Frame and headgear for respiratory mask system

Abstract

To provide a respiratory mask system for delivery of respiratory therapy to a patient.SOLUTION: A respiratory mask system has a patient interface that includes a frame (5) securing a seal (4) and a gas delivery conduit (6) together. A recessed channel and / or headgear retaining features are configured to connect the headgear (3) to the patient interface. An inlet collar connects the frame to the gas delivery conduit (6), converges, and includes bias flow holes forming an arc at 240 degrees, and has a distal rim whose top part and bottom part protrude toward a distal side relative to a lateral side part. The headgear comprises a top strap, a pair of side arms, an arbitrarily selected rear strap, and a yoke configured to connect to the recessed channel. The top strap, side arms and yoke form an integrally formed closed loop (strap).SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] Incorporation by reference of all priority applications All applications in which foreign or domestic priority is identified in the application data sheet filed with this application are hereby incorporated by reference into this specification under 37 C.F.R. § 1.57.

[0002] The present disclosure generally relates to a respiratory mask system for delivering respiratory therapy to a patient. More particularly, the present disclosure relates to various components of a respiratory mask system.

Background Art

[0003] Respiratory masks are used to administer respiratory therapy to the airway of a person suffering from any of a number of respiratory diseases or conditions. Such treatments can include, but are not limited to, continuous positive airway pressure (CPAP) therapy and non-invasive ventilation (NIV) therapy.

[0004] CPAP therapy can be used to treat obstructive sleep apnea (OSA), a condition in which a patient's airway intermittently closes during sleep, preventing the patient's breathing for a period of time. As a result of the apnea, or lack of breathing, the patient wakes up. As a result of repeated and frequent apneas, the patient may not be able to obtain a full restorative sleep at night.

[0005] CPAP therapy involves supplying a continuous positive air pressure to the patient's airway via a respiratory mask. The continuous positive pressure acts as a splint for the patient's airway, holding the airway in an open position so that the patient's breathing and sleep are not interrupted.

[0006] A breathing mask typically includes a patient interface and a headgear. The patient interface is configured to supply a continuous positive air pressure to the patient's airway via a seal or cushion that forms a substantially airtight seal within or around the patient's nose and / or mouth. The breathing mask can be utilized in various forms, including a full-face mask, a nasal mask, and a direct nose / mouth mask, which form a substantially airtight seal with the nose and / or mouth. The seal or cushion is held in place on the patient's face by the headgear. To maintain a substantially airtight seal, the headgear must provide support to the patient interface so that the patient interface is held in a stable position relative to the patient's face during use. Such a breathing mask can also be used to deliver NIV and other treatments.

SUMMARY OF THE INVENTION

MEANS FOR SOLVING THE PROBLEM

[0007] In a first aspect, an embodiment of the present invention can be broadly said to include a headgear for a breathing mask that includes an integrally formed closed loop. The closed loop includes a yoke, a pair of side arms, and a top strap. The yoke is configured to connect to the patient interface. The pair of side arms are each configured to extend from a laterally rearward portion of the yoke and across the user's cheek and above the ear during use. The top strap is configured to extend between the pair of side arms and across the user's crown during use.

[0008] Preferably, the top strap includes an individual left portion and a right portion, each having a free end and a fixed end. The fixed end of the left portion is integrally formed with one of the side arms, and the fixed end of the right portion is integrally formed with the other side arm. The free ends of the left portion and the right portion are adjustably connected to each other.

[0009] Preferably, the closed loop is made of a semi-rigid material.

[0010] Preferably, the closed loop comprises a plastic material.

[0011] Preferably, the side arms include an integrally formed buckle at the free ends.

[0012] Preferably, the headgear further includes a rear strap configured to extend between the buckles of the side arms and around the back of the user's head during use.

[0013] Preferably, the rear strap includes a pair of side ends adjustably connected to the buckles of the side arms, respectively.

[0014] Preferably, the rear strap is removably connected to the buckle.

[0015] Preferably, the rear strap and the top strap are configured to surround the back of the user's head during use.

[0016] In a second aspect, an embodiment of the invention can be broadly said to include a breathing mask including a patient interface and a headgear as described above.

[0017] In a third aspect, an embodiment of the invention can be broadly said to include a headgear for a breathing mask including an integrally formed closed loop and a rear strap. The closed loop includes a yoke, a pair of side arms, and a top strap. The yoke is configured to connect to a patient interface. The side arms are each configured to extend from a laterally rearward portion of the yoke and across the user's cheek and above the ear during use. The top strap is configured to extend across the user's crown and join the pair of side arms during use. The rear strap is configured to extend between the pair of side arms around the back of the user's head.

[0018] In a fourth aspect, embodiments of the present invention can be broadly said to include a headgear for a breathing mask, including a yoke, a pair of opposing side arms, and a top strap. The yoke is configured to connect to the frame of the breathing mask. The pair of opposing side arms are configured to extend from opposite lateral rear portions of the yoke during use, across the user's cheeks and above the tops of the user's ears during use. The top strap is configured to extend between the side arms across the top of the user's head above the user's ears during use. The yoke, side arms, and top strap are integrally formed to provide a closed loop that remains intact when the yoke is separated from the frame.

[0019] In some embodiments, the frame for the breathing mask includes a body having an outer surface and an inner surface. The outer surface includes a yoke receiving structure configured to receive the yoke and an inlet flange defining an inlet. The yoke receiving structure can extend along a longitudinal distance of the body. The inner surface includes an outlet flange defining an outlet. A gas path is formed between the inlet and the outlet. The outer peripheral portion of the gas path at the inlet is smaller than the outer peripheral portion of the gas path at the outlet.

[0020] The inlet flange can include a portion of increasing outer perimeter. The inlet can have an oval shape. The outlet can have an oval shape. The outlet flange can include a truncated portion. A portion of the outlet flange can be longer than another portion of the outlet flange. The outlet flange can include a recess portion that extends partially around the outlet flange.

[0021] In some embodiments, the frame for the breathing mask includes a body having an outer surface and an inner surface. The outer surface includes a yoke receiving structure configured to receive the yoke and an inlet flange defining an inlet. The yoke receiving structure can extend along a longitudinal distance of the body. The inlet flange includes a transition portion of increasing outer perimeter. The inner surface includes an outlet flange defining an outlet. A gas path is formed between the inlet and the outlet. The inlet flange includes an exhaust port that allows gas to pass from the gas path to the exterior of the frame.

[0022] The inlet flange can include a first portion of a first outer periphery and a second portion of a second outer periphery coaxially offset from the first portion. The first portion and the second portion can be separated by a transition portion of an increasing outer periphery, and the transition portion can connect the first portion and the second portion. The second outer periphery can be larger than the first outer periphery. The second portion can be positioned adjacent to the outer surface of the frame. The transition portion can include an exhaust port. The exhaust port can include a plurality of holes.

[0023] In some embodiments, a frame for a breathing mask includes a body having an outer surface and an inner surface. The outer surface includes a yoke receiving structure configured to receive a yoke and an inlet flange defining an inlet. The yoke receiving structure can be defined between a first retaining ridge and a second retaining ridge longitudinally offset from the first retaining ridge, forming a groove configured to receive the yoke. The inner surface can include an outlet flange defining an outlet. A gas path is formed between the inlet and the outlet.

[0024] In some embodiments, a frame for a breathing mask includes a body, an inlet flange, and an outlet flange. The body has an outer surface and an inner surface and extends from a first side edge to a second side edge. The inlet flange extends from the outer surface, defines an opening, and is configured to be coupled to a gas line in use. The outlet flange extends from the inner surface. The body includes a first headgear retaining feature at least partially laterally positioned between the inlet flange and the first side edge and a second headgear retaining feature at least partially laterally positioned between the inlet flange and the second side edge.

[0025] The frame and headgear retaining features are configured such that a first headgear retaining feature can engage a corresponding first frame retaining feature on the headgear, and then the frame and headgear can be rotated relative to each other about the headgear retaining feature to align a second headgear retaining feature with a corresponding second frame retaining feature on the headgear. The centers of the first headgear retaining feature and the second headgear retaining feature can be longitudinally offset relative to a central axis extending through the opening of the inlet flange. The first headgear retaining feature and the second headgear retaining feature can be circular holes.

[0026] In some embodiments, a frame for a respiratory mask has an outer surface and an inner surface, and a body extending from a first side edge to a second side edge, an opening configured to receive gas from a gas delivery conduit in use, and a plurality of bias flow holes disposed around a portion of the frame that surrounds the opening and forms an arc extending over approximately 240°.

[0027] The bias flow holes can extend from approximately 4:00 to approximately 8:00 (similar to a clock). The frame further includes an inlet flange extending from the outer surface, the inlet flange including a wall that defines the opening and is configured to be coupled to a gas conduit in use, the inlet flange including a plurality of bias flow holes extending through the wall. The inlet flange can have an oval cross-section. The wall of the inlet flange can be angled inwardly at an inlet flange face angle relative to an axis extending through the opening as the wall extends away from the frame body. The inlet flange face angle can vary around the periphery of the inlet flange.

[0028] In some embodiments, a frame for a respiratory mask has a body having an outer surface facing distally and an inner surface facing proximally, and an inlet flange extending distally from the outer surface to a distal rim, the inlet flange including a wall that defines an opening and is configured to be coupled to a gas conduit in use, the top and bottom of the distal rim protruding distally relative to the lateral sides of the distal rim. The inlet flange can have an oval cross-sectional shape.

[0029] In some embodiments, a headgear for a breathing mask includes a yoke configured to connect to a patient interface, a first side arm and a second side arm, a top strap, and at least one connector configured to connect to a frame in use. Each of the first side arm and the second side arm extends from a laterally rearward portion of the yoke and is configured to extend across a user's cheek and above the ear in use. The top strap is coupled to the first side arm and the second side arm and extends between the first side arm and the second side arm and is configured to extend across a user's crown in use. At least one of the yoke, the first side arm and the second side arm, and the top strap includes a plastic core and a fabric outer casing at least partially surrounding the plastic core, at least one of the yoke, the first side arm and the second side arm, and the top strap is formed by in-mold forming, and the at least one connector is formed by a burst-through process such that the at least one connector is integrally formed with a plastic material and extends outside the outer casing.

[0030] The connector can include a groove separating two retaining portions. The connector can be substantially circular. The headgear can include two connectors each configured to engage corresponding headgear retaining features on a frame, and the headgear and the connectors are configured such that a first connector of the two connectors can be engaged with a corresponding first headgear retaining feature on the frame and then the frame and the headgear can be rotated relative to each other about the connector to align a second connector of the two connectors with a corresponding second headgear retaining feature on the frame.

[0031] In some embodiments, a headgear for a breathing mask includes a yoke configured to connect to a patient interface, a first side arm and a second side arm, and a top strap. Each of the first side arm and the second side arm extends from a laterally rearward portion of the yoke and is configured to extend across a user's cheek and above the ear in use. The top strap is coupled to the first side arm and the second side arm and extends between the first side arm and the second side arm and is configured to extend across a user's crown in use. The top strap includes a first portion coupled to the first side arm, a second portion coupled to the second side arm, and an adjustment mechanism configured to couple the first portion and the second portion and enable adjustment between the first portion and the second portion. The adjustment mechanism includes a guide loop at a free end of the second portion, a plurality of holes along a length of the second portion in the vicinity of the free end, a protrusion extending from an inner surface of the first portion, the inner surface being configured to face the second portion and at least partially overlap the second portion when the first portion and the second portion are coupled in use, the protrusion being configured to engage any one of the plurality of holes to fix the first portion and the second portion to each other, and a plurality of position guides extending along a length of the first portion in the vicinity of the protrusion, the plurality of position guides including a series of protruding edges having a width greater than a diameter of an opening defined by the guide loop. In use, the first portion is configured to advance and / or retract through the guide loop, and contact between the protruding edge and the guide loop provides a resistance force to movement of the first portion through the guide loop.

[0032] The top strap can include a plastic core and a fabric outer casing at least partially surrounding the plastic core. The second portion can include a peripheral groove extending around at least one of the plurality of holes, and the outer casing does not surround the peripheral groove. The protrusion can include a strut extending from and adjacent to the inner surface of the first portion and an enlarged head at an end of the strut, the enlarged head having a diameter greater than a diameter of the strut.

[0033] In some embodiments, the headgear for a respiratory mask includes a strap that includes a yoke portion, a first side arm, and a second side arm, and a top strap. The yoke portion is configured to connect to a patient interface. Each of the first side arm and the second side arm extends from a laterally rearward portion of the yoke portion and is configured to extend across a user's cheek and above the ear in use. The yoke portion, the first side arm, and the second side arm may be integrally formed. The top strap is coupled to the first side arm and the second side arm and extends between the first side arm and the second side arm and is configured to extend across the top of the user's head in use. A first edge of the strap includes a soft edge, and a second edge opposite the strap includes a soft edge portion and a rigid edge portion.

[0034] The thickness of the soft edge of the first edge may vary between a maximum thickness at the side end of the side arm and a minimum thickness near the center of the yoke portion. The thickness of the soft edge portion of the second edge may vary between a maximum thickness at the side end of the side arm and a minimum thickness at a location laterally spaced from the center of the yoke portion.

[0035] In some embodiments, the headgear for a respiratory mask includes a front strap and a top strap. The front strap includes a yoke configured to connect to a patient interface, and a first side arm portion and a second side arm portion, each of the first side arm portion and the second side arm portion extending from a laterally rearward portion of the yoke and configured to extend across a user's cheek and above the ear in use. The top strap is coupled to the first side arm portion and the second side arm portion and extends between the first side arm portion and the second side arm portion and is configured to extend across a user's crown in use. The top strap includes a first portion coupled to the first side arm portion, a second portion coupled to the second side arm portion, and an adjustment mechanism configured to couple the first portion and the second portion and enable adjustment between the first portion and the second portion. At least one of the yoke, the first side arm portion and the second side arm portion, and the top strap includes a plastic core and a fabric outer casing at least partially surrounding the plastic core. In some embodiments, at least one of the yoke, the first side arm portion and the second side arm portion, and the top strap may be formed by internal molding.

[0036] The adjustment mechanism can include a first mating part such as a female connector at the free end of the second part and a second mating part such as a male connector at the free end of the first part. In use, the first mating part and the second mating part are configured to be selectively engaged in one of a plurality of distinct configurations to set the length of the top strap. The first mating part can be a female connector, which can include a female connector having a plurality of holes along the length of the female connector. The second part can further include a guide loop, and in use, the first part is configured to advance and / or retract through the guide loop. The second mating part can be a male connector, which can include a male connector having a protrusion extending from the inner surface of the male connector. At least a portion of the second mating part can be configured to overlap at least a portion of the first mating part when joined, and the protrusion can be configured to engage any one of the plurality of holes to fix the first part and the second part to each other. The male connector can include a grip on or within the outer surface of the male connector. The male connector can include a grip on or within the inner surface of the male connector. The first part of the top strap can be coupled to the first side arm part via an overmolded joint, and the second part of the top strap can be coupled to the second side arm part via an overmolded joint. The headgear can further include buckles at the side ends of each of the first side arm part and the second side arm part, and the buckles are configured to receive the rear strap. The buckles can be overmolded on the side ends of the first side arm part and the second side arm part. The yoke can include two frame retention features each configured to engage a corresponding headgear retention feature on the frame. The frame retention features can be horseshoe-shaped. The front strap can surround each of the frame retention features and can include pads extending laterally outward from each of the frame retention features, and the pads have a greater thickness than the remainder of the front strap.In some embodiments, the female connector may include a guide loop and a plurality of holes along the length of the female connector, and the male connector may include a protrusion extending from the inner surface of the male connector, the inner surface facing the female connector and configured to at least partially overlap the female connector when the first and second portions are joined in use, the protrusion being configured to engage with any one of the plurality of holes to fix the first and second portions to each other. In use, the first portion is configured to advance and / or retreat through the guide loop.

[0037] The female connector may be overmolded onto the second portion. The male connector may be overmolded onto the first portion. The male connector can include a grip on or within the outer surface of the male connector. The male connector can include a grip on or within the inner surface of the male connector. The first portion of the top strap may be coupled to the first side arm portion via an overmolded joint. The second portion of the top strap may be coupled to the second side arm portion via an overmolded joint. The headgear can further include a buckle at each side end of each of the first side arm portion and the second side arm portion, each buckle being configured to receive an end of the rear strap. The buckle may be overmolded onto the side ends of the first side arm portion and the second side arm portion. The yoke can include two frame retention features each configured to engage a corresponding headgear retention feature on the frame. The frame retention features can be horseshoe-shaped. The front strap can include pads surrounding each of the frame retention features and extending laterally outwardly from each of the frame retention features, the pads having a greater thickness than the remainder of the front strap.

[0038] Further aspects of the invention to be considered in all novel aspects will become apparent from the following description.

[0039] Here, a number of embodiments will be described by way of example with reference to the drawings.

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0041] The present disclosure relates to a frame and headgear for a breathing mask system configured to deliver respiratory therapy to a patient / user. FIG. 1 shows a non-limiting exemplary embodiment of a breathing mask system 1 of the present disclosure. The breathing mask system 1 includes a patient interface 2 and a headgear 3. The patient interface 2 includes a seal 4, a frame 5, and a gas delivery line 6.

[0042] The patient interface 2 is configured to provide an air path through which pressurized air can be supplied to the user's airway. In the embodiments shown and described in detail below, the patient interface 2 is a nasal mask, particularly a sub-nasal mask or a sub-nasal type mask, having a seal 4 configured to seal against the lower surface of the patient / user's nose. The seal 4 is configured to form an airtight seal under the patient / user's nose along the portion of the face extending laterally of the nose and along the user's upper lip.

[0043] In some embodiments, the seal 4 may be made to extend around and cover the bridge of the nose or the alae nasi that flare to form a rounded ridge around the nostrils to seal them. The illustrated mask 1 is made to seal around the perimeter of the surface that defines the opening to the nostrils, which may include a portion or all of the fleshy outer end of the nasal septum, sometimes also referred to as the columella. In some configurations, the seal 4 may be made to extend upward to seal along at least a portion of the left and right dorsal sidewalls of the user's nose. In some configurations, the seal 4 is made to extend upward along at least a portion of the left and right dorsal sidewalls without extending upward to the region of the user's nasal bridge. In some configurations, the primary sealing surface of the seal 4 contacts the underside of the user's nose, the upper lip, and / or the transition region between the underside of the nose and the upper lip. The secondary sealing surface of the mask can contact the sides of the user's nose, in addition to the cheeks at positions near the nose in some cases. Such primary and secondary sealing surfaces need not contact all users' faces, but such an arrangement can provide a suitable seal for a relatively wide range of facial geometries.

[0044] In the illustrated configuration, the seal 4 does not extend over the user's nasal bridge. More specifically, the illustrated seal 4 does not contact the user's nasal bridge. Not contacting the nasal bridge is advantageous as contact, and thus the pressure applied to the nasal bridge, can potentially cause pressure sores and discomfort to the user. The seal may not be compliant with treatment if it causes pain or discomfort to the user.

[0045] As described above, a subnasal mask or subnasal-type mask with a seal 4 may be more unstable on a user's face than many conventional masks that contact the nasal bridge, as a result of having a reduced contact area with the user's face. The reduced contact area places few restrictions on how the seal 4 can move relative to the user's face, and thus the seal 4 may be capable of rolling or rotating relative to the user's face. Any rolling or rotation of the seal 4 can result in disruption of the substantially airtight seal between the seal 4 and the user's face, compromising the delivery of respiratory therapy. In some embodiments, the instability of the seal 4 can be reduced by providing a headgear 3 capable of transmitting a force in a direction away from the seal 4 to another part of the user's head.

[0046] The frame 5 is configured to provide a manifold that connects the components of the patient interface 2 to each other and secures these components to the headgear 3. The frame 5 can include features configured to fluidly connect the gas delivery conduit 6 to the seal 4 such that a continuous air path is provided.

[0047] The headgear 3 is configured to secure the patient interface 2 to the user's face during use. The headgear 3 includes a top strap 7, a pair of side arms 8, and a yoke 9, which are permanently joined to form a closed loop. The top strap 7 is configured to pass over the top of the user's head during use, the side arms are configured to extend across the user's cheeks, and the yoke 9 is configured to connect to the frame 5. The headgear 3 further includes a rear strap 10 adjustably connected to the side arms 8 and configured to pass around the back of the user's head during use.

[0048] The headgear 3 and frame 5 of the present disclosure are described as being used in combination with a subnasal mask, but are not limited thereto, and it should be understood that they can be used in combination with other types of masks, including a nasal prong mask or nasal pillow mask, a full face mask that seals above and / or below the nasal bridge, or a nasal mask.

[0049] Frame Figures 2 and 3 show perspective views of a first non-limiting exemplary embodiment of a frame 100 that is substantially similar to the frame 5 of FIG. 1 and forms part of a respiratory mask system. The longitudinal axis 105 and the transverse axis 107 (shown in FIG. 4) are defined with respect to a starting point at the center of the inlet flange 114 of the frame 100. The frame 100 is symmetric with respect to the longitudinal axis 105. The frame 100 has an outer surface 102 and an inner surface 103. The outer surface 102 serves as an interface between the frame 100, the headgear 3, and the gas supply line 6. The outer surface 102 includes a recessed groove 106. The recessed groove is defined by a first retaining ridge 104 and a second retaining ridge 108 and is located between the first retaining ridge 104 and the second retaining ridge 108. The first retaining ridge 104 is longitudinally offset from the second retaining ridge 108, and the space between the first retaining ridge 104 and the second retaining ridge 108 defines the recessed groove 106. A concave surface 110 is located adjacent to the second retaining ridge 108. The yoke 9 is inserted into the recessed groove 106 during use. The headgear 3 is connected to the frame 100 by inserting the yoke 9 into the recessed groove.

[0050] The outer surface 102 additionally includes an inlet flange 114. The inlet flange 114 includes an inlet flange opening 115 located at the center. The inlet flange 114 also includes an inner flange surface 116 and an inlet flange surface 118. The inlet flange 114 can further include a pipe retaining protrusion 122, a number of seal retaining recesses 130, and / or a number of exhaust holes 127. The first retaining ridge 104 extends from the first side edge 126 to the second side edge 128 of the frame 100. The second retaining ridge 108 extends from the first side edge 126 so as to contact the inlet flange surface 118 of the inlet flange 114 at the laterally offset joint 112a. The second retaining ridge 108 branches off from the inlet flange 114 at the laterally offset second joint 112b and extends to the second side edge 128.

[0051] The inner surface 103 contacts the seal 206 or a fixture connected to the seal 206 and extends from the first side edge 126 to the second side edge 128 of the frame 100. The inner surface 103 includes an outlet flange 137 that extends proximally from the frame 100 to the user, establishing an outlet flange opening 117. In the illustrated embodiment, a number of seal retaining recesses 130 are located on the outlet flange surface 124 to enable the interaction between the frame 100 and the seal 206.

[0052] Figures 4 and 4A show a front view of the frame 100 aligned with the inlet flange opening 115, that is, a front view of the frame 100. The frame 100 serves as a manifold for connecting a plurality of components of the respiratory mask system to each other. The inlet flange opening 115 is oval having a major axis 113 and a minor axis 111. In an alternative embodiment, the inlet flange 114 can follow a circular, triangular, or any other desired polygonal contour.

[0053] The frame 100 is symmetric with respect to the minor axis line 111 of the inlet flange 114. In the illustrated configuration, the minor axis line 111 is aligned with the longitudinal axis 105. In the illustrated configuration, the inlet flange opening 115 is positioned substantially at the center of the frame 100. The inlet flange opening 115 has a major dimension 145 (e.g., the length along the major axis line 113 of the inlet flange opening 115) and a minor dimension 143 (e.g., the length along the minor axis line 111 of the inlet flange opening 115). Additionally, in the illustrated configuration, the major dimension 145 of the inlet flange opening 115 is 20.7 mm, and the minor dimension 143 of the inlet flange opening 115 is 17.2 mm. Another way to express this is that the ratio of the major dimension 145 to the minor dimension 143 of the inlet flange opening 115 is about 1.2:1.

[0054] This ratio is determined, at least to some extent, by the physical characteristics or shape of the gas delivery conduit used in the respiratory mask system. Further, the requirement to minimize the pressure drop that occurs between the pressure generating device and the user also affects the possible ratio of the major dimension 145 to the minor dimension 143. Pressure drop is a known phenomenon that occurs in a respiratory mask system where there is a pressure decrease between the pressure generating device and the outlet of the respiratory mask system. Pressure drop is largely due to flow resistance and inefficiencies within the system. Minimizing the pressure drop observed in the respiratory mask system improves the effectiveness of the treatment delivered to the user.

[0055] Respiratory mask system The measurable pressure drop across the respiratory mask system increases with an increase in the ratio of the major dimension 145 to the minor dimension 143 of the inlet flange opening 115. However, increasing the ratio of the major dimension 145 to the minor dimension 143 is beneficial in order to allow the physical profile of the frame 100 to be reduced. Reducing the physical profile enables the overall profile of the respiratory mask system to be reduced. Thus, in other embodiments of the frame 100, the ratio of the major dimension 145 to the minor dimension 143 of the inlet flange opening 115 can vary from about 1:1 to about 2:1.

[0056] Referring again to FIG. 4, the recessed groove 106 extends from the first side edge portion 126 to the second side edge portion 128 of the frame 100. Like the recessed groove 106, the first retaining rib 104 extends from the first side edge portion 126 to the second side edge portion 128 of the frame 100.

[0057] The lateral portion of the second retaining rib 108 is substantially concave with respect to the transverse axis 107. The lateral portion of the second retaining rib 108 is defined by a bending region near the joint 112 where the relative concave surface changes from concave to convex as the second retaining rib 108 contacts the inlet flange surface 118.

[0058] In the illustrated embodiment, the recessed groove 106 passes over the inlet flange 114. The recessed groove 116 is arcuate in shape and passes over the inlet flange 114. This recessed groove 116 is beneficial because the arcuate shape of the recessed groove 116 allows for an effective force resolution of the forces generated by the seal and the head gear.

[0059] The first retaining rib 104 and the second retaining rib 108 project outwardly in a direction from the outer surface 102 of the frame towards the inlet flange 114. The inlet flange 114 includes a wall extending from the outer surface 102. The longitudinal thickness or height or outward extension of the recessed groove 106 can be defined to displace between a location on the first retaining rib 104 adjacent to the recessed groove 106 and a location on the second retaining rib 108 adjacent to the recessed groove 106 such that each of the two locations is aligned on a common longitudinal axis. When defined in this way, the location of the maximum longitudinal thickness of the recessed groove 106 is located at the first side edge portion 126 and the second side edge portion 128 of the frame 100. The location of the minimum longitudinal thickness of the recessed groove 106 is located on the longitudinal axis 105.

[0060] The longitudinal thickness or height of the concave groove 106 decreases in magnitude as it translates laterally inwardly from the first lateral edge 126 and the second lateral edge 128 toward the longitudinal axis 105 of the frame 100. In the illustrated configuration, the longitudinal minimum thickness of the concave groove 106 is approximately 5.8 mm, and the longitudinal maximum thickness of the concave groove 106 is approximately 12.7 mm. Accordingly, the ratio of the longitudinal minimum thickness to the longitudinal maximum thickness of the concave groove 106 is approximately 1:2.25. The longitudinal thickness of the concave groove 106 corresponds to the thickness of the yoke 9 of the headgear 3 used with the frame 100. In some configurations, the ratio of the longitudinal minimum thickness to the longitudinal maximum thickness of the concave groove 106 can be from about 1:1 to 1:4.

[0061] By reducing the longitudinal thickness of the concave groove 106 along a portion of the length or at least at the central position of the frame 100, it is possible to reduce or minimize the longitudinal profile of the frame 100. By reducing or minimizing the longitudinal profile of the frame 100, both the actual protrusion and the perceived protrusion of the frame are reduced, and the mass of the frame is reduced or minimized, which is desirable for user comfort and can improve the user's fit to the treatment. The reduced longitudinal thickness of the concave groove 106 near the lateral center of the frame 100 can also provide a mating feature between the yoke 9 and the concave groove 106. The mating feature can allow the yoke 9 to be connected to the frame 100 in only one orientation, and thus prevent incorrect assembly of the headgear 3 to the frame 100.

[0062] The yoke 9 can be connected to the frame 100 via the recess 106 using any associated connection means. The yoke 9 can be adhered to the concave surface 106 using an adhesive. In some configurations, the yoke 100 can be connected to the frame 100 using a snap fit mechanism, a friction fit mechanism, or a surface fastener mechanism. In other configurations, the concave surface can include one or more protrusions designed to fit within a recess or hole in the yoke such that a combination of the protrusions and corresponding recesses or holes mates the yoke to the frame. Alternatively, the concave surface 106 can include one or more recesses or holes such that one or more corresponding protrusions on the yoke mate the yoke to the frame.

[0063] Alternative configurations of the frame 100 can utilize a number of alternative recess profiles. For example, the recess can extend above or below the top of the inlet flange (as shown in FIGS. 4 and 4A). In another alternative configuration, the frame includes two or more recesses that extend laterally across the outer surface of the frame. In some configurations, these recesses can include portions where associated retaining ridges are adjacent to each other or where two recesses share a common retaining ridge. In some configurations, these recesses may not include adjacent portions. In some configurations, one or more of the recesses can both pass above the inlet flange. In some configurations, one or more of the recesses can both pass below the inlet flange.

[0064] In some configurations, two or more recesses can first branch from a common recess near one side edge, deviate around the inlet flange, and then converge into a common recess near the opposite side edge of the frame. In some configurations, multiple recesses can be completely independent on the outer surface of the frame. In other words, each of the independent recesses can have its own independent retaining ridge or can share a common retaining ridge with another independent recess while maintaining the completely individual groove itself. In each of the foregoing variations, one or more of the recesses can be used as an interface for connecting the headgear 3 of the respiratory mask system to the frame 100.

[0065] Referring back to FIG. 4, the concave surface 110 extends from the first side edge 126 to the second side edge 128 of the frame 100 below the inlet flange 114. The concave surface 110 is adjacent to the second retaining ridge 108 on the outer surface 102 of the frame 100 and the inlet flange 114. In the illustrated configuration, the concave surface 110 assists in providing support to the seal 206 and maintaining the structural integrity of the frame 100 both during the manufacturing process and in use. However, in an alternative embodiment, the frame 100 may not have this concave surface 110 at all.

[0066] In the illustrated embodiment of FIG. 4A, the lateral length 125 of the frame 100 is approximately 56.00 mm. Thus, the ratio of the longitudinal dimension 145 of the inlet flange opening 115 to the lateral length 125 of the frame 100 is approximately 1:2.70. The defined lateral length 125 of the frame 100 is utilized to optimize the behavior of the frame 100 when combined with the seal 206 and the headgear 3. The headgear 3 is required to flex relatively greatly around the user's face. This behavior is required to best accommodate changes in facial contours that the respiratory mask system can accommodate. The frame 100 has a lateral length 125 sufficient to allow for at least some flexing of the headgear and to reduce displacement of the seal 206.

[0067] In an alternative embodiment of the frame 100, the lateral length 125 can vary from approximately 45.00 mm to approximately 75.00 mm. Variations can be used to accommodate different sizes of the seal 206, different contours of the headgear 3, or different headgear connection methods.

[0068] The longitudinal length 129 of the frame 100 has a longitudinal length that provides a suitable structure for the headgear 3 to effectively connect to the frame 100 and provides the essential structural integrity and rotational integrity required by the seal 206.

[0069] In an alternative embodiment of the frame, the longitudinal length of the frame can vary from about 25.00 mm to about 50.00 mm. Variations can be used to accommodate different seal sizes, different profiles of the headgear 3 or different headgear connection methods.

[0070] Figures 5 and 5A show a left side view (for the user) of the frame 100 illustrated in FIG. 1. The frame 100 is shown from one side of the frame. The longitudinal axis 105, the inlet proximal axis 131, and the outlet proximal axis 133 are illustrated. In the illustrated configuration, the inlet proximal axis 131 intersects the longitudinal axis 105 at a right angle and is centered with respect to the inlet flange opening 115. In other words, the inlet proximal axis 131, the transverse axis 107 (see FIG. 4), and the longitudinal axis 105 form a three-dimensional space that shares a common origin. The inlet proximal axis 131 is generally parallel to the flow of gas through the inlet flange opening 115. The outlet proximal axis 133 intersects the longitudinal axis 105 at a right angle. In other words, the outlet proximal axis 133, the secondary transverse axis 109 (shown in FIG. 6), and the longitudinal axis 105 share a common intersection. The outlet proximal axis 133 is parallel to the flow of gas through the outlet flange opening 117 of the frame 100. The inlet proximal axis 131 is longitudinally offset with respect to the outlet proximal axis 133. In the illustrated configuration, the inlet proximal axis 131 is parallel to the outlet proximal axis 133. In an alternative configuration, the outlet proximal axis 133 and the inlet proximal axis 131 can be aligned on the longitudinal axis 105.

[0071] The distal edge of the inlet flange 114 (for the user) aligns with the longitudinal axis 105 as seen in FIG. 5A. In an alternative configuration, the edge of the inlet flange can be angled with respect to the longitudinal axis 105.

[0072] In the illustrated configuration, the inlet flange surface 118 includes a first portion having a first outer peripheral portion, a second portion having a second outer peripheral portion that is coaxially offset from the first portion, and a transition portion that is integral with the first and second portions and connects the first portion to the second portion. In the illustrated configuration, the outer peripheral portion of the second portion is larger than the outer peripheral portion of the first portion, and the second portion is shifted proximally relative to the first portion (when worn by a user). The difference in the outer peripheral portions of the first and second portions of the inlet flange 114 results in a transition portion that forms an inclined surface 135 that is angled with respect to the inlet proximal axis 131. This inclined surface 135 facilitates the increase in the outer peripheral portion. In some configurations, the inlet flange surface 118 includes only the inclined surface. In other configurations, the inlet flange surface 118 may include a combination of the inclined surface and a surface that is not angled with respect to the inlet proximal axis 131.

[0073] As seen in the figure, the inlet flange 114 has an outer peripheral portion that is smaller than the outer peripheral portion of the outlet flange 137. The inlet flange 114 has a different shape than the outlet flange 137.

[0074] The inclined surface 135 extends to the peripheral edge of the inlet flange surface 118. The protrusion of the inclined surface 135 on the inlet proximal axis 131 has a generally constant length at all locations along the peripheral edge of the inlet flange surface 118. The inclined surface 135 is angled at an angle of approximately 10° with respect to the inlet proximal axis 131. The displacement between the inclined surface 135 and the (user-facing) distal edge of the inlet flange surface 118 varies around the outer periphery of the inlet flange surface 118. In the illustrated embodiment, the inclined surface 135 includes a number of bias flow holes 127. In the configurations shown in FIGS. 4, 5A, and 7, the bias flow holes 127 are located in the inclined surface 135 and extend substantially around the inclined surface 135. The bias flow holes discharge the bias flow substantially longitudinally with respect to the inlet proximal axis 131.

[0075] Including the inclined surface 135 on the inlet flange surface 118 is intended to affect the orientation of the bias flow holes 127 in a beneficial manner. However, the problem faced in holes oriented in the orthogonal direction (where the holes are oriented at 90° with respect to the inlet proximal axis 131) is that when the respiratory mask system is in use, the user perceives an uncomfortable airflow. Thus, the bias flow holes 127 of the frame 100, when located on the inclined surface 135, are angled away from the user. As a result, when the frame 100 is in use, the flow of gas through the bias flow holes 127 is directed away from the user. This prevents the user from feeling an uncomfortable airflow during the use of the respiratory mask system. Alternative embodiments of the frame 100 may include an inclined surface 135 having a modified angle with respect to the inlet proximal axis 131. In some configurations, this angle can be 0° to 20° or 5° to 15°. In other configurations, this angle can be greater than 20°.

[0076] In other configurations, the bias flow holes can extend around the entire circumference of the inclined surface. Alternatively, the configuration of the bias flow holes can be disposed on the inlet flange surface. This configuration can include one or more rows of bias flow holes, and the rows can be aligned or offset relative to each other. In other configurations, the bias flow holes can be located at other locations on the frame 100 in any desired configuration. Some configurations of the frame can include a single exhaust port. Other configurations can include a single exhaust port with a diffuser. The diffuser can be integral with the exhaust port or connected to the frame 100 so as to cover the exhaust port. The diffuser in such a configuration can act to diffuse the noise emitted from the exhaust port when the respiratory mask system is operating.

[0077] Referring again to FIGS. 5 and 5A, the side profile of the concave groove 106 is shown. The concave groove 106 appears to be concave in the lateral direction with respect to the user. The degree of concavity of the concave groove 106 can vary along the lateral length of the frame 100. This variation along the lateral length is the result of the concave groove 106 being twisted along its length. The specified curvature of the concave groove 106 is such that the contour of the frame 100 can provide proper structural support to the seal 206 of the respiratory mask system.

[0078] Referring to FIGS. 6 and 6A, FIG. 6 shows a rear view of the frame 100 with respect to the longitudinal axis 105 and the lateral axis 107. The outlet flange opening 117 is located at the center of the frame 100 with respect to the longitudinal axis 105. The origin of the outlet flange opening 117 is aligned with the secondary lateral axis 109. The secondary lateral axis is longitudinally offset from the lateral axis 107. In some configurations of the frame 100, the secondary lateral axis 109 can coincide with the lateral axis 107.

[0079] FIG. 6A shows a rear view of the frame 100 and shows that the outlet flange 137 is shaped like a truncated circle or is partially D-shaped and includes an outlet major axis 119, an outlet minor axis 121, and a truncated portion 123. The truncated portion 123 of the outlet flange 137 allows the contour of the frame 100 to be reduced with respect to a frame without a truncated portion. Additionally, the truncated portion 123 provides an orientation feature to ensure the correct orientation of the connection of the seal to the frame. The truncated portion 123 also reduces the likelihood of being placed in the wrong orientation when the seal 206 is to be connected to the frame 100. The truncated portion also prevents rotation of the seal 206 with respect to the frame 100.

[0080] In the illustrated configuration, the outlet flange opening 117 includes both a lateral profile and a longitudinal profile that are larger than those of the inlet flange opening 115. Accordingly, the outer peripheral portion of the outlet flange opening 117 is larger than the outer peripheral portion of the inlet flange opening 115. This larger profile is beneficial from both a functional and manufacturability perspective. From a functional perspective, when the frame 100 has an outlet flange 137 that is larger than the inlet flange 114, the airflow to the user is not as restricted. This results in reducing the intake noise, which is a result of the user breathing through the respiratory mask system, at least in some way, and also results in reducing the pressure drop through the respiratory mask system. From a manufacturability perspective, having an outlet flange 137 that is larger than the inlet flange 114 allows the core mold to be more easily removed from the molding portion.

[0081] Following the contour of the first retaining ridge 104, the inner surface 103 adjacent to the first retaining ridge 104 is also substantially concave with respect to the lateral axis 107. In an alternative configuration, the inner surface 103 can be substantially convex with respect to the lateral axis 107. Further, the inner surface 103 can have a region that is substantially concave and a region that is substantially convex with respect to the lateral axis 107.

[0082] Figure 7 shows a top view (with respect to the user) of the frame 100. Both the outer surface 102 and the inner surface 103 are concave with respect to the user. This is illustrated by the fact that the first retaining ridge 104 of the outer surface 102 is also adjacent to the inner surface 103, and thus the first retaining ridge 104 is concave with respect to the user. This configuration is beneficial for allowing a reduction in the proximal profile of the respiratory mask system. In an alternative configuration, the outlet flange 137 can have at least one plane that is convex or flat. Additionally, the outlet flange 137 can include both a concave region and a convex region on at least one plane.

[0083] The outlet flange surface 124 includes a number of seal retaining recesses 130. In the illustrated configuration, the outlet flange surface 124 includes two seal retaining recesses 130. The seal retaining recesses 130 are located near each lateral outermost end of the outlet flange 137. The seal retaining recesses 130 enable the seal 206 to be connected to the frame 100. In the illustrated configuration, the seal 206 is connected to the frame 100 using a fastener that connects to the frame 100. The fastener includes a raised surface corresponding to the seal retaining recess 130 that enables a connection between components to be made. Some configurations of the outlet flange 137 may include a mechanism for connecting to the seal 206 using a snap fit mechanism or a friction fit mechanism. Alternative embodiments of the frame 100 may include one or more recesses in the outlet flange surface 124 that contact the seal. Further, in contrast to the use of one or more recesses, one or more protrusions may be included in the outlet flange surface 124. These protrusions may interact with corresponding recesses or retaining portions in the seal 206 or seal fastener to connect the components to each other.

[0084] Figure 7A shows a top view (for the user) of an alternative configuration of the frame 100. In this configuration, the bias flow hole 127 is disposed, for example, on the inclined surface 135 on the inlet flange 114 as also shown in Figure 5B.

[0085] Figure 8 shows a bottom view (for the user) of the frame 100 illustrated in Figure 1. The outlet flange 137 may have at least one plane that is concave. At least a portion of the outlet flange 137 may be offset proximally relative to a second portion of the outlet flange 137.

[0086] In an alternative configuration, the outlet flange 137 may be aligned on a common plane such that its shape is not concave. In some configurations, this plane is orthogonal to the outlet proximal axis 133. In other words, the longitudinal outermost end and the lateral outermost end all share a common proximal offset from the origin of the outlet proximal axis 133.

[0087] Figure 9 shows a front view of the frame 100 illustrated in FIG. 1 and displays a cuttable cross-sectional plane 132. This cross-sectional plane is centered with respect to the frame 100 and is aligned with the longitudinal axis 105.

[0088] Figure 10 shows a cross-section 10-10 formed when the frame 100 is viewed in a direction orthogonal to the cross-sectional plane 132. The central cross-section 134 shows the cross-sectional contour of the frame 100 as viewed from the cross-sectional plane 132.

[0089] Figure 10A shows the central cross-section 134 of the frame 100. The conduit retaining projection 122 projects inwardly from the peripheral edge of the inlet flange 114. In other words, both the lateral dimension and the longitudinal dimension of the inlet flange opening 115 are smaller than the lateral dimension and the longitudinal dimension of the flange inner surface 116. This dimensional change is the result of the conduit retaining projection 122. In other words, the conduit retaining projection 122 can form a lip around the inside of the distal end of the inlet flange 114. This lip can be continuous around the periphery of the inlet flange opening 115 or can include a protruding peripheral portion and other peripheral portions that do not protrude. The gas supply conduit 6 can be connected to the frame 100 using an adhesive or using a fixture that engages with the conduit retaining projection 122. The gas supply conduit is positioned adjacent to the conduit retaining projection 122 and can then be adhered to the frame 100 with an adhesive. Alternatively, the gas supply conduit 6 can be removably fixed to the frame 100 through a fixture. In some embodiments of the frame 100, the gas supply conduit 6 can be permanently connected to the frame 100 using a fixture or other permanent bonding method including, but not limited to, ultrasonic welding or overmolding. Additionally, the conduit retaining projection 122 may not be included in some embodiments.

[0090] Alternatively, the conduit retaining projection 122 can be located on the inlet flange surface 118 and project radially outward from the center of the inlet flange 114. In other words, the conduit retaining projection 122 can form a lip around the outside of the inlet flange 114. In this configuration, the gas supply conduit 6 can be connected adjacent to the inlet flange surface as opposed to the flange inner surface 116. The lip can be continuous or intermittent around the periphery of the inlet flange 114.

[0091] In the illustrated configuration, the frame 100 is composed of a rigid polymer. In some configurations, the frame 100 can be composed of any of a number of polymer or non-polymer materials, such as nylon 12 or polycarbonate.

[0092] Figures 11 and 12 show non-limiting exemplary embodiments of a respiratory mask system 200 that is substantially similar to the respiratory mask system 1 of FIG. 1. The respiratory mask system 200 includes a patient interface 202 and a headgear 204. The patient interface 202 includes a seal 206 configured to connect to the frame 100, as previously described, and a gas delivery conduit 208. The headgear 204 and the frame 100 are configured to secure the seal 206 in a stable position below the user's nose.

[0093] The seal 206 is substantially similar to the seal 6 described above and has a reduced contact area with the user's face compared to a conventional nasal mask that seals around the user's nose and across or near the nasal bridge of the nose. The reduced contact area may result in a reduction in seal stability that requires a reaction force from the headgear 204 to prevent leakage and loss of treatment. The headgear 204 is configured to provide support against any force that may act to break the seal between the seal 206 and the user's face. Forces that may disrupt the seal include, but are not limited to, the blowing force induced by the pressure of the CPAP therapy being applied, hose drag, and / or contact between the patient interface 202 and bedding caused by movement of the user.

[0094] The frame 100 provides a connection between the seal 206 and the headgear 204. Figures 11 - 12 show that the frame 100 includes a gas delivery inlet or inlet flange 114 through which pressurized air can be supplied to the seal 206 and the patient's airway. Pressurized air is typically provided to the gas delivery inlet 114 via a conduit or hose, such as the gas delivery conduit 208, that connects to a CPAP machine or ventilator (not shown).

[0095] Headgear Figures 11-17 show non-limiting exemplary embodiments of headgear 204, including a bifurcated headgear arrangement. The bifurcated headgear 204 includes a plurality of connected straps including a top strap 212, a pair of opposing side arms 214, a yoke 216, and a rear strap 218. The top strap 212 and the rear strap 218 form a bifurcated arrangement.

[0096] The top strap 212 is configured to pass over the top of the user's head from one side to the other side during use. In the illustrated configuration, the top strap 212 can include a forehead strap that is positioned over the user's frontal bone. In this configuration, the top strap 212 is angled forward of the coronal plane 11 that passes through the user's head, as shown in FIG. 12. An angle θ of 5° - 45° is formed between the top strap 212 and the coronal plane 11. In the illustrated embodiment, the top strap 212 forms an angle of 15° with respect to the coronal plane 11. This angle can direct the top strap 212 towards the user's forehead, thereby improving the stability of the headgear 204. In other configurations, the top strap 212 is a vertex strap that is positioned over the vertex bone or at or near the junction of the vertex bone and the frontal bone.

[0097] The rear strap 218 passes around the user's posterior head and, in some configurations, is positioned over the user's occipital bone. However, in other configurations, the rear strap 218 can be positioned at a higher or lower position on the user's head and / or neck.

[0098] The top strap 212 and the rear strap 218 are joined at their ends by one of the side arms 214 so as to form a bifurcated structure. During use, the top strap 212 and the rear strap 218 surround the user's posterior head portion. The surrounded posterior head portion of the user can include at least a portion of the vertex region and / or the occipital region.

[0099] In the illustrated arrangement, the top strap 212 joins the side arms 214 at the junctions 224 on each side of the headgear 204. Each pair of side arms 214 extends forward from the junction 224 towards the user's nose and transitions to the yoke 216 in use. The headgear 204 is configured such that the junction 224 is positioned above the user's ears in use. The junction 224 may be located in front of or behind the ears depending on the size of the user's head.

[0100] Integrally formed closed loop In the illustrated embodiment, at least some portions of the headgear 204 are rigid, semi-rigid, non-elastic or substantially non-extensible in response to normal or predicted forces acting on the headgear 204. Other portions of the headgear 204 are elastic or extensible or at least substantially flexible compared to other portions in response to normal or predicted forces.

[0101] In the illustrated configuration, the top strap 212, the junctions 224, the side arms 214 and the yoke 216 are rigid, semi-rigid, non-elastic or substantially non-extensible. The top strap 212, the side arms 214 and the yoke 216 are formed as a single, integrally formed component that is flat or substantially two-dimensional as shown in FIG. 13. A three-dimensional closed loop is formed when the free ends of the left and right portions 220 and 222 of the top strap 212 are connected to each other by the adjustment mechanism 228. The closed loop is configured to surround at least a portion of the user's head in use. In the illustrated embodiment, the closed loop surrounds the upper front portion of the user's head from the bottom of the nose to the vertex in front of the ears. In alternative embodiments, the closed loop may surround a larger or smaller portion of the user's head.

[0102] By using a rigid, semi-rigid, inelastic or substantially non-extensible material for the top strap 212, side arms 214 and yoke 216, the closed loop formed by them can effectively transmit force between the patient interface 202 and the user's head. For example, during use, when the gas supply line is pulled by the user, bedding or the CPAP supply line, a force may be applied to the patient interface 202 that pulls the patient interface 202 away from the user's face. This force can be transmitted from the yoke 216 through the side arms 214 to the top strap 216 and then to the user's head so as to resist the rotation of the longitudinal seal 206 and the removal of the seal 206 from the user's face.

[0103] The closed loop allows the headgear 204 to be separated from the patient interface 202 without changing the tightening setting of the top strap 212. This is advantageous because each time the headgear 204 is removed from the patient interface 202, the user does not need to loosen or tighten the headgear 204 and readjust the straps to the correct tightness. This saves time and makes it easier for the user to attach the headgear. The closed loop arrangement also provides a single connection point between the headgear 204 and the patient interface 202.

[0104] In other words, the integrally formed components that form the closed loop are rigid, semi-rigid, inelastic or substantially non-extensible. In the illustrated embodiment, the top strap 212, side arms 214 and yoke 216 are integrally formed from a plastic material that forms a plastic core and are covered with a fabric casing that is permanently adhered to the plastic core. The plastic core provides the necessary structure for the headgear 204 and the fabric casing provides a soft and comfortable finish that contacts the user. In the illustrated embodiment, the fabric casing is a circular braided tube. In an alternative embodiment, the fabric casing may include multiple layers of fabric that are cut to a shape and joined along the edges, or any other tubular fabric may include, but is not limited to, a woven tube or a braided tube. In some embodiments, at least a portion of the integrally formed top strap 212, side arms 214 and yoke 216 are formed by an internal molding process, an example of which is described in PCT / New Zealand Patent Application Publication No. 2015 / 050149, which is the applicant's application and is incorporated herein by reference in its entirety. "Internal molding" includes forming the plastic core as an integral structure and the components as the fabric casing by adding molten plastic into the fabric casing. An "internally molded" strap or any other component is a component formed by adding molten plastic into the fabric casing.

[0105] FIG. 13 shows that the headgear 204 of the illustrated embodiment has a top strap 212 and side arms 214 including soft edges 250. The soft edges 250 are configured to extend along one or both of the longitudinal edges of the top strap 212 and the side arms 214. The soft edge is formed by the longitudinal edge portion of the fabric casing protruding from the edge of the plastic core and is not filled with the plastic core. The soft edge provides a cushioned edge that can improve the user's comfort by cushioning the contact between the edges of the rigid, semi-rigid, inelastic or substantially non-extensible top strap 212 and side arms 214 and the user's head. The provision of the cushioned edge can be particularly beneficial at the lower edge of the side arm 214 located above the user's ear during use.

[0106] In an alternative embodiment, the closed loop can be formed from any material that provides suitable rigidity, inelasticity or non-extensibility. The material can include, but is not limited to, thermoplastics and silicones. In some embodiments, the material may or may not have a fabric casing.

[0107] Top strap In the illustrated embodiment, the top strap 212 includes two strap portions, a left portion 220 and a right portion 222. The left portion 220 and the right portion 222 are separate from each other and have free ends and fixed ends. The free ends are configured to be adjustably connected by an adjustment mechanism 228. The fixed ends are configured to extend at an angle from the side arm 214 at the junction 224.

[0108] The adjustment mechanism 228 is configured to adjust and fix the top strap 212 to a desired adjusted length, and thus provide means for adjusting the size and / or tightening setting of the headgear 204. Adjustment of the length of the top strap 212 can define the positioning of the side arms 214 relative to the top of the user's ear during use. By shortening the length of the top strap 212, the side arms 214 can be positioned higher above the user's ear, and thus contact between the side arms 214 and the user's ear is avoided. Contact between the side arms 214 and the top of the user's ear can result in irritation or pressure points that can cause bedsores over time, and thus avoiding contact between the side arms 214 and the ear may improve the user's comfort.

[0109] FIG. 13 shows the adjustment mechanism 228 in the disengaged position. The free end of the left side portion 220 includes a guide loop 230 and a plurality of holes 232 spaced along the length of the strap. The holes 232 extend through the thickness of the top strap 212. The free end of the right side portion 222 includes a pip or post 234 that projects from the inner surface 236 of the strap.

[0110] The guide loop 230 includes a loop structure that forms an opening at the end of the left side portion 220. The free end of the right side portion 222 is configured to pass through the opening formed by the guide loop 230. Thus, the left side portion 220 and the right side portion 222 can be slid relative to each other to vary the overlapping distance between the left side portion 220 and the right side portion 222, and thus vary the length of the top strap 212. The guide loop 230 also maintains the connection between the left side portion 220 and the right side portion 222 when the adjustment mechanism 228 is not engaged. This may improve ease of use. The guide loop 230 is angled away from the inner surface 236 such that the opening is at least partially offset from the thickness of the strap. This enables the right side portion 222 to pass through the guide loop 230 and overlap the left side portion 220 without bending or deforming the left side portion 222.

[0111] The strut 234 is configured to pass through any of the holes 232. As shown in FIG. 14, the strut 234 includes a stem 238 and a head or cap 240. The illustrated strut 234 is generally T-shaped, although other shapes such as a cylindrical stem 238 and a disc-shaped or spherical head 240 can also be used. The holes 232 are sized, shaped, and / or otherwise configured to allow the head 240 of the strut 234 to hold the strut 234 when the head 240 of the strut 234 passes through and out of the hole 232, at least in response to normal or anticipated forces. However, the strut 234 can be intentionally removed from the hole 232 to allow separation of the left portion 220 and the right portion 222 of the top strap 212 and to allow adjustment of the size of the headgear. Passing the strut 234 through the hole 232 can be accomplished by deformation of one or both of the strut 234 and the hole 232. That is, the head 240 of the strut 234 can flex or otherwise deform, and the hole 232 can stretch or expand to facilitate passage of the head 240 of the strut 234. In alternative embodiments, multiple struts may be present.

[0112] In an alternative embodiment, the adjustment mechanism 228 can include any other suitable means for adjustably connecting the free end of the top strap 212, including but not limited to a surface fastener, a buckle, etc.

[0113] In an alternative arrangement, the inner surface 236 of the left portion 220 can include a hook portion of a surface fastener, and the outer surface 242 of the right portion 222 can include a loop portion of a surface fastener. This arrangement can be reversed. In some configurations, the material of the top strap 212 can define a loop portion of a surface fastener. In other words, the loop portion need not be a separate element of the top strap 212.

[0114] Side arm A pair of opposing side arms 214 are configured to couple a yoke 216 to a top strap 212 at the top of each side of a user's face during use. This arrangement allows a rotational force applied to the patient interface 202 to resist rotation of the seal 206 relative to the user's face to be transmitted from the yoke 216 to the top strap 212 and the user's head.

[0115] The side arms 214 include elongated straps shaped to curve across a user's cheek towards the temple and over the ear during use. The curvature is such that it avoids the eyes to provide an unobstructed field of view and improved user comfort. The curvature follows the line of the user's cheekbone such that contact between the side arm 214 and the user's cheek transmits force in a direction away from the patient interface 202 so as not to impede the seal with the user's face.

[0116] The side arms 214 further include buckles 226 integrally formed at each free end of the side arms 214. During use, the free ends of the side arms 214 extend rearwardly beyond the junction 224 with the top strap 212 and the buckles 226 are positioned either above or behind the user's ear.

[0117] The buckle 226 includes an extension of the free end of the side arm 214 and an opening extending through the thickness of the side arm 214. The opening is configured to receive a rear strap 218. In another embodiment, the buckle 226 may include a hook or any other suitable geometry for adjustably securing the rear strap 218.

[0118] The side arms 214 are elastically flexible in the direction towards and away from the user's face in a generally horizontal plane (when worn) to accommodate different face sizes, but can be relatively inflexible in a generally vertical plane. The illustrated side arms 214 are solid, but other configurations of the side arms can include one or more apertures or notches extending in the length direction of the side arms to increase the elastic flexibility of the side arms in the direction towards and away from the user's face while maintaining relative inflexibility in a generally vertical plane (when worn). The vertical inflexibility of the side arms 214 enables the side arms 214 to transmit forces, such as, but not limited to, blowout force or hose drag / tensile force, that may be applied to the patient interface 202 to the top strap 212 and the rear strap 214. This can help reduce the likelihood that the seal 206 will disengage from the user's face and impede treatment delivery.

[0119] Yoke In use, the yoke 216 is symmetric about the sagittal plane and includes a substantially "U" shaped structure when viewed from above, similar to FIG. 16. The yoke 216 is configured to follow the curvature of the frame 100 and connect the patient interface 202 to the headgear 204 via the frame 100. The yoke 216 includes a central bridge 244 and a pair of laterally rearward portions 248 extending laterally and rearward from each side of the central bridge 244. The yoke 216 provides a single connection between the headgear 204 and the frame 100 that is independent of any other features of the frame 100. This enables the headgear 204 to be detached from the frame without interfering with or disconnecting any other part of the patient interface 202.

[0120] The yoke 216 is configured to provide a connection between the frame 100 and the headgear 204 that supports the patient interface 202 in the vertical and horizontal directions with respect to the user when the breathing mask 200 is worn. By supporting the patient interface 202 in the vertical and horizontal directions, rotation of the seal 206 with respect to the user's face is reduced, and thus leakage can be reduced.

[0121] The central bridge 244 is shaped to fit within the concave groove 106 of the frame 100 (described above). The central bridge 244 is configured to connect temporarily or permanently to the concave surface 106 by means such as, but not limited to, snap-fit connections, friction-fit connections, fastener mechanisms, adhesives, or welding. The central bridge 244 curves over the inlet flange 114 of the frame 100 and transitions to the laterally rearward portion 248.

[0122] The laterally rearward portion 248 forms a transition portion integrally formed between the central bridge 248 and the side arms 214. The laterally rearward portion 248 is positioned laterally of the central bridge 244 when the breathing mask 200 is worn by the user and curves rearwardly around the frame 100.

[0123] As shown in FIG. 16, the central bridge 244 has a height H 2 less than the height H 1 of the laterally rearward portion 248 of the yoke 216. The height H 1 is less than the height H 2 to minimize the size of the frame 100. The height H 2 is greater than the height H 1 to provide a desired level of structure in the vertical direction for the purpose of preventing rotation of the patient interface 202 with respect to the user's face. H 1 can be 1 mm to 12 mm or 4 mm to 7 mm. In the illustrated embodiment, H 1 is 5.5 mm. H 2 can be 5 mm to 16 mm or 8 mm to 13 mm. In the illustrated embodiment, H 2is 12.5 mm.

[0124] The side arm 214 may be continuous from the laterally rearward portion 248 at the same height as H 2 or at a height greater than H 2 In some embodiments, the height of the side arm 214 increases in a direction away from the yoke 216. The transition between H 1 and H 2 occurs between the central bridge 244 and the laterally rearward portion 248. The laterally rearward portion 248 is configured to contact the frame 100 until its height fully transitions to the height of H 2 . This configuration enables structural support to be provided to the yoke 216 with respect to the maximum height such that there is no portion that can form a vulnerable point without being supported by the low - height yoke 216 or side arm 214. This allows force to be transmitted from the frame 100 through the yoke 216 to the side arm 214 without passing through a vulnerable point that could cause longitudinal twisting or bending of the side arm 214 or yoke 216, thereby enabling rotation of the patient interface 202. In some embodiments, the height of the side arm 214 is 16 mm or less to provide a minimal respiratory mask.

[0125] In FIG. 16, it can be seen that the soft edge 250 of the side arm 214 is tapered so as to gradually disappear such that the soft edge 250 is not present on the yoke 216. This tapering of the soft edge 250 can provide an improved connection between the yoke 216 and the frame 100 by providing a rigid, semi - rigid, non - elastic or substantially non - extensible edge that can be engaged by the groove 106 of the frame 100. The soft edge 250 is not required on the edge of the yoke 216 because the edge of the yoke 216 is less likely to contact the user and cause discomfort or irritation. The size of the yoke 216 can be minimized by tapering the soft edge 250 so as to gradually disappear. Thus, the size of the yoke 216 can be minimized to provide a less obtrusive respiratory mask system 200.

[0126] In the illustrated embodiment, FIG. 17 shows that the lateral rear portion 248 of the yoke 216 has a wall thickness T that is greater than the wall thickness T at the center of the yoke 216 and in the side arms 214 2 in a direction orthogonal to the inner surface 236. The increased thickness provides increased structure at the outermost lateral portions of the yoke 216 that contact the frame 100. This enables effective force transmission from the side arms 214 to the frame to minimize the longitudinal rotation of the patient interface 202. The lateral rear portion can have a thickness T of 1 mm to 4 mm 1 . In the illustrated embodiment, the thickness T 1 is 2.9 mm. The central bridge 244 and the side arms 214 have a thickness T of 0.5 mm to 3 mm 1 . In the illustrated embodiment, T 2 is 2.1 mm. 2

[0127] The greater wall thickness T of the lateral rear portion 248 of the yoke 216 1 relative to the reduced wall thickness T of the side arms 214 2 can enhance the horizontal flexibility of the side arms 130 with respect to the yoke 216 (when worn). This allows the side arms 214 to flex horizontally to conform to different facial geometries while providing longitudinal stability when the breathing mask 200 is worn by the user.

[0128] Rear Strap The rear strap 218 includes an elongated strap that extends between the buckles 226 of the side arms 214 and is connected around the buckles 226 of the side arms 214. The ends of the rear strap 218 are adjustably tethered through the openings of the buckles 226 so that the length of the rear strap 218 can be adjusted. Adjusting the length of the rear strap 218 can further adjust the overall size of the headgear 204 to fit individual users.

[0129] In the illustrated configuration, the rear strap 218 is elastic or stretchable. Such an arrangement allows the rear strap 218 to extend to adjust the circumferential length of the headgear 204. The amount of extension of the rear strap 218 can be limited, and thus the rear strap 218 can be adjustable in length as described above. In some configurations, it is preferred that the circumferential length adjustment is performed at the back of the user's head, where the extension due to the blowing output has little effect. The rigid, semi-rigid, non-elastic or substantially non-stretchable nature of the joints 224 and side arms 214 positioned at the side and front portions of the user's head aids in maintaining the desired circumferential length of the headgear 204 despite the elastic nature of the rear strap. In some cases, the frictional force between the portion of the headgear 204 and the side and front portions of the user's head prevents movement or extension of the headgear 204 in response to the blowing output. However, in other arrangements, the rear strap 214 can be rigid, semi-rigid, non-elastic or substantially non-stretchable, and in such cases, the length can be adjustable.

[0130] In the illustrated embodiment, the rear strap 218 includes, but is not limited to, a laminated fabric and foam of a certain length, such as Breathoprene®. The rear strap is elastic so that it can be extended to allow pulling the headgear 204 over the user's head without adjusting the length of the rear strap 218. This improves ease of use. In an alternative embodiment, the rear strap can include any suitable fabric or woven material.

[0131] The rear strap 218 has two side ends 244 configured to pass through the buckle 226 and fold back onto itself (shown in FIG. 12), and these side ends can be fastened at a position determined by the user. The side ends 226 of the rear strap 218 can be fastened to the outer surface of the rear strap 218 by fastening means such as, but not limited to, a hook-and-loop fastener. The overlap between the folded-back side ends 244 and the remainder of the rear strap 218 determines the length of the rear strap 218 and the dimensions of the headgear 204. In the illustrated embodiment, the side ends 244 of the rear strap 218 include fastening tabs in the form of hook components of a hook-and-loop fastener (such as, but not limited to, a Velcro® brand hook-and-loop fastener). The fastening tabs are configured to be fastened to loop components on the outer surface of the rear strap 218. In the illustrated embodiment, the outer surface of the rear strap 218 includes a material that provides loop components of the hook-and-loop fastener. In an alternative embodiment, the arrangement of this hook-and-loop fastener can be reversed such that the hook components are located on the outer surface of the rear strap 218.

[0132] Alternative headgear embodiments FIGS. 18 and 19 show another non-limiting exemplary embodiment of the headgear 304. For the purposes of this description, features of this embodiment that are substantially similar to those of the previous embodiment of the headgear 204 are labeled with reference numerals having 100 added to the same numeral. For example, the headgear 204 is the headgear 304 in this embodiment. For the sake of brevity, only those features that are substantially different from the previous embodiment will be described in detail here. It should be understood that all other features are substantially as described with respect to the headgear 204.

[0133] The headgear 304 includes a top strap 312, a pair of opposing side arms 314, a yoke 316, and a rear strap 318. Similar to the previous embodiments, the top strap 312, side arms 314, and yoke 316 are formed as a single component that is rigid, semi-rigid, non-elastic, or substantially non-extensible and integrally formed. The integrally formed single component can be arranged to form a closed loop that surrounds the upper front portion of the user's face during use. The top strap 312, side arms 314, and rear strap 318 are substantially the same as the top strap 212, side arms 214, and rear strap 218, as described above. As shown, the rear strap 318 extends between the buckles 326 of the side arms 314 and can be connected to the buckles 326 of the side arms 314. One or both ends of the rear strap 318 can advantageously include grip tabs 319 that can enable the user to more easily grasp the ends of the rear strap 318 to adjust and / or secure the rear strap 318. The top strap 312 can be adjusted by an adjustment mechanism 328.

[0134] The yoke 316 of the present embodiment is configured to provide a connection between the headgear 304 and a patient interface (not shown, which may be similar to the patient interface 202). The yoke 316 is symmetric with respect to the sagittal plane (shown in FIG. 19) during use and includes a loop structure formed by an upper bridge 350 and a lower bridge 352 joined by the front end of each of the side arms 314. The upper bridge 350 and the lower bridge 352 are configured to be removably connected to a frame (not shown, which may be similar to the frame 100) around the inlet flange or around the connection of the frame. The upper bridge 350 and the lower bridge 352 are curved so as to define an opening configured such that the loop structure formed by the upper bridge 350 and the lower bridge 352 is continuous and surrounds the inlet flange. This curved shape can be configured to fit around the outer periphery of the frame to reduce the overall size of the patient interface.

[0135] The upper bridge 350 and the lower bridge 352 are configured to resist rotational forces that may be applied to the patient interface. The upper bridge 350 and the lower bridge 352 provide two paths through which force can be transmitted from the frame to the headgear 300. That is, by providing two paths, the rotational forces can be evenly distributed such that there is no biasing in the direction of upward or downward rotation.

[0136] Alternative frame embodiments FIG. 20 shows another non-limiting exemplary embodiment of a respiratory mask assembly 400. The respiratory mask assembly 400 includes a patient interface 402 and a headgear 404. The patient interface 402 includes a seal 406 configured to connect to a frame 410 and a gas delivery conduit 408. In some embodiments, the frame 410 has a reduced or smaller overall profile compared to the frame 100. The headgear 404 and the frame 410 are configured to secure the seal 406 in a stable position below the user's nose during use.

[0137] The seal 406 can be substantially similar to the seal 6 described above and has a reduced contact area with the user's face compared to a conventional nasal mask that seals around the user's nose and across or near the nasal bridge of the nose. The reduced contact area may result in a reduction in seal stability that may require a reaction from the headgear 404 to prevent leakage and loss of therapy. The headgear 404 is configured to provide support to counteract forces that may act to break the seal between the seal 406 and the user's face. Forces that may impede the seal can include, but are not limited to, the blowing force induced by the pressure of the CPAP therapy being applied, hose drag, and / or contact between the patient interface 402 and bedding caused by movement of the user.

[0138] The frame 410 illustrated in FIGS. 21 to 23B and FIGS. 26A to 32B provides a connection portion between the seal 406 and the headgear 404. Similar to the frame 100, the frame 410 has an outer surface 412, an inner surface 413, and a fluid passage 415 extending through the outer surface 412 and the inner surface 413 as shown in FIGS. 21 to 23B. The outer surface 412 and the inner surface 413 extend from a first side edge portion 422 to a second side edge portion 424. The outer surface 412 faces away from the user during use and serves as an interface between the frame 410, the headgear (such as the headgear 404), and the gas supply pipeline (such as the gas supply pipeline 408). The inner surface 413 faces the user during use and can contact the seal 406 and / or the fixture connected to the seal 406. During use, the gas supply pipeline 408 is coupled to the frame 410 such that the gas supply pipeline 408 is in fluid communication with the fluid passage 415.

[0139] The outer surface 412 includes a concave surface 426 and a raised surface 428. In some embodiments, a portion of the headgear 404, such as the yoke 416, can be arranged to be adjacent to the concave surface 426 when assembled. In the illustrated embodiment, the raised surface 428 is below the concave surface 426 and / or adjacent to the bottom edge portion of the frame 410, while the concave surface 426 is above the raised surface 428 and / or adjacent to the top edge portion of the frame 410. The inlet flange 430 projects outwardly from the outer surface 412 (towards the user during use). The inlet flange 430 surrounds the fluid passage 415. In the illustrated embodiment, the boundary between the concave surface 426 and the raised surface 428 is partially defined by the inlet flange 430. The inlet flange 430 includes an inner inlet flange surface 432 (defining the fluid passage 415) and an inlet flange surface 434 (located outside the inlet flange 430). In some embodiments, the inlet flange surface 434 can be regarded as a part of the outer surface 412 or as partially defining the outer surface 412. In the illustrated embodiment, the inlet flange 430 includes a pipeline holding protrusion 436 (shown in FIG. 22). The inlet flange 430 can include one or more bias flow holes 438.

[0140] The outlet flange 440 protrudes inwardly (towards the user in use) from the inner surface 413. The outlet flange 440 has an outlet flange surface 444 which in some embodiments can be considered part of or can be considered to partially define the inner surface 413. The outlet flange 440 can include one or more seal retaining recesses 446. The seal retaining recesses 446 enable the interaction and / or connection of the frame 410 and the seal 406. In some embodiments, the seal retaining recesses 446 enable the interaction and / or connection of the frame 410 and a fastener that connects to the seal 406. In the illustrated embodiment, the outlet flange surface 444 includes the seal retaining recesses 446.

[0141] The fluid path 415 is defined or formed by the inlet flange 430 and the outlet flange 440. In use, the gas supply line 408 is coupled to the inlet flange 430 and the seal 406 is coupled to the outlet flange 440. Gas can be delivered to the seal 406 so as to be delivered to the user through the fluid path 415 from the gas supply line 408 (i.e., through the inlet flange 430 and the outlet flange 440).

[0142] In the illustrated embodiment, the inlet flange 430 can be oval and can have a major axis 113 and a minor axis 111. In some embodiments, the inlet flange 430 can have a circular, triangular, "D-shaped" or other shape. In the illustrated embodiment, the frame 410 is symmetric with respect to the minor axis 111 or the longitudinal axis 105. In the illustrated embodiment, the length dimension D major (shown in FIG. 23B) of the opening defined by the inlet flange 430 is 21.9 mm or about 21.9 mm, and the short dimension D minor of the opening is 16.7 mm or about 16.7 mm. In other words, the ratio of the length dimension to the short dimension is 1.31:1 or about 1.31:1.

[0143] In the illustrated embodiment, the lateral dimension (or width) W of the frame 410 (shown in FIG. 23B) is 49.3 mm or about 49.3 mm. Accordingly, the ratio of the longitudinal dimension of the opening defined by the inlet flange 430 to the lateral dimension W of the frame 410 is 1:2.25 or about 1:2.25. The lateral dimension of the frame 410 can be selected to optimize or enhance the function of the frame 410 when assembled to the seal 406 and the headgear 404. In some embodiments, the lateral dimension of the frame 410 can be in the range of 30 mm (or about 30 mm) to 75 mm (or about 75 mm).

[0144] In the illustrated embodiment, the longitudinal dimension (or height) H of the frame 410 (shown in FIG. 23B) is 28.0 mm or about 28.0 mm. Accordingly, the ratio of the short dimension of the opening defined by the inlet flange 430 to the longitudinal dimension of the frame 410 is 1:1.68 or about 1:1.68. One consideration in selecting the longitudinal dimension of the frame 410 is the area required for the concave surface 426 and / or the headgear retention features as described herein to maintain an effective connection between the frame 410 and the headgear 404. The longitudinal dimension of the frame 410 can be selected to provide a structure suitable for enabling the headgear 404 to effectively connect to the frame 410 and / or to provide the essential structural integrity and rotational integrity required by the seal 406. In some embodiments, the longitudinal dimension of the frame 410 can be in the range of 20 mm (or about 20 mm) to 50 mm (or about 50 mm). The longitudinal dimension can be varied to accommodate different seal sizes, headgear profiles and / or headgear connection methods or connection mechanisms.

[0145] In the illustrated embodiment, the proximal dimension (or thickness) T of the frame 410 (shown in FIG. 26B) is 17.05 mm or about 17.05 mm. As shown in the side views of FIGS. 26A and 26B, the entire peripheral or distal end of the inlet flange 430 (in other words, the rim of the inlet flange 430 that is farthest from the user during use) is not aligned with the illustrated longitudinal axis 105. The longitudinal extreme ends (in other words, the top and bottom) of the inlet flange 430 intersect the longitudinal axis, but the central portion of the inlet flange 430 (in other words, the sides or lateral extreme ends) is offset proximally (or toward the user during use). In other words, when viewed from the side (similar to FIGS. 26A-26B), the peripheral edge of the inlet flange 430 is a recess facing distally (or a recess facing away from the user during use). The concave profile can advantageously enable the frame 410 to have reduced material requirements. In some embodiments, the oval shape of the inlet flange 430 and / or the offset longitudinal and lateral extreme ends of the distal end of the inlet flange 430 provide beneficial behavior when a gas delivery line, such as the gas delivery line 408, is coupled to the inlet flange 430. For example, when the gas delivery line 408 is removably coupled to the inlet flange 430, such as by press fit, snap fit, or other connection that cooperates with the line retaining protrusion 436, it may be difficult to unintentionally remove the gas delivery line 408 when an axial force is applied axially (in the axial direction of the inlet flange 430 and / or the gas delivery line 408). Thus, the oval shape of the inlet flange 430 and / or the concave distal end can prevent the unintentional removal of the gas delivery line 408. However, the gas delivery line can be removed from the frame 410 more easily or with less effort when the gas delivery line is twisted about the axial axis of the inlet flange 430.

[0146] Frame 410 can include various headgear retention features. The retention features are used to couple frame 410 to headgear 404 as shown in FIG. 25. In the illustrated embodiments of FIGS. 21-23B, frame 410 includes two retention features 450 located in concave surface 426. More or fewer retention features 450 are possible. As shown, each retention feature 450 is laterally offset from or laterally spaced from the longitudinal axis such that one of the retention features 450 is located on each side of the longitudinal axis. In the illustrated embodiment, the retention feature 450 is a circular hole. In some embodiments, the retention feature 450 is a hole having an oval shape, a rectangular shape, a "D" shape (e.g., as shown in FIG. 24C), or other shape. In some embodiments, the two retention features 450 are different from each other. The different shapes of the left and right headgear retention features 450 can serve to guide the user in properly connecting headgear 404 to frame 410. In some embodiments, the headgear retention feature 450 has an anti-rotation shape and / or anti-rotation features. Headgear 404 can include protrusions corresponding to the retention features 450 and designed to fit within the retention features 450. The protrusions can be fixed to the retention features 450 and frame 410 via snap fit or other suitable means. In some embodiments, the retention feature 450 can be a structure that protrudes outwardly from concave surface 426, for example as shown in FIG. 24D. In some such embodiments, headgear 404 can include corresponding holes to receive the retention features 450. In the illustrated embodiment, each of the retention features 450 is a circular protrusion that extends between and / or divides the retention feature 450 into two semi-circular or generally semi-circular sides or portions, and has a central groove. The protrusions can be fixed to corresponding sized holes in headgear 404 via snap fit or other suitable means. In some embodiments, the retention feature 450 can include one or more magnets or magnetic materials that attract one or more magnets or magnetic materials within headgear 404.

[0147] As described above, in the illustrated embodiment, the frame 410 includes two retaining features 450. By including two retaining features 450 and / or using a circular retaining feature 450, advantageously, easy attachment and detachment of the headgear 404 to the frame 410 can be enabled. As shown in FIG. 24A, in order to connect the frame 410 and the headgear 404 at an angle, the first retaining feature of the retaining feature 450 can be used. Next, the frame 410 can be rotated about the first retaining feature 450 so that the second retaining feature of the retaining feature 450 can be connected to the headgear 404 as shown in FIG. 24B.

[0148] In the illustrated embodiment, the inlet flange 430 or the inlet flange surface 434 is angled by an inclined surface angle θ such that, as shown in FIGS. 28 and 29C, the diameter of the base of the inlet flange 430 closest to the user during use is larger than the diameter of the peripheral edge of the inlet flange 430 farthest from the user during use. The inlet flange 430 may resemble a hollow frustum. The angle of the inlet flange 430 is such that the air passing through the bias flow holes 438 (substantially or generally perpendicular to the inclined inlet flange 430 or the inlet flange surface 434) is directed or enabled to be directed away from the user's face. Thereby, advantageously, the possibility that the user feels the air flow through the bias flow holes 438 and / or the air flow by entrainment is prevented or reduced. A is angled only by. The inlet flange 430 may resemble a hollow frustum. The angle of the inlet flange 430 is such that the air passing through the bias flow holes 438 (substantially or generally perpendicular to the inclined inlet flange 430 or the inlet flange surface 434) is directed or enabled to be directed away from the user's face. Thereby, advantageously, the possibility that the user feels the air flow through the bias flow holes 438 and / or the air flow by entrainment is prevented or reduced.

[0149] The first inclined surface angle can be defined as the angle between the top (or the uppermost longitudinal end) of the inlet flange 430 or the inlet flange surface 434 and an axis parallel to the proximal axis, and can be located at the intersection of the inlet flange 430 and the outer surface 412 or the raised surface 426 of the frame 410 as shown in FIG. 28. The second inclined surface angle θ A2It can be defined as the angle between the lateral side of the inlet flange 430 or the inlet flange surface 434 and an axis parallel to the proximal axis, and can be located at the intersection of the inlet flange 430 and the outer surface 412 or the raised surface 428 of the frame 410 as shown in FIG. 29C. In some embodiments, the inclined surface angle can be in the range of about 10° to about 15°. In the illustrated embodiment, the first inclined surface angle is about 10°, the second inclined surface angle is about 15°, and the inclined surface angle transitions from about 10° to about 15° between the top and the side of the inlet flange 430. In some embodiments, the inclined surface angle can be a constant angle around the entire inlet flange 430. In some embodiments, the inclined surface angle can vary around the inlet flange 430. In some embodiments, the inclined surface angle can be in the range of about 0° to about 90°, for example, about 0°, about 45°, or about 90°.

[0150] In the illustrated embodiment, each bias flow hole 438 is equally offset or spaced from the distal end of the inlet flange 430. In other words, the arrangement of the bias flow holes 438 is such that the bias flow holes 438 located at or near the longitudinal extreme ends (top or bottom) of the inlet flange 430 are located further distally from the user or further away from the user than the bias flow holes 438 located at or near the lateral side of the inlet flange 430, following the contour of the distal end or the periphery of the inlet flange 430 during use. In some embodiments, the arc connecting the bias flow holes 438 is parallel or substantially parallel to the periphery of the inlet flange 430. Maintaining a constant and controlled distance between the bias flow holes 438 and the periphery of the inlet flange 430 enables better and easier control of the noise generated by the flow through the bias flow holes 438. The distance between the bias flow holes 438 and the periphery of the inlet flange 430 can be selected to reduce or minimize the noise generated by the flow through the bias flow holes 438. In the illustrated embodiment, the bias flow holes 438 are positioned at a position 3.1 mm or about 3.1 mm from the periphery of the inlet flange 430. In the illustrated embodiment, the bias flow holes 438 are located at or approximately at the midpoint of the length of the inlet flange 430.

[0151] In the illustrated embodiment, as shown in FIG. 26D, the bias orifice 428 is disposed around or in a portion of the inlet flange 430. The portion of the inlet flange 430 that includes the bias orifice 428 is defined by an exhaust angle θ with respect to a starting point centered at the intersection of the longitudinal axis 105 and the transverse axis 107 of the inlet flange 430 as shown. E It can be defined by. In some embodiments, the exhaust angle and / or the bias orifice 428 can extend from about 4:00 to about 8:00 (similar to a clock). In some embodiments, the exhaust angle and / or the bias orifice 428 can extend from about 5:00 to about 7:00 or from about 3:00 to about 9:00. In some embodiments, the exhaust angle can be in the range of about 220°, about 218°, about 180° to about 270°, about 190° to about 260°, about 200° to about 250°, about 210° to about 240°, or about 220° to about 230°. In some embodiments, the exhaust angle can be 360°. In other words, in some embodiments, the bias orifice 428 can extend around or completely surround the inlet flange 430.

[0152] As shown in FIG. 26C, in the illustrated embodiment, the bias orifice 438 extends through the inlet flange 430 in a direction orthogonal or generally orthogonal to the inlet flange surface 434 and / or the inner inlet flange surface 432. In some embodiments, as represented by the dashed line in FIG. 26C, the bias orifice 438 can extend through the inlet flange 430 at an angle θ with respect to the perpendicular. The angle θ can be in the range of about ±10° to about ±45°, such as ±10°, ±25°, or ±45°. As shown, the bias orifice 438 oriented at a positive angle extends such that the hole is closer to the periphery of the inlet flange 430 at the inlet flange surface 434 than at the inner inlet flange surface 423. An angle of 0° or greater can advantageously direct the flow through the bias orifice 438 away from the user during use.

[0153] As shown in FIG. 27B, the outlet flange 440 has a major axis 119 and a minor axis 121. In the illustrated embodiment, the outlet flange 440 has a "D" shape. The major axis dimension D of the outlet flange 440 o-major is the dimension of the opening defined by the proximal end or proximal edge of the outlet flange 440 along the major axis 119 at the position where the opening has the maximum lateral dimension. In some embodiments, the outlet flange 440 can have a circular shape, a triangular shape, or other shapes. The minor axis dimension D of the outlet flange 440 o-minor is, in the illustrated embodiment, the dimension of the opening along the minor axis 121 that is parallel to and / or aligned with the longitudinal axis as shown in FIG. 27A. As shown in FIG. 27A, the longitudinal axis and the lateral axis intersect at a starting point at or corresponding to the center of the opening of the inlet flange 430. In the illustrated embodiment, the outlet major axis is corresponding to the lateral axis or is located at the same position as the lateral axis. In some embodiments, the outlet major axis can be shifted or spaced longitudinally from the lateral axis. In other words, in some embodiments, the center of the opening of the inlet flange 430 is offset from the center of the opening of the outlet flange 440.

[0154] In the illustrated embodiment, the outlet major axis dimension D o-major is 25.9 mm or about 25.9 mm, and the outlet minor axis dimension D o-minor is 20.7 mm or about 20.7 mm. In other words, the ratio of the outlet major axis dimension D o-major to the outlet minor axis dimension D o-minor is 1.25:1 or about 1.25:1. In the illustrated embodiment, the opening of the outlet flange 440 is larger than the opening of the inlet flange 430.

[0155] In some embodiments, the outlet flange 440 or a portion of the outlet flange 440, such as the rim 441 of the outlet flange in the illustrated embodiment, is a different color compared to other portions of the frame 410. In some embodiments, most of the frame 410 can be transparent and the outlet flange 440 or a portion of the outlet flange 440 can be a transparent blue color. In some embodiments, most of the frame 410 can be transparent and the outlet flange 440 or a portion of the outlet flange 440 can be opaque. In some embodiments, most of the frame 410 can be opaque and the outlet flange 440 or a portion of the outlet flange 440 can be transparent. The different color (and / or transparency) of the outlet flange 440 or a portion thereof can advantageously provide the user with an indication that the outlet flange 440 is designed to engage with another component of the assembly, such as a fastener for the seal 406, during use. As shown in FIG. 29B, the proximal rim 441 that extends to a particular depth of the outlet flange 440 can have a different color. In some embodiments, the different color can be achieved using a pad printing process. In some embodiments, the inlet flange 430 or a portion of the inlet flange 430 is a different color compared to other portions of the frame 410. In some embodiments, the outlet flange 440 and / or the inlet flange 430 can be made from a material having at least one property different from the material of most of the frame 410 or other portions of the frame 410. For example, the outlet flange 440 can be made from a material having at least one property different from the material of the inlet flange 430. In such embodiments, the frame 410 can be formed using, for example, a two-shot molding, co-molding, or overmolding process. In some embodiments, the frame 410 can be formed using a two-shot molding, co-molding, or overmolding process even if the frame 410 is made of a single material and / or the material of the inlet flange 430 is not different from the material of the outlet flange 440.

[0156] FIG. 32A shows a cross-sectional view taken along line 32A-32A of FIG. 31. The cutting line is centered with respect to the frame 410 and aligned with the longitudinal axis. FIG. 32B shows a 2D view of the cross-section of FIG. 32A. The thickness of the frame 410 or the thickness of the various portions of the frame 410 can be selected to provide sufficient rigidity to the frame 410 during use while reducing or minimizing the weight and / or profile of the frame 410. In some embodiments, the concave surface 426 (or the frame 410 in the region of the concave surface 426) has a thickness t of 1.5 mm or about 1.5 mm rs In some embodiments, the inlet flange 430 has a thickness t of 1.46 mm or about 1.46 mm ic In some embodiments, the conduit retaining projection 436 projects inwardly 0.5 mm or about 0.5 mm from the inner surface 432 of the inlet flange. In the illustrated embodiment, the conduit retaining projection 436 extends around the entire periphery of the inlet flange 430. In some embodiments, the outlet flange 440 has a thickness t of 1.5 mm or about 1.5 mm oc In some embodiments, other thicknesses of the inlet flange 430, the concave surface 426 (or the frame 410 in the region of the concave surface 426) and / or the outlet flange 440 are possible. In some embodiments, the frame 410 is made of or includes nylon 12. If the inlet flange 430, the concave surface 426 (or the frame 410 in the region of the concave surface 426) and / or the outlet flange 440 have a thickness in the range of 0.6 mm or about 0.6 mm to 2 mm or about 2 mm or more than 2 mm, it may be possible for the frame 410 to exhibit the same or similar rigidity by modifying the properties of the compound.

[0157] Alternative headgear embodiments Figures 33-34 illustrate an exemplary embodiment of a headgear 404 that can be used with a frame 410. In the exemplary embodiment, the headgear 404 has a bifurcated configuration. The headgear 404 may be similar to the headgear 204 in some respects. Features of the headgear 404 that are the same as or similar to the corresponding features of the headgear 204 are represented herein by reference numerals with 300 added to the same reference numeral (e.g., the headgear 404 includes a top strap 512, a pair of opposing side arms 514, a yoke 516, and a rear strap 518). The top strap 512 and the rear strap 518 form a bifurcated configuration.

[0158] The side arms 514 and / or the top strap 512 can include a core 549 and an outer casing 551. In some embodiments, the core is made of or includes a plastic material. In some embodiments, the outer casing is or includes a fabric. The outer casing can be permanently adhered to the core. The fabric outer casing can advantageously provide a soft and comfortable finish that contacts the user during use. The longitudinal edge portion of the outer casing 551 that protrudes from the edge of the core 549 and is not filled with the core 549 can form a soft edge 550 as shown in FIG. 37. The soft edge 550 can advantageously provide a cushioned edge that can improve the comfort of the user by, for example, alleviating potential contact between the edges of the top strap 512 and / or the side arms 514 and the user's head. In some cases, having a cushioned edge can be particularly beneficial at the lower edge of the side arm 514 that is located above the user's ear during use. The thickness of the soft edge 550 can vary along the length of each side arm 514. In the illustrated embodiment, the thickness of the soft edge 550 is up to 2 mm or about 2 mm at the side end of the side arm 514 (represented by D in FIG. 37)~(D in FIG. 37) 2 represents) and can range from about 2 mm to (D in FIG. 37) 1(represented by) varies at a minimum of 1 mm or about 1 mm on the upper ridge of the yoke 516. In some embodiments, for example, the lower edge of the yoke 516 is not intended to contact the user's face during use for aesthetic and / or industrial design benefits, tolerances between components, and / or other reasons, so the lower edge of the yoke 516 does not include a soft edge. The omission of the soft edge in this area allows for an increase in the thickness of the core 549 of the yoke 516, providing additional space to improve or increase the structural integrity of that area.

[0159] In the illustrated embodiment, the outer casing 551 is made of a fabric that is a non - stretchable or low - stretchable thread. Non - stretchable or low - stretchable threads require a relatively large force for elastic deformation. In some cases, highly elastic threads do not function well enough (or as well as low - elastic threads) in the internal molding process used to form the top strap 512 and / or the side arms 514 because the fiber of the thread can stretch to an extent that the molten plastic can leak outside the outer casing. Using non - stretchable or low - stretchable threads for the side arms 514, the outer casing advantageously improves the finish and / or consistency of the finished side arms 514. Non - stretchable or low - stretchable threads reduce or minimize the amount or degree to which the fiber of the thread can stretch, thereby preventing or reducing the possibility of the plastic stretching and leaking from the fabric - made outer casing during the internal molding process. Thus, the use of non - stretchable or low - stretchable threads can also help improve the reliability of the manufacturing process. In some embodiments, the fabric - made outer casing can be made of or include threads with some elasticity. Threads with low elasticity (i.e., requiring a relatively large force to stretch elastically) can function properly in the molding process. In some embodiments, the gate 501 for the molding process is located at or near the center on the yoke 516 of the headgear 404, as shown in FIG. 35B.

[0160] As described herein, the frame 410 can include headgear retaining features 450 in the form of holes designed to receive the protrusions 515 of the headgear 404. As shown in FIG. 35A, the protrusions 515, also referred to herein as frame retaining features, can be located on both sides of the yoke 516. In the illustrated embodiment, each of the protrusions 515 includes two retaining portions 517 separated by a groove 519 as shown in FIGS. 35A and 36A - 36B. The groove 519 is formed by protrusions 619 in the mold 600 that fill the area forming the groove 519 as shown in FIG. 36C. During molding, the molten plastic can be forced through the outer casing 551 under pressure or out of the outer casing 551 to form the retaining portions 517. The protrusions 619 of the mold 600 also constrain the fabric or material of the outer casing 551 to prevent or inhibit the fabric or material of the outer casing 551 from spreading beyond the base of the groove 519 because there is plastic present to form the retaining portions 517, represented by 553 in FIG. 36C. The outer casing 551 can be constrained in other ways further or alternatively. For example, if the retaining portions 517 (and / or other protrusions protruding from the outer casing 551) have a thin profile or dimensions relative to the profile or dimensions of the fabric outer casing 551, the outer casing 551 may not have to protrude significantly over the protrusions. This advantageously serves to prevent or inhibit deformation of the outer casing 551 and / or ensure that the retaining portions 517 contain only or are made only of plastic. Having retaining features 517 made only or mainly of plastic rather than including an outer casing advantageously improves the function of the frame retaining features 515, for example, by enabling the frame retaining features 515 to snap more securely into the headgear retaining features 450. The groove 519 can further or alternatively allow the retaining portions 517 to flex relative to each other to improve the performance of the frame retaining features 515, for example, allowing the frame retaining features 515 to flex to snap into the headgear retaining features 450.

[0161] As shown in FIG. 38A, each side arm 514 includes a buckle 526. The buckle 526 is formed by an extension of the free end of the side arm 514 and includes an opening 527 that extends through the thickness of the side arm 514. The opening 527 is configured to receive the rear strap 518. In the illustrated embodiment, the buckle 526 is integrally formed with the side arm 514. In some embodiments, the structure of the buckle 526 can be maintained by a core 549, and the outer casing 551 can soften the feel of the buckle 526. The buckle can be formed by internally molding the entire buckle structure with a finished plastic core including the position of the opening 527 and then punching out the opening 527. Alternatively, the opening 527 can be formed in an internal molding process, and the outer casing 551 of the side arm 514 is split into two tubes at the ends of the opening 527 adjacent to the side arm 514 and then the tubes recombine on the opposite side of the opening 527. In some embodiments, the buckle 526 can be formed by a plastic (or other core 549 material) that pierces through the end of the casing 551, such that the buckle 526 does not include the outer casing 551. In some embodiments, the soft edge 550 of the side arm 514 extends to the top and bottom of the side arm 514 and the buckle 526, and the side end 525 of the buckle 526 does not include the soft edge 550, for example, as shown in FIG. 38B. In the illustrated embodiment, the buckle 526 is in the same plane or in a straight line with the side arm 514 when the headgear 404 is laid flat. In some embodiments, the buckle 526 is offset from the side arm 514, for example, in a direction towards or away from the user during use.

[0162] Similar to the headgear 204, the top strap 512 of the headgear 404 includes a first (or left) portion 520 and a second (or right) portion 522 as shown in FIGS. 39-40. The first portion 520 and the second portion 522 are separate from each other. Each of the first portion 520 and the second portion 522 has a free end and a fixed end. The fixed end extends at an angle from the side arm 514 at the joint 524. The free end is configured to be adjustably connected by an adjustment mechanism 528. The adjustment mechanism 528 enables the top strap 512 to be adjusted and fixed to a desired length.

[0163] As shown in FIGS. 39-41, the free end of the second portion 522 includes a guide loop 530, and the second portion 522 includes a plurality of apertures 532 spaced along the length of the second portion 522 near the free end. In the illustrated embodiment, the guide loop 530 is plastic. The guide loop 530 can be formed by a burst-through molding process. "Burst-through molding" is described in co-pending U.S. patent applications Ser. No. 62 / 309,400, Ser. No. 62 / 323,459, Ser. No. 62 / 364,767, and Ser. No. 62 / 401,462, all of which are filed by the applicant of the present application. Burst-through molding is a variation of the internal molding described above. The burst-through molding process includes introducing molten plastic into a fabric casing and pushing the molten plastic into a portion of the fabric casing. Components formed by the burst-through molding process include a single-piece plastic core integrally formed with the fabric casing, and the single-piece plastic core has a portion extending through the fabric casing. In some embodiments, the guide loop 530 can be coupled to the free end of the second portion 522. In some embodiments, the guide loop 530 includes an outer casing, such as an extension of the outer casing 551. In some embodiments, the guide loop 530 is made of only the outer casing material and not made of plastic (or other core material), or includes only the outer casing material and does not include plastic (or other core material). The first portion 520 includes a protrusion 534 that projects from the inner surface of the first portion 520 near the free end (i.e., the surface of the first portion 520 that faces the second portion 522 in use). The first portion 520 can also include a number of position indicators. To adjust and / or secure the first portion 520 and the second portion 522 relative to each other, the free end of the first portion 520 is passed through the guide loop 530, and the protrusion 534 is passed through and / or secured within one of the apertures, for example, by a snap-fit connection.

[0164] The hole 532 can be formed using a burst-through internal molding process. In some embodiments, the outer casing 551 of the second portion 522 can be divided into two parallel (enclosed) casing portions adjacent to the first hole 532 (i.e., the hole 532 closest to the joint 524) on the side of the joint 524, and the parallel casing portions can extend along the length of the second portion 522 including the hole 532. The parallel casing portions can recombine into a single casing behind (or on the free end side) of the last hole 532 (i.e., the hole 532 farthest from the joint 524). The parallel casing portions can bend towards each other between the holes 532 such that the gaps in the woven fabric or material of the casing 551 cannot be easily observed by the user. In some embodiments, the parallel casing portions do not recombine behind the last hole 532. In some such embodiments, the pressure from the plastic or core 549 material can move the parallel casing portions towards each other behind the final hole 532 such that the gaps in the woven fabric are not easily observed. In some embodiments, the outer casing 551 includes the hole 532, and the mold is designed to prevent the flow of molten plastic (or other core 549 material) from reaching into the hole 532 during molding. In some embodiments, the second portion 522 can be internally molded without the hole 532, and the hole 532 can be created by post-processing, for example, by punching. In some embodiments, the outer casing 551 can terminate near the first hole 532 or adjacent to the first hole 532 on the side of the joint 524, and the remaining portion of the second portion 522 can be formed using a burst-through process to include only plastic (or other core 549 material).

[0165] In some embodiments, each hole 532 is at least partially surrounded by a peripheral groove 533 (on one or both of the inner and outer surfaces of the second portion 522). The peripheral groove 533 can assist in forming the hole 532 by internal molding. The mold can include a protrusion that applies pressure to the outer casing 551 during molding to form the groove 533. The protrusion of the mold can suppress the movement of the outer casing 551 during molding. Suppressing the movement of the outer casing 551 advantageously serves to ensure that the peripheral portion of the hole 532 (i.e., the structure of the plastic or other core 549 material inside the boundary of the peripheral groove 533) is entirely or substantially entirely plastic (or other core 549 material). The peripheral portion of the hole 532 that is entirely plastic (or other core 549 material) can help improve the function of the adjustment mechanism 528 and / or maintain the tolerance associated with the hole 532.

[0166] In some embodiments, each of the first portion 520 and the second portion 522 of the top strap 512 is integrally formed with the adjacent side arms 514, for example, via a burst-through internal molding process. In some embodiments, each of the first portion 520 and the second portion 522 is an independent component that is permanently or removably coupled or connected to the respective side arms 514. For example, as shown in FIG. 42, the junction 524 of each side arm 514 includes a joining protrusion 560. The joining protrusion 560 can be formed, for example, during the molding of the side arms 514 using a burst-through internal molding process. Each of the first portion 520 and the second portion 522 of the top strap 512 includes a concave surface 562 at or near the joining end. The concave surface 562 is opposite (or generally opposite) to the contour of the joining protrusion 560 or has a contour corresponding to the contour of the joining protrusion 560. After molding, each of the joining protrusions 560 is inserted into the outer casing 551 at the joining end of the respective first portion 520 or second portion 522 of the top strap 512 and positioned within the concave surface 562. Next, each side arm 514 can be welded to each of the first portion 520 and the second portion 522 using, for example, ultrasonic welding, RF welding, or other suitable means. After welding, the side arms 514 and the top strap 512 form a single plastic (or other core material) component. The outer casing 551 of the top strap 512 can be welded to the outer casing 551 of the side arms 514. In some embodiments, the region of the top strap 512 adjacent to the junction 524 does not include a soft edge 550. In such embodiments, by welding the core 549 of the side arm 514 to the top strap 512, the outer casings 551 of the side arms 514 and the top strap 512 are sufficiently fixed to each other without the need to weld the outer casings 551. In some embodiments, the joining protrusion 560 is generally the same thickness as the remainder of the core 549 of the side arm 514. In some embodiments, the joining protrusion 560 has a reduced thickness. In some embodiments, the joining protrusion 560 is offset from the central plane of the side arm 514.The offset joining projection 560 of reduced thickness can enable the cores 549 of the side arms 514 and the top strap 512 to be flush at the boundary between the joining projection 560 and the concave surface 562 when the joining projection 560 is received within the concave surface 562.

[0167] In some embodiments, the first portion 520 of the top strap 512 includes a position guide 570 to assist a user in setting and holding a particular headgear setting, length, or size. As shown in FIGS. 43A-43B, the position guide 570 can include a series of protruding edges 572. The central portion 574 of the first portion 520 has a reduced lateral profile compared to the protruding edges 572. The protruding edges 572 have a profile or width that is slightly larger than the diameter or width of the guide loop 530. Thus, when sliding the first portion 520 of the top strap 512 through the guide loop 530 of the second portion 522, frictional or resistive forces are imparted by the contact and interaction between the protruding edges 572 and the guide loop 530. The resistive force can prevent or reduce the likelihood of passive movement of the first portion 520 through the guide loop 530. Thus, the user can disengage the protrusion 534 from the hole 532, and the resistive force serves to resist relative movement between the first portion 520 and the second portion 522 to maintain the length of the strap 512 until and unless the user applies sufficient force to overcome the resistive force. In the illustrated embodiment, the protruding edges 572 are convexly curved outwardly or are dome-shaped. Other shapes or configurations of the protruding edges 572 are possible. For example, the protruding edges 572 can be triangular.

[0168] Figures 44-45 illustrate another non-limiting exemplary embodiment of the breathing mask assembly 600. The breathing mask assembly 600 includes a patient interface and a headgear 604. The patient interface includes a seal 606 configured to connect to a frame 610 and a gas delivery conduit 608. The frame 610 is similar in some or all of its features to the frame 410 and / or includes some or all of the features of the frame 410. The headgear 604 and the frame 610 are configured to secure the seal 606 in a stable position below the user's nose during use. Figures 46-47 illustrate an exemplary embodiment of the headgear 604 used with the frame 610. In the exemplary embodiment, the headgear 604 has a bifurcated configuration. The headgear 604 is similar to the headgear 404 in some respects. For example, the headgear 604 has the same or a similar overall shape as the headgear 404 and includes a top strap 612, a pair of opposing side arms (or bottom or front straps) 614, a yoke 616, and a rear strap 618. The top strap 612 and the rear strap 618 form a bifurcated configuration. In some embodiments, one or more of the top strap 612, the bottom strap 614, and the yoke 616, and / or the rear strap 618 are a different color than one or more of the other straps.

[0169] The side arms 614 and / or the top strap 612 include, for example, a core and an outer casing similar to the headgear 504. In some embodiments, the core is made of or includes a plastic material. In some embodiments, the outer casing is or includes a fabric.

[0170] The top strap 612 of the headgear 604 includes a first (or left) portion 620 and a second (or right) portion 622, as shown in FIGS. 47A-49B. The first portion 620 and the second portion 622 are separate from each other. Each of the first portion 620 and the second portion 622 has a free end and a fixed end. The fixed end extends from the front strap 614 at an angle, for example. In the illustrated embodiment, the front strap 614, the first portion 620 of the top strap 612, and the second portion 622 of the top strap 612 can be formed independently of each other by internal molding and then joined to each other via an overmolded joint. As shown, each of the first portion 620 and the second portion 622 is coupled to the front strap 614 via an overmolded joint 624.

[0171] The free ends of the first portion 620 and the second portion 622 of the top strap 612 are configured to be adjustably connected by an adjustment mechanism 628. The adjustment mechanism 628 allows the top strap 612 to be adjusted to a desired length and fixed. The adjustment mechanism 628 includes mating portions provided on the respective first top strap portion 620 and second top strap portion 622. The mating portions are selectively engaged in one of a plurality of distinct configurations to set the length of the top strap 612. When the mating portions are engaged, the first top strap portion 620 and the second top strap portion 622 are in a partially overlapping configuration. In this overlapping configuration, a portion of the inner surface of the first portion 620 of the top strap covers a portion of the outer surface of the second portion 622 of the top strap 612. The inner surface of the first portion 620 of the top strap faces the user during use, and the outer surface of the second portion 622 of the top strap faces away from the user during use. The mating portions can be disengaged and re-engaged in different configurations to facilitate adjustment of the length of the top strap. For different lengths of the top strap 612, the first portion 620 and the second portion 622 overlap at different lengths or to different extents. In some embodiments, the mating portion of the first portion 620 includes a female connector and the mating portion of the second portion 622 includes a male connector, but in the illustrated embodiment, the mating portion of the first portion 620 includes a male connector 628a and the mating portion of the second portion 622 includes a female connector 628b.

[0172] As shown in FIGS. 47A to 48B, the free end of the second portion 622 includes a guide loop 630. The engagement portion of the second portion 622 includes a plurality of recesses in the form of holes 632 spaced along the length of the second portion 622 near the free end. As shown, each of the holes 632 extends through the second portion 622 of the top strap 612. In other embodiments, the engagement portion of the second portion 622 includes a recess that extends into the second portion of the top strap through the outer surface of the second portion 622. As shown in FIGS. 47A, 49B, and 50B, the engagement portion of the first portion 620 of the top strap includes a protrusion 634 that projects from the inner surface of the first portion 620 near the free end. To adjust and / or fix the first portion 620 and the second portion 622 relative to each other, the free end of the first portion 620 is passed through the guide loop 630, and the protrusion 634 is inserted and / or fixed into one of the holes 632, for example, by a snap-fit connection.

[0173] In the illustrated embodiment, the engagement portions of the adjustment mechanism 628 (i.e., the male connector 628a and the female connector 628b) are not covered by the outer casing. This advantageously can provide a neater finish (e.g., hiding loose thread ends) and / or ease of manufacture.

[0174] As shown in FIGS. 50A - 50C, the first portion 620 of the top strap has a thumb grip 629 provided on and / or within the outer surface of the first portion (e.g., on and / or within the outer surface of the male connector 628a) (i.e., the surface facing away from the second portion of the top strap and the user 622). The thumb grip 629 is provided opposite to or against the protrusion 634 of the first portion 620 of the top strap. The thumb grip 629 can include a recess (e.g., as shown in FIG. 50C) and / or a raised rib (e.g., the raised ring shown in FIG. 50A). The first portion 620 has a finger grip 631 provided on and / or within the inner surface of the first portion 620 of the top strap (e.g., on and / or within the inner surface of the male connector 628a). In the illustrated embodiment, the finger grip 631 includes a depression or recess. The finger grip 631 is located on the first portion of the top strap on the opposite or distal side (i.e., the free end side) of the protrusion 634. The finger grip 631 is provided opposite to or on the same side as the thumb grip 629 of the first portion 620 of the top strap. Thus, the finger grip 631 is located opposite to or on the opposite side from the thumb grip 629 of the first portion 620 of the top strap. The thumb grip 629 and / or the finger grip 631 advantageously enable the user to more easily grip the male connector 628a. The thumb grip 629 and / or the finger grip 631 further or alternatively provide the user with visual and / or tactile cues as to how to grip and use the adjustment mechanism 628 to improve ease of use. The depression or recess of the finger grip 631 thins or reduces the thickness of that portion of the first portion 620 of the top strap. This thinning enables the engagement portion of the first portion 620 of the top strap to be more flexible, thereby advantageously enabling the user to disengage the engagement of the engagement portion. For example, the user can more easily flex and / or lift the male connector 628a away from the female connector 628b.Depending on what is comfortable for the user, during use, the thumb grip 629 can be gripped by the user's thumb or finger, and / or the finger grip 631 can be gripped by the user's thumb or finger. FIG. 51A illustrates the user gripping the finger grip 631 with a finger and the thumb grip 629 with the thumb, while FIG. 51B illustrates the user gripping the finger grip 631 with the thumb and the thumb grip 629 with a finger. In this regard, the thumb grip 629 and the finger grip 631 are the first and second grips that can be interchangeably engaged by the user's thumb and finger to sandwich the free end of the first portion of the top strap between the thumb and the finger.

[0175] As described above, the front strap 614, the first portion 620 of the top strap 612, and the second portion 622 of the top strap 612 are formed independently of each other by internal molding and then joined to each other via an overmolded joint 624. As shown in FIGS. 52A-52B, the top strap 612 includes at least one alignment post 660 (e.g., two alignment posts 660a in the illustrated embodiment) near each of the fixed ends. As shown in FIGS. 53A-53B, the bottom strap 614 includes at least one alignment post 660 (e.g., two alignment posts 660b in the illustrated embodiment) near each end. The bottom strap 614 includes at least one alignment post 660 (e.g., one alignment post 660c in the illustrated embodiment) positioned on each of two tabs 662 extending from the upper or top edge of the bottom strap 614. In some embodiments, the tabs 662 are formed by a burst-through process. The alignment posts 660 project through the outer casing on the inner and / or outer surfaces of the top strap 612. The alignment posts 660 abut against the inner surface of the overmold cavity to assist in aligning and positioning (e.g., in the thickness direction) the ends of the first portion 620 and the second portion 622 relative to the front strap 614 within the overmold tool during manufacture. The alignment posts 660 further or additionally increase the surface area of the top strap 612 available for the overmold material to adhere to.

[0176] The top strap 612 and / or the bottom strap 614 includes one or more pin holes 664 that extend partially into the thickness of the strap from the inner surface of the strap. In the illustrated embodiment, the first portion 620 and the second portion 622 of the top strap 612 each include a pin hole 664 near the fixed end, and the bottom strap 614 includes a pin hole 664 near each end and a pin hole 664 near each burst through tab 662. The pin holes 664 are designed to receive pins that form part of an overmold tool during manufacture. The pins and the pin holes 664 engage with each other to hold the strap in a predetermined position within the overmold tool and prevent the strap from moving within the overmold tool when, for example, an overmold material (e.g., plastic) is injected into the tool.

[0177] During manufacturing, each of the fixed ends of the first portion 620 and the second portion 622 is aligned with one of the burst-through tabs 662, as shown in FIGS. 54A-55B. As shown, the burst-through tab 662, the fixed end of the top strap 612 and / or the end of the bottom strap 614 include a recess 666 on the outer and / or inner surfaces. The recess 666 advantageously provides an increased thickness of the overmold material and / or an increased surface area for the overmold material to adhere in the overmold joint 624, as shown in FIG. 57, to improve the mechanical connection between the overmold joint and the strap, thereby strengthening the joint 624. As shown in FIGS. 54A-55B, the burst-through tab 662 can have a reduced thickness compared to the thickness of the body of the bottom strap 614. This reduced thickness forms a recess for the overmold material to be filled and allows the completed overmold joint 624 to have a thickness that is the same or similar to the thickness of the body of the bottom strap 614 and / or the top strap 612, as shown in FIGS. 56A-58. This prevents the formation of protrusions that could apply force or pressure to the user's head and cause discomfort. In some embodiments, the alignment strut 660 has the same or similar thickness as the overmold joint 624, for example as shown in FIG. 57. In such embodiments, the alignment strut 660 can leave a confirmation mark 661 on the overmold joint 624. In some embodiments, the overmold joint 624 overlaps the edge of the bottom strap 614, for example as shown in FIGS. 56A-56B. This improves the strength of the joint 624 between the top strap 612 and the bottom strap 614. The overmold joint 624 advantageously provides an improvement in strength to the joint between the top strap 612 and the bottom strap 614 and provides a neater and more aesthetically pleasing finish (e.g., compared to an internally molded connection).

[0178] FIG. 59 illustrates an exemplary embodiment of a variant of the geometry of the alignment strut 660. In the illustrated embodiment, the alignment strut is conical. This shape minimizes or reduces the check marks on the overmolded joint 624. The distal end or distal surface of the alignment strut 660 (the end or surface of the alignment strut 660 remote from the strap body) has a reduced diameter that provides a smaller contact area with the inner surface of the overmold cavity. This enables the strap to be positioned longitudinally within the overmold while allowing the overmold material to cover a larger area of the alignment strut 660, which reduces the size of the check marks.

[0179] As shown in FIGS. 50C and 58, each of the first top strap portion and the second top strap portion has a portion wrapped in fabric and an exposed or plastic portion incorporating an interengagement portion. Each portion wrapped in fabric can be produced by internal molding as described above. Each portion wrapped in fabric has a tab over which the respective exposed portion is overmolded.

[0180] As shown in FIGS. 47A - 49B and FIGS. 56A - 56B, the buckle or rear strap connector 626 can be overmolded onto each end of the bottom strap 614. Each buckle 626 includes an opening 627 configured to receive the rear strap 618. In the illustrated embodiment, the buckle 626 is not covered by an outer casing. The overmolded buckle 626 allows the rear strap 618 to be more easily pulled through the buckle 626 during assembly and / or adjustment due to the overmolded buckle 626 having a lower coefficient of friction than a buckle covered in fabric.

[0181] As shown in FIG. 64, each buckle 626 has a width W 1 greater than the width W 2has, as a result, a rear strap 618 having substantially the same width as the bottom strap 614 and can pass through the opening 627 of the buckle 626. The upper edge 626a of each buckle 626 is offset from the upper edge 614a of the bottom strap 614. However, the lower edge 626b of the buckle 626 is aligned with the lower edge 614b of the bottom strap 614. This alignment provides a smooth and continuous lower edge of the headgear that reduces the likelihood of digging into the user's ear when worn. The opening 627 of the buckle 626 has a width substantially equal to the width of the rear strap 618. In some embodiments, the rear strap 618 has substantially the same width as the bottom strap 614.

[0182] Similar to the frame 410 and the headgear 404, the frame 610 includes headgear retention features 650 in the form of holes designed to receive the protrusions 615 of the headgear 604. As shown in FIGS. 60A - 62A, the protrusions 615, also referred to herein as frame retention features or frame retention features, can be located on both sides of the yoke 616. In the illustrated embodiment, the protrusion 615 has a horseshoe shape or a "U" cross - section with an inlet 619 that extends centrally and / or through the center from the outer periphery of the protrusion 615 towards the center of the protrusion 615. The inlet 619 allows the protrusion 615 to flex such that the protrusion 615 snaps into and / or out of the headgear retention feature 650.

[0183] In some embodiments, as shown for example in FIG. 63, the bottom strap 614 includes thumb pads 652 that surround each of the frame retention features 615 and / or extend laterally outwardly (towards the ends of the bottom strap 614 and the buckle 626) from each of the frame retention features 615. The thumb pads 652 are thicker than the surrounding or remaining portion of the bottom strap 614. The thumb pads 652 advantageously provide increased strength and / or elasticity to the yoke 616 such that the yoke 616 is less likely to be permanently deformed and / or fatigued due to repeated removal from and / or attachment to the frame 610. The thumb pads 652 further or alternatively provide a visual indication for the user to grip the headgear 604 at that location (at the thumb pads 652) to detach the headgear 604 from the frame 610 and / or couple the headgear 604 to the frame 610. In the illustrated embodiment, the frame retention feature 615 is oriented such that the inlet 619 (i.e., the mouth of the inlet 619 at the outer periphery of the frame retention feature 615) faces laterally outwardly (or towards the ends of the bottom strap 614 and the buckle 626). Thus, the inlet 619 is aligned with the elongate portion of the thumb pad 652 and can be aesthetically pleasing. In some embodiments, the thumb pads 652 provide an improved visual indicator in the form of differently colored and / or textured regions in the fabric outer casing. In some embodiments, the differently colored and / or textured regions are formed integrally with the remainder of the fabric casing in some embodiments.

[0184] Unless the context clearly requires otherwise, throughout the description and the claims, the words "comprise", "comprising", and the like are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense; that is to say, in the sense of "including, but not limited to". In the foregoing description, reference has been made to integers or components having known equivalents, and those integers or components are incorporated herein as if individually set forth.

[0185] The disclosed methods, apparatuses, and systems can also be broadly said to individually or collectively include any combination of two or more of the parts, elements, and features mentioned or represented in this disclosure.

[0186] Any reference to prior art in this specification should not be construed as an admission or any form of suggestion that the prior art forms part of the common general knowledge in the field of activity of any country in the world, nor should it be so construed.

[0187] Terms such as "generally", "about", "substantially", and "substantially" used in this specification, which express the degree used in this specification, still represent values, amounts, or characteristics close to the specified values, amounts, or characteristics that perform the desired function or achieve the desired result. Deviations from the specified values, amounts, or features can reflect, for example, acceptable tolerances, conversion factors, rounding, measurement errors, or other elements known to those skilled in the art. For example, the terms "substantially parallel" and "substantially parallel" refer to values, amounts, or features that can deviate from being exactly parallel by up to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, 0.1 degree, etc.

[0188] Although the present disclosure has been described with respect to certain embodiments, other embodiments that are apparent to those skilled in the art are also within the scope of the present disclosure. Accordingly, various modifications and variations can be made without departing from the spirit and scope of the present disclosure. For example, various components can be rearranged as needed. Moreover, not all features, aspects, and advantages are necessarily required to practice the present disclosure. Therefore, it is intended that the scope of the present disclosure be defined only by the following claims.

Claims

1. 1. Headgear for a respiratory mask, comprising: a strap including a yoke portion configured to connect to a patient interface, and first and second side arms, each of the first and second side arms extending from a lateral rear portion of the yoke portion and configured to extend across a user's cheek and above an ear in use, wherein the yoke portion and the first and second side arms are integrally formed; a top strap coupled to the first side arm and the second side arm, the top strap extending between the first side arm and the second side arm and configured to extend across the top of the user's head in use; Including, The headgear, wherein a first edge of the strap includes a soft edge portion, and an opposing second edge of the strap includes a soft edge portion and a hard edge portion.

2. The thickness of the soft edge of the first edge is the maximum thickness (D 2 ) and a minimum thickness (D 1 10. The headgear of claim 1, wherein the headgear changes between

3. 3. The headgear of claim 1, wherein the thickness of the soft edge portion of the second edge varies between a maximum thickness at the lateral ends of the side arms and a minimum thickness at a point spaced laterally from the center of the yoke portion.

4. The thickness of the soft edge of the first edge is a maximum thickness (D) of about 2 mm at the side end of the side arm. 2 ) and a minimum thickness (D) of about 1 mm near the center of the yoke portion. 1 4. The headgear of claim 2 or 3, wherein the headgear changes between

5. 5. The headgear of claim 1, wherein at least one of the yoke portion, the first and second side arms, and the top strap includes a plastic core and a fabric outer casing at least partially surrounding the plastic core, the fabric outer casing including the soft edges of the first and second edges of the straps.

6. 6. The headgear of claim 5, wherein the fabric outer casing comprises non-stretch or low-stretch yarns.

7. 7. The headgear of claim 1, wherein the top strap includes a first portion coupled to the first side arm, a second portion coupled to the second side arm, and an adjustment mechanism coupled to the first and second portions and configured to allow adjustment between the first and second portions.

8. 8. The headgear of claim 7, wherein at least the top strap includes a plastic core and a fabric outer casing at least partially surrounding the plastic core, and the adjustment mechanism is not covered by the fabric outer casing.

9. 9. The headgear of claim 7 or 8, wherein the first portion has a free end and a fixed end coupled to the first side arm, and the second portion has a free end and a fixed end coupled to the second side arm, and the free ends of the first portion and the second portion are configured to be adjustably connected by the adjustment mechanism.

10. 10. The headgear of claim 7, wherein the adjustment mechanism includes first and second interengaging portions on first and second top strap portions, respectively, the first and second interengaging portions being selectively engaged in one of a plurality of distinct configurations to set a length of the top strap, and wherein when the first and second interengaging portions are engaged, the first and second top strap portions are in a partially overlapping configuration.

11. 11. The headgear of claim 10, wherein the first interengaging portion includes a female connector including a plurality of holes along a length of the female connector, and the second interengaging portion includes a male connector including a protrusion extending from an inner surface of the male connector.

12. Headgear according to any one of claims 7 to 11, wherein the second portion further comprises a guide loop, and in use the first portion is configured to be advanced and / or retracted through the guide loop.

13. 13. The headgear of any one of claims 7 to 12, wherein the first portion of the top strap is coupled to the first side arm via an overmolded joint, and the second portion of the top strap is coupled to the second side arm via an overmolded joint.

14. Headgear according to any one of claims 1 to 13, wherein the yoke portion includes two frame retention features each configured to engage a corresponding headgear retention feature on the frame.

15. The headgear of claim 14 , wherein the frame retention feature is horseshoe shaped.

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