Nose seal and breathing 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 generally relates to a nasal seal for a respiratory interface and a nasal mask interface or interface assembly including the nasal seal.

Background Art

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

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

[0004] In this specification, where a patent specification, other external document, or other information source is referenced, this is generally for the purpose of providing context for considering the features of the present invention. Unless otherwise specified, such references to external documents are not to be construed as admitting that such documents or such information 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 Problems

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

[0006] In one aspect, the present invention broadly relates to a nasal mask interface comprising a seal housing and a flexible nasal seal connectable or connected to the seal housing to define a mask cavity, the flexible nasal seal extending between a side contacting the face and an outer side and including an edge defining a nasal receiving opening into the mask cavity, and having a contact surface configured to seal around the user's nose, and a nasal support extending within the mask cavity and having a contact surface connected so as not to move into the nasal seal and oriented to contact at least a portion of the lower surface of the user's nose.

[0007] In certain embodiments, the seal housing is more rigid than the flexible nasal seal.

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

[0009] In one embodiment, the sub-nasal support extends laterally across the nasal seal within the mask cavity between opposite sides of the nasal seal, at least at a position spaced from or displaced from the edge of the contact surface of the nasal seal.

[0010] In one embodiment, the sub-nasal support extends laterally across the nasal seal within the mask cavity between opposite sides of the nasal seal, at least at a position displaced from the contact surface of the nasal seal.

[0011] In one embodiment, the sub-nasal support extends from within the mask cavity and includes one or more extension portions that connect to the edge of the contact surface of the nasal seal in the upper lip region of the nasal seal.

[0012] In one embodiment, the sub-nasal support includes a main lateral portion that extends laterally across the mask cavity between opposite sides of the nasal seal.

[0013] In one embodiment, the main lateral portion of the sub-nasal support is integrally connected to the seal at a position spaced from or displaced from at least the edge of the contact surface of the nasal seal.

[0014] In one embodiment, the nasal seal includes side walls that extend rearward from the contact surface of the nasal seal, and the main lateral portion of the sub-nasal support is integrally or non-movably connected to the opposite side wall portions of the nasal seal.

[0015] In one embodiment, the sub-nasal support further includes one or more extension portions that extend from the main lateral portion towards the nasal seal in the upper lip region of the nasal seal and connect to the nasal seal.

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

[0017] In certain embodiments, one or more extension portions of the sub-nasal support are connected to the edges of the contact surface in the upper lip region of the nasal seal.

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

[0019] In certain embodiments, the sub-nasal support includes left and right extension portions that extend on both sides of the nasal seal and are configured to primarily contact at least a portion of the respective left and right wing-like rims of the sub-nasal surface of the user's nose.

[0020] In certain embodiments, at any position along the sub-nasal support, the sub-nasal support is substantially thinner in a transverse direction with respect to its contact surface than the corresponding width of the contact surface at that position.

[0021] In certain embodiments, the flexible nasal seal is formed of 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 certain embodiments, the outside of the nasal seal includes a peripheral channel configured to receive a peripheral ridge of the seal housing in order to connect the nasal seal to the seal housing. complementary

[0025] In certain embodiments, the outer peripheral edge of the nasal seal complementary is overmolded with a rigid clip that is connectable to the seal housing.

[0026] ​In certain embodiments, the nose seal is permanently or semi-permanently attached to the seal housing.

[0027] In certain embodiments, the peripheral edge on the outside of the nose seal is overmolded onto the complementary aperture edge of the shape of the seal housing.

[0028] In another aspect, the present invention broadly relates to a nose seal for a nasal mask or interface, formed of a flexible material and extending between a side that contacts the face and an outside, including an edge that defines a nose receiving opening, and having a contact surface configured to seal around the user's nose, and a sub-nasal support having a contact surface connected so as not to move within the seal and configured to extend rearward of the nose receiving opening and to be oriented to contact at least a portion of the user's sub-nasal surface.

[0029] In another aspect, the present invention broadly relates to a nasal mask interface assembly, including a seal housing, and a flexible nose seal connectable or connected to the seal housing to define a mask cavity, extending between a side that contacts the face and an outside, including an edge that defines a nose receiving opening into the mask cavity, and having a contact surface configured to seal around the user's nose, and a sub-nasal support having a contact surface connected so as not to move within the nose seal and configured to extend within the mask cavity and to be oriented to contact at least a portion of the user's sub-nasal surface, and a headgear including a single left and right strap configured to extend over the user's ears and to connect to the seal housing.

[0030] In certain embodiments, the left and right straps connect at respective attachment positions on or toward respective sides of the seal housing.

[0031] In another aspect, the present invention broadly relates to a nasal mask interface assembly including a seal housing and a flexible nasal seal connectable or connected to the seal housing for defining a mask cavity, the flexible nasal seal extending between a face-contacting side and an outer side and including an edge defining a nasal receiving opening into the mask cavity and having a contact surface configured to seal around the user's nose, and a nasal support extending within the mask cavity and having a contact surface connected so as not to move into the nasal seal and oriented to contact at least a portion of the user's subnasal surface.

[0032] In certain embodiments, the seal housing is more rigid than the flexible nasal seal.

[0033] In certain embodiments, the contact surface seals around the user's nose, including across a portion at or proximal to the user's nasal bridge.

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

[0035] In certain embodiments, the nasal support extends laterally across the nasal seal within the mask cavity at least between connection positions on opposite or upper lateral regions within the nasal seal.

[0036] In certain embodiments, the connection positions on opposite or upper lateral regions within the nasal seal are spaced from or displaced from the edge of the contact surface of the nasal seal.

[0037] In certain embodiments, the connection positions on opposite or upper lateral regions within the nasal seal are displaced from the contact surface of the nasal seal.

[0038] In one embodiment, the sub-nasal support extends from within the mask cavity and includes one or more extension or connection portions that extend and connect to the edge of the contact surface of the nasal seal in the upper lip region of the nasal seal.

[0039] In one embodiment, the sub-nasal support includes at least a main lateral portion having two end portions that extend laterally across at least a portion of the mask cavity between connection positions on opposite or upper lateral regions within the nasal seal.

[0040] In one embodiment, the sub-nasal support further includes one or more extension or connection portions that extend from the main lateral portion towards the nasal seal and connect to the nasal seal in the upper lip region of the nasal seal.

[0041] In one embodiment, the sub-nasal support further includes a central connection portion that extends between the main lateral portion and a portion of the edge of the contact surface in the upper lip region of the nasal seal.

[0042] In one embodiment, the central connection portion of the sub-nasal support has a contact surface that is mainly configured to contact at least a portion of the column of the nasal septum on the sub-nasal surface of the user's nose.

[0043] In one embodiment, the central connection portion of the sub-nasal support varies in thickness over its length from a thicker region at the end connecting to the main lateral portion and a thinner region at the end connecting to or towards the edge of the contact surface.

[0044] In one embodiment, the central connection portion of the sub-nasal support includes a central region that has a reduced width compared to the width at its ends.

[0045] In one embodiment, the width of the central connection portion gradually changes along its length such that the central connection portion is substantially hourglass-shaped or profiled.

[0046] In one embodiment, the main lateral portions of the sub-nasal support are integrally connected within the nasal seal at their ends at a connection position that is at least separated from or displaced from the edge of the contact surface of the nasal seal.

[0047] In one embodiment, the nasal seal includes side walls that extend rearward from the contact surface of the nasal seal to the outside of the nasal seal, and the main lateral portions of the sub-nasal support are integrally or non-movably connected at their ends to at least the opposing side wall portions within the nasal seal.

[0048] In one embodiment, the main lateral portions of the sub-nasal support are integrally or non-movably directly connected to the inner surface of the nasal seal at each end.

[0049] In one embodiment, the main lateral portions of the sub-nasal support are integrally or non-movably indirectly connected to the inner surface of the nasal seal at each end via respective ribs that extend from the inner surface of the nasal seal.

[0050] In one embodiment, each rib includes a panel of flexible material having a first connection edge portion that is connected to a part of the inner surface of the nasal seal and a second connection edge portion that is connected at another part of its peripheral edge to each end of the main lateral portion of the sub-nasal support.

[0051] In one embodiment, the first connection edge portion of each rib is connected to a part of the inner surface of the nasal seal that extends between a thinner front region of the nasal seal that includes the contact surface and faces the side that contacts the face, and a thicker rear region of the nasal seal that faces the outside of the nasal seal.

[0052] In one embodiment, the first connection edge portion of each rib terminates at or towards a thinner edge region of the front region of the nasal seal that is located around the periphery of the edge of the contact surface, and the edge region is thinner than the remaining part of the front region.

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

[0054] In some embodiments, the buckling axis of the zone of each rib is formed by the concave region or zone of the rib.

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

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

[0057] In some embodiments, the nose seal is formed of a material having varying thicknesses across the region of the nose seal, the nose seal extends from an intermediate boundary towards the face-contacting side of the nose seal and is defined by a front region that includes the contact surface and extends from the intermediate boundary towards the face, and a rear region that extends from the intermediate boundary towards the outside of the nose seal, and the rear region is on average thicker than the front region.

[0058] In some embodiments, the front region includes a tapered edge region that extends around the periphery of the edge of the contact surface, and the tapered edge region is thinner than the remainder of the front region.

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

[0060] In some embodiments, the contact surface of the central portion of the sub-nasal support is oriented at an angle in the range of approximately 40° to approximately 80° with respect to the sealing axis.

[0061] In some embodiments, the contact surface of the central portion of the sub-nasal support is oriented at an angle in the range of approximately 55° to approximately 65° with respect to the sealing axis.

[0062] In one embodiment, the ratio of the total height to the total depth of the seal housing and the nose seal when assembled together is in the range of approximately 1:0.8 to approximately 1:1.2.

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

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

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

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

[0067] In one embodiment, the seal housing includes a yoke channel that extends laterally across the outer surface of the seal housing and is configured to releasably receive and hold the yoke.

[0068] In one embodiment, the yoke is bent along its length between its ends and has a concave inner engagement surface and a convex outer surface with the yoke channel.

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

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

[0071] In one embodiment, the lateral portion of the yoke is thicker in height and / or width than the central portion of the yoke.

[0072] In one embodiment, the headgear is an auto-adjusting headgear, and the yoke includes one or more directional locks that interact with a core element extending from a side strap of the auto-adjusting headgear.

[0073] In one embodiment, the conduit frame is releasably received and held in the intake opening of the seal housing, and the conduit frame is connected or connectable to the end of a gas supply conduit.

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

[0075] In one embodiment, at any position along the sub-nasal support, the sub-nasal support is substantially thinner in the transverse direction with respect to its contact surface than the corresponding width of the contact surface at that position.

[0076] In one embodiment, the flexible nose seal is formed of silicone.

[0077] In one embodiment, the seal housing is rigid and formed of plastic.

[0078] In one embodiment, the nose seal is removably connectable to the seal housing.

[0079] In one embodiment, the outside of the nose seal is configured to receive a peripheral ridge of the seal housing in order to connect the nose seal to the seal housing. complementary It includes a peripheral channel configured to receive the peripheral ridge of the seal housing.

[0080] In one embodiment, the outer peripheral edge of the nose seal is overmolded onto a rigid clip, and the rigid clip is connectable to the seal housing. complementary The outer peripheral edge of the nose seal is overmolded onto a rigid clip, and the rigid clip is connectable to the seal housing.

[0081] In one embodiment, the nose seal is permanently or semi - permanently coupled to the seal housing.

[0082] In one embodiment, the outer peripheral edge of the nose seal is fixed to a connecting edge of the shape of the seal housing. complementary It is fixed to a connecting edge of the shape of the seal housing.

[0083] In one embodiment, the outer peripheral edge of the nose seal is overmolded onto an opening edge of the shape of the seal housing. complementary It is overmolded onto an opening edge of the shape of the seal housing.

[0084] In another aspect, the present invention broadly relates to a nose seal for a nasal mask or interface, which is formed of a flexible material and includes an edge that extends between a side that contacts the face and the outside and defines a nose receiving opening, and a contact surface configured to seal around the user's nose, and a nasal support that is connected so as not to move within the seal, is located behind the nose receiving opening, and has a contact surface oriented to contact at least a part of the lower surface of the user's nose.

[0085] In another aspect, the present invention broadly relates to a nasal mask interface assembly, comprising a seal housing and a flexible nasal seal connectable or connected to the seal housing to define a mask cavity, the flexible nasal seal extending between a face-contacting side and an outer side and including an edge defining a nasal receiving opening into the mask cavity and having a contact surface configured to seal around the user's nose, and a nasal support disposed within the nasal seal and having a contact surface configured to extend within the mask cavity and be oriented to contact at least a portion of the user's subnasal surface. The present invention also relates to a headgear including a single left and right strap configured to extend over the user's ears and connect to the seal housing.

[0086] In certain embodiments, the left and right straps connect at respective attachment positions on or toward respective sides of the seal housing.

[0087] In another aspect, the present invention broadly relates to a nasal seal for a nasal mask or interface, formed of a flexible material and extending between a face-contacting side and an outer side, including an edge defining a nasal receiving opening and having a contact surface configured to seal around the user's nose, and a nasal support connected within the nasal seal so as not to move and configured to extend within the nasal seal.

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

[0089] In certain embodiments, the nasal support includes one or more extensions or connection portions extending from within the mask cavity and connecting to an edge of the contact surface of the nasal seal in the upper lip region of the nasal seal.

[0090] In one embodiment, the contact surface of at least the central portion of the sub-nasal support is oriented at an angle with respect to a sealing axis that extends tangentially between the outermost upper and lower contact 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 sub-nasal support is oriented at an angle in the range of approximately 40° to approximately 80° with respect to the sealing axis.

[0092] In one embodiment, the nasal seal includes a contact surface on the side that contacts the face, and a side wall portion that extends rearward from the contact surface to the outside of the nasal seal and complementary for connection to the seal housing or complementary is defined by a side wall portion that terminates at an opening or connection edge connected to the seal housing.

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

[0094] In one embodiment, each arrangement of the bypass ventilation holes is a linear arrangement of spaced-apart holes or apertures extending into the housing.

[0095] In another aspect, the present invention broadly relates to a nasal mask interface assembly, comprising a seal housing including an intake opening, and a flexible nasal seal connectable or connected to the seal housing for defining a mask cavity, the flexible nasal seal extending between a side contacting the face and an outer side, including an edge defining a nasal receiving opening into the mask cavity, and including a contact surface configured to seal around the user's nose. The nasal mask interface assembly further includes a conduit frame releasably received and held in the intake opening of the seal housing, the conduit frame being connectable or connected to an end of a gas supply conduit and being symmetric such that it can be releasably received and held in the intake opening of the seal housing in either of two orientations 180 degrees apart.

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

[0097] In another aspect, the present invention broadly relates to a nasal seal for a nasal mask or interface, formed of a flexible material, extending between a side contacting the face and an outer side, including an edge defining a nasal receiving opening, and including a contact surface configured to seal around the user's nose. The ratio of the overall height to the overall width of the nasal seal is in the range of approximately 1:1 to approximately 1:1.4.

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

[0099] In one embodiment, the ratio of the overall height to the overall width to the overall depth of the nasal seal is in the range of approximately 1:1:0.6 to approximately 1:1.4:1.

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

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

[0102] As used in this specification and the claims, the term "comprising" means "at least partially consisting of". When interpreting each statement in this specification and the claims that includes the term "comprising", there may be features other than the one or more features to which that term is attached. Related terms, such as "comprise" and "comprises", shall be interpreted similarly.

[0103] Range of numbers References in this specification to a range of numbers (e.g., 1 - 10) are intended to include references to all rational numbers within that range (e.g., 1, 1.1, 2, 3, 3.9, 4, 5, 6, 6.5, 7, 8, 9, and 10), as well as to any range of rational numbers within that range (e.g., 2 - 8, 1.5 - 5.5, and 3.1 - 4.7), such that all sub - ranges of the entire range explicitly disclosed in the present invention are hereby explicitly disclosed. These are merely examples of what is specifically intended, and all possible combinations of the recited numerical values between the minimum and maximum values are considered to be equally explicitly stated in this application.

[0104] As used in this specification, the term "and / or" means "and" or "or" or both.

[0105] As used in this specification, "(s)" following a noun means the plural and / or singular of that noun.

[0106] The present invention includes the above and also contemplates structures for which only examples are given below.

[0107] Preferred embodiments of the present invention are described by way of example only and with reference to the following drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0108]

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Mode for Carrying Out the Invention

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

[0110] The humidifying chamber 14 has a thermally conductive base that contacts the heater plate 16 of the humidifier 17 to humidify the air stream. A conduit 12 is connected to the exhaust port 13 of the humidifying chamber 14 to carry the humidified air to the user interface 11. The humidifier 17 includes a controller 18, for example, but not limited to, a controller that uses a microprocessor that executes computer software instructions stored in a related memory. The controller 18 receives input instructions from a plurality of sources including a user input interface 19, such as a dial or touch screen, which enables setting of a predetermined value of humidity, temperature, or other characteristics of the humidified air supplied to the user U. The controller 18 can 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 to communicate with the controller 18, and / or a heater plate temperature sensor 23, etc. Depending on the user-set humidity or temperature value, 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 humidifying chamber 14.

[0111] When the volume of water in the chamber is heated, water vapor begins to fill the volume of the chamber above the surface of the water. The water vapor exits through the exhaust port 13 of the humidifying chamber along with an air stream provided by a supply device 25, such as a blower 27, that enters the humidifying chamber 14 through the intake port 26. The blower 27 can be a variable speed fan or can include a variable pressure regulator. The blower 27 draws in air through the intake port 28. The blower can be controlled, for example, by a controller 29 or the controller 18. The controller can control the blower speed, regulated pressure, etc. according to any suitable criteria. For example, the controller can respond to input from the controller 18 and user-set values (e.g., preset values) of pressure and / or fan speed that can be set at a user interface 30 (e.g., a dial).

[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, whether or not humidified, or alternatively, in other forms of respiratory systems such as, for example, VPAP (Variable Positive Airway Pressure) systems, BiPAP (Bilevel Positive Airway Pressure) systems, or with ventilators, high flow therapy systems, and in such CPAP systems as described herein, which are generally described herein by reference to CPAP therapy only as an example.

[0114] Nasal mask interface with supra-aural headgear Referring to FIGS. 2A and 2B, a user U wearing a nasal mask interface 50 according to an embodiment is shown. 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, for example, from a central connection at the front or underside of the mask that is integral with or connected to the supply conduit 12 of a CPAP or other respiratory system. The conduit 55 may be connected directly to the mask or indirectly via a connector or conduit frame, such as, 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 conforms to the body position of the patient during sleep relative to the position of the mask on the patient's face.

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

[0116] In this embodiment, the nasal mask is fixed to the user U by a headgear 52 that extends above the user's ears. As an example, the headgear 52 is a side strap 54 that connects at an attachment point 56 (visible on only one side) to the opposite side of the nasal mask interface 50 and extends above the user's ear 58 along the side or cheek of the user's face and connects 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 strap 54 is integrally formed with the top 60 and the back strap 62 or otherwise connected to the top 60 and the back strap 62 as will be appreciated by those skilled in the art. In one embodiment, the headgear strap is formed of or includes a flexible breathable material, such as Breath-o-Prene® breathable neoprene material or neoprene material. In some embodiments, the headgear can be an automatically adjustable headgear, as will be described later, for example.

[0117] The illustrated supra-aural headgear 52 with the side straps 54 attached to respective side attachment points or positions at the nasal mask interface 50 is generally a desirable configuration from a comfort perspective compared to a headgear configuration with a pair of upper and lower straps that connect to a nasal mask interface having a T-piece frame. The supra-aural single-side strap headgear configuration 52 shown in FIG. 2A does not require a T-piece frame that extends up to the user's forehead at most, nor does it require the two pairs of upper and lower straps, where, as previously explained, one pair extends from the top of the T-piece frame of the user's forehead above the user's ear and the other pair extends from the nasal mask interface below the user's ear.

[0118] Referring to FIGS. 2A and 2B, the supra-aural unilateral strap headgear configuration 52 is preferred from the perspective of comfort compared to a headgear fixed to a T-piece frame. However, during use, when a force acts on the nasal mask interface when the mask is delivering gas to the user's nose at positive pressure during flow therapy, the nasal mask has a tendency to slip upwards, slide, or slip over the user's face. This has been found to affect the robustness of the seal around the user's nose and can cause leakage or leakage paths. The upward slippage of the nasal seal can be disturbing and uncomfortable for the user. The nasal mask interface is subjected to a substantially diagonal force represented by vector A along the general direction of the side strap between the user's nose and above the ear from each side strap, and a counteracting substantially horizontal jet force B that, during use, substantially horizontally pushes the nasal interface away from the user's nose and face when a positive pressure gas flow is delivered to the wearer. It has been found that the resultant force R acting on the nasal mask interface is the combined force R of the headgear force A and the jet force B represented by vector R.

[0119] As described with reference to the following embodiments, the nasal mask interface of the present disclosure has an internal nasal sub-support configured to contact or engage under the user's nose to generate an opposing downward force D that at least partially counteracts, resists, or otherwise alleviates the combined force R caused by the headgear force A and the jet force B, thereby stabilizing the nasal mask at a position above the user's nose during use and preventing the nasal mask from sliding or otherwise rising up the user's face from its initially fixed position before gas delivery is initiated.

[0120] Referring to FIG. 3, the sub-nasal support of the nasal mask assembly is configured to contact at least one or a plurality of portions of the sub-nasal surface of the user's nose 70 when the mask is worn. The biological structure of the sub-nasal surface of the user's nose extends between the nostrils 74 and is generally defined by the central column region 72 of the septum that divides the nostrils 74 from the base 76 to the tip 78 of the nose and the left and right wing-shaped rim regions 80. The column 72 and the wing-shaped region 80 generally define the contactable skin surface on the lower side of the user's nose around the nostrils or the nostril openings 74.

[0121] As will be described in further detail with reference to the following exemplary embodiments, the sub-nasal support of the nasal mask interface is configured to extend within the mask cavity that receives the user's nose during use and has a contact surface that contacts at least a portion of the sub-nasal surface of the user's nose but does not block or completely block the user's nostrils. Depending on the size of the user's nose, the sub-nasal support, in the best case, contacts one or more portions of the sub-nasal surface without any obstruction of the user's nostrils, or in the worst case, only partially blocks one or both nostrils.

[0122] Various embodiments of the nasal seal of the nasal mask interface and the interface with the sub-nasal support are described below. Such nasal seals can be used or can be used with a variety of different nasal interface assemblies and headgear configurations, but a headgear configuration that, during use, causes the nasal mask to slide or ride up on the user's face, such as the over-ear headgear described and illustrated with reference to FIG. 2A, is understood to be particularly suitable for a headgear configuration that produces an upward lifting force, which is a resultant force.

[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 a seal housing, a conduit frame, a headgear frame or yoke, and / or a headgear. It will be understood that the various embodiments of the nasal seal described can be used interchangeably with each other in various suitable interface assemblies and that the examples and alternatives of the interface assembly described in connection with one embodiment also apply to other embodiments of the nasal seal described. Generally, it will be understood that the various components of the various embodiments can be replaced with each other and / or combined to form alternative configurations.

[0124] First Embodiment - Nasal Seal with a Sub-Nasal Support Having a Central Extension or Connecting Portion Overview Referring to FIGS. 4 - 22, a first form of a first embodiment of a nasal seal and a nasal seal interface assembly including the nasal seal are described in further detail. An alternative second form of the nasal seal of the first embodiment is also described with reference to FIG. 23.

[0125] Referring to FIGS. 4 - 10, the nasal mask interface assembly 100 of the first embodiment, as will be appreciated by those skilled in the art, includes a flexible nasal seal 102 connected to or connectable to a rigid (or at least more rigid than the nasal seal) seal housing 104 to define a mask cavity generally designated 106 that receives the user's nose and the supply of gas for delivery through its nares or nostrils to the user's airway. The rigid seal housing or shell 104 may be directly connectable to a headgear strap 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 on or provided on the seal housing. In this embodiment, the seal housing 104 is provided with an intake opening or aperture 110 configured to connect to a flexible gas delivery conduit 55 of the aforementioned type for delivering a heated and humidified gas flow from a respiratory device, such as a CPAP device. The seal housing 104 in this embodiment is also provided with a collection of one or more holes or apertures in the form of exhaust or bias vents 112.

[0126] The flexible nose seal 102 includes a face contacting surface 120 that defines a nose receiving opening 106 within the mask cavity for receiving the user's nose at the face contacting surface 120 when in use. When in use, the nose mask interface 100 is secured to the user's face using a headgear such that the contacting surface 120 of the nose seal 102 encloses or surrounds the user's nose and makes a sealed engagement around the user's nose, for example, with the surface of the cheek and / or the lateral sides of the user's nose, the upper lip region below the user's nose, as well as across the bridge region of the user's nose. In this embodiment, the nose seal 102 also includes a sub-nasal support 124 that extends internally within the mask cavity 106 at a location substantially posterior or substantially posterior to the face contacting surface 120 of the face contacting surface 120. The sub-nasal support 124 includes a contacting surface configured or oriented to contact at least a portion of the sub-nasal surface of the user's nose when used to at least partially counteract the upward lift force R, which is the resultant force generated by the jet output B and the headgear force A as described above.

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

[0128] Seal Housing and Frame Referring to FIGS. 11 and 12, the seal housing or shell 104 is an opening generally designated 140 that connects or couples to the nose seal 102 on the wearer side of the nasal mask interface 100 and is defined by an opening that extends to the outside or exterior of the nasal interface that includes an inlet 110 and an 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 designated 142 for receiving the gas flow from the inlet 110. The seal housing cavity 142 forms part of the entire mask cavity 106 when the seal housing 104 is assembled to the nose seal 102. In this embodiment, the seal housing 104 tapers slightly inwardly in shape as it extends rearwardly from the opening 140 to the outside.

[0129] In this embodiment, the exhaust vent 112 extends through the seal housing and includes a collection of small holes or apertures or a plurality of small holes or apertures that collectively define the vent 112 in an upper region from an intermediate central portion of the seal housing 104. In other embodiments, the vent or exhaust hole 112 can be omitted from the seal housing and can be provided in another location in the breathing circuit, such as in a connecting conduit or swivel elbow that couples a gas conduit to the inlet 110 of the nasal mask interface at another location along the breathing circuit.

[0130] In this embodiment, the inlet hole or port 110 is provided in and centered in the lower or bottom region of the seal housing 104, although this location is not essential. It will be appreciated that the flexible gas conduit can be coupled directly to the inlet 110 via a connecting conduit or alternatively indirectly via a straight connector or conduit frame, a connecting elbow, such as a swivel elbow, a ball joint connection, etc.

[0131] In this embodiment, the nose seal 102 is removably or releasably coupled or connectable to the seal housing 104 such that the nose seal can be removed for cleaning or replacement as needed. In this embodiment, the opening 140 of the seal housing 104 is configured to engage or receive a peripheral channel provided outside the nose seal 102, as will be described later, such that a peripheral ridge or extension is provided to releasably couple the components together. The nose mask interface, when assembled and secured to the user's nose, substantially seals and defines a substantially enclosed mask cavity 106. complementary By being configured to engage or receive the peripheral channel, a peripheral ridge or extension is provided to releasably couple the components together. The nose mask interface, when assembled and secured to the user's nose, substantially seals and defines a substantially enclosed mask cavity 106.

[0132] In an alternative embodiment, the nose seal 102 may be permanently or semi - permanently connected or coupled to the seal housing 104. As an example, it will be understood that the outer side of the nose seal 102 at the end side that contacts the face may, in an alternative embodiment, be overmolded onto or otherwise fixed or adhered to the opening 140 of the seal housing 104.

[0133] Whether the nose seal 102 is removable or permanently coupled to the seal housing 104, it will be understood that the edge or opening 140 of the seal housing is shaped or dimensioned to compliment or match the corresponding outer edge or connection portion outside the nose seal 102 around the periphery of the nose seal interface.

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

[0135] Referring particularly to FIG. 11, in this embodiment, the nose mask interface includes a headgear frame component 108 in the form of a yoke that extends laterally around the outer side of the seal housing 104 from one side of the seal housing to the other between the vent 112 and the intake port 110. In this embodiment, the frame component 108 is removably received within a channel formed within the surface of the seal housing 104 on the outer side, although the frame can alternatively be permanently fixed 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 each side strap of the headgear system, such as the over-ear headgear system, described with reference to FIG. 2A. In an alternative embodiment, the frame 108 can be omitted, and the seal housing can provide headgear attachment points at each side of the seal housing that are integrally formed with the seal housing or otherwise provided at the sides of the seal housing for connection to a headgear system, such as a single-side strap headgear system. complementary It will be understood that in an alternative embodiment, the frame 108 can be omitted, and the seal housing can provide headgear attachment points at each side of the seal housing that are integrally formed with the seal housing or otherwise provided at the sides of the seal housing for connection to a headgear system, such as a single-side strap headgear system.

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

[0137] Referring to the side of the nose seal 102 that contacts the face or the user side as shown in FIG. 13, the contact surface, generally indicated at (120), is configured to seal around the user's nose including across the user's nasal bridge. 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 indicated at 121 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 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 corresponding to or proximal to the nasal bridge region at the top of the seal 102. The cheek regions 123 of the contact surface 120 are configured to contact the cheek surface near the midline of the user on both sides of the nose and / or the user's lateral nasal surface. 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 conform to and seal against the contour of the user's face around the nose and to be fixed to the user's head via the headgear and to form a sealing engagement around the user's nose when the nasal mask interface receives a gas flow. The nose seal 102 can be considered of the self - inflating type since under pressure, the seal deforms to bias the surface 120 that contacts the face against the user's face and to substantially seal against the user's facial contour including one or more of the upper lip, cheek near the midline, lateral nose, and nasal bridge.

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

[0139] Referring to FIGS. 21 and 22, the nose seal 102 is substantially defined by a face portion 120 that contacts the face and a sidewall portion 126 that extends rearwardly from the contact surface 120 around the periphery of the seal and terminates at a connection edge generally designated 127 on the exterior or outside of the seal that is configured to couple or connect to an opening 140 of the seal housing 104. As noted above, in this embodiment, the nose seal 102 is releasably connectable to the seal housing, and the terminating edge of the sidewall 126 is a peripheral channel 128 that is configured to engage a peripheral ridge or extension provided at the opening 140 of the seal housing 104. As previously discussed, in alternative embodiments, the flexible nose seal 102 may be permanently or semi - permanently connected or coupled to the seal housing 104 via, for example, 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 connection edge 127 on the exterior or outside of the nose seal. In such embodiments, the connection edge 127 of the seal may be overmolded onto the rigid clip component to provide a rigid edge or portion on the outside of the seal, or otherwise permanently connected. The rigid clip component may be configured to engage or otherwise connect to a complementary base or housing component, thereby coupling the nose seal to the base or housing. complementary

[0140] As shown in FIG. 22, the face - contacting surface 120 of the nose seal forms a flange that curls or extends inward from the side - wall 126 portion of the nose seal. In this embodiment, the region at or towards the terminal edge 127 of the side - wall 126 may be a region that is thicker compared to the rest of the side - wall and contact - surface portion of the nose seal in order to accommodate the connection channel 128 or to provide some stability outside the overall shape of the nose seal in other ways.

[0141] As discussed, the nose seal 102 is formed of a flexible and soft material such that the nose seal 102 is more flexible than the rigid housing 104. As an example, the seal 102 may be formed of a silicone material or the like.

[0142] The sub - nasal support of the nose seal In this embodiment, the nose seal 102 is a sub - nasal support 124 (or nose sling) that at least extends across the nose seal between the opposing left and right sides of the nose seal or is laterally suspended when the nose seal 102 is assembled to the seal housing 104 and within the mask cavity 106. The sub - nasal support 124 is configured to contact at least a portion of the sub - nasal surface of the user's nose to counteract the lift force as any resultant force that occurs when the nasal mask is worn and during use, as previously discussed.

[0143] In this embodiment, the sub - nasal support extends laterally across the nose seal at least between the opposing left and right sides of the nose seal. As shown, the sub - nasal support is disposed or positioned behind or rearward of the nose - seal opening 106. The sub - nasal support 124 is connected so as not to move relative to the nose seal in that it is not removable. In one form, the sub - nasal support 124 is integrally molded within the nose seal. In an alternative form, it will be understood that the sub - nasal support part or portion of the nose seal 102 may be formed separately and then fixedly joined within the nose seal, for example, via an adhesive or welding, or it may be connected to the seal housing.

[0144] In this embodiment, the subnasal support configuration 124 includes, for example, an elongate main lateral portion or band 129 that is suspended between opposing sides of the seal and extends across or within the nasal seal. Referring to FIGS. 14, 17, and 22, the main lateral portion 129 of the subnasal support is not only connected to or extends from the nasal seal at a position spaced from or displaced from at least the peripheral opening edge 122 of the contact surface 120, but in this embodiment, the lateral portion 129 is also separated or displaced as a whole from the contact surface 120 so as not to interfere with or reduce the sealing engagement or deformability of the contact surface 120 with the user's face in the cheek and / or lateral nasal region 123. In this embodiment, the main lateral portion 129 extends from or is connected at a position 131 on the inner surface of the opposing side wall 126 portion of the nasal seal behind the contact surface 120. In this embodiment, the connection position 131 corresponds to or includes the terminal edge 127 of the side wall 126, but this is not essential.

[0145] In this embodiment, the subnasal support 124 is a central extension portion 132 that extends centrally from the main lateral portion 129 and is joined or connected to the opening edge 122 of the contact surface 120 in the upper lip region 121 or at the opening edge 122 of the contact surface 120 in the upper lip region 121. In an alternative embodiment, as will be described later with reference to FIG. 23, the central extension portion 132 can alternatively be connected to the lower portion of the upper lip region 121 of the contact surface 120 below the opening edge 122 of the seal, or alternatively, for example, at a position that is at least partially or wholly displaced or separated from the contact surface 120, such as being connected to the lower portion of the side wall 126 of the nasal seal behind the contact surface 120.

[0146] The sub-nasal support 124 includes a main lateral portion 129, and a central extension portion 132 is a contact surface that is configured and / or oriented to contact at least a portion of the user's nose on the sub-nasal surface during use. In this configuration, the main contact surface of the main lateral portion 129 is configured to engage at least a portion of the tip of the sub-nasal surface of the user's nose, which may include, for example, the tip of the column 72 and a portion of the winged rim 80 that extends towards the tip of the nose (as shown in FIG. 3). The central extension portion 132 is configured to contact the column 72 region of the sub-nasal surface of the user's nose, or at least a portion of the column between the tip of the nose and the base, although preferably most of the column extends from the base. The final contact surface area of the sub-nasal support depends on the shape and size of the user's nose. The configuration of the sub-nasal support is designed to contact one or more of the largest portions of the sub-nasal surface without substantially blocking the user's nostrils 74, which tend to align with the open spaces 134 on both sides of the central extension portion 132 as shown in FIG. 13. Depending on the size and shape of the user's nose, the sub-nasal support 124 is generally configured to, at best, completely avoid interfering with the user's nostrils, but at worst, only partially block one or both nostrils.

[0147] As shown, the contact surface of the sub-nasal support 124 is generally oriented and configured relative to the nose seal to engage the sub-nasal surface of the user's nose. In this embodiment, a portion of the sub-nasal support 124 is a thin web or strip integral with the nose seal that engages the sub-nasal surface of the user's nose. For example, the thickness of the sub-nasal support orthogonal to its contact surface is significantly smaller than the corresponding width of the contact surface at any position of the sub-nasal support. In one configuration, the thickness of the sub-nasal support portion can be substantially the same as 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 main lateral portion 129 of the sub-nasal support 124 may vary along its length between the opposing sides of the nasal seal. In this example, the width W1 of the main lateral portion 129 may gradually increase from the center of the nasal seal towards each side. In this embodiment, the width W2 of the central extension portion 132 of the sub-nasal support 124 gradually increases as it extends from the main lateral portion 129 to the contact surface 120. In an alternative embodiment, it will be understood that the width of either or both of the main lateral portion or the central extension portion may be uniform along their lengths, or may have an alternative width profile along their lengths.

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

[0150] As described above, the sub-nasal support 124 in this embodiment is connected so as not to move or is otherwise an integral component of the nose seal 102. The accompanying drawings show the nose seal and its sub-nasal support 124 in a stationary state, i.e., when not in use. Like the contact surface 120 of the nose seal, the sub-nasal support 124 is also configured to be soft and flexible or bendable so that its shape and position can follow the sub-nasal surface of the user's nose with a slinging effect when the nose mask interface is fixed to the user's face or worn in some other way during use. Typically, the sub-nasal support is non-stretchable in any direction, although in alternative embodiments it may have some degree of stretchability.

[0151] Alternative second form - Central extension portion completely separated from or detached from the opening edge of the nose seal Referring to FIG. 23, an alternative form of the nose seal 102A of the first embodiment is shown. The nose seal 102A is similar to the nose seal 102 of the first embodiment, except that it has a different sub-nasal support configuration 124A that is completely separated or detached from the edge of the face-contacting surface 120 of the nose seal. Like reference numerals represent like components. The alternative sub-nasal support configuration 124A includes a main lateral portion 129 and a central extension portion 132A. The difference from the nose seal 102 is that the central extension portion 132A is not coupled or connected to the edge 122 of the contact surface 120, but rather is coupled or connected to the lower part of the contact surface in the upper lip region, or alternatively to a part of the contact surface 120, for example, a part of the lower region of the seal that is not part of the lower sidewall 126 of the nose seal. In this configuration, the sub-nasal support 124A is completely separated from the edge 122 of the contact surface 120, and in some configurations, the main lateral portion 129 and the central extension portion 132A are completely separated from the contact surface 120 such that they are displaced from or adjacent to the contact surface 120 that engages the user's face and connect to the respective sidewall portions of the nose seal. The alternative embodiment of the nose seal 102A is similar to the nose seal 102 in function and configuration in other respects and can be coupled to the seal housing 104 to form a nose seal interface assembly, similar to the nose seal 102 of the first embodiment.

[0152] Second Embodiment - Nose Seal with Sub-Nasal Support Having Lateral Extension Portions Referring to FIGS. 24 - 29, various forms of a second embodiment of a nasal mask interface are described. The nasal mask interface of the second embodiment is substantially the same as the first embodiment, except that the first form includes a nose seal 102B having an alternative sub-nasal support configuration 124B. The nose seal 102 is similar to the nose seal 102 of the first embodiment in other respects and can be coupled to the seal housing 104 to form a nose seal interface assembly as described above. Like reference numerals represent like features.

[0153] In this first form of the second embodiment, the alternative sub-nasal support configuration 124B still includes a main lateral portion 129 that extends rearward of the contact surface 120 between opposite sides of the nasal seal across the nasal seal. The central extension portion is not provided as in the first embodiment configuration. Rather, the sub-nasal support 124B is left and right extension portions 132B that extend from opposite sides of the main lateral portion 129 and connect to the lower opening edge 122 of the contact surface 120 at respective positions, each toward a side portion of the seal in the upper lip region 121 of the contact surface 120. In this embodiment, the sub-nasal support 124B may also include a lateral extension 135 that extends along or adjacent to the lower opening edge 122 of the contact surface 120 between the side extension portions 132B. Alternatively, the lateral extension 135 may be considered an extension of the contact surface 120 in the upper lip region where the side extension portions 132B are connected. It will be appreciated that the lateral extension portion 135 may be omitted in alternative embodiments so that the side extension portions 132B can extend downward to connect directly to the edge 122 of the contact surface 120 without the lateral extension portion 135.

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

[0155] Alternative Second Form - Side Extension Portions Completely Separated or Separated from the Opening Edge of the Nasal Seal Referring to FIG. 29, an alternative second form of the nose seal 102C of the second embodiment is shown. The same reference numerals are used to represent the same features. Also in this case, the nose seal 102C is displaced or separated from the edge 122 of the nose seal such that the side extension portion 132C extends from the main lateral portion 129 and the side extension portion 132C is separated from the edge 122 of the nose seal. It is the same as the nose seal of the second embodiment in other respects except that it includes an alternative subnasal support configuration 124C that connects to a part of the nose seal in the upper lip region. In one configuration, the side extension portion 132C connects to or extends to a part of the contact surface 120 below the edge in the upper lip region, or in an alternative configuration, it connects to the nose seal at a position completely displaced from the contact surface 120, for example, to respective positions on the side walls of the seal in the upper lip region below the lower edge 122 of the opening. This configuration provides a subnasal 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" Subnasal Support Referring to FIGS. 30 - 34, a third embodiment of the nose seal 102D is described. Similar to the previous embodiments, the nose seal 102D is similar to the nose seal 102 of the first embodiment in that it can be used in a nose mask interface assembly as described above, for example, by being coupled or connected to a seal housing 104. The same reference numerals represent the same features.

[0157] The nasal seal 102D of the third embodiment includes an alternative sub-nasal support 124D consisting only of a main lateral portion or band 129 without a central or lateral extension portion. In particular, the sub-nasal support 124D includes an elongate strip or band of material that extends laterally across the nasal seal between opposite sides of the seal and extends behind or is positioned behind the face-contacting surface 120 as in the previous embodiments. Similar to the previous embodiments, the lateral band 129 can be coupled or connected at each end to respective portions of the side walls 126 or other portions of the seal such that the sub-nasal support is separated or disengaged from the surface 120 or at least the edge of the contact surface. Without the central or lateral extension portions of the previous embodiments, the sub-nasal support 124D can be considered a "floating" support with a greater degree of mobility within the seal.

[0158] In this configuration, the sub-nasal support 124D has a smaller contact surface area and thus contacts a smaller portion of the sub-nasal surface of the user's nose. In particular, without either a central or lateral extension portion, the sub-nasal surface contacted by the floating sub-nasal support configuration 124D tends to be smaller. The floating sub-nasal support tends to engage or contact the columns and portions of the alar rim 80 adjacent to or towards the tip of the nose, depending on the size of the user's nose. For a person with a larger nose, the sub-nasal support can contact further towards the sub-nasal surface in the middle region or at the base of the nose.

[0159] Fourth Embodiment - Low Profile Nasal Mask Interface Overview The nasal mask assembly of the fourth embodiment is described with reference to FIGS. 35 - 102.

[0160] Referring to FIGS. 35 and 36, the nasal mask assembly of the fourth embodiment includes a nasal mask interface 200 fixed to the user's head via a headgear 250. The nasal mask interface 200 is connected to a flexible gas supply conduit 260, which, during use, delivers a supply of breathable gas to the nasal mask interface 200 for delivery via the user's nose to the user's airway. In this embodiment, the headgear 250 includes side or front straps 252 that connect at attachment points 256 to opposite sides of the nasal mask interface 200 and extend along the sides of the user's face or cheeks and over the user's ears. A pair of front or side straps 252 connect to one or more other straps or strap portions 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 user's head or top and a back or rear strap 258 that extends around the back of the user's head. The side straps 252 are integrally formed with or otherwise connected to the top 254 and rear 258 straps as will be appreciated by those skilled in the art. As in the previous embodiments, the headgear straps are typically formed of or include a flexible breathable material such as Breath-o-Prene®, breathable neoprene material, or neoprene material. Further aspects of the headgear configuration as well as attachment and interaction with the nasal mask interface 200 will be described later. In this embodiment, the headgear may have an auto-adjustment feature or mechanism as will be further described, although these are not essential to all embodiments.

[0161] Referring particularly to FIGS. 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. Similar to the previous embodiments, the nasal seal 202 and the seal housing 204 together collectively are configured to receive at least a portion of the user's nose during use and to define or form a mask cavity or volume that receives a supply of breathable gas from the 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 connected either permanently or releasably to the end of the gas supply conduit. The conduit frame 211 in this embodiment is releasably connectable to a complementary central air hole or intake 210 provided in the seal housing, thereby connecting the supply conduit 260 to the nasal mask interface 200.

[0162] In this embodiment, the headgear frame in the form of the yoke 208 is releasably connected to the outer surface of the seal housing 204. The yoke 208 has a shape that is generally curved (the outer surface engages with the seal housing that is convex and the inner surface is concave), extends laterally across the seal housing 204, and at each end, extends in an outward direction away from the side of the nose seal 202 toward the side that contacts the face of the nasal mask interface. Each end of the yoke 208 is connected 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 the headgear 250 can 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 bias exhaust ports or vents 212 for providing gas wash - out from the nasal mask interface 200. In this embodiment, the bias vents include an arrangement of small holes or apertures that extend through the seal housing 204. As will be described in more detail, the vent arrangement includes one or more arrays of holes at specific locations on the seal housing. Similar to the previous embodiment, the nose seal 202 is provided with a sub - nasal support 224 that extends laterally across or is suspended within the mask cavity over the nose seal and is configured to contact at least a portion of the sub - nasal surface of the user's nose to counter the lift force as a resultant force that occurs during use when the nasal mask is worn.

[0164] Further details and aspects of the various components of the nasal mask interface 200 are described herein.

[0165] Aspects of general shape and configuration Referring to FIG. 42, in this embodiment, the orientation or angle of the yoke 208 and the conduit frame 211 is offset from each other. For example, the longitudinal axis of the conduit frame 211 represented by line AE is angled with respect to the longitudinal axis or plane that extends through or is defined by 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 is preferably in the range of approximately 20° to approximately 60°, more preferably approximately 30° to approximately 50°, even more preferably approximately 35° to approximately 45°, and even more preferably approximately 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 may assist in guiding the gas supply conduit away from the user and may also assist in reducing hose drag.

[0166] Referring to FIG. 44, the conduit frame 211, the seal housing 204, the nasal seal 202, and the yoke 208 all generally follow the curvature of the user's face and exhibit a substantially concave curvature (on that face facing the surface) that assists in the nasal mask interface following along 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 in the lateral side portions) is generally larger than the radius of curvature of the conduit frame 211 and / or the seal housing 204, which is because the yoke is not intended to contact the user's face and is configured to extend at an angle away from the outer wall of the nasal seal 202 that extends between the face-contacting surface of the nasal seal and the outside of the nasal seal that connects to the seal housing 204.

[0167] Referring to FIG. 43, the nasal apertures or nasal receiving openings 206 on the side of the nasal seal 202 that contacts the face are shown. A pair of single headgear attachments or connection points 272 on each side of the nasal mask interface are indicated at 272 at 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 a position on the yoke 208 that is most distal from the center of the nasal mask interface. The sub-nasal support 224 is visible through the nasal aperture 206 and extends within the mask cavity provided by the nasal seal 202 and the seal housing 204. In this embodiment, the sub-nasal support 224 has three connection points to the nasal seal 224. As will be described in detail later, the sub-nasal support 224 includes connection points toward each upper inner lateral side or surface of the nasal seal and a third connection point toward the central bottom of the nasal seal or the central bottom of the nasal seal. In this embodiment, the third connection portion is for the central bottom edge of the nasal aperture 206.

[0168] Referring to FIGS. 42 and 44, some of the main outer dimensions of the entire profile of the nasal mask interface 200 in this embodiment are described only as an example 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 the nasal seal 202 assembly ranges from approximately 1:0.8 to approximately 1:1.2. In this exemplary embodiment, the overall height is substantially equal to the overall depth of the seal housing and the nasal seal assembly, that is, approximately a ratio of 1:1. In this embodiment, the overall width of the seal housing and the 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 width of the seal housing and the nasal seal assembly is in the range of approximately 1:0.8:1 to approximately 1:1.2:1.4 and approximately 1:1:1.2 in this exemplary embodiment.

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

[0170] Nasal seal Referring to FIGS. 47 - 67, the nasal seal 202 of the nasal mask interface 200 is described in more detail. The nasal seal 202 is flexible and soft and may be formed of a silicone material or other suitable material as would be recognized by one of ordinary skill in the art.

[0171] Referring to the side of the nose seal 202 that contacts the face or the user side, as shown in FIG. 47, the contact surface is generally denoted by 220 and is configured to seal around the user's nose, including across the user's nasal bridge. In this embodiment, the contact surface 220 surrounds at least a portion of the nose and the seal around that portion of the user's nose. The contact surface 220 of the nose seal includes, for example, an upper lip region generally denoted by 221 that is configured to contact the upper lip region of the user's face at a position above the vermilion border and below the nostrils. The contact surface 220 includes left and right cheek or side regions 223 that extend between the upper lip region 221 at the bottom of the seal and the nasal bridge region at the top of the nose seal 202 or an upper region 225 proximal to the proximal end side of the nasal bridge region at the top of the nose seal 202. The cheek regions 223 of the contact surface 220 are configured to contact the cheek surface near the midline of the user and / or the lateral nasal surface of the user on both sides 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 and connect to the two cheek regions 223. As will be described in more detail later, in this embodiment, the nose seal 202 includes a profile height dimension lower than that of a conventional nose mask such that the nasal bridge region 225 of the contact surface contacts the user's nasal bridge at a position on the nasal bridge in the middle region of the nasal bridge between the tip below the user's nose and the upper end above the nasal bridge between the user's eyes. In this embodiment, the nasal bridge region 225 of the contact surface 220 is configured to contact the user's nasal bridge in a region of the nasal bridge below the user's eyes. In some embodiments, the nasal bridge region 225 of the nose seal is configured to contact the user's nasal bridge in a region defined between the nostrils of the nose and the center of the nasal bridge. In some embodiments, the nasal bridge region 225 of the nose seal is configured to contact the lower half of the user's nose.

[0172] Referring to FIG. 52, in this embodiment, the nasal bridge region 225 of the contact surface 220 includes a central valley region or portion denoted by 245 that is recessed compared to the rest of the contact surface. The valley region 245 is configured to engage the user's nasal bridge and is shaped to substantially follow the user's nasal bridge.

[0173] The overall shape and configuration of the contact surface 220 are such that, when the headgear is fixed to the user's head via the headgear and the nasal mask interface receives the gas flow, it seals and conforms to the contour of the user's face around the nose and is arranged to seal-engage around the user's nose. In this embodiment, under pressure, the seal biases the surface 220 that contacts the face against the user's face and deforms to substantially seal against the user's facial contour, including one or more of the upper lip, cheek near the midline, lateral nose, and nasal bridge. Therefore, the nasal seal can be considered of the self-inflating type.

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

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

[0176] In this embodiment, the nose holes 206 formed on the side of the nose seal 202 that contacts the face are substantially or semi-triangular in shape to conform to the natural shape of the human nose. The housing holes 228 outside the nose seal 202 are substantially or semi-rectangular in shape.

[0177] Referring to FIGS. 47 and 48, the sub-nasal support 224 can be seen, and it is substantially concave or U-shaped with three connection or attachment points to or within the nose seal 202. As shown, the sub-nasal 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 connection portions 231 are located on the inner surface of the nose seal 202, one on each side of the central top region of the nasal aperture 206. In this embodiment, the lateral connection portions 231 of the sub-nasal support 224 are configured or arranged in a vertical direction such that the inner or contact surfaces of the sub-nasal support 224 substantially face or oppose each other at or towards the lateral connection points 231. In particular, the lateral contact surfaces of the sub-nasal support 224 can be substantially parallel to each other at or towards the lateral connection points 231. The sub-nasal support 224 in this embodiment further includes a third connection at or towards the central bottom of the nose seal. In this embodiment, the bottom central connection point 232 joins or is joined to the central bottom region of the edge 222 of the contact surface 220 of the nose seal that defines the nasal aperture 206. The sub-nasal support 224 and its connections will be further described later.

[0178] Referring to FIGS. 51 - 53, the nose seal 202 is substantially defined by a face contact portion 220 (shown in FIG. 47) that contacts the face and a side wall portion 226 (shown in FIG. 51) that extends rearwardly from the contact surface around the perimeter of the seal and terminates at an outer or lateral connection edge 227 of the seal that is coupled or connected to the seal housing 204. In this embodiment, the nose seal 202 can include profiles or regions of varying thickness extending from the nasal aperture edge 222 on the face-contact side of the nose seal to the outer connection edge 227 of the nose seal.

[0179] In this embodiment, the nose seal 202 includes at least a first front region generally designated 233 that extends from the nose hole edge 222 to an intermediate peripheral boundary 235 located in the side wall portion 226, and a second rear region 234 that extends from the intermediate peripheral transition boundary 235 to the outer connection edge 227 of the seal.

[0180] In this embodiment, the front region 233 includes the contact surface 220 and at least a portion of the side wall portion 226 of the nose seal adjacent to the contact surface 220. The rear region 234 includes the remaining portion of the side wall portion 226 that extends rearward from the transition boundary 235 to the connection edge 227.

[0181] Referring to FIG. 56, in this embodiment, the front region 233 of the nose seal that includes the contact surface is thinner or has a reduced thickness on average compared to the rear region 234 of the nose seal. In this embodiment, the nose seal further includes an additional third thickness region 236 within the front region 233. In particular, the front region 233 transitions to a thinner edge region 236 adjacent to the nose hole edge 222. The edge region 236 is thinner than the remaining portion of the front region 233. In this embodiment, the edge region 236 is the smaller portion of the front 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, which includes the contact surface 220, facilitates the fit of the nose seal with the user's nose. Further, the edge region 236 around the periphery of the nasal aperture edge 222 is the thinnest portion of the contact surface 220 and provides increased user comfort and sealing fit. It will be appreciated that the thicknesses of the rear region 234, the front region 233, and the edge region 236 may be uniform within each respective region 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 has a substantially uniform thickness in the larger portion and the smaller, thinner edge portion 236, and the edge portion 236 has a reduced, uniform thickness compared to the majority of the front region. In this embodiment, the larger portion of the front region 233 gradually transitions to the thinner edge region 236 as shown in the body transition zone 237 in FIG. 56. As shown in FIG. 56, the face contact surface 220 of the nose seal forms a flange that curls or extends inwardly from the sidewall portion 226 of the nose seal, and the flange includes the thinner edge portion 236.

[0183] Sub-nasal support of the nose seal In this embodiment, the sub-nasal support 224 of the nose seal 202 is at least in the form of a nasal sling or hammock that extends laterally or is suspended across the central portion of the nose seal within the mask cavity. The sub-nasal support 224 is configured to contact at least a portion of the sub-nasal surface of the user's nose and thus, as previously discussed, when the nasal mask is worn and to counteract the lifting force as the resultant force that occurs during use when pressurized gas is flowing.

[0184] In this embodiment, the sub-nasal support 224 is entirely defined or surrounded within the outer envelope of the nasal seal, i.e., it does not project or extend beyond the outer connection edge 227 of the nasal seal that connects to the contact surface edge 222 of the seal housing or the nasal aperture 206. However, it will be understood that in an alternative embodiment, at least a portion of the sub-nasal support 224 may project beyond the housing aperture defined by the connection edge 227.

[0185] In this embodiment, the sub-nasal support 224 is suspended laterally across the central region of the nasal seal 202 between the left and right sides of the nasal seal. As shown, the sub-nasal support is disposed or positioned behind or posterior to the nasal aperture or opening 206 on the side of the nasal seal that contacts the face. The sub-nasal support 224 is connected to the nasal seal so as not to move relative to the nasal seal in that it is not removable in this embodiment. In one form, the sub-nasal support is integrally molded within the nasal seal. In an alternative form, the sub-nasal support component or portion of the nasal seal may be formed separately and then fixedly joined within the nasal seal via an adhesive or welding or the like, or it may be connected to the seal housing.

[0186] In this embodiment, the sub-nasal support structure 224 includes an elongate main lateral portion or band 229 that extends laterally within the nasal seal over at least a portion of the nasal seal. Referring to FIGS. 47-49, 54-56, and 57, in this embodiment, the main lateral portion 229 of the sub-nasal support 224 is suspended or connected at each opposite end to respective upper connection points 231 that are located on the upper inner surfaces of the nasal seal on both sides of the nasal seal with respect to the apex region of the nasal aperture 206. In this embodiment, the end portions of the main lateral portion 229 of the sub-nasal support 224 are connected to the inner surface of the nasal seal via respective reinforcing portions or regions in the form of ribs 241, for example. In this embodiment, the ribs 241 extend in a substantially vertical orientation from an upper lateral position within the inner surface of the nasal seal and extend into or connect to respective end portions of the main lateral portion 229 at the connection positions 231. In this embodiment, the ribs 241 are integrally formed with the main lateral portion 229 of the sub-nasal support 224. It will also be appreciated that the ribs 241 at the ends of the main lateral portion 229 may be considered part of the sub-nasal support and the main lateral portion 229. In other words, the reinforcing portion or region 241 may be considered an extension of the main lateral portion, or simply an end of the main lateral portion. Alternatively, the reinforcing portion or region may be considered an individual component or structure that is connected to or integrally formed with the end of the main lateral portion. The functionality and effect of the reinforcing portion or rib 241 remain substantially the same in either interpretation.

[0187] Referring to FIG. 55, the rib 241 is joined to or extends from the inner surface of the region of the nose seal that includes a portion of the rear region 234 and a portion of the front region 233 at a portion of its peripheral edge. In this embodiment, the rib extends across a portion of the rear region 234 and most of the front region 233 that includes the contact surface, excluding the tapered edge region 236 adjacent to the nostril. However, in alternative embodiments, it will be appreciated that the rib 241 may also extend from at least a portion of the tapered edge region 236, may connect to at least a portion of the tapered edge region 236, or may extend within at least a portion of the tapered edge region 236. In this embodiment, the main lateral portion 229 of the sub-nasal support is connected to each respective rib 241 by a portion of the rib that extends or coincides with the thicker rear region 234 of the nose seal wall. The rib 241 provides a fixed connection within the nose seal to the main lateral portion 229 of the sub-nasal support 224 and also provides a dual function of structural support to the nose seal by increasing the rigidity in that area or region of the nose seal that contacts the patient on both sides of the nose. In particular, the rib 241 stands on the side or is located on both sides of the upper valley region 245 (see FIG. 52) of the contact surface 220 associated with the nasal bridge region of the contact surface 220. In particular, the rib or panel 241 that prevents the nose seal from collapsing under excessive compressive forces while at the same time allowing a robust connection between the sub-nasal support and the inner surface of the nose seal.

[0188] In some embodiments, the rib may also function to provide feedback to the user, either directly or indirectly, if the mask is tightened too tightly. As will be further described below, the buckling of the rib may be configured to deform or change the shape of the sub-nasal support in order to compress the user's nose and / or to gradually push more tightly into the sides of the nose under increased compression of the nose seal, for example due to tightening of the headgear, in the portion of the contact surface adjacent to or associated with the rib.

[0189] Referring to FIG. 55, in this embodiment, the concave region or zone 243 is provided or formed between the front portion 242a of the rib 241 and the rear portion 242b that connects to the main lateral portion 229 of the sub-nasal support 224. This concave 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 top of the concave region 243.

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

[0191] In other configurations, the buckling axis 242 allows the ribs 241 to bend inwardly towards each other during use when the nasal seal is compressed in its entire depth dimension when worn by the user. This inward buckling of the ribs causes the sub-nasal support 224 to tighten or close at least in the lateral direction, which acts to apply pressure to or tightly clamp the surface of the user's nose. In other words, the inward buckling of the ribs moves the contact surfaces of the lateral regions of the main lateral portion of the sub-nasal support towards each other, effectively narrowing or tightening the U-shape of the sub-nasal support to apply pressure to the user's nose.

[0192] The concave region 243 can also be a region or zone of the rib 241 where the depth (i.e., the distance from the edge of the rib connected to the inner surface of the seal to the free peripheral edge of the rib) or surface area is reduced relative to other portions of the rib.

[0193] Referring to FIG. 48, in this embodiment, the upper connection position 231 of the subnasal support is located at the lateral end or the boundary of the side portion of the nasal seal. In particular, the vertical continuation rib 241 and the connection point 231 are offset with respect to the outer lateral width of the nasal seal on their respective sides. In this embodiment, the distance between the connection positions 231 is generally less than or equal to the outermost width of the nasal aperture, indicated as 242A in FIGS. 47 and 48. In particular, the connection points 231 of the main lateral portion 229 of the subnasal support are located within the same width zone as the nasal aperture 206 in relation to the nasal seal. In this embodiment, the connection rib 241 extends from the contact surface 220 in the upper lateral cheek region 223 at a position where it engages the user's cheek and / or the outer lateral nose or lateral nose surface with respect to the user's nasal bridge.

[0194] In some embodiments, referring to FIG. 57, the main lateral portion 229 of the subnasal support 224 is arranged to extend laterally across the nasal seal 202 at approximately the middle or central depth of the overall depth profile of the nasal seal in a dimension extending from the contact surface 220 to the outermost portion of the outer connection edge 227 of the nasal seal. However, in alternative embodiments, the main lateral portion may be arranged to extend laterally across the nasal seal at other depths, closer or further from the contact surface, and may have portions that extend or protrude beyond the outer connection edge 227 or the main envelope of the nasal seal.

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

[0196] Referring to FIGS. 55 and 56, the central connection portion 232 of the subnasal support includes profiles of various thicknesses in a direction orthogonal to the contact surface of the connection portion 232. In this embodiment, the thickness of the central connection 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 nasal aperture edge 222. For example, the thickness of the central connection portion 232 at the second end 232B is substantially equal to or uniform with the thickness of the main lateral portion or band 229 in that region, and tapers or decreases in width from either at a point in the intermediate region of the second end 232B or the connection portion 232 to the reduced thickness at the first end 232A at the nasal aperture edge 222. In this embodiment, the reduced thickness at the first end 232A is substantially equal to or uniform with the thickness of the nasal aperture edge 222 of the contact surface. For example, the thickness of the central connection portion 232 at its first end 232A can be substantially equal to the thickness of the thinned edge region 236 of the contact surface of the nasal seal.

[0197] In particular, referring to FIGS. 47 - 49 and 54, in this embodiment, the subnasal support 224 is configured with a profile that curves across the width of the subnasal support between the upper lateral connection portions 231. The curvature profile can vary across the width of the subnasal support in some embodiments, or alternatively, it can have a uniform curvature in other embodiments. In the illustrated embodiment, the curvature profile varies. In this embodiment, the contact surface of the main lateral portion 229 of the subnasal support 224 has a steeper curve profile in the intermediate or central region 235 compared to the flatter curve profile in the remaining lateral or outer lateral regions 236 that extend to the upper lateral connection portions 231. For example, in the central region indicated by 235, the main lateral portion 229 is provided with a substantially uniform first radius of curvature in the central region 235. The radius of curvature of the remaining lateral regions 236 on both sides of the central region 235 can be constant or vary, but generally, it has a radius of curvature larger than the first radius of curvature of the central region 235 such that it generally has a flatter curvature. In this embodiment, the main lateral portion 229 has or includes a contact surface profile that curves across its entire width without a flat region.

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

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

[0200] As described above, the subnasal support 224 in this embodiment is connected to the nose seal 202 so as not to move, or is otherwise an integral component of the nose seal 202. The drawings show the nose seal 202 and its subnasal support 224 in a stationary state, i.e., not in use. Like the contact surface 220 of the nose seal, the subnasal support 224 is also configured to be soft and flexible or bendable such that when the nose mask interface is fixed to the user's face or worn in some other way, its shape and position can follow the subnasal surface of the user's nose in a sling or hammock-like manner. In this embodiment, the subnasal support is non-elastic in any direction, but in alternative embodiments, it may have some degree of elasticity in the same direction.

[0201] Alternative subnasal support The main lateral portion 229 or band of the subnasal support 224 is generally U-shaped with several curvatures across the width of the subnasal support. In alternative embodiments, the subnasal support may have a flat section or portion, or generally a more rectangular or substantially square shape. For example, referring to FIG. 61, in an alternative embodiment, the subnasal support shown at 224A has a substantially flat central horizontal portion 229A and two substantially vertical or upright portions 229B that extend upwardly from respective ends of the central horizontal portion 229A and are each connected at a connection point 229C either directly or via ribs to the inner surface of the rear side of each of the nasal seals, similar to the previous embodiments.

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

[0203] As an example, the main dimensions of an embodiment of the one-nose seal configuration are described to provide a sense of scale. Referring to FIG. 47, the height of the nasal aperture defined by the contact surface edge 222 indicated by 242B in the central region is in the range of approximately 8 mm to approximately 43 mm, preferably approximately 23 mm, and the outermost width of the nasal aperture indicated by 242A is in the range of approximately 24 mm to approximately 49 mm, preferably approximately 34 mm. The total height of the nose seal indicated by 242D is in the range of approximately 22 mm to approximately 72 mm, preferably approximately 47 mm, and the total width indicated by 242C is in the range of 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 where the width is reduced is, as indicated by 242E, in the range of approximately 2 mm to approximately 15 mm, preferably approximately 3 mm. Referring to FIG. 52, the total depth of the nose seal indicated by 243A is in the range of approximately 29 mm to approximately 49 mm, preferably approximately 39 mm. The depth of the nose seal between the lateral contact surface and the lateral edge of the housing aperture indicated by 243B is in the range of 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 is in the range of 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 connection edge 227 outside the nose seal is in the range of 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 nasal aperture 206 and the bottom surface of the nose seal 202 is in the range of approximately 5 mm to approximately 20 mm.

[0204] Referring to FIG. 58, the thickness of the main lateral portion 229 of the nasal support 224 in the direction orthogonal to the contact surface of the main lateral portion indicated by 244A is in the range of approximately 0.2 mm to approximately 3 mm, preferably approximately 1.1 mm. The central connection portion 232 extending from the center of the main lateral portion 229 starts with a similar thickness and then transitions to a thinner thickness as it connects to the nasal aperture edge 222 of the contact surface 220 as shown. In this exemplary embodiment, the thickness of the edge region 236 of the contact surface is approximately 0.2 mm.

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

[0206] As described, the nasal seal is generally configured to have a generally rectangular shape dimensionally and / or as viewed from the outside as shown in FIG. 48 and from the side that contacts the front or face as shown in FIG. 47.

[0207] Seal housing Referring to FIGS. 68 - 74, the seal housing 204 of this embodiment of the nasal mask interface 200 will be described in more 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 that extends from the main opening on the seal connection side, indicated at 262, to the outside, indicated at 261 (see FIG. 72). The opening of the seal contact side 262 of the seal housing 204 is defined by the outer peripheral edge 263 of the seal housing 204. The seal housing 204 is generally defined by a concave outer surface that extends from the outer peripheral edge 263 of the opening between the top 264A, bottom 264B, and side sides 264C, 264D of the seal housing to the outside 261 of the seal housing, thereby collectively defining a mask cavity or volume for receiving the gas flow from the intake opening 265 provided on the outer surface at the outside 261 of the seal housing, providing a substantially hollow component with a depth that cooperates with the nasal seal 202.

[0209] The outer peripheral edge 263 of the main opening of the seal housing 204 is configured to connect or couple to the connection edge 222 of the nasal seal 202 in order to couple the nasal seal to the seal housing to form a mask cavity. It will be understood that the nasal seal 202 and the seal housing 204 can be permanently or semi - permanently connected or coupled via various methods including over - molding, welding, adhesives, mechanical coupling configurations, or combinations thereof.

[0210] Referring to FIG. 46, in this embodiment, the connection edge 222 of the nose seal 202 is permanently connected or joined to the outer peripheral edge 263 of the seal housing 204 via an adhesive, overmold, or weld of complementary surfaces at the interface between the edges 222, 263 of the components. However, in an alternative embodiment, either the connection edge 222 or the outer peripheral edge 263 may be provided with channels or complementary ridges that engage with each other to form a mechanical connection, or vice versa, and it will be understood that in addition to this mechanical coupling, an overmold, adhesive, or weld may be applied to ensure the connection. For example, the ridge and channel configuration may be similar to that described with reference to the nose 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 connection edge 222 of the nose seal 202 complement each other to allow a robust connection between the components, as recognized. In an alternative embodiment, it will be recognized by those skilled in the art that the nose 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, on the outer surface of the seal housing 204, there is provided a channel or recess, generally designated 266, that forms a yoke channel for releasably receiving and holding a 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 in an intermediate 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 that 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 a conduit frame 211, which is thus releasably or permanently connected to the 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, as viewed from the outside as shown in FIG. 70, the intake opening 265 is wider laterally than in height. As shown in FIG. 72, the intake opening 265 is substantially symmetric with respect to a plane 265A extending through the major axis of the elliptical hole shown by line AE in FIG. 42, for example. Referring 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 outer periphery. For example, the intake hole 265 includes upper 265C and lower 265B surfaces that extend into the seal housing from the outer surface to the inner surface of 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 elongate protrusion that extends across the central portion of the outer periphery of the elliptical hole 265 in the upper and lower regions, either in or towards the inner surface housing of the seal. During operation, the protrusion 267 engages with complementary recesses or channels 287 of 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 protrudes beyond a majority of the surface of the seal housing 204. Referring to FIGS. 70 and 74, in this embodiment, the intake hole configuration also includes a concave local region 268 provided around at least a portion of the periphery of the intake hole, as indicated by 268. In this embodiment, the intake hole 265 is provided with two separate concave regions or surfaces 268, each on or towards each of the lateral sides of the intake hole. In this embodiment, the concave regions 268 terminate before meeting each other, although it will be appreciated that in alternative embodiments, the concave regions may extend around the entire outer periphery of the oval intake hole 265. During operation, the concave regions 268 are shaped and dimensioned to receive the complementary engagement surfaces of the duct frame 211 such that the interface region between the duct frame of the seal housing surrounding the intake hole and the outer peripheral surface is substantially smooth or flat in order to provide a continuous or fused outer surface when the duct 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 positioning features 271 that engage complementary locking features provided on the yoke 208. In this embodiment, the positioning features 271 of the yoke channel 266 are concave structures into which complementary positioning protrusions or structures provided on the yoke 208 engage to lock the yoke 208 to the seal housing 204. In this embodiment, the recesses 271 of the yoke channel 266 and the complementary protrusions of the yoke 208 are aligned such that when the components are engaged together with the yoke protrusions engaged within their complementary recesses 271 of the yoke channel, the yoke is slightly deformed such that there is a remaining tension or compressive force that locks or fixes the two components together. The yoke channel 266, the yoke 208, and the headgear assembly will generally be described in further detail later.

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

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

[0218] Conduit frame Referring to FIGS. 75-81, the conduit frame 211 that releasably engages within the intake hole 265 of the seal housing 204 is described in more detail.

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

[0220] In this embodiment, the duct frame 211 is a main hollow body that includes a main hollow body extending from a first end 283A configured to engage into the intake hole 265 of the seal housing 204 to a second end 283B configured to be connected or coupled, either directly or indirectly via a connector, to an end. The duct frame 211 forms a hollow duct along the longitudinal axis of its body between its first end 283A and its second end 283B, as shown in FIGS. 81 and 82. The duct is open at each end of the body, and in this embodiment, the cross-sectional shape is substantially elliptical along the length of the body of the duct frame 211. Referring to FIG. 79, in this embodiment, the inner circumference of the elliptical duct 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 duct at the first end 283A (connected to the seal housing) is larger than the circumference of the elliptical duct at the second end 283B (connected to the air supply duct) in order to create a funnel-shaped profile.

[0221] Referring to FIGS. 79 and 80, in this embodiment, the duct frame 211 is symmetric about a horizontal plane extending through the 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 duct. This symmetry corresponds to the symmetry of the intake hole 265 of the seal housing 204 and allows the duct frame 211 to be connected to the seal housing 204 in either of two orientations. In other words, the duct frame 211 can be releasably coupled into the intake hole 265 of the seal housing in either of two orientations rotated 180° relative to each other. In this embodiment, the duct frame 211 is also symmetric about a vertical plane indicated by AK extending along the longitudinal axis AI of the duct frame. The vertical plane corresponds to the shorter axis of the oval duct and is perpendicular or orthogonal to the horizontal plane AJ. In particular, the duct frame is symmetric with respect to two cross-sections extending through the longitudinal axis of the duct frame.

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

[0223] The seal housing connection portion 285 extends from a first end 284A of the central gripping portion 284 and terminates at the first end 283A of the conduit frame. The conduit connection portion 286 extends from a second end 284B of the central gripping portion 284 and terminates at the second end 283B of the conduit frame 211. As shown in the figure, both the seal housing connection portion 285 and the conduit connection portion 286 have an elliptical cross-section with respect to the longitudinal axis of the conduit frame. In this embodiment, referring to FIG. 79, the outer perimeters of both connection 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 understood that the conduit frame may have an alternative shape profile to the 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 concave gripping regions 284C, 284D on the upper and lower surfaces allow the user to grip the conduit frame 211 between the thumb and index finger to insert or release it from the seal housing as needed during use.

[0225] In this embodiment, the central gripping portion 284 increases in width laterally towards the first end 284A in order to form lip-winged regions 284E, 284F that project from the lateral sides of the conduit frame. In this embodiment, as shown in FIG. 77, the first end 284A of the central gripping portion is substantially concave in shape. In this embodiment, the inner surfaces 284G, 284H of the winged regions 284E, 284F adjacent to the seal housing connection portion 285 are complementary in shape and dimensions to the concave lateral regions 268 of the 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 with the complementary concave regions 268 associated with the intake holes 265. In this embodiment, the outer or outer surface profile of the gripping portion 284 in the regions indicated by 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 intake holes 265. This complementary shape of the winged regions 284I, 284J provides a flat and continuous surface profile in the outer fitting or interface region of the conduit frame 211 and the seal housing 204 when they are assembled together. The concave profile of the first end 284A of the gripping portion or region 284 is configured or arranged to complement the concave surface profile adjacent to or surrounding the periphery of the intake holes 265 of the seal housing 204 in order to provide a continuous, flat or fused outer surface at the interface between the conduit frame and the seal housing when assembled together.

[0226] Referring to FIGS. 75 and 77, undercuts or concave grooves 287 are provided in the upper and lower portions of the seal housing connection portion 285 at the first end 283A of the conduit frame. These grooves 287 are shaped and dimensioned to complement the upper and lower protrusions 267 of the intake holes 265 of the seal housing in order to enable the conduit frame 211 to engage so as not to move into the intake holes 265 of the seal housing via snap-type engagement.

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

[0228] Referring to FIGS. 77 and 80, exemplary dimensions of one configuration of the conduit frame of this embodiment are described to provide a sense of scale. Referring to FIG. 80, the dimensions of the elliptical hole at the conduit connection end 283B for the main axis 290A are in the range of approximately 9 mm to approximately 29 mm, preferably approximately 19 mm, and for the shorter axis 290B in the range of approximately 5 mm to approximately 21 mm, preferably approximately 11 mm. The elliptical extrusion of the conduit connection portion 286 gradually increases in dimension from approximately 14 mm to approximately 34 mm, preferably approximately 24 mm, in the direction of the main axis, and from approximately 6 mm to approximately 26 mm, preferably approximately 16 mm, in the direction of the shorter axis, towards or at the body gripping portion 284. The overall height 290C of the conduit frame 211 between the outermost upper and lower surfaces in a dimension aligned or parallel with the shorter axis 290B is in the range of approximately 12 mm to approximately 22 mm, preferably approximately 17 mm. The overall width 290D of the conduit frame 211 between the outermost wing-like portion regions of the central gripping portion 284 in a dimension aligned or parallel with the main axis 290A is in the range of approximately 25 mm to approximately 45 mm, preferably approximately 35 mm. Referring to FIG. 77, the overall length between the first and second ends 283A, 283B of the conduit frame, shown at 290F, is in the range of approximately 10 mm to approximately 30 mm, and the width of the seal housing connection portion 285, shown at 290E, is in the range of approximately 14 mm to approximately 34 mm, preferably approximately 24 mm. It will be understood that the dimensions can vary as needed in alternative embodiments.

[0229] Referring to FIG. 79, the first region of the conduit frame 211, shown at 289A, projects or extends into the seal housing 204 complementaryIdentify the connection portion 285 that engages into the intake hole 265. The remaining second portion of the duct frame, indicated by 289B towards the second end 283B, extends or protrudes from the seal housing. The first end 283A of the duct frame 211 can define a housing hole opening that engages or mates with the intake hole 265 of the seal housing, and it will be appreciated that the end 283B of the duct frame represents a duct hole that engages or couples to the end of the gas supply duct, either directly or via a connector.

[0230] Yoke assembly, yoke connection to the seal housing, and headgear With particular reference to FIGS. 82 - 102, the yoke 208, and its connection to the seal housing 204 and the headgear 250 are described in further detail. As described 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, particularly to the seal housing 204 of the nasal mask assembly.

[0231] The yoke 208 is configured to attach to the 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 in use. Each of the various straps can be formed as an integral component where a portion is an extension of another portion and / or otherwise later permanently connected together or can be separately formed strap portions configured for releasable connection to each other. For example, in one illustrated form, the rear strap 258 includes side extensions that form the front or side straps 252 for extending along the patient's cheeks in use, and the upper strap 254 is connected at each end to respective portions of either the rear 258 or side 252 straps on each side of the headgear. In another form, each side strap 252 is attached or releasably connected by a rear connector component to the rear strap 258 of the headgear assembly, e.g., a free end of the rear strap 258 or a connector coupled to the free end, and the upper strap 254 is integrally formed with or releasably connected to the rear strap 258. In yet another form, the upper strap 254 includes side extensions that form the front or side straps 252 for extending along the patient's cheeks in use, and the rear strap 258 is (permanently or releasably) connected at each end to respective portions of either the upper 254 or side 252 straps on each side of the headgear.

[0232] In one form, the headgear can be automatically adjustable and / or can include one or more directional locks that allow the headgear to decrease in length with a relatively small amount of resistance and withstand an increase in the length of the headgear. In some configurations, the locking force of the directional lock can be overcome to allow for extension of the headgear for donning of the interface assembly. In some forms, the yoke 208 can form a collector for filaments used in an automatically adjustable headgear system. In this form, the yoke 208 can include one or more directional locks, each of which can include a washer mechanism configured to frictionally engage the filament during extension of the headgear but allow relatively frictionless movement during storage of the headgear. The washer mechanism can be incorporated within an end of the yoke 208, and the body of the yoke can be substantially hollow to receive the filament therein. The headgear and any portion thereof can be configured in accordance with 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, which are hereby incorporated by reference in their entirety.

[0233] Each side strap 252 can include a free end to which a connector can be attached. Each connector can engage a complementary strap connector located on the yoke 208. In this embodiment, the yoke 208 is substantially elongate and includes strap connectors located at or near each end of the yoke 208 or each end of the yoke 202.

[0234] The connection between the side strap 252 and the yoke 208 can be in any suitable form of connection such as a snap connection, a screw and threaded type connection, or a hook connection. 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 can include an opening such as a hole or recess configured to receive the connector of each respective side strap 252 to secure the end cap 291 to each end of each respective side strap 252. The end cap 291 is then connected to each respective end of the yoke 208 either releasably (e.g., via a snap arrangement) or permanently, thereby connecting the yoke 208 to the side strap 252 of the headgear assembly. In another form, the free ends of the side straps 252 are directly coupled or permanently fixed within each respective end cap 291, and each respective end cap 291 is then connected to each respective end of the yoke 208 either releasably or permanently, thereby connecting the yoke to the side strap 252 of the headgear assembly.

[0235] Referring to FIGS. 68, 70, and FIGS. 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 contemplated, the seal housing 204 can include a concave region 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 more linear 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 within 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 upper 266A and lower 266B walls. In the illustrated embodiment, the connector recesses 271 are positioned adjacent to or proximate 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 edge of the surfaces facing the interior of the upper wall 266A and the lower wall 266B). The yoke 208 includes connector protrusions 293 that project rearwardly from above, below, and / or the rear of the yoke 208. In the illustrated embodiment, the yoke 208 includes connector protrusions 293 on each side of the center of the yoke 208. In the illustrated embodiment, the yoke 208 includes a yoke front 294A and a yoke back 294B that are joined together as described in more detail herein, and the connector protrusions 293 are formed in the yoke back 294B. The connector recesses 271 of the yoke channel 266 are configured to receive complementary connector protrusions 293 when the seal housing 204 and the yoke 208 are joined together to form a snap - type connection between the seal housing 204 and the yoke 208. When the seal housing 204 and the yoke 208 are joined together, the retaining lip 271A engages the yoke 208 in front of the connector protrusions 293, contributes to the snap - type connection, and holds the yoke 208 in the yoke channel 516. In the illustrated embodiment, the connector protrusions 293 and the connector recesses 271 have a square or rectangular profile, which inhibits the yoke 208 from rotating and disengaging from the yoke channel 266.

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

[0238] In some embodiments, the yoke 208 or the central portion of the yoke 208 is the same as, similar to, or has a corresponding depth (when viewed from the top, for example in FIG. 84) as the depth of the yoke channel 266 so that the yoke 208 does not or substantially does not protrude from the yoke channel 266. In other embodiments, as shown in FIG. 46, at least a portion of the yoke 208 can protrude beyond the yoke channel 266.

[0239] As shown in FIGS. 84 and 85, in the illustrated embodiment, the rear or back surface of the yoke 208 includes a rear step or transition at 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, when the yoke 208 is coupled to the seal housing 204, the lateral portions 302 of the yoke 208 that are positioned outwardly lateral to the yoke channel 266 have a depth 304 (at least in the direction from front to back) or thickness that is greater than the depth or thickness 306 of the central portion 300 of the yoke 208 that is positioned within the yoke channel 266 when the yoke 208 is coupled to the seal housing 204. The step or transition forms or defines a contact surface 308 at the transition between the central portion 300 and the lateral portions 302 of the yoke 208. When the yoke 208 is coupled to the seal housing 204, each of the contact 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 contact surfaces 308 and the lateral edges 310 serve to properly align the yoke 208 with the seal housing 204 during assembly. The contact surfaces 308 and the lateral edges 310 also, or alternatively, provide a more robust 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 the yoke 208 assembly.

[0240] As described above, in this embodiment, the yoke 208 has an asymmetry between its upper edge or surface 292A and its lower edge or surface 292B. Referring to FIG. 86, in this embodiment, the upper edge 292A is more linear 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 width of the yoke between the end caps 291. In the illustrated embodiment, as shown in FIGS. 86 and 87, 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. In this embodiment, the height of the yoke in the central region 300 gradually decreases via the curved (e.g., concave) surface profile of the lower edge 292B of the yoke in the central region to the top of the center of the yoke where the height is most reduced.

[0241] Referring to FIGS. 84 - 87, in this embodiment, the various depths (when viewed from the top) and height profiles (when viewed from the front) of the yoke 208 along its length provide various overall thickness profiles along the yoke length. For example, the overall thickness (in depth and height) of the yoke in the central region 300 is smaller or thinner than the overall thickness (in depth and height) of the lateral regions 302. In particular, the yoke can also be considered to have a thin central region 300 and thicker lateral regions 302 on both sides of the central region. The thinner region 300 is generally received in the yoke channel 266 of the seal housing 204, while the thicker lateral regions extend outwardly away from the sides of the seal housing 204 without contacting the seal housing 204. The length, thickness, and convex curvature profile of the yoke are configured to blend with the seal housing and also configured such that the lateral sides of the yoke do not contact the user's face during use.

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

[0243] Referring to FIG. 86, the overall width 301A of the yoke 208 between each lateral edge (when viewed from the front as shown in FIG. 86, for example) is in the range of approximately 60 mm to approximately 120 mm. Referring to FIG. 87, the overall depth 301B of the yoke 208 from the front to the rear end cap 291 (when viewed from the side as shown in FIG. 87, for example) is in the range of approximately 30 mm to approximately 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 one or two end caps 291 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 crack 312 (shown in FIGS. 82, 84, and 85) between the yoke front 294A and the yoke back 294B is in the center or substantially in the center. This improves the ease of manufacture.

[0245] The yoke front 294A and the yoke back 294B can be joined together via a snap fit. In the illustrated embodiment, the yoke front 294A includes a yoke fastener 314 that projects rearwardly from the back surface of the yoke front 294A. In the illustrated embodiment, the yoke fastener 314 is positioned centrally or substantially centrally with respect to the yoke front 294A. The yoke back 294B includes a fastener hole or recess 316 sized, shaped, and positioned to receive the yoke fastener 314 such that when the yoke front 294A and the yoke back 294B are joined together, a snap-type connection is formed. The central connection between the yoke front 294A and the yoke back 294B via the yoke fastener 314 and the fastener hole or recess 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 hole or recess 316 and the yoke back 294B includes the yoke fastener 314. In some embodiments, the fastener hole or recess 316 includes one or more fasteners or interference ridges 318 (see FIG. 88) that extend along the upper and / or lower edges of the fastener hole or recess 316 (e.g., along the sides) and project into the fastener hole or recess 316 from the upper and / or lower edges. In some embodiments, the yoke fastener 314 includes one or more corresponding notches that extend along the upper and / or lower surfaces of the yoke fastener 314 (e.g., along the sides) sized, shaped, and positioned to receive the fastener ridges 318 such that a snap-type connection is formed. 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 the surface of the yoke fastener 314.

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

[0247] In this embodiment, the yoke back 294B includes an upper alignment bead 322a that protrudes forward from the yoke back 294B and extends along the length of the yoke back 294B adjacent to or near the upper surface of the yoke back 294B, and / or a lower alignment bead 322b that protrudes forward from the yoke back 294B and extends along the length of the yoke back 294B adjacent to or near the lower surface of the yoke back 294B. The yoke front 294A (see FIG. 90) includes an upper alignment groove 324a on the back surface of the yoke front 294A that extends along the length of the yoke front 294A adjacent to or near the upper surface of the yoke front 294A, and / or a lower alignment groove 324b on the back surface of the yoke front 294A that extends across the length of the yoke front 294A adjacent to or near the 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 joined together. The alignment beads 322a, 322b and the alignment grooves 324a, 324b facilitate correctly aligning the yoke front 294A and the yoke back 294B. The alignment beads 322a, 322b and the alignment grooves 324a, 324b may also or alternatively, for example, resist or oppose torsion between the yoke front 294A and the yoke back 294B and support against torsion. In some embodiments, the alignment beads 322a, 322b and the alignment grooves 324a, 324b may engage positively with each other in the form of, for example, a friction fit or a snap fit connection.

[0248] The end cap 291 serves to fix the yoke front 294A and the yoke back 294B together by clip-on or snap-fitting over or on top of the lateral ends of the yoke front 294A and the yoke back 294B. The end cap 291 may also enable connection of the front strap 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 to 98, the side ends of the yoke front 294A and the yoke back 294B include or are formed by the end cap inserts 326. The end cap inserts 326 can be integrally formed with the side ends of the yoke front 294A and the yoke back 294B, or can be attached to the side 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 side portions of the yoke 208. The end cap 291 has an internal cavity 328 for receiving the end cap insert 326. During assembly, the end cap 291 is hinged or snap - fastened onto the end cap insert 326 as shown in FIG. 93.

[0250] As shown in FIG. 98, each end cap 291 includes a retaining hole 330 on one side (e.g., the back side in the illustrated embodiment) and a retaining notch 332 on the opposite side (e.g., the front side in the illustrated embodiment). In other embodiments, the positions of the retaining hole 330 and the retaining notch 332 can be reversed. Positioning the retaining hole 330 at the rear of the end cap 291 in the illustrated embodiment advantageously hides the retaining hole 330 during use, which provides an improved aesthetic appearance. The retaining notch 332 extends forward from the cavity 328 into the end cap 291. The end cap insert 326 includes a first retaining feature 334 on one of the front and back surfaces (e.g., extending rearward from the yoke back 294B portion of the end cap insert 326 in the illustrated embodiment) and a second retaining feature 336 on the opposite surface (e.g., extending forward from the yoke front 294A portion of the end cap insert 326 in the illustrated embodiment). To attach the end cap 291 to the yoke 208, e.g., the end cap insert 326, as shown in FIG. 94, the retaining hole 330 engages with the first retaining feature 334. The first retaining feature 334 then functions as a hinge or pivot point, and the end cap 291 pivots over the end cap insert 326 in the direction indicated by the arrow in FIG. 93 until the second retaining feature 336 and the retaining notch 332 engage, e.g., by a raised portion or snap-fit connection. The hinge connection can provide a strong connection between the yoke 208 and the end cap 291 with a reduced length 338 of the end cap insert 326 (shown in FIG. 144). The end cap 291 can thus be more steeply tapered. The reduced length of the end cap insert 326, the end cap 291, and / or the yoke 208 as a whole can advantageously reduce or minimize the yoke 208 that abuts against the patient's face.

[0251] In the illustrated embodiment, the first retaining feature 334 is or includes a post that extends rearward from the yoke back 294B and is oval or stadium-shaped. 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 coplanar or substantially coplanar with the back surface of the yoke back 294B. This increases the contact area and interaction between the end cap 291 and the end cap insert 326 and increases the retaining force. The connection between the end cap 291 and the end cap insert 326 can thus resist greater torsional and / or rotational forces about the joint along the length of the yoke 208.

[0252] In the illustrated embodiment, the second retaining feature 336 is or includes a raised tab that extends 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 introduction portion 336a at one edge in the illustrated embodiment, for example a lateral edge (with respect to the yoke 208), which allows the end cap 291 to be more easily hinged or pivoted above and / or on the second retaining feature 336.

[0253] In some embodiments, the end cap 291 may be overmolded onto an end of a braided element (e.g., side strap 252) of an automatic headgear adjustment mechanism, such as the braided elements 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 PCT / IB2017 / 051522, and PCT Publication No. WO 2014 / 175752, which are hereby incorporated by reference in their entirety. The core element or filament 340 may extend within the braided element (e.g., side strap 252). The end cap 291 may connect the braided element, 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 be automatically adjustable or may form a collector for a core element, such as filament 340, used in an automatically adjustable headgear system. As shown in FIG. 91, the yoke front 294A includes an upper straight track 296A and a lower straight track 296B. In this embodiment, a straight track divider projects rearwardly from the back or inner surface of the yoke front 294A. In some embodiments, the yoke fastener 314 is formed or functions as a straight track divider that extends generally diagonally across a portion of the length of the yoke front 294A. In the illustrated embodiment, the divider wall 344 extends between the straight tracks that face each of the washer housings 295. The divider wall 344 separates the opposing straight tracks from the washer housings 295 to prevent the free end of the filament 340 from being captured in the washer housings 295 where it faces during storage. In the illustrated embodiment, the straight tracks 296A, 296B are not symmetric mirror images due to the asymmetry of the upper and lower edges of the yoke 208.

[0255] FIG. 92 shows a deformed configuration of the yoke 208 in which the straight tracks 296A, 296B extend into and terminate within the end cap 291. The lengths of the straight tracks 296A, 296B can thus extend beyond the ends of the yoke front 294A and the 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 during use. The filament 340 forms part of an automatic headgear adjustment mechanism that allows the entire 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 straight tracks 296A, 296B can be increased or extended by about 5 mm. In such embodiments, the total length of the headgear loop in the extended state can thus increase by about 10 mm.

[0256] An embodiment of a directional lock for an auto-adjusting headgear, which will be described in further detail with reference to FIGS. 99-102, is shown. The directional lock includes a washer housing 295, first and second lock 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 lock 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 need not necessarily be physically separate spaces, but may be part of a chamber. The housing 295 has two end walls 1814, which, 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 each other. 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 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 a pair of an inner wall 1812, one of the end walls 1814, and side walls 1816, which extend between the end walls 1814 of the housing 295. The first and second chambers 1840, 1842 are configured to 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 fixtures 1850 aligned with opposing side walls 1816 of the housing 295. Each of the washer fixtures 1850 is configured to pivotally hold one of the first or second lock washers 1820, 1822 within the respective first or second chamber 1840, 1842. The washer fixture includes a circular bush 1852 and an elongate slot 1854, the circular bush 1852 intersecting the bottom of the housing so as to form an inlet. The inlet is configured to allow the first and / or second lock washers 1820, 1822 to be received within the washer fixture 1850. The slot 1854 extends radially from the circular bush 1852 towards 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 has substantially the same width W as the housing 295, and the arm 1826 is narrower for fitting 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, the first section 1872 extending radially or perpendicularly from the cylindrical shaft 1824, and the second section 1874 extending at an obtuse angle from the end of the first section 1872. The first section 1872 of the arm 1826 of the first washer 1820 is shorter than the first section 1872 of the arm 1826 of the second washer 1822. The angle between the first and second sections 1872, 1874 of the arm 1826 of the first washer 1820 is greater than the corresponding angle of the second washer 1822. The angle is selected such that the second section 1874 of one or both of the first and second washers 1820, 1822 is substantially flat with respect to the corresponding wall (e.g., inner wall 1812 and end wall 1814, respectively) of the housing 295 at one position 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 different in size depending on 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 shafts 1824 of the first and second lock washers 1820, 1822 have a diameter substantially the same as the diameter of the circular bush 1852 of the washer fixing device 1850, and are configured to be received and held by the circular bush 1852 in a snap - type configuration. The snap - type configuration is provided by an inlet of the circular bush 1852 that is narrower in width than the diameter of the cylindrical shaft 1824. The slots 1854 of the washer fixing device 1850 are configured to allow the inlet to be bent and opened to increase the ease with which the first and second lock washers 1820, 1822 can be pushed through the inlet and assembled into the housing 295. The first and second washers 1820, 1822, when assembled within the first and second chambers 1840, 1842 of the housing 295, 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 opening 1860 of the housing 295 and the openings 1876 of the first and second washers 1820, 1822. Applying tension to the core member 340 pivots the first and second lock washers 1820, 1822 backward and / or forward between the locked position and / or the open position. FIGS. 99 and 100 show the directional lock in the 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). The force applied to the core member 340 in this configuration pivots the first and second lock washers 1820, 1822 in a counterclockwise direction, such that the path of the core member 340 through the directional lock 1800 is non-linear or tortuous, restricting movement of the core member 340. FIGS. 101 and 102 show the directional lock in the 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 lock washers 1820, 1822 pivot in a clockwise direction such that the circular openings 1876 and the core opening 1860 are substantially linearly aligned. 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 PCT Application Publication No. WO 2014 / 175752.

[0261] Summary of Features of the Fourth Embodiment The 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 an auto-adjusting headgear (or any single-sided strap type headgear) without the need for a forehead T-piece component, · By the yoke 208, the headgear 250 can be releasably connectable to the seal housing 204 and the nasal seal 202, · The nasal support 224 in combination with a lower profile or shorter nasal seal and ribs 241 contributes to increasing mask stability on the user's face during use. · The low profile or lower height of the nose seal means that the seal contacts the user's nasal bridge at a lower position than conventional nose seals, which is generally less obtrusive than before. · The releasably connectable conduit frame 211 is symmetrical and allows the conduit frame to be connected in either of two orientations. · Auxiliary seal lips (e.g., including 284e, 284F) at the end 284A of the central gripping portion 284 of the conduit frame 211 assist in creating a backup seal at the connection of the conduit frame into the seal housing.

[0262] Fifth Embodiment - Various Alternative Nasal Mask Interface Configurations Various forms of the nasal mask interface assembly of the fifth embodiment are described herein with reference to FIGS. 103 - 149. The various forms of the nasal mask interface of the fifth embodiment are generally similar in configuration and structure, although different from the fourth embodiment. The following description focuses on the differences between the embodiments. It will be understood that the various alternative forms and configurations described with reference to the fourth embodiment or other disclosed embodiments may also apply to the forms of the fifth embodiment.

[0263] First Form of the Nasal Mask Interface of the Fifth Embodiment With reference to FIGS. 103 - 117, a first form 400 of the nasal mask assembly of the fifth embodiment is described. Similar to the fourth embodiment, the nasal mask interface 400 includes a nose 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 the figure at 104, the nose seal 402 includes a sub - nasal support 424 that extends within the mask cavity. Similar to the fourth embodiment, the nasal mask interface 400 of the first form may be connected to a headgear assembly of the aforementioned type via a yoke 408 fixture.

[0264] In this embodiment, the central lower part or portion of the outer housing 404 of the seal includes an integral intake hole 465. In this embodiment, the intake hole 465 is an oval protrusion or extrusion from the seal housing and is configured to be directly or indirectly connected or coupled to a gas supply conduit to supply gas flow into the mask cavity when in use. In this embodiment, the arrangement configuration of the biasing ventilation holes 412 is provided in an arrangement around the periphery of the intake hole protrusion 465. The arrangement of the biasing holes 412 may extend around the entire periphery of the intake hole protrusion 465 or one or more portions of the periphery, depending on the embodiment.

[0265] With reference to FIGS. 107 - 110, the connection of the yoke 408 to the seal housing 404 is described in more detail. In this embodiment, the yoke channel 466 is modified (compared to the fourth embodiment) in that it provides one larger positioning feature 468 that is shaped and dimensioned to receive complementary portions of the thicker lateral regions 410 of the yoke 408 on each lateral side of the yoke channel 466.

[0266] In this embodiment, a concave elongated channel 414 is provided in the lower part of the back surface of the yoke channel 466 that is shaped and dimensioned to receive a complementary shaped elongated protrusion or rib 416 that lies along the bottom of the back surface of the thinner central region 412 of the yoke 408. In particular, the protrusion 416 of the yoke is configured to engage within the complementary recessed channel 414 of the yoke channel 466 by interference or friction fit, thereby coupling the yoke 408 to the seal housing 404.

[0267] Referring to FIGS. 112 and 113, in this first form of the fifth embodiment, the nose seal 402 has a channel 418 provided in its outer seal housing connection edge. This channel 418 is configured to engage a complementary shaped and dimensioned ridge 420 (see FIG. 110) that extends around the opening of the seal housing 404. The coupling of the nose seal 402 to the seal housing 404, particularly 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 understood that in an alternative embodiment, this configuration can be reversed with the channel provided in the seal housing 404 and the projecting ridge provided in the nose seal 402.

[0268] Referring to FIGS. 111 and 112, the lower central connection portion 419 of the sub-nasal support 424 is the same as that of the fourth embodiment. The main lateral portion of the sub-nasal support 424 or the lateral connection portion 421 of the band 422 connects directly to the lateral outer wall portion of the nose seal in the region of the channel 418. In this embodiment, the lateral connection portion of the main lateral band 422 is lower on the nose seal compared to the fourth embodiment, which provides the main lateral band 422 in the central region of the mask cavity with a generally flatter curvature compared to the fourth embodiment.

[0269] The nasal mask interface of the second form of the fifth embodiment Referring to FIGS. 118 - 128, the nasal mask interface 450 of the second form of the fifth embodiment is described. The nasal mask interface 450 of the second form is the same as the first form, and like reference numerals correspond to like components.

[0270] The main difference in the second form of the nasal mask interface relates to the configuration of the yoke 451 and the yoke channel 452. In this second form, the yoke channel 452 does not provide specific positioning features. Rather, the yoke channel 452 is configured to receive and hold the yoke 451 so that it cannot move via an interference fit between the surface of the channel 452 and the abutting outer surface of the yoke 451. In particular, referring 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 push it into the yoke channel 452 to create a semi-permanent interference fit connection.

[0271] The third form of the nasal mask interface of the fifth embodiment Referring to FIGS. 129 - 139, the third form of the nasal mask interface of the fifth embodiment is described.

[0272] The third form of the nasal mask interface is similar to the first and second forms, and similar components use similar reference numerals. The nasal mask interface assembly of the third form uses an interference fit to couple the yoke 451 within the yoke channel 454 of the seal housing 404, as in the second form of the nasal mask interface. However, the shape and configuration of the yoke channel 454 of the seal housing 404 in the third form are changed to angle the longitudinal axis of the yoke 451 upward to enable providing 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 lateral 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 indicated at 456, which is the orientation of the first and second forms of the nasal mask interface. The tilt of the yoke angle, along with the angled tilt indicated at 455, is indicated by the longitudinal axis 457 of the yoke 451 of the third form. In this form, the tilt angle is approximately 5°, although it is recognized that the angle can vary as needed.

[0273] Referring to FIGS. 130 and 137 - 139, the nasal seal 402 of the third form includes modifications to the preceding forms. The nasal seal 402 of the third form has an upper lip region 458 that is thicker as shown at 458 in FIG. 130 compared to the thinner upper lip region 459 of the second - form embodiment shown in FIG. 119. This provides greater compression at the bottom or upper lip region of the nasal seal during use and generally a flatter and smoother transition to the contact surface of the nasal seal.

[0274] The lower connection portion 460 of the sub - nasal support 424 is also thinner laterally at the connection edge of the nasal aperture as shown at 461 in FIG. 137 compared to the wider connection portion shown at 462 in FIG. 121 of the second form. The lateral connection portion 462 of the main lateral band of the sub - nasal support 424 is also thicker and extends further into the nasal seal from the connection channel edge 464 as shown in FIG. 139. For example, the connection portion 462 can be integrally coupled to the channel connection edge 464 of the nasal seal and a part of the inner surface of the side wall. In some embodiments, the lateral connection portion 462 can also be coupled to or extend to a contact surface of a part of the inner surface of the nasal seal.

[0275] In this third form, the length of the sub - nasal support 424 from the connection edge of the nasal aperture to the rear edge of the main lateral band 465 is lengthened to accommodate a longer nose. By way of example only, the length shown at 463 can be approximately 22.8 compared to 17.9 mm in the first and second forms of the fifth embodiment.

[0276] The fourth - form nasal mask interface of the fifth embodiment Referring to FIGS. 140 - 149, the fourth - form nasal mask interface 470 is described in more detail. The fourth - form nasal mask interface 470 is substantially similar to the third - form nasal mask interface 460, and like components have like reference numerals.

[0277] The first main difference in the fourth form as the mask interface 470 for the third form is that the bias ventilation port 471 has moved from the intake hole 465 to the upper central region of the seal housing 404 above the yoke channel. As shown, the bias ventilation port includes a cluster or arrangement of holes or apertures arranged at a close spacing indicated at 471.

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

[0279] Additionally, the length of the nasal support extending from the central connector at the edge of the nasal aperture to the rear edge of the main lateral band, indicated at 474 in FIG. 148, is further lengthened to approximately 26.49 mm compared to 22.8 mm in the nasal seal of the third form.

[0280] Sixth Embodiment Referring to FIGS. 150 - 154, a sixth embodiment 500 of the nasal mask interface is described. The substantial configuration of the nasal mask interface 500 is similar to the previous embodiments, particularly the fourth form 470, and like reference numerals represent like components. The following description mainly focuses on the differences, and it will be understood that alternative forms considered with reference to the previous embodiments may also apply to this sixth embodiment.

[0281] The main difference between the nasal mask interface 500 compared to the fourth form 470 is that the seal housing 504 is reconfigured by exchanging the positions of the yoke connection channel 454 and the air intake hole 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 nasal mask assembly 470 of the fourth form. In some embodiments, the lower positioning of the yoke in the seal housing may limit the amount by which the frame rolls up on the user's face.

[0282] The nasal mask interface 500 also includes an alternative bias event arrangement configuration. In this embodiment, two bias event hole clusters 501 are provided in the upper lateral regions of the seal housing on both sides of the air intake conduit 465.

[0283] Seventh Embodiment With reference to FIGS. 155 - 162, various alternative forms of the nasal seal for use in a nasal mask assembly are described. As will be appreciated by those skilled in the art, the alternative forms of the nasal seal of this seventh embodiment can be used with any of the described embodiments of the nasal seal interface, in particular any of the various forms of the seal housing, yoke assembly and connections, and headgear assembly.

[0284] First Form of the Nasal Seal of the Seventh Embodiment Referring to FIGS. 155 - 157, the nasal seal 600 of the first embodiment is described. The nasal seal 600 of the first embodiment of this implementation is similar to the previously described nasal seal and includes a subnasal support 601 indicated by 601. The main difference from this nasal seal 600 is that it is provided with lateral wing - like portions or flaps 602 along at least a part of the lateral side of the contact surface 603. In this embodiment, the wing - attached portion 602 is located approximately in the middle or intermediate region on the lateral side of the nasal seal. The wing - like portion 602 is shaped and configured to provide an additional contact surface that engages the user's cheekbone / nose region to increase stability, and the increased ground contact area of the contact surface of the nasal seal on the user's face helps to reduce rolling or locking during use in some embodiments. Referring to FIG. 157, each of the wing - like portions 602 includes a connecting portion 602A that joins to the side - wall portion of the nasal seal behind the contact surface 603 to provide a wing - attached contact surface on each lateral side of the nasal seal, and an extension portion 602B that extends forward of the contact surface 603. The wing - attached contact portion 602 provides additional support to prevent the nasal mask from rolling up on the user's face.

[0285] The nasal seal of the second form of the seventh embodiment The nasal seal 610 of the second form is similar to the first form 600 in that it includes a lateral wing - attached portion 604 that extends from the lateral side of the nasal seal. Compared to the nasal seal 600 of the first form, the wing - like portion 604 is longer and is adapted to follow the flat region of the cheekbone / nose region. As shown in the figure, in FIG. 161, the curved or undulating profile of the wing - attached region is adapted to fit the contour of the user's face. Similar to the first form, the wing - like portion 604 includes a connecting portion 604A that joins the wing - like portion to the lateral side of the nasal seal, and an extension or contact portion 604B that is configured to contact the user's cheekbone / nose region of the face to stabilize the nasal mask on the user's face and prevent rolling as in the first form.

[0286] Referring to FIG. 162, a nasal mask interface including a second form of nasal seal 610 with a wing portion 604 is shown in a state fixed to a user's head via the headgear assembly of the aforementioned type. As shown, the winged region 604 can be loosely coupled or moored to the straps of the headgear assembly, such as the side or front straps 252 on each side of the nasal seal. In certain embodiments, the wing portion may be provided with a coupling or connection mechanism at or towards the end of the wing portion 604 for attachment to the side strap 252. In one form, the connector 606 can be a loop member or the like, through which the side strap 252 extends, thereby loosely coupling or mooring the side strap to the winged portion 604 of the nasal seal. In other forms, the wing portion 604 can be separated or unmoored from the side strap 252.

[0287] Eighth Embodiment Referring to FIGS. 163 - 170, various alternative forms of nasal seals for use in a nasal mask assembly are described. As will be appreciated by those skilled in the art, the alternative forms of the nasal seal of this eighth embodiment can be used with any of the described embodiments of the nasal seal interface, particularly any of the various forms of the seal housing, yoke assembly and connection, and the headgear assembly.

[0288] First Form of Nasal Seal of the Eighth Embodiment Referring to FIGS. 163 and 164, a first form of nasal mask interface 700 is shown in FIG. 163, which includes a nasal seal 701, a seal housing 702, and a gas supply conduit 703. In this first form of the eighth embodiment, the nasal mask interface additionally includes a forehead support component indicated at 704. The forehead support component is configured to engage the user's forehead between the user's eyebrows or above the user's eyebrows when the mask starts to roll up or begins to roll up on the face, and to counteract this rolling-up force. In particular, the dimensions and angular orientation of the forehead support 704 are such that during rest or normal use, the forehead support neither engages nor is displaced from the user's forehead, and engages only to counteract upward rolling of the nasal mask during use.

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

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

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

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

[0293] Referring to FIGS. 169 and 170, the nose seal is shown in place on the user, and for clarity, the remainder of the nasal mask interface assembly is omitted from the figure. As shown, during rest and normal use, the upper support protrusion 712 is configured to be offset or displaced from the user's nasal bridge. The support protrusion 712 locks or pivots inward towards the user's nasal bridge region to counter the upward rolling force only when the nasal mask begins to roll up or pivot upward on the user's face during use. In this embodiment, during rest, the displacement of the support protrusion 712 can be approximately 3 mm from the user's nasal bridge.

[0294] Ninth embodiment Referring to FIGS. 171 - 185, various alternative forms of the nose seal for use in a nasal mask interface are described. As will be appreciated by those skilled in the art, the various forms of the nose seal can be used with any of the described nasal mask interface assemblies.

[0295] Nose seal of the first form of the ninth embodiment Referring to FIGS. 171 to 174, the nose seal 750 of the first form of the ninth embodiment is substantially the same as the previously described nose seal, and includes a subnasal support 752 indicated by 752. The nose seal 750 of the first form further includes a thickened region in the upper side portion of the contact surface 754 that adds support to the upper region or cushion of the nose seal 750. As shown in the drawing, the thickened region 754 is located at or adjacent to the proximal ends on both sides of the bridge region of the contact surface indicated by 751.

[0296] The nose seal 750 of the first form further includes a pair of support ribs 756 located within the thickened region 754. The support ribs 756 extend in a direction that is substantially radial with respect to the central region of the nose seal or the nasal aperture, rather than horizontally or vertically. The support ribs 756 add support from the inner surface of the nose seal within the mask cavity to the upper region of the nose seal and assist in reducing the upward rolling of the nasal mask interface during use.

[0297] Referring to FIG. 174, the support ribs are located above the lateral connection portion 758 of the subnasal support 752. In other words, the support ribs 756 in this form are spaced apart from the subnasal support connection portion 758. As shown in the drawing, the support ribs 756 include a part of the contact surface but are connected to a part of the side wall of the nose seal that terminates in front of the thin edge region around the nasal aperture.

[0298] In this embodiment, the support ribs 756 inside the nose seal have an angular direction with respect to the vertical center line extending through the nose seal. In this embodiment, the angular direction indicated by 760 can be in the range of approximately 50° to approximately 70°, preferably approximately 60°. In other words, the ribs have an angular direction of approximately 60° with respect to the vertical center line extending through the nose seal.

[0299] Nose seal of the second form of the ninth embodiment Referring to FIGS. 175 to 182, a second form of the nose seal of the ninth embodiment will be described.

[0300] The nose seal 770 of the second form of the ninth embodiment includes a shape modified with respect to the nose seal 750 of the first form. In particular, the nose seal 770 of the second form is vertically shorter, for example, by approximately 10 mm. The nose seal generally has the same configuration as the previously described nose seal. Referring to FIG. 175, the overall height of the nose seal 770 shown at 772 is approximately 47 mm, and the overall width of the nose seal shown at 774 is approximately 59 mm. Referring to FIG. 177, the overall depth of the nose seal 770 shown 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 contact surface of the nose seal is shown at 771, and the outside including the seal housing hole is shown at 773.

[0302] Referring to FIG. 179, the difference between the upper contact points of the nose seals of the first and second forms of the ninth embodiment on the user's nasal bridge can be seen. The nasal bridge contact point for the nose seal 770 of the second form is shown at 777, which is below the typical contact point on the nasal bridge of the taller first form of the nose seal shown at 778. The reduced vertical height of the nose seal 770 of the second form allows it to contact the nasal bridge at a much lower point, for example, within the area or region of the nasal bridge that extends between the tip of the nose and the center of the nasal bridge or up to the center of the nasal bridge, contacting a part of the nasal bridge. This lower contact area can be more uniform among a plurality of users compared to conventional nose seals, thus increasing the proportion of the population who can use the nasal mask without problems.

[0303] Referring to FIGS. 181 and 182, for comparison to show the difference in shape, the nose seal 750 of the first form is shown covered by the shorter nose seal 770 of the second form.

[0304] The nasal seal of the third form of the ninth embodiment With reference to FIGS. 183 to 185, the nasal seal 780 of the third form of the ninth embodiment will be described.

[0305] The nasal seal 780 of the third form in this embodiment is similar in size and shape to the shorter nasal seal 770 of the second form. The main difference is that the nasal seal 780 of the third form additionally includes support ribs 782 on the inner surface of the nasal seal. In particular, at each lateral end, the main lateral portions of the subnasal support 781 are connected to the respective support ribs 782. As shown, the support ribs 782 have a substantially vertical or nearly vertical direction. The connection portions to the subnasal support and the support ribs are configured in the same manner as those described with reference to the nasal seal of the fourth embodiment.

[0306] In this nasal seal 780 of the third form, the ribs 782 also perform the dual function of strengthening the connection of the subnasal support within the nasal seal and providing structural support to the upper region of the nasal seal. In this third form, the subnasal support has a more or less square shape rather than a U-shape. In particular, the main lateral portions include a substantially flat or horizontal central region 783 and two substantially vertical lateral portions 784 extending upward from each end of the central region.

[0307] Tenth embodiment With reference to FIGS. 186 to 205, various forms and configurations of the seal housing and conduit frame of the nasal mask interface will be described. It will be understood that these various forms of modified seal housings and conduit frames can be incorporated into the various embodiments of the nasal mask assembly described to provide alternative configurations.

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

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

[0310] Referring to FIG. 188, the body of the conduit frame 800 is configured to provide a downward angle of approximately 30° shown at 814 with respect to the horizontal. In particular, the axis at the conduit end of 802 is angled or offset with respect to the axis of the hole at the seal housing connection end 801. It will be understood that the angle can be various.

[0311] Conduit Frame Configuration of the Second Form of the Tenth Embodiment Referring to FIGS. 190 - 193, the conduit frame 820 of the second form of the tenth embodiment is described. In this embodiment, a corrugated gripping region or portion 822 is also provided at the conduit connection end 821 of the conduit frame 820. The seal housing connection end shown at 823 is larger and includes a wing - like portion that overlaps a part of the outer surface of the seal housing 824 adjacent to the intake conduit projection 825 of the seal housing.

[0312] As shown in FIG. 191, the duct frame includes a complementary duct 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 the duct protrusion 825 of the seal housing 824.

[0313] As shown in FIG. 192, the winged side portion of the duct frame at the seal housing connection end 823 may include holes 828. These holes may provide a surface for the diffuser mat to provide a bias vent when the seal housing is provided with aligned complementary holes.

[0314] Conduit Frame Configuration, Third Form of the Tenth Embodiment Referring to FIGS. 194 - 197, the conduit frame 830 of the third form is described. The conduit frame 830 of the third form is substantially similar to the conduit frame 820 of the second form. The main difference is that the seal housing 835 is provided with a larger intake hole opening 833 that receives the winged region 832 of the conduit frame as a whole to provide a fused surface. In other words, there is no overlap with the winged region of the conduit frame on the outer surface of the seal housing as in the configuration of the second form.

[0315] As shown in FIGS. 194 - 197, protrusions or grooves 832 may be provided on the lateral edges of the winged region of the conduit frame that are configured to snap fit or otherwise engage with complementary grooves or protrusions 833 provided on the peripheral surface of the seal housing 835 without holes 831.

[0316] Conduit Frame Configuration, Fourth Form of the Tenth Embodiment Referring to FIGS. 198 - 201, the conduit frame 840 of the fourth embodiment is described. In the conduit frame 840 of the fourth embodiment, a conduit is provided at the seal housing connection end portion indicated by 843, which is received within the complementary conduit 844 of the seal housing 842. The conduit portion 843 of the conduit frame includes either a protrusion or groove 845 on the upper and / or lower surface or other surface that engages with a complementary protrusion or groove 846 aligned through the inner surface of the conduit hole 844 of the seal housing 842.

[0317] Referring to FIG. 201, surrounding the lateral portion of the conduit portion 843 are winged regions 847 extending from the lateral sides of the conduit frame on both sides of the conduit portion 843. These winged regions or portions 847 are received within complementary concave regions 848 provided on the lateral sides of the air intake of the seal housing 842. Generally, the winged regions 846 of the conduit frame and the outer surface profile of the body at the seal housing connection end portion are configured to align or blend with the surface profile of the seal housing in the region surrounding the air intake hole such that when assembled together, as shown in FIG. 198, there is a seamless or fused surface at the interface of the two components.

[0318] On the opposite side of the seal housing connection end portion of the conduit frame, gripping tabs or protrusions 849 are provided that extend laterally from the side of the conduit frame at the gas supply conduit connection end portion of the conduit frame 850. These gripping tabs 849 allow the user to pull the conduit frame from the seal housing as needed. These 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 Referring to FIGS. 202 - 205, the conduit frame 850 of the fifth form of the tenth embodiment is described.

[0320] The conduit frame 850 of the fifth form is the same as the conduit frame 840 of the fourth form. The main difference is that the gripping tabs are replaced by a continuous or row of gripping protrusions indicated at 852 at the gas supply conduit connection end of the conduit frame 850. The finned region 853 and the conduit portion 855 at the seal housing connection end are symmetric with respect to the horizontal plane extending through the axis 856 shown in FIG. 204.

[0321] The conduit frame 850 of the fifth form 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 downward angle of approximately 40° with respect to the axis extending from the seal housing connection end 858, although this angle can be changed as recognized.

[0322] In a symmetric seal housing arrangement configuration, the conduit frame 850 can be connected into the seal housing 862 in either of two orientations rotated 180° relative to each other. Additionally, the 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 the user's leg or extend toward the user's leg, or alternatively, in a second orientation with the conduit connection end 859 angled upward so that the conduit can 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 will be understood that any one or more of these embodiments or configurations can be applied to the general embodiments described above, either alone or in combination.

[0324] Full-face embodiment The above-described 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 understood that such embodiments may also be adapted to a full face or oro-nasal mask configured to seal around both the user's nose and mouth so that a treatment gas can be delivered to the user's airway through the nose and mouth. By way of example only, FIG. 206 shows 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 sub-nasal support 124D configuration. The full face seal 102E has a larger contact surface 120E, although the configuration is substantially the same. The enlarged contact surface 120E is configured to seal around the user's nose and mouth, i.e., is shaped to make external contact around both the nose and mouth. The upper region 125 of or towards the nasal bridge region is substantially the same as the foregoing, but the side cheek region 123 extends further downward and is connected by a lower region 121E configured to seal below the user's mouth, for example at the base of their jaw. This larger contact surface allows both the user's nose and mouth to be enclosed within the seal 102E.

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

[0326] In an alternative embodiment, the sub-nasal support may be formed of a material different from the nasal seal. For example, the nasal seal may be formed of silicone, while the sub-nasal support may be formed of a different material, such as, but not limited to, a fabric material, a foam material, neoprene, Breath-o-Prene® material, or thermoplastic polyurethane (TPU). The sub-nasal support may then be permanently bonded or connected within the nasal seal, for example, by an adhesive or welding, to form a single nasal seal component.

[0327] Sub-nasal support and other connection configurations that are not connected so as not to move In the above-described embodiments described with reference to FIGS. 2A-205, the sub-nasal support is typically connected within the nasal seal so as not to move, for example, integrally formed within the nasal seal or permanently connected in another way. In an alternative embodiment, the sub-nasal support may be removably or releasably connected within the nasal seal by a releasable connection assembly at the connection point or location of the aforementioned nasal seal.

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

[0329] The foregoing description of the invention includes its preferred forms. Modifications may be made thereto without departing from the scope of the invention as described by the appended claims.

Claims

1. A nose seal for a nose mask or interface, formed of a flexible material and extending between a side in contact with the face and an outer side, comprising a contact surface defining a nose seal opening, the contact surface being configured to seal against the user's nose, the edge being an inner peripheral edge, and the contact surface terminating at the inner peripheral edge, the contact surface and, A nose sling connected so as not to move within the seal and located behind the nose seal opening, the nose sling comprising a central extension portion connected to the inner peripheral edge of the contact surface in the upper lip region. A nose seal comprising.

2. The nose seal according to claim 1, wherein the nose sling comprises a contact surface oriented to contact at least a part of the lower surface of the user's nose.

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

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

5. The nose seal according to any one of claims 1 to 4, wherein the central extension portion of the nose sling is configured to contact at least a part of the column region on the lower surface of the user's nose between the tip and the base of the nose.

6. The nose seal according to claim 5, wherein the central extension portion of the nose sling is configured to contact most of the column region on the lower surface of the user's nose extending from the base of the nose.

7. The nasal sling is configured to contact a part or a plurality of parts of the lower nasal surface of the user's nose without substantially blocking the user's nostrils that align with the open spaces of the nasal seal openings on both sides of the central extension part. The nasal seal according to any one of claims 1 to 6.

8. At any position of the nasal sling, the thickness of the nasal sling is smaller than its corresponding width. The nasal seal according to any one of claims 1 to 7.

9. The thickness of the nasal sling is substantially the same as the thickness in the region of the contact surface of the nasal seal. The nasal seal according to any one of claims 1 to 8.

10. The central extension part of the nasal sling includes profiles of various thicknesses. The nasal seal according to any one of claims 1 to 8.

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

12. The thinner region of the central extension part of the nasal seal is of a uniform thickness with the edge of the contact surface of the nasal seal. The nasal seal according to claim 11.

13. The width of the central extension part of the nasal sling gradually increases towards the edge of the contact surface of the nasal seal. The nasal seal according to any one of claims 1 to 12.

14. The width of the central extension part of the nasal sling changes along its length such that the central extension part is substantially in the shape or profile of an hourglass. The nasal seal according to any one of claims 1 to 13.

15. The width of the central extension part of the nasal sling is uniform along its length. The nasal seal according to any one of claims 1 to 12.

16. The nasal seal according to any one of claims 1 to 15, wherein at least a part of the central extension portion of the nasal sling is oriented at an angle with respect to a sealing axis extending in a tangential direction between the outermost upper and lower contact points in the central region of the contact surface of the nasal seal.

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

18. The nasal seal according to any one of claims 1 to 17, wherein the nasal seal is defined by the contact surface on the side contacting the face and a side wall portion that extends rearward from the contact surface to the outside of the nasal seal and terminates at an opening or connection edge that is coupled or connected to a complementary seal housing.

19. The nasal seal according to any one of claims 1 to 18, wherein the outside of the nasal seal includes a peripheral channel configured to receive a complementary peripheral ridge of a complementary seal housing for connecting the nasal seal to the seal housing.

20. The nasal seal according to any one of claims 1 to 19, wherein the nasal seal is formed of a material having various thicknesses across the region of the nasal seal, and the nasal seal is defined by a front region that extends from an intermediate boundary toward the face - contacting side of the nasal seal and includes the contact surface, and a rear region that extends from the intermediate boundary toward the outside of the nasal seal, and the rear region is on average thicker than the front region.

21. The nasal seal according to claim 20, wherein the front region includes a tapered edge region that extends around the periphery of the edge of the contact surface, and the tapered edge region is thinner than the remaining portion of the front region.

22. A nasal mask interface assembly, a seal housing, The nasal seal according to any one of claims 1 to 21, which is connected or connectable to the seal housing to define a mask cavity, A headgear including a single left and right strap configured to extend over the user's ears and connect to the seal housing, A nasal mask interface assembly comprising: **Claim 23** The nasal mask interface assembly according to claim 22, wherein the left and right straps of the headgear connect to respective attachment positions on or towards respective sides of the seal housing. **Claim 24** The nasal mask interface assembly according to claim 22 or 23, wherein the seal housing has an arrangement of bias ventilation holes. **Claim 25** The seal housing has an intake opening, and the assembly further comprises a conduit frame releasably received and held in the intake opening of the seal housing, the conduit frame being connected or connectable to an end of a gas supply conduit. The nasal mask interface assembly according to any one of claims 22 to 24. **Claim 26** The conduit frame is a hollow body having an oval shape and is symmetric such that it can be releasably received and held in the intake opening of the seal housing in either of two orientations 180 degrees apart. The nasal mask interface assembly according to claim 25. **Claim 27** The nasal seal is formed of silicone, and the seal housing is rigid and formed of plastic. The nasal mask interface assembly according to any one of claims 22 to 26. **Claim 28** The 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. The nasal seal is permanently or semi - permanently coupled to the seal housing, the nasal mask interface assembly according to any one of claims 22 - 27.

30. The peripheral edge outside the nasal seal is fixed to the complementary - shaped connection edge of the seal housing, the nasal mask interface assembly according to any one of claims 22 - 29.

31. The peripheral edge outside the nasal seal is overmolded onto the complementary - shaped opening edge of the seal housing, the nasal mask interface assembly according to claim 29.

Images