive the user's nose. The convex regions of the left and right sealing surfaces 2124B, 2124A may be generally flattened. For example, the flattened convex regions may extend from the tops of the left and right sealing surfaces 2124B, 2124A toward the nasal openings 2124. The flattened convex regions may have a generally linear profile as the left and right sealing surfaces 2124B, 2124A extend from their highest points toward the nasal openings 2124. The flattened sealing surfaces 2124B, 2124A may, for example, help prevent or limit the formation of creases in the sealing surfaces 2124B, 2124A when the nose region 2168 engages the user's nose during use. Some configurations may help minimize leakage around the user's nose during use.

[0271] 65 shows an enlarged rear view of a portion of the nasal region 2168. While the left nasal sealing surface 2124B is shown and described, the right nasal sealing surface 2124A may include similar features and is preferably a mirror image of the left nasal sealing surface 2124B. As shown, the nasal sealing surface 2124B may be relatively flat, laterally adjacent the nasal opening 2124. In some embodiments, the curvature of the nasal sealing surface 2124B may be relatively small (e.g., approximately linear) because the nasal sealing surface 2124B extends radially outward from the nasal opening 2124 toward the highest point of the nasal sealing surface 2124B. In some embodiments, the curvature of the nasal sealing surface 2124B can be relatively small because the nasal sealing surface 2124B extends radially outward from the nasal opening 2124 to approximately the midpoint 2725 of the nasal sealing surface 2124B, as shown by curvature lines 2727A, 2727B, 2727C, 2727D, 2727E. In some embodiments, the curvature of the nasal sealing surface 2124B is large because the nasal sealing surface 2124B extends radially outward beyond the midpoint 2725 (e.g., in the outer nasal sealing surface region). As shown by curve plot 2728 and described in more detail below, the radius of curvature of the outer nasal sealing surface region decreases in a posterior-to-anterior direction along the surface of the outer nasal sealing surface region. For example, in some embodiments, the radius of curvature of the outer nasal sealing surface region of a posterior portion of the nasal sealing surface 2124B is larger than the radius of curvature of the outer nasal sealing surface region of an anterior portion of the nasal sealing surface 2124B. That is, the nasal sealing surface 2124B may progress from less curved to more curved in a posterior to anterior direction.

[0272] FIG. 66 shows a top view of the mask seal 2104. FIGS. 67A-67F show cross-sectional views of the mask seal 2104 as viewed from the back. As shown, in some embodiments, the left and right nasal sealing surfaces 2124B, 2124A may be angled relative to one another in at least two dimensions. For example, when viewed from the front or back, the left and right nasal sealing surfaces 2124B, 2124A may extend upwardly and away from the nasal region 2168 at an angle to form a general V-shape. In some embodiments, when viewed from above, the left and right nasal sealing surfaces 2124B, 2124A may be angled away from one another in a direction from the front 2740 to the back 2742 of the mask seal 2104 or seal assembly 2100. In such a configuration, the nasal region 2168, including the left and right nasal sealing surfaces 2124B, 2124A, may form a general triangle. Such a configuration may desirably accommodate or approximately match the geometry of a user's nose. This may provide more stability and / or comfort to the user. Such a configuration may help reduce air leakage from the mask seal 2104.

[0273] FIG. 67A shows a posterior cross-sectional view taken along line AA in FIG. 66. FIG. 67B shows a posterior cross-sectional view taken along line BB in FIG. 66. FIG. 67C shows a posterior cross-sectional view taken along line CC in FIG. 66. FIG. 67D shows a posterior cross-sectional view taken along line DD in FIG. 66. FIG. 67E shows a posterior cross-sectional view taken along line EE in FIG. 66. FIG. 67F shows a posterior cross-sectional view taken along line FF in FIG. 66. As shown in FIGS. 67A-67F, the left and right nasal sealing surfaces 2124B, 2124A of the nasal region 2168 can be angled outward and upward away from each other and from the bottom to the top from a central vertical plane. In some embodiments, the angle between the left and right nasal sealing surfaces 2124B and 2124A increases in the posterior-to-anterior direction. In some embodiments, the depth of the nasal region 2168 decreases in the posterior-to-anterior direction. For example, angle 2744A may be approximately 57 degrees, angle 2744B may be approximately 60 degrees, angle 2744C may be approximately 64 degrees, angle 2744D may be approximately 71 degrees, angle 2744E may be approximately 77 degrees, angle 2744F may be approximately 88 degrees, and angles in between. Such a configuration allows nasal region 2168 to engage with the user's nose during use without extending over the tip of the user's nose. Such a configuration may desirably better conform to the geometry of the user's nose, which may provide more stability and / or comfort to the user. Such a configuration may help reduce air leakage through the mask seal 2104.

[0274] FIG. 73 shows a side view of a patient interface illustrating an embodiment of headgear 2180. FIG. 74 shows an exterior plan view of the outer surface of the headgear 2180, and FIG. 75 shows an interior view of the inner surface of the headgear 2180, with the headgear 2180 in a laid-flat position in both FIG. 74 and FIG. 75. As described above, the headgear 2180 may include, among other components, at least two upper side straps 2804, at least two lower side straps 2802, a back panel 2806, and / or a crown strap 2808. As shown at least in FIG. 74 and FIG. 75, the upper side straps 2804 may be connected to the crown strap 2808 at an angle 2818. For example, the angle 2818 between the upper side straps 2804 and the crown strap 2804 may be approximately 144 degrees. In some embodiments, the angle 2818 is 130 degrees, 135 degrees, 140 degrees, 145 degrees, or 150 degrees or greater. The angle 2818 allows the upper side straps 2804 to extend down to the frame 2178 above the user's ears during use.

[0275] In use, the upper side straps 2804 may be positioned on opposite sides of the headgear 2180 and may extend downward from the crown strap 2808 towards the mask assembly 2100. In some embodiments, the upper side straps 2804 may be configured to extend across the cheeks of the user when worn. In some embodiments, the upper side straps 2804 may be adjustably and / or directly connected to the frame 2178, such as the upper strap connectors 2702 of the frame 2178.

[0276] In some embodiments, the lower side straps 2802 may be positioned on opposite sides of the headgear 2180. During use, the lower side straps 2802 may extend substantially horizontally below the user's ears. The lower side straps 2802 may extend from the rear panel 2806 toward the mask assembly 2100. In some embodiments, the lower side straps 2802 may be configured to extend across the user's face, such as generally along the user's chin, when worn. In some embodiments, the lower side straps 2804 may be adjustably connected to the frame 2178. The connection between the frame 2178 and the lower side straps 2802 may include a direct and / or indirect connection. For example, the lower side straps 2802 may be indirectly connected to the frame 2178 via the headgear clips 2600. As shown in FIGS. 73-75 , the upper and lower side straps 2804, 2802 may be connected by the rear panel 2806. The connections of the upper and lower side straps 2804 at the rear panel 2806 may be positioned behind the user's ears during use. Such a configuration may provide stability and support to the headgear 2180. Such a configuration may provide greater comfort and / or a more aesthetically pleasing appearance to the user when worn.

[0277] In some embodiments, the rear panel 2806 may be positioned approximately in the center of the headgear 2180. The rear panel 2806 may be configured to contact the rear portion of the user's head when worn. In some embodiments, the rear panel 2806 may include at least two or more portions. The rear panel 2806 may include a first portion 2806A and a second portion 2806B. The first portion 2806A may be integrally formed with the upper and lower side straps 2804, 2802. In some embodiments, the second portion 2806B may be positioned approximately in the center of the rear panel 2806. The second portion 2806B may be made, at least in part, of spacer fabric. Examples of such spacer fabrics are disclosed in applicant's International Publication WO 2017021836, which is incorporated herein by reference in its entirety. The spacer fabric may provide additional comfort to the user. For example, the spacer fabric may desirably be lightweight, breathable, and / or form a cushioned area for the back of the user's head. In some embodiments, the second portion of the spacer fabric may extend inward from the first portion 2806A of the back panel 2806. In some embodiments, the spacer fabric may include two layers of spacer fabric. For example, each of the layers may be overlapped with one another.

[0278] In some embodiments, the headgear 2180 includes a crown strap 2808. The crown strap 2808 may include a right portion 2810 and a left portion 2812. In some embodiments, the left and right portions 2812, 2810 may form a strap that extends across an upper region of the user's head, such as the top of the user's head.

[0279] In some embodiments, the left and right portions 2812, 2810 can be adjustably coupled. In some embodiments, the left and right portions 2812, 2810 are adjustably coupled by a buckle. In some embodiments, the left portion 2812 includes an aperture 2813. The aperture 2813 can be positioned near an end of the left portion 2812 of the crown strap 2808. In some embodiments, the aperture 2813 can receive at least a portion of the right portion 2810 of the crown strap 2808. In some embodiments, the aperture 2813 allows the left and right portions 2812, 2810 to be adjustably coupled. For example, the left and right portions 2812, 2810 can be slidingly adjusted relative to one another. In some embodiments, the right portion 2810 includes a first recessed region 2811A and a second recessed region 2811A. First and second recessed regions 2811A, 2811B can be formed along opposite sides of the right portion 2810. The first and second recessed regions 2811A, 2811B can be aligned with one another and positioned offset from the end of the right portion 2810. In some embodiments, the first and second recessed regions 2811A, 2811B define narrowed regions. The narrowed regions can slide through the aperture 2813. In some embodiments, the narrowed regions can slide through the aperture 2813 with little or no deformation of the left and / or right portions 2812, 2810.

[0280] Although several embodiments have been described, such as a left portion 2812 having an aperture 2813 and a right portion 2810 having first and second recessed regions 2811A, 2811B, other configurations are contemplated. For example, the right portion 2810 may include the aperture 2813, and the left portion 2812 may include the first and second recessed regions 2811A, 2811B.

[0281] In some embodiments, the upper side straps 2804, the lower side straps 2802, and / or the crown strap 2808 may include fastening features 2820. The fastening features 2820 may include one or more hook-and-loop fasteners, among other features. The fastening features 2820 allow the headgear to be adjusted to various lengths, such as a user-defined length. In some embodiments, the fastening features 2820 of the lower side straps 2802 and / or the upper side straps 2804 allow the straps 2802, 2804 to be easily adjusted and / or removed from the mask assembly 2100.

[0282] Unless the context clearly dictates otherwise, throughout the description and claims, the words "comprise," "including," and the like may be construed in an inclusive manner, i.e., "including, but not limited to," as opposed to exclusive or exhaustive. Conditional language used herein, such as, among others, "can," "may," "could," "may," "for example," and the like, is intended to generally convey that some embodiments include certain features, elements, and / or conditions, while other embodiments do not, unless specifically stated otherwise or understood otherwise within the context in which it is used. As such, such conditional language does not generally imply that one or more embodiments require these features, elements, and / or conditions, or that one or more embodiments necessarily include logic for determining whether the features, elements, and / or conditions are included or implemented in any particular embodiment, with or without authorial input or direction.

[0283] The term "plurality" refers to two or more items. References to quantities, dimensions, sizes, formulations, parameters, shapes, and other characteristics should be construed as if the quantity, dimension, size, formulation, parameter, shape, or other characteristic were preceded by the term "about" or "approximately." The terms "about" or "approximately" mean that the quantity, dimension, size, formulation, parameter, shape, and other characteristic need not be exact but may be approximate and / or larger or smaller as needed, reflecting acceptable tolerances, conversion factors, rounding, measurement error, etc., and other factors known to those of ordinary skill in the art. References to quantities, dimensions, sizes, formulations, parameters, shapes, and other characteristics should also be construed as if the term "substantially" were preceded by the quantity, dimension, size, formulation, parameter, shape, or other characteristic. As used herein, the terms "approximately," "about," and "substantially" refer to an amount close to the stated amount that still performs a desired function or achieves a desired result. For example, in some embodiments, as may be indicated by context, the terms "approximately," "about," and "substantially" may refer to an amount within 10% or less of the stated amount. As used herein, the term "generally" refers to a value, quantity, or characteristic that primarily includes or tends toward a particular value, quantity, or characteristic. For example, as the context may dictate, the term "substantially linear" may mean that it deviates from exact parallelism by no more than 15°.

[0284] Numerical data may be expressed or presented herein in a range format. It should be understood that such range format is used merely for convenience and brevity and should be interpreted flexibly to include not only the numerical values ​​expressly recited as range limits, but also to include all of the individual numerical values ​​or subranges within the range, as if each individual numerical value and subrange were expressly recited. As an example, the numerical range "1 to 5" should be interpreted not only to include the explicitly recited value of about 1 to about 5, but also to include each individual value and subrange within the recited range. Thus, within this numerical range, individual values ​​such as 2, 3, and 4, as well as subranges such as "1 to 3," "2 to 4," and "3 to 5," are also included. This same principle should apply to ranges reciting only one numerical value (e.g., "greater than 1"), regardless of the breadth or described characteristics of the range.

[0285] Multiple items may be presented in a common list for convenience. However, these lists should be construed as though each element of the list were individually identified as a separate and unique element. As such, individual elements of such lists should not be construed as being effectively equivalent to any other element of the same list merely based on their other presentation in a common group, absent a statement to the contrary. Furthermore, when the terms "and" and "or" are used in conjunction with lists of items, they should be interpreted broadly to mean that any one or more of the listed items may be used alone or in combination with other listed items. The term "instead" refers to a selection of one of two or more alternatives and is not intended to limit the selection to only those listed alternatives, or to only one of the listed alternatives at a time, unless the context clearly dictates otherwise.

[0286] The reference herein to any prior art is not, and should not be taken as, an acknowledgment or any form of suggestion that the prior art forms part of the common general knowledge in the field of endeavor in any country throughout the world.

[0287] The invention may also be broadly said to consist in any or all combinations of two or more of the parts, elements or features, individually or collectively, as mentioned or shown in the specification of this application.

[0288] Where in the above description reference is made to elements known to be whole or equivalent thereto, those wholes are incorporated herein as if individually set forth.

[0289] It should be noted that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present invention and without diminishing its attendant advantages. For example, various components can be repositioned as needed. Therefore, such changes and modifications are intended to be included within the scope of the present invention. Furthermore, not all features, aspects, and advantages are necessarily required to practice the present invention. Therefore, the scope of the present invention is intended to be defined solely by the following claims.

Claims

1. 1. A nose-mouth mask seal for an interface assembly, comprising: a mouth sealing portion, A mouth opening; A nasal region, The nasal opening and Right nasal sealing surface and a left nasal sealing surface; the right nasal sealing surface and the left nasal sealing surface extend outwardly from the nasal opening; the nasal region; Including, the right and left nasal sealing surfaces form a V-shape when viewed from the front or back of the mask seal, and the angle between the right and left nasal sealing surfaces increases in a back-to-front direction; A nose-to-mouth mask seal, wherein the right and left nasal sealing surfaces are angled away from each other in the back-to-front direction of the mask seal when viewed from the top of the mask seal.

2. 10. The nose-mouth mask seal of claim 1, wherein the right and left nasal sealing surfaces form a general triangle configured to accommodate or generally match the geometry of a user's nose.

3. 3. The nose-mouth mask seal of claim 1 or 2, wherein the angle between the right and left nasal sealing surfaces increases from about 57 degrees to about 88 degrees in a back-to-front direction.

4. A nose-mouth mask seal according to any preceding claim, wherein the depth of the nasal region decreases in a posterior-to-anterior direction.

5. A nose-mouth mask seal according to any preceding claim, wherein the right and left nasal sealing surfaces are relatively flat laterally adjacent the nasal openings.

6. 6. The nose-mouth mask seal of claim 1, wherein the right and left nasal sealing surfaces are angled outward and upward away from each other and in a bottom-to-top direction from a vertical plane in the center of the mask seal.

7. 7. A nose-mouth mask seal according to any one of claims 1 to 6, wherein the curvature of the right and left nasal sealing surfaces is generally linear as the right and left nasal sealing surfaces extend radially outward from the nasal openings.

8. 8. A nose-mouth mask seal according to any one of claims 1 to 7, wherein the curvature of the right and left nasal sealing surfaces is generally linear as the right and left nasal sealing surfaces extend radially outward from the nasal opening to approximately a midpoint between the right and left nasal sealing surfaces.

9. The nose-mouth mask seal of any one of claims 1 to 8, further comprising a pair of paddles configured to extend parallel to the user's nares.

10. 10. The nose-mouth mask seal of claim 9, wherein the paddles are configured to expand in volume in response to an increase in pressure within the mask seal and / or flex to conform to various facial and nasal geometries to assist in creating sealing contact with a user's face.

11. 11. The nose-mouth mask seal of claim 9 or 10, further comprising a support for the paddle, the support being a suspension member, a spring, or a thickened area of ​​the mask seal.

12. 12. The nose-mouth mask seal of any one of claims 9 to 11, comprising a recessed surface on the front side of the nose-mouth mask that does not contact the user.

13. 13. The nose-mouth mask seal of claim 12, wherein the recessed surface includes an upper recessed surface positioned along a front side of the paddle that does not contact the user.

14. 14. A nose-mouth mask seal according to claim 12 or 13, wherein the recessed surface and / or the upper recessed surface are configured to allow a frame to be inserted into the nose-mouth mask seal, and the frame is configured to connect to a head strap or headgear.

15. 15. A patient interface including a nose-mouth mask seal according to claim 14, comprising the frame and an anti-asphyxiation valve.

16. 16. A patient interface according to claim 15, wherein the frame includes frame paddles positioned within the upper recessed surface.

17. 17. A patient interface according to claim 15 or 16, wherein the anti-asphyxiation valve is integrally formed with the frame.

Images