Respiratory interface assembly

Abstract

The respiratory interface assembly includes a patient interface and a headgear device. A seal or cushion of the interface assembly may include thickened portions positioned and arranged to improve sealing and / or user comfort. The headgear device may be connectable to the nasal mask by a connection device configured to provide stability to the nasal mask so that a forehead support is not required. The connection device may inhibit or prevent improper connection. The headgear device may have one or more elastic straps having a composite structure of an outer fabric and a plastic core. The outer fabric may be knit. A rear portion of the headgear device may include a knitted panel or a spacer fabric panel.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of priority of U.S. Provisional Patent Application No. 62 / 914,923, filed on October 14, 2019, the entire disclosure of which is incorporated herein by reference.

[0002] This disclosure relates to a respiratory interface assembly. In particular, this disclosure relates to a nasal mask assembly having a nasal mask, a headgear, and a connection between the mask and the headgear.

Background Art

[0003] In assisted respiration, breathing gas is supplied to a patient through a patient interface via one or more flexible breathing tubes. The patient interface can be a nasal cannula, a nasal mask, a full face or oro - nasal mask, an endotracheal tube, or other known types of interfaces. The patient interface is held in place on the user's head by a headgear device.

Summary of the Invention

Problems to be Solved by the Invention

[0004] It is advantageous to provide a patient interface system having improved operation, sealing, comfort, and adjustment features. Such a system can be a nasal mask assembly. Such an improved system can further assist in improving compliance with gas delivery therapy.

[0005] When reference is made herein to a patent specification, other external documents, or other information sources, this is generally for the purpose of providing a context for considering the features of the present disclosure. Unless otherwise stated, such reference to external documents should not be construed in any jurisdiction as an admission that such documents or such information sources are prior art or form part of the common general knowledge in the art.

[0006] Further aspects and advantages of the present disclosure will become apparent from the following description given by way of example only.

Means for Solving the Problems

[0007] The systems, methods, and apparatuses described herein have innovative aspects, and no single one of them is essential for their desirable attributes or solely responsible. Without limiting the scope of the claims, some of the advantageous features are outlined here.

[0008] One aspect of the present disclosure includes a respiratory interface assembly that includes an interface configured to communicate with a user's airway. The interface includes a frame having a post. The frame defines an opening, and the post defines a part of the opening. The frame opening includes a narrow portion defined by opposing upper and lower surfaces, and the narrow portion is positioned adjacent to the post. A headgear is configured to secure the interface in an operable position on the user's head. The headgear includes a clip having a base and a hook portion extending from the base. The hook portion is configured to engage the post of the frame. The hook portion includes upper and lower surfaces that substantially conform to the shapes of the respective upper and lower surfaces of the narrow portion, such that when the hook portion engages the post, the upper and lower surfaces of the hook portion engage the respective opposing upper and lower surfaces of the narrow portion to resist rotation of the clip relative to the frame about an axis perpendicular to the longitudinal axis of the post.

[0009] In some configurations, the section of the hook portion between the upper and lower surfaces of the hook portion is shaped such that it spans a space when the hook portion engages the post.

[0010] In some configurations, the upper and lower surfaces opposing the post cooperate to define a space. The section of the hook portion between the upper and lower surfaces occupies substantially the entire above space when the hook portion engages the post.

[0011] In some configurations, the opposing upper and lower surfaces are parallel to each other.

[0012] In some configurations, the hook portion defines an inner surface facing the post, an outer surface, and a thickness between the inner surface and the outer surface. The thickness is greatest at a portion located between the opposing upper and lower surfaces when the hook portion is engaged with the post.

[0013] In some configurations, the base of the clip has a height greater than the height of the hook portion so as to contact a portion of the frame adjacent to the opposing upper and lower surfaces of the narrow portion and be configured to limit rotation of the clip about the longitudinal axis of the post.

[0014] In some configurations, the headgear includes at least one semi-rigid side strap configured to extend from the breathing interface along each side of the user's face toward the user's ear, and at least one semi-rigid top strap extending from at least one semi-rigid side strap on a first side of the user's face to at least one semi-rigid side strap on a second side of the user's face.

[0015] In some configurations, at least one semi-rigid side strap includes a branched portion on each side, and each of the branched portions has an upper strap portion and a lower strap portion.

[0016] In some configurations, the headgear further includes a rear portion, the rear strap portion connects to the rear portion above the height of the user's ear, and the lower strap portion connects to the rear portion below the height of the user's ear and in front of the ear.

[0017] In some configurations, the rear portion includes a spacer fabric panel.

[0018] In some configurations, the rear portion further comprises an upper strap and a lower strap, and the upper strap is less stretchable than the lower strap.

[0019] In some configurations, the rear portion comprises a knitted panel.

[0020] In some configurations, the knitted panel is less stretchable in the vertical direction than in the horizontal direction.

[0021] In some configurations, one or both of at least one semi-rigid side strap and at least one semi-rigid top strap include a fabric inner layer, a fabric outer layer, and an inner plastic layer, which are joined by introducing the inner plastic layer in a molten state between the fabric inner layer and the fabric outer layer and curing it.

[0022] In some configurations, the fabric inner layer and the fabric outer layer are knitted fabrics.

[0023] In some configurations, at least one semi-rigid side strap includes a first semi-rigid side strap and a second semi-rigid side strap, and each of the first semi-rigid side strap and the second semi-rigid side strap can be connected to the frame by one of the clips.

[0024] In some configurations, at least one semi-rigid top strap includes a first semi-rigid top strap and a second semi-rigid top strap, and the first semi-rigid top strap and the second semi-rigid top strap can be selectively connected to each other at one of a plurality of available adjustment positions.

[0025] In some configurations, the interface comprises a nose mask seal configured to seal around one or both nostrils of the user, and the nose mask seal has a sealing surface that defines an opening.

[0026] In some configurations, the opening defined by the sealing surface of the nasal mask seal defines an aspect ratio of width to height of about 1.3 to 1.6.

[0027] In some configurations, the height range of the nasal mask seal across all available sizes is from about 47.8 mm to 57.8 mm.

[0028] In some configurations, the nasal mask seal includes a rolling bridge portion.

[0029] In some configurations, the nasal mask seal includes a rim by which the nasal mask seal is fixed to a rigid clip or housing, and the rolling bridge portion is connected to the rear edge of the rim. In other configurations, the rolling bridge portion is connected to the front edge of the rim.

[0030] In some configurations, the nasal mask seal further includes a thickening band located between the sealing surface and the rolling bridge, and further includes a pair of thickening bands extending from the thickening band towards the opening on each side of the nasal mask seal.

[0031] In some configurations, the nasal mask seal further includes a thickening band located between the sealing surface and the rolling bridge, a pair of thickening pads that are intermediate between the thickening band and the opening and are spaced apart from the thickening band, and a pair of joining pads extending between a part of the thickening band and a part of each of the pair of thickening pads.

[0032] In some configurations, the thickening band is thicker than the pair of thickening pads, and the pair of thickening pads is thicker than the pair of joining pads.

[0033] In some configurations, a pair of thickening pads and a pair of joining pads each have a length extending in a peripheral direction around the inside of the nose mask seal, and the length of each of the pair of joining pads is about 15% to 50%, preferably about 20% to 45%, more preferably about 25% to 33% of the length of each of the pair of thickening pads.

[0034] In some configurations, each of the pair of joining pads extends between a part of the thickening band and an upper part of each of the pair of thickening pads.

[0035] In some configurations, the pair of joining pads are provided on side walls of the nose mask seal on both sides of the nose mask seal, and at least a part of the pair of thickening pads is provided on an end wall defining a sealing surface of the nose mask seal.

[0036] In some configurations, the nose mask seal includes a pair of elongate thickening portions, and the pair of thickening portions each extend from a first end at or adjacent to or near a lower corner of each side wall of the nose mask seal at or adjacent to or near the rim, to a second end at or adjacent to or near an end wall defining a sealing surface of the nose mask seal.

[0037] In some configurations, the pair of thickening portions diverge from the first ends towards intermediate portions of each of the pair of thickening portions.

[0038] In some configurations, the pair of thickening portions converge from intermediate portions of each of the pair of thickening portions towards the second ends.

[0039] In some configurations, each of the pair of elongate thickening portions is curved in a direction substantially perpendicular to their respective main surfaces.

[0040] One aspect of the present disclosure is a headgear for a respiratory interface, comprising at least one elastic side strap configured to extend from the respiratory interface along each side of the user's face towards the user's ear, and at least one elastic top strap extending from at least one elastic side strap on a first side of the user's face to at least one elastic side strap on a second side of the user's face.

[0041] One aspect of the present disclosure is a headgear for a respiratory interface, comprising at least one semi-rigid side strap configured to extend from the respiratory interface along each side of the user's face towards the user's ear, and at least one semi-rigid top strap extending from at least one semi-rigid side strap on a first side of the user's face to at least one semi-rigid side strap on a second side of the user's face.

[0042] In some configurations, at least one semi-rigid side strap includes a branched portion on each side, and each of the branched portions has an upper strap portion and a lower strap portion.

[0043] In some configurations, the headgear further includes a rear portion, and the rear strap portion is connected to the rear portion above the height of the user's ear, and the lower strap portion is connected to the rear below the height of the user's ear and in front of the ear.

[0044] In some configurations, the rear portion comprises a spacer fabric panel.

[0045] In some configurations, the rear portion further comprises an upper strap and a lower strap, and the upper strap is less stretchable than the lower strap.

[0046] In some configurations, the rear portion comprises a knitted panel.

[0047] In some configurations, the knitting panel is less stretchable in the vertical direction than in the horizontal direction.

[0048] In some configurations, one or both of at least one semi-rigid side strap and at least one semi-rigid top strap include a fabric inner layer, a fabric outer layer, and an inner plastic layer, which are joined by introducing the inner plastic layer in a molten state between the fabric inner layer and the fabric outer layer and curing it.

[0049] In some configurations, the fabric inner layer and the fabric outer layer are knitted fabrics.

[0050] In some configurations, at least one semi-rigid strap includes a first semi-rigid side strap and a second semi-rigid side strap, and the first semi-rigid side strap and the second semi-rigid side strap are selectively connectable to each other at one of a plurality of available adjustment positions.

[0051] In some configurations, at least one semi-rigid side strap is formed from a semi-rigid plastic core and at least one tubular knitted structure injection-molded thereon.

[0052] In some configurations, at least one of the top strap, the upper strap portion and the lower strap portion of at least one side strap includes a separate tubular knitted structure injection-molded with a plastic core and joined to at least one side strap by an overmolded joint portion.

[0053] One aspect of the present disclosure includes a respiratory interface assembly including any of the headgears described above and an interface configured to communicate with a user's airway.

[0054] In some configurations, the interface comprises a frame having posts, the frame defining an opening, and the posts defining part of the opening. The frame opening includes a narrow portion defined by opposing upper and lower surfaces. The narrow portion is located adjacent to the posts. The headgear comprises a clip having a base and a hook portion extending from the base. The hook portion is configured to engage with the posts of the frame. The hook portion includes upper and lower surfaces that substantially conform to the shape of the respective upper and lower surfaces of the narrow portion, such that when the hook portion engages with the post, the upper and lower surfaces of the hook portion engage with the upper and lower surfaces of the narrow portion respectively, resisting the vertical rotation of the clip relative to the frame about an axis perpendicular to the longitudinal axis of the post.

[0055] In some configurations, the section of the hook portion between the upper and lower surfaces of the hook portion is shaped such that it spans a space when the hook portion engages with the post.

[0056] In some configurations, the upper and lower surfaces facing the post cooperate to define a space, and the section of the hook portion between the upper and lower surfaces substantially occupies the entire space when the hook portion engages with the post.

[0057] In some configurations, the opposing upper and lower surfaces are parallel to each other.

[0058] In some configurations, the hook portion defines an inner surface facing the post, an outer surface, and a thickness between the inner surface and the outer surface, and the thickness is maximum at a portion located between the opposing upper and lower surfaces when the hook portion engages with the post.

[0059] In some configurations, the base of the clip has a height greater than the height of the hook portion and is configured to contact a portion of the frame adjacent to the opposing upper and lower surfaces of the narrow portion to limit the rotation of the clip about the longitudinal axis of the post.

[0060] In some configurations, at least one semi-rigid side strap includes a first semi-rigid side strap and a second semi-rigid side strap, and each of the first semi-rigid side strap and the second semi-rigid side strap is configured to be connectable to the frame by one of the clips.

[0061] In some configurations, the interface includes a nose mask seal configured to seal around one or both of the user's nostrils, and the nose mask seal has a sealing surface that defines an opening.

[0062] In some configurations, the opening defined by the sealing surface of the nose mask seal defines an aspect ratio of width to height of about 1.3 to 1.6.

[0063] In some configurations, the height range of the nose mask seal across all available sizes is from about 47.8 mm to 57.8 mm.

[0064] In some configurations, the nose mask seal includes a rolling bridge portion.

[0065] In some configurations, the nose mask seal includes a rim to which the nose mask seal is fixed to a rigid clip or housing, and the rolling bridge portion is connected to the rear edge of the rim.

[0066] In some configurations, the nose mask seal further includes a thickening band located between the sealing surface and the rolling bridge, and further includes a pair of thickening bands extending from the thickening band towards the opening on each side of the nose mask seal.

[0067] One aspect of the present disclosure includes a cushion for a respiratory interface assembly, the cushion comprising a rim configured to be attached to or attachable to a housing of the respiratory interface assembly, an elastic sidewall extending from the rim, and an elastic endwall extending inwardly from the elastic sidewall, the elastic endwall defining a sealing surface that seals against a user's face and an opening that receives the user's nose and / or mouth in use, a thickened band within the sidewall, a pair of thickened pads intermediate the thickened band and spaced from the thickened band, and a pair of thickened pads intermediate respective portions of the thickened band and respective portions of the pair of thickened pads.

[0068] In some configurations, the thickened band is thicker than the pair of thickened pads and / or the pair of thickened pads is thicker than the pair of joining pads.

[0069] In some configurations, the pair of thickened pads and the pair of joining pads each have a length that extends circumferentially around the inner perimeter of the cushion, and the length of each of the pair of joining pads is about 15% to 50%, preferably about 20% to 45%, more preferably about 25% to 33% of the length of each of the pair of thickened pads.

[0070] In some configurations, each of the pair of joining pads extends between a portion of the thickened band and an upper portion of each of the pair of thickened pads.

[0071] In some configurations, the pair of joining pads are provided on sidewalls of a nasal mask seal on both sides of the nasal mask seal, and at least a portion of the pair of thickened pads are provided on a face contact surface of the nasal mask seal.

[0072] One aspect of the present disclosure includes a cushion for a respiratory interface assembly, the cushion comprising a rim configured to be attached to a housing of the respiratory interface assembly, an elastic sidewall extending from the rim, and an elastic endwall extending inwardly from the elastic sidewall, the elastic endwall defining a sealing surface that seals against a user's face and an opening that receives the user's nose and / or mouth in use, and a pair of elongate thickened portions, each extending from a first end at or adjacent to or near each lower corner of the sidewall at or adjacent to or near the rim to a second end at or adjacent to or near the endwall on the opposite side of the opening from the respective thickened portion.

[0073] In some configurations, the pair of thickened portions extend away from each other in a direction from the first ends towards an intermediate portion of each of the pair of thickened portions.

[0074] In some configurations, the pair of thickened portions extend towards each other in a direction from an intermediate portion of each of the pair of thickened portions towards the second ends.

[0075] In some configurations, each of the pair of elongate thickened portions is curved in a direction substantially perpendicular to their respective major surfaces.

[0076] One aspect of the present disclosure includes a connecting device for connecting a headgear strap to an interface of a patient interface assembly, the connecting device including a post provided on or configured to be provided on one of the headgear strap or the patient interface assembly, and a clip provided on the other of the headgear strap or the patient interface assembly, the clip including a base portion and a hook portion defining a space therebetween configured to selectively receive the post, a gap provided on one of the post or the clip, and a rib provided on the other of the post or the clip, the rib and the gap being asymmetrically arranged such that the rib is received by the gap when the clip is connected to the post, the rib being configured to prevent or inhibit an alternative connection.

[0077] In some configurations, the gap is provided in the post and defined between a first post portion and a second post portion arranged coaxially, the rib is provided in the clip and projects into the space, the rib being configured to be received by the gap when the post is received by the space, the rib being configured to prevent or inhibit an alternative connection of the clip to an alternative post.

[0078] In some configurations, the rib is provided on the post, the gap is provided in the clip, the rib being configured to be received by the gap when the post is received by the space, the rib being configured to prevent or inhibit an alternative connection of an alternative clip to the post.

[0079] One aspect of the present disclosure includes a headgear assembly that secures a patient interface to a patient's head. The headgear assembly includes two or more straps and two or more headgear clips provided on or configured to be provided on the two or more straps. At least a first clip of the two or more headgear clips includes a base portion and a hook portion that define a space configured to selectively receive a post of the patient interface therebetween, and further includes a rib protruding into the space. The rib is received by a gap defined within at least a first post of the patient interface when the first clip is coupled to the first post, and is arranged asymmetrically along the length of the space so as to prevent or impede the coupling of the first clip to a second post of the patient interface. The headgear assembly includes two or more headgear clips.

[0080] In some configurations, a second clip of the two or more headgear clips includes a base portion and a hook portion that define a space configured to selectively receive a post of the patient interface therebetween, and further includes a rib protruding into the space. The rib is received by a gap defined within at least a second post of the patient interface when the second clip is coupled to the second post, and is arranged asymmetrically along the length of the space so as to prevent or impede the coupling of the second clip to a first post.

[0081] In some configurations, the first clip and the second clip are mirror images of each other.

[0082] One aspect of the present disclosure includes a headgear clip that attaches a headgear to a patient interface assembly. The headgear clip includes a base portion configured to be attached to or configured to be attached to a strap of the headgear at a first end, a hook portion protruding from a second end of the base portion and defining a space configured to selectively receive a post of the patient interface assembly, and a protrusion extending outwardly from an outer side of the base portion.

[0083] In some configurations, the protrusion is disposed at, adjacent to, or near the first end of the base portion.

[0084] In some configurations, the headgear clip further comprises a recess on the outside of the base portion intermediate the second end and the protrusion.

[0085] In some configurations, at least the hook portion and the first part of the base portion comprise a first material that is elastic and relatively rigid, and at least the second part of the base portion comprises a second material of an elastomer overmolded onto the first material.

[0086] In some configurations, the second material is also overmolded onto the strap.

[0087] In some configurations, the first part of the base portion includes an inner part of the protrusion, and the second part of the base portion includes an outer part of the protrusion.

[0088] In some configurations, the protrusion extends across the width of the base portion.

[0089] In some configurations, the protrusion provides at least one surface that is substantially orthogonal to the direction of the force required to engage or disengage the hook portion and the post.

[0090] In some configurations, the frame comprises or is configured to be coupled to a cushion that sealingly engages the patient's face, and the frame comprises a first post and a second post configured to be coupled to the first headgear clip and the second headgear clip of the headgear assembly of the patient interface assembly, the first post comprising a first portion and a second portion that are coaxially disposed and define a gap therebetween, the gap being axially asymmetrically disposed.

[0091] In some configurations, the second post is a mirror image of the first post.

[0092] In some configurations, the first post is configured to couple with a first headgear clip and is prevented or precluded from coupling with a second headgear clip.

[0093] Further aspects of the present disclosure will become apparent from the following description and the accompanying drawings.

[0094] The above-described features and other features of the present disclosure will become more fully apparent from the following description and the appended claims, considered in conjunction with the accompanying drawings. It is to be understood that the drawings illustrate only some embodiments in accordance with the present disclosure and are not to be considered as limiting its scope, and the present disclosure will be described more specifically and in detail with reference to the accompanying drawings.

Brief Description of the Drawings

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Best Mode for Carrying Out the Invention

[0096] Here, with reference to the accompanying drawings, in which like numerals refer to like or similar elements throughout, embodiments of a system, components, and methods of assembly and manufacture will be described. Several embodiments, examples, and illustrations are disclosed below, but those skilled in the art will understand that the invention described herein extends beyond the specifically disclosed embodiments, examples, and illustrations, and can include other uses of the invention as well as its obvious modifications and equivalents. The terminology used in the description presented herein is not intended to be construed in any limiting or restrictive manner, solely for the reason that it is used in conjunction with a detailed description of some specific embodiments of the invention. Additionally, embodiments of the invention can include several novel features, and no single feature is solely responsible for its desirable attributes and is not essential for practicing the invention described herein.

[0097] In the following description, some terminology may be used for reference purposes only and is therefore not intended to be limiting. For example, terms such as "above," "below," "upper," "lower," "horizontal," "vertical," etc. refer to directions in the referenced drawings. Terms such as "front," "rear," "left," "right," "rear portion," "side portion," "frontward," and "rearward" describe the orientation and / or location of a component or part of a component within a consistent but arbitrary reference system, which becomes apparent by referring to the text and associated drawings describing the component or element under consideration. Further, terms such as "first," "second," "third," etc. may be used to describe separate components. Such terminology may include the specifically mentioned words, their derivatives, and words of similar meaning.

[0098] System Schematic Diagram Figure 1 shows an example of a respiratory therapy system suitable for supplying breathing gas to a user for airway positive pressure (PAP) therapy (e.g., continuous positive airway pressure (CPAP) therapy) or non-invasive ventilation (NIV) therapy. The example respiratory therapy system 100 can include a gas source 102, a humidifier 104, a patient interface assembly 150, and a breathing gas circuit 106 that connects the humidifier 104 (or the gas source 102) to the patient interface assembly 150. The gas source 102 can provide a supply of breathing gas to the humidifier 104. The gas source 102 can include a blower through which breathing gas, such as ambient air, is drawn into the gas source 102 through an inlet 110 within the gas source casing by an impeller 112. The rotational speed of the impeller 112 can be adjusted to regulate the amount of air drawn into the gas source 102 and the supply of breathing gas delivered to the respiratory therapy system 100. The breathing gas can include any single gas or combination of gases that the user of the system 100 can breathe.

[0099] The pressure and / or flow rate of the breathing gas exiting the gas source 102 can be adjusted by a controller 114. The controller 114 can adjust the rotational speed of the impeller 112 according to one or more predetermined algorithms and according to one or more user inputs provided via a user input section 116.

[0100] The gas source 102 represents an actively controlled flow generator. Other gas sources, such as a compressed air cylinder with suitable pressure or flow regulation, can also be used to supply breathing gas. The outlet of the gas source 102 can be coupled to a separate humidifier 104. The humidifier 104 can be configured to heat and / or humidify the breathing gas before delivery, for example, before delivery to the user. In some embodiments, the humidifier is integrated with the gas supply. The humidifier 104 can include a base 120 and a humidifier chamber 122. The chamber 122 can be configured to hold a humidifying fluid 124, such as water, and can be disengaged from the humidifier base 120, for example, temporarily or permanently disengaged, to allow for filling or replacement. The humidifier 104 receives gas from the gas source 102 via a chamber inlet 126. The humidifier base 120 can include a heater, such as a heater plate 130. The chamber 122 rests on the heater plate 130 when engaged with the humidifier base 120. The heater plate 130 dissipates heat, for example, heat generated by electrical resistance, to the chamber 122. The chamber 122 preferably has a thermally conductive base that allows the heat generated by the heater plate 130 to efficiently reach the humidifying fluid 124. The controller 114 also controls the supply of electrical energy to the humidifier 104, particularly the heater plate 130, to regulate any function of the humidifier 104, such as the temperature and humidity of the breathing gas supplied to the user.

[0101] The breathing gas can be supplied to the user via a chamber outlet 132 and a breathing gas circuit 106 in the form of a conduit that incorporates a heating or warming element, such as a heating wire, to heat or warm the breathing gas during transport to the patient interface assembly 150 (e.g., keep it at an elevated temperature or maintain its warmth). The electrical energy supplied to the heating wire can be controlled by the controller 114. The controller 114 can receive feedback from one or more sensors incorporated into the control network throughout the respiratory therapy system to monitor characteristics of the breathing gas, including but not limited to pressure, flow rate, temperature, and / or humidity.

[0102] The patient interface assembly 150 couples a user to a respiratory therapy system 100 such that heated and humidified gas, such as from a humidifier 104, can be delivered to the user's respiratory system. The breathing gas can be delivered to the user at or near optimal temperature and humidity (e.g., heated with water vapor at a temperature of 27 - 37 °C and fully saturated) when delivered to the user's nostrils and / or mouth. Mimicking the healthy adult lung state (37 °C, 44 mg / L humidity) can help maintain the healthy mucosal function of users with respiratory diseases that affect secretion, and for all patients, gas humidification helps maintain comfort and compliance. In system example 100 or similar systems, multiple different styles of patient interface assemblies 150, such as those disclosed herein, can be used.

[0103] Interface Assembly Overview FIG. 2 shows an example patient interface assembly 150 that can be used with the system 100 of FIG. 1. The patient interface assembly 150 generally includes an interface (e.g., a mask) 152 and a headgear device (“headgear”) 154. The interface 152 is configured to deliver a flow of breathing gas to the user's airway. The headgear 154 is configured to secure the interface 152 in place on the user.

[0104] The illustrated interface 152 is a mask that can define a breathing chamber. In particular, the illustrated interface 152 is a nasal mask that forms a seal surrounding one or both nostrils on the user's face. However, other suitable interfaces can be used together with the headgear 154, and / or the headgear 154 can be modified to be used with different types of interfaces. For example, the interface can be a direct nasal mask having a nasal element (e.g., a nasal pillow) configured to deliver the flow of breathing gas directly to the user's nostrils. Although described in the context of the nasal mask 152, it will be understood that various features, aspects, and advantages of the patient interface assembly 150 having any other interface configuration can be used, including, without limitation, an oro-nasal mask and a full-face mask that seal around the user's nose and mouth, a mouth mask that seals around the user's mouth, a nasal pillow that seals under the user's nose, or other types of masks.

[0105] The mask 152 can include a frame 156 and a cushion or seal 158. The cushion or seal 158 can be directly coupled to the frame 156 or can form part of a cushion module 160 that is connectable to the frame 156. Such a cushion module 160 can include a relatively rigid housing 162 composed of a material that is harder than the material of the cushion 158. The relatively rigid housing 162 can interface with the frame 156. The relatively rigid housing 162 can be removably connected to the frame 156. The relatively rigid housing 162 can incorporate a clip portion that engages with a part of the frame 156 to connect the cushion module 160 to the frame 156.

[0106] The mask 152 can also include a connecting tube 164 configured to connect the mask 152 to a breathing conduit (e.g., breathing gas circuit 106). The connecting tube 164 can be carried by any suitable portion of the mask 152, such as the frame 156 or the cushion module 160 (e.g., housing 162). In the illustrated configuration, the connecting tube 164 is directly connected to a cooperating portion of the mask 152 (e.g., frame 156 or cushion module 160). The connecting tube 164 can be connected to the cooperating portion of the mask 152 either permanently or removably. In other configurations, the mask 152 can be connected to the breathing conduit by an elbow or a connector that includes an elbow.

[0107] The mask 152 can also include an exhaust device or vent that allows the exhaled and excess breathing gas to exit from the breathing chamber of the mask 152. In some configurations, the vent can be a bias flow vent 166 having a plurality of vent holes (FIG. 10). In the illustrated arrangement, the bias flow vent 166 is located in the mask frame 156. In other configurations, the bias flow vent 166 can be located in other portions of the mask 152, such as the cushion module 160 or the connecting tube 164. In some configurations, as shown in FIG. 2, the bias flow vent 166 can include a diffuser 168 that covers the plurality of vent holes. The diffuser 168 can be removable from the mask 152 for cleaning or replacement. In some configurations, the diffuser 168 is permanently attached to a portion of the mask 152 by an overmold process that positions the diffuser material within a mold and then injects a suitable plastic material (e.g., polycarbonate) into the mold to result in an integral structure. The diffuser material can be overmolded directly with the frame 156. In other embodiments, the diffuser material can be overmolded with a clip. The clip has an engaging portion that engages a complementary engaging feature of another portion of the mask 152 to attach the clip (and associated diffuser material) to that portion of the mask 152.

[0108] An alternative bias flow vent 166 and diffuser 168 are shown in a modified version of the patient interface assembly shown in FIGS. 48-50. The diffuser material is omitted from the diffuser 168 of FIG. 48 for purposes of illustration. The bias flow vent 166 includes a plurality of ventilation holes 167. The ventilation holes 167 are provided within a concave portion 157 of the frame 156. The concave portion 157 is wider than the opening 256. A depression in the wall of the frame 156 just above the concave portion 157 provides an opening that facilitates removal of the diffuser clip 168 from the frame 156. In use, the concave portion 157 may be hidden by the diffuser 168. The diffuser 168 is wider than the opening 256. The ventilation holes 167 are arranged in three arcuate rows above the opening 256. The ventilation holes 167 extend across a width approximately equal to the width of the opening 256. The radius of curvature of the first row closest to the opening 256 is shorter than that of the second and third rows. The radius of curvature of the third row furthest from the opening 256 is longer than that of the first and second rows. The number of ventilation holes 167 in the first row is less than the number of ventilation holes 167 in the second and third rows. The number of ventilation holes 167 in the third row is greater than the number of ventilation holes 167 in the first and second rows. The outermost ventilation holes 167 in the three rows are approximately aligned vertically. The ventilation holes 167 may vary in diameter along their length. In particular, the ventilation holes 167 taper in the direction of the bias flow (i.e., from the inside to the outside of the patient interface assembly 150). The tapered ventilation holes 167 can reduce noise from the exhaust gas.

[0109] Referring back to FIG. 2, the headgear 154 is coupled to the mask 152. The headgear 154 can be coupled to the frame 156 of the mask 152. The frame 156 or the mask 152 preferably includes a single headgear attachment on each side of the frame 156 or the mask 152. In the illustrated arrangement, the headgear 154 includes headgear straps provided on each side of the user's head, and the headgear straps bifurcate into two at a location along the user's face (e.g., cheek) between the mask 152 and the user's ear. The straps on each side can be separated from each other, or can form an integral strap that extends from one side of the user's head to the other side and has an intermediate portion connected to the frame 156 or the mask 152. The headgear 154 can also include a rear portion and an optional top portion, which will be described in further detail later.

[0110] Interface Continuing to refer to FIG. 2 and further to FIG. 10, the cushion module 160 can be selectively connected to and separated from the frame 156 of the mask 152. The frame 156 and the cushion module 160 preferably connect to each other in a substantially airtight or sealed relationship. For example, the frame 156 can include a connector 170 in the form of a mounting boss, a connecting ring, or a collar that extends in a rearward direction from the frame 156 toward the user or the cushion module 160. The frame connector 170 supports the housing 162 of the cushion module 160. The frame connector 170 has an inner surface and an outer surface. The housing 162 engages the outer surface of the collar 170 in the illustrated arrangement. However, in an alternative arrangement, the housing 162 can engage the inner surface of the frame connector 170. The connector 170 surrounds the opening 256 and the bias vent 166.

[0111] The mask 152 can incorporate an arrangement that reduces the possibility of accidental or unwanted separation of the frame 156 and the cushion module 160. For example, the mask 152 can include an interference fit or engagement (e.g., snap fit) arrangement 320 that helps maintain the connection between the frame 156 and the cushion module 160 and / or increases the force required to separate the frame 156 and the cushion module 160. One such arrangement can include at least one protrusion on one of the frame 156 and the cushion module 160 and at least one recess on the other of the frame 156 and the cushion module 160 that is sized and shaped to receive the protrusion. Other suitable arrangements, such as friction members and cooperating surfaces, can also be used.

[0112] The cooperating openings of the frame connector 170 and the housing 162 can have a non-circular or non-cylindrical shape that fixes the frame connector 170 and the housing 162 so as not to rotate about the axis of the frame connector 170. Alternatively or in addition, other arrangements can be used to prevent rotation between the frame 156 and the cushion module 160. For example, as shown in modified versions of the patient interface assembly in FIGS. 45-47, a cylindrical collar can be used with an interference fit structure that prevents or inhibits rotation or displacement that would otherwise be possible due to the cylindrical shape of the collar. The frame 156 and the cushion module 160 can preferably be attached to each other in only a single orientation. However, in some configurations, the frame 156 and the cushion module 160 can be configured to be selectively attached to each other in two or more predetermined orientations. For example, the user can rotate the frame 156 by 180° with respect to the cushion module so that the bias air vents can be selectively oriented either above or below the opening of the housing 162 prior to attachment. The interference fit structure can be tapered to correct for small displacements when the frame and cushion module are brought together.

[0113] Cushion Module As described above, the illustrated cushion module 160 includes a relatively rigid housing 162 composed of a material that is harder than the material of the cushion 158. In some configurations, the housing 162 is partially or entirely composed of polycarbonate or a similar material. Thus, the cushion 158 can be composed of a material that is softer than the material of the relatively rigid housing 162, such as silicone or a similar material. Unless otherwise indicated, references in this specification to the relative rigidity or stiffness of materials refer to differences in elastic modulus between materials, or differences in the rigidity or stiffness of solid bodies of the same size and shape composed of the materials being compared. References to the relative rigidity or stiffness of particular structures can refer to their resistance to deformation, taking into account both the material properties and physical properties (e.g., size, shape, wall thickness) of those structures.

[0114] In some configurations, the cushion 158 can be removably connected to the housing 162 (or directly to the frame 156). However, in the illustrated arrangement, the cushion 158 is permanently connected to the housing 162. To permanently attach the cushion 158 to the housing 162, a molding process such as integral molding or overmolding can be used. Additionally, a retaining structure such as a mechanical interlock can be used to securely lock the silicone material of the cushion 158 and the polycarbonate material of the housing 162, thereby strengthening their connection. The retaining structure can include a plurality of openings defined by the housing 162 that are occupied by the material of the cushion 158. As an alternative or in addition, the retaining structure can include an annular lip positioned along or adjacent to the edge of the housing 162 that is surrounded by the material of the cushion 158 and provides a keyed engagement with the material of the cushion 158.

[0115] Mask Cushion The cushion 158 can be an inflatable seal that has an inwardly concave curved wall that expands to provide a sufficient seal and a better fit against the face of a particular user when the interior of the mask 152 is pressurized. Thus, the pressure contained within the cushion 158 can bias the face contact portion against the user's face. However, other types of seals can be used if desired.

[0116] Referring to FIGS. 3-7, the illustrated cushion 158 includes a rim 180 that defines an opening 182 through which breathing gas is introduced into the interior of the cushion 158. The housing 162 can be connected to the cushion 158 at the rim 158. The rim 180 can have a greater thickness than other portions of the cushion 158.

[0117] The cushion 158 includes an end wall 184 that defines a face contact surface 186 configured to contact a user's face during use. The end wall 184 is located on the opposite side of the rim 180. A side wall 188 extends between the rim 180 and the end wall 184. The end wall 184 extends inwardly from the side wall 188. That is, portions of the end wall 184 on both sides of the cushion 158 extend toward each other from the side wall 188. The end wall 184 includes an edge 190 that at least partially defines an opening 192. In the illustrated configuration, the edge 190 surrounds the opening 192. In some configurations, the cushion 158 tapers or reduces in thickness in a direction toward the edge 190 or to the edge 190. That is, preferably, the cushion 158 does not include a thickened rim or bead at or adjacent to the edge 190. In some configurations, as shown in modified versions of the cushion 158 in FIGS. 37 and 40, the end wall 184 may include a thickened rim or bead 191 at or adjacent to the edge 190. The thickened rim or bead 191 can improve the noise generated by the flapping of the end wall 158 in the event of leakage and / or can reduce the risk of the cushion 158 being torn from the opening 192. The thickened rim or bead 191 can have a radius of about 0.1 - 0.4 mm, preferably about 0.2 - 0.3 mm, and preferably about 0.26 mm. The opening 192 is designed to accommodate at least the lower portion and tip of the user's nose. Preferably, the opening 192 is generally T-shaped, even if it is an inverted T-shape.

[0118] Referring to FIG. 5, the face contact surface 186 generally includes a lower or lip surface 194 adapted to contact the user's face at a location above the red lip line and below the nostrils. The face contact surface 186 also includes two separate cheek surfaces 196 that extend between the lip surface 194 and the upper surface 198 of the face contact surface 186 on each side of the face contact surface 186. The cheek surfaces 196 can contact the user's inner cheek surface and / or the user's outer nose surface. The upper surface 198 can extend over the user's nose to connect the two cheek surfaces 196.

[0119] The end wall 184 can be the thinnest part or one of the thinnest parts of the seal cushion 158. Advantageously, the end wall 184 can be easily deformed so as to at least substantially seal against the contour of the user's face, including one or more of the upper lip, inner cheek, outer nose, and nasal bridge. Advantageously, the small wall thickness of the end wall 184 within the lip surface 194 can improve elasticity and minimize the pressure applied to the area above the user's lips.

[0120] Referring to FIGS. 3 and 4, a reinforcement in the form of at least one thickening band 200 extends inwardly from the inner surface of the cushion 158. FIGS. 3 and 4 show a single thickening band 200, but in some configurations, two or more thickening bands or thickening regions can be provided, bearing in mind the requirements to achieve the properties provided by the thickening band 200.

[0121] The illustrated thickening band 200 is positioned along the side wall 188 of the cushion 158. The band 200 preferably includes a relatively large lower region 202 on each side surface of the cushion 158 and a relatively thin connecting portion 204 that extends between the lower regions 202 by extending around the upper portion inside the cushion 158. When the cushion 158 receives pressure from the gas source 102 (FIG. 1), the thickening band 200 helps to reduce the possibility and / or extent to which the side wall 188 bulges outward. The outward bulging of the side wall 188 can result in an undesirable change in the shape of the cushion 158, which can have an adverse effect on performance and can lead to undesirable leakage from the cushion 158.

[0122] The cushion 158 can define a stiffness reduction region 210 between the thickening band 200 and the rim 180. The stiffness reduction region 210 enables the upper portion of the cushion 158 to preferentially move forward so that the cushion 158 can adapt to the nasal characteristics and sizes of a wide range of users. The upper portion of the cushion 158 is configured to pivot or hinge relative to the lower portion of the cushion 158 about a hinge axis or hinge region, enabling a pivotal movement of the upper portion of the cushion 158 in the forward direction (away from the user's face or toward the housing 162). The hinge axis or hinge region can be partially defined by the thickening band 200 and is preferably positioned just below the lower region 202. The hinge axis may be partially defined by the lower thickening corner 189 at or adjacent to each lower corner of the side wall 188. The side wall 188 is tapered over a relatively short distance upward from the lower thickening corner 189 toward the lower region 202 of the band 200. The side wall 188 is also tapered over a relatively long distance downward from the lower thickening corner 189.

[0123] In the illustrated arrangement, the stiffness reduction region 210 is configured to roll in response to the pivotal movement of the upper portion 154. As schematically shown by the dashed line in FIG. 4, the stiffness reduction region 210 is designed to roll towards the front of the mask 152 (i.e., away from the user). Thus, the stiffness reduction region 210 can be referred to herein as a rolling portion or a rolling bridge. In the rolling bridge 210, the inflection point between the first or upper portion and the second or lower portion of the rolling bridge 210 moves along the rolling bridge 210, and the lengths of the upper and lower portions change during the rolling motion. In some configurations, the rolling bridge 210 rolls across and / or over the outer surface of the mask 152, which can be part of the cushion 158 and / or the housing 162. The rolling bridge 210 provides one or more of the advantages of predictable deformation of the cushion 158 without the need for buckling or pre-defined concertina-type folds, adaptation of the cushion 158 to a wide range of face and nose dimensions, limitation of the sealing force against the patient's nose, and / or at least partially separating the sealing force against the patient's nose from the headgear tension and / or the tube drag force.

[0124] Referring to FIGS. 3, 4, and 7, the illustrated cushion 158 also includes two thickened panels 220. The thickened panels 220 are positioned along the upper portion of the cheek surface 196 of the cushion 158, near the transition from the cheek surface 196 to the upper surface 198. The panels 220 can be formed on the inner surface of the cushion 158. The illustrated panels 220 represent local thickened regions that have been found to improve the sealing ability of the cushion 158. The panels 220 increase the lateral pressure against the sides of the user's nose, such that the pressure from the cushion 158 can more appropriately follow the contour of the user's nose shape. In the illustrated arrangement, the thickness of the panels 220 is less than the thickness of the thickened band 200. In some configurations, the thickness of the panels 220 is less than about 1 / 2 or less than about 1 / 4 of the thickness of the thickened band 200. In some configurations, the panels 220 can be 1.0 mm to 1.5 mm thick. In some configurations, the panels 220 are about 1.2 mm to 1.3 mm thick. In some configurations, the panels 220 are about 1.25 mm thick. In some configurations, the portion of the sidewall 188 that includes the panels 220 can be about 0.8 mm to 1.2 mm thicker than the adjacent portion of the sidewall 188. In some configurations, the portion of the sidewall 188 that includes the panels 220 is about 0.9 mm to 1.1 mm thick. In some configurations, the portion of the sidewall 188 that includes the panels 220 is about 1 mm thick.

[0125] In the illustrated arrangement, each of the panels 220 has a side or boundary portion that extends from or is immediately adjacent to the thickened band 200. The illustrated panels 220 each generally have a rectangular shape. Each of the thickened panels 220 extends along the sidewall 188 and the endwall 184 from the thickened band 200. One end (e.g., the front end 222) of each of the rectangular panels 220 is connected to or immediately adjacent to the thickened band 200. In the illustrated arrangement, each of the thickened panels 220 extends over the endwall 184. Each of the panels 220 has a rear end 224 that terminates in front of the edge 190 of the opening 192. In other words, the rear end 224 of each of the thickened panels 220 is spaced from the edge 190.

[0126] In some configurations, for example as shown in FIG. 37, the thickened panel 220 may be spaced apart from the thickened band 220, and the cushion 158 may include a bonding pad 221 intermediate a portion of the thickened band 200 and at least a portion of the thickened panel 220. The bonding pad 221 in the illustrated configuration includes a generally rectangular thickened region of the sidewall 188 that joins an upper portion of the thickened panel 220 to the thickened band 200. The lower portion of the thickened panel 220 remains spaced from the thickened band 200. The bonding pad 221 preferably provides support to the sidewall 188 of the cushion 158 to reduce deformation and relieve leakage in a selected region of the cushion 158, particularly around the patient's eyes, without causing respiratory restriction. The bonding pad 221 has a thickness that is less than the thickness of the thickened panel 220 but greater than the thickness of other adjacent portions of the sidewall 188. In some configurations, the portion of the sidewall including the bonding pad 221 may be about 0.5 to 0.9 mm thicker than adjacent portions of the sidewall 188. In some configurations, the portion of the sidewall including the bonding pad 221 may be about 0.65 to 0.75 mm thicker. In some configurations, the portion of the sidewall including the bonding pad 221 may be about 0.2 to 0.4 mm thinner than the adjacent thickened panel 220. In some configurations, the portion of the sidewall including the bonding pad 221 may be about 0.25 to 0.35 mm thinner. The bonding pad 221 has a width measured in the forward direction from the thickened panel 220 to the thickened band 200 that spaces at least a portion of the thickened panel 220 from the thickened band 200 by a corresponding distance. In some configurations, the width of at least a portion of the bonding pad 221 is about 3 to 4 mm. In some configurations, the width may be about 3.2 to 3.6 mm. In some configurations, the width may be about 3.4 mm. The bonding pad 221 is preferably provided only towards the upper end of the thickened panel 220, thereby allowing the sidewall 188 to deform relatively more towards the lower end of the thickened panel 220 so that the pressure on the more sensitive regions of the patient's face is lower. The bonding pad 221 has a length that extends circumferentially inside the cushion 158.In some configurations, the length of the bonding pad 221 is about 15% to 50% of the length of the adjacent thickened panel 220. In some configurations, the length is about 20% to 45% of the length of the adjacent thickened panel 220. In some configurations, the length is about 25% to 33% of the length of the adjacent thickened panel 220.

[0127] Referring to FIG. 7, the cushion 158 can include one or more thickened panels 226 in addition to or instead of the thickened panel 220. For convenience, the thickened panel 226 is referred to herein as the "secondary" thickened panel 226. In the illustrated arrangement, a pair of secondary thickened panels 226 are provided. Both of the pair of secondary thickened panels 226 are located between the thickened panels 220 towards or within the upper portion of the cushion 158. Each of the illustrated secondary thickened panels 226 is substantially smaller than the thickened panel 220. The secondary thickened panel 226 can generally be rectangular in shape and can have a front end 228 that is connected to or immediately adjacent to the thickened band 200. Each of the secondary thickened panels 226 can have a rear end 230 that is spaced from the edge 190 of the opening 192. In some configurations, the secondary thickened panel 226 has a surface area that is about 1 / 10 to 1 / 20 of the surface area of the thickened panel 220.

[0128] In some configurations, the facial contact surface 186 is non-planar. For example, the facial contact surface 186 in the upper portion of the cushion 158 can extend in a forward direction relative to the middle portion and / or the lower portion of the cushion 158. A part or all of the upper surface 198 of the facial contact surface 186 can be positioned forward of a part or all of the cheek surface 196 and / or the lip surface 194. In some configurations, the upper surface 198 can define an angle θ relative to the middle portion of the cushion 158 or the cheek surface 196 of the cushion 158. In some configurations, the rearmost edge of the upper surface 198 can define an angle θ relative to the rearmost edge of the middle portion of the cushion 158. The middle portion of the cushion 158 is located above the upper lip contact portion. In some configurations, when viewed from the side with the cushion 158 in an upright orientation, as shown in FIG. 3, the rearmost edge of the upper surface 198 can define an angle θ relative to the cheek surface 196 and / or the vertical direction. In the upright orientation, the cheek surface 196 can be positioned generally or substantially in the vertical direction. The upright orientation can correspond to the orientation of the cushion 158 during use such that the cushion 158 is properly positioned above the user with the user's head in an upright orientation. The angle θ can be less than 55 degrees. In some configurations, the angle θ is about 40 - 50 degrees or about 42 - 48 degrees. In some configurations, the angle θ is about 45 degrees.

[0129] Referring to FIG. 4, the facial contact surface 186 of the cushion 158 can define a depth 232 of the opening 192 between the rearmost point and the foremost point of the opening 192. The rearmost point can be located on the cheek surface 196. The foremost point can be located on the upper surface 198. In particular, the foremost point can be located on the edge 190 of the opening 192. The depth 232 of the facial contact surface 186 can be greater than 15 mm. In some configurations, the depth 232 is about 16 - 25 mm or about 18 - 22 mm. In some configurations, the depth 232 is 20 mm or 20.5 mm.

[0130] Referring to FIG. 5, the cushion 158 can define a height 234 and a width 236. The height 234 and / or the width 236 can be selected to achieve desirable sealing characteristics while reducing or minimizing the obstruction to the user by the cushion 158 and the mask 152. In particular, the height 234 can be selected such that the upper surface 198 contacts the nasal dorsum of the user. In some configurations, the height 234 can be about 45 mm to 60 mm or about 47.8 mm to 57.8 mm for a single cushion 158 or over the size range of the cushion 158. For example, the cushion 158 can be provided in at least three sizes including a small size having a height 234 of about 47 mm to 48 mm (e.g., 47.8 mm), a medium size having a height 234 of about 52 mm to 53 mm (e.g., 52.8 mm), and a large size having a height 234 of about 57 mm to 58 mm (e.g., 57.8 mm). In some configurations, the width 236 can be about 55 mm to 64 mm or about 56.5 mm to 63.9 mm for a single cushion 158 or over the size range of the cushion 158. For example, the small size can have a width 236 of about 56 mm to 57 mm (about 56.5 mm), the medium size can have a width 236 of about 58 mm to 59 mm (e.g., 58.3 mm), and the large size can have a width 236 of about 63 mm to 64 mm (e.g., 63.9 mm).

[0131] The ratio of the width 236 to the height 234 can be about 1.1 to 1.2 for a single cushion 158 or over the size range of the cushion 158. For example, the ratio of the width 236 to the height 234 of the small-size cushion 158 can be about 1.2 (e.g., 1.18). The ratio of the width 236 to the height 234 of the medium-size cushion 158 can be about 1.1. The ratio of the width 236 to the height 234 of the large-size cushion 158 can be about 1.1 (e.g., 1.12).

[0132] The opening 192 of the cushion 158 can define a height 240 and a width 242. The height 240 and / or the width 242 can be selected to achieve the desired sealing characteristics of the cushion 158. In some configurations, the height 240 can be about 20 mm to 35 mm or about 22.8 mm to 32.5 mm for a single cushion 158 or across the size range of the cushion 158. For example, a small size can have a height 240 of about 22 mm to 23 mm (e.g., 22.8 mm), a medium size can have a height 240 of about 23 mm to 24 mm (e.g., 23.3 mm), and a large size can have a height 240 of about 32 mm to 33 mm (e.g., 32.5 mm). In some configurations, the width 242 can be about 34 mm to 45 mm or about 34.2 mm to 43.1 mm for a single cushion 158 or across the size of the cushion 158. For example, a small size can have a width 242 of about 34 mm to 35 mm (e.g., 34.2 mm), a medium size can have a width 242 of about 37 mm to 38 mm (e.g., 37.4 mm), and a large size can have a width 242 of about 43 mm to 44 mm (e.g., 43.1 mm).

[0133] The ratio of the width 242 to the height 240 can be greater than 1.25. In some configurations, the ratio of the width 242 to the height 240 can be about 1.25 to 1.7 or about 1.3 to 1.65 (e.g., 1.33 to 1.61) for a single cushion 158 or across the size of the cushion 158. For example, the ratio of the width 242 to the height 240 of a small-sized cushion 158 can be about 1.5. The ratio of the width 242 to the height 240 of a medium-sized cushion 158 can be about 1.6 (e.g., 1.61). The ratio of the width 242 to the height 240 of a large-sized cushion 158 can be about 1.3 (e.g., 1.33).

[0134] Referring to FIG. 6, the cushion 158 can define a depth 244 between a foremost point and a rearmost point along a cross-section of the cushion 158. For example, the depth 244 can be measured along a vertical center plane that bisects the cushion 158 into a right side and a left side. In some configurations, the depth 244 is measured at a lower portion of the cushion 158. For example, the depth 244 can be measured between a foremost point of the rim 180 and a rearmost point of the lip surface 194, which are located within the vertical center plane. In some configurations, the depth 244 can be about 20 - 30 mm, about 23 - 28 mm, or about 25 - 26 mm for a single cushion 158 or across the size range of the cushion 158. In some configurations, the depth 244 can be about 25.35 mm.

[0135] FIGS. 6-1 and 6-2 show some differences between the cushion 158 of the present invention and a prior art cushion 158P sold by the applicant, Fisher & Paykel Healthcare Ltd., as a component of the Eson2 nasal mask. As shown in FIG. 6-1, the height 234 of the cushion 158 of the present invention is smaller than the height 234P of the Eson2 cushion 158P. As a result, the upper portion of the cushion 158 of the present invention is positioned below the user's nose as compared to the Eson2 cushion 158P. Thus, a greater proportion of the cushion 158 can be positioned out of the user's field of view and / or the upper portion of the cushion 158 can be positioned closer to the edge of the user's field of view as compared to the Eson2 cushion 158P. Accordingly, the cushion 158 of the present invention is less obtrusive to the user than the Eson2 cushion.

[0136] Similarly, as shown in FIG. 6-1, the depth 232 of the opening 192 of the cushion 158 of the present invention is greater than the depth 232P of the opening 192P of the Eson2 cushion 158P. Such an arrangement can facilitate or accommodate a lower position of the cushion 158 of the present invention over the user's nose.

[0137] In some configurations, the rolling bridge 210 of the cushion 158 of the present invention can be connected to the rim 180 at a location spaced from the front end of the rim 180. In other words, a portion of the rim 180 can project in the forward direction from the rolling bridge 210. In some configurations, the rolling bridge 210 can extend from the rear end of the rim 180 such that the inner surface of the rim 180 is aligned with the inner surface of the rolling bridge 210 at the transition between the rim 180 and the rolling bridge 210. In contrast, the rolling bridge 210P of the Eson2 cushion 158P is connected to the front end of the rim 180P. The arrangement of the cushion 158 of the present invention can make the mold tooling easier and less expensive compared to the arrangement of the Eson2 cushion 158P. However, in other configurations, the rolling bridge 210 can be connected to the front end of the rim 180 as shown in the variant form of the cushion 158 shown in FIG. 38.

[0138] As described above and as shown in FIGS. 6-1 and 7, the thickened panel 220 of the cushion 158 of the present invention extends within or is connected to the thickening band 200. In contrast, the front end of the thickened panel (not shown) of the Eson2 cushion 158P terminates well in front of the thickening band 200P. In some configurations, the rear end of the thickened panel 220 of the cushion 158 of the present invention and the Eson2 cushion 158P are in the same or similar relative positions on the cushions 158, 158P. The longer thickened panel 220 of the cushion 158 of the present invention improves the localized strength or stiffness of the cushion 158 for a better seal to reduce leakage.

[0139] Referring to FIG. 6-2, the opening 192 of the cushion 158 of the present invention is shorter and / or wider than the opening 192P of the Eson2 cushion 158P. That is, the height 240 of the opening 192 of the cushion 158 of the present invention is smaller than the height 240P of the opening 192P of the Eson2 cushion 158P. In the illustrated arrangement, the width 242 of the opening 192 of the cushion 158 of the present invention is larger than the width 242P of the opening 192P of the Eson2 cushion 158P. As described above, the shorter opening 192 of the cushion 158 of the present invention, at least as compared with the Eson2 cushion 158P and the mask, adapts to a lower position above the user's nose so that the cushion 158 and the associated mask 152 are less obtrusive to the user. The wider opening 192 of the cushion 158 of the present invention facilitates the deflection of the seal 158 around the user's nose when the cushion 158 is positioned over the user's nose. Some differences between an embodiment of the cushion 158 of the present invention and the Eson2 cushion 158P are summarized in the following table.

[0140]

Table 1

[0141] Differences between another configuration of the cushion 158 and another configuration of the Eson cushion 158P are summarized in the following table.

[0142]

Table 2

[0143] Referring again to FIG. 37 and also to FIGS. 39 and 40, in some configurations, the cushion 158 includes a pair of lower thickened portions 225 (only one of which is shown in FIG. 37). In the illustrated arrangement, each of the lower portions 225 is an elongate thickened portion of the cushion 158 that extends into the interior of the cushion 158. In some configurations, the portion of the sidewall that includes the lower thickened portion 225 may be about 0.1 to 0.6 mm thicker than the adjacent portions of the sidewall 188 and / or the endwall 184. In some configurations, the portion of the sidewall that includes the lower thickened portion 225 may be about 0.1 to 0.3 mm thicker. In some configurations, the portion of the sidewall that includes the lower thickened portion 225 may be about 0.2 mm thicker. In some configurations, the lower thickened portion 225 can be about 1.2 mm thick. In some configurations, the absolute and / or relative thickness of the lower thickened portion can be substantially uniform along their length.

[0144] As shown in FIGS. 37, 39, and 40, the lower thickened portions 225 are at least partially curved. As shown in FIG. 37, when viewed from the side of the cushion 158, the lower thickened portions 225 appear to curve upward, particularly at the middle portion of the lower thickened portions 225 at the transition of the cushion 158 from the sidewall 188 to the endwall 184. Each lower thickened portion 225 curves or is rounded in a direction substantially perpendicular to their respective major surfaces. In other words, the thickened portions 225 form a substantial planar curve that has a width extending in a direction substantially perpendicular to the plane of the curve. When viewed from a particular angle, as shown in FIG. 38, the lower thickened portions 225 may appear substantially linear. However, when the cushion 158 is viewed from another angle, the lower thickened portions 225 appear to have a lateral curve, as best shown in FIG. 37. When the lower thickened portions 225 and the adjacent portions of the sidewall 188 and endwall 184 are flattened, the lower thickened portions 225 form a planar curve. The lower thickened portions 225 may have a twist along at least a portion of their length.

[0145] The lower thickened portion 225 has a first end portion 225a provided at or adjacent to or near the rim 180, and at or adjacent to or near each lower corner portion of the substantially triangular side wall 188 of the cushion 158. From this first end portion, the lower thickened portion 225 extends substantially rearward (i.e., toward the user during use), then curves upward, and terminates at a second end portion of the end wall 184 adjacent to the cheek surface 196 of the face contact surface 186 on both sides of the opening 192. As viewed from the top or bottom of the cushion 158 as shown in FIG. 39, the lower thickened portions 225 spread outward relative to each other and extend rearward away from each other in a direction from the first end portion 225a toward the middle portion. As viewed from the front or back of the cushion as shown in FIG. 40, the lower thickened portions 225 extend upward toward each other in a direction from the middle portion toward the second end portion 225b. This spreading-toward arrangement has been found to help avoid contact with relatively sensitive areas of the user's face. The lower thickened portion 225 terminates at a second end portion that is vertically above and horizontally spaced from the lower region 202 of the thickening band 200 as shown in FIG. 37. The lower thickened portion 225 terminates at a second end portion that is vertically below and vertically spaced from each lowermost portion of the thickened portion 220. The lower thickened portion 225 extends under each lower thickened corner portion 189 of the side wall 188 and terminates at a first end portion 225a that is vertically below and spaced from each lower thickened corner portion 189.

[0146] In some configurations, the linear distance (i.e., the most direct path through three-dimensional space) between the first end 225a and the second end 225b of the lower thickened portion 225 is about 30 to 35 mm. In some configurations, the linear distance is about 32.9 mm. The second end 225b of the lower thickened portion 225 is spaced from the opening 192 so as not to contact the sensitive area of the patient's nose. In some configurations, the minimum distance between the lower thickened portion 225 and the opening 192 is at least 4 mm. In some configurations, the minimum distance is about 5 to 6 mm. In some configurations, the minimum distance can be about 5.2 to 5.5 mm.

[0147] The lower first end 225a of the lower thickened portion 225 may be narrower in width than the upper second end 225b. The thickened portion 225 is tapered from the second end 225b to the first end 225a, which can help avoid or reduce contact with the sensitive area of the patient's upper lip. In some configurations, the width of the first end is about 4 to 6 mm. In some configurations, the width of the first end is about 4.7 mm, 4.8 mm, or 5.0 mm. In some configurations, the width of the second end is about 7 to 8 mm. In some configurations, the width of the second end is about 7.4 or 7.8 mm. In some configurations, the second end 225b is at least 50% wider in width than the first end 225a. In some configurations, the second end 225b is about 50% to 60% wider in width than the first end 225a. In some configurations, the second end 225b is about 54% wider in width than the first end 225a.

[0148] It has been found that the thickened portion 225 transmits the force towards the housing 162 rather than the user, reduces the crushing of the cushion, and / or provides additional support to transmit the sealing force to the user's cheek rather than to more sensitive areas such as the upper lip and the lower region of the nose.

[0149] Referring again to FIG. 37, in some configurations, the thickness of the sidewall 188 can gradually taper rearwardly from the rim 180 towards the lower surface 194 of the facial contact surface 186 at the bottom portion of the cushion 158. The taper may be non-linear and, in particular, may be a substantially abrupt taper. In contrast, in other regions of the cushion 158, there is a step change in the thickness of the sidewall 188 from the relatively thick rim 180 to the portion immediately adjacent to the sidewall 188, and the thickness of the sidewall 188 remains substantially uniform between the rim 180 and the end wall 184, except for the thickening band 200, the thickening panel 220, and the bonding pad 221.

[0150] The taper of the sidewall 188 at the bottom portion of the cushion 158 is less steep than the taper of the conventional Eson2 cushion shown in FIG. 6-1. In some configurations, the sidewall 188 can taper from the rim 180 by at least about 3 mm to half (50%) of the thickness of the rim 180. In some configurations, the sidewall tapers from the rim 180 by at least about 4 mm to half of the thickness of the rim 180. In some configurations, the sidewall tapers from the rim 180 by at least about 5.5 mm to half of the thickness of the rim 180. In some configurations, the sidewall 188 can taper from the rim 180 by at least about 7 mm to one-fourth (25%) of the thickness of the rim 180. In some configurations, the sidewall tapers from at least about 8 mm of the rim 180 to one-fourth of the thickness of the rim 180. In some configurations, the sidewall tapers from the rim 180 by at least about 9.4 mm to one-fourth of the thickness of the rim 180.

[0151] Headgear-Interface Connection Referring to FIGS. 8-16, the illustrated connection device 248 between the mask 152 and the headgear 154 is configured to secure the mask 152 in an operable position on the user's face. In some configurations, the connection device 248 is configured to provide a suitable level of stability to the mask 152 by a single connection between the headgear 154 and the mask 152 on each side of the mask. Thus, the illustrated mask assembly 150 does not include a forehead support or a corresponding upper headgear portion. As a result, the illustrated mask assembly 150 avoids any portion of the mask frame 156 extending above the cushion module 160, and thus is less obtrusive to the user as compared to masks having at least a forehead support.

[0152] In the illustrated mask assembly 150, a connection device 248 is provided on each side of the mask 152. The connection devices 248 can be the same or substantially the same on each side of the mask 152, except that the connection devices 248 can be mirror images of each other. Thus, only one of the connection devices 248 will be described herein. However, the description can be equally applied to the other connection device 248. Alternatively, the connection devices 248 on each side of the mask 152 may be slightly different from each other, as will be described in more detail later. The illustrated connection device 248 is a removable connection. In an alternative arrangement, the headgear 154 may be permanently connected to the mask 152 on one side and employ a removable connection (e.g., the connection device 248) on the other side.

[0153] Referring to FIG. 8, the connection device 248 includes a headgear clip 250 that is removably connectable to the frame 156. FIG. 8 shows the headgear clip 250 attached to the frame 156. Referring further to FIG. 10, each side of the frame 156 generally includes an ear portion 252 associated with each headgear clip 250. The ear portions 252 preferably extend laterally outward from a central portion 254 of the frame 156, and the frame 156 includes a connector portion 170 and an opening 256 that communicates with the interior of the connector portion 170 and receives the connection tube 164. The ear portions 252 can be configured to position the clip 250 further forward and / or upward relative to a conventional four-point headgear arrangement, positioning the clip 250 within or further within the user's peripheral vision. This can make it easier for at least some patients to engage and / or disengage the clip 250 from the ear portions 252.

[0154] In the illustrated arrangement, the connection device 248 is a hook - post connector. However, other connector types can also be used. In the illustrated arrangement, each of the ear portions 252 of the frame 156 includes a post 260. However, in other arrangements, the post 260 can be located on the clip 250. In the illustrated arrangement, each of the clips 250 includes a hook structure 266. However, in other arrangements, the hook structure 266 can be located on the frame 156. The hook structure 262 and the post 260 provide an easily connectable and separable configuration. In some configurations, the clip 250 is symmetric so that a single clip can be used on both the left and right sides of the frame 156. In other configurations, the posts 260 and / or clips 250 on each side of the mask 152 may be different to reduce the likelihood of an improper connection between the headgear 154 and the frame 156.

[0155] The illustrated clip 250 includes a base portion or base 264 and a hook portion or hook 266. The base 264 and the hook 266 cooperate to form a hook structure 262. The hook 266 extends from a side of the front end of the base 264. In some configurations, the front end of the base 264 is aligned with the front end of the hook 266. The base 264 defines a height 270 in a direction parallel to the longitudinal axis A of the post 260 when the clip 250 is connected to the post 260. Similarly, the hook 266 defines a height 272 in the same direction. In some configurations, the height 270 of the base 264 is greater than the height 272 of the hook 266. Additionally, a portion of the base 264 can extend beyond both the upper and lower ends of the hook 266 in the direction of the heights 270, 272. In some configurations, the hook 266 can be centered with respect to the base 264 in the vertical direction or the direction of the heights 270, 272.

[0156] Referring to FIG. 11, the base 264 and the hook 266 cooperate to define a space 274 that is sized and shaped to receive the post 160. The post 160 can generally be inserted into the space 274 through an opening 276 that faces generally rearward. The space 274 can define a maximum width 278 in a direction perpendicular to the longitudinal axis A of the post 260 when the clip 250 is connected to the post 260, or in a direction perpendicular to the heights 270, 272. The opening 276 can define a minimum width 280 in a direction parallel to the maximum width 278 of the space 274. Referring to FIG. 12, the post 160 can define a maximum width, which in this specification can be referred to as a diameter 282 since the illustrated post 160 is cylindrical. The width 278 of the space 274 can be made equal to the diameter 282 or slightly larger than the diameter 282 so as to provide a tight fit between the post 160 and the clip 250 when the clip 250 is connected to the post 160. Such an arrangement can improve the stability of the connecting device 248, as will be further described below. In one example configuration, the diameter 282 can be 2.47 mm and the width 278 can be 2.52 mm. In some configurations, the width 278 is about 2% larger than the diameter 282. In other configurations, the width 278 of the space 274 can be made smaller than the diameter of the post 160, whereby the hook 266 does not fully elastically recover when the post 160 is inserted.

[0157] Referring to FIG. 12-1, in one example configuration, the clip 250 has a thickness 402 of about 1.5 mm at the tip of the hook 266. In another example configuration, the thickness 402 can be about 1.3 mm. The diameter 404 of the hook opening is about 3.1 mm in the case of a post 260 having a diameter of about 3.0 mm, providing a gap of about 0.05 mm on each side of the post 260. The amount of interference 406 between the post 260 and the protrusion 284 in this configuration is about 0.25 mm.

[0158] The width 280 of the opening 276 can be made smaller than the maximum width 278 of the space 274 and / or the diameter of the post 260 to provide an interference fit between the hook structure 262 and the post 260 so that the clip 250 is less likely to accidentally come off during use. In one particular configuration, an interference greater than 0.25 mm and less than 0.30 mm has been found to be suitable, with an interference of 0.28 mm being preferred. In the illustrated arrangement, the opening 276 of the clip 250 is defined between the base 264 and the protruding portion, interference protrusion, or simply the protrusion 284 of the hook 266. In the illustrated arrangement, the space 274 defines a partial cylindrical shape, such as a semi-cylindrical shape, that can contact the corresponding surface of the cylindrical post 260. The protrusion 284 can be spaced from the portion of the hook 266 that defines the partial cylindrical shape so that there is a space between the post 260 and the hook 266 when the post 260 is inserted into the space 274, as shown in FIG. 12.

[0159] The interference fit between the clip 250 and the post 160 can be configured for a desired separation force that is high enough to prevent unintentional disengagement but low enough to allow for convenient intentional disengagement by the user. In the illustrated arrangement, an interference greater than 0.25 mm and less than 0.3 mm, i.e., the difference between the width 280 of the opening 276 and the width of the space 274 and / or the diameter 282 of the post 260, has been determined to be desirable. For example, the interference can be about 0.26 mm to 0.29 mm, about 0.27 mm to 0.29 mm, or can be about 0.28 mm. Such interference can be expressed as a percentage or ratio of those dimensions based on the dimensions of the post 260 and / or the space 274 disclosed herein. Additionally, the interference can be varied based on the shape or size of the hook 266 and / or the material of the clip 250. In some configurations, the draw-in angle and draw-out angle of the protrusion 284 can be configured so that the required connection force is less than the required separation force to prevent inadvertent separation without making the connection unnecessarily difficult.

[0160] In some configurations, the interference fit between the clip 250 and the post 160 can be configured to provide a tactile and / or audible feedback to confirm a proper connection between components.

[0161] Referring mainly to FIG. 10, each ear portion 252 defines an opening 290 that is positioned adjacent to the post 260. That is, the post 260 defines a part of the boundary of the opening 290. The opening 290 is configured to receive and accommodate at least the hook 266 of the clip 250 to enable the clip 250 to be connected to the post 260. In the illustrated configuration, the ear portion 252 and the opening 290 are configured to limit the movement of the clip 250 relative to the frame 156. In some configurations, the ear portion 252 and the opening 290 are configured to limit the rotational movement of the clip 250 about an axis perpendicular to the longitudinal axis A of the post 260. Such an arrangement can improve the stability of the mask 152 on the user's face, as will be further described below. In some configurations, the ear portion 252 and the opening 290 are configured to limit the rotational movement of the clip 250 about the longitudinal axis A of the post 260. Such an arrangement can prevent an undesirable separation of the clip 250 from the mask 152.

[0162] The illustrated opening 290 is generally trapezoidal in shape, and the end opposite the post 260 has a length greater than the length of the post 260. Such an arrangement improves the user's ability to pass the hook 266 through the opening 290 without the often-occurring situation of not being able to see the mask 152 when the user is wearing the mask 150. However, in other arrangements, the opening 290 can have any desired shape. At least a portion of each side of the opening 290, each extending between the post 260 and the end of the opening 290 opposite the post 260, approaches each other toward the post 260. Such an arrangement can help guide the clip 250 toward the post 260.

[0163] The illustrated opening 290 includes a narrowed portion 292 relative to an adjacent portion of the opening 290. The narrowed portion 292 is located adjacent to the post 260. The narrowed portion 292, together with the post 260, defines a space for receiving the hook 266 of the clip 250. The narrowed portion 292 can be defined by a second or lower face 296 that faces the first or upper face 294. Each of the upper face 294 and the lower face 296 originates from the post 260 and extends away from the post 260 to a terminal end. The space of the narrowed portion 292 can be defined between an imaginary line connecting the post 260 and the terminal ends of the upper face 294 and the lower face 296 in the horizontal direction, and between the upper face 294 and the lower face 296 in the vertical direction. In some configurations, portions on both sides of the opening 290 that approach each other toward the post 260 are provided adjacent to and approach each other toward the respective upper face 294 and lower face 296 of the narrowed portion 292.

[0164] The size and / or shape of the space of the narrowed portion 292 can match or be substantially the same as the size and / or shape, particularly the cross-sectional size and / or shape, of the base or connection portion of the hook 266 that occupies the narrowed portion 292 when the clip 250 is connected to the post 260. In some configurations, the size and / or shape of the space of the narrowed portion 292 can be slightly larger than the base or connection portion of the hook 266 that occupies the narrowed portion 292 when the clip 250 is connected to the post 260. Preferably, the relative size allows for convenient insertion of the hook 266 into the narrowed portion 292, but as described above, is selected to allow a snug fit sufficient to limit any substantial rotation of the clip 250 in a direction perpendicular to the longitudinal axis A of the post 260. Such rotation can be limited at least in part by contact between the base or connection portion of the hook 266 that occupies the narrowed portion 292 and the upper face 294 and the lower face 296 of the narrowed portion 292.

[0165] In some configurations, the hook 266 is shaped such that when the hook 266 engages with the post 260, it spans across the space of the narrow portion 292. In some configurations, the hook 266 can occupy the entire or substantially the entire space of the narrow portion 292. Thus, the distance between the upper surface 294 and the lower surface 296 in a direction parallel to the longitudinal axis A of the post 260 is equal to or only slightly greater than the height 272 of the hook 266. Such an arrangement restricts or prevents the axial movement of the clip 250 along the longitudinal axis A of the post 260 during use. In some configurations, the base portion of the hook 266 extending from the base 264 of the clip 250 is the thickest portion of the hook 266 or can define the maximum wall thickness of the hook 266. The thickness of a part or the whole of the base portion of the hook 266 can be selected such that the hook 266 extends along the whole or part of one or both of the upper surface 294 and the lower surface 296 of the narrow portion 292. In some configurations, the hook 266 may extend beyond the end portions of one or both of the upper surface 294 and the lower surface 296.

[0166] The shape and / or orientation of the upper surface 294 can correspond to the shape and / or orientation of the corresponding upper surface of the hook 266. Similarly, the shape and / or orientation of the lower surface 296 can correspond to the shape and / or orientation of the corresponding lower surface of the hook 266. In the illustrated arrangement, the upper surface 294 is parallel or substantially parallel to the lower surface 296. Additionally, the upper and lower surfaces of the hook 266 are parallel or substantially parallel. Thus, when the fit between the hook 266 and the narrow portion 292 is tight, the hook 266 is in contact with the whole or substantially the whole of the upper surface 294 and the lower surface 296. Even if there is some gap provided between the hook 266 and the narrow portion 292, contact occurs with a smaller angular movement compared to an arrangement where the hook 266 does not correspond in size and / or orientation to the upper surface 294 and the lower surface 296 of the narrow portion 292.

[0167] In some configurations, the clip 250 can be configured to enable pivotal movement of the clip 250 relative to the post 260 and / or the frame 156 about the longitudinal axis A of the post 260. With such an arrangement, the angular orientation of the clip 250 relative to the frame 156 can be changed so as to easily adapt to different head shapes. However, in some configurations, the pivotal movement of the clip 250 can be restricted. For example, since the base 264 of the clip 250 has a height 270 greater than the height 272 of the hook 266, the base 264 can contact the frame 156. In some configurations, the base 264 can contact portions of the frame 156 above and / or below the post 260 and / or the narrow portion 292 to limit the pivotal movement of the clip 250 towards and / or away from the frame 156.

[0168] Figures 13-16 show the interaction between the mask 152 and the headgear 154 resulting from or facilitated by the engagement of the clip 250 and the post 160 of the connecting device 248. Figure 13 shows the direction in which rotation is limited, restricted or prevented by the connecting device 248, particularly the positioning of the hook 266 within the narrow portion 292 of the opening 290 when the clip 250 is connected to the post 260. As described above, the connecting device 248 can limit, restrict or prevent the movement of the clip 250 about an axis perpendicular to the longitudinal axis A of the post 260. In the context of the mask assembly 150, the movement of the clip 250 in a vertical plane or about a horizontal axis is limited, restricted or prevented. As will be described further below, when the headgear 154 provides sufficient support to the clip 250, the headgear 154, in combination with the connecting device 248, limits, restricts or prevents excessive swaying of the mask 152 on the user's face. Figure 14 shows that the connecting device 248 can be configured such that the headgear 154 extends from the mask 152 at a desired angle for a particular application or headgear type. That is, the connector can be fixed at different angles relative to the mask frame for the purpose of better engaging the top of the bottom of the seal.

[0169] Figures 15 and 16 show the direction and range in which the rotation of clip 250 about the longitudinal axis A of post 260 is restricted with respect to mask 152 to enable mask assembly 150 to conform to users having different head widths or sizes. Figure 15 shows that some rotation of clip 250 about the longitudinal axis A of post 260 is possible. In the context of the overall mask assembly 150, this rotation is either in the horizontal plane or about a vertical axis. Figure 16 shows an example of the range of motion that can be achieved. For example, in some configurations, the functional range can be from 0 to 90 degrees. However, in some configurations, the acceptable or operating range is further restricted. For example, in the illustrated arrangement, an operating range α of about 15 degrees is provided. The operating range α of about 15 degrees is possible at an angle of about 45 to about 60 degrees with respect to the central vertical plane that bisects the mask assembly 150 into a right lateral portion and a left lateral portion. Such a range can enable accommodation of an acceptable range of user head sizes while reducing or minimizing the undesirable separation of connection device 248 that can occur with excessive rotational movement. In other configurations, the operating range can be from about 10 degrees to about 30 degrees and can be possible between any angle within the range of about 20 degrees to 80 degrees with respect to the central vertical plane.

[0170] Figures 17A - 17D illustrate a method of fitting the mask assembly 150 to a user. In some configurations, the mask assembly 150 and the connection device 248 can be configured to enable the user to fit (apply or wear) the mask assembly 150 in a substantially single operation using one hand to effect the connection between the headgear 154 and the mask 152. The user's other hand can be used to support the mask 152. Figure 17A shows the direction of movement for separating the headgear 154 from the mask 152. That is, by moving the headgear 154 (and clip 250) away from the user in the forward direction to force the post 260 through the opening 276 of the clip 250 against the separating force generated by the elasticity of the hook 266, the clip 250 can be separated from the post 260. Removal of the headgear 154 as shown in Figure 17A can be done to enable removal of the mask assembly 150 from the user or to form an open loop before the mask assembly 150 is applied to the user.

[0171] Figures 17B and 17C show that the mask 152 can be positioned near or over the user's nose and the separated ends of the headgear 154 can be swung around the user's head or over the head towards the cooperating side of the mask 152. As shown in Figure 17D, the clip 250 can be manipulated to pass the hook 266 through the opening 290 of the frame 156 of the mask 152. By moving the headgear 154 and clip 250 in the rearward direction and pushing the post 260 through the opening 276 of the clip 250 into the space 274, the clip 250 can be connected to the frame 156 and the headgear 154 to the mask 152. Since only a single headgear clip 250 is provided on each side of the mask assembly 150, the connection of the headgear 154 to the mask 152 can be achieved in a single one - hand operation. To remove the mask assembly 150, the user can disengage the clip 250 from the mask 152 as shown and described in connection with Figure 17A.

[0172] FIG. 18 shows that the strap or a part of the headgear 154 connected to the clip 250 can be oriented obliquely with respect to the clip 250. In other words, the longitudinal axis or the center line of the headgear 154 can define an angle with respect to the longitudinal axis or the center line of the clip 250. As used herein, to be oriented obliquely or to define an angle means that the axis or the center line does not form a straight line. In other words, two lines or axes that are oriented obliquely do not define an angle of 0 degrees or 180 degrees. With such an arrangement, the headgear 154 can be oriented as required with respect to the user's head, while enabling the clip 250 to be oriented as required with respect to the frame 156 regardless of the orientation of the frame 156.

[0173] FIGS. 19 - 21 show that the rear portion 298 of the clip 250 located behind the connection portion with the frame 156 of the mask 152 can be enlarged with respect to the portion connected to the frame 156. The enlarged rear portion 298 can be provided to improve the grip of the user on the clip 250. In some configurations, the enlarged rear portion 298 can be configured to limit the rotation of the clip 250 by contacting the end of the frame 156 as shown in FIG. 19.

[0174] In some configurations, the headgear clip 250 can include additional structures for improving the connection device 248. FIGS. 41 - 45 show a modified version of the clip 250 in which the base 264 includes a protrusion 265 that extends outwardly from the main surface facing the outside of the base 264, preferably at least partially in a direction substantially perpendicular to its main surface. In the illustrated clip 250, the protrusion 265 extends across the width of the headgear clip 250. However, in some configurations, the protrusion 265 may extend only across a part of the width of the base 264. In some configurations, the protrusion 265 is located near the front strap portion 306, adjacent to, or towards the rear portion 298 of the clip 250, which can help keep the user's hand away from the hook 266 so that the connection and / or separation of the clip 250 is not hindered.

[0175] In some configurations, the protrusion 265 may protrude from the adjacent portion of the base 264 by about 2 to 5 mm. In some configurations, the protrusion 265 may protrude from the base 264 by about 3.5 mm. In some configurations, the protrusion 265 may protrude from the base 264 by a height equal to about 50% to 150% of the thickness of the base 264. In some configurations, the protrusion 265 may have a height substantially equal to the thickness of the base 264.

[0176] The protrusion 265 can be useful to the user when pushing the headgear clip 250 towards the frame 156 during donning and / or doffing. The protrusion 265 can alternatively or additionally be useful to the user when pulling the clip 250 away from the mask frame (i.e., pulling the hook 233 towards the frame) to secure the interference connection between the clip 250 and the post 260 of the frame 156.

[0177] Each of the headgear clips 250 in FIGS. 41 - 44 also includes a recess 267 in the portion facing the outside of the base 264. The recess 267 acts as a tactile feature that houses the user's finger, particularly the index finger. The presence of the recess 267 in front of and substantially adjacent to the protrusion 265 can increase the effective height of the protrusion 265 relative to the base 264. The recess can provide a visual cue to the user. The provision of tactile and / or visual cues can help the user position a finger on the clip 250 to connect the clip 250 to the frame 156 and / or separate it from the frame 156. As shown in each of FIGS. 41 - 44, at least a portion of the recess 267 can also provide an inclined or substantially vertical ridge or wall 268 against which the user can apply a force to guide the clip 250 towards the frame 156 during donning and / or to remove the clip 250 from the frame 156 when removing the patient interface assembly 150.

[0178] As shown in FIG. 42, one or more raised portions 269 can be provided on the base 264. The raised portions 269 can provide additional friction between the base 264 of the clip 250 and assist the user in gripping the clip 250. The raised portions 269 are smaller in scale than the recesses 267 and can be provided within the recesses 267 as shown. The raised portions 269 can provide a visual cue to the user. For example, in FIG. 40, the raised portions 269 are arranged as arrows indicating that the clip 269 is configured to be moved in a certain direction.

[0179] In some configurations, the headgear clip 250 can extend rearward along the front portion of the front strap portion 306 of the headgear 154. As shown in FIG. 44, the headgear clip 250 extends rearward from the protrusions 265 along the opposing edges 313 of the front strap portion 306, defining a wavy C-shaped recess 263 that exposes the outer surface of the front strap portion 306. Similar to the recess 267, the recess 263 can define inclined or vertical raised portions or walls 268. The C-shaped recess 263, similar to the recess 267, can act as a tactile feature that accommodates the user's finger when connecting and disconnecting the headgear clip 250.

[0180] In some configurations, the plastic core within the front strap portion 306, described in more detail below, can vary in width along the front strap portion 306, particularly adjacent to the clip 250. As shown in the configuration of FIG. 43, the plastic core of the front strap portion 306 has an enlarged region 315 of width adjacent to the headgear clip 250. Region 315 can be substantially planar. Region 315 can extend outwardly beyond the edge 313 of the front strap portion 306. The relatively wide plastic core adjacent to the headgear clip 650 provides a wider area for accommodating the user's finger when connecting the headgear clip 250 to the frame 156. Similarly, the plastic core of the front strap portion 306 can vary in thickness along the front strap portion 306, particularly adjacent to the clip 250. As also shown in FIG. 43, the plastic core of the front strap portion increases in thickness towards the headgear clip 250. The increased thickness portion can define an integral shelf-like protrusion 317. The shelf-like protrusion 317 provides a tactile feature that is useful when the user is gripping the front strap portion 306 and the headgear clip 250. As shown, the shelf-like protrusion 317 can be contoured, for example, to intuitively accommodate the index finger. The headgear clip 250 can have an increased thickness in a location immediately adjacent to the front strap portion 306. This can provide the protrusion 265 as described above. In other configurations, the rear portion 298 of the clip 250 and the front portion of the front strap portion 306 can be substantially in the same plane as each other.

[0181] In some configurations, the clip 250 can be provided with a protrusion 265, alternatively or additionally, as shown in FIG. 45, from the side facing the inside of the base 264 (i.e., the side facing the user).

[0182] As shown in the configurations of FIGS. 41, 42, and 44 - 48, in some configurations, the clip 250 can be formed from two different materials. The front end portion of the clip 250 including the hook 266 is formed from a first material, and the rear portion 298 is formed from a second material. The first material can be an elastic and relatively rigid thermoplastic material suitable for repeated engagement and disengagement with the post 260, such as polyoxymethylene (also known as acetal). The second material can be an elastic and relatively soft thermoplastic elastomer material, such as a polyether block amide (PEBA) sold under the trade name PEBAX® by Arkema Group of Colombes, France. The second material can be overmolded onto the first material and optionally onto the front strap portion 306 of the headgear 154 to fix the clip 250 to the front portion 300 of the headgear 154. The second material can be selected to provide a desired tactile feel and / or improved grip compared to the first material, while the first material can be selected to provide a secure and / or stable connection with the frame 156 of the hook 266. The first material can be the same material as that used in the plastic core of the headgear 154, as will be described later. The protrusion 265 can be formed at least in part from a first relatively rigid material for stability, as shown in FIGS. 42, 45, and 48. Alternatively or additionally, at least the outer portion of the protrusion 267 can be formed from a second relatively soft material for improved grip or tactile feel, as shown in FIGS. 41, 44, and 46. Referring particularly to FIG. 46, a cross-sectional view of an exemplary configuration of the clip 250 including the first and second materials is shown, where the second material is overmolded onto and mechanically intermeshes with both the first material and the front strap portion 306.

[0183] Referring to a further configuration example of FIG. 47, as an alternative or additionally, a protrusion 265 can be provided on the front strap 306. This can ensure sufficient clearance for the user's hand from the hook 266 and the post 260, provide a more distinct and / or attractive aesthetic with respect to the protrusion 265, and / or provide an improved tactile sensation and / or grip with respect to the protrusion 265. The protrusion 265 can be formed when an injection molding of a plastic core is carried out inside a tubular knitting structure, as will be described in more detail later.

[0184] As described above, the posts 260 and / or clips 250 on each side of the mask 152 can be different from each other so as to reduce or eliminate the possibility of an improper connection between the headgear 154 and the frame 156. Here, with reference to another configuration example of the patient interface assembly 150 and its components as shown in FIGS. 48 to 52, an example will be described. Unless otherwise described herein and / or apparent from the accompanying drawings, the patient interface assembly 150 of FIGS. 45 to 48 can be the same as that of FIG. 2. In particular, the patient interface assembly 150 includes a frame 156, a cushion module 160, and a headgear 154. Each side of the frame 156 has an ear portion 252 associated with the headgear clip 250. The ear portion 252 extends laterally outward from the central portion 254 of the frame 156, and the frame 156 includes a frame connector 170 and an opening 256 that communicates with the inside of the connector portion 170 and receives the connection tube 164. The frame 156 includes a cylindrical frame connector 170 and an oval opening 256. The cooperating opening (not shown) of the housing 162 is circular.

[0185] In the configuration shown in FIGS. 48 to 52, the connection device 248 is modified to prevent or block an incorrect connection to the post 260 of the clip 250. That is, the connection device 248 can prevent or block a connection in an incorrect orientation of the clip 250 and / or to an incorrect side of the frame 156. In some configurations, the connection device 248 can limit the connection between the clip 250 and the post 260 to a single desired arrangement.

[0186] Referring to FIGS. 49 and 50, which respectively show front and rear views of frame 156, it can be seen that posts 260 of this configuration each define a gap 261 along their respective longitudinal axes A. The illustrated posts 260 can be referred to as a split post configuration including axially aligned first post portion 260a and second post portion 260b. Gap 261 is eccentric along longitudinal axis A of post 260. The split posts 260 on both sides of frame 156 are identical to each other. That is, each gap 261 can be offset by the same distance and in the same direction from the center of post 260.

[0187] Referring to FIGS. 51 and 52, clip 250 of this configuration includes a rib 275 that extends into a space 274 intended to receive post 260. Rib 275 is also eccentrically positioned and is sized, shaped, and positioned such that it is received by gap 261 when clip 250 is connected to one of posts 260. The width of rib 275 is smaller than the length of gap 261 in the axial direction A. Gap 261 and rib 275 do not prevent rotation of clip 250 about axis A of post 260 when the clip is correctly attached to frame 156. Movement of clip 250 in the direction of longitudinal axis A is restricted by the size and / or shape of the narrow portion 292 and the base or connection portion of hook 266, as described above. However, in some configurations, rib 275 and gap 261 can alternatively or additionally restrict movement of clip 250 in the direction of longitudinal axis A when clip 250 is connected to frame 156. In some configurations, rib 275 can be configured to provide a snap-fit connection between clip 250 and frame 156, together with either or both of first post portion 260a and second post portion 260b, where first post portion 260a and second post portion 260b are elastically deformed when hook 266 engages frame 156 and can partially or fully recover when engaging rib 275.

[0188] Referring further to the interface assemblies 150 of FIGS. 48-52, a pair of clips 250 are configured such that one connects to the post 260 on one side of the frame 156 and the other clip 250 connects to the post 260 on the other side of the frame 156, and are different from each other. The pair of clips 250 can be mirror images of each other. If an attempt is made to connect the clip 250 to the wrong side of the frame 156, the rib 275 and the gap 261 will not align, and the rib 275 will interfere with the post 260 and prevent or block the post 260 from entering the space 274. The upside-down connection of the clip 250 to the post 250 is prevented or blocked by interference between the narrow portion 292 and the height 270 of the base 264.

[0189] In other configurations, an annular or partial annular rib 275 can be provided on the post 260, and a corresponding gap 261 or channel can be provided in the clip 250. In some configurations, the gap 261 and the rib 275 can be provided in the post 260 and the clip 250 only on one side of the patient interface assembly 150 (or vice versa), ensuring that at least one of the clips 250, and thus the headgear 154 as a whole, cannot be incorrectly connected to the frame 156. In some configurations, the clips 250 can be identical to each other, and the posts 260 on each side of the frame 156 can be different.

[0190] Headgear Figures 2, 13 - 16, and 22 - 27 show an example of the above-described headgear 154. The headgear 154 will be described below with reference to Figures 2, 13 - 16, and 22 - 27. In the illustrated arrangement, the headgear 154 has a front portion 300 and a rear portion 302. The front portion 300 is configured to connect to the mask 152 and extends between the mask 152 and the rear portion 302. The rear portion 302 is configured to engage the side and / or rear portion of the user's head. The illustrated front portion 300 includes a front strap or strap arrangement 304 that connects to the mask 152 via clips 250 on each side of the interface assembly 150 or the user's head. In the illustrated arrangement, the front strap arrangements 304 on each side of the interface assembly 150 are separate from each other and connect separately to the mask 152. The front strap arrangements 304 can be mirror images of each other.

[0191] In an alternative configuration, the front strap arrangement 304 on one side can be permanently connected to the mask 152 or connected in such a way that it is more complex and difficult to remove than the clip 250 located on the opposite side of the mask 152 such that the mask assembly 150 is removed using the clip 250. In an alternative arrangement, the front strap arrangement 304 on one side of the headgear 154 can be coupled to the mask 152 and the front strap arrangement 304 on the other side of the headgear 154 can be coupled to the front strap arrangement 304 on the first side.

[0192] Each of the illustrated front strap arrangements 304 includes a single front strap portion 306 that connects to the mask 152 via a clip 250. The front strap arrangement 304 bifurcates to define an upper strap portion 308 and a lower strap portion 310, which extend, or are at least partially located, respectively, above and below the height of the user's ears. The front strap portion 306 extends across the user's cheek from the mask 152 to the bifurcation point. In the illustrated arrangement, the front strap portion 306 extends in a slightly upward direction from the mask end to the bifurcation end. The upper strap portion 308 continues the curvature of the front strap portion 306 and extends toward or to a location above the user's ear. In some configurations, the end of the upper strap portion 308 can be positioned directly above the user's ear, or above the line of the ear and slightly forward of the ear. The end portion of the upper strap portion 308 can curve downward to connect to the rear portion 302 of the headgear 154. The lower strap portion 310 extends downward from the bifurcation end of the front strap portion 306 to a location on the user's jaw at a height below the user's ear. The end of the lower strap portion 310 can be positioned below and in front of the user's ear. The end portion of the lower strap portion 310 can curve upward to connect to the rear portion 302 of the headgear 154.

[0193] In some configurations, the front strap portion 306, the upper strap portion 308, and the lower strap portion 310 of the front strap arrangement 304 can be configured as an integral structure. In some configurations, the front strap arrangement 304 can be configured as a formed composite structure having at least one fabric layer and at least one plastic layer that are permanently connected to each other. In the illustrated arrangement, the front strap arrangement 304 is a formed composite structure having two fabric layers with a plastic core positioned therebetween. The front strap arrangement 304 can be formed as an integral structure by applying molten plastic into the space between the fabric layers within a mold such that the molten plastic cures to form the plastic core in the shape of the mold cavity. The fabric layers can be separate from each other and can be joined or bonded via the plastic core (e.g., a tubular structure surrounding the plastic core).

[0194] Part or all of the front strap arrangement 304 can be semi-rigid. The term "semi-rigid" in this context is intended to mean that the associated structure is flexible and at least somewhat elastic but has little or no extensibility. In the illustrated arrangement, any one, any combination, or all of the front strap portion 306, the upper strap portion 308, and the lower strap portion 310 can be semi-rigid. As used herein, semi-rigid means that the semi-rigid portion of the headgear 154 can generally maintain its shape under its own weight but has some flexibility that allows the semi-rigid portion to bend around the user's head. In some configurations, the semi-rigid portion of the headgear 154 is highly rigid in one direction and less rigid in a second direction. For example, the semi-rigid portion of the headgear 154 can be made substantially rigid in the vertical direction or along the user's face and relatively flexible in the horizontal direction or in a direction toward and away from the user.

[0195] The front strap arrangement 304 can be configured to connect to the rear portion 302 of the headgear 154. In some configurations, the ends of the upper strap portion 308 and the lower strap portion 310 can include loops 312 configured to receive the strap portions of the rear portion 302 of the headgear 154. In the illustrated arrangement, the loop 312 can be a plastic loop overmolded onto the ends of the upper strap portion 308 and the lower strap portion 310. In other arrangements, the loop 312 can be formed by the plastic core material of the front strap arrangement 304, or the loop 312 can be formed separately from and attached to the front strap arrangement 304.

[0196] In some configurations, the headgear 154 includes a top strap arrangement 314 that passes over the user's head from one side of the headgear 154 to the other. In the illustrated arrangement, the top strap arrangement 314 connects to the rear end portions of the upper strap portion 308 of the front strap arrangement 304 on each side of the headgear 154. In particular, the top strap arrangement 314 can connect to the uppermost portion of the upper strap portion 308 before the upper strap portion 308 begins to curve downward toward the rear portion 302 of the headgear 154. In the illustrated arrangement, each end of the top strap arrangement 314 is connected to the upper strap portion 308 by an overmolded connector 316. The overmolded connector 316 can be shaped to join the two components over a portion of each of the top strap arrangement 314 and the upper strap portion 308. Alternatively, the overmolded connector 316 can be joined to one of the components by overmolding and can define a connection structure (e.g., a loop) that can connect the other component. For example, the overmolded connector 316 can be overmolded onto the upper strap portion 308 and can define a loop that can couple the top strap arrangement 314.

[0197] In some configurations, the top strap arrangement 314 includes a first strap portion 320 and a second strap portion 322 (FIG. 13) that can be connected to each other. The first strap portion 320 and the second strap portion 322 can be connected to each other in an adjustable manner, such as by a buckle, a post-hole structure 324, or a similar connector generally located on the user's head top. In the illustrated arrangement, the free end of the second strap portion 322 includes a guide loop through which the first strap portion 320 can pass. The first strap portion 320 can be sized to fit relatively tightly with the guide loop so as to maintain a loose connection between the first strap portion 320 and the second strap portion 322 when the straps 320, 322 are not connected by the post-hole structure 324. Such an arrangement avoids an unintended separation of the straps 320, 322 when the user is adjusting the top strap arrangement 314 for ease of use during the adjustment process. In some configurations, the end of the second strap portion 322 can be made slightly larger (e.g., in width and / or thickness) than the opening of the guide loop to provide an interference fit between the strap portion 322 and the guide loop and further reduce the possibility of an unintended separation.

[0198] The illustrated rear portion 302 of the headgear 154 includes a first or upper strap 330 and a second or lower strap 332. The upper strap 330 and the lower strap 332 are spaced from each other by a panel 334. Each of the upper strap 330 and the lower strap 332 extends around the user's posterior head and is configured to connect to the front strap arrangement 304 of the front portion 300 of the headgear 154. In particular, both ends of the upper strap 330 connect to respective upper strap portions 308 of the front strap arrangement 304 on both sides of the user's face. Similarly, both ends of the lower strap 332 connect to respective lower strap portions 310 of the front strap arrangement 304. As shown, for example, in FIG. 22, the upper strap 330 extends downwardly from each end towards or to the vertical centerline of the panel 334 or the rear portion 302. In other words, the ends or loops 312 of the upper strap portions 308 are located at a height above the upper edge of part or all of the panel 334. In some configurations, the lower strap 332 can extend upwardly from each end towards or to the vertical centerline of the panel 334 or the rear portion 302.

[0199] Each of the upper strap 330 and the lower strap 332 can be composed of a composite material including a pair of fabric layers on both sides of a foam layer. In particular, the straps 330, 332 can include a three-layer structure including layers formed from Lycra, foam, and UBL (unbroken loop) material. The UBL material can form the outer layer of each of the straps 330, 332. Each end of each of the upper strap 330 and the lower strap 332 terminates in a tab 336 that can form a hook portion of a hook-and-loop fastener. The tab 336 can be ultrasonically welded to the ends of the straps 330, 332 or connected in another suitable manner. The UBL material provides a loop surface to which the hook tab 336 can be connected. The ends of the straps 330, 332 can pass through the loop 312 of the front portion 300 of the headgear 154 and double back to their original positions. The hook tab 336 can be connected at any location along the length of the straps 330, 332 to enable sizing adjustment of the headgear 154.

[0200] In some configurations, the panel 334 can be wholly or partly composed of a spacer fabric, which is a composite material including two spaced-apart cover fabrics connected by filaments positioned between the cover layers. Referring to FIG. 25, the spacer fabric of the panel 334 is shown in cross section. The spacer fabric can include a first fabric layer 340, a second fabric layer 342, and a central spacer or connecting layer 344. In some configurations, the first fabric layer 340 is Lycra or a similar material, and the second fabric layer 342 is UBL or a similar material. The spacer layer 344 can be composed of any suitable yarn or filament material, such as polyester. As shown in FIG. 25, a gap can be formed between the first fabric layer 340 and the second fabric layer 342 at the outer edge of the panel 334. In one configuration, the gap between the first fabric layer 340 and the second fabric layer 342 is at least 0.1 mm.

[0201] In the illustrated arrangement, the upper strap 330 and the lower strap 332 are continuous from one end to the other, and the panel 334 extends between the bottom edge of the upper strap 330 and the top edge of the lower strap 332. Such an arrangement allows the ends of the straps 330, 332 to be connected to the portions of the straps 330, 332 that overlap the panel 334, providing a greater range of adjustment for the rear portion 302. However, in other arrangements, the upper strap 330 and / or the lower strap 332 can be provided in two segments, each of which extends from a side edge of the panel 334. In other words, the panel 334 can interrupt a portion of the straps 330, 332. Such an arrangement can limit the adjustability of the rear portion 302 because the ends of the straps 330, 332 can only be connected to the straps 330, 332 up to the edges of the panel 334.

[0202] In the illustrated arrangement, in a relaxed or flat-out orientation, the upper strap 330 is linear or straight, and the lower strap 332 is curved such that the ends are below the central portion. Specifically, the lower strap 332 has a curved central section and linear sections that extend on both sides of the central section. In other arrangements, the upper strap 330 can be curved and the lower strap 332 can be straight. In yet other arrangements, both straps 330, 332 can be linear or curved.

[0203] In some configurations, the straps 330, 332 have different levels of stretchability. In other words, the elongation rate for a given applied force is different between the straps 330, 332. In some configurations, the bottom strap 332 has a higher stretchability or elongation rate than the top strap 330. The higher stretchability of the bottom strap 332 allows the user to move their jaw more easily or comfortably and / or reduces the pressure of the strap 332 on the user's skin. However, in other arrangements, the straps 330, 332 can have the same stretch characteristics or the top strap 330 can be made more stretchable than the bottom strap 332.

[0204] In some configurations, the edges of the straps 330, 332 are radio frequency, dielectric, or high frequency welded (RF welded), pressed, and cut to form rounded edges on the straps 330, 332 that improve comfort for the user. The RF welding process also joins and secures the materials of the composite fabric to prevent or inhibit delamination.

[0205] Referring to FIG. 26, the rear portion 302 of the headgear 154 can be provided in a plurality of sizes. In some configurations, the rear portion 302 of the headgear 154 can provide for the overall circumferential adjustment of the headgear 154 (although the top strap arrangement 314 can provide for some depth adjustment of the headgear 154). Thus, the front portion 300 of the headgear 154 can be provided in a single size. In some configurations, the rear portion 302 is provided in two sizes, namely, a small size and a large size. In some such configurations, the difference between the sizes is only in the length of one or both of the straps 330, 332. In the illustrated arrangement, the length 350 of the upper strap 330, which is small in size, is about 340 - 400 mm or about 370 mm. For the large size, the length 350 can be about 400 - 460 mm or about 430 mm. The length 352 of the lower strap 332, which is small in size (measured as the straight-line distance between the ends with the lower strap 332 in its relaxed or natural curved state), is about 300 mm - 400 mm, about 325 mm - 375 mm or about 350 mm (e.g., 348 mm or 348.14 mm). For the large size, the length 352 is about 400 mm - 500 mm, about 450 mm - 475 mm or about 470 mm (e.g., 470.30 mm). The straps 330, 332 can have a width 354 of about 10 - 20 mm, about 12 - 16 mm or about 14 mm or 15 mm.

[0206] In some configurations, the panel 334 can be the same size at the plurality of sizes of the rear portion 302. For example, the panel 334 can have a maximum height 356 of about 30 - 50 mm, about 35 - 40 mm or about 38 mm (e.g., 38.32 mm). The panel 334 can have a maximum width 358 of about 50 mm - 150 mm, about 75 mm - 125 mm or about 90 mm or 100 mm. In some configurations, the panel 334 can be tapered from the maximum width 358 at the upper and / or lower ends. In the illustrated arrangement, the panel 334 is tapered at the lower end by about 10 - 15 percent of the maximum width 358.

[0207] In some configurations, the straps 330, 332 can define an angle 360 therebetween. As described above, in some configurations, the upper strap 330 can be linear and the lower strap 332 can be curved. Thus, the angle 360 can be defined by the lower strap 332. In other arrangements, the upper strap 330 can be curved and the angle 360 can be defined by the upper strap 330, or both straps 330, 332 can be curved and the angle 360 can be defined by both straps 330, 332. In some configurations, the angle 360 is less than about 30 degrees. In some configurations, the angle 360 is about 10 - 30 degrees, about 15 - 25 degrees, or about 20 degrees.

[0208] Referring to FIGS. 27A-27E, an example of a process or method for constructing the panel 334 and the rear portion 302 of the headgear 154 is shown. Referring to FIG. 27A, two separate layers of spacer fabric (or other suitable fabric) are cut to the overall shape of the panel 334 or otherwise formed. Referring to FIG. 27B, the two layers of spacer fabric are secured to each other along the side edges. In the illustrated arrangement, these layers are secured to each other by sewing to create a sewn joint or seam connection 370. However, other suitable connection arrangements or methods can also be used. Referring to FIG. 27C, the layers of spacer fabric that are now joined are reversed, i.e., turned inside out, to hide the seam connection 370 and protect the seam connection 370 from snagging or fraying from external forces. Referring to FIG. 27D, the upper and lower edges of the panel 334 are connected to the upper strap 330 and the lower strap 332, respectively. In the illustrated arrangement, the upper and lower edges of the panel 334 are connected by sewing to create a sewn connection 372. However, other suitable connection arrangements or methods can be used. In this process, the previously open upper and lower edges of the two spacer fabric layers are closed. The sewn or stitched connection 372 advantageously reduces or prevents tension in the connection 372 and allows the panel 334 and / or the straps 330, 332 to stretch and contract during use. FIG. 27E shows the clean joint that is exposed when the sewn spacer fabric panel is reversed, as described above with respect to FIG. 27C.

[0209] Advantageously, the spacer fabric panel 334, particularly a multi-layer spacer fabric panel 334, provides a panel 334 that is lighter and / or more breathable compared to panels made from conventional materials such as foam composites (e.g., Breath-o-Prene®). In addition, the spacer fabric panel 334 of the present invention provides cushioning and support to the back of the user's head and may be less bulky and / or less obstructive to the user compared to panels made from conventional materials. The breathability of the spacer fabric can reduce the likelihood that the user will become too warm and can reduce or prevent sweating. The spacer fabric panel 334 can be made more compressible than an equivalent foam composite material panel, such that the spacer fabric panel 334 can be compressed to a smaller or minimum thickness depending on the weight of the user's head. Such an arrangement can reduce the likelihood that the user will feel the panel 334 when lying on top of the panel, particularly when lying laterally, due to the compressibility and reduction in thickness under load compared to a foam composite material panel.

[0210] FIG. 28 shows a modified form of the rear portion 302 of the headgear 154, which may be the same as or similar to other rear portions 302 described herein, except as described below. The rear portion 302 of FIG. 28 omits the spacer fabric panel 334 and instead forms a panel portion 380 that utilizes an integral structure of one or both of the straps 330, 332. In the illustrated arrangement, the lower strap 332 defines the panel portion 380, and the panel portion 380 extends upward from the strap portion of the lower strap 332 so as to space the upper strap 330 and the lower strap 332 apart in the same manner as the panel 334 of other embodiments described herein. The panel portion 380 can be coupled to the bottom edge of the upper strap 330 by a suitable connection, such as a stitching connection 382. In other arrangements, the panel portion 380 can be defined by the upper strap 330, or the panel portion 380 can be defined by a combination of protruding portions of each of the straps 330, 332. In some configurations, the upper strap 330 and the lower strap 332 can have the same or similar level of stretchability, which can be similar to the stretchability of the lower strap 332 described above.

[0211] Knitted Rear Panel FIGS. 29-32 show another example of the rear portion 302 of the headgear 154, which may be the same as or similar to other rear portions 302 described herein, except as described below. In the arrangements of FIGS. 29-32, the panel 334 is wholly or partly composed of knitted material. Additionally, the upper strap 330 is a single continuous piece, while the lower strap 332 is interrupted by the panel 334. With such an arrangement, the knitted material of the panel 334 can define the lower edge of the central portion of the rear portion 302 of the headgear 154. However, in other arrangements, the lower strap 332 can be a single continuous piece. In other arrangements, the upper strap 330 can be interrupted by the panel 334.

[0212] In some configurations, panel 334 is formed by a knitting process separately from straps 330, 332 and is then connected to straps 330, 332 in a manner similar to that described herein with respect to spacer fabric panel 334 in a separate process step. Once the knitted panel 334 is formed, panel 334 can be joined to the upper strap 330 and lower strap portion 332 by a suitable connection arrangement or process. For example, in the illustrated arrangement, the knitted panel 334 is connected to the upper strap 330 and lower strap portion 332 by a sewing process that creates a stitched connection 372. In particular, the knitted panel 334 is connected to the upper strap 330 by the stitched connection 372 along the entire upper edge of the knitted panel 334. Each of the lower strap portions 332 is connected to the side edges on both sides of the knitted panel 334 by the stitched connection 372. The lower strap portions 332 are connected at the bottom corners of the knitted panel 334 such that the lower edges of the lower strap portions 332 are aligned with the lower edge of the knitted panel 334 and the junction therebetween. Similar to the arrangement described above, the lower strap portions 332 extend at an angle downward from the knitted panel 334.

[0213] In some configurations, the knitted panel 334 is created by a knitting process that configures panel 334 in a vertical direction such that, as oriented in the drawing, it is used with the patient's head in an upright position. With such an arrangement, the knitted panel 334 has greater stretchability in the horizontal direction than in the vertical direction. That is, for a given applied force, the elongation rate of the knitted panel 334 in the horizontal direction is higher than the elongation rate in the vertical direction. As a result, the greater horizontal stretchability allows the rear portion 302 and associated headgear 154 to conform to a wider range of head sizes. In some configurations, the knitting process starts at the bottom of panel 334 or first creates the bottom of panel 334 and proceeds towards the top of panel 334. However, in other configurations, this direction can be reversed.

[0214] Referring to FIG. 32, different portions of panel 334 can be constructed of different materials or different combinations of materials. For example, in the illustrated arrangement, the bottommost portion 390 of the knitted panel 334 is made using only a first material, such as a first yarn or filament type 502. In some configurations, the first material includes an elastane material (e.g., Lycra). In some configurations, the first material is nylon-coated elastane. As the knitting process progresses upward or creates the relatively upper portion 392 of the knitted panel 334 above the bottommost portion 390, a second material, such as a second yarn or filament type 504, is introduced. In some configurations, the second material is or includes nylon (e.g., textured nylon). The second material can be used exclusively in the upper portion 392 or can be combined with the first material and / or other materials. By using two or more materials in panel 334, advantageous or desirable properties are provided, as will be described further below. However, using a single material in the bottommost portion 390 results in a less bulky structure compared to a bottommost portion 390 incorporating multiple materials, thereby improving comfort for the user.

[0215] Combinations of the first and second materials, such as the materials including elastane and nylon described above, provide an overall knitted panel 334 with desirable properties. For example, the elastane material is less bulky than the nylon material and provides excellent recovery. The nylon material is non-elastic, bulkier, thicker, and more substantial than the elastane material.

[0216] In some configurations, the knitting panel 334 is knitted to have multiple layers. For example, referring to FIG. 31, the knitting panel 334 can include a first layer 400 and a second layer 402. The first layer 400 can be an inner layer that faces the user or is positioned adjacent to the user. The second layer 402 can be an outer layer that faces away from the user. The first layer 400 can be positioned between the second layer 402 and the user. The first layer 400 and the second layer 402 can be joined along their side edges. In some configurations, the first layer 400 and the second layer 402 are fabricated as a single structure during the knitting process. In some configurations, the first layer 400 and the second layer 402 can define a tubular structure. However, in the illustrated arrangement, the first layer 400 and the second layer 402 are connected by an interlock stitch 404 that can be made during the knitting process. Alternatively, the interlock stitch 404 can be made by a process separate from the knitting process (e.g., by subsequent sewing). Further, the first layer 400 and the second layer 402 can be knitted separately and connected by a suitable connection arrangement or process such as sewing.

[0217] FIGS. 32-1 and 32-2 show the process of making the knitting panel 334 and the resulting structure of the knitting panel 334. The panel 334 includes an elastane (e.g., Lycra) material 502 and a nylon (e.g., textured nylon) material 504. As shown, the bottommost portion 390 of the panel 334 is entirely composed of the elastane material 502 knitted on all needles. Similarly as shown, the nylon material 504 is introduced into the upper portion 392 of the knitting panel 334. In the illustrated arrangement, in the upper portion 392, the elastane material 502 is tacked (e.g., skipped every other needle and half-gauge tacked), and the nylon material 504 is knitted on all needles. The tack stitches of the elastane material 502 make the stitches bulkier than the knitting stitches. However, in other configurations, both materials can be knitted. The elastane material 502 and the nylon material 504 can be intertwined, for example, at a timing such as every 4 courses.

[0218] Figures 33A through 33I show alternative configurations of the rear portion 302, generally including an upper strap 330, a lower strap, and a panel 334 or corresponding structure. The panel 334 shown can be partially or fully knitted. In an alternative arrangement, the panel 334 can be composed of a sheet-like material such as a spacer fabric or other composite or suitable material. FIG. 33A shows a rear portion 302 that is the same as or similar to the rear portion 302 of FIGS. 29 through 32, where a single upper strap 330 is provided and a pair of lower straps 332 are provided. The panel 334 interrupts the lower straps 332. The upper strap 330 can be curved, and the lower straps 332 can form a curve that is greater than the curve of the upper strap 330 relative to the horizontal line passing through the panel 334.

[0219] FIG. 33B shows a rear portion 302 in which neither the upper strap 330 nor the lower strap 332 is interrupted. The rear panel 334 is tapered from top to bottom. The upper strap 330 and the lower strap 332 are straight as shown, but one or both can be curved. The rear portion 302 of FIG. 33C is similar to that of FIG. 33B, except that the bottom strap 332 is interrupted by the panel 334 and the panel 334 includes a central tapered portion. The upper and lower portions of the panel 334 have parallel side edges. The rear portion 302 of FIG. 33D is similar to those of FIGS. 33B and 33C, except that the rear panel 334 is not tapered and has a rectangular shape. The rear portion 302 of FIG. 33E includes a rectangular panel 334. However, both the upper strap 330 and the lower strap 332 are interrupted by the panel 334. In addition, the straps 330, 332 include a connecting portion 410 that extends between the straps 330, 332 along the sides of the panel 334. Thus, the straps 330, 332 can be formed by two parts, each of those parts defining a part of the upper strap 330, a part of the lower strap 332, and the connecting portion 410 therebetween.

[0220] Figure 33F shows a rear portion 302 similar to that of Figure 33A. However, the rear portion of Figure 33F includes a knitted lower strap 332 in addition to the knitted panel 334. Figure 33G shows a rear portion 302 similar to that of Figure 33A, but differs in that the knitted panel 334 forms a lower strap portion 412 extending from the main body portion 414 of the panel 334. The lower strap 332 is connected to the strap extension or strap portion 412 of the knitted panel 334. Figure 33H shows a rear portion 302 similar to the rear portion of Figure 33F, but differs in that the knitted panel 334 / lower strap 332 portion interrupts the upper strap 330.

[0221] Figure 33I shows a rear portion 302 similar to the rear portion 302 of Figure 33C, but differs in that the panel 334 forms a lower strap portion 412 similar to that of the rear portion 302 of Figure 33G. The main body portion 414 of the panel 334 is generally rectangular such that the lower strap portion 412 and the main body portion 414 form an inverted T-shape.

[0222] Figure 33J shows a rear portion 302 similar to the rear portion 302 of Figure 33A, but differs in that the panel 334 includes regions of different stretchability and / or porosity. For example, the upper section 420 of the panel 334 can have a higher porosity and / or lower stretchability than the lower section 422 of the panel 334. In other configurations, the upper section 420 of the panel 334 can have a higher stretchability than the lower section 422. However, in such arrangements, it is preferred that the lower section 422 provides some amount of stretchability. In some configurations, the differences in porosity and / or stretchability (or other properties) can be achieved by the knitting process, material selection, or both.

[0223] FIG. 33K shows a rear portion 302 similar to the rear portion 302 of FIG. 33A, but differs in that the bottom edge of panel 334 has a more pronounced curvature such that it creates a large height difference between the side portion and the central portion of panel 334. The lower strap 332 is shown as being horizontal, but can be angled downward in a similar manner to the lower strap 332 of FIG. 33A.

[0224] FIG. 33L shows a rear portion 302 similar to the rear portion 302 of FIG. 33J, but differs in that the upper section 420 and the lower section 422 have different shapes compared to FIG. 33J. For example, in the rear portion 302 of FIG. 33L, the upper section 420 does not define the side edge of panel 334. Rather, the entire side edge is defined by the lower section 422. In some configurations, the upper section 420 of panel 334 can have a higher porosity and / or lower stretchability than the lower section 422 of panel 334. In other configurations, the upper section 420 of panel 334 can have a higher stretchability than the lower section 422. However, in such arrangements, it is preferred that the lower section 422 provides some amount of stretchability.

[0225] FIG. 34 shows a knitting structure example that can be used to make all or part of the knitted portion of the headgear 154, such as the rear panel 334. In the illustrated arrangement, the knitting structure is made of a first material 430, such as a material containing nylon. A second material 432 can be inlaid (inserted) into the knitted first material. The second material can have a higher stretchability than the first material. In some configurations, the second material can include elastane (e.g., Lycra). The inlaid material is captured by the knitting loops of the knitting material. Such an arrangement can increase the stretchability of panel 334 or other knitted portions, but may have a rough feel.

[0226] Knitted cover Figures 35 through 36B show a modified version of the headgear 154. In particular, the headgear 154 of Figures 35 through 36B includes a modified version of the front strap arrangement 304 described mainly with reference to Figures 22 through 27. The front strap arrangement 304 can include a front strap portion 306, an upper strap portion 308, and a lower strap portion 310 configured as a single unitary structure. As described above, the front strap arrangement 304 can be configured as a molded composite structure having at least one fabric layer and at least one plastic layer permanently connected to each other. In the illustrated arrangement, the front strap arrangement 304 is a molded composite structure having a tubular knitted structure 440 that defines an inner fabric layer and an outer fabric layer on each side of a plastic core (the inner and outer sides, or the side facing the user and the side away from the user).

[0227] In some configurations, the tubular knitted structure 440 can be formed by a suitable knitting process using suitable materials such as the processes and materials described herein. The knitted structure 440 can be formed as a single piece that includes one or more of the front strap portion 306, the upper strap portion 308, and the lower strap portion 310. In other words, the knitted structure 440 can be formed by knitting a single piece that includes a branch from the front strap portion 306 to the upper strap portion 308 and the lower strap portion 310. The front strap arrangement 304 can be formed as a single unitary structure by applying molten plastic into the space between the fabric layers within a mold such that the molten plastic hardens to form a plastic core in the shape of the molding cavity. In particular, the knitted structure 440 can be placed within the mold, and molten plastic can be introduced into the internal space of the hollow knitted structure 440 and allowed to cool and harden.

[0228] The knitting structure 440 can be knitted into a shape that approximates or substantially matches the final shape of the front strap arrangement 304 as defined by the cavity of the mold tool. With such an arrangement, the stitch structure and knitting direction generally or substantially match the shape of the plastic core or front strap arrangement 304 as defined by the cavity of the mold tool. The resulting front strap arrangement 304 has a knitted edge that matches the curvature of the plastic core and can reduce material accumulation and / or bunching compared to a fabric cover made from a flat sheet material. Although disclosed in the context of the front strap arrangement 304, other parts of the headgear, straps, or panels can be configured similarly.

[0229] In some configurations, the knitting structure 440 can be knitted such that the grain of the knitting structure 440 follows the shape in which the plastic core is molded. In such an arrangement, separation of the stitches between the welts is prevented and the shape of the strap is maintained. Additionally, by arranging the grain to follow the direction of the plastic core, the number of tuck stitches required to create the knitting structure is minimized. Such a structure is advantageous as it allows for a quick and efficient configuration.

[0230] FIG. 53 shows a portion of the modified front strap arrangement 304 described above, mainly with reference to FIGS. 35 - 36B. Except as described below and / or as apparent from the drawings, the two versions can be otherwise similar. In particular, the front strap arrangement 304 of FIG. 50 includes a front strap portion 306, an upper strap portion 308, a lower strap portion 310, and one of a first strap portion 320 or a second strap portion 322 of the top strap arrangement 314. The front strap arrangement 304 can be configured as a molded composite structure having at least one fabric layer and at least one plastic layer permanently connected to each other.

[0231] In this modified version of the front strap arrangement 304, the front strap portion 306 and the upper strap portion 308 are formed from a single continuous tubular knitting structure 440, and the lower strap portion 310 and the first strap portion 320 are each formed from a separate tubular knitting structure 440. This configuration eliminates the need to knit a bifurcated tubular structure and can simplify manufacturing. In some configurations, the front strap portion 306 and the upper strap portion 308 may be formed from separate tubular knitting structures 440, and / or the front strap portion 306 and the lower strap portion 310 may alternatively be formed as a single continuous tubular knitting structure 440. In some configurations, one or more of the tubular knitting structures 440 can be knitted into a shape that approximates or substantially matches the final shape of each respective strap portion, as described above. In some configurations, one or more of the tubular knitting structures 440 can be knitted such that the grain direction varies along the length of the tubular knitting structure 440, as described above. One or more of the knitting structures 440 may be different from another knitting structure 440. For example, the tubular knitting structures 440 of the lower strap portion 310 and the first strap portion 320 are a different color than the tubular knitting structures 440 of the combined front strap portion 306 and the upper strap portion 308. Using different colors can provide a visual cue to assist the user in orienting the headgear 154. In some configurations, two or more of the tubular knitting structures 440 may be identical to each other, perhaps except for length, and each may be cut to an appropriate length from the same stock of tubular knitting material.

[0232] Each of the tubular knitted structures 440 can be clamped by the edge 313 inside the mold, and molten plastic can be injected inside the tubular knitted structure 440. The molten plastic cools and hardens as described above to form a plastic core in the shape of the mold cavity. The plastic core can have substantially planar opposing main surfaces with convex side edges without sharp corners that could cause discomfort or facial marking. When removed from the mold, there is substantially no plastic material on the outer edge 313 of the newly partially flattened tubular knitted structure 440. As a result, a resulting strap portion can be left having a soft outer edge 313 that can improve user comfort and / or reduce facial marking. Then, each of the lower strap portion 310 and the first strap portion 320 can be arranged simultaneously or sequentially in a desired arrangement in another tubular mold together with the joined front strap portion 306 and upper strap portion 308, and joined by overmolding each of the strap portions 306, 308, 310 together with the joining portion 311 as shown. In some configurations, the plastic core and the joining portion 311 can be formed from the same material. In some configurations, the plastic core and / or the joining portion 311 can be formed from an elastic and relatively soft thermoplastic elastomer material such as PEBAX®. As shown in FIG. 50, the loop 312 of the upper strap portion 308 can form an integral part of the uppermost joining portion 311.

[0233] Conclusion Numerous modifications and variations can be made to the embodiments described herein, and it should be emphasized that these elements are to be understood as being part of other acceptable examples. It is intended that all such modifications and variations be included within the scope of the present disclosure herein and be protected by the following claims. Further, any of the steps described herein can be performed simultaneously or in an order different from the order of the steps recited herein. Additionally, as should be apparent, the features and attributes of the specific embodiments disclosed herein can be combined in different ways to form additional embodiments, all of which are within the scope of the present disclosure.

[0234] Conditional language, such as "can," "could," "might," "may," "for example," and the like, used herein is generally intended to suggest that some features, elements, and / or states are included in some embodiments but not others, unless otherwise specifically defined or understood in the context in which it is used. Thus, such conditional language is generally not intended to imply that a feature, element, and / or state is essential to one or more embodiments in any way, or that one or more embodiments necessarily include logic for determining whether these features, elements, and / or states are included in, or are to be performed in, any particular embodiment, regardless of author input or direction.

[0235] Furthermore, the following terminology may be used in this specification. The singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, a reference to an item includes a reference to one or more items. The term "ones" refers to one, two, or more, and generally applies to some or all selections of a quantity. The term "plural" refers to an item being two or more. The terms "about" or "approximately" mean that a quantity, dimension, size, formulation, parameter, shape, and other features need not be exact and may be approximated and / or may be larger or smaller, reflecting, for example, acceptable tolerances, conversion factors, rounding, measurement errors, and other elements known to those of ordinary skill in the art. The term "substantially" means that the recited features, parameters, or values need not be achieved exactly, and that deviations or variations, including, for example, tolerances, measurement errors, measurement precision limits, and other elements known to those of ordinary skill in the art, may occur in an amount that does not preclude the effect intended by that feature.

[0236] In this specification, numerical data may be presented or represented in a range format. Such a range format is used merely for convenience and brevity, and thus should be interpreted flexibly to include not only the numerical values explicitly listed as the upper and lower limits of the range, but also all of the individual numerical values or sub-ranges subsumed within that range as if each numerical value and sub-range were explicitly listed. By way of illustration, a numerical range such as "about 1 to 5" should not be interpreted as including only the explicitly listed values of about 1 to about 5, but should be interpreted as including also the individual values and sub-ranges within the indicated range. Thus, included within this numerical range are the individual values such as 2, 3, and 4, and sub-ranges such as "about 1 to about 3", "about 2 to about 4", and "about 3 to about 5", "1 to 3", "2 to 4", "3 to 5", etc. This same principle applies to ranges that enumerate only a single numerical value (e.g., "greater than 1"), and should apply regardless of the breadth of the range or the features described. For convenience, multiple items may be presented in a common list. However, these lists should be interpreted as if each element of the list were individually specified as a distinct and unique element. Thus, no individual element of such a list should be interpreted as a de facto equivalent of any other element of the same list based solely on the fact that it is presented in the same common group without further indication. Further, the terms "and" and "or", when used in conjunction with a list of items, should be interpreted broadly in that any one or more of the enumerated items may be used alone or in combination with other enumerated items. The term "alternatively" refers to one of two or more alternatives, and is not intended to limit the selection to only the alternatives enumerated at one time or to only one of the alternatives enumerated, unless there is a clear indication to the contrary in the context.

Claims

1. A nasal cushion for a nasal breathing interface assembly, comprising: a rim configured to be attached to a housing of the nasal breathing interface assembly; an elastic sidewall extending from the rim, the elastic sidewall being triangular and including a pair of lower corner portions; an elastic end wall extending inwardly from the elastic sidewall, the elastic end wall defining a sealing surface that seals against an upper lip, an inner cheek, an outer nose, and a nasal bridge of a user's face during use, and an opening for receiving the user's nose; a pair of elongate thickened portions, each of the pair of elongate thickened portions having a first end and a second end, the first end being provided adjacent to or at each of the lower corner portions of the elastic sidewall and adjacent to the rim, and the second end being provided on or adjacent to the elastic end wall on a side facing the opening; a cushion comprising the above components.

2. The nasal cushion according to claim 1, wherein the pair of elongate thickened portions extend away from each other in a direction from the first end toward an intermediate portion of each of the pair of elongate thickened portions.

3. The nasal cushion according to claim 1 or 2, wherein the pair of elongate thickened portions extend toward each other in a direction from an intermediate portion of each of the pair of elongate thickened portions toward the second end.

4. The nasal cushion according to any one of claims 1 to 3, wherein each of the pair of elongate thickened portions is curved in a direction perpendicular to their respective main surfaces.

5. The nasal cushion according to any one of claims 1 to 4, wherein the pair of elongate thickened portions extend internally.

6. The nasal cushion according to any one of claims 1 to 5, wherein the thickness of the pair of elongate thickened portions is uniform along the length of the pair of elongate thickened portions with respect to the elastic end wall or an adjacent portion of the elastic end wall.

7. The nasal cushion according to any one of claims 1 to 6, wherein the pair of elongate thickened portions is 0.1 to 0.6 mm thicker than an adjacent portion of the elastic sidewall and / or the elastic end wall.

8. The nasal cushion according to any one of claims 1 to 7, wherein the pair of elongate thickened portions is 0.1 to 0.3 mm thicker than an adjacent portion of the elastic sidewall and / or the elastic end wall.

9. The nasal cushion according to any one of claims 1 to 8, wherein the pair of elongated thickened portions are 0.2 mm thicker than adjacent portions of the elastic side wall and / or the elastic end wall.

10. The nasal cushion according to any one of claims 1 to 9, wherein the pair of elongated thickened portions have a uniform thickness along the length of the pair of elongated thickened portions.

11. The nasal cushion according to any one of claims 1 to 10, wherein the pair of elongated thickened portions are 1.2 mm thick.

12. The nasal cushion according to any one of claims 1 to 11, wherein the pair of elongated thickened portions are curved upward at an intermediate portion of the pair of elongated thickened portions and at a transition portion from the elastic side wall to the elastic end wall.

13. The nasal cushion according to any one of claims 1 to 12, wherein the pair of elongated thickened portions form a planar curve.

14. The nasal cushion according to any one of claims 1 to 13, wherein the pair of elongated thickened portions extend rearward from the first end portion, then curve upward toward the second end portion, and terminate at the second end portion of the end wall adjacent to the cheek surface of the facial contact surface on both sides of the opening.

15. Comprising a reinforcing material in the form of at least one thickened band extending inward from the inner surface, The nasal cushion according to any one of claims 1 to 14, wherein the thickened band is positioned along the elastic side wall and consists of a lower region on each side surface and a connecting portion extending around the inner upper portion and extending between the lower regions.

16. The nasal cushion according to claim 15, wherein the pair of elongated thickened portions terminate at the second end portion that is vertically above the lower region of the thickened band and horizontally spaced from the lower region.

17. Each lower corner of the elastic side wall is provided with or adjacent to a lower thickened corner portion, The elastic side wall tapers upward over a first distance from the lower thickened corner portion toward the lower region of the thickened band and tapers downward over a second distance from the lower thickened corner portion, and the first distance is shorter than the second distance. The pair of elongated thickened portions extend under respective lower thickened corners of the elastic side walls and terminate at the first ends that are vertically below and spaced apart from respective lower thickened corners of the lower thickened corners, the nasal cushion according to claim 15 or 16.

18. The minimum distance between the pair of elongated thickened portions and the opening is at least 4 mm, the nasal cushion according to any one of claims 1 to 17.

19. The minimum distance between the pair of elongated thickened portions and the opening is 5 to 6 mm, the nasal cushion according to any one of claims 1 to 18.

20. The minimum distance between the pair of elongated thickened portions and the opening is 5.2 to 5.5 mm, the nasal cushion according to any one of claims 1 to 19.

21. The second end is wider than the first end, the nasal cushion according to any one of claims 1 to 20.

22. The second end is 50% wider than the first end, the nasal cushion according to any one of claims 1 to 21.

23. The second end is 50% to 60% wider than the first end, the nasal cushion according to any one of claims 1 to 22.

24. The second end is 54% wider than the first end, the nasal cushion according to any one of claims 1 to 22.

25. The upper portion is configured to pivot or move in a hinged manner relative to the lower portion about a hinge axis or hinge region, enabling a pivoting movement in the forward direction of the upper portion, the nasal cushion according to any one of claims 1 to 24.

26. A patient interface assembly for a nasal respiratory therapy system, suitable for supplying breathing gas to a user for airway positive pressure therapy or non-invasive ventilation therapy, The nasal cushion according to any one of claims 1 to 25, A relatively rigid housing to which the nasal cushion is permanently or removably connected, A frame configured to interface with the housing, A headgear for fixing to a user's proper position, Comprising a patient interface assembly.

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