Interface including nasal sealing portion

Abstract

To provide a face mask covering at least one of the nose or the mouth of a user in order to supply respiratory gas under positive pressure.SOLUTION: An interface 100 for positive pressure treatment includes a mask assembly 102 and a headgear assembly 106. The mask assembly includes a mask seal which is placed below a nose, extends upward on lateral sides of the nose, and is adapted to define a trough part opening upward where the nose is seated, where the nose of a user is exposed. The mask seal has a primary seal below the nose and has a secondary seal alongside the nose.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Patent Application No. 61 / 553,872, filed October 31, 2011, which is hereby incorporated by reference in its entirety. This application is also a continuation-in-part of PCT / IB2012 / 000858, filed April 13, 2012, which claims the benefit of priority to U.S. Provisional Patent Application No. 61 / 476,188, filed April 15, 2011, U.S. Provisional Patent Application No. 61 / 504,295, filed July 4, 2011, and U.S. Provisional Patent Application No. 61 / 553,067, filed October 28, 2011, each of which is hereby incorporated by reference in its entirety.

[0002] The present invention relates generally to face masks that cover at least one of the nose and mouth of a user to deliver respiratory gas under positive pressure. More particularly, certain aspects of the invention relate to such masks having an improved nose seal. [Background technology]

[0003] A face mask can be used to provide breathing gas under positive pressure to a user. In a configuration that covers both the mouth and nose of a user, a full face mask can typically be placed over the bridge of the nose. Generally, a single seal can surround the nose and mouth of a user. Such a seal spans the bridge of the user's nose.

[0004] Such full face masks are typically secured to the user's head by a headgear. To sufficiently reduce leakage, the headgear is typically tightened, which exerts high pressure on the bridge of the user's nose. In other words, as the headgear tightens, the silicone seal typically exerts a gradually increasing load on the bridge of the nose. This pressure can cause discomfort and, in some circumstances, can cause pressure sores over time. Summary of the Invention [Problem to be solved by the invention]

[0005] It is an object of the present disclosure to provide one or more structures and / or methods that may provide at least some improvement over the above, or that may at least provide a useful option to the public or medical professionals. [Means for solving the problem]

[0006] Accordingly, an interface for use in providing positive airway pressure therapy is provided. The interface includes a mask assembly. The mask assembly includes a mask seal and a mask base removably coupled to the mask seal. The mask seal includes a mask seal clip that is more rigid than at least a portion of the mask seal. The mask seal clip is in a generally cup-shaped configuration with an open proximal end and a generally closed distal end. A generally pentagonal lip extends around the proximal end. The mask seal clip includes an arcuate upper portion having an outer surface. A mask seal clip arc length is defined along the outer surface adjacent an upper end of the upper portion between a pair of hinge points. A hinge axis extends laterally across the mask assembly between the hinge points, and at least a portion of the mask seal clip upper portion is positioned vertically higher than the hinge axis. The mask seal clip upper portion includes a support surface. A generally central passageway extends through the mask clip and into a chamber defined by the mask seal. The mask seal includes a flexible upper portion configured to be positioned over the nose of a user. The mask seal upper portion is positioned vertically above the hinge axis. The mask seal upper portion includes a region of reduced stiffness located between two regions of increased stiffness. The region of reduced stiffness has the ability to roll, allowing pivoting of the mask seal upper portion relative to the mask seal clip. One of the two regions of increased stiffness is located adjacent the small radius bend and the other of the two regions of increased stiffness is adjacent the reinforcement component. The small radius bend and the reinforcement component define a boundary between which the upper portion of the mask exhibits roll during pivoting of the upper portion about the pivot axis. The mask seal upper portion has a first curved length adjacent the small radius bend and a second curved length adjacent the reinforcement band. The first curved length is shorter than the second curved length. The curved length increases as the measurement location moves away from the mask seal clip. The mask base is placed over at least a portion of the mask seal clip. The mask base includes a first pocket and a second pocket, the first and second pockets being positioned substantially symmetrically about a central plane that bisects the mask base, and each of the first pocket and the second pocket includes a vertical dimension that is greater than a horizontal dimension.The mask base also includes a wall that defines a central opening. The wall extends into a generally central passage of the mask seal clip. The connection port assembly includes an elbow that terminates in a ball-shaped member. The ball-shaped member is sized and configured to be retained by the wall that defines the central opening. The connection port assembly also includes a removable swivel member. The removable swivel member is secured by a lever. The lever overlies the port. The port can be selectively covered by a flap. The flap can also close the central passage in the elbow. The port opening is generally toward the mask when the elbow is connected to the mask. The headgear assembly includes a pair of upper straps and a pair of lower straps. One of the pair of upper straps and one of the pair of lower straps are connected to a first clip. The other of the pair of upper straps and the other of the pair of lower straps are connected to a second clip. The first and second clips are securable within the pocket of the mask base such that the clips move in a direction substantially perpendicular to the strap tension direction to become engaged within the pocket.

[0007] In some configurations, the mask seal is a full face mask.

[0008] In some configurations, the mask seal clip is integral to the mask seal such that the mask seal clip cannot be separated from the mask seal.

[0009] In some configurations, the mask base is removably coupled to the mask seal.

[0010] In some configurations, an outer surface of the upper portion rolls over a support surface of the mask seal clip, the support surface defining the outer surface of the upper portion of the mask seal clip.

[0011] In some configurations, the region of reduced stiffness comprises a region of reduced thickness compared to the region of increased stiffness.

[0012] In some configurations, the upper portion of the mask seal includes an apex defined by a first wall and a second wall, and the reinforcing component extends along at least a portion of the first wall and along at least a portion of the second wall. Preferably, the reinforcing component extends over the apex of the upper portion of the mask seal.

[0013] In some configurations, the reinforcement components terminate at both ends generally vertically above the hinge point.

[0014] The mask assembly may include a mask seal. The mask seal includes an upper portion and a lower portion. The upper portion is pivotable relative to the lower portion. The upper portion includes a region of reduced stiffness positioned between a first boundary and a second boundary. The first boundary is defined by a higher stiffness than the region of reduced stiffness. The second boundary is defined by a higher stiffness than the region of reduced stiffness. As the first boundary is moved toward the second boundary, the region of reduced stiffness buckles in a single direction to define a roll of material that changes size as the first boundary continues to move toward the second boundary.

[0015] In some configurations, the area of ​​reduced stiffness facilitates movement of an upper portion of the seal member relative to a lower portion of the seal member. Preferably, the upper portion includes a nasal bridge portion of the mask, and the first boundary moves toward the second boundary to facilitate movement of the nasal bridge portion of the mask relative to the lower portion of the mask.

[0016] In some configurations, the second boundary is positioned between the upper and lower portions. Preferably, the mask further includes a mask seal clip having an increased stiffness relative to the mask seal, and the second boundary is positioned along an edge of the mask seal clip. More preferably, the roll of material overlaps at least a portion of the mask seal clip.

[0017] In some configurations, the first boundary is defined along a reinforcing component. Preferably, the reinforcing component comprises a plastic band.

[0018] In some configurations, the region of reduced stiffness is defined by a reduction in thickness relative to the first boundary.

[0019] In some configurations, the second boundary is defined by a small radius corner.

[0020] In some configurations, the roll extends over at least a portion of the mask seal.

[0021] In some configurations, the roll rests over at least a portion of the mask seal clip when the first boundary is fully moved towards the second boundary.

[0022] The mask assembly may include a mask seal, the mask seal including a nasal region and a mouth region, the nasal region and the mouth region being integrally formed, the nasal region being movable relative to the mouth region such that the force exerted by the nasal region remains substantially constant at a plurality of positions while the force exerted by the mouth region increases.

[0023] The mask assembly includes a mask seal coupled to a headgear assembly, the mask seal configured to encircle the bridge of the nose and the mouth of a user, the mask seal including a non-pleated means for exerting a substantially constant force against the bridge of the nose while increasing the force applied to the mouth when the headgear assembly is tightened.

[0024] The mask assembly includes a seal. The seal includes a flange that engages a face of a user. The seal is removably coupled to a mask base. The mask base includes a first opening and a second opening. The first opening and the second opening receive a first clip and a second clip of an associated headgear assembly. The mask base further includes a passage generally positioned between the first opening and the second opening. The passage is adapted to receive a breathing tube connector.

[0025] In some configurations, the mask assembly further includes a mask seal clip coupled to the mask seal and removably coupled to the mask base. Preferably, the mask base overlies a substantial portion of the mask seal clip. More preferably, the mask base includes a peripheral edge and at least one recess is defined along the peripheral edge of the mask base at a location that overlies the mask seal clip.

[0026] The mask assembly includes a mask seal. The mask seal includes a proximal flange adapted to contact a face of a user. The mask seal includes a distally facing surface. A mask base includes a peripheral edge from which a covering surface extends. The mask base covering surface is positioned over at least a portion of the mask seal distally facing surface such that the mask base covering surface is spaced distally from the mask seal distally facing surface, such that the mask base covering surface and the mask seal distally facing surface provide a shielding effect for the mask assembly that reduces moisture rainout.

[0027] The interface for providing a positive airflow to a user may include a mask base and a mask seal removably coupled to the mask base, the mask seal including a first sealing surface adapted to be placed under the user's nose and a second sealing surface adapted to extend over at least fibroadipose tissue of one or more alae of the user's nose without wrapping around the tip of the user's nose.

[0028] In some configurations, the first sealing surface is defined by the upper surface. A chamber may be defined within the seal member, and an opening through the upper surface may be substantially flush with the upper surface.

[0029] In some configurations, the second sealing surface includes a first paddle and a second paddle, the first paddle and the second paddle extending vertically above the top surface, and the first paddle, the top surface, and the second paddle defining a valley, the valley being adapted to prevent the tip of a user's nose from being covered by the mask seal.

[0030] In some configurations, the first paddle and the second paddle each include an inner pocket in fluid communication with a chamber defined in the seal member, and a lateral portion of the inner pocket extends vertically above a top surface of the mask seal.

[0031] In some configurations, the mask seal further includes a lip that depends downwardly from the upper surface and is adapted to define at least a portion of the mouth opening, the mouth opening being separate from the opening in the upper surface.

[0032] In some configurations, the mask seal further includes a lip that generally surrounds a mouth portion of an integral oronasal opening defined in the mask seal.

[0033] In some configurations, the interface further includes a clip, the clip connecting a first side of the integrated oral-nasal opening with a second side of the integrated oral-nasal opening.

[0034] In some configurations, the mask seal includes a forward facing surface and a rearward facing surface connected by a sidewall.

[0035] In some configurations, a portion of the rearwardly facing surfaces of the first and second paddles has a lesser thickness than a portion of the forwardly facing surfaces of the first and second paddles.

[0036] In some configurations, a portion of a rearwardly facing surface of the central chin region of the mask has a thickness that is less than a thickness of a portion of a laterally outer rearwardly facing surface of the central chin region.

[0037] The interface for providing a positive air flow to a user includes a mask base and a mask seal removably coupled to the mask base. The mask seal includes a first paddle and a second paddle coupled to a first sealing surface. The first paddle and the second paddle define a secondary seal structure. The first paddle and the second paddle may be movable from a first position where a first gap is defined between upper portions of the first and second paddles to a second position where a second gap is defined between the upper portions of the first and second paddles. The first gap is larger than the second gap.

[0038] In some configurations, the first and second paddles are moved from the first position to the second position by the upper surface moving downwardly from the first position to the second position.

[0039] In some configurations, the mask seal includes a forward facing surface and a rearward facing surface connected by a sidewall.

[0040] In some configurations, a portion of the rearwardly facing surfaces of the first and second paddles has a lesser thickness than a portion of the forwardly facing surfaces of the first and second paddles.

[0041] In some configurations, a portion of a rearwardly facing surface of the central chin region of the mask has a thickness that is less than a thickness of a portion of a laterally outer rearwardly facing surface of the central chin region.

[0042] In some configurations, an interface for use in providing positive airway pressure therapy is provided. The interface includes a mask assembly including a mask seal and a mask base. The mask assembly is configured to be positioned entirely below the bridge of the nose on a user's face, the mask assembly configured to provide exposure of the user's nasal tip. The mask base includes a central portion and a pair of wings curving behind the central portion. The wings have a greater vertical extent than the central portion. A connector opening is formed in the central portion of the mask base. The mask seal is coupled to the mask base. The mask seal includes a thickened region adjacent the mask base. The mask seal includes at least one mouth opening in the lower portion and at least one nose opening in the upper portion. The at least one mouth opening is positioned opposite the connector opening, and the at least one nose opening is positioned in an anterior-posterior direction between the connector opening and the mouth opening. The mask seal includes a first paddle and a second paddle. The upper surface is positioned between the first paddle and the second paddle such that an upwardly open valley is defined by the first paddle, the upper support surface, and the second paddle. At least a portion of the at least one nasal opening is positioned in the upper surface within the valley. The first paddle includes a first pocket and the second paddle includes a second pocket. The first and second pockets are in fluid communication with a chamber defined in the mask assembly.

[0043] In some configurations, the mask seal is adapted to seal under the user's nose, along a portion of the user's face adjacent the nose, and around the user's mouth.

[0044] In some configurations, the mask assembly is configured so as not to cover any forward facing portions of the user's nose.

[0045] In some configurations, the upper surface hangs in a hammock-like manner between inner portions of the first and second paddles.

[0046] In some configurations, downward pressure against the upper surface causes the first and second paddles to deflect toward each other.

[0047] In some configurations, the seal member includes a rear surface adapted to contact a user's face, the rear surface including a first protrusion and a second protrusion.

[0048] In some configurations, at least a portion of the first protrusion and at least a portion of the second protrusion are vertically positioned between the upper surface and a top of the at least one mouth opening.

[0049] In some configurations, a portion of the first protrusion includes a first tip and a portion of the second protrusion includes a second tip.

[0050] In some configurations, the first tip and the second tip are positioned vertically between a portion of the at least one nasal opening and the at least one oral opening.

[0051] In some configurations, the first tip and the second tip are positioned vertically closer to the at least one nasal opening than to the at least one oral opening.

[0052] In some configurations, the mask seal is adapted to anchor in two positions on the face.

[0053] In some configurations, the mask seal is configured to anchor below the lower lip and below the nose.

[0054] In some configurations, the mask seal is configured to anchor below the lower lip but above the chin and below the nose.

[0055] In some configurations, the two locations are below the bottom of the nose, but the mask seal extends above and beyond the bottom of the nose.

[0056] In some configurations, the mask seal is adapted to seal against the face at a vertical position above the uppermost anchoring position.

[0057] In some configurations, the upper surface slopes downwardly and rearwardly in the area surrounding the at least one nasal opening.

[0058] In some configurations, at least one nasal opening includes a nose pad insert.

[0059] In some configurations, the nose pad inserts are formed of a different material than the mask seal.

[0060] In some configurations, the nose pad insert is secured to the mask seal at a concave pad support area.

[0061] In some configurations, the nose pad insert and the mask seal include interrelated keying features.

[0062] In some configurations, the nose pad insert and the mask seal have a sealing joint that generally circumscribes the at least one nasal opening.

[0063] In some configurations, the nose pad insert includes a concave central portion.

[0064] In some configurations, the concave central portion is positioned generally forward of the at least one nasal opening.

[0065] In some configurations, the outer periphery of the first and second paddles has an increased hardness as compared to the inwardly facing portions thereof.

[0066] In some configurations, the outer circumferential portion has an increased thickness as compared to the inwardly facing portions of the first and second paddles.

[0067] In some configurations, the first paddle includes a first ridge positioned between the outward facing surface and the inward facing surface and the second paddle includes a second ridge positioned between the outward facing surface and the inward facing surface, the first and second ridges having an increased stiffness compared to the inward facing surface.

[0068] In some configurations, the first paddle includes a first ridge positioned between the outward facing surface and the inward facing surface and the second paddle includes a second ridge positioned between the outward facing surface and the inward facing surface, the first and second ridges having an increased thickness relative to the inward facing surface.

[0069] In some configurations, the interface includes a headgear assembly adapted to provide a slight upward force application between the mask assembly and the user's face.

[0070] In some configurations, the headgear assembly is configured to adjust the angle of the mask assembly.

[0071] In some configurations, the headgear does not include a T-piece.

[0072] In some configurations, the mask assembly and headgear assembly are configured such that no part of the mask assembly or headgear assembly contacts the user's face at any position vertically above the eyes or horizontally between the outer sides of the eyes.

[0073] In some configurations, the mask assembly includes at least one nasal prong.

[0074] In some configurations, at least one nasal prong is angled toward an inner vertical surface of the mask assembly.

[0075] These and other features, aspects, and advantages of embodiments of the present invention are described with reference to the following drawings. [Brief description of the drawings]

[0076] [Figure 1] FIG. 1 is a front view of a user wearing an interface arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Diagram 2] FIG. 2 is a side view of a user wearing the interface of FIG. 1. [Diagram 3] FIG. 2 is a perspective view of a mask seal and a mask seal clip of the interface of FIG. 1; [Figure 4] FIG. 4 is a side view of the mask seal and mask seal clip of FIG. 3. [Diagram 5] FIG. 4 is a rear perspective view of the mask seal clip of FIG. 3. [Figure 6] FIG. 4 is a rear elevational view of the mask seal clip of FIG. 3. [Figure 7] FIG. 4 is a side elevational view of the mask seal clip of FIG. 3. [Figure 8] FIG. 4 is a top plan view of the mask seal clip of FIG. 3. [Figure 9] FIG. 4 is a front elevational view of the mask seal and mask seal clip of FIG. 3. [Figure 10] FIG. 4 is a rear elevational view of the mask seal and mask seal clip of FIG. 3. [Figure 11] FIG. 4 is a side elevational view of the mask seal and mask seal clip of FIG. 3. [Figure 12A] FIG. 4 is an enlarged cross-sectional view of a portion of the mask seal and mask seal clip of FIG. 3. [Figure 12B] FIG. 4 is an enlarged cross-sectional view of a portion of the mask seal and mask seal clip of FIG. 3. [Figure 12C] FIG. 4 is an enlarged cross-sectional view of a portion of the mask seal and mask seal clip of FIG. 3. [Figure 12D] FIG. 4 is an enlarged cross-sectional view of a portion of the mask seal and mask seal clip of FIG. 3. [Figure 13] FIG. 2 is an exploded front perspective view of the mask seal, mask seal clip and mask base of the interface of FIG. 1. [Figure 14] FIG. 14 is a cross-sectional view of the mask seal, mask seal clip and mask base of FIG. 13. [Figure 15] FIG. 14 is a side elevational view of the mask seal, mask seal clip and mask base of FIG. 13. [Figure 16] FIG. 14 is a top plan view of the mask seal, mask seal clip and mask base of FIG. 13. [Figure 17] FIG. 2 is a perspective view of the connection port assembly of FIG. 1. [Figure 18] FIG. 18 is a side elevational view of the connection port assembly of FIG. 17. [Figure 19] FIG. 18 is a rear elevational view of the connection port assembly of FIG. 17. [Figure 20] FIG. 18 is a cross-sectional side elevation view of the connection port assembly of FIG. 17. [Figure 21] FIG. 18 is a cross-sectional perspective view of the connection port assembly of FIG. 17. [Figure 22] FIG. 2 is a perspective view of the clip assembly of FIG. 1. [Figure 23] 23 is a cross-sectional view of the clip assembly of FIG. 22. [Figure 24] 13 is a cross-sectional view similar to that of FIG. 12 showing a mask seal configured to roll under a portion of the mask seal clip 112. FIG. [Diagram 25] 15 is a cross-sectional view similar to that of FIG. 14, where the mask seal clip is reduced in size; [Figure 26] 15 is a cross-sectional view similar to that of FIG. 14, but omitting the mask seal clip. [Figure 27] 15 is another cross-sectional view similar to that of FIG. 14, but omitting the mask seal clip. [Figure 28] FIG. 1 is a graph showing the relationship of load (or force) on a user's body as a function of mask extension. [Figure 29] FIG. 3 is a perspective view of a backbone that fits into the headgear assembly of FIGS. 1 and 2. [Diagram 30] FIG. 30 is an enlarged view of the end region of the lower arm of FIG. 29. [Diagram 31] FIG. 31 is an enlarged cross-sectional view of the end region of FIG. 30. [Diagram 32] FIG. 1 is a perspective view of a mask assembly including a mask, clips, and straps. [Diagram 33] FIG. 33 is a side view of one of the two clips of FIG. 32. [Diagram 34] FIG. 34 is an exploded view of the clip of FIG. 33. [Diagram 35] FIG. 34 is a top view of the inner catch of the clip of FIG. 33. [Diagram 36] FIG. 13 is a front view of a mask base with two mounting posts and one inner catch of a clip attached to the left mounting post. [Figure 37] FIG. 13 is a front view of an alternative mask base configuration having two mounting posts and an alternative clip configuration mounted on the left mounting post of the mask base. [Figure 38] Another configuration of clip and associated mask and mounting post. [Figure 39] Another configuration of clip and associated mask and mounting post. [Diagram 40] Another configuration of clip and associated mask and mounting post. [Diagram 41] Another configuration of clip and associated mask and mounting post. [Diagram 42] Another configuration of clip and associated mask and mounting post. [Diagram 43] Another configuration of clip and associated mask and mounting post. [Diagram 44] Another configuration of clip and associated mask and mounting post. [Diagram 45] Another configuration of clip and associated mask and mounting post. [Diagram 46] Another configuration of clip and associated mask and mounting post. [Figure 47] Another configuration of clip and associated mask and mounting post. [Figure 48] FIG. 13 is a side view of a swivel assembly in another configuration. [Figure 49] FIG. 49 is an exploded view of the swivel assembly of FIG. 48. [Figure 50] FIG. 50 is a cross-sectional view taken along line 50-50 of FIG. 48. [Figure 51] FIG. 51 is a cross-sectional view taken along line 51-51 of FIG. 48. [Figure 52] FIG. 30 is a side view of the backbone of FIG. 29 attached to a user's head. [Diagram 53] FIG. 30 is a rear perspective view of the backbone of FIG. 29 attached to a user's head. [Figure 54] FIG. 2 is a front elevational view of a mask arrangement positioned on a user's face. [Figure 55] FIG. 55 is a cross-sectional view of the mask configuration taken along line 55-55 of FIG. 54. [Figure 56] FIG. 55 is a perspective view of the mask configuration of FIG. [Figure 57] FIG. 55 is a rear perspective view of the mask configuration of FIG. [Figure 58] FIG. 55 is a rear view of the mask configuration of FIG. [Figure 59] FIG. 55 is a rear view of a mask configuration having a different mask seal compared to the mask configuration of FIG. 54. [Figure 60] FIG. 60 is a rear perspective view of an alternative mask configuration having a different mask seal compared to the mask configurations of FIGS. 54 and 59. [Figure 61] FIG. 55 is a side elevational view of the mask configuration of FIG. [Figure 62] 62 is a cross-section taken along line 62-62 of FIG. [Figure 63] FIG. 55 is a rear view of the mask seal of the mask configuration of FIG. [Figure 64] FIG. 55 is a side view of the mask seal of the mask configuration of FIG. [Figure 65] FIG. 55 is a front view of the mask seal of the mask configuration of FIG. [Figure 66] FIG. 13 is a front view of an alternative mask configuration. [Figure 67] FIG. 67 is a perspective view of the mask arrangement of FIG. 66 with the headgear assembly attached. [Figure 68] FIG. 68 is a side view of the mask arrangement and headgear assembly of FIG. [Figure 69] FIG. 70 is a rear perspective view of the mask arrangement and headgear assembly of FIG. [Figure 70] FIG. 2 is a perspective view of a user's face. [Figure 71]FIG. 1 is a front view of the mask arrangement shown in proper position relative to a user. [Figure 72] FIG. 1 is a perspective view of a mask arrangement shown in proper position relative to a user. [Figure 73] FIG. 72 is a front view of the mask arrangement of FIG. 71, shown without the connector. [Figure 74] FIG. 72 is a side view of the mask configuration of FIG. 71, shown without the connector. [Figure 75] FIG. 72 is a side cross-sectional view of the mask arrangement of FIG. 71. [Figure 76] FIG. 72 is a rear view of the mask configuration of FIG. 71. [Figure 77] FIG. 72 is a partially exploded front perspective view of the mask arrangement of FIG. 71. [Figure 78] FIG. 72 is a partially exploded rear perspective view of the mask configuration of FIG. 71. [Figure 79] FIG. 72 is a cross-sectional view of the mask configuration of FIG. 71. [Figure 80] FIG. 72 is a front view of the mask seal of the mask configuration of FIG. 71, showing various thickness regions. [Figure 81] FIG. 72 is a rear view of the mask seal of the mask configuration of FIG. 71 showing various thickness regions. [Figure 82] FIG. 72 is a side view of the mask configuration of FIG. 71 showing various thickness regions. [Figure 83] 82 is a cross section taken along the mask configuration of FIG. 71 at the height shown in the mask seal of FIG. 81. [Figure 84] 82 is a cross section taken along the mask configuration of FIG. 71 at the height shown in the mask seal of FIG. 81. [Figure 85] 82 is a cross section taken along the mask configuration of FIG. 71 at the height shown in the mask seal of FIG. 81. [Figure 86] 82 is a cross section taken along the mask configuration of FIG. 71 at the height shown in the mask seal of FIG. 81. [Figure 87] 82 is a cross section taken along the mask configuration of FIG. 71 at the height shown in the mask seal of FIG. 81. [Figure 88] 82 is a cross section taken along the mask configuration of FIG. 71 at the height shown in the mask seal of FIG. 81. [Figure 89] 72A-72D are diagrams of various headgear assemblies that can be used with the mask assembly of FIG. 71. [Figure 90] 72A-72D are diagrams of various headgear assemblies that can be used with the mask assembly of FIG. 71. [Figure 91] 72A-72D are diagrams of various headgear assemblies that can be used with the mask assembly of FIG. 71. [Figure 92] 72A-72D are diagrams of various headgear assemblies that can be used with the mask assembly of FIG. 71. [Figure 93] 72A-72D are diagrams of various headgear assemblies that can be used with the mask assembly of FIG. 71. [Figure 94] 72A-72D are diagrams of various headgear assemblies that can be used with the mask assembly of FIG. 71. [Figure 95] 72A-72D are diagrams of various headgear assemblies that can be used with the mask assembly of FIG. 71. [Figure 96] 72A-72D are diagrams of various headgear assemblies that can be used with the mask assembly of FIG. 71. [Figure 97] 72A-72D are diagrams of various headgear assemblies that can be used with the mask assembly of FIG. 71. [Figure 98] 72A-72D are diagrams of various headgear assemblies that can be used with the mask assembly of FIG. 71. [Figure 99] 72A-72D are diagrams of various headgear assemblies that can be used with the mask assembly of FIG. 71. [Figure 100] 72A-72D are diagrams of various headgear assemblies that can be used with the mask assembly of FIG. 71. [Figure 101] 72A-72D are diagrams of various headgear assemblies that can be used with the mask assembly of FIG. 71. [Figure 102] 72A-72D are diagrams of various headgear assemblies that can be used with the mask assembly of FIG. 71. [Figure 103] 72A-72D are diagrams of various headgear assemblies that can be used with the mask assembly of FIG. 71. [Figure 104] 72A-72D are diagrams of various headgear assemblies that can be used with the mask assembly of FIG. 71. [Figure 105] 72A-72D are diagrams of various headgear assemblies that can be used with the mask assembly of FIG. 71. [Fig. 106] 72A-72D are diagrams of various headgear assemblies that can be used with the mask assembly of FIG. 71. [Figure 107] 72A-72D are diagrams of various headgear assemblies that can be used with the mask assembly of FIG. 71. [Figure 108] 72A-72D are diagrams of various headgear assemblies that can be used with the mask assembly of FIG. 71. [Fig. 109] 72A-72D are diagrams of various headgear assemblies that can be used with the mask assembly of FIG. 71. [Figure 110] FIG. 13 is a front perspective view of another mask configuration. [Figure 111] FIG. 111 is a rear perspective view of the mask configuration of FIG. [Figure 112] FIG. 111 is a cross-sectional side view of the mask configuration of FIG. [Figure 113] FIG. 111 is a rear perspective view of the mask configuration of FIG. [Fig. 114] FIG. 114 is a cross-sectional view taken along the line indicated in FIG. 113. [Fig. 115] FIG. 114 is a cross-sectional view taken along the line indicated in FIG. 113. [Fig. 116] FIG. 114 is a cross-sectional view taken along the line indicated in FIG. 113. [Figure 117] FIG. 114 is a cross-sectional view taken along the line indicated in FIG. 113. [Fig. 118] FIG. 114 is a cross-sectional view taken along the line indicated in FIG. 113. [Figure 119] FIG. 114 is a cross-sectional view taken along the line indicated in FIG. 113. [Figure 120] FIG. 111 is a rear view of the mask configuration of FIG. 110 with various thickness regions indicated. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0077] 1 and 2, an interface 100 is shown in a suitable position relative to a user U. The interface 100 comprises an interface that can be used in the field of respiratory therapy. The interface 100 has particular utility in forms of positive airway pressure therapy. For example, the interface 100 can be used to administer continuous positive airway pressure ("CPAP") therapy. In addition, the interface 100 can be used with variable positive airway pressure ("VPAP") therapy and bilevel positive airway pressure ("BiPAP") therapy. The interface can be used with any suitable CPAP system.

[0078] The interface 100 may include any suitable mask configuration. For example, certain features, aspects and advantages of the present invention may find utility in a nasal mask, a full face mask, an oral-nasal mask, or any other positive pressure mask. The mask illustrated in FIG. 1 is a full face mask. The illustrated interface 100 generally includes a mask assembly 102, a connection port assembly 104, and a headgear assembly 106.

[0079] 13, the mask assembly 102 generally includes a mask seal 110, which may include a mask seal clip 112, and a mask base 114. As will be explained, the mask seal clip 112 preferably couples the mask seal 110 to the mask base 114. While the illustrated mask seal 110 and mask seal clip 112 are formed separately and secured together, in some configurations the mask seal 110 and mask seal clip 112 may be integrated into a single component. In some configurations the mask seal 110 is overmolded onto the mask seal clip 112.

[0080] 3, the mask seal clip 112 is relatively harder, stiffer or less flexible than the mask seal 110. In some configurations, the mask seal clip 112 is formed of a polycarbonate material. In some configurations, at least a portion of the mask seal clip 112 is formed of polycarbonate or other rigid or semi-rigid material. In some configurations, the mask seal clip 112 is at least partially formed of silicone or another suitable material. In such configurations, at least the silicone portion of the mask seal clip 112 may be formed to be relatively thick compared to the more flexible portions of the mask seal 110. The mask seal clip 112, in the illustrated configuration, provides structural support to the mask seal 110.

[0081] As shown in FIG. 14, the mask seal clip 112 may define a majority of the mask assembly 102. As shown, the illustrated mask base 114 overlies a majority of the mask seal clip 112. With reference to FIGS. 25-27, the mask assembly 102 may be configured in a variety of configurations as desired. For example, with reference to FIG. 25, the mask seal clip 112 extends only a limited amount from its interface with the mask seal 110. In the configuration illustrated in FIG. 25, the mask base 114 overlies at least a portion of the mask seal clip 112, while the mask seal clip 112 defines a very limited rim-shaped configuration around a portion of the mask seal 110.

[0082] With reference to FIG. 26, the mask seal clip itself is omitted and the mask seal 110 is overmolded directly onto the mask base 114. However, in some configurations, the mask seal 110 and the mask base 114 may be configured to allow the two components to be separated. For example, as shown in FIG. 27, the mask seal 110 may include a peripheral flange 111 while the mask base 114 may include a peripheral channel 115 that receives the peripheral flange 111, thereby allowing the mask seal 110 to be removably secured to the mask base 114. In some configurations, other suitable methods may be used to secure the mask seal 110 to the mask base 114. Additionally, the illustrated configuration of FIG. 27 shows an embodiment that does not include the mask seal clip 112; the mask seal clip 112 and the mask base 114 are assembled to the mask base 114.

[0083] With reference to FIG. 5, the illustrated mask seal clip 112 includes a substantially cup-shaped configuration. A proximal end 120 defines an open end of the illustrated mask seal clip 112, while a distal end 122 defines a generally closed end of the illustrated mask seal clip 112. In the illustrated configuration, the proximal end 120 is generally surrounded by a lip 124. The lip 124 is generally pentagonal when viewed from behind (see FIG. 5). As shown in FIG. 7, the wall 126 generally curves forward in an arcuate shape. This arcuate shape for the wall 126 provides the illustrated mask seal clip 112 with a three-dimensional configuration.

[0084] 7, the upper portion 130 of the illustrated mask seal clip 112 is generally arcuate in configuration. Additionally, this generally arcuate configuration of the illustrated mask seal clip 112 is configured to accommodate a larger nose, but not extend upwardly over the nose as far as the extent of the mask seal 110, as shown in FIGS.

[0085] 3, the upper portion 130 of the illustrated mask seal clip 112 preferably includes two arc dimensions. First, an arc length 132 may be defined along the upper end of the upper portion 130 of the illustrated mask seal clip 112. The arc length 132 may be defined between inflection points 134 that exist along the circumference of the illustrated mask seal clip 112.

[0086] 7, the upper portion 130 of the illustrated mask seal clip 112 also includes a side profile radius 136. As shown, the upper portion 130 may have a slightly increasing side profile radius 136, such that the radius increases slightly as the distance from the top increases. In some configurations, the upper portion 130 may include a substantially constant side profile radius 136 or a decreasing side profile radius. Advantageously, the slightly increasing side profile radius 136 provides an increased volume in the mask 100 adjacent the user's nose.

[0087] 3 and 6, the mask seal clip 112 preferably includes at least two recesses 140. In the illustrated configuration, the mask seal clip 112 includes two recesses 140 located on either lateral side of a generally vertical central plane CP (see FIG. 6). The generally vertical central plane CP preferably corresponds to the mid-sagittal plane of the user and divides the illustrated mask seal clip 112 into substantially mirror image halves. The two recesses 140 define two generally enclosed pockets in the illustrated mask seal clip 112. The illustrated recesses 140 include additional recesses 142 that are used to limit the amount of intrusion of the chamber defined by the mask assembly 102 into the nasal region while still providing sufficient separation distance for reasons discussed below.

[0088] The illustrated mask seal also includes a generally central passageway 144 defined by a wall 146. In the illustrated configuration, the wall 146 generally encloses the passageway 144. Preferably, the wall 146 is of generally cylindrical configuration and extends through the wall 126. Other configurations are possible.

[0089] 14, the mask seal 110 includes a flexible portion that extends away from the proximal end 120 of the mask seal clip 112. In the illustrated configuration, the mask seal 110 is overmolded onto the mask seal clip 112, such that the mask seal 110 and the mask seal clip 112 combine to form an integrated, preferably non-separable, assembly. In some configurations, attempts to separate the mask seal 110 and the mask seal clip 112 destroy the interface between the components and / or destroy one or both of the mask seal 110 and the mask seal clip 112. As described above, other assemblies can also be used to couple the mask seal clip 112 to the mask seal 110. However, the illustrated configuration advantageously results in a structure that is easy to clean and maintain.

[0090] 4, the mask seal clip 112 is preferably positioned to be generally flush with an inner rim 150 of the mask seal 110. In the illustrated configuration, the mask seal 110 includes a relatively small radius portion 152 that leads to an upper portion 154. The upper portion 154 of the mask seal 110 is configured to extend over the nose of the user. In some configurations, the upper portion 154 is configured to extend over the bridge of the user's nose.

[0091] The upper portion 154 connects with a lower portion 156 of the mask seal 110. The lower portion 156 extends laterally outward from the mask seal clip 112, as shown in FIG. 9. Additionally, the lower portion 156 wraps back and inward, as shown in FIGS. 4 and 10, respectively. Together, proximal to the full face mask assembly 102, the upper portion 154 and the lower portion 156 combine to define a face-contacting flange 160 (as shown in FIG. 10). The face-contacting flange 160 is configured to rest under the user's lower lip, extend along the outside of the mouth, extend upward along the cheekbones, and extend across the bridge of the user's nose. Thus, the illustrated face-contacting flange 160 defines a generally teardrop-shaped opening 162. When the mask assembly 102 is seated on the user's face, the flange 160 rests over the bridge of the user's nose, cheekbones, the outside of the mouth and under the lower lip. With the application of positive air pressure, the mask seal 110 expands and seals against the user's face, reducing or eliminating the possibility of leakage between the flange 160 and the user's face.

[0092] As indicated by the dashed lines in FIG. 11 , the upper portion 154 of the mask seal 110 is designed to roll over onto the outer surface 170 of the mask assembly 102. In the illustrated configuration, the outer surface of the mask seal 110 smoothly rolls against the outer surface of the mask seal clip 112, such that the outer surface of the mask seal clip 112 forms the support surface. In some configurations, the outer surface 170 over which the upper portion 154 rolls includes at least a portion of the outer surface of the mask seal clip 112. In some configurations, the outer surface 170 over which the upper portion 154 rolls includes substantially only the outer surface of the mask seal clip 112. In some configurations, the upper portion 154 rolls over another portion of the mask seal 110. In some configurations, the upper portion 154 rolls over the mask seal base 114.

[0093] With reference to FIG. 12, to assist the upper portion 154 in rolling, the upper portion 154 may have a varying thickness or varying stiffness. In the configuration shown in FIG. 12, the upper portion 154 includes a thick / thin / thick configuration. In other words, to encourage the upper portion 154 to roll in the area between the face contacting flange 160 and the small radius 152 proximate the mask seal clip 112, a region of reduced stiffness 172 may be incorporated. In the illustrated configuration, the region of reduced stiffness 172 is incorporated into the mask seal 110. The region of reduced stiffness 172 reduces or eliminates the possibility of the mask seal 110 buckling or deforming undesirably in areas other than the area where it is desired to roll.

[0094] While the illustrated configuration uses a region of reduced thickness, other means of providing the reduced stiffness region 172 may be used to encourage the seal member 110 to roll. For example, the material of the seal member 110 may be configured to have reduced stiffness using material selection or material properties. Additionally, a composite of materials may be used to provide a region of reduced stiffness or hardness. Furthermore, any suitable combination of techniques may be used. Nevertheless, the illustrated region 172 configured using reduced thickness provides a simple way to achieve the reduced stiffness region 172. Additionally, by adjusting the stiffness of the reduced stiffness region 172, the force required to encourage the region 172 to roll may be controlled, thereby controlling the force applied to the user's nose. For example, varying the stiffness may provide a gradual increase or decrease in resistance to movement over a range of motion.

[0095] When the upper portion 154 includes regions of reduced stiffness 172, it is believed that the upper portion 154 of the mask seal 110 has a tendency to bulge outward under internal pressure, such as that experienced during a positive pressure therapy regimen, and this bulging is caused by the regions of reduced stiffness 172 defining large areas of silicone that have no significant structure. With reference to Figures 4 and 12, to reduce the prevalence of bulging in the upper portion 154 and to provide a reinforced structure to the upper portion 154, one or more reinforcing components, such as bands 174, can be positioned along at least a portion of the upper portion 154. The bands 174 can be components that are formed of a harder material or that are characterized by increased stiffness relative to the silicone or other material that forms the mask seal 110. For example, a region of significantly increased thickness relative to the regions of reduced stiffness 172 (which region is formed of the same material that forms the mask seal 110) can be used to increase the stiffness of the one or more reinforcing components.

[0096] In some configurations, the band 174 may be a separately formed component that is at least partially encased in the material of the mask seal 110. In the illustrated configuration, the band 174 may be a unitary molded plastic component, or the mask seal 110 may be overmolded onto the band 174. In some configurations, the band 174 may be defined by a portion of the upper portion 154 that is stiffer than the surrounding areas. For example, without limitation, the band 174 may be defined by a portion of increased thickness, a portion of different material or material properties that result in increased stiffness, etc.

[0097] 9, the band 174 extends along at least a portion of the upper portion 154 of the mask seal 110. The upper portion 154 of the mask, when viewed from the front, includes an apex 180. The apex 180 may be defined as the tip, top and corner apex of the mask seal 110, which is positioned adjacent the user's nose in use. In the illustrated configuration, a first wall 182 and a second wall 184 converge toward the apex 180.

[0098] In some configurations, at least a portion of the first wall 182 and at least a portion of the second wall 184 are reinforced by one or more components or structures, such as bands 174. In the illustrated configuration, one or more reinforcing components, such as bands 174, reinforce at least a portion of the first wall 182 and at least a portion of the second wall 184. In some configurations, one or more reinforcing components, such as bands 174, reinforce at least a portion of the first wall 182, at least a portion of the second wall 184, and the top 180.

[0099] 9 , the illustrated band 174 has a first end 186 and a second end 188 opposite the first end 186. In some configurations, the band 174 may be formed separately from the mask seal clip 112 and attached to the mask seal clip 112 by one or more flexible components. In some configurations, the band 174 may be coupled to the mask seal clip 112 by a mechanical hinge structure. In the illustrated configuration, the first end 186 and the second end 188 are positioned on the same side of the hinge axis H as the apex 180. Preferably, the first end 186 and the second end 188 are spaced from the hinge axis H towards the apex 180.

[0100] As shown in FIG. 12, the bend 152 and stiffer regions (e.g., regions of thicker cross section) adjacent the reduced stiffness region 172 help the reduced stiffness region 172 begin to roll. In other words, a controlled buckling of the reduced stiffness region 172 occurs with the assistance of the stiffer adjacent portions. In addition, positioning the relatively stiffer edge of the mask seal clip 112 adjacent the bend 152 further helps encourage the reduced stiffness region 172 to roll. In some configurations, the reduced stiffness region 172 is surrounded by a first boundary and a second boundary, where the first boundary and the second boundary have a higher stiffness compared to the reduced stiffness region. In the illustrated configuration, for example, the first boundary is defined by or along with the band 174, while the second boundary is defined by or along with the bend 152. In some configurations, the second boundary may be defined by or along with the edge of the stiffer mask seal clip 112. In some configurations, the second boundary may be defined along a portion of the mask seal 110 that is positioned between the mask seal clip 112 and the region of reduced stiffness 172 .

[0101] As the upper portion 154 of the mask seal 110 changes position about the hinge axis H, the roll increases in size. In other words, initially, a roll is formed in the mask seal 110 by the first boundary moving toward the second boundary. As the first boundary continues to move toward the second boundary, the roll continues to increase in size. Thus, in the illustrated configuration of FIG. 11, the roll defined in the upper portion 154 starts from nothing and gradually increases as the position of the upper portion 154 changes as shown by the dashed line. Preferably, the rolling movement between the first boundary and the second boundary creates a single bend or inflection between the first boundary and the second boundary. This single bend creates a leg that approaches a bent position, and the leg increases in size as the first boundary moves toward the second boundary. In other words, this rolling movement created by the first boundary moving toward the second boundary preferably does not create a fan-folded appearance, such as a pleated configuration.

[0102] 3, the mask seal 110 may have a geometry that helps the reduced stiffness regions 172 to continue to roll easily after it begins to roll. The arc length may be generally defined as extending from a first intersection of the hinge axis H with the mask seal 110, up, over the upper portion 154 of the mask seal 110, and back down to a second intersection of the hinge axis H with the mask seal 110.

[0103] As shown in FIG. 3, the illustrated mask seal 110 includes at least a first arc length A (shown in dashed lines), a second arc length B (shown in dashed lines), and a third arc length C (shown along the base of the band 174). The first arc length A is preferably longer than the arc length of the mask seal clip 112 immediately adjacent to the first mask arc length A. The second arc length B is positioned between the first arc length A and the third arc length C, and the second arc length B is preferably shorter than the third arc length C and longer than the first arc length A. In some embodiments, the arc length gradually increases from the bend 152 or another region near the outer surface 170 proximally toward the band 174. In other words, the arc length generally increases as the angle α (see FIG. 4) increases from the first arc length A. In some configurations, the arc length may be substantially constant from front to back (i.e., as angle α increases); however, the increasing arc length away from where the roll begins causes the mask seal 110 to continue to roll over itself and onto the outer surface 170 as the apex 180 moves further distally, as shown in FIG. 11.

[0104] 4, the upper portion 154 of the illustrated mask seal 110 also includes varying radii when viewed from a side profile. As shown, R1>R2>R3. Thus, in the illustrated mask seal 110, the radius decreases with increasing angle from proximal to distal. In some configurations, the radius may not decrease in this manner; however, it is believed that the decrease in radius aids in the roll of the mask seal 110.

[0105] Additionally, the radius r1 of the mask seal clip 112 from the hinge point H is preferably less than the radius R3 of the mask seal 110. However, given the pliable nature of the mask seal 110, it is possible for the radii r1 and R3 to be substantially the same while still achieving the ability of the mask seal 110 to roll over onto the mask seal clip 112. However, in the illustrated configuration, an offset is provided by the difference between the radii r1 and R3. This offset provides the ability to slightly increase the side profile radius 136, as described above, without significantly affecting the ability of the mask seal 110 to roll over onto the mask seal clip 112. If the offset was not provided, the ability to increase the side profile radius 136 may be quite limited.

[0106] As discussed above, the flange 160 surrounds a generally teardrop-shaped opening 162. As is well known, hoop stress can be defined as the circumferential stress caused by internal pressure in a cylindrically shaped part. Thus, as the loops tend to expand, the hoop stress increases. It is believed that the hoop stress caused by seating the respirator may be the cause of some discomfort to the user, particularly in the area of ​​the nasal bridge. The lower portion 156 of the illustrated mask assembly 102 is generally fixed in place, while the nasal or upper portion 154 moves relative to the user's nose. The rolling action described above causes the illustrated full face mask assembly 102 to roll and move away from the nose, thereby reducing the occurrence of increased hoop stress, particularly around the nasal bridge. Thus, the rolling mask configuration provides a means of maintaining or reducing hoop stress when the mask is seated.

[0107] As discussed above and shown in FIG. 11, the upper portion 154 of the illustrated mask seal 110 rolls over onto the outer surface 170 in the illustrated configuration. The rollover onto the mask outer surface utilizes the positive pressure present within the full face mask assembly. This is because increased air pressure increases the mask seal's ability to roll over on itself (i.e., the air pressure reduces the surface tension between the two surfaces of the mask seal that slide against each other while rolling) and the slight swelling effect helps reduce the likelihood of the mask seal 110 buckling, creasing or undesired folding. Additionally, in some configurations, the outward rollover may provide a visual clue as to the degree or angle that the upper portion 154 of the mask seal 110 has moved relative to the lower portion 156 of the mask seal 110.

[0108] A visual indicator can be used to provide a user with a more effective indication of the amount the upper portion 154 of the mask has rolled. For example, in some configurations, a scale can be imprinted, embossed, or otherwise placed on or near the reduced stiffness region 172. In some configurations, the scale may be positioned along a portion of the mask 100 over which the reduced stiffness region 172 rolls. To increase fidelity, the scale is preferably positioned in a central location so that the amount the reduced stiffness region 172 has rolled may be maximized. The scale can be, for example, without limitation, a numerical scale or a color-graded scale.

[0109] In some configurations, a ratchet or locking mechanism may be integrated with the mask such that the reduced stiffness region 172 can be set to a desired roll point. For example, a ratchet mechanism with a series of teeth that engage a closure member (e.g., a zip-tie locking ratchet) may be used. This locking mechanism allows the upper portion 154 of the mask to be held in the proper position when the mask 100 is removed from the face of the user U as the position of the upper portion 154 changes about the hinge point. Preferably, the locking mechanism allows the upper portion 154 to be easily released from this locked position as desired, thus allowing the upper portion to relax into a better fit position if the mask moves too much. Thus, the user can set the amount the upper portion 154 rolls once and get the same amount of roll for each subsequent use.

[0110] As pressure is applied against the user's face by the mask flange 160, the upper portion 154 (i.e., the portion of the seal member that contacts the bridge of the nose) moves by rolling. In response to this movement, the force exerted by the upper portion 154 on the bridge of the nose is substantially constant, as compared to the broad range of pressure exerted by the lower portion 156 on the remainder of the user's face. Similarly, the force required to move the upper portion 154 is substantially constant. As shown in FIG. 28, in the illustrated configuration, for a full 25 mm positional change of the upper portion, the increase in force with that range of movement is less than about 0.5 N. Because the force on the nose is substantially constant for various ranges of angles and associated amounts of upper portion movement, the force on the bridge of the nose does not vary significantly at various headgear tension levels. Again, such results are shown in FIG. 28, where the total change in force for a range of 5 mm to 25 mm of movement at the apex 180 is a change in force of about 0.2 N. Additionally, the mask exerts a nearly constant force on the nose over a range of angles, allowing it to be adjusted to improve fit for a variety of facial geometries while reducing pressure on the sensitive bridge of the nose.

[0111] The use of a rolled configuration offers significant improvements when compared to structures featuring pleated geometries. First, rolling outward instead of folding into pleats reduces or eliminates the possibility of the mask seal material intruding into the chamber designed to contain the user's nose. Thus, rolling outward reduces the possibility of contact with the user's nose inside the chamber while the upper portion 154 moves relative to the lower portion 156. Second, rolling outward instead of folding into pleats provides a cleaner appearance and reduces the number of exterior voids, which is believed to improve the user's perception of the full face mask assembly compared to a pleated assembly.

[0112] With reference to FIG. 24, the illustrated mask seal 110 rolls over to the outer surface 170, however the mask seal may be configured to roll on the inside of the mask assembly. In other words, inward rollover may be used in some configurations. Inward rollover is less desirable than outward rollover because positive pressure tends to prevent rolling and the rolling action tends to intrude into the nose receiving chamber. On the other hand, inward rollover provides a cleaner appearance compared to outward rollover because any bulging of the seal member is contained within the mask seal clip.

[0113] 1 and 2, the mask assembly 102 includes a mask base 114, which is stiffer than the mask seal 110. The mask base 114 may be formed of any suitable material. In some configurations, the mask base 114 is formed of a polycarbonate material, which is therefore bendable for coupling with the mask seal 110 and / or the mask seal clip 112.

[0114] 14, the mask assembly 102 is shown with a mask base 114 secured to a mask seal 110. More specifically, in the illustrated configuration, the mask base 114 is secured to a mask seal clip 112 that is attached to the mask seal 110 in any suitable manner. In some configurations, the mask base 114 and the mask seal 110 or the mask seal clip 112 are releasably coupled. In some configurations, the mask base 114 is snapped together with one or both of the mask seal 110 and the mask seal clip 112. Preferably, the mask seal 110 and the mask seal clip 112 can be removed from the mask base 114, and a snap connection secures the mask seal clip 112 to the mask base 114.

[0115] 14 and 15, the illustrated mask base 114 is placed over at least a portion of the mask seal clip 112. In some configurations, the mask base 114 almost completely covers the mask seal clip 112. In some configurations, the mask base 114 extends over more than half of the mask seal clip 112. When the mask base 114 is placed over a substantial portion of the mask seal clip 112 or mask seal 110, a double layer effect is created (e.g., mask seal clip 112 and mask base 114). This double layer effect results in a higher shielding when a majority of the mask base 114 overlaps a majority of the mask seal clip 112 or mask seal 110. This higher shielding results in a warmer interior portion (e.g., mask seal 110 and / or mask seal clip 112), which results in less moisture rainout during use. Preferably, at least a portion of the mask seal clip 112 is exposed from the underside of the mask base 114, so that the mask base 114 can be more easily separated from the mask seal clip 112. 15, the illustrated mask base 114 includes a peripheral surface 200 at a proximal end to aid in separating the mask base 114 from the underlying mask seal 110 and / or mask seal clip 112. The mask base 114 is concave on the inside to receive the underlying components. In other words, the mask base 114 is bowl-shaped in the distal direction relative to the proximal peripheral surface 200.

[0116] The peripheral surface 200 includes one or more recessed portions 202. Preferably, the recessed portions 202 include at least two recessed portions 202 positioned on opposite sides of the mask base 114. The recessed portions 202 are configured to receive a thumb and finger, so that the mask base 114 can be more easily removed from the front of the underlying mask seal clip 112. The recessed portions 202 may define a means for gripping an assembly that is placed under the mask base 114 to remove the mask base, although other configurations may be used, such as, but not limited to, extended tabs, protrusions, and the like. Additionally, although the illustrated recessed portions 202 are located on opposing lateral sides of the mask base 114, the recessed portions 202 may be positioned on the top and bottom, or in other areas, as desired.

[0117] As shown in Figure 13, the mask base 114 preferably includes an opening 210 defined by a wall 212. With reference to Figure 14, which is a cross section through the mask seal 110, the mask seal clip 112, and the mask base 114, the wall 212 defining the opening 210 through the mask base 114 preferably fits within the wall 146 defining the passageway 144 through the mask seal clip 112. As shown in Figure 14, the wall 212 may be axially coextensive with the wall 146. Additionally, the size and shape of the walls 146, 212 may be such that they interact with one another to reduce relative slippage between the walls 146, 212 and reduce the likelihood of the mask seal base 114 being inadvertently separated from the mask seal clip 112. In some configurations, the walls 146, 212 fit together to reduce the likelihood of leakage through the joint between the walls. Preferably, a taper lock secures the walls 146, 212 together.

[0118] 14, the wall 212 includes a contoured inner surface 214. The contoured surface 214 may be radiused to receive a ball end 220 of a swivel elbow 222 as shown in FIG. 17. As better shown in FIG. 18, the ball end 220 has a contoured surface 224 that can snap into the contoured surface 214 formed in the mask base 114. This connection between the two contoured surfaces 214, 224 allows the surfaces to slide relatively freely over one another, thus allowing the position of the swivel elbow 222 to be easily changed. In some configurations, the elbow 222 may be configured to rotate or pivot without having a ball joint configuration.

[0119] 13, the mask base 114 also includes at least two pockets 230. The illustrated mask base 114 includes two pockets 230. The pockets 230 are recessed into and protrude rearwardly from the mask base 114. The pockets 230 are received in recesses 140 in the mask seal clip 112. An opening 232 defined by a peripheral wall 234 overlies a further recess 142 formed in the mask seal clip 112.

[0120] The illustrated pockets 230 are formed such that one pocket 230 is formed on each lateral side of the mask base 114. The pockets 230 may be positioned symmetrically about a central plane CP, which plane substantially bisects the mask base 114. In some configurations, the pockets 230 have an elongated vertical dimension 240 compared to a lateral dimension 242, as shown in FIG. 15. Similarly, the openings 232 have an elongated vertical dimension 244 compared to a lateral dimension 246, as shown in FIG.

[0121] In the illustrated mask base 114, the laterally inner portion of each pocket 230 includes a support wall 250. The support wall 250 is positioned toward the center plane CP relative to a normal to the bottom surface 248 of the pocket 230. Each of the pockets 230 is configured to receive a clip 252 (see FIG. 22 ). When the clip 252 is seated within the pocket 230, the support wall 250 helps to limit rotation of the clip 252 relative to the pocket 230. Additionally, the large vertical dimension helps a user locate the pocket 230 with the clip 252 during seating.

[0122] With reference to FIG. 22, the clips 252 may have a two-piece construction with an outer cover 254 and an inner catch 256. A strap 260 may be secured to each clip 252 in any suitable manner. One suitable configuration is illustrated in FIG. 2. In some configurations, the strap 260 may be sandwiched between the outer cover 254 and the inner catch 256. In some configurations, the clips 252 may be provided with loops or openings or holes through which the strap 260 is threaded. Preferably, one clip 252 may be coupled to both the upper and lower straps of the headgear assembly 106. Such a configuration facilitates easy coupling and uncoupling of the headgear assembly 106 to and from the full face mask assembly 102.

[0123] 23, the clip 252 includes an angled surface 262. The angled surface 262 may be positioned on the outer cover 254. The angled surface 262 cooperates with the support wall 250 to help orient the clip 252 relative to the pocket 203 of the mask base 114.

[0124] The clip 252 includes an interlocking feature 264 configured to be inserted into an opening 232 defined in the pocket 230 of the mask base 114. The interlocking feature 264 can be snap-fit ​​engaged with a tab 236 defined along a wall 234 defining the opening 232 of the mask base 114, as shown in Figure 13. Other interlocking schemes between the clip 252 and the pocket 230 can also be used.

[0125] 23, the interlocking mechanism 264 of the illustrated clip 252 includes a U-shaped component 268 terminating in a release lever 266. The U-shaped end 268 protrudes a sufficient distance to allow for coupling with the tab 236, but not so far that the bottom surface of the further recess 142 of the mask seal clip 112 can prevent proper insertion of the interlocking mechanism 264 into the opening 232. During coupling of the clip 252 to the mask base 114, the U-shaped end 268 initially contacts the wall of the opening 232. In the illustrated configuration, the U-shaped end 268 contacts the wall 234 of the opening 232 during insertion, which guides the clip 252 into the proper position within the pocket 230. During coupling of the clip 252 to the mask base 114, the opening 232, or one or more surfaces defining the opening 232, generally aligns the clip 252 with the mask base 114.

[0126] An end of the release lever 266 projects through an opening 270 defined by a wall 272. Preferably, the end of the release lever 266 projects through the opening 270 a sufficient distance to allow easy manipulation of the release lever 266. Moving the release lever 266 to close the U-shape of the interlock mechanism 264 allows the interlock mechanism 264 to disengage from a tab 236 on the wall 234 that defines the opening 232 in the mask base 112.

[0127] 32-39 illustrate further configurations of clip assemblies 252 configured to secure the mask assembly 102 to the head of a user. The clips 252 of FIGS. 32 and 33 have, for example, raised edges 400 (sometimes referred to as finger tabs 400) that allow a user to easily detach the headgear 106 from the mask assembly 102. The raised edges 400 are oriented such that a user can simply pull them back to pop out the clips 252 of the mask base 114. Once one or more clips 252 are disengaged from the mask base 114, the mask assembly 102 can be easily removed from the user's head. The raised edges 400 provide a gripping point during installation and removal of the headgear 106 from the mask assembly 102. For example, a user's thumb and index finger can be placed on either side of the raised edges 400 while removing the clips 252 from the mask assembly 102. Additionally, the user may grasp and maintain grip on clip 252 throughout the entire process of donning the mask, thereby avoiding the need to grip strap 260 during assembly. It also allows the user to attach clip 252, remove it, and reinstall it while maintaining a grip on raised edge 400.

[0128] Figure 34 shows an exploded view of the clip 252 of Figures 32 and 33. The clip 252 includes an outer cover 254 and an inner catch 256. The inner catch 256 includes one or more slots 402 that receive the distal ends of the headgear straps 260. The inner catch 256 may also include a number of pressure bumps, such as those shown in connection with the configurations of Figures 38 and 39. The pressure bumps provide additional pressure against the outer cover 254 and the inner catch 256, thereby securing them together. In one configuration, the headgear straps 260 are removable from the assembled clip 252.

[0129] The inner catch 256 includes an elongated slot 404, as shown in FIG. 38. The slot 404 includes a circular opening 406 having a diameter greater than the width of the slot 404. The slot 404 and the circular opening 406 may include chamfered recesses that aid in aligning the clip 252 with the mask assembly 102. The circular opening 406 facilitates attachment and detachment of the clip 252 to the mask assembly 102, as will be discussed in further detail below. Two channels 408 extend parallel to the sides of the slot 404, thereby defining slot walls 410 (sometimes referred to as clip levers) on either side of the slot 404. The channels 408 are sized to allow the slot walls 410 to flex sufficiently during attachment and detachment of the clip 252 to the mask assembly 102. Additionally, the slot walls 410 extend vertically along the longest dimension of the inner catch 256, allowing for a longer slot wall 410 to be used. The longer the slot walls 410, the lower the stress levels they are subjected to when the clip is fitted onto the mounting post.

[0130] One configuration of a mask base 114 suitable for use with the clip 252 of Figures 32-35 is shown in Figure 36. The mask base 114 includes two recesses 140 symmetrically positioned on either side of the mask base 114. Within each recess 140, a mounting post 412 extends from the body of the mask base 114. The mounting post 412 may be integrally formed with the mask base 114 or may be formed separately and secured to the mask base 114. The mounting post 412 may have a mushroom-shaped configuration such that when a user snaps the clip 256 into place, the clip 256 is secured to the mask base 114. The rounded top of the spherical mushroom-shaped post 412 helps to position and orient the central hole 406. As the clip 252 is pressed against the post 412, the slot walls 410 flex outwardly, away from the post 412. When the head of the post 412 passes the edge of the slot wall 410, the slot wall 410 rebounds back to its original position, thereby providing tactile, and sometimes audible, feedback that the clip 252 is properly attached to the mask assembly 102.

[0131] The mounting post 412 may also include an elongated oval raised portion 414 (sometimes referred to as a lug or wing) sized to mate with the elongated slot 404 of the inner catch 256. The elongated raised portion 414 includes a chamfered edge that helps to properly align the headgear 106 with the mask assembly 102. The portion 414 also prevents the clip 252 from rotating with respect to the mask assembly 102. This helps to ensure constant tension on the headgear straps 260 while the user is sleeping.

[0132] 37 shows a partial assembly of yet another configuration for securing the clip 252 to the mask base 114 of the mask assembly. The clip 252 seats within a recess 140 in the mask base 114. Within the recess 140, a cylindrical button-head style post 412 extends from a surface of the mask base 114. The post 412 allows slight rotation of the clip 252 when attached to the clip 252 due to its cylindrical configuration. However, as shown in FIGS. 38 and 39, the slot 404, channel 408 and slot walls 410 extend along the shorter planar direction of the inner catch 256 toward its front and rear ends.

[0133] The inner catch 256 also includes a number of pressure bumps 414. As discussed above, the pressure bumps provide additional pressure to the outer cover 254 and the inner catch 256, securing them together.

[0134] Further configurations of the clip 252 are illustrated in Figures 40-47. The clip 252 of Figure 40 includes three elongated oval slots 404 and a finger tab 400. The finger tab 400 is used to create a lever for releasing the clip 252 from the mask assembly 102. The central slot 404 is sized to receive a mounting post 412 extending from the outer surface of the mask body. One such suitable mounting post 412 is illustrated in Figure 43. The mounting post 412 includes a ridge 414 and two slots 416. The slots 416 provide spacing so that as the clip 252 is pressed against the mounting post 412, the outer portions of the post 412 bend towards each other. As the ridges 414 clear the top surface of the clip 252, the mounting post 412 springs back to its original position, and the ridges 414 lock the clip 252 in place.

[0135] A similar configuration is illustrated in Figures 44-47. The clip 252 of Figure 45 does not include finger tabs and its central opening 404 has a rounder, more oval shape compared to the elongated slot of Figures 40-44.

[0136] All of the above configurations simplify the process of securing the mask assembly 102 to the user's head. For example, the clips 252 allow the headgear 106 to unfold rather than be in a closed loop. When the headgear 106 unfolds, the user can wrap it around their head without having to forcefully pull their head through the headgear 106.

[0137] 2, in addition to strap 260, headgear assembly 106 also includes rear strap 280 and top strap 282. Other headgear assemblies may also be used. Rear strap 280 extends around the back of user U's head at a location generally above the nape of the neck but generally below the occipital protuberance. At a location behind the user's ear, rear strap 280 bifurcates into upper arm 284 and lower arm 286. Upper arm 284 arcs upward to a location above the user's ear and then arcs downward to a location generally in front of the user's ear. Lower arm 286 arcs downward to a location generally below the user's ear and extends slightly in front of the ear.

[0138] The strap 260 may be connected to the rear strap 280 in any suitable manner. In the illustrated configuration, the strap 260 is connected to each of the upper and lower arms 284 and 286. Preferably, the upper and lower arms 284 and 286 are stiffer than the strap 260, so that the arms 284, 286 generally maintain their shape when the headgear assembly 106 is being worn. In some configurations, each of the upper and lower arms 284, 286 supports its own weight. In some configurations, each of the upper and lower arms 284, 286 is structured to not tangle when worn. For example, the arms 284, 286 have sufficient torsional stiffness to reduce the likelihood of twisting while being worn.

[0139] Preferably, the strap 260 connects to at least one of the upper arm 284 and the lower arm 286 at a location in front of the ears. Such a configuration helps the user to locate the strap 260 without much difficulty. In addition, since the strap 260 in the illustrated configuration fits into the clip 252, the ends of the upper arm 284 and the lower arm 286 may include slots 290, 292 through which the strap 260 can be threaded. In addition, the strap 260 may include an adjustment mechanism 294, such as a Velcro or buckle configuration. The adjustment mechanism 294 allows for adjustment of the force between the mask seal 110 and the face of the user U. Any suitable adjustment mechanism 294 may be used.

[0140] 2, the upper strap 282 is preferably flexible and has an adjustable length. The upper strap 282 connects to the upper arm 284 via a slot 296 to reduce the chance of the upper arm 284 slipping off the user's head and contacting the user's ear. Preferably, the upper strap 282 connects to the upper arm 284 at a location that is generally above the user's ear.

[0141] 1 and 2, strap 260 exerts a force in the direction of arrow F while coupling to mask base 114 with movement in direction C (which is approximately normal to the direction of force F). In other words, strap 360 is pulled forward under tension, and movement in a direction perpendicular to the forward pull couples clip 252 to mask base 114. Such a configuration facilitates securing of interface 100 to a user's face.

[0142] In another configuration, the headgear assembly 106 includes semi-rigid headgear 380 (as shown in FIG. 29) to secure the mask assembly 102 to the user's head. The semi-rigid headgear 380 is formed as a composite structure including semi-rigid straps 382 joined to flexible edging 384. For example, the flexible edging 384 can be bonded to the semi-rigid straps 382 by plastic overmolding or by use of adhesive. As shown in FIG. 29, the flexible edging 384 can be butted and joined to the semi-rigid straps 382 without overlapping the semi-rigid straps 382, ​​maintaining a continuous shape of the semi-rigid headgear 380. The semi-rigid straps 382 define and maintain the shape of the semi-rigid headgear as tension is applied from the straps 260 and the mask assembly 102 is drawn towards the user's head. In other words, the semi-rigid strap 382 is sufficiently stiff along its planar axis to prevent excessive deformation of its upper and lower arms 284, 286 under tension. The semi-rigid strap 382 can be made of a variety of rigid or semi-rigid materials, including plastic or metal. In some configurations, the semi-rigid strap 382 is made of PVC.

[0143] It has been found that, particularly with respect to semi-rigid headgear assemblies, shape-retaining or self-supporting properties can make the entire assembly intuitive to don. In particular, where the connecting members and / or headgear members are self-supporting to maintain a three-dimensional shape, the headgear can be donned in the correct orientation with very little, if any, guidance. The self-supporting configuration also reduces the time it takes to don the entire assembly, as the straps tend not to become tangled.

[0144] As used herein, the term "semi-rigid" refers to a headgear assembly that is sufficiently rigid so that the headgear assembly 380 can assume a three-dimensional shape with dimensions that approximate the head of a patient for whom the headgear is designed, while also being sufficiently flexible to generally conform to the anatomical shape of the patient. For example, some of the other components of the headgear assembly 380 (e.g., arms or straps) may also be partially or entirely "semi-rigid" such that they are capable of retaining a substantially self-supporting three-dimensional form. A "semi-rigid" headgear assembly is not intended to mean that each and every component of the headgear assembly is necessarily semi-rigid. For example, the substantially three-dimensional form that the self-supporting headgear assembly 380 may assume may primarily relate to the rear and top of the headgear assembly 380. Additionally, the semi-rigid headgear assembly 380 may include semi-rigid regions that extend in front of and above the ears when placed on a patient's head.

[0145] The left and right upper and lower arms 284, 286 may likewise be formed of a semi-rigid material. As used herein, semi-rigid materials may include molded plastic or sheet materials, including but not limited to homogenous plastic materials and bonded nonwoven fibrous materials.

[0146] In some configurations, one or more of the arms or straps are formed of a substantially inelastic material. The arms or straps may be formed of a semi-rigid, self-supporting material such that the semi-rigid headgear assembly 380 can assume a substantially three-dimensional shape and is generally tangle-free. In some configurations, the material may include, for example and without limitation, a laminated structure of both conformable and semi-rigid portions. The semi-rigid straps 382 may be a self-supporting, resilient, substantially inelastic material such as, but not limited to, Santoprene, polyolefin, polypropylene, polyethylene, expanded polyolefin, nylon, or non-woven polymeric material. In some configurations, the semi-rigid straps 382 are formed of a polyethylene or polypropylene system. The material may be a low density polyethylene such as Dowlex 2517. Dowlex 2517 is a linear low density polyethylene with a tensile yield strength of 9.65 MPa, a tensile break strength of 8.96 MPa, and a flexural modulus-2% secant of 234 MPa. The semi-rigid straps 382 are preferably formed from a material such that the semi-rigid headgear 380 is substantially shape-persistent under its own weight regardless of its orientation. In some configurations, the semi-rigid straps 382 do not stretch more than about 6 mm when subjected to a tensile load of 30 N. In some configurations, the semi-rigid straps 382 do not stretch more than about 3 mm when subjected to a tensile load of 30 N.

[0147] In some configurations, the semi-rigid straps 382 are formed of a nonwoven polyolefin (NWP) that is combined (e.g., overmolded or laminated) with a polyolefin. In such configurations, the overmolded polyolefin material provides the primary shape retention properties. Additionally, the softer NWP material conforms to contact the skin and provides a desired level of comfort. Furthermore, the NWP material may help provide desired load bearing properties, such as desired tensile load resistance properties.

[0148] The semi-rigid headgear 380 is generally formed of a semi-rigid material. As used herein, semi-rigid materials may include molded plastic or sheet materials, including, but not limited to, homogenous plastic materials and bonded nonwoven fibrous materials. The upper and lower arms 284, 286 are integrally formed with and part of the semi-rigid headgear 380, so that the arms 284, 286 also comprise such a semi-rigid material. Preferably, the left and right lower arms 286 are formed as a unitary component that may encircle the back of the patient's head and extend above the neck in use.

[0149] A flexible border 384 covers or is attached to at least a portion of the periphery of the semi-rigid straps 382. In one configuration, the flexible border 384 does not cover the front or back of the semi-rigid straps 382. For example, the thickness of the flexible border 384 and the semi-rigid straps 382 may be the same where they are joined together.

[0150] The flexible edging 384 provides a soft, comfortable interface between the perimeter of the semi-rigid strap 382 and the user's skin. The flexible edging 384 can be made of a variety of flexible materials, including but not limited to plastic, elastomer, silicone, or thermoplastic polyurethane (TPU) plastic. The flexible edging 384 can have a Shore hardness ranging from 10 to 80 Shore A.

[0151] As used herein in relation to headgear and straps, "flexible" is used to describe the feel of the material, which refers to the quality of the material as assessed by the response obtained from the sense of touch. Additionally, as used herein in relation to headgear and straps, "conformable" is used to describe the ability of the material to conform to the anatomical features of the patient (e.g., around facial features). In particular, straps comprising at least an element of "flexible" and / or "conformable" material may also be "semi-rigid" and / or axially inelastic.

[0152] The flexible edging 384 may have a uniform thickness, or in some configurations, may have a non-uniform thickness. For example, in some configurations the flexible edging 384 is the same thickness as the semi-rigid straps 382. In other configurations the flexible edging 384 is thinner than the semi-rigid straps 382, ​​forms a bulbous end to the semi-rigid straps 382, ​​or is simply thicker than the semi-rigid straps 382. Various cross-sectional views of the semi-rigid headgear 380 are shown in FIG. 29. Each cross-sectional view (A-A' through F-F') shows one possible configuration of the thickness of the semi-rigid straps 382 and flexible edging 384, which may be combined as desired. For example, any one particular flexible edging 384 thickness and shape may be applied to a portion or the entirety of the semi-rigid straps 382, ​​or may be combined with any other particular coating thickness and shape shown in FIG. 29.

[0153] Many other thickness configurations may be provided as well. Additionally, material thickness may be applied symmetrically or asymmetrically to the semi-rigid straps 382. For example, cross sections C-C' and F-F' are shown as being asymmetric; however, in other configurations the thickness at both ends of the flexible edging 384 is applied symmetrically to the semi-rigid straps 382. In some configurations, the semi-rigid straps 382 are selectively thickened to provide additional stiffness and support. For example, the second of the two configurations illustrated as cross section F-F' is thickened in this manner. Finally, in some configurations, ventilation through-holes 396 are provided throughout the semi-rigid headgear 380 (such as to the semi-rigid straps 382 as shown in FIG. 29 or to the flexible edging 384) to provide ventilation and sweat management.

[0154] 29, the semi-rigid headgear 380 defines three C-shaped arcuate regions 386, 388, 390. Two ear surrounding regions 386, 388 are defined by upper arm 284 and lower arm 286, and a rear region 390 is defined by lower arm 286 and rear strap portion 280. The semi-rigid headgear 380 is flexible enough to flex and conform to the shape of the user's head such that the ear surrounding regions 386, 388 at least partially surround or encircle the user's ears, and the rear region 390 at least partially surrounds or encircles the back of the user's head and upper neck.

[0155] The curvature of each arm 280, 284, 286 can be selected to provide a comfortable fit and ease of application and removal of the semi-rigid headgear 380 from the user's head. For example, in the illustrated configuration, the upper arm 284 has a concave curvature and the lower arm 286 has a convex curvature relative to the openings in the upper arcuate regions 386, 388 that encircle the ears. The rear strap portion 280 and the lower arm 286 all have concave curvatures relative to the openings in the arcuate region 390 that encircle the neck. These curvatures facilitate application and removal of the semi-rigid headgear 380 from the user's head, for example, by providing openings in the arcuate regions that are sized and oriented to easily fit over the user's neck and ears.

[0156] The configuration of FIG. 29 utilizes an integrated crown strap including a first crown arm 392 and a second crown arm 394 for securing the semi-rigid headgear 380 to the user's head. After the semi-rigid headgear 380 is positioned and partially encircles the user's head, the first crown arm 392 and the second crown arm 394 are brought into contact with one another to secure the semi-rigid headgear 380 in place. Any of a variety of mechanisms may be provided on the first crown arm 392 and the second crown arm 394 to enable them to be attached to one another. For example, in some configurations, the first crown arm 392 and the second crown arm 394 may be attached to one another using a hook-and-loop fastener (e.g., Velcro), or one or more snaps or clips.

[0157] The crown strap extends laterally across the top of the skull in line with the ears. With the crown strap so extended and the arcuate regions 386, 388 positioned to partially encircle the user's ears, the rear straps 280 of the semi-rigid headgear 380 should be located on or below the inion. The user's inion is the most prominent protrusion of the occipital bone at the rear-inferior part of the skull. In other words, the inion is the highest point of the external occipital protruberance. The semi-rigid headgear 380 can be positioned relative to the user's head according to any of the configurations described in the applications listed in the Cross-Reference to Related Applications, each of which forms an integral part of this disclosure and is hereby incorporated by reference in its entirety.

[0158] For example, rear strap portion 280 is adapted to engage the back of the user's head. Preferably, rear strap portion 280 is adapted to engage the head at a location on or below the external occipital protuberance. Rear strap portion 280 extends a distance around the back of the head to each side of the head. In some configurations, rear strap portion 280 includes a longitudinal center adapted to be located approximately 25 degrees below a horizontal plane extending through the patient's ear canal.

[0159] On each side of the head, the semi-rigid headgear 380 extends upwardly and downwardly into left and right side regions forming arcuate regions 386, 388. The side regions are adapted to extend behind the patient's ears. Preferably, the side regions are also adapted to extend behind the patient's mastoid processes. Each of the left and right side regions of the semi-rigid headgear 380 extends into or includes an arcuate portion 386, 388. The arcuate portions 386, 388 bend forward. The arcuate portions 386, 388 are adapted to extend around the patient's respective ears. Preferably, each of the arcuate portions 386, 388 terminates in a respective end portion. The end portion is preferably adapted to be located in front of the patient's ears. In some configurations, the side regions and arcuate portions 386, 388 of the semi-rigid headgear 380 do not include a soft inner padded portion, but may include a self-supporting elastic material that is in direct contact with the patient's head / hair.

[0160] The upper portion of the semi-rigid headgear 380 connects the arcuate portions 386, 388 together. The upper portion may be positioned in front of the ears in some configurations. Preferably, the upper portion is positioned generally perpendicular to the ears. More preferably, the longitudinal center of the upper portion is adapted to be spaced more than 13 mm, preferably between 13 and 100 mm, behind a vertical plane that intersects with the ear canal. In some configurations, the upper portion includes a first segment 392 and a second segment 394, which combine to form the upper portion. The first segment 394 extends upwardly from the top of the left arcuate portion 386, while the second segment 392 extends upwardly from the top of the right arcuate portion 388. Preferably, the upper portion is formed of a self-supporting semi-rigid material. In some configurations, the upper portion does not include any backing, including a soft padded backing layer.

[0161] Each of the upper and lower arms 284, 286 includes a slot 292, 290 near the end of each arm. Each slot is configured to receive a strap 260 from the mask assembly 102, as shown in FIG. 2. Additionally, a portion 398 of the semi-rigid headgear 380 covered by the strap 260 is thinner than the corresponding arm 284, 286 to accommodate the thickness of the strap 260. For example, as shown in FIGS. 30 and 31, the portion 398 of the semi-rigid headgear is thinner than the arm 286. The portion 398 is sized such that when the strap 260 is inserted into the slot 290 and tensioned, its thickness does not extend beyond the arm 286. By maintaining the thickness of the strap 260 and portion 398 less than the thickness of the arm 286, the strap 260 does not irritate the user when worn.

[0162] In addition, the upper arms 284 are configured to extend downward from a position above the user's ears such that the adjustable upper straps 260 do not extend closer than approximately 10 mm to the user's eyes when worn. The lower arms 286 are configured to be offset from the user's neck when the head is tilted up or down such that the termination point of the lower arms 286 is located approximately below the user's ears such that the lower straps attached to the lower arms 286 angle upward from this termination point 290 to the mask assembly 120. In such a configuration, as shown in Figures 52 and 53, the lower and upper straps form a triangle and the space between the lower and upper straps on the mask is smaller than the space between the lower and upper straps on the headgear, thus stabilizing the mask assembly 120 against up and down movement.

[0163] 17, the elbow 222 connects to the conduit 300 via a separable swivel assembly 302. As shown in cross-section in FIG 20, the elbow 222 includes a stem 304 that includes an inner wall 306 at its base. The inner wall 306 includes a recess 308.

[0164] A sleeve 310 includes a flange 312 that is received within the recess 308. The sleeve 310 can be secured in place within the elbow 222 using any suitable technique. The sleeve 310 includes a generally cylindrical outer wall 314. The flange 312 includes an outwardly extending section for connection to a lever 316. Preferably, the flange 312 and the lever 316 are integrally formed. With reference to FIG. 21 , the lever 316 includes an inwardly extending lower catch 320 that is pivotable about the section connecting the lever 316 to the flange 312. Thus, pushing an upper portion 322 of the lever 316 inwardly moves the catch 320 away from the generally cylindrical outer wall 314 of the sleeve 310.

[0165] The swivel 330 includes a generally cylindrical inner wall 332 that slides over the outer wall 314 of the sleeve 310, thus providing a snug fit between the swivel 330 and the sleeve 310. The upper portion 334 includes a shoulder 336. A catch 320 of the lever 316 can engage the shoulder 336 to fix the swivel 330 in an axial position relative to the sleeve 310. When the upper portion 322 of the lever 316 is depressed, the catch 320 moves away from the shoulder 336, thereby allowing the swivel 330 to be removed from the sleeve 310.

[0166] A flap 350 may be attached between the stem 304 and the sleeve 310. In the illustrated configuration, the flap 350 extends from a base 354 sandwiched between the stem 304 and the sleeve 310 into the channel 352. The flap 350 may pivot upwardly away from the sleeve 310 (see arrow P as shown in FIG. 20) about an axis X (see FIG. 21) so that flow from the positive pressure generator through the interface 100 to the user may continue substantially unimpeded. When the positive pressure source stops providing pressurized air flow, the flap 350 pivots downward into contact with the sleeve 310 and seals the channel 352. In some configurations, the flap 350 does not fully contact the sleeve 310. In some configurations, the flap 350 does not seal the channel 352 when in the lowered position.

[0167] 21 , a port 360 is defined through the elbow 222 at a location above the flap 350. The port 360 is preferably positioned along a portion of the elbow 222 proximate the axis X. In some configurations, the port 360 is positioned such that the inhalation airflow is substantially blocked by the flap 350. In other words, as air pivots the flap 350 away from the sleeve 310, the flap 350 is moved to a position that at least partially or completely covers the port 360.

[0168] In some configurations, the port 360 extends through a wall of the elbow 222 that includes a generally planar inner wall 362. The generally planar inner wall 362 helps the flap 350 to generally seal the port 360 when the flap is moved upwardly, away from the flange 312 of the sleeve 310.

[0169] In some configurations, the lever 316 is positioned over a majority of the port 360, such that the port 360 is generally obscured from view. However, as shown in FIG. 20, a gap 364 preferably surrounds at least a portion of the lever 316, such that relatively free air flow can pass through the port 360 when the flap 350 is not covering the port 360. Additionally, in some configurations, the port 360 and lever 316 are positioned on the same side of the elbow 222 as an opening 370 defined in the ball end 220 (which opening is positioned in the mask assembly 102 when the connecting port assembly 104 is assembled to the mask assembly 102). Advantageously, such positioning places the port 360 in a position on the elbow 222 facing the user. Such a position further obscures the port 360 from view during use, resulting in a more aesthetically pleasing configuration. Furthermore, flow through port 360 is so minimal that positioning port 360 toward the user does not cause significant discomfort to the user.

[0170] Although not shown, the elbow 222 may also include one or more bias flow vents that are preferably positioned in a forward-facing configuration to prevent any bias flow from impinging directly on the user.

[0171] Alternative configurations of elbow assembly 302 are illustrated in Figures 48-51. Elbow assembly 302 includes elbow 222, sleeve 310, and / or swivel 330, as shown in Figure 49. In some configurations, elbow assembly 302 includes only elbow 222 and sleeve, and swivel 330 is omitted. The swivel may be permanently or removably attached to sleeve 310 and elbow 222; in some configurations, swivel 330 is integrally formed with the end of the delivery conduit. A flap 350 is positioned over sleeve 310 such that flap 350 at least partially obstructs flow path 352 of the sleeve. The elbow assembly 302 functions similarly to the elbow assembly 302 of Figures 17-21; however, the elbow assembly 302 of Figures 48-51 provides the added advantage of directing gas away from the patient when the flap 350 is lowered to its closed position (as shown in Figures 50 and 51).

[0172] With reference to FIG. 49, the sleeve 310 preferably includes two or more cut-out areas or recesses 356. The recesses 356 may have any suitable shape, and in the illustrated configuration, the recesses 356 include a semi-circular configuration that extends upward into the sleeve 310. The sleeve 310 also includes at least one bump 357, and preferably two or more bumps 357. Preferably, each of the bumps 357 extends over an arc of about 70 degrees. More preferably, each of the bumps 357 is approximately centered between two recesses 356, and each of the bumps 357 extends about 70 degrees around the outer surface of the sleeve 310.

[0173] The swivel 330 is preferably generally cylindrical in configuration. As shown in FIG. 49, the swivel 330 has inwardly extending ridges 358. The ridges 358 preferably surround the entire inner surface. In some configurations, the ridges 358 may be interrupted. However, the ridges 358 preferably do not have interruptions large enough to receive the entire bumps 357, so that the ridges 358 and the bumps 357 cooperate to keep the swivel 330 fitted into the sleeve 310. When the swivel 330 is assembled into the sleeve 310, the recesses 216 allow the bumps 220 to flex inwardly, allowing the bumps 357 to slide over the ridges 358 and then bounce back outward, securing the bumps 357 under the ridges 358.

[0174] The elbow 222 includes openings 420 in its side that are in fluid communication with air escape channels 422. The air escape channels 422 are formed by the spacing between the inner wall 362 and the outer wall 424 of the elbow, as shown in Figures 50 and 51.

[0175] 50 and 51, when the flap 350 is lowered to its closed position, air exhaled by the user enters the opening 370 in the elbow 222. The exhaled air flows through the port 360 in the inner wall 362 of the elbow, through the relief channel 422, and finally exits the elbow 222 through the opening 420.

[0176] 48-51 provides a reduced overall length and improves the aesthetics of the product by eliminating an unsightly hole located in front of the elbow 222. Additionally, the configuration of Figures 48-51 improves patient comfort as air is directed away from the user. Instead, the openings 420 direct the airflow out the side of the elbow 222 and away from the patient.

[0177] Fig. 54 illustrates a further mask configuration 500. The exemplary mask configuration 500 in Fig. 54 is shown without any attached headgear assembly for clarity. Any suitable headgear assembly may be used with the mask configuration 500. For example, but not limited to, any of the headgear assemblies disclosed herein may be used with the mask configuration 500.

[0178] 54, the illustrated mask configuration 500 generally includes a mask base 502 and a mask seal 504. The mask base 502 is preferably more rigid than the mask seal 504. For example, in one configuration, the mask base 502 is formed from a polycarbonate material, while the mask seal 504 is formed from a silicone material. Other suitable materials may also be used for each of the mask base 502 and the mask seal 504.

[0179] The mask seal 504 may be secured to the mask base 502 in any suitable manner, including but not limited to, any of the methods disclosed herein. For example, but not limited to, with reference to FIG. 55, a flange 506 of the mask seal 504 may be inserted into a groove 510 provided along the periphery of the mask base 502. In some configurations, at least a portion of the mask seal 504 may underlie at least a portion of the mask base 502. In some configurations, a more rigid member, such as but not limited to a clip, or a more rigid portion may be integrally formed with the mask seal 504, and the mask seal 504 may be coupled to the mask base 502 using the more rigid member or portion.

[0180] 54, the mask seal 504 preferably includes a first paddle or wing 512 and a second paddle or wing 514. Preferably, the first paddle 512 and the second paddle 514 are hollow. For example, but not by way of limitation, as shown in FIG. 62, a pocket 518 may be defined in each of the first paddle 512 and the second paddle 514. The pocket 518 is in fluid communication with a chamber 520 defined by the mask seal 504. Thus, pressure within the chamber 520 defined by the mask seal 504 can be used to inflate the pocket 518 in the first paddle 512 and the second paddle 514.

[0181] With reference to FIG. 55, which is a cross-section of the mask assembly 500 taken along line 55-55 of FIG. 54, the mask seal 504 also preferably includes an upper surface 516. The paddles 512, 514 extend generally upward from the upper surface 516. Preferably, the pocket 518 defined in the paddles 512, 514 extends above the upper surface 516. More preferably, the pocket 518 is defined in a lateral portion such that the pocket 518 extends upward along the lateral side of the nose. By having the pocket 518 extend above the upper surface 516 and along the lateral side of the nose, the bulging effect can be significantly improved to provide a tight seal against the exterior surface of the nose. Together, the upper surface 516 and the paddles 512, 514 allow for an improved seal with the nose, thereby reducing or eliminating pressure-related skin problems. More specifically, the illustrated mask configuration 500 eliminates pressure-related skin problems along the bridge of the nose because the illustrated configuration does not cross the nose from side to side at the bridge.

[0182] 54, the first paddle 512 and the second paddle 514 together with the upper surface 516 define a valley 522. The valley 522 preferably defines a forwardly disposed opening. In other words, the illustrated valley 522 defines a passageway extending from the front to the rear of the illustrated mask seal 504. Moreover, the valley 522 preferably accommodates a range of users in size since the nose is received in a generally open area from front to rear, with at least the tip of the nose being able to protrude through the forward opening defined by the valley 522.

[0183] As illustrated in Figures 54 and 55, the valley 522 preferably accommodates at least the tip of the user's nose with the upper surface 516 positioned under the nose. Preferably, when viewed from the front, a gap G is defined between the paddles 512, 514 of about 5 mm to about 30 mm. More preferably, the gap G between the paddles 512, 514 is about 10 mm to about 25 mm. In one configuration, the gap G is about 15 mm. The upper surface 516 is positioned under the nose to define a primary seal between the mask configuration 500 and the face of the user.

[0184] The paddles 512, 514 preferably extend upwardly to some extent along the lateral sides of the nose. In some configurations, the paddles 512, 514 extend upwardly more than the extent of the sealing upper surface 516. The paddles 512, 514 may be shorter than illustrated or longer than illustrated. By extending upwardly above the upper surface 516 and extending upwardly to the sides of the nose, the paddles 512, 514 create a secondary seal with the user's face. Preferably, the paddles 512, 514 are adapted to extend upwardly at least to the fibro-adipose tissue FFT of the ala (this is represented by line A in FIG. 70). More preferably, the paddles 512, 514 are adapted to extend upwardly beyond the fibro-adipose tissue FFT into the region of the alar cartilage MAC (this is represented by line B in FIG. 70). Even more preferably, the paddles 512, 514 are adapted to extend upwardly beyond the alar cartilage MAC into the region of the lateral projection of the septal cartilage SNC (this is represented by line C in FIG. 70). In some configurations, the paddles 512, 514 extend upwardly such that at least a portion of the paddles 512, 514 extend upwardly beyond the nasal bone NB (i.e., the bridge) of the user's nose (this is represented by line D in FIG. 70). In some configurations, the paddles 512, 514 are adapted to extend along a lateral portion of the lateral edge of the nose.

[0185] The paddles 512, 514 are preferably configured to extend along the surface of the face generally adjacent the nose. As shown in FIG. 55, when viewed from the side, the paddles 512, 514 are generally triangular or fin-shaped in some configurations. Such a configuration provides a large surface area for the paddles 512, 514 to seal against the sides of the nose while also having a reduced side profile to reduce the likelihood that the paddles 512, 514 will be pulled away from the nose due to contact during sleep, such as when turning from side to side. Although the illustrated configuration includes two separate paddles 512, 514, the paddles 512, 514 may be connected together to generally enclose at least a portion of the nose.

[0186] 55 and 57, the upper surface 516 extends rearward (i.e., toward the user's face or away from the mask base 502) to a lip 524. The upper surface 516 rests adjacent the lip 524 and under the nose, preferably sealing against the nose, while the lip 524 may seal against the upper lip area of ​​the face just above the vermilion border.

[0187] As described above, the top surface 516 of the mask seal 504 extends rearwardly to connect to or define a lip 524. With reference to FIG. 57 , the lip 524 preferably surrounds an opening 526 that leads to a chamber 520 defined in the mask seal 504 and connects to or defines a portion of a sidewall 528 of the mask seal 504.

[0188] As shown in FIG. 57, the upper surface 516 includes at least a portion of one or more nasal openings 530. The nasal openings 530 may be positioned laterally between the paddles 512, 514 and may be defined through the upper surface 516 to provide communication of the mask seal with the chamber 520. The nasal openings 530 preferably open substantially upwardly, while the mouth opening 526 preferably opens substantially rearwardly. In the illustrated configuration, the mask seal 504 includes a mouth opening 526 and a separate nasal opening 530. While other configurations have combined nasal and mouth openings (e.g., as shown in FIG. 59), the separate openings 526, 530 as shown in FIG. 58 may be helpful and more indicative to a user in determining whether the illustrated mask configuration 500 is being properly worn.

[0189] The upper surface 516 is preferably substantially flat and does not generally protrude upward into the nasal cavity. Preferably, the nasal openings 530 do not extend upward into the nasal vestibule (the nasal vestibule is the most anterior portion of the user's nasal cavity). More preferably, the nasal openings 530 extend below the nasal vestibule but do not extend upward into the nasal vestibule. The nasal openings 530 are preferably generally flush with the upper surface rather than extending upward into some other superstructure. In some configurations, the upper surface 516 may include one or more nasal prongs, one or more nasal pillows, or the like. In the illustrated configuration, the upper surface 516 is supported by the paddles 512, 514 and defines a somewhat arcuate connection to the upper ends of the paddles 512, 514. This arcing connection supports upper surface 516 by suspending it from a higher pivot point, allowing the nose sealing surface defined along upper surface 516 to stretch, move, and / or conform to the surrounding geometry as well as to noses of various widths, depths, and other geometric characteristics.

[0190] 57, the lip 524 may define a band 532 disposed between the mouth opening 526 and the nasal opening 530. As shown by comparing the embodiment shown in FIG. 58 with the embodiment shown in FIG. 59, the band 532 and the portion of the upper surface 516 extending between the band 532 and the nasal opening 530 may be omitted, thus combining the mouth opening 524 and the nasal opening 530 into a combined oral-nose opening 534.

[0191] As shown in FIG. 60, in some configurations featuring a combined oral-nose opening 534, both sides of the lip 524 may be interconnected with a clip 536. The illustrated clip 536 includes a generally omega (Ω)-like shape. As illustrated in FIG. 60, the clip 536 may include a first leg 540 and a second leg 542 interconnected by a body 544 of the clip 536. The body 544 may have any suitable shape and configuration. For example, and without limitation, the illustrated body 544 includes a U-shape or a C-shape, although the body 544 may be V-shaped, etc. In some configurations, the clip may be formed of silicone or any other suitable material.

[0192] 57, the sidewalls 528 may extend vertically higher than the top surface 516. Preferably, the sidewalls 528 connect to the lip 524, generally surround the mouth opening 526, and extend up to the sides of the user's nose in the region of the first and second paddles 512, 514. The sidewalls 528 extend upwardly and beyond the band 532 in the illustrated configuration, thus providing a higher platform when the mask configuration 500 is viewed from the side (e.g., FIG. 61), which promotes balance of the mask seal 504 and reduces rotational movement of the mask configuration 500 about a generally horizontal axis.

[0193] The band 532 extends between the mouth opening 526 and the nasal opening 530 as shown in FIG. 57. Thus, the illustrated band 532 connects the sidewall 528 at a location between the two openings 526, 530. In some configurations, a clip 536 connects the sidewall 528 at a location between the two portions that define the combined oral-nose opening 534. In other configurations, any suitable connecting structure can be used that generally connects the sidewall 528 from both sides of the opening 526, 530 or opening 534. The location of the connecting structure can be between the upper and lower ends of the opening 524, 530 or opening 534. In other words, in some configurations, a first lateral side of the sidewall 528 is connected to a second lateral side of the sidewall 528 in a region that bridges the combined opening 534.

[0194] By connecting the lateral portions of the side walls 528, the lateral portions of the side walls 528 are in effect anchored together. When the mask arrangement 500 is moved laterally during sleep, for example when the user may turn from one sleeping position to another (e.g. from back to side), which may cause the mask to be pulled by the CPAP tube or contact a pillow, the lateral portions of the side walls 528 are anchored together, improving the stability of the mask seal 504. Furthermore, because the anchors (e.g. bands 532 or clips 536) are flexible, a wide range of facial contours can be accommodated. For example, while a flatter facial contour can be accommodated, the seal is still able to self-adjust to the more prominent facial contours common in European populations.

[0195] The anchoring provided by, for example, band 532 or clip 536 also aids in the rolling of sidewall 528. With reference to Fig. 57, because band 532 extends laterally and connects to sidewall 528, as band 532 is pushed forward, sidewall 528 rolls inward, which enhances the conformability of mask seal 504 to various facial geometries. Additionally, as top surface 516 is pushed downward, first paddle 512 and second paddle 514 pivot inward, such that gap G at the top of paddles 512, 514 is smaller compared to gap G at the bottom of paddles 512, 514.

[0196] Now with reference to Figures 62-65, the illustrated mask seal 504 includes varying stiffness or varying degrees of flexibility to further enhance the conformability of the mask seal 504, which helps to reduce leakage when the mask configuration 500 is used in positive pressure applications.

[0197] The illustrated upper portion of the mask seal 504 includes a stiffer support region 550 and an expansion or flex region 552. In the illustrated configuration, the support region 550 has a thicker cross-section, thereby increasing stiffness, while the expansion or flex region 552 has a thinner cross-section, thereby decreasing stiffness. Other techniques may also be used to vary stiffness or flexibility. For example, material selection, material blends, etc. may be adjusted to adjust stiffness or flexibility in different regions of the mask seal 504. As a further example, some regions may be supported by the mask base 502 or other components to make the regions stiffer as desired.

[0198] The illustrated stiffer support region 550 (best seen in FIG. 64) may be located on the forward facing surfaces of the first paddle 512 and the second paddle 514. The stiffer support region 550 is also part of the mask seal 504 that interfaces with the flange 506 of the mask seal 504 that interfaces with the groove 510 of the mask base 502. The support region 550, in the illustrated configuration, rests above the inflation or flex region 552. The illustrated configuration is desirable to help control the inflation and flexion of the inflation or flex region 552 so that the inflation action may be better directed towards the user.

[0199] 63-65, in addition to the support region 550 and the expansion or flex region 552, the illustrated mask seal 504 also includes lower corner reinforcements 554 and a flexing jaw region 556. Like the support region 550 and the expansion or flex region 552, the corner reinforcements 554 are stiffer than the flexing jaw region 556. The stiffer corner reinforcements 554 help control and / or guide the expansion of the regions of the mask seal 504, while the more flexible jaw region 556 deforms more easily to accommodate users having a wide variety of facial geometries.

[0200] As illustrated, the lower corner reinforcements 554 extend downwardly at or just below the vertical position of the upper surface 516, and the lower corner reinforcements wrap inwardly toward a generally vertical center plane that generally bisects the mask seal 504. Additionally, in the illustrated configuration, the lower corner reinforcements are positioned along the sidewalls 528 of the mask seal 504.

[0201] The illustrated jaw region 556 is positioned between the lower corner stiffeners. Preferably, the jaw region 556 also wraps around at least a portion of the sidewall 528. Additionally, the flexible jaw region 556 preferably extends upwardly and around at least a portion of the lip 524 that defines the opening 526 to the chamber 520 of the mask seal 504. In the illustrated configuration, the flexible jaw region 556 extends upwardly in the vertical direction to substantially the same extent as the lower corner stiffeners 554. In this manner, the lower corner stiffeners 554 can reinforce the lateral portions of the flexible jaw region 556.

[0202] Additionally, in the illustrated configuration, the mask seal 504 includes a forward facing stiffening panel 560. The stiffening panel 560 generally surrounds the area that will mate with the mask base 502. Because the stiffening panel 560 surrounds the mating area, it may further stabilize the connection with the mask base 502.

[0203] In some embodiments, the thicknesses are related to one another as follows: flexion region 550<chin region 556<lower corner reinforcement 554<stiffening panel 556<support region 550. In some embodiments, flexion region 550 has a thickness of about 0.3 mm to about 1.25 mm, preferably about 0.8 mm, chin region 556 has a thickness of about 0.5 mm, lower corner reinforcement has a thickness of about 1.25 mm, stiffening panel 560 has a thickness of about 2.0 mm, and support region 550 has a thickness of about 2.5 mm. Preferably, the thicker portion of mask seal 504 (e.g., support region 550) faces the portion having a thinner thickness (e.g., flexion region 552). In some configurations, at least a portion of the thickest portion (e.g., support region 550) overlies at least a portion of the thinnest portion (e.g., flexion region 552). Such a configuration allows for inflation in a desired direction (i.e., toward the user's face). Preferably, a transitional framework 558 connects the various regions 550 , 552 , 554 , 556 .

[0204] The thinner cross-section of the flex region 552 and the chin region 556 provides a soft, flexible surface adapted to contact the face of a user. Advantageously, the thinner cross-section of the flex region 552 allows the shape defined by the valleys 522 to stretch, move and deform, so that a larger percentage of people can use the same mask. Preferably, the stretching, movement and deformation accommodates a wide range of nose widths. Similarly, the thinner cross-section of the flex region 552 allows the shape of the chin rest region of the mask seal 504 to stretch, move and deform. In other words, the thinner cross-section of one or more of the flex region 552 and the chin region 556 allows the mask seal 504 to conform to a wide variety of facial geometries.

[0205] 55, the mask base 502 preferably features a groove 510 that is secured to the flange 506 of the mask seal 504. In some configurations, the mask base 502 may sit on at least a portion of the thicker stiffening panel 560 and / or at least a portion of the support area 550. The mask base 502 may rest on these portions of the mask seal 504 to reinforce those areas.

[0206] With further reference to Figure 55, the mask base 502 includes a central opening 570 that receives a connector 572. The connector 572 and central opening 570 may have any suitable configuration, including but not limited to any of the configurations described herein. Only a portion of the connector 572 is shown in Figure 54. Other styles of connectors 572 may also be used.

[0207] The central opening 570 may be defined by a wall 574 that includes a contoured inner surface. The contoured surface of the wall 574 may be rounded to receive a ball end 576 of the connector 572, which may include a swivel elbow. The ball end 576 has a contoured surface that may snap into the contoured surface defined by the wall 574. The connection between the two contoured surfaces allows the surfaces to slide relatively freely over one another, thus allowing the position of the swivel connector 572 to be easily changed relative to the mask base 502. In some configurations, the swivel connector 572 may be configured to rotate or pivot without having a ball joint arrangement.

[0208] The illustrated mask base 502 also includes one or more strap connections 580 (see FIG. 59). The strap connections 580 may have any suitable configuration, including, but not limited to, any of the structures that connect to clips or the like as described herein. For example, the illustrated mask base 502 includes at least two pockets 582.

[0209] The pockets 582 are recessed into and protrude rearwardly from the mask base 502, as shown in Fig. 56. The illustrated pockets 582 are formed such that one pocket 582 is formed on each lateral side of the mask base 502. The pockets 582 may be positioned symmetrically about a central generally vertical plane that substantially bisects the mask base 502. In some configurations, as shown in Fig. 56, the pockets 582 have an expanded vertical dimension compared to their transverse or lateral dimension.

[0210] In the illustrated mask base 502, a laterally inner portion of each pocket 582 includes a support wall 584 (as best seen in FIG. 61). The support wall 584 is positioned toward the central plane. Each of the pockets 582 is configured to receive a clip, such as, for example and without limitation, the clip 252 shown in FIG. 22. When the clip 252 is seated within the pocket 582, the support wall 584 helps to limit rotation of the clip 252 relative to the pocket 582. Additionally, its larger vertical dimension helps a user locate the pocket 582 with the clip 252 during seating.

[0211] 61, each of the pockets 582 preferably includes a tab 586 that can engage the interlocking feature 264 of the associated clip 252. Other methods of interlocking the clips 252 with the pockets 582 may also be used. Additionally, any other suitable method of securing the mask base 502 or mask seal 504 with the headgear assembly 600 (see FIGS. 67-69) may be used.

[0212] 66, a further mask configuration 500' illustrates a different style of strap connection, but is otherwise the same as the mask configuration 500 illustrated and described in connection with FIGS. 54-65. The illustrated mask base 502' includes four strap connections 580'. As shown in FIG. 66, in the illustrated configuration, the strap connections 580' have two connections 580' positioned on each lateral side of the mask configuration 500'. The illustrated strap connections 580' include loops through which straps 602 from any suitable headgear assembly 600 can be threaded and / or to which the straps 602 can be secured.

[0213] 67-69, headgear assembly 600 also includes, in addition to strap 602, a rear strap assembly 604 and an upper strap 606. Although headgear assembly 600 may be used, any other suitable headgear assembly may also be used, including, but not limited to, any of the structures disclosed herein.

[0214] The rear strap 604 extends around the back of the user's head at a location generally above the nape of the neck but generally below the occipital protuberance. As such, the rear strap 604 preferably curves upward to reduce or eliminate the possibility of the rear strap 604 contacting the nape of the user's neck. At a location behind the user's ears, the rear strap 604 bifurcates into an upper arm 610 and a lower arm 612.

[0215] The upper arms 610 arc upward to a position above the user's ears and then arc downward to a position generally in front of the user's ears. The downward arc, when combined with the stiffer material of the upper arms 610, allows the attachment point between the upper arms 610 and the straps 602 to be lowered so that the straps 602 can apply the desired force vector UFV to the mask configuration 500'. If the attachment point is too high, the headgear assembly 600 may apply too much upward force to the mask configuration 500', compromising the stability of the mask configuration 500'. Additionally, as shown in FIG. 68, the lower attachment point positions the straps 602 generally lower than the user's eyes, improving the field of vision for the user and improving comfort for the user.

[0216] As shown in Fig. 68, the lower arms 612 extend downward and forward to a position slightly behind the ears. When combined with the stiffer material of the lower arms 612, the position lower and slightly behind the ears improves comfort for the user as the lower arms 612 lie relatively flat alongside the upper neck of the user. When coupled with the lower arms 612, the straps 602 can impart a desired lower force vector LFV to the mask configuration 500'.

[0217] The strap 602 may be connected to the rear strap assembly 604 in any suitable manner. In the illustrated configuration, the strap 602 connects to an upper arm 610 and a lower arm 612, respectively. Preferably, the upper arm 610 and the lower arm 612 are stiffer than the strap 604, so that the arms 610, 612 generally maintain their shape when the headgear assembly 600 is worn. In some configurations, each of the upper arm 610 and the lower arm 612 supports its own weight. In some configurations, each of the upper arm 610 and the lower arm 612 is structured to not tangle when worn. For example, the arms 610, 612 have sufficient torsional stiffness to reduce the likelihood of twisting when worn.

[0218] Preferably, the strap 602 connects to at least one of the upper arm 610 and the lower arm 612 at a position in front of the ears. Such a configuration helps the user to locate the strap 602 without much difficulty. In addition, the ends of the upper arm 610 and the lower arm 612 may include respective slots 614, 616, so that the strap 602 can be threaded through those slots 614, 616. In addition, the strap 602 may include an adjustment mechanism 620, such as a Velcro or buckle configuration. The adjustment mechanism 620 allows for adjustment of the force between the mask seal 504 and the user's face. Any suitable adjustment mechanism 620 may be used.

[0219] 68, the upper strap 606 may extend upward and over the top of the user's head. Preferably, the upper strap 606 is flexible and has an adjustable length. The upper strap 606 may connect to the upper arm 610 via a slot 622 to reduce the likelihood of the upper arm 610 slipping off the user's head and contacting the user's ears. Preferably, the upper strap 606 connects to the upper arm 610 at a location generally above the user's ears.

[0220] With reference to FIG. 68, the angle α defined between the upper force vector UFV and the lower force vector LFV can be in the range of about 25 degrees to about 70 degrees. Preferably, the angle α can be in the range of about 30 degrees to about 60 degrees. More preferably, the angle α can be in the range of about 35 degrees to about 50 degrees. In some embodiments, the angle α can be about 40 degrees.

[0221] Advantageously, a relatively small adjustment in tension of the straps 602 coupled to the upper arms 610 of the headgear assembly 600 (i.e., adjustment of tension along the upper force vector UFV) can significantly reduce or eliminate leakage into the user's eye area when used with the mask configuration 500, 500' including the paddles 512, 514. In other words, as the upper straps 602 are tightened, the mask configuration 500', along with the paddles 512, 514 and upper surface 516, is pulled upward against the bottom of the user's nose, thereby pushing against the upper surface 516 of the mask seal 504, which in turn causes the paddles 512, 514 to pivot inwardly toward the user's nose. Thus, the upward force can help increase the force exerted by the paddles 512, 514 against the user's face near the eyes. Initial testing has shown that approximately 75% of the force required to achieve the desired seal level is provided by the lower strap 602, and the upper strap 602 is adjustable to minimize or eliminate leakage into the eye area.

[0222] 71 and 72, a further mask assembly 700 is illustrated in position on a user's face. The illustrated mask assembly 700 is a combination oral-nose mask. The illustrated mask assembly 700 is designed to seal under the user's nose, along a portion of the face extending to the side of the nose, and around the user's mouth.

[0223] The mask assembly 700 advantageously does not need to contact the user's nasal bridge NB. In the illustrated configuration, the mask assembly 700 does not extend over the user's nasal bridge NB. More specifically, the illustrated mask assembly 700 does not contact the user's nasal bridge. Even more specifically, the illustrated assembly 700 does not contact a forward-facing portion of the user's nasal bridge. In some configurations, the assembly 700 does not contact the face in an area vertically higher than a generally horizontal plane LE that extends along the lower edge of the user's eyes.

[0224] In the illustrated configuration, the mask assembly 700 does not extend over the user's nasal tip NT. In some configurations, the illustrated mask assembly 700 preferably does not obscure the user's nasal tip NT. In some configurations, the user's nasal tip NT extends over an adjacent portion of the mask assembly 700. In some configurations, the mask assembly 700 covers the nasal tip. In some configurations, the mask assembly seal covers the nasal tip.

[0225] As illustrated, the mask assembly 700 is preferably adapted to extend around and seal over the nostrils NW or alae (which expand to form a rounded ridge around the nostrils). The illustrated mask assembly 700 is adapted to seal around the surfaces that define the openings to the nostrils, including the fleshy outer end of the nasal septum, sometimes called the columella. In some configurations, the mask assembly 700 is adapted to extend upwardly to seal along at least a portion of the left and right dorsal sidewalls NDS of the user's nose. In some configurations, the mask assembly 700 is adapted to extend upwardly along at least a portion of the left and right dorsal sidewalls NDS without extending upwardly to the area of ​​the user's nasal bridge NB.

[0226] As illustrated, the mask assembly 700 includes a mask base 702, a mask seal 704 attached to the mask base 702, and a connector 706 also attached to the mask base 702. The connector 706 may be coupled to the base 702 in any suitable manner, including but not limited to any of the manners discussed elsewhere herein. For example, but not limited to, the connector 706 may be coupled to the base 702 such that the connector 706 can swivel, pivot, and rotate relative to the base 702. In some configurations, the connector 706 may define a ball joint portion with the mask base 702 (such as but not limited to, defining the other portion). The ball joint may have any suitable configuration and may be configured according to the description of a ball and socket device discussed elsewhere herein. The connector 706 facilitates connection to a supply conduit or the like for a pressurized breathing gas supply. Any suitable connector 706 may be used.

[0227] In the illustrated configuration, the connector 706 includes an elbow, such as, but not limited to, a polycarbonate elbow, that includes bias flow holes 710. The bias flow holes 710 are a collection of orifices configured to circulate air and reduce the likelihood of the user re-inhaling exhaled carbon dioxide. Although the bias flow holes 710 are illustrated only on the connector 706, in some configurations the bias flow holes 710 may be provided relative to the mask base 702, relative to the mask seal 704, or to any combination of the connector 706, base 702, and seal 704. The bias flow holes 710 may have any suitable cross-section and may be cylindrical, hourglass shaped, tapered in either direction, fully or partially tapered, fully or partially cylindrical, contoured with a varying cross-section, etc.

[0228] The mask base 702 is described in further detail with respect to FIG. 73. The mask base 702 provides some support structure for the mask assembly 700 in general, and for the mask seal 704 in particular. The mask base 702 may be formed of any suitable material. In some configurations, the mask base 702 is formed of a fairly rigid material. In some configurations, the mask base 702 is formed of a plastic material, such as a polycarbonate material. In some configurations, similar to the configuration of FIG. 13 above, the mask assembly 700 may include a mask seal including a mask seal clip that is separate from, but attachable to, the mask base. In such configurations, the mask seal clip may connect the mask seal 704 to the mask base 702. 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 integrated as a single component. In some configurations, the mask seal may be overmolded onto the mask seal clip, and in some configurations, the mask seal may be overmolded directly onto the mask base.

[0229] 73 and 74 , in the illustrated configuration, the mask base 702 curves backward from a central portion 712 with a pair of wings 714. As illustrated, the wings 714 may extend backward and upward relative to the central portion 712 of the mask base 702. Thus, the illustrated wings 714 include upwardly projecting portions 716. The mask base 702 in general, and the upwardly projecting portions 716 of the wings 714, by way of example, may provide reinforcement for lateral portions of the mask seal 704.

[0230] The central portion 712 may have a vertical extent less than the height of the upwardly projecting portions 716 of the wings 714. Thus, with reference to Fig. 73, the mask base 702 includes an edge having a generally M-shaped appearance when viewed from the front. In addition, the upper edge of the central extent of the mask base 702 includes a generally U-shaped appearance when viewed from the front. By incorporating a central portion 712 having a recess between a pair of wings 714, the mask base 702 can provide the desired support for the mask seal 704 while still providing sufficient clearance for the user's nose.

[0231] The mask base 702 and the mask seal 704 may be coupled in any suitable manner. In the configuration illustrated in Figure 75, the mask base 702 includes a generally surrounding flange 720, and the mask seal 704 may be overmolded onto the flange 720 of the mask base 702. Any other suitable technique may be used to form the bond between the mask seal 704 and the mask base 702.

[0232] In some configurations, the mask seal 704 may be formed to be removable from the mask base 702. For example, the mask seal 704 may include a groove, and the mask base 702 may include a flange, or any other cooperating structure, such that the mask seal 704 can be removably coupled to the mask base 702.

[0233] 75, the illustrated mask seal 704 includes a thickened region 721 of greater cross-section adjacent its juncture with the mask base 702. Such a configuration improves the service life of the mask seal 704 as well as improves the integrity of the connection between the mask seal 704 and the mask base 702. In some configurations, the thickest region of the mask seal 704 is this thickened region 721.

[0234] The mask seal 704 is designed to form abutting seal against the face of a user. The mask seal 704 is preferably formed of a flexible material, such as, but not limited to, silicone. In some configurations, at least a portion of the mask seal 704 may be textured to enhance user comfort. For example, in some configurations, at least a portion of the mold used to form the illustrated mask seal 704 may be bead blasted to provide a surface texture to the mask seal 704, at least in areas that may come into contact with the user's skin. Other techniques for texturing one or more surfaces of the mask seal 704 may also be used.

[0235] 76, the illustrated mask seal 704 includes an oral-nose mask seal and thus includes at least one oral opening 722 and at least one nasal opening 724. In some configurations, the mask seal 704 may include a combination oral-nose opening. In some configurations, the mask seal 704 may include two or more nasal openings 724. In some configurations, the mask seal 704 may include nasal openings 724 defined within an upper structure such as pillows, prongs, etc.

[0236] The at least one mouth opening 722 and the at least one nose opening 724 are preferably in communication with a single chamber 725 defined in the mask assembly 700. The chamber 725 of the illustrated mask assembly 700 is defined, at least in part, by the mask base 702 and the mask seal 704. The at least one mouth opening 722 is substantially opposite an opening 728 that receives the connector 706. The at least one nose opening 724 may be vertically above the at least one mouth opening 722. The at least one nose opening 724 may be positioned between the opening 728 for the connector 706 and the at least one mouth opening 722. The at least one mouth opening may have an axis OA that is inclined relative to the vertical and extends generally through the opening 728 for the connector 706.

[0237] Referring again to FIG. 73, the mask seal 704 preferably includes a pair of paddles 726 extending upwardly above the upper surface 730. The paddles 726 are configured to extend upwardly in line with, and in some configurations above, the nostrils. In some configurations, the paddles 726 each include an air pocket that is in direct fluid communication with an air path through the mask assembly from the connector to at least one nasal opening and at least one mouth opening. Preferably, as shown in FIG. 76, the upper surface 730 is suspended in a hammock-like manner between the inner portions 733 of the paddles 726. In such a configuration, downward pressure on the upper surface 730 can cause the paddles 726 to pivot inwardly at the top. Thus, increasing the force between the user's nose and the upper surface 730 can increase the sealing force between the sides of the user's nose and the paddles 726. How much increased force the pivoting action causes can vary depending on the configuration. In other words, the longer paddles 726 exhibit a greater degree of pivoting compared to the shorter paddles 726. On the other hand, the shorter paddles 726 are able to accommodate greater variations in nose geometry compared to the longer paddles 726, resulting in a mask assembly 700 that is easier to fit on the face.

[0238] With reference to FIG. 75, four different planes HP1, HP2, HP3, HP4 are shown extending generally parallel to one another and generally perpendicular to a plane RP defined along a rearmost region 734 of the mask seal 704 (e.g., the rearmost region 734 may correspond to a plane such as a desk top that would support the mask seal 704 if it were placed on a desk). In some configurations, an angle β of about 80 degrees to 100 degrees is defined between at least one of the four planes HP1, HP2, HP3, HP4 and the rear plane RP. In some configurations, the angle β is about 85 degrees to about 95 degrees. In the illustrated configuration, the angle β is about 90 degrees.

[0239] As illustrated, the first plane HP1 extends through the forward-most or lower-most region of the upper portion of the mask base 702, the second plane HP2 extends through the top of the upper surface 730 of the mask seal 704, the third plane HP3 extends along the top of the paddle 726, and the fourth plane HP4 extends along the bottom of the face-contacting surface of the mask seal 704. In the illustrated configuration, the second plane HP2 also extends through the top of the upwardly projecting portion 716 of the wing 714. In some configurations, the upwardly projecting portion 716 may extend above the upper surface 730, and in some configurations, the upwardly projecting portion 716 of the mask base 702 may not extend as far above the upper surface 730. In the illustrated configuration, the planes have the following order from top to bottom: HP3, HP2, HP1, and HP4. Preferably, HP2 is positioned between HP1 and HP3. In some configurations, the distance between the plane HP2 and the plane HP3 is about 10 mm to about 25 mm. In some configurations, the distance between the plane HP2 and the plane HP3 is about 15 mm to about 22 mm. In some configurations, the distance between the plane HP2 and the plane HP3 is about 17 mm.

[0240] The paddle 726 and the upper surface 730 define a valley 732. The valley 732 may be adapted to receive the tip of a user's nose, as shown in FIGS. 71 and 72. The valley 732 is open upward in the illustrated configuration. In other words, the nose receiving area of ​​the illustrated mask assembly 700 is not enclosed at the top and is configured to be placed under the nose. In the illustrated configuration, the valley is positioned vertically higher than the plane HP1 (which extends through the highest part of the central portion 712 of the mask base 702). In the illustrated configuration, the valley 732 may extend down into the area of ​​the second plane HP2 (which extends along the top of the mask base 702). In some configurations, the valley 732 extends down to a position slightly vertically below the second plane HP2. In some configurations, the valley 732 extends down to a position slightly vertically above the second plane HP2. In some configurations, the distance between the valley and the second plane HP2 is between about -5 mm and about 5 mm.

[0241] With reference to FIG. 75, the rearmost portion 734 of the mask seal 704 preferably includes at least two protrusions 736. The protrusions 736 may be integrally formed with the perimeter of the mask seal 704 or may be separate components secured to the perimeter of the mask seal 704. In the illustrated configuration, the protrusions 736 are integrally formed with the perimeter of the mask seal 704, which increases the service life of the mask seal and simplifies manufacturing. In some configurations, the protrusions 736 may be formed of a softer material, such as a softer grade of silicone, for comfort. In some configurations, the protrusions 736 may be formed with a thinner cross-section. In the illustrated configuration, however, the protrusions have a cross-sectional thickness that substantially matches the perimeter of the mask seal 704. In some configurations, the protrusions 736 may be formed of a harder material, such as a harder grade of silicone, for a better seal. In some configurations, the protrusions 736 may be formed with a thicker cross-section than the surrounding areas, which increases the perceived hardness or firmness.

[0242] The protrusion 736 is configured to improve a seal with the user's face by helping to fill a depression generally facing adjacent the nose on the face (e.g., the recess defined by the maxilla just below the infraorbital foramen), such that the protrusion 736 forms a seal with the facial contours in the area adjacent the user's nose. The protrusion 736 extends rearward (i.e., toward the user) from the perimeter of the mask seal 704. The protrusion 736 may have a height of about 0 mm to about 5 mm from the perimeter of the mask seal 704 (i.e., may extend outward from the immediate perimeter by that distance). In some configurations, the protrusion 736 may have a height of about 1.0 mm to about 3.0 mm. In some configurations, the protrusion 736 may have a height of about 2.0 mm.

[0243] At least a portion of each of the projections 736 may be positioned vertically between the planes HP2 and HP1. In some configurations, at least a portion of the projections 736 is positioned vertically between the upper surface 730 (at least the uppermost extension) and the top of the mouth opening 722. In some configurations, each of the projections 736 has one or more tips 738, and the tips 738 are positioned vertically between the upper surface 730 (at least the uppermost extension) and the top of the mouth opening 722. In some configurations, the tips 738 are positioned vertically between a portion of the nasal opening 724 and a portion of the mouth opening 722. In some configurations, the tips 738 are positioned closer to the nasal opening 724 than to the mouth opening 722.

[0244] The illustrated mask seal 704 is designed to anchor at two locations on the user's face: under the nose and under the lower lip. In some configurations, the mask seal 704 is configured to anchor under the nose and between the lower lip and the chin. In the illustrated configurations, the mask seal 704 is designed to anchor proximate to the second plane HP2 and the fourth plane HP4. In some configurations, both anchoring points are positioned between the second plane HP2 and the fourth plane HP4. In some configurations, the upper anchoring point AP1 and the lower anchoring point AP2 are vertically separated from each other by a gap of about 40 mm to about 65 mm. In some configurations, the upper anchoring point AP1 and the lower anchoring point AP2 are separated by a gap of less than about 65 mm. In some configurations, the upper anchoring point AP1 and the lower anchoring point AP2 are separated by less than about 60 mm. In the illustrated configuration, the mask seal 704 also extends above the second plane HP2 by the paddle 726. In some configurations, the mask is designed to block airflow through the mask assembly 700 by sealing against the user's face above any anchoring points. Thus, at least some sealing portions of the illustrated mask seal 704 are positioned vertically higher than the anchoring points.

[0245] The mask seal 704 may have different sizes for use with faces of different sizes and / or geometries. In some configurations, different portions of the mask seal 704 may be sized and configured to accommodate users of different sizes and / or geometries. For example, portions of the mask seal 704 may extend upward to different extents for different users. With reference to FIG. 75, an inclined plane SP2 extending generally parallel to the plane SP1 may extend along the outer edge of the paddle 726. In some configurations, the inclined plane SP2 may be spaced apart from the plane SP1 by about 10 mm to about 30 mm. In some configurations, the inclined plane SP2 may be spaced apart from the plane SP1 by about 15 mm to about 25 mm. In some configurations, the inclined plane SP2 may be spaced apart from the plane SP1 by about 21 mm. The distance between these planes relates to the extent of contact with the face in the vertical direction. In some configurations, a single size of the mask seal 704 may be provided for all face sizes and geometries.

[0246] In some configurations, the mask seal 704 includes multiple components formed of different materials and / or different Shore hardnesses. For example, in some configurations, some components of the mask seal 704 may be formed of silicone, while other components are formed of foam, gel, fabric, or other suitably pliable material. For example, in the illustrated configuration, the mask seal 704 includes nose pad inserts 740, which are formed of different materials and / or different Shore hardnesses.

[0247] 77 and 78 show the nose pad insert 740 disassembled from the mask seal 704. The nose pad insert 740 may be formed of a different grade of silicone than the other portions of the mask seal 704. In some configurations, the nose pad insert 740 may be formed of a softer grade of silicone compared to the other face-contacting portions of the mask seal 704.

[0248] Additionally, in some configurations, the nasal pad insert 740 has a thicker cross-sectional area than any other face-contacting portion of the mask seal 704. In some configurations, the nasal pad insert 740 has a greater maximum thickness than any portion of the mask seal 704 surrounding the nasal pad insert 740. In some configurations, the nasal pad insert 740 has a greater minimum thickness than any portion of the mask seal 704 surrounding the nasal pad insert. In some configurations, the nasal pad insert 740 has a greater maximum thickness than any other portion of the mask seal 704. With respect to thickness, it is believed that an increase in thickness increases the perceived hardness, even when the nasal pad insert 740 is formed from a softer grade of silicone. Thus, in some configurations, the face-contacting portion of the nasal pad insert 740, particularly when formed from silicone, has a thickness of about 1.0 mm to about 8.0 mm, or about 2.0 mm to about 5.0 mm. In some configurations, the nose pad insert has an area of ​​thinner cross section for comfort. In some configurations, at least a portion of the nose pad insert may have a thickness that is small enough to allow expansion of that portion of the nose pad insert. In some configurations, the nose pad insert may have at least a portion that is less than about 0.3 mm thick. In some configurations, the nose pad insert may have at least a portion that is less than about 0.2 mm thick. In some configurations, the nose pad insert includes a thickness that varies across at least a portion of the nose pad insert.

[0249] The mask seal 704 may include a pad support area 742 that interfaces with the nose pad inserts 740. The pad support area 742 may be concave or non-concave. In the illustrated configuration, the pad support area 742 is concave to aid in orienting, locating and / or securing the nose pad inserts 740 in the proper position.

[0250] The nose pad insert 740 may be secured to the mask seal 704 in any suitable manner. In the illustrated configuration, the nose pad insert 740 may be secured to the pad support area 742 in any suitable manner. For example, the nose pad insert 740 may be integrally molded, overmolded, glued, assembled, or mechanically coupled to the mask seal or a portion of the mask seal 704, such as the pad support area 742.

[0251] With reference to FIG. 78, the mask seal 704 and the nose pad insert 740 may include features that provide a cue for the location of the nose pad insert 740 relative to the mask nose seal 704. For example, at least one keying recess 744 may be provided, such as, but not limited to, along a portion of the pad support area 742. In the illustrated configuration, three recesses 744 formed in a generally triangular pattern are provided. The illustrated generally triangular pattern is positioned such that the pattern is generally placed over the at least one nasal opening 724. In some configurations, the at least one nasal opening 724 is centered within the pattern. With reference to FIG. 77, the nose pad insert 740 may include a protrusion 746 that mates with the recess 744. In some configurations, the protrusion 746 may include a post. The protrusion 744 may be integrally formed with the nose pad insert 740 or may be formed separately and attached to the nose pad insert 740. Any other suitable mating or keying mechanism may be used to identify the location of the nose pad insert 740 relative to the mask seal 704.

[0252] In the illustrated configuration, the recess 744 is closed at the bottom, and therefore the nose pad insert 740 need not completely seal any openings. In other words, if the recess included openings, the nose pad insert 740 must cover and seal those openings to reduce the possibility of leakage. In some configurations, however, the recess 744 may include openings. In some such configurations, the nose pad insert 740 may be secured in place by sandwiching at least a portion of the mask seal 704 between the nose pad insert 740 and a member on the opposite side of the mask seal 704 relative to the nose pad insert 740. For example, the opposite member may be secured to the protrusion 744. In either case, the interface between the nose pad insert 740 and the mask seal 704 is preferably sealed. More particularly, in the area surrounding any openings, such as the nasal openings 724, the interface between the nose pad insert 740 and the mask seal 704 is preferably sealed.

[0253] Referring again to FIG. 78, the nose pad insert 740 is preferably sized, shaped and configured to enhance comfort for the user. For example, but not limited to, the illustrated nose pad insert 740 may include a shaped central axial portion 750. The shaped central axial portion 750 is concave beneath a laterally outer edge 752. By shaping the central axial portion 750 to be concave, the nose pad insert 740 is adapted to better support the more sensitive septal region of the user. In some configurations, the shaping of the concave region is primarily anterior to the at least one nasal opening 724. In some configurations, the central portion 750 has a more pronounced concavity in the portion anterior to the at least one opening 724 compared to the portion posterior to the at least one opening. In some configurations, the concave central portion 750 has a reduced thickness in the concave region.

[0254] In some configurations, the nose pad inserts 740 may be removable or replaceable. In some configurations, the nose pad inserts 740 may be replaceable, allowing the mask assembly 700 to be modified to include a single nasal opening, a pair of nasal openings, more than a pair of nasal openings, single or multiple nasal prongs, single or multiple nasal pillows, or any other suitable interface configuration. In some configurations, a kit may be provided that includes a mask base, a mask seal, and multiple nose pad inserts to allow trial and experimentation to determine the most desirable or effective configuration for any particular user. In some configurations, the nose pad inserts 740 cannot be removed or replaced without destroying the mask seal 704, but providing different nose pad inserts 704 (e.g., any of the configurations described in the preceding sentence) allows for simple and easy changes in interface style while still using many of the same underlying components. For example, while a prong-less and pillow-less configuration may be desired in some cases for comfort, prongs may improve the ability to properly position the mask assembly 700 relative to the user's face, while pillows may further improve both the ability to position the mask assembly 700 relative to the user's face and simultaneously seal against the user's nostrils.

[0255] With reference to FIG. 75, the nose contacting portion 754 (which may comprise or include the nose pad insert 740), generally or substantially surrounding the nasal opening 724, is angled downwardly in a rearward direction from a second plane HP2 to a first plane HP1. In some configurations, an angle γ is defined between the nose contacting plane SP1 and the plane HP1. In some configurations, the angle γ is between about 5 degrees and about 50 degrees. In some configurations, the angle γ is between about 15 degrees and about 40 degrees. In one configuration, the angle γ is about 30 degrees. In some configurations, the nose contacting portion, generally or substantially surrounding the nasal opening, may be approximately perpendicular to the rear plane, approximately horizontal in use, or angled in a direction opposite to that shown in FIG. 75.

[0256] The second inclined plane SP2 extends approximately parallel to the first inclined plane SP1. In some configurations, the second inclined plane SP2 and the first inclined plane SP1 are separated by a distance of about 10 mm to about 30 mm. In some configurations, the second inclined plane SP2 and the first inclined plane SP1 are separated by a distance of about 15 mm to about 25 mm. In some configurations, the second inclined plane SP2 and the first inclined plane SP1 are separated by about 21 mm. In this manner, the vertical and horizontal extension ranges of the paddle 726 can be determined, and a paddle of an appropriate size can be obtained for a particular face geometry.

[0257] The illustrated mask seal 704 of the mask assembly 700 includes a fairly complex range and configuration of thicknesses. The thicknesses are varied to take advantage of different properties in different regions of the illustrated mask seal 704. For example, with reference to Figs. 80 and 82, the mask seal 704 shows a connection region 760 that generally corresponds to the thickened portion 721. The connection region 760 generally surrounds the opening that receives the mask base 702. The connection region 760 may be the thickest portion of the seal member 704 in some configurations. The connection region 760 joins the mask seal 704 with the mask base 702. Thus, the connection region 760 preferably has a sufficient thickness to provide sufficient stiffness for connection and sufficient thickness for durability. In some configurations, the connection region has a thickness of about 2 mm to about 5 mm. In the illustrated configuration, the thickness is about 3 mm to about 3.5 mm.

[0258] It has been found that the perimeter portion 762 generally adjacent the face-contacting portion of the mask seal 704 should be fairly stiff to reduce the occurrence of wrinkling in the face-contacting region of the mask seal 704 during use. With reference to Figs. 81 and 82, the illustrated lower perimeter portion 762 extends along a generally vertically extending portion of the rear side of the mask seal 704 and wraps slightly inward at a lower portion of the rear side of the mask seal 704. In addition, the lower perimeter portion 762 wraps around at least a portion of the side-facing side of the mask seal 704 from the rear-facing side of the mask seal. In some configurations, the thickness of the perimeter portion may be from about 1.0 mm to about 1.5 mm. In the illustrated configuration, the perimeter portion 762 has a thickness less than the thickness of the connection region 760, and preferably has a thickness of about 1.25 mm. The upper perimeter portion 763 may be separate from the lower perimeter portion 762 and may have a different thickness. In some configurations, the upper perimeter portion 763 has a smaller thickness than the lower perimeter portion 762. In some configurations, the upper perimeter portion 763 may have a thickness of about 0.5 mm to about 1.25 mm. In the illustrated configuration, the upper perimeter portion 763 may have a thickness of about 0.8 mm.

[0259] With reference to FIG. 81 , the illustrated mask seal 704 also has protruding portions 764, which generally correspond to the projections 736, including the tips 738. The protruding portions 764 may be of the same thickness, or may be thicker or thinner than the surrounding portions, as discussed above. In the illustrated configuration, the protruding portions 764 have a thickness less than the peripheral portion 762. In some configurations, the protruding portions have a thickness of about 0.2 mm to about 1.5 mm. In the illustrated configuration, the protruding portions have a thickness of about 0.7 mm.

[0260] With reference to FIG. 81, the illustrated mask seal 704 also includes a mouth region 766. The mouth region 766, in the illustrated mask seal 704, extends along at least a portion of the mouth opening 722. In the illustrated configuration, the mouth region 766 extends along at least a lower portion of the mouth opening 722. In the illustrated configuration, the mouth region 766 extends along at least the sides and bottom of the mouth opening 722. The mouth region 766 provides a softer area for contacting the face. Thus, the mouth region 766 may have a thinner cross-section. For example, in some configurations, the mouth region 766 has a thickness less than the thickness of the perimeter portion 762, and in some configurations, has a thickness of about 0.2 mm to about 1.0 mm. In the illustrated configuration, the thickness of the mouth region is about 0.5 mm.

[0261] 80 and 81, the nose region 768 may wrap around from the rear to the front of the mask seal 704. The nose region 768 may include or be located under the nose pad insert 740. However, preferably, the nose region 768 is located under the nose pad insert 740 and includes a pad support region 742. Given the desirability of gently sealing against the lower portion of the nose, the nose region 768 has a fairly small thickness in the illustrated configuration. In some configurations, the nose region 768 has the smallest thickness of the mask seal 704. In the illustrated configuration, the nose region 768 has a smaller thickness than the mouth region 766. In some configurations, the nose region 768 has a thickness of about 0.1 mm to about 0.5 mm. In some configurations, the nose region 768 has a thickness of about 0.3 mm.

[0262] 80-82, a transition portion 770 having a transitional thickness may be defined between nasal region 768 and perimeter portion 762, between nasal region 768 and connecting region 760, between nasal region 768 and mouth region 766, between mouth region 766 and perimeter portion 764, between mouth region 766 and connecting region 760, between perimeter portion 764 and connecting region 760, etc. In the illustrated configuration, protruding portion 764 is substantially surrounded by transition portion 770. Other configurations are also possible.

[0263] With reference to Figures 81 and 83-88, various cross sections are provided along the mask seal 704 shown in Figure 81. These cross sections help illustrate the various transitions that appear in the mask seal 704 illustrated in Figures 80-82.

[0264] A paddle as shown in cross section with reference to Figures 87 and 88. As illustrated therein, the paddle 726 may have a relatively thin cross section. In some configurations, the paddle may be formed with a cross section thin enough to allow for controlled inflation or expansion at at least a portion of a typical treatment pressure (e.g., about 3 to about 25 cm H2O). In some configurations, such thickness may be less than about 0.3 mm or less than about 0.2 mm depending on the material used. In some configurations, the portion of the paddle 726 that may contact the face comprises a substantially constant cross section.

[0265] In one configuration, the paddle has a thickened cross-section along the ridge that joins the laterally outer and inner portions. Thus, the paddle 726 may have a thicker cross-section at the bend that joins the inner and outer portions. In some configurations, this thickened area may be about 0.3 mm to about 1.25 mm. In some configurations, this thickened area is about 0.5 mm or about 1.0 mm. This thickened area helps reduce the likelihood of wrinkles or creases in the face-contacting portion of the paddle 726 during use, while still allowing the laterally inner portion to be as thin as desired.

[0266] In some configurations, the paddle 726 includes a thicker cross-section at a laterally outer portion and a thinner cross-section at a laterally inner portion. As shown in FIG. 87, a laterally outer wall 772 of the paddle 726 may include a thicker cross-section as compared to the remainder of the paddle 726 at the same height. This thicker portion of the paddle 726 provides reinforcement to support and control the shape of the paddle 726 during use. Other techniques can also be used; however, using a thicker cross-section has the advantage of providing a sufficiently flexible structure with sufficient reinforcement for structural performance.

[0267] 89-109, several styles of headgear are described that may be used with the mask assembly 700 or with any of the mask assemblies described herein. With reference to FIG. 71, the mask assembly 700 is preferably secured using headgear to generate an upward, backward, or combination upward and backward force vector for the mask assembly 700. Because the mask assembly 700 is configured to anchor under the nose, and because the sealing force of the paddles 726 increases with the upward pressure of the mask assembly 700 against the bottom of the nose, this mask assembly is fairly unique in the force vector that is most suitable for the mask assembly 700. Nonetheless, in some configurations, the mask assembly may be used with headgear that generates force vectors in other directions.

[0268] As can be seen in relation to Figures 89-109, the exemplary headgear depicted in these figures advantageously does not feature a T-piece or any other components that extend upward from the associated mask assembly 700 over (or above) the bridge of the nose. In some configurations, neither the mask assembly nor the headgear assembly contacts the face of the user vertically above the eyes or horizontally between the outer edges of the eyes. Due to the construction of the mask assembly 700, the headgear used with this mask assembly need not contact the facial area of ​​use at all. In some configurations, the headgear does not connect to the face of the user. In some configurations, the mask assembly 700 is anchored on the face at a position below the bridge of the nose. In some configurations, the mask assembly 700 is anchored on the face at a position below the lowest surface of the nose. In some configurations, the mask assembly 700 is only anchored on the face at a position below the lowest surface of the nose and the headgear assembly does not contact the face of the user. In some configurations, the mask assembly 700 is anchored above the nose along the mandible and maxilla, and the headgear does not contact the face in a region vertically above the bottom of the nose. In some configurations, the mask assembly 700 is anchored above the nose along the mandible and maxilla, and the headgear does not contact the face in a region vertically above the bottom of the ears. In some configurations, the mask assembly 700 is anchored above the nose along the mandible and maxilla, and the headgear does not contact the face in a region vertically above the eyes. In some configurations, the mask assembly 700 is anchored in at least two positions vertically below the nose, and the headgear does not contact the face in a region vertically defined immediately above the mask assembly 700. In some configurations, the mask assembly 700 is secured against upward movement by a facial feature of the user, and the headgear assembly exerts an upward force on the mask assembly 700. In some such configurations, this facial feature is the bottom of the nose. In some such configurations, the inferior portion of the nose includes the nasal septum.

[0269] 89-91, a headgear assembly 800 is shown coupled to a mask assembly 700. The headgear assembly 800 generally includes a rear strap 802 and a top strap 804. The rear strap 802 and / or the top strap 804 may be adjustable in length. In some configurations, at least one of the rear strap 802 and the top strap 804 may be fixed in length. In the illustrated configuration, the rear strap 802 is configured to pass around the back of the head generally below the user's ears, while the top strap is configured to pass over the top of the head generally in front of the ears. Other positions and configurations are possible. Additionally, in the illustrated configuration, the rear strap 802 and the top strap 804 may be integrally formed. In some configurations, the straps 802, 804 are formed separately and attached together using buckles or another suitable configuration.

[0270] 89-91, an extension 806 connects to one or both of the rear strap 802 and the top strap 804. In the illustrated configuration, two arms 808 connect the extension 806 to the mask assembly 700. In some configurations, the two arms 808 are formed of a single strap. In some configurations, the two arms 808 are formed of two straps. Advantageously, the two arms 808 can be individually adjusted in length in the illustrated configuration, and therefore are preferably formed of two separate straps. Nevertheless, it is possible to form both arms 808 from a single component, while each of the arms 808 is individually adjustable. By allowing the arms 808 to be individually adjustable, the illustrated headgear assembly 800 is able to adjust the angle of the mask. In other words, the arms 808 can be used to tilt the mask assembly 700 in a desired angular direction. Additionally, arms 808 are independently adjustable such that the fit of a lower portion of seal 704 can be adjusted separately from the fit of an upper portion of seal 704 .

[0271] 92-94, an alternative headgear assembly 810 is illustrated therein. The illustrated headgear assembly 810 includes an upper portion 812 and a lower portion 814. While the illustrated upper portion 812 is separate from the lower portion 814, in some configurations the upper portion 812 and the lower portion 814 may be joined together. For example, in some configurations straps connect the upper portion 812 and the lower portion 814 to form a single, integrated headgear assembly 810. In some such configurations, the interconnecting straps may be positioned such that they may be positioned behind the ears or just in front of the ears. Other configurations are possible.

[0272] In the illustrated configuration, the lower portion 814 includes a member 816 that connects to the mask assembly 700 in any suitable manner. In some configurations, the member 816 connects with a hook, snap, or other suitable type of connector. In some configurations, the member 816 extends through a loop and is secured by folding back over itself. In the illustrated configuration, the member 816 is a single component. In some configurations, the member 816 may include multiple components. Preferably, the member 816 is placed around the back of the head in a position that is generally below the user's ears.

[0273] 92-94, upper portion 812 generally includes member 820 and top member 822. Member 820 and / or top member 822 may be adjustable in length. In some configurations, at least one of member 820 and top member 822 may be fixed in length. In the illustrated configuration, member 820 is configured to go around the back of the head at a location that may generally intersect at least a portion of the user's ear, while top member 822 is configured to go over the top of the head at a location that may also generally intersect perpendicularly to the ear. As illustrated, member 820 may have a portion 824 that is configured to go around and over the ear. Other locations and configurations are possible. Additionally, in the illustrated configuration, member 820 and top member 822 may be integrally formed and may meet at a location generally above the user's ear. In some configurations, members 820, 822 are formed separately and attached together using buckles or another other suitable configuration.

[0274] The headgear assembly 810 allows for separate adjustment of the upper and lower portions 812, 814. As described above, by allowing the upper and lower portions 812, 814 to be separately adjustable, the illustrated headgear assembly 810 is able to adjust the angle of the mask assembly 700, as shown in FIG. 93. In other words, the separately adjustable upper and lower portions 812, 814 can be used to tilt the mask assembly 700 in a desired angular direction. Additionally, because the upper and lower portions 812, 814 are separately adjustable, the fit of the lower portion of the seal 704 can be adjusted separately from the fit of the upper portion of the seal 704.

[0275] 95-97, a further headgear assembly 830 is illustrated. The headgear assembly 830 is shown coupled to the mask assembly 700. The illustrated headgear assembly 830 includes an upper portion 832 and a lower portion 834. As shown in FIG. 97, at least one interconnecting member 836 couples the upper portion 832 to the lower portion 834. The at least one interconnecting member 836, in the illustrated configuration, includes a back panel that joins the upper portion 832 to the lower portion 834 in the region of the occipital region of the user's head. The illustrated interconnecting member 836 is generally hourglass shaped. Other configurations are possible.

[0276] In the illustrated configuration, the lower portion 834 includes at least one member 838 that connects to the mask assembly 700 in any suitable manner. In some configurations, the at least one member 838 connects with a hook, snap, or other suitable type of connector. In some configurations, the at least one member 838 extends through a loop and is folded over and secured. In the illustrated configuration, the at least one member 838 is a single component. In some configurations, the at least one member 838 may include multiple components. For example, two components may extend forward from the interconnecting member 836. Preferably, the at least one member 838 extends from the mask assembly 700 toward the back of the head at a location that is generally below the user's ears.

[0277] 95-97, the upper portion 832 generally includes at least one member 840 and a top member 842. The at least one member 840 and / or the top member 842 may be adjustable in length. In some configurations, at least one of the at least one member 840 and the top member 842 may be fixed in length. In the illustrated configuration, the at least one member 840 is configured to go around the back of the head in a generally straight line from the mask assembly 700 to a location vertically above the user's ears, while the top member 842 is configured to go over the crown of the head in a location that generally meets the ears vertically. Other locations and configurations are possible. Additionally, in the illustrated configuration, the member 840 and the top member 842 may be integrally formed and may meet at a location generally above the user's ears. In some configurations, members 840, 842 are formed separately and attached together using buckles or another other suitable configuration.

[0278] The headgear assembly 830 allows for separate adjustment of the upper and lower portions 832 and 834. As described above, the separate adjustment of the upper and lower portions 832 and 834 allows the illustrated headgear assembly 830 to adjust the angle of the mask assembly 700. In other words, the separately adjustable upper and lower portions 832 and 834 can be used to tilt the mask assembly 700 in a desired angular direction. Additionally, because the upper and lower portions 832 and 834 are separately adjustable, the fit of the lower portion of the seal 704 can be adjusted separately from the fit of the upper portion of the seal 704.

[0279] 98-100, a further headgear assembly 850 is illustrated. The headgear assembly 850 is shown coupled to the mask assembly 700. The illustrated headgear assembly 850 includes an upper portion 852 and a lower portion 854. In general, the headgear assembly 850 of FIGS. 98-100 is similar to the headgear 830 of FIGS. 95-97, except that it does not have an interconnecting member. Thus, the details described above with respect to the headgear 830 of FIGS. 95-97 generally apply equally to the headgear 830 of FIGS. 99-100.

[0280] In the illustrated configurations of FIGS. 98-100, the upper and lower portions 852, 854 of the headgear assembly 850 may be formed of a single, integral component. In some configurations, the first and second members 856, 858 may be formed of a single component. For example, a single loop of material may define both the first and second members 856, 858 by extending through loops on the mask or the like. In some configurations, a separate top member 859 may be separate from the single component defining the first and second members 856, 858, or may be integrally formed as part of the single component. Any suitable components may be used.

[0281] 101-103, a further headgear assembly 860 is illustrated. The headgear assembly 860 is shown coupled to a mask assembly 700. As will be apparent from a comparison of FIGS. 98-100 and 101-103, the headgear assembly 860 shown in FIGS. 98-100 is substantially similar to the headgear assembly 850 shown in FIGS. 98-100, except that the headgear assembly 860 includes an upper portion 862 that lacks a top member. As such, the headgear assembly 860 also includes a lower portion 864 that is substantially similar to the lower portion 854 of the headgear assembly 850 shown in FIGS. 98-100.

[0282] 104-106, a further headgear assembly 870 is illustrated. Shown is a headgear assembly 860 coupled to a mask assembly 700. As will become apparent from a comparison of FIGS. 101-103 with FIGS. 104-106, headgear assembly 870 shown in FIGS. 104-106 is substantially the same as headgear assembly 860 shown in FIGS. 101-103 (including having an upper portion 862), except that headgear assembly 870 lacks a lower portion.

[0283] 107-109, a further headgear assembly 880 is illustrated. A headgear assembly 860 is shown coupled to a mask assembly 700. Similar to the headgear 870 shown in FIGS. 104-106, the headgear 880 shown in FIGS. 107-109 includes an upper portion 882 and does not include a lower portion. The upper portion 882, in the illustrated configuration, includes a member 884 that extends upwardly and rearwardly from the mask assembly 700. The member 884 may include an ear-fitting feature 886. The ear-fitting feature 886 is adapted to transmit a force from in front of the user's ear to behind the user's ear. Thus, the ear-fitting feature 886 allows the member 884 to be positioned low on the user's head where, absent the ear-fitting feature 886, the member 884 would cross the user's ear.

[0284] 108 and 109, in the illustrated configuration, member 884 bifurcates into upper and lower members 886 and 888 at a location immediately behind the user's ears. In the illustrated configuration, the bifurcations are adapted to be vertically higher than the user's ears. By bifurcating member 884 into at least upper and lower members 886 and 888, stability may be improved. Other configurations may also be used, including, but not limited to, using a wide strap in place of at least two members 886, 888, incorporating a panel between upper and lower members 886 and 888, etc. Additionally, in the configuration illustrated in FIGS. 108 and 109, the connection point between the headgear and the mask assembly is lower than the configuration illustrated in FIGS. 104-106.

[0285] Various headgear assemblies have been described throughout this disclosure. In each of the headgear assemblies, one or more straps, members, components, etc. can be formed to be more flexible than others within the same headgear assembly. For example, without limitation, in some configurations, the portion of the headgear assembly that extends around the back of the head can be more elastic or flexible than the portion of the headgear assembly that extends in front of the ears. In some configurations, the portion of the headgear assembly that extends in front of the ears can be more elastic or flexible than the portion of the headgear assembly that extends behind the ears. In some configurations, the more elastic, flexible, or extensible portion of the headgear assembly has an overlap with a less elastic, less flexible, or extensible portion.

[0286] 110, a further mask assembly 900 is illustrated. The illustrated mask assembly 900 is a combination oral-nasal mask that is designed to seal under (and / or in) a user's nose, along a portion of the face extending to the side of the nose, and around the user's mouth. In some configurations, the mask assembly 900 can be designed to extend over the tip of the nose, and in such configurations may seal in areas other than under the nose, in the nose, along a portion of the face extending to the side of the nose, and around the user's mouth.

[0287] Similar to the mask assembly 700 shown in Fig. 71, the mask assembly 900 advantageously does not need to contact the bridge of the user's nose. In the illustrated configuration, the mask assembly 900 does not extend over the bridge of the user's nose. More specifically, the illustrated mask assembly 900 does not contact the bridge of the user's nose. Even more specifically, the illustrated assembly 900 does not contact the forward-facing portion of the bridge of the user's nose. In some configurations, the assembly 900 does not contact the face in an area vertically higher than a generally horizontal plane LE that extends along the lower edge of the user's eyes.

[0288] In some configurations, the mask assembly 900 does not extend over the tip of the user's nose. In some configurations, the mask assembly 900 preferably does not obscure the tip of the user's nose. In some configurations, the tip of the user's nose extends over an adjacent portion of the mask assembly 900. In some configurations, the mask assembly 900 may be designed to extend over the tip of the nose. In some configurations, the mask assembly 900 may be designed to obscure the tip of the nose.

[0289] The mask assembly 900 is preferably adapted to extend around and seal over the nostrils or alae of the nose (which flares out to form a rounded ridge around the nostrils). The mask assembly 900 may be adapted to seal in and around the surfaces that define the openings to the nares, including the fleshy outer end of the nasal septum, sometimes called the columella. In some configurations, the mask assembly 900 is adapted to extend upwardly to seal along at least a portion of the left and right dorsal sidewalls of the user's nose. In some configurations, the mask assembly 900 is adapted to extend upwardly along at least a portion of the left and right dorsal sidewalls, but not upwardly to the area of ​​the user's nose bridge. In comparison to the mask assembly 700 shown in FIG. 71, the mask assembly 900 shown in FIG. 110 may extend into and seal along the nasal airways as desired.

[0290] As illustrated, the mask assembly 900 includes a mask base 902, a mask seal 904 attached to the mask base 902, and a connector (not shown) attached to the mask base 902. The connector may be coupled to the base 902 in any suitable manner, including but not limited to any of the manners discussed elsewhere herein. For example, but not limited to, the connector may be coupled to the base 902 such that the connector can swivel, pivot, and rotate relative to the base 902. In some configurations, the connector may define a ball joint portion with the mask base 902 (such as but not limited to, defining the other portion). The ball joint may have any suitable configuration and may be configured according to the description of a ball and socket device discussed elsewhere herein. The connector facilitates connection to a supply conduit or the like for a pressurized breathing gas supply. Any suitable connector may be used.

[0291] 110, the mask base 902 will be described in detail. The mask base 902 provides some support structure for the mask assembly 900 in general, and more specifically for the mask seal 904. The mask base 902 may be formed of any suitable material. In some configurations, the mask base 902 is formed of a fairly rigid material. In some configurations, the mask base 902 is formed of a plastic material, such as a polycarbonate material.

[0292] 110, in the illustrated configuration, the mask base 902 curves backward from a central portion 912 with a pair of wings 914. As illustrated, the wings 914 may extend backward and upward relative to the central portion 912 of the mask base 902. Thus, the illustrated wings 914 include upwardly projecting portions 916. The upwardly projecting portions 916 of the mask base 902 in general, and the wings 914 in example, may provide reinforcement for lateral portions of the mask seal 904.

[0293] The central portion 912 may have a vertical extent less than the height of the upwardly projecting portions 916 of the wings 914. Thus, the mask base 902 includes an edge having a generally M-shaped appearance when viewed from the front. In addition, the upper edge of the central area of ​​the mask base 902 includes a generally U-shaped appearance when viewed from the front. By incorporating a central portion 912 having a recess between a pair of wings 914, the mask base 902 can provide the desired support for the mask seal 904 while still providing sufficient clearance for the user's nose.

[0294] The mask base 902 and the mask seal 904 may be coupled in any suitable manner. With reference to FIG. 112 , the mask base 902 includes a generally encircling flange 920, and the mask seal 904 may be overmolded onto the flange 920 of the mask base 902. Any other suitable technique may be used to form the joint between the mask seal 904 and the mask base 902. In some configurations, the mask seal 904 may be formed such that it is removable from the mask base 902. For example, but not limited to, the mask seal 904 may include a groove and the mask base 902 may include a flange, or any other cooperating structure, such that the mask seal 904 may be removably coupled to the mask base 902.

[0295] 112, the illustrated mask seal 904 includes a thickened region 921 of greater cross-section adjacent its juncture with the mask base 902. Such a configuration improves the service life of the mask seal 904 as well as improves the integrity of the connection between the mask seal 904 and the mask base 902. In some configurations, the thickest region of the mask seal 904 is this thickened region 921.

[0296] The mask seal 904 is designed to form a seal against the face of a user. The mask seal 904 is preferably formed of a flexible material, such as, but not limited to, silicone. In some configurations, at least a portion of the mask seal 904 may be textured to enhance user comfort. For example, in some configurations, at least a portion of the mold used to form the illustrated mask seal 904 may be bead blasted to provide a surface texture to the mask seal 904, at least in areas that may come into contact with the user's skin. Other techniques for texturing one or more surfaces of the mask seal 904 may also be used.

[0297] As shown in FIG. 110, the illustrated mask seal 904 includes an oral-nose mask seal and thus includes at least one oral opening 922 and at least one nasal opening 924. In some configurations, the mask seal 904 may include a combined oral-nose opening. In some configurations, such as the illustrated embodiment, the mask seal 904 may include two or more nasal openings 924. In the illustrated configuration, the mask seal 904 includes nasal openings 924 defined in a superstructure, such as a pillow, prong, or the like. The illustrated configuration includes prongs 927. In some configurations, a single prong (or other superstructure) may be used. In other applications, two or more prongs (or superstructures) may be used. The one or more prongs (or other superstructures) may allow the mask seal 904 to be more easily positioned as desired relative to the user's face. Additionally, a user may have an upper structure, such as but not limited to prongs, which allows the mask to seal more easily (e.g., the upper structure may seal into the nostrils rather than sealing under the nostrils or along the face) and the at least one opening 924 in the mask seal 904 may be less likely to be partially or completely blocked by the user's facial features.

[0298] Any suitable prong 927 configuration may be used. In the illustrated configuration, the prongs 927 generally taper upward from a spherical base 929 to a small opening 924. The opening 924 may be generally elliptical or oval. Additionally, the transition from bottom to top of the prongs 927 may be shaped to provide an improved seal for many different nasal opening geometries. As such, each prong 927 may be angled toward a generally vertical central plane (e.g., a plane corresponding to the user's medial saggital plane). Additionally, the prongs 927 may have a shape that increases in outer dimensions in a non-uniform manner, as best shown in FIG. 114. In other words, the base 929 may be larger in size from front to back compared to left to right. Additionally, the base 929 may increase in dimension more significantly from back to front compared to front. Other configurations are possible.

[0299] The at least one mouth opening 922 and the at least one nose opening 924 are preferably in communication with a single chamber 925 defined in the mask assembly 900. The chamber 925 of the illustrated mask assembly 900 is defined, at least in part, by the mask base 902 and the mask seal 904. The at least one mouth opening 922 is substantially opposite an opening 928 for receiving a connector. The at least one nose opening 924 may be vertically above the at least one mouth opening 922. The at least one nose opening 924 may be positioned between the opening 928 for the connector and the at least one mouth opening 922.

[0300] Referring again to FIG. 110, the mask seal 904 preferably includes a pair of paddles 926 that extend upwardly above the upper surface 930. The paddles 926 are configured to extend upwardly in line with and in some configurations above the nostrils. Preferably, as shown in FIG. 111, the upper surface 930 hangs in a hammock-like manner between the inner portions 933 of the paddles 926. In such a configuration, downward pressure on the upper surface 930 can cause the paddles 926 to pivot inwardly at the top. Thus, increasing the force between the user's nose and the upper surface 930 can increase the sealing force between the sides of the user's nose and the paddles 926. How much of a force the pivoting action results in can vary by configuration. In other words, a longer paddle 926 will exhibit a greater degree of pivoting compared to a shorter paddle 926. On the other hand, shorter paddles 926 are able to accommodate greater variations in nose geometry compared to longer paddles 926, resulting in a mask assembly 900 that is easier to fit on the face.

[0301] The paddle 926 and the upper surface 930 define a valley 932. The valley 932 may be adapted to receive the tip of a user's nose. The valley 932, in the illustrated configuration, is open upwardly. In other words, the nose-receiving area of ​​the illustrated mask assembly 900 is not enclosed at the top and is configured to rest under the nose.

[0302] 112, the prongs 927 are positioned such that the vertical positioning of the at least one nasal opening 924 is lower than the uppermost extent of the thickened region 921. In some configurations, the prongs 927 may be positioned such that the vertical positioning of the at least one nasal opening 924 is higher than or even with the uppermost extent of the thickened region 921.

[0303] As illustrated, the mask seal 904 tapers in front of the prongs 927 and curls downward toward the prongs 927 to define a top surface 930 and a valley 932. This taper and curl forms a flexure area 935. The flexure area 935 may be thin and / or elastic enough to allow the mask seal 904 to expand at least at the flexure area 935 at the nose. In some configurations, both at least a portion of the inner portion 933 and the flexure area 935 are thin enough to expand around the nose of the user. In some configurations, the material is less than about 0.3 mm thick, more preferably less than about 0.2 mm thick. The flexure area 935 may also be thicker and / or stiffer enough to allow the mask seal 904 to retain its shape at least at the flexure area 935 at the nose. In some configurations, both at least a portion of the inner portion 933 and the flexure area 935 are thick enough to retain their shape. In some configurations, the material is less than about 0.7 mm thick, and more preferably less than about 0.5 mm thick.

[0304] Similar to the mask seal 700 described above, and as shown in Figs. 112-120, the illustrated mask seal 904 of the mask assembly 900 includes a fairly complex range and configuration of thicknesses. The thicknesses are varied to take advantage of different properties in different regions of the illustrated mask seal 904. For example, with reference to Fig. 112, the mask seal 904 shows a connection region 960 that generally corresponds to the thickened portion 921. The connection region 960 generally surrounds the opening that receives the mask base 902. The connection region 960 may be the thickest portion of the seal member 904 in some configurations. The connection region 960 joins the mask seal 904 to the mask base 902. Thus, the connection region 960 preferably has a sufficient thickness to provide sufficient stiffness for connection and sufficient thickness for durability. In some configurations, the connection region has a thickness of about 2 mm to about 4 mm. In the illustrated configuration, the thickness is about 3.3 mm to about 3.5 mm.

[0305] With primary reference to FIG. 120, the perimeter portion 962 generally adjacent the face-contacting portion of the mask seal 904 may be fairly rigid. The perimeter portion 962 may extend from a lower corner of the face-contacting portion surrounding the mouth opening 922 upward to an area just below the beginning of the paddle 926. Thus, the perimeter portion 962 extends along a generally vertically extending portion of the rear of the mask seal 904 and wraps slightly inward at the bottom of the rear of the mask seal 904. However, the perimeter portion 962 terminates short of a final central portion of the lower portion of the mask, which is more flexible to accommodate the various contours created by various facial geometries of users. The perimeter portion 962 may also wrap around at least a portion of the side-facing side of the mask seal 904 from the rear-facing side of the mask seal. In some configurations, the thickness of the perimeter portion may be from about 0.8 mm to about 1.5 mm. In the illustrated construction, the outer perimeter portion 962 has a thickness that is less than the thickness of the connecting region 960, and preferably has a thickness of about 1.2 mm to about 1.3 mm.

[0306] The mask seal 904 also includes a mouth region 966. The mouth region 966 in the illustrated mask seal 904 extends along at least a portion of the mouth opening 922. In the illustrated configuration, the mouth region 966 extends along at least a lower portion of the mouth opening 922. In the illustrated configuration, the mouth region 966 extends along at least the sides and bottom of the mouth opening 922. The mouth region 966 provides a softer area for contacting the face. Thus, the mouth region 966 may have a thinner cross-section. For example, in some configurations, the mouth region 966 has a thickness less than the thickness of the perimeter portion 962, and in some configurations, has a thickness of about 0.3 mm to about 1.0 mm. In the illustrated configuration, the thickness of the mouth region is about 0.5 mm.

[0307] The nasal prongs 927 may be formed in an interface region 967. The interface region 967 is preferably sufficiently rigid to be positioned within the user's nostrils while retaining sufficient flexibility and deformability to be comfortable for the user, for example, for overnight use. In the illustrated configuration, the interface region includes both the prongs 927 as well as the immediately adjacent areas. In some configurations, the interface region 967 has a thickness of about 1.5 mm to about 0.5 mm. In the illustrated configuration, the thickness is about 0.8 mm to about 0.5 mm.

[0308] 120, the paddle region 968 may wrap around the upper portion of the paddle 926. The paddle region 968 may generally surround the valley 932. The paddle region 926 is preferably highly conformable and therefore has a thickness of about 0.3 mm to about 1.2 mm. In the illustrated configuration, the paddle region 968 has a thickness of about 0.5 mm.

[0309] Between the paddle region 968 and the prongs 927 is a flexible region 969. The flexible region 969 is preferably formed along the inner portion 933 of the paddle 926. In some configurations, the flexible region 969 is on each lateral side of the prongs 927. In some configurations, the flexible region 969 extends on both lateral sides of the prongs 927 and wraps around to a generally forward position of the prongs 927. The flexible region 969 rests over pockets defined within the paddle 926, which are in fluid communication with the chamber 925. Thus, pressure from within the chamber 925 may cause some expansion or bulging of the flexible region 969, thus improving the seal with the user's nose. The flexible region preferably has a thickness of less than about 0.5 mm. In some configurations, the expansion region 969 may have a thickness of about 0.2 mm to about 0.7 mm. In the illustrated configuration, the expansion region 969 has a thickness of about 0.2 mm.

[0310] 120, a transition portion 970 having a transition thickness may be defined between each of the above-described regions. Other configurations are also possible.

[0311] 113-119, various cross sections are provided along the mask seal 904 shown in Fig. 110. These cross sections help illustrate the various transitions that occur within the mask seal 904.

[0312] 114 and 115, the paddle 926 as shown in cross section. As illustrated herein, the paddle 926 may have a relatively thin cross section at the inner portion, while having a substantially thicker outer portion. The thicker outer portion may help provide structure and shape, while the inner portion remains thin enough to allow for controlled inflation or expansion at typical treatment pressures (e.g., about 3 cm H2O to about 25 cm H2O). In some configurations, the portion of the paddle 926 that may contact the face includes a substantially constant cross section. In the illustrated configuration, in the upper portion of the paddle 926 (see FIG. 114), the transition between the thicker and thinner cross sections occurs before the radius defined between the inner and outer portions. Such a configuration improves the conformability of the paddle 926 to the user's facial geometry. In the illustrated configuration, in the lower portion of the paddle 926 (see FIG. 115), the transition between the thicker and thinner cross sections occurs along the portion that may come into contact with the user's face, thereby achieving greater control over deformation of the cavity between the nose and cheeks. Other configurations are possible.

[0313] The illustrated mask seal 904 is designed to anchor at two locations on the user's face: under / inside the nose and under the lower lip. In some configurations, the mask seal 904 is configured to anchor under the nose (or in the nostrils) and between the lower lip and the chin. In some configurations, the mask is designed to block airflow through the mask assembly 900 by sealing against the user's face at a location higher than any anchoring points. Thus, at least some sealing portions of the illustrated mask seal 904 are positioned vertically higher than the anchoring points.

[0314] The mask seal 904 may have different sizes for use with different sizes and / or geometries of faces. In some configurations, different portions of the mask seal 904 may be sized and configured to accommodate users of different sizes and / or geometries. For example, portions of the mask seal 904 may extend upward to different degrees for different users. In some configurations, a single size of mask seal 904 may be provided for all face sizes and geometries.

[0315] In some configurations, the mask seal 904 includes multiple components formed of different materials and / or different Shore hardnesses. For example, in some configurations, some components of the mask seal 904 may be formed of silicone, while other components are formed of foam, gel, fabric, or other suitably pliable material. In the illustrated configuration, however, the mask seal 904 is formed of a uniform material, such as, but not limited to, silicone.

[0316] Although the present invention has been described in terms of specific embodiments, other embodiments apparent to those skilled in the art are also within the scope of the present invention. Accordingly, various modifications and improvements can be made without departing from the spirit and scope of the present invention. For example, the location of various components can be changed as desired. Moreover, not all features, aspects and advantages are necessarily required to practice the present invention. Accordingly, the scope of the present invention is intended to be defined solely by the scope of the following claims.

Claims

1. 1. An interface for use in providing positive airway pressure therapy, the interface comprising: a mask assembly including a mask seal and a mask base, the mask assembly being configured to be positioned entirely below the bridge of a nose on a user's face and configured to provide exposure of the tip of the nose of the user; Including, the mask base includes a central portion and a pair of wings curving behind the central portion, the wings having a greater vertical extent than the central portion, and an opening for a connector is formed in the central portion of the mask base; the mask seal is connected to the mask base, the mask seal includes a thickened region adjacent the mask base, the mask seal includes at least one mouth opening in a lower portion and at least one nose opening in an upper portion, the at least one mouth opening positioned opposite the opening for the connector, and the at least one nose opening positioned anterior-posterior between the opening for the connector and the mouth opening; and the mask seal includes a first paddle and a second paddle, an upper surface positioned between the first paddle and the second paddle, whereby an upwardly open valley is defined by the first paddle, the upper support surface and the second paddle, at least a portion of the at least one nasal opening is positioned on the upper surface within the valley, the first paddle includes a first pocket and the second paddle includes a second pocket, the first and second pockets are in fluid communication with a chamber defined in the mask assembly.

2. 10. The interface of claim 1, wherein the mask seal is adapted to seal under the user's nose, along a portion of the user's face adjacent the nose, and around the user's mouth.

3. 3. The interface of claim 1 or 2, wherein the mask assembly is configured to not cover any forward facing portions of the user's nose.

4. An interface according to any preceding claim, wherein the upper surface is suspended in a hammock-like manner between inner portions of the first and second paddles.

5. The interface of claim 4 , wherein downward pressure on the upper surface causes the first and second paddles to deflect toward each other.

6. The interface of any one of claims 1 to 5, wherein the seal member includes a rear surface adapted to contact the face of the user, the rear surface including a first protrusion and a second protrusion.

7. The interface of claim 6 , wherein at least a portion of the first protrusion and at least a portion of the second protrusion are vertically positioned between the upper surface and a top of the at least one mouth opening.

8. The interface of claim 7 , wherein the portion of the first protrusion includes a first tip and the portion of the second protrusion includes a second tip.

9. The interface of claim 8 , wherein the first tip and the second tip are positioned vertically between a portion of the at least one nasal opening and the at least one oral opening.

10. The interface of claim 9 , wherein the first tip and the second tip are positioned vertically closer to the at least one nasal opening than to the at least one oral opening.

11. An interface according to any preceding claim, wherein the mask seal is adapted to anchor in two positions on the face.

12. The interface of claim 11 , wherein the mask seal is configured to anchor below the lower lip and below the nose.

13. The interface of claim 11 , wherein the mask seal is configured to anchor below the lower lip but above the chin and below the nose.

14. The interface of claim 11 , wherein the two locations are below the bottom of the nose, but the mask seal extends above and beyond the bottom of the nose.

15. The interface of claim 14 , wherein the mask seal is adapted to seal against the face at a vertical position above an uppermost anchoring position.

16. An interface according to any one of claims 1 to 5, wherein the upper surface slopes downwardly and backwards in a region surrounding the at least one nasal opening.

17. The interface of any one of claims 1 to 5, wherein the at least one nasal opening includes a nose pad insert.

18. The interface of claim 17 , wherein the nose pad insert is formed of a different material than the mask seal.

19. The interface of claim 17 , wherein the nose pad insert is secured to the mask seal at a concave pad support area.

20. The interface of claim 17 , wherein the nose pad insert and the mask seal include interrelated keying features.

21. The interface of claim 17 , wherein the nose pad insert and the mask seal have a sealing joint that generally surrounds the at least one nasal opening.

22. The interface of claim 17 , wherein the nose pad insert includes a concave central portion.

23. 23. The interface of claim 22, wherein the concave central portion is positioned generally forward of the at least one nasal opening.

24. The interface according to any one of claims 1 to 5, wherein the first and second paddles have an increased hardness at their outer periphery compared to their inwardly facing portions.

25. 25. The interface of claim 24, wherein the outer perimeter portion has an increased thickness as compared to the inwardly facing portions of the first and second paddles.

26. 6. The interface of claim 1, wherein the first paddle includes a first ridge positioned between an outward facing surface and an inward facing surface, and the second paddle includes a second ridge positioned between an outward facing surface and an inward facing surface, the first and second ridges having an increased hardness compared to the inward facing surface.

27. 6. The interface of claim 1, wherein the first paddle includes a first ridge positioned between an outward facing surface and an inward facing surface, and the second paddle includes a second ridge positioned between an outward facing surface and an inward facing surface, the first and second ridges having an increased thickness compared to the inward facing surface.

28. 28. An interface according to any preceding claim, further comprising a headgear assembly adapted to provide a slight upward force application between the mask assembly and the face of the user.

29. The interface of claim 28 , wherein the headgear assembly is configured to adjust the angle of the mask assembly.

30. 30. The interface of claim 28, wherein the headgear does not include a T-piece.

31. 29. The interface of claim 28, wherein the mask assembly and headgear assembly are configured such that no part of the mask assembly or headgear assembly contacts the face of the user at any position vertically above the eyes or horizontally between the outer sides of the eyes.

32. An interface according to any preceding claim, wherein the mask assembly includes at least one nasal prong.

33. 33. The interface of claim 32, wherein the at least one nasal prong is angled toward an inner vertical surface of the mask assembly.

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