Nasal Seal and Breathing Interface

Abstract

This application relates to nasal seals and breathing interfaces. A nasal mask is disclosed, the nasal mask having a sealing housing and a flexible nasal seal that is connected or connectable to the sealing housing to define a mask cavity. The nasal seal extends between a face-contacting side and an outer side. The nasal seal has a contact surface that has an edge defining a nasal receiving opening leading into the mask cavity and is configured to seal around a user's nose. The nasal seal also has a sub-nasal support that is fixedly connected within the seal and is configured to extend within the mask cavity and have a contact surface that is oriented to contact at least a portion of the lower surface of the user's nose.

Description

[0001] This application is a divisional application of the patent application for invention titled "Nasal Seal and Breathing Interface" with the application number 201780036673.4, filed on June 13, 2017. Technical Field

[0002] This disclosure generally relates to nasal seals for breathing interfaces, and nasal mask interfaces or interface assemblies including such nasal seals. Background Art

[0003] Breathing interfaces are used to provide one or more breathing gases to a user under positive pressure, such as air in CPAP therapy. Nasal interfaces deliver the gas to the nose.

[0004] The seals of indirect nasal interfaces or nasal masks contact the upper lip, the face on both sides of the nose, and the bridge of the nose, and substantially enclose the nose. Such nasal interfaces often use a headband to be fixed to the user's head. A nasal mask assembly typically includes a T-shaped frame for connecting to a headband, the headband including a pair of upper side straps and a lower side strap, and the lower side strap generally extends substantially horizontally across the sides of the user's head. The upper strap extends above the user's ears and connects to the upper part of the T-shaped frame in the user's forehead area, and the lower strap extends below the user's ears and connects to the lower part of the T-shaped frame at, towards, or from the nasal interface itself. Although this headband tends to relatively stably fix the nasal interface to the user, it may be rather obstructive or uncomfortable in use. Known single-sided strap headbands are smaller in size, but also tend to be less stable in fixing the nasal interface in a sealed engagement state during use.

[0005] In this specification, reference is made to patent specifications, other external documents, or other information sources, which is generally for the purpose of providing background for discussing the features of the present invention. Unless otherwise expressly stated, the reference to these external documents should not be construed as an admission that these documents or these information sources are prior art in any jurisdiction or form part of the common general knowledge in the art. Summary of the Invention

[0006] An object of at least some embodiments of the present invention is to provide a nasal seal and / or a nasal mask interface including such nasal seal and / or a breathing interface assembly improved in at least one or more aspects, or at least to provide useful alternatives for the public or the medical community.

[0007] In one aspect, the present invention generally relates to a nasal mask interface, the nasal mask interface comprising: a sealing housing; a flexible nasal seal connected or connectable to the sealing housing to define a mask cavity, the nasal seal extending between a face-contacting side and an outer side, and comprising: a contact surface including an edge defining a nasal receiving opening leading to the mask cavity and configured to seal around a user's nose; and a sub-nasal support fixedly connected within the nasal seal and configured to extend within the mask cavity and having a contact surface oriented to contact at least a portion of the user's sub-nasal surface.

[0008] In one embodiment, the sealing housing is rigid relative to the flexible nasal seal.

[0009] In one embodiment, the contact surface seals around the user's nose, including sealing across a portion at or proximal to the bridge region.

[0010] In one embodiment, the sub-nasal support extends at least laterally across the nasal seal between opposite sides of the nasal seal within the mask cavity at a location spaced apart or offset from the edge of the contact surface of the nasal seal.

[0011] In one embodiment, the sub-nasal support extends at least laterally across the nasal seal between opposite sides of the nasal seal within the mask cavity at a location spaced apart or offset from the contact surface of the nasal seal.

[0012] In one embodiment, the sub-nasal support includes one or more extension portions extending from within the mask cavity and connecting to the edge of the contact surface of the nasal seal in the upper lip region of the nasal seal.

[0013] In one embodiment, the sub-nasal support includes at least a main lateral portion that extends laterally across the mask cavity between opposite sides of the nasal seal.

[0014] In one embodiment, the main lateral portion of the sub-nasal support is integrally connected to the seal at a location at least spaced apart or offset from the edge of the contact surface of the nasal seal.

[0015] In one embodiment, the nasal seal includes sidewalls extending rearward from the contact surface of the nasal seal, and wherein the main lateral portion of the sub-nasal support is integrally or fixedly connected to opposite sidewall portions of the nasal seal.

[0016] In one embodiment, the sub-nasal support further includes one or more extension portions that extend from the main lateral portion toward the nasal seal and connect to the nasal seal at the upper lip region of the nasal seal.

[0017] In one embodiment, the one or more extension portions connect to the upper lip region of the nasal seal at a position that is at least isolated or offset from the edge of the contact surface of the nasal seal in the upper lip region of the nasal seal.

[0018] In one embodiment, one or more extension portions of the sub-nasal support connect to the edge of the contact surface in the upper lip region of the nasal seal.

[0019] In one embodiment, the sub-nasal support includes a central extension portion having a contact surface that is configured to contact at least a portion of the columella of the nasal septum on the sub-nasal surface of the user's nose.

[0020] In one embodiment, the sub-nasal support includes a left extension portion and a right extension portion that extend on opposite sides of the nasal seal and include contact surfaces that are configured to contact at least portions of the respective left and right alar margins of the sub-nasal surface of the user's nose.

[0021] In one embodiment, at any position along the sub-nasal support, the sub-nasal support is significantly narrower in the lateral direction relative to its contact surface than the corresponding width of the contact surface at that position.

[0022] In one embodiment, the flexible nasal seal is formed of silicone.

[0023] In one embodiment, the seal housing is rigid and is formed of plastic.

[0024] In one embodiment, the nasal seal is removably connectable to the seal housing.

[0025] In one embodiment, the outer side of the nasal seal includes a peripheral channel that is configured to receive a complementary peripheral ridge of the seal housing to connect the nasal seal to the seal housing.

[0026] In one embodiment, the peripheral edge of the outer side of the nasal seal is overmolded onto a complementary rigid fixture, and the rigid fixture is connectable to the seal housing.

[0027] In one embodiment, the nasal seal is permanently or semi-permanently coupled to the seal housing.

[0028] In one embodiment, the peripheral edge on the outer side of the nasal seal is overmolded onto the complementary-shaped opening edge of the seal housing.

[0029] In another aspect, the present invention generally relates to a nasal seal for a nasal mask or interface, the seal being formed of a flexible material and extending between a face-contacting side and an outer side, the nasal mask or interface comprising: a contact surface including an edge defining a nasal receiving opening and configured to seal around a user's nose; and a sub-nasal support fixedly connected within the seal and configured to extend rearward of the nasal receiving opening and having a contact surface oriented to contact at least a portion of the user's sub-nasal surface.

[0030] In another aspect, the present invention generally relates to a nasal mask interface assembly, the nasal mask interface assembly comprising: a seal housing; a flexible nasal seal connected to or connectable to the seal housing to define a mask cavity, the nasal seal extending between a face-contacting side and an outer side and comprising: a contact surface including an edge defining a nasal receiving opening leading to the mask cavity and configured to seal around a user's nose; and a sub-nasal support fixedly connected to the nasal seal and configured to extend within the mask cavity and having a contact surface oriented to contact at least a portion of the user's sub-nasal surface; and a headband including a single left strap and a single right strap configured to extend over a user's ears and connect to the seal housing.

[0031] In one embodiment, the left strap and the right strap are connected to respective attachment locations at or toward respective sides of the seal housing.

[0032] In another aspect, the present invention generally relates to a nasal mask interface assembly, the nasal mask interface assembly comprising: a seal housing; a flexible nasal seal connected to or connectable to the seal housing to define a mask cavity, the nasal seal extending between a face-contacting side and an outer side and comprising: a contact surface including an edge defining a nasal receiving opening leading to the mask cavity and configured to seal around a user's nose; and a sub-nasal support fixedly connected within the nasal seal and configured to extend within the mask cavity and having a contact surface oriented to contact at least a portion of the user's sub-nasal surface.

[0033] In one embodiment, the seal housing is rigid relative to the flexible nasal seal.

[0034] In one embodiment, the contact surface seals around the user's nose, including sealing across a portion of or proximal to the user's nasal bridge.

[0035] In one embodiment, the contact surface seals around the user's nose, including sealing across the nasal bridge portion in the region extending between the tip of the user's nose and the center of the user's nasal bridge.

[0036] In one embodiment, the sub-nasal support extends at least laterally across the nasal seal within the mask cavity between connection positions at opposite sides or upper lateral regions within the nasal seal.

[0037] In one embodiment, the connection positions at opposite sides or upper lateral regions within the nasal seal are isolated or offset from the edge of the contact surface of the nasal seal.

[0038] In one embodiment, the connection positions at opposite sides or upper lateral regions within the nasal seal are offset from the contact surface of the nasal seal.

[0039] In one embodiment, the sub-nasal support includes one or more extension portions or connection portions that extend from within the mask cavity and connect to the edge of the contact surface of the nasal seal in the upper lip region of the nasal seal.

[0040] In one embodiment, the sub-nasal support includes at least a main lateral portion having two ends, and the main lateral portion extends laterally across at least a portion of the mask cavity between connection positions at opposite sides or upper lateral regions within the nasal seal.

[0041] In one embodiment, the sub-nasal support further includes one or more extension portions or connection portions that extend from the main lateral portion toward the nasal seal and connect to the nasal seal at the upper lip region of the nasal seal.

[0042] In one embodiment, the sub-nasal support further includes a central connection portion that extends between the main lateral portion and the portion of the edge of the contact surface in the upper lip region of the nasal seal.

[0043] In one embodiment, the central connection portion of the sub-nasal support has a contact surface that is mainly configured to contact at least a portion of the columella of the nasal septum of the sub-nasal surface of the user's nose.

[0044] In one embodiment, the thickness of the central connecting portion of the sub-nasal support member varies across its length, changing from a thicker region at the end connected to the main lateral portion and a thinner region at the end connected to the edge of the contact surface or towards that end.

[0045] In one embodiment, the central connecting portion of the sub-nasal support member includes a central region whose width is reduced relative to the width at its ends.

[0046] In one embodiment, the width of the central connecting portion gradually changes along its length such that the shape or profile of the central connecting portion is substantially hourglass-shaped.

[0047] In one embodiment, the ends of the main lateral portions of the sub-nasal support member are integrally connected within the nasal seal at connection positions that are at least isolated or offset from the edge of the contact surface of the nasal seal.

[0048] In one embodiment, the nasal seal includes side walls that extend rearward from the contact surface of the nasal seal to the outside of the nasal seal, and wherein the ends of the main lateral portions of the sub-nasal support member are integrally or fixedly connected to at least the opposing side wall portions within the nasal seal.

[0049] In one embodiment, each end of the main lateral portion of the sub-nasal support member is integrally or fixedly directly connected to the inner surface of the nasal seal.

[0050] In one embodiment, each end of the main lateral portion of the sub-nasal support member is integrally or fixedly indirectly connected to the inner surface of the nasal seal via a respective rib extending from the inner surface of the nasal seal.

[0051] In one embodiment, each rib includes a flexible material panel having a first connecting edge portion connected to a part of the inner surface of the nasal seal and a second connecting edge portion connected to the respective end of the main lateral portion of the sub-nasal support member at another part of the peripheral edge of the nasal seal.

[0052] In one embodiment, the first connecting edge portion of each rib is connected to a part of the inner surface of the nasal seal that extends between a thinner front region of the nasal seal and a thicker rear region of the nasal seal, the thinner front region being positioned towards the contact face side and including the contact surface, and the thicker rear region being positioned towards the outside of the nasal seal.

[0053] In one embodiment, the first connecting edge portion of each rib terminates at or towards a thinning edge region of the front region of the nasal seal, the thinning edge region being around the periphery of the edge of the contact surface and being thinner than the rest of the front region.

[0054] In one embodiment, each rib is shaped or configured to have a buckling axis or zone that permits the rib feature to buckle or flex under compression applied to the contact surface of the nasal seal.

[0055] In one embodiment, the buckling axis of each rib's zone is formed by a recessed area or zone of the rib.

[0056] In one embodiment, each rib has a generally vertical orientation within the nasal seal.

[0057] In one embodiment, the ribs extend from corresponding upper lateral regions of the inner surface of the nasal seal, with one rib extending from each side of the nasal bridge region of the nasal seal.

[0058] In one embodiment, the nasal seal is formed from a material having a varying thickness across multiple regions of the nasal seal. The nasal seal is defined by a front region and a rear region. The front region extends from a middle boundary toward the contact face side of the nasal seal and includes the contact surface. The rear region extends from the middle boundary toward the outer side of the nasal seal, and the average thickness of the rear region is greater than that of the front region.

[0059] In one embodiment, the front region includes a thinned edge region that extends peripherally around the edge of the contact surface and is thinner than the remainder of the front region.

[0060] In one embodiment, the contact surface of at least the central portion of the sub-nasal support is oriented at an angle relative to a sealing axis that tangentially extends between the outermost upper and lower contact points in the central region of the contact surface of the nasal seal.

[0061] In one embodiment, the contact surface of the central portion of the sub-nasal support is oriented at an angle within the range of about 40° to about 80° relative to the sealing axis.

[0062] In one embodiment, the contact surface of the central portion of the sub-nasal support is oriented at an angle within the range of about 55° to about 65° relative to the sealing axis.

[0063] In one embodiment, when the sealing housing and the nasal seal are assembled together, the ratio of the total height to the total depth of the sealing housing and the nasal seal is in the range of about 1:0.8 to about 1:1.2.

[0064] In one embodiment, when the sealing housing and the nasal seal are assembled together, the ratio of the total height to the total depth of the sealing housing and the nasal seal is about 1:1.

[0065] In one embodiment, when the sealed housing and the nose seal are assembled together, the ratio of the total height, total depth, and total lateral width of the sealed housing and the nose seal is in the range of about 1:0.8:1 to about 1:1.2:1.4.

[0066] In one embodiment, when the sealed housing and the nose seal are assembled together, the ratio of the total height, total depth, and total lateral width of the sealed housing and the nose seal is about 1:1:1.2.

[0067] In one embodiment, the assembly further includes: a yoke connected to or capable of being connected to the sealed housing, a headband connected to or capable of being connected to the yoke, and an inlet opening in the sealed housing for connection to a gas supply conduit.

[0068] In one embodiment, the sealed housing includes a yoke channel that laterally extends across the outer surface of the sealed housing, and the yoke channel is configured to releasably receive and hold the yoke.

[0069] In one embodiment, the yoke is curved along its length between its ends, having a concave inner surface that engages the yoke channel and a convex outer surface.

[0070] In one embodiment, the headband includes at least a pair of side straps, each of the pair of side straps extending along the side or cheek of the user's face and above the user's ears, and each side strap being connected to or extending from a respective end of the yoke.

[0071] In one embodiment, a central portion of the yoke is received in the yoke channel of the sealed housing, and lateral portions of the yoke on opposite sides of the central portion extend outwardly away from the side of the nose seal.

[0072] In one embodiment, the lateral portions of the yoke are thicker in height and / or width relative to the central portion of the yoke.

[0073] In one embodiment, the headband automatically adjusts the headband, and the yoke includes one or more directional locks that interact with a core element extending from the side strap of the automatically adjusting headband.

[0074] In one embodiment, a conduit frame is releasably received and held in the inlet opening of the sealed housing, and the conduit frame is connected to or capable of being connected to an end of a gas supply conduit.

[0075] In one embodiment, the conduit frame is an oval-shaped hollow body, and the conduit frame is symmetric such that the conduit frame can be releasably received and held in the inlet opening of the sealed housing in either of two orientations that are 180 degrees apart.

[0076] In one embodiment, at any position along the sub-nasal support, the sub-nasal support is significantly narrower in the lateral direction relative to its contact surface than the corresponding width of the contact surface at that position.

[0077] In one embodiment, the flexible nasal seal is formed of silicone.

[0078] In one embodiment, the seal housing is rigid and is formed of plastic.

[0079] In one embodiment, the nasal seal is removably attachable to the seal housing.

[0080] In one embodiment, the outer side of the nasal seal includes a peripheral channel configured to receive a complementary peripheral ridge of the seal housing to attach the nasal seal to the seal housing.

[0081] In one embodiment, the peripheral edge of the outer side of the nasal seal is overmolded onto a complementary rigid fixture, and wherein the rigid fixture is attachable to the seal housing.

[0082] In one embodiment, the nasal seal is permanently or semi-permanently coupled to the seal housing.

[0083] In one embodiment, the peripheral edge of the outer side of the nasal seal is fixed to a complementary-shaped connection edge of the seal housing.

[0084] In one embodiment, the peripheral edge of the outer side of the nasal seal is overmolded onto a complementary-shaped opening edge of the seal housing.

[0085] In another aspect, the present invention generally relates to a nasal seal for a nasal mask or interface, the seal being formed of a flexible material and extending between a face-contacting side and an outer side, the nasal seal comprising: a contact surface including an edge defining a nasal receiving opening and configured to seal around a user's nose; and a sub-nasal support fixedly connected within the seal and located behind the nasal receiving opening and having a contact surface oriented to contact at least a portion of the user's sub-nasal surface.

[0086] In another aspect, the present invention generally relates to a nasal mask interface assembly, the nasal mask interface assembly comprising: a sealing housing; a flexible nasal seal connected or connectable to the sealing housing to define a mask cavity, the nasal seal extending between a face-contacting side and an outer side, and comprising: a contact surface including an edge defining a nasal receiving opening leading to the mask cavity and configured to seal around a user's nose; and a sub-nasal support fixedly connected within the nasal seal and configured to extend within the mask cavity and having a contact surface oriented to contact at least a portion of the user's sub-nasal surface; and a headband including a single left strap and a single right strap configured to extend over a user's ears and connect to the sealing housing.

[0087] In one embodiment, the left and right straps are connected to respective attachment positions at or toward respective sides of the sealing housing.

[0088] In another aspect, the present invention generally relates to a nasal seal for a nasal mask or interface, the seal formed of a flexible material and extending between a face-contacting side and an outer side, the nasal seal comprising: a contact surface including an edge defining a nasal receiving opening and configured to seal around a user's nose; and a sub-nasal support fixedly connected to extend within the nasal seal.

[0089] In one embodiment, the sub-nasal support extends at least laterally across the nasal seal within the mask cavity between connection positions at opposite sides or upper lateral regions within the nasal seal.

[0090] In one embodiment, the sub-nasal support includes one or more extension portions or connection portions extending from within the mask cavity and connecting to an edge of the contact surface of the nasal seal in an upper lip region of the nasal seal.

[0091] In one embodiment, the contact surface of at least a central portion of the sub-nasal support is oriented at an angle relative to a sealing axis tangentially extending between outermost upper and lower contact points in a central region of the contact surface of the nasal seal.

[0092] In one embodiment, the contact surface of the central portion of the sub-nasal support is oriented at an angle within a range of about 40° to about 80° relative to the sealing axis.

[0093] In one embodiment, the nasal seal is defined by a contact surface on the face - contacting side and a side - wall portion that extends rearward from the contact surface to the outer side of the nasal seal and terminates at an opening or connection edge for coupling or connecting to a complementary seal housing.

[0094] In another aspect, the present invention generally relates to a nasal mask interface assembly, the nasal mask interface assembly comprising: a seal housing including; a flexible nasal seal connected to or connectable to the seal housing to define a mask cavity, the nasal seal extending between a face - contacting side and an outer side and including: a contact surface including an edge defining a nasal receiving opening leading to the mask cavity and configured to seal around a user's nose; and a biasing vent arrangement in the seal housing, wherein the biasing vent arrangement includes at least one upper biasing vent array extending laterally across an upper region of the seal housing and at least one lateral biasing vent array extending at least partially downward along a side of the seal housing.

[0095] In one embodiment, each biasing vent array is an array of spaced - apart apertures or holes extending into the housing.

[0096] In another aspect, the present invention generally relates to a nasal mask interface assembly, the nasal mask interface assembly comprising: a seal housing including an inlet opening; a flexible nasal seal connected to or connectable to the seal housing to define a mask cavity, the nasal seal extending between a face - contacting side and an outer side and including: a contact surface including an edge defining a nasal receiving opening leading to the mask cavity and configured to seal around a user's nose; and a conduit frame releasably received and held in the inlet opening of the seal housing, the conduit frame connected to or connectable to an end of a gas supply conduit, wherein the conduit frame is symmetric such that the conduit frame can be releasably received and held in the inlet opening of the seal housing in either of two orientations separated by 180 degrees.

[0097] In one embodiment, the conduit frame is an oval - shaped hollow body.

[0098] In another aspect, the present invention generally relates to a nasal seal for a nasal mask or interface, the seal formed of a flexible material and extending between a face - contacting side and an outer side, the nasal seal including: a contact surface including an edge defining a nasal receiving opening and configured to seal around a user's nose; and wherein the ratio of the total height to the total lateral width of the nasal seal is in the range of about 1:1 to about 1:1.4.

[0099] In one embodiment, the ratio of the total height to the total lateral width of the nasal seal is about 1:1.2.

[0100] In one embodiment, the ratio of the total height, total lateral width, and total depth of the nasal seal ranges from about 1:1:0.6 to about 1:1.4:1.

[0101] In one embodiment, the ratio of the total height, total lateral width, and total depth of the nasal seal is about 1:1.2:0.8.

[0102] Each aspect of the present invention described above can have any one or more of the features mentioned in any one or more of the other aspects of the present invention described above.

[0103] As used in this specification and the claims, the term "comprising" means "consisting at least in part of". When interpreting each statement in this specification and the claims that includes the term "comprising", there may also be features other than the feature or features that begin with that term. Related terms such as "including" and "containing" shall be interpreted in the same manner.

[0104] Numerical ranges

[0105] References to numerical ranges disclosed herein (e.g., 1 to 10) are intended to also include references to all rational numbers within that range (e.g., 1, 1.1, 2, 3, 3.9, 4, 5, 6, 6.5, 7, 8, 9, and 10), as well as any range of rational numbers within that range (e.g., 2 to 8, 1.5 to 5.5, and 3.1 to 4.7). Accordingly, all sub-ranges of all ranges expressly disclosed herein are hereby expressly disclosed. These are merely examples of specific intended disclosures, and all possible combinations of the numerical values between the recited minimum and maximum values should be considered to be expressly stated in this application in a similar manner.

[0106] As used herein, the term "and / or" means "and" or "or", or both.

[0107] As used herein, one or more of a certain noun means the singular and / or plural form of that noun.

[0108] The present invention includes the foregoing, and also contemplates various structures, only examples of which are given below. BRIEF DESCRIPTION OF THE DRAWINGS

[0109] The preferred embodiments of the present invention will be described only by way of example and with reference to the accompanying drawings, in which:

[0110] Figure 1Schematic diagram of a system (such as a continuous positive airway pressure (CPAP) system) for providing a heated and humidified gas flow to a user;

[0111] Figure 2A Schematic diagram of a nasal mask interface fixed to a user's head using an over-ear headband configuration;

[0112] Figure 2B Shows a force diagram related to the forces experienced by the nasal mask interface during use;

[0113] Figure 3 Schematic diagram of the nasal anatomy of the underside of a user's nose;

[0114] Figure 4 Front view or contact face side (or wearer side) view of a nasal mask interface or assembly in a first form according to a first embodiment, showing the nasal seal, seal housing, and headband frame of the assembly, where the nasal seal has a nasal support configuration with a central extension;

[0115] Figure 5 Rear view or outside view of the nasal mask interface of the first embodiment;

[0116] Figure 6 Upper front perspective view of the nasal mask interface of the first embodiment;

[0117] Figure 7 Lower front perspective view of the nasal mask interface of the first embodiment;

[0118] Figure 8 Bottom side view of the nasal mask interface of the first embodiment;

[0119] Fig. 9 Top view of the nasal mask interface of the first embodiment;

[0120] Fig.10 Side elevation view of the nasal mask interface of the first embodiment;

[0121] Fig.11 Outside bottom perspective view of the seal housing and headband frame of the nasal mask interface of the first embodiment;

[0122] Fig.12 Wearer side upper perspective view of the seal housing and headband frame of the nasal mask interface of the first embodiment;

[0123] Fig.13 Front view as observed from the contact face side (or wearer side) of the nasal seal of the nasal mask interface of the first embodiment;

[0124] Fig.14Is a rear view observed from the outside of the nasal seal of the first embodiment;

[0125] Fig.15 Is a top view of the nasal seal of the first embodiment;

[0126] Fig.16 Is a bottom side view of the nasal seal of the first embodiment;

[0127] Fig.17 Is a first rear bottom perspective view observed from the outside of the nasal seal of the first embodiment;

[0128] Fig.18 Is a second rear upper perspective view observed from the outside of the nasal seal of the first embodiment;

[0129] Fig.19 Is a first upper perspective view observed from the contact face side of the nasal seal of the first embodiment;

[0130] Fig. 20 Is a second bottom perspective view observed from the contact face side of the nasal seal of the first embodiment;

[0131] Fig.21 Is a side elevation view of the nasal seal of the first embodiment;

[0132] Fig. 22 Is the nasal seal of the first embodiment passing through Fig.13 Cross-sectional view of the center line A-A;

[0133] Fig.23 Is a front perspective view observed from the contact face side of the nasal seal of the second form of the first embodiment, where the nasal support is configured to be completely detached or separated from the edge of the contact face surface of the nasal seal;

[0134] Fig.24 Is a front view observed from the contact face side of the nasal seal of the first form of the second embodiment, the nasal seal having a nasal support configuration with a left extension and a right extension;

[0135] Fig.25 Is a rear view observed from the outside of the nasal seal of the second embodiment;

[0136] Fig.26 Is a side elevation view of the nasal seal of the second embodiment;

[0137] Fig. 27 Is a perspective view observed from the outside of the nasal seal of the second embodiment;

[0138] Fig.28Is a rear perspective view observed from the outside of the nasal seal of the second embodiment;

[0139] Fig.29 Is a front perspective view of the nasal seal of the second form of the second embodiment, in which the nasal support is configured to be completely disengaged or separated from the edge of the contact face surface of the nasal seal;

[0140] Fig.30 Is a front view of the nasal seal of the third embodiment, which has a "floating" nasal support configuration;

[0141] Fig.31 Is a rear view observed from the outside of the nasal seal of the third embodiment;

[0142] Fig.32 Is a side elevation view of the nasal seal of the third embodiment;

[0143] Fig.33 Is a front perspective view observed from the contact face side of the nasal seal of the third embodiment;

[0144] Fig.34 Is a rear perspective view observed from the outside of the nasal seal of the third embodiment;

[0145] Fig.35 Is a side elevation view of the nasal mask assembly according to the fourth embodiment, shown in a state of being used on a wearer;

[0146] Fig.36 Is a perspective view of the nasal mask assembly of the fourth embodiment, particularly showing the nasal mask interface, which includes a nasal seal, a sealing housing, a yoke, and a catheter frame, and the nasal mask interface is connected to a headband and a flexible gas supply catheter;

[0147] Fig.37 Is an upper perspective view observed from the outside of the nasal mask interface of the fourth embodiment, showing the nasal seal, the sealing housing, the yoke, and the catheter frame;

[0148] Fig.38 Is an upper perspective view observed from the front side or the contact face side of the nasal mask interface of the fourth embodiment;

[0149] Fig.39 And Fig.40 Respectively show the upper exploded perspective view and the lower exploded perspective view of the nasal mask interface of the fourth embodiment;

[0150] Fig.41 Shows the rear view or the outside view of the nasal mask interface of the fourth embodiment;

[0151] Fig.42is a side elevation view of the nasal mask interface of the fourth embodiment;

[0152] Fig.43 is a front view or a face - contacting side view of the nasal mask interface of the fourth embodiment;

[0153] Fig.44 is a top view of the nasal mask interface of the fourth embodiment;

[0154] Fig.45 is a bottom side view of the nasal mask interface of the fourth embodiment;

[0155] Fig.46 is a cross - sectional view of the nasal mask interface of the fourth embodiment through Fig.41 the center line AA shown in;

[0156] Fig.47 is a front view or a face - contacting side view of the nasal seal of the nasal mask interface of the fourth embodiment;

[0157] Fig.48 is a rear view of the nasal seal of the nasal mask interface of the fourth embodiment;

[0158] Fig.49 is a bottom perspective view of the nasal seal of the nasal mask interface of the fourth embodiment as viewed from the outside;

[0159] Fig.50 is an upper perspective view of the nasal seal of the nasal mask interface of the fourth embodiment as viewed from the outside;

[0160] Fig.51 is a side elevation view of the nasal seal of the nasal mask interface of the fourth embodiment;

[0161] Fig.52 is a top view of the nasal seal of the nasal mask interface of the fourth embodiment;

[0162] Fig.53 is a bottom side view of the nasal seal of the nasal mask interface of the fourth embodiment;

[0163] Fig.54 is a cross - sectional view of the nasal seal of the nasal mask interface of the fourth embodiment through Fig.52 the line AB;

[0164] Fig.55 is a cross - sectional perspective view of the nasal seal of the nasal mask interface of the fourth embodiment through Fig.47 the line AC;

[0165] Fig.56 is a cross - sectional view of the nasal seal of the nasal mask interface of the fourth embodiment through Fig.47Cross-sectional view of line AC;

[0166] Fig.57 is a cross-sectional view of line AG of the nasal seal of the nasal mask interface of the fourth embodiment through Fig.47 Cross-sectional view of line AG;

[0167] Fig.58 is Fig.56 Close-up view of area AD, particularly showing the angular dimension profile of a part of the sub-nasal support of the nasal seal of the nasal mask interface of the fourth embodiment;

[0168] Fig.59 is a rear close-up view of the sub-nasal support of the nasal mask interface of the fourth embodiment, which is configured for a medium-small size sealing configuration, and this figure particularly shows the radius of curvature of the central part of the sub-nasal support;

[0169] Fig.60 is a rear close-up view of the sub-nasal support of the nasal mask interface of the fourth embodiment, which is configured for a medium-large size sealing configuration, and this figure particularly shows the radius of curvature of the central part of the sub-nasal support;

[0170] Fig.61 shows a rear close-up view of another form of the sub-nasal support of the nasal mask interface of the fourth embodiment, which has an improved alternative approximate square shape;

[0171] Fig.62 shows a close-up upper perspective view of the central region of the sub-nasal support of the nasal seal of the nasal mask interface of the fourth embodiment, and particularly identifies the width dimension of a part of the sub-nasal support for a medium-small size sealing configuration;

[0172] Fig.63 shows a close-up upper perspective view of the central region of the sub-nasal support of the nasal seal of the nasal mask interface of the fourth embodiment, and particularly identifies the width dimension of a part of the sub-nasal support for a medium-large size sealing configuration;

[0173] Fig.64 shows a close-up cross-sectional view of a part of the central connecting portion of the sub-nasal support of the nasal seal of the nasal mask interface of the fourth embodiment, and particularly shows the angular dimension of the central connecting portion for a medium-small size sealing configuration;

[0174] Fig.65 shows a close-up cross-sectional view of a part of the central connecting portion of the sub-nasal support of the nasal seal of the nasal mask interface of the fourth embodiment, and particularly shows the angular dimension of the central connecting portion for a medium-large size sealing configuration;

[0175] Fig.66 Shows a close-up upper view of the bridge region of the nasal seal of the nasal mask interface of the fourth embodiment, and particularly shows the valley region of the contact surface for the seal configuration for medium and small sizes;

[0176] Fig.67 Shows a close-up upper view of the bridge region of the nasal seal of the nasal mask interface of the fourth embodiment, and particularly shows the valley region of the contact surface for the seal configuration for large and medium sizes;

[0177] Fig.68 Is an upper perspective view observed from the outside of the seal housing of the nasal mask interface of the fourth embodiment;

[0178] Fig.69 Is a lower perspective view observed from the wearer side of the seal housing of the nasal mask interface of the fourth embodiment;

[0179] Fig.70 Is a rear view of the outside of the seal housing of the nasal mask interface of the fourth embodiment;

[0180] Fig.71 Is a front view of the wearer side of the seal housing of the nasal mask interface of the fourth embodiment;

[0181] Fig.72 Is a side elevation view of the seal housing of the nasal mask interface of the fourth embodiment;

[0182] Fig.73 Is a top view of the seal housing of the nasal mask interface of the fourth embodiment;

[0183] Fig.74 Is a bottom view or lower side view of the seal housing of the nasal mask interface of the fourth embodiment;

[0184] Fig.75 Is an upper perspective view observed from the catheter connection end of the catheter frame of the nasal mask interface of the fourth embodiment;

[0185] Fig.76 Is an upper perspective view observed from the seal housing connection end of the catheter frame of the nasal mask interface of the fourth embodiment;

[0186] Fig.77 Is a top view of the catheter frame of the nasal mask interface of the fourth embodiment;

[0187] Fig.78 Is a side elevation view of the catheter frame of the nasal mask interface of the fourth embodiment;

[0188] Fig.79The cross-sectional view of the wire AL of Fig.77 is of the catheter frame of the nasal mask interface of the fourth embodiment through Fig.77 ;

[0189] Fig.80 The end view of the catheter frame of the nasal mask interface of the fourth embodiment as viewed from the catheter connection end of the catheter frame;

[0190] Fig.81 The end view of the catheter frame of the nasal mask interface of the fourth embodiment as viewed from the sealed housing connection end of the catheter frame;

[0191] Fig.82 The upper perspective view of the yoke of the nasal mask interface of the fourth embodiment as viewed from the outside;

[0192] Fig.83 The exploded top view of the yoke of the nasal mask interface of the fourth embodiment;

[0193] Fig.84 The top view of the yoke of the nasal mask interface of the fourth embodiment;

[0194] Fig.85 The bottom side view of the yoke of the nasal mask interface of the fourth embodiment;

[0195] Fig.86 The front view of the yoke of the nasal mask interface of the fourth embodiment as viewed from the outside;

[0196] Fig.87 The side elevation view of the yoke of the nasal mask interface of the fourth embodiment;

[0197] Fig.88 The partial exploded front view of the yoke of the nasal mask interface of the fourth embodiment, particularly showing the end cap of the yoke being separated;

[0198] Fig.89 Another partial exploded front view of the yoke of the nasal mask interface of the fourth embodiment, particularly showing the end cap of the yoke connected to the back of the yoke;

[0199] Fig.90 The rear view or inner view of the front part of the yoke of the yoke assembly of the nasal mask interface of the fourth embodiment;

[0200] Fig.91 The rear view or inner view of the front part of the yoke of the yoke assembly of the nasal mask interface of the fourth embodiment, showing the direction lock and filaments of the automatically adjustable headband assembly;

[0201] Fig.92 The partial cross-sectional view of an alternative configuration of the yoke assembly, showing the components of the headband adjustment mechanism of the nasal mask interface according to the fourth embodiment;

[0202] Fig.93 Shows a method of attaching an end cap to one end of a yoke of a nasal mask interface of a fourth embodiment;

[0203] Fig.94 Is Fig.93 Partial rear perspective view of the assembled end cap and yoke;

[0204] Fig.95 Is an end view of the yoke end of the yoke of the nasal mask interface of the fourth embodiment;

[0205] Fig.96 Is Fig.95 Top view of the yoke end;

[0206] Fig.97 Is a cross-sectional view of the end cap attached to the yoke end taken along line AK in; Fig.95 ;

[0207] Fig.98 Is Fig.97 Cross-sectional view of the end cap;

[0208] Fig.99 Is a cross-sectional view of the direction lock of the yoke of the nasal mask interface of the fourth embodiment, shown in the locked position;

[0209] Fig.100 Is in the locked position Fig.99 Perspective cross-sectional view of the direction lock shown;

[0210] Fig.101 Is in the unlocked position Fig.99 Cross-sectional view of the direction lock shown;

[0211] Fig.102 Is in the unlocked position Fig.99 Perspective cross-sectional view of the direction lock shown;

[0212] Fig.103 Is a perspective view of the outside of a first form of a nasal mask interface of a fifth embodiment, the nasal mask interface including a nasal seal, a nasal seal housing with an integrated conduit connector, and a yoke;

[0213] Fig.104 Is Fig.103 Upper perspective view of the first form of the nasal mask interface as viewed from the front side or the face-contacting side;

[0214] Fig.105 Is Fig.103 Outside view of the first form of the nasal mask interface;

[0215] Fig.106 Is Fig.103Front elevation view of the side of the first form of nasal mask interface;

[0216] Fig.107 is Fig.106 Front elevation view of the side of the first form of nasal mask interface, which does not have a yoke;

[0217] Fig.108 is Fig.107 Outside perspective view of the first form of nasal mask interface shown;

[0218] Fig.109 is Fig.103 Outside view of the sealing housing of the first form of nasal mask interface;

[0219] Fig.110 is Fig.109 Wearer side view of the sealing housing;

[0220] Fig.111 is Fig.103 Front view or face contact side view of the nasal seal of the first form of nasal mask interface;

[0221] Fig.112 is Fig.111 Rear view or outside view of the nasal seal;

[0222] Fig.113 is Fig.111 Front elevation view of the side of the nasal seal;

[0223] Fig.114 is Fig.103 Cross-sectional view of the first form of nasal mask interface taken through Fig.105 line BB of;

[0224] Fig.115 、 Fig.116 and Fig.117 respectively show Fig.103 Wearer side perspective view, front outside view and top view of the yoke of the first form of nasal mask interface;

[0225] Fig.118 Outside perspective view of the second form of the nasal mask interface of the fifth embodiment;

[0226] Fig.119 is Fig.118 Front elevation view of the side of the second form of nasal mask interface;

[0227] Fig.120 is Fig.118 Outside view of the second form of nasal mask interface;

[0228] Fig.121 is Fig.118 Front view or face - contacting side view of the second - form nasal mask interface;

[0229] Fig.122 is Fig.118 Outside view of the sealing housing of the second - form nasal mask interface;

[0230] Fig.123 is Fig.118 Side - front view of the sealing housing of the second - form nasal mask interface;

[0231] Fig.124 、 Fig.125 and Fig.126 show Fig.118 Front perspective view, outside view and top view of the yoke of the second - form nasal mask interface;

[0232] Fig.127 is Fig.118 Cross - sectional view of the second - form nasal mask interface through the line BC of Fig.120 ;

[0233] Fig.128 is Fig.127 Close - up cross - sectional view of the area BD of

[0234] Fig.129 Outside perspective view of the third - form nasal mask interface of the fifth embodiment;

[0235] Fig.130 is Fig.129 Side - front view of the third - form nasal mask interface;

[0236] Fig.131 is Fig.129 Outside view of the third - form nasal mask interface;

[0237] Fig.132 is Fig.129 Front view or face - contacting side view of the third - form nasal mask interface;

[0238] Fig.133 is Fig.129 Outside view of the sealing housing of the third - form nasal mask interface;

[0239] Fig.134 is Fig.133 Side - front view of the sealing housing;

[0240] Fig.135 is Fig.129 Face - contacting side view of the nasal seal of the third - form nasal mask interface;

[0241] Fig.136Yes Fig.135 External view of the nasal seal of

[0242] Fig.137 Yes Fig.135 Perspective view of the contact face side of the nasal seal of

[0243] Fig.138 Yes Fig.135 Side elevation view of the nasal seal of

[0244] Fig.139 Is the cross-sectional view of the nasal seal through Fig.135 Line BE of

[0245] Fig.140 External perspective view of the fourth form of the nasal mask interface of the fifth embodiment;

[0246] Fig.141 Yes Fig.140 Side elevation view of the fourth form of the nasal mask interface of

[0247] Fig.142 Yes Fig.140 External view of the fourth form of the nasal mask interface of

[0248] Fig.143 Yes Fig.140 Contact face side view of the fourth form of the nasal mask interface of

[0249] Fig.144 Yes Fig.140 External view of the sealing housing of the fourth form of the nasal mask interface of

[0250] Fig.145 Yes Fig.144 Side elevation view of the sealing housing of

[0251] Fig.146 Yes Fig.140 Perspective view of the contact face side of the nasal seal of the fourth form of the nasal mask interface of

[0252] Fig.147 Yes Fig.146 Side elevation view of the nasal seal of

[0253] Fig.148 Yes Fig.146 Cross-sectional view of the nasal seal through Fig.146 Center line BF indicated in

[0254] Fig.149 Is the cross-sectional view of the fourth form of the nasal mask interface through Fig.142 Line BG of; the nasal mask interface includes Fig.135Cover of the nasal seal of the third form of the nasal mask interface, for comparing shapes and sizes;

[0255] Fig.150 Is a front view or a contact face side view of the sixth embodiment of the nasal mask interface, particularly showing the yoke being located directly below the conduit frame or the inlet orifice of the sealing housing;

[0256] Fig.151 Is a side view of the nasal mask interface of the sixth embodiment;

[0257] Fig.152 Is a side front view of the nasal mask interface of the sixth embodiment;

[0258] Fig.153 Is a side view of the sealing housing and the yoke of the nasal mask interface of the sixth embodiment;

[0259] Fig.154 Is a contact face side view of the sealing housing and the yoke of the nasal mask interface;

[0260] Fig.155 Is a contact face side view of the first form of the nasal seal of the nasal mask interface of the seventh embodiment, wherein the nasal seal includes a wing portion extending from the side of the nasal seal;

[0261] Fig.156 Is Fig.155 A side view of the first form of the nasal seal;

[0262] Fig.157 Is Fig.155 A side front view of the first form of the nasal seal;

[0263] Fig.158 Is an outer perspective view of the second form of the nasal seal of the nasal mask interface of this embodiment, particularly showing a longer wing portion (relative to the first form) extending from the side of the nasal seal;

[0264] Fig.159 Is Fig.158 A contact face side view of the second form of the nasal seal;

[0265] Fig.160 Is Fig.158 A side view of the second form of the nasal seal;

[0266] Fig.161 Is Fig.158 A top view of the second form of the nasal seal;

[0267] Fig.162Is a perspective view of a nasal mask interface of a seventh embodiment, the nasal mask interface including a second form of nasal seal being worn by a user;

[0268] Fig.163 Is a side front view of a first form of a nasal mask interface of an eighth embodiment, wherein the interface includes a forehead support extending from the nasal seal or the seal housing;

[0269] Fig.164 Is of a user wearing Fig.163 a first form of nasal mask interface;

[0270] Fig.165 Is a contact face side view of a second form of a nasal mask interface of an eighth embodiment, wherein the nasal seal includes a nose bridge support protrusion;

[0271] Fig.166 Shows the Fig.165 lateral view of the second form of nasal seal;

[0272] Fig.167 Shows the Fig.165 side front view of the second form of nasal seal;

[0273] Fig.168 Shows the Fig.165 cross-sectional view of the second form of nasal seal through the line EE of Fig.166 ;

[0274] Fig.169 Is of a user wearing Fig.165 the second form of nasal seal;

[0275] Fig.170 Is of a user wearing Fig.169 the second form of nasal seal in, showing the gap between the nose bridge support protrusion and the user's nose bridge;

[0276] Fig.171 Is a lateral view of a first form of nasal seal of a nasal mask interface of a ninth embodiment, wherein the nasal seal includes additional support ribs within the nasal mask;

[0277] Fig.172 Is Fig.171 contact face side view of the first form of nasal seal;

[0278] Fig.173 Is a cross-sectional view of the first form of nasal seal through the line FF of Fig.171 ;

[0279] Fig.174 Is Fig.173 Perspective view of a cross-sectional view of the nasal seal;

[0280] Fig.175 Side view of the contact face of the nasal seal of the second form of the nasal mask interface of the ninth embodiment;

[0281] Fig.176 is Fig.175 Outside view of the second form of the nasal mask;

[0282] Fig.177 is Fig.175 Side elevation view of the second form of the nasal seal;

[0283] Fig.178 is the cross-sectional view of the second form of the nasal seal through Fig.175 line FG;

[0284] Fig.179 is a user wearing Fig.175 perspective view of the second form of the nasal seal;

[0285] Fig.180 is a user wearing Fig.179 side cross-sectional view of the user wearing the second form of the nasal seal in;

[0286] Fig.181 is Fig.171 and Fig.175 Cross-sectional views of the first form of the nasal seal and the second form of the nasal seal, with the two nasal seals overlapping each other to show the comparison of shapes and sizes;

[0287] Fig.182 is Fig.171 and Fig.175 Contact face side views of the first form of the nasal seal and the second form of the nasal seal, with the two nasal seals overlapping each other for comparison of shapes and sizes;

[0288] Fig.183 Outside perspective view of the third form of the nasal seal of the nasal mask interface of the ninth embodiment;

[0289] Fig.184 is Fig.183 outside view of the third form of the nasal seal;

[0290] Fig.185 is Fig.183 contact face side view of the third form of the nasal seal;

[0291] Fig.186Is an external perspective view of the sealing housing and catheter frame assembly of the first form of the nasal mask interface of the tenth embodiment;

[0292] Fig.187 Is Fig.186 Exploded view of the sealing housing and catheter frame assembly of the first form;

[0293] Fig.188 Is Fig.186 Side elevation view of the catheter frame of the first form of the assembly;

[0294] Fig.189 Is Fig.186 Top view of the catheter frame of the first form of the assembly;

[0295] Fig.190 Is an external perspective view of the sealing housing and catheter frame assembly of the second form of the nasal mask interface of the tenth embodiment;

[0296] Fig.191 Is Fig.190 Exploded view of the second form of the assembly;

[0297] Fig.192 Is Fig.190 Side elevation view of the catheter frame of the second form of the assembly;

[0298] Fig.193 Is Fig.190 Top view of the catheter frame of the second form of the assembly;

[0299] Fig.194 Is an external perspective view of the sealing housing and catheter frame assembly of the third form of the nasal mask interface of the tenth embodiment;

[0300] Fig.195 Is Fig.194 Exploded perspective view of the third form of the assembly;

[0301] Fig.196 Is Fig.194 Side elevation view of the catheter frame of the third form of the assembly;

[0302] Fig.197 Is Fig.194 Top view of the catheter frame of the third form of the assembly;

[0303] Fig.198 Is an external perspective view of the sealing housing and catheter frame assembly of the fourth form of the nasal mask interface of the tenth embodiment;

[0304] Fig.199 Is Fig.198 Exploded perspective view of the fourth form of the assembly;

[0305] Fig.200 is Fig.198 a side elevation view of a duct frame of a fourth form component of

[0306] Fig.201 is Fig.198 a top view of a duct frame of a fourth form component of

[0307] Fig.202 is an exterior perspective view of a sealed housing and duct frame assembly of a fifth form of a nasal mask interface of a tenth embodiment;

[0308] Fig.203 is Fig.202 an exploded perspective view of a fifth form component of

[0309] Fig.204 is Fig.202 a side elevation view of a duct frame of a fifth form component of

[0310] Fig.205 is Fig.202 a top view of a duct frame of a fifth form component of; and

[0311] Fig.206 is a front view of a full face mask seal having a sub - nasal support configuration according to an eleventh embodiment. Detailed Description

[0312] System Overview

[0313] Figure 1 is a schematic view of a continuous positive airway pressure (CPAP) system 10 for providing a heated and humidified air stream to a user U through an interface 11 worn by the user, where the interface is connected to the CPAP system 10 by a flexible duct or tube 12.

[0314] The humidifying chamber 14 has a heat-conductive substrate in contact with the heating plate 16 of the humidifier 17 to humidify the air stream. A conduit 12 is connected to the outlet 13 of the humidifying chamber 14 to transport the humidified air to the user interface 11. The humidifier 17 includes a controller 18, such as but not limited to a microprocessor-based controller that executes computer software commands stored in an associated memory. The controller 18 receives input commands from a plurality of sources, including the user input interface 19, which may be a dial or touch screen, and is capable of setting a predetermined value for the humidity, temperature, or other characteristics of the humidified air supplied to the user U. The controller 18 may also receive inputs from one or more other sources, such as a temperature sensor 20 and / or a flow rate sensor 21 connected via a connector 22 to communicate with the controller 18, and / or a heating plate temperature sensor 23. In response to the humidity or temperature value set by the user, the controller 19 determines when the heating plate 16 should be energized and / or to what level it should be energized to appropriately heat the water contained in the humidifying chamber 14.

[0315] As a certain volume of water in the chamber is heated, water vapor begins to fill the chamber volume above the water surface. The water vapor exits the outlet 13 of the humidifying chamber along with an air stream that enters the humidifying chamber 30 through an inlet 26 from a supply device 25, such as a blower 27. The blower 27 may be variable in fan speed or may include a variable pressure regulator. The blower 27 draws air through an inlet 28. The blower may be controlled, for example, by the controller 29 or the controller 18. The controller may control the blower speed, regulated pressure, etc. according to any suitable criteria. For example, the controller may respond to inputs from the controller 18 and user-set pressure and / or fan speed values (e.g., preset values), which may be set using the user interface 30 (e.g., a dial).

[0316] The conduit 12 may include a heater, such as a heating wire, to heat the wall of the conduit to reduce condensation of the humidified gas within the conduit.

[0317] The seals and interfaces of the present disclosure may be used in such a CPAP system as described (whether humidified or not), or alternatively in other forms of respiratory systems, such as VPAP (variable positive airway pressure) systems, BiPAP (bi-level positive airway pressure) systems, or in combination with ventilators, high-flow therapy systems, and are generally described herein by way of example only with reference to CPAP therapy.

[0318] A nasal mask interface with a headband above the ears

[0319] See Figure 2A and Figure 2B, according to one embodiment, a user U wearing a nasal mask interface 50 is depicted. The nasal mask interface 50 includes a nasal mask, which includes a seal 51 and a seal housing 53. The interface also includes a headband 52 for securing the mask to the wearer. Typically, the interface also includes a flexible supply conduit or tube 55 from the mask (such as a central connection portion at the front or lower side of the mask), which is integral with or connected to the supply conduit 12 of a CPAP or other respiratory system. The conduit 55 can be directly connected to the mask or indirectly connected to the mask via a connector or conduit frame, such as but not limited to a straight connector or a swivel elbow 34, which can swivel relative to the mask or seal housing so that the positioning of the conduit path relative to the mask on the patient's face can be adapted to the patient's sleeping position.

[0320] As will be explained later, the mask can include a flow-limiting outlet or vent hole (or a bypass outlet or vent hole) 57 for providing a gas flush from the interface. The outlet 57 can be in the form of a collection of small orifices. The outlet can be provided on the seal housing 53 as shown, on a conduit connector or frame (such as an elbow connector or a straight connector), or at other locations on the interface.

[0321] In this embodiment, the nasal mask is secured to the user U by a headband 52 that extends above the user's ears. For example, the headband 52 includes side straps 54 that are connected to opposite sides (only one side is visible) of the nasal mask interface 50 at attachment points 56, extend along the sides or cheeks of the user's face and above the user's ears 58, and are connected to one or more other straps or strap portions. The headband 52 in this embodiment also includes a top strap or crown strap 60 that extends over the user's head or crown, and a back strap or rear strap 62. As those skilled in the art will recognize, the side straps 54 are integrally formed or otherwise connected to the top strap 60 and the back strap 62. In one embodiment, the headband straps are formed of or include a flexible breathable material, such as breathable neoprene material, or neoprene material, or similar materials. In some embodiments, the headband can be an auto-adjusting headband, examples of which will be explained later.

[0322] The depicted headband 52 above the ears with single-sided straps 54 attached to corresponding side attachment points or attachment locations on the nasal mask interface 50 is generally a desirable configuration from a comfort perspective as compared to a headband configuration having a pair of upper and lower straps connected to a nasal mask interface including a T-shaped frame. Figure 2AThe unilateral strap headband configuration 52 above the ear depicted does not require a T-bar frame that extends upward to the user's forehead and also eliminates the need for the following two pairs of upper and lower straps: one pair extending from the top of the T-bar frame at the user's forehead above the user's ears and the other pair extending from the nasal mask interface to below the user's ears, as previously explained.

[0323] See Figure 2A and Figure 2B , although the unilateral strap headband configuration 52 above the ear is preferred from a comfort perspective relative to a headband fixed to a T-bar frame, it has been found that in use, during flow therapy in which the mask delivers positive pressure gas to the user's nose, there is a strong force acting on the nasal mask interface, and thus the nasal mask tends to arch upward, slip upward, or slide upward on the user's face, which may affect the tightness of the seal around the user's nose and create leaks or leak paths. The upward arching of the nasal seal may also distract and discomfort the user. It has been found that the nasal mask interface is subjected to a substantially oblique force represented by vector A along the lateral strap between the user's nose and above the ear from each lateral strap, and a substantially horizontal offset blowing force B that forces the nasal interface substantially horizontally away from the user's nose and face when positive pressure gas flow is delivered to the wearer during use. The resultant force R of the headband force A and the blowing force B acting on the nasal mask interface is a substantially vertical resultant force represented by vector R.

[0324] As will be explained with reference to the following embodiments, the nasal mask interface of the present disclosure is provided with a nasal seal having an internal subnasal support configured to contact or engage below the user's nose to generate an opposing downward force D that at least partially counteracts, resists, or otherwise mitigates the resultant force R generated by the headband force A and the blowing force B, thereby stabilizing the nasal mask in a proper position above the user's nose during use and preventing the nasal mask from slipping upward or otherwise moving upward on the user's face from its initial fixed position before gas delivery begins.

[0325] See Figure 3 , the subnasal support of the nasal mask assembly is configured to contact at least one or more portions of the subnasal surface 70 of the user's nose when the mask is worn. The anatomical structure of the subnasal surface of the user's nose is typically defined by the central columella region 72 of the nasal septum and the left and right alar margin regions 80, the central columella region extending between the two nostrils 74 and separating the two nostrils from the base 76 to the tip 78 of the nose. The columella 72 and the alar regions 80 generally define the contactable skin surface on the lower side of the user's nose surrounding the nostrils or nostril openings 74.

[0326] As will be further explained in detail with reference to the exemplary embodiments below, the sub-nasal support of the nasal mask interface is configured to extend within the mask cavity that receives the user's nose in use and has a contact surface configured to contact at least a portion of the sub-nasal surface of the user's nose without obstructing or fully obstructing the user's nostrils. Depending on the size of the user's nose, the sub-nasal support contacts one or more portions of the sub-nasal surface and, in the best case, does not cause any obstruction to the user's nostrils or, in the worst case, only partially obstructs one or both nostrils.

[0327] Various embodiments of a nasal mask interface having a sub-nasal support and a nasal seal of the interface will be described below. It should be appreciated that such nasal seals can be employed or used with a variety of different nasal interface components and headband configurations, but are particularly suitable for headband configurations that generate an upward lifting force in use, which causes the nasal mask to slide upward or arch upward on the user's face, such headband configurations being, by way of example and not limitation, the headband above the ears as described and shown in reference to Figure 2A the headband above the ears as described and shown in reference to

[0328] Various embodiments of the nasal seal will be described below, and in some embodiments, reference is made to the entire nasal mask interface assembly including any one or more of a seal housing, a conduit frame, a headband frame or yoke, and / or a headband. It should be appreciated that the various embodiments of the nasal seal described can also be used interchangeably in a variety of suitable interface components, and the interface component examples and alternatives described in the context of one embodiment are also applicable to other embodiments of the nasal seal to be described. Generally speaking, it should be appreciated that the various components of the various embodiments can be interchanged and / or combined with one another to form alternative configurations.

[0329] First Embodiment - Nasal Seal with Sub-Nasal Support Having a Central Extension or Connecting Portion

[0330] Overview

[0331] See Figures 4 to 22 for a more detailed description of the first form of the first embodiment of the nasal seal and the nasal seal interface assembly including the nasal seal. Reference will also be made to Fig.23 for a description of an alternative second form of the nasal seal of the first embodiment.

[0332] See Figures 4 to 10, the nasal mask interface assembly 100 of the first embodiment includes a flexible nasal seal 102 that is connected to or capable of being connected to a rigid (or at least more rigid relative to the nasal seal) sealing housing 104 to define a mask cavity generally indicated by 106. As will be appreciated by those skilled in the art, the mask cavity will receive the user's nose and the supply of gas for delivery to the user's airway via the user's nostrils or nose apertures. The rigid sealing housing or shell 104 can be directly connected to the headband strap via one or more attachment or connection points or components provided on the sealing housing, or alternatively can be indirectly connected to the headband via a headband frame member 108 mounted or provided on the sealing housing. In this embodiment, the sealing housing 104 is provided with an inlet opening or aperture 110 that is configured to be connected to a flexible gas delivery conduit 55 of the aforementioned type to deliver a heated and humidified gas stream from a breathing device (such as a CPAP device or the like). In this embodiment, the sealing housing 104 is also provided with a set of one or more apertures or holes in the form of exhaust vent holes or bias vent holes 112.

[0333] The flexible nasal seal 102 includes a contact face surface 120 having an inner peripheral edge 122 that defines a nasal receiving opening leading into the mask cavity 106 for receiving the user's nose in use. In use, the nasal mask interface 100 is secured against the user's face using a headband such that the contact surface 120 of the nasal seal 102 surrounds or circumscribes the user's nose and sealingly engages around the user's nose, such as against the cheek surfaces and / or the lateral side surfaces of the user's nose, the upper lip region below the user's nose, and the bridge region across the user's nose. In this embodiment, the nasal seal 102 also includes a sub-nasal support 124 that extends internally within the mask cavity 106 at a position generally behind or relative to the contact face surface 120. The sub-nasal support 124 includes a contact surface that is configured or oriented to contact at least a portion of the sub-nasal surface of the user's nose in use to at least partially counteract the upward lifting resultant force R generated by the blow-off force B and the headband force A as described above.

[0334] See Fig.10 , the top of the nasal mask interface is indicated by 101, the bottom by 103, the contact face side or wearer side of the nasal mask interface by 105, and the outer side of the nasal seal by 107 for future reference. The sealing housing 104, the headband frame 108, and the nasal seal 102 will each be described in further detail below.

[0335] Sealing Housing and Frame

[0336] See Fig.11 and Fig.12 ,the sealed housing or shell 104 is defined by an opening generally indicated by 140, which is connected or coupled to the nasal seal 102 on the wearer side of the nasal mask interface 100 and extends to the outer or outside side of the nasal interface, which outer or outside side includes Fig.11 the inlet 110 and the exhaust vent 112 shown in. The sealed housing 104 is a substantially hollow member that is generally shaped to provide or define a cavity or volume generally indicated by 142 for receiving a gas flow from the inlet 110. When the sealed housing 104 is assembled to the nasal seal 102, the sealed housing cavity 142 forms part of the overall mask cavity 106. In this embodiment, when the sealed housing 104 extends rearward from the opening 140 to the outside, the shape of the sealed housing generally tapers inwardly.

[0337] In this embodiment, the exhaust vent 112 includes a collection or plurality of small holes or orifices that extend through the sealed housing and together define the vent 112 from the central intermediate region to the upper region of the sealed housing 104. It should be appreciated that in other embodiments, the vent or exhaust hole 112 may be omitted from the sealed housing, and the vent or exhaust hole may be provided at another location in the breathing circuit, such as in a connecting conduit or swivel elbow that couples a gas conduit to the inlet 110 of the nasal mask interface or at other locations along the breathing circuit.

[0338] In this embodiment, the inlet orifice or port 110 is disposed in the lower or bottom region of the sealed housing 104 and is centered, but this location is not required. It should be appreciated that a flexible gas conduit may be directly coupled to the inlet 110 via a connecting conduit, or alternatively indirectly coupled via a straight connector or conduit frame, a connecting elbow (such as a swivel elbow), a ball joint connection, or the like.

[0339] In this embodiment, the nasal seal 102 is removably or releasably coupled to, or capable of being removably or releasably connected to, the sealed housing 104 such that if desired, the nasal seal can be removed for cleaning or replacement. In this embodiment, the opening 140 of the sealed housing 104 is provided with a peripheral ridge or extension that is configured to engage or receive a complementary peripheral channel, to be explained later, disposed on the outer side of the nasal seal 102, thereby releasably coupling these components together. Once the nasal mask interface is assembled and secured to the user's nose, the nasal mask interface is substantially sealed and defines a substantially enclosed mask cavity 106.

[0340] In alternative embodiments, it should be appreciated that the nasal seal 102 may be permanently or semi - permanently attached or coupled to the seal housing 104. For example, in alternative embodiments, the outer side of the nasal seal 102 that is distal to the contact face side may be overmolded or otherwise fixed or adhered to the opening 140 of the seal housing 104 or adjacent to the opening.

[0341] Regardless of whether the nasal seal 102 is removable or permanently coupled to the seal housing 104, it should be appreciated that the shape and dimensions of the edge of the seal housing or the opening 140 are configured to complement or match a corresponding outer edge or connection portion at the outer side of the nasal seal 102 around the perimeter of the nasal seal interface.

[0342] The seal housing 104 may be formed of any suitable material that provides a rigid housing or is at least rigid relative to the flexible nasal seal. In this embodiment, the seal housing is typically formed of a plastic polymer (such as polycarbonate or the like). In alternative embodiments, the seal housing may be semi - rigid. In one example, the seal housing may be formed of the same type of material as the nasal seal (e.g., a silicone material), but may be significantly thicker so as to generally have less flexibility or greater rigidity than the nasal seal.

[0343] Specifically referring to Fig.11 , in this embodiment, the nasal mask interface includes a headband frame member 108 in the form of a yoke that extends laterally from one side of the seal housing 104 to the other side between the vent holes 112 and the inlet 110 around the outer side of the seal housing 104. In this embodiment, the frame member 108 is removably received within complementary channels formed in the outer - side surfaces of the seal housing 104, but the frame may alternatively be permanently fixed or coupled within the receiving channels. As Fig.12 shown, the frame member 108 provides a single headband attachment point 144 on the left and right sides of the seal housing 104. This provides a single connection point or location on each side of the seal housing for connection or coupling to a respective single - side strap of a headband system, such as the over - ear head - mounted system referred to in Figure 2A . In alternative embodiments, it should be appreciated that the frame 108 may be omitted and the seal housing may provide headband attachment points on each side of the seal housing, which are either integrally formed with the seal housing or otherwise provided on the sides of the seal housing for connection to a headband system (such as a single - side strap headband system).

[0344] Nasal seal

[0345] See Figures 13 to 22, the nasal seal component 102 of the nasal mask interface 100 of the first embodiment will be described in further detail. The nasal seal 102 is flexible and soft and can be formed of a silicone material or other suitable material.

[0346] Referring to Fig.13 the contact face side or wearer side of the nasal seal 102 shown in, the contact surface, generally designated (120), is configured to seal around the user's nose, including sealing across the user's nasal bridge. In this embodiment, the contact surface 120 circumscribes the nose and seals around the user's nose. In this embodiment, the contact surface portion of the nasal seal includes an upper lip region generally designated 121, which is configured to contact the upper lip region of the user's face, such as at a location above the vermilion border and below the nostrils. The contact surface 120 also includes left and right cheek or side regions 123 that extend between the upper lip region 121 at the bottom of the seal 102 and a nasal bridge region or a region proximal to the nasal bridge region at the top of the seal 102. The cheek regions 123 of the contact surface 120 are configured to contact the user's medial cheek surfaces and / or the user's lateral nose surfaces on both sides of the nose. The nasal bridge region 125 of the contact surface 120 is configured to extend over the nose, contact the nasal bridge region of the user's nose, and connect the two cheek regions 123. The overall shape and configuration of the contact surface 120 are configured to conform to the contour of the user's face in a sealing manner around the nose and to sealingly engage around the user's nose when secured to the user's head via a headband and when the nasal mask interface receives gas flow. The nasal seal 102 can be considered an inflatable type, since under pressure, the seal will push the contact face surface 120 against the user's face and deform to seal substantially against the user's facial contour, including one or more of the upper lip, medial cheek, lateral nose, and nasal bridge.

[0347] As previously discussed, the contact surface 120 of the nasal seal 102 terminates at an inner peripheral edge 122 that defines a nasal receiving opening into the mask cavity when the seal 102 is assembled to the seal housing 104.

[0348] Referring to Fig.21 and Fig. 22, the nasal seal 102 is substantially defined by a surface portion 120 that contacts the face and a sidewall portion 126 that extends rearwardly from the contact surface 120 around the perimeter of the seal and terminates at a connection edge generally designated 127 on the outer or outside side of the seal, which connection edge is coupled or connectable to an opening 140 of the seal housing 104. As previously described, in this embodiment, the nasal seal 102 is releasably connectable to the seal housing, and the terminating edge of the sidewall 126 includes a peripheral channel 128 that is configured to engage a complementary peripheral ridge or extension provided at the opening 140 of the seal housing 104. As previously discussed, in alternative embodiments, the flexible nasal seal 102 may be permanently or semi - permanently attached or coupled to the seal housing 104, such as via overmolding, welding, or other attachment methods. In further alternative embodiments, the interface may be provided with a semi - rigid or rigid clamp member that is shaped to correspond to the connection edge 127 on the outer or outside side of the nasal seal. In such embodiments, the connection edge 127 of the seal may be overmolded or otherwise permanently attached to the rigid clamp member to provide a rigid edge or portion at the outer side of the seal. The rigid clamp member may be configured to engage or otherwise connect to a complementary base or housing member to couple the nasal seal to the base or housing.

[0349] As Fig. 22 shown, the contact face surface 120 of the nasal seal forms a flange that curls or extends inwardly from the sidewall 126 portion of the nasal seal. In this embodiment, the region at or toward the terminating edge 127 of the sidewall 126 may be a region that is thickened relative to the remainder of the sidewall and the contact surface portion of the nasal seal to accommodate the connection channel 128 or otherwise provide some stability outside the overall shape of the nasal seal.

[0350] As discussed, the nasal seal 102 is formed of a flexible and compliant material such that the nasal seal 102 is flexible relative to the rigid housing 104. By way of example, the seal 102 may be formed of a silicone material or a similar material.

[0351] The sub - nasal support of the nasal seal

[0352] In this embodiment, the nasal seal 102 includes a sub - nasal support 124 (or nasal suspension strap) that extends at least between the sides of the seal and laterally across the nasal seal within the mask cavity 106 when the nasal seal 102 is assembled to the seal housing 104. The sub - nasal support 124 is configured to contact at least a portion of the sub - nasal surface of the user's nose to counteract any lifting forces generated during the wearing and use of the nasal mask as previously discussed.

[0353] In this embodiment, the sub-nasal support extends at least laterally between opposite left and right sides of the nasal seal across the nasal seal. As shown, the sub-nasal support is disposed at or behind the opening 106 of the nasal seal. The sub-nasal support 124 is fixedly connected to the nasal seal in that it cannot be removed. In one form, the sub-nasal support 124 is integrally molded within the nasal seal. In an alternative form, it should be appreciated that the sub-nasal support part or portion of the nasal seal 102 may be formed separately and then fixedly coupled within the nasal seal (such as via an adhesive or welding, etc.), or the sub-nasal support part or portion may be connected to the seal housing.

[0354] In this embodiment, the sub-nasal support configuration 124 includes an elongate main lateral portion or strip 129 that extends across and within the nasal seal, such as being suspended between opposite sides of the seal. Referring Fig.14 , Fig.17 and Fig. 22 , the main lateral portion 129 of the sub-nasal support is connected to or extends from the nasal seal at a position that is at least isolated or offset from the peripheral opening edge 122 of the contact surface 120, but in this embodiment is also completely separated or offset from the contact surface 120 such that the lateral portion 129 does not inhibit or reduce the sealing engagement or deformability of the contact surface 120 with the user's face in the cheek region and / or the lateral nasal region 123. In this embodiment, the main lateral portion 129 extends or is connected at positions on the inner surface of the opposite sidewalls 126 of the nasal seal behind the contact surface 120. In this embodiment, the connection positions 131 correspond to or include the termination edges 127 of the sidewalls 126, but this is not necessary.

[0355] In this embodiment, the sub-nasal support 124 further includes a central extension portion 132 that extends centrally from the main lateral portion 129 and is coupled or connected to or at the opening edge 122 of the contact surface 120 located in the upper lip region 121. In an alternative embodiment, as will be explained later with reference to Fig.23 , the central extension portion 132 may alternatively be connected to the lower portion of the upper lip region 121 of the contact surface 120 below the opening edge 122 of the seal, or alternatively may be connected at a position that is at least partially or completely offset or isolated from the contact surface 121, such as to the lower portion of the sidewall 126 of the nasal seal behind the contact surface 120.

[0356] The sub-nasal support 124, which includes a main lateral portion 129 and a central extension portion 132, provides a contact surface that is configured and / or oriented to contact at least a portion of the sub-nasal surface of the user's nose during use. In this configuration, the main contact surface of the main lateral portion 129 is configured to engage at least a portion of the apex of the sub-nasal surface of the user's nose, which can include, for example, the apex of the columella 72 and multiple portions of the alar margins 80 towards the apex of the nose (as Figure 3 shown). The central extension portion 132 is configured to contact the columella 72 region of the sub-nasal surface of the user's nose, or at least a portion of the columella that is located between the tip and the base of the nose, but preferably, most of the columella extends from this base. The final contact surface area of the sub-nasal support depends on the shape and size of the user's nose. The configuration of the sub-nasal support is designed to contact the largest one or more portions of the sub-nasal surface while substantially not obstructing the user's nostrils 74, where the nostrils tend to align with the open spaces 134 on both sides of the central extension portion 132, as Fig.13 shown. Depending on the size and shape of the user's nose, the sub-nasal support 124 is typically configured to best completely avoid obstructing the user's nostrils, but at worst only partially obstruct one or both nostrils.

[0357] As shown, the contact surface of the sub-nasal support 124 is typically oriented and configured relative to the nasal seal to engage the sub-nasal surface of the user's nose. In this embodiment, multiple portions of the sub-nasal support 124 are an integral thin fiber web or strip formed during the molding of the seal of the nasal seal. For example, the thickness of the sub-nasal support transverse to its contact surface is significantly less than the corresponding width of the contact surface at any location on the sub-nasal support. In one configuration, the thickness of the sub-nasal support portion can be substantially similar to the thickness of the nasal seal in the region of the contact surface 120 of the seal.

[0358] In this embodiment, the width of the main lateral portion 129 of the sub-nasal support 124 can vary along its length between the opposite sides of the nasal seal. In this example, the width W1 of the main lateral portion 129 can gradually increase from the center of the nasal seal towards each side. In this embodiment, as the central extension portion 132 of the sub-nasal support 124 extends from the main lateral portion 129 to the contact surface 120, the width W2 of this central extension portion gradually increases in width W2. In alternative embodiments, it should be recognized that the width of either or both of the main lateral portion or the central extension portion can be uniform along its length, or can have an alternative width profile along its length.

[0359] See Fig. 22, the central sealing axis BB is defined as tangentially extending between the outermost upper and lower contact points at the center when the contact surface 120 is in a relaxed state (e.g., not in use). As Fig. 22 shown, at least a portion of the contact surface in the central region of the sub-nasal support 124 (e.g., indicated by axis CC which extends coincidentally with the contact surface of one or more sub-nasal support portions in the central region) extends at an angle θ with respect to the sealing axis BB such that the contact surface of the sub-nasal support is not parallel or aligned with the sealing axis BB. In this embodiment, the contact surface in the central region of the sub-nasal support 124 is offset from the sealing axis BB by an angular orientation that is in the range of about 30 degrees to about 90 degrees, more preferably in the range of about 45 degrees to about 75 degrees, and even more preferably about 60 degrees. This angular orientation of at least the major nasal contact portion or surface of the sub-nasal support in the central region is configured to substantially align with the general or typical angular orientation of the sub-nasal surface of the user's nose when the user's nose is within the nasal seal.

[0360] As explained above, the sub-nasal support 124 in this embodiment is fixedly attached to the nasal seal 102 or is an integral part of the nasal seal. The drawings depict the nasal seal and its sub-nasal support 124 in a stationary (i.e., not in use) state. Similar to the contact surface 120 of the nasal seal, the sub-nasal support 124 is also configured to be soft and flexible or pliable such that when the nasal mask interface is secured to the user's face or otherwise worn in use, the shape and position of the sub-nasal support can conform to the sling-like effect on the sub-nasal surface of the user's nose. Typically, the sub-nasal support is non-stretchable in any direction, but may have some degree of stretch in alternative embodiments.

[0361] Alternative second form - a central extension that is completely separated or isolated from the opening edge of the nasal seal

[0362] See Fig.23, showing an alternative form of the nasal seal 102A of the first embodiment. The nasal seal 102A is similar to the nasal seal 102 of the first embodiment, except that it has a different sub-nasal support configuration 124A that is completely separated or isolated from the edge of the contact face surface 120 of the nasal seal. Similar numerals denote similar components. The alternative sub-nasal support configuration 124A includes a main lateral portion 129 and a central extension portion 132A. The difference from the nasal seal 102 is that the central extension portion 132A is not coupled or connected to the edge 122 of the contact surface 120, but is coupled or connected to the lower portion of the contact surface in the upper lip region, or alternatively is coupled or connected to a portion of the lower region of the seal that is not part of the contact surface 120, such as a portion of the lower sidewall 126 of the nasal seal. In this configuration, the sub-nasal support 124A is completely separated from the edge 122 of the contact surface 120 and, in some configurations, is completely separated from the contact surface 120 as a whole, such that the main lateral portion 129 and the central extension portion 132A are connected to the respective sidewall portions of the nasal seal at a position offset from or adjacent to the contact surface 120 that engages the user's face. The alternative embodiment of the nasal seal 102A is similar to the nasal seal 102 in these additional aspects of function and configuration and can be coupled to the seal housing 104 to form the nasal seal interface assembly as in the first embodiment.

[0363] Second Embodiment - Nasal Seal with Sub-Nasal Support Having Lateral Extensions

[0364] See Figure 24 to Figure 29 , various forms of a second embodiment of a nasal mask interface will be described. The nasal mask interface of the second embodiment is substantially similar to the first embodiment, except that the first form includes a nasal seal 102B having an alternative sub-nasal support configuration 124B. The nasal seal 102 is otherwise similar to the nasal seal 102 of the first embodiment and can be coupled to the seal housing 104 to form the aforementioned nasal seal interface assembly. Like reference numerals denote like features.

[0365] In this first form of the second embodiment, the alternative sub-nasal support configuration 124B still includes a main lateral portion 129 that extends across the interior of the nasal seal between opposite sides of the nasal seal and behind the contact surface 120. There is no central extension portion provided as in the configuration of the first embodiment. Instead, the sub-nasal support 124B includes a left extension portion and a right extension portion 132B that extend from opposite sides of the main lateral portion 129 and each connect to the open lower edge 122 of the contact surface 120 at corresponding locations on the side facing the upper lip region 121 of the seal. In this embodiment, the sub-nasal support 124B may also include a lateral extension 135 that extends along or near the open lower edge 122 of the contact surface 120 between the side extension portions 132B. Alternatively, the lateral extension 135 may be considered an extension of the contact surface 120 in the upper lip region to which the side extension portions 132B are connected. It should be recognized that the lateral extension portion 135 may be omitted in alternative embodiments such that the side extension portions 132B may extend downward to connect directly to the edge 122 of the contact surface 120 without the lateral extension portion 135.

[0366] In this alternative configuration 124B, the main lateral portion 129 is again configured to substantially contact a portion of the columella 72 that is at or towards the tip of the user's nose and substantially contact the end portion of the alar rim 80 at the tip of the nose. Each of the side extension portions 132B is configured to be substantially aligned with and contact a corresponding portion of the alar rim 80 of the sub-nasal surface (such as including the alar rim portion extending from the base of the nose). Thus, for the user's nostrils 74, this configuration leaves a main opening 134B in the sub-nasal support between the main lateral portion 129, the side extension portions 132B, and the contact surface 120 in the upper lip region.

[0367] Alternative second form - side extension portions completely separated or isolated from the opening edge of the nasal seal

[0368] See Fig.29, showing a second alternative form of the nasal seal 102C of the second embodiment. Like numerals represent like features. Also, the nasal seal 102C is otherwise similar to the nasal seal of the second embodiment, but has an alternative sub-nasal support configuration 124C, where a side extension 132C extends from a main lateral portion 129 and is connected to a portion of the nasal seal in the upper lip region that is offset or separated from the edge 122 of the nasal seal, such that the side extension 132C is separated from the edge 122 of the nasal seal. In one configuration, the side extension 132C is connected or extends to a portion of the contact surface 120 below the edge in the upper lip region, or in an alternative configuration, is connected to the nasal seal at a plurality of positions that are completely offset from the contact surface 120, such as at corresponding positions on the seal sidewall in the upper lip region below the lower edge 122 of the opening. This configuration provides a sub-nasal support 124C that is separated from the edge 122 of the contact surface 120 of the nasal seal.

[0369] Third Embodiment - Nasal Seal with "Floating" Sub-Nasal Support

[0370] See Figure 30 to Figure 34 , the third embodiment of the nasal seal 102D will be explained. As with the previous embodiments, the nasal seal 102D is similar to the nasal seal 102 of the first embodiment in that it can be used, for example, in the aforementioned nasal mask interface assembly by being coupled or connected to the seal housing 104. Like reference numerals represent like features.

[0371] The nasal seal 102D of the third embodiment includes an alternative sub-nasal support 124D that consists only of a main lateral portion or strip 129, without any central extension or side extension. In particular, the sub-nasal support 124D includes an elongated strip or band of material that extends laterally across the nasal seal between opposite sides of the seal and extends to or lies behind the contact facial surface 120, as in the previous embodiments. As with the previous embodiments, the lateral strip 129 can be coupled or connected at each end to a corresponding portion of the sidewall 126 or other portion of the seal, such that the sub-nasal support is separated or isolated from the contact surface 120, or at least from the edge of the contact surface. In the absence of the central extension or side extension of the previous embodiments, the sub-nasal support 124D can be considered a "floating" support that has a greater degree of mobility within the seal.

[0372] In this configuration, the sub-nasal seal 124D has a relatively small contact surface area and thus contacts the sub-nasal surface of the user's nose less. In particular, in the absence of either a central extension or a lateral extension, only a relatively small portion of the sub-nasal surface typically contacts the floating sub-nasal support configuration 124D. Depending on the size of the user's nose, the floating sub-nasal support typically engages or contacts multiple portions of the columella and adjacent alar margins 80 at or toward the tip of the nose. For those with larger noses, the sub-nasal support may contact in the middle region of the sub-nasal surface or further toward the sub-nasal surface at the base of the nose.

[0373] Fourth Embodiment - Low-Profile Nasal Mask Interface

[0374] Overview

[0375] Reference will now be made to Figure 35 to Figure 102 describe the nasal mask assembly of the fourth embodiment.

[0376] Reference Fig.35 and Fig.36 , the nasal mask assembly of the fourth embodiment includes a nasal mask interface 200 secured to a user's head via a headband 250, the nasal mask interface 200 being connected to a flexible gas supply conduit 260 that, in use, delivers a supply of breathable gas to the nasal mask interface 200 for delivery to the user's airway via the user's nose. In this embodiment, the headband 250 includes side straps or front straps 252 that are connected to opposite sides of the nasal mask interface 200 at attachment points 256 and extend along the sides or cheeks of the user's face and over the user's ears. This pair of front straps or side straps 252 is connected to or integrally extends into one or more other straps or strap portions. In this embodiment, the headband 250 includes a top strap or crown strap 254 that extends over the user's head or crown and a back strap or rear strap 258 that extends around the back of the user's head. As will be appreciated by those skilled in the art, the side straps 252 are integrally formed or otherwise connected to the top strap 254 and the back strap 258. As with the previous embodiments, the headband straps are typically formed of or include a flexible breathable material such as breathable neoprene material, or neoprene material, or similar materials. Further aspects of the headband configuration and its attachment and interaction with the nasal mask interface 200 will be explained later. In this embodiment, the headband may have an automatic adjustment capability or mechanism as will be further described, but these are not required for all embodiments.

[0377] Specifically referring to Figures 37 to 46, the nasal mask interface 200 includes a flexible nasal seal 202 that is permanently or releasably connected or attached to a complementary seal housing 204. The seal housing 204 is typically formed of a rigid material, or at least more rigid than the flexible nasal seal 202. As with previous embodiments, the nasal seal 202 and the seal housing 204 together co - define or form a mask cavity or volume that is configured to receive at least a portion of a user's nose in use and to receive a supply of breathable gas from a gas supply conduit 260. In this embodiment, the gas supply conduit 260 is releasably connected to the seal housing 204, but it should be appreciated that in alternative embodiments, the conduit may be permanently or integrally connected to the seal housing 204. In this embodiment, the nasal mask interface 200 includes a conduit frame 211 that is permanently or releasably connected to one end of the gas supply conduit. The conduit frame 211 in this embodiment is capable of releasably connecting to a complementary central air orifice or inlet 210 provided in the seal housing, thereby connecting the supply conduit 260 to the nasal mask interface 200.

[0378] In this embodiment, a headband frame in the form of a yoke 208 is releasably connected to the outer surface of the seal housing 204. The yoke 208 is generally curved in shape (the outer front surface is convex and the inner surface engages the concave seal housing), extends laterally across the seal housing 204, and extends at each end in a direction towards the contact face side of the nasal mask interface but laterally outwardly away from the nasal seal 202. Each distal end of the yoke 208 is connected to a respective end of one of the side straps 252 of the headband 250, such that the headband 250 has a single attachment point on each side of the nasal mask interface 200. In this embodiment, the headband may be permanently or non - releasably connected to the yoke 208. The yoke may be releasably connected to the seal housing 204 such that the yoke 208 and the headband 250 can be removed or released from the seal housing as needed.

[0379] In this embodiment, the nasal mask interface 200 is provided with one or more bias flow outlets or vents 212 for providing gas flushing from the nasal mask interface 200. In this embodiment, the bias flow vents include an arrangement of small orifices or holes extending through the seal housing 204. The vent arrangement includes one or more arrays of orifices at multiple specific locations on the seal housing, as will be explained in further detail. As with previous embodiments, the nasal seal 202 is provided with a sub - nasal support 224 that extends within or laterally across the mask cavity and is configured to contact at least a portion of the sub - nasal surface of the user's nose in order to counteract any lifting resultant force generated when the nasal mask is worn and in use, as previously discussed.

[0380] Further details and aspects of the various components of the nasal mask interface 200 will now be described.

[0381] General shape and configuration aspects

[0382] Referring to Fig.42 , in this embodiment, the orientations or angles of both the yoke 208 and the conduit frame 211 are offset relative to each other. For example, the longitudinal axis of the conduit frame 211, represented by line AE, is at an angle relative to the longitudinal axis or plane of the yoke 208 that extends through or defines line AF. In this embodiment, when viewed from the side of the nasal mask interface 200, the angle between the longitudinal axis AE of the conduit frame 211 and the longitudinal axis AF of the yoke 208 is preferably in the following range: from about 20° to about 60°, more preferably from about 30° to about 50°, even more preferably from about 35° to about 45°, and even more preferably about 38°. In this example, by way of explanation only, the longitudinal axis AE of the conduit frame 211 and the longitudinal axis AF of the yoke 208 are defined relative to the side elevation view of the nasal mask interface 200. In some embodiments, this angular offset between the conduit frame and the yoke can help direct the gas supply conduit away from the user and can also help reduce hose drag force.

[0383] Referring to Fig.44 , the conduit frame 211, the seal housing 204, the nasal seal 202, and the yoke 208 generally all exhibit a substantially concave curvature (on their face-facing surfaces), which generally follows the curvature of the user's face and helps the nasal mask interface conform to the user's face around the user's nose. In this embodiment, as can be seen from the top view in Fig.44 , the radius of curvature of the yoke 208 (at least in the lateral side portions) is generally greater than the radius of curvature of the conduit frame 211 and / or the seal housing 204 because the yoke is not intended to contact the user's face and is configured to extend at an angle away from the outer wall of the nasal seal 202, which extends between the face surface of the nasal seal in contact with the face and the outside of the nasal seal connected to the seal housing 204.

[0384] Referring to Fig.43, shows the nasal aperture or nasal receiving opening 206 on the contact face side of the nasal seal 202. A pair of single headband attachment or connection points 272 on each side of the nasal mask interface are shown at 272 at each distal end of the yoke 208. In this embodiment, the headband connection points 272 are located on each lateral side of the nasal mask interface 200 at the positions on the yoke 208 that are farthest from the center of the nasal mask interface. The sub-nasal support 224 can be seen through the nasal aperture 206 and extends within the mask cavity provided by the nasal seal 202 and the seal housing 204. In this embodiment, the sub-nasal support 224 has three connection points to the nasal seal 202. As will be explained in detail later, the sub-nasal support 224 includes connection points toward each upper inner lateral side or surface of the nasal seal, and a third connection point at or toward the center bottom of the nasal seal. In this embodiment, the third connection is to the center bottom edge of the nasal aperture 206.

[0385] See Fig.42 and Fig.44 , some of the main external dimensions of the overall profile of the nasal mask interface 200 in this embodiment will be described only by way of example to provide a sense of scale. In this embodiment, the ratio of the total height to the total depth of the assembly of the seal housing 204 and the nasal seal 202 is in the range of about 1:0.8 to about 1:1.2, and in this exemplary embodiment, the total height is substantially equal to the total depth of the assembly of the seal housing and the nasal seal, that is, the ratio is about 1:1. In this embodiment, the total lateral width of the assembly of the seal housing and the nasal seal is greater than the total height and the total depth of the assembly. In this embodiment, the ratio of the total height to the total depth to the total lateral width of the assembly of the seal housing and the nasal seal is in the range of about 1:0.8:1 to about 1:1.2:1.4, and in this exemplary embodiment is about 1:1:1.2.

[0386] Only by way of example, reference will be made to Fig.42 and Fig.44Illustrate the example dimensions of an example configuration of a nasal mask interface. In this example, the total height (as indicated by 282) of the assembly of the sealing housing 204 and the nasal seal 202 ranges from about 27 mm to about 67 mm, and is preferably about 47 mm. The total height (as indicated by 274) of the sealing housing 204, the nasal seal, and the mounted conduit frame 211 ranges from about 30 mm to about 70 mm, and is preferably about 50 mm. The total depth (as indicated by 276) of the assembly of the sealing housing 204 and the nasal seal 202 ranges from about 41 mm to about 66 mm, preferably about 46 mm; and the total depth (as indicated by 278) of the sealing housing 204, the nasal seal 202, and the mounted conduit frame 211 ranges from about 51 mm to about 76 mm, preferably about 56 mm. The lateral width (as indicated by 280) of the assembly of the sealing housing 204 and the nasal seal 202 (see Fig.44 ) ranges from about 52 mm to about 77 mm, and is preferably about 57 mm.

[0387] Nasal seal

[0388] See Figures 47 to 67 , the nasal seal 202 of the nasal mask interface 200 will be described in further detail. As those skilled in the art will recognize, the nasal seal 202 is flexible and soft and can be formed of a silicone material or other suitable material.

[0389] See Fig.47On the contact face side or the wearer side of the nasal seal 202 shown in [reference], the contact surface is generally indicated by 220 and is configured to seal around the user's nose, including sealing across the user's nasal bridge. In this embodiment, the contact surface 220 circumscribes at least a portion of the nose and seals around that portion of the user's nose. The contact surface 220 of the nasal seal includes an upper lip region generally indicated by 221, which is configured to contact the upper lip region of the user's face, such as at a position above the vermilion border and below the nostrils. The contact surface 220 also includes left and right cheek or side regions 223 that extend between the upper lip region 221 at the bottom of the seal and a nasal bridge region or an upper region 225 proximal to the nasal bridge region at the top of the nasal seal 202. The cheek regions 223 of the contact surface 220 are configured to contact the user's medial cheek surfaces and / or the user's lateral nose surfaces on both sides of the nose. The nasal bridge region 225 of the contact surface 220 is configured to extend over the nose, contact the nasal bridge region of the user's nose, and connect to the two cheek regions 223. As will be further explained in detail later, in this embodiment, the nasal seal 202 has a lower profile height dimension than a conventional nasal mask, such that the nasal bridge region 225 of the contact surface is configured to contact the user's nasal bridge in the middle region of the nasal bridge, and the position of contact on the nasal bridge is between the lower apex of the user's nose and the upper end of the nasal bridge between the user's eyes. In this embodiment, the nasal bridge region 225 of the contact surface 220 is configured to contact the user's nasal bridge in the region of the nasal bridge that is below the user's eyes. In one embodiment, the nasal bridge region 225 of the nasal seal is configured to contact the user's nasal bridge in the region defined between the nostrils and the center of the nasal bridge. In one embodiment, the nasal bridge region 225 of the nasal seal is configured to contact the lower half of the user's nose.

[0390] See Fig.52 , in this embodiment, the nasal bridge region 225 of the contact surface 220 includes a central valley region or portion (indicated by 245), which is recessed relative to the rest of the contact surface. The valley region 245 is configured to engage with the user's nasal bridge, and its shape is determined to substantially conform to the user's nasal bridge.

[0391] The overall shape and configuration of the contact surface 220 are arranged to conform to the contour of the user's face sealingly around the nose and to engage sealingly around the user's nose when secured to the user's head via a headband and when the nasal mask interface receives gas flow. In this embodiment, the nasal seal may be considered an inflatable type in that, under pressure, the seal pushes the contact face surface 220 against the user's face and deforms to seal substantially against the user's facial contour, including one or more of the upper lip, inner cheeks, side of the nose, and bridge of the nose.

[0392] The contact surface 220 of the nasal seal 202 terminates at an inner peripheral edge 222 that defines a nasal receiving opening or nasal orifice 206 into the mask cavity. The mask cavity is defined or formed when the nasal seal 202 is assembled or connected to the seal housing 204. See Fig.48 , which shows the outer side of the nasal seal opposite the contact face side of Fig.47 . The outer side of the nasal seal 202 is connected to the seal housing 204. In this embodiment, the outer side of the nasal seal 202 terminates at a connection edge 227 that defines an outer or housing orifice 228 for receiving or connecting to the seal housing 204.

[0393] See Fig.51 , the connection edge 227 at the outer side of the nasal seal 202 does not coincide with or extend in a single plane. See Fig.48 and Fig.51 , in this embodiment, the connection edge 227 of the outer side of the nasal seal includes an upper edge 227A, a lower edge 227B, and lateral side edges 227C, 227D extending between the upper edge 227A and the lower edge 227B. In this embodiment, the upper edge 227A projects rearwardly from the lateral side edges 227C and 227D. At least a central portion of the lower edge 227B may also project rearwardly from the lateral edges 227. In this embodiment, at least a central portion of the upper connection edge 227A projects rearwardly beyond both the lateral edges 227C, 227D and the lower edge 227B. As Fig.53 shown, the upper edge 227A projects outwardly or bulges to a vertex at the center of the nasal seal.

[0394] In this embodiment, the nasal orifice 206 formed on the contact face side of the nasal seal 202 is generally triangular or semi-triangular in shape to match the natural geometry of the human nose. The housing orifice 228 on the outer side of the nasal seal 202 is generally rectangular or semi-rectangular in shape.

[0395] See Fig.47 and Fig.48, the sub-nasal support 224 can be seen. The sub-nasal support is typically concave or U-shaped and has three connection points or attachment points to or within the nasal seal 202. As shown, the sub-nasal support 224 is suspended like a sling or strap between two upper connection points 231 located at opposite upper lateral positions or surfaces within the nasal seal 202. In particular, the upper lateral connections 231 are located on the inner surface of the nasal seal 202, one on each side of the central apex region of the nasal aperture 206. In this embodiment, the lateral connections 231 of the sub-nasal support 224 are configured or arranged in a vertical orientation such that the inner or contact surfaces of the sub-nasal support 224 face each other or are opposite each other at or towards the lateral connection points 231. In particular, the lateral contact surfaces of the sub-nasal support 224 can be substantially parallel to each other at or towards the lateral connection points 231. The sub-nasal support 224 in this embodiment further includes a third connection at or towards the center bottom of the nasal seal. In this embodiment, the bottom center connection point 232 is coupled to or at the center bottom region of the edge 222 of the contact surface 220 that defines the nasal aperture 206 of the nasal seal. The sub-nasal support 224 and its connections will be further explained in detail later.

[0396] See Figure 51 to Figure 53 , the nasal seal 202 is substantially defined by a surface portion 220 of the contact face ( Fig.47 shown in) and a sidewall portion 226 ( Fig.51 shown in). The sidewall portion extends rearward from the contact surface around the perimeter of the seal and terminates at a connection edge 227 on the outer or outside side of the seal, which connection edge is coupled or connected to the seal housing 204. In this embodiment, the nasal seal 202 can include profiles or regions of varying thickness that extend from the nasal aperture edge 222 on the contact face side of the nasal seal to the connection edge 227 on the outside of the nasal seal.

[0397] In this embodiment, the nasal seal 202 includes at least a first front region (commonly designated 233) and a second rear region 234, where the first front region extends from the nasal aperture edge 222 to an intermediate perimeter boundary 235 located on the sidewall portion 226, and the second rear region extends from the intermediate perimeter transition boundary 235 to the connection edge 227 on the outside of the seal.

[0398] In this embodiment, the front region 233 includes the contact surface 220 and at least a portion of the sidewall portion 226 of the nasal seal adjacent to the contact surface 220. The rear region 234 includes the remainder of the sidewall portion 226, which remainder extends from the transition boundary 235 back to the connection edge 227.

[0399] See Fig.56 In this embodiment, the front region 233 of the nasal seal including the contact surface is on average thinner or has a reduced thickness relative to the rear region 234 of the nasal seal. In this embodiment, the nasal seal further includes an additional third thickness region 236 within the front region 233. In particular, the front region 233 transitions to a thinner edge region 236 adjacent to the nasal aperture edge 222. The edge region 236 is thinner than the remainder of the front region 233. In this embodiment, the edge region 236 is a minor part of the front region 233.

[0400] The described thickness profile provides stability to the nasal seal 202 and enhances the sealing engagement with the user's nose. In particular, the thicker rear region 234 provides stability to the overall nasal seal shape, while the front region 233 with reduced thickness including the contact surface 220 promotes the nasal seal to conform to the user's nose. Additionally, the edge region 236 around the perimeter of the nasal aperture edge 222 is the thinnest part of the contact surface 220 for enhancing user comfort and sealing conformity. It should be appreciated that the thicknesses of the rear region 234, front region 233, and edge region 236 can be uniform within the respective regions or can have varying thicknesses within these regions. For example, in this embodiment, the thickness of the rear region 234 gradually decreases from the contact edge 227 to the intermediate transition boundary 235. The front region 233 has a substantially uniform thickness in most parts and a minor tapered edge part 236, and this edge part 236 has a uniform reduced thickness relative to the majority of the front region. In this embodiment, most parts of the front region 233 gradually transition to the thinner edge region 236, as shown by the body transition zone 237 in Fig.56 as shown. Fig.56 As shown, the contact face surface 220 of the nasal seal forms a flange that curls or extends inwardly from the sidewall portion 226 of the nasal seal, and the flange includes the tapered edge part 236.

[0401] The sub-nasal support of the nasal seal

[0402] In this embodiment, the sub-nasal support 224 of the nasal seal 202 is in the form of a nasal strap or sling that extends at least across the central portion of the nasal seal within the mask cavity or is suspended laterally across the central portion. The sub-nasal support 224 is configured to contact at least a portion of the sub-nasal surface of the user's nose in order to counteract any lifting resultant force generated by the pressurized gas flow during the wearing and use of the nasal mask as previously discussed.

[0403] In this embodiment, the under-nose support 224 is completely defined or enclosed within the shell layer of the nasal seal, i.e., it does not protrude or extend beyond the connecting edge 227 on the outside of the nasal seal that connects to the contact surface edge 222 of the seal shell or nasal orifice 206. However, it should be recognized that in alternative embodiments, at least a portion of the under-nose support 224 can protrude beyond the shell orifice defined by the connecting edge 227.

[0404] In this embodiment, the under-nose support 224 is suspended laterally across the central area of ​​the nasal seal 202 between the left and right sides of the nasal seal. As shown, the under-nose support is disposed or located behind or behind the nasal orifice or opening 206 on the face-contacting side of the nasal seal. The under-nose support 224 is fixedly connected to the nasal seal because it cannot be removed in this embodiment. In one form, the under-nose support is integrally molded into the nasal seal. In alternative forms, the under-nose support part or portion of the nasal seal can be formed separately and then fixedly connected to the nasal seal via adhesive or welding, etc., or the under-nose support part or portion can be connected to the seal housing.

[0405] In this embodiment, the under-nose support configuration 224 includes an elongated main lateral portion or band 229 that extends laterally across at least a portion of the nasal seal and laterally within the nasal seal. Figure 47 to Figure 49 , Figure 54 to Figure 56 ,as well as Fig.57, in this embodiment, the main lateral portions 229 of the sub-nasal support 224 are suspended or connected at each opposite end to respective upper attachment points 231 located on the upper inner surface of the nasal seal, these attachment points being on opposite sides of the apex region of the seal relative to the nasal aperture 206. In this embodiment, the distal ends of the main lateral portions 229 of the sub-nasal support 224 are connected to the inner surface of the nasal seal via respective reinforcing portions or regions (e.g., in the form of ribs 241). In this embodiment, the ribs 241 extend from an upper lateral position within the inner surface of the nasal seal in a substantially vertical orientation and extend into or connect to the respective distal ends of the main lateral portions 229 at the attachment locations 231. In this embodiment, the ribs 241 are integrally molded with the main lateral portions 229 of the sub-nasal support 224. It should also be recognized that the ribs 241 at the ends of the main lateral portions 229 can be considered part of the sub-nasal support and the main lateral portions 229. In other words, the reinforcing portion or region 241 can be considered an extension of the main lateral portion, or simply an end portion of the main lateral portion. Alternatively, the reinforcing portion or region can be considered a separate component or formation that is connected to or integrally formed with the end of the main lateral portion. Under either interpretation, the function and effect of the reinforcing portion or rib 241 remain substantially the same.

[0406] See Fig.55 , the rib 241 is joined to or extends from a region of the inner surface of the nasal seal at a portion of its peripheral edge, the region including portions of both the posterior region 234 and the anterior region 233. In this embodiment, the rib extends across a portion of the posterior region 234 and most of the anterior region 233 including the contact surface, but not including the thinned edge region 236 adjacent to the nasal aperture. However, it should be recognized that in alternative embodiments, the rib 241 can also extend from, contact, or dip into at least a portion of the thinned edge region 236. In this embodiment, the main lateral portions 229 of the sub-nasal support are connected to each respective rib 241 at a portion that extends with or coincides with the thicker posterior region 234 of the nasal seal wall. The rib 241 provides a firm connection for the main lateral portions 229 of the sub-nasal support 224 within the nasal seal and also provides structural support to the nasal seal by increasing the rigidity in the area or region of the nasal seal that contacts the patient on either side of the nose. In particular, the rib 241 is associated with the contact surface 220 (see Fig.52)abut against the sides of the upper valley region 245 associated with the bridge region of the contact surface 220, or these ribs are located on either side of the upper valley region. In particular, the ribs or panels 241 prevent the nasal seal from collapsing under excessive compressive forces while also allowing for a secure connection between the sub-nasal support and the inner surface of the nasal seal.

[0407] In some embodiments, these ribs can also act directly or indirectly to provide feedback to the user when the mask is overly tightened. As described further below, the buckling of the ribs can be configured to deform or change the shape of the sub-nasal support to squeeze the user's nose, and / or cause multiple portions of the contact surface adjacent or associated with the ribs to press more tightly into the sides of the nose as the compression of the nasal seal increases (e.g., due to headband tightening).

[0408] See Fig.55 , in this embodiment, a recessed area or zone 243 is provided or formed between the front portion 242a and the rear portion 242b of the rib 241, where the rear portion is connected to the main lateral portion 229 of the sub-nasal support 224. The recessed area 243 forms a buckling zone or axis 242 in each rib 241. In this embodiment, the buckling axis 242 extends between the thickness region transition boundary 235 and the apex of the recessed area 243.

[0409] In some configurations, when the nasal seal is worn by the user, if the nasal seal is compressed in its depth dimension, the buckling axis 242 enables the rib 241 to buckle outwardly towards the adjacent inner surface of its associated lateral wall of the nasal seal in use. This buckling of the rib allows the front region 242a of the rib 241 to bend or compress inwardly towards the user's nose to enhance the seal created in use, and can also lift the sub-nasal support into the user's sub-nasal surface.

[0410] In other configurations, when the nasal seal is worn by the user, if the nasal seal is compressed in its depth dimension, the buckling axis 242 enables the rib 241 to buckle inwardly towards each other in use. This inward buckling of the ribs causes the sub-nasal support 224 to tighten or press against at least in the lateral width direction, which is used to cause the sub-nasal support to squeeze against or tighten to the surface of the user's nose. In other words, the inward buckling of the ribs causes the contact surfaces of the lateral regions of the main lateral portion of the sub-nasal support to move towards each other, effectively narrowing or tightening the U-shape of the sub-nasal support to squeeze the user's nose.

[0411] The recessed region 243 can also be such a region or area of the rib 241 that has a reduced depth (i.e., the distance between the free peripheral edge of the rib and the edge of the rib connected to the inner surface of the seal) or surface area relative to other parts of the rib.

[0412] See Fig.48 , in this embodiment, the upper connection location 231 of the sub-nasal support is located in the lateral end or side boundary of the nasal seal. In particular, the vertical connecting rib 241 and the connection point 231 are offset relative to the outer lateral width of the nasal seal on their respective sides. In this embodiment, the distance between the connection locations 231 is generally equal to or less than Fig.47 and Fig.48 the outermost width of the nasal aperture indicated by 242A in

[0413] In some embodiments, see Fig.57 , the main lateral portion 229 of the sub-nasal support 224 is arranged to laterally extend across the nasal seal 202 at a depth generally located in the middle or center of the entire depth profile of the nasal seal, the depth profile being dimensioned from the contact surface 220 to the outermost portion of the connection edge 227 on the outside of the nasal seal. However, in alternative embodiments, the main lateral portion can be arranged to laterally extend across the nasal seal at other depths (either closer to or farther from the contact surface), and can also have multiple portions that extend or protrude beyond the outer connection edge 227 of the nasal seal or the main shell layer.

[0414] In this embodiment, in addition to the two upper lateral connections 231, the sub-nasal support 224 further includes a third connection to the nasal seal. In this embodiment, the sub-nasal support is connected to the central lower part or the bottom part of the nasal seal (as indicated by 232). In this embodiment, the lower central connection of the sub-nasal support 224 is in the form of a central extension or connection part 232 that extends centrally from the main lateral part 229 and is coupled or connected to the nasal orifice edge 222 located in the upper lip region 221 of the nasal seal of the contact surface 220 or is coupled or connected at the nasal orifice edge. In this embodiment, the central connection part 232 has a width profile that is generally hourglass-shaped. In particular, the width dimensions of the central connection part 232 at both the nasal orifice edge 222 and the docking portion with the main lateral band 229 are greater than the width dimension of the central connection part 232 in the middle or intermediate region. For example, the central connection part 232 is an elongated part that extends from a first end 232A to a second end 232B, where the first end is coupled or integrally formed with the nasal orifice edge 222 of the contact surface 220, and the second end is coupled or integrally formed with the main lateral band 229 of the sub-nasal support 224 (see Fig.48 , Fig.49 and Fig.54 ). In this embodiment, the width dimension of the central connection part 232 gradually decreases from each of its ends 232A, 232B towards the central or middle region where the width decreases, so as to provide a width dimension profile that is generally hourglass-shaped.

[0415] See Fig.55 and Fig.56 , the central connection part 232 of the sub-nasal support includes a profile with a thickness variation in a direction transverse to the contact surface of the connection part 232. In this embodiment, the thickness of the central connection part 232 gradually becomes smaller or decreases over the width from its second end 232B at the main lateral part 229 to its first end 232A at the nasal orifice edge 222. For example, the thickness of the central connection part 232 at the second end 232B is substantially the same as or consistent with the thickness of the main lateral part or band 229 in this region, and the thickness gradually becomes smaller or decreases from the second end 232B or a point in the middle region of the connection part 232 to the reduced thickness at the first end 232A at the nasal orifice edge 222. In this embodiment, the reduced thickness at the first end 232A is substantially the same as or consistent with the thickness of the nasal orifice edge 222 of the contact surface. For example, the thickness of the central connection part 232 at its first end 232A can be substantially equal to the thickness of the thinned edge region 236 of the contact surface 220 of the nasal seal.

[0416] Particularly see Figure 47 to Figure 49 and Fig.54 , in this embodiment, the sub-nasal support 224 is configured to have a curved profile that spans the lateral width of the sub-nasal support between the upper lateral connections 231. In some embodiments, the curvature profile may vary across the lateral width of the sub-nasal support, but alternatively, in other embodiments, the curvature profile may have a consistent curvature. In the illustrated embodiment, the curvature profile varies. In this embodiment, the contact surface of the main lateral portion 229 of the sub-nasal support 224 has a steeper curved profile in the central or middle region 235 relative to a flatter curved profile in the remaining lateral regions or outer regions 236 that extend to the upper lateral connections 231. For example, in the central region indicated by 235, the main lateral portion 229 is provided with a first radius of curvature that is substantially consistent in the central region 235. The radius of curvature of the remaining lateral regions 236 on either side of the central region 235 may be constant or vary, but generally has a larger radius of curvature than the first radius of curvature of the central region 235, such that it generally has a flatter curvature. In this embodiment, the main lateral portion 229 is or includes a curved contact surface profile across its entire lateral width without any flat regions.

[0417] In this embodiment, the width of the contact surface of the main lateral portion 229 of the sub-nasal support 224 may vary along its length between opposite sides of the nasal seal. In this embodiment, the main lateral portion 229 includes a substantially consistent width indicated by 238 (see FIG. A15) in the central region 235, which then gradually increases towards the connection points 231 in the outer lateral regions 236.

[0418] See Fig.56 , the central seal axis AG is defined as tangentially extending between the outermost contact point and the lower contact point in the central region of the contact surface 220 when the nasal seal is in a relaxed state (e.g., not in use). As Fig.56 shown, at least a portion of the contact surface of the sub-nasal support in the central region is indicated by an axis AH that extends at an angle defined relative to the seal axis AG or indicated by 239, such that the contact surface of the sub-nasal support is not parallel or aligned with the seal axis AG. In this embodiment, the contact surface in the central region of the sub-nasal support 224 is offset at an angle from the seal axis AG, and the angle is in the range of about 40° to about 80°, more preferably in the range of about 45° to about 75°, even more preferably in the range of about 50° to about 70°, and even more preferably in the range of about 55° to about 65°. As shown, at least a portion of the central connection portion 232 also has a corresponding or aligned angular offset.

[0419] As explained above, the sub-nasal support 224 in this embodiment is fixedly connected to the nasal seal 202, or is an integral part of the nasal seal. The drawings depict the nasal seal 202 and its sub-nasal support 224 in a stationary (i.e., unused) state. Similar to the contact surface 220 of the nasal seal, the sub-nasal support 224 is also configured to be soft and flexible or pliable such that when the nasal mask interface is fixed to or otherwise worn on a user's face, the shape and position of the sub-nasal support can conform to the sub-nasal surface of the user's nose in a manner similar to that of a suspension or strap. In this embodiment, the sub-nasal support is non-stretchable in any direction, but in alternative embodiments, it may have a certain degree of stretch in the same direction.

[0420] Alternative sub-nasal support

[0421] The main lateral portion 229 or band of the sub-nasal support 224 is generally U-shaped and has a certain curvature across the lateral width of the sub-nasal support. In alternative embodiments, the sub-nasal support may have a flat section or portion, or may generally be more similar in shape to a rectangle or approximate square. For example, see Fig.61 , in an alternative embodiment, the sub-nasal support indicated by 224A may have a substantially flat central horizontal portion 229A and two substantially vertical or upright portions 229B extending upward from respective ends of the central horizontal portion 229A, each of the two substantially vertical or upright portions being directly or via ribs connected to the inner surface on each upper lateral side of the nasal seal at a connection point 229C as in the previous embodiment.

[0422] Examples of nasal seal dimensions

[0423] In this embodiment, the ratio of the total height to the total lateral width of the nasal seal 202 is in the range of about 1:1 to about 1:1.4, and is about 1:1.2 in this exemplary embodiment. In this embodiment, the ratio of the total height, total lateral width, and total depth of the nasal seal is in the range of about 1:1:0.6 to about 1:1.4:1, and is about 1:1.2:0.8 in this exemplary embodiment.

[0424] By way of example, the main dimensions of several aspects of a nasal seal configuration will be described to provide a sense of scale. See Fig.47, the height of the nasal orifice defined by the edge 222 of the contact surface (indicated by 242B in the central region) ranges from about 8 mm to about 43 mm, preferably about 23 mm; and the outermost width of the nasal orifice (indicated by 242A) ranges from about 24 mm to about 49 mm, preferably about 34 mm. The total height of the nasal seal (as indicated by 242D) ranges from about 22 mm to about 72 mm, preferably about 47 mm; and the total width of the nasal seal (as indicated by 242C) ranges from about 47 mm to about 87 mm, preferably about 57 mm. In this embodiment, the width of the central connecting portion 232 in the middle region where the width decreases (as indicated by 242E) ranges from about 2 mm to about 15 mm, preferably about 3 mm. See Fig.52 , the total depth of the nasal seal (as indicated by 243A) ranges from about 29 mm to about 49 mm, preferably about 39 mm. The depth of the nasal seal between the lateral contact surface and the lateral edge of the housing orifice (as indicated by 243B) ranges from about 21 mm to about 36 mm, preferably about 31 mm. The depth of the nasal seal between the central nasal bridge valley 245 of the contact surface 220 and the corresponding central housing orifice edge 227 ranges from about 18 mm to about 33 mm, preferably about 28 mm. The lateral width between the two outer lateral points of the connecting edge 227 at the outer side of the nasal seal ranges from about 40 mm to about 50 mm, preferably about 49 mm. See Fig.54 , the height between the bottom edge 222 of the nasal orifice 206 and the bottom surface of the nasal seal 202 ranges from about 5 mm to about 20 mm.

[0425] See Fig.58 , the thickness of the main lateral portion 229 of the sub-nasal support 224 in the direction transverse to the contact surface of the main lateral portion (as indicated by 244A) ranges from about 0.2 mm to about 3 mm, preferably about 1.1 mm. The central connecting portion 232 extending from the center of the main lateral portion 229 starts with a similar thickness and then transitions to a thinner thickness as it connects to the nasal orifice edge 222 of the contact surface 220 as shown. In this exemplary embodiment, the thickness in the edge region 236 of the contact surface is about 0.2 mm.

[0426] The dimensions of various aspects of the nasal seal can be varied to provide for patients with different nasal sizes. In one embodiment, the nasal seal and the interface can be provided in a number of different sizes, such as small, medium, large, or a greater number of size categories. In another embodiment, the nasal seal can be provided in two sizes, such as small-medium size and large-medium size. By way of example, reference will be made to Figure 59 to Figure 67, provide information on the dimensions of small and medium nasal seals compared to large and medium nasal seals by way of example. See Fig.59 and Fig.60 , the radius of curvature R of the central region 235 of the main lateral band 229 of the sub-nasal support is in the range of about 8 mm to about 18 mm, preferably about 12.5 mm for small and medium nasal seals, and for large and medium-sized nasal seals, the central region 235 is longer and includes a substantially uniform larger radius of curvature of about 14 mm. See Fig.62 and Fig.63 , the width of the central connecting portion 232 in the middle thin region is about 2.9 mm for small and medium-sized configurations and about 4.12 mm for large and medium-sized configurations. See Fig.64 and Fig.65 , the angular offset (indicated by 239) between the axis AH of the central region of the main lateral portion 229 and the tangential axis AG of the seal is about 64° for small and medium-sized configurations and about 58° for large and medium-sized configurations. See Fig.66 and Fig.67 , the bridge region of the contact surface of the nasal seal includes the recessed valley portion 245 as described above. In this embodiment, for both small and medium-sized configurations and large and medium-sized configurations, the depth of the valley region 245 (indicated by 245B) is about 7 mm. The width of the valley region (indicated by 245A) is in the range of about 7 mm to about 17 mm for small and medium-sized configurations, preferably about 13.8 mm; and about 14.1 mm for large and medium-sized configurations.

[0427] As described above, the nasal seal is typically sized and / or configured to have a generally rectangular shape when viewed from the outside (as shown in Fig.48 ) and when viewed from the front or the contact face side (as shown in Fig.47 ).

[0428] Sealing housing

[0429] See Figures 68 to 74 , the sealing housing 204 of this embodiment of the nasal mask interface 200 will be described in further detail. In this embodiment, the sealing housing 204 is formed of a rigid material, or is more rigid than the flexible nasal seal. For example, the sealing housing can be formed of a plastic polymer (such as polycarbonate or the like).

[0430] The sealing housing or casing 204 is a generally hollow member that extends from the main opening on the seal connection side indicated by 262 to the outside indicated by 261 (see Fig.72)。The opening on the seal contact side 262 of the sealed housing 204 is defined by the perimeter edge 263 of the sealed housing 204. The sealed housing 204 is generally defined by a concave outer surface that extends from the perimeter edge 263 of the opening to the outer side 261 of the sealed housing between the top 264A, bottom 264B and lateral sides 264C, 264D of the sealed housing, thereby providing a substantially hollow component having a depth that mates with the nose seal 202 to jointly define a face mask cavity or volume for receiving a gas flow from an inlet opening 265 on the outer surface disposed at the outer side 261 of the sealed housing.

[0431] The perimeter edge 263 of the main opening of the sealed housing 204 is configured to connect or couple to the connecting edge 222 of the nose seal 202 to couple the nose seal to the sealed housing, thereby forming a face mask cavity. It should be appreciated that the nose seal 202 and the sealed housing 204 can be permanently or semi-permanently connected or coupled via various methods, including overmolding, welding, adhesives, mechanical coupling configurations, or combinations thereof.

[0432] See Fig.46 , in this embodiment, the connecting edge 222 of the nose seal 202 is permanently connected or coupled to the perimeter edge 263 of the sealed housing 204 via an adhesive, overmolding or welding at the interface of complementary surfaces between the edges 222, 263 of the components. However, it should be appreciated that in alternative embodiments, either the connecting edge 222 or the perimeter edge 263 can be provided with channels or complementary ridges, or ridges or complementary channels that engage with each other to form a mechanical connection, and in addition, such mechanical coupling, overmolding, adhesives or welding can be applied to secure the connection. For example, the configuration of such ridges and channels can be similar to the configuration described with reference to the nose mask interface of the first embodiment.

[0433] In this embodiment, as will be appreciated, the shapes and sizes of the peripheral edge 263 of the sealed housing 204 and the connecting edge 222 of the nose seal 202 are complementary to each other to achieve a secure connection between components. In alternative embodiments, one of ordinary skill in the art will appreciate that if desired, the nose seal 202 can be releasably connected to the sealed housing 204 via a rigid clamp or other releasable coupling mechanism.

[0434] In this embodiment, the outer surface of the sealed housing 204 is provided with a channel or recess, generally indicated by 266, which forms a yoke channel for releasably receiving and holding a yoke 208 associated with a headband 250. In this embodiment, the yoke channel 266 extends laterally across the outer surface of the sealed housing in a mid or upper region of the sealed housing. Below the yoke channel 266, at or towards the bottom of the sealed housing is a central inlet opening 265 configured to receive a gas supply into the nasal mask interface in use. In this embodiment, the inlet opening 265 of the sealed housing 204 is configured to be releasably coupled to a conduit frame 211 which in turn is releasably or permanently connected to the end of a gas supply conduit 260, as previously described.

[0435] In this embodiment, the inlet opening 265 of the sealed housing 204 is generally oval in shape, with its major axis extending laterally across the sealed housing. Thus, when viewed externally as Fig.70 shown, the width of the inlet opening 265 in the lateral direction is greater than its height. As Fig.72 shown, the inlet opening 265 is substantially symmetric with respect to a plane 265A of the major axis extending through the oval aperture (such as indicated by the line AE in Fig.42 ). Referring to Fig.70 and Fig.74 , the inlet opening 265 forms a conduit portion through the front wall surface of the sealed housing 204 that has a depth around at least multiple portions of the perimeter. For example, the inlet aperture 265 includes an upper surface 265C and a lower surface 265B that extend from the outer surface to the inner surface of the sealed housing into the sealed housing. In this embodiment, a protrusion of a formation 267 is provided across the upper surface 265B and the lower surface 265C of the inlet aperture 265. In this embodiment, the protrusion 267 is an elongate protrusion that extends in an upper region and a lower region at or towards the inner surface of the sealed housing along a central portion of the perimeter of the oval aperture 265. In operation, the protrusion 267 engages a complementary recess or channel 287 of the conduit frame 211 to provide a snap-fit releasable engagement of the conduit frame into the inlet aperture 265.

[0436] In this embodiment, as Fig.72 shown, at least a portion of the upper and lower regions of the inlet aperture 265 protrude beyond most of the front surface of the sealed housing 204. See Fig.70 and Fig.74, in this embodiment, the inlet orifice configuration further includes a recessed local area (as indicated by 268) that surrounds at least a portion of the perimeter of the inlet orifice. In this embodiment, the inlet orifice 265 has two discrete recessed regions or surfaces (indicated by 268) disposed at or toward each of the lateral sides of the inlet orifice. In this embodiment, the recessed regions 268 terminate before meeting each other, but in alternative embodiments, it should be appreciated that the recessed regions may extend around the entire perimeter of the oval inlet orifice 265. In operation, the shape and size of the recessed regions 268 are determined to receive the complementary mating surfaces of the catheter frame 211 such that the interface region between the catheter frame and the peripheral surface of the seal housing surrounding the inlet orifice is substantially smooth or flush, thereby providing a continuous or blended outer surface when the catheter frame 211 is assembled into the inlet orifice 265 of the seal housing 204.

[0437] In this embodiment, the yoke channel 266 is provided with positioning features 271 that engage complementary locking features provided on the yoke 208. In this embodiment, the positioning features 271 of the yoke channel 266 are recessed formations into which complementary positioning protrusions or formations provided on the yoke 208 engage to lock the yoke 208 to the seal housing 204. In this embodiment, the recesses 271 of the yoke channel 266 and the complementary protrusions on the yoke 208 are aligned such that when the components are joined together with the yoke protrusions engaging within their complementary recesses 271 in the yoke channel, the yoke is slightly deformed such that there is a residual tensile or compressive force to lock or secure the two components together. The yoke channel 266, the yoke 208, and the headband assembly will be described in greater detail generally later.

[0438] The sealed housing 204 includes a biasing vent hole 212 in the form of an inlet orifice. In this embodiment, the sealed housing 204 includes an arrangement of one or more arrays of biasing vent holes. In this embodiment, the sealed housing 204 includes three separate linear arrays of spaced-apart biasing vent holes. First, an upper array 212 of biasing vent holes extends across the upper surface of the sealed housing above the yoke channel 266 (as indicated by 212A). In this embodiment, the upper horizontal row or array of biasing vent holes extends substantially across the entire width of the upper region of the sealed housing between the lateral sides. Vertical linear arrays of biasing vent holes 212B, 212C are also provided on each of the lateral sides of the sealed housing on either side of the inlet orifice 265. As shown, the vertical arrays of biasing vent holes 212B, 212C extend from below the yoke channel 266 and terminate at or toward the lower surface of the sealed housing 204. In this embodiment, the holes or orifices of the arrays 212A, 212B, 212C are laser drilled, but may be formed by alternative means. Additionally, it should be appreciated that each of the upper vent hole array 212A and the lower lateral vent hole arrays 212B and 212C may include multiple linear arrays or rows, as the configuration is not limited to a single linear array. Additionally, in an alternative configuration, the orifice arrays need not be evenly spaced. The configuration shown with the upper vent hole array 212A and the lower lateral vent hole arrays 212B and 212C is configured to prevent noise and drag when using a nasal mask interface. Alternatively or in addition, the biasing vent holes may be provided on the conduit frame 211.

[0439] See Fig.70 , Fig.71 and Fig.72 , example dimensions of the configuration of the sealed housing 204 will be provided by way of example only to provide a sense of scale. See Fig.71 , the overall height of the sealed housing 204 between the top surface 264A and the bottom surface 264B (as indicated by 272A) is in the range of about 19 mm to about 59 mm, preferably about 39 mm; and the overall width of the sealed housing between the lateral sides 264C and 264D (as indicated by 272B) is in the range of about 45 mm to about 75 mm, preferably about 50 mm. See Fig.72 , the overall depth of the sealed housing between the seal contact side 262 and the outer side 261 (as indicated by 272C) is in the range of about 19 mm to about 49 mm, preferably about 24 mm. See Fig.68 and Fig.70, in this example, the distance or height (as indicated by 272D) between the top surface 264A and the upper inner surface 266A of the yoke channel 266 at the center of the sealed housing is in the range of about 5 mm to about 20 mm, preferably about 10 mm. In this embodiment, the diameter 272F of the orifices in the biasing vent hole arrays 212A, 212B, 212C is in the range of about 0.6 mm to about 0.8 mm, preferably about 0.7 mm.

[0440] Duct frame

[0441] See Figures 75 to 81 , the duct frame 211 releasably engaged to the inlet orifice 265 of the sealed housing 204 will be described in further detail.

[0442] In this embodiment, the duct frame 211 is configured to be releasably engaged or connected to the inlet orifice 265 of the sealed housing via snap-fit engagement, but it should be appreciated that any other operable mechanism or mechanical coupling arrangement for releasably connecting these components may alternatively be used.

[0443] In this embodiment, the duct frame 211 includes a main hollow body that extends from a first end 283A to a second end 283B, where the first end is configured to engage the air inlet orifice 265 of the sealed housing 204, and the second end is configured to be directly connected or coupled to the end of the gas supply duct, or indirectly connected or coupled to the end of the gas supply duct via a connector. As Fig.81 and Fig.82 shown, the duct frame 211 forms a hollow duct along the longitudinal axis of its main body between its first end 283A and second end 283B. The duct is open at each end of the main body and has a substantially elliptical cross-sectional shape along the length of the main body of the duct frame 211 in this embodiment. See Fig.79 , in this embodiment, the inner circumference of the elliptical duct extending through the main body varies along the length of the main body from the first end 283A to the second end 283B. In this embodiment, the circumference of the duct at the first end 283A (connected to the sealed housing) is larger than the circumference of the elliptical duct at the second end 283B (connected to the gas supply duct) to form a funnel-shaped profile.

[0444] See Fig.79 and Fig.80 , in this embodiment, the duct frame 211 is symmetric about at least one horizontal plane that extends through the longitudinal axis AI (see Fig.79 ), as indicated by AJ (see Fig.80)。In this embodiment, the axis of symmetry AJ corresponds to the major axis extending through the elliptical catheter. This symmetry corresponds to the symmetry of the inlet orifice 265 of the seal housing 204 and enables the catheter frame 211 to be connected to the seal housing 204 in either of two orientations. In other words, the catheter frame 211 can be removably coupled to the inlet orifice 265 of the seal housing in either of two orientations that are rotated 180° relative to each other. In this embodiment, the catheter frame 211 is also symmetric about the vertical plane indicated by AK, which extends along the longitudinal axis AI of the catheter frame. This vertical plane corresponds to the minor axis of the elliptical catheter and is orthogonal or transverse to the horizontal plane AJ. In particular, the catheter frame is symmetric about two transverse planes that extend through the longitudinal axis of the catheter frame.

[0445] See Fig.75 , in this embodiment, the main body of the catheter frame 211 includes a central gripping portion 284, a first connecting portion 285 located at the first end 283A and adapted to be connected to the inlet orifice 265 of the seal housing, and a second connecting portion 286 located at the second end 283B and adapted to be connected to the gas supply catheter.

[0446] The seal housing connecting portion 285 extends from the first end 284A of the central gripping portion 284 and terminates at the first end 283A of the catheter frame. The catheter connecting portion 286 extends from the second end 284B of the central gripping portion 284 and terminates at the second end 283B of the catheter frame 211. As shown in the drawings, the cross-sections of both the seal housing connecting portion 285 and the catheter connecting portion 286 are elliptical with respect to the longitudinal axis of the catheter frame. In this embodiment, referring Fig.79 , the outer circumferences of both connecting portions 285, 286 decrease or taper from their respective ends at the central gripping portion 284 to their respective ends 283A, 283B of the catheter frame 211. It should be appreciated that in alternative embodiments, the catheter frame may have an alternative elliptical shape profile. For example, the catheter frame may have an internal catheter that has an alternative form of circular cross-section.

[0447] In this embodiment, the gripping portion 284 includes an upper recessed gripping portion 284C and a lower recessed gripping portion 284D on the upper and lower surfaces of the catheter frame. The recessed gripping areas 284C, 284D on the upper and lower surfaces enable a user to pinch and grip using the thumb and forefinger in order to insert the catheter frame 211 or release the catheter frame from the seal housing in use.

[0448] In this embodiment, the width of the central gripping portion 284 increases from the lateral sides towards the first end 284A to form wing-like regions 284E, 284F of a lip that protrudes from the lateral sides of the catheter frame. In this embodiment, the shape of the first end 284A of the central gripping portion is substantially concave, as Fig.77 shown. In this embodiment, the inner surfaces 284G, 284H of the wing-like regions 284E, 284F adjacent to the seal housing connection portion 285 are complementary in shape and size to the recessed lateral regions 268 of the inlet orifice 265 of the seal housing. In particular, the inner surfaces 284H, 284G of the wing-like regions of the catheter frame 211 are adjacent to or engage the complementary recessed regions 268 associated with the inlet orifice 265. In this embodiment, the outer surface or outer surface profile of the gripping portion 284 in the regions (designated 284I and 284J) associated with the wing-like regions has a curvature or shape that is complementary to the curvature or shape of the seal housing on the lateral sides of the inlet orifice 265. When the wing-like regions 284I, 284J are assembled together, this complementary shape of these wing-like regions provides a flush and continuous surface profile at the outer mating or docking region of the catheter frame 211 and the seal housing 204. The concave profile of the first end 284A of the gripping portion or region 284 is configured or arranged to be complementary to the concave surface profile adjacent to or surrounding the perimeter of the inlet orifice 265 of the seal housing 204, so as to provide a continuous and flush or fused outer surface at the interface between the two when the catheter frame is assembled to the seal housing.

[0449] See Fig.75 and Fig.77 , the seal housing connection portion 285 is provided with undercuts or recessed grooves 287 in the upper and lower portions at the first end 283A of the catheter frame. The shape and size of these grooves 287 are determined to be complementary to the upper and lower protrusions 267 of the inlet orifice 265 of the seal housing, so that the catheter frame 211 can be firmly engaged into the inlet orifice 265 of the seal housing via a snap-fit engagement.

[0450] In this embodiment, as shown, the main body of the catheter frame 211 is generally oval-shaped along its length between the first end 283A and the second end 283B. However, it should be appreciated that alternative cross-sectional shapes can be used for the inner catheter and / or the general shape of the body in alternative embodiments, such as circular or other suitable shapes, if desired. In this embodiment, the oval main body is at least slightly deformable relative to the vertical plane axis AK of the longitudinal axis extending through the body. This enables the gripping regions 284C, 284D to be compressed towards each other by the user, causing the catheter frame 211 to deform slightly, thereby disengaging the snap-fit connection between the catheter frames 211 in the sealed housing 204, and thus enabling the catheter frame (and its associated gas supply catheter) to be removed or disconnected from the sealed housing.

[0451] See Fig.77 and Fig.80 , an example of the dimensions of one configuration of the catheter frame of this embodiment will be described to provide a sense of scale. See Fig.80 , the major axis 290A of the elliptical orifice at the catheter connection end 283B is sized in the range of about 9 mm to about 29 mm, preferably about 19 mm; and the minor axis 290B of the elliptical orifice is in the range of about 5 mm to about 21 mm, preferably about 11 mm. The elliptical extrusion of the catheter connection portion 286 gradually increases in size to the major axis, which is in the range of about 14 mm to about 34 mm, preferably about 24 mm; and gradually increases to the minor axis at or towards the gripping portion 284 of the main body, which is in the range of about 6 mm to about 26 mm, preferably about 16 mm. The total height 290C between the outermost upper and lower surfaces of the catheter frame 211 that is sized to align with or be parallel to the minor axis 290B is in the range of about 12 mm to about 22 mm, preferably about 17 mm. The total width 290D between the outermost wing regions of the central gripping portion 284 of the catheter frame 211 that is sized to align with or be parallel to the major axis 290A is in the range of about 25 mm to about 45 mm, preferably about 35 mm. See Fig.77 , the total length of the catheter frame between its first end 283A and its second end 283B (as indicated by 290F) is in the range of about 10 mm to about 30 mm, and the width of the sealed housing connection portion 285 (as indicated by 290E) is in the range of about 14 mm to about 34 mm, preferably about 24 mm. It should be appreciated that the dimensions can be varied in alternative embodiments if desired.

[0452] See Fig.79, the first region of the conduit frame 211 indicated by 289A identifies the connection portion 285 that projects or extends to engage a complementary inlet orifice 265 of the seal housing 204. The second remainder of the conduit frame (indicated by 289B) toward the second end 283B extends or projects from the seal housing. It should be appreciated that the first end 283A of the conduit frame 211 may define a housing orifice opening that engages or is complementary to the inlet orifice 265 of the seal housing, and the end 283B, the conduit frame represents a conduit orifice that directly engages or is coupled to the end of the gas supply conduit, or engages or is coupled to the end of the gas supply conduit via a connector.

[0453] Yoke assembly, connection of the yoke to the seal housing, and headband

[0454] Specific reference Figure 82 to Figure 102 , the yoke 208 and its connection to the seal housing 204 and the headband 250 will be explained in further detail. As previously mentioned, in this embodiment, the headband assembly includes a yoke or collector 208 that is configured to be releasably attached or coupled to the nasal mask assembly, specifically the seal housing 204 of the nasal mask assembly.

[0455] The yoke 208 is configured to be attached to the strap of the headband 250. In this embodiment, as Fig.35 and Fig.36As shown, the headband 200 includes a strap assembly that includes: a rear strap 258 configured to wrap around the back of the patient's head, an upper strap 254 configured to wrap around the top of the patient's head, and a pair of front straps or side straps 252 configured to extend along the patient's cheeks during use. Each of the various straps can be formed as an integral part (where a portion is an extension of another portion) and / or otherwise formed as separate strap portions that are then permanently joined together or configured to releasably connect to each other. For example, in one form shown, the rear strap 258 includes side extensions that form the front straps or side straps 252 to extend along the patient's cheeks during use, and the upper strap 254 is connected at each end to a corresponding portion of the rear strap 258 or side straps 252 on each respective side of the headband. In another form, each side strap 252 is attached to or releasably connected to the rear strap 258 of the headband assembly by a rear connector member, such as a free end of the rear strap 258 or a connector coupled to the free end, and the upper strap 254 is integrally formed or releasably connected to the rear strap 258. In yet another form, the upper strap 254 includes side extensions that form the front straps or side straps 252 to extend along the patient's cheeks during use, and the rear strap 258 is (permanently or releasably) connected at each end to a corresponding portion of the upper strap 254 or side straps 252 on each respective side of the headband.

[0456] In one form, the headband can be automatically adjustable and / or can incorporate one or more direction locks that allow the headband to decrease in length with relatively low resistance and resist an increase in the length of the headband. In some configurations, the locking force of the direction lock can be overcome to allow the headband to extend in order to don the interface assembly. In some forms, the yoke 208 can form a collector for filaments used in an automatically adjustable headband system. In this form, the yoke 208 can incorporate one or more direction locks, each of which can include a washer mechanism that can be configured to frictionally engage the filaments during headband elongation but allow relatively frictionless movement during headband retraction. The washer mechanism can be incorporated into the ends of the yoke 208, and the body of the yoke can be substantially hollow to receive the filaments within the body. The headband or any portion thereof can be configured according to any of the embodiments disclosed in the following patent application publications of the applicant: U.S. Patent Application Publication No. 2016 / 0082217, U.S. Patent Application Publication No. 2016 / 0144146, and PCT Patent Application Publication No. WO 2016 / 043603, the entire contents of which are incorporated herein by reference.

[0457] Each side strap 256 can include a free end to which a connector can be attached. Each connector can engage a complementary strap connector located on the yoke 208. In this embodiment, the yoke 208 is substantially elongated and includes strap connectors at or near each end of the yoke 202.

[0458] The connection between the side strap 256 and the yoke 208 can be any suitable form of connection, such as a snap-fit connection, a screw and threaded type connection, or a hook connection. In one form, each strap connector of the yoke 208 includes end caps 291 located at each end of the yoke 208 (see Fig.83 ). Each end cap 291 can include an opening, such as an orifice or a recess, that is configured to receive the connector of the corresponding side strap 256 to secure the end cap 291 to each end of the corresponding side strap 256. The end cap 291 is then releasably (e.g., via a snap-fit arrangement) or permanently connected to the corresponding end of the yoke 208, thereby connecting the yoke 208 to the side strap 256 of the headband assembly. In another form, the free end of the side strap 256 can be directly coupled or permanently fixed into the corresponding end cap 291, which is then releasably or permanently connected to the corresponding end of the yoke 208, thereby connecting the yoke to the side strap 256 of the headband assembly.

[0459] See Fig.68 , Fig.70 and Figure 82 to Figure 87 , as mentioned above, the yoke 208 is also configured to be attached to the sealing housing 204 of the nasal mask interface. In one form, as discussed, the sealing housing 204 can include a recessed area or yoke channel 266 that is configured to receive at least a portion of the yoke 208 therein when the yoke 208 and the sealing housing 204 are attached together. The yoke channel 266 is formed or defined by an upper wall 266A, a rear wall 266C, and a lower wall 266B. In this embodiment, the yoke 266 has an asymmetry between the upper edge 292A and the lower edge 292B of the yoke 208. In the illustrated embodiment, the upper edge 292A of the yoke 208 is straighter than the lower edge 292B (see Fig.86 ). This asymmetry advantageously provides an improved visual cue regarding the correct orientation for assembling the yoke 208 into the yoke channel 266 of the sealing housing 204 and helps prevent incorrect assembly.

[0460] As Fig.68 and Fig.70As shown, the yoke channel 266 of the sealed housing 204 includes positioning features or connector recesses 271 in an upper wall 266A and a lower wall 266B. In the illustrated embodiment, the connector recesses 271 are positioned at, near, or adjacent to each lateral end of the yoke channel 266. The connector recesses 271 define or form retaining lips 271A at least partially at or along the front edges of the yoke channel 266 (e.g., at or along the front edges of the inward-facing surfaces of the upper wall 266A and the lower wall 266B). The yoke 208 includes connector protrusions 293 projecting rearward from an upper surface, a lower surface, and / or a rear surface of the yoke 208. In the illustrated embodiment, the yoke 208 includes connector protrusions 293 on each side of the center of the yoke 208. In the illustrated embodiment, the yoke 208 includes a yoke front portion 294A and a yoke back portion 294B joined together, as described in more detail herein, and the connector protrusions 293 are formed in the yoke back portion 294B. The connector recesses 271 of the yoke channel 266 are configured to receive complementary connector protrusions 293 when the sealed housing 204 and the yoke 208 are joined together, thereby forming a snap-fit connection between the sealed housing 204 and the yoke 208. When the sealed housing 204 and the yoke 208 are joined together, the retaining lips 271A engage the yoke 208 in front of the connector protrusions 293 to facilitate the snap-fit connection and retain the yoke 208 in the yoke channel 516. In the illustrated embodiment, the connector protrusions 293 and the connector recesses 271 have a square or rectangular profile that prevents the yoke 208 from rotating out of the yoke channel 266.

[0461] In some embodiments, the yoke 266 has a cross-section that is, for example, oval or substantially oval along its length. This shape advantageously reduces the size or volume of the yoke 266 and / or provides an improved aesthetic appearance. The gasket housings 295 of the orientation lock are discussed in more detail herein and may have a D-shaped, substantially D-shaped, U-shaped, or substantially U-shaped cross-section, such as Figure 88 to Figure 89 shown, to allow and / or facilitate the entire cross-section of the yoke 266 to be oval or substantially oval. The gasket housings 295 are located at or towards each end of the yoke 266 within the body. For clarity, only the right gasket housing 295 in one end of the yoke is shown in Figure 88 to Figure 89 , and the mounting space 295A for the omitted left gasket housing is shown at the other end. This pair of gasket housings 295 may be oriented relative to each other (see Fig.91 ). In other words, one of the gasket housings 295 (e.g., as Fig.88The right washer housing 295) shown in the figure can be oriented in an upward-facing U-shape, while another washer housing (e.g., the left washer housing (omitted from the view)) can be oriented in a downward-facing U-shape. This arrangement and orientation can advantageously help allow the wire tracks or filament tracks 296A, 296B to extend above and below the left washer housing and the right washer housing 295, respectively, as discussed in more detail herein.

[0462] In some embodiments, the depth of the yoke 208 or the central portion of the yoke 208 (when viewed from the top, for example Fig.84 ) is the same as, similar to, or corresponds to the depth of the yoke channel 266, such that the yoke 208 does not protrude from the yoke channel 266, or substantially does not protrude from the yoke channel. In other embodiments, as Fig.46 shown, at least a portion of the yoke 208 may protrude beyond the yoke channel 266.

[0463] As Fig.84 and Fig.85 shown, in the illustrated embodiment, the rear surface or the back surface of the yoke 208 includes a backward step or transition on each side or lateral end 302 of the central portion 300 of the yoke 208, such that the yoke 208 has a stepped or varying depth (when viewed from the top). In other words, the depth 304 (at least in the direction from the front surface to the back surface) or the thickness of the lateral portion 302 of the yoke 208 (which is positioned laterally outside the yoke channel 266 when the yoke 208 is coupled to the seal housing 204) is greater than the depth or thickness 306 of the central portion 300 of the yoke 208, which is positioned in the yoke channel 266 when the yoke 208 is coupled to the seal housing 204. The step or transition forms or defines an abutment surface 308 at the transition between the central portion 300 and the lateral portion 302 of the yoke 208. Each of the abutment surfaces 308 abuts one of the lateral edges or surfaces 310 of the seal housing 204, or is positioned near, or in proximity to, one of the lateral edges or surfaces when the yoke 208 is coupled to the seal housing 204 (see Fig.68 and Fig.72 ). The abutment surfaces 308 and the lateral edges 310 help to properly align the yoke 208 with the seal housing 204 during assembly. The abutment surfaces 308 and the lateral edges 310 also provide a more secure connection between or alternatively between the yoke 208 and the seal housing 204. The reduced depth or thickness of the central portion of the yoke 208 advantageously reduces the overall size of the assembly of the seal housing 204 and the yoke 208.

[0464] As previously mentioned, in this embodiment, the yoke 208 has an asymmetry between its upper edge or upper surface 292A and its lower edge or lower surface 292B. See Fig.86, in this embodiment, the upper edge 292A is straighter than the lower edge 292B. In this embodiment, the height profile of the yoke 208 (when viewed from the front, for example Fig.86 ) varies across the lateral width of the yoke between the end caps 291. In the illustrated embodiment, as Fig.86 and Fig.87 show, the height of the yoke 208 in the central region 300, which is normally received in the yoke channel 266 of the sealed housing, is reduced relative to the height of the yoke in the lateral side regions 302. In this embodiment, the height of the yoke in the central region 300 gradually decreases via the curved (e.g., concave) surface profile of the lower edge 292B of the yoke in this central region to a vertex at the center of the yoke (where the height of the yoke is reduced the most).

[0465] See Figure 84 to Figure 87 , in this embodiment, the depth variation profile (when viewed from the top) and the height variation profile (when viewed from the front) of the yoke 208 along its length provide a total thickness profile that varies along the length of the yoke. For example, the total thickness (in depth and height) of the yoke in the central region 300 is smaller or thinner than the total thickness (in depth and height) of the lateral regions 302. In particular, the yoke can be considered to have a thin central region 300 and thicker lateral regions 302 on either side of this central region. The thinner region 300 is normally received in the yoke channel 266 of the sealed housing 204, while the thicker lateral regions do not contact the sealed housing 204 and extend outwardly away from the sides of the sealed housing. The length, thickness, and convex curvature profile of the yoke are configured to blend with the sealed housing and are also configured such that the lateral sides of the yoke do not contact the user's face during use.

[0466] See Fig.84 and Fig.85 , in this embodiment, the radius of curvature of the yoke 208 (when viewed from the top) is substantially constant in most portions of the thinner central region 300 of the yoke, which radius of curvature then increases or is larger at the thicker lateral sides 302 of the yoke. In some embodiments, the thicker lateral regions 302 may extend at a substantially constant angle along their length without any curvature.

[0467] See Fig.86 , the total width 301A between each lateral edge of the yoke 208 (e.g., when viewed from the front as in Fig.86 ) will be in the range of about 60 mm to about 120 mm. See Fig.87 , the total depth 301B from the front of the yoke 208 to the rear end caps 291 (e.g., when viewed from the side as in Fig.87 ) will be in the range of about 30 mm to about 55 mm.

[0468] As Fig.83 As shown, in the illustrated embodiment, the yoke 208 includes a yoke front portion 294A and a yoke back portion 294B. The yoke 208 may also include two end caps 291, which are respectively located at each lateral end of the yoke 208. In the illustrated embodiment, the yoke front portion 294A and the yoke back portion 294B are formed as separate components that are coupled together. In this embodiment, the dividing line 312( Fig.82 , Fig.84 , Fig.85 shown therein) is centered or substantially centered. This can improve the convenience of manufacturing.

[0469] The yoke front portion 294A and the yoke back portion 294B may be coupled together via a snap fit. In the illustrated embodiment, the yoke front portion 294A includes a yoke fastener 314 that protrudes rearward from the rear surface of the yoke front portion 294A. In the illustrated embodiment, the yoke fastener 314 is positioned centered or substantially centered relative to the yoke front portion 294A. The yoke back portion 294B includes a fastener aperture or recess 316, the size, shape, and position of which are determined to receive the yoke fastener 314 when the yoke front portion 294A and the yoke back portion 294B are coupled together to form a snap-fit connection. The central connection between the yoke front portion 294A and the yoke back portion 294B via the yoke fastener 314 and the fastener aperture or recess 316 provides greater rigidity to the connection between the yoke front portion 294A and the yoke back portion 294B and / or provides support to resist torsion between the yoke front portion 294A and the yoke rear portion 294B or inhibits torsion between the yoke front and the yoke rear. In some embodiments, alternatively, the yoke front portion 294A includes a fastener aperture or recess 316, while the yoke back portion 294B includes a yoke fastener 314. In some embodiments, the fastener aperture or recess 316 includes one or more fastener ridges or interference ridges 318 (see Fig.88 ), which extend along (e.g., laterally along) the upper edge and / or the lower edge of the fastener aperture or recess 316 and protrude into the fastener aperture or recess 316 from the upper edge and / or the lower edge. In some embodiments, the yoke fastener 314 includes one or more corresponding notches that extend along (e.g., laterally along) the upper surface and / or the lower surface of the yoke fastener 314, the size, shape, and position of which are determined to receive one or more fastener ridges 318 to form a snap-fit connection. In some embodiments, the fastener aperture or recess 316 includes one or more notches 320, and the yoke fastener 314 includes one or more fastener ridges 318. In some embodiments, the interference ridge 318 may simply help form an interference fit by engaging the surface of the yoke fastener 314.

[0470] The illustrated embodiment shows a fastener recess 316 that does not extend all the way through the thickness of the yoke back 294B. In one variation, a fastener aperture 316 may alternatively be provided that does extend through the entire thickness of the yoke back 294B. However, the fastener recess 316 configuration may advantageously allow for reduced manufacturing difficulty, provide a neater finish (no aperture in the yoke back 294B), and / or inhibit dust or other debris from entering the wire tracks 296A, 296B (since the lack of an aperture allows the yoke 208 to be fully enclosed along its length), which can help maintain the function of the auto headband adjustment mechanism. When the yoke front 294A and the yoke back 294B are joined together, either form of fastener aperture or fastener recess is used to receive the complementary yoke fastener 314 in the snap-fit and / or friction-fit engagement manner described above.

[0471] In this embodiment, the yoke back 294B includes an upper alignment bead 322a and / or a lower alignment bead 322b that project forward from the yoke back 294B and extend along the length of the yoke back 294B near or adjacent to the upper surface of the yoke back 294B. The lower alignment bead projects forward from the yoke back 294B and extends along the length of the yoke back 294B near or adjacent to the lower surface of the yoke back 294B. The yoke front 294A (see Fig.90 ) includes an upper alignment groove 324a in the rear surface of the yoke front 294A and / or a lower alignment groove 324b in the rear surface of the yoke front 294A. The upper alignment groove extends along the length of the yoke front 294A near or adjacent to the upper surface of the yoke front 294A. The lower alignment groove extends along the length of the yoke front 294A near or adjacent to the lower surface of the yoke front 294A. When the yoke front 294A and the yoke back 294B are joined together, the upper alignment groove 324a and / or the lower alignment groove 324b receive the upper alignment bead 322a and / or the lower alignment bead 322b, respectively. The alignment beads 322a, 322b and the alignment grooves 324a, 324b help to correctly align the yoke front 294A with the yoke back 294B. The alignment beads 322a, 322b and the alignment grooves 324a, 324b may also, or alternatively, resist torsion or provide support against torsion, e.g., torsion between the yoke front 294A and the yoke back 294B. In some embodiments, the alignment beads 322a, 322b and the alignment grooves 324a, 324b may actively engage with each other, e.g., in the form of a friction-fit connection or a snap-fit connection.

[0472] The end cap 291 can help fix the front yoke part 294A and the back yoke part 294B together by being clamped to or clipped onto, or snap - fitted onto the lateral ends of the front yoke part 294A and the back yoke part 294B. The end cap 291 can also allow the front strap of the headband to be connected to the yoke 208. In some embodiments, each end cap 291 is overmolded onto the braided part of the front strap.

[0473] As Figures 93 to 98 shown, the lateral ends of both the front yoke part 294A and the back yoke part 294B include or are formed by end - cap inserts 326. The end - cap inserts 326 can be integrally formed with the lateral ends of both the front yoke part 294A and the back yoke part 294B, or attached to the said lateral ends. The end - cap inserts 326 have a reduced size or profile compared to the lateral part of the yoke 208. The end cap 291 has an internal cavity 328 for receiving the end - cap insert 326. During assembly, the end cap 291 is hingedly connected to or snapped onto the end - cap insert 326, as Fig.93 shown.

[0474] As Fig.98 shown, each end cap 291 includes a retaining hole 330 on one side (e.g., the rear side in the illustrated embodiment), and a retaining notch 332 on the opposite side (e.g., the front side in the illustrated embodiment). In other embodiments, the positions of the retaining hole 330 and the retaining notch 332 can be reversed. In the illustrated embodiment, the positioning of the retaining hole 330 in the rear part of the end cap 291 advantageously hides the retaining hole 330 during use, which provides an improved aesthetic appearance. The retaining notch 332 extends forward from the end - cap cavity 328 into the end cap 291. The end - cap insert 326 includes a first retaining feature 334 (e.g., extending rearward from the back - yoke - part 294B portion of the end - cap insert 326 in the illustrated embodiment) on one of the front surface and the back surface, and a second retaining feature 336 (e.g., extending forward from the front - yoke - part 294A portion of the end - cap insert 326 in the illustrated embodiment) on the opposite surface. To attach the end cap 291 to the yoke 208, e.g., to the end - cap insert 326, the retaining hole 330 is engaged with the first retaining feature 334, as Fig.94 shown. The first retaining feature 334 then serves as a hinge point or pivot point, and then the end cap 291 pivots on the end - cap insert 326 in the direction indicated by the arrow in Fig.93 until the second retaining feature 336 and the retaining notch 332 are engaged, e.g., in the form of a raised - fit or snap - fit connection. This hinged connection reduces the length 338 of the end - cap insert 326 ( Fig.144In the case shown), a firm connection can be provided between the yoke 208 and the end cap 291. Thus, the end cap 291 can taper more steeply. The reduction in the length of the end cap insert 326, the end cap 291, and / or the entire yoke 208 can advantageously reduce or minimize the extent to which the yoke 208 is embedded in the patient's face.

[0475] In the illustrated embodiment, the first retaining feature 334 is or includes an oval or racetrack-shaped post that extends rearwardly from the yoke back 294B. The first retaining feature 334 has a selected length or depth such that the outer or most rear surface of the first retaining feature 334 is flush or substantially flush with the rear surface of the yoke back 294B. This increases the contact area and interaction between the end cap 291 and the end cap insert 326, and increases the retaining force. Thus, the connection between the end cap 291 and the end cap insert 326 can resist greater torsional forces along the length of the yoke 208 and / or rotational forces about the joint.

[0476] In the illustrated embodiment, the second retaining feature 336 is or includes a raised tab that extends forwardly from the yoke front 294A. The second retaining feature 336 has a reduced length or depth compared to the first retaining feature 334, which allows the end cap 291 to pass over the second retaining feature 336 during assembly. In the illustrated embodiment, the second retaining feature 336 has a chamfered lead-in 336a on one edge (e.g., on the lateral (relative to the yoke 208) edge in the illustrated embodiment), which allows the end cap 291 to more easily hinge or pivot over the second retaining feature 336 and / or more easily hinge or pivot onto the second retaining feature.

[0477] In some embodiments, the end cap 291 can be overmolded onto the end of a braided element (e.g., a side strap 252) of an automatic headband adjustment mechanism, e.g., as shown and described in the braided elements of the following applications: U.S. Provisional Patent Application No. 62 / 343,711, filed May 31, 2016, entitled "Directional Lock for Interface Headgear Arrangement", PCT Application No. PCT / IB2017 / 051522, and PCT Publication No. WO 2014 / 175752, the entire contents of which are hereby incorporated by reference. A core element or filament 340 can extend within the braided element (e.g., the side strap 252). The end cap 291 can connect the braided element, and thus the headband, to the yoke 208, thereby forming a closed-loop headband system.

[0478] As described herein, in some embodiments, the yoke 208 can form a collector for a core element (such as a filament 340) for use in an automatically adjustable or self-adjusting headband system. As Fig.91 As shown, the front yoke portion 294A includes an upper wire track 296A and a lower wire track 296B. In this embodiment, the wire track separator projects rearwardly from the rear surface or inner surface of the front yoke portion 294A. In some embodiments, the yoke fastener 314 forms or serves as the wire track separator, which generally extends diagonally across a portion of the length of the front yoke portion 294A. In the illustrated embodiment, the separator wall 344 extends between each of the washer housings 295 and the opposing wire track. The separator wall 644 separates the opposing wire track from the washer housings 295, thereby preventing the free ends of the filaments 340 from getting caught in the opposing washer housings 295 during retraction. In the illustrated embodiment, due to the asymmetry of the upper and lower edges of the yoke 208, the wire tracks 296A, 296B are not mirror symmetric.

[0479] Fig.92 A variant of the yoke 208 is shown, in which the wire tracks 296A, 296B extend into and terminate within the end caps 291. Thus, the lengths of the wire tracks 296A, 296B extend beyond the ends of both the front yoke portion 294A and the back yoke portion 294B. This increases the length of the filaments 340 that can be stored within the yoke 208, thereby increasing the adjustment range or variability of the headband size. The headband assembly defines a headband loop that extends around a user's head in use. The filaments 340 form part of an automatic headband adjustment mechanism that allows the total length of the headband loop to extend during donning and doffing of the mask system. In some such embodiments, the length of each of the wire tracks 296A, 296B can be increased or extended by about 5 mm. In such embodiments, the total length of the headband loop in the extended state can thus be increased by about 10 mm.

[0480] See Figures 99 to 102, showing an embodiment of the directional lock of the auto-adjusting headband, which will be further explained in detail below. The directional lock includes a washer housing 295, a first locking element and a second locking element (e.g., washers 1820, 1822), and a filament or core member 340. The housing includes a first chamber 1840 and a second chamber 1842, wherein the first chamber 1840 and the second chamber 1842 are configured to receive the first locking washer 1820 and the second locking washer 1822, respectively. In the arrangement shown, the first chamber 1840 and the second chamber 1842 are separated by the inner wall 1812 of the housing 295. However, in other arrangements, the first chamber 1840 and the second chamber 1842 need not be physically separate spaces, but may be multiple parts of a single chamber. The housing 295 has two end walls 1814, which together with the inner wall 1812 have an elongated core opening 1860 for the core member 340 to pass through. The core openings 1860 are substantially aligned with each other. The core opening 1860 of the end wall 1814 shown on the right side of the drawing is larger than the core openings of both the inner wall 1812 and the end wall 1814 shown on the left side of the drawing. This allows the path of the core member 340 through the housing 295 to be manipulated. Each of the first chamber 1840 and the second chamber 1842 is defined by one of the inner wall 1812, one of the end walls 1814, and a pair of side walls 1816; wherein the side walls 1816 extend between the end walls 1814 of the housing 295. The first chamber 1840 and the second chamber 1842 are configured to be open at one or both of the top and bottom of the housing 295.

[0481] Each of the first chamber 1840 and the second chamber 1842 has a pair of washer retainers 1850 aligned on opposite side walls 1816 of the housing 295. Each pair of washer retainers 1850 is configured to pivotally hold one of the first locking washer 1820 or the second locking washer 1822 within the corresponding first chamber 1840 or second chamber 1842. The washer retainer includes a circular bushing 1852 and an elongated slot 1854, wherein the circular bushing 1852 intersects the bottom of the housing, thus forming an inlet. The inlet is configured to allow the first locking washer 1820 and / or the second locking washer 1822 to be received into the washer retainer 1850. The slot 1854 extends radially from the circular bushing 1852 towards the top of the housing 295.

[0482] The first washer 1820 and the second washer 1822 include a cylindrical shaft 1824 and arms 1826 extending from the shaft 1824. The cylindrical shaft 1824 has substantially the same width W as the housing 295, and the arms 1826 are relatively narrow to fit within the first chamber 1840 and the second chamber 1842. In the arrangement shown, the arm 1826 includes a first section 1872 and a second section 1874, where the first section 1872 extends radially or perpendicularly from the cylindrical shaft 1824, and the second section 1874 extends at an obtuse angle to the end of the first section 1872. The first section 1872 of the arm 1826 of the first washer 1820 is shorter than the first section 1872 of the arm 1826 of the second washer 1822. The angle between the first section 1872 and the second section 1874 of the arm 1826 of the first washer 1820 is greater than the corresponding angle of the second washer 1822. These angles can be selected such that the second section 1874 of one or both of the first washer 1820 and the second washer 1822 lies substantially against the corresponding walls (e.g., correspondingly, the inner wall 1812 and the end wall 1814) of the housing 295 at a position in one of the washers 1820, 1822. The second section 1874 of the arm 1826 includes a centrally located circular aperture 1876 configured to receive the core member 340. The first chamber 1840 and the second chamber 1842 differ in size according to the size of the washers to be accommodated therein, i.e., since the first washer 1820 is smaller than the second washer 1822, the first chamber 1840 is smaller than the second chamber 1842.

[0483] The cylindrical shafts 1824 of the first locking washer 1820 and the second locking washer 1822 have a diameter substantially the same as the diameter of the circular bushing 1852 of the washer retainer 1850 and are configured to be received and held by the circular bushing 1852 in a snap-fit configuration. The snap-fit configuration is provided because the entrance of the circular bushing 1852 is narrower than the diameter of the cylindrical shaft 1824. The slot 1854 of the washer retainer 1850 is configured to allow the entrance to flex open to reduce the difficulty with which the first locking washer 1820 and the second locking washer 1822 can be pushed through the entrances and assembled into the housing 295. Once assembled within the first chamber 1840 and the second chamber 1842 of the housing 295, the first washer 1820 and the second washer 1822 can pivot back and forth about a central axis extending through the cylindrical shaft 1824.

[0484] The core member 340 is configured to pass through the core opening 1860 of the housing 295 and the apertures 1876 of both the first washer 1820 and the second washer 1822. Applying tension to the core member 340 causes the first locking washer 1820 and the second locking washer 1822 to pivot back and / or forth between a locked position and / or an open position. Fig.99 and Fig.100 Shows a direction lock in a locked configuration, in which a force is applied to the core member 340 in a direction towards the left side of the drawing (as indicated by the arrow). The force applied to the core member 340 in this configuration causes the first locking washer 1820 and the second locking washer 1822 to pivot in the counterclockwise direction, thereby making the path of the core member 340 through the direction lock 1800 non-linear or tortuous, and thus restricting the movement of the core member 340. Fig.101 and Fig.102 Shows a direction lock in an open configuration, in which a force is applied to the core member 340 in a direction towards the right side of the drawing (as indicated by the arrow). In this configuration, the first locking washer 1820 and the second locking washer 1822 pivot in the clockwise direction, thereby aligning the circular orifice 1876 and the core opening 1860 in a substantially straight line. This provides a smooth path for the core member 340 to be pulled through the direction lock 1800 substantially freely. Additional details of the operation of the direction lock 1800 are described above and in the applicant's PCT application publication number WO 2014 / 175752.

[0485] Feature overview of the fourth embodiment

[0486] In some embodiments, various aspects of the nasal mask interface of the fourth embodiment may provide the following advantages or features:

[0487] · A nasal mask interface that can be used with an auto-adjusting headband (or any single-sided strap-type headband) without a forehead T-piece component,

[0488] · The yoke 208 enables the headband 250 to be removably connected to the sealing housing 204 and the nasal seal 202,

[0489] · The sub-nasal support 224, in combination with a lower-profile or shorter nasal seal and ribs 241, helps to increase the stability of the mask on the user's face during use,

[0490] · The lower profile or shorter height of the nasal seal means that the seal contacts the user's nasal bridge at a lower position than a conventional nasal seal, resulting in generally less intrusion,

[0491] · The removably connectable conduit frame 211 is symmetric and allows the conduit frame to be connected in either of two orientations,

[0492] · The secondary sealing lips (e.g., including 284e, 284F) at the ends 284A of the central gripping portion 284 of the conduit frame 211 help to form a backup seal when the conduit frame is connected to the sealing housing.

[0493] Fifth Embodiment - Various Alternative Nasal Mask Interface Configurations

[0494] Now refer to Figures 103 to 149 Various shapes of the nasal mask interface assembly of the fifth embodiment are described. The various forms of the nasal mask interface of the fifth embodiment are generally similar in configuration and construction to the fourth embodiment, although there are some differences. The following description will focus on the differences between embodiments. It should be recognized that the various alternatives and configurations described with reference to the fourth embodiment or other disclosed embodiments can also be applied to the form of the fifth embodiment.

[0495] A first form of nasal mask interface of the fifth embodiment

[0496] See also Figures 103 to 117 , a first form 400 of a nasal mask assembly of a fifth embodiment will be described. As with the fourth embodiment, the nasal mask interface 400 includes a nasal seal 402 coupled to a seal housing 404, and a yoke 408 received in a yoke channel 466 of the seal housing 404. Fig.104 As shown, the nasal seal 402 includes an under-nose support 424 extending within the mask cavity. As with the fourth embodiment, the first form of nasal mask interface 400 can be connected to a headgear assembly of the type previously described via a yoke 408 attachment.

[0497] In this embodiment, the central lower portion or lower part of the outside of the sealing housing 404 includes an integral inlet orifice 465. In this embodiment, the inlet orifice 465 is an oval protrusion or extrusion from the sealing housing and is configured to be connected or coupled directly or indirectly to a gas supply conduit to supply gas flow into the mask cavity when in use. In this embodiment, the arrangement of the bias vents 412 is provided in an array around the perimeter of the inlet orifice protrusion 465. Depending on the embodiment, the array of bias flow orifices 412 can extend around the entire perimeter of the inlet orifice protrusion 465 or one or more portions of the perimeter.

[0498] See also Figures 107 to 110 , the connection of the yoke 408 to the sealed housing 404 will be described in further detail. In this embodiment, the yoke channel 466 is modified (relative to the fourth embodiment) in that it provides larger singular locating features 468 on each lateral side of the yoke channel 466, which are shaped and sized to receive complementary portions of the thicker lateral regions 410 of the yoke 408.

[0499] In this embodiment, a recessed elongate channel 414 is provided in a lower portion of the rear surface of the yoke channel 466, the channel being shaped and sized to receive a complementary-shaped elongate protrusion or rib 416 positioned along the bottom of the rear surface of the thinner central region 412 of the yoke 408. In particular, the protrusion 416 of the yoke is configured to engage into the complementary recessed channel 414 of the yoke channel 466 with an interference fit or a friction fit, thereby coupling the yoke 408 to the seal housing 404.

[0500] See Fig.112 and Fig.113 , in this first form of the fifth embodiment, the nose seal 402 is provided with a channel 418 at its connection edge to the outer seal housing. The channel 418 is configured to engage with a complementary-shaped ridge 420 that extends around the opening of the seal housing 404 (see Fig.110 ). The connection of the nose seal 402 to the seal housing 404 can be seen in a cross-sectional view of Fig.114 , in particular the engagement of the seal housing ridge 420 into the complementary channel 418 of the nose seal. It should be appreciated that in alternative embodiments, this configuration can be inverted, with the channel provided on the seal housing 404 and the protruding ridge provided on the nose seal 402.

[0501] See Fig.111 and Fig.112 , the lower central connection portion 419 of the sub-nasal support 424 is similar to the lower central connection portion of the fourth embodiment. The lateral connection 421 of the main lateral portion or strap 422 of the sub-nasal support 424 is directly connected to the lateral outer wall portion of the nose seal in the region of the channel 418. In this embodiment, the lateral connection of the main lateral strap 422 is at a lower position within the nose seal relative to the fourth embodiment, which provides a generally flatter curvature for the main lateral strap 422 in the central region of the mask cavity relative to the fourth embodiment.

[0502] The nasal mask interface of the second form of the fifth embodiment

[0503] Referring Figures 118 to 128 , the nasal mask interface 450 of the second form of the fifth embodiment will be described. The nasal mask interface 450 of the second form is similar to the first form, and like reference numerals correspond to like components.

[0504] The main difference in the second form of the nasal mask interface relates to the configuration of the yoke 451 and the yoke channel 452. In this second form, the yoke channel 452 does not provide any specific positioning features. Instead, the yoke channel 452 is configured to firmly receive and hold the yoke 451 via an interference fit between the surface of the channel 452 and the adjacent outer surface of the yoke 451. In particular, referring Fig.128 , the maximum height of the yoke (as indicated by 453) is greater than the corresponding width of the yoke channel opening. Force is required to sufficiently deform the yoke to press it into the yoke channel 451, thereby forming a semi-permanent interference fit connection.

[0505] The third form of the nasal mask interface of the fifth embodiment

[0506] Reference Figures 129 to 139 , the third form of the nasal mask interface of the fifth embodiment will be described.

[0507] The third form of the nasal mask interface is similar to the first and second forms, and similar components use similar reference numerals. The third form of the nasal mask interface assembly utilizes an interference fit to couple the yoke 451 into the yoke channel 454 of the seal housing 404, similar to that in the second form of the nasal mask interface. However, the shape and configuration of the yoke channel 454 of the third form of the seal housing 454 are changed to shift the longitudinal axis of the yoke 451 upwardly obliquely so as to enable an improved headband vector. As Fig.133 shown above, the upward angular offset or tilt of the yoke 451 is provided by the shape of the yoke channel 454 and the lateral cutout formations 453 provided at the side surfaces of the channel. See Fig.130 , the horizontal orientation of the longitudinal axis of the yoke 451 is shown by 456, which is the orientation of the first and second forms of the nasal mask interface. The tilt of the yoke angle is shown by the longitudinal axis 457 of the yoke 451 in the third form, where the angular tilt is indicated by 455. In this form, the tilt angle is about 5°, but it should be recognized that this angle can vary as needed.

[0508] See Fig.130 And Figures 137 to 139 , the third form of the nasal seal 402 also includes changes relative to the previous forms. The third form of the nasal seal 402 has an upper lip region (as indicated by 458 in Fig.119 ) that is thickened relative to the thinner upper lip region 459 of the second form embodiment shown in Fig.130 . This provides more compression in the bottom or upper lip region of the nasal seal in the user, and provides a generally flatter and smoother transition to the contact surface of the nasal seal.

[0509] The lower connecting portion 460 of the sub-nasal support 424 is also thinner laterally at the connecting edge of the nasal aperture relative to the wider connection of the second form ( Fig.121 shown by 462 in Fig.137as indicated by 461 in). The lateral connection 462 of the main lateral band of the sub-nasal support 424 is also thicker and extends further into the nasal seal from the connection channel edge 464, as Fig.139 shown. For example, the connection 462 can be integrally coupled to a portion of the channel connection edge 464 of the nasal seal and the inner surface of the side wall. In some embodiments, the lateral connection 462 can also be coupled to, or extend into, a portion of the inner surface of the contact surface of the nasal seal.

[0510] In this third form, the length of the sub-nasal support 424 that originates from the connection edge of the nasal aperture and extends to the rear edge of the main lateral band 465 has been extended to accommodate a longer nose. By way of example only, the length shown as 463 can be about 22.8 mm as compared to, for example, 17.9 mm in the first and second forms of the fifth embodiment.

[0511] The nasal mask interface of the fourth form of the fifth embodiment

[0512] See Figures 140 to 149 , and the nasal mask interface 470 of the fourth form will be described in further detail. The nasal mask interface 470 of the fourth form is substantially similar to the nasal mask interface 460 of the third form, and like components have like reference numerals.

[0513] As a first major difference of the fourth form of the mask interface 470 with respect to the third form, the bias vent hole 471 has been moved from the inlet aperture 465 to the upper central region of the seal housing 404 above the yoke channel. As shown, the bias vent hole includes a cluster or arrangement of apertures or holes that are closely spaced, as indicated by 471.

[0514] See Figures 146 to 149 , the nasal mask interface of the fourth form includes a nasal seal 402A that has an improved geometry to provide a flatter contact surface. In particular, referring to Fig.149 , a comparison between the nasal seal 402 of the third form and the nasal seal 402A of the fourth form is shown. As depicted, the upper region including the bridge region of the nasal seal, and the lower upper lip region of the nasal seal have been advanced relative to the nasal seal 402 of the third form to provide an overall flatter sealing surface, thereby providing greater cushioning.

[0515] In addition, the length of the sub-nasal support that extends from the central connector at the nasal aperture edge to the rear edge of the main lateral band (as Fig.148474 in the illustration) has been further extended relative to the third form of nasal seal to a length of approximately 26.49 mm, as compared to 22.8 mm in the third form of nasal seal.

[0516] Sixth embodiment

[0517] See also Figures 150 to 154 , a sixth embodiment of a nasal mask interface 500 will be described. The substantial configuration of the nasal mask interface 500 is similar to the previous embodiments, particularly the fourth form 470, and like reference numerals represent like parts. The following description will focus on the major differences, and it should be appreciated that the alternatives discussed with reference to the previous embodiments may also be applied to this sixth embodiment.

[0518] The main difference with the nasal mask interface 500 compared to the fourth form 470 is that the seal housing 504 has been reconfigured by swapping the locations of the yoke connection channel 454 and the inlet orifice or conduit connector 465. In particular, the conduit connector 465 is positioned in the upper central region of the seal housing above the yoke channel that receives the yoke 451. The yoke channel (not visible) is similar to the yoke channel 454 of the fourth form nasal mask assembly 470. In some embodiments, a lower yoke positioned on the seal housing can limit the amount that the frame rolls up on the user's face.

[0519] The nasal mask interface 500 also includes an alternative bias event arrangement. In this embodiment, two bias event orifice clusters 501 are provided in the upper lateral region of the seal housing on either side of the inlet conduit 465.

[0520] Seventh embodiment

[0521] refer to Figures 155 to 162 , various alternative forms of nasal seals for use in nasal mask assemblies will be described. As will be appreciated by the skilled artisan, the alternative forms of the nasal seal of this seventh embodiment may be used with any of the embodiments of the described nasal seal interface (particularly any of the various forms of seal housings, yoke assemblies and connections, and headband assemblies).

[0522] The first form of the seventh embodiment of the nose seal

[0523] See also Figures 155 to 157, the first form of the nasal seal 600 will be described. The first form of the nasal seal 600 in this embodiment is similar to the previously described nasal seal and includes a sub-nasal support indicated by 601. The main difference from this nasal seal 600 is that it is provided with lateral wings or fins 602 along at least a part of the lateral sides of the contact surface 603. In this embodiment, the wing-like part 602 is generally located at the middle or central region of the lateral sides of the nasal seal. The fins 602 are configured to provide, and are shaped to provide, additional contact surfaces that are configured to engage the cheek / nose area of the user to increase stability, and the increased footprint of the contact surface of the nasal seal on the user's face helps to reduce rolling or rocking that occurs during use in some embodiments. Refer to Fig.157 , each of the fins 602 includes a connecting portion 602A and an extending portion 602B, where the connecting portion is coupled to the side wall portion of the nasal seal located behind the contact surface 603, and the extending portion extends forward from the contact surface 603 to provide a wing-like contact surface on each lateral side of the nasal seal. The wing-like contact portion 602 provides additional support to prevent the nasal mask from rolling up on the user's face.

[0524] The second form of the nasal seal of the seventh embodiment

[0525] The second form of the nasal seal 610 is similar to the first form 600 in that it includes lateral wing-like portions 604 extending from the lateral sides of the nasal seal. Compared with the nasal seal 600 of the first form, the fins 604 are longer and are adapted to fit against the flat areas of the cheek / nose area. As shown in Fig.161 , the curved or wavy profile of the wing-like area is adapted to match the profile of the user's face. As in the first form, the fins 604 include a connecting portion 604A and an extending or contact portion 604B, where the connecting portion couples the fin to the lateral side of the nasal seal, and the extending or contact portion is configured to contact the cheek / nose area of the user's face to stabilize the nasal mask on the user's face and prevent the nasal mask from rolling up as in the first form.

[0526] See Fig.162, shows a nasal mask interface including a second form of nasal seal 610 having wings 604, the nasal mask interface being fixed to the user's head via a headband assembly of the aforementioned type. As shown, the wing regions 604 may be loosely coupled or tethered to the straps of the headband assembly, such as side straps or front strap 252 on each side of the nasal seal. In one embodiment, these wings may have coupling or connection mechanisms provided at or towards the ends of the wings 604 for coupling to the side straps 252. In one form, the connector 606 may be an annular member or the like through which the side strap 252 extends, thereby loosely coupling or tethering the side strap to the wing portion 604 of the nasal seal. In other forms, the wings 604 may be detached or unfastened from the side straps 252.

[0527] Eighth Embodiment

[0528] Reference Figures 163 to 170 , various alternative forms of nasal seals used in nasal mask assemblies will be described. As those skilled in the art will recognize, the alternative forms of the nasal seal of this eighth embodiment can be used with any of the embodiments of the nasal seal interfaces described (particularly any of the various forms of seal housings, yoke assemblies and connections, and headband assemblies).

[0529] The nasal seal of the first form of the eighth embodiment

[0530] See Fig.163 and Fig.164 , Fig.163 shows a first form of nasal mask interface 700 having a nasal seal 701, a seal housing 702, and a gas supply conduit 703. In this first form of the eighth embodiment, the nasal mask interface further includes a forehead support member (designated by 704). The forehead support member is configured to engage the user's forehead between or above the user's eyebrows when the mask is about to roll up or starts to roll up on the face, thereby canceling out the rolling force. In particular, the size and angular orientation of the forehead support 704 are such that at rest or during normal use, the forehead support does not engage the user's forehead nor deviate from the user's forehead, but engages the forehead only when any upward rolling of the nasal mask should occur during use in order to cancel out such upward rolling.

[0531] In this first form of the eighth embodiment, the forehead support 704 is centrally disposed above the bridge region of the nasal seal. In one form, the forehead support 704 may be coupled to extend only from the seal housing 702, or only from the nasal seal 701, or in yet a further alternative, may be coupled to extend from the upper regions of both the seal housing 702 and the nasal seal 701.

[0532] Forehead support 704 may be an integral part of seal shell 702 and / or nasal seal 701 , or alternatively may be formed separately and coupled or connected to seal shell 702 and / or nasal seal 701 . Fig.164 A forehead support 704 is shown having a contact area 704A located at or towards the end of the forehead support member, which contact area is substantially elongated in this form. Fig.164 700 can be seen being worn by a user, wherein the nasal mask interface is coupled via a headband assembly of the type previously described, which is coupled to the nasal mask interface by a yoke 706. The side straps 705 of the headband assembly can be Fig.164 Seen in.

[0533] Second form of nose seal of the eighth embodiment

[0534] See also Figures 165 to 170 , a second form 710 of a nasal seal for use in a nasal mask interface is shown. The configuration of the nasal seal 710 is substantially similar to the nasal seals previously described. The primary difference is that the nasal seal is provided with a support protrusion 712 extending upwardly from the apex of the seal. The second form of the nasal seal 710 is shorter in height than the first form of the nasal seal 700, and the support protrusion 712 is configured to counteract the rolling up of the nasal mask in use by contacting the nasal bridge area of ​​the user's face rather than the forehead area as in the first form of the nasal seal 700.

[0535] As shown, support protrusion 712 is integrally formed and extends upward from the outer upper side of the nasal seal to above the apex of the bridge of the nose region (indicated by 711) of the contact surface. Fig.167 As shown, the thickness of the support protrusion in this embodiment generally tapers from the nasal seal connection end toward the upper end of the support protrusion.

[0536] See also Fig.169 and Fig.170 , the nasal seal is shown as being worn in place on the user's face, with the remainder of the nasal mask interface assembly omitted from view for clarity. As shown, when stationary and in normal use, the upper support protrusion 712 is configured to be offset or offset from the bridge of the user's nose. Only when the nasal mask begins to roll up or pivot upward on the user's face during use does the support protrusion 712 rock or pivot inward toward the bridge of the nose area of ​​the user, thereby offsetting the rolling force. In this embodiment, the stationary displacement of the support protrusion 712 can be about 3mm away from the bridge of the user's nose.

[0537] Ninth Embodiment

[0538] Reference Figures 171 to 185 , various alternative forms of nasal seals for a nasal mask interface will be described. As will be recognized by those skilled in the art, various forms of nasal seals can be used with any of the nasal mask interface components described.

[0539] Nasal Seal of the First Form of the Ninth Embodiment

[0540] Refer to Figures 171 to 174 , the nasal seal 750 of the first form of the ninth embodiment is substantially similar to the previously described nasal seal and includes a sub-nasal support indicated by 752. The nasal seal 750 of the first form further includes thickened regions (indicated by 754) in the upper lateral side portions of the contact surface, which increase the support for the upper region of the nasal seal or pad 750. As shown, the thickened regions 754 are located proximal or near either side of the bridge region of the contact surface indicated by 751.

[0541] The nasal seal 750 of the first form further includes a pair of support ribs 756 located within the thickened regions 754. The support ribs 756 extend in an orientation that is substantially radial with respect to the central region or nasal aperture of the nasal seal, rather than horizontally or vertically. The support ribs 756 increase the support for the upper region of the nasal seal from the inner surface of the nasal seal within the mask cavity, thereby helping to reduce the degree to which the nasal mask interface rolls up during use.

[0542] Reference Figure 174 , the support ribs are located above the lateral connection 758 of the sub-nasal support 752. In other words, the support ribs 756 of this form are isolated from the sub-nasal support connection 758. As shown, the support ribs 756 are connected to a portion of the sidewall of the nasal seal that includes a portion of the contact surface but terminates before the thinned edge region at the perimeter of the nasal aperture.

[0543] In this embodiment, the support ribs 756 on the inner side of the nasal seal have an angular orientation with respect to the vertical centerline extending through the nasal seal. In this embodiment, the angular orientation indicated by 760 can be in the range of about 50° to about 70°, preferably about 60°, in other words, the ribs have an angular orientation of about 60° with respect to the vertical centerline extending through the nasal seal.

[0544] Nasal Seal of the Second Form of the Ninth Embodiment

[0545] Refer to Figures 175 to 182 , the nasal seal of the second form of the ninth embodiment will be described.

[0546] The second form of the nasal seal 770 of the ninth embodiment includes a modified geometry relative to the first form of the nasal seal 750. In particular, the second form of the nasal seal 770 is shorter in the vertical direction, for example, about 10 mm shorter. The nasal seal otherwise has a similar configuration to the aforementioned nasal seal. Figure 175 The second form nasal seal 770 has an overall height, as indicated at 772, of about 47 mm and an overall width, as indicated at 774, of about 59 mm. Figure 177 , the second form nasal seal 770 has an overall depth as indicated at 776 of about 39 mm. In this embodiment, the ratio of the overall height to the overall width is in the range of about 1:1 to about 1:1.4, preferably about 1:1.3. In this embodiment, the ratio of the overall height to the overall width to the overall depth is in the range of about 1:1:0.6 to about 1:1.4:1, preferably about 1:1.3:0.8.

[0547] The contact surface of the nose seal is indicated at 771 and the outside of the seal housing aperture is indicated at 773.

[0548] See also Figure 179 , the difference between the upper contact points of the first and second forms of the nasal seal of the ninth embodiment on the bridge of the user's nose can be seen. The bridge of the nose contact point of the second form nasal seal 770 is indicated by 777, which is lower than the typical contact point on the bridge of the nose of the taller first form nasal seal (as indicated by 778). The reduced vertical height of the second form nasal seal 770 enables it to contact the bridge of the nose at a much lower point, such as contacting a portion of the bridge of the nose within an area or region below the bridge of the nose that extends between the tip of the nose and midway or to the center of the bridge of the nose. This lower contact area relative to conventional nasal seals can be more consistent between multiple users, thereby increasing the percentage of the population that can successfully use the nasal mask.

[0549] See also Figure 181 and Figure 182 , a first form nasal seal 750 is shown overlaid onto a shorter second form nasal seal 770 to illustrate the difference in geometry for comparison.

[0550] The third form of the nose seal of the ninth embodiment

[0551] refer to Figures 183 to 185 , a third form of nasal seal 780 of the ninth embodiment will be described.

[0552] The third form of the nasal seal 780 in this embodiment is similar in size and shape to the shorter second form of the nasal seal 770. The main difference is that the third form of the nasal seal 780 further includes support ribs 782 on the inner surface of the nasal seal. In particular, the main lateral portions of the sub-nasal support 781 at each lateral end are connected to the corresponding support ribs 782. As shown, the support ribs 782 have a substantially vertical or near-vertical orientation. The sub-nasal support and its connection to the support ribs are similar in configuration to those described with reference to the nasal seal of the fourth embodiment.

[0553] In this third form of the nasal seal 780, the ribs 782 strengthen the connection of the sub-nasal support within the nasal seal and also perform the dual function of providing structural support to the upper region of the nasal seal. In this third form, the shape of the sub-nasal support is more approximately square rather than U-shaped. In particular, the main lateral portion includes a substantially flat or horizontal central region 783 and two substantially vertical lateral portions 784 extending upward from the respective ends of the central region.

[0554] Tenth Embodiment

[0555] Reference Figures 186 to 205 , various forms and configurations of the sealing housing and the conduit frame of the nasal mask interface will be described. It should be recognized that these various forms of sealing housing and conduit frame variations can be incorporated into the various embodiments of the nasal mask assembly to provide alternative configurations.

[0556] Conduit Frame Configuration of the First Form of the Tenth Embodiment

[0557] See Figures 186 to 189 , the first form of the conduit frame 800 is a hollow ovoid body that extends between the housing connection end 801 and the gas supply conduit connected at 802. As shown, the body has a curved surface profile that corresponds to the surface profile of the sealing housing 804 around the perimeter of the orifice 806 to which the conduit frame is connected. In particular, the conduit frame has a surface profile that mates with the surface profile of the sealing housing to provide a fused or continuous surface at the interface between the two components when assembled together.

[0558] The first form of the conduit frame 800 provides a pair of fan-shaped gripping areas, indicated as 808 (only one is visible), on the lateral sides of the body towards the conduit connection end 802. The housing connection end 801 is provided with protrusions (indicated as 810) on the upper and lower surfaces for snap-fit engagement with complementary recesses or grooves 812 provided in the surface of the orifice of the sealing housing 804, which is similar to the configuration described with respect to the fourth embodiment.

[0559] Reference Figure 188 , the body of the duct frame 800 is configured to provide a downward inclination angle of about 30° with respect to the horizontal plane, as indicated by 814. In particular, the axis at the duct end indicated by 802 is angled or offset with respect to the axis of the orifice at the seal housing connection end 801. It should be recognized that the angle can vary.

[0560] Configuration of the duct frame in the second form of the tenth embodiment

[0561] Reference Figures 190 to 193 , the duct frame 820 in the second form of the tenth embodiment will be described. In this embodiment, the duct connection end 821 of the duct frame 820 is again provided with a fan-shaped gripping area or portion 822. The seal housing connection end indicated by 823 is larger and includes wing-like portions that partially overlap with the outer surface of the seal housing 824 adjacent to the air inlet duct protrusion 825 of the seal housing.

[0562] As Figure 191 shown, the duct frame includes a complementary duct portion having one or more protrusions or grooves 826 that are complementary to the complementary protrusions or grooves 827 provided on the duct protrusion 825 of the seal housing 824 for snap-fit or interference engagement.

[0563] As Figure 192 shown, the wing-like lateral portions of the duct frame at the seal housing connection end 823 may include orifices 828. If the seal housing is provided with aligned complementary orifices, these orifices can provide a surface for the diffuser pad to provide a biasing vent hole.

[0564] Configuration of the duct frame in the third form of the tenth embodiment

[0565] Reference Figures 194 to 197 , the third form of the duct frame 830 will be described. The third form of the duct frame 830 is substantially similar to the second form of the duct frame 820. The main difference is that the seal housing 835 is provided with a larger inlet orifice opening 833 that completely receives the wing-like region 832 of the duct frame to provide a fusion surface. In other words, like in the second form of the configuration, the wing-like region of the duct frame does not overlap onto the outer surface of the seal housing.

[0566] As Figures 194 to 197 shown, the lateral edges of the wing-like region of the duct frame may be provided with protrusions or grooves 832 that are configured to snap-fit or otherwise engage with complementary grooves or protrusions 833 provided within the inner peripheral surface of the orifice 831 of the seal housing 835.

[0567] Fourth form of the catheter frame configuration of the tenth embodiment

[0568] Reference Figures 198 to 201 , the fourth form of the catheter frame 840 will be described. The catheter frame 840 of the fourth form is provided with a catheter (indicated as 843) at the sealed housing connection end, and the catheter is received within a complementary catheter 844 of the sealed housing 842. The catheter portion 843 of the catheter frame includes protrusions or grooves 845 on the upper surface and / or lower surface or other surfaces, and the other surfaces are engaged with complementary alignment protrusions or grooves 846 via the inner surface of the catheter orifice 844 of the sealed housing 842.

[0569] See Figure 201 , wing-like regions 847 surround the lateral portions of the catheter portion 843, and these wing-like regions extend from the lateral sides of the catheter frame on either side of the catheter portion 843. These wing-like regions or portions 847 are received within complementary recessed regions 848 provided on the lateral sides of the inlet of the sealed housing 842. Generally, the wing-like regions 846 and the outer surface profile of the main body of the catheter frame at the sealed housing connection end are configured to combine or blend with the surface profile of the sealed housing in the region surrounding the inlet orifice, such that when the two components are assembled together, there is a seamless or blended surface at their interface, as Figure 198 shown.

[0570] Grip tabs or protrusions 849 are provided opposite to the sealed housing connection end of the catheter frame, and these grip tabs or protrusions extend laterally from the sides of the catheter frame at the gas supply catheter connection end 850 of the catheter frame. These grip tabs 849 allow the user to pull the catheter frame out of the sealed housing when needed. They can also assist in inserting the catheter frame into the sealed housing during assembly.

[0571] Fifth form of the catheter frame configuration of the tenth embodiment

[0572] See Figures 202 to 205 , the fifth form of the catheter frame 850 of the tenth embodiment will be described.

[0573] The fifth form of the catheter frame 850 is similar to the fourth form of the catheter frame 840. The main difference is that the grip tabs at the gas supply catheter connection end, the catheter frame 850, are replaced by a series or multiple rows of grip protrusions (indicated as 852). The wing-like regions 853 and the catheter portion 855 at the sealed housing connection end are symmetric about a horizontal plane extending through the axis 856 indicated in Figure 204 .

[0574] The fifth form of conduit frame 850 has an angular offset between the sealed housing connection end 858 and the gas supply conduit supply connection end 859. In this embodiment, the axis extending from the conduit connection end 859 is offset at a downward inclination angle of approximately 40° relative to the axis extending from the sealed housing connection end 858, although this angle can vary as recognized.

[0575] In the case of using a symmetric sealed housing arrangement, the conduit frame 850 can be connected to the sealed housing 862 in either of two orientations that are rotated 180° relative to each other. Additionally, the angled offset at the conduit connection end 859 enables the conduit frame to be assembled into the sealed housing 862 in a first orientation where the conduit connection end 859 is angled downward to allow the conduit to face or extend toward the user's feet; or alternatively, it can be installed in a second orientation such that the conduit connection end 856 is angled upward, thereby enabling the conduit to extend upward in the direction of the user's forehead.

[0576] Further alternative embodiments

[0577] Various alternative embodiments or configurations of the interface are described below. It should be recognized that any one or more of these embodiments or configurations (either alone or in combination) can be applied to the general embodiments described above.

[0578] Full-face mask embodiments

[0579] The embodiments described above with reference to Figures 2A to 205 relate to a nasal seal interface configured to seal around the user's nose. However, it should be recognized that such embodiments can also be adapted to full-face masks or oronasal masks that are configured to seal around both the user's nose and mouth such that therapeutic gas can be delivered to the user's airway via the nose and mouth. By way of example only, Figure 206 An eleventh embodiment in the form of a full-face mask interface 102E is shown. The full-face mask seal 102E is similar to Figures 30 to 34The seal as described in the third embodiment 102D includes a single-band sub-nasal support member 124D configuration. The full-face seal 102E is substantially similar in configuration but has a larger contact surface 120E. The enlarged contact surface 120E is configured to seal around the user's nose and mouth, i.e., its shape is determined to circumscribe both the nose and the mouth. The upper region 125 at or towards the bridge of the nose is substantially similar to the previously described upper region, but the side cheek regions 123 extend further downward and are connected by a lower region 121E that is configured to seal below the user's mouth, such as proximal to the user's chin. With this larger contact surface, both the user's nose and mouth can be encapsulated within the seal 102E.

[0580] Sub-nasal support members formed of different materials for the seal

[0581] In reference Figures 2A to 205 In the above-described embodiments, the sub-nasal support member is typically integrally formed and thus an integral part of the nasal seal. For example, the nasal seal and its sub-nasal support member are integrally molded from silicone or other suitable material into a single unit. Alternatively, the nasal seal and the sub-nasal support member are initially molded as separate parts and then permanently joined or connected together (such as by adhesive or welding or the like) to form an integral nasal seal component.

[0582] In an alternative embodiment, the sub-nasal support member can be formed of a different material than the nasal seal. For example, the nasal seal can be formed of silicone, but the sub-nasal support member can be formed of a different material, such as but not limited to textile materials, foam materials, neoprene, materials, thermoplastic polyurethane (TPU). The sub-nasal support member can then be permanently joined or connected into the nasal seal (such as by adhesive or welding or the like) to form an integral nasal seal component.

[0583] Removable sub-nasal support members and other connection configurations

[0584] In reference Figures 2A to 205 In the above embodiments described, the sub-nasal support member is typically fixedly connected within the nasal seal, such as integrally formed or otherwise permanently connected into the nasal seal. In an alternative embodiment, the sub-nasal support member can be removably or releasably connected to the nasal seal by a releasable connection assembly located at the previously described connection points or connection locations of the nasal seal.

[0585] In a further alternative configuration, the sub-nasal support may be fixedly or releasably connected or coupled to a non-sealing structure or component of the interface. For example, depending on the configuration, the sub-nasal support may be fixedly or releasably connected to a sealed housing or a rigid clamp member or a frame member. As previously mentioned, the sub-nasal support may be formed of any suitable material, including but not limited to silicone, fabric, foam material, neoprene, material or TPU.

[0586] The foregoing description of the invention includes preferred forms of the invention. Modifications may be made to the invention without departing from the scope of the invention as described by the appended claims.

Claims

1. A nasal seal for a nasal mask or interface, the nasal seal being formed of a flexible material and extending between a face - contacting side and an outer side, the nasal seal comprises: A contact surface, including an edge that defines an opening of the nasal seal and being configured to seal on a user's nose; and A nasal suspension, fixedly connected within the nasal seal and located behind the opening of the nasal seal, the nasal suspension including a central extension portion that is connected to the edge of the contact surface in the upper - lip region; wherein at least a portion of the central extension portion of the nasal suspension is oriented at an angle within a range of about 40° to about 80° relative to a sealing axis that tangentially extends between the outermost upper contact point and the lower contact point in the central region of the contact surface of the nasal seal.

2. The nasal seal according to claim 1, wherein the nasal suspension has a contact surface that is oriented to contact at least a portion of the lower surface of the user's nose.

3. The nasal seal according to claim 1, wherein the central extension portion of the nasal suspension is configured to contact at least a portion of the columella of the nasal septum on the lower surface of the user's nose.

4. The nasal seal according to claim 1, wherein the contact surface seals on the user's nose, including sealing across a nasal bridge portion in a region extending between the tip of the user's nose and the center of the user's nasal bridge.

5. The nasal seal according to claim 1, wherein the central extension portion of the nasal suspension is configured to contact at least a portion of the columella region on the lower surface of the user's nose that is between the tip and the base of the nose.

6. The nasal seal according to claim 5, wherein the central extension portion of the nasal suspension is configured to contact a majority of the columella region on the lower surface of the user's nose that extends from the base of the nose.

7. The nasal seal according to claim 1, wherein the nasal suspension is configured to contact one or more portions of the lower surface of the user's nose while substantially not obstructing the user's nostrils, and the nostrils are aligned with the open space of the nasal seal opening on both sides of the central extension portion.

8. The nasal seal according to claim 1, wherein the thickness of the nasal suspension is significantly less than the corresponding width of the nasal suspension at any position on the nasal suspension.

9. The nasal seal according to claim 1, wherein the thickness of the nasal suspension is substantially similar to the thickness in the region of the contact surface of the nasal seal.

10. The nasal seal according to claim 1, wherein the central extension portion of the nasal suspension includes a thickness - varying profile.

11. The nasal seal according to claim 1, wherein the central extension portion of the nasal suspension includes a thickness that varies from a thicker region to a thinner region at the edge of the contact surface of the nasal seal, or the central extension portion of the nasal suspension includes a thickness that varies from a thicker region to a thinner region towards the edge of the contact surface of the nasal seal.

12. The nasal seal according to claim 11, wherein The thickness of the thinner region of the central extension of the nasal seal is substantially the same as the thickness of the edge of the contact surface of the nasal seal.

13. The nasal seal according to claim 1, wherein, the width of the central extension of the nasal suspension strap gradually increases towards the edge of the contact surface of the nasal seal.

14. The nasal seal according to claim 1, wherein, the width of the central extension of the nasal suspension strap varies along its length such that the shape or profile of the central extension is substantially hourglass-shaped.

15. The nasal seal according to claim 1, wherein, the width of the central extension of the nasal suspension strap is consistent along its length.

16. The nasal seal according to claim 1, wherein, the nasal seal is defined by a contact surface on the contact face side and a side wall portion that extends rearward from the contact surface to the outside of the nasal seal and terminates at an opening or connection edge for coupling or connecting to a complementary seal housing.

17. The nasal seal according to claim 1, wherein, the outside of the nasal seal includes a peripheral channel configured to receive a complementary peripheral ridge of a complementary seal housing to connect the nasal seal to the seal housing.

18. The nasal seal according to claim 1, wherein, the nasal seal is formed of a material having a varying thickness across multiple regions of the nasal seal, the nasal seal is defined by a front region and a rear region, the front region extends from a middle boundary towards the contact face side of the nasal seal and includes the contact surface, and the rear region extends from the middle boundary towards the outside of the nasal seal, and the average thickness of the rear region is greater than that of the front region.

19. The nasal seal according to claim 18, wherein, the front region includes a thinning edge region that extends peripherally around the edge of the contact surface, and the thinning edge region is thinner than the rest of the front region.

20. A nasal mask interface assembly, comprising: a seal housing; the nasal seal according to any one of claims 1-19, the nasal seal being connected to or capable of being connected to the seal housing to define a mask cavity; and a headband including a single left strap and a single right strap, the single left strap and the single right strap being configured to extend above the user's ears and connect to the seal housing.

21. The nasal mask interface assembly according to claim 20, wherein, the single left strap and the single right strap of the headband are connected to respective attachment positions at or towards respective sides of the seal housing.

22. The nasal mask interface assembly according to claim 20, wherein, the seal housing includes an offset vent arrangement.

23. The nasal mask interface assembly according to claim 20, wherein, the seal housing includes an inlet opening, and the nasal mask interface assembly further includes a conduit frame that is releasably received and held in the inlet opening of the seal housing, and the conduit frame is connected to or capable of being connected to the end of a gas supply conduit.

24. The nasal mask interface assembly according to claim 23, wherein, The catheter frame is an oval-shaped hollow body and is symmetric such that the catheter frame can be releasably received and held in the inlet opening of the sealed housing in either of two orientations that are 180 degrees apart.

25. The nasal mask interface assembly according to claim 20, wherein, the nasal seal is formed of silicone, and the sealed housing is rigid and formed of plastic.

26. The nasal mask interface assembly according to claim 20, wherein, the nasal seal is removably connectable to the sealed housing.

27. The nasal mask interface assembly according to claim 20, wherein, the nasal seal is permanently or semi-permanently coupled to the sealed housing.

28. The nasal mask interface assembly according to claim 20, wherein, the peripheral edge on the outer side of the nasal seal is fixed to the complementary-shaped connection edge of the sealed housing.

29. The nasal mask interface assembly according to claim 27, wherein, the peripheral edge on the outer side of the nasal seal is overmolded onto the complementary-shaped opening edge of the sealed housing.

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