Patient interfaces

Abstract

To provide under-nose interface assemblies improved in comfort and / or sealing performance.SOLUTION: An interface for positive pressure respiratory therapy includes a mask assembly having a mask seal and a mask shell. The mask assembly is positioned lower than and exposes a bridge of a user's nose. The mask seal includes first and second portions on respective first and second sides of a nasal region that contact opposing sides of the user's nose. The first and second portions each include supports that help maintain a shape of the mask seal. A pair of covers can each be supported relatively to the mask assembly and adjacently to a corresponding one of the first and second portions of the mask seal. The covers limit expansion of the first and second portions of the mask seal in response to pressurized air within the mask seal. The supports of the first and second portions can transfer a load from the mask seal to the covers.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] Incorporation by reference of any priority application Any application claiming foreign or domestic priority identified in connection with this application is hereby incorporated by reference and made a part of this disclosure.

[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 in conjunction with PAP therapy or other respiratory therapy involving the administration of gases includes a seal that contacts the bridge of the user's nose. 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 administering positive airway pressure therapy includes a mask assembly having a mask seal and a mask shell. The mask assembly is configured to be positioned sufficiently lower than the bridge of the nose on a user's face and expose the bridge of the nose. The mask seal is connected to the mask shell. 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. A frame is removably coupled to the mask assembly. A pair of covers is supported relative to the mask assembly, each of the covers positioned adjacent a portion of a respective one of the first and second paddles. The covers limit the expansion of at least a portion of the first and second paddles.

[0008] In some configurations, the cover is supported by the frame. In some configurations, the cover is integrally formed with the frame.

[0009] In some configurations, the cover is positioned adjacent to only a portion of the paddle, leaving a portion of the paddle exposed, and in some configurations, a rear portion of the paddle is left exposed by the cover.

[0010] In some configurations, the paddle covers substantially the entire height of the adjacent portion of the paddle.

[0011] In some configurations, the paddles define spaces between them, thereby exposing a portion of the top of the mask seal.

[0012] In some configurations, the covers are formed as part of the mask seal, and each of the covers includes a flap portion extending from the mask seal adjacent a respective one of the paddles.

[0013] In some configurations, the seal includes at least one living hinge adjacent to and below the paddle. The living hinge is configured to allow the paddle to bend inward toward the user's nose and to resist bending the paddle outward away from the user's nose. In some configurations, the living hinge includes a thinned portion of the seal adjacent to the paddle.

[0014] In some arrangements, the cover is configured to rotate relative to the mask assembly. In some arrangements, the adjustment mechanism is configured to allow adjustment of the rotation of the cover relative to the mask assembly.

[0015] In some configurations, the cover is removably attachable to the frame or to the mask assembly.

[0016] In some configurations, the cover is adjustable relative to the mask assembly.

[0017] In some configurations, the height of the cover relative to the mask assembly is adjustable.

[0018] In some configurations, the interface further includes headgear, the headgear including upper and lower straps on each side of the mask assembly, the headgear removably connected to the frame, and the upper straps of the headgear movably support the cover, allowing the cover to slide along the upper straps.

[0019] In some configurations, the cover is formed as part of the mask shell and extends upwardly along the mask seal adjacent the paddle.

[0020] In some configurations, a tether extends from one side of the mask assembly to the other side of the mask assembly, and the tether defines a cover.

[0021] In some configurations, each of the paddles includes a support in the form of a suspension member that helps maintain the desired shape of the paddle.

[0022] In some configurations, the suspension member comprises an elongated, thickened region of the mask seal that extends from the patient side of the mask assembly towards the frame, hi some configurations, the suspension member is thicker in the paddle and nose regions than in other parts of the mask seal.

[0023] In some configurations, each of the suspension members is aligned with a respective one of the covers and configured to transfer loads from the seal to the cover through the suspension members.

[0024] In some configurations, the suspension members are connected to one another.

[0025] In some configurations, a mask assembly for use in administering positive airway pressure therapy includes a mask seal and a mask shell. The mask assembly is configured to be positioned sufficiently lower than the bridge of the nose on a user's face and expose the bridge of the nose. The mask seal is connected to the mask shell. 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 seal has a varying thickness, and each of the paddles includes a support in the form of a suspension member that helps maintain a desired shape of the paddle.

[0026] In some configurations, the nose region has the smallest thickness of the mask seal.

[0027] In some configurations, the support of the paddle has a maximum thickness of the mask seal.

[0028] In some configurations, the suspension member extends from a user-contacting surface of the mask seal towards the mask shell.

[0029] In some configurations, the suspension members are connected to one another to form a connecting region of increased thickness.

[0030] In some configurations, the mask seal further includes a mouth opening, and an area surrounding the mouth opening has a minimum thickness or is equal to the minimum thickness of the mask seal.

[0031] In some configurations, the mask seal further includes outer peripheries on either side of the mouth opening, each outer periphery wrapping from a rearward-facing side of the mask seal to at least a portion of a sideward-facing side of the mask seal, the thickness of the outer peripheries being greater than the thickness of the nose region.

[0032] In some configurations, the support includes a generally triangular shape, with the base of the triangle positioned rearward of the apex of the triangle.

[0033] In some configurations, the interface assembly includes any one of the mask assemblies described above, the interface assembly further including a removably attachable frame, the frame including one or more covers extending therefrom, and configured to prevent the mask seal from expanding outward and collapsing when pressurized air is introduced into the mask seal.

[0034] In some configurations, each of the suspension members is aligned with a respective one of the covers and configured to transfer loads from the seal to the cover through the suspension members.

[0035] 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]

[0036] [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] 5 is a top view of the mask seal of the mask assembly of FIG. 4 showing regions of different thickness of the mask seal. [Figure 8] 8 is a rear view of the mask seal of FIG. 7 showing regions of different thickness of the mask seal. [Figure 9] 8 is a side view of the mask seal of FIG. 7 showing regions of different thickness of the mask seal. [Figure 10] 8 is a front view of the mask seal of FIG. 7 showing regions of different thickness of the mask seal. [Figure 11] FIG. 8 is a rear view of the mask seal of FIG. 7. [Figure 12] FIG. 12 is a cross-sectional view of the mask seal taken along line 12-12. [Figure 13] 13 is a cross-sectional view of the mask seal taken along line 13-13 of FIG. 11. [Figure 14] 14 is a cross-sectional view of the mask seal taken along line 14-14 of FIG. 11. [Figure 15] 15 is a cross-sectional view of the mask seal taken along line 15-15 of FIG. 11. [Figure 16] 16 is a cross-sectional view of the mask seal taken along line 16-16 of FIG. 11. [Figure 17] 17 is a cross-sectional view of the mask seal taken along line 17-17 of FIG. 11. [Figure 18] 18 is a cross-sectional view of the mask seal taken along line 18-18 of FIG. 11. [Figure 19] 19 is a cross-sectional view of the mask seal taken along line 19-19 of FIG. 11. [Figure 20] 20 is a cross-sectional view of the mask seal taken along line 20-20 of FIG. 11. [Figure 21] 21 is a cross-sectional view of the mask seal taken along line 21-21 of FIG. 11. [Figure 22] 2 is a top view of an interface portion of the interface assembly of FIG. 1 showing an exemplary arrangement of support structures for the mask seal. [Figure 23] FIG. 23 is a rear view of the interface portion of FIG. 22. [Figure 24] FIG. 23 is a rear view of a portion of the interface portion of FIG. 22. [Figure 25] FIG. 10 is a side view of another mask assembly shown in place on a user's head. [Figure 26] 26 is a cross-sectional view of a portion of the mask assembly taken along line 26-26 of FIG. 25. [Figure 27] FIG. 10 is a side view of another mask assembly with adjustable support for the upper part of the mask seal shown in place on a user's head. [Figure 28] FIG. 10 is a side view of yet another mask assembly having an alternative adjustable support for the upper part of the mask seal, shown in place on a user's head. [Figure 29] 29 is a cross-sectional view of a portion of the mask assembly taken along line 29-29 of FIG. 28. [Figure 30] FIG. 10 is a side view of another mask assembly having a hinged portion within the mask seal. [Figure 31] 31 is a cross-sectional view of a portion of the mask assembly taken along line 31-31 of FIG. 30. [Figure 32] FIG. 10 is a side view of another mask assembly having an alternative adjustable support for the upper part of the mask seal, shown in place on a user's head. [Figure 33] 33 is a cross-sectional view of a portion of the mask assembly taken along line 33-33 of FIG. 32. [Figure 34] FIG. 10 is a perspective view of another mask assembly having a removable support for the upper portion of the mask seal. [Figure 35] FIG. 10 is a perspective view of a portion of another mask assembly having a removable support including an alternative connection arrangement. [Figure 36] FIG. 10 is a perspective view of a portion of another mask assembly having a removable support including another alternative connection arrangement. [Figure 37]FIG. 10 is a perspective view of another mask assembly that uses headgear as support for the upper part of the mask seal. [Figure 38] FIG. 10 is a perspective view of an alternative mask assembly in which the headgear carries support for the upper part of the mask seal. [Figure 39] FIG. 10 is a perspective view of another mask assembly having a tether or strap that provides support to the top of the mask seal. [Figure 40] FIG. 1 is a perspective view of another interface assembly having certain features, aspects and advantages of the present disclosure. [Figure 41] FIG. 41 is a perspective view of a mask assembly of the interface assembly of FIG. 40. [Figure 42] 42 is a cross-sectional view of the mask assembly taken along line 42-42 of FIG. 41. [Figure 43] 43 is a cross-sectional view of the mask assembly taken along line 43-43 of FIG. 41. DETAILED DESCRIPTION OF THE INVENTION

[0037] 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.

[0038] 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 referenced directions 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 but arbitrary coordinate system that is made clear by reference to the text and associated drawings that describe the component or element under consideration. Furthermore, terms such as "first," "second," and "third" may be used to describe separate components. Such terminology may include the words specifically mentioned above, derivatives thereof, and words of similar import.

[0039] One or more of the embodiments described herein address stability challenges 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 the user's nose and around the nares. 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 the user's nose). Most full-face masks have a forehead rest, headgear mount, or "T" piece that extends upward from the rest of the mask and rests on the forehead, significantly increasing stability compared to full-face masks without a "T" piece. Instability can result from pressure on the nasal tip or septum and / or seal leakage due to forces exerted by the breathing tube of a breathing circuit attached to a mask or other patient interface. This force is often referred to as "hose pull" and can arise from the breathing circuit or tube or from user movement.

[0040] The embodiments shown herein do not have T-pieces and seals below the nasal bridge, around the nostrils, and under the nose. In at least some configurations, the interface or mask also seals around the user's mouth. A combined nose and mouth mask with a reduced footprint on the user's face compared to a traditional full-face mask that contacts the nasal bridge and / or has a T-piece may have a negative impact on stability. Similarly, a combined nose and mouth mask with a reduced footprint on the user's face compared to a traditional nasal mask that contacts the nasal bridge and / or has a T-piece may also have a negative impact on stability. As such, the seal around and below the nose may be challenged due to variations in facial geometry between different users. In some circumstances, even slight movement of the seal may cause the seal to lose contact with the user, resulting in leakage.

[0041] 1-24 show a mask assembly 2100 both in position on a user's face and in a position away from the 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 user's nasal bridge. In the illustrated configuration, the mask assembly 2100 does not extend across the top of the user's nasal bridge. More specifically, the illustrated mask assembly 2100 does not contact the user's nasal bridge. Even more specifically, the illustrated assembly 2100 does not contact the forward-facing portion of the user's nasal bridge. 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.

[0042] 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 a portion 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 to 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 into the area of ​​the user's nasal bridge. 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 area 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 also preferably 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.

[0043] As shown, the mask assembly 2100 includes a mask support, such as, for example, a base, housing, or shell 2102 (see, e.g., FIG. 4). The mask seal 2104 is attached to the mask shell 2102, such that the mask shell 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 mask support 2102 may be substantially smaller than the illustrated shell. For example, the mask support 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 mask support 2102 may be localized to the opening without providing direct support to other portions of the mask assembly 2100.

[0044] 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. A conduit connector 2106 may also be attached to the mask shell 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 position 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.

[0045] The illustrated conduit connector 2106 may be connected to the frame 2178 and / or shell 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 shell 2102 such that the connector 2106 can pivot, rotate, or pivot relative to the shell 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 mask shell 2102 defining the other portion. 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 in some cases include a swivel or rotary coupling that allows relative rotation between the connector 2106 and the gas conduit.

[0046] 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, for example, controlled leaks 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 mask shell 2102, the mask seal 2104, or any combination of the connector 2106, shell 2102, and 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.

[0047] The mask shell 2102 provides some support structure to the mask assembly 2100 generally, and more specifically, to the mask seal 2104. The mask shell 2102 may be formed from any suitable material. In some configurations, the mask shell 2102 is formed from a fairly rigid material. In some configurations, the mask shell 2102 is formed from a plastic material, such as a polycarbonate material. In some configurations, the mask assembly 2100 may include a mask seal that includes a mask seal clip that is separate from but attachable to the mask shell. In such configurations, the mask seal clip connects the mask seal 2104 to the mask shell 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 can be overmolded onto a mask seal clip, and in some configurations, the mask seal 2104 can be overmolded directly onto the mask shell 2102, which may include, for example, chemical and / or mechanical overmolding.

[0048] In some configurations, the mask shell 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 mask shell 2102 comprises a substantial portion of the mouth portion of the anterior wall of the mask assembly 2100. In some configurations, the mask shell 2102 is entirely restricted to the mouth portion of the mask assembly 2100 and does not extend, at least to an impacting extent, into the nose portion of the mask assembly 2100. 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 the illustrated configuration, the mask shell 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 mask shell 2102 may have an overall or substantially constant height throughout the central portion 2112 and the opposing side portions 2116. In other arrangements, the mask shell 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 mask shell 2102 may be substantially equal to the height of the mouth portion of the mask seal 2104. The width of the mask shell 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 mask shell 2102 may reinforce the center and lateral portions of the mask seal 2104. In some configurations, the mask shell 2102 may be minimal, such as, for example, an annular support ring or frame.

[0049] 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.

[0050] 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 WO 2014 / 062070, which is incorporated herein by reference in its entirety.

[0051] The at least one oral opening 2122 and the at least one nasal opening 2124 preferably communicate with a single chamber defined within the mask assembly 2100. The chamber of the illustrated mask assembly 2100 is defined at least in part by the mask shell 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.

[0052] The mask seal 2104 preferably includes a pair of paddles 2126 extending upwardly above an upper surface 2130 (FIG. 8) 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.

[0053] 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 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.

[0054] The height of the paddle 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 paddle 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 values ​​or subranges within the aforementioned ranges. In some configurations, the paddle height is about 18.5 mm.

[0055] The illustrated mask seal 2104 of the mask assembly 2100 includes a fairly complex range of thicknesses and configurations, as shown in Figures 7-21. 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 properties 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.

[0056] FIGS. 7-10 show diagrams of the mask seal 2104 in which regions of different thicknesses are outlined. Generally, the outer surface of the mask seal 2104 defines a relatively smooth shape or curve without abrupt changes in direction. As shown in the cross-sectional views of FIGS. 12-21, the different thicknesses are caused by variations in wall thickness that are evident in or caused by changes in the shape of the inner surface of the mask seal 2104. FIGS. 7-10 illustrate differences in thickness of the mask seal 2104, such as in the regions or portions described above. 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 support 2163. In contrast, the transition in thickness between the outer periphery 2162, the support 2163, and the upper rear surface 2156 is more gradual. Additionally, in at least some configurations, the transition in thickness between the outer periphery 2162, the upper posterior surface 2156, and the mouth region 2166 is relatively gradual. The various portions of the mask seal 2104 are further described below.

[0057] To reduce the occurrence of wrinkles in at least some of the face-contacting areas 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 onto at least a portion of the side-facing side of the mask seal 2104.

[0058] 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.

[0059] 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, facilitating donning and providing 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 help maintain separation between the rear wall of the mask seal 2104 (defining 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 thickness of a portion or the entire outer periphery may be from about 1.0 mm to about 2.0 mm. In the illustrated configuration, the thickness of a portion or the entire 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.

[0060] The illustrated mask seal 2104 also includes a mouth region 2166. The mouth region 2166 in the illustrated mask seal 2104 extends along at least a portion of the mouth opening 2122. Preferably, the mouth region 2166 extends along at least the bottom of the mouth opening 2122. The mouth region 2166 may extend along at least the sides and bottom of the mouth opening 2122. In the illustrated arrangement, the mouth region 2166 defines the boundary of the mouth opening 2122. The mouth region 2166 may include a relatively thin band that surrounds some or all of the mouth opening 2122, for example, the sides and top in the illustrated arrangement. The illustrated mouth region 2166 includes a lower thickened band portion that extends downwardly away from the mouth opening 2122 and may extend toward or to the lower edge of the mask seal 2104. The lower thickened portion of the mouth region 2166 can contact the area below the user's lower lip and allow the mask seal 2104 to conform to a range of cheek geometries. The lower thickened portion of the mouth region 2166 can define a curved edge that opposes the edge adjacent the mouth opening 2122.

[0061] The mouth region 2166 provides a softer area that contacts the face. Thus, the mouth region 2166 may have a thinner cross-section than the outer periphery 2162 and / or other areas of the mask seal 2104. In some configurations, the mouth region 2166 may have the smallest thickness or be the smallest thickness of the mask seal 2104. For example, the thickness of a portion or the entire mouth region 2166 may be about 0.2 mm to about 0.5 mm. In the illustrated configuration, the thickness of a portion or the entire mouth region 2166 is about 0.3 mm. The thickness of the mouth region 2166 may be consistent or variable within the mouth region 2166.

[0062] The mask seal 2104 may also include a nasal region 2168 disposed near the nasal openings 2124. The nasal region 2168 may surround part of or all of the nasal openings 2124. In the illustrated arrangement, the nasal region 2168 surrounds the entire nasal openings 2124 and has side portions that are at least partially disposed over the paddles 2126. The nasal region 2168 may wrap from the back to the front of the mask seal 2104. In the illustrated arrangement, the nasal region 2168 is radially spaced from the nasal openings 2124. Given the requirement for a gentle seal against the lower part of the nose, in the illustrated configuration, the nasal region 2168 is fairly thin in thickness. In some configurations, the nasal region 2168 of the mask seal 2104 may have a minimum thickness, or be equal to or the minimum thickness of the mask seal 2104. For example, a portion or all of the nose region 2168 may have a thickness equal to or slightly greater than the thickness of the mouth region 2166. In some configurations, the thickness of a portion or all of the nose region 2168 is about 0.3 mm to about 0.5 mm or 0.6 mm. In some configurations, the thickness of a portion or all of the nose region 2168 is about 0.3 mm. The thickness of the nose region 2168 may be consistent or variable within the nose region 2168. The thickness of a portion or all of the nose region 2168 may be less than about 0.3 mm. For example, the thickness may be as thin as about 0.15 mm. However, it has been determined that thinner thicknesses may create or increase the likelihood of crease formation in the nose region 2168 for some facial geometries and / or under certain operating gas pressures. Maintaining a thickness greater than about 0.3 mm throughout a significant portion or all of the nose region 2168 may reduce the incidence of crease formation over a significant range of operating pressures, which may include the full range of normal operating pressures.

[0063] The mask seal 2104 may also include a front top 2150 positioned above the mask shell 2102. In the illustrated arrangement, the front top 2150 extends laterally across the front of the mask seal 2104, vertically between the mask shell 2102 and the nasal region 2168. The front top 2150 may extend any suitable distance across the mask seal 2104, such as along substantially the entire width of the mask seal 2104, or at least along the width of the mask seal 2104 at the front top 2150. The upper edge of the front top 2150 may be curved, and the sides of the front top 2150 may be taller than the center portion of the front top 2150, so that the center portion defines a valley in the front top 2150. In some configurations, the sides of the front top 2150 may extend into the portion of the mask seal 2104 that defines the paddle 2126. In some configurations, the lower edge of the front upper portion 2150 can be generally linear and can extend horizontally or laterally. The lower edge of the front upper portion 2150 can have approximately the same shape as the upper edge of the mask shell 2102.

[0064] The front upper portion 2150 preferably has a fairly thin thickness to promote flexibility of the front upper portion 2150. That is, the front upper portion 2150 preferably can bend, fold, or otherwise deform in response to pressure acting on other portions of the mask seal 2104, such as downward pressure on the nasal region 2168. Such an arrangement may assist the mask seal 2104 in conforming to different facial geometries of potential users. Furthermore, such an arrangement may encourage the paddles 2126 to expand or bulge, at least in the absence of external constraints on such expansion. In some configurations, the front upper portion 2150 has a minimum thickness of the mask seal 2104, or is equal to or is the minimum thickness of the mask seal 2104. For example, the thickness of a portion or the entire front upper portion 2150 can be equal to the thickness of one or both of the mouth region 2166 and the nasal region 2168. In some configurations, the thickness of a portion or the entire front upper portion 2150 is about 0.2 mm to about 0.5 mm. In some configurations, the thickness of a portion or the entire front upper portion 2150 is about 0.3 mm. The thickness of the front upper portion 2150 can be constant or variable within the front upper portion 2150. The thickness of the front upper portion 2150 can be thin or thick depending on the desired characteristics of the mask seal 2104, such as the compliance of the nasal region 2168.

[0065] 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 may preferably be sized, shaped, and / or otherwise configured to transmit force 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 force 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 rear surface of the paddles 2126 toward or to the mask seal 2104 (e.g., mask shell 2102) or another supporting portion of the interface. 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 provide feedback to the user, such as in response to applied forces (e.g., headgear forces). 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. The supports 2163 may 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, at least in response to forces experienced during normal use. Additionally, the support 2163 may provide support to the nose area or nose sealing portion 2168. In particular, the support 2163 may provide structure to the nose sealing portion 2168 and / or upper front portion 2150 and inhibit or prevent them from folding, wrinkling, or collapsing.As mentioned above, the nose seal portion 2168 and / or front upper portion 2150 are preferably relatively thin to allow these portions of the mask seal 2104 to conform to the user's nose. The relatively thin nose seal portion 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 portion 2150 to inhibit or prevent collapse. The rear upper portion 2156 may assist in preventing collapse of the nose seal portion 2168 and / or front upper portion 2150.

[0066] In some configurations, the supports 2163 reduce the likelihood of wrinkles or creases forming in the face-contacting portion of the paddle 2126 during use, while facilitating 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 the paddle 2126 or to other portions of the 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 in other types of mask assemblies or interfaces, including, for example, but not limited to, 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.

[0067] 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 and inner surface portions join. The support 2163 may extend along a portion of the side of the nose 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 to provide support in other directions. For example, the supports 2163 may connect to one another, such as along one or both of the anterior or posterior sides of the nasal openings 2124. In some configurations, the supports 2163 may extend completely through the paddles 2126, such as to the mask shell 2102.

[0068] The support 2163 can have a different thickness than the rest of the paddle 2126, and may be thicker than the rest of the paddle 2126. In some configurations, the support 2163 may have the greatest thickness, or may be the greatest thickness of the mask seal 2104. In some configurations, the thickness of a portion or the entire support 2163 may be from about 1.5 mm to about 3.5 mm. In the configuration shown, the thickness of a portion or the entire support 2163 may be about 2.5 mm. The thickness of the support 2163 may be constant or variable.

[0069] 19-21, a portion of the mask seal 2104 incorporating a paddle 2126 is shown in cross-section. As shown here and as described above, the paddle 2126 may have a relatively thin cross-section, at least in sections other than the support 2163. In some configurations, the paddle 2126 may be formed, at least in part, with a sufficiently thin cross-section to allow for controllably inflating or expanding at typical treatment temperatures (e.g., about 3 to about 25 cmH2O). In some configurations, such thickness may be about 0.5 or 0.6 mm or less, 0.3 mm or less, or about 0.2 mm or less, depending on the particular location within the paddle 2126 and / or the materials used. In some configurations, the portion of the paddle 2126 that contacts the face comprises an overall constant cross-sectional thickness. As shown in FIGS. 16-21, the thickened portion may continue below the support 2163 of the paddle 2126 and into the area of ​​the mask seal 2104 below the paddle 2126.

[0070] In some configurations, the mask seal 2104 includes a rear top 2156 that extends laterally along the rear of the mask seal 2104 between the nasal region 2168 and the mouth region 2166. In the illustrated arrangement, the rear top 2156 is an elongated strip region of the mask seal 2104 defined by internal ribs. In some configurations, the ends of the rear top 2156 may have a greater height or vertical dimension than a central portion of the rear top 2156. In some configurations, the upper and lower edges of the rear top 2156 may generally follow the curvature or shape of the corresponding portions of the nasal region 2168 and the mouth region 2166, respectively. The rear top 2156 may extend along a substantial width of the mask seal 2104. For example, the rear top 2156 may have a length that is at least half the width of the mask seal 2104 at the rear top 2156 and / or is greater than the width of the nasal openings 2124. In some configurations, the upper rear surface 2156 may have a length that is greater than the width of the mouth opening 2122. The upper rear surface 2156 may be laterally centered on the mask seal 2104. In some configurations, the upper rear surface 2156 may extend into or be connected to the outer periphery 2162. Such an arrangement helps maintain an open shape of the rear surface of the mask seal 2104 to facilitate fit on the user's face.

[0071] The rear upper portion 2156 may provide support to the mask seal 2104 between the nasal region 2168 and the mouth region 2166 to limit, inhibit, or prevent collapse of the mask seal 2104, for example, laterally between the outer periphery 2162 and / or vertically between the nasal region 2168 and the mouth region 2166, or to maintain a desired separation of those portions 2162 or regions 2168, 2166. The thickness of the rear upper portion 2156 is sufficient to provide such support and may be thicker than one or both of the nasal region 2168 and the mouth region 2166. The rear upper portion 2156 may have a thickness less than one or both of the outer periphery 2162 and the support 2163. In some configurations, the rear upper portion 2156 has a thickness greater than both the nasal region 2168 and the mouth region 2166 and less than both the outer periphery 2162 and the support 2163. In some configurations, the thickness of the portion or the entire upper rear surface 2156 can be from about 0.5 mm to about 1.5 mm. In the configuration shown, the thickness of the portion or the entire upper rear surface 2156 is about 1.0 mm. The thickness can be thinner or thicker depending on the desired characteristics of the support provided by the upper rear surface 2156.

[0072] The mask seal 2104 may have other portions outside of those mentioned above. For example, the mask seal 2104 may have one or more transition portions 2170 in the region between the above-mentioned portions. The transition portion 2170 may be referred to herein as singular. However, the transition portion 2170 need not necessarily be a single continuous region, but may include several discrete or discontinuous regions. The transition portion 2170 may define a thickness that transitions between any one or more (including all) of the front upper portion 2150, the back upper portion 2156, the support 2163, the outer periphery 2162, the mouth region 2166, and the nose region 2168. The transition portion 2170 may define a thickness that extends away from, is positioned at, or transitions between two regions in any suitable manner, such as, for example, a gradual or abrupt transition. The thickness transition may occur, for example, within the transition portion 2170 or along the edge of the transition portion 2170. In the illustrated configuration, outer perimeter 2162 is generally surrounded by transition portion 2170. Outer perimeter 2162 provides a relatively smooth transition into support 2163, such that outer perimeter 2162, transition portion 2170, and support 2163 comprise a generally continuous region of thickness, as shown in FIG. 5. Mouth region 2166 is separated from outer perimeter 2162 and / or upper posterior portion 2156 by transition portion 2170. Other configurations are possible.

[0073] The illustrated mask seal 2104 includes a connection region 2160 generally surrounding the opening, which may be configured to receive the mask shell 2102 and bond the mask seal 2104 to the mask shell 2102. In the illustrated arrangement, the connection region 2160 is described as forming part of or being included within the transition portion 2170. In some configurations, the connection region 2160 may have a specific configuration that provides desired characteristics, such as enabling connection to the mask shell 2102 and / or providing durability. In some configurations, the connection region 2160 may be the thickest portion of the seal member 2104. In some configurations, the thickness of the connection region may be about 2 mm to about 5 mm or about 3 mm to about 3.5 mm. In other configurations, the thickness may be thinner or thicker depending on the desired characteristics, the type of connection with the mask shell 2102 (e.g., an overmolded connection), etc. The thickness may vary within the connection region 2160, such as when the mask seal 2104 mechanically engages the mask shell 2102. For example, the periphery of the mask shell 2102 may include recesses or openings that are engaged or passed through by the material of the mask seal 2104.

[0074] The illustrated mask seal 2104 also includes a nasal opening support 2158 that surrounds a portion or all of the nasal opening 2124. The nasal opening support 2158 may help maintain a desired shape of the nasal opening 2124 and / or may limit, inhibit, or prevent collapse of the nasal opening 2124. In the illustrated arrangement, the nasal opening support 2158 is shown as forming a portion of the transition portion 2170. The nasal opening support 2158 may have a variable or relatively constant thickness. The thickness of the nasal opening support 2158 may exceed the thickness of the nasal region 2168. In some configurations, the thickness of the nasal opening support 2158 may be, for example, without limitation, from about 1.0 mm to about 2.5 mm. As mentioned above, the nasal opening support 2158 may be an insert or cushion that is bonded to the material of other portions of the mask seal 2104, such as substantially the entire mask seal 2104.

[0075] 1-3 and 22-24, as described above, the mask seal 2104 and mask shell 2102 (mask assembly 2100) may form part of an interface assembly, which may include a frame 2178 and headgear 2180. The frame 2178 may be removably connected to the mask assembly 2100 by any suitable arrangement. For example, the frame 2178 may be coupled at or around the aperture 2114 of the mask shell 2102 by a snap fit, friction fit, or clip fastening, among other possibilities. The mask assembly 2100 may be adjustably secured to the frame 2178 to allow assembly only in the correct orientation. The conduit connector 2106 may also be attached to the mask shell 2102, the frame 2178, or otherwise adapted to be supported against and in communication with the interior space of the mask assembly 2100.

[0076] In the illustrated arrangement, the frame 2178 includes one or more portions positioned adjacent to or in contact with a portion of the paddles 2126. In some configurations, the frame 2178 includes a pair of support portions or covers 2182, each of which is associated with one of the paddles 2126 of the mask seal 2104. References herein to covers 2182 may refer to other suitable support structures for the paddles 2126 unless otherwise indicated. The covers 2182 may provide a desired level of support for the paddles 2126, such as inhibiting or preventing over-expansion and / or outward bulging of the paddles 2126, which may occur in response to gas pressure within the mask seal 2104. As mentioned above, portions of the mask seal 2104 may be textured for user comfort. Texturing the surface of the paddle 2126 that contacts or faces the paddle cover 2182 may allow or facilitate relative movement (e.g., sliding movement) of the paddle 2126 and paddle cover 2182. However, if it is desired for the paddle cover 2182 to grip the paddle 2126 and prevent movement therebetween, the surface of the paddle 2126 that faces or contacts the paddle cover 2182 may be non-textured or may have a smooth surface finish. Any suitable method for texturing the mask seal 2104 may be used, such as bead blasting a mold for the mask seal 2104.

[0077] While the illustrated cover 2182 is integral with the frame 2178, in other configurations, the cover 2182 may be supported in a desired position relative to the paddle 2126 in other ways by any component of the interface assembly. For example, the cover 2182 may be a separate component coupled to the frame 2178 or other portions of the interface assembly, including the mask shell 2102. Such a separate cover 2182 may be glued, clipped, welded, or otherwise attached to an underlying support structure. In some configurations, the cover 2182 may be integral with the mask shell 2102. In some configurations, the cover 2182 may be a portion of the mask seal 2104, such as a portion that exceeds the thickness or stiffness of the paddle 2126. In the illustrated arrangement, the cover 2182 is integrally formed with the frame 2178. Similarly, the cover 2182 may be integrally formed with the mask shell 2102, the mask seal 2104, or other portions of the interface assembly.

[0078] In some configurations, the cover 2182 is positioned next to or against the lateral outer surface of the paddle 2126, with or without a gap or variable gap therebetween, before the paddle 2126 is pressurized. In such an arrangement, the cover 2182 may contact the paddle 2126 to limit, inhibit, or prevent an undesirable amount of expansion or outward movement of the paddle 2126, such as due to gas pressure within the mask seal 2104. While some expansion of the paddle 2126 may be desirable, for example, to control creases in the upper portion (e.g., nasal region 2168) of the paddle 2126 or mask seal 2104, too much expansion may be uncomfortable for the user, such as by pressing the nasal region against the underside of the user's nose, and / or may compromise the seal between the user's face and other portions of the paddle 2126 or mask seal 2104. As such, characteristics of the cover 2182 (e.g., size, shape, or location) may be selected to provide a desired level of support and / or allow a desired level of expansion of the paddle 2126 or other portions of the mask seal 2104. Preferably, the paddle 2126, or at least the upper portion of the paddle 2126, is not coupled to the cover 2182, allowing the paddle 2126 to flex or pivot inwardly away from the cover 2182. In some configurations, the lateral outer surface of the paddle 2126 may move inwardly away from the cover 2182. Such an arrangement may advantageously help maintain contact between the lateral inner surface of the paddle 2126 and the user's face when downward pressure is applied to the nasal region 2168.

[0079] In some configurations, the cover 2182 covers only a portion of the laterally outward or forward-facing surface of the paddle 2126. In such an arrangement, the cover 2182 may provide a desired balance between user comfort and providing support to the paddle 2126. For example, the cover 2182 may cover only a portion of the paddle 2126 in the front-to-rear direction. In the illustrated arrangement, the cover 2182 supports the front portion of the paddle 2126 and leaves at least a rear portion of the paddle 2126 exposed. In the illustrated arrangement, the cover 2182 covers substantially the entire height of the paddle 2126. In some configurations, the cover 2182 covers substantially the entire or the entire length of the paddle 2126 while leaving some of the height of the paddle 2126 exposed. In some configurations, the cover 2182 may cover a middle portion of the paddle 2126 and leave the front and rear portions exposed. In some configurations, the cover 2182 covers or overlaps at least about one-third or one-half of the laterally outward or forward-facing surface of the paddle 2126. In some configurations, the cover 2182 covers or overlaps at least about two-thirds or three-quarters of the laterally outward or forward-facing surface of the paddle 2126.

[0080] In some configurations, the paddle cover 2182 can be configured to provide localized support to a portion of the paddle 2126. For example, the paddle cover 2182 can be in the form of elongated finger structures. Such finger structures can provide support to a relatively small portion of the paddle 2126. The finger structures can originate at any desired point relative to the paddle 2126, such as the front end, rear end, or middle portion of the paddle 2126. In some configurations, the finger structures are curved, such as curved toward the rear or curved toward the front. For example, the finger structures can be curved to follow a portion or the entire top peripheral edge of the paddle 2126. Such finger structures can be located at or spaced from the peripheral edge of the paddle 2126. In some configurations, the finger structures can be configured to overlap a support structure of the paddle 2126, such as the support 2163, described further below.

[0081] Preferably, a space or valley 2184 is defined between the covers 2182. In the illustrated arrangement, the valley 2184 exposes a portion of the mask seal 2104, for example, the anterior portion of the nasal region 2168, to allow a desired amount of expansion of the mask seal 2104. Additionally, such an arrangement may provide a space that can accommodate the tip of a user's nose or a portion of the mask seal 2104 that is deflected by the user's nose.

[0082] 22 , the cover 2182 may cooperate with features of the mask seal 2104 to provide desired performance characteristics. For example, the supports 2163 for the paddles 2126 may be positioned relative to the cover 2182 such that loads applied to the paddles 2126 by the user's face are transferred to the cover 2182 by the supports 2163. As such, the supports 2163 may terminate at or immediately after the portion of the mask seal 2104 that contacts or is positioned adjacent to the cover 2182, and may not extend completely into the upper front surface 2150 or to the mask shell 2102. The supports 2163 may extend generally in a direction from the rear or user-contacting surface of the mask seal 2104 toward its respective cover 2182. In some configurations, each of the supports 2163 extends generally or substantially in a longitudinal direction of the mask seal 2104. The supports 2163 may extend generally parallel to one another or may be closer at the front end compared to the rear end. In other words, the supports 2163 may converge in a direction moving from the rear or user-contacting surface of the mask seal 2104 toward the front portion of the mask seal 2104. However, in other configurations, the supports 2163 may diverge from rear to front.

[0083] As described above, the supports 2163 may be in the form of or function similarly to suspension members or springs to provide a resistive force in response to planned compression or collapse of the paddle 2126 in the anterior-posterior direction. Because the supports 2163 transmit the force to the cover 2182, the thickness, shape, orientation, and / or location of the supports 2163 inhibit or prevent collapse. Because the force is transmitted to the cover 2182, collapse of areas of the mask seal 2104 near or surrounding the supports 2163 (e.g., the nasal region 2168 and / or the upper front 2150) is inhibited or prevented. Portions of the mask seal 2104 may deform or stretch, but preferably collapse is inhibited or prevented. Seal collapse includes deformation, which may cause leakage or other detrimental performance of the mask seal 2104. In some cases, the collapse involves contact of normally spaced-apart wall portions of the mask seal 2104 (e.g., contact of a relatively posterior wall portion with a relatively anterior wall portion). The supports 2163 may also inhibit or prevent collapse of valleys of the mask seal 2104. In other words, the supports 2163 may help maintain the paddles 2126 in a laterally spaced or separated positioning.

[0084] In at least some configurations, the cover 2182 may also provide support for the paddles 2126 in the absence of the support 2163. Furthermore, while the cover 2182 (or other similar support structure) is particularly useful for under-the-nose nasal masks or combination nose-mouth masks, the cover 2182 or similar structures may also be used with other types of interfaces. For example, the cover 2182 may be used in a nasal or combination nose-mouth mask assembly, or in an interface that covers, contacts, or seals with the bridge of the user's nose and / or includes a T-piece or other type of forehead support, for example, but not limited to. The cover 2182 may be used, or modified for use, at any point in an 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 alongside the user's nose, or may be elsewhere. As noted above, the cover 2182 may be used with or without a corresponding support 2163.

[0085] Possible locations of the support 2163 relative to the cover 2182 are shown in FIG. 22 . In some configurations, the support 2163 generally extends between the cover 2182 and the posterior surface of the paddle 2126 that contacts the user's face. Such a surface may, for example, coincide with the side of the nose region 2168. The forward end of the support 2163 may be laterally aligned with the cover 2182. In some configurations, the forward ends of the support 2163 may be joined together, such as by a semicircular interface, and / or may extend completely or substantially completely into the mask shell 2102. Such an arrangement may provide better shape retention functionality and feedback. However, it has been determined that the cover 2182 allows the support 2163 to terminate more quickly while still providing a desired amount of shape retention and feedback. The shape of the support 2163 may be selected to provide a desired interaction with the cover 2182, complementarily or otherwise. Such an arrangement may allow at least portions of the nasal region 2168 (e.g., the area of ​​the tip of the nose), if not the entire nasal region 2168, to be relatively thin to provide comfort to the user and / or a desired seal.

[0086] If desired, one or more structures similar to the support 2163 (e.g., springs or suspension structures) may be provided in the nasal tip region (or other areas of the nasal region 2168) to help maintain a desired shape of the mask seal 2104. It is believed that the provision of the cover 2182 allows such supports to have a thinner thickness than would be provided in the absence of the cover 2182, thereby increasing compliance and improving user comfort and seal.

[0087] 23 and 24, there are shown views of the rear or user-contacting surface of a portion of the mask seal 2104 and nasal region 2168, respectively. It has been discovered that the inner portion of the nasal region 2168 can be an area of ​​the mask seal 2104 that can affect performance, and that there are several features or characteristics that have been found to improve seal comfort, leakage, and overall performance. For example, the width 2186 of the nasal region 2168, or the width between the spring structures or supports 2163, can affect seal comfort, leakage, and overall performance. In some configurations, this width is in the range of about 45 mm to about 50 mm, but can be smaller or larger for different sized mask seals 2104, etc.

[0088] 24, in some configurations, the outer geometric profile of the mask seal 2104 from the spring structure or support 2163 to the inner portion of the nasal region 2168 is a convex profile. Such an arrangement allows the paddles 2126 to be displaced as the user's nose conforms to the nasal region 2168 and provides a desired sealing profile around the user's nares.

[0089] Further, as described above, in some configurations, the thickness of a portion or the entire nasal region 2168 is about 0.3 mm to about 0.5 mm or 0.6 mm. In some configurations, the thickness of at least the inner portion of the nasal region 2168 (excluding the nasal opening support 2158) is at least about 0.3 mm to provide a desired level of compliance while also preventing creases across a range of facial geometries and / or operating pressures. In some configurations, the inner region of the nasal region 2168 has a constant thickness. However, the thickness may be variable within the inner region of the nasal region 2168. In some configurations, the thickness of the inner region of the nasal region 2168 may vary from about 0.3 mm to slightly thicker values. In some configurations, the thickness of a portion or the entire nasal region 2168 may be less than about 0.3 mm, thereby increasing compliance. However, such a thickness may result in creases with some facial geometries and / or at lower operating pressures.

[0090] 25-39 show an additional mask assembly 2100 having a paddle 2126 and a support structure 2182 that provides support for the paddle 2126. The mask assembly 2100 of FIGS. 25-39, including the paddle 2126 and support structure 2182, may be similar to or substantially the same as the mask assemblies 2100, paddles 2126, and support structures 2182 described anywhere herein, including the mask assembly 2100 of FIGS. 1-24. Accordingly, the same reference numerals used in connection with the mask assembly 2100 of FIGS. 1-24 are used to refer to the same or corresponding features in the mask assembly 2100 of FIGS. 25-39. The following description of the mask assembly 2100 of FIGS. 25-39 will be primarily directed to the differences compared to the mask assembly 2100 described above. Features or components of the mask assembly 2100 of Figures 25-39 that are not specifically described may be the same as or similar to the same or corresponding features or components of the mask assembly 2100 of Figures 1-24, or may be in any other suitable arrangement.

[0091] 25 and 26 show the mask assembly 2100 positioned on a user's face. The mask assembly 2100 includes a pair of paddle covers 2182, each of which overlaps at least a portion of a corresponding paddle 2126 of the mask seal 2104. Only one paddle 2126 and paddle cover 2182 are shown in FIGS. 25 and 26. However, the mask assembly 2100 is substantially or completely symmetrical about a central vertical axis. Thus, the paddle 2126 and paddle cover 2182 on the other side of the mask assembly 2100 may be the same or substantially identical to the paddle 2126 and paddle cover 2182 shown.

[0092] 25 and 26, the paddle cover 2182 is carried directly by the mask seal 2104, rather than by the mask shell 2102. In some configurations, the paddle cover 2182 is a flap portion that is integrally formed or integrally formed with at least a portion of the mask seal 2104. The paddle cover 2182 may be substantially similar in size, shape, position, and rigidity to other paddle covers 2182 described herein. The illustrated paddle cover 2182 is separated from the outer surface of the paddle 2126, defining a space 2200 therebetween, at least in the absence of elevated pressure within the mask assembly 2100. The shape of the paddle cover 2182 may correspond to the shape of the adjacent surface of the paddle 2126 so that the width of the space 2200 is constant. In other configurations, the width of the space 2200 may vary.

[0093] In some configurations, the paddle cover 2182 is stiffer than the portion of the paddle 2126 that it covers or overlaps. Being stiffer than the paddle 2126 can be achieved by various arrangements. In the illustrated arrangement, the paddle cover 2182 comprises the same material (e.g., silicone) as the paddle 2126, but has a wall thickness that is thicker than the wall thickness of the corresponding wall portion of the paddle 2126. In some configurations, the wall thickness of the paddle cover 2182 is at least twice the wall thickness of the corresponding portion of the paddle 2126. In some configurations, the wall thickness of the paddle cover 2182 is at least three times the wall thickness of the corresponding portion of the paddle 2126. In some configurations, the wall thickness of the paddle cover 2182 is at least or about four times the wall thickness of the corresponding portion of the paddle 2126. The paddle cover 2182 can have a constant or variable wall thickness. The wall thickness may be varied to vary the stiffness of the paddle cover 2182 and provide different levels of support to different portions of the paddle 2126.

[0094] Other suitable arrangements may also be used for the paddle cover 2182. For example, the paddle cover 2182 may be constructed, in whole or in part, from a material that is stiffer than the material of the paddle 2126. In some configurations, the material may be similar (e.g., a silicone material with different stiffness characteristics). The paddle cover 2182 may be bonded or connected to the remainder of the mask seal 2104 by any suitable process or arrangement. For example, the paddle cover 2182 and the remainder of the mask seal 2104 may be constructed in a multi-shot injection molding process (e.g., overmolding or co-molding). In other configurations, the paddle cover 2182 may be constructed as a separate component and bonded to the remainder of the mask seal 2104 by adhesives, welding, mechanical fasteners, or other suitable arrangements, etc.

[0095] 27 shows an adjustable support structure 2202 for the paddle 2126. In the arrangement shown, the adjustable support structure 2202 is a single structure that defines a pair of paddle cover portions 2182 (hereinafter "paddle covers"). In other arrangements, the paddle covers 2182 may be defined by separate structures. The support structure 2202 may be moved relative to the paddle 2126 and / or the remainder of the mask assembly 2100. In the arrangement shown, the support structure 2202 may be moved to a desired one of multiple possible separate adjustment positions. However, in other arrangements, the support structure 2202 is infinitely adjustable.

[0096] The mask assembly 2100 of FIG. 27 includes an adjustment mechanism 2210 that allows adjustment of the support structure 2202 relative to the paddle 2126 and / or the remainder of the mask assembly 2100. The adjustment mechanism 2210 includes a detent assembly that allows the support structure 2202 to be secured in a selected one of a plurality of adjustment positions, such as, but not limited to, three, four, or five adjustment positions. The illustrated adjustment mechanism 2210 includes an elongated arm 2212 that extends downwardly from the paddle cover 2182 of the support structure 2202. The elongated arm 2212 includes a plurality of protrusions that define the adjustment positions therebetween. The mask shell 2102 (or another portion of the mask assembly 2100, such as the mask seal 2104) includes a slot 2214 configured to receive the elongated arm 2212. The elongated arm 2212 can be secured in the slot 2214 in any one of a plurality of adjustment positions. Advantageously, the downwardly projecting elongate arm 2212 can be positioned to be out of the user's field of view. However, in other configurations, the illustrated arrangement can be reversed, and the elongate arm 2212 can be provided on the mask assembly 2100 (e.g., the mask shell 2102 or the mask seal 2104), and the slot 2214 can be defined by the support structure 2202. Other suitable detent arrangements can also be used.

[0097] The support structure 2202 may be adjusted in any desired direction relative to the paddle 2126 and / or the remainder of the mask assembly 2100. In some configurations, the support structure 2202 is vertically adjustable relative to the paddle 2126 and / or the remainder of the mask assembly 2100. In some configurations, the support structure 2202 is horizontally or front-to-back adjustable relative to the paddle 2126 and / or the remainder of the mask assembly 2100. In the illustrated arrangement, the support structure 2202 is adjustable both vertically and horizontally relative to the paddle 2126 and / or the remainder of the mask assembly 2100. As such, the support structure 2202 moves upward and backward in one adjustment direction and downward and forward in the other adjustment direction. The adjustment directions may be approximately perpendicular to the top surface 2130 ( FIG. 8 ) of the mask seal 2104 and / or below the user's nose when the mask assembly 2100 is properly positioned on the user's face. The adjustment direction may be configured in other ways to provide the desired adjustment to the support provided to the paddle 2126.

[0098] 28 and 29 show a mask assembly 2100 including adjustable support structures 2202 on the paddles 2126. The adjustable support structures 2202 are similar in many respects to the adjustable support structures 2202 of FIG. 27. However, in the arrangements of FIGS. 28 and 29, the adjustable support structures 2202 include individual structures on each of the paddle cover portions 2182 (hereinafter "paddle covers"). Each of the support structures 2202 can be moved individually relative to the paddles 2126 and / or the remainder of the mask assembly 2100. The support structures 2202 can be moved to any desired one of a plurality of possible individual adjustment positions. However, in other configurations, the support structures 2202 are infinitely adjustable.

[0099] The mask assembly 2100 of Figures 28 and 29 includes an adjustment mechanism 2210 associated with each support structure 2202 to allow adjustment of the support structure 2202 relative to the paddle 2126 and / or the remainder of the mask assembly 2100. The adjustment mechanism 2210 includes a detent assembly that allows the support structure 2202 to be secured in a selected one of a plurality of adjustment positions, such as, but not limited to, three, four, or five adjustment positions. Each of the illustrated adjustment mechanisms 2210 includes an elongate arm 2212 extending downwardly from the paddle cover 2182 of the support structure 2202. The elongate arm 2212 includes a plurality of protrusions that define adjustment positions therebetween. However, in contrast to the arrangement of Figure 27, the protrusions are provided on a face (e.g., an outward-facing face) of the elongate arm 2212 instead of the edge protrusions of Figure 27. The mask shell 2102 (or another portion of the mask assembly 2100, e.g., the mask seal 2104) includes a slot 2214 configured to receive the elongated arm 2212. The elongated arm 2212 can be secured within the slot 2214 in any one of a number of adjustment positions. As in FIG. 27 , the elongated arm 2212 in FIGS. 28 and 29 positions the elongated arm 2212 to protrude downward and out of the user's field of view. However, in other configurations, the illustrated arrangement can be reversed, and the elongated arm 2212 can be provided on the mask assembly 2100 (e.g., the mask shell 2102 or the mask seal 2104), and the slot 2214 can be defined by the support structure 2202. Other suitable detent arrangements can also be used.

[0100] 27, the support structures 2202 of Figures 28 and 29 are adjustable in any desired direction relative to the paddles 2126 and / or the remainder of the mask assembly 2100, for example, vertically, horizontally, or a combination of vertical and horizontally. The adjustment direction may be approximately perpendicular to the upper surface 2130 (Figure 8) of the mask seal 2104 and / or relative to the underside of the user's nose when the mask assembly 2100 is properly positioned on the user's face. The adjustment direction may be configured in other ways to provide the desired adjustment to the support provided to the paddles 2126.

[0101] 30 and 31 show a mask assembly 2100 including a hinge arrangement 2220 configured to facilitate movement of the paddle 2126 or a portion of the paddle 2126 relative to the mask seal 2104 or another portion of the mask assembly 2100, for example, a portion of the mask seal 2104 that is below the paddle 2126 and / or on which the paddle 2126 is supported. In some configurations, the hinge arrangement 2220 is configured to allow at least a portion of the paddle 2126 to move inwardly from a relaxed or normal position. In particular, in the illustrated arrangement, the hinge arrangement 2220 is configured to allow the lateral outer wall 2222 of the paddle 2126 to move inwardly from a relaxed or normal position. In some configurations, the hinge arrangement 2220 is configured to allow the paddle 2126 to move inwardly in response to sufficient force applied to the top surface 2130 (FIG. 8) of the mask seal 2104. As such, the hinge arrangement 2220 allows the paddles 2126 to be moved inward from any starting position (eg, an inflated or expanded position) before a force is applied to the top surface 2130 .

[0102] The hinge arrangement 2220 can be substantially or completely unidirectional. That is, the hinge arrangement 2220 can facilitate movement of the paddle 2126, or a portion thereof, in one direction and inhibit, hinder, or prevent movement of the paddle 2126, or a portion thereof, in another direction. For example, the illustrated hinge arrangement 2220 is configured to allow inward movement of at least the outer wall 2222 of the paddle 2126 and inhibit outward movement of at least the outer wall 2222 of the paddle 2126. The hinge arrangement 2220 allows at least a small amount of outward movement of the outer wall 2222 of the paddle 2126, which is preferably much less than the amount of inward movement allowed.

[0103] In some configurations, the hinge arrangement 2220 includes a living hinge defined by an inwardly extending slot 2224 defined in the mask seal 2104. The slot 2224 preferably extends substantially perpendicular to the lateral outer surface of the paddle 2126, where the slot 2224 begins to extend. The slot 2224 may be located at or near the lower end of the paddle 2126. The slot 2224 may extend any desired distance into the outer wall 2222, which may affect the ease with which the outer wall 2222 can flex or move about the hinge axis 2226 defined by the hinge arrangement 2220. Generally, the farther the slot 2224 extends through the outer wall 2222, the easier the outer wall 2222 can flex or move about the hinge axis 2226 due to the thinner wall thickness at the end of the slot 2224. In some configurations, the slot 2224 extends at least about one-half the thickness of the outer wall 2222 at the hinge arrangement 2220. In some configurations, the slot 2224 extends at least about three-quarters the thickness of the outer wall 2222 at the hinge arrangement 2220.

[0104] The slot 2224 may define a width 2228. The width 2228 may affect the amount of outward movement permitted by the outer wall 2222. Generally, the wider the width 2228, the farther the outer wall 2222 can move outward as a result of the hinge arrangement 2220. The hinge arrangement 2220 allows the outer wall 2222 to move outward until opposing faces of the slot 2224 contact one another. In some configurations, the width 2228 is less than about one-half the length of the slot 2224. In some configurations, the width 2228 is less than about one-quarter the length of the slot 2224. In the illustrated arrangement, the hinge arrangement 2220 includes protrusions 2230 that protrude outward on each side of the slot 2224. The protrusions 2230 can locally increase the wall thickness of the outer wall 2222 and limit outward movement of the outer wall 2222 compared to movement permitted by a relatively thinner wall thickness because the free ends of opposite sides of the slot 2224 are further away from the hinge axis 2226 and contact each other at a smaller deflection angle than the free ends closer to the hinge axis 2226.

[0105] In the arrangement shown, the hinge arrangement 2220 includes a single slot 2224 that extends generally laterally from a paddle 2126 on one side of the mask assembly 2100 to a paddle 2126 on the other side of the mask assembly 2100. However, in other arrangements, pairs of slots 2224 may be provided, with each slot 2224 associated with one of the paddles 2126.

[0106] The paddle 2126 shown in FIGS. 30 and 31 includes a thick outer wall 2222. As a result, the outer wall 2222 is more rigid than the rest of the paddle 2126. Other suitable methods or arrangements for creating greater rigidity in the outer wall 2222 may also be used. A thick outer wall 2222 may reduce or eliminate the need for a paddle support (e.g., paddle cover 2182) for the mask assembly 2100 of FIGS. 30 and 31. Furthermore, providing a hinge arrangement 2220 in combination with a thick or otherwise stiffened outer wall 2222 may control the outward movement or expansion of the paddle 2126 while allowing inward movement of the paddle 2126, similar to a less rigid paddle 2126 in combination with a paddle support 2182. However, in some configurations, a thickened or otherwise stiffened outer wall 2222 may be used in combination with a paddle cover 2182 or other paddle support, such as any of the paddle supports disclosed herein.

[0107] 32 and 33 illustrate another adjustable support structure 2202 for a paddle 2126 that is similar in some respects to the adjustable support structure 2202 of FIGS. 27-29. Features or components not specifically described with respect to FIGS. 32 and 33 may be the same or similar to the same or corresponding features or components of the support structure 2202 of FIGS. 27-29. In the illustrated arrangement, the adjustable support structure 2202 is a single structure that defines a pair of paddle cover portions 2182 (hereinafter "paddle covers"). In other configurations, the paddle covers 2182 may be defined by separate structures. As discussed above, the support structure 2202 may be adjustable in any desired direction relative to the paddle 2126 and / or the remainder of the mask assembly 2100, such as vertically, horizontally, or anterior-posteriorly, or a combination of vertical and horizontal directions.

[0108] The support structure 2202 may be moved relative to the paddles 2126 and / or the rest of the mask assembly 2100 by an adjustment mechanism 2210 including a rack and pinion arrangement. The adjustment mechanism 2210 may include a rack and pinion arrangement associated with each paddle cover 2182, or may include a single rack and pinion that adjusts both paddle covers 2182 of the support structure 2202. The illustrated adjustment mechanism 2210 includes an elongated arm 2212 extending downwardly from the paddle cover 2182 of the support structure 2202. The elongated arm 2212 includes a plurality of teeth that define a rack 2240. The rack 2240 extends the length of the elongated arm 2212. The mask shell 2102 (or another portion of the mask assembly 2100, for example, the mask seal 2104) includes a gear or pinion 2242 having teeth that engage with the teeth of the rack 2240.

[0109] In the illustrated arrangement, the pinion 2242 includes a mounting shaft 2244 that passes through an opening in the mask shell 2102. The mounting shaft 2244 may couple the pinion 2242 to the mask shell 2102 via a snap-fit ​​connection that includes an enlarged end portion of the shaft 2244 that, in response to an intentional assembly force, can pass through the opening in the mask shell 2102 but resists passing back through the opening, retaining the shaft 2244 and pinion 2242 on the mask shell 2102. The pinion 2242 is rotatable relative to the shaft 2244 and / or the mask shell 2102. A rotational adjuster, such as an adjustment knob 2246, is coupled to the pinion 2242 and includes a gripping surface that allows a user to manually rotate the knob 2246 to adjust the position or height of the support structure 2202. In other configurations, the rotational adjuster 2246 may allow or require a tool for adjustment. In some configurations, the rotation adjuster 2246 may not be manually adjustable. However, in some configurations, the illustrated arrangement can be reversed, and the elongated arm 2212 may be provided on the mask assembly 2100 (e.g., the mask shell 2102 or the mask seal 2104), and the pinion 2242 may be coupled to the support structure 2202. The adjustment mechanism 2210 may include guides 2248, such as ribs, that guide movement of the support structure 2202 and / or inhibit or prevent rotation of the support structure 2202 relative to the mask shell 2102 or the mask seal 2104.

[0110] In an alternative arrangement, the support structure 2202 and / or paddle cover 2182 are configured to pivot inwardly toward the paddle 2126 and outwardly away from the paddle 2126, in addition to or instead of movement in other directions. In such an arrangement, the adjustment mechanism 2210 is configured to pivot the support structure 2202 and / or paddle cover 2182 about a pivot axis, which may be a generally horizontal axis located at or near the lower end of the paddle 2126. Such an arrangement allows for adjustment of the level of support provided by the paddle 2126. Furthermore, such an arrangement may allow for inward displacement of the paddle 2126, as needed or desired, to accommodate the facial geometry of a particular user. Furthermore, the support structure 2202 and / or paddle cover 2182 move away from the paddle 2126 to allow for outward expansion of the paddle 2126 when appropriate or desired.

[0111] Figures 34-36 illustrate various embodiments of removable support structures 2202 for paddles 2126 that are similar in some respects to the support structures 2202 of Figures 27-29, 32, and 33. Features or components not specifically described with respect to Figures 34-36 may be the same or similar to the same or corresponding features or components of the support structures 2202 of Figures 27-29, 32, and 33. In the illustrated arrangement, each of the removable support structures 2202 is a unitary structure that defines a pair of paddle cover portions 2182 (hereinafter "paddle covers"). In other configurations, the paddle covers 2182 may be defined by separate structures.

[0112] 34 includes a protrusion 2250 extending inwardly from a lower end portion of each downwardly extending side arm portion 2212 of the support structure 2202. The protrusion 2250 is received within an inwardly extending pocket or recess 2252 in the mask seal 2104 when the support structure 2202 is coupled to the remainder of the mask assembly 2100. In other configurations, the pocket 2252 may be defined by another portion of the mask assembly 2100, such as, but not limited to, the mask shell 2102. The protrusion 2250 may be retained within the pocket 2252 by frictional engagement, by a snap fit, by another interlocking arrangement, and / or by the resiliency of the support structure 2202, among other possibilities. In some configurations, multiple sizes and / or shapes of the support structure 2202 are available for a particular mask assembly 2100, for example, to provide more or less support or deflection of the paddle 2126. As with the other support structures 2202 disclosed herein, the stiffness of the support structure 2202 can be configured to provide a desired level of support to the paddle 2126.

[0113] The support structure 2202 of Figure 35 may be substantially similar in many respects to the support structure 2202 of Figure 34. Features or components not specifically described with respect to Figure 35 may be the same or similar to the same or corresponding features or components of the support structure 2202 of Figure 34 and other support structures disclosed herein, or may be in any other suitable arrangement. The support structure 2202 of Figure 35 has end portions 2254 of side arms 2212 configured to be received in vertically oriented pockets 2252 in the mask seal 2104. However, in other configurations, the pockets 2252 may be defined in another portion of the mask assembly 2100, such as, but not limited to, the mask shell 2102.

[0114] The support structure 2202 of Figure 36 may be substantially similar in many respects to the support structure 2202 of Figure 34 or Figure 35. Features or components not specifically described with respect to Figure 36 may be the same or similar to the same or corresponding features or components of the support structure 2202 of Figure 34 or Figure 35, other support structures disclosed herein, or may be in any other suitable arrangement. The end portions 2254 of the side arms 2212 of the support structure 2202 of Figure 36 may include protruding or engaging portions 2250 configured to be received within respective slots or openings 2252 in the mask seal 2104 or other portions of the mask assembly 2100 (e.g., the mask shell 2102). The engaging portions 2250 may be aligned with the remainder of the side arms 2212. The mask seal 2104 or other portions of the mask assembly 2100 may include straps 2256, walls, or other suitable structures that at least partially define the slots 2252. In such an arrangement, the support structure 2202 may be clipped to the mask assembly 2100 if additional support is desired for the paddle 2126. As shown in Figure 36, the support structure 2202 may be configured to clip to the mask assembly 2100 from multiple directions, such as with a forward or rearward movement.

[0115] In some configurations, portions of the interface assembly that primarily serve another function may also be used to support the paddles 2126. For example, as shown in FIG. 37 , the interface assembly may be configured such that a portion of the headgear 2180 is positioned to overlap at least a portion of the paddles 2126. The portion of the headgear 2180 may provide the same or similar function as the paddle covers 2182 described herein. In such an arrangement, adjustments to the headgear 2180, e.g., the position and / or tension of the headgear, may adjust the amount of support provided by the paddles 2126. Generally, the greater the tension in the headgear 2180, the greater the support or deflection of the paddles 2126. The tension in the headgear 2180 may be greater to move the paddles 2126 inward toward each other, or less to allow the paddles 2126 to move outward away from each other.

[0116] In the illustrated arrangement, the headgear 2180 includes an upper strap 2260 and a lower strap 2262 on each side of the interface assembly. In some configurations, the upper strap 2260 is positioned to overlap at least a portion of the paddle 2126. However, in other configurations, other portions of the headgear 2180 may be used to serve as support for the paddle 2126. In the illustrated arrangement, the upper strap 2260 and the lower strap 2262 are connected to the frame 2178, which is connected to the mask assembly 2100. The upper strap 2260, or other portions of the headgear 2180, may be positioned to overlap the paddle 2126 as a result of the shape of the headgear 2180 and / or its attachment location on the frame 2178, or may be guided or deflected into a position to overlap the paddle 2126 by guiding structure, such as a slot or channel, which may in some cases be an integral part of the mask seal 2104. 1-3, a portion of the frame 2178 may include or carry support for the paddles 2126. Thus, in some configurations, both a portion of the headgear 2180 and the frame 2178 may provide support for the paddles 2126.

[0117] 38 , the headgear 2180 may carry one or more paddle supports or paddle covers 2182 configured to provide support for the paddles 2126. For example, each of the upper straps 2260 may carry a paddle cover 2182 that may be positioned on the strap 2260 to provide support for the corresponding paddle 2126. In some configurations, the paddle cover 2182 includes an opening 2264 through which the headgear strap 2260 can pass, and the paddle cover 2182 can slide along the strap 2260 to a desired position relative to the paddle 2126. The paddle cover 2182 may be held in place on the strap 2260 by frictional engagement between the paddle cover 2182 and the strap 2260. Similar to the arrangement of FIG. 37 , adjustments to the headgear 2180 can adjust the level of support or deflection provided to the paddle 2126 by the paddle cover 2182. Different sizes and / or shapes of the paddle covers 2182 may be provided to adjust the amount of support or flex provided to the paddles 2126.

[0118] 39 shows a support arrangement for the paddles 2126 in the form of tethers or straps 2182. The straps 2182 are coupled to each side of the mask assembly 2100 and pass over the top of the paddles 2126 on each side of the mask assembly 2100 to support and / or flex the paddles 2126. In the arrangement shown, the straps 2182 pass over the top of the mask seal 2104 such that a portion of the straps 2182 is disposed above the upper surface 2130 (FIG. 8) of the mask seal 2104. The straps 2182 may be rigid or semi-rigid such that they may retain a curved or other shape in the absence of an external force acting on the straps 2182. In other configurations, the straps 2182 may be non-rigid or flexible and rely on resistance provided by the paddles 2126, other portions of the mask seal 2104, the mask shell 2102, or another portion of the mask assembly 2100 to shape the straps 2182 during use. For example, the paddles 2126 may support a central portion of the straps 2182 and keep the straps 2182 away from the user's nose.

[0119] The strap 2182 may be coupled to the mask assembly 2100 by any suitable arrangement. In some configurations, the mask seal 2104, the mask shell 2102, or another portion of the mask assembly 2100 includes an attachment element that may engage with a corresponding attachment element on the strap 2182. The strap 2182 may be coupled to each side of the mask assembly 2100. In the illustrated arrangement, the mask seal 2104 or mask shell 2102 includes an attachment post 2270, and the strap 2182 includes an opening 2272 through which the attachment post 2270 can pass. When the strap 2182 is assembled to the attachment post 2270, the remaining enlarged portion or head of the attachment post 2270 may hold the strap 2182 in place. In other configurations, this arrangement may be reversed. Other suitable arrangements, such as a tab and slot arrangement, a snap fit, or a hook and bar arrangement, may also be used. In yet other configurations, the straps 2182 may be attached to the headgear 2180 by upper straps 2260 on each side of the interface assembly. The straps 2182 may be adjustable relative to the mask assembly 2100 to adjust the effective length of the straps 2182, thereby adjusting the amount of support or flex provided to the paddles 2126. For example, the straps 2182 may include multiple openings 2272 or other attachment elements on each side.

[0120] Although shown in connection with the nasal-oral mask assembly 2100, the features and advantages of the paddles 2126, support structure 2163, and paddle cover 2182 may also be used in other types of masks. Figures 40-43 show a nasal mask assembly 3100 that includes similar features to the paddles 2126, support structure 2163, and paddle cover 2182 described above. The nasal mask assembly 3100 is described in terms of its differences compared to the nasal-oral masks described above. As such, features, components, or other structures not expressly described may be the same or similar to the same or corresponding features, components, or structures of the mask assembly 2100 disclosed herein, or may be in any other suitable arrangement.

[0121] The illustrated mask assembly 3100 includes a mask support, which may be, for example, a base, housing, or shell 2102. The mask seal 2104 is attached to the mask shell 2102, such that the mask shell 2102 provides some support to the mask seal 2104. The mask assembly 3100 is engaged with or otherwise supported by a frame 2178, allowing it to be connected to headgear (e.g., headgear 2180) in any suitable arrangement. In the illustrated arrangement, the mask shell 2102 is in the form of a connector that allows it to be connected to the frame 2178. The illustrated mask shell 2102 is generally annular and, at least in some configurations, does not cover a significant portion of the forward-facing surface of the mask seal 2104. In some configurations, the headgear is coupled directly to the mask assembly 3100, and the frame 2178 may be used for other purposes or may be omitted. A conduit connector, such as the elbow 2106, may also be attached to the mask shell 2102, the frame 2178, or otherwise supported relative to and adapted to communicate with the interior space of the mask assembly 3100. Together, the frame 2178 and the headgear 2180 may support the mask assembly 3100 in place on the user's face. Collectively, the mask assembly 3100, the frame 2178, and the headgear 2180 may be referred to as an interface assembly. The mask assembly 3100, or the mask assembly 3100 in combination with the frame 2178, may be referred to as an interface.

[0122] The frame 2178 may be removably connected to the mask assembly 3100 by any suitable arrangement. For example, the frame 2178 may be coupled to or around the aperture 2114 of the mask shell 2102 by a snap fit, friction fit, or clip fastening, among other possibilities. The mask assembly 3100 may be adjustably secured to the frame 2178 to only allow the assembly to be properly oriented. The conduit connector 2106 may also be attached to the mask shell 2102, the frame 2178, or otherwise supported relative to and adapted to communicate with the interior space of the mask assembly 3100. For example, but not limited to, the connector 2106 may be connected to the shell 2102 such that the connector 2106 can pivot, rotate, or pivot relative to the shell 2102 about a single axis or multiple axes. In some configurations, the connector 2106 may define a portion of a ball-and-socket joint with the frame 2178 and / or mask shell 2102, for example, but not limited to, 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 3100. Any suitable connector 2106 may be used, which in some cases may include a swivel or rotational coupling that allows relative rotation between the connector 2106 and the gas conduit.

[0123] In the illustrated configuration, the connector 2106 includes an elbow, such as, for example, but not limited to, a polycarbonate elbow, including a vent. In the illustrated arrangement, the vent includes bias flow holes 2110. However, the vent may include other geometries or configurations, such as slots, or may include 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 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 may be provided in the mask shell 2102, the mask seal 2104, or any combination of the connector 2106, shell 2102, and seal 2104, or any other component of the interface assembly or associated breathing circuit. The bias flow holes 2110 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.

[0124] The illustrated seal 2104 is configured to seal under the user's nose, along a portion of the face extending laterally to the nose, and along the user's upper lip. The mask assembly 3100 advantageously does not need to contact the bridge of the user's nose. In the illustrated configuration, the mask assembly 3100 does not extend over the top of the user's nose bridge. More particularly, the illustrated mask assembly 3100 does not contact the bridge of the user's nose.

[0125] The mask assembly 3100 may or may not extend over the tip of the user's nose. As such, in some configurations, the mask assembly 3100 covers the tip of the nose. In some configurations, the seal of the mask assembly 3100 covers the tip of the nose. In some configurations, the illustrated mask assembly 3100 preferably does not obscure the tip of the user's nose. In some configurations, or for some facial geometries, the tip of the user's nose extends to cover an adjacent portion of the mask assembly 3100. In some configurations, the frame 2178 and other portions of the mask assembly 3100 can accommodate deflection of the mask seal 2104 by multiple portions of the user's nose (e.g., the tip of the nose), allowing the interface to accommodate various nose lengths.

[0126] As shown, the mask assembly 3100 is preferably adapted to extend around and cover the upper sides of the alae of the nose, which flares to form rounded ridges around the nostrils. The illustrated mask assembly 3100 is adapted to seal around the surfaces defining the openings to the nostrils, which may include a portion or all of the fleshy outer edge of the nasal septum, sometimes referred to as the columella. In some configurations, the mask assembly 3100 is adapted to extend upward to 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 3100 is adapted to extend upward along at least a portion of the left and right sidewalls of the dorsum without extending upward to the area of ​​the user's nose bridge. In some configurations, the primary sealing surface of the mask assembly 3100 contacts the underside of the user's nose, upper lip, and / or the transition area between the underside of the nose and upper lip. The secondary sealing surface of the mask may contact the sides of the user's nose, possibly along with the cheeks near the nose. Such primary and secondary sealing surfaces may not contact all of a user's face, however, such an arrangement may provide a suitable seal with a relatively wide range of facial geometries.

[0127] The mask seal 2104 includes at least one nasal opening 2124. In some configurations, the mask seal 2104 may include two or more nasal openings 2124. In some configurations, the mask seal 2104 may include nasal openings 2124 defined in an upper structure such as pillows, prongs, etc. In some configurations, the nasal 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 suitable arrangements for the mask seal 2104 are disclosed in applicant's published application WO 2014 / 077708, which is incorporated herein by reference in its entirety.

[0128] The mask seal 2104 includes an inward- or rearward-facing central portion 3102 that faces or contacts the user during use of the mask assembly 3100. The mask seal 2104 also includes a pair of opposing lateral inner portions 3104 and a pair of opposing lateral outer portions 3106. The lateral inner portions 3104 are configured to contact the sides of the nose and / or portions of the user's face on either side of the nose. The lateral inner portions 3104 include both an inward-facing surface and a rearward-facing surface. That is, each of the lateral inner portions 3104 wraps from the inward-facing surface of the mask seal 2104 toward or to the rearward-facing surface of the mask seal 2104. The lateral outer portions 3106 may include both a rearward-facing surface and an outward-facing surface. The rearward-facing surfaces of the lateral outer portions 3106 may contact the user's face during use of the mask assembly 3100. The mask seal 2104 may also include a nasal opening support 3108 that partially or completely surrounds and provides support to the nasal openings 2124 .

[0129] Similar to the mask seal 2104 described above with reference to FIGS. 1-39, the mask seal 2104 of FIGS. 40-43 may include regions of varying thickness, allowing the mask seal 2104 to have different properties or characteristics within different regions. For example, the central portion 3102 may have a relatively thin thickness to allow the central portion 3102 to conform to a user's particular facial geometry. In some configurations, the relatively thin thickness allows the central portion 3102 to stretch. In some configurations, the thickness of the central portion 3102 may be 0.3 mm to 0.5 mm or 0.6 mm. In some configurations, the thickness of the central portion 3102 is 0.3 mm. Optionally, the thickness of the central portion 3102 may be as thin as 0.15 mm. However, it has been found that thinner thicknesses may cause or increase the likelihood of creases with some facial geometries and / or at some operating gas pressures. By maintaining a thickness of 0.3 mm or greater throughout a significant portion or the entire central portion 3102, the occurrence of creases can be reduced over a significant range of operating pressures, which may include the full range of normal operating pressures.

[0130] The thickness of the lateral inner portions 3104 may be greater than the thickness of the central portion 3102. In some configurations, the thickness of the lateral inner portions 3104 may be 0.4 mm to 0.6 mm. In some configurations, the thickness of the lateral inner portions 3104 is 0.5 mm. The thickness of the nasal opening support 3108 is greater than one or both of the central portion 3102 and the lateral inner portions 3104. The relatively greater thickness may protect the mask seal 2104 from tears at the nasal opening 2124 and may help the nasal opening 2124 maintain an open shape. In some configurations, the thickness of the nasal opening support 3108 is 1 mm to 2.5 mm. In some configurations, the thickness of the nasal opening support 3108 is 1.2 mm. The thickness may be constant or may vary within any of the central portion 3102, the lateral inner portions 3104, or the nasal opening support 3108.

[0131] The lateral portions 2126 of the mask assembly 3100, including portions or the entire lateral inner portion 3104 and lateral outer portion 3106, may function in the same or similar manner as the paddles 2126 of the mask assembly 2100. Accordingly, the lateral portions 2126 of the mask assembly 3100 may be referred to herein as paddles. The paddles 2126 may refer to any portion of the interface seal that is positioned with the user's nose during use of the interface. The paddles 2126 are disclosed herein in the context of under-the-nose interfaces, but may also be used with other types of interfaces, such as those that contact, cover, or seal with the bridge of the user's nose, unless otherwise indicated.

[0132] The lateral outer portions 3106 may include features that assist in maintaining the shape of the mask seal 2104. In some configurations, the lateral outer portions 3106 include regions of increased thickness, rigidity, or stiffness to assist in maintaining the shape of the mask seal 2104. Such features may be similar in structure and / or function to the support structures 2163 described herein with respect to the paddles 2126 of the mask assembly 2100. Accordingly, the same reference numbers are used to refer to both the support structures 2163 of the mask assembly 3100 and the support structures 2163 of the mask assembly 3100. The support structures 2163 of the mask assembly 3100 may inhibit or prevent over-expansion or unwanted expansion of the lateral end portions of the mask seal 2104, which may result in leakage and / or unwanted pressure being exerted on the user's nose by the central portion 3102 of the mask seal 2104, in a manner similar to that described above with respect to the paddles 2126. Similarly, the support structure 2163 may inhibit or prevent collapse of at least portions of the mask seal 2104 when engaging the nose during use. For example, the support structure 2163 may inhibit or prevent collapse of the nose region or central portion 3102 of the mask seal 3100.

[0133] The support structures 2163 may also transmit forces from one portion of the mask seal 2104 to another portion of the mask seal 2104. For example, the support structures 2163 may transmit a force applied to a rear portion of the mask seal 2104 to a front portion of the mask seal 2104. In some configurations, the support structures 2163 can transmit a force applied to the rear-facing surface of the mask seal 2104 by the user's face to another portion of the mask seal 2104, which may resist some or all of the transmitted force. In some configurations, the support structures 2163 transmit the force from the rear-facing or user-contacting surface of the mask seal 2104 to a frame 2178 or other structure that supports the mask seal 2104 (e.g., mask shell 2102). As such, in some configurations, the support structures 2163 extend between a rearward-facing surface of the mask seal 2104 and a surface of the mask seal 2104 that is contacted or overlaid by a frame 2178 or other support structure for the mask seal 2104. Preferably, the support structures extend from the rearward-facing surface to a surface that is overlaid by the frame 2178 or other support structure. However, as noted above, the support structures 2163 can provide structure to the mask seal 2104, and can be used to provide such support, without necessarily transmitting force.

[0134] In some configurations, the frame 2178 includes a central portion and lateral portions on each side of the central portion. The lateral portions may function in a similar or identical manner to the paddle covers 2182 described with respect to the interface of FIGS. 1-39 . Accordingly, the same reference numerals used to refer to the paddle covers 2182 are used to refer to the lateral portions 2182 of the frame 2178. Furthermore, unless otherwise indicated, references to the paddle covers 2182 may also refer to the lateral portions 2182 of the frame 2178 of FIG. 40 . The lateral portions or paddle covers 2182 are aligned with or overlap the portions of the mask seal 2104 including the support structures 2163, allowing the support structures 2163 to transfer loads to the lateral portions 2182 of the frame 2178 in a similar or identical manner as described above with reference to FIGS. 1-39 .

[0135] The supports 2163 may generally extend in a direction from the rear or user-contacting surface of the mask seal 2104 toward its respective lateral portion of the cover 2182 of the frame 2178. In some configurations, each of the supports 2163 extends entirely or substantially in the longitudinal direction of the mask seal 2104. The supports 2163 may extend approximately parallel to one another or may be closer at the front end compared to the rear end. In other words, the supports 2163 may converge in a direction moving from the rear or user-contacting surface of the mask seal 2104 toward the front portion of the mask seal 2104. However, in other configurations, the supports 2163 may diverge from back to front.

[0136] In the arrangement shown, each support structure 2163 is shaped or otherwise configured to follow part or all of the peripheral edge of the associated laterally outer portion 3106. Each support structure 2163 may comprise a generally C-shape (or an inverted C-shape) when the mask seal 2104 is viewed from the side, including a posterior portion 3110 and upper and lower extensions or legs 3112, 3114 that extend forward from the posterior portion 3110. In the arrangement shown, the support structures 2163 are thickened regions of the mask seal 2104, each of which projects inward into the interior space of the mask seal 2104. Either one or both of the extensions 3112, 3114 may extend into and / or contact the mask shell 2102. In the configuration shown, only the lower extension 3114 extends to the mask shell 2102, and the upper extension 3112 is spaced rearward from the mask shell 2102. However, in other configurations, this arrangement may be reversed.

[0137] Each of the illustrated support structures 2163 includes a cutout or relief 3120 that provides a region of reduced thickness, stiffness, or rigidity within the support structure 2163. In the illustrated arrangement, the relief 3120 is a region of reduced thickness compared to other portions of the support structure 2163. The illustrated relief 3120 also includes a generally C-shape (or an inverted C-shape) when the mask seal 2104 is viewed from the side. In some configurations, the relief 3120 may also follow part or all of the peripheral edge of the associated lateral outer portion 3106. Preferably, however, the relief 3120 is spaced inwardly from the peripheral edge of the lateral outer portion 3106. In at least some configurations, the relief 3120 is completely contained within the support structure 2163. The relief 3120 allows portions of the support structure 2163 to move relative to one another. Thus, the relief 3120 allows corresponding portions of the mask seal 2104 to move relative to one another. As such, the portion of the support structure 2163 behind the relief 3120 and the mask seal 2104 may move towards the portion of the support structure 2163 in front of the relief 3120 and the mask seal 2104 .

[0138] The support structure 2163 may have varying thicknesses to provide different levels of support for the mask seal 2104. For example, the thickness of the upper extension 3112 and / or the lower extension 3114 may be less than the thickness of at least a portion of the posterior portion 3110. In some configurations, the thickness of a portion of the posterior portion 3110 posterior to the relief 3120 and / or disposed on or adjacent to the posterior surface of the mask seal 2104 is greater than the thickness of a portion of the posterior portion 3110 anterior to the relief 3120. The thickness of the relief 3120 may be less than the thickness of both the portion of the posterior portion 3110 anterior to the relief 3120 and the portion of the posterior portion 3110 posterior to the relief 3120. Additionally, the thickness of a portion of the exterior (e.g., anterior) laterally outer portion 3106 of the support structure 2163 may be less than the thickness of any portion of the support structure 2163. In some configurations, the thickness of the portion of the exterior laterally outer portion 3106 of the support structure 2163 can be equal to or substantially equal to the thickness of the relief 3120 .

[0139] In some configurations, the thickness of the portion of the posterior portion 3110 posterior to the relief 3120 and / or disposed on or adjacent the posterior surface of the mask seal 2104 is between 2 mm and 5 mm. In some configurations, the thickness is 4 mm. In some configurations, the thickness of the portion of the posterior portion 3110 anterior to the relief 3120 is between 1.5 mm and 3 mm. In some configurations, the thickness is 2 mm. In some configurations, the thickness of the relief 3120 is between 0.3 mm and 0.6 mm. In some configurations, the thickness is 0.5 mm. In some configurations, the thickness of the portion of the external laterally outer portion 3106 of the support structure 2163 can be between 0.3 mm and 0.6 mm. In some configurations, the thickness is 0.5 mm. The mask seal 2104 can also have thicknesses proportional to those disclosed herein without having any or all of the specific thicknesses disclosed.

[0140] Unless the context clearly dictates otherwise, throughout the description and claims, the words "comprise," "comprising," and the like may be construed inclusively, 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.

[0141] The term "plurality" refers to two or more items. References to quantities, dimensions, sizes, formulations, parameters, shapes, and other characteristics should be interpreted 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 skilled in the art. References to quantities, dimensions, sizes, formulations, parameters, shapes, and other characteristics should also be interpreted as if the term "substantially" were preceded by the quantity, dimension, size, formulation, parameter, shape, or other characteristic. The term "substantially" means that the referenced characteristic, parameter, or value need not be achieved exactly, but that deviations or variations, including, for example, tolerances, measurement errors, measurement accuracy limits, and other factors known to those skilled in the art, may occur to an extent that does not exclude the effect that the characteristic is intended to achieve.

[0142] 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 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, and 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.

[0143] 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.

[0144] 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.

[0145] 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, said parts, elements and features referred to or shown in the specification of this application.

[0146] 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.

[0147] 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 may 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. An interface for use in administering positive airway pressure therapy, comprising: a mask assembly including a mask seal and a mask shell, the mask assembly being configured to be positioned sufficiently lower than a bridge of the nose of a user's face and to expose the bridge of the nose of the user, the mask seal being connected to the mask shell, the mask seal including a nasal region including at least one nasal opening, the mask seal including 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 being configured to contact one side of the nose of the user and the second paddle being configured to contact the other side of the nose of the user; a frame removably coupled to the mask assembly; a pair of covers supported relative to the mask assembly, each of the covers positioned adjacent a portion of a respective one of the first and second paddles, the covers limiting expansion of at least the portions of the first and second paddles; Including, the interface.

2. The interface of claim 1 , wherein the cover is supported by the frame.

3. The interface of claim 2 , wherein the cover is integrally formed with the frame.

4. An interface according to any preceding claim, wherein the cover is positioned adjacent only a portion of the paddle, leaving the portion of the paddle exposed.

5. The interface of claim 4 , wherein a rear portion of the paddle remains exposed by the cover.

6. An interface according to any one of claims 1 to 5, wherein the paddle covers substantially the entire height of the adjacent portion of the paddle.

7. The interface of any one of claims 1 to 6, wherein the paddles define spaces between them, thereby exposing a portion of an upper portion of the mask seal.

8. 8. The interface of claim 1, wherein the covers are formed as part of the mask seal, and each of the covers includes a flap portion extending from the mask seal adjacent a respective one of the paddles.

9. 9. The interface of claim 1, wherein the seal includes at least one living hinge adjacent to and below the paddle, the living hinge configured to allow the paddle to bend inwardly toward the user's nose and to resist bending of the paddle outwardly, away from the user's nose.

10. The interface of claim 9 , wherein the living hinge comprises a thinned portion of the seal adjacent the paddle.

11. The interface of any preceding claim, wherein the cover is configured to rotate relative to the mask assembly.

12. The interface of claim 11 , further comprising an adjustment mechanism configured to allow adjustment of the rotation of the cover relative to the mask assembly.

13. An interface according to any preceding claim, wherein the cover is removably attachable to the frame or the mask assembly.

14. The interface of any preceding claim, wherein the cover is adjustable relative to the mask assembly.

15. The interface of claim 14 , wherein the height of the cover relative to the mask assembly is adjustable.

16. 10. The interface of claim 1, further comprising headgear, the headgear including upper and lower straps on each side of the mask assembly, the headgear being removably connected to the frame, the upper straps of the headgear movably supporting the cover such that the cover can slide along the upper straps.

17. The interface of claim 1 , wherein the cover is formed as part of the mask shell and extends upwardly along the mask seal adjacent the paddle.

18. The interface of claim 1 , further comprising a tether extending from one side of the mask assembly to the other side of the mask assembly, the tether defining the cover.

19. An interface according to any preceding claim, wherein each of the paddles includes a support in the form of a suspension member, the support assisting in maintaining a desired shape of the paddle.

20. 20. The interface of claim 19, wherein the suspension member comprises an elongated, thickened region of the mask seal that extends from a patient side of the mask assembly toward the frame.

21. 21. The interface of claim 20, wherein the suspension members are thicker in the paddle and nose regions than in other portions of the mask seal.

22. 22. The interface of any one of claims 19 to 21, wherein each of the suspension members is aligned with a respective one of the covers and configured to transfer loads from the seal to the cover via the suspension member.

23. An interface according to any one of claims 19 to 22, wherein the suspension members are connected to each other.

24. 1. A mask assembly for use in administering positive airway pressure therapy, comprising: a mask seal; and Mask Shell a mask seal connected to the mask shell, the mask seal including a nose region including at least one nasal opening, the mask seal including a first paddle on a first side of the nose region and a second paddle on a second side of the nose region, the first paddle configured to contact one side of the nose of the user and the second paddle configured to contact the other side of the nose of the user; A mask assembly wherein the mask seal has a varying thickness and each of the paddles includes a support in the form of a suspension member, the support assisting in maintaining a desired shape of the paddle.

25. 25. The mask assembly of claim 24, wherein the nose region has the smallest thickness of the mask seal.

26. 26. The mask assembly of claim 24 or 25, wherein the support for the paddle has a maximum thickness of the mask seal.

27. The mask assembly of any one of claims 24 to 26, wherein the suspension members extend from a user-contacting surface of the mask seal towards the mask shell.

28. A mask assembly according to any one of claims 24 to 27, wherein the suspension members are connected to each other to form connecting areas of increased thickness.

29. 29. The mask assembly of any one of claims 24 to 28, wherein the mask seal further comprises a mouth opening, and wherein an area surrounding the mouth opening has the minimum thickness or is equal to the minimum thickness of the mask seal.

30. 30. The mask assembly of claim 29, wherein the mask seal further includes outer peripheries on either side of the mouth opening, each outer periphery wrapping from a rearward-facing side of the mask seal to at least a portion of a lateral-facing side of the mask seal, and wherein a thickness of the outer periphery exceeds a thickness of the nose region.

31. A mask assembly according to any one of claims 24 to 30, wherein the support comprises a generally triangular shape, the base of the triangle being positioned rearward of the apex of the triangle.

32. 32. An interface assembly comprising the mask assembly of any one of claims 24 to 31, further comprising a removably attachable frame, the frame including one or more covers extending therefrom, and configured to prevent the mask seal from expanding outwardly and collapsing when pressurized air is introduced into the mask seal.

33. 33. The interface assembly of claim 32, wherein each of the suspension members is aligned with a respective one of the covers and configured to transfer loads from the seal to the cover via the suspension members.

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