Frame and headgear for respiratory mask assembly

Abstract

To provide a respiratory mask assembly.SOLUTION: The respiratory mask assembly has a patient interface that is secured to a user's head by a headgear. The patient interface comprises a seal, a frame and a gas delivery conduit. The frame is configured to secure the seal and the gas delivery conduit together. The frame comprises a recessed channel and / or headgear retaining features configured to connect the headgear to the patient interface. The frame can include an inlet collar that connects to the gas delivery conduit. The inlet collar can include bias flow holes. The headgear comprises a top strap, a pair of side arms, a yoke and a rear strap. The yoke is configured to connect to the recessed channel of the frame. The top strap, the side arms and the yoke form an integrally formed closed loop. The top strap can include two portions adjustably connected to each other.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] This disclosure relates, in general, to a respiratory mask system for delivering respiratory therapy to a patient. More specifically, this disclosure relates to various components of a respiratory mask system. [Background technology]

[0002] Respiratory masks are used to provide respiratory therapy to the airways of individuals suffering from any of a number of respiratory diseases or conditions. Such therapies may include, but are not limited to, continuous positive airway pressure (CPAP) therapy and non-invasive ventilation (NIV) therapy.

[0003] CPAP therapy can be used to treat obstructive sleep apnea (OSA), a condition in which the patient's airway is intermittently blocked during sleep, disrupting their breathing for periods of time. The patient awakens as a result of breathing cessation, or apnea. Due to recurrent and frequent apnea, the patient may experience little to no full restful sleep at night.

[0004] CPAP therapy involves supplying continuous positive air pressure to the patient's airway through a breathing mask. The continuous positive pressure acts as a splint for the patient's airway, holding it open to prevent interruption of the patient's breathing and sleep.

[0005] A breathing mask typically includes a patient interface and a headgear, the patient interface configured to deliver sustained positive air pressure to the patient's airway via a seal or cushion that forms a substantially airtight seal in or around the patient's nose and / or mouth. Breathing masks are available in various forms, including full-face masks, nasal masks, and direct nose / mouth masks, 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 it remains in a stable position relative to the patient's face during use. Such breathing masks may also be used to deliver NIV and other treatments. [Overview of the project] [Means for solving the problem]

[0006] In a first embodiment, embodiments of the present invention may be broadly described as including a headgear for a breathing mask, comprising a integrally formed closed loop. The closed loop comprises a yoke, a pair of lateral arms, and a top strap. The yoke is configured to connect to a patient interface. The pair of lateral arms are configured to extend from the lateral rear portion of the yoke and, when in use, across the user's cheeks and above the ears. The top strap is configured to extend between the pair of lateral arms and, when in use, across the top of the user's head.

[0007] Preferably, the top strap includes separate left and right portions, each having a free end and a fixed end. The fixed end of the left portion is formed integrally with one of the side arms, and the fixed end of the right portion is formed integrally with the other side arm. The free ends of the left and right portions are adjustablely connected to each other.

[0008] Preferably, the closed loop is made of a semi-rigid material.

[0009] Preferably, it includes a plastic material.

[0010] Preferably, the side arm includes a buckle integrally formed at its free end.

[0011] Preferably, the headgear further includes a rear strap configured to extend between buckles on the side arms and around the back of the user's head when in use.

[0012] Preferably, the rear strap includes a pair of side ends that are adjustablely connected to buckles on the side arms.

[0013] Preferably, the rear strap is detachably connected to a buckle.

[0014] Preferably, the rear strap and the top strap are configured to surround the back of the user's head when in use.

[0015] In a second embodiment, embodiments of the present invention can be broadly said to include a breathing mask comprising a patient interface and headgear as described above.

[0016] In a third embodiment, embodiments of the present invention may be broadly described as including a headgear for a breathing mask, comprising a integrally formed closed loop and a rear strap. The closed loop includes a yoke, a pair of lateral arms, and a top strap. The yoke is configured to connect to a patient interface. The lateral arms are configured to extend from the lateral rear portion of the yoke and, when in use, across the user's cheeks and above the ears. The top strap extends across the top of the user's head when in use and is configured to connect the pair of lateral arms. The rear strap is configured to extend between the pair of lateral arms around the back of the user's head.

[0017] In a fourth embodiment, embodiments of the present invention may be broadly described as including a headgear for a breathing mask, comprising a yoke, a pair of opposing lateral arms, and a top strap. The yoke is configured to connect to the frame of the breathing mask. The pair of opposing lateral arms are configured to extend from a pair of lateral rear portions of the yoke in use, across the user's cheeks and above the tops of the user's ears in use. The top strap is configured to extend between the lateral arms across the top of the user's head above the user's ears in use. The yoke, lateral arms, and top strap are integrally formed to provide a closed loop that remains intact when the yoke is separated from the frame.

[0018] In some embodiments, the 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 may extend along the 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 circumference of the gas path at the inlet is smaller than the outer circumference of the gas path at the outlet.

[0019] The inlet flange may include an enlarged outer portion. The inlet may have an oval shape. The outlet may have an oval shape. The outlet flange may include a truncated portion. One portion of the outlet flange may be longer than another portion of the outlet flange. The outlet flange may include a recessed portion that partially extends around the periphery of the outlet flange.

[0020] In some embodiments, the 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 may extend along the longitudinal distance of the body. The inlet flange includes an increasing transitional portion of the outer periphery. 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 outside of the frame.

[0021] 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.

[0022] 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.

[0023] 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 conduit 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.

[0024] The frame and headgear retention features are configured such that a first headgear retention feature can engage a corresponding first frame retention feature on the headgear, and then the frame and headgear can be rotated relative to each other about the headgear retention feature to align a second headgear retention feature with a corresponding second frame retention feature on the headgear. The centers of the first headgear retention feature and the second headgear retention feature can be longitudinally offset relative to a central axis extending through the opening of the inlet flange. The first headgear retention feature and the second headgear retention feature can be circular holes.

[0025] 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°.

[0026] 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 defining the opening and 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.

[0027] 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 defining an opening and 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. < In some embodiments, the headgear for a breathing mask includes a yoke configured to connect to a patient interface, first and second lateral arms, a top strap, and at least one connector configured to connect to a frame when in use. Each of the first and second lateral arms extends from the lateral rear portion of the yoke and is configured to extend across the user's cheeks and above the ears when in use. The top strap is coupled to the first and second lateral arms and extends between the first and second lateral arms and is configured to extend across the top of the user's head when in use. At least one of the yoke, first side arm and second side arm, and top strap includes a plastic core and a fabric outer casing that at least partially surrounds the plastic core, the yoke, first side arm and second side arm, and top strap are formed by internal molding, and at least one connector is formed by a burst-through process such that at least one connector is formed integrally with the plastic material and extends to the outside of the outer casing.

[0029] The connector may include a groove separating two retaining portions. The connector may be substantially circular. The headgear may include two connectors, each configured to engage with a corresponding headgear retaining feature on a frame, and the headgear and connectors may be configured such that a first connector of the two connectors can engage with a corresponding first headgear retaining feature on a frame, and then the frame and headgear can rotate relative to each other about the connectors to align a second connector of the two connectors with a corresponding second headgear retaining feature on a frame.

[0030] In some embodiments, the headgear for a breathing mask includes a yoke configured to connect to a patient interface, first and second lateral arms, and a top strap. Each of the first and second lateral arms extends from the lateral rear portion of the yoke and is configured to extend across the user's cheeks and above the ears when in use. The top strap is coupled to the first and second lateral arms and extends between the first and second lateral arms and is configured to extend across the top of the user's head when in use. The top strap includes a first portion coupled to the first lateral arm, a second portion coupled to the second lateral arm, and an adjustment mechanism that connects the first and second portions and is configured to allow adjustment between the first and second portions. The adjustment mechanism includes a guide loop at the free end of the second part, a plurality of holes along the length of the second part near the free end, a projection extending from the inner surface of the first part, the inner surface being configured to face the second part when the first and second parts are joined in use and to at least partially overlap the second part, and the projection being configured to engage with any one of the plurality of holes to fix the first and second parts together, and a plurality of position guides extending along the length of the first part near the projection, the position guides including a series of protruding edges having a width greater than the diameter of the opening defined by the guide loop. In use, the first part is configured to move forward and / or backward through the guide loop, and contact between the protruding edges and the guide loop provides resistance to the movement of the first part through the guide loop.

[0031] The top strap may include a plastic core and a fabric outer casing that at least partially surrounds the plastic core, the second part including a peripheral groove extending around at least one of a plurality of holes, the outer casing not surrounding the peripheral groove. The projection may include a strut extending from and adjacent to the inner surface of the first part and an enlarged head at the end of the strut, the enlarged head having a diameter greater than the diameter of the strut.

[0032] In some embodiments, the headgear for the breathing mask includes a yoke portion, a strap including first and second lateral arms, and a top strap. The yoke portion is configured to connect to a patient interface. Each of the first and second lateral arms extends from the lateral rear portion of the yoke portion and is configured to extend across the user's cheeks and above the ears when in use. The yoke portion and the first and second lateral arms may be formed integrally. The top strap is coupled to the first and second lateral arms and extends between the first and second lateral arms and is configured to extend across the top of the user's head when in use. The first edge of the strap includes a soft edge portion, and the second edge of the strap on the opposite side includes a soft edge portion and a hard edge portion.

[0033] The thickness of the soft edge of the first edge may vary between the maximum thickness at the side end of the side arm and the minimum thickness near the center of the yoke portion. The thickness of the soft edge of the second edge may vary between the maximum thickness at the side end of the side arm and the minimum thickness at a point laterally spaced from the center of the yoke portion.

[0034] In some embodiments, the headgear for the breathing 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 lateral arm portion and a second lateral arm portion, each of which extends from the lateral rear portion of the yoke and is configured to extend across the user's cheek and above the ear when in use. The top strap is coupled to the first lateral arm portion and the second lateral arm portion and extends between the first lateral arm portion and the second lateral arm portion and is configured to extend across the top of the user's head when in use. The top strap includes a first portion coupled to the first lateral arm portion, a second portion coupled to the second lateral arm portion, and an adjustment mechanism that connects the first portion and the second portion and is configured to allow 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 that at least partially surrounds the plastic core, and at least one of the yoke, the first side arm portion and the second side arm portion, and the top strap is formed by internal molding.

[0035] The adjustment mechanism may include a female connector at the free end of the second part and a male connector at the free end of the first part, wherein the female connector includes a guide loop and a plurality of holes along the length of the female connector, and the male connector includes a projection extending from the inner surface of the male connector, the inner surface being configured to face and at least partially overlap the female connector when the first and second parts are joined together in use, and the projection being configured to engage with any one of the plurality of holes to fix the first and second parts together. In use, the first part is configured to move forward and / or backward through the guide loop.

[0036] A female connector may be overmolded onto the second portion. A male connector may be overmolded onto the first portion. The male connector may include a grip on or within its outer surface. The male connector may include a grip on or within its inner surface. 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 may further include buckles at the side ends of each of the first and second side arm portions, each buckle configured to receive the end of the rear strap. The buckles may be overmolded onto the side ends of the first and second side arm portions. The yoke may include two frame retaining features, each configured to engage with corresponding headgear retaining features on the frame. The frame retaining features may be horseshoe-shaped. The front strap may include pads that surround each of the frame-retaining features and extend laterally outward from each of the frame-retaining features, the pads having a greater thickness than the rest of the front strap.

[0037] In some embodiments, the breathing mask assembly includes a headgear, a frame, and a headgear connector. The headgear is configured to secure the mask assembly to the user's face when in use. The frame has a body extending along a longitudinal axis, a top, a bottom, and two sides. The headgear connector is configured to connect to the headgear and to connect to the frame by approaching the frame from either the top or the bottom.

[0038] The headgear connector can be permanently coupled to the headgear. The headgear connector may include at least one locking projection, and the frame may include at least one recess, the at least one locking projection may be configured to be received in at least one recess when the headgear connector is coupled to the frame. The frame may also include at least one scalloped portion positioned near at least one recess. The scalloped portion may be positioned above the corresponding recess. At least one scalloped portion may be configured to act as an introduction for at least one locking projection into at least one recess. At least one scalloped portion may be separated from at least one recess by a projection. A barrier may be configured to prevent or block coupling of the headgear connector when approached from the top or bottom (the other, the wrong) side of the frame.

[0039] In some embodiments, the headgear includes a yoke, first and second lateral arms, and a top strap. Each of the first and second lateral arms extends from the lateral portion of the yoke and is configured to extend across the user's cheek and above the ear when in use. The top strap is coupled to the first and second lateral arms and extends between the first and second lateral arms and is configured to extend across the top of the user's head when in use. The headgear connector is coupled to the yoke. The yoke may extend across the front of the headgear connector from a first lateral end of the headgear connector to a second lateral end on the opposite side of the headgear connector.

[0040] In some embodiments, the breathing mask assembly includes a headgear, a frame, and a connector. The headgear is configured to secure the mask assembly to the user's face when in use. The frame extends in a first direction from inlet to outlet. The longitudinal axis of the frame and the flow path passing through the frame extend from inlet to outlet. The frame extends in a second direction perpendicular to the first direction from a first side edge to a second side edge. The frame extends in a third direction perpendicular to the first and second directions from top to bottom. The connector is coupled to the headgear and is configured to be coupled to the frame by approaching the frame along a third direction from top or bottom.

[0041] In some embodiments, the breathing mask assembly includes a headgear, a frame, and a connector. The headgear is configured to secure the mask assembly to the user's face when in use. The frame has an inlet at the front end of the frame, an outlet at the rear end of the frame, a channel extending through the frame from the inlet to the outlet, a top surface, a bottom surface, and sides. The connector is configured to be coupled to the headgear and to the frame. The connector has a lateral portion configured to extend along the sides of the frame, and an intersecting portion extending between the lateral portions, configured to extend along either the top surface or the bottom surface of the frame when the connector is coupled to the frame.

[0042] The connector can be permanently coupled to the headgear. The connector may include at least one locking projection, and the frame may include at least one recess, the at least one locking projection may be configured to be received in at least one recess when the connector is coupled to the frame. The frame may include at least one scalloped portion positioned near and above at least one recess. The scalloped portion may act as an introduction for at least one locking projection into at least one recess. At least one scalloped portion may be separated from at least one recess by a projection. A barrier may be configured to prevent or stop the coupling of the connector when the user attempts to extend the connector along the top or bottom of the frame (the wrong portion).

[0043] In some embodiments, the headgear includes a yoke, first and second lateral arms, and a top strap. Each of the first and second lateral arms extends from the lateral portion of the yoke and is configured to extend across the user's cheek and above the ear when in use. The top strap is coupled to the first and second lateral arms and extends between the first and second lateral arms and is configured to extend across the top of the user's head when in use. A connector is coupled to the yoke. The yoke may extend across the front of the connector from a first lateral end of the connector to a second lateral end on the opposite side of the connector.

[0044] In some embodiments, the frame for a respiratory mask assembly includes a body and a flexible engaging portion. The body includes an inlet end defining an inlet opening, an outlet end defining an outlet opening, and a flow path extending through the body from the inlet opening to the outlet opening. The flexible engaging portion is configured to engage with a cushion module that is positioned on and coupled to the body. The flexible engaging portion may be configured to compress when the cushion module is coupled to the body. Compression of the flexible engaging portion creates an interference fit between the patient interface and the frame. In the illustrated configuration, the interference fit is a friction fit that frictionally connects the compressed flexible portion and the patient interface.

[0045] In some embodiments, the cushion module includes a coupling structure configured to be coupled to a body such that the coupling structure engages with a flexible engaging portion. The coupling structure may include a first portion having a first internal dimension and a second portion having a second internal dimension different from the first internal dimension. The first internal dimension may be the inner periphery of the first portion. The second internal dimension may be the inner periphery of the second portion. The coupling structure may include a transition portion between the first and second portions. The second internal dimension may be larger than the first internal dimension. When the coupling structure is coupled to the body, the flexible engaging member may engage with the second portion and / or the transition portion of the coupling structure. Interference between the flexible engaging member and the coupling structure may be lower when the coupling structure is in its final connection position on the body than when the coupling structure is being connected to the body. The coupling structure may be in the form of a fastener.

[0046] In some embodiments, the frame for a breathing mask assembly includes a body and a flange. The body includes an inlet end defining an inlet opening, an outlet end defining an outlet opening, and a flow path extending through the body from the inlet opening to the outlet opening. The flange extends outward from the central portion of the body and extends at least partially circumferentially around the body. In some embodiments, the breathing mask assembly includes the frame and a headgear configured to secure the mask assembly to the user's face when in use. The headgear is configured to be coupled to the frame so that the headgear contacts the front surface of the flange. In some embodiments, the breathing mask assembly includes the frame and a cushion module including a seal configured to seal to the user's face when in use. The cushion module is configured to be coupled to the frame so that the cushion module contacts the rear surface of the flange.

[0047] In some embodiments, the headgear for the respiratory mask assembly includes a body portion and one or more connecting portions. The body portion defines a surface and includes a plastic core portion and an outer layer portion. Each connecting portion is integrally formed with the core portion and extends through the outer layer portion. Each connecting portion can be formed by molten plastic material creating an opening in the outer layer portion, or by molten plastic material passing through an existing opening in the outer layer portion during a molding process for creating the core portion.

[0048] In some embodiments, the breathing mask assembly includes a headgear and a connector overmolded onto the headgear, configured to connect the headgear to the frame of the breathing mask assembly. The headgear may include a yoke, first and second lateral arms, and a top strap. Each of the first and second lateral arms extends from the lateral portion of the yoke and, when in use, crosses the user's cheek and extends above the ear. The top strap is connected to the first and second lateral arms and extends between the first and second lateral arms and, when in use, is configured to cross the top of the user's head. The connector may be overmolded onto the yoke.

[0049] In some embodiments, the respiratory mask assembly includes a frame and a cushion module. The frame includes a body and a flexible engaging portion positioned within the body. The body includes an inlet end defining an inlet opening, an outlet end defining an outlet opening, and a flow path extending through the body from the inlet opening to the outlet opening. The body may be more rigid than the flexible engaging portion. The cushion module is configured to be coupled to the frame. The cushion module includes a seal and a coupling structure coupled to the seal. The surface of the coupling structure is configured to engage with the flexible engaging portion of the frame when the cushion module is coupled to the frame.

[0050] The flexible engagement portion can be configured to compress when the cushion module is coupled to the main body, and the compression of the flexible engagement portion can form a friction fit between the cushion module and the frame.

[0051] The coupling structure may include an inner fastener and an outer fastener. A portion of the seal may be sandwiched between the inner and outer fasteners. The inner fastener may include a surface configured to engage with a flexible engagement portion. The surface of the coupling structure configured to engage with the flexible engagement portion may include a first portion and a second portion, the dimensions of which the first portion are smaller than the dimensions of the second portion. The first portion may be adjacent to the leading edge of the inner fastener and extend from the leading edge in the assembly direction when the inner fastener is coupled to the frame. The first portion of the surface of the inner fastener may contact the flexible engagement portion at an intermediate position of the inner fastener relative to the frame when the inner fastener is coupled to the frame. The second portion of the surface of the inner fastener may contact the flexible engagement portion at the final connection position of the inner fastener on the frame. The surface of the inner fastener may further include a transition portion between the first and second portions, the transition portion may contact the flexible engagement portion at the final connection position of the inner fastener on the frame.

[0052] Further aspects of the present invention, which should be considered in all novel embodiments, will become apparent from the following description.

[0053] Here, we will describe numerous embodiments using examples with reference to the drawings. [Brief explanation of the drawing]

[0054] [Figure 1] This is a perspective view of a first non-limiting exemplary embodiment of a respiratory mask as described herein. [Figure 2] Figure 1 is a front perspective view of the frame of the breathing mask. [Figure 3] Figure 2 is a rear perspective view of the frame. [Figure 4] Figure 2 is a front view of the frame. [Figure 4A] Figure 2 is a front view of the frame. [Figure 5] Figure 2 is a left side view of the frame. [Figure 5A]Figure 2 is a left side view of the frame. [Figure 5B] This is a left side view of an alternative embodiment of the frame in Figure 2. [Figure 6] Figure 2 is a rear view of the frame. [Figure 6A] Figure 2 is a rear view of the frame. [Figure 7] Figure 2 is a top view of the frame. [Figure 7A] This is a top view of an alternative embodiment of the frame in Figure 2. [Figure 8] Figure 2 is a bottom view of the frame. [Figure 9] This is a front view of the frame in Figure 2, with the central section cut off. [Figure 10] This is a central cross-sectional view of the frame in Figure 2. [Figure 10A] Figure 2 is a 2D view of the central cross-section of the frame. [Figure 11] This is a perspective view of a second non-limiting exemplary embodiment of a respiratory mask according to the present disclosure. [Figure 12] Figure 11 is a side view of the breathing mask in use. [Figure 13] Figures 11 and 12 are front views of a portion of the headgear of the breathing mask in the disengaged position. [Figure 14] This is an enlarged side view of the top strap of the headgear in the disengaged position shown in Figure 13. [Figure 15] Figure 11 is a perspective view of the top of the breathing mask. [Figure 16] This is an enlarged front view of the headgear yoke in the disengaged position shown in Figure 13. [Figure 17] This is an enlarged plan view of the headgear yoke in the disengaged configuration shown in Figure 13. [Figure 18] Figure 1 is a perspective view of a second, non-limiting, exemplary embodiment of a headgear used in combination with the breathing mask. [Figure 19] Figure 18 is a front perspective view of the yoke of the headgear. [Figure 20]This is a perspective view of non-limiting exemplary embodiments of a respiratory mask as disclosed herein. [Figure 21] Figure 20 is a front perspective view of the frame of the breathing mask. [Figure 22] Figure 21 is a rear perspective view of the frame. [Figure 23A] Figure 21 is a front view of the frame, showing the frame's axis. [Figure 23B] Figure 21 is a front view of the frame showing various axes and dimensions. [Figure 24A] Figure 20 shows how to attach the breathing mask headgear to the frame shown in Figure 21. [Figure 24B] Figure 20 shows how to attach the breathing mask headgear to the frame shown in Figure 21. [Figure 24C] This is a front view of an alternative embodiment of the frame shown in Figure 21. [Figure 24D] This is a front perspective view of an alternative embodiment of the frame in Figure 21. [Figure 25] Figure 20 is a partially exploded perspective view of a breathing mask. [Figure 26A] Figure 21 is a side view of the frame. [Figure 26B] Figure 21 is a side view of the frame showing various axes and dimensions. [Figure 26C] This is a partial cross-sectional view of the entrance flange of the frame shown in Figure 21. [Figure 26D] Figure 21 is a front view of the frame. [Figure 27A] This is a rear view of the frame shown in Figure 21, illustrating various axes. [Figure 27B] This is a rear view of the frame in Figure 21, showing various axes and dimensions. [Figure 28] Figure 21 is a side view of the frame. [Figure 29A] Figure 21 is a top view of the frame. [Figure 29B] This is a top view of an alternative embodiment of the frame in Figure 29A. [Figure 29C] Figure 21 is a top view of the frame. [Figure 30]Figure 21 is a bottom view of the frame. [Figure 31] This is a partial front view of the frame in Figure 21, showing the cross-sectional plane. [Figure 32A] This is a cross-sectional view of the frame in Figure 21, cut along line 32A-32A in Figure 31. [Figure 32B] Figure 32A is a 2D cross-sectional view. [Figure 33] This is a perspective view of non-limiting exemplary embodiments of a respiratory mask as disclosed herein. [Figure 34] Figure 33 is a side view of the breathing mask. [Figure 35A] This is a side view of the respiratory mask shown in Figure 33 when worn by a user. [Figure 35B] Figure 33 shows a rear view of the headgear yoke of the mask, which indicates the gate used during molding. [Figure 36A] Figure 33 is a side view of the frame holding feature of the mask's headgear. [Figure 36B] This is a side view of the frame holding feature section of Figure 36A, which shows the outer shape of the headgear casing. [Figure 36C] Figure 36A is a side view of the mold used to create the frame holding feature. [Figure 37] Figure 33 is a front view of the yoke and a portion of the side arm of the mask's headgear. [Figure 38A] Figure 33 is a magnified view of a portion of the mask's headgear. [Figure 38B] Figure 33 is a magnified view of a portion of the mask's headgear. [Figure 39] Figure 33 is a top view of the top strap of the mask's headgear. [Figure 40] Figure 33 is a top perspective view of the top strap of the mask headgear in the disengaged position or configuration. [Figure 41] Figure 40 is a magnified view of a portion of the second part of the top strap. [Figure 42]Figure 33 is an enlarged view of a portion of the headgear mask, showing an embodiment of the connection between the side arms and the top strap of the headgear. [Figure 43A] This is a bottom view of an exemplary embodiment of a position guide for the first portion of the top strap of a headgear. [Figure 43B] This is a bottom view of an exemplary embodiment of a position guide for the first portion of the top strap of a headgear. [Figure 43C] This is a side view of a portion of the first part of the top strap. [Figure 44] This is a top perspective view of a non-limiting exemplary embodiment of a respiratory mask assembly according to the present disclosure. [Figure 45] Figure 44 is a front view of the respiratory mask assembly. [Figure 46] Figure 44 is a rear view of the headgear of the respiratory mask assembly. [Figure 47A] Figure 46 is a rear or inner view of the separated and spread-out portion of the headgear. [Figure 47B] Figure 47A is a front or external view of a portion of the headgear. [Figure 48A] Figure 47A is a front or external view of the right side of the headgear. [Figure 48B] This is a rear or inner view of Figure 48A. [Figure 49A] Figure 47A is a front or external view of the left side of the headgear. [Figure 49B] This is a rear or inner view of Figure 49A. [Figure 50A] Figures 46 and 47A show the front or external view of the male connector of the headgear. [Figure 50B] Figure 50A is a rear or inner view of the male connector. [Figure 50C] Figure 50A is a perspective cross-sectional view of a modified example of the male connector. [Figure 51A] This shows different methods for connecting and / or disconnecting the male connector in Figure 50A from the female connectors of the headgear in Figures 46 and 47A. [Figure 51B]This shows different methods for connecting and / or disconnecting the male connector in Figure 50A from the female connectors of the headgear in Figures 46 and 47A. [Figure 52A] Figure 46 is a partial external perspective view of the top strap of the headgear. [Figure 52B] Figure 52A is a partial view of the inner surface of the top strap. [Figure 53A] Figure 46 is a partial external view of the bottom strap of the headgear. [Figure 53B] Figure 53A is a partial view of the inner surface of the bottom strap. [Figure 54A] This is a partial external view of the joint between the top strap in Figure 52A and the bottom strap in Figure 53A. [Figure 54B] Figure 54A is a perspective view of the joint. [Figure 55A] Figure 54A is a partial internal view of the end of the joint and bottom strap. [Figure 55B] Figure 54A is a cross-sectional view of the joint. [Figure 56A] This is a partial internal view of the overmolded joint between the top strap and the bottom strap, and the overmolded buckle on the end of the bottom strap. [Figure 56B] This is an external view of Figure 56A. [Figure 57] Figure 56A is a cross-sectional view of the overmolded joint. [Figure 58] This is a cross-sectional view of the male connector of Figure 50A, overmolded on the top strap. [Figure 59] A perspective view of an alternative embodiment of the end of the top strap. [Figure 60A] Figure 46 is a rear view of the bottom strap and yoke of the headgear. [Figure 60B] Figure 60A is a bottom view of the yoke. [Figure 61] Figure 44 is a front top perspective view of the frame and gas supply pipeline of the respiratory mask assembly. [Figure 62A] This is a rear view of the bottom strap of Figure 60A, which is attached to the frame of Figure 61. [Figure 62B] Figure 62A is a front view of the bottom strap and frame. [Figure 63] This is a rear view of an alternative embodiment of the bottom strap and yoke. [Figure 64] This shows the relative dimensions between the buckle and the bottom strap. [Figure 65] Figure 65 is a top perspective view of a non-limiting exemplary embodiment of a breathing mask assembly according to the present disclosure. [Figure 66] Figure 65 is a front view of the yoke and fasteners of the respiratory mask assembly. [Figure 67] Figure 66 is a rear view of the yoke and fasteners. [Figure 67B] Figure 66 is a rear cross-sectional view of the yoke and fastener. [Figure 68] Figure 66 is a bottom perspective view of the yoke and fastener. [Figure 69A] This shows how to attach the fastener shown in Figure 66 to the yoke shown in Figure 66. [Figure 69B] This shows how to attach the fastener shown in Figure 66 to the yoke shown in Figure 66. [Figure 70] Figure 65 is a side perspective view of the frame of the respiratory mask assembly. [Figure 71] Figure 70 is a side view of the frame. [Figure 72] Figure 70 is a front view of the frame. [Figure 73] Figure 70 is a top view of the frame. [Figure 74] Figure 70 is a top perspective view of the yoke and fasteners of Figure 66, joined to the frame. [Figure 75] Figure 74 is a top view of the assembly. [Figure 76] Figure 74 is a bottom view of the assembled structure. [Figure 77] Figure 74 is a rear view of the assembly. [Figure 78A] Figure 74 is a front view of the seal and coupling structure, which is connected to the yoke, fasteners, and frame. [Figure 78B] Figure 78A is a magnified view of a portion of the assembly. [Figure 79] Figure 65 is a top view of the seal and coupling structure of the respiratory mask assembly, showing the side edge of the seal deflected away from the coupling structure. [Figure 80] Figure 79 is a front perspective view of the seal and coupling structure. [Figure 81A] Various embodiments of the coupling structure connector for the frame shown in Figure 70 are illustrated. [Figure 81B] Various embodiments of the coupling structure connector for the frame shown in Figure 70 are illustrated. [Figure 81C] Various embodiments of the coupling structure connector for the frame shown in Figure 70 are illustrated. [Figure 81D] Various embodiments of the coupling structure connector for the frame shown in Figure 70 are illustrated. [Figure 82A] This is a side view of a frame including an embodiment of a coupling structure connector having a double projection. [Figure 82B] Figure 82A is a perspective view of the frame. [Figure 83] This is a front perspective view of another exemplary embodiment of the frame. [Figure 84] Figure 83 is a side view of the frame. [Figure 85] Figure 83 is a front view of the frame. [Figure 86] Figure 83 is a top view of the frame. [Figure 87] This is a side view of the fastener attached to the frame in Figure 83. [Figure 88] Figure 87 is a front view of the fasteners and frame. [Figure 89] This is an exploded front perspective view of another exemplary embodiment of the fasteners and frame. [Figure 90] Figure 89 is a front perspective view of the frame. [Figure 91] Figure 89 is a front view of the fastener. [Figure 92A] This is a side cross-sectional view of another exemplary embodiment of the frame and fasteners. [Figure 92B] This is a side cross-sectional view of another exemplary embodiment of the frame and fasteners. [Figure 92C] This is a side cross-sectional view of another exemplary embodiment of the frame and fasteners. [Figure 93] This is a front view of a non-limiting exemplary embodiment of a respiratory mask assembly according to the present disclosure. [Figure 94] Figure 93 is a side view of the respiratory mask assembly. [Figure 95] Figure 93 is a front view of a portion of the respiratory mask assembly. [Figure 96] Figure 93 is a front perspective view of a portion of the respiratory mask assembly. [Figure 97] Figure 93 is a bottom view perspective of a portion of the respiratory mask assembly. [Figure 98] Figure 93 is a bottom perspective view of a portion of the respiratory mask assembly. [Figure 99] Figure 93 is a front view of the frame of the respiratory mask assembly. [Figure 100] This is a side view of the frame in Figure 99. [Figure 101] This is a bottom view of the frame shown in Figure 99. [Figure 102] Figure 99 is a front perspective view of the bottom of the frame. [Figure 103] This is a front perspective view of a non-limiting exemplary embodiment of an assembly of a frame, seal, and coupling structure. [Figure 104] Figure 103 is a front perspective view of the frame. [Figure 105] Figure 103 is a rear perspective view of the frame. [Figure 106] Figure 103 is a front view of the frame. [Figure 107] Figure 103 is a rear view of the frame. [Figure 108] Figure 103 is a top view of the frame. [Figure 109] Figure 103 is a bottom view of the frame. [Figure 110] Figure 103 is a side view of the frame. [Figure 111] This is a cross-sectional view of the frame in Figure 103, cut along line 111-111 in Figure 106, with the frame connectors omitted. [Figure 112] This is a cross-sectional view of Figure 111, including the connector. [Figure 113] Figure 103 is a front view of the assembly of the frame, seal, and connecting structure. [Figure 114] This is a cross-sectional view of the assembly in Figures 103 and 113, cut along line 114-114 in Figure 113. [Figure 115] Figure 114 is an enlarged cross-sectional view of the frame region 115. [Figure 116] Figure 103 is a front perspective view of the frame and internal fasteners. [Figure 117] Figure 116 is a front view of the frame and internal fasteners. [Figure 118] Figure 116 is a side view of the frame and internal fasteners. [Figure 119] Figure 116 is a rear view of the frame and inner fasteners. [Figure 120] Figure 116 is a top view of the frame and internal fasteners. [Figure 121] Figure 116 is a bottom view of the frame and internal fasteners. [Figure 122] This is a cross-sectional view of the frame and inner fastener in Figure 116, cut along line 122-122 in Figure 117, showing the inner fastener in an intermediate position during its connection to the frame. [Figure 123] Figure 122 is a cross-sectional view showing the internal fastener at the final connection point on the frame. [Figure 124] This is an enlarged cross-sectional view of region 124, as shown in Figure 122, indicating the internal fastener located in the intermediate position. [Figure 125] Figure 123 is an enlarged cross-sectional view of region 125, showing the internal fastener at the final connection position. [Modes for carrying out the invention]

[0055] This disclosure relates to a frame and headgear for a respiratory mask system configured to deliver respiratory therapy to a patient / user. Figure 1 shows a non-limiting exemplary embodiment of the respiratory mask system 1 of this disclosure. The respiratory mask system 1 includes a patient interface 2, a headgear 3, and a gas delivery line 6. The patient interface 2 includes a cushion module and a frame 5. The cushion module includes a seal 4. The cushion module may also include a coupling structure configured to bond to the frame 5, as will be described in more detail herein.

[0056] The patient interface 2 is configured to provide an airway that can supply pressurized air to the user's airway. In the embodiments described and detailed below, the patient interface 2 is a nasal mask, particularly a subnasal mask or subnasal-type mask, having a seal 4 configured to seal to the underside 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 from the nose and along the user's upper lip.

[0057] In some embodiments, the seal 4 may extend around the alae or nasal wings, which widen to form a rounded ridge around the nostrils, covering and sealing them. The illustrated mask 1 is made to seal around a surface defining the opening to the nostrils, which may include a portion or all of the fleshy outer end of the nasal septum, sometimes also called the columella. In some configurations, the seal 4 may extend upward to seal along at least a portion of the left and right dorsal side walls 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 side walls without extending upward to the area 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 area between the underside of the nose and the upper lip. The secondary sealing surface of the mask may contact the sides of the user's nose, in addition to the cheeks in a position near the nose. Such primary and secondary sealing surfaces do not necessarily have to come into contact with the face of every user, but such arrangement can provide a suitable seal over a relatively wide range of facial geometric shapes.

[0058] In the illustrated configuration, seal 4 does not extend over the user's nasal bridge. More specifically, seal 4 in the illustration does not contact the user's nasal bridge. Non-contact with the nasal bridge is advantageous as it does not cause pressure on the nasal bridge, which could lead to pressure sores and discomfort in the user. If the seal causes pain or discomfort to the user, it may not be suitable for treatment.

[0059] Subnasal masks or subnasal-type masks equipped with seal 4 may be more unstable on the user's face than many conventional masks that contact the bridge of the nose, as a result of having a reduced contact area with the user's face, as described above. The reduced contact area provides little constraint on how seal 4 can move relative to the user's face, and therefore seal 4 may be able to roll or rotate relative to the user's face. Any rolling or rotation of seal 4 may result in the breakdown of the substantially airtight seal between seal 4 and the user's face, impairing the delivery of respiratory therapy. In some embodiments, the instability of seal 4 can be reduced by providing a headgear 3 that is capable of transmitting force to other parts of the user's head in a direction away from seal 4.

[0060] 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. Frame 5 may include a feature configured to fluidly connect a gas supply line 6 to the seal 4 so that a continuous air path is provided.

[0061] The headgear 3 is configured to secure the patient interface 2 to the user's face when in 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 when in 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 that is adjustablely connected to the side arms 8 and is configured to pass around the back of the user's head when in use.

[0062] Although the headgear 3 and frame 5 of this disclosure are described as being used in combination with a subnasal mask, it should be understood that they may be used in combination with any other type of mask, including, but not limited to, a nasal prong mask or nasal pillow mask, a full-face mask or nasal mask that seals above and / or below the bridge of the nose.

[0063] frame Figures 2 and 3 show perspective views of a first non-limiting exemplary embodiment of frame 100, which is substantially similar to frame 5 in Figure 1 and forms part of the breathing mask system. The longitudinal axis 105 and the transverse axis 107 (shown in Figure 4) are defined with respect to the origin at the center of the inlet flange 114 of frame 100. Frame 100 is symmetrical with respect to the longitudinal axis 105. Frame 100 has an outer surface 102 and an inner surface 103. The outer surface 102 serves as an interface between frame 100, the headgear 3, and the gas supply pipeline 6. The outer surface 102 includes a groove 106. The groove is defined by a first retaining projection 104 and a second retaining projection 108, and is located between the first retaining projection 104 and the second retaining projection 108. The first retaining ridge 104 is offset longitudinally from the second retaining ridge 108, and the space between the first retaining ridge 104 and the second retaining ridge 108 defines the groove 106. The concave surface 110 is located adjacent to the second retaining ridge 108. The yoke 9 is inserted into the groove 106 when in use. The headgear 3 is connected to the frame 100 by inserting the yoke 9 into the groove.

[0064] The outer surface 102 additionally includes an inlet flange 114. The inlet flange 114 includes a centrally located inlet flange opening 115. The inlet flange 114 also includes an inner flange surface 116 and an inlet flange surface 118. The inlet flange 114 may further include a pipe retaining projection 122, a number of seal retaining recesses 130 and / or a number of exhaust holes 127. The first retaining projection 104 extends from the first side edge 126 to the second side edge 128 of the frame 100. The second retaining projection 108 extends from the first side edge 126 so as to be in contact with the inlet flange surface 118 of the inlet flange 114 at a laterally offset joint 112a. The second retaining projection 108 branches off from the entrance flange 114 at the laterally shifted second joint 112b and extends to the second side edge 128.

[0065] The inner surface 103 is in contact with the seal 206 or the coupling structure 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 extending proximal to the user from the frame 100, 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 allow interaction between the frame 100 and the seal 206.

[0066] Figures 4 and 4A show a front view of the frame 100 aligned with the inlet flange opening 115, i.e., a front view of the frame 100. The frame 100 acts as a manifold connecting multiple components of the breathing mask system to each other. The inlet flange opening 115 is oval-shaped with a major axis 113 and a minor axis 111. In an alternative embodiment, the inlet flange 114 may be circular, triangular, or follow the contour of any other desired polygon.

[0067] Frame 100 is symmetrical with respect to the minor axis 111 of the entrance flange 114. In the illustrated configuration, the minor axis 111 is aligned with the longitudinal axis 105. In the illustrated configuration, the entrance flange opening 115 is positioned substantially in the center of frame 100. The entrance flange opening 115 has a long dimension 145 (e.g., the length along the major axis 113 of the entrance flange opening 115) and a short dimension 143 (e.g., the length along the minor axis 111 of the entrance flange opening 115). Additionally, in the illustrated configuration, the long dimension 145 of the entrance flange opening 115 is 20.7 mm, and the short dimension 143 of the entrance flange opening 115 is 17.2 mm. Another way to express this is that the ratio of the long dimension 145 to the short dimension 143 of the entrance flange opening 115 is approximately 1.2:1.

[0068] This ratio is determined, at least to some extent, by the physical properties or shape of the gas delivery pipeline used in the respiratory mask system. Furthermore, the requirement to minimize the pressure drop between the pressure generator and the user also influences the possible ratio of the long dimension 145 to the short dimension 143. Pressure drop is a phenomenon known to occur in respiratory mask systems where a pressure drop occurs between the pressure generator and the outlet of the respiratory mask system. Pressure drop is largely attributable 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.

[0069] Respiratory mask system The measurable pressure drop across the breathing mask system increases with increasing ratio of the long dimension 145 to the short dimension 143 of the inlet flange opening 115. However, increasing the ratio of the long dimension 145 to the short dimension 143 is beneficial in order to allow for a reduction in the physical contour of the frame 100. This reduction in physical contour makes it possible to reduce the overall contour of the breathing mask system. Therefore, in other embodiments of the frame 100, the ratio of the long dimension 145 to the short dimension 143 of the inlet flange opening 115 can vary from about 1:1 to about 2:1.

[0070] Referring again to Figure 4, the groove 106 extends from the first side edge 126 to the second side edge 128 of the frame 100. Like the groove 106, the first retaining projection 104 extends from the first side edge 126 to the second side edge 128 of the frame 100.

[0071] The lateral portion of the second retaining projection 108 is substantially concave with respect to the transverse axis 107. The lateral portion of the second retaining projection 108 is defined by an inflection region near the joint 112, where the relative concave surface changes from concave to convex as the second retaining projection 108 comes into contact with the entrance flange surface 118.

[0072] In the illustrated embodiment, the groove 106 passes over the inlet flange 114. The groove 116 is arched and passes over the inlet flange 114. The arched shape of the groove 116 is beneficial in that it allows for effective force decomposition of the forces generated by the seal and headgear.

[0073] The first retaining ridge 104 and the second retaining ridge 108 project outward from the outer surface 102 of the frame toward the entrance flange 114. The entrance flange 114 includes a wall extending from the outer surface 102. The longitudinal thickness or height or outward extension of the groove 106 can be defined to be displaced between a location on the first retaining ridge 104 adjacent to the groove 106 and a location on the second retaining ridge 104 adjacent to the 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 groove 106 with the maximum longitudinal thickness is located on the first side edge 126 and the second side edge 128 of the frame 100. The location of the groove 106 with the minimum longitudinal thickness is located on the longitudinal axis 105.

[0074] The longitudinal thickness or height of the groove 106 decreases as it is translated laterally inward from the first transverse edge 126 and the second transverse edge 128 toward the longitudinal axis 105 of the frame 100. In the illustrated configuration, the minimum longitudinal thickness of the groove 106 is approximately 5.8 mm, and the maximum longitudinal thickness of the groove 106 is approximately 12.7 mm. Therefore, the ratio of the minimum longitudinal thickness to the maximum longitudinal thickness of the groove 106 is approximately 1:2.25. The longitudinal thickness of the 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 minimum longitudinal thickness to the maximum longitudinal thickness of the groove 106 can be approximately 1:1 to 1:4.

[0075] By reducing the longitudinal thickness of the groove 106 along a portion of its length or at least at the central position of the frame 100, the longitudinal contour of the frame 100 can be reduced or minimized. Reducing or minimizing the longitudinal contour of the frame 100 reduces both the actual and perceived protrusion of the frame, and reduces or minimizes the mass of the frame, which is desirable for user comfort and can improve the user's fit to treatment. The reduced longitudinal thickness of the groove 106 near the lateral center of the frame 100 may also provide a matching feature between the yoke 9 and the groove 106. The matching feature allows the yoke 9 to be connected to the frame 100 in only one orientation, thus preventing incorrect assembly of the headgear 3 to the frame 100.

[0076] The yoke 9 may be connected to the frame 100 via the groove 106 using any associated connecting means. The yoke 9 may be bonded to the recess 106 using adhesive. In some configurations, the yoke 100 may be connected to the frame 100 using a snap-fit ​​mechanism, a friction-fit mechanism, or a hook-and-loop fastener mechanism. In other configurations, the recess may include one or more projections designed to fit into the recesses or holes in the yoke, such that a combination of projections and corresponding recesses or holes causes the yoke to fit into the frame. Alternatively, the recess 106 may include one or more recesses or holes such that one or more corresponding projections on the yoke cause the yoke to fit into the frame.

[0077] Alternative configurations of frame 100 can utilize a number of alternative groove contours. For example, the grooves may extend above or below the top of the inlet flange (as shown in Figures 4 and 4A). In another alternative configuration, the frame includes two or more grooves that may extend laterally across the outer surface of the frame. In some configurations, these grooves may include portions where the relevant retaining protrusions are adjacent to each other or portions where two grooves share a common retaining protrusion. In some configurations, these grooves may not include adjacent portions. In some configurations, one or more grooves may both pass above the inlet flange. In some configurations, one or more grooves may both pass below the inlet flange.

[0078] In some configurations, two or more grooves may first branch off from a common groove near one side edge, diverge around the entrance flange, and then converge into a common groove near the opposite side edge of the frame. In some configurations, multiple grooves may be completely independent on the outer surface of the frame. In other words, each independent groove may have its own independent retaining projection, or it may share a common retaining projection with another independent groove while maintaining itself as a completely separate groove. In each of the above modifications, one or more grooves may be used as an interface for connecting the headgear 3 of the breathing mask system to the frame 100.

[0079] Referring again to Figure 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 projection 108 and the inlet flange 114 on the outer surface 102 of the frame 100. In the illustrated configuration, the concave surface 110 provides support to the seal 206, helping to maintain the structural integrity of the frame 100 both during the manufacturing process and in use. However, in alternative embodiments, the frame 100 may not have this concave surface 110 at all.

[0080] The lateral length 125 of the frame 100 in the embodiment shown in Figure 4A is approximately 56.00 mm. Therefore, the ratio of the length dimension 145 of the entrance flange opening 115 to the lateral length 125 of the frame 100 is approximately 1:2.70. The specified lateral length 125 of the frame 100 is used 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 significantly around the user's face. This behavior is required to accommodate the changes in facial contour that the breathing mask system may be able to handle to the greatest extent possible. The frame 100 has a lateral length 125 that allows at least some degree of headgear flexing and reduces slippage of the seal 206.

[0081] In alternative embodiments of frame 100, the lateral length 125 may vary from approximately 45.00 mm to approximately 75.00 mm. Modifications may be used to accommodate different sizes of seal 206, different contours of headgear 3, or different headgear connection methods.

[0082] The longitudinal length 129 of the frame 100 provides a suitable structure for enabling the headgear 3 to connect effectively to the frame 100, and also provides the essential structural integrity and rotational integrity required by the seal 206.

[0083] In alternative embodiments of the frame, the longitudinal length of the frame may vary from approximately 25.00 mm to approximately 50.00 mm. Modifications may be used to accommodate different seal sizes, different contours of the headgear 3, or different headgear connection methods.

[0084] Figures 5 and 5A show the left side view (from the user's perspective) of the frame 100 shown in Figure 1. The frame 100 is shown from one side. The longitudinal axis 105, the inlet proximal axis 131, and the outlet proximal axis 133 are shown. In the illustrated configuration, the inlet proximal axis 131 intersects the longitudinal axis 105 at a right angle and is centered relative to the inlet flange opening 115. In other words, the inlet proximal axis 131, the transverse axis 107 (see Figure 4), and the longitudinal axis 105 form a three-dimensional space sharing a common starting point. The inlet proximal axis 131 is approximately parallel to the gas flow 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 Figure 6), and the longitudinal axis 105 share a common intersection point. The outlet proximal axis 133 is parallel to the gas flow through the outlet flange opening 117 of the frame 100. The inlet proximal axis 131 is offset longitudinally relative 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.

[0085] The distal edge (towards the user) of the entrance flange 114 is aligned with the longitudinal axis 105, as shown in Figure 5A. In an alternative configuration, the edge of the entrance flange may be angled with respect to the longitudinal axis 105.

[0086] In the illustrated configuration, the entrance flange surface 118 includes a first portion having a first outer circumference, a second portion of a second outer circumference coaxially offset from the first portion, and a transition portion integral with the first and second portions and connecting the first portion to the second portion. In the illustrated configuration, the outer circumference of the second portion is larger than that of the first portion, and the second portion is shifted proximal to the first portion (when worn by a user). The difference in the outer circumferences of the first and second portions of the entrance flange 114 results in a transition portion that forms an inclined surface 135 angled with respect to the proximal entrance axis 131. This inclined surface 135 facilitates the increase in the outer circumference. In some configurations, the entrance flange surface 118 includes only the inclined surface. In other configurations, the entrance flange surface 118 may include a combination of the inclined surface and a surface that is not angled with respect to the proximal entrance axis 131.

[0087] As can be seen in the figure, the inlet flange 114 has a smaller outer circumference than the outer circumference of the outlet flange 137. The inlet flange 114 has a different shape from the outlet flange 137.

[0088] The inclined surface 135 extends to the periphery of the inlet flange surface 118. The projection of the inclined surface 135 on the inlet proximal axis 131 has a substantially constant length at all points along the periphery 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 offset between the inclined surface 135 and the distal edge (relative to the user) of the inlet flange surface 118 varies around the outer circumference of the inlet flange surface 118. In the illustrated embodiment, the inclined surface 135 includes a number of bias holes 127. In the configurations shown in Figures 4, 5A, and 7, the bias holes 127 are located on the inclined surface 135 and extend substantially around the inclined surface 135. The bias holes discharge bias flow substantially longitudinally with respect to the inlet proximal axis 131.

[0089] The inclusion of an inclined surface 135 on the inlet flange surface 118 is intended to influence the orientation of the bias airflow vents 127 in a beneficial manner. However, a problem faced with orthogonally oriented vents is that the user perceives an unpleasant airflow when the breathing mask system is in use (where the vents are oriented at 90° with respect to the inlet proximal axis 131). Therefore, the bias airflow vents 127 of the frame 100 are angled away from the user when located on the inclined surface 135. As a result, when the frame 100 is in use, the gas flow through the bias airflow vents 127 is directed away from the user. This prevents the user from feeling an unpleasant airflow while using the breathing 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 may be 0° to 20° or 5° to 15°. In other configurations, this angle may be greater than 20°.

[0090] In other configurations, bias vents may extend around the entire circumference of the inclined surface. Alternatively, the bias vent configuration may be arranged on the inlet flange surface. This configuration may include one or more rows of bias vents, and the rows may be aligned or offset relative to each other. In other configurations, the bias vents may be located elsewhere on the frame 100 in any desired configuration. Some configurations of the frame may include a single exhaust port. Other configurations may include a single exhaust port with a diffuser. The diffuser may be integrated with the exhaust port or connected to the frame 100 to cover the exhaust port. In such configurations, the diffuser may act to diffuse the noise emitted from the exhaust port when the breathing mask system is operating.

[0091] Referring again to Figures 5 and 5A, the side contour of the groove 106 is shown. The groove 106 appears laterally concave to the user. The degree of concavity of the groove 106 may vary along the lateral length of the frame 100. This variation along the lateral length is a result of the groove 106 twisting along its length. The specified curvature of the groove 106 is such that the contour of the frame 100 can provide adequate structural support to the seal 206 of the breathing mask system.

[0092] Referring to Figures 6 and 6A, Figure 6 shows a rear view of the frame 100 with respect to the longitudinal axis 105 and the transverse axis 107. The outlet flange opening 117 is located at the center of the frame 100 with respect to the longitudinal axis 105. The starting point of the outlet flange opening 117 is aligned with the secondary transverse axis 109. The secondary transverse axis is offset vertically from the transverse axis 107. In some configurations of the frame 100, the secondary transverse axis 109 may coincide with the transverse axis 107.

[0093] Figure 6A shows a rear view of frame 100 and indicates that the outlet flange 137 is shaped like a truncated circle or partially D-shaped and includes an outlet long axis 119, an outlet short axis 121, and a truncated portion 123. The truncated portion 123 of the outlet flange 137 allows the contour of frame 100 to be reduced compared to a frame without a truncated portion. Additionally, the truncated portion 123 provides an orientation feature to ensure the correct orientation of the seal connection to the frame. The truncated portion 123 also reduces the possibility of the seal 206 being positioned incorrectly when it is to be connected to frame 100. The truncated portion also prevents rotation of the seal 206 relative to frame 100.

[0094] In the illustrated configuration, the outlet flange opening 117 includes both a larger lateral and longitudinal profile than the inlet flange opening 115. Therefore, the outer circumference of the outlet flange opening 117 is larger than that of the inlet flange opening 115. This larger profile is beneficial from both a functional and manufacturability standpoint. From a functional standpoint, if the frame 100 has an outlet flange 137 that is larger than the inlet flange 114, the airflow to the user is less restricted. This results in a reduction of the pressure drop through the breathing mask system, in addition to at least some reduction in inhalation noise resulting from the user breathing through the breathing mask system. From a manufacturability standpoint, having an outlet flange 137 that is larger than the inlet flange 114 makes it easier to remove the mold core from the molded part.

[0095] 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 transverse axis 107. In an alternative configuration, the inner surface 103 may be substantially convex with respect to the transverse axis 107. Furthermore, the inner surface 103 may be substantially concave in some areas and substantially convex with respect to the transverse axis 107 in other areas.

[0096] Figure 7 shows a top view of the frame 100 (relative to the user). Both the outer surface 102 and the inner surface 103 are concave relative to the user. This is illustrated by the fact that the first retaining projection 104 of the outer surface 102 is also concave relative to the user, as it is adjacent to the inner surface 103. This configuration is beneficial for allowing a reduction in the proximal contour of the breathing mask system. In an alternative configuration, the outlet flange 137 may have at least one plane that is convex or flat. Additionally, the outlet flange 137 may include both a concave region and a convex region in at least one plane.

[0097] 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 end of the outlet flange 137. The seal-retaining recesses 130 allow 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 coupling structure such as a fastener that connects to the frame 100. The coupling structure or fastener includes raised surfaces corresponding to the seal-retaining recesses 130 that allow the connection between the 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 abuts the seal and its boundary. Furthermore, 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 coupling structure to connect the components to each other.

[0098] Figure 7A shows a top view (for the user) of an alternative configuration of frame 100. In this configuration, the bias flow hole 127 is located on the inclined surface 135 on the inlet flange 114, for example, as also shown in Figure 5B.

[0099] Figure 8 shows a bottom view (to the user) of the frame 100 shown in Figure 1. The outlet flange 137 may have at least one concave plane. At least a portion of the outlet flange 137 may be shifted proximal to a second portion of the outlet flange 137.

[0100] In alternative configurations, the outlet flange 137 can be aligned on a common plane so that its shape is not concave. In some configurations, this plane is perpendicular to the outlet proximal axis 133. In other words, the outermost ends in the longitudinal and lateral directions all share a common proximal displacement from the starting point of the outlet proximal axis 133.

[0101] Figure 9 shows a front view of the frame 100 shown in Figure 1, and displays a cross-sectional plane 132 that can be cut. This cross-sectional plane is located in the center of the frame 100 and is aligned with the vertical axis 105.

[0102] Figure 10 shows the formed cross-section 10-10 when the frame 100 is viewed in a direction perpendicular 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.

[0103] Figure 10A shows the central cross-section 134 of the frame 100. The pipeline retaining projection 122 protrudes inward from the periphery of the inlet flange 114. In other words, both the lateral and vertical dimensions of the inlet flange opening 115 are smaller than the lateral and vertical dimensions of the inner surface of the flange 116. This dimensional change is a result of the pipeline retaining projection 122. In other words, the pipeline retaining projection 122 may form a lip around the inner periphery of the distal end of the inlet flange 114. This lip may be continuous with the periphery of the inlet flange opening 115, or may include a protruding peripheral portion and other non-protruding peripheral portions. The gas supply pipeline 6 may be connected to the frame 100 using adhesive or using coupling structures or fasteners that engage with the pipeline retaining projection 122. The gas supply pipeline may be positioned adjacent to the pipeline retaining projection 122 and then bonded to the frame 100 with adhesive. Alternatively, the gas supply pipeline 6 may be removably secured to the frame 100 through a coupling structure or fastener. In some embodiments of the frame 100, the gas supply pipeline 6 may be permanently connected to the frame 100 using a coupling structure or fastener, or other permanent bonding methods including, but not limited to, ultrasonic welding or overmolding. Additionally, the pipeline retaining projection 122 may be omitted in some embodiments.

[0104] Alternatively, the pipeline retaining projection 122 may be located on the inlet flange surface 118 and project radially outward from the center of the inlet flange 114. In other words, the pipeline retaining projection 122 may form a lip around the outside of the inlet flange 114. In this configuration, the gas supply pipeline 6 may be connected adjacent to the inlet flange surface, as opposed to the inner flange surface 116. The lip may be continuous or intermittent around the periphery of the inlet flange 114.

[0105] In the illustrated configuration, the frame 100 is made of a rigid polymer. In some configurations, the frame 100 may be made of a number of polymer materials or non-polymer materials, such as nylon 12 or polycarbonate.

[0106] Figures 11 and 12 show non-limiting exemplary embodiments of a respiratory mask system 200 which is substantially similar to the respiratory mask system 1 of Figure 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 line 208. The headgear 204 and frame 100 are configured to secure the seal 206 in a stable position below the user's nose.

[0107] Seal 206 is substantially similar to seal 6 described above, and has a reduced contact area with the user's face compared to conventional nasal masks that seal around the user's nose and across or near the nasal bridge. The reduced contact area may result in decreased seal stability, requiring a reaction 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 seal 206 and the user's face. Forces that may interfere with the seal may include, but are not limited to, blow force induced by the pressure of the CPAP therapy being administered, hose drag, and / or contact between the patient interface 202 and bedding resulting from user movement.

[0108] 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 inlet or inlet flange 114 that can supply pressurized air to the seal 206 and the patient's airway. The pressurized air is typically supplied to the gas inlet 114 via a conduit or hose, such as a gas conduit 208 connected to a CPAP machine or ventilator (not shown).

[0109] headgear Figures 11 to 17 show non-limiting exemplary embodiments of the headgear 204, including a bifurcated headgear configuration. The bifurcated headgear 204 includes a top strap 212, a pair of opposing side arms 214, a yoke 216, and a number of connected straps including a rear strap 218. The top strap 212 and the rear strap 218 form a bifurcated configuration.

[0110] The apex strap 212 is configured to pass over the top of the user's head from one side to the other when in use. In the illustrated configuration, the apex strap 212 may include a forehead strap positioned over the user's frontal bone. In this configuration, the apex strap 212 is angled forward of the coronal plane 11 passing over the user's head, as shown in Figure 12. An angle θ of 5° to 45° is formed between the apex strap 212 and the coronal plane 11. In the illustrated embodiment, the apex strap 212 is at an angle of 15° with respect to the coronal plane 11. This angle directs the apex strap 212 towards the patient's forehead, which may improve the stability of the headgear 204. In other configurations, the apex strap 212 is a vertex strap positioned over the parietal bone or at or near the junction of the parietal bone and frontal bone.

[0111] The rear strap 218 passes around the back of the user's head and, in some configurations, is positioned over the user's occipital bone. However, in other configurations, the rear strap 218 can be positioned higher or lower on the user's head and / or neck.

[0112] The top strap 212 and the rear strap 218 are joined at their ends by one of the side arms 214 to form a bifurcated structure. When in use, the top strap 212 and the rear strap 218 surround the occipital region of the user. The occipital region of the user that is surrounded may include at least a portion of the occipital region and / or the occipital region.

[0113] In the illustrated configuration, the top strap 212 connects to the side arms 214 at joints 224 on each side of the headgear 204. Each pair of side arms 214 extends forward from the joints 224 toward the user's nose and transitions into the yoke 216 during use. The headgear 204 is configured such that the joints 224 are positioned above the user's ears during use. The joints 224 may be positioned in front of or behind the ears depending on the user's head size.

[0114] A closed loop formed as a single unit In the illustrated embodiment, at least some portions of the headgear 204 are rigid, semi-rigid, inelastic, or substantially inextensible depending on the normal or expected forces acting on the headgear 204. Other portions of the headgear 204 are elastic or extensible, or at least substantially more flexible than the other portions, depending on the normal or expected forces.

[0115] In the illustrated configuration, the top strap 212, joint 224, side arms 214, and yoke 216 are rigid, semi-rigid, inelastic, or substantially inextensible. The top strap 212, side arms 214, and yoke 216 are formed as a single, integrally formed component that is flat or substantially two-dimensional, as shown in Figure 13. A three-dimensional closed loop is formed when the free ends of the left portion 220 and the right portion 222 of the top strap 212 are connected to each other by the adjustment mechanism 228. The closed loop is configured to enclose at least a portion of the user's head when in use. In the illustrated embodiment, the closed loop encloses the front upper portion of the user's head from the base of the nose to the parietal bone in front of the ears. In alternative embodiments, the closed loop may enclose a larger or smaller portion of the user's head.

[0116] By using rigid, semi-rigid, inelastic, or substantially non-stretchable materials for the top strap 212, side arms 214, and yoke 216, the closed loop they form can effectively transmit force between the patient interface 202 and the user's head. For example, during use, if the gas supply line is pulled by the user, bedding, or CPAP supply line, a force may be applied to the patient interface 202 pulling it 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 seal 206 being pulled away from the user's face by the longitudinal rotation of the seal 206.

[0117] The closed-loop configuration allows the headgear 204 to be detached from the patient interface 202 without changing the tightening setting of the top strap 212. This is advantageous because the user does not need to loosen or tighten the headgear 204 and readjust the strap to the correct tightness each time the headgear 204 is removed from the patient interface 202. This saves time and makes attaching the headgear easier for the user. The closed-loop configuration also provides a single point of connection between the headgear 204 and the patient interface 202.

[0118] In other words, the integrally formed components that form a closed loop are rigid, semi-rigid, inelastic, or substantially non-stretchable. In the illustrated embodiment, the top strap 212, side arms 214, and yoke 216 are integrally formed from a plastic material forming a plastic core, covered with a fabric casing, which is permanently bonded 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 to the user. In the illustrated embodiment, the fabric casing is a circular braided tube. In alternative embodiments, the fabric casing may include several layers of fabric cut into a certain shape and joined along the edges, or any other tubular fabric, including, but not limited to, woven or braided tubes. In some embodiments, at least a portion of the integrally formed top strap 212, side arms 214 and yoke 216 is formed by an internal molding process, an example of which is described in the present applicant's PCT / New Zealand Patent Application Publication No. 2015 / 050149, which is incorporated by reference in whole. "Internal molding" includes forming components as a plastic core and fabric casing as a single structure by adding molten plastic into a fabric casing. An internally molded strap or any other component is a component formed by adding molten plastic into a fabric casing.

[0119] Figure 13 shows that the headgear 204 of the illustrated embodiment has a top strap 212 and side arms 214 including a soft edge 250. The soft edge 250 is 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 a fabric casing that protrudes from the edge of a plastic core and is not filled with the plastic core. The soft edge provides a cushioned edge that can improve user comfort by mitigating contact between the rigid, semi-rigid, inelastic, or substantially instretchable edges of the top strap 212 and side arms 214 and the user's head. Providing a cushioned edge may be particularly beneficial at the lower edge of the side arms 214, which are positioned above the user's ears when in use.

[0120] In alternative embodiments, the closed loop may be formed from any material that provides suitable rigidity, inelasticity, or non-stretchability. The material may include, but is not limited to, thermoplastics and silicones. In some embodiments, the material may or may not have a fabric casing.

[0121] 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 a free end and a fixed end. The free end is configured to be adjustablely connected by an adjustment mechanism 228. The fixed end is configured to extend at an angle from the side arm 214 at the joint 224.

[0122] The adjustment mechanism 228 is configured to adjust and fix the top strap 212 to a desired adjustment length, and thus provide a means for adjusting the size and / or tightness setting of the headgear 204. Adjusting the length of the top strap 212 can determine the positioning of the side arms 214 relative to the tops of the user's ears during use. By shortening the length of the top strap 212, the side arms 214 can be positioned higher above the user's ears, thus avoiding contact between the side arms 214 and the user's ears. Since contact between the side arms 214 and the tops of the user's ears can result in irritation or pressure points that may cause pressure sores over time, avoiding contact between the side arms 214 and the ears may improve user comfort.

[0123] Figure 13 shows the adjustment mechanism 228 in the disengaged position. The free end of the left portion 220 includes a guide loop 230 and a number of holes 232 spaced apart along the length of the strap. The holes 232 extend through the thickness of the top strap 212. The free end of the right portion 222 includes a pip or support 234 protruding from the inner surface 236 of the strap.

[0124] The guide loop 230 includes a loop structure that forms an opening at the end of the left portion 220. The free end of the right portion 222 is configured to pass through the opening formed by the guide loop 230. Thus, the left portion 220 and the right portion 222 can slide against each other to change the overlapping distance between the left portion 220 and the right portion 222, and thus change the length of the top strap 212. The guide loop 230 also maintains the connection between the left portion 220 and the right 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 allows the right portion 222 to pass through the guide loop 230 and overlap with the left portion 220 without bending or deformation of the left portion 222.

[0125] The strut 234 is configured to pass through either of the holes 232. As shown in Figure 14, the strut 234 includes a stem 238 and a head or cap 240. The strut 234 shown is substantially T-shaped, but other shapes can also be used, such as a cylindrical stem 238 and a disc-shaped or spherical head 240. The hole 232 is sized, shaped, and / or otherwise configured to allow the head 240 of the strut 234 to pass through the hole 232 and hold the strut 234 once it has passed through the hole 232, at least according to normal or expected forces. However, the strut 234 can be intentionally removed from the hole 232 to allow for the separation of the left portion 220 and the right portion 222 of the top strap 212, thereby allowing for the sizing of the headgear. Passing the strut 234 through the hole 232 can be achieved by deformation of either or both of the strut 234 and the hole 232. That is, the head 240 of the support column 234 can bend or otherwise deform, and the hole 232 can be extended or enlarged to facilitate the passage of the head 240 of the support column 234. In an alternative embodiment, there may be multiple support columns.

[0126] In an alternative embodiment, the adjustment mechanism 228 may include, but is not limited to, any other suitable means for adjustably connecting the free end of the top strap 212, such as hook-and-loop fasteners or buckles.

[0127] In an alternative configuration, the inner surface 236 of the left portion 220 may include the hook portion of the hook fastener, and the outer surface 242 of the right portion 222 may include the loop portion of the hook fastener. This configuration can also be reversed. In some configurations, the material of the top strap 212 may define the loop portion of the hook fastener. In other words, the loop portion does not have to be a separate element of the top strap 212.

[0128] Side arm The opposing pair of lateral arms 214 are configured to connect the yoke 216 to the top straps 212 on each side of the user's face during use. This arrangement allows the rotational force applied to the patient interface 202 to resist rotation of the seal 206 against the user's face to be transmitted from the yoke 216 to the top straps 212 and the user's head.

[0129] The lateral arm 214 includes an elongated strap shaped to curve across the user's cheek and towards the temple, extending over the ear, during use. The curvature is such that the lateral arm 214 avoids the eye, providing an uninterrupted field of vision and improved user comfort. The curvature is such that the contact between the lateral arm 214 and the user's cheek transmits force away from the patient interface 202, so as not to impede the seal with the user's face.

[0130] The side arms 214 further include buckles 226 integrally formed at each free end of the side arms 214. When in use, the free ends of the side arms 214 extend rearward beyond the joint 224 with the top strap 212, and the buckles 226 are positioned either above or behind the user's ears.

[0131] 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 the rear strap 218. In another embodiment, the buckle 226 may include a hook or other arbitrary geometric shape suitable for adjustable mooring the rear strap 218.

[0132] The side arms 214 may be elastically flexible in the direction toward and away from the user's face in a generally horizontal plane (when worn) to accommodate different face sizes, but relatively inflexible in a generally longitudinal plane. The illustrated side arms 214 are solid, but other variations of the side arms may include one or more openings or notches extending in the longitudinal direction of the side arm to increase the elastic flexibility of the side arm toward and away from the user's face, while maintaining relative inflexibility in a generally longitudinal plane (when worn). The longitudinal inflexibility of the side arms 214 allows the side arms 214 to transmit forces that may be applied to the patient interface 202, such as blow force or hose drag / tensile force, to the top strap 212 and rear strap 214. This can help reduce the possibility of the seal 206 coming off the user's face and interfering with the delivery of treatment.

[0133] yoke When in use, the yoke 216 is symmetrical with respect to the sagittal plane and, as in Figure 16, includes a substantially "U" shaped structure when viewed from above. The yoke 216 follows the curvature of the frame 100 and is configured to connect the patient interface 202 to the headgear 204 via the frame 100. The yoke 216 includes a central bridge 244 and pairs of lateral rear portions 248 extending laterally and rearward from each side of the central bridge 244. The yoke 216 provides a single connection point between the headgear 204 and the frame 100, independent of any other feature parts of the frame 100. This allows the headgear 204 to be detached from the frame without interfering with or detaching any other part of the patient interface 202.

[0134] 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 longitudinal and horizontal directions relative to the user when the respiratory mask 200 is worn. By supporting the patient interface 202 in the longitudinal and horizontal directions, rotation of the seal 206 relative to the user's face is reduced, and therefore leakage can be reduced.

[0135] The central bridge 244 is shaped to fit into the groove 106 of the frame 100 (described above). The central bridge 244 is configured to be temporarily or permanently connected to the groove 106 by means of means such as, but not limited to, snap-fit ​​connections, friction-fit connections, fastening mechanisms, adhesives, or welding. The central bridge 244 curves over the entrance flange 114 of the frame 100 and transitions into the lateral rear portion 248.

[0136] The lateral rear portion 248 forms a transition section integrally formed between the central bridge 248 and the side arms 214. The lateral rear portion 248 is positioned laterally to the central bridge 244 when the breathing mask 200 is worn by the user, and curves rearward around the frame 100.

[0137] As shown in Figure 16, the central bridge 244 has a height H1 that is smaller than the height H2 of the lateral rear portion 248 of the yoke 216. Height H1 is smaller than height H2 to minimize the size of the frame 100. Height H2 is larger than height H1 to provide a desired level of structure longitudinally for the purpose of preventing rotation of the patient interface 202 relative to the user's face. H1 may be 1 mm to 12 mm or 4 mm to 7 mm. In the illustrated embodiment, H1 is 5.5 mm. H2 may be 5 mm to 16 mm or 8 mm to 13 mm. In the illustrated embodiment, H2 is 12.5 mm.

[0138] The lateral arm 214 may be continuous with the lateral rear portion 248 at a height equal to or greater than H2. In some embodiments, the height of the lateral arm 214 increases away from the yoke 216. The transition between H1 and H2 occurs between the central bridge 244 and the lateral rear portion 248. The lateral rear portion 248 is configured to contact the frame 100 until its height fully transitions to the height of H2. This configuration allows for structural support of the yoke 216 to its maximum height so that there are no unsupported portions of the lower yoke 216 or lateral arm 214 that could form weak points. This allows forces to be transmitted from the frame 100 through the yoke 216 to the lateral arm 214 without passing through weak points that could result in longitudinal twisting or bending of the lateral arm 214 or yoke 216, allowing rotation of the patient interface 202. In some embodiments, the height of the lateral arm 214 is 16 mm or less to provide a minimal breathing mask.

[0139] Figure 16 shows that the soft edge 250 of the side arm 214 is gradually transitioned so that the soft edge 250 is no longer present on the yoke 216. This transition of the soft edge 250 can provide an improved connection between the yoke 216 and the frame 100 by providing a rigid, semi-rigid, inelastic, or substantially non-stretchable edge that can be engaged by the groove 106 of the frame 100. The soft edge 250 is not necessary on the edge of the yoke 216 because the edge of the yoke 216 is unlikely to come into contact with the user and cause discomfort or irritation. The size of the yoke 216 can be minimized by gradually transitioning the soft edge 250 so that it does not come into contact with the user. Thus, the size of the yoke 216 can be minimized to provide a less cumbersome breathing mask system 200.

[0140] Figure 17 shows that, in the illustrated embodiment, the lateral rear portion 248 of the yoke 216 has a wall thickness T1 perpendicular to the inner surface 236, which is greater than the wall thickness T2 of the central and side arms 214 of the yoke 216. The increased thickness provides an increased structure to the outermost lateral portion of the yoke 216 that contacts the frame 100. This allows for effective force transmission from the side arms 214 to the frame to minimize longitudinal rotation of the patient interface 202. The lateral rear portion can have a thickness T1 of 1 mm to 4 mm. In the illustrated embodiment, the thickness T1 is 2.9 mm. The central bridge 244 and side arms 214 have a thickness T2 of 0.5 mm to 3 mm. In the illustrated embodiment, T2 is 2.1 mm.

[0141] The reduced thickness T2 of the side arm 214 relative to the larger wall thickness T1 of the lateral rear portion 248 of the yoke 216 can increase the horizontal flexibility of the side arm 130 relative to the yoke 216 (when worn). This allows the side arm 214 to flex horizontally to conform to different facial geometric shapes while providing longitudinal stability when the breathing mask 200 is worn by the user.

[0142] Rear strap The rear strap 218 includes an elongated strap that extends between the buckles 226 of the side arms 214 and connects around the buckles 226 of the side arms 214. The ends of the rear strap 218 are adjustablely secured through openings in the buckles 226 so that the length of the rear strap 218 can be adjusted. By adjusting the length of the rear strap 218, the overall size of the headgear 204 can be further adjusted to fit individual users.

[0143] In the illustrated configuration, the rear strap 218 is elastic or stretchable. Such an arrangement allows the rear strap 218 to stretch to adjust the circumferential length of the headgear 204. The amount of stretching of the rear strap 218 can be limited, and therefore the rear strap 218 may be length-adjustable as previously described. In some configurations, it is preferable that the circumferential length adjustment is performed at the back of the user's head, where it is less affected by stretching in response to blowing force. The rigid, semi-rigid, inelastic, or substantially instretchable nature of the joints 224 and side arms 214 positioned on the sides and front of the user's head helps maintain the desired circumferential length of the headgear 204, despite the elastic nature of the rear strap. In some cases, frictional forces between the headgear 204 and the sides and front of the user's head prevent the headgear 204 from moving or stretching in response to blowing force. However, in other configurations, the rear strap 214 may be rigid, semi-rigid, inelastic, or substantially instretchable, and in such cases, its length may be adjustable.

[0144] In the illustrated embodiment, the rear strap 218 includes, but is not limited to, a length of laminated fabric and foam, such as Breathhoprene®. The rear strap is elastic so that it can be stretched, allowing the headgear 204 to be pulled 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 may include any suitable fabric or woven material.

[0145] The rear strap 218 has two side ends 244 (shown in Figure 12) configured to pass through the buckle 226 and fold back to itself, 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 hook fasteners, but are not limited to these. The overlap between the folded side ends 244 and the rest 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 hook fasteners (such as hook fasteners of the Velcro® brand, but are not limited to these). The fastening tabs are configured to fasten 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 material that provides the loop components of the hook fastener. In an alternative embodiment, the arrangement of this hook fastener can be reversed so that the hook component is located on the outer surface of the rear strap 218.

[0146] Alternative headgear embodiment Figures 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 the same as those of the previous embodiment of the headgear 204 are denoted by the same reference numeral plus 100. For example, headgear 204 becomes headgear 304 in this embodiment. For brevity, only those features that are substantially different from the previous embodiment are described in detail here. It should be understood that all other features are substantially the same as those described with respect to headgear 204.

[0147] The headgear 304 includes a top strap 312, a pair of opposing side arms 314, a yoke 316, and a rear strap 318. As in the previous embodiment, the top strap 312, side arms 314, and yoke 316 are rigid, semi-rigid, inelastic, or substantially instretchable and are formed as a single, integrally formed component. The single, integrally formed component can be arranged to form a closed loop that encloses the front upper portion of the user's face when in 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 previously described. As shown in the figure, 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 may include grip tabs 319, which are advantageous for adjusting and / or securing the rear strap 318 and may allow the user to more easily grasp the ends of the rear strap 318. The top strap 312 can be adjusted by an adjustment mechanism 328.

[0148] The yoke 316 of this embodiment is configured to provide a connection between the headgear 304 and the patient interface (which may be similar to the patient interface 202, though not shown). The yoke 316 is symmetrical with respect to the sagittal plane (shown in Figure 19) when in use and includes a loop structure formed by an upper bridge 350 and a lower bridge 352 joined by the respective front ends of the side arms 314. The upper bridge 350 and the lower bridge 352 are configured to be removablely connected to the frame (which may be similar to the frame 100, though not shown) around the entrance flange or around the frame connection. The upper bridge 350 and the lower bridge 352 are curved 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 entrance flange. This curved shape may be configured to fit onto the outer periphery of the frame in order to reduce the overall size of the patient interface.

[0149] 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 forces can be transmitted from the frame to the headgear 300. That is, by providing two paths, rotational forces can be evenly distributed so as not to be biased in the direction of upward or downward rotation.

[0150] Alternative frame embodiment Figure 20 shows another non-limiting exemplary embodiment of the 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 line 408. In some embodiments, the frame 410 has a reduced or smaller overall contour compared to the frame 100. The headgear 404 and frame 410 are configured to secure the seal 406 in a stable position below the user's nose when in use.

[0151] Seal 406 may be substantially similar to seal 6 described above and have a reduced contact area with the user's face compared to conventional nasal masks that seal around the user's nose and across or near the nasal bridge. The reduced contact area may result in decreased seal stability, which may require a reaction from the headgear 404 to prevent leakage and loss of treatment. The headgear 404 is configured to provide support to counteract forces that may act to break the seal between seal 406 and the user's face. Forces that may interfere with the seal may include, but are not limited to, blow force induced by the pressure of the CPAP therapy being administered, hose drag, and / or contact between the patient interface 402 and bedding resulting from the user's movement.

[0152] The frame 410 shown in Figures 21-23B and 26A-32B provides a connection between the seal 406 and the headgear 404. Like frame 100, frame 410 has an outer surface 412, an inner surface 413, and a fluid path 415 extending through the outer surface 412 and the inner surface 413 as shown in Figures 21-23B. The outer surface 412 and the inner surface 413 extend from a first side edge 422 to a second side edge 424. The outer surface 412 faces away from the user during use and acts as an interface between frame 410, the headgear (such as headgear 404), and the gas supply pipeline (such as gas supply pipeline 408). The inner surface 413 faces the user during use and may contact the seal 406 and / or the coupling structure connected to the seal 406. During use, the gas supply pipeline 408 is connected to the frame 410 so that it is in fluid communication with the fluid path 415.

[0153] 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 positioned 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 of the frame 410, while the concave surface 426 is above the raised surface 428 and / or adjacent to the top edge of the frame 410. The inlet flange 430 protrudes outward from the outer surface 412 (towards the user when in use). The inlet flange 430 surrounds the fluid path 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 inlet flange inner surface 432 (which defines the fluid path 415) and an inlet flange surface 434 (located outside the inlet flange 430). In some embodiments, the inlet flange surface 434 can be considered as part of the outer surface 412 or as partially defining the outer surface 412. In the illustrated embodiment, the inlet flange 430 includes a pipe-holding projection 436 (shown in Figure 22). The inlet flange 430 may include one or more bias holes 438.

[0154] The outlet flange 440 protrudes inward from the inner surface 413 (towards the user when in use). In some embodiments, the outlet flange 440 has an outlet flange surface 444 which can be considered as part of the inner surface 413 or as partially defining the inner surface 413. The outlet flange 440 may include one or more seal-retaining recesses 446. The seal-retaining recesses 446 enable interaction and / or connection between the frame 410 and the seal 406. In some embodiments, the seal-retaining recesses 446 enable interaction and / or connection with a coupling structure such as a fastener that connects the frame 410 and the seal 406. In the illustrated embodiment, the outlet flange surface 444 includes the seal-retaining recesses 446.

[0155] The fluid path 415 is defined or formed by an inlet flange 430 and an outlet flange 440. During use, the gas supply pipeline 408 is coupled to the inlet flange 430, and the seal 406 is coupled to the outlet flange 440. Gas can be delivered from the gas supply pipeline 408 to the seal 406 through the fluid path 415 (i.e., through the inlet flange 430 and the outlet flange 440) to be delivered to the user.

[0156] In the illustrated embodiment, the entrance flange 430 may be oval and may have a major axis 113 and a minor axis 111. In some embodiments, the entrance flange 430 may have a circular, triangular, "D" shape or other shape. In the illustrated embodiment, the frame 410 is symmetrical with respect to the minor axis 111 or the longitudinal axis 105. In the illustrated embodiment, the length dimension D of the opening defined by the entrance flange 430 major (As shown in Figure 23B) is 21.9 mm or approximately 21.9 mm, and the short dimension D of the opening minor It is 16.7 mm or approximately 16.7 mm. In other words, the ratio of the length to the length is 1.31:1 or approximately 1.31:1.

[0157] In the illustrated embodiment, the lateral dimension (or width) W of the frame 410 (as shown in Figure 23B) is 49.3 mm or approximately 49.3 mm. Therefore, the ratio of the length of the opening defined by the entrance flange 430 to the lateral dimension W of the frame 410 is 1:2.25 or approximately 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 headgear 404. In some embodiments, the lateral dimension of the frame 410 may range from 30 mm (or approximately 30 mm) to 75 mm (or approximately 75 mm).

[0158] In the illustrated embodiment, the longitudinal dimension (or height) H of the frame 410 (as shown in Figure 23B) is 28.0 mm or approximately 28.0 mm. Therefore, the ratio of the short dimension of the opening defined by the entrance flange 430 to the longitudinal dimension of the frame 410 is 1:1.68 or approximately 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 headgear retaining features, as described herein, in order 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 suitable structure that allows the headgear 404 to connect effectively 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 may range from 20 mm (or approximately 20 mm) to 50 mm (or approximately 50 mm). The vertical dimensions can be varied to accommodate different seal sizes, headgear contours, and / or headgear connection methods or mechanisms.

[0159] In the illustrated embodiment, the proximal dimension (or thickness) T of the frame 410 (as shown in Figure 26B) is 17.05 mm or approximately 17.05 mm. As shown in the side views of Figures 26A and 26B, the entire peripheral or distal end of the inlet flange 430 (in other words, the rim of the inlet flange 430 furthest from the user during use) is not aligned with the illustrated longitudinal axis 105. The longitudinal ends of the inlet flange 430 (in other words, the top and bottom) intersect the longitudinal axis, but the central portion of the inlet flange 430 (in other words, the side or lateral end) is shifted proximal (or toward the user during use). In other words, when viewed from the side (similar to Figures 26A and 26B), the peripheral edge of the inlet flange 430 is a recess facing distal (or a recess facing away from the user during use). The concave contour can, advantageously, allow 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 transverse ends of the distal end of the inlet flange 430 provide beneficial behavior when a gas supply pipeline, such as a gas supply pipeline 408, is coupled to the inlet flange 430. For example, if the gas supply pipeline 408 is removably coupled to the inlet flange 430 by, for example, press-fit, snap-fit ​​or other connection cooperating with a pipeline retaining projection 436, it may be difficult to unintentionally remove the gas supply pipeline 408 when an axial force is applied (axially to the inlet flange 430 and / or the gas supply pipeline 408). Therefore, the oval shape and / or concave distal end of the inlet flange 430 can prevent unintentional removal of the gas supply pipeline 408. However, the gas supply pipeline can be removed from the frame 410 more easily or with less effort if the gas supply pipeline is twisted around the axial axis of the inlet flange 430.

[0160] The frame 410 may include various headgear retaining features. The retaining features are used to connect the frame 410 to the headgear 404, as shown in Figure 25. In the illustrated embodiments of Figures 21 to 23B, the frame 410 includes two retaining features 450 located in the concave surface 426. More or fewer retaining features 450 are also possible. As shown, each retaining feature 450 is offset laterally from the longitudinal axis or spaced laterally from the longitudinal axis, with one of the retaining features 450 located on each side of the longitudinal axis. In the illustrated embodiments, the retaining features 450 are circular holes. In some embodiments, the retaining features 450 are oval, rectangular, "D" shaped (as shown in Figure 24C), or other shaped holes. In some embodiments, the two retaining features 450 are different from each other. The different shapes of the left and right headgear retaining features 450 can help guide the user when properly connecting the headgear 404 to the frame 410. In some embodiments, the headgear retaining features 450 have an anti-rotation shape and / or anti-rotation feature. The headgear 404 may include projections corresponding to the retaining features 450, which are designed to fit into the retaining features 450. The projections can be secured to the retaining features 450 and the frame 410 via snap fastening or other preferred means. In some embodiments, the retaining features 450 may be a structure that protrudes outward from a concave surface 426, as shown, for example, in Figure 24D. In some such embodiments, the headgear 404 may include corresponding holes to receive the retaining features 450. In the illustrated embodiment, each of the retaining features 450 is a circular projection with a central groove extending between two semicircular or generally semicircular sides or portions and / or dividing the retaining features 450 into two semicircular or generally semicircular sides or portions. The projections can be secured to correspondingly sized holes in the headgear 404 via snap fastening or other suitable means. In some embodiments, the retaining feature 450 may include one or more magnets or magnetic materials that attract one or more magnets or magnetic materials within the headgear 404.

[0161] As described above, in the illustrated embodiment, the frame 410 includes two retaining feature portions 450. Including two retaining feature portions 450 and / or using a circular retaining feature portion 450 is advantageous in that it allows for easy attachment and detachment of the headgear 404 to and from the frame 410. As shown in Figure 24A, the first retaining feature portion of the retaining feature portion 450 can be used to connect the frame 410 and the headgear 404 at a certain angle. The frame 410 can then be rotated around the first retaining feature portion 450 so that the second retaining feature portion of the retaining feature portion 450 can be connected to the headgear 404, as shown in Figure 24B.

[0162] In the illustrated embodiment, the inlet flange 430 or inlet flange surface 434 is inclined at an angle θ such that, as shown in Figures 28 and 29C, the diameter of the base of the inlet flange 430 closest to the user during use is greater than the diameter of the peripheral edge of the inlet flange 430 furthest from the user during use. A Only the angle is adjusted. The inlet flange 430 may resemble a hollow frustoconical shape. The angle of the inlet flange 430 (approximately or nearly perpendicular to the inclined inlet flange 430 or inlet flange surface 434) is such that or allows the air passing through the bias vent 438 to be directed away from the user's face. This advantageously prevents or reduces the possibility that the user may feel airflow and / or entrainment through the bias vent 438.

[0163] The first inclination angle can be defined as the angle between the top (or the uppermost vertical end) of the entrance flange 430 or entrance flange surface 434 and an axis parallel to the proximal axis, and can be located at the intersection of the entrance flange 430 and the outer surface 412 or raised surface 426 of the frame 410, as shown in Figure 28. The second inclination angle θ A2The angle can be defined as the angle between the lateral side of the inlet flange 430 or 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 raised surface 428 of the frame 410, as shown in Figure 29C. In some embodiments, the inclination angle may be in the range of about 10° to about 15°. In the illustrated embodiment, the first inclination angle is about 10°, the second inclination angle is about 15°, and the inclination angle transitions from about 10° to about 15° between the top and side of the inlet flange 430. In some embodiments, the inclination angle may be a constant angle around the entire inlet flange 430. In some embodiments, the inclination angle may vary around the inlet flange 430. In some embodiments, the inclination angle may be in the range of about 0° to about 90°, for example, about 0°, about 45°, or about 90°.

[0164] In the illustrated embodiment, each bias hole 438 is offset or spaced equally from the distal end of the inlet flange 430. In other words, the arrangement of the bias holes 438 follows the contour of the distal end or periphery of the inlet flange 430, such that bias holes 438 located at or near the longitudinal end (top or bottom) of the inlet flange 430 are located distal to or farther from the user during use than bias holes 438 located at or near the lateral side of the inlet flange 430. In some embodiments, the arcs connecting the bias holes 438 are parallel or substantially parallel to the periphery of the inlet flange 430. Maintaining a constant and controlled distance between the bias holes 438 and the periphery of the inlet flange 430 allows for better and easier control of noise generated by the flow through the bias holes 438. The distance between the bias hole 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 hole 438. In the illustrated embodiment, the bias hole 438 is positioned 3.1 mm or approximately 3.1 mm from the periphery of the inlet flange 430. In the illustrated embodiment, the bias hole 438 is located at the midpoint or approximately midpoint of the length of the inlet flange 430.

[0165] In the illustrated embodiment, as shown in Figure 26D, the bias vents 428 are positioned around or on a portion of the inlet flange 430. The portion of the inlet flange 430 containing the bias vents 428 is positioned at an exhaust angle θ defined 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 in the illustration. E It can be defined by the following. In some embodiments, the exhaust angle and / or bias vent 428 can range from about 4:00 to about 8:00 (similar to a clock). In some embodiments, the exhaust angle and / or bias vent 428 can range from about 5:00 to about 7:00 or from about 3:00 to about 9:00. In some embodiments, the exhaust angle may 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 may be 360°. In other words, in some embodiments, the bias vent 428 can extend around the inlet flange 430 or completely surround the inlet flange 430.

[0166] As shown in Figure 26C, in the illustrated embodiment, the biased flow hole 438 extends through the inlet flange 430 in a direction perpendicular or approximately perpendicular to the inlet flange surface 434 and / or the inlet flange inner surface 432. In some embodiments, as shown by the dashed line in Figure 26C, the biased flow hole 438 can extend through the inlet flange 430 at an angle θ with respect to the perpendicular. The angle θ may be in the range of about ±10° to about ±45°, for example, ±10°, ±25°, or ±45°. As shown, a biased flow hole 438 oriented at a positive angle extends such that the hole is closer to the periphery of the inlet flange 430 on the inlet flange surface 434 than on the inlet flange inner surface 423. An angle of 0° or more is advantageous because it can guide the flow through the biased flow hole 438 in a direction away from the user during use.

[0167] As shown in Figure 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. Major axis dimension D of the outlet flange 440o-major is the dimension of the opening defined by the proximal end or proximal edge of the inlet flange 440 along the major axis line 119 at the position where the opening has the maximum lateral dimension. In some embodiments, the outlet flange 440 can have a circular, triangular or other shape. 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 line 121 shown in FIG. 27A, which is parallel to and / or aligned with the longitudinal axis. 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 line corresponds to or is located at the same position as the lateral axis. In some embodiments, the outlet major axis line 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.

[0168] 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.

[0169] In some embodiments, the outlet flange 440 or a portion of the outlet flange 440, for example, the rim 441 of the outlet flange in the illustrated embodiment, is a different color from the rest of the frame 410. In some embodiments, the majority of the frame 410 may be transparent, and the outlet flange 440 or a portion of the outlet flange 440 may be transparent blue. In some embodiments, the majority of the frame 410 may be transparent, and the outlet flange 440 or a portion of the outlet flange 440 may be opaque. In some embodiments, the majority of the frame 410 may be opaque, and the outlet flange 440 or a portion of the outlet flange 440 may be transparent. The different color (and / or transparency) of the outlet flange 440 or a portion thereof can advantageously give the user 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, when in use. As shown in Figure 29B, the proximal rim 441 extending to a specific depth of the exit flange 440 may 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 the rest of the frame 410. In some embodiments, the exit flange 440 and / or the inlet flange 430 may be made from a material in which at least one characteristic differs from the material of the majority of the frame 410 or the rest of the frame 410. For example, the exit flange 440 may be made from a material in which at least one characteristic differs from the material of the inlet flange 430. In such embodiments, the frame 410 may 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 from a single material and / or the material of the inlet flange 430 is not different from the material of the outlet flange 440.

[0170] Figure 32A shows a cross-sectional view taken along line 32A-32A in Figure 31. The cutting line is central to the frame 410 and aligned with the longitudinal axis. Figure 32B shows a 2D view of the cross-section in Figure 32A. The thickness of the frame 410 or the thickness of various parts of the frame 410 can be selected to give the frame 410 sufficient rigidity in use while reducing or minimizing the weight and / or contour of the frame 410. In some embodiments, the concave surface 426 (or the frame 410 in the area of ​​the concave surface 426) has a thickness of 1.5 mm or about 1.5 mm t rs It has. In some embodiments, the inlet flange 430 has a thickness of 1.46 mm or about 1.46 mm. ic In some embodiments, the conduit retaining projection 436 protrudes 0.5 mm or about 0.5 mm inward from the inner surface of the inlet flange 432. 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 of 1.5 mm or about 1.5 mm. oc It has the following characteristics. Other thicknesses are also possible for the inlet flange 430, the concave surface 426 (or the frame 410 in the area of ​​the concave surface 426) and / or the outlet flange 440. In some embodiments, the frame 410 is made of or contains nylon 12. When the inlet flange 430, the concave surface 426 (or the frame 410 in the area 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 to make the frame 410 exhibit the same or similar hardness by modifying the properties of the compound.

[0171] Alternative headgear embodiment Figures 33-34 show exemplary embodiments of a headgear 404 that can be used with the frame 410. In the exemplary embodiment, the headgear 404 has a bifurcated configuration. The headgear 404 may be similar in some respects to the headgear 204. Features of the headgear 404 that are the same as or similar to the corresponding features of the headgear 204 are referred to herein by the same reference numeral plus 300 (for example, 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.

[0172] The side arms 514 and / or top strap 512 may 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 fabric or includes a fabric. The outer casing can be permanently bonded to the core. A fabric outer casing can advantageously provide a soft and comfortable finish that comes into contact with 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 by the core 549 can form a soft edge 550 as shown in Figure 37. The soft edge 550 can advantageously provide a cushioned edge that can improve user comfort, for example, by mitigating potential contact between the edges of the top strap 512 and / or side arms 514 and the user's head. In some cases, having a cushioned edge may be particularly beneficial at the lower edge of the side arm 514, which is positioned above the user's ears 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 varies from a maximum of 2 mm or about 2 mm at the side end of the side arm 514 (represented as D2 in Figure 37) to a minimum of 1 mm or about 1 mm at the upper projection of the yoke 516 (represented as D1 in Figure 37). In some embodiments, for example, the lower edge of the yoke 516 does not include a soft edge because it is not intended to come into contact with the user's face during use for aesthetic and / or industrial design reasons, tolerances between parts and / or other reasons. The omission of the soft edge in this area allows for an increase in the thickness of the core 549 of the yoke 516, resulting in additional space to improve or increase the structural integrity of that area.

[0173] In the illustrated embodiment, the outer casing 551 is made of a fabric which is a non-stretch or low-stretch yarn. Non-stretch or low-stretch yarns require relatively large forces for elastic deformation. In some cases, yarns with high elasticity do not function well (or better than yarns with low elasticity) in the internal molding process used to form the top strap 512 and / or side arms 514, because the yarn fibers may stretch to such an extent that molten plastic can leak out of the outer casing. By using non-stretch or low-stretch yarn for the side arms 514, the outer casing advantageously improves the finish and / or consistency of the finished side arms 514. Non-stretch or low-stretch yarns reduce or minimize the amount or degree to which the yarn fibers can stretch, thereby preventing or reducing the possibility of plastic stretching and leaking out of the fabric outer casing during the internal molding process. Thus, the use of non-stretch or low-stretch yarns may also help improve the reliability of the manufacturing process. In some embodiments, the fabric outer casing may be made of or contain yarn having some degree of elasticity. Yarn with low elasticity (i.e., requiring a relatively large force to stretch elastically) may function well in the molding process. In some embodiments, the gate 501 for the molding process is located in or near the center of the yoke 516 of the headgear 404, as shown in Figure 35B.

[0174] As described herein, the frame 410 may include a headgear retaining feature 450 in the form of a hole designed to receive a projection 515 of the headgear 404. As shown in Figure 35A, the projection 515, also referred herein as a frame retaining feature, may be located on both sides of the yoke 516. In the illustrated embodiment, each of the projections 515 includes two retaining portions 517 separated by a groove 519, as shown in Figures 35A and 36A-36B. The groove 519 is formed by projections 619 in the mold 600 that fill the area forming the groove 519, as shown in Figure 36C. During molding, the molten plastic can be forced under pressure to pass through the outer casing 551 or out of the outer casing 551 to form the retaining portions 517. The projection 619 of the mold 600 also restrains the fabric or material of the outer casing 551 to prevent or stop the fabric or material of the outer casing 551 from spreading beyond the base of the groove 519, as plastic is present to form the retaining portion 517, as shown by 553 in Figure 36C. The outer casing 551 may be restrained further or alternatively in other ways. For example, if the retaining portion 517 (and / or other projections protruding from the outer casing 551) has a thin profile or dimensions relative to the profile or dimensions of the fabric outer casing 551, the outer casing 551 may not be able to protrude significantly over the projection. This is advantageous in preventing or stopping deformation of the outer casing 551 and / or ensuring that the retaining portion 517 contains or is made of plastic only. Having a retaining feature 517 made of plastic alone or primarily of plastic, rather than including an outer casing, is advantageous in that it can improve the function of the frame retaining feature 515, for example, by enabling the frame retaining feature 515 to snap securely into the headgear retaining feature 450. The groove 519 can further or alternatively allow the retaining parts 517 to flex relative to each other to improve the performance of the frame retaining feature 515, for example, by allowing the frame retaining feature 515 to flex in order to snap securely into the headgear retaining feature 450.

[0175] 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 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 placed 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.

[0176] 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 allows the top strap 512 to be adjusted and fixed to a desired length.

[0177] As shown in Figures 39 to 41, the free end of the second portion 522 includes a guide loop 530, and the second portion 522 includes a plurality of holes 532 spaced apart along the length of the second portion 522 near the free end. In the illustrated embodiment, the guide loop 530 is made of plastic. The guide loop 530 can be formed by a burst-through molding process. "Burst-through molding" is described in the concurrently pending U.S. Patent Application No. 62 / 309,400, U.S. Patent Application No. 62 / 323,459, U.S. Patent Application No. 62 / 364,767, and U.S. Patent Application No. 62 / 401,462 of the present applicant. Burst-through molding is a variation of the internal molding described above. The burst-through molding process involves introducing molten plastic into a fabric casing and injecting the molten plastic into a portion of the fabric casing. The components formed by the burst-through molding process include a single plastic core formed integrally with a fabric casing, and the single 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 the outer casing, such as an extended portion of the outer casing 551. In some embodiments, the guide loop 530 is made of outer casing material only and not of plastic (or other core material), or includes outer casing material only and does not include plastic (or other core material). The first portion 520 includes a projection 534 protruding from the inner surface of the first portion 520 near the free end (i.e., the surface of the first portion 520 facing the second portion 522 when in use). The first portion 520 may 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 projection 534 is passed through and / or secured in one of the holes, for example, by a snap-fit ​​connection.

[0178] The holes 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 joint 524 side), and the parallel casing portions can extend along the length of the second portion 522 containing the holes 532. The parallel casing portions can be rejoined into a single casing behind (or on the free end side of) the last hole 532 (i.e., the hole 532 furthest from the joint 524). The parallel casing portions can be bent toward each other between the holes 532 so that gaps in the woven fabric or material of the casing 551 are not easily observed by the user. In some embodiments, the parallel casing portions do not rejoin behind the last hole 532. In some such embodiments, pressure from the plastic or core 549 material can cause parallel casing portions to move closer to each other behind the final hole 532 so that 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 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 made by post-processing, for example, by punching. In some embodiments, the outer casing 551 can be terminated near the first hole 532 or adjacent to the first hole 532 (on the joint 524 side), and the remainder of the second portion 522 can be formed using a burst-through process so that it consists only of plastic (or other core 549 material).

[0179] In some embodiments, each hole 532 is at least partially surrounded by a peripheral groove 533 (on one or both 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 may include projections that apply pressure to the outer casing 551 during molding to form the groove 533. The projections on the mold can restrict movement of the outer casing 551 during molding. Restricting movement of the outer casing 551 advantageously helps ensure that the periphery of the hole 532 (in other words, the structure of the plastic or other core 549 material inside the boundary of the peripheral groove 533) is plastic (or other core 549 material) entirely or substantially entirely. A periphery 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 tolerances associated with the hole 532.

[0180] In some embodiments, each of the first portion 520 and second portion 522 of the top strap 512 is formed integrally with the adjacent side arm 514, for example, by a burst-through internal molding process. In some embodiments, each of the first portion 520 and second portion 522 is an independent component that is permanently or detachably coupled or connected to the respective side arm 514. For example, as shown in Figure 42, the joint 524 of each side arm 514 includes a joint projection 560. The joint projection 560 can be formed, for example, during the molding of the side arm 514 using a burst-through internal molding process. Each of the first portion 520 and second portion 522 of the top strap 512 includes a concave surface 562 at or near the joint end. The concave surface 562 is either inverse (or generally inverse) to the contour of the joint projection 560, or has a contour corresponding to the contour of the joint projection 560. After molding, each of the joining projections 560 is inserted into the outer casing 551 of the joining end of each first portion 520 or second portion 522 of the top strap 512 and positioned within the concave surface 562. Next, each side arm 514 and each of the first portion 520 and second portion 522 can be welded to each other, for example, using ultrasonic welding, RF welding or other preferred 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 arm 514. In some embodiments, the region of the top strap 512 adjacent to the joint 524 does not include the soft edge 550. In such embodiments, the outer casings 551 are sufficiently fixed to each other without the need to weld the outer casings 551 of the side arm 514 and the top strap 512 together by welding the core 549 of the side arm 514 to the top strap 512. In some embodiments, the joining projection 560 is approximately the same thickness as the rest of the core 549 of the side arm 514. In some embodiments, the joining projection 560 has a reduced thickness. In some embodiments, the joining projection 560 is offset from the central plane of the side arm 514.The reduced thickness and offset joint projection 560 allow the cores 549 of the side arms 514 and top strap 512 to be flush with the boundary between the joint projection 560 and the recess 562 when the joint projection 560 is housed within the concave surface 562.

[0181] In some embodiments, the first portion 520 of the top strap 512 includes a position guide 570 to assist the user in setting and holding a particular headgear setting, length, or size. As shown in Figures 43A–43B, the position guide 570 may 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 slightly larger than the diameter or width of the guide loop 530. Thus, when the first portion 520 of the top strap 512 is slid through the guide loop 530 of the second portion 522, a frictional or resistive force is provided by the contact and interaction between the protruding edges 572 and the guide loop 530. The resistive force can prevent or reduce the possibility of passive movement of the first portion 520 through the guide loop 530. Therefore, the user can disengage the projection 534 from the hole 532, and the resistance can help resist relative movement between the first portion 520 and the second portion 522 in order to maintain the length of the strap 512, unless and until the user applies sufficient force to overcome the resistance. In the illustrated embodiment, the projection edge 572 is curved outward in a convex shape or is dome-shaped. Other shapes or configurations of the projection edge 572 are also possible. For example, the projection edge 572 may be triangular.

[0182] Figures 44-45 show another non-limiting exemplary embodiment of the respiratory mask assembly 600. The respiratory 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 line 608. The frame 610 is similar in some or all features to and / or includes some or all features of the frame 410. The headgear 604 and frame 610 are configured to secure the seal 606 in a stable position below the user's nose when in use. Figures 46-47 show exemplary embodiments of the headgear 604 used with the frame 610. In the exemplary embodiment, the headgear 604 has a bifurcated configuration. Headgear 604 is similar in some respects to headgear 404, for example, headgear 604 has the same or similar overall shape as 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, bottom strap 614, and yoke 616, and / or rear strap 618, are a different color from one or more of the other straps.

[0183] The side arms 614 and / or top strap 612 include a core and an outer casing, similar to, for example, the headgear 504. In some embodiments, the core is made of or includes a plastic material. In some embodiments, the outer casing is made of or includes a fabric.

[0184] 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 Figures 47A to 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, for example, an angle. 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 from 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.

[0185] The free ends of the first portion 620 and the second portion 622 of the top strap 612 are configured to be adjustablely connected by an adjustment mechanism 628. The adjustment mechanism 628 allows the top strap 612 to be adjusted and fixed to a desired length. The adjustment mechanism 628 includes interlocking portions provided on each of the first and second top strap portions 620 and 622. The interlocking portions are selectively engaged in one of a plurality of separate configurations to set the length of the top strap 612. When the interlocking portions are engaged, the first and second top strap portions 620 and 622 are configured to partially overlap. 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 toward the user when in use, and the outer surface of the second portion 622 of the top strap faces toward the user when in use. The interlocking portions can be disengaged and reengaged 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 by different lengths or to different degrees. In some embodiments, the interlocking portion of the first portion 620 includes a female connector and the interlocking portion of the second portion 622 includes a male connector, but in the illustrated embodiment, the interlocking portion of the first portion 620 includes a male connector 628a and the interlocking portion of the second portion 622 includes a female connector 628b.

[0186] As shown in Figures 47A to 48B, the free end of the second portion 622 includes a guide loop 630. The interlocking portion of the second portion 622 includes a plurality of recesses in the form of holes 632 spaced apart 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 interlocking portion of the second portion 622 includes recesses extending into the second portion of the top strap through the outer surface of the second portion 622. As shown in Figures 47A, 49B and 50B, the interlocking portion of the first portion 620 of the top strap includes projections 634 protruding from the inner surface of the first portion 620 near the free end. To adjust and / or secure 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 projection 634 is inserted and / or secured into one of the holes 632, for example by a snap-fit ​​connection.

[0187] In the illustrated embodiment, the interlocking 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 can advantageously provide a neater finish (e.g., concealing loose thread ends) and / or ease of manufacture.

[0188] As shown in Figures 50A to 50C, the first portion 620 of the top strap is provided with or includes a thumb grip 629 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 with or on the opposite side of the projection 634 of the first portion 620 of the top strap. The thumb grip 629 may include a recessed portion (e.g., shown in Figure 50C) and / or a raised rib (e.g., a raised ring shown in Figure 50A). The first portion 620 is provided with or includes a finger grip 631 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 recess or recessed portion. The finger grip 631 is located on the first portion of the top strap on the far or distal (i.e., free end) side of the projection 634. The finger grip 631 is provided on the first portion 620 of the top strap with respect to the thumb grip 629 or on the same side as the thumb grip 629. Thus, the finger grip 631 is located on the first portion 620 of the top strap with respect to the thumb grip 629 or on the opposite side from the thumb grip 629. The thumb grip 629 and / or finger grip 631 advantageously allow the user to grasp the male connector 628a more easily. The thumb grip 629 and / or finger grip 631 further or alternatively provide the user with visual and / or tactile cues on how to grasp and use the adjustment mechanism 628, which improves ease of use. The recess or concave portion of the finger grip 631 thins or reduces the thickness of that portion of the first portion 620 of the top strap. This thinning makes the interlocking portion of the first part 620 of the top strap more flexible, which advantageously allows the user to disengage the interlocking portion. For example, the user can more easily bend and / or lift the male connector 628a away from the female connector 628b.Depending on what is comfortable for the user, the thumb grip 629 can be grasped by the user's thumb or fingers during use, and / or the finger grip 631 can be grasped by the user's thumb or fingers. Figure 51A illustrates the user grasping the finger grip 631 with their fingers and the thumb grip 629 with their thumb, while Figure 51B illustrates the user grasping the finger grip 631 with their thumb and the thumb grip 629 with their fingers. In this regard, the thumb grip 629 and the finger grip 631 are first and second grips that can be interchangeably engaged by the user's thumb and fingers to hold the free end of the first portion of the top strap between the thumb and fingers.

[0189] 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 Figures 52A to 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 its fixed ends. As shown in Figures 53A to 53B, the bottom strap 614 includes at least one alignment post 660 (e.g., two alignment posts 660b in the illustrated embodiment) near each of its ends. The bottom strap 614 includes at least one alignment post 660 (e.g., one alignment post 660c in the illustrated embodiment) positioned at 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 support 660 protrudes through the outer casing onto the inner and / or outer surfaces of the top strap 612. The alignment support 660 abuts against the inner surface of the overmolding mold cavity to assist in the alignment and positioning (e.g., in the thickness direction) of the ends of the first portion 620 and the second portion 622 relative to the front strap 614 within the overmolding mold during manufacturing. The alignment support 660 further or additionally increases the surface area of ​​the top strap 612 available for the overmolding material to adhere to.

[0190] The top strap 612 and / or bottom strap 614 include one or more pinholes 664 that partially extend from the inner surface of the strap into the thickness of the strap. In the illustrated embodiment, the first portion 620 and the second portion 622 of the top strap 612 each include pinholes 664 near their fixed ends, and the bottom strap 614 includes pinholes 664 near each end and pinholes 664 near each burst-through tab 662. The pinholes 664 are designed to receive pins that form part of the overmolding mold during manufacturing. The pins and pinholes 664 engage with each other to hold the strap in place within the overmolding mold and prevent the strap from moving within the overmolding mold, for example, when the overmolding material (e.g., plastic) is injected into the mold.

[0191] During manufacturing, each of the fixed ends of the first section 620 and the second section 622 is aligned with one of the burst-through tabs 662, as shown in Figures 54A to 55B. As shown, the burst-through tabs 662, the fixed ends of the top strap 612 and / or the ends of the bottom strap 614 include recesses 666 on their outer and / or inner surfaces. The recesses 666 advantageously provide an increased thickness of the overmolded material in the overmolded joint 624 and / or an increased surface area for the overmolded material to bond, as shown in Figure 57, thereby improving the mechanical connection between the overmolded joint and the strap and thereby strengthening the joint 624. As shown in Figures 54A to 55B, the burst-through tabs 662 may have a reduced thickness compared to the thickness of the body of the bottom strap 614. This reduced thickness forms a recess for the overmolding material to be filled, and allows the finished overmolded joint 624 to have a thickness equal to or similar to the thickness of the body of the bottom strap 614 and / or top strap 612, as shown in Figures 56A to 58. This prevents the formation of protrusions that could cause discomfort by applying force or pressure to the user's head. In some embodiments, the alignment post 660 has the same or similar thickness as the overmolded joint 624, as shown, for example, in Figure 57. In such embodiments, the alignment post 660 may leave a confirmation mark 661 on the overmolded joint 624. In some embodiments, the overmolded joint 624 overlaps the edge of the bottom strap 614, as shown, for example, in Figures 56A to 56B. This improves the strength of the joint 624 between the top strap 612 and the bottom strap 614. The overmolded joint 624 advantageously provides increased strength to the joint between the top strap 612 and the bottom strap 614, and offers a neater and more aesthetically pleasing finish (compared, for example, to internally molded connections).

[0192] Figure 59 illustrates an exemplary embodiment of a modified geometric shape of the alignment post 660. In the illustrated embodiment, the alignment post is conical. This shape minimizes or reduces the confirmation mark on the overmolded joint 624. The distal end or distal surface of the alignment post 660 (the end or surface of the alignment post 660 away from the strap body) has a reduced diameter, providing a smaller contact area with the inner surface of the overmolded cavity. This allows the strap to be longitudinally positioned within the overmolded mold, while also allowing the overmolded material to cover a wider area of ​​the alignment post 660, which reduces the size of the confirmation mark.

[0193] As shown in Figures 50C and 58, each of the first and second top strap portions has a fabric-wrapped portion and an exposed or plastic portion incorporating an interlocking portion. Each fabric-wrapped portion can be produced by internal molding as described above. Each fabric-wrapped portion has a tab overmolded from its respective exposed portion.

[0194] As shown in Figures 47A to 49B and 56A to 56B, the buckles or rear strap connectors 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 buckles 626 are not covered by an outer casing. The overmolded buckles 626 allow the rear strap 618 to be pulled out more easily through the buckles 626 during assembly and / or adjustment, due to the fact that the overmolded buckles 626 have a lower coefficient of friction than the fabric-covered buckles.

[0195] As shown in Figure 64, each buckle 626 has a width W2 greater than the width W1 of the bottom strap 614, and as a result, the rear strap 618, which has substantially the same width as the bottom strap 614, 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 aligns with the lower edge 614b of the bottom strap 614. This alignment provides a smooth, continuous lower edge of the headgear, reducing the possibility of it digging into the wearer's ears 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.

[0196] Similar to the frame 410 and the headgear 404, the frame 610 includes a headgear retaining feature 650 in the form of a hole designed to receive a projection 615 of the headgear 604. As shown in Figures 60A to 62A, the projection 615, also referred herein as the frame retaining feature or frame retaining feature, can be located on both sides of the yoke 616. In the illustrated embodiment, the projection 615 has a horseshoe-shaped or "U-shaped" cross section with an inlet 619 extending from the outer periphery of the projection 615 toward and / or through the center toward the center of the projection 615. The inlet 619 allows the projection 615 to flex so that it snaps into and / or snaps out of the headgear retaining feature 650.

[0197] 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 (toward 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 portions of the bottom strap 614. The thumb pads 652 advantageously provide increased strength and / or resilience to the yoke 616 such that the yoke 616 is less likely to be permanently deformed and / or fatigued due to repeated removal 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 disconnect the headgear 604 from the frame 610 and / or to 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 toward the ends of the bottom strap 614 and the buckle 626). Thus, the inlet 619 is aligned with the elongated 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 remaining portion of the fabric casing in some embodiments.

[0198] Figure 65 shows another non-limiting exemplary embodiment of the respiratory mask assembly 700. The respiratory mask assembly 700 includes a patient interface and a headgear 704. The patient interface includes a seal 706 configured to connect to a frame 710 and a gas delivery line 708. The mask assembly 700 may be similar to and / or include some or all of the features of the aforementioned embodiments, such as the mask assemblies 600 and / or 400. The headgear 704 and frame 710 are configured to secure the seal 706 in a stable position below the user's nose when in use.

[0199] Headgear 704 is similar in some respects to headgears 604, 404 and / or 204, for example, headgear 704 has the same or similar overall shape as headgears 604, 404 and / or 204 and includes a top strap 712, a pair of opposing side arms (or bottom or front straps) 714, a yoke 716, and a rear strap 718. A buckle or rear strap connector 726 can be fixed onto each end of the bottom strap 714, for example, by overmolding. In embodiments where headgear 704 is made of a core material, such as plastic, covered with a casing, such as fabric, the buckle or rear strap connector 726 can be formed from the core material of headgear 704. For example, the buckle or rear strap connector 726 can be formed through a burst-through process. In the illustrated embodiment, the buckle 726 is a closed loop. Buckle 726 may be wider than the front strap 714 and / or rear strap 718, as shown in the figure. Each buckle 726 is configured to connect to the rear strap 718. The top strap 712 and the rear strap form a bifurcated configuration. The top strap 712 may include a first portion 720 and a second portion 722 that are adjustablely connected to each other by an adjustment mechanism 728, allowing the top strap 712 to be adjusted and secured to a desired length, similar to the top strap 612.

[0200] When in use, the top strap 712 is configured to pass over the top of the user's head from one side to the other. The rear strap 718 is configured to pass around the back of the user's head. The top strap 712 and the rear strap 718 are joined at their ends by the side arms 714 to form a bifurcated structure. In the illustrated arrangement, the top strap 712 connects to the side arms 714 at joints 724 on each side of the headgear 704. Each pair of side arms 714 extends forward from the joints 724 toward the user's nose and transitions into the yoke 716 when in use. When in use, the headgear 704 is configured such that the joints 724 are positioned above the user's ears. The joints 724 may be positioned in front of or behind the ears depending on the size of the user's head. Thus, as shown in the illustration, the buckle 726 is positioned behind the user's ears.

[0201] The mask assembly 700 also includes a headgear connector or fastener 770 coupled to the yoke 716, as shown in Figures 66 to 69B. The fastener 770 may be permanently coupled to, attached to, fitted to, or formed integrally with the yoke 716. In the illustrated arrangement, a portion of the front or side of the fastener 770 faces, contacts, abuts against, and / or secures to the rear or side of the yoke 716. The fastener 770 connects the headgear 704 to the frame 710 when in use.

[0202] The fastener 770 includes a body having a lip 772 projecting forward from the body, for example, a bottom lip 772, as can be seen in Figure 66. The front surface 770a of the lip 772 is exposed or not covered by or in contact with the yoke 716. In other words, the lip 772 projects below the bottom surface or bottom edge of the yoke 716. The lip 772 can be substantially curved, arched, horseshoe-shaped, or partially elliptical. In some configurations, the lip 772 projects from the body of the fastener 770 by a distance equal to or approximately equal to the thickness of the yoke 716 (measured from the front surface of the yoke 716 to the rear surface of the yoke 716 that contacts the fastener 770, as can be seen in Figure 66), or has a thickness equal to or approximately equal to the thickness of the yoke 716. Thus, the front surface of the lip 772 is flush or substantially flush with the front surface of the yoke 716. In other configurations, the lip 772 may be thicker than the yoke 716 or may extend forward beyond the yoke 716. In other words, the lip 772 may protrude from the front body of the fastener 770 by a distance greater than the thickness of the yoke 716, as shown in Figure 67B. The locking projection 774 protrudes inward toward the center of the arc or horseshoe shape. The locking projection 774 is positioned at the end of the lip 772, for example, the side end, adjacent to the side end, or in the vicinity of the side end.

[0203] The rear surface 770b of the fastener 770 includes a frame contact portion 776 and a raised portion 778, as shown in Figures 67-68. The frame contact portion 776 can be curved, arched, horseshoe-shaped, or partially elliptical. The frame contact portion 776 extends along or near the bottom edge of the fastener 770 and follows the shape and / or contour of the lip 772. The raised edge portion 780 extends along and / or defines the boundary between the frame contact portion 776 and the raised portion 778. In the illustrated arrangement, the raised edge portion 780 is a shoulder or surface form that extends substantially perpendicular to the surface of the frame contact portion 776 and / or the surface of the raised portion. Thus, the frame contact portion 776 is defined between two elliptical arcs. In other words, the raised edge 780 forms a larger first elliptical arc, and the inner or bottom edge of the rear surface of the fastener 770 forms a smaller second elliptical arc. The inner or bottom edge, or the smaller second elliptical arc, is shaped to correspond to or coincide with the geometric shape of the frame 710. The raised portion 778 is thicker than the frame contact portion 776. The top edges of the fastener 770 and / or the raised portion 778 can follow or correspond to the contour of the top edge of the yoke 716, as shown in Figure 67. Preferably, the raised portion 778 has a surface area large enough to allow a secure connection to the yoke 716, but is sized not to extend beyond the boundary or upper periphery of the yoke 716.

[0204] To assemble the fastener 770 and the yoke 716, the fastener 770 may be manufactured to have one or more mounting recesses or mounting openings 782, as shown in Figure 69A (and also in Figures 87 and 88), and the yoke 716 may be manufactured to have one or more corresponding projections 784. The projections 784 may be formed by a burst-through process as described herein. In the illustrated embodiment, the fastener 770 includes three mounting recesses or mounting openings 782, and the yoke 716 includes three corresponding projections 784. More or fewer recesses or openings 782 and corresponding projections 784 are also possible. The fastener 770 and the yoke 716 are assembled such that the projections 784 extend into the recesses or openings 782, and the connecting structure is overmolded or otherwise formed on the assembly of the fastener 770 and the yoke 716 to secure the fastener 770 and the yoke 716 to each other. The overmolded portion 787 (shown in Figure 69B and represented by the outline 786 in Figure 69A) extends across at least a portion of the rear surface of the fastener 770 and over the projection 784. Such arrangement provides a clean and attractive appearance by covering the recess or opening 782 and the projection 784, while also ensuring a secure connection between the fastener 770 and the yoke 716. In other configurations, the fastener 770 and the yoke 716 can be joined by a snap-fit ​​or other preferred type of connection. Furthermore, the locking projection 774 can be formed integrally with the yoke 716 through a burst-through process. In some configurations, a portion or the entire fastener 770 can be formed through a burst-through process and / or by burst-through material. In some configurations, the entire fastener 770 can be overmolded onto the yoke 716.

[0205] As shown in Figures 70 to 73, the frame 710 includes a circumferential wall, skirt, or flange 735, an inlet flange 730 projecting outward from the front surface of the circumferential wall 735 (away from the user during use), and an outlet flange 740 projecting inward from the rear surface of the circumferential wall 735 (facing the user during use). The circumferential wall 735 extends around the periphery or circumference of the outer surface of the frame 710. The fluid path 715 extends through the inlet flange 730 and the outlet flange 740, substantially or substantially along the longitudinal axis of the frame 710. The longitudinal axis can be substantially straight or linear, or it can be curved. The internal shape of the frame 710 defining the fluid path 715 can vary along the length of the frame 710. Thus, the longitudinal axis can be defined as an average centerline, or by the geometric centers of multiple axial positions within the fluid path 715 of the frame 710. The inlet flange 730 may include one or more bias holes, for example, as shown and described in relation to other embodiments herein. The bias holes may be arranged similarly to the bias holes 729 shown in Figure 83.

[0206] During use, the seal 706 is coupled to the outlet flange 740, and the gas supply line 708 is coupled to the inlet flange 730. As shown in Figures 71 and 76, the top of the inlet flange 730 may be longer than the bottom of the inlet flange 730, while the top and bottom of the outlet flange 740 may be the same length or approximately the same length. With such a configuration, when the seal 706 is coupled to the outlet flange 740 and the mask assembly 700 is placed on the user's face during use (when the user's head is in an upright position), the inlet flange 730 and / or the gas supply line 708 face slightly downward rather than directly outward. This configuration can help reduce the hose drag that may be generated on the frame 710 by the gas supply line 708.

[0207] For use, the fastener 770 is coupled to the entrance flange 730. The entrance flange 730 includes one or more positioning features that help align the fastener 770 with the frame 710 and / or couple the fastener 770 to the frame 710. For example, the entrance flange 730 may include a positioning feature 732, which may be in the form of a tab or partial wall projecting from the entrance flange 730 along a portion of the top or upper surface of the entrance flange 730. The entrance flange 730 may include recesses 734 on its outer or side surfaces. As shown, the recesses 734 may be located on opposing sides of the entrance flange 730. The recesses 734 are dimensioned, shaped and positioned to receive the locking projection 774 of the fastener 770. The entrance flange 730 may further include introduction or alignment recesses or scalloped portions 736 associated with each of the recessed portions 734 and positioned above and near (or close to the top of) each of the recessed portions 734. Each scalloped portion 736 is separated from the associated recessed portion 734 by a projection 738. Each scalloped portion 736 is formed by a recess whose depth increases in the direction from the end furthest from the projection 738 toward the end closest to the projection 738. Each of the scalloped portions 736 may act as an introduction to the respective recessed portion 734, which helps to guide the locking projection 774 of the fastener 770 into the recessed portion 734 and align the locking projection 774 with the recessed portion 734, or to maintain the alignment of the locking projection 774 of the fastener 770 with the recessed portion 734 during the assembly or connection of the fastener 770 to the frame 710. The protrusion 738 can help hold the locking projection 774 within the recess 734 when assembled by restricting or preventing its upward movement relative to the frame 710.

[0208] To connect the fastener 770 to the frame 710, the fastener 770 can be slid in the space between the positioning feature 732 and the peripheral wall 735, as shown in Figures 74 to 77. The scalloped portion 736 helps guide the locking projection 774 into the recessed portion 734. The movement of the locking projection 774 beyond the ridge 738 into the recessed portion 734 can provide the user with tactile feedback that the fastener 770 is being secured to the frame 710. The peripheral wall 735, the positioning feature 732, the recessed portion 734, and / or the locking projection 774 help guide the connection of the fastener 770 and the yoke 716 to the frame 710 and / or help secure the fastener 770 and the yoke 716 to the frame 710 when assembled. When the fastener 770 is connected to the frame 710, the frame contact portion 776 of the fastener 770 contacts the front surface of the peripheral wall 735 of the frame 710. The raised edge portion 780 contacts the front and / or outer edge of the peripheral wall 735. The positioning feature portion 732 contacts the front surface of the fastener 770, for example, the lip 772. The frame contact portion 776 is recessed from the raised portion 778 by a distance D (shown in Figure 67B) that is equal to or approximately equal to the thickness T of the peripheral wall 735 (shown in Figure 71). Thus, when the fastener 770 is coupled to the frame 710, the recess defined by the frame contact portion 776 and the raised edge portion 780 accepts the peripheral wall 735 such that the raised portion 778 is at the same height as or flush with (or substantially at the same height as or flush with) the rear surface of the peripheral wall 735, as shown in Figures 75-76.

[0209] As shown in Figures 78A and 78B, the shape of the fastener 770 is designed to conform to or complement the aesthetic appearance of the yoke 716 and frame 710 by integrating with the overall contour curve of the yoke 716 and frame 710, as represented by the curved contour 798 shown in Figure 78A.

[0210] The exit flange 740 includes an engaging portion / member, a sealing element, or a connector 742. The connector 742 helps to secure the seal 706 and / or a coupling structure 790, such as a seal fastener coupled to the seal 706, to the frame 710. Figures 79 and 80 show exemplary embodiments of the seal 706 and the coupling structure 790. Thus, the cushion module includes the seal 706 and the coupling structure 790. The coupling structure 790 couples the seal 706 to the frame 710. The coupling structure 790 can take the form of a seal fastener. The seal fastener can be attached to the seal 706 to secure the seal 706 to the seal fastener. Alternatively, the seal 706 can be overmolded onto the coupling structure and / or coupled to the coupling structure by other preferred means. As shown in Figure 79, the side end or side edge 792 of the coupling structure 790 is thicker than the rest of the coupling structure 790. For example, the lateral end or edge portion 792 may have a thickness of approximately 2 mm to 6 mm. For example, the lateral end or edge portion 792 may have a thickness of approximately 4 mm at its outermost edge. In the illustrated embodiment, the outermost edge is the thickest part of the joint structure 790, and the joint structure 790 tapers or narrows from the outermost edge towards the center of the joint structure 790. In some embodiments, the lateral portion of the joint structure 790 includes recessed or scalloped portions 793 on the inner or outer surface of the joint structure 790, which can help reduce the weight of the joint structure 790. The thicker end or edge portion 792 can help improve comfort by avoiding sharp edges that may come into contact with the patient's face during use. In other words, the blunt edges created by the thicker end portion 792 will cause less pain when the end portion 792 of the joint structure 790 comes into contact with the user's face. The blunt edges can also, or alternatively, help prevent or deter sharp edges from coming into contact with the seal 706 and potentially causing holes or tears in the seal 706.

[0211] As shown in Figure 80, the coupling structure 790 includes an inner surface 794 that extends into and / or defines the central opening of the seal 706. For use, the inner surface 794 slides on or over the outlet flange 740 of the frame 710 to couple the seal 706 to the frame 710. The inner surface 794 can be smooth, for example, without steps, to facilitate the coupling structure 790 sliding on the outlet flange 740. The peripheral wall 735 provides a stopper for the seal 706 and the coupling structure 790 when the seal 706 and the coupling structure 790 are pressed against the outlet flange 740.

[0212] When the coupling structure 790 is pressed onto the outlet flange 740, the inner surface 794 also slides on the connector 742. The connector 742 can be made of a compressible, flexible, and / or elastic material. For example, the connector 742 can be made of TPE or silicone material, which in some configurations can be a self-adhesive silicone that adheres to the surface of the outlet flange 740. The connector 742 can be permanently coupled or bonded to the frame 710. In some embodiments, the connector 742 can be overmolded onto the outlet flange 740. When the coupling structure 790 slides on the connector 742, the connector 742 is compressed. The compression of the connector 742 forms a friction fit between the coupling structure 790 and the frame 710 and creates a sealing passage through the frame 710 and the coupling structure 790, and consequently through the seal 706. The connector 742 may take the form of an annular seal or flange, such as an O-ring or similar, extending over the entire circumference of the outlet flange 740 as shown in the figure. However, the connector 742 may have any preferred cross-sectional shape, including, but not limited to, a circular shape. In the illustrated arrangement, as will be further described below, the connector 742 includes a semicircular or partially circular sealing / connector portion (e.g., projection 745) and a noncircular base portion (e.g., joint portion 743). Alternatively, the connector 742 may not extend over the entire circumference of the outlet flange 740. In some configurations, the connector 742 is provided in a color (e.g., blue) that matches the color (e.g., blue) of the coupling structure 790 (or a portion thereof) to indicate to the user that the coupling structure 790, which includes the connector 742, should be assembled to the outlet flange 740. Alternatively, another portion of the outlet flange 740 may include a color (e.g., blue).

[0213] As shown in Figures 71 and 73, the connector 742 can be positioned within the groove 744. As shown in Figures 81A to 81D, the groove 744 may have a cross-sectional shape that is substantially or substantially similar to a trapezoid or an unequal quadrilateral. The inner diameter of the groove 744 may have a shorter axial length than the outer diameter of the groove 744. The cross-sectional shape of the groove 744 may be symmetrical or asymmetrical with respect to the central axis, as in the configuration of Figure 81D. Other suitable cross-sectional shapes may also be used, for example, including, but not limited to, rectangles (squares) and circles (e.g., semicircles). Further referring to Figures 81A to 81D, the connector 742 may include a joint portion 743 and a projection 745 protruding from the joint portion 743. The bottom or inner surface of the joint portion 743 may have a cross-sectional shape corresponding to the cross-sectional shape of the groove 744. The connector 742, for example, the joint portion 743 of the connector 742, may be molded in appropriate place on the frame 710, for example, within the groove 744. Alternatively, the connector 742 can be formed separately from the frame 710 and coupled to the frame 710. Figures 81A to 81D show various embodiments of the connector 742. Figure 81A shows a medium-sized joint portion 743 with a projection 745 located approximately in the center of the joint portion 743. Figure 81B shows a larger joint portion 743 (compared to the joint portion 743 in Figure 81A) with a projection 745 offset away from the center of the joint portion 743 toward the trailing or distal edge of the exit flange 740 (i.e., the edge of the exit flange 740 furthest from the peripheral wall 735). The position of this projection 745 can help provide greater tactile feedback to the user when the coupling structure 790 is coupled to the frame 710, because the larger portion of the coupling structure must move over the projection during coupling. Figure 81C illustrates a medium-sized joint 743 and a relatively wide or thick projection 745 extending across the width of the joint 743 (compared to the projection 745 in Figures 81A and 81B). Figure 81D illustrates a medium-sized joint 743 extending to and / or opening at the trailing or distal edge of the exit flange 740. This configuration can simplify the manufacturing process using tools. Figures 82A and 82B illustrate another exemplary embodiment of the connector 742.In this embodiment, the connector 742 has a double projection configuration with a recess between two projections. In other words, the connector 742 includes a joint portion 743 bounded by two projections 745. In some or all of the illustrated configurations, the cross-section of the joint portion 743 defines a surface length in contact with the outlet flange 740 that is greater than the surface length of the cross-section of the projections 745. Thus, the connector 742 has a larger surface area for joining or other connection with the outlet flange 740 than if the connector 742 were symmetrical such that the joint portion 743 is a mirror image of the projections 745. Such an arrangement can advantageously result in improved joining or other connection of the connector 742 to the outlet flange 740.

[0214] As shown in Figure 71, the connector 742 is spaced apart from the peripheral wall 735. For example, the connector 742 may be spaced about 4-5 mm apart from the peripheral wall 735. The spacing from the peripheral wall 735 is advantageous as it allows sufficient travel length after contact with the connector 742 when the seal 706 is slid over the exit flange 740, thereby providing tactile feedback to the user when the seal 706 is connected to the frame 710.

[0215] Figures 83–86 show another example of a frame 710' that can be used with the breathing mask assembly 700 of Figure 65. The frame 710' is similar in many respects to the frame 710. The frame 710' includes tabs or guide walls 739 positioned along the sides of each recessed portion 734, scalloped portion 736, and projection 738, closest to the leading edge of the inlet flange 730 (in other words, the sides are away from the circumferential wall 735 such that the boundaries of the recessed portion 734, scalloped portion 736, and projection 738 are at least partially defined by the circumferential wall 735 and the guide walls 739). The guide walls 739 advantageously help guide the locking projection 774 into place when connecting the yoke 716 and fastener 770 to the frame 710', as shown in Figures 87–88.

[0216] Figures 99 to 102 show another example of a frame 710''' that can be used with the breathing mask assembly 700, and Figures 93 to 98 show the frame 710''' assembled to the breathing mask assembly 700. Frame 710''' is similar in many respects to frame 710'. For example, frame 710''' includes a recessed portion 734, a scalloped portion 736, a projection 738, a guide wall 739, and a positioning feature portion 732. Frame 710''' also includes two bottom projections 741. In the illustrated embodiment, each bottom projection 741 extends from below its respective recessed portion 734. A connecting portion 741b extends between the bottom projections 741 around the outer circumference or bottom of the outer edge of the inlet flange 730. In this embodiment, the bottom projections 741 and the connecting portion 741b form a single projection around the bottom of the inlet flange. Each bottom projection 741 includes a corner portion 741a (Figure 99) adjacent to or near the respective recess 734. Each corner portion 741a protrudes laterally outward and downward from the body of the entrance flange 730. In other words, the side edge portion 741c (shown in Figure 99) of the projection 741 extends laterally outward and downward from the body of the entrance flange 730 adjacent to or near the bottom edge of the recess 734. In other configurations, the frame 710''' may include only the corner portions 741a without the connecting portion 741b. As shown, the connecting portion 741b may be integrated (aesthetically and / or structurally) with or joined to the perimeter wall 735. As shown in Figures 95 to 98, each projection 741 is aesthetically integrated with the fastener 770 to form an extension of the fastener 770. In the illustrated embodiment, the side edge 741c of each projection 741 abuts against the bottom edge 771 of the fastener 770 (shown in Figure 66), and the bottom edge of each projection 741 generally follows or conforms to the curvature of the side edge 769 of the fastener 770 (also shown in Figure 66). Advantageously, the projections 741 act as barriers to prevent or deter the user from attempting to attach the fastener 770 from the top or from the bottom of the frame 710''' rather than the top.

[0217] Figures 103 to 125 show another example of a frame 710'''' that can be used in a respiratory mask assembly, such as the respiratory mask assembly 700. Frame 710'''' is similar in many respects to frame 710''''. For example, frame 710'''' includes a recessed portion 734, a scalloped portion 736, a projection 738, a guide wall 739, a positioning feature portion 732, two bottom projections 741, and a connecting portion 741b extending between the bottom projections 741 around the outer circumference or bottom of the outer edge of the inlet flange 730. However, in other configurations, frame 710'''' may not include all of these features.

[0218] For example, as shown in Figures 112-115 and 122-125, the frame 710 also includes a connector 742 positioned around the periphery or outer surface of the outlet flange 740. As shown, the connector 742 can be positioned at an intermediate location between the outlet end or edge of the outlet flange 740 and the periphery wall 735. The connector 742 extends along the entire periphery of the outlet flange 740. However, in at least one alternative configuration, the connector 742 can extend around only or more portions of the periphery of the outlet flange 740. The connector 742 can be made of a compressible, flexible, and / or elastic material. For example, the connector 742 can be made of a TPE or silicone material, which in some configurations can be a self-adhesive silicone that adheres to the surface of the outlet flange 740. In the illustrated embodiment, the connector 742 is positioned within a groove 744. The groove 744 can form a channel in the outlet flange 740. The connector 742 may include a joint portion 743 and a projection 745 protruding from the joint portion 743. The projection 745 may also project outward from or relative to the outer surface of the outlet flange 740 to form a step or ridge. The connector 742, for example, the joint portion 743 of the connector 742, may be molded in place on the frame 710, for example, in a groove 744. Alternatively, the connector 742 may be molded separately from the frame 710 and bonded to the frame 710. The connector 742 may be bonded to the surface of the outlet flange 740 by chemical bonding. In another alternative, the connector 742 may be connected to the outlet flange 740 by mechanical bonding. For example, the outlet flange 740 may include through holes that penetrate the groove 744. The connector 742 may include portions that extend through their through holes to facilitate the mechanical connection between the connector 742 and the outlet flange 740.

[0219] The bottom or inner surface of the joint portion 743 of the connector 742 may have a cross-sectional shape corresponding to the cross-sectional shape of the groove 744. In the illustrated embodiment, the groove 744 and the bottom or inner surface of the joint portion 743 have a substantially rectangular cross-section. In some embodiments, at least a portion of the groove 744, and therefore in the connector 742, the distal and proximal walls of the groove 744 are parallel or substantially parallel. This configuration advantageously improves the durability of the connection between the connector 742 and the groove 744. By maximizing the proportion of walls extending perpendicular or substantially perpendicular to the outer surface of the frame, stress concentrations that could adversely affect the functional life of the connector 742 can be reduced.

[0220] Figures 103 and 113-115 show exemplary embodiments of a coupling structure 790 that can be used in, for example, a breathing mask assembly 700, together with a frame 710''''. In the illustrated embodiments, the coupling structure 790 includes an outer fastener 990 and an inner fastener 890. The outer fastener 990 and the inner fastener 890 can be formed integrally (i.e., to form a single coupling structure) or can be coupled to each other permanently or detachably. The coupling structure is relatively rigid compared to, for example, a connector 742. In other words, one or more of the inner fastener 890 and the outer fastener 990 are rigider than the connector 742. In the illustrated embodiments, the outer fastener 990 has an inner wall, arm, portion, or flange 791 and an outer wall, arm, portion, or flange 795 extending radially outward from the inner wall 791. In the illustrated embodiment, the inner fastener 890 includes an inner surface 794 that extends into and / or defines the central opening of the seal 706. In the illustrated embodiment, the inner fastener 890 has an inner wall 891, an outer wall 893, and a connecting wall 895 that extends between the inner wall 891 and the outer wall 893. The outer wall 893 is offset or positioned to be further away from the flow path than the inner wall 891. As shown in the illustration, the inner surface of the inner wall 891 forms the inner surface 794.

[0221] The outer fastener 990 and the inner fastener 890 connect the seal 706 to the frame 710''''. When connected, the outer fastener 990 and the inner fastener 890 are positioned around the exit flange 740 and surround the exit flange 740. In the illustrated embodiment, the outer fastener 990 is positioned on the patient distal side of the connecting wall 895 of the inner fastener 890. When the outer fastener 990 and the inner fastener 890 are fully connected to the frame 710'''' together with the seal 706, for example as shown in Figure 115, the patient distal end or edge of the inner wall 891 of the inner fastener 890 and / or the patient most distal surface of the outer fastener 990 may abut against the peripheral wall 735 as shown. The outer fastener 990 and the inner fastener 890 can be connected to each other. For example, the outer fastener 990 and the inner fastener 890 can be joined by ultrasonic welding, adhesive bonding, and / or permanent or removable snap fastening. In the illustrated embodiment, the inner surface of the inner wall 791 of the outer fastener 990 abuts against and / or joins with a portion of the outer surface of the inner wall 891 of the inner fastener 890.

[0222] The seal 706 is coupled to the outer fastener 990 and / or the inner fastener 890. In some embodiments, a portion of the seal 706 is sandwiched between the outer fastener 990 and the inner fastener 890. Thus, the seal 706, the inner fastener 890 and the outer fastener 990 form an integrated unit. In the illustrated embodiment, a portion of the seal 706 is positioned within a cavity that is at least partially formed, defined, and / or bounded by the outer surface of the inner wall 791 of the outer fastener 990, the patient-proximal surface of the outer wall 795 of the outer fastener 990, the patient-distal surface of the connecting wall 895 of the inner fastener 890, and / or the patient-distal surface of the outer wall 893 of the inner fastener 890, as shown in Figure 115. The portion of the seal 706 positioned within the cavity may have a substantially T-shaped cross-section. For example, in the illustrated embodiment, the portion of the seal 706 positioned within the cavity has an axially elongated flange portion 707 and a wall 705 extending radially outward from the flange portion 707 to the body of the seal 706. The flange portion 707 is trapped within the cavity to resist radially outward forces. In the illustrated embodiment, the flange portion 707 is trapped within a region defined by the outer surface of the inner wall 791 of the outer fastener 990, the patient-proximal surface of the outer wall 795 of the outer fastener 990, and the patient-distal surface of the connecting wall 895 of the inner fastener 890. In the illustrated embodiment, the wall 705 is trapped between the patient-distal surface of the outer wall 893 of the inner fastener 890 and the end face of the outer wall 795 of the outer fastener 990.

[0223] The connector 742 helps to connect the seal 706 to the frame 710''''. Specifically, in the illustrated embodiment, the connector 742 helps to connect the inner fastener 890 to the frame 710''''. When the inner fastener 890 is pressed against the exit flange 740, the inner surface 794 of the inner fastener 890 slides over the connector 742, causing the connector 742 to compress. The compression of the connector 742 forms a friction fit between the inner fastener 890 and the frame 710'''', which helps to hold the inner fastener 890 on the frame 710'''', and creates a sealing passage through the frame 710'''', the inner fastener 890, and consequently the seal 706.

[0224] The inner wall 891 of the inner fastener 890 includes a first portion 892 and a second portion 894. The first portion 892 extends away from the connecting wall 895. The second portion 894 extends away from the connecting wall 895. The first portion 892 extends away from the connecting wall 895 in a direction away from the user of the interface when in use. The second portion 894 extends away from the connecting wall 895 in a direction toward the user of the interface when in use. In other words, the first portion 892 extends away from the connecting wall 895 in a direction substantially opposite to the direction in which the second portion 894 extends away from the connecting wall 895. Together, the first portion 892 and the second portion 894 define the inner surface 794. In the illustrated configuration, the first portion 892 and the second portion 894 are offset to define a transition portion 896. The first portion 892 and the second portion 894 are radially offset with respect to the center of the fluid path 715. The second portion 894 is radially offset from the first portion 892 such that the second portion 894 is further off-center from the center of the fluid path 715 than the first portion 892. The dimensions of the first portion 892 (e.g., circumference, diameter, perimeter length, or cross-sectional dimensions) are smaller than the corresponding dimensions of the second portion 894. For example, the perimeter defined by the region of the inner surface 794 defined by the first portion 892 is smaller than the perimeter defined by the region of the inner surface 794 defined by the second portion 894. The perimeter of the inner surface 794 changes across the transition portion 896. In the illustrated configuration, the perimeter of the inner surface 794 increases across the transition portion 896 as the transition portion moves from the first portion 892 to the second portion 894. When the inner fastener 890 is slid onto the frame 710'''' to connect the seal 706 to the frame 710'''', the portion of the inner surface 794 defined by the first portion 892 slides onto the connector 742, as shown in Figures 122 and 124. When the inner fastener 890 is fully connected to the frame 710'''', the connector 742 contacts the portion of the inner surface 794 defined by the transition portion 896 and / or the second portion 894, as shown in Figures 123 and 125.

[0225] The first portion 892 may have constant or non-constant dimensions (e.g., circumference, diameter, periphery length, or cross-sectional dimensions) along its length (e.g., axial length along the direction of gas flow). The second portion 894 may have constant or non-constant dimensions (e.g., circumference, diameter, periphery length, or cross-sectional dimensions) along its length (e.g., axial length along the direction of gas flow). In other words, either or both of the first portion 892 and the second portion 894 may taper towards the transition portion 896, for example, along the length of the transition portion 896. The dimensions of the inner surface 794 vary in the transition portion 896. Since the dimensions of the first portion 892 are smaller than those of the second portion 894, the compression of the connector 742 when the inner fastener 890 is coupled to the frame, and consequently the interference between the connector 742 and the inner fastener 890, is greater in the first portion 892 than in the second portion 894. Therefore, interference between the connector 742 and the inner fastener 890 is greater when the inner fastener 890 is in the process of being coupled to the frame 710'''' (and thus the connector 742 is in contact with the first portion 892), as shown in Figures 122 and 124, compared to when the inner fastener 890 is fully connected to the frame 710'''' (and thus the connector 742 is in contact with the transition portion 896 and / or the second portion 894), as shown in Figures 123 and 125.

[0226] Therefore, interference between the connector 742 and the internal fastener 890 is less at the connection position than during assembly or disassembly. To remove the internal fastener 890 from the frame 710'''', the internal fastener 890 and the frame 710'''' must be pulled apart or pulled against each other to the partial connection position. At the connection position, the connector 742 is in contact with the transition portion 896 and / or the second portion 894, and therefore there is less interference between the internal fastener 890 and the connector 742. Thus, the maximum removing force required to separate the frame 710'''' from the coupling structure 790 is at least partially determined by the interference between the first portion 892 and the connector 742 at the partial connection position.

[0227] Less interference between the connector 742 and the internal fastener 890 (and thus the coupling structure 790) in the connection position compared to the partial connection position and / or during assembly or disassembly can advantageously help maintain the long-term performance of the connection between the frame 710 and the internal fastener 890. The cushion module (seal 706 and coupling structure 790) and the frame 710 can be housed in the connection position. The cushion module and the frame 710 are also in the connection position during nighttime use. Sustained large deformations of the connector 742 (such as when in the partial connection position, or when the portion of the internal fastener that contacts the connector 742 during storage and / or use has a smaller diameter) can lead to a decrease in the long-term performance of the connector 742, for example, if it is compressed more heavily over a longer period of time, as this can reduce the elasticity of the connector 742. Therefore, reducing interference between the connector 742 and the internal fastener 890 (and thus the coupling structure 790) can extend the service life of the mask assembly.

[0228] Figures 89–90 show another exemplary embodiment of the frame 710'' and fastener 770'' that can be used with the breathing mask assembly 700 of Figure 65. The frame 710'' is similar in some respects to the frame 710. As shown in the figures, the peripheral wall 735'' of the frame 710'' is a partial peripheral wall 735'' and does not extend over the entire circumference / periphery of the frame 710''. The partial peripheral wall 735'' is dimensioned and shaped to match or correspond to the geometry and size of the fastener 770''. The partial peripheral wall 735'' does not extend substantially beyond the side edges of the fastener 770'' (further down) when the fastener 770'' is coupled to the frame 710''.

[0229] The frame 710'' includes two channels 737 that extend circumferentially around a portion of the outer surface of the inlet flange 730. As shown, each channel 737 begins near the top of the inlet flange 730 and extends downward to or toward a recessed portion 734 adjacent to the circumferential wall 735'' around the circumference of the inlet flange 730. The frame 710'' may include a positioning feature 733 at the top of the inlet flange 730 adjacent to the circumferential wall 735''. As shown, the positioning feature 733 can be flush with the body of the inlet flange 730 between the channel 737 and the leading edge of the inlet flange 730, or it can be slightly raised relative to the body. In some configurations, the upper surface of the positioning feature 733 is flat, while the surface of the inlet flange 730 in front of the positioning feature 733 is curved. Therefore, the channel 737 is recessed relative to the positioning feature portion 733 and the body of the entrance flange. A step 731, which is at the same height as the body of the entrance flange 730 or raised relative to the body, is positioned between the end of each channel 737 and the associated recess portion 734. The channel 737 can provide the same or similar function as the introduction or alignment recess or scallop portion 736 described above. The step 731 can provide the same or similar function as the projection 738 described above.

[0230] As shown in Figure 91, the fastener 770'' includes a recess 773 located at the lateral center of the fastener 770'' on the lower surface or inner arc of the fastener 770''. The locking projections 774 extend inward from the inner arc at or adjacent to the side end of the fastener 770''. The fastener 770'' may also include recesses 775 located adjacent to each locking projection 774 and closer to the lateral center than each locking projection 774. The recesses 775 may be configured to accommodate the step 731 so that the locking projection 774 can fully engage with the recess 734 without interference between the step 731 and the fastener 770''.

[0231] When the fastener 770'' is coupled to the frame 710'', the channel 737 helps guide the fastener 770'' into place. The depth of the channel 737 helps provide horizontal or axial support to the fastener 770'' to prevent or deter undesirable separation in directions other than vertical or straight away from the channel 737, which are perpendicular to the upper surface of the positioning feature 733 in the illustrated arrangement. The recess 773 aligns with and accepts the positioning feature 733. The positioning feature 733 acts as a visual and / or tactile guide to help the user properly align the fastener 770'' with the frame 710''. The engagement of the positioning feature 733 with the recess 773 helps to secure the fastener 770'' to the frame 710'' by preventing or deterring lateral movement of the fastener 770'' relative to the frame 710''.

[0232] Figures 92A to 92C illustrate modified versions of the fastener 770 and the frame 710. These modifications can be combined with features of any of the embodiments described above. In Figure 92A, the fastener 770 seats in a recess 796 in the entrance flange 730 of the frame 710, and an upwardly extending wall portion defining the frame contact portion 776 of the fastener 770 contacts the entrance flange 730 side of the circumferential wall 735. In Figure 92B, a portion of the fastener 770 wraps around the top of the circumferential wall 735 and, consequently, contacts both sides of the circumferential wall 735. In this arrangement, the fastener 770 can be fixed to the frame 710 without requiring the recess 796 and / or the positioning feature portion 732. In Figure 92C, the fastener 770 includes a channel 797 that receives the circumferential wall 735 to align the fastener 770 with the frame 710 and fix the fastener 770 to the frame 710.

[0233] Unless otherwise clearly required by the context, throughout this specification and the claims, words such as “includes” and “contains” should be interpreted in a comprehensive sense, as opposed to an exclusive or exhaustive sense; in other words, “includes but not limited to.” Although the foregoing description refers to complete bodies or components having known equivalents, those complete bodies or components are incorporated herein as if they were individually specified.

[0234] The methods, devices, and systems of disclosure may also be broadly said to include, individually or collectively, any combination of two or more of the parts, elements, and features referred to or represented in this disclosure.

[0235] Any reference to prior art in this specification shall not, and should not, be construed as an acknowledgment or suggestion in any form that the prior art forms part of common general knowledge in the fields of activity of all countries around the world.

[0236] As used herein, terms expressing degree, such as “approximately,” “about,” “approximately,” and “substantially,” describe values, quantities, or characteristics that are close to a given value, quantity, or characteristic, while still performing the desired function or achieving the desired result. Deviations from a given value, quantity, or characteristic may reflect, for example, acceptable tolerances, conversion factors, rounding, measurement errors, or other factors known to those skilled in the art. For example, the terms “approximately parallel” and “substantially parallel” refer to values, quantities, or characteristics that may deviate from strictly parallel by only 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, 0.1 degrees or less, etc.

[0237] While this disclosure describes certain embodiments, other embodiments that would be apparent to those skilled in the art are also within the scope of this disclosure. Therefore, various modifications and alterations can be made without departing from the spirit and scope of this disclosure. For example, various components can be rearranged as needed. Furthermore, not all features, embodiments, and advantages described herein are necessarily required to implement this disclosure. Accordingly, the scope of this disclosure is intended to be defined solely by the following claims.

Claims

1. 1. Headgear for a respiratory mask assembly, comprising: a top strap, a pair of opposing side arms, a rear strap, and a yoke; the top strap, the pair of opposing side arms, and the yoke are formed from a plastic material forming a plastic core and covered with a fabric material, the fabric material being permanently bonded to the plastic core; the yoke includes one or more protrusions, each protrusion being integrally formed with the plastic core and extending through the fabric material; the headgear comprises a fastener, the fastener comprising one or more recesses or openings; the one or more protrusions are configured to extend into the one or more recesses or openings; the fasteners are permanently joined to the yoke, the fasteners being configured to couple the headgear to a frame of the respiratory mask assembly. headgear.

2. 10. The headgear of claim 1, wherein each protrusion is formed from molten plastic material that creates an opening in the fabric material or passes through a pre-existing opening in the fabric material during a molding process to form the core portion.

3. the pair of opposing side arms comprising a first side arm and a second side arm, each of the first side arm and the second side arm extending from a side portion of the yoke and configured to extend across a user's cheek and above an ear in use; 3. The headgear of claim 1 or 2, wherein 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 a user's head in use.

4. Headgear according to any one of claims 1 to 3, wherein the fastener comprises a lip that projects below a bottom surface or edge of the yoke.

5. The headgear of claim 4 , wherein the front surface of the lip is substantially flush with the front surface of the yoke.

6. The headgear according to any one of claims 1 to 5, wherein the rear surface of the fastener comprises a frame contacting portion and a raised portion that is thicker than the frame contacting portion.

7. 7. Headgear according to claim 6, which relies on claim 4 or 5, wherein the frame contact portion extends along a bottom edge of the fastener and follows the shape and / or contour of the lip.

8. Headgear according to claim 4 or any one of claims 5 to 7 when relying on claim 4, wherein a locking protrusion is positioned at or adjacent to the edge of the lip.

9. The headgear of claim 8 , wherein the locking projection is integrally formed with the yoke.

10. The headgear of any one of claims 1 to 9, wherein connecting structures are formed on the fasteners and the yoke to secure the fasteners and the yoke to one another.

11. The headgear of claim 10 , wherein the connecting structure is formed by overmolding onto the fasteners and the yoke.

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