Nasal seal and respiratory interface

Abstract

To provide an improved nasal seal, and / or nasal mask interface including the nasal seal, and / or respiratory interface assembly.SOLUTION: A nasal mask has a seal housing and a flexible nasal seal connected or connectable to the seal housing to define a mask cavity. The nasal seal extends between a face-contacting side and an outer side. The nasal seal has a contacting surface having an edge that defines a nose-receiving opening into the mask cavity and which is configured to seal around the user's nose. The nasal seal also has an under-nose support fixedly connected into the seal and which is configured to extend within the mask cavity and having a contact surface that is oriented to contact at least a portion of the under-nose surface of the user.SELECTED DRAWING: Figure 36

Description

[Technical field]

[0001] The present disclosure relates generally to a nasal seal for a respiratory interface, and a nasal mask interface or interface assembly including the nasal seal. [Background technology]

[0002] Respiratory interfaces are used to provide one or more breathable gases, such as air in CPAP therapy, to a user under positive pressure. Nasal interfaces deliver the gases to the nose.

[0003] The seal of an indirect nasal interface or nasal mask contacts the upper lip, the face on either side of the nose, and the bridge of the nose, substantially encircling the nose. Such nasal interfaces are often secured to the user's head with headgear. Often, a nasal mask assembly includes a T-piece frame for connection to the headgear, the T-piece frame including a pair of upper and lower straps that generally extend substantially horizontally across the sides of the user's head. The upper straps extend over the user's ears and connect to the upper part of the T-piece frame at the user's forehead region, and the lower straps extend below the user's ears and connect to the lower part of the T-piece frame at or towards the nasal interface, or from the nasal interface itself. While such headgear tends to provide a relatively stable fixation of the nasal interface to the user, it can be intrusive or uncomfortable in use. Single-sided strap headgear is known, which is less bulky, but at the same time tends to be less stable in securing the nasal interface in sealing engagement during use.

[0004] Where patent specifications, other external documents, or other sources of information are referenced herein, this is generally for the purpose of providing a context for discussing the features of the present invention. Unless otherwise specified, the reference to such external documents is not to be construed as an admission that such documents or such sources are prior art in any jurisdiction or form part of the common general knowledge in the art. Summary of the Invention [Means for solving the problem]

[0005] It is an object of at least some embodiments of the present invention to provide a nasal seal, and / or a nasal mask interface including a nasal seal, and / or a respiratory interface assembly which is improved in at least one or more respects, or at least to provide the public or medical professionals with a useful choice.

[0006] In one aspect, the invention broadly relates to a nasal mask interface including a seal housing, a flexible nasal seal connected or connectable to the seal housing to define a mask cavity, the flexible nasal seal having a contact surface extending between a face-contacting side and an exterior side and including an edge defining a nose receiving opening into the mask cavity and configured to seal around a user's nose, and an under-nose 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 a under-nose surface of the user.

[0007] In some embodiments, the seal housing is rigid relative to the flexible nasal seal.

[0008] In some embodiments, the contact surface seals around the user's nose, including at or over a proximal portion of the nasal bridge region.

[0009] In certain embodiments, the under-nose support extends laterally across the nasal seal within the mask cavity between opposite sides of the nasal seal, at least at a location that is spaced or displaced from the edge of the contact surface of the nasal seal.

[0010] In certain embodiments, the under-nose support extends laterally across the nasal seal within the mask cavity between opposite sides of the nasal seal, at least at a location displaced from the contact surface of the nasal seal.

[0011] In some embodiments, the under-nose support includes one or more extensions that extend from within the mask cavity and connect to an edge of the contact surface of the nose seal at the upper lip area of ​​the nose seal.

[0012] In certain embodiments, the under-nose support includes at least a major lateral portion that extends laterally across the mask cavity between opposing sides of the nasal seal.

[0013] In some embodiments, the major lateral portions of the under-nose support are integrally connected to the nasal seal at least at a location spaced or displaced from the edge of the contact surface of the seal.

[0014] In certain embodiments, the nose seal includes a sidewall extending rearwardly from a contact surface of the nose seal, and a major lateral portion of the under-nose support is integrally or fixedly connected to an opposing sidewall portion of the nose seal.

[0015] In some embodiments, the under-nose support further includes one or more extension portions that extend from the main lateral portions toward and connect to the nose seal at the upper lip region of the nose seal.

[0016] In some embodiments, the one or more extension portions connect to the upper lip region of the nose seal at least at a location in the upper lip region of the nose seal that is spaced or displaced from the edge of the contact surface of the nose seal.

[0017] In some embodiments, the one or more extensions of the under nose support are connected to the edge of the contact surface at the upper lip region of the nose seal.

[0018] In certain embodiments, the under-nose support includes a central extension portion having a contact surface configured primarily to contact at least a portion of the pillars of the nasal septum of the under-nose surface of the user's nose.

[0019] In certain embodiments, the under-nose support includes left and right extension portions that extend on either side of the nose seal and include contact surfaces configured to primarily contact at least a portion of the respective left and right alar rims of the under-nose surface of the user's nose.

[0020] In some embodiments, at any location along the under-nose support, the under-nose support is substantially thinner in a direction transverse to its contact surface than the corresponding width of the contact surface at that location.

[0021] In certain embodiments, the flexible nasal seal is formed from silicone.

[0022] In certain embodiments, the seal housing is rigid and formed from plastic.

[0023] In certain embodiments, the nasal seal is removably connectable to the seal housing.

[0024] In some embodiments, the exterior of the nose seal may include a seal housing closure for connecting the nose seal to the seal housing. Complementary It includes a peripheral channel configured to receive the peripheral ridge.

[0025] In certain embodiments, the outer peripheral edge of the nose seal is Complementary It is overmolded onto a rigid clip, which is connectable to the seal housing.

[0026] In certain embodiments, the nasal seal is permanently or semi-permanently bonded to the seal housing.

[0027] In one embodiment, the outer peripheral edge of the nose seal is Complementary The molded part is overmolded onto the opening edge of the profile.

[0028] In another aspect, the invention broadly relates to a nasal seal for a nasal mask or interface including a contact surface formed of a flexible material and extending between a face-contacting side and an exterior side, including edges defining a nose-receiving opening and configured to seal around a user's nose, and an under-nose support fixedly connected within the seal and configured to extend rearward of the nose-receiving opening and having a contact surface oriented to contact at least a portion of the under-nose surface of the user.

[0029] In another aspect, the invention broadly relates to a nasal mask interface assembly including a seal housing, a flexible nasal seal connected or connectable to the seal housing to define a mask cavity, the flexible nasal seal including a contact surface extending between a face-contacting side and an exterior side and including edges defining a nose receiving opening into the mask cavity and configured to seal around a user's nose, an under-nose 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 a under-nose surface of the user, and headgear including single left and right side straps configured to extend over the user's ears and connect to the seal housing.

[0030] In some embodiments, the left and right straps connect to respective attachment points at or towards each side of the seal housing.

[0031] In another aspect, the invention broadly relates to a nasal mask interface assembly including a seal housing, a flexible nasal seal connected or connectable to the seal housing to define a mask cavity, the flexible nasal seal having a contact surface extending between a face-contacting side and an exterior side and including an edge defining a nose receiving opening into the mask cavity and configured to seal around a user's nose, and an under-nose 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 a under-nose surface of the user.

[0032] In some embodiments, the seal housing is rigid relative to the flexible nasal seal.

[0033] In some embodiments, the contact surface seals around the user's nose, including at the bridge of the user's nose or over a proximal portion of the bridge of the user's nose.

[0034] In some embodiments, the contact surface seals around the user's nose, including over a portion of the bridge of the nose in a region extending between the tip of the user's nose and the center of the bridge of the user's nose.

[0035] In certain embodiments, the under-nose support extends laterally across the nasal seal within the mask cavity at least between connection locations of opposing sides or upper lateral regions within the nasal seal.

[0036] In certain embodiments, the connection locations of the opposing sides or upper lateral regions within the nasal seal are spaced or displaced from the edges of the contact surface of the nasal seal.

[0037] In certain embodiments, the connection locations of the opposing sides or upper lateral regions within the nasal seal are displaced from the contact surface of the nasal seal.

[0038] In some embodiments, the under-nose support includes one or more extensions or connecting portions that extend from within the mask cavity and connect to an edge of the contact surface of the nasal seal at the upper lip area of ​​the nasal seal.

[0039] In one embodiment, the under-nose support includes at least a major lateral portion having two ends that extend laterally across at least a portion of the mask cavity between connection locations of opposing side or upper lateral regions within the nasal seal.

[0040] In some embodiments, the under-nose support further includes one or more extension or connecting portions that extend from the main lateral portions at the upper lip region of the nose seal toward and connect to the nose seal.

[0041] In some embodiments, the under-nose support further includes a central connecting portion extending between the major lateral portions and a portion of the edge of the contact surface at the upper lip region of the nose seal.

[0042] In some embodiments, the central connecting portion of the under-nose support has a contact surface that is primarily configured to contact at least a portion of the pillars of the nasal septum of the under-nose surface of the user's nose.

[0043] In certain embodiments, the central connecting portion of the under-nose support varies in thickness over its length from thicker regions at the ends that connect to the major lateral portions and thinner regions at or toward the ends that connect to the edges of the contact surfaces.

[0044] In some embodiments, the central connecting portion of the under-nose support includes a central region that is reduced in width compared to the width at its ends.

[0045] In certain embodiments, the width of the central connecting portion varies gradually along its length such that the central connecting portion has a substantially hourglass shape or profile.

[0046] In certain embodiments, the major lateral portions of the under-nose support are integrally connected at their ends into the nose seal at connection locations that are spaced or displaced from at least the edges of the contact surface of the nose seal.

[0047] In one embodiment, the nasal seal includes a sidewall extending rearwardly from the contact surface of the nasal seal to the exterior of the nasal seal, and a major lateral portion of the under-nose support is integrally or fixedly connected at its end to at least an opposing lateral wall portion within the nasal seal.

[0048] In certain embodiments, the major lateral portions of the under-nose support are integrally or non-movably connected directly to the inner surface of the nose seal at each end.

[0049] In certain embodiments, the major lateral portions of the under-nose support are integrally or fixedly connected at each end to the inner surface of the nose seal indirectly via respective ribs extending from the inner surface of the nose seal.

[0050] In one embodiment, each rib comprises a panel of flexible material having a first connecting edge portion connected to a portion of the inner surface of the nose seal and a second connecting edge portion connected to each end of the major lateral portion of the under-nose support at another portion of its peripheral edge.

[0051] In one embodiment, a first connecting edge portion of each rib is connected to a portion of the inner surface of the nose seal that extends between a thinner anterior region of the nose seal that is located toward the face-contacting side and includes the contact surface, and a thicker posterior region of the nose seal that is located toward the exterior of the nose seal.

[0052] In one embodiment, the first connecting edge portion of each rib terminates at or towards a thinned edge region of the front region of the nose seal located around the periphery of the edge of the contact surface, the edge region being thinner than the remainder of the front region.

[0053] In certain embodiments, each rib is shaped or configured with a buckling axis or zone that allows the rib feature to bend or flex under compression applied to the nasal seal contact surface.

[0054] In certain embodiments, the buckling axis of each rib zone is formed by a concave area or zone of the rib.

[0055] In certain embodiments, each rib has a substantially vertical orientation within the nasal seal.

[0056] In one embodiment, the ribs extend from respective upper lateral regions of the inner surface of the nose seal, one from each side of the nasal bridge region of the nose seal.

[0057] In certain embodiments, the nose seal is formed of a material having a varying thickness across the area of ​​the nose seal, the nose seal being defined by an anterior region extending from the intermediate boundary toward the face-contacting side of the nose seal and including the contact surface, and a posterior region extending from the intermediate boundary toward an exterior side of the nose seal, the posterior region being on average thicker than the anterior region.

[0058] In some embodiments, the front region includes a thinned edge region extending around the periphery of the edge of the contact surface, the thinned edge region being thinner than the remainder of the front region.

[0059] In some embodiments, the contact surface of at least a central portion of the under-nose support is oriented at an angle relative to a sealing axis that extends tangentially between the outermost upper and lower tangent points in the central region of the contact surface of the nasal seal.

[0060] In one embodiment, the contact surface of the central portion of the under-nose support is oriented at an angle in the range of about 40° to about 80° relative to the seal axis.

[0061] In one embodiment, the contact surface of the central portion of the under-nose support is oriented at an angle in the range of approximately 55° to approximately 65° relative to the seal axis.

[0062] In certain embodiments, the ratio of the overall height to the overall depth of the seal housing and nose seal when assembled together ranges from approximately 1:0.8 to approximately 1:1.2.

[0063] In one embodiment, the ratio of overall height to overall depth of the seal housing and nasal seal when assembled together is approximately 1:1.

[0064] In one embodiment, the ratio of overall height to overall depth to overall width of the seal housing and nose seal when assembled together ranges from approximately 1:0.8:1 to approximately 1:1.2:1.4.

[0065] In one embodiment, the ratio of overall height to overall depth to overall width of the seal housing and nasal seal when assembled together is approximately 1:1:1.2.

[0066] In certain embodiments, the assembly further includes a yoke connected or connectable to the seal housing, headgear connected or connectable to the yoke, and an intake opening in the seal housing for connection to a gas supply conduit.

[0067] In certain embodiments, the seal housing includes a yoke channel extending laterally across an exterior surface of the seal housing that is configured to releasably receive and retain a yoke.

[0068] In some embodiments, the yoke is curved along its length between its ends and has a concave internal mating surface with the yoke channel and a convex outer surface.

[0069] In one embodiment, the headgear includes at least a pair of side straps, each of which extends along the side or cheek of the user's face and over the user's ear, with each side strap connected or extending from a respective end of the yoke.

[0070] In one embodiment, a central portion of the yoke is received in a yoke channel in the seal housing, and side portions of the yoke on either side of the central portion extend outwardly, away from the sides of the nose seal.

[0071] In some embodiments, the side portions of the yoke are thicker in height and / or width than the central portion of the yoke.

[0072] In one embodiment, the headgear is self-adjusting headgear and the yoke includes one or more directional locks that interact with core elements extending from the side straps of the self-adjusting headgear.

[0073] In certain embodiments, the conduit frame is releasably received and retained in the inlet opening of the seal housing, the conduit frame being connected or connectable to an end of a gas supply conduit.

[0074] In one embodiment, the conduit frame is a hollow body that is oval in shape and is symmetrical such that it can be releasably received and retained in the intake opening of the seal housing in either of two orientations that are 180 degrees apart.

[0075] In some embodiments, at any location along the under-nose support, the under-nose support is substantially thinner in a direction transverse to its contact surface than the corresponding width of the contact surface at that location.

[0076] In certain embodiments, the flexible nasal seal is formed from silicone.

[0077] In certain embodiments, the seal housing is rigid and formed from plastic.

[0078] In certain embodiments, the nasal seal is removably connectable to the seal housing.

[0079] In one embodiment, the exterior of the nose seal is provided with a seal housing closure for connecting the nose seal to the seal housing. Complementary It includes a peripheral channel configured to receive the peripheral ridge.

[0080] In certain embodiments, the outer peripheral edge of the nose seal is Complementary It is overmolded onto a rigid clip, which is connectable to the seal housing.

[0081] In certain embodiments, the nasal seal is permanently or semi-permanently bonded to the seal housing.

[0082] In one embodiment, the outer peripheral edge of the nose seal is Complementary The shape is fixed to its connecting edge.

[0083] In one embodiment, the outer peripheral edge of the nose seal is Complementary The molded part is overmolded onto the opening edge of the profile.

[0084] In another aspect, the invention broadly relates to a nasal seal for a nasal mask or interface including a contact surface formed of a flexible material and extending between a face-contacting side and an exterior side, including edges defining a nose-receiving opening, and configured to seal around a user's nose, and an under-nose support fixedly connected within the seal and having a contact surface located posterior to the nose-receiving opening and oriented to contact at least a portion of the under-nose surface of the user.

[0085] In another aspect, the invention broadly relates to a nasal mask interface assembly including a seal housing, a flexible nasal seal connected or connectable to the seal housing to define a mask cavity, the flexible nasal seal including a contact surface extending between a face-contacting side and an exterior side and including an edge defining a nose receiving opening into the mask cavity and configured to seal around a user's nose, an under-nose 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 a under-nose surface of the user, and headgear including single left and right side straps configured to extend over the user's ears and connect to the seal housing.

[0086] In some embodiments, the left and right straps connect to respective attachment points at or towards each side of the seal housing.

[0087] In another aspect, the invention broadly relates to a nose seal for a nasal mask or interface, the nose seal including a contact surface formed of a flexible material and extending between a face-contacting side and an exterior, including edges defining a nose-receiving opening, and configured to seal around a user's nose, and an under-nose support stationarily connected to extend within the nose seal.

[0088] In certain embodiments, the under-nose support extends laterally across the nasal seal within the mask cavity at least between connection locations of opposing sides or upper lateral regions within the nasal seal.

[0089] In some embodiments, the under-nose support includes one or more extensions or connecting portions that extend from within the mask cavity and connect to an edge of the contact surface of the nasal seal at the upper lip area of ​​the nasal seal.

[0090] In some embodiments, the contact surface of at least a central portion of the under-nose support is oriented at an angle relative to a sealing axis that extends tangentially between the outermost upper and lower tangent points in the central region of the contact surface of the nasal seal.

[0091] In one embodiment, the contact surface of the central portion of the under-nose support is oriented at an angle in the range of about 40° to about 80° relative to the seal axis.

[0092] In some embodiments, the nose seal includes a face-contacting surface and a sidewall portion extending rearwardly from the face-contacting surface to the exterior of the nose seal; Complementary For connection to seal housing or Complementary and a sidewall portion terminating in an opening or connecting edge connected to the seal housing.

[0093] In another aspect, the invention broadly relates to a nasal mask interface assembly including a seal housing, a flexible nasal seal connected or connectable to the seal housing to define a mask cavity, the flexible nasal seal including a contact surface extending between a face-contacting side and an exterior side and including edges defining a nose receiving opening into the mask cavity and configured to seal around a user's nose, and an arrangement of bias air holes in the seal housing including at least one upper array of bias air holes extending laterally across an upper region of the seal housing and at least one lateral array of bias air holes extending into a lower portion of a side of the seal housing.

[0094] In certain embodiments, each array of bias air holes is a linear array of spaced holes or apertures extending into the housing.

[0095] In another aspect, the invention broadly relates to a nasal mask interface assembly including a seal housing including an intake opening, a flexible nasal seal connected or connectable to the seal housing to define a mask cavity, the flexible nasal seal including a contact surface extending between a face-contacting side and an exterior and including edges defining a nose receiving opening into the mask cavity and configured to seal around a user's nose, and a conduit frame releasably received and retained in the intake opening of the seal housing, the conduit frame being connected or connectable to an end of a gas delivery conduit and being symmetrical such that it can be releasably received and retained in the intake opening of the seal housing in either of two orientations that are 180 degrees apart.

[0096] In one embodiment, the conduit frame is a hollow body that is oval in shape.

[0097] In another aspect, the invention broadly relates to a nose seal for a nasal mask or interface, the nose seal comprising a contact surface formed of a flexible material and extending between a face-contacting side and an exterior side, the contact surface including an edge defining a nose-receiving opening, and configured to seal around a user's nose, the nose seal having an overall height to overall lateral width ratio ranging from about 1:1 to about 1:1.4.

[0098] In one embodiment, the ratio of overall height to overall width of the nose seal is approximately 1:1.2.

[0099] In one embodiment, the ratio of overall height to overall width to overall depth of the nose seal ranges from about 1:1:0.6 to about 1:1.4:1.

[0100] In one embodiment, the ratio of overall height to overall width to overall depth of the nose seal is approximately 1:1.2:0.8.

[0101] Each aspect of the invention described above may have any one or more of the features mentioned for any one or more of the other aspects of the invention described above.

[0102] The term "comprising" as used in the present specification and claims means "consisting at least in part of." When interpreting each statement in the present specification and claims that includes the term "comprising," there may be features present other than the feature or features to which the term is attached. Related terms, such as "comprise" and "comprises," are to be interpreted in a similar manner.

[0103] Number range Reference to a range of numbers disclosed herein (e.g., 1-10) is also intended to encompass reference 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., 2-8, 1.5-5.5, and 3.1-4.7), and thus all subranges of the entire range expressly disclosed in the present invention are hereby expressly disclosed. These are merely examples of what is specifically intended, and all possible combinations of the recited numerical values ​​between the lowest and highest values ​​are considered to be expressly set forth in this application as well.

[0104] As used herein, the term "and / or" means "and" or "or" or both.

[0105] As used herein, "(s)" following a noun refers to the plural and / or singular form of that noun.

[0106] The present invention also contemplates structures including those mentioned above, and of which only examples are given below.

[0107] Preferred embodiments of the present invention will now be described, by way of example only, and with reference to the following drawings, in which: [Brief description of the drawings]

[0108] [Figure 1]1 is a schematic diagram of a system for providing a flow of heated and humidified gas to a user, for example in a continuous positive airway pressure (CPAP) system. [Figure 2A] FIG. 1 is a schematic diagram of a nasal mask interface secured to a user's head in an over-the-ear headgear configuration. [Figure 2B] 1 shows a force diagram relating to the forces experienced by a nasal mask interface during use. [Diagram 3] FIG. 2 is a schematic diagram of the nasal anatomy of the underside of a user's nose. [Figure 4] FIG. 2 is a front or face-contacting side (or wearer side) view of a nasal mask interface or assembly according to a first configuration of a first embodiment, showing a nasal seal with an under-nose support arrangement along with a central extension, seal housing, and headgear frame of the assembly. [Diagram 5] FIG. 2 shows a rear or outer view of the nasal mask interface of the first embodiment. [Figure 6] FIG. 2 is an upper front perspective view of the nasal mask interface of the first embodiment; [Figure 7] FIG. 2 is a lower front perspective view of the nasal mask interface of the first embodiment; [Figure 8] FIG. 2 is a bottom view of the nasal mask interface of the first embodiment. [Figure 9] FIG. 2 is a top view of a nasal mask interface according to a first embodiment. [Figure 10] FIG. 1 is a side view of a nasal mask interface of a first embodiment. [Figure 11] Figure 2 shows an outer bottom perspective view of the seal housing and headgear frame of the nasal mask interface of the first embodiment; [Figure 12] FIG. 2 is a wearer-side, upper perspective view of the seal housing and headgear frame of the nasal mask interface of the first embodiment; [Figure 13] FIG. 2 shows a front view from the face-contacting side (or wearer's side) of the nose seal of the nasal mask interface of the first embodiment. [Figure 14] FIG. 2 is a rear view from the outside of the nose seal of the first embodiment. [Figure 15] FIG. 2 is a top view of the nasal seal of the first embodiment. [Figure 16] FIG. 1 is a bottom view of the nose seal of the first embodiment; [Figure 17] FIG. 13 is a first rear underside perspective view from the exterior of the nasal seal of the first embodiment. [Figure 18] FIG. 13 is a second rear top perspective view from the exterior of the nasal seal of the first embodiment. [Figure 19] FIG. 2 is a first top perspective view from the face-contacting side of the nose seal of the first embodiment. [Figure 20] FIG. 13 is a second underside perspective view from the face-contacting side of the nose seal of the first embodiment. [Figure 21] FIG. 2 is a side view of the nose seal of the first embodiment. [Figure 22] FIG. 14 is a cross-sectional view of the first embodiment of the nasal seal taken through centerline AA of FIG. 13. [Figure 23] FIG. 13 is a front perspective view from the face-contacting side of a second configuration of the nose seal of the first embodiment, where the under-nose support arrangement is completely separate or spaced apart from the edge of the face-contacting surface of the nose seal. [Figure 24] FIG. 13 is a front view from the face-contacting side of a first configuration of a second embodiment of a nose seal having an under-nose support arrangement with left and right side extensions; [Diagram 25] FIG. 13 is a rear view from the outside of the nose seal of the second embodiment. [Figure 26] FIG. 13 is a side view of a nose seal of the second embodiment. [Figure 27] FIG. 13 is a perspective view of the outside of a nose seal of a second embodiment. [Figure 28] FIG. 13 is a rear perspective view from the outside of the nasal seal of the second embodiment. [Figure 29] FIG. 13 is a front perspective view of a second configuration of the nose seal of the second embodiment, in which the under-nose support arrangement is completely separate or spaced apart from the edge of the face-contacting surface of the nose seal. [Diagram 30] FIG. 13 is a front view of a third embodiment of a nose seal having a "floating" under-nose support configuration. [Diagram 31]FIG. 13 is a rear view from the outside of the nose seal of the third embodiment. [Diagram 32] FIG. 13 is a side view of a nose seal of the third embodiment. [Diagram 33] FIG. 13 is a front perspective view of the face-contacting side of a nose seal of a third embodiment. [Diagram 34] FIG. 13 is a rear perspective view from the outside of the nose seal of the third embodiment. [Diagram 35] FIG. 13 is a side view of a nasal mask assembly according to a fourth embodiment, shown in use on a wearer. [Diagram 36] FIG. 13 is a perspective view of a fourth embodiment of a nasal mask assembly, particularly showing a nasal mask interface including a nasal seal, a seal housing, a yoke, and a conduit frame, the nasal mask interface being connected to headgear and a flexible gas supply conduit. [Figure 37] FIG. 13 is an external, top perspective view of a fourth embodiment of a nasal mask interface showing the nasal seal, seal housing, yoke and conduit frame. [Figure 38] FIG. 13 is a top perspective front or face-contacting side view of a nasal mask interface of a fourth embodiment. [Figure 39] 13 shows a top perspective exploded view of a nasal mask interface of the fourth embodiment. [Diagram 40] 13 shows a bottom perspective exploded view of a nasal mask interface of the fourth embodiment. [Diagram 41] FIG. 13 shows a rear or outer view of a nasal mask interface of the fourth embodiment. [Diagram 42] FIG. 13 is a side view of a nasal mask interface according to a fourth embodiment. [Diagram 43] FIG. 13 is a front or face-contacting side view of a nasal mask interface of a fourth embodiment. [Diagram 44] FIG. 13 is a top view of a nasal mask interface according to a fourth embodiment. [Diagram 45] FIG. 13 is a bottom view of a nasal mask interface according to the fourth embodiment. [Figure 46]FIG. 42 is a cross-sectional view of the nasal mask interface of the fourth embodiment taken through the center line AA shown in FIG. 41. [Figure 47] FIG. 13 is a front or face-contacting side view of the nasal seal of the nasal mask interface of the fourth embodiment. [Figure 48] FIG. 13 is a rear view of the nasal seal of the nasal mask interface of the fourth embodiment. [Figure 49] FIG. 13 is an external underside perspective view of a nasal mask interface of a fourth embodiment of a nasal seal; [Figure 50] FIG. 13 is a top perspective view from the outside of a nasal mask interface of a fourth embodiment of a nasal seal. [Figure 51] FIG. 13 is a side view of the nasal seal of the nasal mask interface of the fourth embodiment. [Figure 52] FIG. 13 is a top view of the nasal seal of the nasal mask interface of the fourth embodiment; [Figure 53] FIG. 13 shows an underside view of the nasal seal of the nasal mask interface of the fourth embodiment; [Figure 54] FIG. 53 is a cross-sectional view of the nasal seal of the fourth embodiment of the nasal mask interface taken through line AB of FIG. 52. [Figure 55] FIG. 48 is a perspective cross-sectional view of the nasal seal of the fourth embodiment of the nasal mask interface taken through line AC of FIG. 47. [Figure 56] FIG. 48 is a cross-sectional view of the nasal seal of the fourth embodiment of the nasal mask interface taken through line AC of FIG. 47. [Figure 57] FIG. 48 is a cross-sectional view of the nasal seal of the fourth embodiment of the nasal mask interface taken through line AG in FIG. 47. [Figure 58] FIG. 57 is a detailed view of area AD of FIG. 56, particularly showing the angular dimension profile of a portion of the under-nose support of the nasal seal of the nasal mask interface of the fourth embodiment. [Figure 59] FIG. 13 is a rear detailed view of the under-nose support of a fourth embodiment of a nasal mask interface configured for a small to medium sized sealing configuration, particularly showing the radius of curvature of the central portion of the under-nose support. [Figure 60]FIG. 13 is a rear detailed view of the under-nose support of a fourth embodiment of a nasal mask interface configured for a medium to large sealing configuration, particularly showing the radius of curvature of the central portion of the under-nose support. [Figure 61] 13 shows a rear detailed view of an alternative form of under-the-nose support of the nasal mask interface of the fourth embodiment, the under-nose support having a modified alternative generally square shape; [Figure 62] 13 shows a detailed top perspective view of a central region of the under-nose support of the nasal seal of the nasal mask interface of the fourth embodiment, particularly identifying the width dimension of a portion of the under-nose support for a small to medium sized sealing configuration; [Figure 63] 13 shows a detailed top perspective view of a central region of the under-nose support of the nasal seal of the nasal mask interface of the fourth embodiment, particularly identifying the width dimension of a portion of the under-nose support for a medium to large size sealing configuration; [Figure 64] FIG. 11 is a detailed cross-sectional view of a portion of the central connection portion of the under-nose support of the nasal seal of the nasal mask interface of the fourth embodiment, particularly showing the angular dimensions of the central connection portion for a small to medium sized sealing configuration. [Figure 65] FIG. 11 is a detailed cross-sectional view of a portion of the central connection portion of the under-nose support of the nasal seal of the nasal mask interface of the fourth embodiment, particularly showing the angular dimensions of the central connection portion for a medium to large size sealing configuration. [Figure 66] FIG. 13 is a detailed top view of the nasal bridge area of ​​the nasal seal of the nasal mask interface of the fourth embodiment, particularly showing the valley area of ​​the contact surface for a small to medium sized sealing configuration. [Figure 67] FIG. 13 is a detailed top view of the nasal bridge area of ​​the nasal seal of the nasal mask interface of the fourth embodiment, particularly showing the valley area of ​​the contact surface for a medium to large size sealing configuration. [Figure 68] FIG. 13 is a top perspective view from the outside of the seal housing of the nasal mask interface of the fourth embodiment. [Figure 69] FIG. 13 is a wearer-side underside perspective view of the seal housing of the nasal mask interface of the fourth embodiment; [Figure 70] FIG. 13 is a rear view of the exterior of the seal housing of the nasal mask interface of the fourth embodiment; [Figure 71] FIG. 13 is a wearer-side front view of the seal housing of the nasal mask interface of the fourth embodiment. [Figure 72] FIG. 13 is a side view of the seal housing of the nasal mask interface of the fourth embodiment. [Figure 73] FIG. 13 is a top view of the seal housing of the nasal mask interface of the fourth embodiment. [Figure 74] FIG. 13 is a bottom or underside view of the seal housing of the nasal mask interface of the fourth embodiment. [Figure 75] FIG. 13 is a top perspective view from the conduit connection end of the conduit frame of the nasal mask interface of the fourth embodiment. [Figure 76] FIG. 13 is a top perspective view from the seal housing connection end of the conduit frame of the nasal mask interface of the fourth embodiment. [Figure 77] FIG. 13 is a top view of the conduit frame of the nasal mask interface of the fourth embodiment. [Figure 78] FIG. 13 is a side view of the conduit frame of the nasal mask interface of the fourth embodiment. [Figure 79] FIG. 78 is a cross-sectional view of the conduit frame of the fourth embodiment of a nasal mask interface taken through line AL in FIG. 77. [Figure 80] FIG. 13 is an end view of the conduit frame of the fourth embodiment of a nasal mask interface from the conduit connection end of the conduit frame. [Figure 81] FIG. 13 is an end view of the conduit frame of the fourth embodiment nasal mask interface from the seal housing connection end of the conduit frame. [Figure 82] FIG. 13 is a top perspective view of the yoke of the nasal mask interface of the fourth embodiment from the outside. [Figure 83] FIG. 13 is a top exploded view of the yoke of the nasal mask interface of the fourth embodiment. [Figure 84] FIG. 13 is a top view of the yoke of the nasal mask interface of the fourth embodiment. [Figure 85] FIG. 13 is an underside view of a yoke of a nasal mask interface according to the fourth embodiment; [Figure 86]FIG. 13 is a front view of the yoke of the nasal mask interface of the fourth embodiment from the outside. [Figure 87] FIG. 13 is a side view of the yoke of the nasal mask interface of the fourth embodiment. [Figure 88] FIG. 13 is a partially exploded front view of the yoke of the nasal mask interface of the fourth embodiment, particularly showing the end cap of the yoke separated. [Figure 89] FIG. 13 is another partially 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 yoke back. [Figure 90] FIG. 13 is a rear or inner side view of the yoke front of the yoke assembly of the nasal mask interface of the fourth embodiment. [Figure 91] FIG. 13 is a rear or interior side view of the yoke front of the yoke assembly of the nasal mask interface of the fourth embodiment, showing the directional locks and filaments of the automatically adjustable headgear assembly. [Figure 92] FIG. 13 is a partial cross-sectional view of an alternative configuration of the yoke assembly showing components of the headgear adjustment mechanism with the nasal mask interface of the fourth embodiment. [Figure 93] 13 illustrates how the end caps are coupled to the ends of the yoke of the nasal mask interface of the fourth embodiment. [Figure 94] FIG. 94 is a partial rear perspective view of the end cap and yoke of FIG. 93 assembled. [Figure 95] FIG. 13 is an end view of the yoke end of the yoke of the nasal mask interface of the fourth embodiment. [Figure 96] FIG. 96 is a top view of the yoke end of FIG. 95. [Figure 97] 96 is a cross-sectional view of an end cap coupled to a yoke end taken along line AK in FIG. 95. [Figure 98] FIG. 98 is a cross-sectional view of the end cap of FIG. 97. [Figure 99] FIG. 13 is a cross-sectional view of the directional lock of the yoke of the nasal mask interface of the fourth embodiment, the lock being shown in the locked position. [Figure 100] FIG. 100 is a perspective cross-sectional view of the directional lock of FIG. 99 in a locked position. [Figure 101] FIG. 100 is a cross-sectional view of the directional lock of FIG. 99 in an unlocked position. [Figure 102] FIG. 100 is a perspective cross-sectional view of the directional lock of FIG. 99 in an unlocked position. [Figure 103] FIG. 13 is a perspective view of the exterior of a first configuration of a fifth embodiment of a nasal mask interface including a nasal seal, a nasal seal housing with an integral conduit connector, and a yoke. [Figure 104] FIG. 104 is an upper perspective view of the first form of nasal mask interface of FIG. 103 from the front or face-contacting side. [Figure 105] FIG. 104 is an exterior view of the first form of nasal mask interface of FIG. 103. [Fig. 106] FIG. 104 is a side view of the first form of nasal mask interface of FIG. 103. [Figure 107] FIG. 107 is a side view of the first form of nasal mask interface of FIG. 106 without the yoke. [Figure 108] FIG. 108 is an exterior perspective view of the first form of nasal mask interface shown in FIG. 107. [Fig. 109] FIG. 104 is an exterior view of the seal housing of the first form of nasal mask interface of FIG. 103; [Figure 110] FIG. 110 is a wearer side view of the seal housing of FIG. [Figure 111] FIG. 104 is a view of the front or face-contacting side of the nasal seal of the first form of nasal mask interface of FIG. 103. [Figure 112] FIG. 112 is a rear or outer view of the nose seal of FIG. [Figure 113] FIG. 112 is a side view of the nose seal of FIG. [Fig. 114] 105 is a cross-sectional view of the first embodiment of the nasal mask interface of FIG. 103 taken along line BB of FIG. 105; [Figure 115] FIG. 104 shows a wearer-side perspective view of the yoke of the nasal mask interface of the first embodiment of FIG. 103. [Fig. 116] FIG. 104 shows a front exterior view of the yoke of the first form of nasal mask interface of FIG. 103; [Figure 117] FIG. 104 shows a top view of the yoke of the first form of nasal mask interface of FIG. 103; [Fig. 118] FIG. 13 is a perspective view of the outside of a second configuration of a nasal mask interface according to the fifth embodiment; [Figure 119] FIG. 119 is a side view of the second configuration nasal mask interface of FIG. [Figure 120] FIG. 119 is an exterior view of the second form of nasal mask interface of FIG. 118. [Figure 121] FIG. 119 is a front or face-contacting side view of the second form of nasal mask interface of FIG. 118. [Figure 122] FIG. 119 is an exterior view of the seal housing of the second embodiment nasal mask interface of FIG. 118; [Figure 123] FIG. 119 is a side view of the seal housing of the second embodiment nasal mask interface of FIG. 118. [Figure 124] FIG. 119 shows a front perspective view of the yoke of the second form of nasal mask interface of FIG. [Fig. 125] FIG. 119 shows an external view of the yoke of the second form of nasal mask interface of FIG. [Fig. 126] FIG. 119 shows a top view of the yoke of the second form of nasal mask interface of FIG. [Figure 127] 120 through line BC of FIG. 120. FIG. 120 is a cross-sectional view of the second embodiment nasal mask interface of FIG. 118. [Figure 128] FIG. 128 is a detailed cross-sectional view of region BD of FIG. 127. [Figure 129] FIG. 13 is an exterior perspective view of a third configuration of a nasal mask interface according to the fifth embodiment; [Fig. 130] FIG. 130 is a side view of the third embodiment of the nasal mask interface of FIG. 129. [Fig. 131] FIG. 130 is an exterior view of the third form of nasal mask interface of FIG. 129; [Fig. 132]FIG. 130 is a front or face-contacting side view of the third form of nasal mask interface of FIG. 129. [Fig. 133] FIG. 130 is an exterior view of the seal housing of the third embodiment nasal mask interface of FIG. 129; [Fig. 134] FIG. 134 is a side view of the seal housing of FIG. 133. [Fig. 135] FIG. 130 is a view of the face-contacting side of the nose seal of the third form of nasal mask interface of FIG. 129; [Fig. 136] FIG. 136 is an exterior view of the nose seal of FIG. 135. [Fig. 137] FIG. 136 is a perspective view of the face-contacting side of the nose seal of FIG. 135; [Figure 138] FIG. 136 is a side view of the nose seal of FIG. 135. [Figure 139] FIG. 136 is a cross-sectional view of the nose seal through line BE of FIG. 135. [Fig. 140] FIG. 13 is an exterior perspective view of a fourth configuration of a nasal mask interface of the fifth embodiment; [Fig. 141] FIG. 141 is a side view of the fourth embodiment of the nasal mask interface of FIG. 140. [Fig. 142] FIG. 141 is an exterior view of the fourth embodiment of the nasal mask interface of FIG. 140. [Fig. 143] FIG. 141 is a view of the face-contacting side of the fourth embodiment nasal mask interface of FIG. 140; [Fig. 144] FIG. 141 is an exterior view of the seal housing of the fourth embodiment of the nasal mask interface of FIG. 140; [Fig. 145] FIG. 145 is a side view of the seal housing of FIG. 144. [Fig. 146] FIG. 141 is a perspective view from the face-contacting side of the nose seal of the fourth embodiment of the nasal mask interface of FIG. 140; [Fig. 147] FIG. 147 is a side view of the nose seal of FIG. 146. [Fig. 148] 147 is a cross-sectional view of the nose seal of FIG. 146 through the centerline BF shown in FIG. 146. [Figure 149]FIG. 143 is a cross-sectional view of the fourth configuration nasal mask interface through line BG in FIG. 142, including the nasal seal overlay of the third configuration nasal mask interface in FIG. 135 for comparison of shape and size. [Fig. 150] FIG. 13 is a front or face-contacting side view of a sixth embodiment of a nasal mask interface, particularly showing the yoke located under the conduit frame or intake hole of the seal housing. [Fig. 151] FIG. 13 is an exterior view of a nasal mask interface according to a sixth embodiment. [Fig. 152] FIG. 13 is a side view of a nasal mask interface of a sixth embodiment. [Fig. 153] FIG. 13 is an exterior view of the seal housing and yoke of the nasal mask interface of the sixth embodiment. [Fig. 154] FIG. 2 is a view of the face-contacting side of the seal housing and yoke of the nasal mask interface. [Fig. 155] FIG. 13 is a view of the face-contacting side of the nose seal of a first form of a seventh embodiment of a nasal mask interface, the nose seal including wing portions extending from the sides of the nose seal. [Fig. 156] FIG. 156 is an exterior view of the first form of nose seal of FIG. 155; [Fig. 157] FIG. 156 is a side view of the first embodiment nasal seal of FIG. 155. [Fig. 158] FIG. 2 is an exterior perspective view of the nasal seal of a second configuration of a nasal mask interface according to an embodiment, particularly showing the longer wing portions (compared to the first configuration) extending from the sides of the nasal seal. [Fig. 159] FIG. 159 is a view of the face-contacting side of the second form of nose seal of FIG. 158; [Fig. 160] FIG. 159 is an exterior view of the second embodiment of the nose seal of FIG. 158; [Fig. 161] FIG. 159 is a top view of the second embodiment of the nose seal of FIG. 158; [Fig. 162] FIG. 13 is a perspective view of a seventh embodiment of a nasal mask interface including a nasal seal in a second configuration being worn by a user. [Fig. 163]FIG. 13 is a side view of a first configuration of an eighth embodiment of a nasal mask interface, the interface including a forehead support extending from a nasal seal or seal housing. [Fig. 164] FIG. 164 is a perspective view of a user wearing a first form of the nasal mask interface of FIG. 163. [Fig. 165] FIG. 13 is a face-contacting side view of a second configuration of a nasal mask interface of an eighth embodiment, the nose seal including a nasal bridge support protrusion; [Fig. 166] 166 shows an exterior view of the second form of nose seal of FIG. 165. [Fig. 167] 166 shows a side view of the second form of nose seal of FIG. 165. [Fig. 168] 166 shows a cross-sectional view of the second embodiment nose seal of FIG. 165 through line EE of FIG. 166. [Fig. 169] FIG. 166 is a perspective view of a user wearing the second form of nose seal of FIG. 165. [Fig. 170] FIG. 170 is a side view of a user wearing the second form of nose seal of FIG. 169, showing the gap between the nasal bridge support protrusion and the bridge of the user's nose. [Fig. 171] FIG. 13 is an exterior view of a nasal seal of a first configuration of a ninth embodiment of a nasal mask interface, the nasal seal including additional support ribs within the nasal mask. [Fig. 172] FIG. 172 is a view of the face-contacting side of the first form of nose seal of FIG. 171. [Fig. 173] 172 is a cross-sectional view of the first configuration nose seal taken through line FF of FIG. 171. FIG. [Fig. 174] FIG. 174 is a perspective view of the cross-sectional view of the nose seal of FIG. 173. [Fig. 175] FIG. 13 is a view of the face-contacting side of the nasal seal of a second configuration of the nasal mask interface of the ninth embodiment. [Fig. 176] FIG. 176 is an outer view of the second form of nasal mask of FIG. 175. [Fig. 177] FIG. 176 is a side view of the second embodiment of the nose seal of FIG. 175. [Fig. 178] FIG. 176 is a cross-sectional view of the second configuration nose seal taken through line FG of FIG. 175. [Fig. 179]FIG. 176 is a perspective view of a user wearing the second form of nose seal of FIG. 175. [Fig. 180] FIG. 179 is a side cross-sectional view of a user wearing the second configuration nose seal of FIG. [Fig. 181] 176 is a cross-sectional view of the first and second configuration nose seals of FIGS. 171 and 175 superimposed on one another to show a comparison of shapes and dimensions. FIG. [Fig. 182] FIG. 176 is a view of the face-contacting sides of the first and second forms of nose seals of FIGS. 171 and 175 superimposed on one another for comparison of shape and size. [Fig. 183] FIG. 13 is an exterior perspective view of a nasal seal of a third configuration of the nasal mask interface of the ninth embodiment; [Fig. 184] FIG. 184 is an exterior view of the third embodiment of the nose seal of FIG. 183; [Fig. 185] FIG. 184 is a view of the face-contacting side of the third form of nose seal of FIG. 183; [Fig. 186] FIG. 23 is an exterior perspective view of a first configuration of the seal housing and conduit frame assembly of the nasal mask interface of the tenth embodiment; [Fig. 187] FIG. 187 is an exploded view of the first embodiment of the seal housing and conduit frame assembly of FIG. 186. [Fig. 188] FIG. 187 is a side view of the conduit frame of the first embodiment of the assembly of FIG. 186. [Fig. 189] FIG. 187 is a top view of the conduit frame of the first embodiment of the assembly of FIG. 186. [Fig. 190] FIG. 23 is an exterior perspective view of the seal housing and conduit frame assembly of the second configuration of the nasal mask interface of the tenth embodiment. [Fig. 191] FIG. 191 is an exploded view of the second form of assembly of FIG. 190. [Fig. 192] FIG. 191 is a side view of the conduit frame of the second embodiment of the assembly of FIG. 190. [Fig. 193] FIG. 191 is a top view of the conduit frame of the second embodiment of the assembly of FIG. 190; [Fig. 194] FIG. 23 is an exterior perspective view of the seal housing and conduit frame assembly of the third configuration of the nasal mask interface of the tenth embodiment; [Fig. 195] FIG. 195 is an exploded perspective view of the third embodiment of the assembly of FIG. 194. [Fig. 196] FIG. 195 is a side view of the conduit frame of the third embodiment of the assembly of FIG. 194. [Figure 197] FIG. 195 is a top view of the conduit frame of the third embodiment of the assembly of FIG. 194; [Figure 198] FIG. 23 is an exterior perspective view of a seal housing and conduit frame assembly of a fourth configuration of a nasal mask interface of a tenth embodiment; [Figure 199] FIG. 199 is an exploded perspective view of the fourth embodiment of the assembly of FIG. 198. [Figure 200] FIG. 199 is a side view of the duct frame of the fourth embodiment of the assembly of FIG. 198. [Figure 201] FIG. 199 is a top view of the duct frame of the fourth embodiment of the assembly of FIG. 198. [Fig. 202] FIG. 23 is an exterior perspective view of the seal housing and conduit frame assembly of the nasal mask interface of the fifth configuration of the tenth embodiment. [Fig. 203] FIG. 203 is an exploded perspective view of the assembly of the fifth embodiment of FIG. 202. [Fig. 204] FIG. 203 is a side view of the conduit frame of the fifth embodiment of the assembly of FIG. 202. [Fig. 205] FIG. 203 is a top view of the conduit frame of the fifth embodiment of the assembly of FIG. 202. [Fig. 206] FIG. 19 is a front view of a full face seal with under-nose support arrangement according to an eleventh embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0109] System Overview FIG. 1 is a schematic diagram of a continuous positive airway pressure (CPAP) system 10 for supplying a flow of heated and humidified air to a user U through an interface 11 worn by the user and connected to the CPAP system 10 by a flexible conduit or tube 12.

[0110] The humidification chamber 14 has a thermally conductive base in contact with a heater plate 16 of a humidifier 17 to humidify the airflow. A conduit 12 is connected to an exhaust port 13 of the humidification chamber 14 to carry the humidified air to a user interface 11. The humidifier 17 includes a controller 18, such as, but not limited to, a controller employing a microprocessor executing computer software instructions stored in an associated memory. The controller 18 receives input instructions from a number of sources including a user input interface 19, such as a dial or touch screen, which allows for setting predetermined values ​​of humidity, temperature, or other characteristics of the humidified air provided to the user U. The controller 18 may also receive input from one or more other sources, such as temperature and / or flow rate sensors 20 and 21 connected through a connector 22 for communication with the controller 18, and / or a heater plate temperature sensor 23. Responsive to user-set humidity or temperature values, the controller 18 determines when and / or at what level the heater plate 16 should be energized to suitably heat the water contained in the humidification chamber 14 .

[0111] As the volume of water in the chamber heats, water vapor begins to fill the volume of the chamber above the surface of the water. The water vapor enters the humidification chamber 14 through an air inlet 26 and exits through the humidification chamber exhaust 13 with an airflow provided from a supply 25, such as a blower 27. The blower 27 may be a variable speed fan or may include a variable pressure regulator. The blower 27 draws air through an air inlet 28. The blower may be controlled, for example, by a controller 29 or by 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 as well as user settings (e.g., preset values) of pressure and / or fan speed, which may be set on a user interface 30 (e.g., dials).

[0112] The conduit 12 may include a heater, such as a heater wire, to heat the walls of the conduit to reduce condensation of the humidified gas within the conduit.

[0113] The seals and interfaces of the present disclosure may be used in other forms of respiratory systems, whether humidified or not, or alternatively, such as VPAP (variable positive airway pressure) systems, BiPAP (bilevel positive airway pressure) systems, or in conjunction with ventilators, high flow therapy systems, such as CPAP systems as described, and are generally described herein with reference to CPAP therapy by way of example only.

[0114] Nasal mask interface with over-the-ear headgear 2A and 2B, a user U is shown wearing a nasal mask interface 50 according to an embodiment. The nasal mask interface 50 includes a nasal mask including a seal 51 and a seal housing 53. The interface also includes headgear 52 for securing the mask to the wearer. Typically, the interface also includes a flexible supply conduit or tube 55 from the mask, e.g., from a central connection at the front or bottom of the mask that is integral with or connects to a supply conduit 12 of a CPAP or other respiratory system. The conduit 55 may connect directly to the mask or indirectly via a connector or conduit frame, e.g., but not limited to, a straight connector or swivel elbow 34 that can pivot relative to the mask or seal housing so that the path of the conduit can conform to the patient's sleep position relative to the position of the mask on the patient's face.

[0115] As will be explained later, the mask may include a limited flow exhaust or vent (or drift exhaust or vent) 57 to provide for gas washout from the interface. The exhaust 57 may be in the form of a collection of small holes. The exhaust may be provided in the seal housing 53 as shown, in the conduit connector or frame, such as an elbow or straight connector, or elsewhere on the interface.

[0116] In this embodiment, the nasal mask is secured to the user U by headgear 52 that extends above the user's ears. By way of example, the headgear 52 includes side straps 54 that connect to opposing sides of the nasal mask interface 50 at attachment points 56 (only one side visible) and extend along the sides or cheeks of the user's face above the user's ears 58 and connect to one or more other straps or strap portions. The headgear 52 in this embodiment also includes a top or crown strap 60 that extends over the user's head or top, and a back or rear strap 62. The side straps 54 may be integrally formed with or otherwise connected to the top 60 and back straps 62, as will be appreciated by those skilled in the art. In one embodiment, the headgear straps are formed from or include a flexible breathable material, such as Breath-o-Prene® breathable neoprene material or neoprene material. In some embodiments, the headgear may be an automatically adjustable headgear, such as will be described below.

[0117] The illustrated over-the-ear headgear 52, with side straps 54 attached to respective side attachment points or locations on the nasal mask interface 50, is generally more desirable from a comfort standpoint than headgear configurations with a pair of upper and lower straps that connect to a nasal mask interface with a T-piece frame. The over-the-ear single-sided strap headgear configuration 52 shown in Figure 2A does not require a T-piece frame that extends up to the user's forehead, and it also eliminates the need for two pairs of upper and lower straps, as previously described, one pair extending from the top of the T-piece frame at the user's forehead and over the user's ears, and the other pair extending from the nasal mask interface below the user's ears.

[0118] 2A and 2B, it has been discovered that although the over-the-ear single-strap headgear configuration 52 is preferred in terms of comfort compared to headgear secured to a T-piece frame, in use, when forces act on the nasal mask interface during flow therapy when the mask is delivering gas at positive pressure to the user's nose, the nasal mask has a tendency to ride up, slide or slip on the user's face, which can affect the tightness of the seal around the user's nose and can result in leakage or leakage paths. The riding up of the nose seal can be disturbing and uncomfortable for the user. It has been discovered that the nasal mask interface is subjected to a substantially oblique force represented by vector A along the general direction of the side straps between the user's nose and over the ears from each side strap, and an opposing substantially horizontal ejection force B which, in use, pushes the nasal interface substantially horizontally away from the user's nose and face when a flow of gas at positive pressure is delivered to the wearer. The resultant force R of the headgear force A and the ejection force B acting on the nasal mask interface in a substantially perpendicular resultant force represented by vector R.

[0119] As described with reference to the embodiments below, the nasal mask interface of the present disclosure is provided with a nasal seal having an internal under-nose support configured to contact or engage under the user's nose to generate an opposing downward force D that at least partially counters, resists or otherwise counters the resultant force R created by the headgear force A and the ejection force B, thereby stabilizing the nasal mask in position over the user's nose during use and preventing any tendency of the nasal mask to slide or otherwise move up the user's face from its initially fixed position before gas delivery begins.

[0120] 3, the under-nose support of the nasal mask assembly is configured to contact at least one or more portions of the under-nose surface of a user's nose 70 when the mask is worn. The under-nose anatomy of the user's nose is generally defined by a central post region 72 of the septum that extends between and divides the nostrils 74 from a base 76 to a nasal tip 78 and left and right alar rim regions 80. The post 72 and alar regions 80 generally define the contactable skin surface on the underside of the user's nose around the nostrils or nostril openings 74.

[0121] As will be described in further detail with reference to exemplary embodiments below, the under-nose 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 that contacts at least a portion of the under-nose surface of the user's nose, but does not obstruct or completely obstruct the user's nares. Depending on the size of the user's nose, the under-nose support will, in the best case, contact one or more portions of the under-nose surface without any obstruction of the user's nares, or, in the worst case, only partially obstruct one or both nostrils.

[0122] Various embodiments of nasal seals for nasal mask interfaces and interfaces with under-nose supports are described below, it being understood that such nasal seals may be employed or used with a variety of different nasal interface assemblies and headgear configurations, but are particularly suited to headgear configurations that, in use, produce a resultant upward lifting force that causes the nasal mask to slide or ride up on the user's face, such as, but not limited to, over-the-ear headgear as described and illustrated with reference to FIG.

[0123] Various embodiments of the nasal seal are described, and in some embodiments are described with reference to the entire nasal mask interface assembly, including any one or more of the seal housing, conduit frame, headgear frame or yoke, and / or headgear. It will be understood that the various embodiments of the nasal seal described may be used interchangeably with one another in various suitable interface assemblies, and that examples and alternatives of an interface assembly described in connection with one embodiment also apply to other embodiments of the nasal seal described. In general, it will be understood that the various components of the various embodiments may be substituted and / or combined with one another to form alternative configurations.

[0124] First embodiment - Nose seal with under-nose support having a central extension or connecting portion Overview A first configuration of a first embodiment of a nasal seal interface assembly including a nasal seal and a second configuration of the nasal seal of the first embodiment will also be described with reference to Figure 23.

[0125] 4-10, a first embodiment of a nasal mask interface assembly 100 includes a flexible nasal seal 102 that is connected or connectable to a rigid (or at least more rigid than the nasal seal) seal housing 104 to define a mask cavity, generally indicated at 106, that receives a supply of gas for delivery via the user's nose and its nares or nostrils to the user's airway, as will be appreciated by those skilled in the art. The rigid seal housing or shell 104 may be directly connectable to headgear straps via one or more attachment or connection points or assemblies provided on the seal housing, or alternatively may be indirectly connectable to the headgear via a headgear frame component 108 mounted or provided on the seal housing. In this embodiment, the seal housing 104 is provided with an inlet opening or hole 110 that is configured to connect to a flexible gas delivery conduit 55 of the type previously described for delivery of a heated and humidified gas flow from a respiratory apparatus, such as a CPAP device. The seal housing 104 in this embodiment is also provided with one or more holes or a collection of holes in the form of exhaust or vector air vents 112 .

[0126] The flexible nose seal 102 includes a face-contacting surface 120 having an inner peripheral edge 122 that defines a nose-receiving opening 106 into the mask cavity for receiving the user's nose in use. In use, the nasal mask interface 100 is secured to the user's face using headgear such that the contacting surface 120 of the nose seal 102 wraps or surrounds the user's nose and sealingly engages around the user's nose, for example against the cheek surfaces and / or lateral surfaces of the user's nose, the upper lip area below the user's nose, and across the nasal bridge area of ​​the user's nose. In this embodiment, the nose seal 102 also includes an under-nose support 124 that extends inwardly within the mask cavity 106 at a location or position substantially posterior to or substantially posterior to the face-contacting surface 120. The under-nose support 124 includes a contact surface that is configured or oriented to contact at least a portion of the under-nose surface of the user's nose when in use to at least partially counter the resultant upward lift force R caused by the ejection force B and the headgear force A, as described above.

[0127] 10, for future reference, the top of the nasal mask interface is designated 101, the bottom is designated 103, the face-contacting or wearer side of the nasal mask interface is designated 105, and the outer or exterior side of the nose seal is designated 107. The seal housing 104, headgear frame 108, and nose seal 102 are each described in further detail below.

[0128] Seal Housings and Frames 11 and 12, the seal housing or shell 104 is defined by an opening generally indicated at 140 that connects or couples to the nasal seal 102 on the wearer side of the nasal mask interface 100 and extends to the exterior or outside of the nasal interface including the inlet 110 and the exhaust vent 112 shown in FIG. 11. The seal housing 104 is a substantially hollow component generally shaped to provide or define a cavity or volume indicated at 142 for receiving gas flow from the inlet 110. The seal housing cavity 142 forms a portion of the overall mask cavity 106 when the seal housing 104 is assembled to the nasal seal 102. In this embodiment, the seal housing 104 is generally tapered inwardly in shape as it extends rearwardly from the opening 140 to the exterior side.

[0129] In this embodiment, the exhaust vent 112 includes a group or plurality of small holes or holes that extend through the seal housing and collectively define the vent 112 in the central mid-to-upper region of the seal housing 104. It will be appreciated that in other embodiments, the vent or exhaust hole 112 may be omitted from the seal housing and provided at another location in the breathing circuit, for example in a connecting conduit or swivel elbow that couples the gas conduit to the inlet 110 of the nasal mask interface at another location along the breathing circuit.

[0130] In this embodiment, an air inlet or port 110 is provided and centrally located in a lower or bottom region of the seal housing 104, although this location is not required. It will be appreciated that the flexible gas conduit may be directly coupled to the air inlet 110 via a connecting conduit or, alternatively, may be indirectly coupled via a straight connector or conduit frame, a connecting elbow, such as a swivel elbow, a ball and socket connection, or the like.

[0131] In this embodiment, the nasal seal 102 is removably or releasably coupled or connectable to the seal housing 104 so that the nasal seal may be removed for cleaning or replacement as needed. In this embodiment, an opening 140 in the seal housing 104 includes an aperture 142 provided on the exterior of the nasal seal 102, as will be described later. Complementary A peripheral ridge or extension is provided that is configured to engage or receive the peripheral channel, thereby releasably coupling the components together. When assembled and secured to the user's nose, the nasal mask interface is substantially sealed and defines a substantially enclosed mask cavity 106.

[0132] In alternative embodiments, the nose seal 102 may be permanently or semi-permanently connected or bonded to the seal housing 104. As an example, it will be appreciated that the exterior of the nose seal 102 on the face-contacting distal side may be overmolded or otherwise secured or adhered to or at the opening 140 in the seal housing 104 in alternative embodiments.

[0133] It will be appreciated that whether the nose seal 102 is removably or permanently joined to the seal housing 104, the edges or openings 140 of the seal housing will be shaped or dimensioned to complement or mate with corresponding outer edges or connecting portions on the outside of the nose seal 102 around the periphery of the nose seal interface.

[0134] The seal housing 104 may be formed of any suitable material that provides a rigid housing, or is at least as rigid as the flexible nose seal. In this embodiment, the seal housing is typically formed from a plastic polymer, such as polycarbonate. In an alternative embodiment, the seal housing may be semi-rigid. In one example, the seal housing may be formed from the same type of material as the nose seal (e.g., a silicone material), but may be substantially thicker so as to generally be less flexible or more rigid than the nose seal.

[0135] 11, in this embodiment the nasal mask interface includes a headgear frame component 108 in the form of a yoke that extends laterally around the exterior side of the seal housing 104, from one side of the seal housing to the other, between the vent 112 and the inlet 110. In this embodiment the frame component 108 is formed into a surface of the seal housing 104 on the exterior side. Complementary While the frame is removably received within the channel, the frame may alternatively be permanently secured or coupled within the receiving channel. As shown in FIG. 12, the frame component 108 provides a single headgear 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 one-sided strap of a headgear system, such as an over-the-ear headgear system, as described with reference to FIG. 2A. It will be appreciated that in alternative embodiments, the frame 108 may be omitted and the seal housing may provide a headgear attachment point on each side of the seal housing, either integrally formed with the seal housing or otherwise provided on a side of the seal housing, for connection to a headgear system, such as a one-sided strap headgear system.

[0136] Nose seal 13-22, the nasal seal component 102 of the first embodiment nasal mask interface 100 is described in further detail. The nasal seal 102 is flexible and soft and may be formed from a silicone material or other suitable material.

[0137] Referring to the face-contacting or wearer side of the nose seal 102 shown in FIG. 13, the contact surface, generally designated (120), is configured to seal around the user's nose, including over the bridge of the user's nose. In this embodiment, the contact surface 120 surrounds the nose and seals around the user's nose. In this embodiment, the contact surface portion of the nose seal includes an upper lip region, generally designated 121, configured to contact the upper lip region of the user's face, for example, 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 region 125 at the top of the seal 102 that corresponds to the nasal bridge region or is proximal to the nasal bridge region. The cheek regions 123 of the contact surface 120 are configured to contact the cheek surfaces proximate the user's midline on either side of the nose and / or the lateral nasal surfaces of the user. The nasal bridge region 125 of the contact surface 120 is configured to extend over the nose and contact the nasal bridge region of the user's nose, connecting the two cheek regions 123. The overall shape and configuration of the contact surface 120 is configured to sealingly conform to the contours of the user's face around the nose and to sealingly engage around the user's nose when secured to the user's head via the headgear and the nasal mask interface is subjected to a flow of gas. The nasal seal 102 may be considered to be of the self-inflating type because under pressure the seal urges the face-contacting surface 120 against the user's face and deforms to substantially seal against the user's facial contours, including one or more of the upper lip, midline cheeks, lateral nose, and nasal bridge.

[0138] As previously discussed, the contact surface 120 of the nasal seal 102 terminates in an inner peripheral edge 122 that defines a nose-receiving opening into the mask cavity when the seal 102 is assembled into the seal housing 104.

[0139] 21 and 22, the nasal seal 102 is substantially defined by a face-contacting face portion 120 and a sidewall portion 126 that extends rearwardly from the contacting face 120 around the periphery of the seal and terminates in a connecting edge, generally indicated at 127, on the exterior or outside of the seal that is mated or connectable to an opening 140 in the seal housing 104. As mentioned above, in this embodiment, the nasal seal 102 is releasably connectable to the seal housing, and the terminating edge of the sidewall 126 is a peripheral channel 128 that is provided in the opening 140 in the seal housing 104. Complementary The flexible nasal seal 102 includes a peripheral channel 128 configured to engage with a peripheral ridge or extension. As previously discussed, in alternative embodiments, the flexible nasal seal 102 may be permanently or semi-permanently connected or coupled to the seal housing 104, for example, via overmolding, welding or other connection methods. In further alternative embodiments, the interface may be provided with a semi-rigid or rigid clip component molded to correspond to the connecting edge 127 on the exterior or outside of the nasal seal. In such embodiments, the connecting edge 127 of the seal may be overmolded or otherwise permanently connected to the rigid clip component to provide a rigid edge or portion on the exterior of the seal. The rigid clip component may be configured to engage or otherwise connect with a complementary base or housing component, thereby coupling the nasal seal to the base or housing.

[0140] 22, the face-contacting surface 120 of the nose seal forms a flange that curls or extends inwardly from a sidewall 126 portion of the nose seal. In this embodiment, the area at or toward the terminal edge 127 of the sidewall 126 may be a thickened area compared to the remainder of the sidewall and contact surface portion of the nose seal to accommodate the connecting channel 128 or otherwise provide some stability outside the overall shape of the nose seal.

[0141] As discussed, the nasal seal 102 is formed from a flexible, soft 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 from a silicone material or the like.

[0142] Nose seal under-nose support In this embodiment, the nasal seal 102 includes an under-nose support 124 (or nasal sling) that at least extends across or hangs laterally between the sides of the nasal seal 102 when it is assembled into the seal housing 104 and within the mask cavity 106. The under-nose support 124 is configured to contact at least a portion of the under-nose surface of the user's nose when the nasal mask is donned and to counter any resultant lift forces that arise during use, as previously discussed.

[0143] In this embodiment, the under-nose support extends laterally across the nose seal, at least between the opposing left and right sides of the nose seal. As shown, the under-nose support is disposed or located behind or posterior to the nose seal opening 106. The under-nose support 124 is fixedly connected to the nose seal in that it is not removable. In one form, the under-nose support 124 is integrally molded within the nose seal. It will be appreciated that in alternative forms, the under-nose support component or portion of the nose seal 102 may be formed separately and then fixedly joined within the nose seal, for example via adhesive or welding, or it may be connected to the seal housing.

[0144] In this embodiment, the under nose support arrangement 124 includes elongate main lateral portions or bands 129 that extend across or within the nose seal, for example suspended between opposing sides of the seal. With reference to Figures 14, 17 and 22, not only are the main lateral portions 129 of the under nose support connected to or extending from the nose seal at a location that is spaced or displaced from at least the peripheral opening edge 122 of the contact surface 120, but in this embodiment the lateral portions 129 are also entirely separate or displaced from the contact surface 120 so as not to impede or reduce the sealing engagement or deformability of the contact surface 120 with the user's face at the cheek and / or lateral nose regions 123. In this embodiment, the main lateral portions 129 extend from or are connected at a location 131 on the inner surface of the opposing sidewall 126 portions of the nose seal rearward of the contact surface 120. In this embodiment, the connection location 131 corresponds to or includes the terminal edge 127 of the sidewall 126, although this is not required.

[0145] In this embodiment, the under nose support 124 further includes a central extension portion 132 extending centrally from the main lateral portions 129 and joined or connected to or at the open edge 122 of the contact surface 120 in the upper lip region 121. In alternative embodiments, as will be described below with reference to FIG. 23 , the central extension portion 132 may alternatively be connected to a lower portion of the upper lip region 121 of the contact surface 120 below the open edge 122 of the seal, or alternatively may be connected at a location that is at least partially or wholly displaced or spaced from the contact surface 120, such as connected to a lower portion of the nose seal's side wall 126 rearward of the contact surface 120.

[0146] The under-nose support 124 includes a main lateral portion 129 and a central extension portion 132 that provides a contact surface that is configured and / or oriented to contact, in use, at least a portion of the nose of the under-nose surface of the user. In this configuration, the main contact surface of the main lateral portion 129 is configured to engage at least a portion of the tip of the under-nose surface of the user's nose (as shown in FIG. 3), which may include, for example, the tip of the post 72 and a portion of the alar rim 80 toward the tip of the nose. The central extension portion 132 is configured to contact the post 72 region of the under-nose surface of the user's nose, or at least a portion of the post between the tip of the nose and the base, although preferably the majority of the post extends from the base. The final contact surface area of ​​the under-nose support depends on the shape and size of the user's nose. The configuration of the under-nose support is designed to contact one or more maximum portions of the under-nose surface without substantially obstructing the user's nostrils 74, which tend to align with the open spaces 134 on either side of the central extension portion 132, as shown in FIG. 13. Depending on the size and shape of the user's nose, the under-nose support 124 is generally configured to, at best, avoid obstructing the user's nostrils entirely, but at worst, only partially block one or both nostrils.

[0147] As shown, the contact surface of the under-nose support 124 is generally oriented and configured relative to the nose seal to engage the under-nose surface of the user's nose. In this embodiment, a portion of the under-nose support 124 is an integral narrow web or strip of the nose seal to engage the under-nose surface of the user's nose. For example, the thickness of the under-nose support perpendicular to its contact surface is significantly less than the corresponding width of the contact surface at any location of the under-nose support. In one configuration, the thickness of the under-nose support portion can be substantially similar to the thickness of the seal in the region of the contact surface 120 of the nose seal.

[0148] In this embodiment, the width of the major lateral portions 129 of the under-nose support 124 may vary along its length between opposing sides of the nose seal. In this example, the width W1 of the major lateral portions 129 may gradually increase from the center of the nose seal toward each side. In this embodiment, the width W2 of the central extension portion 132 of the under-nose support 124 gradually increases in width W2 as it extends from the major lateral portions 129 to the contact surface 120. It will be appreciated that in alternative embodiments, the width of either or both of the major lateral portions or the central extension may be uniform along their lengths or may have alternative width profiles along their lengths.

[0149] 22, the central sealing axis BB is defined as extending tangentially between the outer uppermost and the outer lowermost contacts at the center of the contact surface 120 when in a relaxed state (e.g., not in use). As shown in FIG. 22, at least a portion of the contact surface of the under-nose support 124 in the central region of the under-nose support (e.g., as indicated by axis CC extending coincident with the contact surface of the under-nose support portion in the central region) extends at an angle θ to the sealing axis BB such that the contact surface of the under-nose support is not parallel to or aligned with the sealing axis BB. In this embodiment, the contact surface in the central region of the under-nose support 124 is oriented at an angle offset from the sealing axis BB in a range of approximately 30 to approximately 90 degrees, more preferably approximately 45 to approximately 75 degrees, and more preferably approximately 60 degrees. This angular orientation of the primary nose contact portion or surface of at least the under-nose support in the central region is configured to be substantially aligned with the general or typical angular orientation of the under-nose surface of a user's nose when the nose is in the nose seal.

[0150] As explained above, the under-nose support 124 in this embodiment is fixedly connected or otherwise an integral component of the nose seal 102. The accompanying drawing shows the nose seal and its under-nose support 124 in a resting state, i.e., when not in use. Like the nose seal contact surface 120, the under-nose support 124 is also configured to be soft, flexible or pliable such that its shape and position may conform to the under-nose surface of the user's nose with a sling-like effect when the nasal mask interface is secured to the user's face or otherwise worn in use. Typically, the under-nose support is non-elastic in any direction, although in alternative embodiments, it may be somewhat elastic.

[0151] Alternative 2 - a central extension that is completely separate or spaced apart from the opening edge of the nose seal 23, an alternative form of the first embodiment nose seal 102A is shown. The nose seal 102A is similar to the first embodiment nose seal 102, except that the nose seal 102A has a different under-nose support arrangement 124A that is completely separate or spaced apart from the edge of the face-contacting surface 120 of the nose seal. Like numbers represent like components. The alternative under-nose support arrangement 124A includes a main lateral portion 129 and a central extension portion 132A. The difference with the nose seal 102 is that the central extension portion 132A does not bond or connect to the edge 122 of the contact surface 120, but rather is bonded or connected to a lower portion of the contact surface in the upper lip region, or alternatively to a portion of the contact surface 120, such as a portion of the lower region of the seal that is not part of the lower sidewall 126 of the nose seal. In this configuration, the under-nose support 124A is completely separate from the edge 122 of the contact surface 120, and in some configurations are all completely separate from the contact surface 120 such that the main lateral portions 129 and central extension portion 132A connect to respective sidewall portions of the nose seal at locations displaced from or adjacent to the contact surface 120 that engages the user's face. The alternative embodiment of nose seal 102A is otherwise similar in function and configuration to nose seal 102, and like the first embodiment nose seal 102, may be coupled to seal housing 104 to form a nose seal interface assembly.

[0152] Second embodiment - Nose seal with under-nose support having side extensions With reference to Figures 24-29, various configurations of a second embodiment of a nasal mask interface are described. The nasal mask interface of the second embodiment is substantially similar to the first embodiment, except that the first configuration includes a nasal seal 102B having an alternative under-nose support arrangement 124B. The nasal seal 102 is otherwise similar to the nasal seal 102 of the first embodiment, and may be coupled to a seal housing 104 to form a nasal seal interface assembly, as described above. Like reference numbers refer to like features.

[0153] In this first form of the second embodiment, the alternative under-nose support configuration 124B still includes a main side portion 129 that extends rearwardly of the contact surface 120 between opposing sides of the nose seal across the nose seal. A central extension portion is not provided as in the first embodiment configuration. Rather, the under-nose support 124B includes left and right extension portions 132B that extend from opposing sides of the main side portion 129, respectively, toward the sides of the seal at the upper lip region 121 of the contact surface 120 and connect at respective locations to the lower opening edge 122 of the contact surface 120. In this embodiment, the under-nose support 124B may also include lateral extensions 135 that extend along or adjacent the lower opening edge 122 of the contact surface 120 between the lateral extension portions 132B. Alternatively, the lateral extensions 135 may be considered to be extensions of the contact surface 120 at the upper lip region to which the lateral extensions 132B are connected. It will be understood that lateral extension portion 135 may be omitted in alternative embodiments such that lateral extension portion 132B may extend downward to connect directly to edge 122 of contact surface 120 without lateral extension portion 135.

[0154] In this alternative configuration 124B, the main lateral portion 129 is again configured to substantially contact a portion of the column 72 of the user's under-nose surface, for example at or toward the end of the alar rim 80 at the tip and tip of the user's nose. The side extension portions 132B are configured for substantial alignment and contact with, respectively, a portion of the alar rim 80 of the under-nose surface, for example including the portion of the alar rim extending from the base of the nose. This configuration thus leaves a main opening 134B in the under-nose support between the main lateral portion 129, the side extension portion 132B, and the contact surface 120 in the upper lip region for the user's nostril 74.

[0155] Alternative 2 - Side extensions that are completely separate or spaced apart from the opening edge of the nose seal. Referring to FIG. 29, a second alternative configuration of the second embodiment nose seal 102C is shown, with like numbers representing like features. Again, this nose seal 102C is otherwise similar to the second embodiment nose seal, except that it includes an alternative under-nose support arrangement 124C in which side extensions 132C extend from the main side portion 129 and connect to a portion of the nose seal in the upper lip region that is displaced or spaced from the edge 122 of the nose seal such that the side extensions 132C are separate from the edge 122 of the nose seal. In one arrangement, the side extensions 132C connect to or extend to a portion of the contact surface 120 below the edge in the upper lip region, or in an alternative arrangement, connect to the nose seal at a location completely displaced from the contact surface 120, such as connecting to a respective location of the side wall of the seal in the upper lip region below the lower edge 122 of the opening. This configuration provides an under-nose support 124C that is separated from the contact surface 120 of the edge 122 of the nose seal.

[0156] Third embodiment - Nose seal with "floating" under-nose support 30-34, a third embodiment of a nasal seal 102D will now be described. As with the previous embodiments, the nasal seal 102D is similar to the first embodiment nasal seal 102 in that it may be used in a nasal mask interface assembly, as described above, for example by being coupled or connected to a seal housing 104. Like reference numbers refer to like features.

[0157] The third embodiment nose seal 102D includes an alternative under-nose support 124D consisting only of main side portions or bands 129 without a central or side extension portion. In particular, the under-nose support 124D includes an elongated strip or band of material that extends laterally across the nose seal between opposing sides of the seal and extends or is located behind the face-contacting surface 120 as in the previous embodiment. As in the previous embodiment, the side bands 129 may be bonded or connected at each end to respective portions of the side walls 126 or other portions of the seal such that the under-nose support is separate or spaced from the contacting surface 120 or at least the edges of the contacting surface. Without the central or side extension portions of the previous embodiment, the under-nose support 124D may be considered a "floaty" support having a greater degree of movement potential within the seal.

[0158] In this configuration, the under-nose support 124D has less contact surface area and therefore contacts less of the under-nose surface of the user's nose. In particular, without either the central or side extensions, the buoyant under-nose support configuration 124D tends to contact less of the under-nose surface. The buoyant under-nose support tends to engage or contact the pillar and portion of the alar rim 80 adjacent at or toward the tip of the nose, depending on the size of the user's nose. For individuals with larger noses, the under-nose support may contact the under-nose surface further in the mid-region of the under-nose surface or at the base of the nose.

[0159] Fourth embodiment – ​​Low profile nasal mask interface Overview A nasal mask assembly of the fourth embodiment will now be described with reference to Figures 35 to 102.

[0160] 35 and 36, a fourth embodiment of a nasal mask assembly includes a nasal mask interface 200 secured to a user's head via headgear 250 connected to a flexible gas supply conduit 260 which, in use, delivers a supply of breathable gas to the nasal mask interface 200 for delivery to the user's airways via their nose. In this embodiment, the headgear 250 includes side or front straps 252 which connect 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. The pair of front or side straps 252 connect to or extend integrally within one or more other straps or strap portions. In this embodiment, the headgear 250 includes a top or crown strap 254 that extends over the head or top of the user, and a back or rear strap 258 that extends around the back of the user's head. Side straps 252 are integrally formed or otherwise connected to the top 254 and rear 258 straps, as will be appreciated by those skilled in the art. As with the previous embodiment, the headgear straps are typically formed of or include a flexible, breathable material, such as Breath-o-Prene®, a breathable neoprene material, or a neoprene material. Further aspects of the headgear configuration and attachment and interaction with the nasal mask interface 200 are described below. In this embodiment, the headgear may have an auto-adjusting capability or mechanism, as will be further described, although these are not required for all embodiments.

[0161] 37-46, the nasal mask interface 200 includes a flexible nasal seal 202 that is either permanently or releasably connected or attached to a complementary seal housing 204. The seal housing 204 is typically formed of a rigid material or is at least more rigid than the flexible nasal seal 202. As with the previous embodiment, the nasal seal 202 and the seal housing 204 together collectively 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 that receives 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, although it will be understood that in alternative embodiments the conduit may be permanently or integrally connected within the seal housing 204. In this embodiment, the nasal mask interface 200 includes a conduit frame 211 that is either permanently or releasably connected to an end of the gas supply conduit. The conduit frame 211 in this embodiment is releasably connectable to a complementary central air hole or inlet 210 provided in the seal housing, thereby connecting the supply conduit 260 to the nasal mask interface 200.

[0162] In this embodiment, a headgear 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 curvilinear in shape (the outer surface is convex and the inner surface engages the seal housing which is concave) and extends laterally across the seal housing 204, extending in an outward direction at each end toward the face-contacting side of the nasal mask interface but away from the lateral side of the nasal seal 202. Each end of the yoke 208 connects to a respective end of one of the side straps 252 of the headgear 250 such that the headgear 250 has a single attachment point on each side of the nasal mask interface 200. In this embodiment, the headgear 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 headgear 250 may be removed or released from the seal housing as needed.

[0163] In this embodiment, the nasal mask interface 200 is provided with one or more drift exhaust or vents 212 to provide for the washout of gas from the nasal mask interface 200. In this embodiment, the drift exhaust comprises an arrangement of small holes or holes extending through the seal housing 204. As will be described in further detail, the vent arrangement comprises one or more arrays of holes at specific locations on the seal housing. As in the previous embodiment, the nasal seal 202 is provided with an under-nose support 224 that extends or is suspended laterally across the nasal seal within the mask cavity and is configured to contact at least a portion of the under-nose surface of the user's nose when the nasal mask is worn to counteract resultant lift forces generated in use, as discussed above.

[0164] Further details and aspects of the various components of the nasal mask interface 200 will now be described.

[0165] General Shape and Configuration Aspects 42, in this embodiment, the orientation or angle of the yoke 208 and the conduit frame 211 are offset from one another. For example, the longitudinal axis of the conduit frame 211, represented by line AE, is angled relative to a longitudinal axis or plane extending through or defining the yoke 208, represented by AF. In this embodiment, the angle between the longitudinal axis AE of the conduit frame 211 and the longitudinal axis AF of the yoke 208 when viewed from the side of the nasal mask interface 200 preferably ranges 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, the longitudinal axis AE of the conduit frame 211 and the longitudinal axis AF of the yoke 208 are defined with respect to a side view of the nasal mask interface 200 for illustrative purposes only. In some embodiments, this angular offset between the conduit frame and the yoke can help direct the gas delivery conduit away from the user and can also help reduce hose drag.

[0166] 44, the conduit frame 211, seal housing 204, nose seal 202, and yoke 208 all generally exhibit a substantially concave curvature (at its face facing surface) that generally follows the curvature of the user's face and helps the nasal mask interface conform to the 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 at its lateral side portions) is generally larger than the radius of curvature of the conduit frame 211 and / or 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 nose seal 202 that extends between the face-contacting surface of the nose seal and the outside of the nose seal that connects to the seal housing 204.

[0167] 43, the nostrils or nose receiving openings 206 on the face contacting side of the nose seal 202 are shown. A pair of single headgear attachment or connection points 272 on each side of the nasal mask interface are shown at 272 on each end of the yoke 208. In this embodiment, the headgear connection points 272 are located on each lateral side of the nasal mask interface 200 at locations on the yoke 208 that are most distal from the center of the nasal mask interface. The under-nose supports 224 are visible through the nostrils 206 and extend within the mask cavity provided by the nose seal 202 and the seal housing 204. In this embodiment, the under-nose supports 224 have three connection points to the nose seal 202. As will be described in more detail below, the under-nose supports 224 include a connection point toward each upper inner lateral side or surface of the nose seal and a third connection point toward or at the center bottom of the nose seal. In this embodiment, the third connection point is to the center bottom edge of the nostrils 206.

[0168] 42 and 44, some major exterior dimensions of the overall profile of the nasal mask interface 200 in this embodiment are described by way of example only to provide a sense of scale. In this embodiment, the ratio of the overall height to the overall depth of the seal housing 204 and nasal seal 202 assembly ranges from approximately 1:0.8 to approximately 1:1.2, and in this exemplary embodiment, the overall height is substantially equal to the overall depth of the seal housing and nasal seal assembly, i.e., approximately a 1:1 ratio. In this embodiment, the overall lateral width of the seal housing and nasal seal assembly is greater than the overall height and depth of the assembly. In this embodiment, the ratio of the overall height to the overall depth to the overall lateral width of the seal housing and nasal seal assembly ranges from approximately 1:0.8:1 to approximately 1:1.2:1.4, and is approximately 1:1:1.2 in this exemplary embodiment.

[0169] By way of example only, exemplary dimensions of one exemplary configuration of a nasal mask interface are shown with reference to Figures 42 and 44. In this example, the overall height of the seal housing 204 and nose seal 202 assembly from top to bottom, indicated at 282, ranges from approximately 27 mm to approximately 67 mm, and preferably is approximately 47 mm. The overall height of the seal housing 204, nose seal, and installed conduit frame 211, indicated at 274, ranges from approximately 30 mm to approximately 70 mm, and preferably is approximately 50 mm. The overall depth of the seal housing 204 and nose seal 202 assembly, indicated at 276, ranges from approximately 41 mm to approximately 66 mm, and preferably is approximately 46 mm, and the overall depth of the seal housing 204, nose seal 202, and installed conduit frame 211, indicated at 278, ranges from approximately 51 mm to approximately 76 mm, and preferably is approximately 56 mm. The lateral width of the seal housing 204 and nose seal 202 assembly, indicated at 280 (see FIG. 44), ranges from approximately 52 mm to approximately 77 mm, and preferably is approximately 57 mm.

[0170] Nose seal 47-67, the nasal seal 202 of the nasal mask interface 200 is described in further detail. The nasal seal 202 is flexible and soft and may be formed from a silicone material or other suitable material as will be appreciated by those skilled in the art.

[0171] Referring to the face-contacting or wearer side of the nose seal 202 shown in FIG. 47, the contact surface is generally indicated at 220 and is configured to seal around the user's nose, including over the bridge of the user's nose. In this embodiment, the contact surface 220 surrounds the nose and at least a portion of the seal around that portion of the user's nose. The contact surface 220 of the nose seal includes an upper lip region, generally indicated at 221, that is configured to contact the upper lip region of the user's face, for example, above the vermilion border and below the nostrils. The contact surface 220 also includes left and right cheek or side regions 223 that correspond to the upper lip region 221 at the bottom of the seal and an upper region 225 that corresponds to the nasal bridge region at the top of the nose seal 202 or extends proximal to the nasal bridge region at the top of the nose seal 202. The cheek region 223 of the contact surface 220 is configured to contact the cheek surface proximate the user's midline and / or the user's lateral nasal surface on either side of the nose. The nasal bridge region 225 of the contact surface 220 is configured to extend over the nose and contact the nasal bridge region of the user's nose, connecting the two cheek regions 223. As will be described in more detail below, in this embodiment, the nose seal 202 includes 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 nose bridge in a mid-region of the nose bridge at a location on the nose bridge between the lower tip of the user's nose between the user's eyes and the upper end of the nose bridge. In this embodiment, the nasal bridge region 225 of the contact surface 220 is configured to contact the user's nose bridge in a region of the nose bridge below the user's eyes. In one embodiment, the nasal bridge region 225 of the nose seal is configured to contact the user's nose bridge in a region defined between the nostrils of the nose and the center of the nose bridge. In one embodiment, the nasal bridge region 225 of the nose seal is configured to contact the lower half of the user's nose.

[0172] 52, in this embodiment, the nasal bridge region 225 of the contact surface 220 includes a central valley region or portion, indicated at 245, that is recessed relative to the remainder of the contact surface. The valley region 245 is configured to engage the bridge of the user's nose and is shaped to substantially conform to the bridge of the user's nose.

[0173] The overall shape and configuration of the contact surface 220 is arranged to sealingly conform to and sealingly engage the contours of the user's face about the nose when secured to the user's head via the headgear and the nasal mask interface is subjected to a flow of gas. In this embodiment, the nose seal may be considered to be of the self-inflating type because under pressure the seal urges the face-contacting surface 220 against the user's face and deforms to substantially seal against the contours of the user's face, including one or more of the upper lip, cheeks near the midline, lateral nose, and bridge of the nose.

[0174] The contact surface 220 of the nose seal 202 terminates in an inner peripheral edge 222 that defines nose receiving openings or nostrils 206 into the mask cavity. The mask cavity is defined or formed when the nose seal 202 is assembled or connected to the seal housing 204. Referring to FIG. 48, the outer side of the nose seal opposite the face contacting side of FIG. 47 is shown. The outer side of the nose seal 202 connects to the seal housing 204. In this embodiment, the outer side of the nose seal 202 terminates in a connecting edge 227 that defines an outer side or housing aperture 228 for receiving or connecting with the seal housing 204.

[0175] With reference to FIG. 51, the outer connecting edge 227 of the nose seal 202 does not coincide with or extend in a single plane. With reference to FIGS. 48 and 51, in this embodiment, the outer connecting edge 227 of the nose seal includes an upper edge 227A, a lower edge 227B, and lateral side edges 227C, 227D extending between the upper 227A and lower 227B edges. In this embodiment, the upper edge 227A projects rearward of the lateral side edges 227C and 227D. At least a central portion of the lower edge 227B may also project rearward of the lateral edges 227. In this embodiment, at least a central portion of the upper connecting edge 227A projects rearward beyond both the lateral edges 227C, 227D and the lower edge 227B. As shown in FIG. 53, the upper edge 227A projects or bulges outward to a peak in the center of the nose seal.

[0176] In this embodiment, the nostrils 206 formed on the face-contacting side of the nose seal 202 are generally or semi-triangular in shape to match the natural shape of the human nose. The outer housing holes 228 of the nose seal 202 are generally or semi-rectangular in shape.

[0177] 47 and 48, the under nose support 224 can be seen and is generally concave or U-shaped with three connection or attachment points to or within the nose seal 202. As shown, the under nose support 224 is suspended like a sling or hammock between two upper connection points 231 located at opposing upper lateral positions or surfaces within the nose seal 202. In particular, the upper lateral connections 231 are located on the inner surface of the nose seal 202, one on each side of the central top region of the nostril 206. In this embodiment, the lateral connections 231 of the under nose support 224 are configured or positioned vertically such that the inner surfaces or contact surfaces of the under nose support 224 substantially face or face each other at or toward the lateral connection points 231. In particular, the lateral contact surfaces of the under nose support 224 may be substantially parallel to each other at or toward the lateral connection points 231. The under nose support 224 in this embodiment further includes a third connection at or toward the central bottom of the nose seal. In this embodiment, the bottom central connection point 232 joins to or at the central bottom region of the edge 222 of the nose seal contact surface 220 that defines the nostril 206. The under nose support 224 and its connections are further described below.

[0178] 51-53, the nose seal 202 is substantially defined by a face-contacting face portion 220 (shown in FIG. 47) and a sidewall portion 226 (shown in FIG. 51) that extends rearwardly from the contacting face around the periphery of the seal and terminates at an exterior or outer connecting edge 227 of the seal that is bonded or connected to the seal housing 204. In this embodiment, the nose seal 202 may include profiles or regions of varying thickness extending from the nostril edge 222 on the face-contacting side of the nose seal to the outer connecting edge 227 of the nose seal.

[0179] In this embodiment, the nasal seal 202 includes at least a first front region, generally designated 233, extending from the nostril edge 222 to an intermediate peripheral boundary 235 located at the sidewall portion 226, and a second rear region 234 extending from the intermediate peripheral transition boundary 235 to a connecting edge 227 on the outside of the seal.

[0180] In this embodiment, the front region 233 includes the contact surface 220 and at least a portion of the sidewall portion 226 of the nose seal adjacent the contact surface 220. The rear region 234 includes the remaining portion of the sidewall portion 226 extending back from the transition boundary 235 to the connecting edge 227.

[0181] 56, in this embodiment, the anterior region 233 of the nasal seal, including the contact surface, is thinner or of reduced thickness on average compared to the posterior region 234 of the nasal seal. In this embodiment, the nasal seal further includes an additional third thickness region 236 in the anterior region 233. In particular, the anterior region 233 transitions to a thinner edge region 236 adjacent the nostril edge 222. The edge region 236 is thinner than the remainder of the anterior region 233. In this embodiment, the edge region 236 is a smaller portion of the anterior region 233.

[0182] The described thickness profile provides stability to the nose seal 202 and enhances the sealing engagement with the user's nose. In particular, the thicker rear region 234 provides stability to the overall nose seal shape, while the reduced thickness of the front region 233, including the contact surface 220, promotes conformity of the nose seal with the user's nose. Additionally, the edge region 236 around the periphery of the nostril edge 222 is the thinnest portion of the contact surface 220, providing increased user comfort and sealing conformity. It will be appreciated that the thicknesses of the rear region 234, front region 233, and edge region 236 may be uniform within the respective regions or may have varying thicknesses within the regions. For example, in this embodiment, the rear region 234 gradually decreases in thickness from the contact edge 227 to the intermediate transition boundary 235. The front region 233 is of substantially uniform thickness at the larger and smaller thinned edge portions 236, which have a reduced uniform thickness relative to the majority of the front region. In this embodiment, the larger portion of the front region 233 gradually transitions at the body transition zone 237 in FIG 56 into a thinned edge region 236 as shown. As shown in FIG 56, the face-contacting surface 220 of the nose seal forms a flange that curls or extends inwardly from the sidewall portion 226 of the nose seal, the flange including the thinned edge portion 236.

[0183] Nose seal under-nose support In this embodiment, the under-nose support 224 of the nasal seal 202 is in the form of a nasal sling or hammock that extends laterally or is suspended across at least a central portion of the nasal seal within the mask cavity. The under-nose support 224 is configured to contact at least a portion of the under-nose surface of the user's nose and thus oppose the resultant lift forces that arise when the nasal mask is worn and in use under pressurized gas flow as discussed above.

[0184] In this embodiment, the under-nose support 224 is entirely defined or enclosed within the outer envelope of the nose seal, i.e., it does not protrude or extend beyond the outer connecting edge 227 of the nose seal which connects to the contact edge 222 of the seal housing or nostril 206. It will be appreciated, however, that in alternative embodiments, at least a portion of the under-nose support 224 may protrude beyond the housing aperture defined by the connecting edge 227.

[0185] In this embodiment, the under-nose support 224 is suspended laterally across a central region of the nose seal 202 between the left and right sides of the nose seal. As shown, the under-nose support is disposed or located behind or posterior to the nostrils or openings 206 on the face-contacting side of the nose seal. The under-nose support 224 is fixedly connected to the nose seal in that it is not removable in this embodiment. In one form, the under-nose support is integrally molded within the nose seal. In an alternative form, the under-nose support component or portion of the nose seal may be formed separately and then fixedly joined within the nose seal via adhesive or welding or the like, or it may be connected to the seal housing.

[0186] In this embodiment, the under nose support arrangement 224 includes an elongate main lateral portion or band 229 that extends laterally within the nose seal across at least a portion of the nose seal. With reference to Figures 47-49, and 54-56, and 57, in this embodiment, the main lateral portions 229 of the under nose support 224 are suspended or connected at each opposite end to respective upper connection points 231 located on the upper inner surface of the nose seal on either side of the seal relative to the apex region of the nostril 206. In this embodiment, the ends of the main lateral portions 229 of the under nose support 224 are connected to the inner surface of the nose seal via respective reinforcement portions or regions in the form of, for example, ribs 241. In this embodiment, the ribs 241 extend in a substantially vertical orientation from an upper lateral location within the inner surface of the nose seal and extend into or connect to the respective ends of the main lateral portions 229 at the connection locations 231. In this embodiment, the ribs 241 are integrally molded with the main lateral portions 229 of the under-the-nose support 224. It will also be appreciated that the ribs 241 at the ends of the main lateral portions 229 may be considered to be part of the under-the-nose support as well as the main lateral portions 229. In other words, the reinforced portions or regions 241 may be considered to be extensions of the main lateral portions, or simply the ends of the main lateral portions. Alternatively, the reinforced portions or regions may be considered to be separate components or structures connected to or integrally formed with the ends of the main lateral portions. The functionality and effect of the reinforced portions or ribs 241 remain substantially the same in either interpretation.

[0187] 55, the rib 241 is joined at a portion of its peripheral edge to or extends from the inner surface of the area of ​​the nose seal including the rear region 234 and a portion of the front region 233. In this embodiment, the rib extends over a portion of the rear region 234, except for the thinned edge region 236 adjacent the nostrils, and most of the front region 233 including the contact surface. However, it will be appreciated that in alternative embodiments, the rib 241 may also extend from, connect to, or extend within at least a portion of the thinned edge region 236. In this embodiment, the main lateral portions 229 of the under-nose support connect to each respective rib 241 at a portion of the rib that extends or coincides with the thicker rear region 234 of the nose seal wall. The ribs 241 provide the dual function of structural support to the nasal seal by providing a fixed connection within the nasal seal for the main lateral portions 229 of the under-nose support 224 and also increasing the stiffness in that area or region of the nasal seal that contacts the patient on either side of the nose. In particular, the ribs 241 flank or are located on either side of the upper valley region 245 (see FIG. 52 ) of the contact surface 220 that is associated with the nasal bridge region of the contact surface 220. In particular, it is the ribs or panels 241 that prevent the nasal seal from collapsing under excessive compressive forces while also allowing for a sturdy connection between the under-nose support and the inner surface of the nasal seal.

[0188] In some embodiments, the ribs may also function to provide feedback to the user, either directly or indirectly, if the mask is being tightened too tight. As described further below, buckling of the ribs may be configured to deform or change the shape of the under-nose support to pinch the user's nose and / or force portions of the contact surface adjacent or associated with the ribs progressively tighter into the sides of the nose under increased compression of the nose seal, e.g., due to tightening of the headgear.

[0189] 55, in this embodiment, a recessed region or zone 243 is provided or formed between a front portion 242a of the rib 241 and a rear portion 242b that connects to the major lateral portion 229 of the under-nose support 224. This recessed region 243 creates 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 region 243.

[0190] In some configurations, the buckling axis 242 allows the rib 241 to flex outwardly toward its adjacent inner surface of its associated sidewall of the nose seal in use when the nose seal worn by a user is compressed in its full depth dimension. This buckling of the rib allows the front region 242a of the rib 241 to flex or compress inwardly toward the user's nose to enhance the seal created in use and may also lift the under-nose support into the under-nose surface of the user.

[0191] In another configuration, the buckling axis 242 allows the ribs 241 to flex inwardly toward one another in use when the nose seal is compressed in its entire depth dimension when worn by a user. This inward buckling of the ribs causes the under-nose support 224 to tighten or close in at least the lateral width direction, which acts to cause the under-nose support to apply pressure against or grip 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 major lateral portions of the under-nose support to move toward one another, effectively narrowing or tightening the U-shape of the under-nose support to apply pressure against the user's nose.

[0192] A recessed region 243 may also be an area or zone of the rib 241 that has a reduced depth (i.e., the distance of the free peripheral edge of the rib from the edge of the rib connected to the inner surface of the seal) or surface area relative to other portions of the rib.

[0193] Referring to FIG. 48, in this embodiment, the upper connection location 231 of the under-nose support is located at the lateral end or side boundary of the nose seal. In particular, the vertical connection rib 241 and the connection point 231 are offset relative to the outer lateral width of the nose seal on their respective sides. In this embodiment, the distance between the connection locations 231 is generally equal to or less than the outermost width of the nostrils, shown at 242A in FIGS. 47 and 48. In particular, the connection point 231 of the main lateral portion 229 of the under-nose support is located within the same width zone as the nostrils 206 in relation to the nose seal. In this embodiment, the connection rib 241 extends from the contact surface 220 at the upper lateral cheek region 223 of the contact surface at a location that engages the cheek and / or lateral or lateral nasal surface against the bridge of the user's nose.

[0194] 57, the major lateral portions 229 of the under-nose support 224 are positioned to extend laterally across the nose seal 202 at approximately the middle or central depth of the overall depth profile of the nose seal in the dimension extending from the contact surface 220 to the outermost portion of the outer connecting edge 227 of the nose seal. However, in alternative embodiments, the major lateral portions may be positioned to extend laterally across the nose seal at other depths, whether closer or further from the contact surface, and may have portions that extend or protrude beyond the outer connecting edge 227 or main envelope of the nose seal.

[0195] In this embodiment, the under nose support 224 includes a third connection to the nose seal in addition to the two upper lateral connections 231. In this embodiment, the under nose support is connected to the central lower or bottom of the nose seal as shown at 232. In this embodiment, the lower central connection of the under nose support 224 is in the form of a central extension or connection portion 232 that extends centrally from the main lateral portions 229 and is joined or connected to or at the nostril edges 222 of the contact surface 220 in the upper lip region 221 of the nose seal. In this embodiment, the central connection portion 232 has an approximately hourglass width profile. Notably, the width dimension of the central connection portion 232 at both the interfaces with the nostril edges 222 and the main lateral bands 229 is greater than the width dimension of the central connection portion 232 in the central or middle region. For example, the central connecting portion 232 is an elongate portion that extends from a first end 232A that is coupled or integrally formed with the nostril edge 222 of the contact surface 220 to a second end 232B that is coupled or integrally formed with the main lateral band 229 of the under-nose support 224 (see FIGS. 48, 49 and 54). In this embodiment, the width dimension of the central connecting portion 232 gradually decreases from each of its ends 232A, 232B toward a central or intermediate region of reduced width to provide an approximately hourglass width dimension profile.

[0196] 55 and 56, the central connecting portion 232 of the under-nose support includes a varying thickness profile in a direction perpendicular to the contact surface of the connecting portion 232. In this embodiment, the thickness of the central connecting portion 232 tapers or decreases in width from its second end 232B at the main lateral portion 229 to its first end 232A at the nostril edge 222. For example, the thickness of the central connecting portion 232 at the second end 232B is substantially equal to or uniform to the thickness of the main lateral portion or band 229 in that region, and tapers or decreases in width from either the second end 232B or a point in the middle region of the connecting portion 232 to a reduced thickness at the first end 232A at the nostril edge 222. In this embodiment, the reduced thickness at the first end 232A is substantially equal to or uniform to the thickness of the nostril edge 222 at the contact surface. For example, the thickness of the central connecting portion 232 at its first end 232A can be substantially equal to the thickness of the thinned edge region 236 of the nasal seal contact surface 220.

[0197] With particular reference to FIGS. 47-49 and 54, in this embodiment, the under-nose support 224 is configured with a curved profile across the lateral width of the under-nose support between the upper lateral connections 231. The curvature profile may vary across the lateral width of the under-nose support in some embodiments, but alternatively, it may have a uniform curvature in other embodiments. In the illustrated embodiment, the curvature profile varies. In this embodiment, the contact surface of the major lateral portions 229 of the under-nose support 224 has a steeper curvilinear profile in the intermediate or central region 235 compared to a flatter curvilinear profile in the remaining lateral or lateral regions 236 extending to the upper lateral connections 231. For example, in the central region indicated at 235, the major lateral portions 229 are provided with a first radius of curvature that is substantially uniform 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 may vary, but generally has a greater radius of curvature than the first radius of curvature of the central region 235 such that it is generally a flatter curvature. In this embodiment, the main lateral portion 229 is or includes a curved interface profile across its entire lateral width without any flat regions.

[0198] In this embodiment, the width of the contact surface of the major lateral portion 229 of the under-nose support 224 may vary along its length between opposing sides of the nose seal. In this embodiment, the major lateral portion 229 includes a substantially uniform width in the central region 235, indicated at 238 (see FIG. A15), which then gradually increases in the outer lateral regions 236 towards the connection point 231.

[0199] 56, when the nose seal is in a relaxed state (e.g., not in use), a central sealing axis AG is defined as extending tangentially between the outermost upper and lower tangent points of the central region of the contact surface 220. As shown in FIG. 56, at least a portion of the contact surface of the under-nose support in the central region extends at an angle defined or indicated at 239 relative to the sealing axis AG such that the contact surface of the under-nose support is not parallel or aligned with the sealing axis AG, as indicated by axis AH. In this embodiment, the contact surface in the central region of the under-nose support 224 is oriented at an angle offset from the sealing axis AG in the range of approximately 40° to approximately 80°, more preferably approximately 45° to approximately 75°, even more preferably approximately 50° to approximately 70°, and even more preferably approximately 55° to approximately 65°. As shown, at least a portion of the central connecting portion 232 also has a corresponding or aligned angular offset.

[0200] As explained above, the under-nose support 224 in this embodiment is fixedly connected to or is otherwise an integral component of the nasal seal 202. The figures show the nasal seal 202 and its under-nose support 224 in a resting state, i.e., not in use. Like the nasal seal contact surface 220, the under-nose support 224 is also configured to be soft, flexible or pliable such that its shape and position may conform to the under-nose surface of the user's nose in a sling or hammock-like manner once the nasal mask interface is secured to the user's face or otherwise worn. In this embodiment, the under-nose support is non-stretchable in any direction, although in alternative embodiments it may have some stretch in the same directions.

[0201] Alternative subnasal support The main lateral portions 229 or bands of the under nose support 224 are generally U-shaped with some curvature across the lateral width of the under nose support. In alternative embodiments, the under nose support may have flat sections or portions, or a generally more rectangular or generally square shape. For example, referring to FIG. 61, in an alternative embodiment, the under nose support shown at 224A may have a substantially flat central horizontal portion 229A and two substantially vertical or upstanding portions 229B extending upwardly from each end of the central horizontal portion 229A and each connecting to the inner surface of each upper rear side of the nose seal at connection point 229C, either directly or via a rib as in the previous embodiment.

[0202] Nose seal dimensions example In this embodiment, the ratio of the overall height to the overall width of the nasal seal 202 ranges from about 1:1 to about 1:1.4, and in this exemplary embodiment is about 1:1.2. In this embodiment, the ratio of the overall height to the overall width to the overall depth of the nasal seal ranges from about 1:1:0.6 to about 1:1.4:1, and in this exemplary embodiment is about 1:1.2:0.8.

[0203] By way of example, the main dimensions of one embodiment of the nasal seal configuration are described to provide a sense of scale. With reference to FIG. 47, the height of the nasal aperture defined by the contact surface edge 222 in the central region, indicated at 242B, ranges from approximately 8 mm to approximately 43 mm, preferably approximately 23 mm, and the outermost width of the nasal aperture, indicated at 242A, ranges from approximately 24 mm to approximately 49 mm, preferably approximately 34 mm. The overall height of the nasal seal, indicated at 242D, ranges from approximately 22 mm to approximately 72 mm, preferably approximately 47 mm, and the overall width, indicated at 242C, ranges from approximately 47 mm to approximately 87 mm, preferably approximately 57 mm. In this embodiment, the width 232 of the central connection portion in the intermediate region of reduced width, indicated at 242E, ranges from approximately 2 mm to approximately 15 mm, preferably approximately 3 mm. With reference to FIG. 52, the overall depth of the nasal seal, indicated at 243A, ranges from approximately 29 mm to approximately 49 mm, preferably approximately 39 mm. The depth of the nose seal between the lateral contact surfaces and lateral edges of the housing apertures, designated 243B, ranges from approximately 21 mm to approximately 36 mm, preferably approximately 31 mm. The depth of the nose seal between the central nasal bridge valley 245 of the contact surface 220 and the corresponding central housing aperture edge 227 ranges from approximately 18 mm to approximately 33 mm, preferably approximately 28 mm. The lateral width of the nose seal between the outer lateral points of the connecting edge 227 on the outside of the nose seal ranges from approximately 40 mm to approximately 50 mm, preferably approximately 49 mm. Referring to FIG. 54, the height of the nose seal between the bottom edge 222 of the nostril 206 and the bottom surface of the nose seal 202 ranges from approximately 5 mm to approximately 20 mm.

[0204] 58, the thickness of the major lateral portions 229 of the under-nose support 224 in a direction perpendicular to the contact surface of the major lateral portions, designated 244A, ranges from about 0.2 mm to about 3 mm, preferably about 1.1 mm. A central connecting portion 232 extending from the center of the major lateral portions 229 begins with a similar thickness and then transitions to a thinner thickness as it connects to the nostril edges 222 of the contact surface 220, as shown. In this exemplary embodiment, the thickness of the edge regions 236 of the contact surface is about 0.2 mm.

[0205] The dimensions of the various aspects of the nose seal may vary to accommodate different sized patients. In one embodiment, the nose seal and interface may be provided in several different sizes, such as small, medium and large, or a larger number of size categories. In another embodiment, the nose seal may be provided in two sizes, such as small-medium and medium-large. By way of example, the dimensions of the small-medium nose seal compared to the medium-large nose seal are provided by way of example with reference to FIGS. 59-67. With reference to FIGS. 59 and 60, the radius of curvature R of the central region 235 of the main lateral band 229 of the under-nose support ranges from approximately 8 mm to approximately 18 mm, preferably approximately 12.5 mm for the small-medium nose seal, and for the medium-large nose seal, the central region 235 is longer and includes a substantially constant larger radius of curvature of approximately 14 mm. With reference to FIGS. 62 and 63, the width 232 of the central connection portion at the middle thin region is approximately 2.9 mm for the small-medium size configuration and approximately 4.12 mm for the medium-large configuration. With reference to Figures 64 and 65, the angular offset indicated at 239 between axis AH of the central region of the main lateral portion 229 and the seal tangential axis AG is approximately 64° for the small-medium configuration and approximately 58° for the medium-large configuration. With reference to Figures 66 and 67, the contact surface of the nasal bridge region of the nose seal includes a concave valley portion 245 as described above. In this embodiment, the depth of valley region 245 indicated at 245B is approximately 7 mm for both the small-medium and medium-large configurations. The width of valley region indicated at 245A ranges from approximately 7 mm to approximately 17 mm, preferably approximately 13.8 mm for the small-medium configuration and approximately 14.1 mm for the medium-large configuration.

[0206] As described, the nose seal is generally configured to have a generally rectangular shape in dimensions and / or when viewed from the outside as shown in FIG. 48 and from the front or face-contacting side as shown in FIG. 47.

[0207] Seal housing 68-74, the seal housing 204 of this embodiment of the nasal mask interface 200 will be described in further detail. In this embodiment, the seal housing 204 is formed of a rigid material or is more rigid than the flexible nasal seal. For example, the seal housing may be formed from a plastic polymer, such as polycarbonate.

[0208] The seal housing or shell 204 is a generally hollow component extending from a main opening on the seal connection side indicated at 262 to an exterior side indicated at 261 (see FIG. 72). The opening on the seal contact side 262 of the seal housing 204 is defined by a peripheral edge 263 of the seal housing 204. The seal housing 204 is generally defined by a concave shaped exterior surface extending from the peripheral edge 263 of the opening to the exterior 261 of the seal housing between the top 264A, bottom 264B and lateral sides 264C, 264D of the seal housing, thereby providing a substantially hollow component with a depth which cooperates with the nose seal 202 to collectively define a mask cavity or volume for receiving gas flow from inlet openings 265 provided in the exterior surface at the exterior 261 of the seal housing.

[0209] A peripheral edge 263 of the main opening of the seal housing 204 is configured to connect or couple to a connecting edge 222 of the nasal seal 202 to couple the nasal seal to the seal housing to form a mask cavity. It will be appreciated that the nasal seal 202 and the seal housing 204 may be permanently or semi-permanently connected or coupled via a variety of methods including overmolding, welding, adhesives, mechanical bonding configurations, or combinations thereof.

[0210] 46, in this embodiment, the connecting edge 222 of the nasal seal 202 is permanently connected or bonded to the outer peripheral edge 263 of the seal housing 204 via adhesive, overmolding or welding of complementary surfaces at the interface between the edges 222, 263 of the components. However, it will be appreciated that in alternative embodiments, either the connecting edge 222 or the outer peripheral edge 263 may be provided with channels or complementary ridges or vice versa that engage with one another to form a mechanical connection, and that in addition to this mechanical bond, an overmolding, adhesive or welding may be applied to secure the connection. For example, the ridge and channel configuration may be similar to that described with reference to the nasal mask interface of the first embodiment.

[0211] In this embodiment, the shapes and dimensions of the peripheral edge 263 of the seal housing 204 and the connecting edge 222 of the nasal seal 202 complement one another to enable a sturdy connection between the components, as will be appreciated. It will be appreciated by those skilled in the art that in alternative embodiments, the nasal seal 202 may be releasably connectable to the seal housing 204 via a rigid clip or other releasable coupling mechanism, if desired.

[0212] In this embodiment, the outer surface of the seal housing 204 is provided with a channel or recess, generally indicated at 266, which forms a yoke channel for releasably receiving and retaining the yoke 208 associated with the headgear 250. In this embodiment, the yoke channel 266 extends laterally across the outer surface of the seal housing 204 at a middle or upper region of the seal housing. Below the yoke channel 266 at or towards the bottom of the seal housing is a central intake opening 265 which is configured to receive a supply of gas into the nasal mask interface when in use. In this embodiment, the intake opening 265 of the seal housing 204 is configured to releasably couple to the conduit frame 211 which is, in turn, releasably or permanently connected to an end of the gas supply conduit 260 as described above.

[0213] In this embodiment, the intake opening 265 of the seal housing 204 is substantially in the shape of an ellipse with a major axis extending laterally across the seal housing. Thus, when viewed from the outside as shown in FIG. 70, the intake opening 265 is wider on the sides than in height. As shown in FIG. 72, the intake opening 265 is substantially symmetrical about a plane 265A that extends through the major axis of the elliptical hole, for example, as shown by line AE in FIG. 42. With reference to FIGS. 70 and 74, the intake opening 265 forms a conduit portion through the front wall surface of the seal housing 204 in that it has a depth around at least a portion of its circumference. For example, the intake hole 265 includes upper 265C and lower 265B surfaces that extend from the outer surface of the seal housing to the inner surface into the seal housing. In this embodiment, a structural protrusion 267 is provided across the upper and lower surfaces 265B, 265C of the intake hole 265. In this embodiment, the protrusion 267 is an elongated protrusion that extends across a central portion of the circumference of the elliptical hole 265 at the top and bottom regions at or toward the inner surface housing of the seal. In operation, the protrusion 267 engages a complementary recess or channel 287 in the conduit frame 211 to provide a snap-fit ​​releasable engagement of the conduit frame into the intake hole 265.

[0214] In this embodiment, as shown in Fig. 72, at least a portion of the upper and lower regions of the intake hole 265 protrude beyond a majority of the surface of the seal housing 204. With reference to Figs. 70 and 74, in this embodiment the intake hole configuration is also provided with a localized recessed area around at least a portion of the periphery of the intake hole, as shown at 268. In this embodiment the intake hole 265 is provided with two separate recessed areas or faces, shown at 268, at or towards each of the lateral sides of the intake hole. In this embodiment the recessed areas 268 terminate before meeting one another, although it will be appreciated that in alternative embodiments the recessed areas may extend around the entire circumference of the elliptical intake hole 265. In operation, the recessed area 268 is shaped and dimensioned to receive a complementary mating surface of the conduit frame 211 such that the interface area between the conduit frame and the outer circumferential surface of the seal housing surrounding the intake hole is substantially smooth or flat to provide a continuous or blended outer surface when the conduit frame 211 is assembled into the intake hole 265 of the seal housing 204.

[0215] In this embodiment, the yoke channel 266 is provided with a positioning feature 271 that engages with a complementary locking feature provided on the yoke 208. In this embodiment, the positioning feature 271 of the yoke channel 266 is a recessed structure into which a complementary positioning protrusion or structure provided on the yoke 208 engages 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 of the yoke 208 align such that when the components are engaged together with the yoke protrusions engaged in their complementary recesses 271 of the yoke channel, the yoke deforms slightly such that there is a residual tension or compression force that locks or secures the two components together. The yoke channel 266, yoke 208, and headgear assembly are generally described in further detail below.

[0216] The seal housing 204 includes a bias air opening 212 in the form of an arrangement of intake openings. In this embodiment, the seal housing 204 includes an arrangement of one or more arrays of bias air holes. In this embodiment, the seal housing 204 includes three separate linear arrays of spaced bias air holes. First, an upper array 212 of bias air holes extends across the top surface of the seal housing above the yoke channel 266, shown at 212A. In this embodiment, the upper horizontal row or array of bias air holes extends across the entire width of the top region of the seal housing between the lateral sides. Vertical linear arrays 212B, 212C of bias air holes are also provided on each of the lateral sides of the seal housing on either side of the intake opening 265. As shown, the vertical arrays 212B, 212C of bias air holes extend from below the yoke channel 266 and terminate at or toward the bottom surface of the seal housing 204. In this embodiment, the holes or apertures of the arrays 212A, 212B, 212C are laser drilled, but may be formed by alternative means. Additionally, it will be appreciated that each of the upper 212A and lower 212B and 212C vent arrays may include multiple line arrays or rows in that the configuration is not limited to a single line array. Additionally, the arrays of holes may not necessarily be uniformly spaced in alternative configurations. The configuration with the upper 212A and lower 212B, 212C vent arrays is configured to prevent noise and drafts when the nasal mask interface is used. Alternatively or additionally, bias air holes may be provided in the conduit frame 211.

[0217] With reference to Figures 70, 71 and 72, exemplary dimensions of the configuration of the seal housing 204 are provided by way of example only to provide a sense of scale. With reference to Figure 71, the overall height of the seal housing 204 between the top surface 264A and the bottom surface 264B, shown at 272A, ranges from approximately 19 mm to approximately 59 mm, preferably approximately 39 mm, and the overall width of the seal housing between the lateral sides 264C and 264D, shown at 272B, ranges from approximately 45 mm to approximately 75 mm, preferably approximately 50 mm. With reference to Figure 72, the overall depth of the seal housing between the seal contact side 262 and the outer side 261, shown at 272C, ranges from approximately 19 mm to approximately 49 mm, preferably approximately 24 mm. With reference to Figures 68 and 70, in this example, the distance or height between the top surface 264A and the upper inner surface 266A of the yoke channel 266 at the center of the seal housing, shown at 272D, ranges from approximately 5 mm to approximately 20 mm, preferably approximately 10 mm. In this embodiment, the diameter 272F of the openings in the biased air port arrays 212A, 212B, 212C ranges from approximately 0.6 mm to approximately 0.8 mm, and preferably is approximately 0.7 mm.

[0218] Conduit Frame 75-81, the conduit frame 211 which releasably engages within the intake hole 265 of the seal housing 204 will be described in further detail.

[0219] In this embodiment, the conduit frame 211 is configured to releasably engage or connect within the seal housing intake port 265 via a snap-fit ​​engagement, although it will be understood that any other actuable mechanism or mechanical coupling arrangement for releasably connecting these components may alternatively be used.

[0220] In this embodiment, the conduit frame 211 includes a main hollow body extending from a first end 283A configured to engage within the intake port 265 of the seal housing 204 to a second end 283B configured to connect or couple with the end either directly or indirectly via a connector. The conduit frame 211 forms a hollow conduit along the longitudinal axis of its body between its first end 283A and second end 283B, as shown in FIGS. 81 and 82. The conduit is open at each end of the body and, in this embodiment, is substantially elliptical in cross-sectional shape along the length of the body of the conduit frame 211. Referring to FIG. 79, in this embodiment, the inner circumference of the elliptical conduit extending through the body varies along the length of the body from the first end 283A to the second end 283B. In this embodiment, the circumference of the conduit at the first end 283A (which connects to the seal housing) is larger compared to the circumference of the elliptical conduit at the second end 283B (which connects to the air supply conduit) to create a funnel-shaped profile.

[0221] 79 and 80, in this embodiment, the conduit frame 211 is symmetrical about at least a horizontal plane extending through a longitudinal axis AI (see FIG. 79) indicated by AJ (see FIG. 80). In this embodiment, the axis of symmetry AJ corresponds to the major axis extending through the elliptical conduit. This symmetry corresponds to the symmetry of the inlet hole 265 of the seal housing 204 and allows the conduit frame 211 to be connected to the seal housing 204 in either of two orientations. In other words, the conduit frame 211 can be releasably coupled within the inlet hole 265 of the seal housing in either of two orientations rotated 180° relative to each other. In this embodiment, the conduit frame 211 is also symmetrical about a vertical plane indicated by AK extending along the longitudinal axis AI of the conduit frame. The vertical plane corresponds to the shorter axis of the oval conduit and is perpendicular or orthogonal to the horizontal plane AJ. In particular, the conduit frame is symmetrical about two transverse planes extending through the longitudinal axis of the conduit frame.

[0222] Referring to FIG. 75, in this embodiment, the body of the conduit frame 211 includes a central gripping portion 284, a first connecting portion 285 at a first end 283A for connecting to the intake port 265 of the seal housing, and a second connecting portion 286 at a second end 283B for connecting to a gas supply conduit.

[0223] The seal housing connecting portion 285 extends from a first end 284A of the central gripping portion 284 and terminates at a first end 283A of the conduit frame. The conduit connecting portion 286 extends from a second end 284B of the central gripping portion 284 and terminates at a second end 283B of the conduit frame 211. As shown in the figures, both the seal housing connecting portion 285 and the conduit connecting portion 286 are elliptical in cross section relative to the longitudinal axis of the conduit frame. In this embodiment, with reference to FIG. 79, both of the circumferences of the connecting portions 285, 286 decrease or taper from their respective ends of the central gripping portion 284 to their respective ends 283A, 283B of the conduit frame 211. It will be appreciated that the conduit frame may have alternative shape profiles to an ellipse in alternative embodiments. For example, the conduit frame may have an internal conduit with a circular cross section in an alternative form.

[0224] In this embodiment, the gripping portion 284 includes upper and lower concave gripping portions 284C, 284D on the upper and lower surfaces of the conduit frame. The upper and lower concave gripping areas 284C, 284D allow a user to grasp the conduit frame 211 between thumb and index finger for inserting or releasing it from the seal housing during use as needed.

[0225] In this embodiment, the central gripping portion 284 increases in width laterally toward the first end 284A to form winged regions 284E, 284F of the lip that protrude from the lateral side of the conduit frame. In this embodiment, the first end 284A of the central gripping portion is substantially concave in shape, as shown in FIG. 77. In this embodiment, the inner surfaces 284G, 284H of the winged regions 284E, 284F adjacent the seal housing connecting portion 285 are complementary in shape and size to the concave lateral regions 268 of the air intake holes 265 of the seal housing. In particular, the inner surfaces 284H, 284G of the winged regions of the conduit frame 211 abut or engage the complementary concave regions 268 associated with the air intake holes 265. In this embodiment, the exterior or outer surface profile of gripping portion 284 in the areas designated 284I and 284J associated with the winged regions has a curvature or shape that complements the curvature or shape of the seal housing on the lateral sides of the air inlet 265. This complementary shape of the winged regions 284I, 284J provides a flat, continuous surface profile at the exterior mating or interface region of the conduit frame 211 and seal housing 204 when they are assembled together. The concave profile of the first end 284A of gripping portion or region 284 is configured or arranged to complement the concave surface profile adjacent or surrounding the periphery of the air inlet 265 of the seal housing 204 to provide a continuous, flat or blended outer surface at the interface between the conduit frame and seal housing when assembled together.

[0226] 75 and 77, upper and lower portions of the seal housing connecting portion 285 at the first end 283A of the conduit frame are provided with undercut or recessed grooves 287. These grooves 287 are shaped and sized to complement upper and lower projections 267 of the seal housing intake hole 265 to allow the conduit frame 211 to non-movably engage within the seal housing intake hole 265 via a snap-fit ​​engagement.

[0227] In this embodiment, as shown, the body of the conduit frame 211 is a substantially oval body along its length between the first end 283A and the second end 283B. However, it will be understood that alternative cross-sectional shapes, such as circular or other suitable shapes, may be used with the internal conduits and / or general shapes of the body in alternative embodiments, as desired. In this embodiment, the oval body is at least slightly deformable relative to a vertical plane axis AK extending through the longitudinal axis of the body. This allows the gripping areas 284C, 284D to be compressed toward each other by a user to slightly deform the conduit frame 211, thereby allowing disengagement of the snap-fit ​​connection between the conduit frames 211 in the seal housing 204 to allow the conduit frame (and its associated air supply conduit) to be removed or separated from the seal housing.

[0228] With reference to Figures 77 and 80, example dimensions of one configuration of the conduit frame of this embodiment are described to provide a sense of scale. With reference to Figure 80, the dimensions of the elliptical holes at the conduit connection end 283B for the major axis 290A range from about 9 mm to about 29 mm, preferably about 19 mm, and for the minor axis 290B range from about 5 mm to about 21 mm, preferably about 11 mm. The elliptical extrusion of the conduit connection portion 286 increases in size toward the major axis, ranging from about 14 mm to about 34 mm, preferably about 24 mm, and toward the minor axis, ranging from about 6 mm to about 26 mm, preferably about 16 mm, at or toward the gripping portion 284 of the body. The overall height 290C of the conduit frame 211 between the outermost upper and lower faces in the dimension aligned or parallel to the minor axis 290B ranges from about 12 mm to about 22 mm, preferably about 17 mm. The overall width 290D of the conduit frame 211 between the outermost wing regions of the central gripping portion 284 in the dimension aligned or parallel to the major axis 290A ranges from about 25 mm to about 45 mm, preferably about 35 mm. With reference to FIG. 77, the overall length of the conduit frame between its first and second ends 283A, 283B, shown at 290F, ranges from about 10 mm to about 30 mm, and the width of the seal housing connecting portion 285, shown at 290E, ranges from about 14 mm to about 34 mm, preferably about 24 mm. It will be understood that dimensions may vary as desired in alternative embodiments.

[0229] 79, a first region, designated 289A, of the conduit frame 211 protrudes or extends to contact the seal housing 204. ComplementaryA connection portion 285 is identified which engages into the intake hole 265. A second remaining portion of the conduit frame, indicated at 289B towards the second end 283B, extends or protrudes from the seal housing. It will be appreciated that the first end 283A of the conduit frame 211 may define a housing hole opening which engages or compliments the intake hole 265 of the seal housing, and the end 283B of the conduit frame represents a conduit hole which engages or couples to an end of a gas supply conduit, either directly or via a connector.

[0230] Yoke Assembly, Yoke to Seal Housing Connection, and Headgear 82-102, the yoke 208 and its connections to the seal housing 204 and headgear 250 will now be described in further detail. As noted above, in this embodiment the headgear assembly includes a yoke or collector 208 that is configured to releasably attach or couple to a nasal mask assembly, and in particular to the seal housing 204 of the nasal mask assembly.

[0231] The yoke 208 is configured to attach to straps of the headgear 250. In an embodiment, as shown in FIGS. 35 and 36, the headgear 250 includes an assembly of straps including a rear strap 258 configured to wrap around the back of the patient's head, an upper strap 254 configured to wrap over the top of the patient's head, and a pair of front or side straps 252 configured to extend along the patient's cheeks during use. Each of the various straps may be formed as an integral component, one portion being an extension of the other, and / or may otherwise be separately formed strap portions that are either later permanently connected together or configured for releasable connection to one another. For example, in one form shown, the rear strap 258 includes side extensions that form the front or side strap 252 to extend along the patient's cheeks during use, and the upper strap 254 is connected at each end to a respective portion of either the rear 258 or side 252 strap on each respective side of the headgear. In another form, each side strap 252 is attached or releasably connected to a rear strap 258 of the headgear assembly, e.g., by a rear connector component at a free end or a connector coupled to the free end of the rear strap 258, and the top strap 254 is integrally formed or releasably connected to the rear strap 258. In yet another form, the top strap 254 includes side extensions that form the front or side strap 252 to extend along the patient's cheek in use, and the rear strap 258 is connected at each end (permanently or releasably) to a respective portion of either the top 254 or side 252 strap, on each respective side of the headgear.

[0232] In one form, the headgear may be automatically adjustable and / or may include one or more directional locks that allow the headgear to decrease in length and tolerate increases in headgear length with a relatively small amount of resistance. In some configurations, the locking force of the directional locks may be overcome to allow for extension of the headgear for donning of the interface assembly. In some forms, the yoke 208 may form a collector for filaments used in an automatically adjustable headgear system. In this form, the yoke 208 may include one or more directional locks, each of which may include a washer mechanism that may be configured to frictionally engage the filament during extension of the headgear, but allow for relatively frictionless movement during retraction of the headgear. The washer mechanism may be incorporated into an end of the yoke 208, and the body of the yoke may be substantially hollow to receive the filament within the body. The headgear, and any portion thereof, may be configured according to any of the embodiments disclosed in applicant's 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 entireties of which are incorporated herein by reference.

[0233] Each side strap 252 may include a free end to which a connector may be attached. Each connector may engage a complementary strap connector located on the yoke 208. In this embodiment, the yoke 208 is substantially elongated and includes strap connectors located at or near each end of the yoke 208.

[0234] The connections between the side straps 252 and the yoke 208 may be in the form of any suitable connection, such as snap-fit ​​connections, screw-and-screw type connections, or hook connections. In one form, each strap connector of the yoke 208 includes an end cap 291 (see FIG. 83 ) located at each end of the yoke 208. Each end cap 291 may include an opening, such as a hole or recess, configured to receive a connector of the respective side strap 252 to secure the end cap 291 to each end of the respective side strap 252. The end caps 291 are then either releasably (e.g., via a snap-fit ​​arrangement) or permanently connected to the respective ends of the yoke 208, thereby connecting the yoke 208 to the side straps 252 of the headgear assembly. In another form, the free ends of the side straps 252 are directly bonded or permanently secured within respective end caps 291 which are then either releasably or permanently connected to respective ends of the yoke 208, thereby connecting the yoke to the side straps 252 of the headgear assembly.

[0235] 68, 70, and 82-87, as mentioned above, the yoke 208 is also configured to attach to the seal housing 204 of the nasal mask interface. In one form, as discussed, the seal housing 204 may include a recessed area or yoke channel 266 configured to receive at least a portion of the yoke 208 when the yoke 208 and the seal 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 292A and lower 292B edges 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). The asymmetry advantageously provides an improved visual cue regarding the correct orientation for assembly of the yoke 208 into the yoke channel 266 of the seal housing 204 and helps prevent incorrect assembly.

[0236] As shown in FIGS. 68 and 70, the yoke channel 266 of the seal housing 204 includes positioning features or connector recesses 271 in the top 266A and bottom 266B walls. In the illustrated embodiment, the connector recesses 271 are positioned adjacent or proximate to each lateral end of the yoke channel 266. The connector recesses 271 at least partially define or form a retaining lip 271A at or along the front edge of the yoke channel 266 (e.g., at or along the front edges of the interior-facing faces of the top and bottom walls 266A and 266B). The yoke 208 includes connector protrusions 293 that protrude rearwardly from the top, bottom, and / or rear of the yoke 208. In the illustrated embodiment, the yoke 208 includes a connector protrusion 293 on each side of the center of the yoke 208. In the illustrated embodiment, the yoke 208 includes a yoke front 294A and a yoke back 294B that are coupled together, with the connector protrusion 293 formed in the yoke back 294B, as described in more detail herein. The connector recess 271 in the yoke channel 266 is configured to receive the complementary connector protrusion 293 when the seal housing 204 and the yoke 208 are coupled together to form a snap-fit ​​connection between the seal housing 204 and the yoke 208. When the seal housing 204 and the yoke 208 are coupled together, the retaining lip 271A engages the yoke 208 in front of the connector protrusion 293, contributing to the snap-fit ​​connection and retaining the yoke 208 in the yoke channel 516. In the illustrated embodiment, the connector protrusion 293 and the connector recess 271 have a square or rectangular profile that inhibits the yoke 208 from rotating out of the yoke channel 266.

[0237] In some embodiments, the yoke 266 has an elliptical or substantially elliptical cross-section, for example, along its length. This shape advantageously reduces the size or bulk of the yoke 266 and / or provides an improved aesthetic appearance. The washer housings 295 of the directional locks discussed in more detail herein may have a D-shaped, substantially D-shaped, U-shaped, or substantially U-shaped cross-section to enable and / or contribute to the generally elliptical or substantially elliptical cross-section of the yoke 266, for example, as shown in Figs. 88-89. A washer housing 295 is located at or toward each end of the yoke 266 within the body. For clarity, only the right washer housing 295 is shown at one end of the yoke in Figs. 88-89, with the mounting space 295A of the other, omitted left washer housing shown at the other end. The pair of washer housings 295 may be oriented opposite each other (see Fig. 91). In other words, one of the washer housings 295, e.g., the right washer housing 295 shown in FIG. 136C, may be oriented as an upward U, and the other washer housing, e.g., the left washer housing (omitted from the figure), may be oriented as a downward U. This arrangement and orientation may help to allow the straight lines or filament tracks 296A, 296B to extend above and below the left and right washer housings 295, respectively, as will be discussed in more detail herein.

[0238] In some embodiments, the yoke 208 or a central portion of the yoke 208 has a depth (when viewed from the top, e.g., FIG. 84) that is the same as, similar to, or corresponds to the depth of the yoke channel 266, such that the yoke 208 does not protrude or does not substantially protrude from the yoke channel 266. In other embodiments, at least a portion of the yoke 208 may protrude beyond the yoke channel 266, as shown in FIG.

[0239] 84 and 85, in the illustrated embodiment, the rear or underside of the yoke 208 includes a rear step or transition on each side or lateral side 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 side portions 302 of the yoke 208 positioned laterally outward of the yoke channel 266 when the yoke 208 is coupled to the seal housing 204 have a greater depth 304 (at least in the front-to-back direction) or thickness than the depth or thickness 306 of the central portion 300 of the yoke 208 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 side portions 302 of the yoke 208. When the yoke 208 is coupled to the seal housing 204, each of the abutment surfaces 308 abuts or is positioned adjacent or proximate to one of the lateral edges or surfaces 310 of the seal housing 204 (see FIGS. 68 and 72). The abutment surfaces 308 and lateral edges 310 help to properly align the yoke 208 with the seal housing 204 during assembly. The abutment surfaces 308 and lateral edges 310 also or alternatively provide a more sturdy connection 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 seal housing 204 and yoke 208 assembly.

[0240] As discussed above, in this embodiment, the yoke 208 has an asymmetry between its upper edge or surface 292A and lower edge or surface 292B. Referring to 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, e.g., FIG. 86) varies across the lateral width of the yoke between the end caps 291. In the illustrated embodiment, the height of the yoke 208 in the central region 300 generally received in the yoke channel 266 of the seal housing is reduced compared to the height of the yoke in the lateral side regions 302, as shown in FIGS. 86 and 87. In this embodiment, the height of the yoke in the central region 300 gradually decreases through the curved (e.g., concave) surface profile of the lower edge 292B of the yoke in the central region to the top in the center of the yoke where the height is reduced the most.

[0241] 84-87, in this embodiment, the varying depth (when viewed from the top) and height (when viewed from the front) profile of the yoke 208 along its length provides a varying overall thickness profile along the yoke length. For example, the overall thickness (in depth and height) of the yoke at the central region 300 is less than or thinner than the overall thickness (in depth and height) of the lateral regions 302. In particular, the yoke may also be considered to have a thin central region 300 and thicker lateral regions 302 on either side of the central region. The thinner regions 300 are generally received in the yoke channel 266 of the seal housing 204, while the thicker lateral regions do not contact the seal housing 204 and extend outwardly away from the sides of the seal housing. The length, thickness, and convex curvature profile of the yoke are configured to blend with the seal housing and are configured so that the lateral sides of the yoke do not contact the user's face during use.

[0242] 84 and 85, in this embodiment, the radius of curvature of the yoke 208 (when viewed from the top) is substantially constant throughout most of the thinner central region 300 of the yoke, and then the radius of curvature increases or becomes greater at the thicker sides 302 of the yoke. In some embodiments, the thicker side regions 302 may extend at a substantially constant angle without curvature along their length.

[0243] With reference to Figure 86, the overall width 301A of the yoke 208 between side edges (e.g., when viewed from the front as in Figure 86) ranges from about 60 mm to about 120 mm. With reference to Figure 87, the overall depth 301B of the yoke 208 from the front to the rear end cap 291 (e.g., when viewed from the side as in Figure 87) ranges from about 30 mm to about 55 mm.

[0244] As shown in FIG. 83, in the illustrated embodiment, the yoke 208 includes a yoke front 294A and a yoke back 294B. The yoke 208 may also include two end caps 291, one at each lateral end of the yoke 208. In the illustrated embodiment, the yoke front 294A and the yoke back 294B are formed as separate components that are joined together. In this embodiment, the cleft 312 (shown in FIGS. 82, 84, 85) between the yoke front 294A and the yoke back 294B is central or near central. This improves ease of manufacturing.

[0245] The yoke front 294A and the yoke back 294B may be coupled together via a snap fit. In the illustrated embodiment, the yoke front 294A includes a yoke fastener 314 that protrudes rearwardly from a backside of the yoke front 294A. In the illustrated embodiment, the yoke fastener 314 is centrally or approximately centrally positioned relative to the yoke front 294A. The yoke back 294B includes a fastener hole or recess 316 that is sized, shaped, and positioned to receive the yoke fastener 314 to form a snap-fit ​​connection when the yoke front 294A and the yoke back 294B are coupled together. The central connection between the yoke front 294A and the yoke back 294B via the yoke fasteners 314 and the fastener holes or recesses 316 provides greater rigidity to the connection between the yoke front 294A and the yoke back 294B and / or provides support against or inhibits twisting between the yoke front 294A and the yoke back 294B. In some embodiments, the yoke front 294A instead includes the fastener holes or recesses 316 and the yoke back 294B includes the yoke fasteners 314. In some embodiments, the fastener holes or recesses 316 include one or more fastener or interference ridges 318 (see FIG. 88 ) that extend along (e.g., laterally along) the top and / or bottom edges of the fastener holes or recesses 316 and protrude from the top and / or bottom edges into the fastener holes or recesses 316. In some embodiments, the yoke fastener 314 includes one or more corresponding notches extending along (e.g., along the sides) an upper and / or lower surface of the yoke fastener 314 that is sized, shaped, and positioned to receive the fastener ridges 318 to form a snap-fit ​​connection. In some embodiments, the fastener hole 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 ridges 318 simply assist in forming an interference fit by engaging a surface of the yoke fastener 314.

[0246] The illustrated embodiment shows fastener recesses 316 that do not extend through all of the thickness of the yoke back 294B. In a variation, fastener holes 316 that do not extend through the entire thickness of the yoke back 294B may alternatively be provided. However, the fastener recess 316 configuration may allow for easier manufacturing, may provide a neater finish (without holes in the yoke back 294B), and / or may prevent ingress of dirt or other debris into the linear tracks 296A, 296B (due to the lack of holes, which allows the yoke 208 to be fully enclosed along its length), which may help maintain the functionality of the automatic headgear adjustment mechanism. Either form of fastener hole or fastener recess functions to receive a complementary yoke fastener 314 in a snap-fit ​​and / or friction fit engagement as described above when the yoke front 294A and yoke back 294B are coupled together.

[0247] In this embodiment, the yoke back 294B includes an upper alignment bead 322a that projects forward from the yoke back 294B and extends along the length of the yoke back 294B adjacent or adjacent to an upper surface of the yoke back 294B, and / or a lower alignment bead 322b that projects forward from the yoke back 294B and extends the length of the yoke back 294B adjacent or adjacent to a lower surface of the yoke back 294B. The yoke front 294A (see FIG. 90) includes an upper alignment groove 324a in the underside of the yoke front 294A that extends along the length of the yoke front 294A adjacent or adjacent to an upper surface of the yoke front 294A, and / or a lower alignment groove 324b in the underside of the yoke front 294A that extends the length of the yoke front 294A adjacent or adjacent to a lower surface of the yoke front 294A. The upper and / or lower alignment grooves 324a, 324b receive the upper and / or lower alignment beads 322a, 322b, respectively, when the yoke front 294A and the yoke back 294B are coupled together. The alignment beads 322a, 322b and the alignment grooves 324a, 324b facilitate proper alignment of the yoke front 294A and the yoke back 294B. The alignment beads 322a, 322b and the alignment grooves 324a, 324b may also or alternatively resist or support against twisting between the yoke front 294A and the yoke back 294B, for example. In some embodiments, the alignment beads 322a, 322b and the alignment grooves 324a, 324b may positively engage with one another, for example, in the form of a friction-fit or snap-fit ​​connection.

[0248] The end caps 291 serve to secure the yoke front 294A and the yoke back 294B together by clipping or snapping over or onto the lateral ends of the yoke front 294A and the yoke back 294B. The end caps 291 may also allow for connection of the front straps of the headgear to the yoke 208. In some embodiments, each end cap 291 is overmolded onto the braided portion of the front strap.

[0249] As shown in FIGS. 93-98, the lateral ends of the yoke front 294A and the yoke back 294B include or are formed by end cap inserts 326. The end cap inserts 326 may be integrally formed with the lateral ends of the yoke front 294A and the yoke back 294B or may be attached to the lateral ends of the yoke front 294A and the yoke back 294B. The end cap inserts 326 have a reduced dimension or profile compared to the lateral portions of the yoke 208. The end cap 291 has an internal cavity 328 that receives the end cap inserts 326. During assembly, the end cap 291 is hinged or snapped onto the end cap inserts 326 as shown in FIG.

[0250] As shown in FIG. 98, each end cap 291 includes a retention hole 330 on one side (e.g., the back side in the illustrated embodiment) and a retention notch 332 on the opposite side (e.g., the front side in the illustrated embodiment). In other embodiments, the locations of the retention holes 330 and retention notches 332 may be reversed. Locating the retention holes 330 at the rear of the end cap 291 in the illustrated embodiment advantageously hides the retention holes 330 in use, which provides an improved aesthetic appearance. The retention notches 332 extend forwardly from the cavity 328 into the end cap 291. The end cap insert 326 includes a first retention feature 334 on one of the front and back sides (e.g., in the illustrated embodiment, extending rearward from the yoke back 294B portion of the end cap insert 326) and a second retention feature 336 on the opposite side (e.g., in the illustrated embodiment, extending forward from the yoke front 294A portion of the end cap insert 326). To attach the end cap 291 to the yoke 208, for example the end cap insert 326, the retention hole 330 engages the first retention feature 334, as shown in FIG. 94. The first retention feature 334 then acts as a hinge or pivot point, and the end cap 291 pivots over the end cap insert 326 in the direction shown by the arrow in FIG. 93 until the second retention feature 336 and the retention notch 332 engage, for example with a ridge or snap-fit ​​connection. The hinged connection may provide a strong connection between the yoke 208 and the end cap 291 with the reduced length 338 of the end cap insert 326 (shown in FIG. 144). The end cap 291 may therefore taper more steeply. The reduced length of the end cap insert 326, the end cap 291, and / or the overall yoke 208 may advantageously reduce or minimize the yoke 208 impinging on the patient's face.

[0251] In the illustrated embodiment, the first retaining feature 334 is or includes an oval or stadium shaped post that extends rearwardly from the yoke back 294B. The first retaining feature 334 has a length or depth selected such that the outer or rearmost surface of the first retaining feature 334 is flush or substantially flush with the underside 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 retention force. The connection between the end cap 291 and the end cap insert 326 can therefore resist greater twisting forces along the length of the yoke 208 and / or rotational forces about the joint.

[0252] In the illustrated embodiment, the second retaining feature 336 is or includes a raised tab extending forward 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 in the illustrated embodiment, e.g., a side edge (relative to the yoke 208), which allows the end cap 291 to more easily hinge or pivot over and / or on the second retaining feature 336.

[0253] In some embodiments, the end caps 291 may be overmolded onto the ends of the braided elements (e.g., side straps 252) of the automatic headgear adjustment mechanism, such as those illustrated and described in 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, which are incorporated by reference in their entireties herein. The core element or filament 340 may extend within the braided elements (e.g., side straps 252). The end caps 291 may connect the braided elements, and thus the headgear, to the yoke 208 and may create a closed loop headgear system.

[0254] As described herein, in some embodiments, the yoke 208 may form a collector for core elements, such as filaments 340, used in an automatically adjustable or self-adjusting headgear system. As shown in FIG. 91, the yoke front 294A includes an upper linear track 296A and a lower linear track 296B. In this embodiment, a linear track divider projects rearwardly from the rear or inner surface of the yoke front 294A. In some embodiments, the yoke fastener 314 forms or functions as a linear track divider that extends generally diagonally over a portion of the length of the yoke front 294A. In the illustrated embodiment, a divider wall 344 extends between each of the washer housings 295 and the opposing linear track. The divider wall 344 separates the opposing linear track from the washer housing 295 to inhibit the free end of the filament 340 from being caught in the opposing washer housing 295 during storage. In the illustrated embodiment, the linear tracks 296 A, 296 B are not symmetrical mirror images due to the asymmetry of the upper and lower edges of the yoke 208 .

[0255] FIG. 92 shows a variation of the yoke 208 in which the linear tracks 296A, 296B extend into and terminate within the end cap 291. The length of the linear tracks 296A, 296B can therefore be extended beyond the ends of the yoke front 294A and yoke back 294B. This increases the length of the filament 340 that can be stored within the yoke 208, which increases the range of adjustment or variation in the dimensions of the headgear. The headgear assembly defines a headgear loop that extends around the user's head in use. The filament 340 forms part of an automatic headgear adjustment mechanism that allows the overall length of the headgear loop to be extended during donning and doffing of the mask system. In some such embodiments, the length of each of the linear tracks 296A, 296B can be increased or extended by about 5 mm. In such embodiments, the overall length of the headgear loop in the expanded state can therefore be increased by about 10 mm.

[0256] 99-102, an embodiment of a directional lock for self-adjusting headgear is shown, which will be described in further detail. The directional lock includes a washer housing 295, first and second locking elements (e.g., washers 1820, 1822) and a filament or core member 340. The housing includes first and second chambers 1840, 1842, which are configured to receive the first and second locking washers 1820, 1822, respectively. In the illustrated arrangement, the first and second chambers 1840, 1842 are separated by an inner wall 1812 of the housing 295. However, in other arrangements, the first and second chambers 1840, 1842 do not necessarily have to be physically separate spaces, but can be part of a chamber. The housing 295 has two end walls 1814 that, in addition to the inner wall 1812, have an elongated core opening 1860 through which the core member 340 passes. The core openings 1860 are substantially aligned with one another. The core opening 1860 in the end wall 1814 shown on the right side of the figure is larger than the core openings in the inner wall 1812 and the end wall 1814 shown on the left side of the figure. This allows for manipulation of the path of the core member 340 through the housing 295. The first and second chambers 1840, 1842 are each bounded by the inner wall 1812, one of the end walls 1814, and a pair of side walls 1816, which extend between the end walls 1814 of the housing 295. The first and second chambers 1840, 1842 are configured to be open at one or both of the top and bottom of the housing 295.

[0257] Each of the first and second chambers 1840, 1842 has a pair of washer retainers 1850 aligned on opposing sidewalls 1816 of the housing 295. Each of the washer retainers 1850 is configured to pivotally retain one of the first or second locking washers 1820, 1822 within the respective first or second chamber 1840, 1842. The washer retainers include a circular bushing 1852 and an elongated slot 1854, where the circular bushing 1852 intersects with the bottom of the housing such that an entrance is formed. The entrance is configured to allow the first and / or second locking washers 1820, 1822 to be received within the washer retainer 1850. The slot 1854 extends radially from the circular bushing 1852 toward the top of the housing 295.

[0258] The first and second washers 1820, 1822 include a cylindrical shaft 1824 and an arm 1826 extending from the shaft 1824. The cylindrical shaft 1824 is substantially the same width W as the housing 295, and the arm 1826 is narrower to fit within the first and second chambers 1840, 1842. In the illustrated arrangement, 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 from an 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 and second sections 1872, 1874 of the arms 1826 of the first washer 1820 is greater than the corresponding angle of the second washer 1822. The angles are selected such that the second sections 1874 of one or both of the first and second washers 1820, 1822 are substantially flat against a corresponding wall of the housing 295 (e.g., the inner wall 1812 and the end wall 1814, respectively) at one location of the washers 1820, 1822. The second section 1874 of the arm 1826 includes a centrally located circular hole 1876 configured to receive the core member 340. The first and second chambers 1840, 1842 are sized according to the size of the washers stored therein, i.e., the first chamber 1840 is smaller than the second chamber 1842 because the first washer 1820 is smaller than the second washer 1822.

[0259] The cylindrical shaft 1824 of the first and second locking washers 1820, 1822 has a diameter substantially the same as the diameter of the circular bushing 1852 of the washer retainer 1850 and is configured to be received and held by the circular bushing 1852 in a snap-fit ​​configuration. The snap-fit ​​configuration is provided by an opening in the circular bushing 1852 that is narrower than the diameter of the cylindrical shaft 1824. To increase the ease with which the first and second locking washers 1820, 1822 can be pushed through the opening and assembled to the housing 295, the slot 1854 of the washer retainer 1850 is configured to allow the opening to be bent open. When assembled within the first and second chambers 1840, 1842 of the housing 295, the first and second washers 1820, 1822 can pivot back and forth about a central axis extending through the cylindrical shaft 1824.

[0260] The core member 340 is configured to pass through the core aperture 1860 of the housing 295 and the apertures 1876 of the first and second washers 1820, 1822. Applying tension to the core member 340 causes the first and second locking washers 1820, 1822 to pivot back and / or forward between a locked position and / or an open position. FIGS. 99 and 100 show the directional lock in a locked configuration, where a force is applied to the core member 340 in a direction toward the left side of the figure (indicated by the arrow). A force applied to the core member 340 in this configuration causes the first and second locking washers 1820, 1822 to pivot in a counterclockwise direction, such that the path of the core member 340 through the directional lock 1800 is non-linear or tortuous, limiting the movement of the core member 340. 101 and 102 show the directional lock in an open configuration, where a force is applied to the core member 340 in a direction toward the right side of the figure (indicated by the arrow). In this configuration, the first and second locking washers 1820, 1822 pivot in a clockwise direction such that the circular opening 1876 and the core opening 1860 are aligned in a substantially straight line. This provides a smooth path for the core member 340 to be pulled substantially freely through the directional lock 1800. Additional details of the operation of the directional lock 1800 are described above and in applicant's published PCT application WO 2014 / 175752.

[0261] Overview of Features of Fourth Embodiment Aspects of the nasal mask interface of the fourth embodiment may provide the following advantages or features in some embodiments: The nasal mask interface can be used with auto-adjusting headgear (or any single-strap type headgear) without the need for a forehead T-piece component; The yoke 208 may allow the headgear 250 to be releasably connectable to the seal housing 204 and the nose seal 202; The lower profile or shorter nose seal and under-nose support 224 in combination with the ribs 241 contribute to increasing mask stability on the user's face during use; The lower profile or height of the nose seal means that the seal contacts the bridge of the user's nose lower than traditional nose seals, which is generally less intrusive and The releasably connectable conduit frame 211 is symmetrical and allows the conduit frame to be connected in either of two orientations; · Auxiliary sealing lips (eg, including 284e, 284F) at end 284A of central gripping portion 284 of conduit frame 211 help create a backup seal at the connection of the conduit frame into the seal housing.

[0262] Fifth embodiment - Various alternative nasal mask interface configurations Various configurations of the nasal mask interface assembly of the fifth embodiment will now be described with reference to Figures 103-149. The various configurations of the nasal mask interface of the fifth embodiment are generally similar in configuration and structure to the fourth embodiment with some differences. The following description will focus on the differences between the embodiments. It will be appreciated that the various alternative configurations and configurations described with reference to the fourth embodiment or other disclosed embodiments may also be applied to the fifth embodiment.

[0263] Nasal mask interface of the first form of the fifth embodiment 103-117, a first form 400 of a nasal mask assembly of the 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 within a yoke channel 466 of the seal housing 404. As shown in FIG. 104, the nasal seal 402 includes an under-nose support 424 that extends within the mask cavity. As with the fourth embodiment, the first form nasal mask interface 400 may be connected via a yoke 408 attachment to a headgear assembly of the type previously described.

[0264] In this embodiment, a central lower portion or portion of the seal outer housing 404 includes an integral air inlet 465. In this embodiment, the air inlet 465 is an elliptical protrusion or extrusion from the seal housing and is configured to directly or indirectly connect or couple to a gas supply conduit to provide a flow of gas into the mask cavity when in use. In this embodiment, an arrangement of deflection holes 412 is provided in an array around the periphery of the air inlet protrusion 465. The array of deflection holes 412 may extend around the entire periphery of the air inlet protrusion 465 or one or more portions of the periphery, depending on the embodiment.

[0265] 107-110, the connection of the yoke 408 to the seal housing 404 will be described in further detail. In this embodiment, the yoke channel 466 is modified (compared to the fourth embodiment) in providing one larger positioning feature 468 on each lateral side of the yoke channel 466 that is shaped and dimensioned to receive a complementary portion of the thicker lateral region 410 of the yoke 408.

[0266] In this embodiment, the lower portion of the underside of the yoke channel 466 is provided with a recessed elongated channel 414 that is shaped and dimensioned to receive a complementarily shaped elongated protrusion or rib 416 located along the bottom of the underside of the thinner central region 412 of the yoke 408. In particular, the yoke protrusion 416 is configured to engage with an interference or friction fit into the complementary recessed channel 414 of the yoke channel 466, thereby coupling the yoke 408 to the seal housing 404.

[0267] 112 and 113, in this first configuration of the fifth embodiment, the nose seal 402 is provided with a channel 418 in its outer seal housing connecting edge. This channel 418 is configured to engage a complementarily shaped and dimensioned ridge 420 (see FIG. 110) that extends around an opening in the seal housing 404. The coupling of the nose seal 402 to the seal housing 404, and in particular the coupling of the seal housing ridge 420 into the complementary channel 418 of the nose seal, can be seen in the cross-sectional view of FIG. 114. It will be appreciated that this configuration may be reversed in alternative embodiments, with the channel provided in the seal housing 404 and the protruding ridge provided in the nose seal 402.

[0268] 111 and 112, the lower central connection portion 419 of the under-nose support 424 is similar to that of the fourth embodiment. The lateral connections 421 of the main lateral portions or bands 422 of the under-nose support 424 connect directly to the lateral outer wall portions of the nose seal in the region of the channel 418. In this embodiment, the lateral connections of the main lateral bands 422 are lower at the nose seal compared to the fourth embodiment, which provides the main lateral bands 422 with a generally flatter curvature in the central region of the mask cavity compared to the fourth embodiment.

[0269] The nasal mask interface of the second embodiment of the fifth embodiment 118 to 128, a second form of a nasal mask interface 450 of the fifth embodiment will be described. The second form of the nasal mask interface 450 is similar to the first form, and like reference numerals correspond to like components.

[0270] The primary difference in the second configuration of the nasal mask interface relates to the configuration of the yoke 451 and yoke channel 452. In this second configuration, the yoke channel 452 does not provide a specific positioning feature. Rather, the yoke channel 452 is configured to receive and hold the yoke 451 stationarily via an interference fit between a surface of the channel 452 and an abutting outer surface of the yoke 451. In particular, with reference to FIG. 128, the maximum height of the yoke, indicated at 453, is greater than the corresponding width of the yoke channel opening. A force is required to deform the yoke sufficiently to force it into the yoke channel 452 to create a semi-permanent interference fit connection.

[0271] The third aspect of the fifth embodiment of the nasal mask interface With reference to Figures 129 to 139, a third configuration of the nasal mask interface of the fifth embodiment will now be described.

[0272] The third configuration of the nasal mask interface is similar to the first and second configurations and like components use like reference numerals. The third configuration of the nasal mask interface assembly uses an interference fit to couple the yoke 451 within the yoke channel 454 of the seal housing 404 as in the second configuration of the nasal mask interface. However, the shape and configuration of the yoke channel 454 of the seal housing 404 in the third configuration is altered to angle the longitudinal axis of the yoke 451 upwardly to allow for an improved headgear vector. The upward angular offset or tilt of the yoke 451 is provided by the shape of the yoke channel 454 and the side notch structure 453 provided on the side of the channel as shown in FIG. 133. Referring to FIG. 130, the horizontal orientation of the longitudinal axis of the yoke 451 is shown at 456, which is the orientation of the first and second configurations of the nasal mask interface. The tilt of the yoke angle is shown at the longitudinal axis 457 of the third configuration of yoke 451, with the angled tilt indicated at 455. In this configuration, the tilt angle is approximately 5°, although it is recognized that the angle may vary as desired.

[0273] 130 and 137-139, the third configuration nose seal 402 also includes a modification to the preceding configurations. The third configuration nose seal 402 has a thickened upper lip region as shown at 458 in Fig. 130 compared to the thinner upper lip region 459 of the second configuration embodiment shown in Fig. 119. This provides for greater compression at the bottom or upper lip region of the nose seal in use and a generally flatter and smoother transition to the contact surface of the nose seal.

[0274] The lower connecting portion 460 of the under-nose support 424 is also thinner laterally at the connecting edge of the nostril as shown at 461 in FIG. 137 compared to the wider connecting portion shown at 462 in FIG. 121 of the second form. The lateral connecting portions 462 of the main lateral bands of the under-nose support 424 are also thicker and extend further into the nose seal from the connecting channel edge 464 as shown in FIG. 139. For example, the connecting portion 462 may be integrally bonded to the channel connecting edge 464 of the nose seal and a portion of the inner surface of the side wall. In some embodiments, the lateral connecting portion 462 may also bond to or extend into a contacting surface of a portion of the inner surface of the nose seal.

[0275] In this third configuration, the length of the under-nose support 424 occurring from the connecting edge of the nostrils to the rear edge of the main lateral band 465 is increased to accommodate longer noses. By way of example only, the length indicated at 463 may be approximately 22.8 mm compared to 17.9 mm in the first and second configurations of the fifth embodiment.

[0276] The nasal mask interface of the fourth aspect of the fifth embodiment 140-149, the fourth configuration nasal mask interface 470 will now be described in further detail. The fourth configuration nasal mask interface 470 is substantially similar to the third configuration nasal mask interface 460, and like components have like reference numerals.

[0277] The first major difference in the fourth configuration as a mask interface 470 relative to the third configuration is that the bias air vent 471 has been moved from the intake hole 465 to the top central region of the seal housing 404 above the yoke channel. As shown, the bias air vent comprises a cluster or arrangement of closely spaced holes or apertures, designated 471.

[0278] 146-149, the fourth configuration of the nasal mask interface includes a nose seal 402A having a modified shape that provides a flatter contact surface. In particular, referring to FIG. 149, a comparison is shown between the third configuration of the nose seal 402 and the fourth configuration of the nose seal 402A. As shown, the upper region of the nose seal, including the nasal bridge region, and the lower and upper lip region of the nose seal are more forward than the third configuration of the nose seal 402 to provide a generally flatter sealing surface that provides greater cushioning.

[0279] Additionally, the length of the under-nose support extending from the central connector of the nostril edge to the rear edge of the main side band, shown at 474 in FIG. 148, is further increased in length compared to the third configuration nose seal to approximately 26.49 mm in length compared to 22.8 mm in the third configuration nose seal.

[0280] Sixth embodiment 150-154, a sixth embodiment 500 of a nasal mask interface will be described. The substantial configuration of the nasal mask interface 500 is similar to the previous embodiments, particularly the fourth embodiment 470, and like reference numerals represent like components. The following description will focus primarily on the differences, and it will be understood that the alternatives discussed with reference to the previous embodiments may also be applied to this sixth embodiment.

[0281] The primary difference between the nasal mask interface 500 as compared to the fourth configuration 470 is that the seal housing 504 has been reconfigured by swapping the locations of the yoke connection channel 454 and the air inlet 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 configuration nasal mask assembly 470. In some embodiments, the positioning of the yoke lower on the seal housing may limit the amount that the frame rolls up on the user's face.

[0282] The nasal mask interface 500 also includes an alternative drift event arrangement. In this embodiment, two drift event hole clusters 501 are provided on either side of the inlet conduit 465 in the upper lateral region of the seal housing.

[0283] Seventh embodiment 155-162, various alternative configurations of nasal seals for use in a nasal mask assembly are described. As will be appreciated by one skilled in the art, this alternative configuration of the nasal seal of the seventh embodiment may be used with any of the embodiments of the nasal seal interface described, particularly the various configurations of the seal housing, yoke assembly and connections, and headgear assembly.

[0284] Nose seal of the first form of the seventh embodiment With reference to Figures 155-157, a first form of nose seal 600 will be described. This embodiment of the first form of nose seal 600 is similar to the previous nose seals described and includes an under-nose support, designated 601. The primary difference with this nose seal 600 is that it is provided with lateral wings or flaps 602 along at least a portion of the lateral sides of the contact surface 603. In this embodiment, the winged portions 602 are located approximately midway or in the middle region of the lateral sides of the nose seal. The wings 602 are shaped and configured to provide additional contact surface configured to engage the cheekbone / nose region of the user for increased stability, and the increased contact area of ​​the nose seal's contact surface on the user's face helps to reduce rolling or locking during use in some embodiments. 157, each of the wings 602 includes a connecting portion 602A that couples to a sidewall portion of the nasal seal rearward of the contact surface 603 to provide a winged contact surface on each lateral side of the nasal seal, and an extension portion 602B that extends forward of the contact surface 603. The winged contact portions 602 provide added support to prevent the nasal mask from rolling up on the user's face.

[0285] Nose seal of the second form of the seventh embodiment The second configuration nose seal 610 is similar to the first configuration 600 in that it includes lateral winged portions 604 extending from the lateral sides of the nose seal. Compared to the first configuration nose seal 600, the wings 604 are longer and adapted to follow the flat areas of the cheekbone / nose region. As shown, in FIG. 161, the curved or contoured profile of the winged region is adapted to suit the contours of the user's face. As with the first configuration, the wings 604 include a connecting portion 604A that couples the wings to the lateral sides of the nose seal and an extension or contact portion 604B that is configured to contact the cheekbone / nose region of the user's face to stabilize the nasal mask on the user's face and prevent rolling as with the first configuration.

[0286] Referring to FIG. 162, a nasal mask interface including a second configuration nose seal 610 with wings 604 is shown secured to a user's head via a headgear assembly of the type previously described. As shown, the winged region 604 may be loosely coupled or tethered to straps of the headgear assembly, such as side or front straps 252 on either side of the nose seal. In an embodiment, the wings may be provided with coupling or connection mechanisms at or towards the ends of the wings 604 for coupling to the side straps 252. In one form, the connector 606 may be a loop member or the like through which the side straps 252 extend, thereby loosely coupling or tethering the side straps to the winged portion 604 of the nose seal. In other forms, the wings 604 may be separated or untethered from the side straps 252.

[0287] Eighth embodiment 163-170, various alternative configurations of nasal seals for use in a nasal mask assembly are described. As will be appreciated by one skilled in the art, this alternative configuration of the nasal seal of the eighth embodiment may be used with any of the embodiments of the nasal seal interface described, particularly the various configurations of the seal housing, yoke assembly and connections, and headgear assembly.

[0288] Nose seal of the first form of the eighth embodiment 163 and 164, a first form of the nasal mask interface 700 is shown in FIG. 163, including a nose seal 701, a seal housing 702, and a gas delivery conduit 703. In this first form of the eighth embodiment, the nasal mask interface additionally includes a forehead support component, indicated at 704. The forehead support component is configured to engage the user's forehead between or above the user's eyebrows as the mask rolls up or begins to roll up on the face, to counteract this rolling up force. In particular, the dimensions and angular orientation of the forehead support 704 are such that at rest or in normal use, the forehead support does not engage or is displaced from the user's forehead, but only engages to counter any upward rolling of the nasal mask that may occur during use.

[0289] In this first form of the eighth embodiment, a forehead support 704 is provided centrally above the nasal bridge region of the nasal seal. In one form, the forehead support 704 may be coupled to the seal housing 702, or may extend exclusively from the seal housing 702 or exclusively from the nasal seal 701, or in yet a further alternative form, may be coupled so as to extend from both an upper region of the seal housing 702 and the nasal seal 701.

[0290] The forehead support 704 may be an integral part of the seal housing 702 and / or the nasal seal 701 or alternatively may be formed separately and coupled or connected to the seal housing 702 and / or the nasal seal 701. FIG. 164 shows the forehead support 704 with a contact area 704A located at or towards the end of the forehead support component, which in this form is substantially elongated. The first form of the nasal mask interface 700 can be seen in FIG. 164 as worn by a user, the nasal mask interface being coupled via a headgear assembly of the type previously described which is coupled to the nasal mask interface by a yoke 706. Side straps 705 of the headgear assembly are visible in FIG. 164.

[0291] Nose seal of the second form of the eighth embodiment 165-170, there is shown a nose seal in a second configuration 710 for use in a nasal mask interface. The nose seal 710 is substantially similar in construction to the previous nose seals described. The main difference is that the nose seal is provided with a support protrusion 712 that extends upwardly from the top of the seal. The second configuration nose seal 710 is shorter in height than the first configuration nose seal 700, and the support protrusion 712 is configured to resist rolling up of the nasal mask in use by contacting the nasal bridge region of the user's face rather than the forehead region as in the first configuration nose seal 700.

[0292] As shown, the support protrusion 712 is integrally formed and extends from the outer upper side of the nose seal to or above the top of the nasal bridge region of the contact surface designated 711. As shown in FIG. 167, the support protrusion in this embodiment generally tapers in thickness from the nose seal connection end to the upper end of the support protrusion.

[0293] 169 and 170, the nose seal is shown in place on a user, with the remainder of the nasal mask interface assembly omitted from the figures for clarity. As shown, at rest and in normal use, the upper support protrusions 712 are configured to be offset or displaced from the bridge of the user's nose. It is only when the nasal mask begins to roll up or pivot up on the user's face during use that the support protrusions 712 lock or pivot inwardly toward the user's nasal bridge area, thereby opposing the roll-up force. In this embodiment, at rest, the displacement of the support protrusions 712 may be approximately 3 mm from the bridge of the user's nose.

[0294] Ninth embodiment 171-185, various alternative configurations of nasal seals for use with the nasal mask interface are described. As will be appreciated by one of ordinary skill in the art, various configurations of nasal seals may be used with any of the nasal mask interface assemblies described.

[0295] Nose seal of the first form of the ninth embodiment 171-174, a first form of nasal seal 750 of the ninth embodiment is substantially similar to the previous nasal seals described and includes an under-nose support indicated at 752. The first form of nasal seal 750 additionally includes thickened regions in the upper lateral portions of the contact surface indicated at 754 which add support to the upper region or cushion of the nasal seal 750. As shown, the thickened regions 754 are located proximally on either side of or adjacent to the nasal bridge region of the contact surface indicated at 751.

[0296] The first configuration nasal seal 750 further includes a pair of support ribs 756 located within the thickened region 754. The support ribs 756 extend in an orientation that is substantially radial to a central region of the nasal seal or nostrils, rather than horizontally or vertically. The support ribs 756 provide added support from the inner surface of the nasal seal within the mask cavity to an upper region of the nasal seal and help reduce upward rolling of the nasal-mask interface during use.

[0297] 174, the support rib is located above the side connection 758 of the under-nose support 752. In other words, the support rib 756 in this configuration is spaced from the under-nose support connection 758. As shown, the support rib 756 includes a portion of the contact surface but is connected to a portion of the side wall of the nose seal that terminates before the thinned edge region around the nares.

[0298] In this embodiment, the support ribs 756 on the interior of the nose seal have an angular orientation relative to a vertical centerline extending through the nose seal. In this embodiment, the angular orientation indicated at 760 may range from approximately 50° to approximately 70°, preferably approximately 60°, in other words the ribs have an angular orientation of approximately 60° relative to a vertical centerline extending through the nose seal.

[0299] Nose seal of the second form of the ninth embodiment 175-182, a second configuration of the nasal seal of the ninth embodiment will be described.

[0300] The second configuration nose seal 770 of the ninth embodiment includes a modified shape relative to the first configuration nose seal 750. In particular, the second configuration nose seal 770 is shorter vertically, for example by approximately 10 mm. The nose seal generally has a similar configuration to the previous nose seals described. With reference to FIG. 175, the overall height of the second configuration nose seal 770, indicated at 772, is approximately 47 mm, and the overall width of the nose seal, indicated at 774, is approximately 59 mm. With reference to FIG. 177, the overall depth of the second configuration nose seal 770, indicated at 776, is approximately 39 mm. In this embodiment, the ratio of the overall height to the overall width is in the range of approximately 1:1 to approximately 1:1.4, preferably approximately 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 approximately 1:1:0.6 to approximately 1:1.4:1, preferably approximately 1:1.3:0.8.

[0301] The nose seal contact surface is indicated at 771 and the outside including the seal housing aperture is indicated at 773.

[0302] Referring to FIG. 179, one can see the difference between the upper contact point of the nose seal of the first and second forms of the ninth embodiment at the bridge of the user's nose. The nose bridge contact point for the second form nose seal 770 is shown at 777, which is below the typical contact point at the bridge of the nose for the taller first form nose seal shown at 778. The reduced vertical height of the second form nose seal 770 allows it to contact the bridge of the nose at a much lower point, for example contacting a portion of the bridge of the nose in an area or region of the bridge that extends between the tip of the nose and halfway to or up to the center of the bridge. This lower contact area relative to a conventional nose seal may be more uniform across multiple users, thus increasing the percentage of the population that can use a nasal mask without issue.

[0303] 181 and 182, a first configuration nose seal 750 is shown over a shorter second configuration nose seal 770 to illustrate the difference in shapes for comparison.

[0304] Nose seal of the third form of the ninth embodiment 183-185, a third configuration nose seal 780 of the ninth embodiment will be described.

[0305] The third configuration nose seal 780 in this embodiment is similar in size and shape to the shorter second configuration nose seal 770. The primary difference is that the third configuration nose seal 780 additionally includes support ribs 782 on the inner surface of the nose seal. In particular, at each lateral end, a major lateral portion of the under-nose support 781 connects to a respective support rib 782. As shown, the support ribs 782 have a substantially vertical or near-vertical orientation. The under-nose support and its connection to the support ribs are similar in configuration to that described with reference to the fourth embodiment nose seal.

[0306] In this third configuration of nose seal 780, ribs 782 perform the dual function of strengthening the connection of the under-nose support within the nose seal and also providing structural support to the upper region of the nose seal. In this third configuration, the under-nose support is more generally rectangular in shape rather than U-shaped. In particular, the main lateral portions include a substantially flat or horizontal central region 783 and two substantially vertical lateral portions 784 extending upwardly from each end of the central region.

[0307] Tenth embodiment Various forms and configurations of the seal housing and conduit frame of the nasal mask interface are described with reference to Figures 186-205. It will be appreciated that these various forms of seal housing and conduit frame modifications may be incorporated into the various embodiments of the nasal mask assembly described to provide alternative configurations.

[0308] Conduit frame configuration of the first form of the tenth embodiment 186-189, the first form of conduit frame 800 is a hollow oval shaped body extending between a housing connection end 801 and a gas supply conduit connecting at 802. As shown, the body has a curved surface profile that matches the surface profile of the seal housing 804 around the periphery of the aperture 806 into which the conduit frame connects. In particular, the conduit frame has a surface profile that cooperates with the surface profile of the seal housing to provide a blended or continuous surface at the interface between the two components when assembled together.

[0309] The first form of conduit frame 800 provides a pair of corrugated gripping areas (only one visible) on the lateral side of the body towards the conduit connection end 802 indicated at 808. The seal housing connection end 801 is provided with protrusions indicated at 810 on its upper and lower surfaces for snap-fit ​​engagement with complementary recesses or grooves 812 provided in the surface of the bore of the seal housing 804, similar to the configuration described for the fourth embodiment.

[0310] 188, the body of the conduit frame 800 is configured to provide an approximately 30° down angle, indicated at 814, relative to the horizontal. In particular, the axis at the conduit end of 802 is angled or offset relative to the axis of the hole at the seal housing connection end 801. It will be appreciated that the angle may vary.

[0311] Conduit frame configuration of the second form of the tenth embodiment 190-193 a second form of conduit frame 820 of the tenth embodiment is described. In this embodiment the conduit connection end 821 of the conduit frame 820 is again provided with a corrugated gripping area or portion 822. The seal housing connection end, indicated at 823, is larger and includes a winged portion which overlaps with part of the outer surface of the seal housing 824 adjacent the seal housing inlet conduit projection 825.

[0312] As shown in FIG. 191 , the conduit frame includes a complementary conduit portion having one or more protrusions or grooves 826 that complement a snap-fit ​​or interference engagement with a complementary protrusion or groove 827 provided on a conduit protrusion 825 of the seal housing 824 .

[0313] As shown in Fig. 192, the winged side portions of the conduit frame at the seal housing connection end 823 may include holes 828. These holes may provide a surface for a diffuser mat to provide a bias air vent when aligned complementary holes are provided in the seal housing.

[0314] Conduit frame configuration of the third form of the tenth embodiment With reference to Figures 194 to 197, a third embodiment of the conduit frame 830 will now be described. The third embodiment of the conduit frame 830 is substantially similar to the second embodiment of the conduit frame 820. The main difference is that the seal housing 835 is provided with a larger air inlet opening 833 which generally receives the winged region 832 of the conduit frame to provide a blended surface. In other words, there is no overlap of the outer surface of the seal housing with the winged region of the conduit frame as in the second embodiment of the configuration.

[0315] As shown in Figures 194-197, the lateral edges of the winged region of the conduit frame may be provided with protrusions or grooves 832 configured to snap-fit ​​or otherwise engage with complementary grooves or protrusions 833 provided in the aperture-free peripheral surface of the seal housing 835.

[0316] The fourth embodiment of the tenth embodiment of the conduit frame configuration 198-201, a fourth form of conduit frame 840 will be described. The fourth form of conduit frame 840 is provided with a conduit at a seal housing connection end indicated at 843 which is received within a complementary conduit 844 in a seal housing 842. The conduit portion 843 of the conduit frame includes either a protrusion or groove 845 on an upper and / or lower surface or other surface which engages a complementary aligned protrusion or groove 846 through the inner surface of the conduit bore 844 in the seal housing 842.

[0317] 201, surrounding the lateral portions of the conduit section 843 are winged regions 847 that extend from the lateral sides of the conduit frame on either side of the conduit section 843. These winged regions or portions 847 are received within complementary recessed regions 848 provided on the lateral sides of the inlet of the seal housing 842. Generally the exterior surface profile of the winged region 846 and body of the conduit frame at the seal housing connection end is configured to merge or blend with the surface profile of the seal housing in the area surrounding the inlet, such that there is a seamless or blended surface at the interface of the two components when assembled together, as shown in FIG.

[0318] Opposite the seal housing connection end of the conduit frame are provided with gripping tabs or protrusions 849 that extend laterally from the side of the conduit frame at the gas supply conduit connection end of the conduit frame 850. These gripping tabs 849 allow a user to pull the conduit frame from the seal housing if necessary. They may also assist in inserting the conduit frame into the seal housing during assembly.

[0319] Conduit frame configuration of the fifth form of the tenth embodiment 202 to 205, a conduit frame 850 of a fifth form of the tenth embodiment will be described.

[0320] The fifth embodiment conduit frame 850 is similar to the fourth embodiment conduit frame 840. The primary difference is that the gripping tabs are replaced with a series or row of gripping protrusions, indicated at 852, at the gas supply conduit connection end of the conduit frame 850. The winged region 853 and conduit portion 855 at the seal housing connection end are symmetrical about a horizontal plane extending through axis 856 as indicated in FIG.

[0321] The fifth configuration conduit frame 850 has an angular offset between the seal 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 downhill angle of approximately 40° relative to the axis extending from the seal housing connection end 858, although this angle may be varied as will be appreciated.

[0322] With a symmetric seal housing arrangement, the conduit frame 850 can be connected into the seal housing 862 in either of two orientations that are rotated 180 degrees relative to one another. Additionally, an angled offset at the conduit connection end 859 allows the conduit frame to be assembled into the seal housing 862 in a first orientation with the conduit connection end 859 angled downward to allow the conduit to face or extend toward the user's legs, or alternatively can be installed in a second orientation with the conduit connection end 859 angled upward so that the conduit may extend upward in the direction of the user's forehead.

[0323] Further Alternative Embodiments The following describes various alternative embodiments or configurations of the interface, it being understood that any one or more of these embodiments or configurations may be applied to the general embodiment described above, either alone or in combination.

[0324] Full-face embodiment The above-mentioned embodiments described above with reference to Figs. 2A-205 relate to a nasal seal interface configured to seal around a user's nose. However, it will be appreciated that such embodiments may also be adapted to a full face or oral-nasal mask configured to seal around both the nose and mouth of a user such that therapeutic gas may be delivered to the user's airway via the nose and mouth. By way of example only, Fig. 206 illustrates an eleventh embodiment in the form of a full face interface 102E. The full face seal 102E is similar to that described in the third embodiment 102D of Figs. 30-34 and includes a single band under-nose support 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. is shaped to externally contact around both the nose and mouth. An upper region 125 at or toward the nasal bridge region is substantially similar to that described above, but the side cheek regions 123 extend further down and are connected by a lower region 121E that is configured to seal below the user's mouth, e.g., proximal to the chin. This larger contact surface allows both the user's nose and mouth to be enclosed within the seal 102E.

[0325] Under-the-nose supports formed of different materials for sealing In the embodiments described with reference to Figures 2A-205, the under-nose support is typically integrally formed and is an integral part of the nose seal. For example, the nose seal and its under-nose support are integrally molded as a single unit from silicone or other suitable material. Alternatively, the nose seal and under-nose support are first molded as separate pieces and then permanently bonded or connected together, such as by adhesive or welding, to form a single nose seal component.

[0326] In alternative embodiments, the under-nose support may be formed of a different material than the nose seal. For example, the nose seal may be formed of silicone, while the under-nose support may be formed of a different material, such as, but not limited to, a woven material, a foam material, neoprene, Breath-o-Prene® material, thermoplastic polyurethane (TPU). The under-nose support may then be permanently bonded or connected, such as by adhesive or welding, within the nose seal to form a unitary nose seal component.

[0327] Nose supports and other connection structures that are not fixedly connected 2A-205, the under-nose support is typically fixedly connected within the nasal seal, for example being integrally formed or otherwise permanently connected within the nasal seal. In alternative embodiments, the under-nose support may be removably or releasably connected within the nasal seal by a releasable connection assembly at the connection points or locations of the aforementioned nasal seal.

[0328] In further alternative configurations, the under-nose support may be fixedly or releasably connected or coupled to a non-sealing structure or component of the interface. For example, the under-nose support may be fixedly or releasably connected to a seal housing or a rigid clip component or a frame component, depending on the configuration. As mentioned above, the under-nose support may be formed of any suitable material, including, but not limited to, silicone, fabric, foam material, neoprene, Breath-o-Prene® material, or TPU.

[0329] The foregoing description of the invention includes preferred forms thereof. Modifications may be made thereto without departing from the scope of the invention as set forth in the appended claims.

Claims

1. A nose seal for a nasal mask or interface, the nose seal being formed of a flexible material and extending between a face-contacting side and an exterior side; a contact surface including an edge defining a nose seal opening, the contact surface configured to seal against a user's nose, the edge being an inner peripheral edge, the contact surface terminating at the inner peripheral edge; a nasal sling fixedly connected within the seal and positioned rearwardly of the nasal seal opening, the nasal sling including a central extension portion connected to the inner peripheral edge of the contact surface at an upper lip region; Includes nose seal.

2. The nasal seal of claim 1 , wherein the nasal sling comprises a contact surface oriented to contact at least a portion of an under-nose surface of the user.

3. 3. The nasal seal of claim 1 or 2, wherein the central extension of the nasal sling is configured to contact at least a portion of the pillars of the nasal septum of the subnasal surface of the user's nose.

4. A nose seal according to any one of claims 1 to 3, wherein the contact surface seals against the user's nose including over a portion of the bridge of the nose in a region extending between the tip of the user's nose and the centre of the bridge of the user's nose.

5. 5. The nose seal of claim 1, wherein the central extension of the nasal sling is configured to contact at least a portion of a region of the bridge of the subnasal surface of the user's nose between the tip and base of the nose.

6. 6. The nose seal of claim 5, wherein the central extension of the nasal sling is configured to contact a majority of the area of ​​the pillar of the subnasal surface of the user's nose that extends from the base of the nose.

7. 7. The nose seal of claim 1, wherein the nasal sling is configured to contact a portion or portions of the subnasal surface of the user's nose without substantially obstructing the user's nares that are aligned with open spaces of the nasal seal opening on either side of the central extension.

8. A nasal seal according to any preceding claim, wherein at any position of the nasal sling the thickness of the nasal sling is less than its corresponding width.

9. A nasal seal according to any preceding claim, wherein the thickness of the nasal sling is substantially similar to the thickness of the nasal seal in the region of the contact surface.

10. The nasal seal of any one of claims 1 to 8, wherein the central extension of the nasal sling comprises a varying thickness profile.

11. A nasal seal according to any one of claims 1 to 8, wherein the central extension of the nasal sling has a thickness that varies from a thicker region to a thinner region at or towards the edge of the contact surface of the nasal seal.

12. The nasal seal of claim 11, wherein the thinner area of ​​the central extension of the nasal seal is of uniform thickness with the edge of the contact surface of the nasal seal.

13. A nasal seal according to any preceding claim, wherein the width of the central extension of the nasal sling gradually increases towards the edge of the contact surface of the nasal seal.

14. 14. The nasal seal of any one of claims 1 to 13, wherein a width of the central extension of the nasal sling varies along its length such that the central extension has a substantially hourglass shape or profile.

15. A nasal seal according to any preceding claim, wherein the width of the central extension of the nasal sling is uniform along its length.

16. A nasal seal according to any one of claims 1 to 15, wherein at least a portion of the central extension of the nasal sling is oriented at an angle relative to a sealing axis extending tangentially between the outermost upper and lower tangent points in a central region of the contact surface of the nasal seal.

17. The nasal seal of claim 16, wherein at least a portion of the central extension of the nasal sling is oriented at an angle in the range of approximately 40° to approximately 80° relative to the sealing axis.

18. A nasal seal according to any one of claims 1 to 17, wherein the nasal seal is defined by the contact surface which contacts the face and a side wall portion which extends rearwardly from the contact surface to the outside of the nasal seal and terminates in an opening or connecting edge which joins or is connected to a complementary seal housing.

19. A nasal seal according to any preceding claim, wherein an exterior 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.

20. A nose seal according to any one of claims 1 to 19, wherein the nose seal is formed of a material having a varying thickness across the area of ​​the nose seal, the nose seal being defined by an anterior region extending from an intermediate boundary towards a face-contacting side of the nose seal and including the contact surface, and a posterior region extending from the intermediate boundary towards an exterior side of the nose seal, the posterior region being on average thicker than the anterior region.

21. 21. The nasal seal of claim 20, wherein the front region includes a thinned edge region extending around a periphery of an edge of the contact surface, the thinned edge region being thinner than a remainder of the front region.

22. 1. A nasal mask interface assembly comprising: A seal housing; A nose seal according to any one of claims 1 to 21 connected or connectable to the seal housing to define a mask cavity; headgear configured to extend over the user's ears and including single left and right straps connecting to the seal housing; 1. A nasal mask interface assembly comprising:

23. 23. The nasal mask interface assembly of claim 22, wherein the left and right side straps of the headgear connect to respective attachment points at or towards respective sides of the seal housing.

24. 24. A nasal mask interface assembly according to claim 22 or 23, wherein the seal housing comprises an arrangement of bias air holes.

25. 25. A nasal mask interface assembly according to any one of claims 22 to 24, wherein the seal housing includes an intake opening, the assembly further including a conduit frame releasably received and retained in the intake opening of the seal housing, the conduit frame being connected or connectable to an end of a gas supply conduit.

26. 26. The nasal mask interface assembly of claim 25, wherein the conduit frame is a hollow body that is oval in shape and is symmetrical such that it can be releasably received and retained in the intake opening of the seal housing in either of two orientations that are 180 degrees apart.

27. A nasal mask interface assembly according to any one of claims 22 to 26, wherein the nasal seal is formed from silicone and the seal housing is rigid and formed from plastic.

28. A nasal mask interface assembly according to any one of claims 22 to 27, wherein the nasal seal is removably connectable to the seal housing.

29. A nasal mask interface assembly according to any one of claims 22 to 27, wherein the nasal seal is permanently or semi-permanently bonded to the seal housing.

30. A nasal mask interface assembly according to any one of claims 22 to 29, wherein an outer peripheral edge of the nasal seal is secured to a complementarily shaped connecting edge of the seal housing.

31. 30. The nasal mask interface assembly of claim 29, wherein an outer peripheral edge of the nasal seal is overmolded to a complementary shaped opening edge of the seal housing.

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