JPWO2019053666A5 - - Google Patents

Description

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

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

CPAP therapy can be used to treat obstructive sleep apnea (OSA), a condition in which a patient's airway becomes intermittently blocked during sleep, preventing the patient from breathing for periods of time. The cessation of breathing, or apnea, results in the patient waking up. As a result of repetitive and frequent apnea, the patient may rarely be able to get a full night's restorative sleep.

CPAP therapy involves the delivery of continuous positive air pressure to a patient's airway via a breathing mask. The continuous positive pressure acts as a splint for the patient's airway, holding the airway in an open position so that the patient's breathing and sleep are uninterrupted.

Respiratory masks typically include a patient interface and headgear, where the patient interface is configured to deliver continuous 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. Respiratory masks are available in a variety of forms, including full face masks, nasal masks, and direct nose/mouth masks, that 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 such that it is held in a stable position against the patient's face during use. Such respiratory masks may also be used to deliver NIV and other therapies.

In a first aspect, an embodiment of the present invention may be broadly said to include headgear for a respiratory mask including an integrally formed closed loop. The closed loop includes a yoke, a pair of side arms, and a top strap. The yoke is configured to connect to a patient interface. The pair of side arms are configured to extend from a lateral rear portion of the yoke and across the cheeks and above the ears of a user, respectively, in use. The top strap is configured to extend between the pair of side arms and across the top of the user's head in use.

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 integrally formed with one of the side arms, and the fixed end of the right portion is integrally formed with the other side arm. The free ends of the left and right portions are adjustably connected to one another.

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

Preferably, it contains a plastic material.

Preferably, the side arms include integrally formed buckles at their free ends.

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

Preferably, the rear strap includes a pair of side ends that are each adjustably connected to a buckle on the side arm.

Preferably, the rear strap is removably connected to the buckle.

Preferably, the rear strap and the top strap are configured to encircle the rear of the user's head when in use.

In a second aspect, embodiments of the present invention may be broadly said to include a respiratory mask including a patient interface and headgear as described above.

In a third aspect, an embodiment of the present invention may be broadly said to include headgear for a respiratory mask including an integrally formed closed loop and rear strap. The closed loop includes a yoke, a pair of side arms, and a top strap. The yoke is configured to connect to a patient interface. The side arms are configured to extend from a lateral rear portion of the yoke and across a user's cheeks and above the ears, respectively, in use. The top strap is configured to extend across the top of the user's head in use and join the pair of side arms. The rear strap is configured to extend between the pair of side arms around the back of the user's head.

In a fourth aspect, an embodiment of the present invention may be broadly said to include headgear for a respiratory mask, including a yoke, a pair of opposing side arms, and a top strap. The yoke is configured to connect to a frame of the respiratory mask. The pair of opposing side arms are configured to extend from a pair of laterally rearward portions of the yoke in use across a user's cheeks and above the tops of the user's ears in use. The top strap is configured to extend between the side arms above the user's ears and over the top of the user's head in use. The yoke, side arms, and top strap are integrally formed to provide a closed loop that remains intact when the yoke is separated from the frame.

In some embodiments, a frame for a respiratory mask includes a body having an exterior surface and an interior surface. The exterior surface includes a yoke receiving structure configured to receive a yoke and an inlet collar defining an inlet. The yoke receiving structure can span a longitudinal distance of the body. The interior surface includes an outlet collar defining an outlet. A gas path is formed between the inlet and the outlet. A perimeter of the gas path at the inlet is smaller than a perimeter of the gas path at the outlet.

The inlet collar may include a portion of increasing circumference. The inlet may have an oval shape. The outlet may have an oval shape. The outlet collar may include a truncated portion. A portion of the outlet collar may be longer than another portion of the outlet collar . The outlet collar may include a recessed portion extending partially around the circumference of the outlet collar .

In some embodiments, a frame for a respiratory mask includes a body having an exterior surface and an interior surface. The exterior surface includes a yoke receiving structure configured to receive a yoke and an inlet collar defining an inlet. The yoke receiving structure can span a longitudinal distance of the body. The inlet collar includes an increasing perimeter transition portion. The interior surface includes an outlet collar defining an outlet. A gas pathway is formed between the inlet and the outlet. The inlet collar includes an exhaust port that allows passage of gas from the gas pathway to an exterior of the frame.

The inlet collar can include a first portion of a first perimeter and a second portion of a second perimeter coaxially offset from the first portion. The first and second portions can be separated by a transition portion of increasing perimeter, and the transition portion can connect the first and second portions. The second perimeter can be greater than the first perimeter. The second portion can be located adjacent an outer surface of the frame. The transition portion can include an exhaust port. The exhaust port can include a plurality of holes.

In some embodiments, a frame for a respiratory mask includes a body having an exterior surface and an interior surface. The exterior surface includes a yoke receiving structure configured to receive a yoke and an inlet collar defining an inlet. The yoke receiving structure may be defined between a first retention ridge and a second retention ridge longitudinally offset from the first retention ridge to form a recessed groove configured to receive the yoke. The interior surface may include an outlet collar defining an outlet. A gas pathway is formed between the inlet and the outlet.

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

The frame and headgear retention features may be configured such that a first headgear retention feature may be engaged with a corresponding first frame retention feature on the headgear, and then the frame and headgear may be rotated relative to one another 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 and second headgear retention features may be offset longitudinally relative to a central axis extending through the opening in the inlet collar . The first and second headgear retention features may be circular holes.

In some embodiments, a frame for a respiratory mask includes a body having an outer surface and an inner surface and extending from a first side edge to a second side edge, an opening configured to receive gas from a gas delivery line in use, and a plurality of bias flow holes disposed about a portion of the frame surrounding the opening and forming an arc extending through approximately 240°.

The bias flow holes can extend from about 4:00 to about 8:00 (similar to a clock). The frame further includes an inlet collar extending from the outer surface, the inlet collar including a wall defining an opening and configured to be coupled to a gas line in use, the inlet collar including a plurality of bias flow holes extending through the wall. The inlet collar can have an oval cross-section. The walls of the inlet collar can be angled inwardly at an inlet collar face angle relative to an axis extending through the opening as the walls extend away from the frame body. The inlet collar face angle can vary around a periphery of the inlet collar .

In some embodiments, a frame for a respiratory mask includes a body having a distally facing outer surface and a proximally facing inner surface, and an inlet collar extending distally from the outer surface to a distal rim, the inlet collar including a wall defining an opening and configured to be coupled to a gas line in use, the top and bottom of the distal rim projecting distally relative to lateral sides of the distal rim. The inlet collar can have an oval cross-sectional shape.

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

The connector may include a groove separating the two retention portions. The connector may be generally circular. The headgear may include two connectors each configured to engage a corresponding headgear retention feature on the frame, the headgear and connectors configured such that a first connector of the two connectors may be engaged with a corresponding first headgear retention feature on the frame, and the frame and headgear may then be rotated relative to one another about the connector to align a second connector of the two connectors with a corresponding second headgear retention feature on the frame.

In some embodiments, headgear for a respiratory mask includes a yoke configured to connect to a patient interface, a first side arm and a second side arm, and a top strap. Each of the first side arm and the second side arm extends from a lateral rear portion of the yoke and is configured to extend across a user's cheek and above an ear in use. The top strap is coupled to the first side arm and the second side arm, extends between the first side arm and the second side arm, and is configured to extend across a top of the user's head in use. The top strap includes a first portion coupled to the first side arm, a second portion coupled to the second side arm, and an adjustment mechanism coupled to the first portion and the second portion and configured to allow adjustment between the first portion and the second portion. The adjustment mechanism includes a guide loop at a free end of the second part, a plurality of holes along the length of the second part near the free end, a protrusion extending from an inner surface of the first part, the inner surface configured to face the second part and at least partially overlap the second part when the first and second parts are joined in use, the protrusion configured to engage any one of the plurality of holes to secure the first and second parts together, and a plurality of position guides extending along the length of the first part near the protrusion, the plurality of position guides including a series of protruding edges having a width greater than a diameter of an opening defined by the guide loop. In use, the first part is configured to be advanced and/or retracted through the guide loop, and contact between the protruding edges and the guide loop provides resistance to movement of the first part through the guide loop.

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

In some embodiments, headgear for a respiratory mask includes a strap including a yoke portion and first and second side arms, and a top strap. The yoke portion is configured to connect to a patient interface. Each of the first and second side arms extends from a lateral rear portion of the yoke portion and is configured to extend across a user's cheek and above an ear in use. The yoke portion and the first and second side arms may be integrally formed. The top strap is coupled to the first and second side arms and extends between the first and second side arms and is configured to extend across a top of the user's head in use. A first edge of the strap includes a soft edge, and an opposing second edge of the strap includes a soft edge portion and a hard edge portion.

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

In some embodiments, the headgear for the respiratory mask includes a front strap and a top strap. The front strap includes a yoke configured to connect to a patient interface, and a first side arm portion and a second side arm portion, each of which extends from a lateral rear portion of the yoke and is configured to extend across a user's cheek and above an ear in use. The top strap is coupled to the first side arm portion and the second side arm portion, and extends between the first side arm portion and the second side arm portion, and is configured to extend across a top of the user's head in use. The top strap includes a first portion coupled to the first side arm portion, a second portion coupled to the second side arm portion, and an adjustment mechanism coupled to the first portion and the second portion and configured to allow adjustment between the first portion and the second portion. At least one of the yoke, the first and second side arm portions, and the top strap includes a plastic core and a fabric outer casing at least partially surrounding the plastic core, and at least one of the yoke, the first and second side arm portions, and the top strap is formed by internal molding.

The adjustment mechanism may include a female connector at a free end of the second portion and a male connector at a free end of the first portion, the female connector including a guide loop and a plurality of holes along the length of the female connector, and the male connector including a protrusion extending from an inner surface of the male connector, the inner surface configured to face and at least partially overlap the female connector when the first and second portions are coupled in use, the protrusion configured to engage any one of the plurality of holes to secure the first and second portions together. In use, the first portion is configured to be advanced and/or retracted through the guide loop.

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

In some embodiments, the respiratory mask assembly includes a headgear, a frame, and a headgear connector. The headgear is configured to secure the mask assembly to a user's face during use. The frame has a body extending along a longitudinal axis, a top, a bottom, and two sides. The headgear connector is coupled to the headgear and is configured to be coupled to the frame by approaching the frame from one of the top or bottom.

The headgear connector can be permanently coupled to the headgear. The headgear connector can include at least one locking projection, the frame can include at least one recessed portion, and the at least one locking projection can be configured to be received in the at least one recessed portion when the headgear connector is coupled to the frame. The frame can also include at least one scalloped portion positioned near the at least one recessed portion. The scalloped portion can be positioned above the corresponding recessed portion. The at least one scalloped portion can be configured to act as a lead-in for the at least one locking projection into the at least one recessed portion. The at least one scalloped portion can be separated from the at least one recessed portion by a ridge. The barrier can be configured to block or prevent coupling of the headgear connector when approaching the frame from the other (wrong portion) of the top or bottom.

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

In some embodiments, the respiratory mask assembly includes a headgear, a frame, and a connector. The headgear is configured to secure the mask assembly to a user's face during use. The frame extends in a first direction from an inlet to an outlet. A longitudinal axis of the frame and a flow passage through the frame extends from the inlet to the outlet. The frame extends in a second direction from a first side edge to a second side edge, the second direction being perpendicular to the first direction. The frame extends from a top to a bottom in a third direction, the third direction being perpendicular to the first direction and the second direction. The connector is coupled to the headgear and is configured to be coupled to the frame by approaching the frame from the top or bottom along the third direction.

In some embodiments, the respiratory mask assembly includes headgear, a frame, and a connector. The headgear is configured to secure the mask assembly to a user's face during use. The frame has an inlet at a front end of the frame, an outlet at a rear end of the frame, a flow passage extending through the frame from the inlet to the outlet, and a top surface, a bottom surface, and a side surface. The connector is coupled to the headgear and configured to be coupled to the frame. The connector has side portions configured to extend along the sides of the frame and cross portions extending between the side portions, the cross portions configured to extend along one of the top surface or the bottom surface of the frame when the connector is coupled to the frame.

The connector may be permanently coupled to the headgear. The connector may include at least one locking projection, the frame may include at least one recessed portion, and the at least one locking projection may be configured to be received in the at least one recessed portion when the connector is coupled to the frame. The frame may include at least one scalloped portion positioned adjacent to and above the at least one recessed portion. The scalloped portion may act as a lead-in for the at least one locking projection into the at least one recessed portion. The at least one scalloped portion may be separated from the at least one recessed portion by a ridge. The barrier may be configured to block or prevent coupling of the connector when a user attempts to extend the connector along the other (wrong portion) of the top or bottom surface of the frame.

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

In some embodiments, a frame for a respiratory mask assembly includes a body and a flexible engagement portion. The body includes an inlet end defining an inlet opening, an outlet end defining an outlet opening, and a flow passage extending through the body from the inlet opening to the outlet opening. The flexible engagement portion is configured to be engaged by a cushion module disposed on the body and configured to be coupled to the body. The flexible engagement portion can be configured to compress when the cushion module is coupled to the body. Compression of the flexible engagement portion forms 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.

In some embodiments, the cushioning module includes a coupling structure configured to be coupled to the body such that the coupling structure engages the flexible engagement portion. The coupling structure can include a first portion having a first inner dimension and a second portion having a second inner dimension different from the first inner dimension. The first inner dimension can be an inner periphery of the first portion. The second inner dimension can be an inner periphery of the second portion. The coupling structure can include a transition portion between the first portion and the second portion. The second inner dimension can be greater than the first inner dimension. When the coupling structure is coupled to the body, the flexible engagement member can engage the second portion and/or the transition portion of the coupling structure. Interference between the flexible engagement member and the coupling structure can be lower when the coupling structure is in a final connection position on the body than during connection of the coupling structure to the body. The coupling structure can be in the form of a fastener.

In some embodiments, a frame for a respiratory 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 passage extending through the body from the inlet opening to the outlet opening. The flange extends outwardly from a central portion of the body and extends at least partially circumferentially around the body. In some embodiments, the respiratory mask assembly includes a frame and headgear configured to secure the mask assembly to a user's face in use. The headgear is configured to be coupled to the frame such that the headgear contacts a front surface of the flange. In some embodiments, the respiratory mask assembly includes a frame and a cushion module including a seal configured to seal to a user's face in use. The cushion module is configured to be coupled to the frame such that the cushion module contacts a rear surface of the flange.

In some embodiments, headgear for a 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 exterior layer portion. Each connecting portion is integrally formed with the core portion and extends through the exterior layer portion. Each connecting portion can be formed by molten plastic material creating an opening in the exterior layer portion or by molten plastic material passing through a pre-existing opening in the exterior layer portion during the molding process to create the core portion.

In some embodiments, the respiratory mask assembly includes a headgear and a connector overmolded onto the headgear, the connector configured to couple the headgear to a frame of the respiratory mask assembly. The headgear can include a yoke, first and second side arms, and a top strap. Each of the first and second side arms extends from a lateral portion of the yoke and extends across a user's cheek and above an ear in use. The top strap is coupled to the first and second side arms and extends between the first and second side arms and is configured to extend across a top of the user's head in use. The connector can be overmolded onto the yoke.

In some embodiments, the respiratory mask assembly includes a frame and a cushion module. The frame includes a body and a flexible engagement portion disposed on the body. The body includes an inlet end defining an inlet opening, an outlet end defining an outlet opening, and a flow passage extending through the body from the inlet opening to the outlet opening. The body can be stiffer than the flexible engagement 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. A surface of the coupling structure is configured to engage the flexible engagement portion of the frame when the cushion module is coupled to the frame.

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

The coupling structure may include an inner fastener and an outer fastener. A portion of the seal may be sandwiched between the inner fastener and the outer fastener. The inner fastener may include a surface configured to engage the flexible engagement portion. The surface of the coupling structure configured to engage the flexible engagement portion may include a first portion and a second portion, the first portion having a dimension smaller than the dimension of the second portion. The first portion may be adjacent to and extend from a front edge of the inner fastener in an 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 a 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 portion and the second portion, and the transition portion may contact the flexible engagement portion at a final connection position of the inner fastener on the frame.

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

A number of embodiments will now be described by way of example with reference to the drawings.

FIG. 1 is a perspective view of a first non-limiting exemplary embodiment of a respiratory mask according to the present disclosure. FIG. 2 is a front perspective view of the frame of the respiratory mask of FIG. FIG. 3 is a rear perspective view of the frame of FIG. 2 . FIG. 3 is a front view of the frame of FIG. 2 . FIG. 3 is a front view of the frame of FIG. 2 . FIG. 3 is a left side view of the frame of FIG. 2 . FIG. 3 is a left side view of the frame of FIG. 2 . FIG. 3 is a left side view of an alternative embodiment of the frame of FIG. 2 . FIG. 3 is a rear view of the frame of FIG. 2 . FIG. 3 is a rear view of the frame of FIG. 2 . FIG. 3 is a top view of the frame of FIG. 2 . FIG. 3 is a top view of an alternative embodiment of the frame of FIG. 2. FIG. 3 is a bottom view of the frame of FIG. 2 . FIG. 3 is a front view of the frame of FIG. 2 with a central cross section cut therethrough. FIG. 3 is a central cross-sectional view of the frame of FIG. 2 . FIG. 3 is a 2D view of a central cross section of the frame of FIG. 2 . FIG. 2 is a perspective view of a second non-limiting exemplary embodiment of a respiratory mask according to the present disclosure. FIG. 12 is a side view of the respiratory mask of FIG. 11 in use. FIG. 13 is a front view of a portion of the headgear of the respiratory mask of FIGS. 11 and 12 in a disengaged configuration. FIG. 14 is an enlarged side view of the top strap of the headgear of FIG. 13 in a disengaged configuration. FIG. 12 is a perspective view of the top of the respiratory mask of FIG. FIG. 14 is an enlarged front view of the yoke of the headgear of FIG. 13 in a disengaged configuration. FIG. 14 is an enlarged plan view of the yoke of the headgear of FIG. 13 in a disengaged configuration. FIG. 2 is a perspective view of a second non-limiting exemplary embodiment of headgear for use in combination with the respiratory mask of FIG. FIG. 19 is a front perspective view of the yoke of the headgear of FIG. FIG. 1 is a perspective view of a non-limiting exemplary embodiment of a respiratory mask according to the present disclosure. FIG. 21 is a front perspective view of the frame of the respiratory mask of FIG. 20. FIG. 22 is a rear perspective view of the frame of FIG. 21 . FIG. 22 is a front view of the frame of FIG. 21 showing the frame axes. FIG. 22 is a front view of the frame of FIG. 21 showing various axes and dimensions. 22 shows how the headgear of the respiratory mask of FIG. 20 can be coupled to the frame of FIG. 21. 22 shows how the headgear of the respiratory mask of FIG. 20 can be coupled to the frame of FIG. 21. FIG. 22 is a front view of an alternative embodiment of the frame of FIG. 21. FIG. 22 is a front perspective view of an alternative embodiment of the frame of FIG. 21 . FIG. 21 is a partially exploded perspective view of the respiratory mask of FIG. 20. FIG. 22 is a side view of the frame of FIG. 21 . FIG. 22 is a side view of the frame of FIG. 21 showing various axes and dimensions. FIG. 22 is a partial cross-sectional view of the inlet collar of the frame of FIG. 21 . FIG. 22 is a front view of the frame of FIG. 21 . FIG. 22 is a rear view of the frame of FIG. 21 showing various axes. FIG. 22 is a rear view of the frame of FIG. 21 showing various axes and dimensions. FIG. 22 is a side view of the frame of FIG. 21 . FIG. 22 is a top view of the frame of FIG. 21 . FIG. 29B is a top view of an alternative embodiment of the frame of FIG. 29A. FIG. 22 is a top view of the frame of FIG. 21 . FIG. 22 is a bottom view of the frame of FIG. 21 . FIG. 22 is a partial front view of the frame of FIG. 21 showing the cutting plane. 32A is a cross-sectional view of the frame of FIG. 21 taken along line 32A-32A of FIG. 31. FIG. 32B is a 2D view of the cross section of FIG. FIG. 1 is a perspective view of a non-limiting exemplary embodiment of a respiratory mask according to the present disclosure. FIG. 34 is a side view of the respiratory mask of FIG. FIG. 34 is a side view of the respiratory mask of FIG. 33 as worn by a user. FIG. 34 is a rear view of the yoke of the headgear of the mask of FIG. 33 showing the gates used during molding. FIG. 34 is a side view of a frame retention feature of the headgear of the mask of FIG. FIG. 36B is a side view of the frame retention feature of FIG. 36A showing the outline of the headgear casing. FIG. 36B is a side view of a mold used to make the frame retention feature of FIG. 36A. FIG. 34 is a front view of a portion of the yoke and side arms of the headgear of the mask of FIG. 33. FIG. 34 is an enlarged view of a portion of the headgear of the mask of FIG. FIG. 34 is an enlarged view of a portion of the headgear of the mask of FIG. FIG. 34 is a top view of the top strap of the headgear of the mask of FIG. 33. FIG. 34 is a top perspective view of the top strap of the headgear of the mask of FIG. 33 in a disengaged position or configuration. FIG. 41 is an enlarged view of a portion of the second portion of the top strap of FIG. 40. FIG. 34 is a close-up view of a portion of the headgear of the mask of FIG. 33 showing an embodiment of the connections between the side arms and top straps of the headgear. FIG. 13 is a bottom view of an exemplary embodiment of a position guide for a first portion of a top strap of headgear. FIG. 13 is a bottom view of an exemplary embodiment of a position guide for a first portion of a top strap of headgear. FIG. 13 is a side view of a portion of the first portion of the top strap. FIG. 1 is a top perspective view of a non-limiting exemplary embodiment of a respiratory mask assembly according to the present disclosure. FIG. 45 is a front view of the respiratory mask assembly of FIG. FIG. 45 is a rear view of the headgear of the respiratory mask assembly of FIG. FIG. 47 is a rear or inside view of the section of headgear of FIG. 46 separated and unfolded. FIG. 47B is a front or exterior view of a portion of the headgear of FIG. FIG. 47B is a front or exterior view of the right side of the headgear of FIG. FIG. 48B is a rear or interior view of FIG. 48A. FIG. 47B is a front or exterior view of the left side of the headgear of FIG. FIG. 49B is a rear or interior view of FIG. 49A. FIG. 47B is a front or exterior view of the male connector of the headgear of FIGS. 46 and 47A. FIG. 50B is a rear or inside view of the male connector of FIG. 50A. 50B is an oblique cross-sectional view of a variation of the male connector of FIG. 50A. 50A and 50B show different ways of connecting and/or disconnecting the male connector of FIG. 50A and the female connector of the headgear of FIGS. 46 and 47A. 50A and 50B show different ways of connecting and/or disconnecting the male connector of FIG. 50A and the female connector of the headgear of FIGS. 46 and 47A. FIG. 47 is a partial exterior perspective view of a top strap of the headgear of FIG. 46. FIG. 52B is a partial inside view of the top strap of FIG. 52A. FIG. 47 is a partial exterior view of the bottom strap of the headgear of FIG. 46. FIG. 53B is a partial inside view of the bottom strap of FIG. 53A. FIG. 53B is a partial exterior view of the joint between the top strap of FIG. 52A and the bottom strap of FIG. 53A. FIG. 54B is a perspective view of the fitting of FIG. 54A. FIG. 54B is a partial inside view of the joint and the end of the bottom strap of FIG. 54A. FIG. 54B is a cross-sectional view of the fitting of FIG. 54A. FIG. 13 is a partial inside view of the overmolded joint between the top and bottom straps and the buckle overmolded onto the end of the bottom strap. FIG. 56B is an exterior view of FIG. FIG. 56B is a cross-sectional view of the overmolded fitting of FIG. 56A. FIG. 50B is a cross-sectional view of the male connector of FIG. 50A overmolded onto the top strap. 13 is a perspective view of an alternative embodiment of the end of the top strap. FIG. FIG. 47 is a rear view of the bottom straps and yoke of the headgear of FIG. 46. FIG. 60B is a bottom view of the yoke of FIG. 60A. FIG. 45 is a front top perspective view of the frame and gas delivery lines of the respiratory mask assembly of FIG. 44. FIG. 62 is a rear view of the bottom strap of FIG. 60A coupled to the frame of FIG. 61. FIG. 62B is a front view of the bottom strap and frame of FIG. 62A. FIG. 13 is a rear view of an alternative embodiment of the bottom strap and yoke. The relative dimensions of the buckle and bottom strap are shown. FIG. 65 is a top perspective view of a non-limiting exemplary embodiment of a respiratory mask assembly according to the present disclosure. FIG. 66 is a front view of the yoke and fastener of the respiratory mask assembly of FIG. FIG. 67 is a rear view of the yoke and fastener of FIG. 66. FIG. 67 is a rear cross-sectional view of the yoke and fastener of FIG. 66. FIG. 67 is a bottom perspective view of the yoke and fastener of FIG. 67 illustrates how the fastener of FIG. 66 is attached to the yoke of FIG. 66. FIG. 66 is a side perspective view of a frame of the respiratory mask assembly of FIG. 65. FIG. 71 is a side view of the frame of FIG. 70. FIG. 71 is a front view of the frame of FIG. 70. FIG. 71 is a top view of the frame of FIG. 70. FIG. 71 is a top perspective view of the yoke and fastener of FIG. 66 coupled to the frame of FIG. 70; FIG. 75 is a top view of the assembly of FIG. FIG. 75 is a bottom view of the assembly of FIG. 74 . FIG. 75 is a rear view of the assembly of FIG. 74 . FIG. 75 is a front view of the seal and coupling structure coupled to the yoke, fastener and frame of FIG. FIG. 78B is a partial enlarged view of the assembly of FIG. 78A. FIG. 66 is a top view of the seal and bonding structure of the respiratory mask assembly of FIG. 65 showing the side edge of the seal deflected away from the bonding structure. FIG. 80 is a front perspective view of the seal and coupling structure of FIG. 79; 71A-71C show various embodiments of a mating structure connector for the frame of FIG. 70. FIG. 13 is a side view of a frame including an embodiment of a mating structure connector having a double prong. FIG. 82B is a perspective view of the frame of FIG. 82A. FIG. 13 is a front perspective view of another exemplary embodiment of a frame. FIG. 84 is a side view of the frame of FIG. 83. FIG. 84 is a front view of the frame of FIG. 83. FIG. 84 is a top view of the frame of FIG. 83. FIG. 84 is a side view of a fastener coupled to the frame of FIG. 83; FIG. 88 is a front view of the fastener and frame of FIG. FIG. 13 is an exploded front perspective view of another exemplary embodiment of a fastener and frame. FIG. 90 is a front perspective view of the frame of FIG. 89 . FIG. 90 is a front view of the fastener of FIG. 89 . FIG. 13 is a side cross-sectional view of another exemplary embodiment of a frame and fastener. FIG. 1 is a front view of a non-limiting exemplary embodiment of a respiratory mask assembly according to the present disclosure. FIG. 94 is a side view of the respiratory mask assembly of FIG. 93. FIG. 94 is a front view of a portion of the respiratory mask assembly of FIG. 93. FIG. 94 is a front perspective view of a portion of the respiratory mask assembly of FIG. 93. FIG. 94 is a bottom perspective view of a portion of the respiratory mask assembly of FIG. 93. FIG. 94 is a bottom perspective view of a portion of the respiratory mask assembly of FIG. 93. FIG. 94 is a front view of the frame of the respiratory mask assembly of FIG. 93. FIG. 100 is a side view of the frame of FIG. 99; FIG. 100 is a bottom view of the frame of FIG. 99; FIG. 100 is a bottom front perspective view of the frame of FIG. FIG. 2 is a front perspective view of a non-limiting exemplary embodiment of a frame, seal, and coupling structure assembly; FIG. 104 is a front perspective view of the frame of FIG. 103; FIG. 104 is a rear perspective view of the frame of FIG. 103; FIG. 104 is a front view of the frame of FIG. 103. FIG. 104 is a rear view of the frame of FIG. 103. FIG. 104 is a top view of the frame of FIG. 103; FIG. 104 is a bottom view of the frame of FIG. 103. FIG. 104 is a side view of the frame of FIG. 103. 106 is a cross-sectional view of the frame of FIG. 103 taken along line 111-111 of FIG. 106, with the connector of the frame omitted. FIG. 112 is a cross-sectional view of FIG. 111 including a connector. FIG. 104 is a front view of the frame, seal and coupling structure assembly of FIG. 103; 114 is a cross-sectional view of the assembly of FIGS. 103 and 113 taken along line 114-114 of FIG. 113. 115 is an enlarged cross-sectional view of region 115 of the frame as depicted in FIG. FIG. 104 is a front perspective view of the frame and inner fastener of FIG. 103 . FIG. 117 is a front view of the frame and inner fastener of FIG. 116. FIG. 117 is a side view of the frame and inner fastener of FIG. 116 . FIG. 117 is a rear view of the frame and inner fastener of FIG. 116 . FIG. 117 is a top view of the frame and inner fastener of FIG. 116 . FIG. 117 is a bottom view of the frame and inner fastener of FIG. 116 . 117 is a cross-sectional view of the frame and inner fastener of FIG. 116 taken along line 122-122 of FIG. 117, showing the inner fastener in an intermediate position during coupling of the inner fastener to the frame. 123 is a cross-sectional view of FIG. 122 showing the inner fastener in final connected position on the frame; FIG. 123 is an enlarged cross-sectional view of area 124 as depicted in FIG. 122 showing the inner catch in an intermediate position. 124 is an enlarged cross-sectional view of area 125 depicted in FIG. 123 showing the inner catch in a final connected position.

The present disclosure relates to a frame and headgear for a respiratory mask system configured to deliver respiratory therapy to a patient/user. FIG. 1 illustrates a non-limiting exemplary embodiment of a respiratory mask system 1 of the present 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 couple to the frame 5, as described in more detail herein.

The patient interface 2 is configured to provide an air path through which pressurized air can be delivered to the airway of a user. In the embodiment shown and described below, the patient interface 2 is a nasal mask, particularly an under-the-nose mask or under-the-nose style 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 portions of the face extending laterally from the nose and along the user's upper lip.

In some embodiments, the seal 4 may be adapted to extend and seal around the nostrils or alae of the nose, which flares out to form a rounded ridge around the nostrils. The illustrated mask 1 is adapted to seal around the surfaces that define the openings to the nostrils, which may include a portion or the entirety of the fleshy outer end of the nasal septum, sometimes referred to as the columella. In some configurations, the seal 4 may be adapted to extend upwardly to seal along at least a portion of the left and right dorsal sidewalls of the user's nose. In some configurations, the seal 4 is adapted to extend upwardly along at least a portion of the left and right dorsal sidewalls without extending upwardly 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, possibly in a position near the nose. While such primary and secondary sealing surfaces may not contact the face of all users, such an arrangement can provide a suitable seal for a relatively wide range of facial geometries.

In the illustrated configuration, the seal 4 does not extend over the bridge of the user's nose. More specifically, the illustrated seal 4 does not contact the bridge of the user's nose. Not contacting the bridge of the nose is advantageous as contact and therefore pressure applied to the bridge of the nose can cause sores and discomfort to the user. If the seal causes pain or discomfort to the user, it may not be suitable for treatment.

As a result of having a reduced contact area against the user's face, as explained above, under-the-nose masks with seal 4 may be less stable on the user's face than many conventional masks that contact the bridge of the nose. The reduced contact area provides fewer constraints on how the seal 4 can move relative to the user's face, and therefore the seal 4 may be able to roll or rotate relative to the user's face. Any rolling or rotation of the seal 4 may result in the substantially airtight seal between the seal 4 and the user's face being broken, resulting in compromised delivery of respiratory therapy. In some embodiments, the instability of the seal 4 may be reduced by providing headgear 3 capable of transmitting forces away from the seal 4 to other parts of the user's head.

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

The headgear 3 is configured to secure the patient interface 2 to the user's face in use. The headgear 3 includes a top strap 7, a pair of side arms 8, and a yoke 9 that are permanently joined to form a closed loop. The top strap 7 is configured to pass over the top of the user's head 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 adjustably connected to the side arms 8 and is configured to pass around the back of the user's head in use.

Although the headgear 3 and frame 5 of the present disclosure are described as being used in combination with a nose-under-the-nose 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 or pillow mask, a full face mask that seals above and/or below the bridge of the nose, or a nasal mask.

2 and 3 show perspective views of a first non-limiting exemplary embodiment of a frame 100 substantially similar to the frame 5 of FIG. 1 and forming part of a respiratory mask system. A longitudinal axis 105 and a transverse axis 107 (shown in FIG. 4) are defined relative to an origin at a central location of the inlet collar 114 of the frame 100. The frame 100 is symmetrical about the longitudinal axis 105. The frame 100 has an outer surface 102 and an inner surface 103. The outer surface 102 serves as an interface between the frame 100, the headgear 3, and the gas delivery line 6. The outer surface 102 includes a recessed groove 106. The recessed groove is defined by and located between a first retention ridge 104 and a second retention ridge 108. The first retention ridge 104 is longitudinally offset from the second retention ridge 108, with the space between the first retention ridge 104 and the second retention ridge 108 defining a recessed groove 106. The recessed surface 110 is located adjacent the second retention ridge 108. The yoke 9 is inserted into the recessed groove 106 in use. The headgear 3 is connected to the frame 100 by inserting the yoke 9 into the recessed groove.

The outer surface 102 additionally includes an inlet collar 114. The inlet collar 114 includes a centrally located inlet collar opening 115. The inlet collar 114 also includes an inner collar surface 116 and an inlet collar face 118. The inlet collar 114 may further include a line retaining projection 122, a number of seal retaining recesses 130, and/or a number of vent holes 127. The first retention ridge 104 extends from a first side edge 126 to a second side edge 128 of the frame 100. The second retention ridge 108 extends from the first side edge 126 to abut the inlet collar face 118 of the inlet collar 114 at a laterally offset junction 112a. The second retention ridge 108 branches off from the inlet collar 114 at a laterally offset second junction 112b and extends to the second side edge 128.

The inner surface 103 contacts the seal 206 or a 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 collar 137 that extends proximally from the frame 100 relative to the user and establishes the outlet collar opening 117. In the illustrated embodiment, a number of seal retaining recesses 130 are located in the outlet collar face 124 to allow for interaction between the frame 100 and the seal 206.

4 and 4A show a front view of the frame 100 aligned with the inlet collar opening 115, i.e., a front view of the frame 100. The frame 100 serves as a manifold connecting multiple components of the respiratory mask system together. The inlet collar opening 115 is oval having a major axis 113 and a minor axis 111. In alternative embodiments, the inlet collar 114 may be circular, triangular, or follow the contour of any other desired polygon.

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

This ratio is determined, at least in part, by the physical characteristics or geometry of the gas delivery lines used in the respiratory mask system. Furthermore, the desire to minimize the pressure drop between the pressure generator and the user also influences the possible ratio of major dimension 145 to minor 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 due to flow resistance and inefficiencies within the system. Minimizing the pressure drop observed in the respiratory mask system improves the effectiveness of the therapy delivered to the user.

The measurable pressure drop across the respiratory mask system increases with increasing ratio of the major dimension 145 to the minor dimension 143 of the inlet collar opening 115. However, increasing the ratio of the major dimension 145 to the minor dimension 143 is beneficial because it allows the physical profile of the frame 100 to be reduced. The reduced physical profile allows for the overall profile of the respiratory mask system to be reduced. Thus, in other embodiments of the frame 100, the ratio of the major dimension 145 to the minor dimension 143 of the inlet collar opening 115 may vary from about 1:1 to about 2:1.

Referring again to FIG. 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 retention ridge 104 extends from the first side edge 126 to the second side edge 128 of the frame 100.

The lateral portions of the second retention ridges 108 are substantially concave relative to the lateral axis 107. The lateral portions of the second retention ridges 108 are defined by an inflection region near the junction 112 where the relative concavity changes from concave to convex as the second retention ridges 108 contact the inlet collar surface 118.

In the illustrated embodiment, the groove 106 passes over an inlet collar 114. The groove 116 is arcuate in shape and passes over the inlet collar 114. This groove 116 is beneficial because the arcuate shape of the groove 116 allows for effective force resolution of the forces generated by the seal and the headgear.

The first and second retention ridges 104, 108 project outwardly from the outer surface 102 of the frame in a direction toward an inlet collar 114. The inlet collar 114 includes a wall extending from the outer surface 102. The longitudinal thickness or height or outward extension of the groove 106 may be defined to vary between a location on the first retention ridge 104 adjacent the groove 106 and a location on the second retention ridge 104 adjacent the groove 106 with each of the two locations aligned on a common longitudinal axis. When so defined, the location of maximum longitudinal thickness of the groove 106 is located at the first and second side edges 126, 128 of the frame 100. The location of minimum longitudinal thickness of the groove 106 is located on the longitudinal axis 105.

The longitudinal thickness or height of the groove 106 decreases in magnitude as one moves laterally inwardly from the first lateral edge 126 and the second lateral edge 128 toward the longitudinal axis 105 of the frame 100. In the illustrated configuration, the longitudinal minimum thickness of the groove 106 is about 5.8 mm, and the longitudinal maximum thickness of the groove 106 is about 12.7 mm. Thus, the ratio of the longitudinal minimum thickness to the longitudinal maximum thickness of the groove 106 is about 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 longitudinal minimum thickness to the longitudinal maximum thickness of the groove 106 can be about 1:1 to 1:4.

By reducing the longitudinal thickness of the groove 106 along a portion of the length or at least at the center of the frame 100, it is possible to reduce or minimize the longitudinal profile of the frame 100. By reducing or minimizing the longitudinal profile of the frame 100, both the actual and perceived prominence of the frame is reduced, and the mass of the frame is reduced or minimized, which may be desirable for user comfort and improve the user's compliance with the treatment. The reduced longitudinal thickness of the groove 106 near the lateral center of the frame 100 may also provide an alignment feature between the yoke 9 and the groove 106. The alignment feature may allow 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.

The yoke 9 may be connected to the frame 100 via the recessed groove 106 using any relevant connection means. The yoke 9 may be glued to the recessed surface 106 using an 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 mechanism. In other configurations, the recessed surface may include one or more protrusions designed to fit into recesses or holes in the yoke such that a combination of the protrusion and the corresponding recess or hole mates the yoke to the frame. Alternatively, the recessed surface 106 may include one or more recesses or holes such that one or more corresponding protrusions on the yoke mates the yoke to the frame.

Alternative configurations of the frame 100 may utilize a number of alternative groove profiles. For example, the grooves may extend above the top of the inlet collar (as shown in FIGS. 4 and 4A) or below the inlet collar . 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, the grooves may include portions where associated retaining ridges are adjacent to one another or where two grooves share a common retaining ridge. In some configurations, the grooves may not include adjacent portions. In some configurations, one or more grooves may both pass above the inlet collar . In some configurations, one or more grooves may both pass below the inlet collar .

In some configurations, two or more grooves may diverge from a common groove near one side edge, diverge around the inlet collar , and then converge to a common groove near the opposite side edge of the frame. In some configurations, the grooves may be completely independent on the outer surface of the frame. In other words, each independent groove may have its own independent retaining ridge, or may share a common retaining ridge with another independent groove while remaining completely separate itself. In each of the aforementioned variations, one or more of the grooves may be used as an interface to connect the headgear 3 of the respiratory mask system to the frame 100.

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 collar 114. The concave surface 110 is adjacent the second retention ridge 108 on the exterior surface 102 of the frame 100 and the inlet collar 114. In the illustrated configuration, the concave surface 110 provides support to the seal 206 to help maintain the structural integrity of the frame 100 both during the manufacturing process and in use. However, in alternative embodiments, the frame 100 may be lacking this concave surface 110 altogether.

The lateral length 125 of the frame 100 according to the embodiment shown in FIG. 4A is approximately 56.00 mm. The ratio of the major dimension 145 of the inlet collar opening 115 to the lateral length 125 of the frame 100 is therefore approximately 1:2.70. The specified lateral length 125 of the frame 100 is utilized to optimize the behavior of the frame 100 when combined with the seal 206 and the headgear 3. The headgear 3 is required to flex relatively large around the face of the user. This behavior is required to maximize the adaptation of the facial contour variations that the respiratory mask system can accommodate. The frame 100 has a sufficient lateral length 125 to allow at least some headgear flexing and reduce displacement of the seal 206.

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

The longitudinal length 129 of the frame 100 provides adequate structure to allow the headgear 3 to effectively connect to the frame 100, and has a longitudinal length that provides the requisite structural and rotational integrity required by the seal 206.

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

5 and 5A show a left side view (relative to the user) of the frame 100 shown in FIG. 1. The frame 100 is shown from one side of the frame. The longitudinal axis 105, the inlet proximal axis 131, and the outlet proximal axis 133 are 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 collar opening 115. In other words, the inlet proximal axis 131, the transverse axis 107 (see FIG. 4), and the longitudinal axis 105 form a three-dimensional space that shares a common origin. The inlet proximal axis 131 is generally parallel to the flow of gas through the inlet collar 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 lateral axis 109 (shown in FIG. 6 ), and the longitudinal axis 105 share a common intersection. The outlet proximal axis 133 is parallel to the flow of gas through the outlet collar opening 117 of the frame 100. The inlet proximal axis 131 is longitudinally offset 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 may be aligned on the longitudinal axis 105.

The distal edge (relative to the user) of the inlet collar 114 is aligned with the longitudinal axis 105 as seen in Figure 5 A. In an alternative configuration, the edge of the inlet collar may be angled relative to the longitudinal axis 105.

In the illustrated configuration, the inlet collar surface 118 includes a first portion having a first circumference, a second portion of a second circumference coaxially offset from the first portion, and a transition portion integral with and connecting the first portion to the second portion. In the illustrated configuration, the circumference of the second portion is greater than the circumference of the first portion, and the second portion is offset proximally relative to the first portion (when worn by a user). The difference in circumference between the first and second portions of the inlet collar 114 results in a transition portion that forms a sloped surface 135 that is angled relative to the inlet proximal axis 131. This sloped surface 135 facilitates the increase in circumference. In some configurations, the inlet collar surface 118 includes only a sloped surface. In other configurations, the inlet collar surface 118 may include a combination of a sloped surface and a surface that is not angled relative to the inlet proximal axis 131.

As can be seen, the inlet collar 114 has a smaller outer periphery than the outer periphery of the outlet collar 137. The inlet collar 114 has a different shape than the outlet collar 137.

The angled surface 135 spans the periphery of the inlet collar surface 118. The projection of the angled surface 135 on the inlet proximal axis 131 has a generally constant length all along the periphery of the inlet collar surface 118. The angled surface 135 is angled at an angle of approximately 10° relative to the inlet proximal axis 131. The offset between the angled surface 135 and the distal edge (relative to the user) of the inlet collar surface 118 varies around the circumference of the inlet collar surface 118. In the illustrated embodiment, the angled surface 135 includes a number of bias flow holes 127. In the configurations shown in Figures 4, 5A and 7, the bias flow holes 127 are located in the angled surface 135 and extend substantially around the circumference of the angled surface 135. The bias flow holes discharge a bias flow substantially longitudinally relative to the inlet proximal axis 131.

The inclusion of the angled surface 135 on the inlet collar surface 118 is intended to affect the orientation of the bias flow holes 127 in a beneficial manner. However, a problem faced with orthogonally oriented holes (holes oriented at 90° to the inlet proximal axis 131) is that the user perceives an unpleasant airflow when the respiratory mask system is in use. Thus, the bias flow holes 127 of the frame 100, when located on the angled surface 135, are angled away from the user. As a result, when the frame 100 is in use, the flow of gas through the bias flow holes 127 is directed away from the user. This prevents the user from perceiving an unpleasant airflow when the respiratory mask system is in use. Alternative embodiments of the frame 100 may include an angled surface 135 having a modified angle relative to the inlet proximal axis 131. In some configurations, the angle may be 0° to 20° or 5° to 15°. In other configurations, the angle may be greater than 20°.

In other configurations, the bias flow holes may span the entire circumference of the inclined surface. Alternatively, the bias flow hole arrangement may be disposed on the inlet collar surface. This arrangement may include one or more rows of bias flow holes, and the rows may be aligned or offset with respect to one another. In other configurations, the bias flow holes 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 integral with the exhaust port or may be connected to the frame 100 to cover the exhaust port. The diffuser in such a configuration may act to diffuse noise emanating from the exhaust port when the respiratory mask system is operating.

5 and 5A, the side profile of the groove 106 is shown. The groove 106 appears laterally concave to a 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 profile of the frame 100 provides adequate structural support for the seal 206 of the respiratory mask system.

6 and 6A, FIG. 6 shows a rear view of the frame 100 relative to the longitudinal axis 105 and the lateral axis 107. The exit collar opening 117 is located in the center of the frame 100 relative to the longitudinal axis 105. The origin of the exit collar opening 117 is aligned with the secondary lateral axis 109. The secondary lateral axis is offset longitudinally from the lateral axis 107. In some configurations of the frame 100, the secondary lateral axis 109 may coincide with the lateral axis 107.

6A shows a rear view of frame 100 and shows that outlet collar 137 is shaped like a truncated circle or partially D-shaped and includes an outlet major axis 119, an outlet minor axis 121, and a truncated portion 123. The truncated portion 123 of outlet collar 137 allows the profile of frame 100 to be reduced relative to a frame without the truncated portion. Additionally, truncated portion 123 provides an orientation feature to ensure correct orientation of connection of the seal to the frame. The truncated portion 123 also reduces the chance that seal 206 will be misoriented when it is to be connected to frame 100. The truncated portion also prevents rotation of seal 206 relative to frame 100.

In the illustrated configuration, the outlet collar opening 117 includes both a larger lateral and vertical profile than the inlet collar opening 115. Thus, the perimeter of the outlet collar opening 117 is larger than the perimeter of the inlet collar 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 collar 137 that is larger than the inlet collar 114, the airflow to the user is less restricted. This results in a reduced pressure drop through the respiratory mask system, in addition to at least in some way reducing the inhalation noise resulting from the user breathing through the respiratory mask system. From a manufacturability standpoint, having an outlet collar 137 that is larger than the inlet collar 114 allows the mold core to be more easily removed from the molded part.

Following the contour of the first retention ridge 104, the inner surface 103 adjacent the first retention ridge 104 is also substantially concave relative to the lateral axis 107. In an alternative configuration, the inner surface 103 may be substantially convex relative to the lateral axis 107. Additionally, the inner surface 103 may be substantially concave in some areas and substantially convex relative to the lateral axis 107 in other areas.

7 shows a top view (relative to the user) of the frame 100. Both the outer surface 102 and the inner surface 103 are concave relative to the user. This is exemplified by the first retention ridge 104 of the outer surface 102 being concave relative to the user because it is also adjacent to the inner surface 103. This configuration is beneficial to allow for a reduction in the proximal profile of the respiratory mask system. In alternative configurations, the outlet collar 137 may be convex or flat in at least one plane. Additionally, the outlet collar 137 may include both concave and convex areas in at least one plane.

The outlet collar face 124 includes multiple seal retaining recesses 130. In the illustrated configuration, the outlet collar face 124 includes two seal retaining recesses 130. The seal retaining recesses 130 are located near each lateral extreme end of the outlet collar 37. The seal retaining recesses 130 allow the seal 206 to be connected to the frame 100. In the illustrated configuration, the seal 206 connects to the frame 100 using a coupling structure, such as a fastener that connects to the frame 100. The coupling structure or fastener includes a raised surface that corresponds to the seal retaining recesses 130 that allows the connection between the components to be made. Some configurations of the outlet collar 137 may include a feature that connects to the seal 206 using a snap-fit or friction-fit mechanism. Alternative embodiments of the frame 100 may include one or more recesses in the outlet collar face 124 that interfaces with the seal. Additionally, one or more protrusions may be included in the outlet collar face 124 as opposed to the use of one or more recesses. These protrusions may interact with corresponding recesses or retaining portions in the seal 206 or mating structure to connect the components together.

7A shows a top view (relative to the user) of an alternative configuration of frame 100. In this configuration, bias flow holes 127 are located in an angled surface 135 on inlet collar 114, for example, as also shown in FIG.

Figure 8 shows a bottom view (relative to the user) of the frame 100 illustrated in Figure 1. The outlet collar 137 can be concave in at least one plane. At least a portion of the outlet collar 137 can be proximally offset relative to a second portion of the outlet collar 137.

In an alternative configuration, the outlet collars 137 may be aligned in a common plane such that they are not concave in shape. In some configurations, this plane is perpendicular to the outlet proximal axis 133. In other words, the extreme longitudinal ends and extreme lateral ends all share a common proximal offset from the origin of the outlet proximal axis 133.

Figure 9 shows a front view of the frame 100 shown in Figure 1 and indicates a cross-sectional plane 132 that may be cut. This cross-sectional plane is central to the frame 100 and aligned with the longitudinal axis 105.

Figure 10 shows the cross-section 10-10 formed when the frame 100 is viewed in a direction perpendicular to the cross-section plane 132. The central cross-section 134 shows the cross-sectional profile of the frame 100 as viewed from the cross-section plane 132.

10A shows a central cross section 134 of the frame 100. The conduit retention projection 122 projects inwardly from the periphery of the inlet collar 114. In other words, both the lateral and longitudinal dimensions of the inlet collar opening 115 are smaller than the lateral and longitudinal dimensions of the collar inner surface 116. This change in dimension is the result of the conduit retention projection 122. In other words, the conduit retention projection 122 may form a lip around the inside of the distal end of the inlet collar 114. This lip may be continuous around the periphery of the inlet collar opening 115 or may include a peripheral portion that projects and another peripheral portion that does not. The gas delivery conduit 6 may be connected to the frame 100 using an adhesive or using a coupling structure or fastener that engages the conduit retention projection 122. The gas delivery conduit may be positioned adjacent the conduit retention projection 122 and then adhesively bonded to the frame 100. Alternatively, the gas delivery conduit 6 may be removably secured to the frame 100 through a bonding structure or fasteners. In some embodiments of the frame 100, the gas delivery conduit 6 may be permanently connected to the frame 100 using a bonding structure or fasteners or other permanent attachment methods including, but not limited to, ultrasonic welding or overmolding. Additionally, the conduit retention protrusions 122 may not be included in some embodiments.

The line retention projection 122 may alternatively be located on the inlet collar face 118 and project radially outward from the center of the inlet collar 114. In other words, the line retention projection 122 may form a lip around the exterior of the inlet collar 114. In this configuration, the gas delivery line 6 may connect adjacent to the inlet collar face as opposed to the collar inner surface 116. The lip may be continuous or intermittent around the periphery of the inlet collar 114.

In the illustrated configuration, the frame 100 is constructed of a rigid polymer. In some configurations, the frame 100 may be constructed of any of a number of polymeric or non-polymeric materials, such as nylon 12 or polycarbonate.

11 and 12 show a non-limiting exemplary embodiment of a respiratory mask system 200 that is substantially similar to the respiratory mask system 1 of FIG. 1. The respiratory mask system 200 includes a patient interface 202 and 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.

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

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

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

The top strap 212 is configured to pass over the top of the user's head from one side to the other in use. In the illustrated configuration, the top strap 212 can include a forehead strap that sits over the user's frontal bone. In this configuration, the top strap 212 is angled forward of the coronal plane 11 that passes through the user's head, as shown in FIG. 12. An angle θ of 5° to 45° is formed between the top strap 212 and the coronal plane 11. In the illustrated embodiment, the top strap 212 is angled at 15° with respect to the coronal plane 11. This angle points the top strap 212 toward the patient's forehead, which may improve stability of the headgear 204. In other configurations, the top strap 212 is a parietal strap that sits over the parietal bone or at or near the junction of the parietal and frontal bones.

The rear strap 218 passes around the back of the user's head and in some configurations sits above 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.

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. In use, the top strap 212 and the rear strap 218 encircle the occipital portion of the user's head. The enclosed occipital portion of the user's head may include at least a portion of the crown region and/or the occipital region.

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

Integrally Formed Closed Loops In the illustrated embodiment, at least some portions of the headgear 204 are rigid, semi-rigid, inelastic, or substantially inextensible in response to normal or anticipated forces acting on the headgear 204. Other portions of the headgear 204 are elastic or extensible, or at least substantially flexible compared to other portions, in response to normal or anticipated forces.

In the illustrated configuration, the top strap 212, joints 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 FIG. 13. A three-dimensional closed loop is formed when the free ends of the left and right portions 220, 222 of the top strap 212 are connected to one another by the adjustment mechanism 228. The closed loop is configured to encircle at least a portion of the user's head in use. In the illustrated embodiment, the closed loop encircles the front upper portion of the user's head from the bottom of the nose to the parietal bone in front of the ears. In alternative embodiments, the closed loop may encircle a larger or smaller portion of the user's head.

The use of rigid, semi-rigid, inelastic or substantially inextensible materials for the top strap 212, side arms 214 and yoke 216 allows the closed loop they form to effectively transfer forces between the patient interface 202 and the user's head. For example, in use, if the gas delivery 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 may be transferred from the yoke 216 through the side arms 214 to the top strap 216 and then to the user's head such that rotation of the seal 206 in a vertical direction resists removal of the seal 206 from the user's face.

The closed loop allows the headgear 204 to be separated from the patient interface 202 without changing the fastening setting of the top straps 212. This is advantageous because the user does not have to loosen and fasten the headgear 204 to readjust the straps at the correct fastening every time the headgear 204 is removed from the patient interface 202. This saves time and makes it easier for the user to attach the headgear. The closed loop arrangement also provides a single connection point between the headgear 204 and the patient interface 202.

In other words, the integrally formed components forming the closed loop are rigid, semi-rigid, inelastic or substantially inextensible. 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 and covered with a fabric casing that is permanently bonded to the plastic core. The plastic core provides the necessary structure to the headgear 204, and the fabric casing provides a soft, comfortable finish that contacts 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 to a shape and joined along the edges, or any other tubular fabric may include, but is not limited to, a woven or braided tube. In some embodiments, at least a portion of the integrally formed top strap 212, side arms 214 and yoke 216 are formed by an in-molding process, examples of which are described in applicant's application PCT/NZP2015/050149, which is incorporated by reference in its entirety. "In-molding" includes forming a component as a unitary plastic core and fabric casing by adding molten plastic into a fabric casing. "In-molded" straps or any other components are components formed by adding molten plastic into a fabric casing.

13 shows that the headgear 204 of the illustrated embodiment has a top strap 212 and side arms 214 that include soft edges 250. The soft edges 250 are configured to extend along one or both of the longitudinal edges of the top strap 212 and side arms 214. The soft edges are formed by longitudinal edge portions of the fabric casing that protrude from the edges of the plastic core and are not filled with the plastic core. The soft edges provide a cushioned edge that may improve user comfort by cushioning contact between the rigid, semi-rigid, inelastic or substantially inextensible 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 edges of the side arms 214 that are located above the user's ears in use.

In alternative embodiments, the closed loop may be formed from any material that provides suitable rigidity, inelasticity, or inextensibility. Materials may include, but are not limited to, thermoplastics and silicones. In some embodiments, the material may or may not have a fabric casing.

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 one another and have a free end and a fixed end. The free end is configured to be adjustably connected by an adjustment mechanism 228. The fixed end is configured to extend at an angle from the side arm 214 at a junction 224.

The adjustment mechanism 228 is configured to adjust and secure the top strap 212 to a desired adjustment length, thus providing 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. Avoiding contact between the side arms 214 and the ears may improve the user's comfort, as contact between the side arms 214 and the tops of the user's ears can cause irritation or pressure points that may cause pressure sores over time.

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

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 be slid relative to each other to change the overlap distance of the left portion 220 and the right portion 222 and thus 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 the left portion 220 without bending or deforming the left portion 222.

The post 234 is configured to pass through one of the holes 232. As shown in FIG. 14, the post 234 includes a stem 238 and a head or cap 240. The illustrated post 234 is generally T-shaped, but other shapes, such as a cylindrical stem 238 and a disk-shaped or spherical head 240, can also be used. The hole 232 is sized, shaped, and/or otherwise configured to allow the head 240 of the post 234 to pass through the hole 232 and retain the post 234 once it has passed through the hole 232, at least in response to normal or expected forces. However, the post 234 can be purposefully removed from the hole 232 to allow separation of the left and right portions 220 and 222 of the top strap 212 to allow for size adjustment of the headgear. Passing the post 234 through the hole 232 can be achieved by deformation of one or both of the post 234 and the hole 232. That is, the heads 240 of the posts 234 may flex or otherwise deform, and the holes 232 may stretch or enlarge to facilitate passage of the heads 240 of the posts 234. In alternative embodiments, there may be multiple posts.

In alternative embodiments, the adjustment mechanism 228 may include any other suitable means for adjustably connecting the free ends of the top strap 212, such as, but not limited to, hook-and-loop fasteners, buckles, etc.

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

Side Arms A pair of opposing side arms 214 are configured to connect a yoke 216 to the top strap 212 on each side of the user's face in use. This arrangement allows rotational forces applied to the patient interface 202 to be transferred from the yoke 216 to the top strap 212 and the user's head to resist rotation of the seal 206 relative to the user's face.

The side arms 214 include elongated straps that are shaped to curve across the user's cheeks, toward the temples, and over the ears when in use. The curvature is such that the side arms 214 avoid the eyes to provide an uninterrupted view and improved comfort for the user. The curvature can follow the line of the user's cheekbones such that contact between the side arms 214 and the user's cheeks transfers force away from the patient interface 202 so that the seal with the user's face is not disrupted.

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

The buckle 226 includes an extension of the free end of the side arm 214 and an opening that extends 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 any other geometric shape suitable for adjustably anchoring the rear strap 218.

The side arms 214 may be elastically flexible in a generally horizontal plane (when worn) toward and away from the user's face, but relatively inflexible in a generally vertical plane, to accommodate different face sizes. The illustrated side arms 214 are solid, but other variations of the side arms may include one or more openings or notches extending along the length of the side arms to increase the elastic flexibility of the side arms toward and away from the user's face, but retain relative inflexibility in a generally vertical plane (when worn). The vertical 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, but not limited to, blowing forces or hose drag/pulling forces, to the top strap 212 and rear strap 214. This may help reduce the likelihood of the seal 206 dislodging from the user's face and impeding the delivery of treatment.

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

The yoke 216 is configured to provide a connection between the frame 100 and the headgear 204 that supports the patient interface 202 vertically and horizontally relative to the user when the respiratory mask 200 is worn. By supporting the patient interface 202 vertically and horizontally, rotation of the seal 206 relative to the user's face may be reduced, thus reducing leakage.

The central bridge 244 is shaped such that the central bridge 244 fits within the recessed groove 106 of the frame 100 (discussed above). The central bridge 244 is configured to temporarily or permanently connect to the recessed surface 106 by means such as, but not limited to, a snap-fit connection, a friction-fit connection, a fastener mechanism, adhesive, or welding. The central bridge 244 curves over the entry collar 114 of the frame 100 and transitions to a lateral rear portion 248.

The lateral rear portion 248 forms an integrally formed transition between the central bridge 248 and the side arms 214. The lateral rear portion 248 is positioned laterally of the central bridge 244 and curves rearwardly around the frame 100 when the respirator 200 is worn by a user.

16, the central bridge 244 has a height _H1 that is less than the height _H2 of the lateral rear portion 248 of the yoke 216. The height _H1 is less than the height H2 to minimize the bulk of the frame 100. The height _H2 is greater than the height _H1 to provide a desired level of structure vertically for purposes of preventing rotation of the patient interface 202 relative to the user's face. _H1 may be between 1 mm and 12 mm _{, or between 4 mm and 7 mm. In the illustrated embodiment, H1 is 5.5 mm. H2 may be} between 5 mm and 16 mm, or between 8 mm and 13 mm. In the illustrated embodiment, _H2 is 12.5 mm.

The side arms 214 may continue from the lateral rear portion 248 at a height equal to or greater than _H2 . In some embodiments, the height of the side arms 214 increases in _a direction 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 the height transitions completely to the height of _H2 . This configuration allows the yoke 216 to be provided with structural support for its maximum height such that there are no unsupported portions of the yoke 216 or side arms 214 that are low in height and could form weak points. This allows forces to be transferred from the frame 100 through the yoke 216 to the side arms 214 without passing through weak points that could cause the side arms 214 or yoke 216 to twist or bend longitudinally, allowing the patient interface 202 to rotate. In some embodiments, the height of the side arms 214 is 16 mm or less to provide a minimal respiratory mask.

16, it can be seen that the soft edges 250 of the side arms 214 are transitioned to fade away so that the soft edges 250 are not present in the yoke 216. This transition of the soft edges 250 may provide an improved connection between the yoke 216 and the frame 100 by providing a rigid, semi-rigid, inelastic or substantially inextensible edge that may be engaged by the recessed groove 106 of the frame 100. The soft edges 250 are not required at the edges of the yoke 216 because they are unlikely to contact the user and cause discomfort or irritation. The size of the yoke 216 may be minimized by transitioning the soft edges 250 to fade away. Thus, the size of the yoke 216 may be minimized to provide a less intrusive respiratory mask system 200.

17 shows that in the illustrated embodiment, the lateral rear portion 248 of the yoke 216 has a wall thickness _T1 in a direction perpendicular to the inner surface 236 that is greater than the wall thickness _T2 at the center and side arms 214 of the yoke 216. The increased thickness provides increased structure at the lateral outermost portion of the yoke 216 that contacts the frame 100. This allows for effective force transfer 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 between 1 mm and 4 mm. In the illustrated embodiment, thickness _T1 is 2.9 mm. The central bridge 244 and side arms 214 have a thickness _T2 between 0.5 mm and 3 mm. In the illustrated embodiment, _T2 is 2.1 mm.

The reduced thickness _T2 of the side arms 214 relative to the greater wall thickness _T1 of the lateral rear portion 248 of the yoke 216 allows for increased horizontal flexibility of the side arms 130 relative to the yoke 216 (when worn), allowing the side arms 214 to flex horizontally to conform to different facial geometries while providing vertical stability when the respirator 200 is worn by a user.

Rear Straps The rear straps 218 comprise elongated straps that extend between and connect around the buckles 226 of the side arms 214. Ends of the rear straps 218 are adjustably anchored through openings in the buckles 226 so that the length of the rear straps 218 can be adjusted. Adjusting the length of the rear straps 218 allows the overall size of the headgear 204 to be further tailored to fit an individual user.

In the illustrated configuration, the rear straps 218 are elastic or extensible. Such an arrangement allows the rear straps 218 to stretch to adjust the circumferential length of the headgear 204. The amount of stretch of the rear straps 218 can be limited, and therefore the rear straps 218 can be adjustable in length as previously described. In some configurations, it is preferred that the circumferential length adjustment occurs at the back of the user's head, which is less susceptible to stretching in response to blowing forces. The rigid, semi-rigid, inelastic or substantially inextensible nature of the joints 224 and side arms 214 positioned at the side and front portions of the user's head assist in maintaining the desired circumferential length of the headgear 204 despite the elastic nature of the rear straps. In some cases, frictional forces between portions of the headgear 204 and the side and front portions of the user's head prevent the headgear 204 from moving or stretching in response to blowing forces. However, in other arrangements, the rear straps 214 may be rigid, semi-rigid, inelastic, or substantially inextensible, in which case the length may be adjustable.

In the illustrated embodiment, the rear straps 218 comprise a length of laminated fabric and foam, such as, but not limited to, Breathoprene®. The rear straps are elastic so that they can be stretched to allow the headgear 204 to be pulled over the user's head without adjusting the length of the rear straps 218. This improves ease of use. In alternative embodiments, the rear straps may comprise any suitable fabric or woven material.

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

Alternative Headgear Embodiments Figures 18 and 19 show another non-limiting exemplary embodiment of headgear 304. For purposes of this description, features of this embodiment that are substantially similar to features of the previous embodiment of headgear 204 are labeled with the same reference numerals plus 100. For example, headgear 204 becomes headgear 304 in this embodiment. For the sake of brevity, only those features that are substantially different from the previous embodiment will be described in detail here. It should be understood that all other features are substantially as described with respect to headgear 204.

The headgear 304 includes a top strap 312, a pair of opposing side arms 314, a yoke 316, and a rear strap 318. As with the previous embodiment, the top strap 312, side arms 314, and yoke 316 are rigid, semi-rigid, inelastic, or substantially inextensible, and are formed as a single integrally formed component. The single integrally formed component can be arranged to form a closed loop that encircles the front upper portion of the user's face 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, the rear strap 318 can extend between and connect to the buckles 326 of the side arms 314. One or both ends of the rear strap 318 may include grip tabs 319 that may advantageously allow a user to more easily grip the ends of the rear strap 318 to adjust and/or secure the rear strap 318. The top strap 312 may be adjusted by an adjustment mechanism 328.

The yoke 316 in this embodiment is configured to provide a connection between the headgear 304 and a patient interface (not shown, but may be similar to the patient interface 202). The yoke 316 is symmetrical in use with respect to the sagittal plane (as shown in FIG. 19 ) and includes a loop structure formed by an upper bridge 350 and a lower bridge 352 joined by the front ends of each of the side arms 314. The upper bridge 350 and the lower bridge 352 are configured to removably connect to a frame (not shown, but may be similar to the frame 100) around an entry collar or around a connection of the frame. The upper bridge 350 and the lower bridge 352 are curved such that the loop structure formed by the upper bridge 350 and the lower bridge 352 is continuous and defines an opening configured to surround the entry collar . This curved shape may be configured to fit around the periphery of the frame to reduce the overall size of the patient interface.

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 by which forces may be transferred from the frame to the headgear 300. That is, by providing two paths, rotational forces may be evenly distributed such that there is no bias in the direction of upward or downward rotation.

20 illustrates another non-limiting exemplary embodiment of a respiratory mask assembly 400. The respiratory mask assembly 400 includes a patient interface 402 and 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 profile 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 during use.

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

21-23B and 26A-32B, the frame 410 provides the connection between the seal 406 and the headgear 404. Like the frame 100, the frame 410 has an outer surface 412, an inner surface 413, and a fluid pathway 415 extending through the outer surface 412 and the inner surface 413 as shown in FIGS. 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 in use and acts as an interface between the frame 410, the headgear (such as headgear 404), and the gas delivery line (such as gas delivery line 408). The inner surface 413 faces the user in use and may contact the seal 406 and/or a coupling structure connected to the seal 406. In use, the gas delivery line 408 is coupled to the frame 410 such that the gas delivery line 408 is in fluid communication with the fluid path 415.

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 the concave surface 426 when assembled. In the illustrated embodiment, the raised surface 428 is below the concave surface 426 and/or adjacent the bottom edge of the frame 410, while the concave surface 426 is above the raised surface 428 and/or adjacent the top edge of the frame 410. An inlet collar 430 projects outwardly (towards a user in use) from the outer surface 412. The inlet collar 430 surrounds the fluid pathway 415. In the illustrated embodiment, the boundary between the concave surface 426 and the raised surface 428 is partially defined by the inlet collar 430. The inlet collar 430 includes an inlet collar inner surface 432 (which defines the fluid pathway 415) and an inlet collar surface 434 (located outside the inlet collar 430). In some embodiments, the inlet collar surface 434 may be considered a part of or partially define the exterior surface 412. In the illustrated embodiment, the inlet collar 430 includes a line retention protrusion 436 (shown in FIG. 22 ). The inlet collar 430 may include one or more bias flow holes 438.

The outlet collar 440 projects inwardly (towards a user in use) from the inner surface 413. The outlet collar 440 has an outlet collar face 444 which in some embodiments can be considered part of the inner surface 413 or can be considered to partially define the inner surface 413. The outlet collar 440 can include one or more seal retaining recesses 446. The seal retaining recesses 446 allow for interaction and/or connection between the frame 410 and the seal 406. In some embodiments, the seal retaining recesses 446 allow for 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 collar face 444 includes the seal retaining recesses 446.

Fluid pathway 415 is defined or formed by inlet collar 430 and outlet collar 440. In use, gas delivery line 408 is coupled to inlet collar 430 and seal 406 is coupled to outlet collar 440. Gas can be delivered from gas delivery line 408 through fluid pathway 415 (i.e., through inlet collar 430 and outlet collar 440) to seal 406 for delivery to a user.

In the illustrated embodiment, the inlet collar 430 may be oval and may have a major axis 113 and a minor axis 111. In some embodiments, the inlet collar 430 may be circular, triangular, "D" shaped, or other shapes. In the illustrated embodiment, the frame 410 is symmetrical about the minor axis 111 or longitudinal axis 105. In the illustrated embodiment, the major dimension D _major (shown in FIG. 23B ) of the opening defined by the inlet collar 430 is at or about 21.9 mm, and the minor dimension D _minor of the opening is at or about 16.7 mm. In other words, the ratio of the major dimension to the minor dimension is at or about 1.31:1.

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

In the illustrated embodiment, the vertical dimension (or height) H of the frame 410 (illustrated in FIG. 23B) is 28.0 mm or approximately 28.0 mm. Thus, the ratio of the short dimension of the opening defined by the inlet collar 430 to the vertical dimension of the frame 410 is 1:1.68 or approximately 1:1.68. One consideration in selecting the vertical dimension of the frame 410 is the area required for the concave surface 426 and/or headgear retention features as described herein to maintain an effective connection between the frame 410 and the headgear 404. The vertical dimension of the frame 410 can be selected to provide an appropriate structure to allow the headgear 404 to effectively connect to the frame 410 and/or to provide the requisite structural and rotational integrity required by the seal 406. In some embodiments, the vertical dimension of the frame 410 can 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.

In the illustrated embodiment, the proximal dimension (or thickness) T of the frame 410 (illustrated in FIG. 26B) is 17.05 mm or approximately 17.05 mm. As shown in the side views of FIGS. 26A and 26B, the entire periphery or distal end of the inlet collar 430 (i.e., the rim of the inlet collar 430 furthest from the user in use) is not aligned with the illustrated longitudinal axis 105. The longitudinal extremes (i.e., the top and bottom) of the inlet collar 430 intersect the longitudinal axis, but the central portion (i.e., the side or lateral extremes) of the inlet collar 430 are offset proximally (or toward the user in use). In other words, when viewed from the side (as in FIGS. 26A-B), the periphery of the inlet collar 430 is recessed distally (or recessed facing away from the user in use). The concave contour can advantageously allow the frame 410 to have reduced material requirements. In some embodiments, the oval shape of the inlet collar 430 and/or the offset longitudinal and lateral extremes of the distal end of the inlet collar 430 provide beneficial behavior when a gas delivery line, such as the gas delivery line 408, is coupled to the inlet collar 430. For example, if the gas delivery line 408 is removably coupled to the inlet collar 430, such as by a press fit, snap fit, or other connection that cooperates with the line retention protrusions 436, it may be difficult to unintentionally remove the gas delivery line 408 when a force is applied axially (in the axial direction of the inlet collar 430 and/or the gas delivery line 408). Thus, the oval shape and/or the concave distal end of the inlet collar 430 can inhibit unintentional removal of the gas delivery line 408. However, the gas delivery line may be more easily or with less effort removed from the frame 410 if the gas delivery line is twisted about the axial axis of the inlet collar 430 .

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

As described above, in the illustrated embodiment, the frame 410 includes two retaining features 450. Including two retaining features 450 and/or using a circular retaining feature 450 can advantageously allow for easy attachment and detachment of the headgear 404 to the frame 410. As shown in FIG. 24A, a first retaining feature of the retaining feature 450 can be used to connect the frame 410 and the headgear 404 at an angle. The frame 410 can then be rotated about the first retaining feature 450 so that a second retaining feature of the retaining feature 450 can be connected to the headgear 404 as shown in FIG. 24B.

In the illustrated embodiment, the inlet collar 430 or inlet collar surface 434 is angled by a slope angle θ _A such that the diameter of the base of the inlet collar 430 closest to the user in use is greater than the diameter of the periphery of the inlet collar 430 furthest from the user in use, as shown in Figures 28 and 29C. The inlet collar 430 may resemble a hollow frustum of a cone. The angle of the inlet collar 430 causes or allows air passing through the bias flow holes 438 to be directed away from the user's face (approximately or approximately perpendicular to the sloped inlet collar 430 or inlet collar surface 434). This advantageously prevents or reduces the possibility that the user may feel airflow through the bias flow holes 438 and/or airflow due to entrainment.

The first bevel angle can be defined as an angle between the top (or upper vertical extreme) of the inlet collar 430 or inlet collar face 434 and an axis parallel to the proximal axis, and can be located at the intersection of the inlet collar 430 and the outer surface 412 or raised surface 426 of the frame 410, as shown in FIG. 28. The second bevel angle θ _A2 can be defined as an angle between a lateral side of the inlet collar 430 or inlet collar face 434 and an axis parallel to the proximal axis, and can be located at the intersection of the inlet collar 430 and the outer surface 412 or raised surface 428 of the frame 410, as shown in FIG. 29C. In some embodiments, the bevel angle can range from about 10° to about 15°. In the illustrated embodiment, the first bevel angle is about 10°, the second bevel angle is about 15°, and the bevel angle transitions from about 10° to about 15° between the top and side of the inlet collar 430. In some embodiments, the bevel angle can be a constant angle around the entire circumference of the inlet collar 430. In some embodiments, the bevel angle can vary around the circumference of the inlet collar 430. In some embodiments, the bevel angle can range from about 0° to about 90°, such as about 0°, about 45°, or about 90°.

In the illustrated embodiment, each bias flow hole 438 is equally offset or spaced from the distal end of the inlet collar 430. In other words, the arrangement of the bias flow holes 438 follows the contour of the distal end or periphery of the inlet collar 430, with bias flow holes 438 located at or near the extreme longitudinal ends (top or bottom) of the inlet collar 430 being located distal or farther away from a user in use than bias flow holes 438 located at or near the lateral sides of the inlet collar 430. In some embodiments, the arc connecting the bias flow holes 438 is parallel or approximately parallel to the periphery of the inlet collar 430. Maintaining a constant and controlled distance between the bias flow holes 438 and the periphery of the inlet collar 430 can allow for better and easier control of noise caused by flow through the bias flow holes 438. The distance between the bias flow holes 438 and the periphery of the inlet collar 430 can be selected to reduce or minimize noise caused by flow through the bias flow holes 438. In the illustrated embodiment, the bias flow holes 438 are positioned at or about 3.1 mm from the periphery of the inlet collar 430. In the illustrated embodiment, the bias flow holes 438 are located at or about the midpoint of the length of the inlet collar 430.

In the illustrated embodiment, the bias flow holes 428 are disposed about or in a portion of the inlet collar 430, as shown in FIG. 26D. The portion of the inlet collar 430 that includes the bias flow holes 428 may be defined by an exhaust angle θ _E defined relative to an origin centered at the intersection of the longitudinal axis 105 and the lateral axis 107 of the inlet collar 430 as shown. In some embodiments, the exhaust angle and/or the bias flow holes 428 may range from about 4:00 to about 8:00 (as with a clock). In some embodiments, the exhaust angle and/or the bias flow holes 428 may 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 about 220°, about 218°, in the range of about 180° to about 270°, in the range of about 190° to about 260°, in the range of about 200° to about 250°, in the range of about 210° to about 240°, or in the range of about 220° to about 230°. In some embodiments, the exhaust angle may be 360°. In other words, in some embodiments, the bias flow holes 428 may span the periphery of the inlet collar 430 or completely surround the inlet collar 430.

As shown in FIG. 26C, in the illustrated embodiment, the bias flow holes 438 extend through the inlet collar 430 in a direction perpendicular or generally perpendicular to the inlet collar surface 434 and/or the inlet collar inner surface 432. In some embodiments, as represented by dashed lines in FIG. 26C, the bias flow holes 438 can extend through the inlet collar 430 at an angle θ relative to normal. The angle θ can range from about ±10° to about ±45°, such as ±10°, ±25° or ±45°. As shown, bias flow holes 438 oriented at a positive angle extend such that the holes are closer to the periphery of the inlet collar 430 at the inlet collar surface 434 than to the inlet collar inner surface 423. An angle of 0° or greater can advantageously direct flow through the bias flow holes 438 in a direction away from the user during use.

As shown in FIG. 27B, the outlet collar 440 has a major axis 119 and a minor axis 121. In the illustrated embodiment, the outlet collar 440 has a "D" shape. The major axis dimension D _o-major of the outlet collar 440 is the dimension of the opening defined by the proximal-most end or edge of the inlet collar 440 along the major axis 119 at the location where the opening has its largest lateral dimension. In some embodiments, the outlet collar 440 can have a circular, triangular, or other shape. The minor axis dimension D _o-minor of the outlet collar 440 is the dimension of the opening along the minor axis 121, which in the illustrated embodiment is parallel to and/or aligned with the longitudinal axis, as shown in FIG. 27A. As shown in FIG. 27A, the longitudinal and lateral axes intersect at an origin at or corresponding to the center of the opening of the inlet collar 430. In the illustrated embodiment, the outlet major axis corresponds to or is co-located with the lateral axis. In some embodiments, the outlet major axis may be longitudinally offset or spaced apart from the lateral axis, i.e., the center of the opening in the inlet collar 430 is offset from the center of the opening in the outlet collar 440.

In the illustrated embodiment, the outlet major dimension D _o-major is at or about 25.9 mm and the outlet minor dimension D _o-minor is at or about 20.7 mm. In other words, the ratio of the outlet major dimension D _o-major to the outlet minor dimension D _o-minor is at or about 1.25:1. In the illustrated embodiment, the opening of the outlet collar 440 is larger than the opening of the inlet collar 430.

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

FIG. 32A illustrates a cross-sectional view taken along line 32A-32A of FIG. 31. The cut line is central to the frame 410 and aligned with the longitudinal axis. FIG. 32B illustrates a 2D view of the cross-section of FIG. 32A. The thickness of the frame 410, or the thickness of various portions of the frame 410, can be selected to provide the frame 410 with sufficient rigidity in use while reducing or minimizing the weight and/or profile of the frame 410. In some embodiments, the concave surface 426 (or the frame 410 in the region of the concave surface 426) has a thickness t _rs of 1.5 mm or about 1.5 mm. In some embodiments, the inlet collar 430 has a thickness t _ic of 1.46 mm or about 1.46 mm. In some embodiments, the conduit retaining projection 436 projects inwardly from the inlet collar inner surface 432 by 0.5 mm or about 0.5 mm. In the illustrated embodiment, the conduit retention projections 436 extend around the entire periphery of the inlet collar 430. In some embodiments, the outlet collar 440 has a thickness t _oc of 1.5 mm or about 1.5 mm. Other thicknesses of the inlet collar 430, the concave surface 426 (or the frame 410 in the area of the concave surface 426) and/or the outlet collar 440 are possible. In some embodiments, the frame 410 is made of or includes nylon 12. When the inlet collar 430, the concave surface 426 (or the frame 410 in the area of the concave surface 426) and/or the outlet collar 440 have a thickness in the range of at or about 0.6 mm to 2 mm or about or greater than 2 mm, modifying the compound properties may enable the frame 410 to exhibit the same or similar hardness.

Alternative Headgear Embodiments Figures 33-34 show an exemplary embodiment of headgear 404 that can be used with frame 410. In the exemplary embodiment, headgear 404 has a bifurcated configuration. Headgear 404 may be similar in some respects to headgear 204. Features of headgear 404 that are the same or similar to corresponding features of headgear 204 are designated herein with the same reference numbers plus 300 (e.g., headgear 404 includes a top strap 512, a pair of opposing side arms 514, a yoke 516, and a rear strap 518). Top strap 512 and rear strap 518 form a bifurcated configuration.

The side arms 514 and/or top straps 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 or includes a fabric. The outer casing may be permanently attached to the core. A fabric outer casing may advantageously provide a soft, comfortable finish that contacts the user during use. The longitudinal edge portions of the outer casing 551 that protrude beyond the edges of the core 549 and are not filled by the core 549 may form soft edges 550 as shown in FIG. 37. The soft edges 550 may advantageously provide a cushioned edge that may improve user comfort, for example, by cushioning potential contact between the edges of the top straps 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 edges of the side arms 514 that are located above the user's ears during use. The thickness of the soft edges 550 can vary along the length of each side arm 514. In the illustrated embodiment, the thickness of the soft edges 550 varies from a maximum of or about 2 mm at the side ends of the side arms 514 (represented as _D2 in FIG. 37) to a minimum of or about 1 mm at the upper ridge of the yoke 516 (represented as _D1 in FIG. 37). In some embodiments, for example, the bottom edge of the yoke 516 does not include a soft edge because the bottom edge is not intended to contact the user's face during use due to aesthetic and/or industrial design benefits, part-to-part tolerances, and/or other reasons. The omission of the soft edge in this region provides additional space to allow for an increase in the thickness of the core 549 of the yoke 516 to improve or increase the structural integrity of that region.

In the illustrated embodiment, the outer casing 551 is made of a fabric that is a non-stretch or low-stretch yarn. Non-stretch or low-stretch yarns require a relatively large force for elastic deformation. In some cases, yarns with high elasticity do not perform well (or as well as yarns with low elasticity) in the internal molding process used to form the top strap 512 and/or the side arms 514 because the yarn fibers may stretch to such an extent that molten plastic can leak outside the outer casing. Using non-stretch or low-stretch yarns in the side arms 514, the outer casing advantageously improves the finish and/or consistency of the finished side arms 514. The non-stretch or low-stretch yarns reduce or minimize the amount or extent 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 can be made of or include yarns that have some elasticity. Yarns that have low elasticity (i.e., require a relatively large force to elastically stretch) can function well in the molding process. In some embodiments, the gate 501 for the molding process is located at or near a central location on the yoke 516 of the headgear 404, as shown in FIG. 35B.

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

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 the 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 completed plastic core, including the location of the opening 527, and then stamping out the opening 527. Alternatively, the opening 527 can be formed in an internal molding process, where the outer casing 551 of the side arm 514 splits into two tubes at the end of the opening 527 adjacent the side arm 514, and then the tubes rejoin on the other side of the opening 527. In some embodiments, the buckle 526 can be formed by plastic (or other core 549 material) punching through the end of the casing 551, such that the buckle 526 does not include the outer casing 551. In some embodiments, the soft edges 550 of the side arms 514 extend to the top and bottom of the side arms 514 and the buckle 526, and the side ends 525 of the buckle 526 do not include the soft edges 550, as shown, for example, in FIG. 38B. In the illustrated embodiment, the buckle 526 is flush or in line with the side arms 514 when the headgear 404 is laid flat. In some embodiments, the buckle 526 is offset from the side arm 514, for example, toward or away from the user during use.

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 one another. The first portion 520 and the second portion 522 each have a free end and a fixed end. The fixed end extends at an angle from the side arm 514 at a 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.

As shown in FIGS. 39-41, the free end of the second portion 522 includes a guide loop 530, and the second portion 522 includes a plurality of holes 532 spaced along the length of the second portion 522 near the free end. In the illustrated embodiment, the guide loop 530 is plastic. The guide loop 530 can be formed by a burst-through molding process. "Burst-through molding" is described in applicant's co-pending applications U.S. Patent Application Nos. 62/309,400, 62/323,459, 62/364,767, and 62/401,462. Burst-through molding is a variation of the internal molding described above. The burst-through molding process involves introducing molten plastic into the fabric casing and forcing the molten plastic into a portion of the fabric casing. The component formed by the burst-through molding process includes a unitary plastic core integrally formed with a fabric casing, and the unitary plastic core has a portion that extends through the fabric casing. In some embodiments, the guide loop 530 can be bonded to the free end of the second portion 522. In some embodiments, the guide loop 530 includes an outer casing, such as an extension of the outer casing 551. In some embodiments, the guide loop 530 is made only of the outer casing material and not of plastic (or other core material), or includes only the outer casing material and does not include plastic (or other core material). The first portion 520 includes a protrusion 534 that protrudes from an inner surface of the first portion 520 (i.e., the surface of the first portion 520 that faces the second portion 522 in use) near the free end. The first portion 520 can also include a number of position indicators. To adjust and/or secure the first and second parts 520 and 522 relative to one another, the free end of the first part 520 is threaded through the guide loop 530 and the protrusion 534 is threaded and/or secured in one of the holes, for example, by a snap-fit connection.

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 split into two parallel (encircled) casing portions adjacent to the first hole 532 (i.e., the hole 532 closest to the junction 524), and the parallel casing portions can extend along the length of the second portion 522 including the holes 532. The parallel casing portions can rejoin into a single casing after (or at the free end) the last hole 532 (i.e., the hole 532 furthest from the junction 524). The parallel casing portions can bend toward each other between the holes 532 such that gaps in the weave or material of the casing 551 cannot be easily observed by the user. In some embodiments, the parallel casing portions do not rejoin after the last hole 532. In some such embodiments, pressure from the plastic or core 549 material can move the parallel casing portions closer together behind the final holes 532 so that gaps in the woven fabric are not easily observed. In some embodiments, the outer casing 551 includes holes 532, and the mold is designed to inhibit the flow of molten plastic (or other core 549 material) from extending into the holes 532 during molding. In some embodiments, the second portion 522 can be internally molded without holes 532, and the holes 532 can be made by post-processing, for example by stamping. In some embodiments, the outer casing 551 can terminate near or adjacent to the first holes 532 (on the joint 524 side of the first holes 532), and the remaining portion of the second portion 522 can be formed using a burst-through process to include only plastic (or other core 549 material).

In some embodiments, each hole 532 is at least partially surrounded by a peripheral groove 533 (on one or both of the inner and outer surfaces of the second portion 522). The peripheral groove 533 can aid in forming the hole 532 by internal molding. The mold can include protrusions that apply pressure to the outer casing 551 during molding to form the grooves 533. The mold protrusions can constrain the movement of the outer casing 551 during molding. Constraining the 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 entirely or substantially entirely plastic (or other core 549 material). An entirely plastic (or other core 549 material) periphery of the hole 532 can improve the function of the adjustment mechanism 528 and/or help maintain the tolerances associated with the hole 532.

In some embodiments, each of the first and second portions 520, 522 of the top strap 512 is integrally formed with the adjacent side arm 514, for example, via a burst-through internal molding process. In some embodiments, each of the first and second portions 520, 522 is an independent component that is permanently or removably coupled or connected to the respective side arm 514. For example, as shown in FIG. 42, the joint 524 of each side arm 514 includes a joint protrusion 560. The joint protrusion 560 can be formed during molding of the side arm 514, for example, using a burst-through internal molding process. Each of the first and second portions 520, 522 of the top strap 512 includes a concave surface 562 at or near the joint end. The concave surface 562 has a profile that is the inverse (or generally the inverse) of the profile of the joint protrusion 560 or corresponds to the profile of the joint protrusion 560. After molding, each of the joining projections 560 is inserted into the outer casing 551 of the joining end of the respective first portion 520 or second portion 522 of the top strap 512 and positioned within the concave surface 562. Each side arm 514 and each of the first portion 520 and second portion 522 can then be welded together using, for example, ultrasonic welding, RF welding or other suitable means. After welding, the side arms 514 and the top strap 512 form a single plastic (or other core material) component. The outer casing 551 of the top strap 512 can be welded to the outer casing 551 of the side arms 514. In some embodiments, the area of the top strap 512 adjacent the joining portion 524 does not include a soft edge 550. In such an embodiment, welding the core 549 of the side arm 514 to the top strap 512 sufficiently secures the outer casing 551 to one another without the need to weld the outer casing 551 of the side arm 514 and the top strap 512. In some embodiments, the mating projection 560 is generally the same thickness as the remainder of the core 549 of the side arm 514. In some embodiments, the mating projection 560 has a reduced thickness. In some embodiments, the mating projection 560 is offset from the mid-plane of the side arm 514. The offset mating projection 560 of reduced thickness can allow the core 549 of the side arm 514 and the top strap 512 to be flush at the interface of the mating projection 560 and the concave surface 562 when the mating projection 560 is received within the concave surface 562.

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

44-45 show another non-limiting exemplary embodiment of a 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 has some or all of the features similar to and/or includes some or all of the features of the frame 410. The headgear 604 and the frame 610 are configured to secure the seal 606 in a stable position below the nose of a user during use. FIGS. 46-47 show an exemplary embodiment of the headgear 604 for use 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. Top strap 612 and rear strap 618 form a bifurcated configuration. In some embodiments, one or more of top strap 612, bottom strap 614, and yoke 616, and/or rear strap 618 are a different color than one or more of the other straps.

The side arms 614 and/or top straps 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 or includes a fabric.

The top strap 612 of the headgear 604 includes a first (or left) portion 620 and a second (or right) portion 622 as shown in FIGS. 47A-49B. The first portion 620 and the second portion 622 are separate from one another. 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, for example at 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 of one another by internal molding and then joined together 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.

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

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

In the illustrated embodiment, the interengaging 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 may advantageously provide a neater finish (e.g., hiding loose thread ends) and/or ease of manufacture.

As shown in FIGS. 50A-50C, the first portion 620 of the top strap is provided with or includes a thumb grip 629 on and/or within an outer surface of the first portion (e.g., on and/or within an 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 against or opposite a protrusion 634 of the first portion 620 of the top strap. The thumb grip 629 may include a recessed portion (e.g., as shown in FIG. 50C) and/or a raised rib (e.g., a raised ring as shown in FIG. 50A). The first portion 620 is provided with or includes a finger grip 631 on and/or within an inner surface of the first portion 620 of the top strap (e.g., on and/or within an inner surface of the male connector 628a). In the illustrated embodiment, the finger grip 631 includes a recessed or recessed portion. The finger grip 631 is located on the first portion of the top strap beyond or distal to the projection 634 (i.e., the free end side). The finger grip 631 is provided on the same side as or relative to the thumb grip 629 of the first portion 620 of the top strap. Thus, the finger grip 631 is located on the opposite side of or relative to the thumb grip 629 of the first portion 620 of the top strap. The thumb grip 629 and/or finger grip 631 advantageously allow a user to more easily grip the male connector 628a. The thumb grip 629 and/or finger grip 631 may additionally or alternatively provide a user with visual and/or tactile cues as to how to grip and use the adjustment mechanism 628, enhancing 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 allows the interengaging portion of the first portion 620 of the top strap to be more flexible, which advantageously allows the user to disengage the interengaging portion. For example, the user can more easily flex and/or lift the male connector 628a away from the female connector 628b. In use, the thumb grip 629 can be grasped by the user's thumb or fingers, and/or the finger grip 631 can be grasped by the user's thumb or fingers, depending on what is comfortable for the user. FIG. 51A illustrates a user grasping the finger grip 631 with his or her fingers and the thumb grip 629 with his or her thumb, while FIG. 51B illustrates a user grasping the finger grip 631 with his or her thumb and the thumb grip 629 with his or her 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 clamp the free end of the first portion of the top strap between the thumb and fingers.

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

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

During manufacture, each of the fixed ends of the first and second portions 620 and 622 are aligned with one of the burst-through tabs 662, as shown in FIGS. 54A-55B. As shown, the burst-through tabs 662, the fixed ends of the top straps 612, and/or the ends of the bottom straps 614 include recesses 666 on the outer and/or inner surfaces. The recesses 666 advantageously provide an increased thickness of the overmolded material at the overmolded joint 624 and/or an increased surface area for the overmolded material to adhere to, as shown in FIG. 57, improving the mechanical connection between the overmolded joint and the straps, thereby strengthening the joint 624. As shown in FIGS. 54A-55B, the burst-through tabs 662 can have a reduced thickness compared to the thickness of the body of the bottom straps 614. This reduced thickness forms a recess for the overmolded material to fill, and allows the finished overmolded joint 624 to have a thickness that is the same or similar to the thickness of the body of the bottom strap 614 and/or the top strap 612, as shown in Figures 56A-58. This prevents the formation of protrusions that may exert force or pressure on the user's head and cause discomfort. 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 an embodiment, the alignment post 660 may leave a verification 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-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 provides a neater and more aesthetically pleasing finish (e.g., compared to an internally molded connection).

59 illustrates an exemplary embodiment of a variation in the geometry of the alignment post 660. In the illustrated embodiment, the alignment post is conical. This shape minimizes or reduces the identification mark on the overmolded joint 624. The distal end or face of the alignment post 660 (the end or surface of the alignment post 660 away from the strap body) has a reduced diameter that provides a smaller contact area with the inner surface of the overmolded mold cavity. This allows the strap to be positioned vertically within the overmolded mold while allowing the overmolded material to cover a larger area of the alignment post 660, which reduces the size of the identification mark.

As shown in Figs. 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 interengaging portion. Each fabric wrapped portion can be produced by internal molding as described above. Each fabric wrapped portion has a tab over which the respective exposed portion is overmolded.

As shown in FIGS. 47A-49B and 56A-56B, a buckle or rear strap connector 626 can be overmolded onto each end of the bottom strap 614. Each buckle 626 includes an opening 627 configured to receive a 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 through the buckles 626 more easily during assembly and/or adjustment due to the overmolded buckles 626 having a lower coefficient of friction than fabric covered buckles.

As shown in FIG. 64 , each buckle 626 has a width W ₂ that is greater than the width W ₁ of the bottom strap 614, such that the rear strap 618, having substantially the same width as the bottom strap 614, can pass through an opening 627 in the buckle 626. The top edge 626a of each buckle 626 is offset from the top edge 614a of the bottom strap 614. However, the bottom edge 626b of the buckle 626 is aligned with the bottom edge 614b of the bottom strap 614. This alignment provides a smooth, continuous bottom edge of the headgear that reduces the possibility of digging into the user's ears when worn. The opening 627 in the buckle 626 has a width that is 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.

Similar to the frame 410 and headgear 404, the frame 610 includes headgear retention features 650 in the form of holes designed to receive the protrusions 615 of the headgear 604. As shown in FIGS. 60A-62A, the protrusions 615, also referred to herein as frame retention features or frame retention features, can be located on both sides of the yoke 616. In the illustrated embodiment, the protrusions 615 have a horseshoe-shaped or "U" cross-section with an entrance 619 extending from the outer periphery of the protrusion 615 to and/or through the center of the protrusion 615. The entrance 619 allows the protrusions 615 to flex so that they can snap into and/or out of the headgear retention features 650.

In some embodiments, as shown, for example, in FIG. 63, the bottom strap 614 includes a thumb pad 652 that surrounds and/or extends laterally outward from each of the frame retention features 615 (towards the end of the bottom strap 614 and the buckle 626). The thumb pad 652 is thicker than the surrounding or remaining portion of the bottom strap 614. The thumb pad 652 advantageously provides increased strength and/or resilience to the yoke 616 such that the yoke 616 is less likely to become permanently deformed and/or fatigued due to repeated removal from and/or attachment to the frame 610. The thumb pad 652 may also or alternatively provide a visual indication to the user to grasp the headgear 604 in that position (at the thumb pad 652) to separate and/or couple the headgear 604 to the frame 610. In the illustrated embodiment, the frame retaining feature 615 is oriented such that the inlet 619 (i.e., the mouth of the inlet 619 at the periphery of the frame retaining feature 615) faces laterally outward (or toward the end of the bottom strap 614 and the buckle 626). Thus, the inlet 619 is aligned with the elongated portion of the thumb pad 652, which may be aesthetically pleasing. In some embodiments, the thumb pad 652 provides an improved visual indication of the form of the different colored and/or textured regions in the fabric outer casing. In some embodiments, the different colored and/or textured regions are integrally formed with the remainder of the fabric casing in some embodiments.

65 illustrates another non-limiting exemplary embodiment of a respiratory mask assembly 700. The respiratory mask assembly 700 includes a patient interface and 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 previous embodiments, such as 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 during use.

The headgear 704 is similar in some respects to the headgear 604, 404 and/or 204, e.g., the headgear 704 has the same or similar overall shape as the headgear 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. Buckles or rear strap connectors 726 can be secured, e.g., overmolded, onto each end of the bottom strap 714. In embodiments in which the headgear 704 is made of a core material, e.g., plastic, covered with a casing, e.g., fabric, the buckles or rear strap connectors 726 can be formed from the core material of the headgear 704. For example, the buckles or rear strap connectors 726 can be formed through a burst-through process. In the illustrated embodiment, the buckles 726 are closed loops. The buckles 726 can be wider than the front straps 714 and/or the rear straps 718, as shown. Each buckle 726 is configured to couple to the rear straps 718. The top straps 712 and the rear straps form a bifurcated configuration. The top straps 712 can include a first portion 720 and a second portion 722 that are adjustably connected to one another by an adjustment mechanism 728 to allow the top straps 712 to be adjusted and secured to a desired length similar to the top straps 612.

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 rear strap 718 are joined at the ends by 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 of the pair of side arms 714 extends forward from the joints 724 towards the user's nose and transitions into the yoke 716 in use. In use, the headgear 704 is configured such that the joints 724 are positioned above the user's ears. The joints 724 may be located in front of or behind the ears depending on the size of the user's head. Thus, as illustrated, the buckles 726 are positioned behind the user's ears.

The mask assembly 700 also includes a headgear connector or fastener 770 coupled to the yoke 716 as shown in FIGS. 66-69B. The fastener 770 may be permanently coupled, attached, mounted, or integrally formed with the yoke 716. In the illustrated arrangement, a portion of the front or side of the fastener 770 faces, contacts, abuts, and/or is secured to the rear or side of the yoke 716. The fastener 770 couples the headgear 704 to the frame 710 during use.

The fastener 770 includes a body having a lip 772, e.g., a bottom lip 772, protruding forward from the body, visible in FIG. 66. A front surface 770a of the lip 772 is exposed or is not covered by or does not contact the yoke 716. In other words, the lip 772 protrudes below the bottom surface or edge of the yoke 716. The lip 772 can be generally curved, arcuate, horseshoe, or partially elliptical in shape. In some configurations, the lip 772 protrudes 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, visible in FIG. 66, to the rear surface of the yoke 716, which contacts the fastener 770) 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 can be thicker than the yoke 716 or extend forward beyond the yoke 716. In other words, the lip 772 can protrude from the front body of the fastener 770 a distance greater than the thickness of the yoke 716, as shown in FIG. 67B. The locking projection 774 protrudes inward toward the center of the arc or horseshoe shape. The locking projection 774 is positioned at an end of the lip 772, e.g., at, adjacent to, or near a side end.

The rear surface 770b of the fastener 770 includes a frame contact portion 776 and a raised portion 778, as shown in FIGS. 67-68. The frame contact portion 776 can be curved, arcuate, horseshoe, 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 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 780 is in the form of a shoulder or surface 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. That is, 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 or match the geometry of the frame 710. The raised portion 778 is thicker than the frame contact portion 776. The top edge 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 FIG. 67. Preferably, the raised portion 778 is sized to have a surface area large enough to allow a secure connection to the yoke 716, but not to extend beyond the border or upper periphery of the yoke 716.

To assemble the fastener 770 and the yoke 716, the fastener 770 can be manufactured with one or more mounting recesses or mounting openings 782, as shown in FIG. 69A (also shown in FIGS. 87 and 88), and the yoke 716 can be manufactured with one or more corresponding protrusions 784. The protrusions 784 can 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 protrusions 784. More or fewer recesses or openings 782 and corresponding protrusions 784 are also possible. The fastener 770 and the yoke 716 are assembled with the protrusions 784 extending into the recesses or openings 782, and a 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 one another. An overmolded portion 787 (shown in FIG. 69B and represented by outline 786 in FIG. 69A ) extends across at least a portion of the rear surface of the catch 770 and over the protrusion 784. Such an arrangement can provide a clean and attractive appearance by covering the recess or opening 782 and the protrusion 784 while providing a secure connection between the catch 770 and the yoke 716. In other configurations, the catch 770 and the yoke 716 can be joined by a snap fit or other suitable type of connection. Additionally, the locking protrusion 774 can be integrally formed with the yoke 716 through a burst-through process. In some configurations, a portion of the catch 770 or the entire catch 770 can be formed through a burst-through process and/or by a burst-through material. In some configurations, the entire catch 770 can be overmolded to the yoke 716.

As shown in Figures 70-73, the frame 710 includes a peripheral wall, skirt, or flange 735, an inlet collar 730 that projects outwardly from a front surface of the peripheral wall 735 (away from a user in use), and an outlet collar 740 that projects inwardly from a rear surface of the peripheral wall 735 (toward a user in use). The peripheral wall 735 extends around the periphery or circumference of the outer surface of the frame 710. The fluid pathway 715 extends through the inlet collar 730 and the outlet collar 740 generally or substantially along a longitudinal axis of the frame 710. The longitudinal axis may be substantially straight or linear, or may be curved. The internal shape of the frame 710 that defines the fluid pathway 715 may vary along the length of the frame 710. Thus, the longitudinal axis may be defined as a mean centerline or by the geometric center of multiple axial positions within the fluid pathway 715 of the frame 710. The inlet collar 730 may include one or more bias flow holes, for example, as shown and described with respect to other embodiments herein. The bias flow holes may be arranged similarly to the bias flow holes 729 shown in FIG.

In use, the seal 706 is coupled to the outlet collar 740 and the gas delivery line 708 is coupled to the inlet collar 730. As shown in Figures 71 and 76, the top of the inlet collar 730 may be longer than the bottom of the inlet collar 730, while the top and bottom of the outlet collar 740 have the same or approximately the same length. Such a configuration ensures that when the seal 706 is coupled to the outlet collar 740 and the mask assembly 700 is placed on the user's face in use, the inlet collar 730 and/or the gas delivery line 708 point slightly downward (when the user's head is in an upright position) rather than straight outward. This configuration can help reduce hose drag that may be caused by the gas delivery line 708 on the frame 710.

For use, the fastener 770 is coupled to the entry collar 730. The entry collar 730 includes one or more positioning features that aid in aligning the fastener 770 with the frame 710 and/or coupling the fastener 770 to the frame 710. For example, the entry collar 730 can include a positioning feature 732 that can be in the form of a tab or partial wall that projects from the entry collar 730 along a portion of the top or upper surface of the entry collar 730. The entry collar 730 can include a recessed portion 734 on an outer surface or side of the entry collar 730. As shown, the recessed portions 734 can be located on opposing sides of the entry collar 730. The recessed portions 734 are sized, shaped, and positioned to receive the locking protrusions 774 of the fastener 770. The inlet collar 730 may further include a lead-in or alignment recess, or scallop portion 736, associated with and positioned adjacent to (or near the top of) each of the recess portions 734. Each scallop portion 736 is separated from its associated recess portion 734 by a ridge 738. Each scallop portion 736 is formed by a recess that increases in depth in a direction moving from the end furthest from the ridge 738 toward the end closest to the ridge 738. Each scallop portion 736 may act as a lead-in to the respective recess portion 734 to help guide the locking projection 774 of the fastener 770 into the recess portion 734 and align the locking projection 774 with the recess portion 734 or to maintain alignment of the locking projection 774 of the fastener 770 with the recess portion 734 during assembly or connection of the fastener 770 to the frame 710. The ridges 738 may help retain the locking projections 774 within the recessed portions 734 once assembled by restricting or preventing upward movement of the locking projections 774 relative to the frame 710 .

To couple the fastener 770 to the frame 710, the fastener 770 can be slid into the space between the positioning feature 732 and the peripheral wall 735, as shown in FIGS. 74-77. The scalloped portion 736 helps guide the locking projection 774 into the recessed portion 734. The movement of the locking projection 774 over the ridge 738 and into the recessed portion 734 can provide tactile feedback to the user that the fastener 770 is 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 coupled 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 780 contacts the front and/or outer edge of the peripheral wall 735. The positioning feature 732 contacts the front surface of the fastener 770, e.g., the lip 772. The frame contact portion 776 is recessed from the raised portion 778 by a distance D shown in FIG. 67B that is equal to or approximately equal to the thickness T (shown in FIG. 71) of the peripheral wall 735. Thus, when the fastener 770 is coupled to the frame 710, the recess defined by the frame contact portion 776 and the raised edge 780 receives the peripheral wall 735 such that the raised portion 778 is flush (or substantially flush) with the rear surface of the peripheral wall 735, as shown in FIGS. 75-76.

As shown in Figures 78A and 78B, the shape of the fastener 770 is designed to follow 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.

The outlet collar 740 includes an engaging portion/member, sealing element or connector 742. The connector 742 serves 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. FIGS. 79 and 80 show an exemplary embodiment 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 be in the form of a seal fastener. The seal fastener can be fastened 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 via other suitable means. As shown in FIG. 79, a side end or edge 792 of the coupling structure 790 is thickened as compared to the remainder of the coupling structure 790. For example, the side ends or edges 792 can have a thickness of about 2 mm to 6 mm. For example, the side ends or edges 792 can have a thickness of about 4 mm at the outermost edge. In the illustrated embodiment, the outermost edge is the thickest portion of the coupling structure 790, and the coupling structure 790 tapers or narrows from the outermost edge toward the center of the coupling structure 790. In some embodiments, the side portions of the coupling structure 790 include recessed or scalloped portions 793 on the inner or outer surface of the coupling structure 790, which can help reduce the weight of the coupling structure 790. The thickened ends or edges 792 can help improve comfort by avoiding sharp edges that may contact the patient's face during use. That is, the blunt edge created by the thickened ends 792 will cause less pain when the ends 792 of the coupling structure 790 contact the face of the user. The blunt edges may also or alternatively help to prevent or discourage sharp edges from contacting the seal 706 and potentially causing holes or tears in the seal 706 .

80 , the coupling structure 790 includes an inner surface 794 that extends into and/or defines a central opening of the seal 706. For use, the inner surface 794 slides over or onto the outlet collar 740 of the frame 710 to couple the seal 706 to the frame 710. The inner surface 794 may be smooth, e.g., without any steps, which may help the coupling structure 790 slide onto the outlet collar 740. The peripheral wall 735 provides a stop for the seal 706 and coupling structure 790 when they are pressed onto the outlet collar 740.

When the coupling structure 790 is pressed onto the outlet collar 740, the inner surface 794 also slides onto 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 a TPE or silicone material, which in some configurations can be a self-adhesive silicone that adheres to the surface of the outlet collar 740. The connector 742 can be permanently bonded or bonded to the frame 710. In some embodiments, the connector 742 can be overmolded onto the outlet collar 740. When the coupling structure 790 is slid onto the connector 742, the connector 742 compresses. The compression of the connector 742 creates a friction fit between the coupling structure 790 and the frame 710 and creates a sealed passage through the frame 710 and the coupling structure 790, and thus the seal 706. The connector 742 can take the form of an annular seal or flange, such as or similar to an O-ring, that extends around the entire circumference of the outlet collar 740 as shown. However, the connector 742 can have any suitable cross-sectional shape, including, but not limited to, circular. In the illustrated arrangement, the connector 742 includes a semicircular or partial circular sealing/connector portion (e.g., protrusion 745) and a non-circular base portion (e.g., interface portion 743), as described further below. Alternatively, the connector 742 may not extend around the entire circumference of the outlet collar 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 a user that the coupling structure 790 should be assembled to the outlet collar 740, including the connector 742. Alternatively, another portion of the outlet collar 740 may include a color (e.g., blue).

As shown in FIGS. 71 and 73, the connector 742 can be disposed within a groove 744. As shown in FIGS. 81A-81D, the groove 744 can have a cross-sectional shape that is generally or substantially similar to a trapezoid or trapezoid. The inner diameter of the groove 744 can have a short axial length compared to the outer diameter of the groove 744. The cross-sectional shape of the groove 744 can be symmetrical about a central axis, as in the configuration of FIG. 81D, or can be asymmetrical. Other suitable cross-sectional shapes can also be used, including, for example, but not limited to, rectangular (square) and circular (e.g., semicircular). With further reference to FIGS. 81A-81D, the connector 742 can include an interface portion 743 and a protrusion 745 protruding from the interface portion 743. A bottom or inner surface of the interface portion 743 can have a cross-sectional shape that corresponds to the cross-sectional shape of the groove 744. The connector 742, for example the interface portion 743 of the connector 742, can be molded in 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. FIGS. 81A-D show various embodiments of the connector 742. FIG. 81A illustrates a medium sized interface 743 and a protrusion 745 located approximately in the center of the interface 743. FIG. 81B illustrates a larger interface 743 (compared to the interface 743 of FIG. 81A) and a protrusion 745 that is offset away from the center of the interface 743 toward the trailing or distal edge of the outlet collar 740 (i.e., the edge of the outlet collar 740 furthest from the peripheral wall 735). This location of the protrusion 745 can help provide greater tactile feedback to the user when the coupling structure 790 is coupled to the frame 710, since a larger portion of the coupling structure must move over the protrusion upon coupling. FIG. 81C illustrates a medium sized interface 743 and a relatively wide or thick protrusion 745 (compared to the protrusion 745 of FIG. 81A and FIG. 81B) that spans the width of the interface 743. FIG. 81D illustrates a medium sized interface 743 that extends to and/or opens to the trailing or distal edge of the outlet collar 740. This configuration may allow for simplified tooling. FIG. 82A and FIG. 82B illustrate another exemplary embodiment of a connector 742. In this embodiment, the connector 742 has a double protrusion configuration with a recess between the two protrusions. In other words, the connector 742 includes an interface 743 bounded by two protrusions 745. In some or all of the illustrated configurations, the cross section of the interface 743 defines a surface length that contacts the outlet collar 740 that is greater than the surface length of the cross section of the protrusion 745. Thus, connector 742 has a larger surface area for mating or other connection with outlet collar 740 than if connector 742 were symmetrical such that mating portion 743 was a mirror image of protrusion 745. Such an arrangement can advantageously provide improved mating or other coupling of connector 742 to outlet collar 740.

71, the connector 742 is spaced from the peripheral wall 735. For example, the connector 742 may be spaced from the peripheral wall 735 by about 4-5 mm. The spacing from the peripheral wall 735 advantageously allows a sufficient length of travel after contact with the connector 742 when the seal 706 is slid onto the outlet collar 740, thereby providing tactile feedback to the user when the seal 706 is connected to the frame 710.

Figures 83-86 show another example of a frame 710' that can be used with the respiratory 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 ridge 738 that are closest to the front edge of the inlet collar 730 (in other words, the sides are away from the peripheral wall 735 such that the boundaries of the recessed portion 734, scalloped portion 736 and ridge 738 are at least partially defined by the peripheral wall 735 and the guide walls 739). The guide walls 739 advantageously help to guide the locking projections 774 into place when connecting the yoke 716 and fasteners 770 to the frame 710', as shown in Figures 87-88.

99-102 show another example of a frame 710''' that can be used with the respiratory mask assembly 700, and FIGS. 93-98 show the frame 710''' assembled to the respiratory mask assembly 700. The frame 710''' is similar to the frame 710' in many respects. For example, the frame 710''' includes the recessed portion 734, the scalloped portion 736, the ridge 738, the guide wall 739, and the positioning feature 732. The frame 710''' also includes two bottom projections 741. In the illustrated embodiment, each bottom projection 741 extends below the respective recessed portion 734. The connecting portion 741b extends between the bottom projections 741 around the bottom of the outer periphery or outer edge of the inlet collar 730. In this embodiment, the bottom projections 741 and the connecting portion 741b form a unitary projection around the bottom of the inlet collar . Each bottom projection 741 includes a corner portion 741a (FIG. 99) adjacent or adjacent to a respective recessed portion 734. Each corner portion 741a projects laterally outward and downward from the body of the inlet collar 730. In other words, a side edge 741c (shown in FIG. 99) of the projection 741 extends laterally outward and downward from the body of the inlet collar 730 adjacent or adjacent to the bottom edge of the recessed portion 734. In other configurations, the frame 710''' can include only the corner portion 741a without the connecting portion 741b. As shown, the connecting portion 741b can be integral or coupled (aesthetically and/or structurally) with the peripheral wall 735. As shown in FIGS. 95-98, each projection 741 is aesthetically integrated with the catch 770 to form an extension of the catch 770. In the illustrated embodiment, side edge 741c of each protrusion 741 abuts bottom edge 771 (shown in FIG. 66) of fastener 770, and the bottom edge of each protrusion 741 generally follows or conforms to the curvature of side edge 769 (also shown in FIG. 66) of fastener 770. Protrusions 741 advantageously act as a barrier to prevent or discourage a user from attempting to attach fastener 770 from or to the bottom of frame 710''' rather than from or to the top.

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

112-115 and 122-125, the frame 710'''' also includes a connector 742 disposed around the periphery or outer surface of the outlet collar 740. As shown, the connector 742 can be positioned at an intermediate location between the outlet end or edge of the outlet collar 740 and the peripheral wall 735. The connector 742 extends around the entire periphery of the outlet collar 740. However, in at least one alternative configuration, the connector 742 can extend around only a portion or portions of the periphery of the outlet collar 740. The connector 742 can be made of a compressible, flexible, and/or resilient 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 collar 740. In the illustrated embodiment, the connector 742 is disposed within a groove 744. The groove 744 can form a channel in the outlet collar 740. The connector 742 may include an interface portion 743 and a protrusion 745 protruding from the interface portion 743. The protrusion 745 also protrudes outward from or relative to an outer surface of the outlet collar 740 to form a step or ridge. The connector 742, e.g., the interface portion 743 of the connector 742, may be molded in place on the frame 710, e.g., in the groove 744. Alternatively, the connector 742 may be formed separately from the frame 710 and coupled to the frame 710. The connector 742 may be bonded to a surface of the outlet collar 740 by a chemical bond. In another alternative, the connector 742 may be connected to the outlet collar 740 by a mechanical bond. For example, the outlet collar 740 may include through holes that extend through the groove 744. The connector 742 may include portions that extend through those through holes to facilitate a mechanical connection between the connector 742 and the outlet collar 740.

The bottom or inner surface of the interface portion 743 of the connector 742 can have a cross-sectional shape that corresponds to the cross-sectional shape of the groove 744. In the illustrated embodiment, the groove 744 and the bottom or inner surface of the interface portion 743 have a generally rectangular cross-section. In some embodiments, at least a portion of the groove 744, and thus 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 the walls that extend perpendicular or substantially perpendicular to the outer surface of the frame, stress concentrations that may adversely affect the functional life of the connector 742 can be reduced.

103 and 113-115 show an exemplary embodiment of a coupling structure 790 that can be used, for example, in the respiratory mask assembly 700 with the frame 710''''. In the illustrated embodiment, 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 integrally formed (i.e., to form a unitary coupling structure) or can be permanently or removably coupled to one another. The coupling structure is relatively rigid, for example, compared to the connector 742. In other words, one or more of the inner fastener 890 and the outer fastener 990 are rigid than the connector 742. In the illustrated embodiment, 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 catch 890 includes an inner surface 794 that extends into and/or defines a central opening of the seal 706. In the illustrated embodiment, the inner catch 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 farther away from the flow path than the inner wall 891. As illustrated, the inner surface of the inner wall 891 forms the inner surface 794.

The outer fastener 990 and the inner fastener 890 couple the seal 706 to the frame 710''''. When coupled, the outer fastener 990 and the inner fastener 890 are disposed around and encircle the outlet collar 740. In the illustrated embodiment, the outer fastener 990 is disposed 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, along with the seal 706, are fully connected to the frame 710'''', as shown, for example, in FIG. 115, a patient-distal end or edge of the inner wall 891 of the inner fastener 890 and/or a patient-distal most face of the outer fastener 990 may abut the perimeter wall 735 as shown. The outer fastener 990 and the inner fastener 890 may be coupled to one another. For example, the outer fastener 990 and the inner fastener 890 may be coupled by ultrasonic welding, adhesive bonding, and/or a permanent or removable snap fit. In the illustrated embodiment, the inner surface of the inner wall 791 of the outer catch 990 abuts and/or is coupled to a portion of the outer surface of the inner wall 891 of the inner catch 890 .

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

The connector 742 serves to couple the seal 706 to the frame 710''''. Specifically, in the illustrated embodiment, the connector 742 serves to couple the inner catch 890 to the frame 710''''. When the inner catch 890 is pressed onto the outlet collar 740, an inner surface 794 of the inner catch 890 slides over the connector 742, causing the connector 742 to compress. The compression of the connector 742 creates a friction fit between the inner catch 890 and the frame 710'''' to help retain the inner catch 890 on the frame 710'''', and creates a sealed passageway through the frame 710'''' and the inner catch 890, and thus the seal 706.

The inner wall 891 of the inner catch 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 a user of the interface in use. The second portion 894 extends away from the connecting wall 895 in a direction toward a user of the interface in use. In other words, the first portion 892 extends away from the connecting wall 895 in a direction generally opposite 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 relative 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 offset more from the center of the fluid path 715 than the first portion 892. A dimension (e.g., circumference, diameter, circumferential length, or cross-sectional dimension) of the first portion 892 is less than a corresponding dimension of the second portion 894. For example, the circumference defined by the area of the inner surface 794 defined by the first portion 892 is less than the circumference defined by the area of the inner surface 794 defined by the second portion 894. The circumference of the inner surface 794 varies across the transition portion 896. In the illustrated configuration, the circumference of the inner surface 794 increases across the transition portion 896 as the transition portion transitions from the first portion 892 to the second portion 894. When the inner catch 890 is slid onto the frame 710'''' to couple the seal 706 to the frame 710'', the portion of the inner surface 794 defined by the first portion 892 slides over the connector 742, as shown in FIGS. 122 and 124. When the inner catch 890 is fully coupled 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 FIGS. 123 and 125.

The first portion 892 can have a constant or non-constant dimension (e.g., circumference, diameter, perimeter, or cross-sectional dimension) along the length of the first portion 892 (e.g., axial length along the direction of gas flow). The second portion 894 can have a constant or non-constant dimension (e.g., circumference, diameter, perimeter, or cross-sectional dimension) along the length of the second portion 894 (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 can taper along the length of the transition portion 896, for example toward the transition portion 896. The dimension of the inner surface 794 changes at the transition portion 896. Because the dimension of the first portion 892 is smaller than the dimension of the second portion 894, the compression of the connector 742 when the inner fastener 890 is coupled to the frame '''' and therefore 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, the 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'''' (thus the connector 742 contacts the first portion 892), as shown in, for example, FIGS. 122 and 124, compared to when the inner fastener 890 is completely connected to the frame 710'''' (thus the connector 742 contacts the transition portion 896 and/or the second portion 894), as shown in, for example, FIGS.

Thus, there is less interference between the connector 742 and the inner fastener 890 in the connected position than during assembly or disassembly. To remove the inner fastener 890 from the frame 710'''', the inner fastener 890 and the frame 710'''' must be pulled away from or toward each other to the partially connected position. In the connected position, the connector 742 contacts the transition portion 896 and/or the second portion 894, and thus there is less interference between the inner fastener 890 and the connector 742. Thus, the maximum removal force required to separate the frame 710'''' and the coupling structure 790 is determined at least in part by the interference between the first portion 892 and the connector 742 in the partially connected position.

Less interference between the connector 742 and the inner fastener 890 (and thus the coupling structure 790) in the coupled position compared to the partial coupled position and/or compared to during assembly or disassembly can advantageously help maintain long-term performance of the connection between the frame 710'''' and the inner fastener 890. The cushion module (seal 706 and coupling structure 790) and the frame 710 can be stored in the coupled position. The cushion module and the frame 710 are also in the coupled position during overnight use. Persistent large deformation of the connector 742 (such as when in the partial coupled position or when the portion of the inner fastener that contacts the connector 742 has a smaller diameter during storage and/or use) can result in a decrease in the long-term performance of the connector 742, for example, because the elasticity of the connector 742 may decrease when compressed more over time. Thus, reduced interference between the connector 742 and the inner fastener 890 (and thus the coupling structure 790) can extend the useful life of the mask assembly.

89-90 show another exemplary embodiment of a frame 710'' and fastener 770'' that can be used with the respiratory mask assembly 700 of FIG. 65. The frame 710'' is similar to the frame 710 in several respects. As shown, the peripheral wall 735'' of the frame 710'' is a partial peripheral wall 735'' and does not extend around the entire circumference/periphery of the frame 710''. The partial peripheral wall 735'' is sized 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 (further below) the side ends of the fastener 770'' when the fastener 770'' is coupled to the frame 710''.

The frame 710'' includes two channels 737 that extend circumferentially around a portion of the outer surface of the inlet collar 730. As shown, each channel 737 begins near the top of the inlet collar 730 and extends around the circumference of the inlet collar 730 adjacent the perimeter wall 735'' downward to or toward the recessed portion 734. The frame 710'' may include a positioning feature 733 at the top of the inlet collar 730 adjacent the perimeter wall 735''. As shown, the positioning feature 733 may be flush with the body of the inlet collar 730 between the channels 737 and the front edge of the inlet collar 730 or may be slightly raised relative to the body. In some configurations, the top surface of the positioning feature 733 is flat, while the surface of the inlet collar 730 forward of the positioning feature 733 is curved. Thus, the channel 737 is recessed relative to the positioning feature 733 and the body of the inlet collar . A step 731, flush with or raised relative to the body of inlet collar 730, is disposed between the end of each channel 737 and the associated recessed portion 734. Channel 737 may provide the same or similar function as lead-in or alignment recess, or scalloped portion 736, described above. Step 731 may provide the same or similar function as ridge 738, described above.

As shown in FIG. 91, the fastener 770'' includes recesses 773 on the underside or inner arc of the fastener 770'' positioned laterally centrally. Locking projections 774 extend inwardly from the inner arc at or near the side ends of the fastener 770''. The fastener 770'' may also include recesses 775 positioned adjacent to and closer to the lateral center than each locking projection 774. The recesses 775 may be configured to accommodate the step 731 such that the locking projections 774 can fully engage the recessed portion 734 without interference between the step 731 and the fastener 770''.

The channel 737 helps guide the fastener 770'' into place when it is coupled to the frame 710''. The depth of the channel 737 helps provide horizontal or axial support to the fastener 770'' to inhibit or prevent undesired separation in any direction other than vertically or straight away from the channel 737, which in the illustrated arrangement is perpendicular to the top surface of the positioning feature 733. The recess 773 is aligned with the positioning feature 733 to receive the positioning feature 733. The positioning feature 733 serves 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 secure the fastener 770'' to the frame 710'' by inhibiting or preventing lateral movement of the fastener 770'' relative to the frame 710''.

92A-92C illustrate variations of the fastener 770 and frame 710. These variations may be combined with features of any of the embodiments described above. In FIG. 92A, the fastener 770 seats in a recess 796 in the inlet collar 730 of the frame 710, and the upwardly extending wall portion that defines the frame contacting portion 776 of the fastener 770 contacts the inlet collar 730 side of the peripheral wall 735. In FIG. 92B, a portion of the fastener 770 wraps around the top of the peripheral wall 735 and thus contacts both sides of the peripheral wall 735. In this arrangement, the fastener 770 may be secured to the frame 710 without the need for recesses 796 and/or positioning features 732. In FIG. 92C, the fastener 770 includes a channel 797 that receives the peripheral wall 735 to align the fastener 770 with the frame 710 and secure the fastener 770 to the frame 710.

Unless otherwise clearly required by context, throughout this specification and claims, the words "include", "comprises", and the like are to be construed in an inclusive sense, as opposed to an exclusive or exhaustive sense, in other words, in a "including but not limited to" sense. Where the foregoing description refers to whole entities or components that have known equivalents, those whole entities or components are incorporated herein as if individually set forth.

The disclosed methods, apparatus, and systems may also be broadly described as including the parts, elements, and features referred to or depicted in this disclosure, individually or collectively, in any combination of two or more of said parts, elements, or features.

The reference to any prior art in this specification is not and should not be construed as an acknowledgment or any form of suggestion that the prior art forms part of the common general knowledge in the field of activity of any country in the world.

Words of degree used herein, such as the terms "generally," "about," "approximately," and "substantially," refer to a value, amount, or characteristic that is close to the stated value, amount, or characteristic that still performs the desired function or achieves the desired result. Deviations from the stated value, amount, or characteristic can reflect, for example, acceptable tolerances, conversion factors, rounding, measurement errors, or other factors known to those of skill in the art. For example, the terms "approximately parallel" and "substantially parallel" refer to a value, amount, or characteristic that can deviate from strictly parallel by 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, 0.1 degrees, or less.

Although the present disclosure has been described with respect to certain embodiments, other embodiments that are apparent to those of ordinary skill in the art are within the scope of the present disclosure. Accordingly, various changes and modifications may be made without departing from the spirit and scope of the present disclosure. For example, various components may be rearranged as desired. Moreover, not all of the features, aspects and advantages are necessarily required to practice the present disclosure. Accordingly, it is intended that the scope of the present disclosure be defined solely by the scope of the following claims.

Claims (13)

1. A respiratory mask assembly comprising:
headgear configured to secure the mask assembly to a user's face in use, the headgear comprising:
York and
a first side arm and a second side arm, each of the first side arm and the second side arm extending from a lateral portion of the yoke and configured to extend across a user's cheek and above an ear in use;
the headgear having a top strap coupled to and extending between the first and second side arms and configured to extend across a top of the user's head in use;
a frame extending along a longitudinal axis and having a top, a bottom and two sides, the frame also comprising an inlet having an inlet collar configured to be coupled to a gas delivery line, the inlet collar having an exterior surface or side, the exterior surface or side of the inlet collar including at least one recessed portion;
a headgear connector coupled to the yoke and configured to be coupled to the frame by approaching the frame from one of the top or bottom, the headgear connector also including at least one locking protrusion configured to be received in each recessed portion of the entrance collar when the headgear connector is coupled to the frame;
the yoke extends across a front surface of the headgear connector from a first side end of the headgear connector to an opposite second side end of the headgear connector. The respiratory mask assembly of claim 1, wherein the headgear connector is permanently coupled to the headgear. The respiratory mask assembly of claim 1 or 2, wherein the frame includes at least one scalloped portion positioned adjacent the at least one recessed portion and configured to act as a lead-in for the at least one locking protrusion into the at least one recessed portion. The respiratory mask assembly of claim 3, wherein the at least one scalloped portion is separated from the at least one recessed portion by a ridge. The respiratory mask assembly of any one of claims 1 to 4, further comprising a barrier configured to inhibit or prevent coupling of the headgear connector when approaching the frame from the other of the top or bottom. A respiratory mask assembly according to any one of claims 1 to 5,
the frame extends in a first direction from the inlet to the outlet, a longitudinal axis of the frame and a flow path through the frame extends from the inlet to the outlet, the frame extends in a second direction perpendicular to the first direction from a first side edge to a second side edge, the first side edge and the second side edge having two sides, and the frame extends from the top to the bottom in a third direction perpendicular to the first direction and the second direction;
The headgear connector is configured to be coupled to the frame by approaching the frame from the top or the bottom along the third direction. A respiratory mask assembly according to any one of claims 1 to 5,
the frame having an inlet at a front end of the frame, an outlet at a rear end of the frame, and a flow passage extending through the frame from the inlet to the outlet;
a headgear connector coupled to the yoke and configured to be coupled to the frame, the headgear connector having side portions configured to extend along the two side surfaces of the frame and an intersection portion extending between the side portions, the intersection portion configured to extend along one of the top surface of the frame or the bottom surface of the frame when the headgear connector is coupled to the frame. The respiratory mask assembly of claim 6 or 7, wherein the headgear connector is permanently coupled to the headgear. The respiratory mask assembly according to any one of claims 1 to 8, wherein the frame includes at least one scalloped portion positioned adjacent to the at least one recessed portion and configured to act as a lead-in for the at least one locking protrusion into the at least one recessed portion. The respiratory mask assembly of claim 9, wherein the at least one scalloped portion is separated from the at least one recessed portion by a ridge. 8. A respiratory mask assembly according to claim 6 or 7 , wherein the inlet and/or the outlet have an oval shape. 12. The respiratory mask assembly of claim 6, 7 or 11 , wherein the outlet comprises an outlet collar, the outlet collar including a recessed portion extending partially around a periphery of the outlet collar . 13. The respiratory mask assembly of any one of claims 1 to 12, wherein the yoke, the first side arm, the second side arm and the top strap form an integrally formed closed loop, and the headgear further comprises a rear strap configured to extend between the pair of side arms around the rear of the user 's head.