Headgear assembly and interface assembly having headgear

Abstract

A headgear system and / or interface assembly including a headgear system is disclosed that in some configurations is configured to transition from an elasticized or "stretchy" behavior to a "non-elastic" behavior at least in response to normal or expected forces encountered during an intended therapy. In some configurations, the system automatically adjusts toward or to the proper size when fitted to a user's head. A headgear portion or assembly for use in conjunction with a respiratory device in some configurations is disclosed that is at least substantially non-elastic and three-dimensional in shape. The headgear portion or assembly can include a plastic core and a textile shell. The headgear or portions thereof can also have integrally molded labels, connectors, adjustment mechanisms, and / or clips.

Description

[0001] This application is a divisional application of application no. 201580049820.2, filed September 16, 2015, entitled "Headgear Assembly and Interface Assembly Having Headgear".

[0002] Any priority application is incorporated by reference

[0003] All applications claiming priority from a foreign or domestic priority application are incorporated herein by reference and constitute a part of the disclosure of this application.

[0004] BACKGROUND TECHNICAL FIELD

[0005] The present disclosure relates to headgear and interface assemblies for use in respiratory therapy. More particularly, the present disclosure relates to a substantially inelastic three-dimensional headgear, portions thereof, and a method for molding such headgear. Further applications of the molding method are also disclosed. BACKGROUND

[0006] Treating respiratory diseases or conditions by therapy, such as NIV, bi-level or CPAP therapy involves the delivery of pressurized air to the airway of a human via a conduit and a respiratory device (e.g. a mask or a cannula). Typically, a mask forms at least a substantial "seal" over or around the nose and / or mouth of the user, while a cannula provides no seal but provides a delivery pathway for supplemental respiratory gas delivery.

[0007] As a result of forming this "seal", the combination of the enclosed area of the respiratory device and the pressure within it creates a resultant force which seeks to push the respiratory device away from the face. To counteract this force, a headgear is typically used which comprises a series of straps which pass around the back and / or top of the user's head. Headgear like this is typically made from a compliant material, such as Breath-o-prene TM The use of such a material causes the headgear to have a relatively small structure when not being worn. This lack of structure can cause headgears like this to become entangled, which in turn can make it difficult for the user to put on the headgear and respiratory device.

[0008] The straps require some form of adjustment to take into account head size, which adjustment mechanism is typically provided via an adjustment loop between the mask body and the headgear. The adjustment loop can have hook and loop or similar fasteners which allow the end of the strap to pass through a mounting location on the mask or through a clip attached to the mask and then to attach to another section of the strap. This adjustment allows the headgear to be adjusted by positioning the end of the strap at a desired location on the other section of the strap to change the size of the adjustment loop.

[0009] These types of mechanisms are one solution for providing adjustment mechanisms for headgear and thus for interface assemblies. Such systems also require a reasonable level of user interaction and are therefore susceptible to misuse or misadjustment (e.g., over-tightening). Indeed, making minor adjustments to such systems is difficult and time consuming. Practical and not-so-practical solutions to this have been the subject of considerable development efforts from several organizations, which has resulted in a number of patents.

[0010] In addition, these conventional headgear are often configured to have some elasticity. This can cause the headgear to stretch over the user's head and exert a clamping force on the head, which can be uncomfortable. It is desirable to make headgear and respiratory devices that are easy to use and comfortable to wear, as this can improve user compliance with the therapy being provided. SUMMARY

[0011] The systems, methods, and devices described herein have innovative aspects, no single one of which is solely responsible for its desirable attributes. The following, presented by way of overview, summarizes some advantageous features.

[0012] The headgear system and / or interface assembly including the headgear system automatically adjusts to the correct size when fitted to the user's head and, once in use, transitions in nature from an elasticized "taut" strap / tie to a "non-elastic" strap / tie.

[0013] In some configurations, a headgear assembly for supporting a respiratory interface on a user includes a rear headgear portion configured to contact a rearward and / or superior portion of the user's head. The rear headgear portion includes a plastic core and a textile shell. The plastic core and the textile shell are formed as a unitary structure by applying molten plastic material into the textile shell. Each side of the rear headgear portion includes a mounting portion configured to be located forward of the user's ears in use. An interface connection device is provided to the mounting portion on each side of the headgear assembly. Each interface connection device is configured for direct or indirect coupling to the respiratory interface. Each interface connection device includes at least one length adjustment device. Each length adjustment device includes an elastic element, a core member, and a restraining device. The core member is associated with the elastic element and is fixed relative to one end of the elastic element. The core member passes through the restraining device. The restraining device is configured to selectively engage the core member to resist movement of the core member relative to the restraining device.

[0014] In some configurations, the rear headgear portion does not have a structure under the user's ears that inhibits removal of the rear headgear portion in an upward direction.

[0015] In some configurations, each of the interface connection devices comprises at least a first length adjustment device and a second length adjustment device.

[0016] In some configurations, a position of at least one of the first length adjustment device and the second length adjustment device on the mounting portion is adjustable.

[0017] In some configurations, each of the mounting portions comprises a plurality of mounting positions for the first length adjustment device and the second length adjustment device, wherein the mounting positions are integrally formed with the plastic core portion.

[0018] In some configurations, at least one connector is configured for connecting the interface connection devices to the breathing interface.

[0019] In some configurations, the at least one connector comprises at least one collection channel configured for receiving a portion of the core member.

[0020] In some configurations, the constraining devices are located on the rear headgear portion.

[0021] In some configurations, the rear headgear portion defines at least one collection channel configured for receiving a portion of the core member.

[0022] In some configurations, the at least one collection channel is defined by the plastic core portion or between the plastic core portion and the textile shell.

[0023] In some configurations, the constraining devices are located distally from the ends of the elastic elements.

[0024] In some configurations, a guide for a portion of the core member is provided between the ends of the elastic elements and the constraining devices.

[0025] In some configurations, the elastic elements comprise a non-elastic portion constraining the elastic elements to a maximum length.

[0026] In some configurations, a headgear assembly for supporting a respiratory interface on a user includes a rear headgear portion configured to contact a rearward and / or superior portion of a user's head. The rear headgear portion includes a plastic core and a textile shell. The plastic core and the textile shell are formed as a unitary structure by applying molten plastic material into the textile shell. An interface connection device is provided to each side of the headgear assembly. Each interface connection device is configured to couple directly or indirectly to the respiratory interface. Each interface connection device includes at least one length adjustment device. Each length adjustment device includes an elastic element, a core member, and a restraining device. The core member is associated with and fixed relative to one end of the elastic element. The core member passes through the restraining device. The restraining device is configured to selectively engage the core member to resist movement of the core member relative to the restraining device. The at least one restraining device is located on the rear headgear portion.

[0027] In some configurations, the rear headgear portion does not have a structure under the user's ears that inhibits removal of the rear headgear portion in an upward direction.

[0028] In some configurations, the rear headgear portion defines at least one collection channel configured to receive a portion of the core member.

[0029] In some configurations, the at least one collection channel is defined by the plastic core or between the plastic core and the textile shell.

[0030] In some configurations, the restraining device is located distally from the other end of the elastic element.

[0031] In some configurations, a guide for a portion of the core member is provided between the end of the elastic element and the restraining device.

[0032] In some configurations, the elastic element includes a non-elastic portion that restrains the elastic element to a maximum length.

[0033] The headgear system and / or interface assembly containing the headgear system automatically adjusts to the correct size when fitted to a user's head and once in use, transitions in nature from an elasticized "slack" strap / tie to a "non-elastic" strap / tie.

[0034] In some configurations, a headgear assembly for supporting a respiratory interface on a user includes a substantially inelastic rear portion, a substantially inelastic front portion, a first elastic side portion on a first side of the headgear assembly, and a second elastic side portion on a second side of the headgear assembly. At least one filament extends through or along the first elastic side portion and the second elastic side portion. The at least one filament is coupled to one of the inelastic rear portion and the inelastic front portion and at least one restraining device. The at least one filament passes through the at least one restraining device. The at least one restraining device is configured to selectively engage the at least one filament to resist movement of the at least one filament relative to the at least one restraining device.

[0035] In some configurations, the at least one restraining device is configured to provide a first resistance to movement or attempted movement of the at least one filament in a direction that allows the inelastic rear portion and the inelastic front portion to move away from each other.

[0036] In some configurations, the at least one restraining device is configured to provide a second resistance to movement or attempted movement of the at least one filament in a direction that allows the inelastic rear portion and the inelastic front portion to move toward each other, where the second resistance is less than the first resistance.

[0037] In some configurations, the inelastic front portion is rigid.

[0038] In some configurations, the inelastic front portion is configured to be connected to a respiratory interface.

[0039] In some configurations, the inelastic front portion defines at least one collection channel that accommodates a portion of the at least one filament.

[0040] In some configurations, each of the first elastic side portion and the second elastic side portion includes an end cap having an opening through which the at least one filament passes. The end cap can be overmolded onto the corresponding one of the first elastic side portion and the second elastic side portion. The end cap can be coupled to the inelastic front portion.

[0041] In some configurations, the inelastic rear portion, the inelastic front portion, the first elastic side portion, and the second elastic side portion define a closed loop periphery.

[0042] In some configurations, the at least one filament includes a first filament associated with the first elastic side portion and a second filament associated with the second elastic side portion. The at least one restraining device can include a first restraining device associated with the first elastic side portion and a second restraining device associated with the second elastic side portion.

[0043] In some configurations, the at least one collection channel includes a first collection channel that houses a portion of the first filament and a second collection channel that houses a portion of the second filament.

[0044] In some configurations, the constraining device includes a pair of locking jaws that define a space through which the filament passes. The locking jaws have a first relative position that engages the filament to provide a first resistance and a second relative position that provides a second resistance.

[0045] In some configurations, the interface includes a forehead support and the at least one collection channel is located on the forehead support.

[0046] In some configurations, the headgear includes an upper elastic side portion and a lower elastic side portion on each side, an upper filament and a lower filament, and an upper constraining device and a lower constraining device. In some such configurations, there are upper collection channels and lower collection channels on each side of the headgear. The upper and lower collection channels on each side of the headgear can be separate from each other.

[0047] In some configurations, the non-elastic front portion defines an opening configured to receive a portion of the respiratory interface, wherein the at least one collection channel includes a first collection channel and a second collection channel, wherein at least a portion of the first collection channel is located above the opening and at least a portion of the second collection channel is located below the opening.

[0048] In some configurations, the non-elastic front portion is configured to connect to a plurality of different interfaces.

[0049] In some configurations, the non-elastic front portion includes separate portions on each side of the headgear assembly.

[0050] In some configurations, a headgear assembly for supporting a respiratory interface on a user defines a perimeter around the head of the user. The headgear assembly can include a first portion having a fixed length along the perimeter and a second portion having a fixed length along the perimeter. At least one elastic portion has a length that is variable along the perimeter, wherein the at least one elastic portion has a first length and a second length that is greater than the first length. At least one filament is secured to one of the first portion and the second portion and extends through the at least one elastic portion and into at least one collection channel of the other of the first portion and the second portion. The at least one filament has a filament length that is greater than the second length of the at least one elastic portion. At least one constraining device is configured to selectively engage the at least one filament to resist movement of the at least one filament relative to the at least one constraining device. The at least one constraining device is located at an entrance to the at least one collection channel.

[0051] In some configurations, the first portion is an anterior portion of the headgear assembly.

[0052] In some configurations, the second portion is a posterior portion of the headgear assembly.

[0053] In some configurations, the first portion defines the at least one collection channel.

[0054] In some configurations, the at least one elastic portion is constrained to a maximum length.

[0055] In some configurations, the at least one elastic portion includes a non-elastic element that defines the maximum length.

[0056] In some configurations, the at least one elastic portion includes a first elastic portion and a second elastic portion, wherein each of the first and second elastic portions extends between the first portion and the second portion.

[0057] In some configurations, the at least one filament includes a first filament associated with the first elastic portion and a second filament associated with the second elastic portion. The at least one constraining device includes a first constraining device associated with the first elastic side portion and a second constraining device associated with the second elastic side portion.

[0058] In some configurations, the at least one collection channel includes a first collection channel that houses a portion of the first filament and a second collection channel that houses a portion of the second filament.

[0059] In some configurations, the constraining device includes a pair of locking jaws that define a space through which the filament passes. The locking jaws have a first relative position that engages the filament to provide a first level of resistance and a second relative position that provides a second level of resistance that is lower than the first level.

[0060] In some configurations, a directional lock includes a housing that defines an interior space, a first opening, and a second opening. Each of the first and second openings is in communication with the interior space. At least one locking element is pivotally coupled to the housing for rotation about a fixed pivot axis. The locking element has an aperture that is configured to receive a core element. The locking element is movable between a first position in which the aperture is aligned with the first and second openings and a second position in which the aperture is not aligned with the first and second openings.

[0061] In some configurations, the locking element is a locking washer.

[0062] In some configurations, at least one of the first and second openings is elongated in a direction perpendicular to the pivot axis, such that the at least one of the first and second openings can accommodate a core element passing through the aperture of the at least one locking element in both the first and second positions.

[0063] In some configurations, the at least one locking element comprises a first locking element and a second locking element.

[0064] In some configurations, the housing comprises an internal wall positioned between the first and second locking elements.

[0065] In some configurations, a headgear assembly for supporting a respiratory interface on a user comprises a rear headgear portion configured to contact a rearward and / or superior portion of a user's head. Each side of the rear headgear portion comprises a mounting portion configured to be positioned in front of a user's ear in use. The rear headgear portion has no structure passing under a user's ear that would inhibit removal of the rear headgear portion in an upward direction. An interface connection device is provided to the mounting portion on each side of the headgear assembly. Each interface connection device is configured to couple directly or indirectly to the respiratory interface. Each interface connection device comprises at least one length adjustment device. Each length adjustment device comprises an elastic element, a core member, and a restraining device. The core member is associated with the elastic element and is fixed relative to one end of the elastic element. The core member passes through the restraining device. The restraining device is configured to selectively engage the core member so as to resist movement of the core member relative to the restraining device.

[0066] In some configurations, each of the interface connection devices comprises at least a first length adjustment device and a second length adjustment device.

[0067] In some configurations, the first and second length adjustment devices are spaced apart from each other on the mounting portion.

[0068] In some configurations, a position of at least one of the first and second length adjustment devices on the mounting portion is adjustable.

[0069] In some configurations, at least one connector is configured to connect the interface connection devices to the respiratory interface.

[0070] In some configurations, the at least one connector comprises at least one collection channel configured to receive a portion of the core member.

[0071] In some configurations, a single connector is configured to connect both of the interface connection devices to the respiratory interface.

[0072] In some configurations, the connector defines an opening configured to receive a portion of the respiratory interface, wherein the at least one collection channel includes a first collection channel and a second collection channel, wherein at least a portion of the first collection channel is positioned above the opening and at least a portion of the second collection channel is positioned below the opening.

[0073] In some configurations, the connector is configured to connect to a plurality of different interfaces.

[0074] In some configurations, the at least one connector includes a connector positioned on each side of the headgear assembly.

[0075] In some configurations, the restraining device includes a pair of locking jaws defining a space through which the core member passes. The locking jaws have a first relative position in which they engage the core member to provide a first level of resistance and a second relative position in which they provide a second level of resistance lower than the first level.

[0076] In some configurations, a headgear assembly for supporting a respiratory interface on a user includes at least one inelastic portion and at least one elastic portion having a first end and a second end. At least one filament extends through or along the at least one elastic portion. The first end of the at least one elastic portion is fixed relative to the at least one inelastic portion and the at least one filament. The second end of the at least one elastic portion is movable relative to the at least one inelastic portion and the at least one filament. The headgear assembly further includes at least one restraining device. The at least one filament passes through the at least one restraining device. The at least one restraining device is configured to selectively engage the at least one filament to resist movement of the at least one filament relative to the at least one restraining device. The at least one restraining device is positioned away from each of the first end and the second end of the at least one elastic portion.

[0077] In some configurations, the inelastic portion is a rear headgear portion configured to contact a rear portion and / or an upper portion of the user's head in use, wherein the at least one restraining device is positioned on the rear headgear portion.

[0078] In some configurations, the rear headgear portion includes a top strap and the at least one restraining device is positioned on the top strap.

[0079] In some configurations, the headgear assembly is configured such that the at least one restraining device is positioned on a top of the user's head in use.

[0080] In some configurations, the rear headgear portion includes a rear strap and the at least one restraining device is positioned on the rear strap.

[0081] In some configurations, the headgear assembly is configured such that the at least one restraining device is located behind the user's ear in use.

[0082] In some configurations, a guide for the at least one filament is provided between the restraining device and one of the first and second end portions of the at least one resilient portion.

[0083] In some configurations, the restraining device comprises a pair of locking jaws defining a space through which the filament passes. The locking jaws have a first relative position in which they engage the filament to provide a first level of resistance and a second relative position in which they provide a second level of resistance lower than the first level.

[0084] In some configurations, the patient interface system comprises a body portion sized and shaped to surround the user's nose and / or mouth and be fitted to form at least a substantial seal with the user's face. A coupling allows the patient interface to be coupled to a gas delivery system. Because the headgear system provides the ability to transition from an elastic type of elongation behavior to a non-elongation type behavior, the headgear system allows the body portion to be positioned and held on the user's head when the interface system is in use.

[0085] In some configurations, the transition locking behavior is provided by a set of directional locking features.

[0086] In some configurations, the transition locking behavior is provided by a set of directional locking features located on a retention plane.

[0087] In some configurations, the transition locking behavior is provided by a set of directional locking features that achieve independent relative movement with respect to each other.

[0088] In some configurations, the transition locking behavior is provided by a set of directional locking features that have non-independent movement with respect to each other.

[0089] In some configurations, the interface system comprises a combination of independent and non-independent movement.

[0090] In some configurations, the transition locking behavior is provided by directional locking features located on the mask body.

[0091] In some configurations, the transition locking behavior is provided by directional locking features located on or in the headgear system.

[0092] In some configurations, a combination of directional locking features located on the mask body and directional locking features located on or in the headgear system are used.

[0093] In some configurations, the directional lock is positioned in a location proximate to a connection point with the headgear.

[0094] In some configurations, the directional lock is positioned in a location distal from the point of connection with the headgear.

[0095] In some configurations, the directional lock module contains mechanisms to enable user attachment / detachment between it and the mask body.

[0096] In some configurations, the directional lock module contains mechanisms to enable user attachment / detachment between it and the remaining portion of the headgear system.

[0097] In some configurations, the non-stretch behavior of the headgear system is such that there is less than 4mm of mask movement when the patient interface system is subjected to a variable pressure waveform.

[0098] In some configurations, the patient interface system includes a body portion sized and shaped to provide a gas delivery system into the nasal passages. A coupling allows the patient interface to be coupled to a gas delivery system. Because the headgear system provides the ability to transition from an elastic type elongation behavior to a non-elongation type behavior, the headgear system allows the body portion to be positioned and held on the user's head while the interface system is in use.

[0099] In some configurations, the patient interface system includes a body portion sized and shaped to surround the user's nose and / or mouth and fitted to form at least a substantial seal with the user's face. A coupling allows the patient interface to be coupled to a gas delivery system. Because the headgear system provides the ability to transition from an elastic type elongation behavior to a non-elongation type behavior, the headgear system allows the body portion to be positioned and held on the user's head while the interface system is in use.

[0100] In some configurations, the positional stability of the headgear system is achieved via two main portions: one passing over or under the occipital protuberance and the other passing loosely over the top of the head in a position over the crown of the head. The relative position of the two main portions is maintained because the material of the headgear maintains its shape.

[0101] In some configurations, the positional stability of the headgear system is achieved via two main portions: one passing over or under the occipital protuberance and the other passing loosely over the top of the head in a position over the crown of the head. The relative position of the two main portions is maintained by gusset or connecting members.

[0102] In some configurations, the non-stretch behavior of the body portion of the headgear is achieved by constructing the body portion from a single non-elastic material and variable cross-sectional geometry.

[0103] In some configurations, the non-stretch behavior of the body portion of the headgear is achieved by constructing the body portion from a single thermoplastic material and a variable cross-sectional geometry.

[0104] In some configurations, the non-stretch behavior of the body portion of the headgear is achieved by constructing the body portion from a single thermoset material and a variable cross-sectional geometry.

[0105] In some configurations, the non-stretch behavior of the body portion of the headgear is achieved by constructing the body portion from a single thermoplastic material and a variable cross-sectional geometry.

[0106] In some configurations, the non-stretch behavior of the body portion of the headgear is achieved by constructing the body portion from a single thermoset material and a variable cross-sectional geometry.

[0107] In some configurations, the non-stretch behavior of the body portion of the headgear is achieved by constructing the body portion from a single thermoplastic material and a variable cross-sectional geometry.

[0108] In some configurations, the non-stretch behavior of the body portion of the headgear is achieved by constructing the body portion from a single thermoplastic material and a variable cross-sectional geometry.

[0109] In some configurations, the non-stretch behavior of the body portion of the headgear is achieved by constructing the body portion from a single thermoset material and a variable cross-sectional geometry.

[0110] In some configurations, a headgear assembly for a respiratory interface includes a rear headgear portion, an interface coupling portion, and a length adjustment portion that adjusts a length of the headgear assembly or a perimeter length of the interface assembly when coupled to a respiratory interface. The headgear assembly exhibits an elastic force that tends to contract the headgear length or the perimeter length and a non-elastic locking force that tends to inhibit the headgear length or the perimeter length from elongating.

[0111] In some configurations, the headgear assembly includes at least one retention plane.

[0112] In some configurations, the headgear assembly includes two retention planes.

[0113] In some configurations, the retention planes converge in a direction moving from rearward to forward.

[0114] In some configurations, the retention planes converge in a direction moving from forward to rearward.

[0115] In some configurations, one of the retention planes is angled relative to the other retention plane.

[0116] In some configurations, the retention planes diverge from each other at the interface attachment locations.

[0117] In some configurations, the retention planes are generally parallel to each other.

[0118] In some configurations, the retention planes are generally horizontal.

[0119] In some configurations, the headgear assembly further comprises a manually adjustable length adjustment portion.

[0120] In some configurations, the interface coupling portion can be connected to multiple types of interfaces.

[0121] In some configurations, the length adjustment portion comprises at least a first portion and a second portion.

[0122] In some configurations, the first portion and the second portion are located on opposite sides of the headgear assembly.

[0123] In some configurations, the interface coupling portion extends between the first portion and the second portion.

[0124] In some configurations, the first portion and the second portion are located on the same side of the headgear assembly.

[0125] In some configurations, the interface coupling portion extends between the first portion and the second portion.

[0126] In some configurations, at least one core member forms a portion of the headgear length or the perimeter length and can be locked relative to another portion of the headgear assembly or interface assembly so as to inhibit elongation of the headgear length or the perimeter length.

[0127] In some configurations, the length of the core member is greater than the maximum extended length of the length adjustment portion.

[0128] In some configurations, the length of the rear headgear portion is greater than or equal to the length of the core member.

[0129] In some configurations, at least one core collector houses excess portions of the core that do not form a portion of the headgear length or the perimeter length at any particular headgear length or perimeter length.

[0130] In some configurations, the length of the core member is less than the length of the core collector combined and the maximum extended length of the length adjustment portion.

[0131] In some configurations, the length of the rear headgear portion and the length of the core collector are fixed and adjustment of the length of the length adjustment member provides length adjustment of substantially all of the headgear length or the perimeter length.

[0132] In some configurations, a nasal cannula system includes a nasal cannula and a headgear. At least one adjustment device allows adjustment of a perimeter length of the nasal cannula system. The at least one adjustment device includes a core member coupled to one of the headgear and the nasal cannula and a lock coupled to the other of the headgear and the nasal cannula. The lock can engage the core member to maintain the nasal cannula system at a desired adjusted perimeter length.

[0133] In some configurations, the lock can maintain the desired adjusted perimeter length in response to normal or expected forces in use, such as, for example, the weight of the nasal cannula and hose pull.

[0134] In some configurations, the lock allows the core member to slide at forces above a threshold, such that the perimeter length can increase beyond the desired adjusted perimeter length.

[0135] In some configurations, the lock is a directional lock and allows the core member to move in a direction that decreases the perimeter length at a relatively low force, the force being less than normal or expected forces in use.

[0136] In some configurations, the directional lock has any of the structures or arrangements disclosed herein.

[0137] In some configurations, at least one biasing element applies a force to the nasal cannula system that tends to decrease the perimeter length.

[0138] In some configurations, the biasing element allows the nasal cannula system to be self-fitting or automatically adjustable.

[0139] In some configurations, the nasal cannula system includes at least one quick release device that allows the perimeter loop to be quickly and easily disconnected, such as to remove the nasal cannula system from a user or to apply it to a user.

[0140] In some configurations, the headgear is a single strap or a bifurcated strap device.

[0141] In some configurations, the nasal cannula includes a body having a rigid frame portion and a softer user-contacting portion.

[0142] In some configurations, an excess portion of the at least one core member that does not effectively define a portion of the perimeter length is housed in the nasal cannula or the headgear. In some such configurations, the excess portion is internal to the nasal cannula or the headgear. In some such configurations, the excess portion is housed in a circular accumulator.

[0143] In some configurations, multiple adjustment devices are provided. In some such configurations, an adjustment device is provided on each side of the nasal cannula system. In some such configurations, the excess portions of the core members on each side are positioned one above the other over or within the nasal cannula.

[0144] In some configurations, a nasal cannula system includes a nasal cannula and a headgear. At least one adjustment device allows adjustment of a perimeter length of the nasal cannula system. The at least one adjustment device includes a core member coupled to one portion of the headgear and a lock coupled to another portion of the headgear, the other portion being movable relative to the first portion. The lock can engage the core member to hold the nasal cannula system at a desired adjusted perimeter length.

[0145] In some configurations, the lock can hold the desired adjusted perimeter length in response to normal or expected forces in use, such as, for example, the weight of the nasal cannula and hose pull.

[0146] In some configurations, the lock allows the core member to slide at forces above a threshold, such that the perimeter length can increase beyond the desired adjusted perimeter length.

[0147] In some configurations, the lock is a directional lock and allows the core member to move in a direction that decreases the perimeter length at a relatively low force, the force being less than normal or expected forces in use.

[0148] In some configurations, the directional lock has any of the structures or arrangements disclosed herein.

[0149] In some configurations, at least one biasing element applies a force to the nasal cannula system that tends to decrease the perimeter length.

[0150] In some configurations, the biasing element allows the nasal cannula system to be self-fitting or automatically adjustable.

[0151] In some configurations, the nasal cannula system includes at least one quick release device that allows the perimeter loop to be quickly and easily disconnected, such as to remove the nasal cannula system from a user or to apply it to a user.

[0152] In some configurations, the headgear is a single strap or a bifurcated strap device.

[0153] In some configurations, the nasal cannula includes a body having a rigid frame portion and a softer portion that contacts a user.

[0154] In some configurations, an excess portion of the at least one core member that does not effectively define a portion of the perimeter length is housed in the headgear. In some such configurations, the excess portion is internal to the headgear. In some such configurations, the excess portion is housed in a circular accumulator.

[0155] In some configurations, a plurality of adjustment devices are provided. In some such configurations, an adjustment device is provided on each side of the nasal cannula system.

[0156] In some configurations, the directional lock includes a locking member having an aperture or opening and is configured to engage a core member or filament therethrough. The opening can change the cross-sectional dimension between one side of the locking member and the other side of the locking member and / or the profile of the opening can be tapered.

[0157] In some configurations, the side of the opening that defines the working edge of the locking member engaging the core member in the locked position is less than the opposite side of the opening.

[0158] In some configurations, the profile of the opening tapers toward the pivot axis of the locking member.

[0159] In some configurations, the directional lock includes a first locking member and a second locking member each having an aperture or opening and configured to engage a core member or filament therethrough. A motion transfer element causes the second locking member to move in response to movement of the first locking member.

[0160] In some configurations, the motion transfer element pushes the second locking member in response to movement of the first locking member but allows the second locking member to move away from the first locking member.

[0161] In some configurations, the motion transfer element is a link that flexes to allow the second locking member to move away from the first locking member.

[0162] According to at least one of the embodiments disclosed herein, a headgear is provided that includes a top strap, a back strap, a front strap, a yoke, and a connector. The headgear is configured to be substantially inelastic and structurally three-dimensional.

[0163] According to another aspect, the headgear is constructed of a composite material, wherein a textile shell is integrally molded around a plastic core.

[0164] According to another aspect, the headgear includes integrally molded labels, connectors, and / or adjustment features.

[0165] According to another aspect, the headgear component includes a clip molded onto a textile strap.

[0166] According to another aspect, the textile shell includes a first portion covering an inner-facing surface of the headgear.

[0167] According to another aspect, the textile shell includes a second portion covering an outer-facing surface of the headgear.

[0168] According to another aspect, the first portion and the second portion of the textile shell meet at a first edge and a second edge.

[0169] According to another aspect, the first portion and the second portion are not connected to each other at the first edge and the second edge.

[0170] According to another aspect, the textile shell includes one or more locator hole configured to engage a locator pin of a molding tool.

[0171] According to another aspect, the headgear includes at least one flexible joint that allows the strap to bend.

[0172] According to another aspect, the at least one flexible joint includes a gap between portions of a plastic core, and wherein the textile shell extends within the gap to connect the portions of the plastic core.

[0173] According to another aspect, the headgear includes at least one bridge portion extending between the portions of the plastic core within the flexible joint.

[0174] According to another aspect, the at least one bridge portion is integrally formed with the portions of the plastic core.

[0175] According to another aspect, the headgear assembly includes a top strap, a rear strap connected to the top strap at an upper connection point located on one side of a user's forehead, and a lower side strap connected to the top strap and the rear strap at the upper connection point. The headgear assembly further includes a first length adjustment portion that adjusts a distance between the upper connection point and a frame of a breathing interface, and a second length adjustment portion connected to the lower side strap at a lower connection point located in front of a user's ear and approximately in line with the user's mouth, wherein the second adjustment mechanism adjusts a distance between the lower connection point and the frame of the breathing interface.

[0176] According to another aspect, the top strap and the rear strap are integrally formed as a unitary structure.

[0177] According to another aspect, the top strap, the rear strap, and the lower side strap are integrally formed as a unitary structure.

[0178] According to another aspect, the first length adjustment portion includes a fabric strap having a hook-and-loop fastener mechanism.

[0179] According to another aspect, the second length adjustment portion includes a plurality of length adjustment mechanisms.

[0180] According to another aspect, the headgear assembly includes a top strap and a rear strap connected to the top strap at an upper connection point on a side of a user's forehead. The headgear assembly also includes an upper side strap connected to the top strap and the rear strap at the upper connection point and to a frame of the respiratory interface. The upper side strap extends between a user's ear and eye and across a user's cheek toward the frame of the respiratory interface. The headgear assembly further includes a lower side strap connected to the rear strap at a rear connection point behind a user's ear. The lower side strap extends below a user's ear and across a user's cheek toward the frame of the respiratory interface. The headgear assembly additionally includes a first length adjustment portion connected to the lower side strap and the frame of the respiratory interface. The first length adjustment portion adjusts a distance between the lower side strap and the frame of the respiratory interface.

[0181] According to another aspect, the top strap and the rear strap are integrally formed as a unitary structure.

[0182] According to another aspect, the top strap, the rear strap, the upper side strap, and the lower side strap are integrally formed as a unitary structure.

[0183] According to another aspect, the first length adjustment portion includes a one-way adjustment mechanism.

[0184] According to another aspect, the headgear assembly further includes a second length adjustment portion connected between the upper side strap and the frame of the respiratory interface, wherein the second length adjustment portion adjusts a distance between the upper side strap and the frame of the respiratory interface.

[0185] According to another aspect, the headgear assembly includes a top strap, a rear strap connected to the top strap at an upper connection point on a side of a user's forehead, and a front strap connected to the top strap and the rear strap at the upper connection point and to the respiratory interface. The front strap extends between a user's ear and eye and toward a bottom of a user's nose.

[0186] According to another aspect, the top strap and the rear strap are integrally formed as a unitary structure.

[0187] According to another aspect, the top strap, the rear strap, and the front strap are integrally formed as a unitary structure.

[0188] According to another aspect, the front strap extends across a front of the respiratory interface and forms a portion of a frame of the respiratory interface.

[0189] According to another aspect, the headgear assembly further includes a length adjustment portion connected between the front strap and the breathing interface, wherein the length adjustment portion adjusts a distance between the front strap and the breathing interface.

[0190] According to another aspect, the headgear assembly includes a top strap, a rear strap connected to the top strap at an upper connection point located on one side of a user's forehead, and a lower side strap connected to the top strap and the rear strap at the upper connection point and extending away from the upper connection point in a substantially vertical direction. The lower strap is positioned in front of a user's ear. The headgear assembly further includes a first length adjustment portion connected to the lower strap at a first lower connection point, the first length adjustment portion adjusting a distance between the first lower connection point and a frame of the breathing interface. The first lower connection point is positioned in line with a user's eye, and the first length adjustment portion extends just below the eye, across a user's cheek. The headgear assembly further includes a second length adjustment portion connected to the lower strap at a second lower connection point, the second length adjustment portion adjusting a distance between the second lower connection point and the frame of the breathing interface. The second lower connection point is positioned approximately in line with a user's nose bottom, and the second length adjustment portion extends substantially horizontally across a user's cheek.

[0191] According to another aspect, the top strap and the rear strap are integrally formed as a unitary structure.

[0192] According to another aspect, the top strap, the rear strap, and the lower side strap are integrally formed as a unitary structure.

[0193] According to another aspect, at least one of the first length adjustment portion or the second length adjustment portion includes a one-way adjustment mechanism.

[0194] According to at least one of the embodiments disclosed herein, a headgear includes a plastic core and a textile shell. The plastic core and the textile shell are integrally formed by applying a molten plastic material to the textile shell.

[0195] According to another aspect, the textile shell includes a first portion covering an inward-facing surface of the headgear.

[0196] According to another aspect, the textile shell includes a second portion covering an outward-facing surface of the headgear.

[0197] According to another aspect, the first portion and the second portion of the textile shell meet at first and second edges.

[0198] According to another aspect, the first portion and the second portion are not connected to each other at the first and second edges.

[0199] According to another aspect, the textile shell includes one or more locator hole configured to engage a locator pin of a molding tool.

[0200] According to another aspect, the headgear includes at least one flexible joint that allows the strap to bend.

[0201] According to another aspect, the at least one flexible joint includes a gap between portions of the plastic core, and wherein the textile shell extends within the gap to connect the portions of the plastic core.

[0202] According to another aspect, the headgear includes at least one bridge portion extending within the flexible joint between the portions of the plastic core.

[0203] According to another aspect, the at least one bridge portion is integrally formed with the portions of the plastic core.

[0204] According to at least one of the embodiments disclosed herein, a method of making a headgear includes: placing a textile shell within a molding tool; introducing a molten plastic material into the molding tool and into contact with the textile shell; and allowing the molten plastic material to solidify on the textile shell to form a plastic core.

[0205] According to another aspect, placing the textile shell into the molding tool includes placing a first textile portion and a second textile portion into the molding tool, and introducing the molten plastic material into the molding tool includes introducing the molten plastic material between the first textile portion and the second textile portion.

[0206] According to another aspect, the method further includes: holding an end of each of the first textile portion and the second textile portion within a holding feature of the molding tool at which the molten plastic material is introduced.

[0207] According to another aspect, the method further includes: capturing at least one edge of the textile shell between a first separable portion and a second separable portion of a molding tool.

[0208] According to another aspect, the method further includes: engaging an opening of the textile shell with a locator pin of the molding tool.

[0209] According to another aspect, the method further includes: securing the textile shell within the molding tool prior to introducing the molten plastic material.

[0210] According to another aspect, securing the textile shell includes securing the textile shell by one or more of: an electrostatic charge; air pressure; holding the textile shell with another component inserted into the molding tool; or supporting a strip of material forming the textile shell that extends through the molding tool on each side of the molding tool.

[0211] According to another aspect, supporting the strip of material includes supporting one end on a roller and fixing the free end relative to the molding tool.

[0212] According to another aspect, the method further includes forming a flexible joint by providing a gap in the plastic core along the length of the headgear and extending the textile shell along the gap.

[0213] According to another aspect, the method further includes extending a flexible bridge portion of plastic material from a portion of the plastic core on one side of the gap to a portion of the plastic core on an opposite side of the gap through the flexible joint.

[0214] According to at least one embodiment disclosed herein, the headgear includes a first strap and a second strap, wherein the first strap and the second strap cooperate to form at least one of a top strap, a rear strap, and a front strap of the headgear.

[0215] According to at least one of the embodiments disclosed herein, a method of making a headgear includes placing a textile shell within a molding tool; introducing molten plastic material into the molding tool and into contact with an inside of the textile shell; and allowing the molten plastic material to solidify in the textile shell to form a plastic core.

[0216] According to another aspect, the first strap and the second strap cooperate to form a rear strap, wherein within the rear strap, the first strap and the second strap overlap one another, and wherein only one of the first strap and the second strap defines a top strap.

[0217] According to another aspect, the first strap and the second strap cooperate to form a front strap, wherein within the front strap, the first strap and the second strap stack up, and wherein the first strap and the second strap individually define a corresponding one of a top strap and a rear strap.

[0218] According to another aspect, one or both of the straps are constructed of a plastic core and a textile shell formed as a unitary structure by applying molten plastic material to the textile shell.

[0219] According to at least one embodiment disclosed herein, a headgear includes an inner core; a first outer layer defining an inner surface of the headgear that faces a user in use; and a second outer layer defining an outer surface of the headgear that faces away from the user in use. The first and second layers have different colors, textures, or other indicia that allow the inner and outer surfaces to be distinguished tactilely or visually.

[0220] According to another aspect, the first outer layer or the second outer layer comprises one of polyurethane (leatherette), patterned polyester, wool with mesh knit, full loop, nylon, spacer fabric and full loop composite, or foam and full loop composite.

[0221] According to another aspect, an edge of one or both of the first outer layer and the second outer layer extends beyond the inner core.

[0222] According to another aspect, the inner core includes an internal cutout.

[0223] According to at least one embodiment disclosed herein, a headgear includes a first strap, a second strap, and a connector coupling the first strap to the second strap, wherein the connector is formed by overmolding onto the first strap and the second strap.

[0224] According to another aspect, the first strap and the second strap are stacked in a vertical direction within the connector.

[0225] According to another aspect, the connector includes a portion extending between and separating the first strap and the second strap.

[0226] According to another aspect, the connector includes a front strap portion and a rear strap portion separated by a bridge portion, wherein the bridge portion does not surround all of both the first strap and the second strap.

[0227] According to another aspect, the connector includes a front strap portion and a rear gusset.

[0228] According to another aspect, the front strap portion and the rear gusset are separated by a bridge portion, wherein the bridge portion does not surround all of both the first strap and the second strap.

[0229] According to at least one embodiment disclosed herein, a strap of a headgear includes an inner core, at least one outer layer at least partially surrounding the inner core, and at least one air gap within the outer layer.

[0230] According to another aspect, the at least one air gap includes a first air gap at one lateral edge of the strap and a second air gap at an opposite lateral edge of the strap.

[0231] According to another aspect, a portion of the inner core is exposed.

[0232] According to another aspect, a conduit is positioned within the air gap.

[0233] According to another aspect, the air gap is defined by the inner core.

[0234] According to at least one embodiment disclosed herein, a strap of a headgear includes an inner core, at least one outer layer, and at least one conduit extending longitudinally along the strap and within the outer layer.

[0235] According to another aspect, the conduit is at least partially received within a recess of the inner core.

[0236] According to another aspect, the conduit is completely encapsulated within the inner core.

[0237] According to another aspect, the at least one conduit includes a first conduit and a second conduit.

[0238] According to another aspect, the at least one conduit is defined by the core.

[0239] According to at least one embodiment disclosed herein, a strap of a headgear includes an inner core, at least one outer layer, and at least one reinforcing member.

[0240] According to another aspect, the reinforcing member is embedded within the core.

[0241] According to another aspect, the reinforcing member is configured to keep opposing outer layers or opposite sides of an outer layer apart from each other prior to forming the inner core.

[0242] According to at least one embodiment disclosed herein, a strap of a headgear includes an inner core, at least one outer layer, and at least one cushioning layer.

[0243] According to another aspect, the cushioning layer surrounds the inner core.

[0244] According to another aspect, a portion of the cushioning layer is exposed.

[0245] According to at least one embodiment disclosed herein, a strap of a headgear includes an inner core and an outer layer at least partially surrounding the inner core, the outer layer including edges. The edges are embedded within the inner core.

[0246] According to another aspect, the outer layer includes more than one piece or more than two pieces.

[0247] According to another aspect, a first piece of the outer layer is located on one side of the strap and a second piece of the outer layer is located on an opposite side of the strap.

[0248] According to another aspect, a third piece of the outer layer is located on one edge of the strap and a fourth piece of the outer layer is located on an opposite edge of the strap.

[0249] According to another aspect, at least two pieces of the outer layer are located on one side of the strap.

[0250] According to at least one embodiment disclosed herein, a strap of a headgear includes an inner core and an outer layer, wherein the outer layer is textured.

[0251] According to another aspect, the outer layer is ribbed or fluffed.

[0252] According to another aspect, the core is textured such that it imparts texture to the outer layer.

[0253] According to at least one embodiment disclosed herein, a headgear, strap or other portion of a headgear has one or more features as described herein or is made by a method described herein. BRIEF DESCRIPTION OF DRAWINGS

[0254] Preferred embodiments of the present application will be described with reference to the accompanying drawings.

[0255] Figure 1 is a graph showing the operating envelope representing the relationship between the forces developed when the mask enclosed area is pressurized and the range of headgear sizes of potential patients;

[0256] Figure 2 shows the operating envelope of Figure 1 superimposed with the force curve of the elasticized headgear system;

[0257] Figure 3 shows the operating envelope of Figure 1 superimposed with the force curve of the exemplary embodiment;

[0258] Figure 4 is a graph of the force-deflection curve of an exemplary headgear device;

[0259] Figure 4.1 shows the position of an exemplary headgear device at the beginning of donning onto a user;

[0260] Figure 4.2 shows the position of an exemplary headgear device at the beginning of retraction;

[0261] Figure 4.3 shows the position of an exemplary headgear device at the end of donning;

[0262] Figure 5 is a graph including an exemplary "composite" force-deflection curve;

[0263] Figure 6 is a force-area graph for maintaining the interface in sealing contact;

[0264] Figure 7 is a three-dimensional graph of the relationship between headgear force, projected sealing area, and head circumference;

[0265] Figure 8A shows the force distribution and elongation distribution for constant pressure therapy for elastic and inelastic headgear systems;

[0266] Figure 8B Force distribution and elongation distribution of variable pressure therapy is shown for elastic and non-elastic headgear systems;

[0267] Figure 9 is a side view of a nasal interface with a single retention plane;

[0268] Figure 10 is a side view of a nasal interface with two retention planes;

[0269] Figure 11 is a side view of a full face mask with two retention planes;

[0270] Figure 12 is a side view of a nasal mask with two retention planes;

[0271] Figure 13 is a side view of a mask with two retention planes converging to a single point;

[0272] Figure 13.1 is a stability chart for different headgear types;

[0273] Figure 13.2 a single retention plane interface assembly is shown;

[0274] Figure 14 is a side view of a full face mask with a forehead support having directional lock mechanism locations positioned at the connection between the headgear and the mask;

[0275] Figure 15 is a side view of a full face mask with a forehead support having directional lock mechanism locations positioned within the headgear;

[0276] Figure 16 is a side view of a nasal mask with directional lock mechanisms located on flat straps;

[0277] Figure 17 is a side view of a nasal mask with directional lock mechanisms having a flexible core design;

[0278] Figure 18 a module of an interface assembly configured to extend between a mask or other interface and a rear portion of a headgear containing directional lock devices is shown;

[0279] Figure 19 an alternative module of an interface assembly configured to extend between a mask or other interface and a rear portion of a headgear containing directional lock devices spaced from biasing devices is shown;

[0280] Figure 20 is a side view of an exemplary interface assembly;

[0281] Figure 21 is a side view of an example full-face mask;

[0282] Figure 22 is a side view of an example nasal pillow mask;

[0283] Figure 23 is a rear perspective view of an example headgear assembly positioned on a user;

[0284] Figure 24 is a rear perspective view of an example headgear assembly in Figure 23

[0285] Figure 25 is a rear perspective view of an example headgear assembly positioned on a user;

[0286] Figure 26 is a cross-sectional view of an example headgear assembly along line 26-26 in Figure 25

[0287] Figure 27 is a cross-sectional view of an example headgear assembly along line 27-27 in Figure 25

[0288] Figure 28 is a cross-sectional view of an example headgear assembly along line 28-28 in Figure 25

[0289] Figure 29 is a rear perspective view of an example headgear assembly illustrating portions of the example headgear constructed of different material types;

[0290] Figure 30 illustrates a position in which an automatic adjuster can be positioned within an example headgear assembly;

[0291] Figure 31 illustrates a position in which an automatic adjuster can be positioned within an example headgear assembly worn by a user;

[0292] Figure 32 illustrates an example strap adjustment mechanism in an assembled form;

[0293] Figure 33 is a plan view of an example strap adjustment mechanism in Figure 32 separated into a first portion and a second portion;

[0294] Figure 34 is a perspective view of the second portion of an example strap adjustment mechanism in Figure 32

[0295] Figure 35 is a cross-sectional view of an orientation lock in a locked position and a released position;​​​​​

[0296] Figure 36 Operation cycle of a headgear incorporating directional locks is demonstrated;

[0297] Figure 37 Perspective view of an exemplary headgear assembly incorporating one or more directional locks;

[0298] Figure 38 Perspective view of an exemplary headgear assembly incorporating one or more directional locks;

[0299] Figure 39 Side view of an attachment member attached to the rear portion of an exemplary headgear assembly in Figure 38

[0300] Figure 40 Perspective view of an exemplary interface assembly;

[0301] Figure 41 Left side perspective view of an exemplary interface assembly attached to an interface coupling portion;

[0302] Figure 42 Side view of an exemplary interface assembly;

[0303] Figure 43 Perspective view of a frame element of an interface member attached to an interface coupling portion;

[0304] Figure 44 Front view of a frame element of an interface member and an interface coupling portion;

[0305] Figure 45 Front view of a frame element of an interface member attached to an interface coupling portion;

[0306] Figure 46 Right side perspective view of an exemplary interface assembly attached to an interface coupling portion;

[0307] Figure 47 Top perspective view of an exemplary interface assembly attached to a second piece of an interface coupling portion;

[0308] Figure 48 Top perspective view of a first piece of an interface coupling portion;

[0309] Figure 49 Top perspective view of a second piece of an interface coupling portion;

[0310] Figure 50 Right side perspective view of an exemplary interface assembly;

[0311] Figure 51 Exploded view of an exemplary interface assembly; ​

[0312] Figure 52 is an exploded view of an exemplary interface coupling portion;

[0313] Figure 53 is an inverted exploded view of an exemplary interface coupling portion;

[0314] Figure 54 is a top view of an exemplary collapsible headgear assembly;

[0315] Figure 55 is a rear view of an exemplary collapsible headgear assembly;

[0316] Figure 56 is a side view of an exemplary collapsible headgear assembly;

[0317] Figure 57 illustrates an exemplary headgear assembly coupled to a full face mask type interface;

[0318] Figure 57 illustrates an exemplary headgear assembly coupled to a nasal mask in Figure 59

[0319] illustrates an exemplary headgear assembly coupled to a nasal pillow / prong mask in Figure 57 Figure 60 illustrates an exemplary headgear and interface assembly with a T-piece;

[0320] Figure 61 illustrates an exemplary headgear and interface assembly without a T-piece;

[0321] Figure 62 illustrates an exemplary headgear and interface assembly with an interface coupling portion removably attached to the interface;

[0322] Figure 63 illustrates a first position when donning an exemplary interface assembly of

[0323] Figure 62 Figure 64 illustrates a second position when donning an exemplary interface assembly of

[0324] Figure 62 illustrates a third position when donning an exemplary interface assembly of Figure 65

[0325] illustrates a third position when donning an exemplary interface assembly of Figure 62 Figure 66 illustrates a perimeter of an adjustable interface assembly or headgear assembly at a minimum length;

[0326] Figure 67

[0327] Figure 68A ​​​​The perimeter of the adjustable interface assembly or headgear assembly at maximum length is shown;

[0328] Figure 68B is a cross-sectional view of the directional lock in the locked position;

[0329] Figure 68A is a perspective cross-section of the directional lock in the locked position; Figure 68C

[0330] Figure 68A is a cross-sectional view of the directional lock in the unlocked position; Figure 68D

[0331] Figure 68A is a perspective cross-section of the directional lock in the unlocked position; Figure 69A

[0332] Figure 69B is a view of the first assembly step for attaching a locking grommet to the shell of an example directional lock;

[0333] Figure 69A is a view of the second assembly step for attaching a locking grommet to the shell of an example directional lock of Figure 70A ;

[0334] Figure 70B is a view of the first assembly step for attaching a locking grommet to the shells of a plurality of example directional locks;

[0335] Figure 70A is a view of the second assembly step for attaching a locking grommet to the shells of a plurality of example directional locks of Figure 71 ;

[0336] Figure 72 is a view of an assembly step for attaching a locking grommet to the shell of an example directional lock;

[0337] Figure 73 is a view of an assembly step for attaching a locking grommet to the shell of an example directional lock;

[0338] Figure 74 is a side view of an example full-face mask without a forehead support;

[0339] Figure 75 is a side view of another example full-face mask without a forehead support;

[0340] Figure 76 is a side view of an example nasal mask;

[0341] Figure 77 is an example headgear system with a headgear rear portion and two retention planes;​​​

[0342] Figure 78 is a front perspective view of another exemplary headgear;

[0343] Figure 77 is a front view of an exemplary headgear system in Figure 79

[0344] Figure 77 is a rear perspective view of an exemplary headgear system in Figure 80

[0345] Figure 77 is a front view of an exemplary headgear system in Figure 81

[0346] Figure 82 is a front perspective view of an exemplary cushion module and frame assembly;

[0347] Figure 83 is a front perspective view of a frame assembly connected to a shell of a headgear system;

[0348] Figure 84 is a rear view of a frame assembly connected to a shell of a headgear system;

[0349] Figure 85 is a rear view of a frame assembly removed from a shell of a headgear;

[0350] Figure 86 illustrates a verification test of the functionality of a headgear device including at least one directional locking module;

[0351] Figure 87 is a graph illustrating the relationship between force versus elongation of a tested exemplary headgear device; and

[0352] Figure 88 is a force-elongation graph illustrating force fluctuations during elongation after a transformation.

[0353] Figure 89A-89C is a perspective view of a respiratory cannula incorporating a headgear device of the present disclosure, which can include at least one directional lock device.

[0354] Figure 90 is a perspective view of a further respiratory cannula incorporating a headgear device of the present disclosure, which can include at least one directional lock device and a headgear quick release device.

[0355] Figure 91 is a perspective view of another respiratory cannula incorporating a headgear device of the present disclosure, which can include at least one directional lock device.

[0356] Figure 92 ​​​is a perspective view of a respiratory cannula comprising a headgear device of the present disclosure, which can include at least one directional lock device and one headgear quick release device.

[0357] Figure 93 is a perspective view of a respiratory cannula comprising a headgear device of the present disclosure, which can include at least one directional lock device.

[0358] Figure 94 is a perspective view of a respiratory cannula comprising a headgear device of the present disclosure, which can include at least one directional lock device and one headgear quick release device.

[0359] Figure 95 is a perspective view of a respiratory cannula comprising a headgear device of the present disclosure, which can include at least one directional lock device.

[0360] Figure 96 is a perspective view of a respiratory cannula comprising a headgear device of the present disclosure, which can include at least one directional lock device and one headgear quick release device.

[0361] Figure 97 is a perspective view of a respiratory cannula comprising a headgear device of the present disclosure, which can include a pair of directional lock devices and a pair of headgear quick release devices.

[0362] Figure 98 is a perspective view of a respiratory cannula comprising a headgear device of the present disclosure, which can include a pair of directional lock devices and a pair of headgear quick release devices.

[0363] Figure 99 is a perspective view of a respiratory cannula comprising a headgear device of the present disclosure, which can include a pair of directional lock devices and one headgear quick release device.

[0364] Figure 100 is a perspective view of a respiratory cannula comprising a headgear device of the present disclosure, which can include a pair of directional lock devices and one headgear quick release device.

[0365] Figure 101 is a perspective view of a respiratory cannula comprising a headgear device of the present disclosure, which can include a pair of directional lock devices and a pair of headgear quick release devices.

[0366] Figure 102 is a perspective view of a respiratory cannula comprising a headgear device of the present disclosure, which can include at least one directional lock device and a pair of headgear quick release devices.

[0367] Figure 103 is a perspective view of a respiratory cannula comprising a headgear device of the present disclosure, which can include a pair of directional lock devices.

[0368] Figure 104 is a perspective view of an augmented or controlled exhalation pressure system including a respiratory mask for use in conjunction with a high flow nasal cannula. The respiratory mask can include one or more directional lock devices.

[0369] Figure 103 is Figure 105 a perspective view of a respiratory mask.

[0370] Figure 106 is a side view of a lock member and a core member of a directional lock device.

[0371] Figure 107 is a plot of lock member edge sharpness versus lock member thickness showing the preferred operating envelope of a lock member.

[0372] Figure 108 is a close-up view of a lock member in a locked position.

[0373] Figure 107 is a close-up view of a lock member in an unlocked position Figure 109A-109C of the directional lock device.

[0374] Figure 110 illustrates several lock members having different possible cross-sectional opening shapes.

[0375] Figure 111A is a perspective view of a lock member having a tapered bore geometry.

[0376] Figure 112 and 111B illustrates a lock member having an alternative tapered bore geometry.

[0377] Figure 113A is a plot of force versus distance showing the progressive holding force profile of the tapered bore geometry compared to the linear holding force profile.

[0378] Figure 113A and 113B illustrates a directional lock device including a pair of lock members and an alternative motion transfer element for transferring motion between the lock members. Figure 113B illustrates a directional lock device in an unlocked position, and Figure 114A illustrates a directional lock device in a locked position.

[0379] Figure 114A and 114B illustrates another directional lock device including a pair of lock members and an alternative motion transfer element for transferring motion between the lock members. Figure 114B illustrates a directional lock device in an unlocked position, and Figure 115A directional lock device in a locked position is shown.

[0380] Figure 116 A respiratory mask system comprising a headgear device including at least one directional lock device is shown. The directional lock device is positioned behind the user's ear.

[0381] Figure 117 Possible positions for placing a directional lock device on a user are shown.

[0382] Figure 118A Possible positions for placing a directional lock behind a user's ear are shown, with the placement area shown relative to the bone of the skull.

[0383] Figure 118B is a side view of a headgear of the present disclosure being worn by a user.

[0384] Figure 119 is a perspective view of a headgear of the present disclosure.

[0385] Figure 120 is a cross-sectional view of a strap forming part of the presently disclosed headgear.

[0386] Figure 120A is a third angle elevation view of one half of an injection molding tool configured for molding a strap component similar to the headgear of the present disclosure, Figure 120 is a 3A-3A cross-sectional view of Figure 120B Figure 120 is a 120B-120B cross-sectional view of Figure 121

[0387] is an isometric view of a strap component produced by the injection molding tool of Figure 120 Figure 122 is a cross-sectional view of the injection molding tool of

[0388] Figure 120 Figure 120B-120B wherein a textile shell is placed inside. Figure 123

[0389] Figure 120 is an enlarged view of the cross-sectional 3A-3A of the injection molding tool of Figure 124A

[0390] Figure 124B is a perspective view of a second embodiment of a headgear of the present disclosure.

[0391] Figure 125A is an enlarged cross-sectional view of a sizing system of a second embodiment of a headgear of the present disclosure.

[0392] Figure 124A is​​​​​Figure 125B and 124B a cross-sectional view of a second embodiment of a sizing system of

[0393] Figure 125A is a plan view of a first strap of a sizing system of Figure 125C

[0394] Figure 125D is a perspective view of an alternative first strap of a sizing system.

[0395] Figure 125C is a cross-sectional view of a connected first strap and second strap of a sizing system of Figure 125E

[0396] Figure 125C is a cross-sectional view of an unconnected first strap and second strap of a sizing system of Figure 125F

[0397] Figure 125G is an exploded perspective view of another alternative sizing system.

[0398] Figure 125F is a close-up exploded perspective view of a sizing system of Figure 125H

[0399] Figure 125A is a top-down view of a first strap of a sizing system of Figure 125I

[0400] Figure 125F is a cross-sectional view of a second strap of a sizing system of Figure 126

[0401] is a perspective view of a respiratory device having cushion pads connected using the sizing system of Figures 124A and 124B. Figure 127A

[0402] and Figure 128 are plan views of connections between respiratory device components. 127B

[0403] is a plan view of a headgear component having a molded clip. Figure 129

[0404] is a cross-sectional view of a molding tool configured to form a headgear component of Figure 128 Figure 130

[0405] Figure 131 ​​​​​​​is a side view of a headgear strap portion having a relatively inelastic core, a fabric shell on at least one surface of the core, and a flexible joint between portions of the core.

[0406] Figure 130 is Figure 130 the headgear strap portion of Figure 132 taken along line 14-14 of

[0407] Figure 133 is a side view of a headgear strap portion having a relatively inelastic core, a fabric shell on at least one surface of the core, and a flexible joint between portions of the core, wherein the flexible joint comprises a flexible bridge portion extending between the portions of the core.

[0408] Figure 132 is Figure 132 the headgear strap portion of Figure 134 taken along line 16-16 of

[0409] Figure 135 A system for forming a headgear strap portion using electrostatic charge to hold a fabric shell in place within a forming mold is shown.

[0410] Figure 136 A system for forming a headgear strap portion using air pressure to hold a fabric shell in place within a forming mold is shown.

[0411] Figure 137 A system for forming a headgear strap portion using one or more components for holding a fabric shell in place within a forming mold is shown.

[0412] Figure 138 A system for forming a headgear strap portion using a material roll for feeding a fabric shell into a forming mold is shown.

[0413] Figure 139A A headgear having a first strap and a second strap is shown.

[0414] Figure 139B is a cross-sectional view of the second strap, and Figure 139C is a cross-sectional view of the first strap.

[0415] Figure 139D is a cross-sectional view of an alternative strap, wherein the core of the strap includes a recess configured to receive a seam of a cover layer of the strap.

[0416] Figure 139EIt is a cross-sectional view of another alternative strap, wherein the core has one or more recesses occupying a large portion of the width direction of the core, and the seam of the cover layer is located within the recesses.

[0417] Figure 140A This is another cross-sectional view of an alternative strap, showing an alternative seam arrangement in which the seam of the overlay is folded over the surface of the overlay.

[0418] Figure 140B This is a view of the outer layer of the first strap, and Figure 141 This is a view of the outer layer of the second strap.

[0419] Figure 142A A headgear with a first strap and a second strap is shown.

[0420] Figure 142B This is a cross-sectional view of the first strap, and Figure 143A This is a cross-sectional view of the second strap.

[0421] Figure 143B This is a view of the outer layer of the first strap, and Figure 144 This is a view of the outer layer of the second strap.

[0422] Figure 145 The headgear shown has an inner core, a first outer layer, and a second outer layer.

[0423] Figure 144 yes Figure 146A A cross-sectional view of a portion of the headgear.

[0424] Figure 144 yes Figure 146B The first outer view of the headgear, and Figure 147 It is the second outermost view.

[0425] Figure 148 The headgear shown has an inner core, a first outer layer, and a second outer layer.

[0426] Figure 147 yes Figure 149A A cross-sectional view of a portion of the headgear.

[0427] Figure 147 yes Figure 149B The first outer view of the headgear, and Figure 150 It is the second outermost view.

[0428] Figure 151 The headgear shown has an inner core, a first outer layer, and a second outer layer.

[0429] Figure 150 yes Figure 152A A cross-sectional view of a portion of the headgear.

[0430] Figure 150 is a view of a first outer layer of a headgear of Figure 152B , and Figure 153 is a view of a second outer layer.

[0431] Figure 154 illustrates a headgear having an inner core, a first outer layer, and a second outer layer.

[0432] Figure 153 is a cross-sectional view of a portion of a headgear of Figure 155

[0433] Figure 156 illustrates a headgear having an inner core, a first outer layer, and a second outer layer.

[0434] Figure 155 is a cross-sectional view of a portion of a headgear of Figure 157A

[0435] Figure 155 is a view of a first outer layer of a headgear of Figure 157B , and Figure 158 is a view of a second outer layer.

[0436] Figure 159 is a cross-sectional view of a headgear strap arrangement having a core and one or more outer layers.

[0437] Figure 158 is a side view of a core of a headgear strap arrangement of Figure 160

[0438] Figure 161 is a cross-sectional view of a headgear strap arrangement having a core and one or more outer layers.

[0439] Figure 160 is a side view of a core of a headgear strap arrangement of Figure 162

[0440] is a cross-sectional view of a headgear strap arrangement having a core and one or more outer layers. Figure 163

[0441] is a side view of a core of a headgear strap arrangement of Figure 162 Figure 164 is a cross-sectional view of a headgear strap arrangement having a core and one or more outer layers.

[0442] Figure 165 is a side view of a core of a headgear strap arrangement of

[0443] Figure 164 Figure 166

[0444] Figure 167 ​​​​​​is a cross-sectional view of a headgear strap arrangement having a core and one or more outer layers.

[0445] Figure 166 is a side view of a core of a headgear strap arrangement of Figure 168

[0446] Figure 169 is a cross-sectional view of a headgear strap arrangement having a core and one or more outer layers.

[0447] Figure 168 is a side view of a core of a headgear strap arrangement of ​

[0448] Figure 170 is a cross-sectional view of a headgear strap arrangement having a core and one or more outer layers.

[0449] Figure 171 is a side view of a core of a headgear strap arrangement of Figure 170

[0450] Figure 172 is a cross-sectional view of a headgear strap arrangement having a core and one or more outer layers.

[0451] Figure 173 is a side view of a core of a headgear strap arrangement of Figure 172

[0452] Figure 174 is a perspective view of a headgear having at least a first strap and a second strap.

[0453] Figure 175A is a cross-sectional view of a portion of a headgear of Figure 174

[0454] Figure 175B is a cross-sectional view of an alternative arrangement of the straps of a headgear of Figure 174

[0455] Figure 175C is a cross-sectional view of another alternative arrangement of the straps of a headgear of Figure 174

[0456] Figure 176 is a perspective view of a headgear having at least a first strap and a second strap.

[0457] Figure 177 is a magnified view of a headgear of Figure 176

[0458] is a cross-sectional view of a portion of a headgear of Figure 178 Figure 177 Figure 176 is a cross-sectional view of a portion of a headgear of​​​​​​​​​

[0459] Figure 179 is a perspective view of a headgear having at least a first strap and a second strap.

[0460] Figure 180 is Figure 179 is a close-up view of the headgear of

[0461] Figure 181 is a cross-sectional view of a portion of the headgear of Figure 180 taken through the coupling means of Figure 179

[0462] Figure 182 is a perspective view of a headgear having at least a first strap and a second strap.

[0463] Figure 183 is a close-up view of the headgear of Figure 182

[0464] Figure 184 is a cross-sectional view of a portion of the headgear of Figure 183 taken through the coupling means of Figure 182

[0465] Figure 185 is a perspective view of a headgear having at least a first strap and a second strap.

[0466] Figure 186 is a close-up view of the headgear of Figure 185

[0467] Figure 187 is a cross-sectional view of a portion of the headgear of Figure 186 taken through the coupling means of Figure 185

[0468] Figure 188 is a perspective view of a headgear having at least a first strap and a second strap.

[0469] Figure 189 is a close-up view of the headgear of Figure 188

[0470] Figure 190 is a cross-sectional view of a portion of the headgear of Figure 189 taken through the coupling means of Figure 188

[0471] Figure 191 ​​​​​​​is a perspective view of a headgear having at least a first strap and a second strap.

[0472] Figure 192 is Figure 191 is a close-up view of a headgear including a coupling device coupling at least a first strap and a second strap.

[0473] Figure 193 is a cross-sectional view of a portion of the headgear of Figure 192 Figure 191

[0474] Figure 194 is a cross-sectional view of a headgear strap having a core and an outer layer with one or more air gaps or voids between the core and the outer layer.

[0475] Figure 195 is a cross-sectional view of a headgear strap having a core and an outer layer with one or more conduits between the core and the outer layer.

[0476] Figure 196 is a cross-sectional view of another headgear strap having a core and an outer layer with one or more conduits between the core and the outer layer.

[0477] Figure 197 is a cross-sectional view of a headgear strap having a core and an outer layer with the core at least partially surrounding one or more conduits.

[0478] Figure 198 is a cross-sectional view of another headgear strap having a core and an outer layer with the core at least partially surrounded by one or more conduits.

[0479] Figure 199 is a cross-sectional view of a headgear strap having a core and an outer layer with the core defining a pair of conduits.

[0480] Figure 200 is a cross-sectional view of a headgear strap having a core and an outer layer with an air gap between the core and the outer layer.

[0481] Figure 201A is Figure 200 is a cross-sectional view of the headgear strap of

[0482] Figure 201B is Figure 200 is a cross-sectional view of the headgear strap of

[0483] Figure 202 ​​is a cross-sectional view of a headgear strap having a core and an outer layer with an air gap between the core and the outer layer, wherein a portion of the core is exposed.

[0484] Figure 203 is a cross-sectional view of another headgear strap having a core and an outer layer with an air gap between the core and the outer layer, wherein a portion of the core is exposed.

[0485] Figure 204 is an exploded view of an outer layer and a reinforcing member of a headgear strap.

[0486] Figure 205 is a cross-sectional view of a headgear strap including Figure 204 an outer layer and a reinforcing member.

[0487] Figure 206 is a cross-sectional view of a headgear strap having a core, a first outer layer, a second outer layer, and one or more reinforcing or separating members that separate the outer layers prior to introduction of core material.

[0488] Figure 207 is a cross-sectional view of a headgear strap having a core, a first outer layer, a second outer layer, and a reinforcing member encapsulated within the core.

[0489] Figure 208 is a cross-sectional view of a headgear strap having a core, a cushion layer, and an outer layer.

[0490] Figure 209 is a cross-sectional view of another headgear strap having a core, a cushion layer, and an outer layer, wherein a portion of the cushion layer is exposed.

[0491] Figure 210 is a side view of a portion of a headgear having a number of straps and a connector connecting two or more of the straps.

[0492] Figure 211 is a cross-sectional view of a connector of Figure 210 and one of the straps.

[0493] Figure 212 is a cross-sectional view of a headgear strap having a core and a one-piece seamless outer layer.

[0494] Figure 213 is a cross-sectional view of a headgear strap having a core and a one-piece outer layer having a seam, wherein edges of the outer layer are embedded within the core.

[0495] Figure 214It is a cross-sectional view of another headband with a core and a one-piece outer layer with seams, wherein the edge of the outer layer is embedded in the core.

[0496] Figure 215 It is a cross-sectional view of a headband with a core and a pair of outer layers with a seam, wherein the edges of the outer layers are embedded in the core.

[0497] Figure 216A It is a cross-sectional view of the two-piece outer layer without the core, and Figure 216B This is a cross-sectional view of the two-piece outer layer after it has been formed in the core.

[0498] Figure 217 It is a cross-sectional view of a headband with a core and a four-piece outer layer with four seams, wherein the edges of the outer layer pieces are embedded in the core.

[0499] Figure 218 It is a cross-sectional view of another headband with a core and a three-piece outer layer with three seams, wherein the edges of the outer layer pieces are embedded in the core.

[0500] Figure 219 It is a perspective view of a headband with a core and a textured outer layer, in which a portion of the outer layer has been cut away to expose the core.

[0501] Figure 220 It is a perspective view of a headband with a core and an outer layer filled with soft material, wherein a portion of the outer layer has been cut off to expose the core.

[0502] Figure 221 It is a cross-sectional view of a headband with a core and an outer layer, wherein the core gives the outer layer a textured shape.

[0503] Figure 222 It is a perspective view of a headgear with a first strap and a second strap.

[0504] Figure 223 yes Figure 222 A cross-sectional view of the first strap of the headgear.

[0505] Figure 224 yes Figure 222 A cross-sectional view of the second strap of the headgear.

[0506] Figure 225 It is a perspective view of a headgear having a first strap, a second strap, and a connection between the first strap and the second strap.

[0507] Figure 226 yes Figure 225 The headgear includes an enlarged view of the connecting part.

[0508] Figure 227 is Figure 226 a cross-sectional view of the connection portion of

[0509] Figure 228 is a perspective view of a headgear having a first strap, a second strap, and a connection portion between the first strap and the second strap.

[0510] Figure 229 is Figure 228 a headgear of

[0511] Figure 230 illustrates several possible cross-sectional views of the straps within the connection portion.

[0512] Figure 231 is Figure 228 a cross-sectional view of the second strap of the headgear of

[0513] Figure 232A is a top view of a front strap and a diverging strap of an intra-moulded diverging headgear.

[0514] Figure 232B is a perspective view of a first cover layer and a second cover layer of straps of an intra-moulded diverging headgear joined together so as to form Figure 232A

[0515] is a cross-sectional view of a first cover layer and a second cover layer of straps of an intra-moulded diverging headgear joined together so as to form Figure 232C Figure 232A is a perspective view of an intra-moulded diverging headgear of

[0516] Figure 233 Figure 232A is a perspective view of an intra-moulded diverging headgear of

[0517] Figure 234 is a perspective view of an intra-moulded diverging headgear of Figure 232A

[0518] is a perspective view of an intra-moulded diverging headgear of Figure 235 Figure 232A is a perspective view of an intra-moulded diverging headgear of

[0519] Figure 236A Figures 232A to 235 is a perspective view of a mould tool configured for forming an intra-moulded diverging headgear configuration of

[0520] Figure 236B is Figure 236A ​​​​mold tool of FIG. 1 1 along line 236B-236B.

[0521] Figure 236C is a cross-sectional view of a mold tool configured for securing a fabric shell in place within the mold tool.

[0522] Figure 236D is a cross-sectional view of a mold tool having retention spikes that secure a fabric shell in place within the mold tool.

[0523] Figure 236E is a Figure 236D partial perspective view of a mold tool of FIG. 1 1 showing retention spikes securing a fabric shell in place within the mold tool.

[0524] Figure 236F is a Figure 236D cross-sectional view of a mold tool of FIG. 1 1 showing retention spikes penetrating but not extending through a fabric shell.

[0525] Figure 236G is a Figure 236D cross-sectional view of a mold tool of FIG. 1 1 showing retention spikes penetrating a fabric shell.

[0526] Figure 237A is a perspective view of a mold tool for forming a headgear using a woven fabric shell.

[0527] Figure 237B is a Figure 237A cross-sectional view of a mold tool of FIG. 1 1.

[0528] Figure 238 is a cross-sectional perspective view of an alternative construction of an insert-molded strap having a core, a cover layer, and a rail.

[0529] Figure 239A is a cross-sectional view of an alternative construction of an insert-molded strap having a cellular core, a cover layer, and an insert-molded rail.

[0530] Figure 239B is a Figure 239A perspective view of an insert-molded strap of FIG. 1 1.

[0531] Figure 239C is a Figure 239A cross-sectional view of an insert-molded strap of FIG. 1 1 when donned by a user.

[0532] Figure 240A is a cross-sectional perspective view of an alternative construction of an insert-molded strap having a structured core.

[0533] Figure 240B is a perspective view of a mold tool for constructing Figure 240ACross-sectional view of a mold tool for a structured core of an in-mold formed strap in

[0534] Figure 241A Perspective view of an alternate construction of an in-mold formed strap having a complex 3D shape with continuously variable geometry and cross-section along its length.

[0535] Figure 241B is a cross-sectional view of the in-mold formed strap of Figure 241A along line 241B-241B.

[0536] Figure 241C is a cross-sectional view of the in-mold formed strap of Figure 241A along line 241C-241C.

[0537] Figure 242A is a cross-sectional perspective view of an alternate in-mold formed strap having an embossed brand logo.

[0538] Figure 242B is a cross-sectional perspective view of an alternate in-mold formed strap having a laser cut brand logo.

[0539] Figure 242C is a cross-sectional perspective view of an alternate in-mold formed strap of Figure 242B

[0540] Figure 242D is a cross-sectional perspective view of an alternate in-mold formed strap having a laser cut portion removed to expose core material.

[0541] Figure 242E is a cross-sectional perspective view of an alternate in-mold formed strap having an embossed indicator and a raised indicator formed from exposed core material.

[0542] Figure 242F is a cross-sectional perspective view of an alternate in-mold formed strap having a raised clip bump with an embossed feature.

[0543] Figure 242G is a cross-sectional perspective view of an alternate in-mold formed strap having an embossed and raised clip bump.

[0544] Figure 243A is a cross-sectional perspective view of an alternate in-mold formed strap having an overmolded brand logo.

[0545] Figure 243B is a cross-sectional perspective view of an alternate in-mold formed strap having an overmolded clip bump.

[0546] Figure 243C is a cross-sectional perspective view of an alternate in-mold formed strap of Figure 243B ​Alternative in-mold formed strap with overmolded clip bump of FIG. 1 1 1 along line 243C-243C.

[0547] Figure 244A Rear perspective view of molded headgear configuration with single rear strap.

[0548] Figure 244B Rear perspective view of molded headgear configuration of FIG. 1 1 1. Figure 244A Cross-sectional view of molded headgear configuration of FIG. 1 1 1 along line 244B-244B.

[0549] Figure 245A Side perspective view of molded headgear configuration with lower strap connected to overhead strap by arch connector.

[0550] Figure 245B Cross-sectional view of molded headgear configuration of FIG. 1 1 1 along line 245B-245B. Figure 245A

[0551] Side view of molded headgear configuration of FIG. 1 1 1. Figure 245C Figure 245A Rear perspective view of molded headgear configuration with rigid front strap and elastic rear and overhead straps.

[0552] Figure 246 Rear perspective view of molded split headgear configuration with in-mold formed variable knit.

[0553] Figure 247A Cross-sectional view of molded headgear configuration of FIG. 1 1 1 along line 247B-247B.

[0554] Figure 247B Figure 247A Cross-sectional view of molded headgear configuration of FIG. 1 1 1 along line 247A-247A.

[0555] Figure 247C Molding tool for forming molded headgear configuration of FIG. 1 1 1. Figure 247A

[0556] Side perspective view of molded headgear configuration with fully integrated split rear and overhead straps. Figure 247D Figure 247A Partial exploded perspective view of molded headgear configuration of FIG. 1 1 1.

[0557] Figure 248A Cross-sectional perspective view of molded headgear configuration of FIG. 1 1 1.

[0558] Figure 248B Cross-sectional view of molded headgear configuration of FIG. 1 1 1 along line 248B-248B. Figure 248A

[0559] Cross-sectional view of molded headgear configuration of FIG. 1 1 1 along line 248A-248A. Figure 248C Figure 248A Cross-sectional view of molded headgear configuration of FIG. 1 1 1 along line 249B-249B.

[0560] ​​​​Figure 249A is a side perspective view of a molded headgear configuration having core material exposed and formed on an outer surface of an outer cover.

[0561] Figure 249B is a cross-sectional perspective view of a molded headgear configuration having core material recessed within an outer cover. Figure 248A

[0562] Figure 249C is a cross-sectional perspective view showing an alternative construction of a molded headgear configuration of Figure 248A having core material positioned over an outer cover rather than recessed into the outer cover.

[0563] Figure 250 is a side view of an exemplary in-mold formed headgear configuration for use in conjunction with a full face mask.

[0564] Figure 251 is a side view of an exemplary in-mold formed headgear configuration for use in conjunction with a nasal mask having lower straps positioned below the ears.

[0565] Figure 252 is a side view of an exemplary in-mold formed headgear configuration for use in conjunction with a nasal pillow mask.

[0566] Figure 253 is a side view of an exemplary in-mold formed headgear configuration for use in conjunction with a nasal mask.

[0567] Throughout the drawings, reference numbers can be re-used to indicate general correspondence between referenced elements. The drawings are provided to illustrate exemplary embodiments described herein and are not intended to limit the scope of the disclosure. DETAILED DESCRIPTION

[0568] Embodiments of systems, components, and assembly and manufacturing methods will now be described with reference to the drawings, wherein like reference numbers can refer to like or similar elements throughout. While several embodiments, examples, and illustrations are disclosed herein, it will be understood by those of ordinary skill in the art that the present application extends beyond the specifically disclosed embodiments, examples, and illustrations, and includes other uses of the present application 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 present application. Moreover, the embodiments of the present application can include several novel features and no single feature, alone, is solely responsible for its desirable attributes or is essential to practicing the present application described herein.

[0569] ​Certain terminology can be used in the following description for the purpose of reference only, and, thus, is not intended to be limiting. For example, terms such as "above," "below," "upper," "lower," and the like refer to the drawings as oriented in the figures. Terms such as "front," "back," "left," "right," "rear," and "side" describe the orientation of portions of the components or elements in a consistent but arbitrary manner with respect to the text describing the discussion of those components or elements. Additionally, terms such as "first," "second," "third," and the like can be used herein to describe separate components. Such terminology can include the words specifically mentioned above, derivatives thereof, and words of similar import.

[0570] As used herein, the term "substantially inelastic" shall mean the ability of a headgear or material to resist stretching relative to a load to which it is subjected. Thus, a headgear or material can be substantially inelastic in one direction and somewhat elastic in another direction. In some configurations, a headgear or material is configured to be substantially inelastic in the direction of the load applied in the therapy for which it is intended. A substantially inelastic headgear or material may, for example, resist stretching that would compromise the seal of a respiratory mask in a sealed system under normal or expected conditions. In a non-sealed system, a substantially inelastic headgear or material may, for example, resist stretching that would compromise the proper layout of a respiratory interface in response to normal or expected conditions such as hose pull or movement of the user. When the expected loading forces are relatively low, a headgear or material can have greater elasticity because the load will not be sufficient to cause stretching. Conversely, if it is expected that a headgear and / or material will be subjected to high loading forces, then greater inelastic forces will be required to resist stretching.

[0571] Some embodiments disclosed herein relate to headgear systems and / or interface assemblies including headgear systems that automatically adjust to the correct size when donned to a user's head and once in use, transition in nature from elasticized "taut" straps / ties to "inelastic" straps / ties. In some configurations, the headgear (alone or integrated in an interface assembly) exhibits a relatively small headgear contraction force that tends to shorten the headgear. When coupled to a mask, the headgear and mask cooperate to define a perimeter of the interface assembly, the length of which decreases toward a minimum perimeter length due to the contraction force. Although not necessarily perfectly circular, the perimeter length is often referred to as the "perimeter." Thus, in such arrangements, the interface assembly can be positioned on a user's head and will automatically contract to the appropriate head size or very close to that appropriate head size in a manner similar to an elasticized or "taut" headgear. The contraction force is preferably sufficient to support the weight of the interface assembly at the minimum head size or minimum useful perimeter length of the interface assembly (which can or can not coincide with the minimum perimeter length) and at least substantially hold the interface assembly in place on the user's head. In some configurations, the retraction force can be sufficient to support the weight of a nasal cannula or other small interface, which can have a weight of, for example, about 50 grams. In other configurations, the retraction force can be between about 0.5 Newton and about 5.2 Newton, or between about 1 Newton and about 2.6 Newton, or between about 1 Newton and about 1.5 Newton, including any values or sub-ranges within these ranges. In other configurations, the retraction force can not be sufficient to support the weight of the interface and can require manual assistance to move the interface to a sealing position on the user's face. Preferably, however, once the headgear is sufficiently retracted, the headgear is held in place by, for example, directional locks. In some configurations, the contraction force is only sufficient to support the weight of the headgear or is configured to support the weight of the headgear.

[0572] However, in at least some configurations, the contraction force is less than the force required to maintain the mask in sealing contact with the user's face during treatment / use. That is, the contraction force alone is not able to resist the blowout force. In some configurations, the contraction force is insufficient to resist the blowout force throughout the range of available perimeter length or headgear size. Accordingly, the headgear and / or interface assembly also exhibits inelastic behavior in response to forces tending to elongate the headgear or increase the perimeter length of the interface assembly. The headgear and / or interface assembly can have a locking mode that can generate a locking force tending to resist expansion, elongation, or lengthening of the perimeter length. The locking force can be sufficient to resist elongation or at least any significant elongation of the perimeter length in response to the blowout force. In some configurations, the locking force is sufficient to resist elongation in response to the highest blowout force expected under a variety of uses or treatments (e.g., bi-level or CPAP, NIV, etc.). In some configurations, the locking force can be selected for one or more particular uses / treatments, but can not be suitable for all uses / treatments. In some configurations, the locking force can be selected to resist elongation in response to forces other than blowout force (e.g., like hose pull force). Such additional forces can be referred to collectively herein as "hose pull force," and this additional resistance to elongation can be referred to herein as "reserve force."

[0573] In some configurations, the headgear and / or interface assembly also exhibits a yield force above which expansion or elongation of the perimeter length is permitted. Preferably, the yield force is greater than the expected blowout force. In some configurations, the yield force is greater than the expected blowout force and hose pull force. Accordingly, such headgear and / or interface assemblies have a reserve force. Preferably, the yield force is set low enough so that a user can at least relatively easily apply an elongation force to the headgear and / or interface assembly that is sufficient to exceed the yield force in order to allow the interface assembly to lengthen and be applied to the user's head. As described above, the contraction force decreases the perimeter length toward the appropriate head size.

[0574] In some configurations, the headgear and / or interface assembly automatically transitions between the collapsed mode, the locked mode, and the yielding mode in response to the presence or absence of an external force. For example, in the absence of an external lengthening or expanding force, the headgear and / or interface assembly moves toward or to a minimum perimeter length. A lengthening or expanding force greater than the yielding force can be applied in order to increase the perimeter length of the headgear and / or interface assembly to a length sufficient to allow the interface assembly to be positioned on the head of the user. Once the lengthening or expanding force is removed (or reduced below the collapsing force), the collapsing force acts to automatically reduce the perimeter length to or substantially to the appropriate head size, such that the interface assembly is supported on the head of the user. At the beginning of therapy (application of the blowout force) and / or application of the hose pull force, the headgear and / or interface assembly automatically transitions to the locked mode to resist elongation of the perimeter length, or at least to resist any significant elongation or increase in the perimeter length. At the end of therapy, or at any time as desired, a force above the yielding force can be applied to the headgear and / or interface assembly in order to increase the perimeter length and allow the interface assembly to be removed from the head of the user.

[0575] Advantageously, in this arrangement, minor adjustments to the perimeter length of the headgear and / or interface assembly can be accomplished quickly and conveniently. For example, during therapy or use, the mask can be manipulated to effect a minor adjustment to the perimeter length. For example, in the event of a leak between the mask and the user's face, the mask can be shaken or otherwise moved to effect a minor adjustment to the perimeter length, thereby resolving the leak. In some cases, the seal of the mask can be compressed against the user's face, which can allow the contraction force to automatically decrease the perimeter length. Upon release of the mask, the headgear and / or interface assembly locks at or very close to the decreased perimeter length. Thus, such a configuration allows the headgear and / or interface assembly to be adjusted or moved to an adjusted perimeter length as a result of a small manipulation (e.g., shaking) of the mask. Manipulation of other portions of the interface assembly (e.g., the headgear or breathing tube / gas conduit) can similarly result in a minor adjustment. Because of the nature of the human head and / or conditions under which the interface assembly is used, quick and convenient minor adjustments can dramatically improve the performance of the interface assembly and user satisfaction. Therapy often occurs at night and / or in other situations when the user is lying down. Thus, the headgear can be in contact with a surface, such as a pillow or bed. Movement of the user's head relative to such a surface can cause the headgear to move, which can alter the fit of the headgear. For example, hair can move or "compress" under the headgear, which can alter the fit. The headgear straps can move up, down, or rotationally on the head, which can alter the fit. Such alterations in the fit can result in a leak between the mask and the user's face. The adjustment techniques described above can allow such changes in the fit to be accommodated automatically or with a small manipulation of the mask or other portion of the interface assembly. Furthermore, the interface assembly can be removed and reapplied and automatically adjusted to at or very close to the appropriate headgear size. In contrast, if a conventional non-stretch headgear is moved from its desired adjusted position, such as due to an error or because of cleaning, it can be difficult and time consuming to reestablish the desired adjusted position. Conventional elasticized headgear addresses the adjustment issue, but because the contraction force must resist the highest expected blowout and hose pull at the smallest available headgear size, the elasticized headgear exerts a relatively large pressure on the user's head, which is only partially relieved by the application of blowout force. This pressure can be large for users with a relatively large head size and low therapy pressure.

[0576] As described below with reference to a specific directional locking device, in some configurations, a certain amount of movement occurs in the cap and / or interface assembly during the transition from the resilient mode to the locked mode. For example, in some directional locking devices, the perimeter length may increase slightly during the transition from the resilient mode to the locked mode. In some cases, there is a trade-off between the increased yield force and the reduced change in perimeter length during the transition. Therefore, any reference to a particular location or perimeter length of the cap and / or interface assembly may include such a slight length change (if any) during the transition.

[0577] The following examples of the adjustment techniques described above are based on CPAP delivery. This series of graphs illustrates the typical operating envelope under which the cap system must be designed to operate, and how different current embodiments operate relative to this envelope. The envelope can include the entire CPAP treatment domain, i.e., the entire range of typical, approximate, or possible CPAP pressures and the entire range of typical, approximate, or possible head sizes. Alternatively, the envelope can include a subset of the CPAP treatment domain, such as a subset of pressures (e.g., low-pressure or high-pressure CPAP) or a subset of head (cap or interface assembly) sizes (e.g., small, medium, or large). The principles described regarding CPAP treatment can also be applied to other treatments.

[0578] Figure 1 It is a graph showing the relationship between the force generated when pressure is applied to the mask's occlusal area and the range of head size adjustments that may be encountered across the potential patient's range. The operational envelope is shown as a rectangular area defined between the minimum and maximum forces and between the minimum and maximum head sizes (circumferences).

[0579] Figure 2 The performance characteristics (force curves) of the superimposed elastic headgear system are shown. Figure 1 The operating envelope of the mask system. Clearly, for the elastic system to provide sufficient performance across the mask system's operating envelope, the elastic system must provide a force greater than the force the mask system can generate. Therefore, at low CPAP pressures, the hood provides a much greater force than is required to counteract the blow-off force. Additional force applies pressure to the user above the area defined by the mask and hood (primarily concentrated at the mask and the back of the head). The area of ​​the hood can be increased to apply force over a larger area, thereby reducing the applied pressure. However, a large hood can be annoying or uncomfortable. For example, such a large hood can retain heat over a larger area than desired.

[0580] Figure 3 This demonstrates the performance of an instance with a superimposed headgear system. Figure 1the operating envelope, the headgear system has the automatic adjustment technology described above. In the illustrated example, the force generated by the headgear and / or interface assembly is sufficient to balance the force generated by pressurizing the enclosed region of the mask. In essence, the example headgear system automatically adjusts to the proper head size (girth or perimeter length) at a relatively low constricting force and then provides a "just-in-time" retention force that matches the actual CPAP pressure. Thus, the example headgear system can automatically adjust to meet the needs of any potential point within the CPAP envelope.

[0581] Figure 4 A graph of a force-deflection curve for an example headgear device or interface assembly including a headgear device is illustrated. The deflection axis of the graph can represent the girth or perimeter length of the headgear device or interface assembly. The girth or perimeter length, in turn, can represent the head girth of a particular user when the headgear device or interface assembly is donned to that user. Figures 4.1-4.3 A number of discrete positions in which a user dons ("fits") an example interface assembly including a headgear device and makes minor adjustments thereto are illustrated. The following is described with additional reference to Figures 4.1-4.3 the fitted positions of Figure 4 the graph.

[0582] Figure 4 The graph of Figures 1-3 also illustrates an operating envelope 10 associated with the headgear device or interface assembly, which can be the same as the operating envelope illustrated and described above with respect to The operating envelope 10 is illustrated as a rectangular region defined between the minimum and maximum force applied to the headgear device or interface assembly as a result of therapy and the minimum and maximum head size or girth / perimeter length of the headgear device. The operating envelope 10 can be specific to one therapy (e.g., CPAP or bi-level PAP) or can cover multiple therapies. Similarly, the head size or girth / perimeter length can be specific to one size of headgear device or can cover multiple sizes. The operating envelope 10 can be used to establish a functional or behavioral index for a particular headgear device and is utilized herein to illustrate certain features or behaviors of certain disclosed embodiments.

[0583] A graph of an example force-deflection curve for an example headgear device or interface assembly (referred to in the discussion of this graph for convenience as "headgear") is illustrated with respect to the example operating envelope 10. The curve begins at or near the origin of the graph, which can represent a force of approximately zero and the minimum girth or perimeter length of the headgear (referred to in the discussion of this graph for convenience as "girth"). The minimum girth is greater than zero, but typically at a value below the minimum head girth of the intended user or range of users (taking into account the interface, if any).

[0584] AsFigure 4.1 As shown, in order to place the hood 100 on a user, the hood 100 is typically stretched to a length greater than the actual circumference of the user's head. Typically, the rear portion of the hood 100 is placed at the back of the user's head, and the user grasps the front portion of the hood 100 (e.g., a mask or other interface) and applies a pull to stretch the hood 100 and move the mask or other interface over the head and toward the face.

[0585] like Figure 4 As shown in the graph, the exemplary force-flexure curve initially rises with a steep slope, where the force increases by a large amount while the increase in circumference is relatively small. In some configurations, the force-flexure curve rises to a level above the maximum force of the operating envelope 10 before reaching the minimum circumference of the operating envelope 10. This portion of the curve may be referred to as the initial elongation portion 12a.

[0586] At a point above the maximum force of the operating envelope 10, the force-flexure curve transitions to a gentler slope, where the perimeter increases significantly while the force increase is relatively small. This gentler slope portion of the force-flexure curve may relate to the yield force of the retention mechanism of the cap 100. Preferably, the gentler slope portion of the force-flexure curve, which may be referred to as the elongation portion 12b, extends partially or entirely along the perimeter of the operating envelope 10 at or above the maximum force level of the operating envelope 10. In some configurations, the elongation portion 12b extends beyond the maximum perimeter level of the operating envelope 10. That is, the cap 100 may be configured to achieve a larger perimeter than the desired maximum head perimeter in order to allow convenient placement of the cap 100 on a user having the maximum head perimeter of the operating envelope 10 of the cap 100. In use, especially for users with a head size at the smaller end of the operating envelope 10, the headgear 100 may not be stretched to its maximum circumference during the wearing process, and in some cases, may not be stretched beyond the maximum circumference level of the operating envelope 10.

[0587] After the cap 100 has been stretched to its maximum circumference, stretched to a circumference greater than the operating envelope 10, or stretched to another circumference sufficient to allow it to be worn on the user, the force-flexure curve exhibited drops sharply (initial retraction portion 14a) and then transitions to a relatively gentle portion in which the circumference is greatly reduced while the change in force is relatively small. This gentle portion of the curve may be referred to as the retraction portion 14b and is partly composed of... Figure 4.2The headgear 100 can be positioned on the user's head at this low force level (the left end of the retraction portion 14b or "fit point 16") until therapy is initiated or another force is applied that attempts to elongate the headgear 100.

[0588] Advantageously, this relatively low force level allows the headgear 100 to be comfortable for the user. In some configurations, the retraction portion 14b of the force-deflection curve is at or below the minimum force level of the operating envelope 10. Thus, in such an arrangement, the retraction force of the headgear 100 can be lower than the force required or desired to resist the minimum force induced in the headgear 100 by therapy (e.g., a low CPAP level). Thus, even at low therapy levels, the headgear 100 can be configured to generate a retention force sufficient only to resist the therapy-induced force, as the minimum force level of the operating envelope 10 is higher than the retraction portion 14b of the force-deflection curve. In some configurations, as described below, the retraction portion 14b of the force-deflection curve can fall within the operating envelope 10. Such an arrangement can be referred to as exhibiting "composite" behavior. Preferably, however, the composite behavior headgear force-deflection curve retraction portion 14b is still below the maximum force level of the operating envelope 10.

[0589] When treatment is initiated or another elongation force is applied to headgear 100, the force-deflection curve rises relatively steeply from fit point 16 to a point within operating envelope 10 at which the retention force of headgear 100 balances the treatment-induced force and / or other forces (e.g., hose pull) that attempt to elongate headgear 100. This point can be referred to as a balanced fit point 18. The force-deflection curve between fit point 16 and balanced fit point 18 can have substantially the same slope as initial elongation portion 12a. The actual location of balanced fit point 18 can be anywhere within operating envelope 10, depending on the actual force induced by treatment and the actual head size of the user. In any particular case, the force exerted on the user in the region above the headgear size-dependent region in headgear 100 as pressure is substantially only the force required to counteract the actual force induced by treatment. Thus, in at least some configurations, the pressure exerted on the user can be minimized for any particular headgear size and shape of the particular treatment level being utilized. Elongation portion 12b of the force-deflection curve can be spaced above the maximum force level of operating envelope 10 so as to provide a reserve force in which additional forces (e.g., hose pull) can be applied without elongating headgear 100. Elongation of headgear 100 can occur once a force sufficient to reach elongation portion 12b of the force-deflection curve is applied to headgear 100. However, headgear 100 can be designed or configured to have a force-deflection curve that accommodates the expected or typical treatment force and hose pull or any combination thereof.

[0590] As described above, in at least some configurations, the user can manipulate headgear 100 so as to cause a slight adjustment to the perimeter length. Advantageously, such an arrangement allows the user to, for example, address leaks or tighten or loosen (decrease the perimeter length) headgear 100 to a desired level by simply grasping the face mask or other interface and moving (e.g., shaking) the face mask or other interface relative to the user's face and the rear portion of headgear 100, as illustrated in FIG. 6. As illustrated by the dashed lines in FIG. 6, the perimeter length of headgear 100 can be decreased by moving the face mask or other interface relative to the user's face and the rear portion of headgear 100. As illustrated by the dashed lines in FIG. 6, the perimeter length of headgear 100 can be increased by moving the face mask or other interface relative to the user's face and the rear portion of headgear 100. Figure 4.3 Figure 4.3 ​As indicated by the arrows in FIG. 1, the mask or other interface can be moved or adjusted in multiple directions, including toward and away from the face of the user, or in a rotational manner (e.g., about a vertical or horizontal / lateral axis). Movement toward the face can result in a decrease in the perimeter length or tightening of the headgear 100, so as to, for example, achieve a tight end of the range of acceptable or desirable fit, which can be referred to as a "tight fit." Movement away from the face can result in an elongation of the perimeter length or loosening of the headgear 100, so as to, for example, achieve a loose end of the range of acceptable or desirable fit, which can be referred to as a "loose fit." Rotational movement about a vertical axis can cause one side of the headgear 100 to tighten and the other side to remain the same or loosen. Rotation about a horizontal or lateral axis can cause one of the upper or lower portions of the headgear 100 to tighten and the other to loosen.

[0591] As described above, in all configurations, the retractive portion 14b of the force-deflection curve need not all be below the minimum force level of the operational envelope 10. The headgear 100 can be designed or configured to position the retractive portion 14b of the force-deflection curve within the operational envelope 10 and at a level that provides sufficient comfort to the user. In some cases, a user can desire that the headgear 100 exert a certain degree of force so as to provide the user with some tactile feedback that the headgear 100 is holding the interface in place securely, which provides a comfortable feeling. For some users, this force exerted by the headgear 100 can fall within the operational envelope 10 for a particular therapy. Thus, in the case of such an arrangement, the retractive force of the headgear 100 can be sufficient to resist the therapy force at least under some conditions, and / or for some larger head sizes.

[0592] Figure 5 A graph is shown that includes an example "composite" force-deflection curve. For purposes of illustration, in addition to the composite force-deflection curve, an example of an elastic headgear force-deflection curve is also shown in the graph. The composite force-deflection curve can be similar to or identical to the force-deflection curves described above in connection with Figure 4 The force-deflection curves described are substantially similar or identical, except that the composite force-deflection curve positions the retractive portion 14b within the operational envelope. The retractive portion 14b of the force-deflection curve divides the operational envelope into a lower portion 20 and an upper portion 22. The forces in the lower portion 20, which are below the retractive portion 14b of the force-deflection curve, can be absorbed by the retractive force of the headgear, which can be provided by one or more retractive elements. The forces in the upper portion 22, which are above the retractive portion 14b of the force-deflection curve, can be absorbed by the retention force of the headgear, in a manner similar to the force-deflection curves described above in connection with Figure 4 The retention force can be provided by one or more retention elements (e.g., locks), in the manner described above.

[0593] An example of an elastic headgear force curve 15 is shown superimposed over the recoil portion 14 of the force-deflection curve. The elastic headgear force curve 15 includes an upper curve portion and a lower curve portion separated by a relatively small vertical distance, which represents the internal friction losses or hysteresis within the headgear. The force required to elongate the headgear is slightly greater than the recoil force of the headgear. An elastic headgear exhibiting the elastic force-deflection curve 15 shown can accommodate only applied therapeutic or other forces below the elastic force-deflection curve 15. Applied forces above the elastic force-deflection curve 15 will result in elongation of the elastic headgear. Thus, the force-deflection curve 15 of an elastic headgear must be positioned above the maximum force level of the operating envelope in order to avoid undesirable elongation under at least some conditions (e.g., high therapeutic forces or large head sizes). The level of pressure applied to the user as a result of such a force-deflection curve 15 is likely to be uncomfortable under at least some conditions (e.g., low therapeutic forces or large head sizes).

[0594] In contrast, the composite force-deflection curve (or combined Figure 4 The balanced fit force-deflection curve shown and described exhibits a relatively large vertical distance between the upper portion 12b of the curve and the lower portion 14b of the curve. At least a portion of the operating envelope falls within the vertical space between the upper portion 12b of the curve and the lower portion 14b of the curve. Thus, a headgear exhibiting such a force-deflection curve can resist relatively high forces while applying relatively low forces or pressures to the user in the absence of therapeutic or other elongation forces. In addition, once therapy is initiated, the force or pressure applied to the user remains constant (if below the recoil portion 14b of the force-deflection curve in the composite arrangement) or increases only to the level necessary to substantially resist the applied force.

[0595] The force applied by the interface to the headgear is typically related to the projected area of the seal of the interface. Smaller interfaces, such as nasal pillows or nasal masks, seal around a smaller area relative to larger interfaces, such as full face masks, and thus generate a smaller force. Some interfaces (e.g., nasal cannula) can not form a seal with the user's face, and thus the force applied to the headgear can be primarily related to the weight of the interface. Figure 6 A graph of the force required to maintain the interface in sealing contact with the user's face is shown, which is related to the projected area of the seal. Generally, the greater the projected area of the seal, the greater the force required to maintain the interface in sealing contact with the user's face, and thus the greater the force that the headgear is required to resist. This force can be referred to as the retention force of the headgear.

[0596] Figure 6The plot of FIG. 1 includes two lines 24, 26 defining upper and lower limits of an acceptable range of retention forces for interfaces having different projected seal areas. The two lines 24, 26 are vertically spaced from each other and extend upwardly with a moderate slope from left to right. The lower line 24 can represent a minimum force required or desired to maintain a seal with the user's face. The upper line 26 can represent a maximum desired force, which can be greater than the force required to maintain a seal, but is preferably low enough to maintain user comfort or avoid excessive seal collapse. The space between the lower line 24 and the upper line 26 can represent an available or target adjustment range 28, with the lower line 24 representing an available or acceptable loose fit and the upper line 26 representing an available or acceptable tight fit. The lower line 24 can include one or more relatively short, steep upwardly sloped sections, which represent transitions between interface types, such as a nasal pillow to a nasal mask transition and a nasal mask to a full face mask transition. The upper line 26 is shown as straight, but can include steeply sloped sections that correspond to the steeply sloped sections of the lower line 24 to maintain a constant target adjustment range.

[0597] Figure 6 The plot of FIG. 1 further includes a flat or horizontal line 30 at a force level above the target range or target zone 28. This line 30 represents a force that will or is likely to cause damage to the user's skin over a relatively short period of use of a particular headgear. This line 30 can be referred to as a maximum force line 30. The actual force value can vary depending on the characteristics of a particular headgear, such as the type of contact area or material. The vertical distance between the target zone 28 and the maximum force line 30 represents an error margin 32 for adjusting the force of the headgear. As shown, the error margin 32 is reduced for interfaces having larger projected seal areas, such as full face masks, compared to interfaces having smaller projected seal areas, such as nasal pillows or nasal masks. Thus, it can be desirable, especially for larger projected seal area interfaces, for the headgear to be easily or conveniently adjustable within or close to the target zone 28. Conventional non-elastic headgear includes relatively crude adjustments, such as one or more adjustable loops secured with hook and loop fasteners. Such headgear can be difficult to adjust within the target zone 28, especially in environments where the wearer of the headgear is not the person making the adjustments, which often occurs, for example, in a hospital setting.

[0598] Figure 7 A three-dimensional plot showing the relationship between headgear force, projected seal area, and perimeter is shown. Figure 7 The plot of FIG. 1 is Figure 6 The plot of FIG. 1 is combined with Figure 4 The plot of FIG. 1 is combined with Figure 7 The plot of FIG. 1 shows a minimum force 24( Figure 6the minimum force line 24. Below the minimum force line 24, the headgear force can be insufficient to form or maintain the seal. Figure 7 The graph also illustrates a maximum force line 30 above which skin damage is likely to occur. A safe operating envelope for the headgear lies between the minimum force line 24 and the maximum force line 30. For the sake of clarity, the upper line of the target range is omitted.

[0599] Figure 7 The graph also illustrates a force-deflection curve for an exemplary headgear. The force-deflection curve can lie in any plane along the projected seal area axis in order to illustrate design indicators for a headgear intended for use with a particular type of interface having a particular projected seal area. The headgear can also be designed to take into account headgear force and circumference along a segment or all of the projected seal area axis in order to design a headgear that will operate with multiple types of interfaces or that is universal for all types of interfaces (at least with respect to a particular treatment). In some configurations, such as by Figure 7 As illustrated by the force-deflection curve in FIG. 3, the elongated portion 12 of the force-deflection curve can lie above the maximum force line 30.

[0600] In at least some configurations, as described above, headgear exhibiting a balanced fit or a composite force-deflection curve advantageously provides a retention force that falls within the safe operating envelope, and preferably within the target zone. In at least some configurations, such headgear automatically adjusts to an appropriate retention force that is within the safe operating envelope, and preferably within the target zone. As a result, insufficient or excessive tightening by the user or another person can be reduced or eliminated.

[0601] As described above, the example headgear system performs several functions in the process of donning, using, and removing the interface or mask system. For donning, the headgear system elongates in length so that it can be placed over the user's head. The headgear system retracts in length during "donning" and provides sufficient force to the mask system so that the user feels that the mask system is secure. Once airway pressure is applied, the headgear system "shifts" in performance from an elastic or stretchy behavior to one that is inelastic. The headgear system also provides for micro-adjustments to tighten or loosen the mask based on the user's preference during use. For removal, the headgear system elongates in length so that it can be removed over the user's head. The combination of one or more of these features, including all of them, provides a mask system that requires minimal user interaction for donning and removal. This eliminates the potential for misuse and can help improve the usability of the mask system. The example headgear system can also mitigate the effects of overpressure on the skin by reducing the probability or even the likelihood of headgear over-tightening. The example headgear system can improve overall compliance with therapy. It is additionally characterized by features of high positional positioning and stability. This is both in terms of activities of removing and re-donning the mask, as well as during use of the mask. One or more concepts are disclosed herein for achieving repeatable and stable positioning of the headgear and associated interface components on the head of the patient or user. One or more concepts are also disclosed herein for achieving a headgear system that supports a shift behavior by providing portions that can be selectively made elastic or inelastic, as well as providing portions of inelastic behavior.

[0602] Figure 8A and 8B The force profiles of constant pressure therapy and variable pressure therapy are shown, along with the associated elongation behavior of elastic and inelastic headgear systems in graphical form for a full-face mask. Figure 8AThe upper plot shows the force induced in the headgear by the combination of the applied gas pressure and the mask enclosed area or simply the mask area. The lower plot shows the elongation or movement in the headgear system and thus the mask body as a result of the applied force. Two lines of elongation 34, 36 are shown in the lower elongation plot. The first line 34 shows the elongation behavior of a state of the art elastic headgear that elongates in response to the application of force. In the example shown, the elastic headgear elongates by about 8 mm under CPAP pressure compared to the length with no CPAP pressure. The second line 36 shows the elongation behavior of a state of the art inelastic headgear. As shown, the inelastic headgear exhibits very little elongation in response to the applied force.

[0603] Figure 8B Similarly, the plots of force and elongation induced in the headgear over time are included in the case of an oscillating or variable pressure therapy, such as NIV or BiPAP. For example, the therapy shown varies between a pressure of about 5 cm of H20 (e.g., expiratory positive airway pressure - EPAP) and a pressure of about 12 cm of H20 (e.g., inspiratory positive airway pressure - IPAP). The upper plot shows the force induced in the headgear by the combination of the applied gas pressure and the mask enclosed area or simply the mask area. The lower plot shows the elongation or movement in the headgear system and thus the mask body as a result of the applied force. Two lines of elongation 34, 36 are shown in the elongation plot. The first line 34 shows the elongation behavior of a state of the art elastic headgear that elongates and contracts as the applied force increases and decreases. In the example shown, the elastic headgear moves between about 4 mm and about 12 mm of elongation (correspondingly at the low and high pressures) in response to the variable force curve compared to the length with no CPAP pressure. A typical practice to reduce or prevent this movement is to over-tighten the headgear system such that the force required to elongate the headgear is greater than the force generated by the combination of the mask area and the ventilation pressure. The application of this practice often results in skin damage and the resulting wound care practices. The second line 36 shows the elongation behavior of a state of the art inelastic headgear that exhibits very little elongation but has the limitations and drawbacks described above as exhibited in Figure 8A

[0604] ​As shown in this example, today's state-of-the-art headgear systems, when used with a full-face mask and not over-tightened, will elongate in length such that the mask body will move about 8 mm to about 12 mm during the course of changing from the inspiratory peak pressure of NIV to the end- tidal pressure or changing from the IPAP to the EPAP of bi-level ventilation. In at least some configurations, the directional locking headgear systems of the present invention exhibit similar behavior to inelastic headgear in response to applied forces tending to elongate the headgear. However, such configurations of these directional locking headgear systems exhibit one or more benefits of elastic headgear (e.g., automatic sizing or automatic fit) without the drawbacks associated with related inelastic headgear (e.g., time consuming and difficult to adjust). In at least some configurations, the headgear systems incorporating directional locking devices provide less than about 4 mm of headgear elongation or mask movement in response to applied forces during therapy compared to conditions when applied to a user without system pressure. In some configurations, the headgear systems incorporating directional locking devices provide less than about 4 mm of headgear elongation or mask movement between high or maximum therapy pressure conditions and low or minimum therapy pressure conditions (e.g., inspiratory peak pressure to end-tidal pressure of NIV).

[0605] The functional behavior of this example headgear system involves different headgear elements having elongation properties in design-specific locations such that the elasticized or stretch behavior can be switched on and off as needed, preferably with one or more of the directional locks and / or directional friction mechanisms disclosed herein. This can involve different features of the headgear being configured to deliver specific performance attributes in specific locations. In the case of patient interfaces for respiratory applications, the locations of these features can depend on the interface type and the number of retention planes desired. A retention plane can be defined as one or more planes through which forces generated in the interface assembly are resolved.

[0606] For example, Figure 9 A nasal interface with a single retention plane is shown, such as a nasal pillow mask, nasal mask, or nasal cannula. A first line extends between a mounting point on a first side of the nasal interface and a mounting point on a first side of a posterior portion of the headgear. A second line extends between a mounting point on a second side of the nasal interface and a mounting point on a second side of the posterior portion of the headgear. The first and second lines cooperate to define a single retention plane. The retention plane can extend through or near the center of the nasal interface, which can be, for example, the geometric center or vertical center. In some configurations, the retention plane can be off-center, such as in configurations where it can be desirable to apply a biasing force to the nasal interface (e.g., bias upward or downward). The retention plane can extend generally from a location at or near the underside of the user's nose (e.g., slightly below the underside) to a location near but slightly above the user's ear. This arrangement can result in the retention plane having an upward tilt in the anterior-posterior direction.

[0607] Figure 10 Nasal interfaces, such as nasal pillow masks, nasal masks, or nasal cannula, are shown having multiple (e.g., two) retention planes. As described with respect to Figure 9 each retention plane is defined by lines located on each side of the interface assembly that extend between points located on the rear portion of the nasal interface and the cap. In Figure 10 arrangements, the retention planes are offset from one another so as to define an angle in the anterior-posterior direction or from the lateral view. In the shown arrangements, the first retention plane extends through a point located on an upper relative portion of the nasal interface, and the second retention plane extends through a point located on a lower relative portion of the nasal interface. The first and second retention planes can extend through a single point (or in close proximity to one another) located on the rear portion of the headgear or can be spaced apart on the rear portion of the headgear, where the planes intersect one another (cross one another) between the nasal interface and the rear portion of the headgear or can be spaced apart between the nasal interface and the rear portion of the headgear. In the shown arrangements, the first retention plane is positioned at or near the upper edge of the inlet, breathing tube connector, or gas conduit connector, and the second retention plane is positioned at or near the lower edge of the inlet, breathing tube, or gas conduit. In some configurations, the retention planes can extend along a physical portion of the headgear or interface assembly. However, in other configurations, the retention planes can not extend along a physical portion of the headgear or interface assembly. That is, for example, the retention planes can not align with the straps of the headgear.

[0608] Other types of interface assemblies can similarly utilize retention planes between the interface and the rear portion of the headgear. For example, Figure 11Full-face masks having two retention planes are shown. The shown full-face masks include an upwardly extending frame portion or T-piece that extends from a lower portion of the mask toward or to the user's forehead. In the shown arrangement, a first or upper retention plane extends between the T-piece and an upper location on the rear portion of the headgear. The upper retention plane can extend above the user's eyes and ears. The upper retention plane can be generally horizontal, but can be slightly inclined in the front-to-rear direction. For example, the upper retention plane can be slightly inclined downward in the front-to-rear direction so as to pass between the user's forehead and a central or rearmost point on the rear of the user's head. A second or lower retention plane extends between a base portion of the mask and a lower location on the rear portion of the headgear. The lower retention plane can extend between a point around the user's mouth to a point below the user's ears. The lower retention plane can be generally horizontal, but can be slightly inclined in the front-to-rear direction. For example, the lower retention plane can be slightly inclined upward in the front-to-rear direction. The upper retention plane can extend along the upper strap of the headgear. The lower retention plane can generally extend along the lower strap of the headgear; however, the lower strap can be curved so as to accommodate the user's ears such that the lower retention plane overlies end portions of the lower strap, but does not overlie at least a middle portion of the lower strap. In other configurations, one or both of the upper and lower retention planes can partially or completely overlie, partially or completely space from, or any combination of the two, the associated strap.

[0609] Figure 12 Nose masks having two retention planes are shown. Similar to the full-face masks, the shown nose masks include an upwardly extending frame portion or T-piece that extends from a lower portion of the mask toward or to the user's nose. In the shown arrangement, a first or upper retention plane extends between the T-piece and an upper location on the rear portion of the headgear. The upper retention plane can extend above the user's eyes and ears. The upper retention plane can be generally horizontal, but can be slightly inclined in the front-to-rear direction. For example, the upper retention plane can be slightly inclined downward in the front-to-rear direction so as to pass between the user's nose and a central or rearmost point on the rear of the user's head. A second or lower retention plane extends between a base portion of the mask and a lower location on the rear portion of the headgear. The lower retention plane can extend between a point around the user's mouth to a point below the user's ears. The lower retention plane can be generally horizontal, but can be slightly inclined in the front-to-rear direction. For example, the lower retention plane can be slightly inclined upward in the front-to-rear direction. The upper retention plane can extend along the upper strap of the headgear. The lower retention plane can generally extend along the lower strap of the headgear; however, the lower strap can be curved so as to accommodate the user's ears such that the lower retention plane overlies end portions of the lower strap, but does not overlie at least a middle portion of the lower strap. In other configurations, one or both of the upper and lower retention planes can partially or completely overlie, partially or completely space from, or any combination of the two, the associated strap. Figure 11The full-face mask, the nasal mask is shown to include an upwardly extending frame portion or T-piece that extends from a lower portion of the mask toward or to the user's forehead. In the arrangement shown, a first or upper retention plane extends between the T-piece and an upper location on the rear portion of the headgear. The upper retention plane can extend above the user's eyes and ears. The upper retention plane can be generally horizontal, but can be slightly inclined in the front-to-rear direction. For example, the upper retention plane can be slightly inclined downward in the front-to-rear direction so as to pass between the user's forehead and a central point or rearmost point on the rear of the user's head. A second or lower retention plane extends between a base portion of the mask and a lower location on the rear portion of the headgear. The lower retention plane can extend between a point around the user's nose to a point aligned with or below the user's ears. The lower retention plane can be generally horizontal, but can be slightly inclined in the front-to-rear direction. For example, the lower retention plane can be slightly inclined downward in the front-to-rear direction. The upper retention plane can extend along an upper strap of the headgear. The lower retention plane can extend between forward and rearward end portions of a lower strap of the headgear. The lower strap is shown to be curved so as to accommodate the user's ears, such that the lower retention plane does not overlie an intermediate portion of the lower strap. In the full-face mask, the lower retention plane can pass through the inlet of the interface, the breathing tube connector or the gas conduit connector, such as through or near the center of the inlet or connector. Figure 11 and 12 In either of the interface assemblies of

[0610] Figure 13 Alternative arrangements are shown that can be applied to either a full-face mask or a nasal mask, in which there are two retention planes that converge to a single point within the headgear system. These retention planes can be vertically spaced from one another on the interface so as to provide some degree of stability to the interface. For example, in a full-face mask, the upper retention plane can pass below or above the user's nose, and the lower retention plane can pass near or below the user's mouth. In a nasal mask, the upper retention plane can pass above the user's nose, and the lower retention plane can pass below the user's nose. These retention planes can intersect at a point that is generally above and / or forward of the user's ears. The portions of the interface assembly that couple the mask to the rear portion of the headgear can be separate or interconnected, such that a single adjustment can at least potentially alter the length of both the upper and lower portions. The ratio of the lengths of the upper and lower portions can be readily adjusted by moving the point at which the interconnected portion is located at the headgear connection point. The full-face mask shown does not include a forehead support or "T-piece." However, in some configurations, a T-piece can be provided. Additional headgear elements or straps can couple the rear portion of the headgear to the T-piece of the mask, if desired.

[0611] Figure 13.1 is a chart that identifies several general categories of headgear types based on the number and / or relative positioning of retention planes. The chart also identifies several interface types and provides an indication of the desirability or utility of the resulting headgear type and interface type combination. Because of the automatic fitting of at least some of the headgear assemblies disclosed herein, it is possible for a single headgear type to be used with multiple types of interfaces. Reference is made to Figure 13.1 Examples of possible combinations are described. These headgear types are listed in order from those that provide relatively lower stability in at least some configurations, such as those in which rotation of the interface provides little or no source of external resistance, to those that provide relatively higher stability. Figure 13.1 The headgear types listed in the chart of are not exclusive. Other headgear types can be used with the concepts disclosed herein, including modifications and hybrids of the headgear types shown.

[0612] Generally, more stable headgear configurations can be universal, or can provide at least an acceptable level of support to many or all interface types, or at least those interface types shown. In contrast, less stable headgear configurations can not be able to provide a desired or acceptable level of support to all interface types, at least without specific measures to increase the stability of such inherently less stable configurations. Generally, larger interfaces require or benefit from headgear that provides greater stability. It is often desirable or sometimes necessary to provide at least two retention planes for larger interfaces, such as full-face masks. It can be advantageous for two retention planes to be separated from one another in the vertical or height direction of the interface (e.g., at the point of attachment to the interface). Generally, the further apart the retention planes are at the interface for a given headgear assembly, the more stable the configuration. In some configurations, it can be advantageous for at least one of the retention planes to include an upward vector component.

[0613] One exemplary headgear type provides a single retention plane. Reference is made to Figure 9Examples of such arrangements are discussed. Generally, a single-locating plane headgear can be impractical for use with full-face interface types because the single-locating plane headgear does not provide the desired level of stability to the mask. Thus, the headgear can be able to secure the mask in place and maintain a seal, but the mask can not allow for relatively easy movement and breaking of the seal, or the interface assembly can not provide a secure feeling to the user despite being operable. In some cases, a single-locating plane headgear can not provide an acceptable level of stability to the mask. However, it can be possible that some configurations of single-locating plane headgear can be suitable for use with full-face masks. For example, a single-locating plane headgear utilizing rigid materials and / or configurations (e.g., shapes) can be suitable for use with full-face masks by providing resistance to rotation of the mask about a lateral axis. Additionally, a single-locating plane headgear can be suitable for use with a full-face mask by carefully positioning the single-locating plane relative to the full-face mask, as shown in Figure 13.2 and as described below with respect to Figure 13.2 A single-locating plane interface is suitable or practical for use with a nasal interface, such as a nasal mask, nasal pillows, or prongs and cannula.

[0614] Figure 13.2 A single-locating plane interface assembly is shown that includes a headgear assembly and an interface in the form of a full-face mask. The shown mask omits an over-the-ear or T-piece; however, in other configurations, a T-piece can be provided. The headgear assembly includes a headgear rear portion and a headgear length or perimeter adjustment portion that allows adjustment of the position of the mask relative to the headgear rear portion. A single-locating plane can extend from the mask to the headgear rear portion at, for example, a position above the user's ears.

[0615] The forces acting on the mask can be summarized as: a blow-off force created by the pressure within the mask acting on the sealed region of the user's face and attempting to move the mask away from the user's face, a headgear force acting on the mask to resist the blow-off force, a force exerted by the user's face along the contact region between the mask and the user's face, and a gravitational force acting on the mass of the mask and CPAP hose. The force exerted by the user's face can be summarized by an upper force and a lower force. The upper force can be a force at or near the bridge of the user's nose ("bridge force"), which can be the generally highest contact point or region in the vertical direction. The lower force can be a force at or near the user's chin ("chin force"), which can be the generally lowest contact point or region in the vertical direction.

[0616] The distributed gravity force can be summarized as a single point force ("gravity force") acting at the center of gravity of the mask and CPAP hose, which can be determined by the specific size and shape of the mask. In some configurations, a single retention plane extends in the vertical direction between the chin force and the blowout force or through a point located between the chin force and the blowout force.

[0617] The distributed blowout force can be summarized as a single point force ("blowout force") acting at a specific location of the mask, which can be determined by the specific size and shape of the mask and / or the shape of the user's face. The blowout force can be generally located in the lower half of the mask height, such as at or near the geometric center of the mask. Assuming a generally triangular mask, the blowout force can be located at approximately 1 / 3 of the height from the bottom of the mask. In some configurations, a single retention plane extends in the vertical direction between the chin force and the blowout force or through a point located between the chin force and the blowout force. Advantageously, such an arrangement can provide a desirable level of stability for a full-face mask having a single retention plane. However, this arrangement can also be applied to a multi-retention plane arrangement, where additional retention planes provide additional stability.

[0618] The nasal bridge region can be a sensitive anatomical region, and it can be desirable to avoid excessive force or pressure in this region. Thus, if the nasal bridge force is zero or minimal, the headgear force can be the only force opposing the blowout force. If the headgear force passes through a point vertically higher than the blowout force, the nasal bridge force will increase, which is generally undesirable. If the headgear force is too low or too close to the chin force, the headgear force can not be able to oppose the blowout force or can provide an undesirably low level of opposition to the blowout force, such that the sealing performance of the interface assembly is compromised. As described herein, preferably, the retention plane includes a directional lock that provides appropriate resistance to elongation of the headgear in response to the blowout force. In combination with the positioning of the retention plane as described herein, the resulting interface or headgear assembly can provide a suitable level of stability for a full-face mask with a single retention plane type headgear. For other headgear assemblies described herein, appropriate stability can be achieved without over-tightening the headgear, which is often the case with prior art headgear arrangements.

[0619] Another example headgear type provides two retention planes converging at a forward position (i.e., toward or at the interface). As described herein in connection with the example headgear types, the retention planes can be oriented to provide a desired level of stability for the interface assembly. For example, the retention planes can be oriented to provide a desired level of stability for a full-face mask, a nasal mask, or a nasal pillow mask. In some configurations, the retention planes can be oriented to provide a desired level of stability for a full-face mask having a single retention plane. In some configurations, the retention planes can be oriented to provide a desired level of stability for a full-face mask having two retention planes. Figure 13.1As used, the term "converging" is intended to describe retention planes that lack substantial spacing from one another at the interface or attachment location. It is possible that these retention planes can meet at a single attachment point; however, converging headgear types can also include those in which the retention planes attach in the vicinity of or near one another. Two-retention plane forward converging headgear types can be suitable or at least somewhat practical for use with full-face headgear, as the additional retention plane can provide sufficient additional stability. As described with respect to single retention plane headgear types, two-retention plane forward converging headgear types can employ anti-rotation materials and / or configurations in order to provide improved performance to full-face masks. Two-retention plane forward converging headgear types can be suitable or practical for use with nasal interfaces, such as nasal masks, pillows, or prongs and cannulae.

[0620] Yet another example headgear type provides two retention planes that converge at a rearward location, i.e., away from the interface, such as at a rear portion of the headgear. Two-retention plane rearward converging headgear types can provide sufficient horizontal stability in order to be suitable or practical for use with full-face masks and nasal masks. Examples of such headgear types with corresponding nasal and full-face interfaces are described herein. Figure 10 and 13 Examples of such headgear types with corresponding nasal and full-face interfaces are described. Two-retention plane rearward converging headgear types can be less practical for use with pillow or prong interface types, as such interface types typically have a relatively small vertical or height dimension. The small height of pillow and prong interface types can limit the ability to space the attachment locations of the retention planes apart on the interface and provide triangulation of the retention planes, at least without increasing the height dimension above that which is required, which can be undesirable as pillows and prongs are often precisely selected by the user due to their relatively small height dimension. Two-retention plane rearward converging headgear types can be impractical for use with cannulae, as there is no necessity to generate a sealing force against a cannula. Thus, two-retention plane headgear types can be excessive for use with cannulae. Additionally, for the same reasons as with pillows and prongs, two-retention plane rearward converging headgear types can be impractical for use with cannulae. Cannulae generally have an even smaller height dimension than pillows and prongs. However, in at least some configurations or in some cases, two-retention plane rearward converging headgear types can be practical or even desirable for use with pillows, prongs, or cannulae.

[0621] Another example headgear type provides two retention planes that are relatively, generally, or substantially horizontal or parallel to each other. In combination with the above-described reasons for the two-retention-plane converging rearward headgear type, the two-retention-plane parallel headgear type can be less practical for use with pillow or prong interface types because such interface types typically have a relatively small vertical or height dimension. For the same reasons as described above for the two-retention-plane converging rearward headgear type, the two-retention-plane parallel headgear type can be impractical for use with cannulae.

[0622] Another example headgear type provides two retention planes that are relatively, generally, or substantially horizontal or parallel to each other. In combination with the above-described reasons for the two-retention-plane converging rearward headgear type, the two-retention-plane parallel headgear type can be less practical for use with pillow or prong interface types because such interface types typically have a relatively small vertical or height dimension. For the same reasons as described above for the two-retention-plane converging rearward headgear type, the two-retention-plane parallel headgear type can be impractical for use with cannulae. Figure 11 and 12 Examples of such two-retention-plane parallel headgear types are shown and described. The two-retention-plane parallel headgear type can provide sufficient horizontal stability to be suitable or practical for use with full-face masks and nasal masks. For the reasons described above for the two-retention-plane converging rearward headgear type, the two-retention-plane parallel headgear type can be less practical for use with pillow or prong interface types because such interface types typically have a relatively small vertical or height dimension. For the same reasons as described above for the two-retention-plane converging rearward headgear type, the two-retention-plane parallel headgear type can be impractical for use with cannulae.

[0623] At least one mechanism or feature ("locking mechanism") is positioned or otherwise configured to act along at least one of the retention planes or lines, which provides the ability to transition the functionality of the headgear from an elongation behavior to a non-elongation behavior. Along this plane, the directional locking functionality can be configured to operate as a single mechanism for a given retention plane, or configured to provide two independent locking mechanisms, preferably. The single mechanism arrangement enables a change in circumference or perimeter length of the headgear or interface assembly. The two locking mechanism arrangement (e.g., one on each side of the headgear or interface assembly) provides independent left and right fine adjustment control for donning the face mask or other interface. In other arrangements, more than two locking mechanisms can be provided. In such arrangements, multiple locking mechanisms can be provided on each side of the headgear or interface assembly. Alternatively, the locking mechanisms can be positioned in other ways (e.g., one on each side and additional mechanisms on the top and / or back) and can cooperate to allow adjustment of the circumference or perimeter length of the headgear or interface assembly.

[0624] In some configurations, at least one locking mechanism is disposed on each side of the interface assembly between the face mask (or other interface) and the back portion of the headgear. In some configurations, such as the full face mask 210 with forehead support or T-piece illustrated in FIGS. 14 and 15, the face mask 210 is connected to the back portion of the headgear 220 by upper and lower connection portions, e.g., in the form of straps 230, located on each side of the interface assembly 200. Figure 14 and 15 These arrangements illustrate several exemplary locations where the locking feature or mechanism 240 can be located. In the illustrated arrangements, the interface assembly 200 includes a elasticized retraction feature or mechanism 250 that works in conjunction with or cooperates with the directional locking mechanism 240. The elasticized retraction mechanism 250 and the directional locking mechanism 240 can be incorporated into a module, which can be referred to herein as a directional locking module or simply a module. In the illustrated arrangements, the directional locking mechanism 240 can be positioned at the connection between the headgear 220 and the face mask 210, such as in an attachment clamping mechanism 260 (e.g., a clip) incorporated into the face mask body, as illustrated in Figure 14 Alternatively, as illustrated in Figure 15 the directional locking mechanism can be positioned at a suitable location within the headgear 220, such as between the back portion of the headgear 220 and the strap portion 230 of the face mask 210 that connects the back portion of the headgear 220, as illustrated in Figure 15 Similar arrangements can be utilized in other configurations that use multiple retention planes.

[0625] In some arrangements, the directional locking mechanism or module utilizes a lock coupled to or otherwise movable relative to one portion of the interface assembly and an adjustment member coupled to or otherwise movable relative to a second portion of the interface assembly. The adjustment member can be moved relative to the lock in order to allow adjustment of the circumference or perimeter length of the headgear or interface assembly. The adjustment member can be in the form of a core member, which can be a wire or filament, for example, or can be a strap. At any given size adjustment of the interface assembly, a portion of the adjustment member is utilized to define a portion of the circumference or perimeter length, and another portion can be excess or surplus length that is not utilized at the given size adjustment. The surplus length will change with changes in the circumference or perimeter length of the headgear or interface assembly. The accumulation of surplus length can be accommodated by any suitable means, such as within the overall components housed within the mask frame or headgear system.

[0626] Figure 16 and 17 Arrangements applicable to nasal interfaces 300, such as nasal masks 310 (with or without a brow support or T-piece, but typically without a brow support or T-piece), or nasal cannula are shown. In these arrangements, the directional locking mechanism 340 can be included on or operate on a flat strap 330 or webbing, as discussed above. The use of a flat strap 330 is particularly beneficial in applications where the force vector between the pressurized mask seal area and the headgear is not aligned. This results in a situation where a moment is generated that is preferably fully resolved by the rigidity within the headgear system. This is achievable by selection of the torsional and bending rigidity characteristics of the headgear strap, the combination of which significantly improves the level of rotational stability of the mask system.

[0627] In situations where the straight line between the mounting points on the headgear and the mounting points on the mask 410 provides an acceptable position for the headgear component or the component that provides the connection between the mask and the rear portion of the headgear 420, the use of a flexible core design can be desirable, as shown in Figure 17 That is, unless constrained into a modified shape, the flexible core will assume a straight line between the mounting points. Thus, the flexible core design is well suited for use in arrangements where the straight line path of the directional locking mechanism 440 (e.g., between the rear portion of the headgear 420 and the mask 410) is the desired or acceptable position for the mechanism 440.

[0628] In some arrangements, the flat strap arrangement and the flexible core arrangement can be used in combination, such as in applications where two or more planes of retention are desired or required. For example, the arrangements of Figures 11 and 12, or Figure 14 and 15The arrangement of the headgear can utilize flat strap arrangements along one of the upper leave plane or the lower retention plane and flexible core arrangements along the other of the upper leave plane or the lower retention plane. In some configurations, the lower strap can be configured for use with flat strap arrangements and the strap can be configured for use with flexible core arrangements. For example, as shown, the lower strap can have a curved shape along its length so as to pass under the user's ear and provide space to accommodate the ear. However, the upper strap can be generally straight along its length. In some configurations, the upper strap can utilize flat strap arrangements and the lower strap can utilize flexible core arrangements. For example, the rear portion of the headgear can be configured to position the mounting points such that a straight line between the headgear mounting points and the mounting points on the mask are properly positioned. In addition, as shown in FIGS. 1 1 A and 1 1 B, the use of flat or relatively rigid headgear portions that, when connected in series with the flexible core arrangements, facilitate torsional or bending stability along the sides of the user's head. Figure 18 and Figure 20 The flexibility to position the directional locking mechanism is achieved using flat or relatively rigid headgear portions that, when connected in series with the flexible core arrangements, facilitate torsional or bending stability along the sides of the user's head.

[0629] Significant performance benefits of the directional locking type headgear system or interface assembly arise when used in conjunction with respiratory ventilation modalities in which there is a high constant pressure or variable pressure waveform, such as non-invasive ventilation or bi-level ventilation, as the headgear system does not elongate during use or the circumference or perimeter length of the interface assembly remains constant. As described above, current state-of-the-art headgear devices can be generally categorized as elastic or inelastic systems. As described, inelastic systems can accommodate high constant pressure or variable pressure; however, such systems tend to over-tighten and are difficult and time consuming to adjust. Current state-of-the-art elastic headgear systems tend to elongate in response to high constant pressure or elongate or recoil in response to pressure waves of variable pressure waveforms. This elongation and recoil results in the mask cycling on the user's face, which can result in leaks. Leaks in turn can result in loss of therapy and / or mis-triggering of breaths due to the resulting volume and pressure changes within the mask. In addition, the cycling of the mask can result in abrasion due to the mask moving or migrating on the user's face and potentially result in skin damage.

[0630] Figure 18 and 19Examples are shown of portions or modules of interface assemblies configured to extend between a mask or other interface and a rear portion of a headgear, incorporating a directional locking device. Each of the shown module devices includes a detachable clip 510 that defines a coupling between a mask body and an overall headgear system that includes the module. The module includes an elastic section 520 that extends between the detachable clip 510 and a directional lock 530, which creates a retraction force that tends to move the clip 510 and the directional lock 530 toward one another. The elastic section 520 can have any suitable device, such as, for example, a braid with one or more elastic elements. Figure 18 Variations are shown with the directional lock 530 located at a rearward end of the elastic section 520 and / or at a connection point between the module and a rearward portion of the headgear, which can position the directional lock 530 in spaced relation to the mask, such as, for example, in a position shown in Figure 15 and Figure 17 .

[0631] Figure 19 Alternative variations are shown that position the directional lock 530 at a location spaced from the module and / or a connection point between the module and a rearward portion of the headgear. Such arrangements can be referred to herein as “remote” locking devices. In some configurations, the lock can be positioned elsewhere within the headgear system, such as within a rear portion of the headgear, with a hollow conduit bridging the distance between the connection point between the module and the rear portion of the headgear and the location of the directional lock. Such arrangements provide the ability to position the directional lock at a more suitable or desirable location within the headgear system, such as, for example, in a position shown in Figure 20 .

[0632] Referring to Figure 20 , the interface assembly 600 includes a mask 610 or interface, such as a nasal interface in the shown arrangement, and a headgear device that includes a rear headgear portion 620 that engages a rear portion and / or an upper portion of a user’s head. The interface assembly 600 also includes an adjustment portion 630 that allows for adjustment of the distance between the mask 610 and the rear portion 620 of the headgear. The adjustment portion 630 can be part of the headgear device, part of the interface, or can be a separate component of the interface assembly.

[0633] In the shown arrangement, the adjustment portion 630 includes a stretchable material 640 that can be configured to return toward its unstretched position. Thus, the stretchable material 640 can exhibit a retraction force that tends to decrease the circumference or perimeter length of the interface assembly. In some configurations, the stretchable material 640 is a braided material that includes non-stretch elements and stretch elements. The non-stretch elements can provide a hard stop or maximum extension, and the stretch elements can provide the retraction force. In other configurations, the stretch elements 640 or other biasing device can be positioned away from the stretchable material of the adjustment portion 630.

[0634] The illustrated interface assembly also includes a transition locking device, such as a directional lock. The illustrated directional lock includes a directional lock 650, a filament core 660, and a filament guide 670 or housing (e.g., a catheter or tube). This arrangement allows the directional lock 650 to be spaced or distanced from the attachment location 680 between the adjustment portion 630 and the nape cap portion 620. Additionally, the filament arrangement allows the directional lock 650 and the adjustment portion 630 to be in a non-linear arrangement. In other words, the functional axis of the directional lock 650 can be offset or angled relative to the axis of the adjustment portion 630 and / or the retention plane of the interface assembly 600.

[0635] The filament housing 670 can extend between the directional lock 650 and the attachment location 680 between the adjustment portion 630 and the nape cap portion 620. In the illustrated arrangement, the filament housing 670 follows a complete path between the directional lock 650 and the attachment location 680 between the adjustment portion 630 and the nape cap portion 620. For example, the directional lock 650 can be located on the crown strap 690 of the nape cap portion 620, and the filament housing 670 can bend up onto the crown strap 690 at a point located rearward of the attachment location 680. The directional lock 650 can be located at any desired point on the crown strap 690, including, for example, a side portion or an upper or top portion. In other configurations, the directional lock 650 can be located on other portions or at other locations of the nape cap portion 620, such as a side or rear portion of a rear strap of the nape cap portion 620. Such arrangements can allow the directional lock 650 to be disposed in a location that is desirably higher than the attachment point between the adjustment portion 630 and the nape cap portion 620 (referred to herein as a "remote" installation). For example, positioning the directional lock 650 on a top portion of the crown strap 690 can avoid contact with other objects (e.g., a pillow) in many situations (e.g., a user lying on their back or on their side). The particular location of the directional lock 650 can be selected based on a variety of relevant factors, such as comfort, clearance (e.g., for eyeglasses), filament length, among other things.

[0636] In some configurations, the filament housing 670 extends past the directional lock 650 to accommodate excess filament 660 that is not utilized to carry a load within the interface assembly 600. The portion of the filament housing 670 that extends past the directional lock 650 can be referred to as an accumulation portion 700 or accumulation conduit. The portion of the filament housing 670 between the directional lock 650 and the attachment location 680 between the adjustment portion 630 and the nape cap portion 620 can be referred to as a connection portion 710 or connection conduit. While shown here as a tube, the filament housing 670 can be provided in other forms, such as, for example, a filament guide. Rather than completely enclosing the filament, the filament guide device can simply provide a guide surface at particular discrete locations to guide the filament along a desired path.

[0637] One or more adjustment portions and / or transition locking devices can be provided on each side of the interface assembly. Portions of these transition locking devices located on opposite sides of the interface assembly can integrate or share components with one another. For example, an accumulation portion of a filament housing can connect a directional lock located on one side of the interface assembly with a directional lock located on another side of the interface assembly. In some configurations, a single housing can be provided on the top or back of the interface assembly and can include two separate locking mechanisms that interact with elements (e.g., filaments) associated with transition locking devices located on opposite sides of the interface assembly. Alternatively, separate transition or directional lock housings associated with locking devices located on opposite sides of the interface assembly can be positioned proximate to one another (longitudinally or laterally adjacent) on, for example, a top portion or back portion of the nape cap portion.

[0638] Headgear systems incorporating transition mechanisms as disclosed enable a portion of the headgear to selectively switch from a non-elastic-type behavior to an elastic-type behavior in order to provide comfortable donning and removal have several user benefits. Exemplary mechanisms to achieve this behavior are disclosed herein and in applicant's application number PCT / NZ2014 / 000074, the entire contents of which are incorporated herein by reference. In some configurations, one or more of these benefits relate to the ability to provide a user with the ability to interact with automatic, self-sizing, or more intuitive adjustments. Additionally, in at least some configurations, headgear systems incorporating transition mechanisms as disclosed enable undesirable movement of the mask body to be reduced or minimized as compared to today's state-of-the-art headgear systems, which are typically constructed from laminates of elasticized material with added sewn components or components that are sewn, or from elasticized knits. With these existing designs, movement of the mask due to hose pull or interaction of applied breathing pressure with the mask is likely to occur. This movement can result in conditions ranging from leaks due to resulting volume and pressure changes, loss of therapy, false triggering of breathing patterns, to skin abrasion or potential skin damage. To combat this movement, it is customary to over-tighten the headgear (by providing a high elastic force in elastic systems or manually over-tightening in adjustable non-elastic systems) so that the force required to elongate the headgear is greater than the force generated by hose pull or the force generated via pressurization of the mask. The additional pressure applied to the user as a result of this over-tightening can result in user discomfort, skin irritation, or skin damage.

[0639] Due to the functionality of one or more of the automatic-fitting or transition headgear systems disclosed herein, the elasticized behavior can be constrained to specific regions of the headgear system (in which the elasticized behavior is selectively switched on or off depending on the conditions of use) rather than the general nature of the headgear. This creates the opportunity to "design" the remainder of the headgear system to deliver specific performance attributes. In at least some configurations, the primary result of the combination of the designed, transition headgear system is to provide a behavior in which there is little to no movement in the mask body when in use.

[0640] Figure 21 and 22 For full-face masks 810 Figure 21 ) and nasal pillow masks 812 Figure 22) An exemplary headgear system 800 is shown. The indicated area 840 illustrates the presently preferred location of the portion where the selectable elastic / non-elastic functionality exists. In each application, the selectable elastic / non-elastic portion 830 is positioned between the face mask 810, 812 and the rear portion 820 of the headgear system and extends along the sides of the user's head. The remaining rear portion of the headgear system is ideally a relatively rigid three-dimensional (3D) structure that has very little elastic behavior within the range of forces encountered during normal or expected use. To achieve this behavior, in some configurations, both the form and the material construction of the headgear have a significant impact.

[0641] Form

[0642] Reference Figure 23 and 24 The use of a top strap or head top strap 940 as disclosed herein and a strap that goes around the back of the user's head (back strap 910) takes advantage of the geometry of the human head to provide repeatability of fit location and to provide stability to the headgear 900 when in use. Additional design features can be added to this basic head top strap 940 and back strap 910 arrangement in order to further enhance these desirable properties, i.e., to add gussets 920 or mesh to the back or lower strap 910 that link to the head top strap 940, as shown in Figure 23 and 24 The addition of the gusset 920 or mesh member reduces the relative movement between the back strap 910 and the head top strap 940, resulting in a laterally more stable design.

[0643] The gusset 920 can be attached to the rear strap 910 and the overhead strap 940 at any suitable location. The attachment points 930, 960 of the gusset 920 to the rear strap 910 and the overhead strap 940 can be substantially equidistant or can be equidistant, or spaced different distances from the junction 950 between the rear strap 910 and the overhead strap 940. In the illustrated arrangement, the gusset 920 is attached to the overhead strap 940 at a location that is farther from the junction 950 than the gusset 920 is attached to the rear strap 910. The distance on the overhead strap 940 from the junction 950 to the gusset 920 can be approximately twice or more the distance on the rear strap 910 from the junction 950 to the gusset 920. In the illustrated arrangement, the distance on the overhead strap 940 between the attachment points 960 of the gusset 920 on each side of the headgear 900 can be less than the distance between the junction 950 and the attachment point 960 of one of the gussets 920. That is, the length of the distance between the gussets 920 on the overhead strap 940 is less than one-third of the total length of the overhead strap 940. The rear strap 910 and / or the overhead strap 940 can be continuous or can be discontinuous. Segments of a discontinuous rear strap 910 or overhead strap 940 can be connected by suitable links, which can be fixed length, elastic, or adjustable.

[0644] Construction / Manufacture

[0645] The overall form of the headgear can be produced by several different techniques. For example, the headgear can be cut from a single piece of at least relatively or substantially inelastic material. In other configurations, the headgear can be injection molded from a single or multiple thermoplastic or thermoset materials. In some configurations, the headgear or headframe is constructed from a single material that varies in cross-sectional geometry, providing portions with enhanced or reduced torsional and / or bending stiffness, to enable the profile of the headgear to smoothly conform to the human head form, as Figures 25-28 illustrated. In other configurations, the headgear can be constructed by co-molding or multi-molding different materials in different portions to achieve the same or similar behavior, as Figure 29 illustrated.

[0646] Different portions of the headgear can be constructed to have desired properties in desired portions or regions of the headgear. For example, for the portion extending over the user's ears (cross-section 1), it can be desirable to provide limited flexibility such that bending movement about a lateral axis or twisting movement about a longitudinal axis is limited. The portions behind cross-section 1 (cross-sections 2 and 3) desirably conform closely to the shape of a human head. Desirably, each of cross-sections 1, 2 and 3 exhibit relatively inelastic behavior over the range of forces normally encountered or expected in use. To achieve this behavior, different material combinations can be used. In the illustrated example, thermoplastic elastomers or thermoplastic urethanes having different Shore hardnesses are used to achieve the desired behavior.

[0647] As described above, the headgear can include different portions having different cross-sectional dimensions such that the properties of the headgear can be varied in different regions of the headgear. With reference to Figs. 25-28, a rear headgear portion ending generally forward of the user's ears is shown, and the headgear rear portion is simply referred to as headgear 1000. Three vertical cross-sections of headgear 1000 are illustrated. Cross-section 1 is taken in the portion of headgear 1000 extending over the front of the user's ears. Cross-section 2 is taken in the portion of headgear 1000 rearward of cross-section 1 and can be generally positioned rearward of the user's ears. In the illustrated arrangement, cross-section 2 is between head top strap 1010 and gusset 1030. Cross-section 3 is taken in a position of the headgear rearward of cross-section 1 and cross-section 2. In the illustrated arrangement, cross-section 3 is taken in a position on the rear portion of headgear 1000 that can contact the rear of the user's head.

[0648] Preferably, the portion containing cross-section 1 is relatively high so as to provide resistance to vertical bending loads that will attempt to move the front end of headgear 1000 in the vertical direction. In the illustrated arrangement, the portion containing cross-section 1 has a greater height than the portion containing cross-section 2. In some configurations, the portion containing cross-section 3 has a greater height than the portion containing cross-section 2. In some configurations, the portion containing cross-section 3 has a greater height than the portion containing cross-section 1. The portion of headgear 1000 behind the user's head (e.g., the portion containing cross-section 3) typically exerts a greater force on the user's head because it directly opposes the blowing open force of the interface. It can therefore be preferable to enlarge the area of this rear portion by providing a relatively large height to the rear portion so as to improve user comfort. In the illustrated configuration, the height at cross-section 1 is about 10 mm, the height at cross-section 2 is about 3 mm, and the height at cross-section 3 is about 15 mm. In other configurations, other dimensions can be used. For example, the dimensions can be different, but headgear 1000 can maintain the same height ratio between any or all of cross-sections 1, 2, and 3. In other configurations, the dimensions can vary by a particular number (e.g., 1 mm, 2 mm, or 3 mm) or by a proportion that is higher or shorter than the illustrated dimensions. In some configurations, the height of headgear 1000 changes gradually between cross-sections 1, 2, and 3. The actual height at any point on headgear 1000 can be selected to meet appropriate performance parameters, such as bending resistance, force distribution, and fit or clearance considerations.

[0649] In some configurations, the thickness of the headgear 1000 can decrease in a direction from the front end toward the rear end. For example, the portion containing cross-section 1 can have a thicker cross-section relative to the portions containing cross-sections 2 and 3, such that the portion containing cross-section 1 (the front end portion) has a greater resistance to torsional loads. Additionally, the portion containing cross-section 2 can have a thicker cross-section relative to the portion containing cross-section 3. Thus, the portion containing cross-section 2 has a greater resistance to torsional loads than the portion containing cross-section 3. In some configurations, the difference in thickness between the portion containing cross-section 1 and the portion containing cross-section 2 is greater than the difference in thickness between the portion containing cross-section 2 and the portion containing cross-section 3. The reduced thickness of the portions containing cross-sections 2 and 3 allows these portions to bend in the lateral direction in order to more highly conform to the particular shape of the user's head. In the illustrated arrangement, the thickness at cross-section 1 is about 1.5 mm, the thickness at cross-section 2 is about 1 mm, and the thickness at cross-section 3 is about 0.8 mm. In other configurations, other dimensions can be used. For example, these dimensions can be different, but the headgear 1000 can maintain the same thickness ratio between any or all of cross-sections 1, 2, and 3. In other configurations, these dimensions can vary by a particular amount (e.g., 0.1 mm, 0.2 mm, or 0.3 mm) or by a proportion that is thicker or thinner than the illustrated dimensions. In some configurations, the thickness of the headgear 1000 changes gradually between cross-sections 1, 2, and 3. The actual thickness at any point on the headgear 1000 can be selected to meet appropriate performance parameters, such as resistance to torsional loads and lateral flexibility, in order to improve fit.

[0650] Reference Figure 29 As discussed above, the headgear 1100 can alternatively or additionally vary in material type throughout the headgear 1100 in order to provide different properties in different portions of the headgear 1100. Figure 29 The headgear 1100 of FIG. 1 1 illustrates three cross-sections taken at different locations within the headgear 1100, which can be the same or substantially the same as the locations of the headgear 1100 of FIG. 1 1. Figures 25-28 The portion containing cross-section 1 can be constructed of a first material or material combination, such as, for example, polypropylene. Similar to the headgear 1000 of FIG. 1, the portion containing cross-section 2 can be constructed of a second material or material combination, such as, for example, polyethylene. The portion containing cross-section 3 can be constructed of a third material or material combination, such as, for example, polyethylene terephthalate. Figures 25-28The material selection for the portion containing cross-section 1 of headgear 1000 can take into account a desire to provide bending resistance in the vertical direction. The material or material combination for the portion containing cross-section 2 can be different than the material for one or both of the portions containing cross-sections 1 and 3. For example, the portion containing cross-section 2 can be constructed from a second material or material combination, such as a combination of thermoplastic polyurethane (TPU) and thermoplastic elastomer (TPE). The material or material combination for the portion containing cross-section 3 can be different than the material for one or both of the portions containing cross-sections 1 and 2. For example, the portion containing cross-section 3 can be constructed from a third material or material combination, such as TPE. The considerations for material selection for different portions of headgear 1100 can be the same or similar to the considerations described with respect to the size selection for headgear 1000. Figures 25-28

[0651] In some configurations, the material selection results in headgear 1100 having different durometers or hardnesses in different portions. For example, the portion containing cross-section 1 can have the highest durometer. In some configurations, the portion containing cross-section 1 can have a durometer of about 65-70 Shore D. The portion containing cross-section 2 can have a lower durometer than the durometer of the portion containing cross-section 1. In some configurations, the portion containing cross-section 2 has the lowest durometer of the portions containing cross-sections 1, 2, and 3. For example, the portion containing cross-section 2 can have a durometer of about 70 Shore A. The portion containing cross-section 3 can have a durometer between the durometers of the portions containing cross-sections 1 and 2. For example, the portion containing cross-section 3 can have a durometer of about 40 Shore D. The considerations for hardness selection for different portions of headgear 1100 can be the same or similar to the considerations described with respect to the size selection for headgear 1000. Figures 25-28

[0652] Combinations of these techniques are also possible. For example, two or more of these sizes, materials, and hardnesses can be selected to provide varying properties throughout the headgear. In some cases, the headgear takes on a 3D form that contours to a human head, behaves in a substantially non-elasticized manner, and provides stable connection points for a transition locking device.

[0653] The material selection for one or more portions of the headgear can also involve other considerations. For example, in some configurations, a portion or the entire headgear can comprise a material that exhibits little tendency to absorb moisture. In some configurations, a portion or the entire headgear can comprise a material that exhibits water vapor permeability. Advantageously, in the case of such configurations, the headgear can avoid or prevent moisture absorption, such as sweat absorption, or can allow moisture to move through the headgear material. Either configuration can improve the comfort of the user.

[0654] ​​The headgear can be further improved by incorporating a textile-based liner or padding into either or both of the inner and outer surfaces in order to design the textural and / or three-dimensional conformance properties of the headgear. In some configurations, hair pull and / or edge awareness by the wearer is reduced or minimized. When the liner or padding is provided on only one side (inner or outer) of the headgear, or is otherwise distinguishable between sides (e.g., different colors on the inner side than on the outer side), this feature aids in the usability of the overall device as it provides a visual cue to the user regarding the wear orientation of the headgear.

[0655] In some configurations, the headgear can include one or more adjusters that allow the size of the headgear to be adjusted. For example, an adjuster can be provided in a strap portion of the headgear in order to allow the length of the strap portion to be adjusted. An adjuster can also be provided between strap portions in order to allow the relative position of the strap portions to be adjusted. In some configurations, the adjusters are self-adjusting or allow self-adjustment of the headgear. As used herein, self-adjusting refers to an adjuster that allows the headgear to be adjusted from a first position (e.g., a first length or relative position) to a second position (e.g., a second length or relative position) and to be held in the second position without manipulation by the user (e.g., a manual lock). In some configurations, the adjusters can include a biasing element or device. For example, an adjuster can include a biasing device that tends to bias the strap portions in a first direction (e.g., toward a reduced length). Thus, the adjusters can simply allow the user to manipulate the headgear and then automatically secure the headgear in the desired position, or the adjusters can aid in moving the headgear toward a proper fitting position and then automatically secure the headgear in the proper fitting position. Such adjusters can include any of the transition locking devices disclosed in Applicant's application number PCT / NZ2014 / 000074.

[0656] Figure 30 and 31Examples of positions in which the automatic adjuster can be positioned within the headgear 1200 are shown. For example, the automatic adjuster can be positioned at position 1200A, at or near the junction between the top strap or headband portion and the circumferential or upper portion located above the user's ears. The automatic adjuster can be positioned at position 1200A on each side of the headgear 1200. The automatic adjuster at position 1200A allows adjustment of the relative position of the upper portion of the headgear 1200 with respect to the headband 1210, such as in the front-back direction. Alternatively, the automatic adjuster at position 1200A can allow adjustment of the circumferential length of a portion of the headgear 1200. In other words, the length of the upper portion of the headgear 1200 can be adjusted by the automatic adjuster at position 1200A. The automatic adjuster can be positioned at position 1200B, located within the top strap or headband 1210. The automatic adjuster at position 1200B allows adjustment of the length of the head strap 1210. The automatic adjuster can be positioned at position 1200C, which is within the rear or lower portion of the hood 1200. A single automatic adjuster can be positioned within the rear portion, or the automatic adjuster can be located within each side of the lower portion of the hood 1200. Alternatively, the automatic adjuster at position 1200C can allow adjustment of the circumferential length of the lower portion of the hood 1200.

[0657] The automatic adjuster can be located in any one, any combination, or all of positions 1200A, 1200B, and 1200C, and / or elsewhere within the hood. In some configurations, the automatic adjuster is provided to allow adjustment of the rear hood portion to fit the user's head. Therefore, in addition to a shift locking mechanism, such an automatic adjuster can be located between the rear hood portion and the interface, and can be configured to adjust the relative position of the interface and the rear hood portion and apply an appropriate sealing or retaining force to the interface.

[0658] refer to Figures 32-34 The specific strap adjustment mechanism 1300 is shown. Figures 32-34 The adjustment mechanism 1300 is essentially similar to that in the applicant's PCT application number PCT / NZ2014 / 000074. Figures 40-42 The flat strap adjustment mechanism or directional locking mechanism is shown and described. However, in some configurations, Figures 32-34 The strap adjustment mechanism 1300 includes integrated padding or lining, as described above. In some configurations, the components of the strap adjustment mechanism 1300 are constructed by molding a moldable material onto a textile-based material.

[0659] Figures 32-34An adjustable strap 1300 is shown in assembled form, and portions of the adjustable strap are shown separately and in plan view, in order to show different components of the adjustment mechanism. The adjustment mechanism 1300 includes a first portion 1310 that can be coupled to a second portion 1320 in a plurality of adjustment positions. In some configurations, the first portion 1310 and the second portion 1320 can be infinitely adjustable over a provided adjustment range. The first portion 1310 and the second portion 1320 shown are first and second portions of an adjustable top strap or overhead strap; however, adjustable straps can be provided in other locations, as described in connection with, for example, FIGS. 30 and 31. As described above, a biasing device can be provided to bias the first portion 1310 and the second portion 1320 relative to one another, for example, toward a shortened position.

[0660] Preferably, the adjustment mechanism 1300 includes a directional lock that allows relative movement of the first portion 1310 and the second portion 1320 in a first direction (e.g., toward a shortened position) and provides a yield force that inhibits movement in a second direction. The yield force is preferably sufficient to prevent significant movement in the second direction under normal or expected operating conditions, but can be overcome by an applied force in order to allow desired adjustment of the first portion 1310 and the second portion 1320.

[0661] The first portion 1310 of the adjustment mechanism 1300 can include a substantially flat strap 1312 that forms a convex portion of the adjustment mechanism 1300. The second portion 1320 of the adjustment mechanism can include a receiver or lock housing 1322 that forms a concave portion of the adjustment mechanism. The lock housing 1322 can include a space 1324 that receives a locking member, such as a locking washer. The flat strap 1312 is movable within the receiver 1322 and through the space 1324 that receives the locking washer. The flat strap 1312 also passes through the locking washer. The locking washer is movable within the space 1324 of the lock housing 1322 between a released position and a locked position. In some configurations, the released position is defined by orienting the locking washer substantially perpendicular to the length of the flat strap 1312, and the locked position is defined by tilting the locking washer from the perpendicular orientation of the released position.

[0662] The position of the locking washer can be controlled by any suitable means, such as by being urged into a desired position by the ends of the space 1324 of the lock housing 1322. For example, one end of the space 1324 of the lock housing 1322 can have a vertical surface and the other end can have an inclined surface. When the flat strap 1312 is moved in a direction toward the vertical surface, the locking washer is urged into a vertical orientation or release position and the flat strap 1312 can be moved relative to the lock housing 1322 with relatively low resistance. When the flat strap 1312 is moved in a direction toward the inclined surface, the locking washer is urged into an inclined orientation or locked position and relative movement between the flat strap 1312 and the lock housing 1322 is resisted by the yield force. The flat strap 1312 can include a gripping portion that facilitates movement of the locking washer. The gripping portion can be a higher friction material or a material that has a higher grip on the locking washer than the base material of the flat strap 1312.

[0663] In some configurations, each of the flat strap 1312 and the lock housing 1322 are constructed by molding a material onto the textile-based material of the first strap portion 1310 and the second strap portion 1320, respectively. In the illustrated configuration, a portion of the flat strap 1312 extends beyond the end of the textile-based material of the first strap portion 1310. In contrast, the textile-based material of the second strap portion 1320 extends beyond the lock housing 1322. Desirably, the portion of the flat strap 1312 received within the lock housing 1322 extends beyond the textile-based material of the first strap portion 1310 so as to avoid interference between the first strap portion 1310 and the textile-based material of the second strap portion 1320 over the adjustment range of the adjustment mechanism. The portion of the second strap portion 1320 that extends beyond the lock housing 1322 can be configured so that the textile-based material of the first strap portion 1310 abuts or overlaps with the textile-based material of the second strap portion 1320 in the maximum position or the position of greatest separation of the first portion 1310 and the second portion 1320.

[0664] In some configurations, the molded material extends beyond the flat strap and / or the lock housing along the textile-based material of the strap portions. For example, the molded material can be provided as a reinforcement for the textile-based material of the strap portions or as a stiffening member for the textile-based material. Additional molded material can be provided to increase the surface area between the molded material and the textile-based material so as to improve the connection therebetween and / or increase the holding force therebetween. In the illustrated arrangement, the additional molded material is in the form of strips or ribs that are separated from one another in the width direction of the strap portions and generally extend in the length direction of the strap portions.

[0665] In the illustrated configuration, the strap portions 1310, 1320 are desirably relatively rigid in one direction (in the width direction, so as to inhibit bending), but remain flexible in the other direction (in the thickness direction, so as to allow the strap to bend and conform to the user's head). This can be achieved through the textile-based strap portions and / or the geometry of the overmoulded features and / or through the use of different overmoulding materials. In other configurations, other properties can be desirable, such as other locations of adjustment mechanisms. Accordingly, other geometries and / or materials can be selected to provide the desired properties to these strap portions.

[0666] In some configurations, the composite strap portions are constructed through an overmoulding process involving moulding a mouldable material 1340 onto a textile or fabric material 1350. In some configurations, the mouldable material 1340 can be a plastic material. The textile or fabric material 1350 is preferably selected to provide good adhesion of the mouldable material.

[0667] The textile-based material can be placed into a mould. The mould can be closed and portions (e.g. edges) of the textile-based material can be captured between separate portions (e.g. halves) of the mould. The mouldable material can then be injected into the mould and onto the textile-based material.

[0668] As disclosed in applicant's patent application number PCT / NZ2014 / 000074, a number of different types of directional locking mechanisms can be utilised in headgear exhibiting balanced fit characteristics. In at least some configurations, the directional lock inhibits or prevents relative movement between two portions of the headgear in a first direction, at least below the yield force of the directional lock. The directional lock also allows relative movement between the two portions of the headgear in a second direction, opposite to the first direction. Preferably, movement in the second direction is allowed without more than a relatively small amount of resistance.

[0669] Reference Figure 35In some configurations, the first portion of the cap includes a core member 1400. The core member 1400 may be a filament, a filament-like element, or a thread. The second portion of the cap may include a housing 1410. The first and second portions of the cap may be coupled to any suitable part or component of the cap, which is movable relative to each other to change or adjust the circumference of the cap. The housing 1410 may be an element or receiver defining a space 1412 for receiving a locking device 1420. The housing 1410 may be a separate component from the cap, or it may be an integral part or portion of the cap. The locking device 1420 may engage the core member 1400 to inhibit or prevent movement of the core member 1400 relative to the housing 1410 in a first direction, at least below the yield force of the directional lock. The locking device 1420 may also disengage from the core member 1400 to allow movement of the core member 1400 relative to the housing 1410 in a second direction opposite to the first direction.

[0670] Locking device 1420 may include two or more locking elements movable between a first or locked position 1430 and a second or released position 1440. The illustrated locking device 1420 includes a pair of locking elements in the form of locking claws 1422. Each of the locking claws 1422 is a generally semi-cylindrical member. The locking claws 1422 cooperate to surround the core member 1400. The inner surface of each of the locking claws 1422 facing the core member 1400 is concave. Each of the locking claws 1422 includes an engaging portion 1424 that contacts the core member 1400 in the locked position 1430, such that the locking claws 1422 cooperate to engage the core member 1400. In the illustrated arrangement, the engaging portion 1424 is defined by an end portion of each of the locking claws 1422.

[0671] Each of the locking claws 1422 has its opposite end extending through the housing 1410 and includes a radially extending flange 1426. The directional lock may include a biasing device, in some configurations, which provides a tendency to orient the locking device toward a locked position or toward... Figure 35 A relatively light biasing force is applied to the left side of the page. The biasing device may include a biasing element 1428, such as a spring, that acts against the flange 1426 of the locking pawl 1422 and the end surface 1414 of the housing 1410. Preferably, the biasing device provides a light biasing force when the core member 1400 moves in a direction that tends to increase the circumference of the cap (towards...). Figure 35 When the core member moves to the left side of the cap, the slight biasing force assists the initial movement of the locking pawl 1422 toward the locking position 1430. Figure 35When the locking pawls 1422 are moved upward (to the right in FIG. 14A), the locking pawls 1422 can move against the biasing force of the biasing device toward the release position 1440.

[0672] As described above, the housing 1410 defines a space or channel for receiving the locking pawls 1422 and through which the core member 1400 can pass. The channel 1412 can define a chamfered, angled, or tapered surface 1416 that facilitates movement of the locking pawls 1422 between the locked position 1430 and the release position 1440. One or more locking elements or roller elements 1418 can be positioned between each of the locking pawls 1422 and the housing 1410. Movement of the locking pawls 1422 along the longitudinal axis of the housing 1410 or channel 1412 in a direction toward the locked position 1430 causes the roller elements 1418 to engage the tapered surface 1416, which causes the roller elements 1418 and thus the locking pawls 1422 to move closer to one another, such that the core member 1400 is clamped between the locking pawls 1422. Movement of the locking pawls 1422 along the horizontal axis in a direction toward the release position 1440 causes the roller elements 1418 to move freely in a radial direction away from the locking pawls 1422, thereby releasing the clamping force from the locking pawls 1422 and allowing the core member 1400 to move relatively without significant resistance. Such movement of the core member 1400 can cause the locking pawls 1422 to move axially via the frictional force against the biasing force of the biasing device.

[0673] The core member 1400, the locking pawls 1422, the tapered surface 1416, and / or the roller elements 1418 can be configured such that the directional locks exert a clamping force on the core member 1400 that substantially inhibits or prevents movement of the core member 1400 relative to the housing 1410 when a force below the yield force that attempts to elongate the headgear is applied to the core member 1400, and that allows movement of the core member 1400 when a force above the yield force that attempts to elongate the headgear is applied to the core member 1400. As described above, such an arrangement can allow the headgear to incorporate one or more of the directional locks to resist normal or expected forces associated with therapy, while also allowing the headgear to be elongated for donning on or removal from a user. The directional locks can release the core member 1400 in response to movement of the core member 1400 attempting to retract the headgear, in order to allow the core member 1400 to move relative to the housing 1410 with relatively little resistance. Such an arrangement can allow the headgear to incorporate one or more of the directional locks to retract, in order to fit the head size of a particular user. A retraction force that tends to retract the headgear can be provided by any suitable method or mechanism, including manual retraction or automatic retraction caused by a resilient device or element of the headgear.

[0674] Figure 36The operating cycle of a headgear incorporating a directional lock, such as the directional lock described above, any other directional lock described or incorporated by reference herein, or any other suitable directional lock, is illustrated. In the operating cycle diagram, the component of the arrow in the upward direction represents elongation of the headgear (an increase in the circumference of the headgear), and the component of the arrow in the downward direction represents retraction of the headgear (a decrease in the circumference of the headgear). The component of the arrow to the right in Figure 36 represents an elongation movement of the headgear, and the component of the arrow to the left represents a retraction movement of the headgear.

[0675] Figure 36 Described with reference to the structure of the directional lock just described above; however, the basic concepts highlighted by the present specification can equally apply to many or all of the other directional locks described or incorporated herein. The central arrow above represents movement of the core member in a direction tending to elongate the headgear due to an applied force above the yield force of the directional lock. As a result, the core member is able to slide past the locking jaws, which are clamped against the core member by the interaction of the roller elements with the tapered surface of the passage of the outer shell. Such a force can be applied when the headgear is applied or removed.

[0676] The next arrow in the clockwise direction represents a change in direction of the core member from elongation to retraction. Such a change in direction results in the release of the clamping force on the core member.

[0677] The next arrow in the clockwise direction represents a retraction movement of the core member. As a result, the core member movement can cause the locking jaws to move such that the roller elements are not forced into the narrow portion of the tapered surface. As a result, a relatively free retraction movement of the core member can occur. Such movement can allow the headgear to retract to fit a particular user or to a minimum circumference when not in use.

[0678] The next arrow in the clockwise direction represents a change in direction of the core member from retraction to elongation. Such a change in direction results in the application of a clamping force on the core member. In each case of a change in direction, some movement of the core member can occur before the change in clamping force or the change in position of the directional lock occurs or is fully achieved. Such a cycle can be repeated when the headgear is applied to or removed from a user. In some cases, the cycle can occur when a user is making fine adjustments to the headgear.

[0679] Figures 37-53A headgear assembly 1500 including one or more directional locks 1510 is illustrated. The illustrated headgear assembly 1500 is configured for coupling to a portion of an interface 1520. In particular, the illustrated headgear assembly 1500 includes a headgear rear portion 1530, an interface coupling portion 1540, and a length or circumference adjustment portion 1550 interposed between the headgear rear portion 1530 and the interface coupling portion 1540. The headgear rear portion 1530 is configured to contact a rear portion of a user's head in use. The interface coupling portion 1540 is configured to couple to the interface 1520 in use such that the headgear assembly 1500 can support the interface 1520 in place on a user's face. The length or circumference adjustment portion 1550 is configured to allow adjustment of the position of the interface coupling portion 1540 relative to the headgear rear portion 1530 in use such that the headgear assembly 1500 can be adjusted to a particular user's head size. Thus, the length or circumference adjustment portion 1550 can allow adjustment of the peripheral length or circumference of the headgear in order to allow the headgear assembly 1500 to fit a particular user's head size.

[0680] Although illustrated and described as a headgear assembly 1500, in some configurations, the portions of the illustrated headgear assembly 1500 can be included in any other suitable portion of an overall interface assembly. For example, the interface coupling portion 1540 can comprise a component or portion of the interface that is separate from and connectable to the headgear assembly 1500. The length or circumference adjustment portion 1550 can comprise a component or portion of the interface that is separate from and connectable to the headgear assembly 1500, or a component or portion of the headgear assembly 1500 that is separate from and connectable to the interface 1520. Advantageously, however, and as further described above, the illustrated headgear assembly 1500 can comprise a self-contained, automatic fitting headgear unit that exhibits a balance-fitting characteristic and can be coupled to at least one and possibly multiple types of interfaces. Thus, in at least some configurations, one type of illustrated headgear assembly 1500 can be used with multiple types of interfaces. As a result, a seller can stock a smaller number of unique products while offering the same interface options. Additionally, a user can utilize a single headgear assembly and swap interfaces as desired without having to manually adjust the headgear assembly when changing from one interface to another.

[0681] In the illustrated arrangement, the headgear rear portion 1530 includes at least one strap portion 1560 that contacts the user's head. Preferably, the at least one strap portion 1560 contacts a rear portion or the back of the user's head such that the at least one strap portion 1560 can resist forces induced in the headgear assembly 1500 by pressurization of the interface during therapy. In some configurations, the strap portion 1560 extends generally or substantially in a lateral direction around the back of the user's head and has one end on each side of the user's head. Each end can be coupled to another portion of the headgear assembly 1500, such as, for example, the circumference adjustment portion 1550.

[0682] In some configurations, the at least one strap portion 1560 includes a first strap portion and a second strap portion. The first strap portion can be a rear strap portion 1562 that extends around the back of the user's head and the second strap portion can be a top strap portion or an upper strap portion 1564 that extends over the user's head. The rear strap portion 1562 can be positioned to contact a portion corresponding to one or both of the occipital or parietal bones of the user's head. The top strap portion 1564 can be positioned to contact a portion corresponding to one or both of the parietal or frontal bones of the user's head. Thus, the top strap 1564 can be configured as either a crown strap or a forehead strap, as such straps are sometimes characterized in the prior art. Other suitable arrangements can also be used.

[0683] Preferably, the headgear rear portion 1530 engages the user's head and provides a relatively stable platform for connection of the interface, such as with the interface coupling portion 1540 and the circumference adjustment portion 1550. Thus, in at least some configurations, the headgear rear portion 1530 is substantially inelastic such that it maintains its shape and effective length in response to applied forces within a range that is characteristic or expected for the desired application. In some configurations, the headgear rear portion 1530 can include a layer of relatively rigid material, such as a plastic material, coupled to one or more layers of fabric material. Preferably, a fabric layer is provided on at least the surface of the rigid material layer that contacts the user. In some configurations, a fabric layer is provided on each side of the rigid material layer. Further, in some configurations, the rigid material layer can be formed between the material layers, such as by injection molding of the rigid material into a space between the two material layers within a mold. Examples of such headgear and methods of making such headgear are disclosed in Applicant's U.S. Provisional Application No. 62 / 050,925, which is hereby incorporated by reference in its entirety.

[0684] The circumference adjustment portion 1550 can include a pair of adjustment elements 1552, one of which is positioned on each side of the headgear assembly 1500. In particular, each of the adjustment elements 1552 can couple one side of the headgear rear portion 1530 with one side of the interface coupling portion 1540. The adjustment elements 1552 can be coupled at or near the junction between the top strap 1564 and the rear strap 1562. In the illustrated arrangement, the adjustment elements 1552 are coupled to forwardly extending portions of the headgear rear portion 1530 that extend in a forward direction from the junction between the top strap 1564 and the rear strap 1562. The adjustment elements 1552 are adjustable in length between a retracted length and an extended length. In some configurations, the adjustment elements 1552 cooperate to provide adjustment of substantially all of the circumference of the headgear assembly 1500. Each of the adjustment elements 1552 can also include a resilient element or biasing means that biases the adjustment element 1552 toward one of the retracted length or the extended length. Preferably, the adjustment elements 1552 are biased toward the retracted length, such that the headgear assembly 1500 is biased toward its minimum circumference. This arrangement allows the headgear assembly 1500 to be extended and then automatically retract to fit a particular user under the biasing force of the resilient element or other biasing means of the adjustment elements 1552. In addition, preferably the adjustment elements 1552 define a hard stop or maximum extended length, to limit the extension of the headgear 1500 and define a maximum circumference of the headgear 1500.

[0685] In some configurations, the adjustment elements 1552 include a braided element 1554 that can be extended or retracted in length. The braided element 1554 can include one or more resilient elements parallel to the braided element 1554. These resilient elements can be separate from or contained within the braided element 1554. In some configurations, these resilient elements are contained within the internal space between the filaments of the braided element 1554. Examples of suitable braided elements are described in connection with the Applicant's patent application number PCT / NZ2014 / 000074 Figures 46-54 However, other suitable configurations or arrangements can also be used. Alternatively, the resilient or biasing elements can be located within the interface coupling portion and can interact with the core member to draw the core member into the interface coupling portion.

[0686] The interface coupling portion 1540 of the headgear assembly 1500 can extend between a pair of adjustment elements 1552 that make up a circumference adjustment portion 1550. In some configurations, the interface coupling portion 1540 is directly coupled to the adjustment elements 1552. As described above, the interface coupling portion 1540 can facilitate connection of the headgear assembly 1500 to the interface 1520. However, the interface coupling portion 1540 can also house at least a portion of one or more directional locks 1510. In the illustrated arrangement, a pair of directional locks 1510 are provided, with one directional lock 1510 associated with one of the pair of adjustment elements 1552. Portions of the directional locks 1510 (e.g., housings 1512) can be located at each end of the interface coupling portion 1540. In some configurations, a core member 1570 associated with each of the directional locks 1510 is coupled to the headgear rear portion 1530, extending along or through the adjustment elements 1552, through the housings 1512 of the directional locks 1510, and into a collection space 1542 of the interface coupling portion 1540. The housings 1512 of the directional locks 1510 can include one or more members or elements (e.g., locking washers or locking claws) that interact with the core member 1570 to selectively allow the headgear assembly 1500 to be retracted or locked in a particular circumference, and inhibit or prevent the headgear 1500 from being extended at least at forces below a yield force provided by the directional locks 1510. Further details of the operation of the directional locks 1510 are described above and in Applicant's patent application number PCT / NZ2014 / 000074.

[0687] In some configurations, one or both of the core member 1570 and the adjustment elements 1552 are secured to the headgear rear portion 1530 by encapsulating the core member 1570 and / or the adjustment elements 1552 within the headgear rear portion 1530. For example, the core member 1570 and / or the adjustment elements 1552 can be positioned within a mold, and a rigid material portion of the headgear rear portion 1530 can be formed by injection molding such that the rigid material portion encapsulates the core member 1570 and / or the adjustment elements 1552. In the illustrated arrangement, end portions of the adjustment elements 1552 and end portions of the core member 1570 are encapsulated within the rigid material portion of the headgear rear portion 1530. However, other suitable arrangements can also be used.

[0688] In some configurations, the adjustment elements 1552 include end cap portions 1556 that couple the braided elements 1554 with the elastic elements. The end cap portions 1556 can be applied to the ends of the adjustment elements 1552 by an overmolding process. Specifically, the braided elements 1554 and the elastic elements can be placed in a mold, and the end cap portions 1556 can be formed by injection molding over the end portions of the braided elements 1554 and the elastic elements. In some configurations, the braided elements 1554 and / or the elastic elements are held in a stretched state during the overmolding process. In some configurations, the adjustment element subassemblies are then coupled to the headgear rear portion 1530, such as by the overmolding process described above. Accordingly, the end cap portions 1556 of the adjustment elements 1552 can be encapsulated by the headgear rear portion 1530.

[0689] The end cap portions 1556 of each of the adjustment elements 1552 opposite the headgear rear portion 1530 can be coupled to the interface coupling portion 1540 by any suitable means. In the illustrated configuration, the end cap portions 1556 of the adjustment elements 1552 are coupled to collars or sockets 1580, which in turn are coupled to the interface coupling portion 1540. For example, the end cap portions 1556 can be press fit or otherwise secured within the sockets 1580. The sockets 1580 can include neck portions 1582 that space the retention portions 1584 of the sockets 1580 from the main bodies 1586. The neck portions 1582 can extend through the openings 1544 in the interface coupling portion 1540, and the retention portions 1584 of the sockets 1580 can prevent the sockets 1580 from being separated from the interface coupling portion 1540. In some configurations, the retention portions 1584 of the sockets 1580 can be integrated with the housings 1512 of the directional locks 1510.

[0690] In some configurations, the interface coupling portion 1540 can be defined by multiple pieces that cooperate to define a collection space. The multiple pieces can also cooperate to define spaces 1590 for receiving the housings 1512 of each of the directional locks 1510. In the illustrated arrangement, the interface coupling portion 1540 includes a first piece 1592 and a second piece 1594 that can be connected to define the collection space 1596 and a pair of the spaces 1590 for receiving the housings 1512 of the directional locks 1510. The first piece 1592 and the second piece 1594 can correspondingly be an upper piece and a lower piece. In other arrangements, the first piece 1592 and the second piece 1594 can be, for example, a front piece and a rear piece. The provision of separate pieces facilitates assembly of the housings 1512 of the directional locks 1510, the core members 1570 of the directional locks 1510, and the sockets 1580 to the interface coupling portion 1540.

[0691] The collection space 1596 of the interface coupling portion 1540 is configured as an accumulator to receive end portions of the core member 1570 that, in the illustrated arrangement, are excess or inactive portions and do not form operational portions of the core member 1570. That is, the portions of the core member 1570 between the mounting points at the headgear rear portion 1530 and the mounting points at the housing 1512 of the orientation lock 1510 (or at the locking elements of the orientation lock) are active and form part of the headgear circumference. These portions of the core member 1570 are placed under tension when a force tending to elongate the headgear is applied. The lengths of the active and inactive core member portions will change with changes in the adjusted or instantaneous circumference of the headgear assembly 1500. Accordingly, the collection space 1596 provides a location to accumulate and protect the inactive portions of the core member 1570.

[0692] Desirably, the length of the collection space 1596 is at least as great as the stretch distance (the difference between the extended length and the retracted length) of one of the adjustment members 1552. In other words, the stretch distance of the adjustment members 1552 is preferably less than or equal to the length of the collection space 1596, such that there is ample space in the collection space 1596 for excess core member portions having sufficient length to allow the adjustment members 1552 to move from the retracted position to the extended position with at least some excess core member 1570 length remaining within the collection space 1596, such that the core member 1570 is not pulled completely through the housing 1512 of the orientation lock 1510. In some configurations, the collection space 1596 can include separate spaces or channels for each of the core members 1570.

[0693] A portion of the interface coupling portion 1540 can be configured for connection to the interface 1520 or a portion of the interface 1520. In some configurations, the interface coupling portion 1540 is selectively couplable or removably couplable to the interface 1520. In the illustrated arrangement, the portion of the interface coupling portion 1540 that defines the collection space 1596 is configured to be received within the receiving channel 1522 of the interface member 1524. The receiving channel 1522 can be a semi-cylindrical space defined by the interface member 1524 and configured to receive the interface coupling portion 1540 in a snap-fit manner. The central portion of the interface coupling portion 1540 that defines the collection space 1542 can be generally cylindrical or circular in exterior shape. In the illustrated arrangement, the central portion of the interface coupling portion 1540 is curved along its length.

[0694] The interface member 1524 can be any portion of the interface 1520. For example, the interface member 1524 can be a relatively rigid portion of the interface 1520, such as a shell or frame element 1526. In the illustrated arrangement, the interface member 1524 is a frame element 1526 that can directly or indirectly support a mask seal 1528, a cushion 1532, or other interface element. The frame element 1526 (or another portion of the interface) can support a conduit connector, such as an elbow 1534. In some configurations, the interface member 1524 can be configured to support several different types of mask seals 1528, cushions 1532, or other interface elements. In some configurations, the interface member 1524 can be integrated with or designed for use with a particular mask seal 1528, cushion 1532, or other interface element, and different interface members 1524 can be integrated with or associated with each type of mask seal 1528, cushion 1532, or interface element. In any case, in at least some configurations, the headgear assembly 1500 can be used with multiple types of mask seals 1528, cushions 1532, or other interface elements, including, for example, nasal prongs, nasal pillows, nasal masks, or full-face masks.

[0695] Figures 54-56 An interface assembly including a headgear assembly 1500 is illustrated, which can be the same as or substantially the same as the headgear assembly 1500 just described above or can have another suitable arrangement. In the illustrated arrangement, the headgear rear portion 1530 is collapsible. In some configurations, the headgear rear portion 1530 can collapse or fold from an expanded configuration in which the headgear rear portion 1530 is in three dimensions to a collapsed configuration in which the headgear rear portion 1530 can lie relatively flat. In the illustrated arrangement, a hinge, joint, or crease 1536 is disposed in one or both of the rear strap and the top strap. The hinge, joint, or crease 1536 can include a section of the headgear rear portion 1530 that has less rigidity than other portions of the headgear rear portion 1530. The hinge, joint, or crease 1536 can include a portion of the rigid headgear material that has a reduced thickness, i.e., a separation between portions of the rigid headgear material, such that one or more fabric layers define a joint, e.g., like a sewn joint, between the hinge, joint, or crease 1536 or the separated portions of the headgear rear portion 1530. Separated hinge members can be utilized to join multiple portions of the headgear rear portion.

[0696] This arrangement allows the hood to lie relatively flat, which helps in packing it while the user is walking with the mask on. The designed folds or creases allow the hood unit to maintain a shape that sustains its function, while also making it a compact unit even when already packed in a suitcase, etc. The folds or hinge lines 1536 can be constructed by any suitable process, such as by sewing or injection molding rigid material sections on both the left and right sides all the way to that point and then leaving one or more un-backed fabric pieces to act as hinges.

[0697] Figures 57-59 Another headgear assembly 1600 is shown, which, in at least some configurations, can be used with two or more interface types. For example, Figure 57 A headgear assembly 1600 is shown as a modular component forming an interface assembly including a full-face mask-type interface 1650. The headgear assembly 1600 may include a mating interface 1650 or a portion 1602 that can be otherwise coupled to the interface 1650. In some configurations, the mating or coupling portion 1602 of the headgear assembly 1600 may mat or couple to at least one other type of interface. For example, Figure 58 Showing the support for the nose mask 1660 Figure 57 The headgear assembly 1600 (shown in dashed lines), and Figure 59 Showcasing the nose pillow / fork-head mask 1670 Figures 37-53 The headgear assembly 1600 (shown in dashed lines) is thus included. Therefore, in this modular arrangement, a single headgear assembly can be used with multiple types of interfaces. Advantageously, the on-demand resistance characteristics of the headgear assembly, as described herein, allow a single headgear assembly to operate suitably with different interface types. For example, the retention force provided by the headgear can be automatically adjusted to the force exerted on the headgear by the specific interface used. The engagement or connection portion 1602 can have any suitable arrangement, such as with a coupling... Figures 46-54 The disclosed arrangement methods are the same or similar.

[0698] The headgear assembly 1600 can be generally similar to other headgear assemblies disclosed herein or in applicant's application number PCT / NZ2014 / 000074. In particular, the illustrated headgear assembly 1600 includes a headgear rear portion 1604, an interface coupling portion 1602, and a length or circumference adjustment portion 1606 interposed between the headgear rear portion 1604 to the interface coupling portion 1602. The headgear rear portion 1604 is configured to contact a rear portion of a user's head in use. The interface coupling portion 1602 is configured to couple to an interface in use such that the headgear assembly 1600 can support the interface in place on a user's face. The length or circumference adjustment portion 1606 is configured to allow adjustment of the position of the interface coupling portion 1602 relative to the headgear rear portion 1604 in use such that the headgear assembly 1600 can be adjusted to a particular user's head size. Thus, the length or circumference adjustment portion 1606 can allow adjustment of the peripheral length or circumference of the headgear in order to allow the headgear assembly 1600 to fit a particular user's head size.

[0699] The headgear rear portion 1604 can have any suitable arrangement, such as the same or similar to any of those described herein or in applicant's application number PCT / NZ2014 / 000074. Preferably, the headgear rear portion 1604 engages a user's head and provides a relatively stable platform for connection of an interface, such as with the interface coupling portion 1602 and the circumference adjustment portion 1606. Thus, in at least some configurations, the headgear rear portion 1604 is substantially inelastic such that it maintains its shape and effective length in response to applied forces within a range that is characteristic or expected for the desired application. The headgear rear portion 1604 can include a top strap portion 1608 that extends over a top of a user's head and a rear strap portion 1610 that extends around a rear of a user's head. The top strap portion 1608 and the rear strap portion 1610 can be separate or coupled in any suitable manner, such as by an intermediate connection portion 1612.

[0700] The length or circumference adjustment portion 1606 can have any suitable arrangement, such as the same or similar to any of those described herein or in applicant's application number PCT / NZ2014 / 000074. The circumference adjustment portion 1606 can include two pairs of adjustment elements 1614, with one pair of adjustment elements 1614 positioned on each side of the headgear assembly 1600. Thus, the illustrated headgear device 1600 can be generally described or classified as a two-anchorage planar headgear type. The headgear device 1600 can be described as a two-anchorage planar forward converging headgear type or possibly a mixture of a two-anchorage planar forward converging headgear type and a two-anchorage planar split / angled headgear type.

[0701] Each pair of adjustment elements 1614 can couple one side of the headgear rear portion 1604 with one side of the interface coupling portion 1602. The pair of adjustment elements 1614 on each side are coupled to the headgear rear portion 1604 at spaced locations. For example, one of the adjustment elements 1614 is coupled to the headgear rear portion 1604 at or near a portion of the top strap 1608, and the other of the adjustment elements 1614 is coupled to the headgear rear portion 1604 at or near a portion of the rear strap 1610. In the illustrated arrangement, the upper adjustment element 1614 is coupled to a forwardly extending portion of the headgear rear portion 1604 that extends in a forward direction from the portion of the top strap 1608 above or near the user's ears. The lower adjustment element 1614 is coupled to an end portion of the rear strap 1610 of the headgear rear portion 1604.

[0702] The adjustment elements 1614 are adjustable in length between a retracted length and an extended length. In some configurations, the adjustment elements 1614 cooperate to provide adjustment of substantially all of the circumference of the headgear assembly 1600. Each of the adjustment elements 1614 can also include a resilient element or biasing means that biases the adjustment element 1614 towards one of the retracted length or the extended length. Preferably, the adjustment elements 1614 are biased towards the retracted length, such that the headgear assembly 1600 is biased towards its minimum circumference. This arrangement allows the headgear assembly 1600 to be extended and then automatically retract to fit a particular user under the biasing force of the resilient element or other biasing means of the adjustment elements 1614. In addition, preferably the adjustment elements 1614 define a hard stop or maximum extended length, to limit the extension of the headgear 1600 and define a maximum circumference of the headgear 1600.

[0703] In some configurations, each of the adjustment elements 1614 comprises a braided element that can be extended or retracted in length. The braided element can include one or more resilient elements parallel to the braided element. The resilient elements can be separate from or contained within the braided element. In some configurations, the resilient elements are contained within the internal space between the filaments of the braided element. Examples of suitable braided elements are described in connection with the Applicant's patent application number PCT / NZ2014 / 000074 Figure 60 However, other suitable configurations or arrangements can also be used. Alternatively, the resilient or biasing elements can be located within the interface coupling portion and can interact with the core member to draw the core member into the interface coupling portion.

[0704] The interface coupling portion 1602 of the headgear assembly 1600 can extend between a pair of adjustment elements 1614 that make up the circumference adjustment portion 1606. In some configurations, the interface coupling portion 1602 can be relatively rigid. In some configurations, the interface coupling portion 1602 is directly coupled to the adjustment elements 1614. As described above, the interface coupling portion 1602 can facilitate connection of the headgear assembly 1600 to an interface. However, the interface coupling portion 1602 can also house at least a portion of one or more directional locks 1616. In the illustrated arrangement, two pairs of directional locks 1616 are provided, with one directional lock 1616 associated with each of the adjustment elements 1614. Portions of the directional locks 1616 (e.g., housings 1618) can be located at each end of the interface coupling portion 1602. In some configurations, a core member 1620 associated with each of the directional locks 1616 is coupled to the headgear rear portion 1604, extending along or through the adjustment elements 1614, through the housings 1618 of the directional locks 1616, and into a collection space 1622. The collection space 1622 can be defined by a collection tube or conduit, which can be a separate member from the interface coupling portion 1602 or can be incorporated into the interface coupling portion. The housings 1620 of the directional locks 1616 can include one or more members or elements (e.g., locking washers or locking claws) that interact with the core member 1618 to selectively allow the headgear assembly 1600 to be retracted or locked in a particular circumference, and inhibit or prevent the headgear from being extended at least at forces below the yield force provided by the directional locks. Further details of the operation of the directional locks 1616 are described above and in Applicant's patent application number PCT / NZ2014 / 000074.

[0705] In the illustrated arrangement, the directional locks 1616 on each side of the interface coupling portion 1602 are vertically stacked or positioned side-by-side. Although the directional locks 1616 are illustrated as separate units, in some configurations, portions of the directional locks 1616 can be integrated. For example, a single housing can house separate locking elements that interact with separate core members for each of the adjustment elements.

[0706] The interface coupling portion 1602 can be curved, and the collection space 1622 (e.g., defined by a collection tube or channel) can be curved along with the interface coupling portion 1602. In the illustrated arrangement, a central portion of the interface coupling portion 1602 is located above end portions of the interface coupling portion 1602. Further, side portions of the interface coupling portion 1602 curve downward from the central portion when viewed from the front. Thus, the interface coupling portion 1602 can complement or correspond to the shape of the body or envelope portion of the full-face mask interface 1650. The central portion of the interface coupling portion 1602 can be located above an elbow or other conduit connector of the mask 1650. Similarly, the interface coupling portion 1602 can be configured to complement or correspond to the shape of the body or envelope portion of the nasal mask interface 1660. The central portion of the interface coupling portion 1602 can be located above an elbow or other conduit connector of the nasal mask 1660. The interface coupling portion 1602 can be configured to complement or correspond to the shape of the body or envelope portion of the nasal pillow / prong mask 1670. The central portion of the interface coupling portion 1602 can be located above an elbow or other conduit connector of the nasal pillow / prong mask 1670. In some configurations, the interface coupling portion 1602 can be located between the elbow or other conduit connector and the pillow / prong of the nasal pillow / prong mask 1670.

[0707] Figures 57-59 An interface assembly 1680 is illustrated that is similar in many respects to other interface assemblies disclosed herein, such as the interface assemblies of Figures 37-53 and Figure 60 of the present disclosure. Figures 37-53 The interface assembly 1680 of the present disclosure includes a headgear assembly 1600 and an interface in the form of a full-face mask 1650 or a nasal mask. The headgear assembly 1600 generally includes a headgear rear portion 1604, a length or circumference adjustment portion 1606, and an interface coupling portion 1602. Figures 37-53 The headgear 1600 of the present disclosure is described in the context of differences from the interface assemblies of Figures 57-59 and Figures 57-59. Features or details not described can be the same as or similar to corresponding features or details of the interface assemblies of Figure 60 the interface assembly of the present disclosure, Figure 60 the interface assembly of the present disclosure, other interface assemblies disclosed herein or in applicant's application number PCT / NZ2014 / 000074, or can have any other suitable arrangement.

[0708] Figure 61The headgear assembly 1600 can be described or categorized as a two- retainer planar parallel headgear type. The illustrated headgear rear portion 1604 includes a top strap 1608, a pair of upper straps 1624, and a pair of lower straps 1626. The headgear rear portion 1604 includes a vertically elongated middle rear portion 1628 extending between and coupling the upper straps 1624 and the lower straps 1626. The illustrated interface coupling portion 1602 is in the form of a support frame 1630 for a full-coverage face mask or a nasal mask. The enclosure portion 1682 and elbow 1684 or other conduit connector (collectively "elbow") can be secured to the frame 1630 directly or indirectly by any suitable means. For example, the enclosure portion 1682 and elbow 1684 can be separately coupled to the support frame 1630 (directly or indirectly), the enclosure portion 1682 can be coupled directly to the frame 1630 and the elbow 1684 can be coupled to the enclosure portion 1682, or the elbow 1684 can be coupled directly to the frame 1630 and the enclosure portion 1682 can be coupled to the elbow 1684.

[0709] In the illustrated arrangement, the interface coupling portion or support frame defines a headrest or T-piece 1632. The pair of upper adjustment elements 1614 including perimeter adjustment portions 1606 can be coupled to the T-piece 1632 such that the upper adjustment elements 1614 are positioned above the user's eyes and extend above the user's ears. The pair of lower adjustment elements 1614 including perimeter adjustment portions 1606 can be coupled to a lower portion of the support frame 1630 (directly or through another member such as an enclosure) such that the lower adjustment elements 1614 are positioned below the user's eyes and ears. A collection space 1622 (e.g., defined by a collection tube or channel) for the upper adjustment elements 1614 can curve and extend down the T-piece 1632 toward the elbow. The upper orientation lock 1616 can be carried by the T-piece 1632. The lower orientation lock 1616 can be carried by the lower portion of the support frame 1630 (directly or indirectly).

[0710] Figures 57-59The ability to provide micro-adjustment provided by the headgear assembly or interface assembly 1680 of the present application is particularly advantageous in the T-piece configuration, as it allows for small adjustments to the fit around the bridge of the user's nose, which can be a particularly sensitive area, to be made quickly and easily. Although each connection between the headgear rear portion 1604 and the interface coupling portion 1602 or interface is shown as being an auto-adjustment device, in some configurations a combination of auto-adjustment devices and manual adjustment devices can be used. For example, the upper connection (e.g. to the T-piece 1632) can be manually adjustable (such as a hook-and-loop fastened strap), and the lower connection can be automatically adjustable. In the case of such an arrangement, the upper connection can be set and maintained in place over a number of fitting cycles, while the lower connection provides all of the elongation required to don and doff ("take off") the headgear assembly or interface assembly 1600. Such an arrangement can for example provide some of the advantages of auto-adjustment at a lower price point. Other suitable combinations can also be used, such as lower manual adjustment and upper auto-adjustment, or manual adjustment on one side and auto-adjustment on the opposite side.

[0711] Figure 60 The interface assembly 1680 is shown as being similar in many respects to other interface assemblies disclosed herein, such as the interface assemblies of Figures 37-53, Figure 61 and Figures 37-53 of the present application. Figures 57-59 The headgear 1600 of the present application is described in the context of the differences from these interface assemblies of Figure 60 , Figures 37-53 and Figures 57-59 of the present application. Features or details not described can be the same as or similar to corresponding features or details of the interface assemblies of Figure 60 of the present application, Figure 61 of the present application, Figure 60 other interface assemblies disclosed herein or in the applicant's application number PCT / NZ2014 / 000074, or can have any other suitable arrangement.

[0712] Figure 61 The interface assembly 1680 of the present application includes a headgear assembly 1600 and an interface in the form of a full-face mask 1650 or a nasal mask. The headgear assembly generally includes a headgear rear portion 1604, a length or circumference adjustment portion 1606, and an interface coupling portion 1602. However, unlike the interface assemblies of Figure 60 of the present application, Figure 61 The interface assembly 1680 of the present application does not include an over-the-ear or T-piece 1632. Accordingly, each of the pair of upper adjustment elements 1614 is connected to the interface coupling portion 1602 or interface at a lower position relative to the interface assemblies of Figures 57-60 of the present application. For example, the upper adjustment elements 1614 can generally pass along the cheek and below the user's eyes.

[0713] Figure 62 Headgear assembly 1600 of FIGS. 37-53 can be described or categorized as a two- retainer plane split / angled headgear type. The upper and lower adjustment elements 1614 are spaced apart from one another on the mask 1650 so as to provide a retainer force to the mask 1650 at the spaced apart vertical locations, which can provide stability to the mask 1650. The headgear assembly 1600 can be coupled to the mask 1650 by split interface coupling portions 1602, each of which can be substantially similar to the interface coupling portions 1602 described in connection with Figures 57-59 FIGS. 37-53. One of the interface coupling portions 1602 can be located on a lower portion (e.g., lower half) of the mask 1650, and another of the interface coupling portions 1602 can be located on an upper portion (e.g., upper half) of the mask 1650. The lower interface coupling 1602 can be through an elbow or other conduit connector. In some configurations, the upper and lower interface coupling portions 1602 can be coupled to or integrated with one another. For example, a bridge portion can extend between and connect the upper and lower interface coupling portions 1602. The bridge portion can be separate from or integral with one or both of the interface coupling portions.

[0714] Figure 60 An interface assembly 1680 is shown that is similar in many respects to other interface assemblies disclosed herein, such as the interface assemblies of FIGS. 37-53, Figure 61 , Figure 62 and Figures 37-53 . Figures 57-59 The headgear 1600 of FIGS. 37-53 is described in the context of differences from the interface assemblies of Figure 60 , Figure 61 , Figures 57-59 and Figure 60 . Features or details not described can be the same as or similar to corresponding features or details of the interface assemblies of FIGS. 37-53, the interface assemblies of Figure 61 , the interface assemblies of Figure 62 , the interface assemblies of Figure 60 , other interface assemblies disclosed herein or in applicant's application number PCT / NZ2014 / 000074, or can have any other suitable arrangement.

[0715] Figure 62 The interface assembly 1680 of FIGS. 37-53 includes a headgear assembly 1600 and an interface in the form of, for example, a full-face mask 1650 or a nasal mask. The headgear assembly 1600 generally includes a headgear rear portion 1604, a length or perimeter adjustment portion 1606, and interface coupling portions 1602. However, unlike the interface assemblies 1680 of Figure 62 and 61, for example, Figures 63-65The interface coupling portions 1602 of the interface assembly 1680 do not extend between adjustment elements located on opposite sides of the interface assembly 1680 or headgear assembly 1600. Instead, the interface coupling portions 1602 couple adjustment elements 1614 located on the same side of the interface assembly 1680 or headgear assembly 1600. That is, each of the pair of interface coupling portions 1602 couple the upper and lower adjustment elements 1614 on one side of the interface assembly 1680 or headgear assembly 1600 to each other.

[0716] In the illustrated arrangement, the interface coupling portions 1602 are generally U-shaped members having upper end portions 1634 coupled to the upper adjustment elements 1614 and lower end portions 1636 coupled to the lower adjustment elements 1614. The curved portions of the interface coupling portions 1602 extend between the upper end portions 1634 and the lower end portions 1636. The orientation locks 1616 for the upper and lower adjustment elements 1614 can be carried by the corresponding upper end portions 1634 and lower end portions 1636. Collection spaces 1622 (e.g., defined by collection tubes or channels) can curve along the central curved body portions of the interface coupling portions 1602, and in some configurations, can overlap each other.

[0717] In Figure 62 In the illustrated arrangement, the headgear assembly 1600 can not itself define the entire closed perimeter. Rather, the interface 1650 can form a portion of the closed perimeter, and thus, a portion of the girth or perimeter length of the interface assembly 1680. Advantageously, this arrangement allows the interface assembly 1680 to be optionally configured with a closed perimeter that opens quickly and easily for donning or doffing the interface assembly 1680. That is, one (or both) of the interface coupling portions 1602 can be removably attached to the interface 1650 (such as by one or more clips) such that one (or both) of the interface coupling portions 1602 can be disconnected and the closed perimeter can open. In some configurations, the automatic adjustment mechanism can be provided on only one side of the interface assembly. Similarly, other interface assemblies or headgear assemblies disclosed herein or in applicant's application number PCT / NZ2014 / 000074 can have a single-sided or asymmetric arrangement in which the automatic adjustment mechanism can be provided on only one side.

[0718] Figure 63 A series of discrete positions or steps of donning Figure 64 the interface assembly 1680 are illustrated. Figure 65 A user is illustrated placing the interface such that the interface coupling portions 1602 are attached on one side of the head, wrapping the interface assembly 1600 around the back of the head, and pulling the disconnected interface coupling portions 1600 towards the face. In Figure 64In some configurations, the interface is brought toward the proper location on the face, and the disconnected interface coupling portion 1602 is brought toward the interface 1680. Figure 66 The interface 1680 is shown in place on the face of the user and the user reconnects the loose or disconnected interface coupling portion 1602 to close the perimeter loop. Figure 66 With 65 Some or all of the movement between the interface coupling portion 1602 and the interface 1680 can require the yield force of the directional lock, as described above. To remove or doff the interface assembly 1680, the procedure can be reversed.

[0719] Figure 62 And 67 The perimeter of the automatically adjustable interface assembly or headgear assembly 1700 is shown in a first position (e.g., a minimum perimeter length) and a second position (e.g., a maximum perimeter length), respectively. As described with respect to the interface assemblies and headgear assemblies disclosed herein, the perimeter can include a length L 后部 defined by the headgear rear portion 1704. In some configurations, the length L 后部 may be zero. In other words, the headgear rear portion 1704, which is of fixed length, can be omitted, and the rear section can be formed by the length adjustment portion or elastic member. Additionally, one or more of these portions of the perimeter shown can be in alternative locations or can be split into multiple portions.

[0720] The perimeter can also include a length L 弹性 defined by the circumference or length adjustment portion 1706, which in the arrangement shown is defined by a pair of elastic or adjustable elements 1714. However, in other configurations, the circumference or length adjustment portion 1706 can be defined by one elastic or adjustable element 1714 or more than two elastic or adjustable elements 1714, among other suitable arrangements. As described above, in some configurations, the headgear rear portion 1704, which defines the length L 后部 may be omitted, and the length adjustment portion 1706 can extend along the entire perimeter portion from one end of the interface coupling portion 1702 to the other end of the interface coupling portion 1702. In Figure 66 and 67 the length L 弹性 is annotated with relative position indicators for a minimum length L 最小 and a maximum length L 最大 , respectively.

[0721] The perimeter can also include a collector length L 收集器, it can represent the individual or total available length of the collection space 1722 that receives the excess portion of the core member of the directional locking device. As described above, the collector space 1722 need not extend from adjustable element 1714 to another adjustable element 1714 and thereby define a physical section of the perimeter length. For example, in the interface assembly 1680 of Figure 66 , the collector space 1622 does not extend between opposing adjustable elements 1614. Thus, in a physical sense, the interface coupling portion 1602, the interface 1650, or other structure can define a portion of the perimeter length. However, in a conceptual sense, the elastic length L 弹性 (minimum length L 最小 and maximum length L 最大 ) define Figure 66 and 67 the length adjustable portion of the perimeter, while the remaining portions (the headgear rear portion length L 后部 and the collector length L 收集器 ) have fixed lengths.

[0722] In the illustrated arrangement, the perimeter length can include the sum of, or be defined by, the headgear rear portion length L 后部 , the collector length L 收集器 , and the total elastic length L 弹性 , which in the illustrated configuration is twice (2x) L 弹性 , as two equivalent length adjustable elements 1714 are provided. The total elastic length L 弹性 at any point in time or for any particular position of the interface or headgear assembly 1700 is equal to the minimum length L 最小 or the maximum length L 最大 or some value therebetween. As described herein, the length of each core member L 芯部 is preferably greater than or equal to the maximum length L 最大 of each adjustable element, and thus the total core member length L 芯部 is preferably greater than or equal to the total maximum length L 最大 , such that the headgear assembly can be deployed to its maximum perimeter length without having to fully pull the core member through the directional locking elements. In other words, it is preferred that a portion of the core member be available for engagement by the directional locking elements when the headgear assembly is deployed to its maximum perimeter length.

[0723] Additionally, it is preferred that the collector length L 收集器 be sufficient to accommodate the total excess or unused portion of the core member at the minimum and maximum perimeter lengths of the headgear assembly. Thus, in at least some configurations, the individual or total core length L 芯部 is less than or equal to the individual or total maximum length L 最大plus the individual or total collector length L 收集器 In at least some configurations, the individual or total core length L 芯部 is less than or equal to the individual or total minimum length L 最小 plus the individual or total collector length L 收集器 In some configurations, the individual or total maximum length L 最大 is less than or equal to the individual or total core length L 芯部 , the individual or total core length L 芯部 is less than the individual or total maximum length L 最大 plus the individual or total collector length L 收集器 The length of the directional locking mechanism is not specifically shown within the perimeter, but it can be considered to form a portion of any one of the lengths of the headgear rear portion L 后部 , the resilient length L 弹性 , or the collector length L 收集器 In any case, the length of the directional locking mechanism can be taken into account in determining the minimum length of the core L 芯部 .

[0724] In at least some configurations, the individual or total core length L 芯部 may be greater than the sum of the individual or total resilient length L 弹性 and the collector length L 收集器 In at least some configurations, the individual or total core length L 芯部 may be between the individual or total maximum length L 最大 and the headgear rear portion length L 后部 , or can be equal to either one of the individual or total maximum length L 最大 and the headgear rear portion length L 后部 .

[0725] Figure 66 The perimeter of 67 may represent the actual perimeter of the interface assembly or headgear assembly. That is, Figures 68A to 68D and 67 may represent the physical configuration of the single retention plane interface or the physical configuration of one retention plane in a multi-retention plane interface or headgear assembly. However, as described, Figure 68A and 67 may represent other interface or headgear types in a conceptual sense. The exhibited perimeter can represent a single retention plane (e.g., upper or lower) of a multi-retention plane headgear type or can represent an average of two or more retention planes of a multi-retention plane headgear type, for example, but not limited to.

[0726] Figure 68CAn embodiment of an orientation lock including a housing 1810, first and second locking elements (e.g., washers 1820, 1822), and a core member 1830 is shown. The housing includes a first channel 1840 and a second channel 1842, where the first and second channels 1840, 1842 are configured to respectively house the first and second locking washers 1820, 1822. In the illustrated arrangement, the first and second channels 1840, 1842 are physically separate spaces separated by an interior wall 1812 of the housing 1810. However, in other arrangements, the first and second channels 1840, 1842 need not be physically separate spaces, but can be portions of one channel. The housing 1810 has two end walls 1814, which along with the interior wall 1812 have an elongated core opening 1860 for the core member 1830 to pass through. The core openings 1860 are substantially aligned with each other. The core opening 1860 of the end wall 1814 shown on the right side of the figure is larger than the core opening of the interior wall 1812 and the end wall 1814 shown on the left side of the figure. This allows for a path for the core member 1830 to be manipulated through the housing 1810. The first and second channels 1840, 1842 are each bounded by the interior wall 1812, one of the end walls 1814, and a pair of side walls 1816; where the side walls 1816 extend between the end walls 1814 of the housing 1810. The first and second channels 1840, 1842 are configured to be open at one or both of the top and bottom of the housing 1810.

[0727] Each of the first and second channels 1840, 1842 has a pair of washer retainers 1850 aligned on opposite side walls 1816 of the housing 1810. Each pair of washer retainers 1850 is configured to pivotally retain the first or second locking washer 1820, 1822 within the corresponding first or second channel 1840, 1842. The washer retainers include a circular bushing 1852 and an elongated slot 1854, where the circular bushing 1852 intersects the bottom of the housing such that an entrance is formed. The entrance is configured to allow the first and / or second locking washers 1820, 1822 to be received into the washer retainers 1850. The slot 1854 extends radially from the circular bushing 1852 toward the top of the housing 1810.

[0728] The first and second grommets 1820, 1822 include a cylindrical shaft 1824 and an arm extending from the shaft 1824. The cylindrical shaft 1824 has substantially the same width W as the housing 1810, and the arm is narrower so as to fit within the first and second channels 1840, 1842. In the illustrated arrangement, the arm includes a first segment 1872 and a second segment 1874, with the first segment 1872 extending radially or perpendicularly from the cylindrical shaft 1824, and the second segment 1874 extending at an obtuse angle from the end of the first segment 1872. The first segment 1872 of the arm of the first grommet 1820 is shorter than the first segment 1872 of the arm of the second grommet 1822. The angle between the first segment 1872 and the second segment 1874 of the arm of the first grommet 1820 is greater than the corresponding angle of the second grommet 1822. These angles can be selected so that the second segment 1874 of one or both of the first and second grommets 1820, 1822 lies substantially flat against the respective wall (e.g., the inner wall 1812 and the end wall 1814, respectively) in one of the grommets 1820, 1822. The second segment 1874 of the arm includes a centrally located circular aperture 1876 configured to receive the core member 1830. The first and second channels 1840, 1842 differ in size according to the size of the grommet to be received within, i.e., the first channel 1840 is smaller than the second channel 1842, as the first grommet 1820 is smaller than the second grommet 1822.

[0729] The cylindrical shaft 1824 of the first and second locking grommets 1820, 1822 has substantially the same diameter as the diameter of the circular bushing 1852 of the grommet retainer 1850, and is configured to be received and held by the circular bushing 1852 in a snap-fit configuration. The snap-fit configuration is provided by the entrance of the circular bushing 1852 being narrower than the diameter of the cylindrical shaft 1824. The slots 1854 of the grommet retainer 1850 are configured to allow the entrance to flex open so as to increase the ease with which the first and second locking grommets 1820, 1822 can be pushed through the entrances and assembled to the housing 1810. Once assembled within the first and second channels 1840, 1842 of the housing 1810, the first and second grommets 1820, 1822 can be pivoted back and around the central axis extending through the cylindrical shaft 1824.

[0730] The core member 1830 is configured to pass through the core opening 1860 of the housing 1810 and the aperture 1876 of the first and second grommets 1820, 1822. Applying tension to the core member 1830 causes the first and second locking grommets 1820, 1822 to pivot back and / or towards between the locked and / or open positions. Figures 69A-69B and 68BA directional lock in a locked configuration is shown, in which a force is applied to the core member 1830 in a direction towards the left of the figure, as indicated by the arrow. The force applied to the core member 1830 in this configuration causes the first and second locking washers 1820, 1822 to pivot in an anti-clockwise direction, such that the path of the core member 1830 through the directional lock 1800 is non-linear or tortuous and movement of the core member 1830 is restricted. Figure 69B and 68D A directional lock in an open configuration is shown, in which a force is applied to the core member 1830 in a direction towards the left of the figure, as indicated by the arrow. In this configuration, the first and second locking washers 1820, 1822 pivot in a clockwise direction, such that the circular aperture 1876 and the core opening 1860 are aligned in a substantially straight line. This provides a smooth path for the core member 1830 to be pulled through the directional lock 1800 substantially freely. Further details of the operation of the directional lock 1800 are described above and in the applicant's patent application number PCT / NZ2014 / 000074.

[0731] Figure 70A A non-limiting exemplary embodiment of a housing 1810 and first and second locking washers 1820, 1822 is shown. The first and second locking washers 1820, 1822 are configured to be moulded as a single component, with their known prior art runner and gate system 1900 connected. The runner and gate system is configured to be used as an aid to assembly of the first and second locking washers 1820, 1822, where the runner and gate system 1900 can be grasped by a person or machine to align the first and second washers 1820, 1822 with the washer retainer 1850 of the housing 1810. A force can be applied to the locking washers 1820, 1822 through the gate and runner system 1900, as indicated by the arrow, to provide relative movement between the housing 1810 and the locking washers 1820, 1822. This relative movement can be utilised to engage the first and second locking washers 1820, 1822 with the housing 1810, such that the cylindrical shafts 1824 of the locking washers 1820, 1822 are snap fitted into the circular bushings 1852 of the washer retainer 1850.

[0732] As Figure 71As shown in FIG. 69A, once the first locking washer 1820 and the second locking washer 1822 are assembled within the housing 1810, the gate and runner system 1900 can be disconnected or peeled away from the locking washers 1820, 1822. Force can be applied to the gate and runner system 1900 (as shown by the arrow) in a direction substantially perpendicular to the direction of the assembly force (arrow in FIG. 69A) in order to disengage the gate and runner system 1900 from the locking washers 1820, 1822. As the gate and runner system 1900 is disengaged, the locking washers 1820, 1822 remain assembled with the housing 1810. The gates 1910 of the gate and runner system 1900 can be designed to have a weakness that encourages the gates to break as close as possible to the cylindrical shaft 1824 of the locking washers 1820, 1822, such that the range of pivotal motion of the locking washers 1820, 1822 is not limited by excess gate material.

[0733] Figure 72 and 70B Embodiments are shown in which multiple sets of first locking washers 1820 and second locking washers 1822 are molded together on a single gate and runner system 1900. This configuration allows for the immediate or sequential assembly of multiple locking washers 1820, 1822, thereby increasing manufacturing efficiency. To assemble the multiple sets of locking washers 1820, 1822 to the housing 1810, the runner and gate system 1900 can be grasped by a person or machine in order to align the first and second washers 1820, 1822 with the washer retainers 1850 of each of the housing 1810. Force can be applied through the gate and runner system 1900 (as shown by the arrow) in order to engage the multiple sets of first locking washers 1820 and second locking washers 1822 with the housing 1810, such that the cylindrical shaft 1824 of the locking washers 1820, 1822 is snap-fitted into the circular bushing 1852 of the washer retainers 1850.

[0734] Figures 69A to 71A non-limiting exemplary configuration for assembling first locking grommets 1820 and second locking grommets 1822 to the housing 1810 of the directional lock 1800 is shown. Such a configuration includes a gripping portion or element, such as gripping tab 1830, for aligning to and applying assembly force to the locking grommets 1820, 1822. The gripping tab 1830 is formed between the locking grommets 1820, 1822 and the gate and runner system 1900 and can have a geometry specifically configured to be easily gripped by a person or machine. In some configurations, the gate and runner system 1900 is configured to be removed from the gripping tab 1830 during the molding process. In a variation of such a configuration (not shown), multiple pairs of first locking grommets 1820 and second locking grommets 1822 can be connected by a single gripping tab 1830, which is then used to assemble the directional lock in a single motion.

[0735] Figures 73-80 A non-limiting exemplary embodiment of a directional lock is shown. In this embodiment, the grommet retainers 1850 are positioned in an opposite arrangement, with the first grommet retainers 1850 extending downward from the top of the housing and the second grommet retainers 1850 extending upward from the bottom of the housing. The first locking grommets 1820 and the second locking grommets 1822 are assembled to the housing 1810 in opposite directions. For example, the gripping tab 1830 or the gate and runner system 1900 as described with respect to the embodiment of Figure 73

[0736] Figure 74 Interfaces are shown having headgear arrangements configured to allow the interface to be donned and doffed in a manner similar to a baseball cap. Preferably, the headgear arrangements do not include a strap that passes under the user's ears. Thus, an interface having such headgear arrangements can be donned or put on by passing the interface over the user's head from above. The headgear arrangement can be positioned onto the back of the user's head and then the interface arrangement is rotated downward and the interface is positioned on the user's face, or vice versa. The headgear arrangements can include a portion that is positioned in front of the user's ears that can provide a mounting location for orienting to or interfacing with the interface. In some configurations, the back portion of the headgear arrangement is relatively rigid (e.g., so as to maintain an open shape when not on the user) and / or is relatively inextensible.

[0737] Figure 74 ​An alternative apparatus of a headgear system 2000 configured for use with a full-face mask 2100 having a forehead support is shown. However, the headgear system 2000 or portions thereof can also be used with other types of interfaces, including those having forehead supports, if desired. The full-face mask 2100 is configured to seal around the nose and mouth of the user, with the full-face mask contacting the bridge of the nose, the cheeks, and the lower lip or chin area. The headgear system 2000 includes a headgear rear portion 2010, an upper retention plane 2020, and a lower retention plane 2030.

[0738] Preferably, the headgear rear portion 2010 engages the head of the user and provides a relatively stable platform for connecting the interface, such as with the interface coupling portion 2040 and perimeter adjustment portions (e.g., directional locking modules 2060). Thus, in at least some configurations, the headgear rear portion 2010 is substantially inelastic, such that it retains its shape and effective length in response to applied forces within a range that is characteristic or expected for the desired application. In some configurations, the headgear rear portion 2010 can include a layer of relatively rigid material, such as a plastic material, coupled to one or more layers of fabric material. Preferably, a fabric layer is provided on at least the surface of the rigid material layer that contacts the user. In some configurations, a fabric layer is provided on each side of the rigid material layer. Further, in some configurations, the rigid material layer can be formed between the material layers, such as by injection molding the rigid material into the space between the two material layers in a mold. Examples of such headgear and methods of making such headgear are disclosed in Applicant's U.S. Provisional Application No. WO 62 / 050,925, which is hereby incorporated by reference in its entirety.

[0739] The headgear rear portion 2010 includes arms 2012 that extend forward of the ears of the user. The arms 2012 include a plurality of vertically spaced connectors 2014 configured to provide a range of positions at which one or more directional locking modules 2060 can be connected. The full-face mask is generally larger and heavier than the direct nasal masks of the previous embodiments. Thus, the full-face mask can require more than one retention plane to provide the desired or required level of stability to achieve a substantially airtight seal with the face of the user.

[0740] The two retention planes 2020, 2030 converge toward a single point located on each side of the full-face mask 2100 or possibly in front of the full-face mask, where they can or can not intersect. The retention planes 2020, 2030 can be vertically spaced apart from each other such that they are further apart at the points where they connect with the headgear than at the points where they connect with the mask. This provides a degree of stability to the interface. For example, the upper retention plane 2020 can pass from the top of the ears, through or above the user's nose, and the lower retention plane 2030 can pass from the bottom of the ears to near or below the user's mouth.

[0741] Each of the two retention planes 2020, 2030 can be provided by two directional lock modules 2060, one on each side of the headgear system 2000. The directional lock modules 2060 each include a directional lock 2062 and a resilient portion 2064 connected to the directional lock 2062 at one end and to the plurality of connectors 2014 at the other end. The angle of the retention planes 2020, 2030 can be adjusted by connecting the resilient portion 2064 to different connectors 2014 on the headgear arms 2012. The illustrated full-face mask 2100 does not include a brow or "T-piece". However, in some configurations, a T-piece can be provided. Additional headgear elements or straps can couple the rear portion of the headgear to the T-piece of the mask, if desired.

[0742] Figure 73 A headgear system device 2000 is illustrated that includes a headgear rear portion 2010 and two retention planes 2020, 2030 configured to secure a full-face mask 2100 to a user's face. In this arrangement, the full-face mask 2100 is configured to seal under the user's nose and around their mouth, such that the mask 2100 does not contact the bridge of the nose. Relative to the previous embodiments, the different sealing location requires the angles of the retention planes 2020, 2030 to be different in order to apply force to the mask in the optimal or desired direction or at least such that this is desired. In Figure 75 In this embodiment, the two retention planes 2020, 2030 are shown as being vertically spaced apart and attached to the arms 2012 of the headgear rear portion 2010 such that there is an upper retention plane 2020 and a lower retention plane 2030 that are substantially parallel to each other. The upper retention plane 2020 is more horizontal and located lower on the user's face than the upper retention plane 2020 of the previous embodiments. The angles of the retention planes 2020, 2030 can be adjustable via the plurality of connectors 2014, such as those shown in the embodiment of Figure 73

[0743] ​Each of the retention planes 2020, 2030 is shown to include a directional locking module 2060, which in turn includes an elastic portion 2064 and a directional lock 2062. In variations of this arrangement, each directional locking module 2060 can include more than one directional lock 2062.

[0744] Figure 76 A headgear system 2000 is shown in combination with a nasal mask 2110. The nasal mask 2110 is configured to seal around the user's nose, contacting the bridge, cheeks, and upper lip. It is desirable or possible to require both retention planes 2020, 2030 to provide proper stability to the mask 2110 when donned to the user's face. Figures 77 to 79

[0745] Figure 76 A non-limiting exemplary embodiment of a headgear system 2000 is shown, including a headgear rear portion 2010 and two retention planes 2020, 2030 configured to secure a nasal mask 2110 to a user's face. The headgear rear portion 2010 includes a molded plastic structure 2016 with an integrally formed fabric cover, having arms 2012 that extend downward in front of the user's ears. The upper retention plane 2020 and the lower retention plane 2030 are provided by directional locking modules 2060 on each side of the headgear. The upper retention plane 2020 extends from the top of the arms 2012 to a position just above the user's tip of the nose. The lower retention plane 2030 extends from the bottom of the arms 2012 to a position approximately on the underside of the user's nose. In the arrangement shown, the directional locking modules 2060 include a braided elastic portion, a core filament (not shown), and a directional lock, with the braided elastic portion and the core filament permanently joined to the arms 2012 and the directional locks 2060 by an overmolded connector. The angle of the retention planes 2020, 2030 is fixed by the overmolded connector 2016.

[0746] Figure 80 A view of a headgear system 2200 according to the presently disclosed subject matter is shown. The headgear system 2200 is a closed loop and includes a headgear 2210, two upper directional locking modules 2220, two lower directional locking modules 2230, and a shell 2240. The headgear rear portion 2250 includes a bifurcated molded plastic structure with an integrally formed fabric cover, and a pair of arms 2252 configured to extend downward in front of the user's ears in use.

[0747] ​The upper and lower directional locking modules 2220, 2230 include an elastic portion 2222, a core filament (not shown), and a directional lock 2224. The core filament is configured to extend partially or completely along the length of the elastic portion 2222 and extend through the directional lock 2224. The directional lock 2224 is configured to interact with the core filament to allow for automatic adjustment of the length of the directional locking modules 2220, 2230. The core filament and the elastic portion 2222 are permanently joined to the arms 2252 of the headgear 2210 by overmolded connectors 2260, with the upper directional locking modules 2220 being joined to the upper regions of the arms 2252 and the lower directional locking modules 2230 being joined to the lower regions of the arms 2252. The elastic portion 2222 is permanently joined to the directional locks 2220, 2230 by the overmolded connectors 2260. The directional locks 2220, 2230 are housed within the housing 2240. The two upper directional locking modules 2220 form an upper retention plane, and the two lower directional locking modules 2230 form a lower retention plane, which are substantially identical to those of the headgear 2100. Figure 79

[0748] The housing 2240 includes a substantially rigid body having four directional locking shelves 2242, an upper conduit 2244, a lower conduit 2246, and a central opening 2248 formed between the upper and lower conduits. Two directional locking shelves 2242 are positioned one above the other at each of the lateral ends of the housing 2240. The directional locking shelves 2242 are configured to hold the directional locks 2224. The upper conduit 2244 extends laterally between the two upper locking shelves 2242, and the lower conduit 2246 extends laterally between the lower locking shelves 2242. The upper and lower conduits 2244, 2246 are configured to house the free ends of the core filaments. The central opening 2248 formed between the upper and lower conduits 2244, 2246 is configured to receive the nasal mask device.

[0749] Figure 81 It is shown that Figure 82 ​headgear system 2200. In some configurations, the elbow is made of a different material than the frame 2282, such as polycarbonate, such that the two parts do not stick together when assembled. This can improve the freedom of movement of the elbow relative to the frame 2282 and can reduce hose drag. It is contemplated that other material combinations can also be used.

[0750] The tube connector 2286 is connected to the end of the elbow 2284 opposite the end connected to the frame 2282 in a snap-fit configuration. The tube connector 2286 can swivel or rotate around the end of the elbow 2284. In some embodiments, the tube connector 2286 can be made of a different material than the elbow 2284, such as nylon. The tube connector 2286 is configured to provide a means for connecting the nasal mask device 2270 to a CPAP tube providing a supply of pressurized air.

[0751] The cushion module 2290 includes a sealing cushion 2292 that is integrally formed with a connector portion 2294 by means such as, but not limited to, overmolding. The sealing cushion 2292 includes a compliant interface that can be made of a flexibly resilient material such as, but not limited to, silicone or thermoplastic elastomer. The sealing cushion is configured to form a substantially airtight breathing channel that seals around the user's nose. The connector portion 2294 is made of a substantially rigid material such as, but not limited to, polycarbonate, and includes a circular opening 2296 opposite the sealing cushion 2292. The connector portion is configured to provide a repeatedly removable connection between the cushion module 2290 and the frame assembly 2280. The cushion module 2290 and the frame assembly 2280 are connected together such that an air path is formed through the tube connector 2286 and the elbow 2284 and into the cushion module 2290, as shown in Figure 83

[0752] Figure 85 and 83 ​The manner in which the frame assembly 2280 is connected to the shell 2240 of the headgear system 2200 is shown. The elbow 2284 and tube connector 2286 are configured to pass through the central opening of the shell 2240 in order to connect the frame 2282 to the rear surface 2310 of the shell 2240. A portion of the frame 2282 extends through the central opening 2248 of the shell 2240 and is substantially flush with the front surface 2300 of the shell 2240.

[0753] The rear surface 2320 of the frame 2282 is shown in Figure 85 and 84 It can be seen that the rear surface 2320 of the frame 2282 includes a number of protrusions that form a circular inner collar 2420 around the periphery of the socket of the ball 2400 and socket 2410 connector. The inner collar 2420 has a number of cutouts 2430 that provide flexibility. A recessed channel 2450 extends around the periphery of the inner collar 2420. The recessed channel 2450 retains the circular opening 2296 of the cushion module 2290 in a snap-fit configuration. There is one or more (e.g., a pair of) keying features 2440 located on the lower periphery of the recessed channel 2450. The keying features 2440 are configured to interact with corresponding features on the connector portion 2294 of the cushion module 2290 such that rotation of the cushion module 2290 is prevented.

[0754] An advantage of the headgear adjustment system disclosed in the previously described embodiments is that it is silent to provide adjustment. Hook and loop fastener systems (such as Velcro) are often used in the prior art to provide size adjustment to headgear systems for respiratory masks. When the tightness of the headgear system needs to be adjusted, the hook and loop fastener components must be separated from one another. The separation of the hook and loop fastener components often generates a crackling sound, which can be annoying to the mask user and in some cases can wake the user's bed partner. The headgear system of the present disclosure is less likely to require manual adjustment by the user in order to achieve improved sizing and fit, and any adjustment that is required will not generate noise or at least not a significant level of noise, thereby improving ease of use and improving comfort for the user and their bed partner.

[0755] Headgear testing:

[0756] Figure 86 A testing device for verifying the functionality of a headgear device including at least one directional locking module 2510 is shown. Figure 85The headgear assembly under test includes a headgear 2502 and a mask frame 2504 connected together by a pair of laterally oriented locking modules 2510. The frame 2504 is configured to receive a nasal pillow seal. The ends of the locking modules 2510 that are connected to the headgear are held within a test rig 2520 that secures the headgear assembly to a moving crosshead 2530 of a universal testing machine. The mask frame 2504 is anchored to a stationary crosshead 2540 of the universal testing machine. The universal testing machine can run tests in several stages that simulate donning and wearing a mask. It should be understood that this test apparatus can be modified to test headgear assemblies configured for use with different mask types, such as full face masks and nasal masks.

[0757] The first stage of the test simulates donning of the mask and headgear assembly. The moving crosshead is programmed to pull the headgear away from the frame, thereby elongating the locking modules, until the headgear assembly approaches its maximum circumference. The second stage of the test simulates fitting of the mask and headgear assembly to a user's head. The universal testing machine is programme...

Claims

1. A self-contained, self-adjusting hood assembly for supporting a breathing interface on a user, the hood assembly comprising: The latter part is essentially inelastic; The essentially inflexible front section is configured to be removably connected to a variety of different breathing interfaces; The first elastic side portion located on the first side of the headgear assembly; The second elastic side portion is located on the second side of the headgear assembly; At least one filament extends through or along at least one of the first elastic side portion and the second elastic side portion, and the at least one filament is connected to one of (i) the non-elastic rear portion and (ii) the non-elastic front portion. At least one restraint device; The at least one filament passes through the at least one restraining device, which is configured to selectively engage the at least one filament to resist movement of the at least one filament relative to the at least one restraining device. Wherein, the at least one constraint device is configured to: (i) provide a first resistance to the movement or attempted movement of the at least one filament in a direction that allows the inelastic rear portion and the inelastic front portion to move away from each other; and (ii) provide a second resistance to the movement or attempted movement of the at least one filament in a direction that allows the inelastic rear portion and the inelastic front portion to move toward each other, the second resistance being less than the first resistance; The inelastic rear portion, the inelastic front portion, the first elastic side portion, and the second elastic side portion define the periphery of the closed loop. The headgear assembly automatically switches between a contraction mode, a locking mode, and a yielding mode in response to the presence or absence of an external force. In the shrinking mode, the first elastic side portion and the second elastic side portion provide shrinking force, which automatically reduces the perimeter length of the cap towards the minimum perimeter length or circumference of the user's head or reduces the perimeter length of the cap to the minimum perimeter length or circumference of the user's head without user operation. In the locking mode, the headgear is automatically held at the minimum perimeter or circumference of the user's head by the restraint device, without the need for user operation. In the yielding mode, applying a yield force allows the user to increase the perimeter length of the cap, with the yield force being greater than the first resistance and the contraction force.

2. The headgear assembly as claimed in claim 1, wherein, The inelastic front part is rigid.

3. The headgear assembly as claimed in claim 1 or 2, wherein, The inelastic front portion defines at least one collection channel to accommodate a portion of the at least one filament.

4. The headgear assembly as claimed in claim 1, wherein, Each of the first and second elastic side portions includes an end cap with an opening through which the at least one filament passes.

5. The headgear assembly as claimed in claim 4, wherein, The end cap is overmolded onto a corresponding one of the first elastic side portion and the second elastic side portion.

6. The headgear assembly as claimed in claim 4 or 5, wherein, The end cap is attached to the non-elastic front portion.

7. The headgear assembly as claimed in claim 1, wherein, The rear portion does not have a structure that would inhibit the removal of the rear portion in the upward direction, passing below the user's ear.

8. The headgear assembly as claimed in claim 1, wherein, The restraint device is located on the rear part.

9. The headgear assembly as claimed in claim 8, wherein, The rear portion defines at least one collection channel, configured to receive a portion of the filament.

10. The headgear assembly as claimed in claim 1, wherein, The restraint device is positioned at the end away from the first elastic side portion or the second elastic side portion.

11. The headgear assembly of claim 10, further comprising a guide for a portion of the filament, the guide being located between the end of the first elastic side portion or the second elastic side portion and the restraint device.

12. The headgear assembly as claimed in claim 1, wherein, The first elastic side portion or the second elastic side portion includes an inelastic portion that constrains the first elastic side portion or the second elastic side portion to a maximum length.

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