Patent Description:
Respiratory masks are used to provide respiratory therapy to the airways of a person suffering from any of a number of respiratory illnesses or conditions. Such therapies may include but are 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 intermittently collapses, during sleep, preventing the patient from breathing for a period of time. The cessation of breathing, or apnea, results in the patient awakening. Repetitive and frequent apneas may result in the patient rarely achieving a full and restorative night's sleep.

CPAP therapy involves the delivery of a supply of continuous positive air pressure to the airway of the patient via a respiratory mask. The continuous positive pressure acts as a splint within the patient's airway, which secures the airway in an open position such that the patient's breathing and sleep are not interrupted.

Respiratory masks typically comprise a patient interface and a headgear, wherein the patient interface is configured to deliver the supply of continuous positive air pressure to the patient's airway via a seal or cushion that forms an airtight seal in or around the patient's nose and/or mouth. Respiratory masks are available in a range of styles including full-face, nasal, direct nasal and oral masks, which create an airtight seal with the nose and/or mouth. The seal or cushion is held in place on the patient's face by the headgear. In order to maintain an airtight seal the headgear should provide support to the patient interface such that it is held in a stable position relative to the patient's face during use. Such respiratory masks may also be used to deliver NIV and other therapies.

<CIT> discloses a directional lock for an interface headgear arrangement. <CIT> and <CIT> disclose headgear assemblies and interface assemblies with a headgear.

The present invention provides a headgear assembly according to claim <NUM>.

In a first aspect, disclosed but not independently claimed, the invention relates to a respiratory mask assembly comprising:.

In another aspect, disclosed but not independently claimed, the invention relates to a respiratory mask assembly comprising:.

In another aspect the invention relates to a headgear assembly for a respiratory mask assembly, the headgear assembly comprising:.

In some embodiments the mask interface is a full face mask and the seal is configured to cover the user's nose and mouth in use.

In some embodiments the respiratory mask assembly further comprises a removable frame.

In some embodiments the removable frame comprises two upper headgear connector arms and two lower headgear connector arms, wherein an upper side strap of a headgear can be coupled, permanently or removably, to each of the upper arms and a lower side strap of the headgear can be coupled, permanently or removably, to each of the lower arms.

In some embodiments the frame comprises a top edge and two opposing side edges, wherein the top edge and each of the side edges follow a continuous arc.

In some embodiments the frame is generally quadrilateral in shape and comprises a front surface and a rear surface, each having upper, lower and side edges, and the two lower headgear connector arms extend from the rear surface, at, adjacent or spaced from the lower edge of the front surface.

In some embodiments the frame comprises a gas path positioned within a space defined by a portion of the rear surface of the frame.

In some embodiments the frame and the gas path are integrated to form a single component.

In some embodiments the front surface is curved and is substantially smooth.

In some embodiments the frame comprises insert recesses, each insert recess housing one of the two automatically adjusting headgear mechanism and their associated components.

In some embodiments each insert recess is formed in the front surface of the frame.

In some embodiments each insert recess comprises a shelf portion, a mouth, a chamber and a channel that terminates at a blind end.

In some embodiments each insert recess extends along the side edge of the frame.

In some embodiments each insert recess houses a control mechanism and an associated filament of one automatically adjusting headgear mechanism.

The respiratory mask assembly of any one of claims <NUM> to <NUM>, wherein an insert may be inserted into each insert recess.

In some embodiments the insert is inserted into the insert recess engaging at least the shelf and providing a cover that forms an enclosed space within the insert recess.

In some embodiments, in use, the filament can move longitudinally within the insert recess, with a free end of the filament able to move towards and away from the blind end of the insert recess, as dictated by the motion of the headgear and operation of the automatically adjusting headgear mechanism.

In some embodiments each insert comprises an alignment feature.

In some embodiments when the insert is engaged with the frame the alignment feature is positioned within the chamber and oriented to correctly orient the automatically adjusting headgear mechanism for operation.

In some embodiments connectors housing control mechanisms of the upper automatically adjusting headgear mechanisms are configured to be located above the user's ears in use.

In some embodiments control mechanisms of the upper automatically adjusting headgear mechanisms are disposed in a yoke, the yoke coupled to two upper side straps of the headgear assembly configured to be removably coupled to the housing in use.

In some embodiments the respiratory mask assembly further comprises at least one upper storage sleeve extending along a top strap of the headgear assembly configured to extend across a top of the user's head in use, the at least one upper storage sleeve configured to receive and store at least a portion of at least one filament of at least one of the two upper automatically adjusting headgear mechanisms.

In some embodiments the respiratory mask assembly further comprises at least one lower storage sleeve extending along a rear section of the headgear assembly configured to positioned on aback of the user's head in use, the at least one lower storage sleeve configured to receive and store at least a portion of at least one filament of at least one of the two lower automatically adjusting headgear mechanisms.

In some embodiments the headgear assembly further comprises a rear section, the rear section comprising a rigid upper section or strap and a temporarily expandable lower section.

In some embodiments the lower section comprises an elastic material.

In some embodiments the lower section comprises a first section comprising at least one magnet and a second section comprising at least one magnet, wherein the magnets of the first and second sections attract one another to connect the first and second sections in a closed position of the lower section, and wherein the first and second sections can be separated for donning and/or doffing of the mask assembly by applying a force greater than a magnetic force between the magnets.

In some embodiments the lower section comprises a foldable connection.

In some embodiments the lower section comprises a first rail and a second rail, the first and second rails configured to overlap and interlock with each other and slide relative to each other, wherein the first and second rails are configured to slide relative to each other to decrease an overlap between the first and second rails to temporarily lengthen the lower section.

In some embodiments the lower section comprises a first portion comprising a male connector and a second portion comprising a female connector configured to receive the male connector, and wherein the male connector is configured to be removed from the female connector to temporarily lengthen the lower section.

In some embodiments the upper section of the headgear assembly comprises a top strap configured to extend across a top of the user's head in use and an upper rear strap configured to extend across a back of the user's head in use.

In some embodiments the headgear assembly further comprises a storage sleeve extending along the top strap, the storage sleeve configured to receive and storage at least a portion of at least one of the filaments.

In some embodiments each connector is coupled to an end of the top strap and an end of the upper rear strap.

In some embodiments the lower section of the headgear assembly comprises an adjustable lower rear section configured to extend along a back of the user's neck in use.

In some embodiments each of the two side straps is coupled to one side of a mask interface of the mask assembly.

In some embodiments each of the two side straps extends through a passage formed on one side of a mask interface of the mask assembly.

In some embodiments each side strap is configured to slide within its respective passage to adjust relative lengths of the upper portion and the lower portion.

In some embodiments the headgear assembly further comprises a blocking element coupled to each of the side straps, each blocking element configured to limit sliding of the side strap within the passage to maintain a minimum length of the lower portion.

In some embodiments the blocking element does not limit movement of the filament within the side strap.

In some embodiments the headgear assembly comprises a top strap configured to extend across a top of the user's head in use, the top strap extending between and connecting opposing sides of the upper headgear loop.

In some embodiments the side straps are elastic.

In some embodiments each side strap forms a portion of the upper headgear loop and the lower headgear loop.

In some embodiments, a respiratory mask assembly includes a mask interface and a headgear assembly. The mask interface includes a housing and a seal coupled to the housing. The seal is configured to seal on a user's face in use. The headgear assembly is coupled to the mask interface at four locations. The headgear assembly includes at least two automatically adjusting headgear mechanisms, with one disposed on each side of the user's face in use. The mask interface can be a full face mask, with the seal configured to cover the user's nose and mouth in use.

In some embodiments, a respiratory mask assembly includes a mask interface and a headgear assembly. The mask interface includes a housing and a seal coupled to the housing. The seal is configured to seal on a user's face in use. The headgear assembly includes two upper automatically adjusting headgear mechanisms and two lower automatically adjusting mechanisms, with one of each of the upper and lower automatically adjusting headgear mechanisms disposed on each side of the user's face in use. A connector housing a control mechanism of each of the lower automatically adjusting headgear mechanisms can be configured to be located behind one of the user's ears in use. Two upper side straps extend from the mask interface. Two lower side straps include an elastic portion and extend from the mask interface.

Connectors housing control mechanisms of the upper automatically adjusting headgear mechanism can be configured to be located above the user's ears in use. Alternatively, control mechanisms of the upper automatically adjusting headgear mechanisms can be disposed in a yoke that is coupled to two upper side straps of the headgear assembly and configured to be removably coupled to the mask interface housing. The mask assembly can include at least one upper storage sleeve extending along a top strap of the headgear assembly configured to extend across a top of the user's head in use. The at least one upper storage sleeve is configured to receive and store at least a portion of at least one filament of at least one of the two upper automatically adjusting headgear mechanisms. The mask assembly can include at least one lower storage sleeve extending along a rear section of the headgear assembly so that at least a portion of the storage sleeve is positioned on a back of the user's head in use. The at least one lower storage sleeve can be configured to receive and store at least a portion of at least one filament of at least one of the two lower automatically adjusting headgear mechanisms.

The headgear assembly can further include a rear section comprising a rigid upper section and a temporarily expandable lower section. The rigid upper section may comprise a strap. The lower section can include an elastic material. The lower section can include a first section comprising at least one magnet and a second section comprising at least one magnet, wherein the magnets of the first and second sections attract one another to connect the first and second sections in a closed position of the lower section, and wherein the first and second sections can be separated for donning and/or doffing of the mask assembly by applying a force greater than a magnetic force between the magnets. The lower section can include a foldable connection. The lower section can include a first rail and a second rail, the first and second rails configured to overlap and interlock with each other and slide relative to each other, wherein the first and second rails are configured to slide relative to each other to decrease an overlap between the first and second rails to temporarily lengthen the lower section. The lower section can include a first portion including a male connector and a second portion including a female connector configured to receive the male connector. The male connector is configured to be removed from the female connector to temporarily lengthen the lower section.

In some embodiments, a headgear assembly for a respiratory mask assembly includes two side straps, a connector housing a control mechanism of an automatically adjusting headgear mechanism coupled to one end of each of the side straps, and a filament extending through at least a portion of each of the side straps. One of the two side straps is disposed on each side of a user's face in use. Each of the side straps includes a single continuous strap having an upper portion and a lower portion, each upper portion connected to an upper section of the headgear assembly and each lower portion connected to a lower section of the headgear assembly.

The upper section of the headgear assembly can include a top strap configured to extend across a top of the user's head in use and an upper rear strap configured to extend across a back of the user's head in use. The headgear assembly can include a storage sleeve extending along the top strap and configured to receive and store at least a portion of at least one of the filaments. Each connector can be coupled to an end of the top strap and an end of the upper rear strap. The lower section of the headgear assembly can include an adjustable lower rear section configured to extend along a back of the user's neck in use. Each of the two side straps can be coupled to one side of a mask interface of the mask assembly. Each of the two side straps can extend through a passage formed on one side of a mask interface of the mask assembly. Each side strap can be configured to slide within its respective passage to adjust relative lengths of the upper and lower portion. The headgear assembly can include a blocking element coupled to each of the side straps, each blocking element configured to limit sliding of the side strap within the passage to maintain a minimum length of the lower portion. The blocking element may not limit movement of the filament within the side strap.

In some embodiments, a respiratory mask assembly includes a headgear assembly and a mask interface. The headgear assembly includes an upper headgear loop, a lower headgear loop, and a side strap coupling the upper headgear loop and the lower headgear loop on each side of a user's face in use. The mask interface is coupled to the side straps, and a position of the mask interface along a length of the side straps is configured to be adjusted to adjust a length of the upper headgear loop relative to the lower headgear loop.

The headgear assembly can include a top strap configured to extend across a top of the user's head in use, the top strap extending between and connecting opposing sides of the upper headgear loop. The side straps can be elastic. The side strap can form a portion of the upper headgear loop and the lower headgear loop.

Embodiments of systems, components and methods of assembly and manufacture will now be described with reference to the accompanying figures, wherein like numerals refer to like or similar elements throughout. Although several embodiments, examples and illustrations are disclosed below, it will be understood by those of ordinary skill in the art that the inventions described herein extend beyond the specifically disclosed embodiments, examples and illustrations, and can include other uses of the inventions and obvious modifications and equivalents thereof. The terminology used in the description presented herein is not intended to be interpreted in any limited or restrictive manner simply because it is being used in conjunction with a detailed description of certain specific embodiments of the inventions. In addition, embodiments of the inventions can comprise several novel features and no single feature is solely responsible for its desirable attributes or is essential to practicing the inventions herein described.

Certain terminology may be used in the following description for the purpose of reference only, and thus are not intended to be limiting. For example, terms such as "above" and "below" refer to directions in the drawings to which reference is made. Terms such as "front," "back," "left," "right," "rear," and "side" describe the orientation and/or location of portions of the components or elements within a consistent but arbitrary frame of reference which is made clear by reference to the text and the associated drawings describing the components or elements under discussion. Moreover, terms such as "first," "second," "third," and so on may be used to describe separate components. Such terminology may include the words specifically mentioned above, derivatives thereof, and words of similar import.

The present disclosure relates to a respiratory mask system or mask assembly <NUM> for the delivery of respiratory therapy to a patient. For example, <FIG> and <FIG> illustrate an example embodiment of a mask assembly <NUM> including a mask interface <NUM> and a headgear assembly <NUM>. The mask interface <NUM> includes a seal or cushion <NUM> that seals around the user's nose and/or mouth in use and a frame or housing <NUM> that supports the seal <NUM> and couples the seal <NUM> to the headgear <NUM> and/or a gas delivery conduit <NUM>. In the illustrated embodiment, the mask interface <NUM> is a full face mask, and the seal <NUM> seals around the user's nose and mouth in use. The seal <NUM> can be removably coupled to the housing <NUM> in use. The housing <NUM> can comprise one or more portions or pieces. For example, the housing <NUM> can have a first piece that directly supports the seal <NUM> and a second piece that directly supports the headgear <NUM>. The first and second pieces can be permanently or removably coupled to one another. The headgear <NUM> supports the mask interface <NUM> in a suitable position on the user's face in use.

The headgear <NUM> includes a pair of upper side straps <NUM>, a pair of lower side straps <NUM>, a top strap <NUM>, and a rear section <NUM>. One of the pair of upper side straps <NUM> and one of the pair of lower side straps <NUM> are located on each side of the user's head in use and can be mirror images of one another. Each of the upper <NUM> and lower <NUM> side straps apply force vectors to the mask interface <NUM> in use. The headgear <NUM> can therefore be considered a four-point headgear. The side straps <NUM> and <NUM> on each side of the user's head can be coupled to one another by the top strap <NUM> and the rear section <NUM>.

The headgear <NUM> can also include at least one connector on each side of the headgear <NUM>. Each connector connects two or more straps or portions of the headgear assembly. That is, each connector connects two or more of one of the side straps <NUM>, <NUM>, the rear section <NUM>, and the top strap <NUM>. Each connector may be considered to form a junction body or junction element of the headgear <NUM>. The headgear <NUM> of <FIG> and <FIG> includes two upper connectors <NUM> (also referred to as upper side strap connectors herein) and two lower connectors <NUM> (also referred to as lower side strap connectors herein), with one of each located on each side of the headgear <NUM>. Therefore, each side of the headgear <NUM> includes an upper connector <NUM> and a lower connector <NUM>. Each connector <NUM>, <NUM> is disposed or positioned away from the mask interface <NUM>. Each upper connector <NUM> is configured to be disposed above a user's ear in use. In the illustrated embodiment, each upper connector <NUM> connects one of the upper side straps <NUM>, the top strap <NUM>, and the rear section <NUM>, e.g., an upper section <NUM> of the rear section <NUM> as described herein. Each lower connector <NUM> is configured to be disposed below and/or behind the user's ear in use. Each lower connector <NUM> connects one of the lower side straps <NUM> and the rear section <NUM>, e.g., a lower section <NUM> of the rear section <NUM> as described herein.

Each connector <NUM>, <NUM> is associated with an automatically adjusting headgear mechanism as described herein. Examples of such an automatically adjusting headgear mechanism are discussed in relation to <FIG> below. For example, each connector <NUM>, <NUM> houses a control mechanism of one of the automatically adjusting headgear mechanisms. The control mechanisms can include one or more lock mechanisms, for example, directional locks, as described herein. Each connector <NUM>, <NUM> has a generally hollow body that receives and/or houses the respective control mechanism. The body may be formed of a rigid material or a soft material such as silicone. Forming the body from silicon can provide for a more comfortable engagement with the user's head in use. The connector body may be formed as two components that are clipped or otherwise coupled together over, around, or about the control mechanism. Alternatively, the connector body may be formed by overmoulding the connector body to or around the control mechanism. Alternatively, the connector body may be formed with an opening through which the control mechanism is inserted. A cap may be attached to the connector body over the opening to enclose the control mechanism. The connector body includes apertures at first and second ends of the connector body that allow a filament of the automatically adjusting headgear mechanism to extend into and/or through the connector and/or control mechanism from either end of the connector and/or control mechanism.

In the illustrated embodiment, each upper side strap <NUM> has a first end connected to the mask interface <NUM> and a second end connected to one of the upper side strap connectors <NUM>. Each lower side strap <NUM> has a first end connected to the mask interface <NUM> and a second end connected to one of the lower side strap connectors <NUM>. The upper side straps <NUM> and/or lower side straps <NUM> can be rigidly, fixedly, or permanently connected to the mask interface <NUM> as shown in <FIG> and <FIG>. Alternatively, the upper side straps <NUM> and/or lower side straps <NUM> can be removably connected to the mask interface <NUM>. The side straps <NUM>, <NUM> are coupled to lateral sides of the mask interface <NUM>. This can advantageously allow for a relatively clear and unobstructed view above and/or through the center of the housing <NUM>. A relatively clear and unobstructed view may present a more humanistic and/or aesthetically pleasing appearance to the patient's bed partner. The top strap <NUM> extends between and is connected to the upper side strap connectors <NUM>. The rear section <NUM> extends between and is connected to the upper side strap connectors <NUM> and lower side strap connectors <NUM>. As described in greater detail herein, the rear section <NUM> can include an upper strap or section <NUM> and a lower strap or section <NUM>. The upper strap or section <NUM> can include two ends, each connected to one of the upper side strap connectors <NUM>. The lower strap or section <NUM> can include two ends, each connected to one of the lower side strap connectors <NUM>. The upper and lower straps <NUM>, <NUM> can be interconnected, such as via vertical straps or sections.

The headgear <NUM> includes one or more adjustable components and/or adjustment mechanisms to allow for donning and/or doffing of the headgear <NUM> and/or to allow the headgear <NUM> to be adjusted to an appropriate size for the user. For example, the top strap <NUM> can be adjustable, e.g., manually adjustable in the illustrated embodiment, and the upper <NUM> and/or lower <NUM> side straps can be adjustable, e.g., automatically adjustable in the illustrated embodiment. In some configurations, the rear section <NUM> can allow for temporary expansion during donning and/or doffing of the mask assembly <NUM>.

In the illustrated embodiment the top strap <NUM> comprises two strap portions, a left portion <NUM> and a right portion <NUM>. The left and right portions <NUM>, <NUM> are separate from one another and have a free end and a fixed end. The free ends are configured to be adjustably connected by an adjustment mechanism <NUM>. In the illustrated embodiment, each of the fixed ends extends from a location at or near a junction between one of the upper side straps <NUM> and the rear section <NUM>.

The adjustment mechanism <NUM> is configured to provide a means to adjust and secure the top strap <NUM> in a desired adjusted length and thus adjust the size and/or tightness setting of the headgear <NUM>. Adjustment of the length of the top strap <NUM> can define the positioning, in use, of the upper side straps <NUM> relative to the top of a user's ear. Shortening the length of the top strap <NUM> may position the upper side straps <NUM> higher above the user's ears thus avoiding contact between the upper side straps <NUM> and the user's ears. This may improve comfort for the user, as contact between the upper side straps <NUM> and the top of the user's ears may cause irritation or pressure points that over time can lead to pressure sores.

In the illustrated embodiment, the free end of the right portion <NUM> includes a guide loop <NUM> and a plurality of holes spaced along the length of the strap. The holes extend through the thickness of the top strap <NUM>. The free end of the left portion <NUM> includes a pip or post that protrudes from an internal surface of the strap. In other embodiments, the right portion <NUM> can instead include a pip or post and the left portion <NUM> can include a guide loop and plurality of holes.

The guide loop <NUM> comprises a loop structure that forms an aperture at the end of the right portion <NUM>. The free end of the left portion <NUM> is configured to pass through the aperture formed by the guide loop <NUM>. Thus, the left portion <NUM> and the right portion <NUM> can be slid relative to one another to vary an overlapping distance of the left and right portions <NUM>, <NUM> and, thus, vary a length of the top strap <NUM>. The guide loop <NUM> can also maintain a link between the left and right portions <NUM>, <NUM> when the adjustment mechanism <NUM> is not engaged. This may improve ease of use by maintaining a connection between the portions <NUM>, <NUM>. The guide loop <NUM> can be angled away from the internal surface such that the aperture is at least partially offset from the thickness of the strap. This allows the left portion <NUM> to pass through the guide loop <NUM> and overlap with the right portion <NUM> without the left portion <NUM> having to bend or deform to any significant extent.

The post is configured to pass through any of the holes in the right portion <NUM>. The holes and post are sized, shaped and/or otherwise configured to allow the post to pass through the holes and to retain the post once passed through a selected one of the holes, at least in response to normal or expected forces. However, the post can be deliberately removed from the holes to permit separation of the left and right portions <NUM>, <NUM> of the top strap <NUM>, to allow for re-sizing of the headgear <NUM>. Passing of the post through the holes can be accomplished by deformation of one or both the post and holes. In alternative embodiments there may be a plurality of posts.

In alternative embodiments the adjustment mechanism <NUM> may comprise any other suitable means of adjustably connecting the free ends of the top strap <NUM>, such as but not limited to hook and loop fasteners, buckles, magnetic connectors, etc. Alternatively, the left and right portions <NUM>, <NUM> can be connected, e.g., permanently connected via, for example, a section of an elastic material that allows the top strap <NUM> to stretch and lengthen to some extent if needed. In other embodiments, the top strap <NUM> can be a one-piece and/or non-adjustable strap.

The rear section <NUM> can allow for temporary expansion during donning and/or doffing of the mask assembly <NUM>. The rear section <NUM> can have a rigid or non-adjustable upper strap or section <NUM> and an adjustable lower strap or section <NUM>. The lower section <NUM> can be elastic, as shown in <FIG>. Other adjustment mechanisms are also possible, for example as shown and described herein. The adjustable lower section <NUM> allows the lower section <NUM> to be expanded temporarily while donning and/or doffing the mask assembly <NUM>. The temporary expansion allows the lower side straps <NUM> to pass over the patient's ears with reduced, minimal, or no contact to avoid causing patient discomfort. Once the lower side straps <NUM> have passed the ears, the tension and/or expansion of the lower section <NUM> can be released to allow the lower section <NUM> to return to its regular, default, or non-expanded size. Although the lower section <NUM> is adjustable to allow for temporary expansion for donning and/or doffing, when disposed on the user's head in use, the lower section <NUM> has a fixed length. The lower section <NUM> may allow for only temporarily expansion for donning and/or doffing, and may not allow for headgear size adjustment <NUM>. In other words, the fixed length of the lower section <NUM> when not temporarily expanded for donning and/or doffing may not be adjusted by the user.

The lower section <NUM> can include other adjustment mechanisms instead of or in addition to elastic. For example, the lower section <NUM> can include a break-fit arrangement in the form of a magnetic connection as shown in <FIG>. The break-fit arrangement can include a sleeve or tether to help guide movement of components of the magnetic connection together. In the illustrated embodiment, the lower section <NUM> includes two non-elastic sections <NUM>. The two non-elastic sections <NUM> are removably connected to each other at or near a center or middle of the lower section <NUM> with magnets <NUM> positioned at or near free ends of each of the non-elastic sections. In the illustrated embodiment, each non-elastic section <NUM> includes an upper magnet <NUM> and a lower magnet <NUM>, but more or fewer magnets are also possible. The magnets <NUM> of one of the non-elastic sections <NUM> have a polarity opposite to the polarity of the magnets <NUM> of the other non-elastic section <NUM> such that the magnets <NUM> of the two non-elastic sections <NUM> are attracted to each other. Therefore, in a default state, shown in <FIG>, the two non-elastic sections <NUM> are coupled together. The two non-elastic sections <NUM> are permanently connected to each other with a tether, e.g., an elastic tether <NUM>, to maintain a connection and/or guide the sections <NUM> toward one another. The elastic tether <NUM> can extend through or along both non-elastic sections <NUM>.

To don and/or doff the headgear <NUM>, the user pulls the non-elastic sections <NUM> away from each other, applying sufficient force to break the magnetic bond between the magnets <NUM> and separate the two non-elastic sections <NUM> from each other as shown in <FIG>. This enlarges the lower section <NUM> and allows the mask assembly <NUM> to be donned and/or doffed with reduced, minimal, or no contact of the lower side straps <NUM> with the user's ears. As the two non-elastic sections <NUM> separate from each other, the elastic tether <NUM> stretches, as shown in <FIG>. When the user releases the tension or force pulling the non-elastic sections <NUM> apart, the elastic tether <NUM> attempts to return to its unstretched state, thereby pulling the two non-elastic sections <NUM> back toward each other. When the magnets <NUM> of the two non-elastic sections <NUM> are in close enough proximity to each other, the magnets <NUM> attract each other to reconnect the two non-elastic sections <NUM>. The magnets can be designed or selected such that the force of attraction between the magnets <NUM> is greater than the blow-off force in use. For example, the force of attraction may be at least <NUM> N.

In other arrangements, the lower section <NUM> can include a foldable adjustment mechanism, for example, similar to a deployment buckle and/or deployment clasp as shown in <FIG>. The lower section <NUM> includes a first link <NUM>, a second link <NUM>, and a third link <NUM>. A first end of the second link <NUM> is hingedly coupled to the first link <NUM>, and an opposite second end of the second link <NUM> is hingedly coupled to the third link <NUM>. In a closed state, shown in <FIG> and <FIG>, the first <NUM>, second <NUM>, and third <NUM> links are folded such that the first <NUM>, second <NUM>, and third <NUM> links are stacked or overlap each other and the second link <NUM> is sandwiched between the first link <NUM> and the third link <NUM>. The links can have a curved shape or contour. The links can be curved or contoured such that when in the closed state and positioned on the user's head, as shown in <FIG>, the links are forward facing concave. Such a contour can generally accommodate or follow the curvature of the back of the user's head. When in an open, expanded state, as described below, the first <NUM> and third <NUM> links can be forward facing concave and the second link <NUM> can be forward facing convex.

To move the adjustment mechanism to the open, expanded state, shown in <FIG> and <FIG>, the user lifts and/or pulls the first link <NUM> (e.g., lifts and/or pulls the end of the first link <NUM> overlapping the second <NUM> and third <NUM> links) away from the third link <NUM>. This movement also lifts and/or pulls the first end of the second link <NUM> away from the third link <NUM> so that the second link <NUM> hinges relative to the first <NUM> and third <NUM> links and the first <NUM>, second <NUM>, and third <NUM> links unfold. In the open state, the second link <NUM> is disposed longitudinally between, or substantially between, the first link <NUM> and the third link <NUM>. The first <NUM>, second <NUM>, and/or third <NUM> links can be rigid or semi-rigid, which can allow for defined folding points (e.g., at the hinges between the first <NUM> and second <NUM> links and between the second <NUM> and third <NUM> links). In some embodiments, the first link <NUM> includes a tab <NUM> at or near the end of the first link <NUM> connected to the second link <NUM>. The tab <NUM> can provide the user a location to grip to open and/or close the connection mechanism. The tab <NUM> may be constructed to give tactile feedback to the patient to signal they have gripped the correct location.

In the open state, the lower section <NUM> has an expanded length to allow the headgear <NUM> to be donned and/or doffed with reduced, minimal, or no contact of the lower side straps <NUM> with the user's ears. To close the connection mechanism, e.g., once the lower side straps <NUM> have cleared the user's ears, the user moves the first link <NUM> back toward the third link <NUM> such that the second link <NUM> hinges relative to the first <NUM> and third <NUM> links to fold the links and sandwich the second link <NUM> between the first <NUM> and third <NUM> links. The lower section <NUM> can be secured in the closed state via any appropriate means, e.g., hook and loop fastener(s), one or more clips, one or more magnets, interference fit(s), etc. between the first link <NUM> and the second link <NUM>, between the second link <NUM> and the third link <NUM>, between the tab <NUM> and the second link <NUM> and/or between the tab <NUM> and the third link <NUM>.

In some embodiments, the lower section <NUM> includes a sliding or telescoping assembly. In the illustrated arrangement, the lower section <NUM> includes overlapping and/or interlocking rails housed in an elastic sleeve <NUM> as shown in <FIG>. The lower section <NUM> includes an inner rail <NUM> having a first end at or near a first lateral side of the lower section <NUM> (the user's left in the illustrated embodiment) and a second end extending toward a second, opposite lateral side of the lower section <NUM>, and an outer rail <NUM> having a first end at or near the second lateral side of the lower section <NUM> (the user's right in the illustrated embodiment) and a second end extending toward the first lateral side. The inner <NUM> and outer <NUM> rails overlap and/or interlock, for example as shown in <FIG>, to allow sliding movement in a length direction and prevent separation and/or relative movement in one or both of the other (width and thickness) directions. A first end of the elastic sleeve <NUM> is fixed relative to the first end of the inner rail <NUM>, and a second, opposite end of the elastic sleeve <NUM> is fixed relative to the first end of the outer rail <NUM>.

In some configurations, the inner rail <NUM> includes a metal or magnetic portion <NUM> at the second end of the inner rail <NUM>. The outer rail <NUM> includes a metal or magnetic portion <NUM> at the second end of the outer rail <NUM>. A first magnet <NUM> is disposed along the inner rail <NUM> at a location spaced from the second end of the inner rail <NUM>. A second magnet <NUM> is disposed along the outer rail <NUM> at a location spaced from the second end of the outer rail <NUM>. The metal or magnetic portion <NUM> of the outer rail <NUM> is attracted to the first magnet <NUM>, and the metal or magnetic portion <NUM> of the inner rail <NUM> is attracted to the second magnet <NUM>. In a closed state, shown in <FIG> and <FIG>, the magnetic portion <NUM> of the outer rail <NUM> abuts or is in magnetic connection with the first magnet <NUM> and the magnetic portion <NUM> of the inner rail <NUM> abuts or is in magnetic connection with the second magnet <NUM>. The magnetic attraction or bond between the respective magnetic portions and magnets holds the lower section <NUM> in the closed state.

To move the lower section <NUM> to an open or expanded state, the user pulls the first ends of the inner <NUM> and outer <NUM> rails away from each other in a lengthwise direction along an axis parallel or generally parallel to longitudinal axes of the inner <NUM> and outer <NUM> rails. When the user applies sufficient force to overcome or break the magnetic bond between the respective magnetic portions and magnets, the inner <NUM> and outer <NUM> rails slide relative to each other and away from each other along an axis parallel or generally parallel to the longitudinal axes of the inner <NUM> and outer <NUM> rails, thereby decreasing the overlap between the inner <NUM> and outer <NUM> rails. As the inner <NUM> and outer <NUM> rails slide away from each other, the lower section <NUM> lengthens and the elastic sleeve <NUM> stretches. The inner <NUM> and outer <NUM> rails can have lengths selected such that at a maximum length of the lower section <NUM>, the inner <NUM> and outer <NUM> rails still overlap to some extent to ensure the inner <NUM> and outer <NUM> rails remain connected.

In the open or expanded state, the lower section <NUM> has an expanded length to allow the headgear <NUM> to be donned and/or doffed with reduced, minimal, or no contact of the lower side straps <NUM> with the user's ears. Once the lower side straps <NUM> have cleared the user's ears, the user can release the tension on the lower section <NUM>. When the tension on the lower section <NUM> pulling the inner <NUM> and outer <NUM> rails apart is released, the elastic sleeve <NUM> attempts to return to its unstretched state, thereby moving the inner <NUM> and outer <NUM> rails toward each other and increasing the overlap of the inner <NUM> and outer <NUM> rails. When the magnetic portions are in close enough proximity to the magnets, the magnetic portions and magnets attract each other to return the lower section <NUM> to the closed state. Although an elastic sleeve <NUM> is shown, other biasing members or arrangements can be used to bias the inner <NUM> and outer <NUM> rails toward the closed state.

<FIG> illustrate another embodiment of the lower section <NUM> including a clip together connection mechanism. The lower section <NUM> includes a first strap <NUM> and a second strap <NUM>. The first <NUM> and second <NUM> straps can be non-elastic. In the illustrated embodiment, the first strap <NUM> is on the user's left in use and the second strap <NUM> is on the user's right in use, but the first <NUM> and second <NUM> straps can be reversed. The first strap <NUM> includes a female connector <NUM> at a medial end of the first strap <NUM>. The second strap <NUM> includes a male connector <NUM> at a medial end of the second strap <NUM>. In a closed state, shown in <FIG>, <FIG>, <FIG>, the male connector <NUM> is received in, e.g., clipped into, the female connector <NUM>. The male connector <NUM> and female connector <NUM> can be secured together via an interference, interlocking or snap fit. The lower section <NUM> also includes an elastic tether <NUM> coupled to and connecting the first strap <NUM> and second strap <NUM>. The elastic tether <NUM> can contact the rear of the patient's head in use, which can cushion contact between the connectors and the patient's head.

To transition the lower section <NUM> to an open or expanded state, the male connector <NUM> is removed from the female connector <NUM>, and the first <NUM> and second <NUM> straps are pulled apart from each other, as shown in <FIG>. As the first <NUM> and second <NUM> straps are pulled apart from each other, the elastic tether <NUM> stretches. In the open or expanded state, the lower section <NUM> has an expanded length to allow the headgear <NUM> to be donned and/or doffed with reduced, minimal, or no contact of the lower side straps <NUM> with the user's ears. Once the lower side straps <NUM> have cleared the user's ears, the user can release the tension on the lower section <NUM>. When the tension on the lower section <NUM> pulling the first <NUM> and second <NUM> straps apart is released, the elastic tether <NUM> attempts to return to its unstretched state, thereby moving the first <NUM> and second <NUM> straps toward each other. When the first <NUM> and second <NUM> straps have returned to a position close enough together, the male connector <NUM> can be inserted into the female connector <NUM> to secure the lower section <NUM> in the closed state.

In some embodiments, the female connector <NUM> includes at least a rear face <NUM> made of a deformable material, e.g., rubber. As shown in <FIG> and <FIG>, the rear face <NUM> has a split <NUM> extending from the open end of the female connector <NUM> that receives the male connector <NUM>. To disconnect the male connector <NUM> from the female connector <NUM>, the user deflects, pivots, and/or pulls the male connector <NUM> rearward relative to the female connector <NUM> such that the male connector <NUM> applies force to the rear face <NUM>. This force causes portions of the rear face <NUM> on either side of the split <NUM> to deform and/or deflect outward (relative to the split <NUM>) and rearward (in use; upward in the orientation of <FIG>), as shown in <FIG> and <FIG>, thereby widening the split <NUM> and allowing the male connector <NUM> to pass through the split <NUM> and disengage from the female connector <NUM>. The male connector <NUM> is therefore "peeled" out of the female connector <NUM>. In such a configuration, the male connector <NUM> and female connector <NUM> are connected and disconnected via different motions or methods - the male connector <NUM> is longitudinally inserted into the female connector <NUM> to connect the male connector <NUM> and female connector <NUM>, whereas the male connector <NUM> is deflected rearward to peel the male connector <NUM> rearwardly out of the female connector <NUM> (perpendicular to the insertion direction). These different motions help reduce the likelihood of the male connector <NUM> being accidentally disconnected from the female connector <NUM>. The male connector <NUM> could alternatively or additionally include a release mechanism configured to allow removal in a reverse direction from the insertion direction.

The lower section <NUM> can include two clip together mechanisms as shown and described, or similar to as shown and described, with respect to <FIG>. For example, the lower section <NUM> can include a first side portion <NUM>, a second side portion <NUM>, and a central handle portion <NUM>, as shown in <FIG>. The first <NUM> and second <NUM> side portions and/or central handle portion <NUM> can be non-elastic. Each of the first <NUM> and second <NUM> side portions includes a female connector <NUM> at its medial end. Each end of the central handle portion <NUM> includes a male connector <NUM> (however, this arrangement could also be reversed). In a closed state, shown in <FIG> and <FIG>, each male connector <NUM> is received in, e.g., clipped into, one of the female connectors <NUM>. The male connectors <NUM> and female connectors <NUM> can be secured together via an interference, interlocking or snap fit. The lower section <NUM> also includes one or more biasing members or elastic tethers <NUM> coupled to and connecting the central handle portion <NUM> to the first <NUM> and second <NUM> side portions. In the illustrated embodiment, the lower section <NUM> includes a first elastic tether <NUM> coupled to and connecting the central handle portion <NUM> and the first side portion <NUM> and a second elastic tether <NUM> coupled to and connecting the central handle portion <NUM> and the second side portion <NUM>.

To transition the lower section <NUM> to an open or expanded state, the male connectors <NUM> are removed from the female connectors <NUM>, and the central handle portion <NUM> is pulled away from the first <NUM> and second <NUM> side portions, as shown in <FIG>. The female connectors <NUM> can have rear faces <NUM> made of a deformable material, e.g., rubber, with a split <NUM> extending from the end of the female connector <NUM> that receives the male connector <NUM>, as shown and described herein with respect to <FIG>. To disconnect the male connectors <NUM> from the female connectors <NUM>, the user can pull the central handle portion <NUM> rearward away from the first <NUM> and second <NUM> side portions such that the male connectors <NUM> apply force to the rear faces <NUM>. This force causes the portions of the rear faces <NUM> on either side of the splits <NUM> to deform and/or deflect outward (relative to the split <NUM>) and rearward (in use), thereby widening the splits <NUM> and allowing the male connectors <NUM> to pass through the splits <NUM> and disengage from the female connectors <NUM>. The male connectors <NUM> can therefore be "peeled" out of the female connector <NUM>.

With the central handle portion <NUM> separated from the first <NUM> and second <NUM> side portions, the first <NUM> and second <NUM> side portions can be pulled longitudinally away from each other to lengthen or expand the lower section <NUM>. As the first <NUM> and second <NUM> portions are pulled apart from each other and from the central handle portion <NUM>, the elastic tethers <NUM> stretch. In the open or expanded state, the lower section <NUM> has an expanded length to allow the headgear <NUM> to be donned and/or doffed with reduced, minimal, or no contact of the lower side straps <NUM> with the user's ears. Once the lower side straps <NUM> have cleared the user's ears, the user can release the tension on the lower section <NUM>. When the tension on the lower section <NUM> pulling the first <NUM> and second <NUM> side portions apart is released, the elastic tethers <NUM> attempt to return to their unstretched state, thereby moving the first <NUM> and second <NUM> side portions toward each other and the central handle portion <NUM>. When the first <NUM> and second <NUM> side portions have returned to a position close enough to the central handle portion <NUM>, the male connectors <NUM> can be inserted into the female connectors <NUM> to secure the lower section <NUM> in the closed state.

As described herein, one or more portions of the headgear <NUM>, e.g., the upper <NUM> and/or lower <NUM> side straps, can be automatically adjustable and/or can incorporate one or more directional locks that allow the headgear to reduce in length with a relatively low amount of resistance and resist an increase in length of the headgear with a greater amount of resistance. Preferably, the directional lock(s) are configured to resist at least the blow-off force produced by the mask assembly <NUM> and, in some configurations, may also resist some amount of hose pull force. In some configurations, a locking force of the directional locks can be overcome to allow lengthening of the headgear for donning of the interface assembly.

As shown in <FIG>, each of the upper side straps <NUM> and lower side straps <NUM> has an associated connector <NUM>, <NUM>, respectively, housing a control mechanism for filaments <NUM> (shown in <FIG>) used in an automatically adjustable headgear mechanism. Examples of such an automatically adjusting headgear mechanism are discussed in relation to <FIG> below. In the illustrated embodiment, the connectors <NUM>, <NUM> and control mechanisms are located on or connected to the headgear <NUM>, rather than on or connected to the mask interface <NUM>. Each upper side strap <NUM> has an associated upper connector <NUM>, and each lower side strap <NUM> has an associated lower connector <NUM>. The illustrated embodiment therefore includes four connectors, each housing a control mechanism for an automatically adjustable headgear mechanism. A filament <NUM> extends within each of the upper side straps <NUM> and the lower side straps <NUM>. The side straps <NUM>, <NUM> or portions thereof can form or include variable length sections, in this case defined by braided elements <NUM>, of an automatic headgear adjustment mechanism, and the filaments <NUM> can extend within the braided elements <NUM> as shown in <FIG>. One or more elastic elements <NUM> (or other suitable biasing arrangements) can be provided and configured to apply a retraction force to the headgear <NUM>, which tends to reduce a circumference of the headgear <NUM> or reduce a length of a portion of the headgear <NUM>, such as the braided elements <NUM>.

Each control mechanism in the connectors <NUM>, <NUM> incorporates or includes one or more directional locks, each of which can include one or more lock members <NUM>. Each lock member may be generally in the form of a washer and referred to as "lock washers" or "washers" herein. That is, the lock washers can be relatively flat members defining an aperture through which the filament passes. The lock washers can be configured to frictionally engage with the filament during elongation of the headgear, but allow reduced-friction or relatively friction-free movement during retraction of the headgear. The directional locks can be overcome by application of manual force or can otherwise allow for deliberate extension of the associated headgear strap or portion to facilitate donning or doffing. The headgear or any portion thereof can be configured in accordance with any of the embodiments disclosed in Applicant's <CIT>,<CIT>, and <CIT>.

As shown in <FIG>, each filament extending within one of the upper side straps <NUM> can extend through the respective upper connector <NUM> and into or along the top strap <NUM>, e.g., in an upper side strap filament storage sleeve <NUM>. Each filament extending within one of the lower side straps <NUM> can extend through the respective lower connector <NUM> and into or along the rear section <NUM>, e.g., in a lower side strap filament storage sleeve <NUM>. The storage sleeves <NUM>, <NUM> provide locations to store the accumulated or excess length of filaments that allow for side strap extension. In other words, the storage sleeves <NUM>, <NUM> can store portions of the filaments adjacent untensioned or free ends of the filaments. These portions vary in length with adjustment of the length of the side straps <NUM>, <NUM>, and the excess length of filament, which is stored in the storage sleeves <NUM>, <NUM> increases as the strap <NUM>, <NUM> length and/or headgear size is reduced. The storage sleeves <NUM>, <NUM> can also protect the filaments and help reduce jamming or snagging of the filaments during adjustment in use. The storage sleeves <NUM>, <NUM> can be mounted so as to be non-obtrusive and to take up minimal additional space. The storage sleeves <NUM>, <NUM> may be formed within the headgear <NUM> structure and therefore hidden to some extent. In the illustrated embodiment, a first end of each filament and each of the upper <NUM> and lower <NUM> side straps are permanently fixed to or relative to the mask interface <NUM>. A second, opposite end of each of the upper <NUM> and lower <NUM> side straps, e.g., the outer braided element <NUM> of each of the straps, is permanently fixed to or relative to its respective connector <NUM>, <NUM>. A second, opposite end of each filament is not fixed to the headgear <NUM> such that the filament can slide or travel through its associated connector <NUM>, <NUM> and control mechanism therein, storage sleeve <NUM>, <NUM>, and/or braided element <NUM> during adjustment.

<FIG> illustrate a schematic of the automatic headgear adjustment mechanism in an extended state and a retracted state, respectively. Further detail of mechanisms is discussed in relation to <FIG>below. The second, opposite or "free" end of the filament <NUM> is connected, e.g., permanently connected, to a first end of a biasing member or elastic element <NUM>. For example, the filament <NUM> can be connected to the elastic element <NUM> via a crimp <NUM> as shown in <FIG>. A second, opposite end of the elastic element <NUM> is connected, e.g., permanently connected, to or relative to the storage sleeve <NUM>, <NUM>. To extend or length the headgear, e.g., the side straps <NUM>, <NUM>, the user can pull the mask interface <NUM> away from or relative to the headgear <NUM>. During extension, the braided element <NUM> is stretched away from or relative to the connector <NUM>, <NUM>, pulling the filament <NUM> through the connector <NUM>, <NUM> (and therefore the lock member(s) <NUM>) and storage sleeve <NUM>, <NUM> toward the braided element <NUM> (toward the left in the orientation of <FIG>) as shown in <FIG> and stretching the elastic element <NUM>. To allow the headgear, e.g., the side straps <NUM>, <NUM>, to retract or shorten, the user releases the tension on the mask interface <NUM>. The elastic element <NUM> then relaxes and attempts to return to its unstretched state, pulling the filament <NUM> through the connector <NUM>, <NUM> (and therefore the lock member(s) <NUM>) and storage sleeve <NUM>, <NUM> toward and into the storage sleeve <NUM>, <NUM> (toward the right in the orientation of <FIG>) as shown in <FIG>. If the automatic headgear adjustment mechanism did not include the elastic element <NUM> or the biasing element was located on an opposite side of the directional lock (e.g., in the braided element <NUM>), during retraction the filament <NUM> would instead be pushed through the connector <NUM>, <NUM>, control mechanism, and/or lock member(s) <NUM> into the storage sleeve <NUM>, <NUM>, which could cause the filament <NUM> to buckle, bend, and/or jam in the braided element, control mechanism, or connector <NUM>, <NUM>. The pulling motion by the elastic element <NUM> in the illustrated embodiment can advantageously inhibit, reduce, or minimize bucking, bending, and/or jamming.

Instead of an elastic element <NUM> as shown in <FIG>, the automatic headgear adjustment mechanism can include a spring <NUM> that surrounds a portion of the filament <NUM> as shown in <FIG>. The spring can be a coiled spring, recoil spring, non-coiled spring, elastomer tube, plastic helix, or any other suitable spring. One end of the spring <NUM> is connected to the connector <NUM>, <NUM> and/or the storage sleeve <NUM>, <NUM> at or near a junction between the connector <NUM>, <NUM> and the storage sleeve <NUM>, <NUM>. The other end of the spring <NUM> is connected to the filament <NUM>, e.g., via a crimp. During extension or elongation, as the filament <NUM> is pulled through the connector <NUM>, <NUM> and control mechanism toward the braided element <NUM> (toward the left in <FIG>) and against the resistance of the directional locks, the spring <NUM> is compressed. The maximum compression of the spring <NUM> can limit the degree or amount of extension or elongation. In some cases, the spring <NUM> in compression during extension can be more reliable than the elastic element <NUM> in tension during extension. Because the filament <NUM> extends within, or is connected in parallel with, the spring <NUM>, a greater length of filament <NUM> can be stored in the same length of storage sleeve <NUM>, <NUM> compared to embodiments including an elastic element <NUM> in series with the filament <NUM>.

The mask assembly <NUM> of <FIG> can be donned by the user in a two-stage process, as shown in <FIG>. In a first stage, shown in <FIG>, the user can rest the mask interface <NUM> on his or her forehead while moving the rear section <NUM> into the correct position. The user temporarily expands the lower section <NUM> of the rear section <NUM> to allow the lower side straps <NUM> to pass over the user's ears with reduced, minimal, or no contact with the ears. Once the lower side straps <NUM> have cleared the user's ears, the user returns the lower section <NUM> to its closed state. With the rear section <NUM> in place, the user lifts the mask interface <NUM> off of his or her forehead, pulls the mask interface <NUM> down to cover the nose and/or mouth, and presses the seal <NUM> into place. The automatically adjustable headgear mechanisms of the upper <NUM> and lower <NUM> side straps allow the side straps <NUM>, <NUM> to automatically adjust and secure the mask interface <NUM> in the desired position. Before, during, and/or after the donning process, the top strap <NUM> can be manually adjusted as needed. Therefore, during donning, the top strap <NUM> allows for manual, macro-size adjustments to the headgear <NUM>, the temporarily expandable rear section <NUM> allows the lower side straps <NUM> to be passed over the user's ears with reduced, minimal, or no contact, and the automatically adjustable side straps <NUM>, <NUM> allow for micro-size adjustments to the headgear <NUM>.

The upper <NUM> and/or lower <NUM> side straps can be removably connected to the mask interface <NUM>. For example, any or all of the upper <NUM> and/or lower <NUM> side straps can be removably connected to the mask interface <NUM> via clips or hooks. <FIG> show a variation of the mask assembly <NUM> in which each lower side strap <NUM> is removably connected to the mask interface <NUM>, e.g., the housing <NUM>, via a clip or hook <NUM>. The mask assembly of <FIG> includes a yoke <NUM> coupling the upper side straps <NUM> and the mask interface <NUM>. As shown, one end of each of the upper side straps <NUM> is connected to one lateral end of the yoke <NUM>. The opposite ends of each of the upper side straps <NUM> are connected, e.g., permanently connected, to the top strap <NUM> and/or rear section <NUM> at or near a junction <NUM> between the top strap <NUM> and rear section <NUM>. The yoke <NUM> is removably connected to the housing <NUM> in use. The removable connections between the clips or hooks <NUM> and the mask interface <NUM> and between the yoke <NUM> and the mask interface <NUM> advantageously allow the mask interface to be completely separated from the headgear assembly <NUM>.

As shown, the yoke <NUM> can extend across part or all of a width of the housing <NUM>. The yoke <NUM> can be secured to the housing <NUM> in use via, for example, a snap-fit, interference fit, or any other appropriate means. The upper side strap filaments of the automatically adjustable headgear mechanisms can extend into and be stored in the yoke <NUM>. As the accumulated upper side strap filaments are stored in the yoke <NUM>, the headgear <NUM> may omit upper strap filament storage sleeve <NUM>. In the illustrated embodiment, the headgear <NUM> does not include the upper connectors <NUM>. Instead, the yoke <NUM> houses the directional locks or lock members. The yoke <NUM> can house one or more directional locks or lock members at or proximate a first lateral end of the yoke <NUM> and configured to receive one of the upper side strap filaments, and one or more directional locks or lock members at or proximate a second, opposite lateral end of the yoke <NUM> and configured to receive the other of the upper side strap filaments. A magnitude of the length adjustment allowed within the upper straps <NUM> can be different (e.g., less than) a magnitude of the length adjustment allowed within the lower straps <NUM>.

The mask assembly of <FIG> can be donned by the user via a two-stage process, as shown in and described with respect to <FIG>. <FIG> illustrates the mask assembly following the first stage, with the seal <NUM> resting on the user's forehead and the lower side straps <NUM> positioned below the user's ears. Alternatively, the mask assembly of <FIG> can be donned in a three-stage process due to the removably connected lower side straps <NUM>. In a first stage, with the clips <NUM> of the lower side straps <NUM> disconnected from the mask interface <NUM> as shown in <FIG>, the headgear <NUM> can be slid or pulled down on top of the head, similar to donning a baseball cap. In a second stage, the pulls the mask interface <NUM> down to cover the nose and/or mouth, and presses the seal <NUM> into place. In a third stage, the user connects the clips <NUM> of the lower side straps <NUM> to the mask interface <NUM>, e.g., the housing <NUM> and makes any final adjustments needed to move the seal <NUM> into the desired position. The automatically adjustable headgear mechanisms of the upper <NUM> and lower <NUM> side straps allow the side straps <NUM>, <NUM> to automatically adjust and secure the mask interface <NUM> in the desired position.

<FIG> illustrate an embodiment of a mask assembly including a mask interface <NUM> and a frame <NUM>. The frame <NUM> can function similarly to the yoke <NUM> of <FIG> in some respects. The mask assembly also includes headgear, such as headgear <NUM>. The frame <NUM> is removably coupled to the mask interface <NUM>, e.g., the housing <NUM>. The frame <NUM> couples one or more components of the headgear <NUM> to the mask interface <NUM>. For example, the frame <NUM> can include two upper strap connection locations <NUM> as shown. One of the upper side straps <NUM> can be coupled, permanently or removably, to each of the upper strap connection locations <NUM>. The frame <NUM> can also or alternatively include two lower strap connection locations <NUM> one for each of the lower side straps <NUM>. In the illustrated embodiment, each of the lower strap connection locations <NUM> receives a clip or hook <NUM> coupled to one of the lower side straps <NUM> to removably couple the lower side straps <NUM> to the frame <NUM>. The frame <NUM> can therefore allow the headgear <NUM> to be completely separated from the mask interface <NUM> as needed or desired.

Similar to the yoke <NUM>, the frame <NUM> houses the control mechanisms, e.g., directional locks, associated with the automatically adjustable headgear mechanisms of the upper side straps and accommodate the upper side strap filaments <NUM>. Examples of such an automatically adjusting headgear mechanism are discussed in relation to <FIG> below. The control mechanisms are disposed proximate the upper side strap connection locations <NUM>, for example, in the control mechanism housing portions <NUM> shown in <FIG>. The filaments <NUM> can extend, be stored, and/or move within channels extending within or internally through the frame <NUM>, such as described below in relation to <FIG>. For example, <FIG> illustrates possible paths for the filaments <NUM>. Storing the filaments <NUM> within separate channels within the frame <NUM> can help isolate the filaments <NUM> from each other to prevent or inhibit the filaments <NUM> from interfering with each other. Storing the filaments <NUM> in the frame <NUM> can help hide the filament <NUM> storage from view at least to some extent and can help improve the aesthetic appeal of the mask assembly. Storing the filaments <NUM> within the frame <NUM> also utilizes existing space within the mask assembly and can therefore enable the size of the mask assembly to be reduced.

In some embodiments, an elbow <NUM>, shown in <FIG>, is coupled to the mask assembly such that the frame <NUM> is positioned or sandwiched between the elbow <NUM> and housing <NUM>. The elbow <NUM> removably couples to the housing <NUM> through and aperture in the frame <NUM>, which removably secures the frame <NUM> in place. A gas supply conduit is coupled to the elbow <NUM> to deliver gases to the mask interface <NUM> in use.

<FIG> illustrate an embodiment of a mask assembly <NUM> comprising a mask interface <NUM> and a frame <NUM>. As described for earlier embodiments, the mask assembly can be used in conjunction with headgear, for example headgear described herein. The frame <NUM> is removably coupled to the mask interface <NUM>, e.g., the housing <NUM>. The frame <NUM> can therefore allow headgear to be completely separated from the mask interface <NUM> as needed or desired.

Frame <NUM> comprises two upper headgear connector arms <NUM> and two lower headgear connector arms <NUM>. An upper side strap of a headgear can be coupled, permanently or removably, to each of the upper arms <NUM> and a lower side strap of a headgear can be coupled, permanently or removably, to each of the lower arms <NUM>.

Upper arms <NUM> and lower arms <NUM> are integral with and extend from a central portion of the frame <NUM>. Each arm comprises a distal end spaced away from frame <NUM>. Upper arms <NUM> and/or lower arms <NUM> may comprise a slot or hole <NUM> to fit and interact with a headgear strap or a headgear connector clip or hook of an upper side strap or lower side strap respectively, to couple the headgear to the frame <NUM>. The clip or hook may be connected to the upper and/or lower side straps by any suitable means, for example by any of the means described herein. In some embodiments the clip or hook may be connected to the strap by over-moulding. Slot or hole <NUM> may be located at or near the distal end of each arm <NUM>/<NUM>. In the illustrated embodiment, lower arms <NUM> comprise a slot or hole <NUM> to fit and interact with a strap, connector clip or hook of a lower side strap of a headgear. In some embodiments the slot or hole <NUM> comprises one or more notches <NUM>. The notches <NUM> may facilitate coupling between the headgear and the frame <NUM>. For example, when an upwards force is applied to the headgear or clip, the clip will contact the edge of the notch <NUM> that will act as a "stop bump" to stop rotation of clip. This action of the notch edge will limit any further rotation and reduce or minimize the likelihood of the clip becoming detached from the post.

Frame <NUM> is generally quadrilateral in shape. The frame <NUM> comprises a front surface <NUM> and a rear surface <NUM>, each having upper, lower and side edges. Rear surface <NUM> faces mask interface <NUM> and is provided with a connection for mask interface <NUM>. The front surface <NUM> faces away from the mask interface <NUM> and has upper edge <NUM>, side edges <NUM>, and lower edge <NUM>. Upper arms <NUM> extend from the upper corners of frame <NUM>, as defined by upper edge <NUM> and side edges <NUM>. Upper arms <NUM> each comprise at least one forward surface <NUM> that is continuous with front surface <NUM>, a first side that is continuous with upper edge <NUM> and a second side that is continuous with side edge <NUM>. Lower arms <NUM> extend from rear surface <NUM> of the frame. The lower arms <NUM> are upwardly spaced from the lower edge <NUM> of the frame <NUM>.

The upper edge <NUM> and each of the side edges <NUM> of the frame <NUM> each follow continuous arcs. The lower edge <NUM> is substantially linear. By "continuous arc" it is meant that the edge forms part of a curve, which gradually and consistently deviates from being a straight line along its length. For example, a continuous arc may form part of the circumference of a circle.

In the illustrated embodiment the two upper arms <NUM> are wider and thicker than the two lower arms <NUM>. In some embodiments, each of the upper arms <NUM> and/or lower arms <NUM> may curve along their length. In some embodiments the horizontal thickness and/or vertical width of each of the upper arms <NUM> and lower arms <NUM> may be substantially constant along their length. Alternatively, each of the upper arms <NUM> and/or lower arms <NUM> may have a variable thickness or width along their length. For example, either the thickness or the width or both the thickness and the width of each upper arm and/or each lower arm <NUM> may taper, by reducing along their length. This tapering may be a substantially linear fashion as the distance along the length of the arm from the frame <NUM> increases.

As described herein, in various embodiments a gas delivery conduit delivers gases to mask interface <NUM>. The frame <NUM> incorporates a gas path <NUM>. The gas path <NUM> can be removably and/or permanently attached to housing <NUM>. Gas path <NUM> may comprise an anti-asphyxia valve.

The front surface <NUM> of the frame <NUM> is convex and the rear surface <NUM> is concave. The gas path <NUM> is positioned within a space defined by a portion of the rear concave surface <NUM> of the frame <NUM>. The gas path <NUM> extends rearwardly from the rear surface of the frame. The gas path <NUM> may be attached to the rear surface <NUM> of the frame <NUM> or may be integrally formed with the rear surface <NUM> of the frame <NUM>. For example, the frame <NUM> and the gas path <NUM> may be integrated to form a single component. In the illustrated embodiment, the gas path <NUM> is provided to the rear surface <NUM> of the frame <NUM> such that the frame <NUM> and the gas path <NUM> form a single component. Such an arrangement provides a frame <NUM> comprising a curved front surface <NUM> that is substantially smooth. By "smooth" it is meant that the curved surface is continuous and without indentations, raised areas or protrusions, for example without a protruding elbow.

Gas path <NUM> comprises a first collar <NUM> and a second collar <NUM>, each of the first and second collars <NUM>/<NUM> comprising a bore defining a central axis. Each of the collars are generally annular or oval in shape. The first collar <NUM> is oriented such that a central axis defined by the bore of the first collar <NUM> is orthogonal to the rear surface <NUM> of the frame <NUM>. In some embodiments, the central axis defined by the bore of the first collar <NUM> is oriented at <NUM> to <NUM> degrees to the rear surface <NUM> of the frame <NUM>. The second collar <NUM> is oriented such that a central axis defined by the bore of the second collar <NUM> is substantially parallel to the rear surface <NUM> of the frame <NUM>. The second collar is also oriented such that the central axis of its bore is orthogonal to the central axis defined by the bore of the first collar <NUM>, preferably at <NUM> to <NUM> degrees to the central axis defined by bore of the first collar <NUM>. Collars <NUM>/<NUM> are in fluid communication to form gas path <NUM>. A gas delivery conduit connects to second collar <NUM>, for supply of gas to mask interface <NUM>. The first collar <NUM> is configured to connect to the housing <NUM> so that the gas path <NUM> of the frame is in fluid communication with the housing. First collar <NUM> extends from rear surface <NUM> at a point equidistant between upper arms <NUM> and lower arms <NUM>. Each lower arm <NUM> extends from rear surface <NUM> adjacent gas path <NUM>, at, adjacent or spaced from collar <NUM>.

Frame <NUM> may comprise insert recesses <NUM> that house automatically adjusting headgear mechanisms and their associated components, as described herein. In various embodiments each insert recess <NUM> may be formed in the front surface <NUM> of frame <NUM>. For example, each insert recess <NUM> may house a control mechanism and associated filament of one automatically adjusting headgear mechanism. The control mechanism can include one or more lock mechanisms, for example, directional locks, as described herein. Insert recesses <NUM> comprise shelf <NUM>, mouth <NUM>, chamber <NUM>, and channel <NUM> that terminates at blind end <NUM>. Mouth <NUM> and chamber <NUM> are located at the distal ends of upper arms <NUM> and are at least partly defined by wall 772a. Chamber <NUM> may comprise an opening <NUM> along its lower edge. When assembled, the filament of an automatically adjusting headgear mechanism extends from a headgear strap or clip into insert recess <NUM> through mouth <NUM>. The filament passes through chamber <NUM> and an automatically adjusting headgear mechanism housed within chamber <NUM>, and terminates in channel <NUM>. In use, the filament can move longitudinally within insert recess <NUM>, with a free end of the filament able to move towards and away from blind end <NUM>, as dictated by the motion of the headgear and operation of the automatically adjusting headgear mechanism. Channels <NUM> provide locations to store the excess length of filaments that allow for headgear extension. In other words, channels <NUM> operate in a similar fashion to storage sleeves described herein and can store portions of the filaments untensioned or free ends of the filaments. These filament portions vary in length with adjustment of the length of headgear straps, and the excess length of filament, which is stored in the channels <NUM> increases as the length of headgear straps and/or headgear size is reduced. The channels <NUM> can also protect the filaments and help reduce jamming or snagging of the filaments during adjustment in use. The channels <NUM> extend within or internally through the frame <NUM>, along each side <NUM> of the frame <NUM>. Each insert recess <NUM> may extend along the side edge of the frame <NUM>. However, in other embodiments, the insert recess <NUM> may be spaced inwardly from the side edge. Each of the insert recesses <NUM> has a width that varies along the length of the insert recesses <NUM>. For example, there may be an inverse relationship between the width of the insert recess <NUM> and distance from the top edge <NUM> of the frame <NUM>. In other embodiments each of the insert recesses <NUM> may have a width that is substantially constant along the length of the insert recesses <NUM>. In <FIG>, channel <NUM> is flared to provide a first width where it joins chamber <NUM>, tapers to a second width at an intermediate point spaced from chamber <NUM>, and then remains of constant width from the intermediate point to blind end <NUM>. Insert recesses <NUM> have a generally U-shaped cross-section, with a flat bottom surface, but may alternatively be V-shaped or have a curved bottom surface.

Shelf <NUM> comprises a shelf, or ledge, or ridge extending along or surrounding at least a portion of each insert recess <NUM>, which may extend entirely along a longitudinal edge or both longitudinal edges of, or fully surround insert recess <NUM>. An insert <NUM> may be inserted into each insert recess <NUM>, as shown in <FIG>, engaging at least shelf <NUM> and providing a cover that forms an enclosed space within insert recess <NUM>. The configuration of insert recess <NUM> and insert <NUM> allows frame <NUM> to provide chamber <NUM> and channel <NUM> as an enclosed space. It would be technically challenging to manufacture chamber <NUM> and channel <NUM> as an enclosed space in frame <NUM> in a single shot moulding process. Insert <NUM> may be attached post manufacture by techniques known in the art, such as for example by interference fit, gluing, over-moulding, welding or otherwise attaching insert <NUM> to frame <NUM>, to or within shelf <NUM>. In some embodiments insert <NUM> may be attached permanently, for example by welding. In other embodiments insert <NUM> may be removably attached.

Referring to <FIG>, insert <NUM> may carry an automatically adjusting headgear mechanism <NUM> as described herein, with or without its associated filament, and orient the mechanism <NUM> and associated filament for operation within chamber <NUM>. Insert <NUM> comprises front surface <NUM>, rear surface <NUM>, optional over-moulding or strap material attachment feature <NUM>, filament passage <NUM>, alignment feature <NUM>, lower lip <NUM>, and inner lip <NUM>. The location of the housing of automatically adjusting headgear mechanism <NUM> in insert <NUM> is shown by a dotted box in <FIG>. The rear surface <NUM> faces the frame <NUM> and at least a portion of rear surface <NUM> engages shelf <NUM> such that the enclosed space is formed. The front surface <NUM> of the insert <NUM> faces away from the insert recess <NUM>. The front surface <NUM> of the insert <NUM> may be configured to follow the contours of the frame <NUM> to provide a substantially smooth front surface <NUM> of the frame <NUM> when the frame <NUM> and the insert <NUM> are assembled. When assembled, filament passage <NUM> aligns with mouth <NUM> of insert recess <NUM>.

The insert <NUM> has a shape, including a thickness, a length and a width substantially corresponding to the shape, including the depth, the length and/or the width of, and sufficient to cover insert recess <NUM> such that the enclosed space is formed. In some embodiments the shape including the thickness, length and width of insert <NUM>, particularly of front surface <NUM> and rear surface <NUM> will correspond to the shape and proportions, including the depth, width and length of shelf <NUM>.

As described above, rear surface <NUM> of insert <NUM> faces insert recess <NUM> and may be substantially smooth. Such an arrangement may provide for a smooth passage of the filament through the insert recess <NUM>. Rear surface <NUM> may comprise alignment feature <NUM> in a position and orientation such that when insert <NUM> is engaged with the frame <NUM> alignment feature <NUM> is positioned within chamber <NUM> and oriented to correctly orient automatically adjusting headgear mechanism <NUM> for operation. Lower lip <NUM> and inner lip <NUM> may extend from rear surface <NUM> and along with alignment feature <NUM> are configured to support and orient automatically adjusting headgear mechanism <NUM> when it is positioned within insert <NUM>. When insert <NUM> is in position on frame <NUM>, lower lip <NUM> is configured to close opening <NUM> of chamber <NUM> in insert recess <NUM>. Alignment feature <NUM> may comprise a protrusion, lug, or abutment, shaped to fit within a corresponding alignment feature in the housing of automatically adjusting headgear mechanism <NUM> comprising cavity <NUM>. A cavity <NUM> may be present on one or both sides of the housing of automatically adjusting headgear mechanism <NUM>, configured to engage corresponding alignment features both on rear surface <NUM> (alignment features <NUM>) and in chamber <NUM> (not shown). On rear surface <NUM>, alignment feature <NUM> is located adjacent lower lip <NUM> and spaced from filament passage <NUM> and inner lip <NUM>. In an alternative embodiment, the housing of automatically adjusting headgear mechanism <NUM> may be integral with the rear surface <NUM>. In such an embodiment alignment feature <NUM>, lower lip <NUM>, and inner lip <NUM> are omitted. In either embodiment, the housing of automatically adjusting headgear mechanism <NUM> may comprise cavity <NUM> to engage with a corresponding alignment feature (not shown) within chamber <NUM>.

Insert <NUM> comprises first end <NUM> and a second end <NUM>. First end <NUM> comprises optional over-moulding or strap material attachment feature <NUM> configured to attach to or be attached to components of a corresponding headgear, such as a polymeric side strap, a textile side strap, or a polymeric side strap with a textile cover, and filament passage <NUM> that allows a filament to pass through the insert and engage a corresponding headgear as described above. The width of the insert <NUM> may taper along its length to follow the curvature of shelf <NUM> and side edges <NUM> of the frame <NUM>. For example, as shown in the illustrated embodiment, the insert <NUM> may be wider at the first end <NUM> than the second end <NUM>.

<FIG>show an automatically adjusting headgear mechanism <NUM> that may be used with any embodiment described herein. Automatically adjusting headgear mechanism <NUM> comprises housing <NUM> that houses one or more lock members <NUM> that act as part of a locking mechanism for the automatically adjusting headgear mechanism <NUM>. Filament <NUM> extends through an aperture in lock member(s) <NUM> as shown. Lock members <NUM> may be the same (<FIG>) or different (<FIG>). When lock members <NUM> are in the position illustrated in solid lines with an axis of the lock member apertures aligned or more closely aligned with a longitudinal axis of the filament <NUM>, the filament <NUM> is able to move through the apertures of the lock members <NUM> with a relatively low amount of resistance in a direction from right to left in <FIG>, C, or D, or in a direction tending to reduce a circumference of the associated headgear or a length of a portion or strap of the headgear. This position of the lock members <NUM> can be referred to as a released or unlocked position of the lock members <NUM> or the automatically adjusting headgear mechanism <NUM>. In response to movement of the filament <NUM> in the opposite direction (left to right in <FIG>, C, or D or in a direction tending to increase the circumference of the associated headgear or length of a portion or strap of the headgear), the lock members <NUM> move with the filament <NUM> to or toward a position shown in dashed lines in which the resistance to movement is relative greater than the released position as a result of frictional contact between the lock members <NUM> and the filament <NUM>. This position of the lock members <NUM> can be referred to as a locked position of the lock members <NUM> or the automatically adjusting headgear mechanism <NUM>. Preferably, the resistance to movement of the filament <NUM> in the locked position is sufficient to resist blow-off forces created by the pressurized gas within the interface for a given therapy taking into account the overall arrangement of the headgear (e.g., the number of automatically adjusting headgear mechanisms <NUM> employed). Other variations of the illustrated automatically adjusting headgear mechanism <NUM> or other types of directional locks could also be employed. Examples of such locking mechanisms are shown and described in <CIT> and <CIT>.

<FIG> illustrate another embodiment of a mask assembly including a mask interface <NUM> and a headgear <NUM>. The headgear <NUM> includes a pair of side straps <NUM>, a top strap <NUM>, an upper rear strap <NUM>, and a lower rear section <NUM>. Each side strap <NUM> has an upper portion <NUM> and a lower portion <NUM> as described in greater detail herein. Each lower portion <NUM> is connected (e.g., permanently connected) and extends from one lateral side of the lower rear strap <NUM>. The top strap <NUM> can be adjustable or non-adjustable. The upper rear strap <NUM> can be rigid and/or non-adjustable. The lower rear section <NUM> can include one or more lower rear straps <NUM>. In the illustrated embodiment, the lower rear section <NUM> includes two lower rear straps <NUM>. The lower rear strap(s) <NUM> can be adjustable. For example, the lower rear strap(s) <NUM> can include an adjustment mechanism the same as or similar to that of the top strap <NUM> shown in, for example, <FIG>. Other adjustment mechanisms are also possible. <FIG> shows the lower rear straps <NUM> at their maximum length or size, and <FIG> shows the lower rear straps <NUM> at the minimum length or size.

The headgear <NUM> also includes two connectors <NUM> housing control mechanisms that are part of an automatically adjustable headgear mechanism as described herein. One connector <NUM> is positioned on each side of the user's head above the user's ear in use. The connectors <NUM> can be generally Y-shaped as shown. A first limb of each connector <NUM> is coupled to the upper portion <NUM> of one of the side straps <NUM>, a second limb is coupled to one end of the top strap <NUM>, and a third limb is coupled to one end of the upper rear strap <NUM>. A filament extends within each of the side straps <NUM>, through the respective connector <NUM> and associated control mechanism, and into, along, and/or parallel to the top strap <NUM>, e.g., in a filament storage sleeve <NUM> that may extend in, along, and/or parallel to the top strap <NUM>.

In the embodiment of <FIG>, the upper portion <NUM> and lower portion <NUM> of each side strap <NUM> forms a continuous strap having a braided element and a filament extending within the braided element. The mask interface <NUM>, e.g., the housing <NUM>, includes two passages or channels <NUM>, e.g., in the form of tubes in the illustrated embodiment, one on each side of the mask interface <NUM>. The passages <NUM> can be curved as shown. For example, the passages <NUM> can be outwardly and/or rearwardly-facing concave. In the illustrated embodiment, each passage or tube <NUM> has an upper and lower opening. The upper and lower openings are located towards the face contacting side of the interface. Each side strap <NUM> extends from one of the connectors <NUM>, forward across the user's face in use (e.g., across the cheek bone region), through one of the passages <NUM>, and back toward the back of the patient's neck to connect to the lower rear strap <NUM>. The upper portion <NUM> of each side strap <NUM> is or includes the portion of the side strap <NUM> between the connector <NUM> and the passage <NUM> (e.g., an upper end of the passage <NUM>). The lower portion <NUM> is or includes the portion of the side strap <NUM> between the passage <NUM> (e.g., a lower end of the passage <NUM>) and the lower rear strap <NUM>.

The side straps <NUM> can move relative to, e.g., slide through, the passages <NUM>. In other words, the passages <NUM> can slide along the side straps <NUM>. The relative sizes of the upper <NUM> and lower <NUM> portions can therefore be adjusted. This relative size adjustment can help allow the user to don the mask assembly in a comfortable manner. The passages <NUM> are designed and manufactured to have a low enough friction between the passage <NUM> and side strap <NUM> to allow the side strap <NUM> to slide within the passage <NUM>. For example, the radius of curvature of the passage <NUM> may affect the friction between the passage <NUM> and side strap <NUM>. The passages <NUM> are preferably free or reasonably free of sharp or rough edges or spots that could snag the side strap <NUM>, particularly when the braided element is stretch or extended during use. In use, the filaments pin or press the braided elements of the side straps <NUM> to the walls of the passages <NUM> due to tension forces of the headgear <NUM>. This creates a friction force that allows angular adjustments to be made to the mask interface <NUM> as the friction force can maintain the angle of the mask interface <NUM> relative to the headgear <NUM> and/or user's head.

A stop or blocking element, for example, in the form of a braid clip in the illustrated embodiment, <NUM> is attached, e.g., permanently attached, to the lower portion <NUM> of each side strap <NUM>. The blocking element s <NUM> are larger than the lower opening of the passages <NUM> in at least one dimension such that the blocking element <NUM> cannot pass into or through the passage <NUM>. The blocking element <NUM> therefore limits the degree or amount of relative movement between the side strap <NUM> and mask interface <NUM> and maintains a minimum length of the lower portion <NUM>, for example, during donning and/or doffing. The blocking element <NUM> can be attached to only the braided element such that the filament can still travel within the braided element unrestricted by the blocking element <NUM>. In some embodiments, a crimp is placed on the filaments, and the crimp cannot slide freely through the blocking element <NUM>. The crimp could therefore help maintain a minimum length of filament in the lower portion <NUM>, for example, during donning and/or doffing.

The lower rear strap <NUM> sits or rests on or against the back of the user's neck in use. The lower rear strap <NUM> is adjustable to allow for macro or larger scale adjustments of the headgear size. The automatic adjustment mechanisms, including the braided elements and filaments of the side straps <NUM> and the control mechanisms within the connectors <NUM>, allow for micro, finer, or smaller scale adjustments to the headgear size. The degree of adjustment allowed or accommodated by the automatic adjustment mechanisms is at least partially dependent on the amount of filament storage available in the headgear and the elasticity of the braided element.

The mask assembly can be adjusted to a "docked" position in which the connectors <NUM> are partially inserted into the passages, e.g., tubes, <NUM> for shipping and/or storage, as shown in <FIG>. The docked position advantageously secures at least part of the headgear assembly <NUM> to the mask interface <NUM> and/or provides some protection to the face contacting portion of the seal <NUM>. The docked position can provide a convenient starting position for donning the mask assembly more quickly and easily.

<FIG> illustrate a donning process of the mask assembly of <FIG>. In a first stage, shown in <FIG>, with the connectors <NUM> in the docked position such that the lower portions <NUM> of the side straps <NUM> are at their maximum length or size (and the upper portions <NUM> are at their minimum length or size), the mask assembly is placed around the user's neck (e.g., by pulling the mask assembly over the user's head) such that the lower rear section <NUM>, side straps <NUM>, and mask interface <NUM> form a loop around the user's neck. In this position, the mask interface can hang from the user's neck, e.g., with the seal <NUM> resting against the user's chest, in a "ready position. " Next, the user can grasp the upper rear strap <NUM> and pull the top strap <NUM> over and/or on top of the user's head, for example, similar to pulling on a baseball cap. During this stage, the connectors <NUM> are undocked from the passages, e.g., tubes, <NUM>, and some of the slack or length of the side straps <NUM> is removed from the lower portions <NUM> such that the upper portions <NUM> increase in length or size, so that the seal <NUM> can be positioned over the nose and/or mouth. The user can therefore place the mask assembly in the "ready position" and leave it in this ready position as long as desired, then continue with the donning process when ready for bed. The automatic headgear adjustment mechanisms can then allow for further adjustment. The lower rear section <NUM> and/or top strap <NUM> can be adjusted as needed. The lower rear section <NUM> and/or top strap <NUM> can allow for larger scale adjustments, and the automatic adjustment mechanisms can then allow for finer, smaller scale adjustments.

The automatic headgear adjustment mechanisms described herein advantageously allow for small and precise angular adjustment of the mask interface <NUM> relative to the headgear and the user's face in use simply by manually moving or adjusting the mask interface <NUM>, e.g., by wiggling the mask interface <NUM>. Movement of the mask interface <NUM> to a new position is maintained by the automatic headgear adjustment mechanisms described herein. For example, if a portion (e.g., the upper portion) of the mask interface <NUM> is moved toward the user's face, the corresponding portion or straps (e.g., the upper straps <NUM> are automatically adjusted (shortened) as a result of the biasing element(s) (elastic elements <NUM> or springs <NUM>) and the directional locks then maintain the portion or straps in the newly adjusted position. The user can therefore adjust the angle of the mask interface <NUM> and seal <NUM> relative to the face such that the headgear resultant force opposes or compensates for mask blow-off forces. For example, <FIG> illustrates a reference plane <NUM>, an angle <NUM> of the seal <NUM> relative to the reference plane <NUM>, the headgear resultant force vector <NUM>, and the mask blow-off force vector <NUM>. As shown, the headgear resultant force vector <NUM> and mask blow-off force vector <NUM> are equal and opposite, which results in a balanced fit with reduced, minimal, or no residual forces to optimize the fit of the mask. A balanced fit position can be a position or length (size) of the headgear at which the retention force of the headgear balances with the force induced by the therapy (e.g., blow-off force) and/or other forces (e.g., hose pull forces) attempting to elongate the headgear. In <FIG>, the mask blow-off force vector <NUM> has been shifted via the angular adjustment allowed by the automatic headgear adjustment mechanism. The angular adjustment advantageously allows the user to find a position of the mask that is comfortable and offers a balanced fit to reduce unnecessary headgear tension forces. The user advantageously has improved control over the vertical and horizonal axis forces, which allows for minor fine tuning to find the improved or optimized fit compared to a traditional four-point headgear with only traditional adjustment straps, each of which are difficult to precisely adjust in small increments. Furthermore, angular adjustments to the mask as a whole are accomplished by the combination of separate strap adjustments, which can be difficult for a user to determine which straps to adjust and by how much to achieve the desired angular adjustment. Without the availability of precise angular adjustment, the user typically increases the force of the seal <NUM> against the face to match the blow-off forces. Such excess forces can cause the seal <NUM> to feel unsettled.

Conditional language used herein, such as, among others, "can," "could," "might," "may," "e.g.," and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and/or states. Thus, such conditional language is not generally intended to imply that features, elements and/or states are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and/or states are included or are to be performed in any particular embodiment.

The term "plurality" refers to two or more of an item. Recitations of quantities, dimensions, sizes, formulations, parameters, shapes and other characteristics should be construed as if the term "about" or "approximately" precedes the quantity, dimension, size, formulation, parameter, shape or other characteristic. The terms "about" or "approximately" mean that quantities, dimensions, sizes, formulations, parameters, shapes and other characteristics need not be exact, but may be approximated and/or larger or smaller, as desired, reflecting acceptable tolerances, conversion factors, rounding off, measurement error and the like and other factors known to those of skill in the art. Recitations of quantities, dimensions, sizes, formulations, parameters, shapes and other characteristics should also be construed as if the term "substantially" precedes the quantity, dimension, size, formulation, parameter, shape or other characteristic. The term "substantially" means that the recited characteristic, parameter, or value need not be achieved exactly, but that deviations or variations, including for example, tolerances, measurement error, measurement accuracy limitations and other factors known to those of skill in the art, may occur in amounts that do not preclude the effect the characteristic was intended to provide.

Numerical data may be expressed or presented herein in a range format. It is to be understood that such a range format is used merely for convenience and brevity and thus should be interpreted flexibly to include not only the numerical values explicitly recited as the limits of the range, but also interpreted to include all of the individual numerical values or sub-ranges encompassed within that range as if each numerical value and sub-range is explicitly recited. As an illustration, a numerical range of "<NUM> to <NUM>" should be interpreted to include not only the explicitly recited values of about <NUM> to about <NUM>, but should also be interpreted to also include individual values and sub-ranges within the indicated range. Thus, included in this numerical range are individual values such as <NUM>, <NUM> and <NUM> and sub-ranges such as "<NUM> to <NUM>," "<NUM> to <NUM>" and "<NUM> to <NUM>," etc. This same principle applies to ranges reciting only one numerical value (e.g., "greater than <NUM>") and should apply regardless of the breadth of the range or the characteristics being described.

A plurality of items may be presented in a common list for convenience. Furthermore, where the terms "and" and "or" are used in conjunction with a list of items, they are to be interpreted broadly, in that any one or more of the listed items may be used alone or in combination with other listed items. The term "alternatively" refers to selection of one of two or more alternatives, and is not intended to limit the selection to only those listed alternatives or to only one of the listed alternatives at a time, unless the context clearly indicates otherwise.

Claim 1:
A headgear assembly (<NUM>) for a respiratory mask assembly, the headgear assembly (<NUM>) comprising:
two side straps (<NUM>), one of the two side straps (<NUM>) disposed on each side of a user's face in use, each of the side straps (<NUM>) comprising a single continuous strap having an upper portion (<NUM>) and a lower portion (<NUM>), each upper portion (<NUM>) connected to an upper section of the headgear assembly (<NUM>), and each lower portion (<NUM>) connected to a lower section of the headgear assembly (<NUM>);
a connector (<NUM>) housing a control mechanism of an automatically adjusting headgear mechanism coupled to one end of each of the side straps (<NUM>);
a filament extending through at least a portion of each of the side straps (<NUM>);
wherein each of the two side straps (<NUM>) is configured to extend through a passage (<NUM>) formed on a respective side of a mask interface (<NUM>) of the mask assembly; and
wherein each side strap (<NUM>) is configured to slide within its respective passage (<NUM>) to adjust relative lengths of the upper portion (<NUM>) and the lower portion (<NUM>).