Headgear assembly and headgear-equipped interface assembly

Abstract

To manufacture headgear and breathing apparatus that are easy to use and comfortable to wear. [Solution] In some configurations, a headgear system and / or interface assembly incorporating a headgear system configured to transform from elastic or "stretchable" behavior to "inelastic" behavior in response to normal or anticipated forces occurring during intended treatment. In some configurations, once fitted to the user's head, the system automatically adjusts toward or to the appropriate size. The headgear portion or assembly used in combination with a respiratory device is, in some configurations, at least substantially inelastic and has a three-dimensional shape. The headgear portion or assembly may comprise a plastic core and a textile casing. The headgear or a portion thereof may also have integrally molded labels, connectors, adjustment mechanisms and / or grips.

Description

[Technical Field]

[0001] Referencing any priority application Any foreign or domestic application claiming priority in connection with this application is incorporated herein by reference and constitutes part of this disclosure. [Background technology]

[0002] This disclosure relates to headgear and interface assemblies used in respiratory therapy. More specifically, this disclosure relates to substantially inelastic three-dimensional headgear, a portion thereof, and processes for molding such headgear. Further applications of the molding process are also disclosed.

[0003] The treatment of respiratory diseases or conditions with therapies such as NIV, bi-level, or CPAP requires the delivery of pressurized air into the human airway via a conduit and respiratory device (e.g., mask or cannula). Typically, a mask provides at least a substantial "seal" over or around the user's nose and / or mouth, while a cannula does not provide a seal but provides a delivery route for the delivery of the assisted breathing gas.

[0004] This "seal" results in a force that attempts to push the breathing apparatus away from the face, due to the combination of the enclosed area of ​​the breathing apparatus and its internal pressure. To counteract this force, a headgear is typically used, which has a series of straps that pass around the back and / or top of the user's head. Such headgear is typically breath-o-prene TM These are made from high-compliance materials. Using these materials allows the headgear to have a relatively small structure when not being worn. This inadequate structure can cause the headgear straps to tangle, which can make it difficult for the user to put on the headgear and breathing apparatus.

[0005] The strap requires some form of adjustment to accommodate variations in head size, and this adjustment mechanism is typically provided via an adjustment loop between the mask body and the headgear. The adjustment loop may have a hook-and-loop or similar fastener, thereby allowing the end of the strap to be passed through an attachment point on the mask or through a clip attached to the mask and then attached to another part of the strap. This configuration allows the headgear to be adjusted by positioning the end of the strap at the desired position on the other part of the strap to change the size of the adjustment loop. [Overview of the project] [Problems that the invention aims to solve]

[0006] This type of mechanism is one solution to providing an adjustment mechanism for headgear, and therefore interface assemblies. Such systems also require a moderate level of user interaction, which can result in them being misused or not properly adjusted (e.g., overtightened). In practice, fine-tuning such systems is difficult and time-consuming to achieve. Providing practical and less practical solutions to this has been the subject of considerable development efforts by numerous organizations, resulting in a number of patents.

[0007] Furthermore, these conventional headgears are typically constructed to have some degree of elasticity. This can cause the headgear to stretch over the user's head, potentially creating a tightening force that can be uncomfortable. It is desirable to create headgear and respiratory devices that are easy to use and comfortable to wear, as this can improve the user's compliance with the treatment being provided. [Means for solving the problem]

[0008] The systems, methods, and apparatuses described herein have innovative aspects, and none of those aspects are essential or solely involved with respect to their desirable attributes. Here, without limiting the scope of the claims, some of the advantageous features will be outlined.

[0009] A headgear system and / or an interface assembly incorporating a headgear system that, when attached to a user's head, automatically adjusts to the correct size and whose characteristics transform from an elasticated "stretchy" strap / strapping to a "non-elastic" strap / strapping when in use.

[0010] In some configurations, a headgear assembly that supports a breathing interface on a user includes a rear headgear portion configured to contact a rearward and / or upward portion of the user's head. The rear headgear portion includes a plastic core and a textile casing. The plastic core and the textile casing are formed as an integral structure by adding molten plastic material into the textile casing. Each side portion of the rear headgear portion includes an attachment portion configured to be positioned in front of the user's ear during use. An interface connection mechanism is provided at the attachment portion of each side of the headgear assembly. Each interface connection mechanism is configured to be coupled directly or indirectly to a breathing interface. Each interface connection mechanism includes at least one length adjustment mechanism. Each length adjustment mechanism includes an elastic element, a core member, and a limiting mechanism. The core member is associated with the elastic element and is fixed to one end of the elastic element. The core member passes through the limiting mechanism. The limiting mechanism is configured to selectively engage with the core member so as to resist the movement of the core member relative to the limiting mechanism.

[0011] In some configurations, the rear headgear portion does not have a structure that passes under the user's ear that prevents removal of the rear headgear portion in the upward direction.

[0012] In some configurations, each of the interface connection mechanisms comprises at least a first length adjustment mechanism and a second length adjustment mechanism.

[0013] In some configurations, the position of at least one of the first length adjustment mechanism and the second length adjustment mechanism at the attachment portion is adjustable.

[0014] In some configurations, each of the attachment portions comprises a plurality of attachment positions for the first length adjustment mechanism and the second length adjustment mechanism, and the attachment positions are formed integrally with the plastic core.

[0015] In some configurations, at least one connector is configured to connect the interface connection mechanism to the breathing interface.

[0016] In some configurations, at least one connector comprises at least one collection passage configured to receive a portion of the core member.

[0017] In some configurations, the restriction mechanism is located at the rear headgear portion.

[0018] In some configurations, the rear headgear portion defines at least one collection passage configured to receive a portion of the core member.

[0019] In some configurations, at least one collection passage is defined by the plastic core or between the plastic core and the textile casing.

[0020] In some configurations, the restriction mechanism is located away from the end of the elastic element.

[0021] In some configurations, a guide for a portion of the core member is provided between the end of the elastic element and the restriction mechanism.

[0022] In some configurations, the elastic element includes an inelastic portion that limits the elastic element to its maximum length.

[0023] In some configurations, the headgear assembly supporting the breathing interface over the user includes a rear headgear portion configured to contact the rear and / or upper portion of the user's head. The rear headgear portion comprises a plastic core and a textile casing. The plastic core and textile casing are formed as a single unit by adding molten plastic material to the textile casing. Interface connection mechanisms are provided on each side of the headgear assembly. Each interface connection mechanism is configured to connect directly or indirectly to the breathing interface. Each interface connection mechanism includes at least one length adjustment mechanism. Each length adjustment mechanism comprises an elastic element, a core member, and a limiting mechanism. The core member is associated with the elastic element and fixed to one end of the elastic element. The core member passes through the limiting mechanism. The limiting mechanism is configured to selectively engage with the core member to resist movement of the core member relative to the limiting mechanism. At least one limiting mechanism is located in the rear headgear portion.

[0024] In some configurations, the rear headgear portion does not have a structure that passes under the user's ears to prevent removal of the rear headgear portion in the upward direction.

[0025] In some configurations, the rear headgear section defines at least one collection passage configured to receive a portion of the core member.

[0026] In some configurations, at least one collection channel is defined by a plastic core, or between a plastic core and a textile casing.

[0027] In some configurations, the limiting mechanism is located away from the ends of the elastic element.

[0028] In some configurations, a guide for a portion of the core member is provided between the end of the elastic element and the limiting mechanism.

[0029] In some configurations, the elastic element includes an inelastic portion that limits the elastic element to its maximum length.

[0030] A headgear system and / or interface assembly incorporating a headgear system, which, when attached to the user's head, automatically adjusts to the correct size and, when used, transforms from an elastic "stretchable" strap / strapping to an "inelastic" strap / strapping.

[0031] In some configurations, a headgear assembly supporting a breathing interface over a user includes a substantially inelastic rear portion, a substantially inelastic front portion, a first elastic lateral portion of a first side of the headgear assembly, and a second elastic lateral portion of a second side of the headgear assembly. At least one filament extends through or along the first and second elastic lateral portions. At least one filament is coupled to one of the inelastic rear portion and the inelastic front portion and to at least one limiting mechanism. At least one filament passes through at least one limiting mechanism. At least one limiting mechanism is configured to selectively engage with at least one filament to resist the movement of at least one filament relative to at least one limiting mechanism.

[0032] In some configurations, at least one limiting mechanism is configured to provide a first resistance force against the movement or attempt to move at least one filament in a direction that allows the inelastic rear portion and the inelastic front portion to move away from each other.

[0033] In some configurations, at least one limiting mechanism is configured to provide a second resistance force against the movement or attempt to move 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 force being smaller than the first resistance force.

[0034] In some configurations, the inelastic front portion is rigid.

[0035] In some configurations, the inelastic anterior portion is configured to connect to the breathing interface.

[0036] In some configurations, the inelastic forward portion defines at least one collection passage that accommodates a portion of at least one filament.

[0037] In some configurations, the first elastic lateral portion and the second elastic lateral portion are provided with end caps having openings through which at least one filament passes. The end caps can be overmolded onto the first elastic lateral portion and the second elastic lateral portion, respectively. The end caps can be bonded to the inelastic front portion.

[0038] In some configurations, the inelastic rear portion, inelastic front portion, first elastic lateral portion, and second elastic lateral portion define the outer periphery of a closed loop.

[0039] In some configurations, at least one filament comprises a first filament associated with a first elastic lateral portion and a second filament associated with a second elastic lateral portion. At least one limiting mechanism may comprise a first limiting mechanism associated with the first elastic lateral portion and a second limiting mechanism associated with the second elastic lateral portion.

[0040] In some configurations, at least one collection passage comprises a first collection passage for accommodating a portion of the first filament and a second collection passage for accommodating a portion of the second filament.

[0041] In some configurations, the limiting mechanism comprises a pair of lock jaws that define a space through which the filament passes. The lock jaws have a first relative position that engages with the filament to provide a first resistance force and a second relative position that provides a second resistance force.

[0042] In some configurations, the interface includes a forehead support, and at least one collection passage is located within the forehead support.

[0043] In some configurations, the headgear comprises an upper elastic lateral portion and a lower elastic lateral portion at each side, an upper filament and a lower filament, and an upper limiting mechanism and a lower limiting mechanism. In some such configurations, there is an upper collection passage and a lower collection passage. These upper and lower collection passages at each side of the headgear may be separate from each other.

[0044] In some configurations, an inelastic frontal portion defines an opening configured to receive a portion of the breathing interface, and at least one collection passage comprises a first collection passage and a second collection passage, with at least a portion of the first collection passage located above the opening and at least a portion of the second collection passage located below the opening.

[0045] In some configurations, the inelastic front section is configured to connect to multiple different interfaces.

[0046] In some configurations, the inelastic frontal portion comprises separate parts on each side of the headgear assembly.

[0047] In some configurations, a headgear assembly supporting a breathing interface over the user defines a periphery that surrounds the user's head. The headgear assembly may include a first portion having a fixed length along the periphery and a second portion having a fixed length along the periphery. At least one elastic portion may have a variable length along the periphery, and at least one elastic portion may have a first length and a second length greater than the first length. At least one filament may be fixed to one of the first and second portions and extend through at least one elastic portion into at least one collection passage in the other of the first and second portions. At least one filament may have a filament length greater than the second length of at least one elastic portion. At least one limiting mechanism may be configured to selectively engage with at least one filament to restrict the movement of at least one filament relative to at least one limiting mechanism. At least one limiting mechanism may be located at the entrance to at least one collection passage.

[0048] In some configurations, the first part is the front portion of the headgear assembly.

[0049] In some configurations, the second part is the rear portion of the headgear assembly.

[0050] In some configurations, the first part defines at least one collection pathway.

[0051] In some configurations, at least one elastic portion is limited to a maximum length.

[0052] In some configurations, at least one elastic portion comprises an inelastic element that defines the maximum length.

[0053] In some configurations, at least one elastic portion comprises a first elastic portion and a second elastic portion, each of which extends between the first and second elastic portions.

[0054] In some configurations, at least one filament comprises a first filament associated with a first elastic portion and a second filament associated with a second elastic portion. At least one limiting mechanism comprises a first limiting mechanism associated with a first elastic lateral portion and a second limiting mechanism associated with a second elastic lateral portion.

[0055] In some configurations, at least one collection passage comprises a first collection passage for collecting a portion of the first filament and a second collection passage for collecting a portion of the second filament.

[0056] In some configurations, the limiting mechanism comprises a pair of lock jaws that define a space through which the filament passes. The lock jaws have a first relative position that engages with the filament to provide a first resistance force and a second relative position that provides a second resistance force.

[0057] In some configurations, the directional lock includes a housing that defines an internal space, a first opening, and a second opening. Each of the first and second openings communicates with the internal space. At least one locking element is pivotally coupled to the housing so as to rotate about a fixed pivot axis. The locking element has an aperture 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.

[0058] In some configurations, the locking element is a lock washer.

[0059] In some configurations, at least one of the first and second openings is elongated perpendicular to the pivot axis, thereby allowing at least one of the first and second openings to accommodate a core element passing through the aperture of at least one locking element in both the first and second positions.

[0060] In some configurations, at least one locking element comprises a first locking element and a second locking element.

[0061] In some configurations, the housing includes an inner wall positioned between the first locking element and the second locking element.

[0062] In some configurations, the headgear assembly supporting the breathing interface over the user includes a rear headgear portion configured to contact the rear and / or upper portion of the user's head. Each side of the rear headgear portion has a mounting portion configured to be positioned in front of the user's ears when in use. The rear headgear portion does not have a structure passing below the user's ears that would prevent the rear headgear portion from being removed upward. Interface connection mechanisms are provided on the mounting portions of each side of the headgear assembly. Each interface connection mechanism is configured to be coupled directly or indirectly to the breathing interface. Each interface connection mechanism includes at least one length adjustment mechanism. Each length adjustment mechanism includes an elastic element, a core member, and a limiting mechanism. The core member is related to the elastic element and fixed to one end of the elastic element. The core member passes through the limiting mechanism. The limiting mechanism is configured to selectively engage with the core member to resist movement of the core member relative to the limiting mechanism.

[0063] In some configurations, each interface connection mechanism includes at least a first length adjustment mechanism and a second length adjustment mechanism.

[0064] In some configurations, the first length adjustment mechanism and the second length adjustment mechanism are spaced apart from each other at the mounting portion.

[0065] In some configurations, the position of at least one of the first length adjustment mechanism and the second length adjustment mechanism in the mounting portion is adjustable.

[0066] In some configurations, at least one connector is configured to connect the interface connection mechanism to the respiratory interface.

[0067] In some configurations, at least one connector has at least one collection passage configured to receive a portion of the core material.

[0068] In some configurations, a single connector is configured to connect both interface connection mechanisms to the breathing interface.

[0069] In some configurations, the connector defines an opening configured to receive a portion of the respiratory interface, and at least one collection passage comprises a first collection passage and a second collection passage, with at least a portion of the first collection passage located above the opening and at least a portion of the second collection passage located below the opening.

[0070] In some configurations, the connector is configured to connect to multiple different interfaces.

[0071] In some configurations, at least one connector is provided on each side of the headgear assembly.

[0072] In some configurations, the limiting mechanism comprises a pair of lock jaws that define a space through which the core member passes. The lock jaws have a first relative position that engages with the filament to provide a first level of resistance, and a second relative position that provides a second level or resistance lower than the first level.

[0073] In some configurations, the headgear assembly supporting the breathing interface over the user comprises 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 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 also comprises at least one restricting mechanism. At least one filament passes through the at least one restricting mechanism. The at least one restricting mechanism is configured to selectively engage with the at least one filament to resist the movement of the at least one filament relative to the at least one restricting mechanism. The at least one restricting mechanism is located away from each of the first and second ends of the at least one elastic portion.

[0074] In some configurations, the non-elastic portion is a rear headgear portion configured to contact the rear and / or upper portion of the user's head during use, and at least one limiting mechanism is located in the rear headgear portion.

[0075] In some configurations, the rear headgear section features a top strap, and at least one restriction mechanism is located on the top strap.

[0076] In some configurations, the headgear assembly is configured such that at least one limiting mechanism is positioned at the top of the user's head when in use.

[0077] In some configurations, the rear headgear section is equipped with a rear strap, and at least one restriction mechanism is located on the rear strap.

[0078] In some configurations, the headgear assembly is configured such that at least one limiting mechanism is positioned behind the user's ear when in use.

[0079] In some configurations, a guide for at least one filament is provided between the limiting mechanism and one of the first and second ends of at least one elastic portion.

[0080] In some configurations, the limiting mechanism comprises a pair of lock jaws that define a space through which the filament passes. The lock jaws have a first relative position that engages with the filament to provide a first level of resistance, and a second relative position that provides a second level or resistance lower than the first level.

[0081] In some configurations, the patient interface system comprises a main body portion that is sized and shaped to surround the user's nose and / or mouth and is adapted to create a seal with at least substantially the user's face. A fitting allows the patient interface to be coupled to a gas delivery system. A headgear system allows the main body portion to be positioned and held on the user's head, and the headgear system allows the interface system to transform from elastic stretching behavior to non-stretching behavior when in use.

[0082] In some configurations, transformative locking behavior is provided by a set of directional locking mechanisms.

[0083] In some configurations, the transformation locking behavior is provided by a group of directional locking mechanisms located on the retaining surface.

[0084] In some configurations, the transformation locking behavior is provided by a set of directional locking mechanisms that allow for relative movement that is independent of each other.

[0085] In some configurations, transformative locking behavior is provided by a group of directional locking mechanisms that move in an interdependent manner.

[0086] In some configurations, the interface system includes a combination of independent and dependent movements.

[0087] In some configurations, the transformation locking behavior is provided by a directional locking mechanism located on top of the mask body.

[0088] In some configurations, the variability locking behavior is provided by a directional locking mechanism located on or within the headgear system.

[0089] In some configurations, a combination of a directional locking mechanism located on top of the mask body and a directional locking mechanism located on or within the headgear system is used.

[0090] In some configurations, the directional lock is located at the connection point to the headgear and at the base end.

[0091] In some configurations, the directional lock is located at the connection point to the headgear and at the tip.

[0092] In some configurations, the directional lock incorporates a mechanism that allows the user to attach / detach it from the mask body.

[0093] In some configurations, the directional lock module incorporates a mechanism that allows user attachment / detachment between it and the rest of the headgear system.

[0094] In some configurations, the non-stretching behavior of the headgear system results in mask movement of less than 4 mm when the patient interface system receives a variable pressure waveform.

[0095] In some configurations, the patient interface comprises a main body that is sized and shaped to provide a cannular gas delivery system within the nostrils. A fitting allows the patient interface to be connected to the gas delivery system. A headgear system allows the main body to be positioned and held on the user's head, and when the interface system is used, the headgear system allows for a transformation from elastic stretching behavior to non-stretching behavior.

[0096] In some configurations, the patient interface system includes a main body portion that is sized and shaped to surround the user's nose and / or mouth and is adapted to create a substantial seal with at least the user's face. A fitting allows the patient interface to be coupled to a gas delivery system. A headgear system allows the main body portion to be positioned and held on the user's head, and when the interface system is used, the headgear system allows for a transformation from elastic stretching behavior to non-stretching behavior.

[0097] In some configurations, the positional stability of the headgear system is achieved through two main parts: one that passes above or below the occipital prominence, and the other that loosely passes above the crown of the head at the position of the apex of the head. These two relative positions are maintained by the headgear material maintaining its shape.

[0098] In some configurations, the positional stability of the headgear system is achieved through two main parts: one that passes above or below the occipital prominence, and the other that loosely passes above the crown of the head at the position of the apex of the head. These two relative positions are maintained by gussets or connecting members.

[0099] In some configurations, the non-stretchable behavior of the headgear body is achieved by constructing it from a single inelastic material and a variable cross-sectional shape.

[0100] In some configurations, the non-stretchable behavior of the headgear body is achieved by constructing it from a single thermoplastic material and a variable cross-sectional shape.

[0101] In some configurations, the non-stretchable behavior of the headgear body is achieved by constructing it from a single thermosetting material and a variable cross-sectional shape.

[0102] In some configurations, the non-stretchable behavior of the headgear body is achieved by constructing it from multiple thermoplastic materials.

[0103] In some configurations, the non-stretchable behavior of the headgear body is achieved by constructing it from multiple thermosetting materials.

[0104] In some configurations, the non-stretchable behavior of the headgear body is achieved by constructing it from multiple thermoplastic materials and a variable cross-sectional shape.

[0105] In some configurations, the non-stretchable behavior of the headgear body is achieved by constructing it from a thermoplastic material and an incorporated lining or padding.

[0106] In some configurations, the non-stretchable behavior of the headgear body is achieved by constructing it from a thermosetting material and an incorporated backing or padding.

[0107] In some configurations, the headgear assembly for the breathing interface includes a rear headgear portion, an interface coupling portion, and a length adjustment portion that adjusts the length of the headgear assembly or the circumference of the interface assembly when coupled to the breathing interface. The headgear assembly exhibits an elastic force that tends to contract the headgear length or circumference and an inelastic locking force that tends to prevent the headgear length or circumference from stretching.

[0108] In some configurations, the headgear assembly has at least one retaining surface.

[0109] In some configurations, the headgear assembly has two retaining surfaces.

[0110] In some configurations, the holding surfaces converge in a direction from rear to front.

[0111] In some configurations, the holding surfaces converge in a direction from front to back.

[0112] In some configurations, one of the retaining surfaces is angled relative to the other retaining surface.

[0113] In some configurations, the retaining surfaces are separated from each other at the interface mounting position.

[0114] In some configurations, the holding surfaces are generally parallel to each other.

[0115] In some configurations, the holding surface is generally horizontal.

[0116] In some configurations, the headgear assembly further includes a manually adjustable length adjustment section.

[0117] In some configurations, the interface coupling portion can connect to multiple types of interfaces.

[0118] In some configurations, the length adjustment section comprises at least a first and a second section.

[0119] In some configurations, the first and second parts are located on either side of the headgear assembly.

[0120] In some configurations, the interface connection extends between the first and second parts.

[0121] In some configurations, the first and second parts are located on the same side of the headgear assembly.

[0122] In some configurations, the interface connection extends between the first and second parts.

[0123] In some configurations, at least one core can form part of the headgear length or perimeter and lock against another part of the headgear assembly or interface assembly to prevent the headgear length or perimeter from extending.

[0124] In some configurations, the length of the core member is greater than the maximum extension length of the length adjustment portion.

[0125] In some configurations, the length of the rear headgear section is greater than the length of the core member.

[0126] In some configurations, the length of the rear headgear section is greater than the length of the core member.

[0127] In some configurations, at least one collection unit accommodates an excess portion of the core that does not form part of the headgear length or circumference at any given specific headgear length or circumference.

[0128] In some configurations, the length of the core member is less than the combined length of the maximum extension lengths of the core collection section and the length adjustment section.

[0129] In some configurations, the length of the rear headgear section and the core collection section are fixed, and substantially all length adjustments for the headgear length or circumference are provided by adjusting the length of the length adjustment member.

[0130] In some configurations, the nasal cannula system comprises a nasal cannula and a headgear. At least one adjustment mechanism allows for adjustment of the circumference of the nasal cannula system. The at least one adjustment mechanism 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 engages with the core member to hold the nasal cannula system at the desired adjusted circumference.

[0131] In some configurations, the lock can maintain the desired adjusted circumference length depending on the normal or anticipated forces during use, such as the weight of the nasal cannula and the tensile force of the hose.

[0132] In some configurations, the locking mechanism allows the core member to slide under forces exceeding a threshold, thereby increasing the perimeter beyond the desired adjusted perimeter.

[0133] In some configurations, the lock is directional, allowing movement of the core member in a direction that reduces the perimeter length with a relatively low force, lower than the normal or expected force during use.

[0134] In some configurations, the directional lock is any structure or configuration disclosed herein.

[0135] In some configurations, at least one biasing element applies a force to the nasal cannula system that tends to reduce the circumference.

[0136] In some configurations, the biasing element allows the nasal cannula system to self-fit or automatically adjust.

[0137] In some configurations, the nasal cannula system includes at least one quick-release mechanism that allows the surrounding loop to be quickly and easily broken, for example, to remove the nasal cannula system from the user or to apply it to the user.

[0138] In some configurations, the headgear has either a single-strap or a bifurcated strap configuration.

[0139] In some configurations, the nasal cannula comprises a body having a rigid frame portion and a softer user contact portion.

[0140] In some configurations, any excess portion of at least one core member that does not effectively define part of the circumference is housed in either a nasal cannula or a headgear. In some such configurations, the excess portion is located inside the nasal cannula or headgear. In some such configurations, the excess portion is housed within a circular reservoir.

[0141] In some configurations, multiple adjustment mechanisms are provided. In some such configurations, the adjustment mechanisms are located on each side of the nasal cannula system. In some such configurations, the excess portion of the core member on each side is positioned vertically above or inside the nasal cannula.

[0142] In some configurations, the nasal cannula system comprises a nasal cannula and a headgear. At least one adjustment mechanism allows for adjustment of the circumference of the nasal cannula system. The at least one adjustment mechanism includes a core member coupled to a part of the headgear and a lock coupled to another part of the headgear that is movable relative to the first part. The lock engages with the core member to maintain the nasal cannula system at the desired adjusted circumference.

[0143] In some configurations, the lock can maintain the desired adjusted circumference length in response to normal or expected forces during use, such as the weight of the nasal cannula and the tensile force of the hose.

[0144] In some configurations, the locking mechanism allows the core member to slide under forces exceeding a threshold, thereby increasing the perimeter beyond the desired adjusted perimeter.

[0145] In some configurations, the lock is directional, allowing movement of the core member in a direction that reduces the perimeter length with a relatively low force, lower than the normal or expected force during use.

[0146] In some configurations, the directional lock is any structure or configuration disclosed herein.

[0147] In some configurations, at least one biasing element applies a force to the nasal cannula system that tends to reduce the circumference.

[0148] In some configurations, the biasing element allows the nasal cannula to self-fit or automatically adjust.

[0149] In some configurations, the nasal cannula system includes at least one quick-release mechanism that allows the surrounding loop to be quickly and easily broken, for example, to remove the nasal cannula system from the user or to apply it to the user.

[0150] In some configurations, the headgear has either a single-strap or a bifurcated strap configuration.

[0151] In some configurations, the nasal cannula comprises a body having a rigid frame portion and a softer user contact portion.

[0152] In some configurations, any excess portion of at least one core member that does not effectively define a portion of the perimeter is housed in the headgear. In some such configurations, the excess portion is located inside the headgear. In some such configurations, the excess portion is housed within a circular storage section.

[0153] In some configurations, multiple adjustment mechanisms are provided. In some such configurations, the adjustment mechanisms are located on each side of the nasal cannula system.

[0154] In some configurations, the directional lock includes a locking member having an aperture or opening, configured to engage with a core member or filament passing through the opening. The opening can vary in cross-sectional dimensions between one side of the locking member and the other side, and / or the contour of the opening can be tapered.

[0155] In some configurations, the side of the opening that defines the working edge of the locking member that engages with the core member in the locked position is smaller than the opposite side of the opening.

[0156] In some configurations, the contour of the opening is tapered toward the pivot axis of the locking member.

[0157] In some configurations, the directional lock includes a first locking member and a second locking member, each having an aperture or opening, and is configured to engage with a core member or filament passing through the opening. A motion transmission element causes the second locking member to move in response to the movement of the first locking member.

[0158] In some configurations, the motion transmission element pushes the second locking member in response to the movement of the first locking member, but allows the second locking member to move away from the first locking member.

[0159] In some configurations, the motion transmission element is a coupling mechanism that deflects to allow the second locking member to move away from the first locking member.

[0160] According to at least one of the embodiments disclosed herein, a headgear is provided comprising a top strap, a rear strap, a front strap, a yoke, and a connector. The headgear is substantially inelastic and configured to have a three-dimensional structure.

[0161] In a further embodiment, the headgear is made of a composite material, with a textile casing integrally formed around a plastic core.

[0162] In a further embodiment, the headgear comprises a molded label, connector and / or adjustment mechanism.

[0163] In a further embodiment, the headgear component comprises a grip formed from a textile strap.

[0164] In a further embodiment, the textile casing comprises a first portion that covers the surface facing the inside of the headgear.

[0165] In a further embodiment, the textile casing comprises a second portion that covers the surface facing the outside of the headgear.

[0166] In a further embodiment, the first and second parts of the textile casing are in contact at the first and second edges.

[0167] In a further embodiment, the first part and the second part are not connected to each other at the first edge and the second edge.

[0168] In a further embodiment, the textile casing comprises one or more retainer holes configured to engage with retaining pins of a mold.

[0169] In a further embodiment, the headgear includes at least one flexible joint that allows the strap to bend.

[0170] In a further embodiment, at least one flexible joint includes a gap between multiple portions of a plastic core, and the textile casing extends into the gap to connect those portions of the plastic core.

[0171] In a further embodiment, the headgear comprises at least one bridge portion extending between the aforementioned portions of the plastic core within the textile joint.

[0172] In a further embodiment, at least one bridge portion is integrally formed with the aforementioned portion of the plastic core.

[0173] In a further embodiment, the headgear assembly comprises a top strap, a rear strap connected to the top strap at an upper connection point located on the side of the user's forehead, and lower side straps connected to the top strap and rear strap at the upper connection point. The headgear assembly also comprises a first length adjustment section for adjusting the distance between the upper connection point and the frame of the breathing interface, and a second length adjustment section connected to the lower side strap at a lower connection point located in front of the user's ears and aligned approximately in line with the user's mouth, the second adjustment mechanism for adjusting the distance between the lower connection point and the frame of the breathing interface.

[0174] In a further embodiment, the top strap and the rear strap are integrally formed as a single integrated structure.

[0175] In a further embodiment, the top strap, rear strap, and front strap are integrally formed as a single integrated structure.

[0176] In a further embodiment, the first length adjustment portion includes a fabric strap having a hook-loop fastener mechanism.

[0177] In a further embodiment, the second length adjustment section includes a plurality of length adjustment mechanisms.

[0178] In a further embodiment, the headgear assembly comprises a top strap and a rear strap connected to the top strap at an upper connection point located on the side of the user's forehead. The headgear assembly also comprises an upper side strap connected to the top and rear straps at the upper connection point and connected to the frame of the breathing interface. The upper side strap extends between the user's ears and eyes and across the user's cheek toward the frame of the breathing interface. The headgear assembly further comprises a lower side strap connected to the rear strap at a rear connection point located behind the user's ears. The lower side strap extends below the user's ears and across the user's cheek toward the frame of the breathing interface. The headgear assembly further comprises a first length adjustment section connected to the lower side strap and the frame of the breathing interface. The first length adjustment section adjusts the distance between the lower side strap and the frame of the breathing interface.

[0179] In a further embodiment, the top strap and the rear strap are integrally formed as a single integrated structure.

[0180] In a further embodiment, the top strap, rear strap, upper side strap, and lower side strap are integrally formed as a single integrated structure.

[0181] In a further embodiment, the first length adjustment portion includes a one-way adjustment mechanism.

[0182] In a further embodiment, the headgear assembly further comprises a second length adjustment portion connected between the upper side strap and the frame of the breathing interface, the second length adjustment portion adjusting the distance between the upper side strap and the frame of the breathing interface.

[0183] In a further embodiment, the headgear assembly comprises a top strap, a rear strap connected to the top strap at an upper connection point located on the side of the user's forehead, and a front strap connected to the top strap and the rear strap at the upper connection point and connected to a breathing interface. The front strap extends between the user's ears and eyes and toward the base of the user's nose.

[0184] In a further embodiment, the top strap and the rear strap are integrally formed as a single integrated structure.

[0185] In a further embodiment, the top strap, rear strap, and front strap are integrally formed as a single integrated structure.

[0186] In a further embodiment, the front strap extends across the front of the breathing interface and forms part of the frame of the breathing interface.

[0187] In a further embodiment, the headgear assembly further comprises a length adjustment portion connected between the front strap and the breathing interface, the length adjustment portion adjusting the distance between the front strap and the breathing interface.

[0188] In a further embodiment, the headgear assembly comprises a top strap, a rear strap connected to the top strap at an upper connection point located on the side of the user's forehead, and a lower side strap connected to the top and rear straps at the upper connection point and extending substantially vertically away from the upper connection point. The lower strap is positioned in front of the user's ears. The headgear assembly also comprises a first length adjustment portion connected to the lower strap at a first lower connection point, which adjusts the distance between the first lower connection point and the frame of the breathing interface. The first lower connection point is positioned in line with the user's ears, and the first length adjustment portion extends across the cheek directly below the user's eyes. The headgear assembly further comprises a second length adjustment portion connected to the lower strap at a second lower connection point, which adjusts the 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 the base of the user's nose, and the second length adjustment section extends substantially horizontally across the user's cheek.

[0189] In a further embodiment, the top strap and the rear strap are integrally formed as a single integrated structure.

[0190] In a further embodiment, the top strap, rear strap, and lower side strap are integrally formed as a single integrated structure.

[0191] In a further embodiment, at least one of the first length adjustment portion or the second length adjustment portion includes a one-way adjustment mechanism.

[0192] According to at least one of the embodiments disclosed herein, the headgear comprises a plastic core and a textile casing. The plastic core and the textile casing are formed as a single unit by adding molten plastic material to the textile casing.

[0193] In a further embodiment, the textile casing comprises a first portion that covers the surface facing the inside of the headgear.

[0194] In a further embodiment, the textile casing comprises a second portion that covers the surface facing the outside of the headgear.

[0195] In a further embodiment, the first and second portions of the textile casing are in contact at the first and second edges.

[0196] In a further embodiment, the first part and the second part are not connected to each other at the first edge and the second edge.

[0197] In a further embodiment, the textile casing comprises one or more retainer holes configured to engage with retaining pins of a mold.

[0198] In a further embodiment, the headgear comprises at least one flexible joint that allows the headgear to bend and / or fold.

[0199] In a further embodiment, at least one flexible joint includes a gap between multiple portions of a plastic core, and the textile casing extends into the gap to connect the aforementioned portions of the plastic core.

[0200] In a further embodiment, the headgear comprises at least one bridge portion extending within a flexible joint between the aforementioned portions of the plastic core.

[0201] In a further embodiment, at least one bridge portion is integrally formed with the plastic core portion.

[0202] According to at least one of the embodiments disclosed herein, a method for manufacturing a headgear includes the steps of: placing a textile casing in a mold; introducing a molten plastic material into the mold and in contact with the textile casing; and allowing the molten plastic material to solidify on the textile casing to form a plastic core.

[0203] In a further embodiment, the step of placing a textile casing in a mold includes placing a first textile portion and a second textile portion in the mold, and the step of introducing molten plastic material into the mold includes introducing molten plastic material between the first textile portion and the second textile portion.

[0204] In a further embodiment, the method further includes the step of holding the respective ends of the first textile portion and the second textile portion, into which the molten plastic material is introduced into the holding mechanism of the mold.

[0205] In a further embodiment, the method further includes incorporating at least one edge of the textile casing between separate first and second parts of the mold.

[0206] In a further embodiment, the method further includes the step of engaging the opening of the textile casing with the retaining pins of the mold.

[0207] In a further embodiment, the method further includes the step of fixing a textile casing in a mold before introducing the molten plastic material.

[0208] In a further embodiment, the step of securing the textile casing includes securing the textile casing by one or more of the following: holding the textile casing with an electrostatic charge, pneumatic pressure, another component inserted into the mold, or supporting strips of material forming the textile casing that extend through the mold to each side of the mold.

[0209] In a further embodiment, supporting a strip of material includes supporting one end on a roll and securing the free end to a mold.

[0210] In a further embodiment, the method further includes the steps of forming a flexible joint by providing a gap in a plastic core along the length of the headgear, and extending a textile casing along the gap.

[0211] In a further embodiment, the method further includes extending a flexible bridge portion of plastic material through a flexible joint from a portion of the plastic core on one side of the gap to a portion of the plastic core on the opposite side of the gap.

[0212] According to at least one embodiment disclosed herein, the headgear comprises a first strap and a second strap, the first strap and the second strap working together to form at least one of a top strap, a rear strap and a front strap of the headgear.

[0213] According to at least one of the embodiments disclosed herein, a method for manufacturing a headgear includes the steps of: placing a textile casing in a mold; introducing a molten plastic material into the mold and in contact with the textile casing; and allowing the molten plastic material to solidify within the textile casing to form a plastic core.

[0214] In a further embodiment, the first strap and the second strap cooperate to form a rear strap, the first strap and the second strap overlap each other within the rear strap, and only one of the first strap or the second strap defines the top strap.

[0215] In a further embodiment, the first strap and the second strap cooperate to form a front strap, the first strap and the second strap are stacked within the front strap, and only the first strap and the second strap define one of the top strap and one of the rear straps, respectively.

[0216] In a further embodiment, one or both of the straps are composed of a plastic core and a textile casing, which are formed as a single integrated structure by adding molten plastic material on top of the textile casing.

[0217] According to at least one embodiment disclosed herein, the headgear includes an internal core, a first outer layer defining the inner surface of the headgear facing the user during use, and a second outer layer defining the outer surface of the headgear facing away from the user during use. The first and second layers have different colors, textures, or other indicators that enable tactile or visual identification of the inner and outer surfaces.

[0218] In a further embodiment, the first or second outer layer includes one of the following: polyurethane (imitation leather), patterned polyester, wool including a mesh-like knit, continuous loops, nylon, a composite of spacer fabric and continuous loops, or a composite of foam continuous loops.

[0219] In a further embodiment, one or both edges of the first and second outer layers extend beyond the inner core.

[0220] In a further embodiment, the internal core includes an internal cutout.

[0221] According to at least one embodiment disclosed herein, the headgear comprises a first strap, a second strap, and a connector for connecting the first strap to the second strap, the connector being formed by overmolding onto the first and second straps.

[0222] In a further embodiment, the first strap and the second strap are stacked vertically within the connector.

[0223] In a further embodiment, the connector includes a portion that extends between the first strap and the second strap and separates the first strap from the second strap.

[0224] In a further embodiment, the connector includes a front band portion and a rear band portion separated by a bridge portion, the bridge portion not enclosing the entirety of both the first strap and the second strap.

[0225] In a further embodiment, the connector includes a front band portion and a rear gusset.

[0226] In a further embodiment, the front band portion and the rear gusset are separated by the bridge portion, and the bridge portion does not enclose the entirety of both the first and second straps.

[0227] According to at least one embodiment disclosed herein, the strap of the headgear comprises an internal core, at least one outer layer that at least partially surrounds the internal core, and at least one air gap within the outer layer.

[0228] In a further embodiment, at least one air gap comprises a first air gap at one side edge of the strap and a second air gap at the opposite side edge of the strap.

[0229] In a further embodiment, a portion of the internal core is exposed to the outside.

[0230] In a further embodiment, a conduit is arranged within the air gap.

[0231] In a further embodiment, the air gap is defined by the internal core.

[0232] According to at least one embodiment disclosed herein, the strap of the headgear comprises an internal core, at least one outer layer, and at least one conduit extending longitudinally along the strap and within the outer layer.

[0233] In a further embodiment, the conduit is at least partially received within a recess of the internal core.

[0234] In a further embodiment, the conduit is completely sealed within the internal core.

[0235] In a further embodiment, at least one conduit comprises a first conduit and a second conduit.

[0236] In a further embodiment, at least one conduit is defined by a core.

[0237] According to at least one embodiment disclosed herein, the strap of the headgear includes an internal core, at least one outer layer, and at least one reinforcing member.

[0238] In a further embodiment, the reinforcing member is embedded within the core.

[0239] In a further embodiment, the reinforcing member is configured to hold opposing outer layers or opposing sides of outer layers apart from each other before forming the inner core.

[0240] According to at least one embodiment disclosed herein, the strap of the headgear comprises an internal core, at least one outer layer, and at least one buffer layer.

[0241] In a further embodiment, the buffer layer surrounds the inner core.

[0242] In a further embodiment, a portion of the buffer layer is exposed to the outside.

[0243] According to at least one embodiment disclosed herein, the strap of the headgear comprises an inner core and an outer layer that at least partially encloses the inner core, the outer layer having a rim, the rim being embedded within the inner core.

[0244] In a further embodiment, the outer layer comprises two or more segments or three or more segments.

[0245] In a further embodiment, the first part of the outer layer is located on one side of the strap, and the second part of the outer layer is located on the opposite side of the strap.

[0246] In a further embodiment, the third piece of the outer layer is located at one edge of the strap, and the fourth piece of the outer layer is located at the opposite edge of the strap.

[0247] In a further embodiment, at least two parts of the outer layer are located on one side of the strap.

[0248] According to at least one embodiment disclosed herein, the headgear strap comprises an inner core and an outer layer, the outer layer being textured.

[0249] In a further embodiment, the outer layer is ribbed or quilted.

[0250] In a further embodiment, the core is textured to give texture to the outer layer.

[0251] According to at least one embodiment disclosed herein, a headgear, strap, or other part of a headgear has one or more features described herein, or a method for manufacturing such headgear, strap, or other part of a headgear.

[0252] Preferred embodiments of the present invention will be described with reference to the accompanying drawings. [Brief explanation of the drawing]

[0253] [Figure 1] This graph shows the motion envelope, illustrating the relationship between the force generated when the mask enclosure is pressurized and the possible patient headgear sizing range. [Figure 2] Figure 1 shows the motion envelope, where the force curves of the elastic headgear system are superimposed. [Figure 3] Figure 1 shows the motion envelope with the force curves of exemplary embodiments superimposed. [Figure 4] This is a graph of the force-deflection curve of an exemplary headgear device. [Figure 4.1] This shows an example of the position of the headgear device when the user begins to wear it. [Figure 4.2] This shows the position of an exemplary headgear device at the start of contraction. [Figure 4.3] This shows the position of an exemplary headgear device at the end of wearing. [Figure 5] This graph includes an example of a "composite" force-deflection curve. [Figure 6] This is a force-area graph that shows the force-area relationship between the interface, which is sealed and maintains contact. [Figure 7] This is a three-dimensional graph showing the relationship between headgear force, protruding seal area, and head size. [Figure 8A] The force and extension profiles for constant pressure therapy are shown for elastic and non-elastic headgear systems. [Figure 8B]The force and extension profiles of variable pressure therapy for elastic and non-elastic headgear systems are shown. [Figure 9] This is a side view of a nasal interface having a single retaining surface. [Figure 10] This is a side view of a nasal interface having two retaining surfaces. [Figure 11] This is a side view of a full-face mask with two retention surfaces. [Figure 12] This is a side view of a nasal mask having two retaining surfaces. [Figure 13] This is a side view of a mask having two holding surfaces that converge to a single point. [Figure 13.1] This is a table showing the stability of various headgear types. [Figure 13.2] This shows a single-retaining-face interface assembly. [Figure 14] This is a side view of a full-face mask equipped with a forehead support section having a directional locking mechanism located at the connection point between the headgear and the mask. [Figure 15] This is a side view of a full-face mask equipped with a forehead support section having a directional locking mechanism located within the headgear. [Figure 16] This is a side view of a nose mask with a directional locking mechanism on a flat strap. [Figure 17] This is a side view of a nasal mask with a directional locking mechanism featuring a flexible core design. [Figure 18] This shows a module of an interface assembly configured to extend between the mask or other interface and the rear portion of the headgear incorporating a directional locking mechanism. [Figure 19] This shows an alternative module for an interface assembly configured to extend between the rear portion of a headgear, which incorporates a directional locking mechanism positioned at a distance from the mask or other interface and biasing mechanism. [Figure 20] This is a side view of an exemplary interface assembly. [Figure 21]It is a side view of an exemplary full-face mask. [Figure 22] It is a side view of an exemplary nasal pillow mask. [Figure 23] It is a rear perspective view of an exemplary headgear assembly placed on a user. [Figure 24] It is a rear perspective view of the exemplary headgear assembly in FIG. 23. [Figure 25] It is a rear perspective view of an exemplary headgear assembly on a user. [Figure 26] It is a cross-sectional view of the exemplary headgear assembly along line 26-26 in FIG. 25. [Figure 27] It is a cross-sectional view of the exemplary headgear assembly along line 27-27 in FIG. 25. [Figure 28] It is a cross-sectional view of the exemplary headgear assembly along line 28-28 in FIG. 25. [Figure 29] It is a rear perspective view of an exemplary headgear assembly showing some parts of the headgear composed of various material types. [Figure 30] It shows the positions where an automatic adjuster can be placed within an exemplary headgear assembly. [Figure 31] It shows the positions where an automatic adjuster can be placed within an exemplary headgear assembly worn by a user. [Figure 32] It shows an exemplary strap adjustment mechanism in an assembled form. [Figure 33] It is a plan view of the exemplary strap adjustment mechanism in FIG. 32 separated into a first part and a second part. [Figure 34] It is a perspective view of the second part of the exemplary strap adjustment mechanism in FIG. 32. [Figure 35] It is a cross-sectional view of a directional lock in a locked position and an unlocked position. [Figure 36] It shows the operating cycle for a headgear incorporating a directional lock. [Figure 37]Perspective view of an exemplary headgear assembly incorporating one or more directional locks. [Figure 38] Perspective view of an exemplary headgear assembly incorporating one or more directional locks. [Figure 39] Side view of an attachment member attached to the rear portion of the headgear of the exemplary headgear assembly in FIG. 38. [Figure 40] Perspective view of an exemplary interface assembly. [Figure 41] Left side perspective view of an exemplary interface assembly attached to an interface coupling portion. [Figure 42] Side view of an exemplary interface assembly. [Figure 43] Perspective view of a frame element of an interface member attached to an interface coupling portion. [Figure 44] Front view of a frame element of an interface member and an interface coupling portion. [Figure 45] Front view of a frame element of an interface member attached to an interface coupling portion. [Figure 46] Right side perspective view of an exemplary interface assembly attached to an interface coupling portion. [Figure 47] Top perspective view of an exemplary interface assembly attached to a second component of an interface coupling portion. [Figure 48] Top perspective view of a first component of an interface coupling portion. [Figure 49] Top perspective view of a second component of an interface coupling portion. [Figure 50] Right side perspective view of an exemplary interface assembly. [Figure 51] Exploded view of an exemplary interface assembly. [Figure 52] Exploded view of an exemplary interface coupling portion. [Figure 53]This is an inverted exploded view of an exemplary interface connection. [Figure 54] This is a top view of an exemplary folding headgear assembly. [Figure 55] This is a rear view of an exemplary folding headgear assembly. [Figure 56] This is a side view of an exemplary folding headgear assembly. [Figure 57] This shows an exemplary headgear assembly coupled to a full-face mask type interface. [Figure 58] Figure 57 shows an exemplary headgear assembly coupled to a nasal mask. [Figure 59] Figure 57 shows an exemplary headgear assembly coupled to a nose pillow / prong mask. [Figure 60] An interface assembly with an exemplary headgear and T-piece is shown. [Figure 61] An exemplary headgear and interface assembly without a T-piece are shown. [Figure 62] An exemplary headgear and an interface assembly with an interface coupling portion that is detachably attached to the interface are shown. [Figure 63] Figure 62 shows the first position when wearing an exemplary interface assembly. [Figure 64] Figure 62 shows the second position when wearing the exemplary interface assembly. [Figure 65] Figure 62 shows the third position when wearing an exemplary interface assembly. [Figure 66] This shows the outer circumference of an adjustable interface assembly or headgear assembly at its minimum length. [Figure 67] This shows the outer circumference of an adjustable interface assembly or headgear assembly at its maximum length. [Figure 68A] This is a cross-sectional view of a directional lock in the locked position. [Figure 68B]It is a cross-sectional perspective view of the directional lock of FIG. 68A in the locked position. [Figure 68C] It is a cross-sectional view of the directional lock of FIG. 68A in the unlocked position. [Figure 68D] It is a cross-sectional perspective view of the directional lock of FIG. 68A in the unlocked position. [Figure 69A] It is a view of the first assembly step of attaching a lock washer to the housing of an exemplary directional lock. [Figure 69B] It is a view of the second assembly step of attaching a lock washer to the housing of the exemplary directional lock of FIG. 69A. [Figure 70A] It is a view of the first assembly step of attaching lock washers to the housings of a plurality of exemplary directional locks. [Figure 70B] It is a view of the second assembly step of attaching lock washers to the housings of the plurality of exemplary directional locks of FIG. 70A. <= [Figure 71] It is a view of the assembly step of attaching a lock washer to the housing of an exemplary directional lock. [Figure 72] It is a view of the assembly step of attaching a lock washer to the housing of an exemplary directional lock. [Figure 73] It is a side view of an exemplary full-face mask without a forehead support. [Figure 74] It is a side view of another exemplary full-face mask without a forehead support. [Figure 75] It is a side view of an exemplary nose mask. [Figure 76] It is an exemplary headgear system having a rear portion of the headgear and two retaining surfaces. [Figure 77] It is a front perspective view of another exemplary headgear. [Figure 78] It is a front view of the exemplary headgear system of FIG. 77. [Figure 79] It is a rear perspective view of the exemplary headgear system of FIG. 77. [Figure 80]Figure 77 is a front view of an exemplary headgear system equipped with a fitting nose mask device. [Figure 81] This is a front perspective view of an exemplary cushion module and frame assembly. [Figure 82] This is a front perspective view of the frame assembly connected to the housing of the headgear system. [Figure 83] This is a rear view of the frame assembly connected to the housing of the headgear system. [Figure 84] This is a rear view of the frame assembly after it has been removed from the headgear housing. [Figure 85] This demonstrates a functional verification test of a headgear device that includes at least one directional locking module. [Figure 86] This graph shows the relationship between force and the extension of a tested, exemplary headgear device. [Figure 87] This is a force-extension graph showing the fluctuation of force during extension after the transition. [Figure 88] This is a perspective view of a respiratory cannula incorporating the headgear device of the present disclosure, which may include at least one directional locking mechanism. [Figure 89a] This is a perspective view of a further respiratory cannula incorporating the headgear device of the present disclosure, which may include at least one directional locking mechanism and a headgear quick-release mechanism. [Figure 89b] This is a perspective view of a further respiratory cannula incorporating the headgear device of the present disclosure, which may include at least one directional locking mechanism and a headgear quick-release mechanism. [Figure 89c] This is a perspective view of a further respiratory cannula incorporating the headgear device of the present disclosure, which may include at least one directional locking mechanism and a headgear quick-release mechanism. [Figure 90] This is a perspective view of another respiratory cannula incorporating the headgear device of the present disclosure, which may include at least one directional locking mechanism. [Figure 91] This is a perspective view of a respiratory cannula incorporating the headgear device of the present disclosure, which may include at least one directional locking mechanism and a headgear quick-release mechanism. [Figure 92] This is a perspective view of a respiratory cannula incorporating the headgear device of the present disclosure, which may include at least one directional locking mechanism. [Figure 93] This is a perspective view of a respiratory cannula incorporating the headgear device of the present disclosure, which may include at least one directional locking mechanism and a headgear quick-release mechanism. [Figure 94] This is a perspective view of a respiratory cannula incorporating the headgear device of the present disclosure, which may include at least one directional locking mechanism. [Figure 95] This is a perspective view of a respiratory cannula incorporating the headgear device of the present disclosure, which may include at least one directional locking mechanism and a headgear quick-release mechanism. [Figure 96] This is a perspective view of a respiratory cannula incorporating the headgear device of the present disclosure, which may include a pair of directional locking mechanisms and a pair of headgear quick-release mechanisms. [Figure 97] This is a perspective view of a respiratory cannula incorporating the headgear device of the present disclosure, which may include a pair of directional locking mechanisms and a pair of headgear quick-release mechanisms. [Figure 98] This is a perspective view of a respiratory cannula incorporating the headgear device of the present disclosure, which may include a pair of directional locking mechanisms and a headgear quick-release mechanism. [Figure 99] This is a perspective view of a respiratory cannula incorporating the headgear device of the present disclosure, which may include a pair of directional locking mechanisms and a headgear quick-release mechanism. [Figure 100] This is a perspective view of a respiratory cannula incorporating the headgear device of the present disclosure, which may include a pair of directional locking mechanisms and a pair of headgear quick-release mechanisms. [Figure 101]This is a perspective view of a respiratory cannula incorporating the headgear device of the present disclosure, which may include at least one directional locking mechanism and a pair of headgear quick-release mechanisms. [Figure 102] This is a perspective view of a respiratory cannula incorporating the headgear device of the present disclosure, which may include a pair of directional locking mechanisms. [Figure 103] This is a perspective view of an elevation or controlled respiratory pressure system equipped with a respiratory mask used in combination with a nasal high-flow cannula. The respiratory mask may be equipped with one or more directional locking mechanisms. [Figure 104] Figure 103 is a perspective view of a breathing mask. [Figure 105] This is a side view of the locking member and core member of the directional locking mechanism. [Figure 106] This graph shows the preferred operating envelope for the locking member, specifically the sharpness of the locking member's edge versus the locking member's thickness. [Figure 107] This is a magnified view of the locking member in the locked position. [Figure 108] This is an enlarged view of the locking member in Figure 107 in the unlocked position. [Figure 109a] Several locking members with different possible cross-sectional opening shapes are shown. [Figure 109b] Several locking members with different possible cross-sectional opening shapes are shown. [Figure 110] This is a perspective view of a locking member having a tapered hole shape. [Figure 111a] An alternative locking member with a tapered hole shape is shown. [Figure 111b] An alternative locking member with a tapered hole shape is shown. [Figure 112] This is a force-to-distance graph showing the progressive holding force profile of a tapered bore shape compared to a linear holding force profile. [Figure 113a]The diagram shows a directional locking mechanism comprising a pair of locking members and a motion transmission element that transmits movement between the locking members. Figure 113a shows the directional locking mechanism in the unlocked position, and Figure 113b shows the directional locking mechanism in the locked position. [Figure 113b] The diagram shows a directional locking mechanism comprising a pair of locking members and a motion transmission element that transmits movement between the locking members. Figure 113a shows the directional locking mechanism in the unlocked position, and Figure 113b shows the directional locking mechanism in the locked position. [Figure 114a] Another directional locking mechanism is shown, comprising a pair of locking members and an alternative motion transmission element that transmits motion between the locking members. Figure 114a shows the directional locking mechanism in the unlocked position, and Figure 114b shows the directional locking mechanism in the locked position. [Figure 114b] Another directional locking mechanism is shown, comprising a pair of locking members and an alternative motion transmission element that transmits motion between the locking members. Figure 114a shows the directional locking mechanism in the unlocked position, and Figure 114b shows the directional locking mechanism in the locked position. [Figure 115] The image shows a breathing mask system equipped with a headgear device incorporating at least one directional locking mechanism. The directional locking mechanism is located behind the user's ear. [Figure 116] This indicates possible positions for placing the directional locking mechanism above the user. [Figure 117] The placement area relative to the skull is indicated, showing possible positions for positioning the directional lock behind the user's ear. [Figure 118A] This is a side view of the headgear of this disclosure worn by the user. [Figure 118B] This is a perspective view of the headgear of this disclosure. [Figure 119] This is a cross-sectional view of a strap forming part of the headgear disclosed herein. [Figure 120] This is a third-angle orthographic projection of one half of an injection mold configured to mold a strap component similar to that of the headgear of the present disclosure. [Figure 121]Figure 120 is an isometric view of a strap component manufactured by an injection molding die. [Figure 122] Figure 120 shows a cross-sectional view BB of the injection mold, in which the textile casing is located inside. [Figure 123] This is an enlarged view of cross-section AA of the injection mold shown in Figure 120, where the textile casing is located inside. [Figure 124A] This is a perspective view of a second embodiment of the headgear of the present disclosure. [Figure 124B] This is an enlarged cross-sectional view of the sizing adjustment system of a second embodiment of the headgear of the present disclosure. [Figure 125A] Figures 124A and 124B are cross-sectional views of a second embodiment of the size adjustment system. [Figure 125B] Figure 8A is a plan view of the first strap of the size adjustment system. [Figure 125C] A perspective view of the first strap of an alternative size adjustment system. [Figure 125D] Figure 125C is a cross-sectional view of the connected first and second straps of the size adjustment system. [Figure 125E] Figure 125C is a cross-sectional view of the unconnected first and second straps of the size adjustment system. [Figure 125F] This is an assembly and disassembly perspective view of another alternative size adjustment system. [Figure 125G] Figure 125F is a close-up, disassembled perspective view of the size adjustment system. [Figure 125H] This is a top view of the first strap of the size adjustment system in Figure 125F. [Figure 125I] Figure 125F is a cross-sectional view of the second strap of the size adjustment system. [Figure 126] This is a perspective view of a respiratory device equipped with cushion pads connected using the size adjustment system shown in Figures 124A and 124B. [Figure 127A] This is a plan view of the connection points between components of a respiratory apparatus. [Figure 127B]This is a plan view of the connection points between components of a respiratory apparatus. [Figure 128] This is a plan view of a headgear component with a molded grip. [Figure 129] This is a cross-sectional view of a mold configured to form the headgear components shown in Figure 128. [Figure 130] This is a side view of a headgear strap portion having a relatively inelastic core, a fabric casing on at least one face of the core, and flexible joints between several parts of the core. [Figure 131] This is a cross-sectional view of the headgear strap portion of Figure 130 along line 14-14 in Figure 130. [Figure 132] A side view of a headgear strap portion having a relatively inelastic core, a fabric casing on at least one face of the core, and a flexible joint between several parts of the core, the flexible joint comprising a flexible bridge portion extending between those parts of the core. [Figure 133] This is a cross-sectional view of the headgear strap portion of Figure 132 along line 16-16. [Figure 134] This exhibits a system for forming a headgear strap portion that utilizes static electricity to hold the fabric casing in place within the molding die. [Figure 135] This diagram illustrates a system for forming a headgear strap portion that utilizes air pressure to hold the fabric casing in place within the molding die. [Figure 136] This document describes a system for forming a headgear strap portion, utilizing one or more components to hold a fabric casing in place within a molding die. [Figure 137] This diagram illustrates a system for forming a headgear strap portion, utilizing a roll of material to feed a fabric casing into a molding die. [Figure 138] This shows a headgear with a first strap and a second strap. [Figure 139A] This is a cross-section of the second strap. [Figure 139B] This is a cross-section of the first strap. [Figure 139C] This is a cross-sectional view of an alternative strap, in which the strap core includes a recess configured to receive the seam of the strap's cover layer. [Figure 139D] This is a cross-sectional view of another alternative strap, in which the core has one or more recesses that occupy a substantial portion of the core in the width direction, and the seams of the cover layers are located within the recesses. [Figure 139E] This is a cross-sectional view of yet another alternative strap, showing an alternative seam configuration where the seams of the cover layers are folded over the surface of the cover layers. [Figure 140A] This is a diagram of the outer layer of the first strap. [Figure 140B] This is a diagram of the outer layer of the second strap. [Figure 141] This shows a headgear with a first strap and a second strap. [Figure 142A] This is a cross-section of the first strap. [Figure 142B] This is a cross-section of the second strap. [Figure 143A] This is a diagram of the outer layer of the first strap. [Figure 143B] This is a diagram of the outer layer of the second strap. [Figure 144] This shows a headgear having an inner core, a first outer layer, and a second outer layer. [Figure 145] Figure 144 is a cross-sectional view of a part of the headgear. [Figure 146A] Figure 144 shows the first outer layer of the headgear. [Figure 146B] Figure 144 shows the second outer layer of the headgear. [Figure 147] This shows a headgear having an inner core, a first outer layer, and a second outer layer. [Figure 148] Figure 147 is a cross-sectional view of a part of the headgear. [Figure 149A] Figure 147 shows the first outer layer of the headgear. [Figure 148B] Figure 147 shows the second outer layer of the headgear. [Figure 150]This shows a headgear having an inner core, a first outer layer, and a second outer layer. [Figure 151] Figure 150 is a cross-sectional view of a part of the headgear. [Figure 152A] Figure 150 shows the first outer layer of the headgear. [Figure 152B] Figure 150 shows the second outer layer of the headgear. [Figure 153] This shows a headgear having an inner core, a first outer layer, and a second outer layer. [Figure 154] Figure 153 is a cross-sectional view of a part of the headgear. [Figure 155] This shows a headgear having an inner core, a first outer layer, and a second outer layer. [Figure 156] Figure 155 is a cross-sectional view of a part of the headgear. [Figure 157A] Figure 155 shows the first outer layer of the headgear. [Figure 157B] Figure 155 shows the second outer layer of the headgear. [Figure 158] This is a cross-sectional view of a headgear strap device having a core and one or more outer layers. [Figure 159] Figure 158 is a side view of the core of the headgear strap device. [Figure 160] This is a cross-sectional view of a headgear strap device having a core and one or more outer layers. [Figure 161] Figure 160 is a side view of the core of the headgear strap device. [Figure 162] This is a cross-sectional view of a headgear strap device having a core and one or more outer layers. [Figure 163] Figure 162 is a side view of the core of the headgear strap device. [Figure 164] This is a cross-sectional view of a headgear strap device having a core and one or more outer layers. [Figure 165] Figure 164 is a side view of the core of the headgear strap device. [Figure 166]This is a cross-sectional view of a headgear strap device having a core and one or more outer layers. [Figure 167] Figure 166 is a side view of the core of the headgear strap device. [Figure 168] This is a cross-sectional view of a headgear strap device having a core and one or more outer layers. [Figure 169] Figure 168 is a side view of the core of the headgear strap device. [Figure 170] This is a cross-sectional view of a headgear strap device having a core and one or more outer layers. [Figure 171] Figure 170 is a side view of the core of the headgear strap device. [Figure 172] This is a cross-sectional view of a headgear strap device having a core and one or more outer layers. [Figure 173] Figure 172 is a side view of the core of the headgear strap device. [Figure 174] This is a perspective view of a headgear having a first strap and a second strap. [Figure 175A] Figure 174 is a cross-sectional view of a part of the headgear. [Figure 175B] Figure 174 is a cross-sectional view of an alternative configuration for the headgear strap. [Figure 175C] Figure 174 is a cross-sectional view of another alternative configuration for the headgear strap. [Figure 176] This is a perspective view of a headgear having at least a first strap and a second strap. [Figure 177] This is an enlarged view of the headgear in Figure 176, which includes a coupling mechanism that connects at least the first and second straps. [Figure 178] This is a cross-sectional view of a portion of the headgear in Figure 176, passing through the coupling mechanism in Figure 177. [Figure 179] This is a perspective view of a headgear having at least a first strap and a second strap. [Figure 180]This is an enlarged view of the headgear in Figure 179, which includes a coupling mechanism that connects at least the first and second straps. [Figure 181] This is a cross-sectional view of a portion of the headgear shown in Figure 179, passing through the coupling mechanism shown in Figure 180. [Figure 182] This is a perspective view of a headgear having at least a first strap and a second strap. [Figure 183] This is an enlarged view of the headgear in Figure 182, which includes a coupling mechanism that connects at least the first and second straps. [Figure 187] This is a cross-sectional view of a portion of the headgear shown in Figure 182, passing through the coupling mechanism shown in Figure 183. [Figure 185] This is a perspective view of a headgear having at least a first strap and a second strap. [Figure 186] This is an enlarged view of the headgear in Figure 185, which includes a coupling mechanism that connects at least the first and second straps. [Figure 187] This is a cross-sectional view of a portion of the headgear in Figure 185, passing through the coupling mechanism in Figure 186. [Figure 188] This is a perspective view of a headgear having at least a first strap and a second strap. [Figure 189] This is an enlarged view of the headgear in Figure 188, which includes a coupling mechanism that connects at least the first and second straps. [Figure 190] This is a cross-sectional view of a portion of the headgear shown in Figure 188, passing through the coupling mechanism shown in Figure 189. [Figure 191] This is a perspective view of a headgear having at least a first strap and a second strap. [Figure 192] This is an enlarged view of the headgear in Figure 191, including a coupling mechanism that connects at least the first and second straps. [Figure 193] This is a cross-sectional view of a portion of the headgear in Figure 191, passing through the coupling mechanism in Figure 192. [Figure 194]This 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 outer layer and the core. [Figure 195] This is a cross-sectional view of a headgear strap having a core and an outer layer, with one or more conduits between the outer layer and the core. [Figure 196] This is a cross-sectional view of another headgear strap, having a core and an outer layer, with one or more conduits between the outer layer and the core. [Figure 197] This is a cross-sectional view of a headgear strap having a core and an outer layer, with one or more conduits at least partially surrounded by the core. [Figure 198] This is a cross-sectional view of another headgear strap, having a core and an outer layer, with one or more conduits at least partially surrounded by the core. [Figure 199] This is a cross-sectional view of a headgear strap having a core and an outer layer, with a pair of conduits defined by the core. [Figure 200] This is a cross-sectional view of a headgear strap having a core and an outer layer, with an air gap between the outer layer and the core. [Figure 201A] This is a cross-sectional view of the headgear strap in Figure 200, in a first position relative to the surface. [Figure 201B] This is a cross-sectional view of the headgear strap in Figure 200, located in a second position relative to the surface. [Figure 202] This is a cross-sectional view of a headgear strap having a core and an outer layer, with an air gap between the outer layer and the core, and a portion of the core exposed to the outside. [Figure 203] This is a cross-sectional view of another headgear strap, which has a core and an outer layer, with an air gap between the outer layer and the core, and a portion of the core exposed to the outside. [Figure 204] This is an exploded view of the outer layer and reinforcing members of the headgear strap. [Figure 205] Figure 204 is a cross-sectional view of the headgear strap incorporating the outer layer and reinforcing members. [Figure 206]This is a cross-sectional view of a headgear assembly having a core, a first outer layer, a second outer layer, and one or more reinforcing or separating members that separate the outer layers before the introduction of the core material. [Figure 207] This is a cross-sectional view of a headgear strap having a core, a first outer layer, a second outer layer, and a reinforcing member enclosed within the core. [Figure 208] This is a cross-sectional view of a headgear strap having a core, a buffer layer, and an outer layer. [Figure 209] This is a cross-sectional view of another headgear strap, having a core, a buffer layer, and an outer layer, with a portion of the buffer layer exposed to the outside. [Figure 210] This is a side view of part of a headgear having several straps and connectors for connecting two or more of the straps. [Figure 211] This is a cross-sectional view of one of the connectors and straps in Figure 210. [Figure 212] This is a cross-sectional view of a headgear strap having a core and a seamless outer layer made of a single piece. [Figure 213] This is a cross-sectional view of a headgear strap, which has a core and an outer layer consisting of a single piece with a seam, the edge of which is embedded within the core. [Figure 214] This is a cross-sectional view of another headgear strap, having a core and an outer layer consisting of a single piece with a seam, the edge of which is embedded within the core. [Figure 215] This is a cross-sectional view of a headgear strap, which has a core and an outer layer consisting of two pieces with a pair of joints, the edges of which are embedded within the core. [Figure 216A] This is a cross-sectional view of the outer layer of a bipartite piece without a core. [Figure 216B] This is a cross-sectional view of the outer layer of the two-part piece after the core has been formed. [Figure 217] This is a cross-sectional view of a headgear strap, which has a core and an outer layer consisting of four pieces with four joints, the edges of which are embedded within the core. [Figure 218]This is a cross-sectional view of another headgear strap, having a core and an outer layer consisting of three pieces with three joints, the edges of which are embedded within the core. [Figure 219] This is a perspective view of a headgear strap, which has a core and a textured outer layer, with a portion of the outer layer cut out to expose the core. [Figure 220] This is a perspective view of a headgear strap, which has a core and a quilted outer layer, with a portion of the outer layer cut out to expose the core. [Figure 221] This is a cross-sectional view of a headgear layer having a core and an outer layer, the core giving the outer layer a textured shape. [Figure 222] This is a perspective view of a headgear having a first strap and a second strap. [Figure 223] Figure 222 is a cross-sectional view of the first strap of the headgear. [Figure 224] Figure 222 is a cross-sectional view of the second strap of the headgear. [Figure 225] This is a perspective view of a headgear having a first strap, a second strap, and a connection between the first and second straps. [Figure 226] This is a magnified view of a portion of the headgear in Figure 225, including the connecting part. [Figure 227] This is a cross-sectional view of the connection point shown in Figure 226. [Figure 228] This is a perspective view of a headgear having a first strap, a second strap, and a connection between the first and second straps. [Figure 229] This is an enlarged view of the part of the headgear including the connection point shown in Figure 228. [Figure 230] Several possible cross-sectional views of the strap within the connection point are shown. [Figure 231] Figure 228 is a cross-sectional view of the second strap of the headgear. [Figure 232A] This is a view of the front strap and a top view of the bifurcated strap of an intra-moulded bifurcated headgear. [Figure 232B] Figure 232A is a perspective view of the first and second cover layers joined to each other to form the strap of the in-mold bifurcated headgear. [Figure 232C] Figure 232A is a cross-sectional view of the first and second cover layers joined to each other to form the strap of the in-mold bifurcated headgear. [Figure 233] Figure 232A is a perspective view of an in-molded bifurcated headgear having a partially rigid front strap. [Figure 234] Figure 232A is a perspective view of an in-molded bifurcated headgear having a rigid front strap and a partially rigid bifurcated strap. [Figure 235] Figure 232A is a perspective view of an in-molded bifurcated headgear having a rigid front strap and a bifurcated strap. [Figure 236A] Figures 232A to 235 are perspective views of a mold configured to form the in-mold bifurcated headgear configuration shown in Figures 232A to 235. [Figure 236B] Figure 236A is a cross-sectional view of the mold along line AA. [Figure 236C] This is a cross-sectional view of a mold configured to secure a cloth casing in the appropriate place inside. [Figure 236D] This is a cross-sectional view of a mold having retaining spikes to secure a cloth casing in place inside. [Figure 236E] Figure 236D is a partial perspective view of the mold, showing retaining spikes that secure the cloth casing in place inside. [Figure 236F] Figure 236D is a cross-sectional view of the mold showing retaining spikes that pierce the fabric casing but do not extend through it. [Figure 236G] Figure 236D is a cross-sectional view of the mold showing the retaining spikes that penetrate and pierce the fabric casing. [Figure 237A] This is a perspective view of a mold used to form a headgear using a woven fabric casing. [Figure 237B] Figure 237A is a cross-sectional view of the molding die. [Figure 238]This is a cross-sectional perspective view of an alternative structure for an in-mold strap having a core, cover layer, and rails. [Figure 239A] This is a cross-sectional view of an alternative structure for an in-mold strap having an air pocket core, a cover layer, and an in-mold rail. [Figure 239B] Figure 239A is a perspective view of the in-mold strap. [Figure 239C] Figure 239A is a cross-sectional view of the in-molded strap when worn by a user. [Figure 240A] This is a cross-sectional perspective view of an alternative structure for an in-mold strap with a structured core. [Figure 240B] Figure 240A is a cross-sectional view of the mold for constructing the in-mold structured core of the strap. [Figure 241A] This is a perspective view of an alternative structure for an in-mold strap, which has a complex 3D shape in which the shape and cross-section continuously change along its length. [Figure 241B] Figure 241A is a cross-sectional view of the in-mold strap along line AA. [Figure 241C] Figure 241A is a cross-sectional view of the in-mold strap along line BB. [Figure 242A] This is a cross-sectional perspective view of an alternative in-mold strap with an embossed brand logo. [Figure 242B] This is a cross-sectional perspective view of an alternative in-mold strap with a laser-cut brand logo. [Figure 242C] Figure 242B is a cross-sectional perspective view of an alternative in-mold strap. [Figure 242D] This is a cross-sectional perspective view of an alternative in-mold strap, where the laser-cut portion has been removed to expose the core material. [Figure 242E] This is a cross-sectional perspective view of an alternative in-mold strap having embossed indices and protruding indices formed from a protruding exposed core material. [Figure 242F]This is a cross-sectional perspective view of an alternative in-mold strap with embossed features and protruding grip bumps. [Figure 242G] This is a cross-sectional perspective view of an alternative in-mold strap with embossed, protruding grip bumps. [Figure 243A] This is a cross-sectional perspective view of an alternative in-mold strap with an overmolded brand logo. [Figure 243B] This is a cross-sectional perspective view of an alternative in-mold strap having an overmolded grip bump. [Figure 243C] Figure 243B shows a cross-sectional view of an alternative in-molded strap with an overmolded gripping protrusion, known along line AA. [Figure 244A] This is a rear perspective view of a molded headgear configuration with a single rear strap. [Figure 244B] Figure 244A is a cross-sectional view of the molded headgear configuration along line AA. [Figure 245A] This is a side perspective view of a molded headgear configuration having a lower strap connected to a crown strap by an arched connector. [Figure 245B] Figure 245A is a cross-sectional view of the molded headgear configuration along line AA. [Figure 245C] Figure 245A is a side view of the molded headgear configuration. [Figure 246] This is a rear perspective view of a molded headgear configuration having a rigid front strap, an elastic rear strap, and a crown strap. [Figure 247A] This is a rear perspective view of a molded bifurcated headgear configuration having a variable knit fabric formed in a mold. [Figure 247B] Figure 247A is a cross-sectional view of the molded headgear configuration along line AA. [Figure 247C] Figure 247A is a cross-sectional view of the molded headgear configuration along line BB. [Figure 247D]This is the mold used to form the molded headgear configuration shown in Figure 247A. [Figure 248A] This is a side view of a molded headgear configuration with a fully integrated bifurcated rear strap and crown strap. [Figure 248B] Figure 248A is a partially assembled and disassembled perspective view of the molded headgear configuration. [Figure 248C] Figure 248A is a cross-sectional perspective view of the molded headgear configuration along line AA. [Figure 249A] This is a side perspective view of a molded headgear configuration having a core material that is exposed and formed on the outer surface of the outer cover. [Figure 249B] Figure 248A is a cross-sectional perspective view of a molded headgear configuration having a core material positioned in a recess of the outer cover. [Figure 249C] This is a cross-sectional perspective view showing an alternative structure to the molded headgear configuration of Figure 248A, having a core material positioned on top of the outer cover rather than in a recess of the outer cover. [Figure 250] This is a side view of an exemplary in-mold headgear configuration used in combination with a full face mask. [Figure 251] This is a side view of an exemplary in-mold headgear configuration having a lower ear strap for use in combination with a nasal mask. [Figure 252] This is a side view of an exemplary in-mold headgear configuration used in combination with a nose pillow mask. [Figure 253] This is a side view of an exemplary in-mold headgear configuration used in combination with a nose mask. [Modes for carrying out the invention]

[0254] Reference numerals may be reused throughout the drawings to indicate the overall correspondence between reference elements. The drawings are provided to illustrate the embodiments described herein and are not intended to limit the scope of this disclosure. Hereinafter, embodiments of systems, components, and methods of assembly and manufacture are described with reference to the accompanying drawings. Throughout the drawings, similar numerals refer to similar or analogous elements. While several embodiments, examples, and illustrations are disclosed below, it will be understood by those skilled in the art that the invention described herein extends beyond the scope of the embodiments, examples, and illustrations specifically disclosed and may include other uses of the invention and its obvious variations and equivalents. The terminology used in the descriptions presented herein is not intended to be construed as limiting or restricting in any way, but is simply used in connection with the detailed description of some specific embodiments of the invention. Furthermore, embodiments of the invention may include several novel features, and no single feature is solely responsible for its desired attributes or essential for carrying out the invention described herein.

[0255] In the following explanation, some terms may be used merely for reference and are therefore not intended to be limiting. For example, the terms “up” and “down” refer to directions in the referenced drawings. Terms such as “front,” “rear,” “left,” “right,” “back,” and “side” describe the orientation and / or position of a component or element within a consistent but arbitrary evaluation criteria system, as becomes clear by referring to the text and related drawings describing the component or element under consideration. Furthermore, terms such as “first,” “second,” and “third” may be used to describe distinct components. These terms may include the terms specifically mentioned above, their derivatives, and terms with similar meanings.

[0256] As used herein, the term “substantially inelastic” refers to the ability of a headgear or material to resist stretching under loads it may be subjected to. Thus, a headgear or material may be substantially inelastic in one direction and somewhat elastic in another. In some configurations, the headgear or material is configured to be substantially inelastic in the direction in which it is loaded by the treatment in which it is intended to be used. A substantially inelastic headgear or material may resist stretching that would impair the seal of a breathing mask in a sealed system under normal or expected conditions. In an unsealed system, a substantially inelastic headgear or material may resist stretching that would impair the proper positioning of the breathing interface depending on normal or expected conditions, such as hose tension or user movement. If the expected load force is relatively low, the load is not sufficient to cause stretching, and the headgear or material may have greater elasticity. Conversely, if the headgear and / or material is expected to be subjected to high load forces, greater inelasticity is required to resist stretching.

[0257] Some embodiments disclosed herein include a headgear system and / or an interface assembly incorporating a headgear system, which, when attached to the user's head, automatically adjusts to the correct size and, when in use, transforms its properties from elastic "stretchable" straps / strapping to "non-elastic" straps / strapping. In some configurations, the headgear (either alone or integrated into the interface assembly) exhibits a relatively small contraction force that tends to shorten the headgear. When coupled to a mask, the headgear and mask work together to define the perimeter of the interface assembly, its length reduced as a result of a contraction force toward a minimum circumference. Although unlikely to be perfectly circular, the circumference is often referred to as the "circumference." Thus, in such configurations, the interface assembly can be positioned on the user's head and, like elastic or "stretchable" headgear, automatically contract to or very close to the appropriate head size. The retraction force is preferably sufficient to support the weight of the interface assembly and to hold the interface assembly in place on the user's head, at least substantially, within the minimum head size or the minimum useful circumference of the interface assembly (which may or may not coincide with the minimum circumference). In some configurations, the retraction force may be sufficient to support the weight of a nasal cannula or other small interface, which may, for example, have a weight of about 50 grams. In other configurations, the retraction force may be about 0.5 Newtons to about 5.2 Newtons, or about 1 Newton to about 2.6 Newtons, or about 1 Newton to about 1.5 Newtons (including any value and partial ranges within these ranges). In other configurations, the retraction force may be insufficient to support the weight of the interface, and manual assistance may be required to move the interface to the sealing position on the user's face. However, preferably, once the headgear is sufficiently retracted, it is held in place, for example, by a directional lock. In some configurations, the retraction force is either sufficient to support the weight of the headgear or is configured to support it.

[0258] However, in at least some configurations, the contraction force is less than necessary to maintain sealing contact with the user's face and keep the mask in place during treatment / use. That is, the contraction force alone cannot resist the blow-off force. In some configurations, the contraction force is insufficient to resist the blow-off force throughout the range of usable circumference or headgear size. Therefore, the headgear and / or interface assembly also exhibit inelastic behavior in response to forces that tend to stretch the headgear or increase the circumference of the interface assembly. The headgear and / or interface assembly may have a locking mode that can result in a locking force that tends to resist expansion, stretching, or lengthening of the circumference. The locking force may be sufficient to resist the stretching of the circumference or at least any significant stretching in response to the blow-off force. In some configurations, the locking force is sufficient to resist stretching in response to the maximum blow-off force expected in various uses or treatments (e.g., bilevel or CPAP, NIV, etc.). In some configurations, the locking force can be selected for one or more specific uses / therapies, but may not be suitable for all uses / therapies. In some configurations, the locking force can be selected to resist stretching in accordance with several forces in addition to the blowing force, such as hose tension force. These additional forces may be collectively referred to herein as "hose tension force," and these additional resistances to stretching may be referred to herein as "reserve force."

[0259] In some configurations, the headgear and / or interface assembly also exhibit a yield force, beyond which the circumference can be extended or stretched. Preferably, the yield force is greater than the expected blow force. In some configurations, the yield force is greater than the expected blow force and hose tensile force. Thus, such headgear and / or interface assemblies have a reserve force. Preferably, the yield force is set low enough so that the user can apply at least relatively favorably enough extension force to the headgear and / or interface assembly to exceed the yield force so that the interface assembly can be extended and fitted to the user's head. As described above, the contraction force reduces the circumference toward the appropriate head size.

[0260] In some configurations, the headgear and / or interface assembly automatically transitions between contraction mode, lock mode, and yield mode depending on the presence or absence of an external force. For example, the headgear and / or interface assembly moves toward or to the minimum circumference when no external extension or stretching force is present. Applying an extension or expansion force greater than the yield force can increase the circumference of the headgear and / or interface assembly to a length sufficient to position the interface assembly on the user's head. When the extension or expansion force is removed (or reduced to less than the contraction force), the contraction force acts to automatically reduce the circumference to a head size appropriate for or substantially such a head size so that the interface assembly can be supported on the user's head. When treatment begins (blowing force is applied) and / or hose tensile force is applied, the headgear and / or interface assembly transforms into lock mode to resist extension or increase of the circumference, or at least resist any significant extension or increase. At the end of treatment, or at any time as requested, a force exceeding the yield force can be applied to the headgear and / or interface assembly to increase its circumference and allow the interface assembly to be removed from the user's head.

[0261] Advantageously, this configuration allows for quick and convenient fine-tuning of the circumference of the headgear and / or interface assembly. For example, the mask can be manipulated to fine-tune the circumference during treatment or use. For instance, if there is a leak between the mask and the user's face, the circumference can be adjusted to address the leak by shaking or otherwise moving the mask. In some cases, the mask seal can be pressurized against the user's face, thereby allowing the contraction force to automatically reduce the circumference. When the mask is released, the headgear and / or interface assembly locks at or very close to the reduced circumference. Thus, this configuration allows for fine-tuning or moving the headgear and / or interface assembly to the adjusted circumference as a result of slight manipulation of the mask (e.g., shaking). Fine-tuning can also be achieved by manipulating other parts of the interface assembly (e.g., the headgear or breathing tube / gas conduit). Due to the nature of the human head and / or the conditions under which the interface assembly is used, quick and convenient fine-tuning can dramatically improve the performance of the interface assembly and user satisfaction. Treatment is often performed at night and / or under other circumstances while the user is lying down. Therefore, the headgear may come into contact with surfaces such as pillows or beds. As the user's head moves against these surfaces, the headgear may shift, which can alter its fit. For example, hair may shift or be "compressed" directly beneath the headgear, which can alter the fit. The headgear straps may move upward, downward, or rotate over the head, which can alter the fit. These changes in fit can lead to leaks between the mask and the user's face. The adjustment techniques described above can address these changes in fit automatically or through slight manipulation of the mask or other parts of the interface assembly.Furthermore, the interface assembly can be removed and reattached to automatically adjust to the appropriate headgear size or a size very close to it. In contrast, conventional non-stretchable headgear can be difficult and time-consuming to re-establish the desired adjustment position if it moves from its desired adjustment position due to error or as a result of cleaning, etc. Conventional elastic headgear addresses the adjustment problem, but because the contraction force must resist the expected maximum blow force and hose tension at the smallest usable headgear size, elastic headgear applies relatively large pressure to the user's head, which is only partially relieved by applying blow force. Such pressure can be substantial for users with relatively large head sizes at low therapeutic pressures.

[0262] As will be discussed later regarding specific directional locking mechanisms, in some configurations, some amount of movement occurs in the headgear and / or interface assembly during the transition from elastic mode to locking mode. For example, some directional locking mechanisms may cause a slight increase in perimeter during the transition from elastic mode to locking mode. In some cases, a compromise exists between increasing yield force and reducing the change in perimeter during the transition. Therefore, any reference to any particular position or perimeter of the headgear and / or interface assembly may include such slight length changes during the transition, if present.

[0263] The following examples of the adjustment techniques described above are based on CPAP delivery. A series of graphs illustrates a typical operating envelope that a headgear system must be designed to operate under, and how various current embodiments operate under that envelope. The envelope may include the entire CPAP treatment area, i.e., the entire range of typical, possible, or feasible CPAP pressures and the entire range of typical, possible, or feasible head sizes. Alternatively, the envelope may include a portion of the CPAP treatment area, such as a portion of the pressure (e.g., low-pressure CPAP or high-pressure CPAP) or a portion of the head size (size of the headgear or interface assembly) (e.g., small, medium, or large). The principles considered in relation to CPAP treatment can be similarly applied to other treatments.

[0264] Figure 1 is a graph showing the relationship between the force generated when the mask enclosure is pressurized and the possible headgear sizing range that may occur across a range of possible patients. The action envelope is shown as a rectangular region defined between the minimum and maximum force and between the maximum and minimum head sizes (circumference).

[0265] Figure 2 shows the operating envelope of Figure 1 with the performance characteristics (force curves) of the elastic headgear system superimposed. It is clear that for the elastic system to provide sufficient performance across the mask system operating envelope, it must provide a force greater than the force the mask system may generate. Therefore, at low CPAP pressures, the headgear provides a much greater force than is necessary to suppress the blow force. Further pressure is applied to the user across the area defined by the mask and headgear, which is concentrated primarily at the back of the head, in the mask. The area of ​​the headgear can be increased to apply force over a larger area, thereby reducing the applied pressure. However, larger headgear can be cumbersome or uncomfortable. For example, such large headgear may retain heat over a larger area than desired.

[0266] Figure 3 shows the operating envelope of Figure 1 with the performance of an example headgear system having the auto-adjustment technology described above superimposed. In the illustrated example, the force generated by the headgear and / or interface assembly is sufficient to balance the force generated by the pressurization of the enclosed area of ​​the mask. Essentially, the example headgear system automatically adjusts to the appropriate head size (head circumference or perimeter) with relatively low contractile force, and then provides a holding force that matches the actual CPAP pressure "on request". Thus, the example headgear system can automatically adjust to meet the needs of any possible point in the CPAP envelope.

[0267] Figure 4 shows a graph of the force-deflection curve for an example of a headgear device or an interface assembly with a headgear device. The deflection axis of the graph can represent the circumference or perimeter of the headgear device or interface assembly. The circumference or perimeter can represent the head circumference of a particular user when the headgear device or interface assembly is fitted to that user. Figures 4.1 to 4.3 show several distinct positions in which a user wears ("wears") and fine-tunes an example of an interface assembly with a headgear device. The graphs in Figure 4 will be discussed later with further reference to the wearing positions in Figures 4.1 to 4.3.

[0268] The graph in Figure 4 also shows an action envelope 10 relating to a headgear device or interface assembly, which may be the same action envelope illustrated and described above with reference to Figures 1-3. The action envelope 10 is shown as a rectangular region defined between the minimum and maximum force applied to the headgear device or interface assembly as a result of treatment, and between the minimum and maximum head size or head circumference / circumference of the headgear device. The action envelope 10 may be specific to a treatment (e.g., CPAP or bilevel PAP) or may cover multiple treatments. Similarly, the head size or head circumference / circumference may be specific to the size of the headgear device or may cover multiple sizes. The action envelope 10 can be used to establish functional or behavioral criteria for a particular headgear device, and this specification uses the action envelope 10 to illustrate features or behaviors of several disclosed embodiments.

[0269] For example, with respect to the motion envelope 10, a graph is shown that includes an example of a force-deflection curve for an example headgear device or interface assembly (referred to as "headgear" for convenience in the graph analysis). The curve originates at or near the origin of the graph, where the force is approximately zero and the minimum circumference or perimeter of the headgear (referred to as "circumference" for convenience in the graph analysis) can be represented. The minimum circumference is greater than zero but is typically less than the minimum head circumference of the intended user or range of users (considering the interface, if any).

[0270] As shown in Figure 4.1, in order to position the headgear 100 over the user, the headgear 100 is typically stretched to a circumference larger than the user's actual head circumference. Typically, the rear portion of the headgear 100 is positioned at the back of the user's head, and the user grasps the front of the headgear 100 (e.g., a mask or other interface) and applies tensile force to stretch the headgear 100, moving the mask or other interface across the top of the head and toward the face.

[0271] As shown in the graph of Figure 4, the force-deflection curve example initially rises at a steep pitch, where the force increases substantially with a relatively small increase in circumference. In some configurations, the force-deflection curve rises above the minimum force level of the operating envelope 10 before reaching the minimum circumference of the operating envelope 10. This portion of the curve can be called the initial extension portion 12a.

[0272] At any point where the maximum force of the operating envelope 10 is exceeded, the force-deflection curve transitions to a shallower pitch, where the circumference increases substantially with relatively small increases in force. This shallower pitch portion of the force-deflection curve can relate to the yield force of the holding mechanism of the headgear 100. Preferably, the shallower pitch portion of the force-deflection curve, which can be called the elongation portion 12b, extends along part or all of the circumferential range of the operating envelope 10 at or beyond the maximum force level of the operating envelope 10. In some configurations, the elongation portion 12b extends beyond the maximum circumferential level of the operating envelope 10. That is, the headgear 100 can be configured to achieve a circumference larger than the intended maximum head circumference, allowing the headgear 100 to be conveniently positioned over a user with the maximum head circumference of the operating envelope 10 of the headgear 100. During use, especially for users whose head size is located at the smaller end of the operating envelope 10, the headgear 100 may not stretch to its maximum circumference while worn, and in some cases may not stretch beyond the maximum circumference level of the operating envelope 10.

[0273] After the headgear 100 has been stretched to its maximum circumference, to a circumference exceeding the operating envelope 10, or to any other circumference sufficient to allow it to be worn by the user during use, the illustrated force-deflection curve drops steeply (initial contraction portion 14a), then transitions to a relatively shallow portion, where the circumference is substantially reduced with relatively small force changes. This shallow portion of the curve can be called the contraction portion 14b, which is partially shown by Figure 4.2. Preferably, in the contraction portion 14b, the headgear 100 reduces its circumference at a relatively low force level until it reaches a circumference suitable for fitting the user's head. The headgear 100 can be positioned on the user's head at this low force level (the left end of the contraction portion 14b, i.e., the "fit point 16") until treatment is initiated or another force is applied to stretch the headgear 100.

[0274] Advantageously, the relatively low force level allows the headgear 100 to be comfortable for the user. In some configurations, the contraction portion 14b of the force-deflection curve is at or below the minimum force level of the operating envelope 10. Thus, in such configurations, the contraction force of the headgear 100 may be lower than the minimum force required or desired to resist the minimum force induced in the headgear 100 by treatment (e.g., low CPAP level). Thus, even at low treatment levels, the headgear 100 can be configured to generate only sufficient holding force to resist the force induced by treatment, because the minimum force level of the operating envelope 10 exceeds the contraction portion 14b of the force-deflection curve. In some configurations, as will be discussed later, the contraction portion 14b of the force-deflection curve may be within the operating envelope 10. Such configurations can be said to exhibit "compound" behavior. However, preferably, the contraction portion 14b of the force-deflection curve of the compound behavior headgear remains below the maximum force level of the operating envelope 10.

[0275] When treatment begins or another stretching force is applied to the headgear 100, the force-deflection curve rises relatively steeply from the fit point 16 to a point in the operating envelope 10 where the holding force of the headgear 100 balances the force caused by the treatment and / or other forces (e.g., hose tension) attempting to stretch the headgear 100. This point can be called the equilibrium fit point 18. The force-deflection curve between the fit point 16 and the equilibrium fit point 18 can have substantially the same slope as the initial stretch portion 12a. The actual location of the equilibrium fit point 18 can be any location in the operating envelope 10, depending on the actual forces caused by the treatment and the actual head size of the user. In any particular case, the force on the headgear 100 applied over a region related to the headgear size as pressure on the user is substantially only the force necessary to suppress the force caused by the treatment. Thus, in at least some configurations, the pressure applied to the user can be minimized for any particular headgear size and shape for any particular level of treatment being utilized. The elongation portion 12b of the force-deflection curve can be positioned at a gap above the maximum force level of the operating envelope 10 to provide a reserve force that allows for the application of further forces (e.g., hose tensile force) without elongation of the headgear 100. When sufficient force is applied to the headgear 100 to reach the elongation portion 12b of the force-deflection curve, elongation of the headgear 100 can occur. However, the headgear 100 can be designed or configured to have a force-deflection curve that adapts to expected or normal treatment forces and hose tensile forces or any combination thereof.

[0276] As described above, in at least some configurations, the user can manipulate the headgear 100 to make fine adjustments to the circumference. Advantageously, such configurations allow the user to address leaks or tighten or loosen the headgear 100 to a desired level (reducing the circumference) simply by grasping the mask or other interface and moving (e.g., wiggling) the mask or other interface relative to the user's face and the rear portion of the headgear 100, as shown in Figure 4.3. The mask or other interface can be moved or adjusted in multiple directions, such as toward and away from the user's face or rotating (e.g., around a vertical or horizontal / lateral axis), as indicated by the arrows in Figure 4.3. Movement toward the face can reduce the circumference or tighten the headgear 100 to achieve a fit toward, for example, a rigid limit of an acceptable or desirable range of fit (which may be called a “tight fit”). Moving away from the face can extend the circumference or loosen the headgear 100 to achieve a fit toward, for example, the loosest limit of an acceptable or desirable range of fit (which may be called a “loose fit”). Rotating it about a vertical axis can tighten one side of the headgear 100 while keeping the other side the same or loosening it. Rotating it about a horizontal or transverse axis can tighten one side of the top or bottom of the headgear 100 while loosening the other side.

[0277] As described above, in all configurations, it is not essential that the contraction portion 14b of the force-deflection curve is located below the minimum force level of the motion envelope 10. The headgear 100 can be designed or configured so that the contraction portion 14b of the force-deflection curve is located within the motion envelope 10 and at a level that provides a sufficient degree of comfort to the user. In some cases, the user may want the headgear 100 to apply some force to give the user some tactile feedback that gives the user a sense of comfort that the headgear 100 is holding the interface in place. Such force applied by the headgear 100 may, for some users, be within the motion envelope 10 of a particular treatment. Thus, with such a configuration, under at least some conditions, the contraction force of the headgear 100 may be sufficient to resist the therapeutic force as at least some low therapeutic levels and / or some large head size.

[0278] Figure 5 shows a graph including an example of a “compound” force-deflection curve. For illustrative purposes, the graph also shows an example of an elastic headgear force-deflection curve in addition to the compound force-deflection curve. The compound force-deflection curve may be substantially similar to or identical to the force-deflection curve described above in relation to Figure 4, except that the compound force-deflection curve places the contraction portion 14b within the operating envelope. The contraction portion 14b of the force-deflection curve divides the operating envelope into a lower portion 20 and an upper portion 22. The headgear can absorb the force in the lower portion 20 below the contraction portion 14b of the force-deflection curve by utilizing the contraction force of the headgear, which can be provided by one or more elastic elements. The force in the upper portion 22 above the contraction portion 14b of the force-deflection curve can be absorbed by the holding force of the headgear, which can be provided by one or more holding elements (e.g., locks), similar to the method described above in relation to Figure 4.

[0279] An example of an elastic headgear force curve 15 is shown superimposed on the contraction portion 14 of the force-deflection curve. The elastic headgear force curve 15 includes an upper and lower curve portion separated by a relatively small vertical distance representing internal friction loss or hysteresis within the headgear. The force required to extend the headgear is slightly greater than the contraction force of the headgear. An elastic headgear showing the elastic force-deflection curve 15 shown can only be adapted to the treatment or other forces applied below the force-deflection curve 15. The elastic headgear will stretch when a force is applied above the force-deflection curve 15. Therefore, the force-deflection curve 15 of an elastic headgear must be positioned above the maximum force level of the operating envelope to avoid undesirable stretching under at least some conditions (e.g., high treatment force or small head size). The level of pressure applied to the user as a result of such a force-deflection curve 15 may be uncomfortable under at least some conditions (e.g., low treatment force or large head size).

[0280] In contrast, the combined force-deflection curve (or the equilibrium fit force-deflection curve illustrated and described in relation to Figure 4) 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 motion envelope falls within the vertical space between the upper portion 12b of the curve and the lower portion 14b of the curve. Thus, headgear exhibiting such force-deflection curves can resist relatively high forces while applying relatively low forces or pressure to the user when there is no treatment or other stretching force. Furthermore, once treatment begins, the force or pressure applied to the user remains the same (if it is below the contraction portion 14b of the force-deflection curve in the combined configuration), or increases only to the level necessary to resist the applied force.

[0281] The force exerted on the headgear by an interface is typically related to the protruding area of ​​the interface's seal. Smaller interfaces, such as nasal pillows or nasal masks, seal around a relatively smaller area compared to larger interfaces, such as full-face masks, and therefore result in less force. Some interfaces (e.g., nasal cannulas) may not provide a seal with the user's face, and therefore the force exerted on the headgear may be primarily related to the weight of the interface. Figure 6 shows a graph of the force required to maintain a sealing contact between the interface and the user's face, in relation to the protruding area of ​​the seal. Generally, the larger the protruding area of ​​the seal, the greater the force required to maintain a sealing contact between the interface and the user's face, and therefore the greater the force that the headgear must resist. These forces can be called the headgear's retaining force.

[0282] The graph in Figure 6 includes two lines 24, 26 that define the upper and lower limits of the acceptable range of retaining force for interfaces with different protruding seal areas. The two lines 24, 26 are spaced perpendicularly apart from each other and extend upward from left to right with a moderate slope. The lower line 24 may represent the minimum force required or desired to maintain a seal with the user's face. The upper line 26 may represent the maximum desired force, which may be greater than the force required to maintain the 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 may represent the available or target range 28 of adjustment to accommodate user preferences, with the lower line 24 representing a usable or acceptable loose fit and the upper line 26 representing a usable or acceptable tight fit. The lower line 24 may include one or more relatively short, steep upward slopes representing transitions between interface types, such as from a nasal pillow to a nasal mask and from a nasal mask to a full-face mask. The upper line 26 is shown as a straight line, but may include steep slopes corresponding to those of the lower line 24 in order to maintain a certain target adjustment range.

[0283] The graph in Figure 6 also includes a flat or horizontal line 30 at the force level above the target range or target zone 28. This line 30 represents the force that causes or could cause skin damage to the user over a relatively short period of continuous use of a particular headgear. This line 30 can be called the maximum force line 30. The actual force value may vary depending on the characteristics of the particular headgear, such as the contact area or material type. The vertical distance between the target zone 28 and the maximum force line 30 represents the error range 32 for adjusting the headgear force. As shown in the figure, the error range 32 is reduced for interfaces with a large protruding seal area, such as a full-face mask, compared to interfaces with a small protruding seal area, such as a nose pillow or nose mask. Therefore, especially for interfaces with a large protruding seal area, it is desirable that the headgear be easily or conveniently adjustable to within or near the target zone 28. Conventional non-elastic headgear incorporates relatively coarse adjustments, such as one or more adjustable loops secured with hook-loop fasteners. These types of headgear may be difficult to adjust within the target zone 28, especially in environments such as hospitals, where the person wearing the headgear is not the one performing the adjustments.

[0284] Figure 7 shows a three-dimensional graph of the relationship between headgear force, protruding seal area, and circumference. The graph in Figure 7 is a combination of the graphs in Figure 6 and Figure 4. The graph in Figure 7 shows the minimum force 24 (the line 24 below the target zone 28 in Figure 6) that provides a seal between the interface and the user's face. Below the minimum force line 24, the headgear force may be insufficient to provide or maintain a seal. The graph in Figure 7 also shows the maximum force line 30 beyond which skin damage may occur. Between the minimum force line 24 and the maximum force line 30 lies the safe operating envelope for headgear force. The line above the target range is omitted for clarity.

[0285] The graph in Figure 7 also shows the force-deflection curve for an example of headgear. The force-deflection curve can be located in any plane along the protruding seal area axis to indicate design criteria for headgear intended for use with a specific type of interface having a particular protruding seal area. Headgear can also be designed considering headgear forces and circumference along part or all of the protruding seal area axis to design headgear that works with multiple types of interfaces or is general-purpose for all types of interfaces (at least with respect to a particular treatment). In some configurations, the extended portion 12 of the force-deflection curve can be located above the maximum force line 30, as shown by the force-deflection curve in Figure 7.

[0286] In at least some configurations, headgear exhibiting the balanced fit or combined force-deflection curve described above advantageously provides a holding force that falls within a safe operating envelope, preferably within a target zone. In at least some configurations, such headgear automatically adjusts to a suitable holding force within a safe operating envelope, preferably within a target zone. This thus reduces or eliminates under-tightening or over-tightening by the user or another person.

[0287] As described above, the headgear system example performs several functions in the process of attaching, using, and removing the interface or mask system. For example, the headgear system extends in length so that it can be positioned over the user's head. The headgear system contracts in length during the "attachment" process, applying sufficient force to the mask system so that the user feels the mask system is secured. When airway pressure is applied, the headgear system "transforms" in performance from elastic or stretchable behavior to inelastic behavior. The headgear system also allows for fine adjustments to tighten or loosen the mask based on the user's preference during use. To remove it, the headgear system extends in length so that it can be removed over the user's head. One or more combinations of all of these features provide a mask system that requires minimal user interaction to attach and remove. This can eliminate the possibility of misuse and contribute to the improved usability of the mask system. The headgear system example can also mitigate the effects of excessive pressure on the skin by reducing the probability, or even possibility, of overtightening of the headgear. Examples of headgear systems can improve overall compliance with treatment. A further feature of these is that they possess advanced positioning and stability, both during the act of removing and reattaching the mask and during use. This specification discloses one or more concepts for achieving repeatable and stable positioning of the headgear and associated interface assembly on the head of a patient or user. This specification also discloses one or more concepts for achieving a headgear system that supports variable behavior by providing parts that can be selectively elastic or inelastic and parts that provide inelastic behavior.

[0288] Figures 8A and 8B graphically show the force profiles for constant-pressure and variable-pressure therapy, respectively, along with the associated stretch behavior of elastic and non-elastic headgear systems, for a full-face mask. Figure 8A includes two graphs of force and stretch, respectively, induced within the headgear over time by applying constant-pressure therapy, such as CPAP at 10 cm of H2O. The upper graph shows the force induced within the headgear by the combination of applied gas pressure and mask enclosure area, or simply mask area. Although the treatment delivery pressure is constant, the force curve includes small oscillations caused by the user breathing and resulting pressure changes within the mask. The lower graph shows the resulting stretch or movement within the headgear system, and therefore within the mask body, as a result of the applied force. Two stretch lines 34 and 36 are shown in the lower stretch graph. The first line 34 shows the stretch behavior of a state-of-the-art elastic headgear, which stretches in response to the applied force. In the illustrated example, the elastic headgear stretches approximately 8 mm under CPAP pressure compared to its length without CPAP pressure. Line 2, 36, shows the stretching behavior of a non-elastic headgear using the latest technology. As illustrated, the non-elastic headgear exhibits very slight stretching in response to the applied force.

[0289] Figure 8B similarly includes graphs of force and elongation, respectively, induced within the headgear over time by applying vibration or variable pressure therapy, such as NIV or bilevel PAP. For example, the exemplary therapy varies between a pressure of approximately 5 cm of H2O (e.g., positive expiratory airway pressure - EPAP) and approximately 12 cm of H2O (e.g., positive inspiratory airway pressure - IPAP). The upper graph shows the force induced within the headgear by a combination of the applied gas pressure and the mask enclosure area or simply the mask area. The lower graph shows the resulting elongation or movement of the headgear system, and therefore within the mask body, as a result of the applied force. Two elongation lines 34 and 36 are shown in the elongation graph. The first line 34 shows the elongation behavior of a state-of-the-art elastic headgear, which elongates and contracts with increasing and decreasing applied force. In the illustrated example, the elastic headgear elongates approximately 4 mm to approximately 12 mm (at low and high pressure, respectively) according to the variable force curve compared to the length without CPAP pressure. To reduce or prevent this movement, the headgear system is typically overtightened so that the force required to stretch the headgear is greater than the force generated by the combination of mask area and ventilation pressure. This practice can result in skin damage and the need for wound care. Line 236, similar to Figure 8A, shows the stretching behavior of a modern, non-elastic headgear, exhibiting very slight stretching but with the limitations and drawbacks described above.

[0290] As illustrated in the example, a modern, non-overtightened headgear system, when used with a full-face mask, will stretch in length to approximately 8 mm to 12 mm during the transition from peak inspiratory pressure to final expiratory pressure in the case of NIV, or from IPAP to EPAP in the case of bilevel ventilation. In at least some configurations, this directional lock headgear system behaves similarly to inelastic headgear in response to forces applied in the direction that tends to stretch the headgear. However, these configurations of directional lock headgear systems exhibit one or more advantages of elastic headgear (e.g., automatic sizing or automatic fit) without the disadvantages associated with inelastic headgear (e.g., time-consuming and difficult adjustment). In at least some configurations, a headgear system incorporating a directional lock mechanism will result in less than approximately 4 mm of headgear stretch or mask movement in response to forces applied during treatment, compared to the conditions under which it is applied to the user, except with no system pressure. In some configurations, headgear systems incorporating a directional locking mechanism result in less than approximately 4 mm of headgear extension or mask movement between high or maximum therapeutic pressure states and low or minimum therapeutic pressure states (for example, between peak inspiratory pressure and final expiratory pressure in the case of NIV).

[0291] The functional behavior of the example headgear system includes various headgear elements having elongation characteristics at design-specific locations, thereby allowing elastic or stretchable behavior to be switched on and off as required, preferably by one or more of the directional locking and / or directional friction mechanisms disclosed herein. This may include the configuration of various headgear features to provide predetermined performance attributes at given locations. In patient interfaces used in respiratory applications, the locations of these features may be determined by the desired interface type and the number of retaining surfaces. Retaining surfaces can be defined as one or more planes for decomposing forces occurring within the interface assembly.

[0292] For example, Figure 9 shows a nasal interface such as a nasal pillow mask, nasal mask, or nasal cannula having a single retaining surface. The first line extends between the first attachment point of the nasal interface and the first attachment point of the rear portion of the headgear. The second line extends between the second attachment point of the nasal interface and the second attachment point of the rear portion of the headgear. The first and second lines work together to define a single retaining surface. The retaining surface can extend through or near the center of the nasal interface, which may be, for example, the geometric center or vertical center. In some configurations, the retaining surface may be off-center, such as in configurations where it may be desirable to apply a biasing force (e.g., upward or downward bias) to the nasal interface. The retaining surface can generally extend from a position below or near the user's nose (e.g., somewhat downward) to a position closer to the user's ear but somewhat upward. In such configurations, the retaining surface can have an upward inclination in the anterior-posterior direction.

[0293] Figure 10 shows a nasal interface such as a nasal pillow mask, nasal mask, or nasal cannula having multiple (e.g., two) retaining surfaces. As described with reference to Figure 9, each retaining surface is defined by lines on each side of the interface assembly, and these lines extend between a point on the nasal interface and a point on the rear portion of the headgear. In the configuration of Figure 10, the retaining surfaces are offset from each other and define angles in the anterior-posterior direction or from the side. In the illustrated configuration, the first retaining surface extends through a relatively upper point on the nasal interface, and the second retaining surface extends through a relatively lower point on the nasal interface. The first and second retaining surfaces can extend through a single point on the rear portion of the headgear (or very close to each other), or they can be spaced apart on the rear portion of the headgear, and their surfaces can bisect each other (intersect each other) between the nasal interface and the rear portion of the headgear, or they can be spaced apart between the nasal interface and the rear portion of the headgear. In the illustrated configuration, the first retaining surface is located at or near the upper edge of the inlet, breathing tube connector, or gas conduit connector, and the second retaining surface is located at or near the lower edge of the inlet, breathing tube, or gas conduit. In some configurations, the retaining surfaces may extend along the physical parts of the headgear or interface assembly. However, in other configurations, the retaining surfaces may not extend along the physical parts of the headgear or interface assembly. That is, for example, the retaining surfaces may not be aligned with the straps of the headgear.

[0294] Other types of interface assemblies can similarly utilize a retaining surface between the interface and the rear portion of the headgear. For example, Figure 11 shows a full-face mask with two retaining surfaces. The illustrated full-face mask includes an upwardly extending frame portion or T-piece that extends from the lower portion of the mask toward or to the user's forehead. In the illustrated configuration, the first retaining surface, or upper retaining surface, extends between the T-piece and an upper position of the rear portion of the headgear. The upper retaining surface can extend toward the user's eyes and ears. The upper retaining surface can generally be horizontal but can be inclined somewhat in the anterior-posterior direction. For example, the upper retaining surface can be inclined somewhat downward in the anterior-posterior direction to pass between the user's forehead and the center or rearmost point of the back of the user's head. The second retaining surface, or lower retaining surface, extends between the base portion of the mask and an inferior position of the rear portion of the headgear. The lower retaining surface can extend from a point around the user's mouth to a point below the user's ears. The lower retaining surface can generally be horizontal, but can be inclined somewhat in the front-to-back direction. For example, the lower retaining surface can be inclined somewhat upward in the front-to-back direction. The upper retaining surface can extend along the upper strap of the headgear. The lower retaining surface can generally extend along the lower strap of the headgear, but the lower strap can be curved to conform to the user's ears such that the lower retaining surface overlaps the ends of the lower strap but not at least the middle portion of the lower strap. In other configurations, one or both of the upper and lower retaining surfaces can partially or completely overlap the associated strap, be positioned partially or completely spaced away from the associated strap, or be any combination of the two.

[0295] Figure 12 shows a nose mask having two retaining surfaces. Similar to the full-face mask in Figure 11, the illustrated nose mask includes an upwardly extending frame portion or T-piece, which extends from the lower portion of the mask toward or to the user's forehead. In the illustrated configuration, the first retaining surface, or upper retaining surface, extends between the T-piece and an upper position above the rear portion of the headgear. The upper retaining surface may extend above the user's eyes and ears. The upper retaining surface may generally be horizontal but may be inclined somewhat in the anterior-posterior direction. For example, the upper retaining surface may be inclined somewhat downward in the anterior-posterior direction, passing between the user's forehead and the center or rearmost point of the back of the user's head. The second retaining surface, or lower retaining surface, extends between the base portion of the mask and an inferior position below the rear portion of the headgear. The lower retaining surface may extend from a point around the user's nose to a point aligned with or below the user's ears. The lower retaining surface may generally be horizontal but may be inclined somewhat in the anterior-posterior direction. For example, the lower retaining surface can be inclined slightly downward in the front-to-back direction. The upper retaining surface can extend along the upper strap of the headgear. The lower retaining surface can extend between the front and rear ends of the lower strap of the headgear. The lower strap shown can be curved to conform to the user's ears so that the lower retaining surface does not overlap the middle portion of the lower strap. In either of the interface assemblies in Figures 11 and 12, the lower retaining surface can pass through (or near, for example, the inlet or breathing tube connector) of the interface, or through the gas conduit connector.

[0296] Figure 13 shows an alternative configuration applicable to either a full-face mask or a nose mask, where there are two retaining surfaces converging at a single point within the headgear system. The retaining surfaces can be positioned perpendicularly and spaced apart on the interface to provide some degree of stability to the interface. For example, in a full-face mask, the upper retaining surface can pass under or above the user's nose, and the lower retaining surface can pass near or below the user's mouth. In a nose mask, the upper retaining surface can pass above the underside of the user's nose, and the lower retaining surface can pass above the underside of the user's nose. The retaining surfaces can intersect at a point generally above and / or in front of the user's ears. The parts of the interface assembly that connect the mask to the rear portion of the headgear can be separate or interconnected, thereby potentially allowing the lengths of at least the upper and lower portions to be changed in a single adjustment. The ratio of the lengths of the upper and lower portions can be easily adjusted by moving the point of the interconnected portion located at the headgear connection point. The full-face mask shown does not include a forehead rest or "T-piece". However, in some configurations, a T-piece can be provided. If desired, an additional headgear element or strap can be attached to the T-piece of the mask, connecting the rear portion of the headgear.

[0297] Figure 13.1 is a table identifying several common categories of headgear types based on the number of retaining surfaces and / or relative positioning. The table also identifies multiple interface types and provides an indicator of the desirability or practicality of the resulting combinations of headgear types and interface types. Since at least some of the headgear assemblies disclosed herein are automatically fitted, it may be possible to utilize multiple types of interfaces with a single headgear type. Examples of possible combinations are described with reference to Figure 13.1. The headgear types are listed from top to bottom in order from those providing relatively low stability to those providing relatively high stability, such as configurations that provide little or no external resistance to interface rotation. The headgear types listed in the table in Figure 13.1 are not exclusive. Other headgear types, including modifications and hybrids of the illustrated headgear types, may be used with the concepts disclosed herein.

[0298] Generally, a highly stable headgear configuration may be versatile or capable of providing at least an acceptable level of support for many or all interface types, or at least for the interface types illustrated. In contrast, a less stable headgear configuration may not be able to provide a desirable or acceptable level of support for all interface types unless certain measures are taken to increase the stability of the inherently less stable configuration. Generally, larger interfaces require or benefit from headgear that provides greater stability. For large interfaces, such as full-face masks, it is often desirable or necessary to provide at least two retaining surfaces. It may be advantageous for the two retaining surfaces to be separated from each other in the vertical or height direction of the interface (e.g., at the attachment points to the interface). Generally, for a given headgear configuration, the greater the separation distance between the retaining surfaces at the interface, the more stable the configuration. In some configurations, it may be advantageous for at least one of the retaining surfaces to include an upward vector component.

[0299] One example of a headgear type provides a single retaining surface. Examples of such configurations are discussed herein with reference to Figure 9. In general, single-retaining-surface headgear may not be practical for use with full-face interface types because it does not provide the desired level of stability to the mask. Thus, while the headgear may be able to hold the mask in place and maintain the seal, the mask may relatively easily displace and break the seal, or the interface assembly may be functional but not give the user a firm sense of security. In some cases, single-retaining-surface headgear may not provide an acceptable level of stability to the mask. However, some configurations of single-retaining-surface headgear may be suitable for use with full-face masks. For example, single-retaining-surface headgear utilizing rigid materials and / or configurations (e.g., shape) may be suitable for use with full-face masks by providing resistance to rotation of the mask around a transverse axis. Furthermore, the single-retention face headgear may be suitable for use with a full-face mask by carefully positioning the single-retention face relative to the full-face mask, as illustrated in and described later with reference to Figure 13.2. The single-retention face interface may be suitable or practical for use with a nasal interface such as a nasal mask, nasal pillow, or prongs and cannula.

[0300] Figure 13.2 shows a single-retention surface interface assembly comprising a headgear assembly and an interface in the form of a full-face mask. The illustrated mask omits a forehead rest or T-piece, but other configurations may include a T-piece. The headgear assembly includes a rear portion of the headgear and a headgear length or circumference adjustment portion that allows adjustment of the position of the mask relative to the rear portion of the headgear. The single-retention surface may extend, for example, from the mask to the rear portion of the headgear at a position above the user's ears.

[0301] The forces acting on the mask can be summarized as the blow force resulting from the pressure inside the mask acting on the sealing area of ​​the user's face and attempting to move the mask away from the user's face, the headgear force acting on the mask to resist the blow force, the force exerted by the user's face along the contact area between the mask and the user's face, and gravity acting on most of the mask and CPAP hose. The forces exerted by the user's face can be summarized as an upward force and a downward force. The upward force may be a force located at or near the bridge of the user's nose, which is generally the highest point or area of ​​contact in the vertical direction ("bridge force"). The downward force may be a force located at or near the tip of the user's chin, which is generally the lowest point or area of ​​contact in the vertical direction ("chin force").

[0302] Distributed gravity can be summarized as a single point force ("gravity") acting on the mask and CPAP at its center of gravity, which may be determined by the specific size and shape of the mask. In some configurations, the single holding surface extends between or passes through a point between the chin force and the blow force in the vertical direction.

[0303] Distributed blow force can be summarized as a single point force ("blow force") acting on the mask at a specific location, which may be determined by the mask's specific size and shape and / or the given shape of the user's face. The blow force may generally be located in the lower half of the mask's height, such as at or near the mask's geometric center. Assuming a generally triangular mask, the blow force may be located at approximately one-third of the mask's height from the bottom. In some configurations, a single retaining surface extends vertically between the chin force and the blow force, or passes through a point between them. Advantageously, such configurations can provide a desirable level of stability for a full-face mask with a single retaining surface. However, this configuration can also be applied to multi-retaining-surface configurations, where additional retaining surfaces provide further stability.

[0304] The bridge of the nose region may be a sensitive anatomical area, and it may be desirable to avoid excessive force or pressure in this area. Therefore, if the bridge of the nose force is zero or minimal, the headgear force may be the only force that suppresses the blow force. If the headgear force passes through a point that is vertically higher than the blow force, the bridge of the nose force increases, which is generally undesirable. If the headgear force is too low or too close to the chin force, it may not be able to suppress the blow force, or it may provide an undesirably low level of suppression of the blow force, thereby impairing the sealing performance of the interface assembly. Preferably, as described herein, the retaining surface is provided with a directional locking mechanism that provides appropriate resistance to the extension of the headgear in response to the blow force. Combined with the positioning of the retaining surface as described herein, the resulting interface or headgear assembly can provide a suitable level of stability for a full-face mask with a single-retaining-surface type headgear. As with other headgear assemblies described herein, adequate stability can be achieved without the excessive tightening of the headgear that often occurs with prior art headgear devices.

[0305] Another example of a headgear type provides two retaining surfaces that converge at a forward position (i.e., toward or at the interface). The term “converging” as used herein in reference to Figure 13.1 is intended to describe retaining surfaces that are not substantially separated from each other at the interface or mounting position. While the retaining surfaces may be in contact at a single mounting location, convergent headgear types may also include those where the retaining surfaces are mounted adjacent to or close to each other. Two-retaining-surface, forward-converging headgear types may be suitable, or at least somewhat practical, for use with full-face headgear, because the additional retaining surfaces can provide a significant additional stability compared to single-retaining-surface headgear. As described with respect to single-retaining-surface headgear types, two-retaining-surface, forward-converging headgear types may employ rotation-resistant materials and / or configurations to provide improved performance compared to full-face masks. Two-retaining-surface, forward-converging headgear types may be suitable, or practical, for use with nasal interfaces such as nasal masks, nasal pillows, or prongs and cannulas.

[0306] Another example of a headgear type provides two retaining surfaces that converge at a rearward position (i.e., away from the interface, e.g., in the rear portion of the headgear). The two-retaining-surface, rearward-converging headgear type can provide a sufficient level of stability to be suitable or practical for use with full-face masks and nasal masks. Examples of such headgear types are illustrated and described herein in relation to Figures 10 and 13, which include nasal and full-face interfaces, respectively. The two-retaining-surface, rearward-converging headgear type may be less practical for use with pillow or prong interface types because these interface types typically have relatively small vertical or height dimensions. The small height of pillow and prong interface types may limit the ability to space the mounting positions of the retaining surfaces on the interface and provide triangulation of the retaining surfaces unless the height dimension is increased beyond the required height, and increasing the height dimension may be undesirable because pillows and prongs are often chosen by users precisely because they have relatively small height dimensions. Two-retaining, rear-converging headgear types may not be practical for use with cannulas because they do not need to provide a sealing force to the cannula. Therefore, two-retaining headgear types may be more than necessary for use with cannulas. Furthermore, two-retaining, rear-converging headgear types may not be practical for use with cannulas for the same reasons as pillows and prongs. Cannulas generally have an even smaller height dimension than pillows and prongs. However, in at least some configurations, or under some circumstances, it may be practical or even desirable to use two-retaining, rear-converging headgear types with pillows, prongs, or cannulas.

[0307] Another example of a headgear type provides two retaining surfaces that are separate and angled or non-parallel to each other. In some configurations, the upper retaining surface can be angled upward in the front-to-back direction. The lower retaining surface can generally be horizontal or angled. In other configurations, the lower retaining surface can be angled in either direction. The upper retaining surface can generally be horizontal or angled. Two-retaining-surface, separate / angled headgear types can provide a sufficient level of stability to be suitable or practical for use with full-face masks and nasal masks. Two-retaining-surface, separate / angled headgear types may be less practical for use with pillow or prong interface types, because these interface types typically have relatively small vertical or height dimensions for the reasons mentioned above with respect to two-retaining-surface, rear-converging headgear types. Similarly, two-retaining-surface, separate / angled headgear types may be less practical for use with cannulas for the same reasons as pillow and prongs, as mentioned above.

[0308] Another example of a headgear type provides two retaining surfaces that are relatively, generally or substantially horizontal, or parallel to each other. Examples of such two-retaining-surface, parallel headgear types are illustrated and described in relation to Figures 11 and 12. Two-retaining-surface, parallel headgear types can provide a sufficient level of stability to be suitable or practical for use with full-face masks and nasal masks. Two-retaining-surface, parallel headgear types may be less practical for use with pillow or prong interface types, because, for the reasons described above with respect to two-retaining-surface, rear-converging headgear types, these interface types typically have relatively small vertical or height dimensions. Two-retaining-surface, parallel headgear types may be impractical for use with cannulas for the same reasons as pillow and prong types, as described with respect to two-retaining-surface, rear-converging headgear types.

[0309] At least one mechanism or feature ("locking mechanism") that can transform the function of the headgear from extended to non-extended behavior is positioned or otherwise configured to act along at least one of the retaining surfaces or lines. Along this surface, the directional locking mechanism can be configured to act as a single mechanism for a given retaining surface, or preferably to provide two independent locking mechanisms. A single mechanism configuration can change the circumference or perimeter of the headgear or interface assembly. A two-locking mechanism configuration (e.g., one mechanism on each side of the headgear or interface assembly) provides independent left-right control for fine-tuning to mount a mask or other interface. Other configurations may provide three or more locking mechanisms. In such configurations, multiple locking mechanisms may 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 rear), and the locking mechanisms can cooperate to allow adjustment of the circumference or perimeter of the headgear or interface assembly.

[0310] In some configurations, at least one locking mechanism is provided on each side of the interface assembly between the mask (or other interface) and the rear portion of the headgear. In some configurations, such as the full-face mask 210 with a forehead support or T-piece as shown in Figures 14 and 15, the mask 210 is connected to the rear portion of the headgear 220 at each side of the interface assembly 200 by upper and lower connecting portions, for example, in the form of straps 230. The configurations in Figures 14 and 15 illustrate examples of multiple locations where the locking function or mechanism 240 can be positioned. In the illustrated configurations, the interface assembly 200 includes an elastic retraction function or mechanism 250 that acts in combination with or in cooperation with the directional locking mechanism 240. The elastic retraction mechanism 250 and the directional locking mechanism 240 can be integrated into a module which may be referred to herein as a directional locking module or simply a module. In the illustrated configuration, the directional locking mechanism 240 can be positioned at the connection point between the headgear 220 and the mask 210, such as being incorporated into a mounting fixture 260 (e.g., a clip) to the mask body, as shown in Figure 14. Alternatively, as shown in Figure 15, the directional locking mechanism can be positioned at a suitable location within the headgear 220, such as between the rear portion of the headgear 220 and the strap portion 230 that connects the rear portion of the headgear 220 to the mask 210. Similar configurations using multiple retaining surfaces can be utilized in other configurations.

[0311] In some configurations, the directional locking mechanism or module utilizes a lock that is coupled to or otherwise movable with a portion of the interface assembly, and an adjustment member that is coupled to or otherwise movable with a second portion of the interface assembly. The adjustment member can move relative to the lock to allow adjustment of the circumference or perimeter of the headgear or interface assembly. The adjustment member may be in the form of a core member that may be a wire or filament, or it may be a strap, for example. Part of the adjustment member is utilized to define a portion of the circumference or perimeter when the interface assembly is sized to any given size, while another portion may be extra or surplus length that is not utilized at a given adjusted size. The surplus length changes with the change in the circumference or perimeter of the headgear or interface assembly. The accumulation of surplus length can be accommodated by any preferred configuration, such as housing it within a mask frame or an integrated component within the headgear system.

[0312] Figures 16 and 17 show configurations applicable to the nasal interface 300, such as a nasal mask 310 (with or without a forehead rest or T-piece, though often absent) or a nasal cannula. In these configurations, the directional locking mechanism 340 can be integrated onto or operate on a flat strap 330 or web, as described above. The use of a flat strap 330 is particularly beneficial in applications where the force vectors between the pressurized mask seal and the headgear are not aligned. This results in a situation where moments are generated that are preferably well-dispersed by the stiffness within the headgear system. This can be achieved by selecting the torsional and flexural stiffness characteristics of the headgear strap, and the combination thereof significantly improves the level of rotational stability relative to the mask system.

[0313] In situations where a straight line between the mounting points of the headgear and the mask 410 provides an acceptable position for the headgear components or components providing a connection between the mask and the rear portion of the headgear 420, the use of a flexible core design 430 may be desirable, as shown in Figure 17. That is, unless constrained by a modified shape, the flexible core assumes a straight line between the mounting points. Therefore, the flexible core design is suitable for use in configurations where a straight path (for example, between the rear portion of the headgear 420 and the mask 430) for the directional locking mechanism 440 is a desirable or acceptable position for the mechanism 440.

[0314] In some configurations, a combination of a flat strap configuration and a flexible core configuration can be used in applications where two or more retaining surfaces are desirable or required. For example, the configurations in Figures 11 and 12 or Figures 14 and 15 can utilize a flat strap configuration along one of the upper or lower retaining surfaces and a flexible core configuration along the other of the upper or lower retaining surfaces. In some configurations, the lower strap can be configured to use a flat strap configuration, and the upper strap can be configured to use a flexible core configuration. For example, as shown, the lower strap can have a curved shape along its length to pass below the user's ears and provide space that conforms to the user's ears. However, the upper strap may be generally straight along its length. In some configurations, the upper strap can utilize a flat strap configuration, and the lower strap can utilize a flexible core configuration. For example, the rear portion of the headgear can be configured to position the mounting points so that a straight line between the headgear mounting points and the mask mounting points is appropriately aligned. Furthermore, as shown in Figures 18 and 20, when connected in a line with the flexible core configuration, the use of flat or relatively rigid headgear sections contributes to torsional or bending stability along the sides of the user's head, enabling flexibility in positioning of the directional locking mechanism.

[0315] When used in conjunction with respiratory ventilation patterns that involve either high constant pressure waveforms or variable pressure waveforms, such as non-invasive ventilation or bilevel ventilation, a significant performance advantage arises from the directional locking type of headgear system or interface assembly, because the headgear system does not stretch during use, or the circumference or perimeter of the interface assembly remains constant. As mentioned above, headgear devices with current state technology can generally be classified into elastic or non-elastic systems. As described, non-elastic systems can adapt to high constant pressure or variable pressure, but such systems are prone to overtightening, difficult to adjust, and time-consuming. Elastic headgear systems with current state technology tend to stretch in response to high constant pressure or to stretch and contract in response to pressure waves in variable pressure waveforms. This stretching and contracting can cause the mask to move periodically on the user's face, potentially leading to leakage. This leakage can then lead to loss of treatment and / or incorrect respiratory induction due to the resulting volume and associated pressure changes within the mask. Furthermore, the periodic movement of the mask can cause abrasions and, in some cases, skin damage due to the movement or shifting of the mask on the user's face.

[0316] Figures 18 and 19 show examples of parts or modules of interface assemblies configured to extend between a mask or other interface and the rear portion of a headgear incorporating a directional locking mechanism. Each of the illustrated module configurations includes a removable clip 510 that defines a connection between the mask body and the entire headgear system including the module. The module includes an elastic section 520 extending between the removable clip 510 and the directional lock 530, which provides a contractile force that tends to move the clip 510 and the directional lock 530 toward each other. The elastic section 520 may be any preferred configuration, such as a braided member containing one or more elastic elements. Figure 18 shows a variation having the directional lock 530 located at the rear end of the elastic section 520 and / or at the connection point between the module and the rear portion of the headgear, which positions the directional lock 530 spaced away from the mask, for example, in the positions shown in Figures 15 and 17.

[0317] Figure 19 shows an alternative variation in which the directional lock 530 is positioned at a location spaced apart from the module and / or at the connection point between the module and the rear portion of the headgear. Such configurations may be referred to herein as “remote” locking mechanisms. In some configurations, the lock can be located at another location within the headgear system, such as within the 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 configurations allow the directional lock to be positioned at a more suitable or desirable location within the headgear system, such as the location shown in Figure 20.

[0318] Referring to Figure 20, the interface assembly 600 includes a mask 610 or interface (such as a nose interface in the illustrated configuration) and a headgear device having a rear headgear portion 620 that engages with the rear and / or upper part of the user's head. The interface assembly 600 also includes an adjustment portion 630 that allows adjustment of the distance between the mask 610 and the rear portion of the headgear 620. The adjustment portion 630 may be part of the headgear device, part of the interface, or a separate component of the interface assembly.

[0319] In the illustrated configuration, the adjustment section 630 includes an elastic material 640, which can be configured to return to its non-stretched position. Thus, the elastic material 640 can exhibit a contraction force that tends to reduce the circumference or perimeter of the interface assembly. In some configurations, the elastic material 640 is a braided material incorporating non-stretch and stretch elements. The non-stretch elements can provide a hard stop or maximum stretch, while the stretch elements can provide a contraction force. In other configurations, the stretch elements 640 or other biasing mechanisms can be located far from the elastic material of the adjustment section 630.

[0320] The illustrated interface assembly also includes a variable locking mechanism, such as a directional locking mechanism. The illustrated directional locking mechanism comprises a directional lock 650, a filament core 660, and a filament guide 670 or housing (e.g., a conduit or tube). This configuration allows the directional lock 650 to be spaced away from or far from the mounting position 680 between the adjustment section 630 and the rear headgear section 620. Furthermore, the filament configuration allows the directional lock 650 to be positioned in a non-linear configuration with the adjustment section 630. In other words, the functional axis of the directional lock 650 can be offset or angled with respect to the axis of the adjustment section 630 and / or the retaining surface of the interface assembly 600.

[0321] The filament housing 670 may extend between the directional lock 650 and the mounting position 680 between the adjustment section 630 and the rear headgear section 620. In the illustrated configuration, the filament housing 670 follows a curved path between the directional lock 650 and the mounting position 680 between the adjustment section 630 and the rear headgear section 620. For example, the directional lock 650 may be located on the crown strap 690 of the rear headgear section 620, and the filament housing 670 may curve upward at a location on the crown strap 690 rear of the mounting position 680. The directional lock 650 may be located at any desired location on the crown strap 690, including, for example, the side, top, or top. In other configurations, the directional lock 650 may be located on other parts of the rear headgear section 620 or at other locations, such as the side or rear of the rear strap of the rear headgear section 620. This configuration allows the directional lock 650 to be positioned at a more desirable location than the mounting point between the adjustment section 630 and the rear headgear section 620 (referred to herein as “remote” mounting). For example, by positioning the directional lock 650 at the top of the crown strap 690, contact with other objects (e.g., pillows) can be avoided in many environments (e.g., when the user is lying on their back or side). The specific position of the directional lock 650 can be selected based on various relevant factors, particularly comfort, gaps (e.g., for eyeglasses), filament length, etc.

[0322] In some configurations, the filament housing 670 extends beyond the directional lock 650 to accommodate excess filament 660 not being used to support the load within the interface assembly 600. The portion of the filament housing 670 beyond the directional lock 650 may be referred to as the storage portion 700 or storage conduit. The portion of the filament housing 670 between the directional lock 650 and the mounting position 680 between the adjustment portion 630 and the rear headgear portion 620 may be referred to as the connecting portion 710 or connecting conduit. Although shown herein as a tube, the filament housing 670 may also be provided in other forms, such as a filament guide. A filament guide configuration may not completely enclose the filament and may simply provide a guide surface at a specific, separate position to orient the filament along a desired path.

[0323] Each side of the interface assembly may be provided with one or more adjustment parts and / or variable locking mechanisms. The parts of the variable locking mechanisms on both sides of the interface assembly may be integrated with each other or share components. For example, the storage part of the filament housing may connect the directional lock on one side of the interface assembly to the directional lock on the other side of the interface assembly. In some configurations, a single housing may be provided at the top or rear of the interface assembly, which may house two separate locking mechanisms that interact with elements (e.g., filaments) associated with the variable locking mechanisms on both sides of the interface assembly. Alternatively, separate variable or directional locking housings associated with the locking mechanisms on both sides of the interface assembly may be located close to each other (adjacent in the longitudinal or lateral direction), for example, at the top or rear of the rear headgear portion.

[0324] Headgear systems incorporating a transformable mechanism, such as the one disclosed, which allows for the selective switching of a portion of the headgear from inelastic to elastic behavior to enable convenient attachment and removal, offer numerous advantages to the user. Examples of mechanisms achieving this behavior are disclosed herein and in the applicant's application PCT / NZ2014 / 000074, the entire application of which is incorporated herein by reference. In some configurations, one or more of these advantages relate to the ability to provide the user with auto-adjustment, self-sizing, or a more intuitive adjustment interaction. Furthermore, in at least some configurations, headgear systems incorporating a transformable mechanism, such as the one disclosed, can reduce or minimize undesirable movement of the mask body compared to state-of-the-art headgear systems, which typically consist of laminates of elastic materials or elastic knitted structures with sewn or sewn components added. These conventional designs can result in mask movement caused by hose tension or the interaction of applied breathing pressure with the mask. Such movement can lead to conditions ranging from leakage, loss of treatment, and mis-inducing breathing patterns due to resulting volume and pressure changes, to skin abrasions or possible skin damage. To suppress this movement, a common practice is to overtighten the headgear (by applying a high elastic force in the elastic system or by overtightening by hand in the adjustable non-elastic system) so that the force required to stretch the headgear is greater than the force generated by hose tension or through mask pressurization. This overtightening can result in additional pressure on the user, potentially causing discomfort, skin irritation, or skin damage.

[0325] One or more features of the autofitting or adaptable headgear systems disclosed herein allow the elastic behavior to be constrained to a predetermined region of the headgear system, where the elastic behavior is selectively switched on or off depending on usefulness conditions, rather than as an overall characteristic of the headgear. This provides an opportunity to "scheme" the rest of the headgear system to provide predetermined performance attributes. In at least some configurations, the primary result of the schemed adaptable headgear system combination is to provide behavior in which there is little to no movement of the mask body during use.

[0326] Figures 21 and 22 show the headgear system 800 as an example for a full-face mask 810 (Figure 21) and a nose pillow mask 812 (Figure 22). The indicated region 840 indicates the currently preferred location for a portion where selectable elastic / inelastic functionality exists. In each application, the selectable elastic / inelastic portion 830 is located between the mask 800 and the rear portion of the headgear system 820 and extends along the side 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 slight elastic behavior within the range of forces that occur during normal or expected use. In some configurations, both the form and material structure of the headgear have a significant influence in achieving such behavior.

[0327] form Referring to Figures 23 and 24, the use of a top or crown strap 940 and a strap (rear strap 910) that passes around the back of the user's head, as disclosed herein, utilizes the shape of the human head to provide repeatability through filament positioning and stability of the headgear 900 when in use. Further design features can be added to this basic crown strap 940 and rear strap 910 configuration, namely, by adding a gusset 920 or web connecting the rear or lower strap 910 to the crown strap 940, as shown in Figures 23 and 24, to further improve these desirable properties. By adding a gusset 920 or web member, relative movement between the rear strap 910 and the crown strap 940 is reduced, resulting in a more laterally stable design.

[0328] The gusset 920 can be attached to any preferred position on the rear strap 910 and the crown strap 940. The attachment points 930 and 960 of the gusset 930 on the rear strap 910 and the crown strap 940 may be substantially equidistant from the joint 950 between the rear strap 910 and the crown strap 940, or they may be spaced apart at different distances from the joint 950. In the illustrated configuration, the gusset 920 is attached to the crown strap 940 at a distance from the joint 950 that the gusset 920 is attached to is greater than the distance from the joint 950 to the rear strap 910. The distance from the joint 950 to the gusset 920 on the crown strap 940 may be approximately twice or more the distance from the joint 950 to the gusset 920 on the rear strap 910. In the illustrated configuration, the distance between the attachment points 960 of the gussets 920 on each side of the headgear 900 may be less than the distance between the joint 950 on the crown strap 940 and one of the attachment points 960 of the gussets 920. That is, the length of the distance between the gussets 920 on the crown strap 940 is less than one-third of the total length of the crown strap 940. The rear strap 910 and / or the crown strap 940 may be continuous or discontinuous. Several sections of the discontinuous rear strap 910 or crown strap 940 can be connected by suitable joints that may be fixed length, elastic, or adjustable.

[0329] construction / manufacturing The overall form of the headgear can be manufactured using several different techniques. For example, the headgear can be cut from a single sheet of material that is at least relatively or substantially inelastic. In other configurations, the headgear can be injection molded from one or more thermoplastic or thermosetting materials. In some configurations, the headgear or head frame is made from a single material with various cross-sectional shapes that provide portions with increased or decreased torsional stiffness and / or bending stiffness, allowing the headgear to smoothly conform to the human head morphology, as shown in Figures 25–28. In other configurations, the headgear can be constructed by commolding or multi-molding different materials in different portions to achieve the same or similar behavior, as shown in Figure 29.

[0330] Various parts of the headgear can be constructed to have desired properties in desired parts or areas of the headgear. For example, in the case of the part extending over the user's ears (section 1), it may be desirable to provide limited flexibility so as to restrict bending motion around the transverse axis or torsional motion around the longitudinal axis. The rear parts of section 1 (sections 2 and 3) preferably conform closely to the shape of the human head. Preferably, each of sections 1, 2, and 3 exhibits relatively inelastic behavior within the force range that normally occurs or is expected during use. Various combinations of materials can be used to achieve this behavior. In the illustrated example, thermoplastic elastomers or thermoplastic urethanes with varying Shore hardnesses are used to achieve the desired behavior.

[0331] As described above, the headgear may comprise various sections with different cross-sectional dimensions so that the characteristics of the headgear can be varied in different areas of the headgear. Referring to Figures 25-28, a rear headgear section is shown that generally terminates in front of and above the user's ears and is simply referred to as headgear 1000. Three vertical sections of headgear 1000 are shown. Section 1 is the portion of headgear 1000 that extends above and forward of the user's ears. Section 2 is the portion of headgear 1000 that is behind section 1 and can generally be positioned behind the user's ears. In the illustrated configuration, section 2 is located between the crown strap 1010 and the gusset 1030. Section 3 is the rear headgear position behind sections 1 and 2. In the illustrated configuration, section 3 is the rear position of headgear 1000 that can contact the back of the user's head.

[0332] Preferably, the portion including section 1 is relatively elongated and provides resistance to vertical bending loads that would attempt to move the front end of the headgear 1000 in the vertical direction. In the illustrated configuration, the portion including section 1 is taller than the portion including section 2. In some configurations, the portion including section 3 is taller than the portion including section 2. In some configurations, the portion including section 3 is taller than the portion including section 1. The portion of the headgear 1000 at the rear of the user's head (e.g., the portion including section 3) typically exerts greater force on the user's head as a result of directly facing the blowing force of the interface. Consequently, it may be preferable to enlarge the area of ​​the rear portion by giving it a relatively greater height to improve user comfort. In the illustrated configuration, the height of section 1 is approximately 10 mm, the height of section 2 is approximately 3 mm, and the height of section 3 is approximately 15 mm. Other dimensions may be used in other configurations. For example, the dimensions may differ, and the headgear 1000 may maintain the same height ratio between all of sections 1, 2, and 3. In other configurations, dimensions can vary by a predetermined number (e.g., 1 mm, 2 mm, or 3 mm), or by a percentage higher or lower than the dimensions shown. In some configurations, the height of the headgear 1000 changes gradually between sections 1, 2, and 3. The actual height of the headgear 1000 at any point can be selected to address appropriate performance parameters such as resistance to bending, force distribution, and fit or clearance considerations.

[0333] In some configurations, the headgear 1000 can have reduced thickness from front to rear. For example, the section containing section 1 may have a thicker cross-section than the sections containing sections 2 and 3, thereby giving the section containing section 1 (front section) greater resistance to torsional loads. Furthermore, the section containing section 2 may have a thicker cross-section than the section containing section 3. Therefore, the section containing section 2 has greater resistance to torsional loads than the section containing section 3. In some configurations, the thickness difference between the section containing section 1 and the section containing section 2 is greater than the thickness difference between the section containing section 2 and the section containing section 3. The reduced thickness of the sections containing sections 2 and 3 allows them to bend laterally to better conform to the specific shape of the user's head. In the illustrated configuration, the thickness in section 1 is approximately 1.5 mm, the thickness in section 2 is approximately 1 mm, and the thickness in section 3 is approximately 0.8 mm. Other dimensions can be used in other configurations. For example, although dimensions may vary, the headgear 1000 can maintain the same thickness ratio throughout all of sections 1, 2, and 3. In other configurations, dimensions can vary by a predetermined number (e.g., 0.1 mm, 0.2 mm, or 0.3 mm), or by a percentage thicker or thinner than the dimensions shown. In some configurations, the thickness of the headgear 1000 changes gradually between sections 1, 2, and 3. The actual thickness at any point in the headgear 1000 can be chosen to address appropriate performance parameters, such as resistance to torsional loads and lateral flexibility to improve fit.

[0334] Referring to Figure 29, as described above, the headgear 1100 may have different material types throughout the headgear 1100 to give different properties in different parts of the headgear 1100. The headgear 1100 in Figure 29 shows three sections taken out at three different positions within the headgear 1100, which may be the same as or substantially the same as the positions of the headgear 1100 in Figures 25-28. The part containing section 1 may be made of a first material or combination of materials, such as polypropylene. Similar to the headgear 1000 in Figures 25-28, the material selection for the part containing section 1 may take into account the requirement to provide resistance to bending in the vertical direction. The material or combination of materials for the part containing section 2 may be different from the materials of one or both of the parts containing section 1 and section 3. For example, the part containing section 2 may be made of a second material or combination of materials such as a combination of thermoplastic pre-urethane (TPU) and thermoplastic elastomer (TPE). The material or combination of materials in the portion including Section 3 may differ from the material of one or both of the portions including Section 1 and Section 2. For example, the portion including Section 3 may be composed of a third material or combination of materials, such as TPE. The considerations for material selection for different portions of the headgear 1100 may be the same as or similar to the considerations for dimensional selection described in Figures 25 to 28.

[0335] In some configurations, material selection can result in different parts of the headgear 1100 having different durometer hardnesses. For example, the part containing section 1 may have the highest durometer hardness. In some configurations, the part containing section 1 may have a durometer hardness of approximately 65 Shore D to 70 Shore D. The part containing section 2 may have a durometer hardness lower than that of the part containing section 1. In some configurations, the part containing section 2 may have the lowest durometer hardness of the parts containing sections 1, 2, and 3. For example, the part containing section 2 may have a durometer hardness of approximately 70 Shore A. The part containing section 3 may have a durometer hardness between that of the parts containing sections 1 and 2. For example, the part containing section 3 may have a durometer hardness of approximately 40 Shore D. Considerations in hardness selection for different parts of the headgear 1100 may be the same as or similar to the considerations described for dimensional selection in Figures 25 to 28. Changes in hardness can be achieved, for example, by other methods such as material selection or material manipulation.

[0336] Combinations of these techniques are also possible. For example, two or more of the dimensions, materials, and hardness can be selected so that their properties change through the headgear. In some cases, the headgear is a 3D form that conforms to the human head, behaves substantially inelastically, and provides a stable connection point for a variable locking mechanism.

[0337] The material selection for one or more parts of the headgear can, likewise, involve other considerations. For example, some configurations may include materials that exhibit little or no tendency to absorb moisture, either partially or entirely. Other configurations may include materials that exhibit water vapor permeability, either partially or entirely. Advantageously, such configurations allow the headgear to avoid or prevent the absorption of moisture such as sweat, or to allow moisture to move through the headgear material. Any configuration can improve comfort for the user.

[0338] Headgear can be further improved by incorporating textile-based lining or padding on either the inner or outer surface, or both, to design the feel and / or tactical characteristics of the headgear. In some configurations, hair pulling and / or the wearer's sense of the headgear's edges are reduced or minimized. When the lining or padding is provided on only one side of the headgear (inner or outer surface), or when the surface is otherwise identifiable (e.g., the inner surface is a different color from the outer surface), this feature contributes to the overall usefulness of the device by providing the user with a visual cue regarding the orientation in which to wear the headgear.

[0339] In some configurations, the headgear may be equipped with one or more adjusters that allow the headgear's size to be adjusted. For example, an adjuster may be provided on the strap portion of the headgear so as to allow adjustment of the length of the strap portion. It is also possible to provide adjusters between the strap portions so as to allow adjustment of the relative position of the strap portions. In some configurations, the adjusters are self-adjusting or enable self-adjustment of the headgear. As used herein, self-adjustment refers to an adjuster that allows adjustment of the headgear 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 holds the headgear in the second position without user intervention (e.g., manual locking). In some configurations, the adjuster may be equipped with a biasing element or mechanism. For example, the adjuster may be equipped with a biasing mechanism that tends to bias the strap portion in a first direction (e.g., in the direction of reducing the length). Therefore, the adjuster can simply allow the user to operate the headgear, thereby automatically locking it in the desired position, or the adjuster can help move the headgear toward a proper fit position, and then automatically lock the headgear in that proper fit position. Such adjusters may be equipped with any of the variable locking mechanisms disclosed in the applicant's application PCT / NZ2014 / 000074.

[0340] Figures 30 and 31 show examples of locations where an automatic adjuster can be placed within the headgear 1200. For example, an automatic adjuster can be placed at or near the junction between the top or crown strap portion and the circumferential or upper portion located above the user's ears at position 1200A. An automatic adjuster can be placed at position 1200A on each side of the headgear 1200. The automatic adjuster at position 1200A allows the relative position of the upper portion of the headgear 1200 to be adjusted with respect to the crown strap 1210, for example, in the front-to-back direction. Alternatively, the automatic adjuster at position 1200A can adjust the circumference of a portion of the headgear 1200. In other words, the automatic adjuster at position 1200A can adjust the length of the upper portion of the headgear 1200. An automatic adjuster can be placed at position 1200B within the top or crown strap 1210. The length of the crown strap 1210 can be adjusted by the automatic adjuster at position 1200B. An automatic adjuster can be located at position 1200C, which is located in the rear or lower part of the headgear 1200. A single automatic adjuster can be located in the rear part, or automatic adjusters can be provided in each side of the lower part of the headgear 1200. The circumference of the lower part of the headgear 1200 can be adjusted by the automatic adjuster at position 1200C.

[0341] The automatic adjuster can be positioned in any one, any combination or all of positions 1200A, 1200B, and 1200C, and / or at any other location within the headgear. In some configurations, the automatic adjuster allows the rear headgear portion to be adjusted to fit the user's head. Thus, such an automatic adjuster can be added to a variable locking mechanism between the headgear portion and the interface, and can be configured to adjust the relative position of the interface and the rear headgear portion, as well as to apply appropriate sealing or retaining force to the interface.

[0342] Referring to Figures 32-34, a specific strap adjustment mechanism 1300 is shown. The adjustment mechanism 1300 in Figures 32-34 is substantially similar to the flat strap adjustment or directional locking mechanism illustrated and described in relation to Figures 40-42 in the applicant's PCT application PCT / NZ2014 / 000074. However, in some configurations, the strap adjustment mechanism 1300 in Figures 32-34 incorporates an 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.

[0343] Figures 32 to 34 illustrate the various components of the adjustment mechanism by showing the adjustable strap 1300 in an assembled form and separate adjustable strap portions in plan view. The adjustment mechanism 1300 comprises a first portion 1310 which can be coupled to a second portion 1320 at multiple adjustment positions. In some configurations, the first portion 1310 and the second portion 1320 may be infinitely adjustable within a provided adjustment range. The first portion 1310 and the second portion 1320 shown are the first and second portions of an adjustable top or crown strap, but the adjustable strap may be provided at other positions, for example, as described in relation to Figures 30 and 31. As described above, a biasing mechanism may be provided to bias the first portion 1310 and the second portion 1320 toward each other, for example toward a reduced position.

[0344] Preferably, the adjustment mechanism 1300 includes a directional lock 1330 which allows relative movement of the first portion 1310 and the second portion 1320 in a first direction (e.g., toward the retracted position) and provides a yield force that prevents movement in a second direction. The yield force is preferably sufficient to prevent substantial movement in the second direction under normal or expected operating conditions, but can be overcome by an applied force to allow the desired adjustment of the first portion 1310 and the second portion 1320.

[0345] The first part 1310 of the adjustment mechanism 1300 may include a substantially flat strap 1312 that forms the male part of the adjustment mechanism 1310. The second part 1320 of the adjustment mechanism may include a receiving part or lock housing 1322 that forms the female part of the adjustment mechanism. The lock housing 1322 may include a space 1324 for receiving a locking member, such as a lock washer. The flat strap 1312 is movable within the receiving part 1322 and passes through the space 1324 for receiving the lock washer. The flat strap 1312 also passes through the lock washer. The lock washer is movable between an unlocked position and a locked position within the space 1324 of the lock housing 1322. In some configurations, the unlocked position is defined by the lock washer being oriented substantially perpendicular to the longitudinal direction of the flat strap 1312, and the locked position is defined by the lock washer being inclined from the perpendicular orientation of the unlocked position.

[0346] The position of the lock washer can be controlled by any preferred configuration, such as being pushed to a desired position by the end of the space 1324 of the lock housing 1322. For example, one end of the space 1324 of the lock housing 1322 may have a vertical surface, and the other end may have an inclined surface. When the flat strap 1312 moves toward the vertical surface, the lock washer is biased to be in a vertical or released position, and the flat strap 1312 can move relative to the lock housing 1322 with relatively low resistance. When the flat strap 1312 moves toward the inclined surface, the lock washer is biased to an inclined position or a locked position, and the relative movement between the flat strap 1312 and the lock housing 1322 is resisted by a yield force. The flat strap 1312 may include a gripping portion that facilitates the movement of the lock washer. The gripping portion may be a high-friction material or a material that has a high gripping force against the lock washer compared to the base material of the flat strap 1312.

[0347] In some configurations, each of the flat strap 1312 and the lock housing 1322 is constructed by molding material onto the textile 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 material of the first strap portion 1310. In contrast, the textile material of the second strap portion 1320 extends beyond the lock housing 1322. Preferably, the portion of the flat strap 1312 that is received within the lock housing 1322 extends beyond the textile material of the first strap portion 1310 to avoid interference between the textile material of the first strap portion 1310 and the second strap portion 1320 through the adjustment range of the adjustment mechanism. The portion of the second strap portion 1320 that extends beyond the lock housing 1322 may be configured such that the textile material of the first strap portion 1310 abuts against or overlaps with the textile material of the second strap portion 1320 at the maximum or most separated position of the first portion 1310 and the second portion 1320.

[0348] In some configurations, the molded material extends along the textile material of the strap portion beyond the flat strap and / or lock housing. For example, the molded material can be provided as a reinforcement to or as a reinforcing member of the textile material of the strap portion. Additional molded material can be provided to increase the surface area between the molded material and the textile material, thereby strengthening the connection between them and / or increasing the holding force between them. In the illustrated configuration, the additional molded material is in the form of strips or ribs that are separated from each other in the width direction of the strap portion and generally extend in the length direction of the strap portion.

[0349] In the illustrated configuration, the strap portions 1310 and 1320 are preferably relatively rigid in one direction (in the width direction to prevent bending) but retain flexibility in another direction (in the thickness direction to allow the strap to bend and conform to the user's head). This can be achieved by the geometric design of the textile strap portions and / or overmolded features, and / or by using different overmolded materials. In other configurations, such as other positions of the adjustment mechanism, other properties may be desirable. Therefore, other geometric shapes and / or materials can be selected to give the strap portions the desired properties.

[0350] In some configurations, the composite strap portion is constructed by an overmolding process that involves molding a moldable material 1340 onto a textile or fabric material 1350. In some configurations, the moldable material 1340 may be a plastic material. The textile or fabric material 1350 is preferably selected to allow for good adhesion of the moldable material.

[0351] Textile material can be placed inside the mold. The mold can be closed, and a portion of the textile material (e.g., an edge) can be captured between the separable parts (e.g., halves) of the mold. Then, moldable material can be injected into the mold and onto the textile material.

[0352] As disclosed in the present applicant's patent application PCT / NZ2014 / 000074, many different types of directional locking mechanisms can be utilized in headgear exhibiting balanced fit characteristics. In at least some configurations, the directional lock prevents or inhibits relative movement between two parts of the headgear in a first direction, at least below the yield force of the directional lock. The directional lock also enables relative movement between two parts of the headgear in a second direction opposite to the first direction. Preferably, movement in the second direction is enabled simply by a relatively small amount of resistance.

[0353] Referring to Figure 35, in some configurations, the first part of the headgear comprises a core member 1400. The core member 1400 may be a wire, a wire-like element, or a filament. The second part of the headgear may comprise a housing 1410. The first and second parts of the headgear can be coupled to any suitable part or component of the headgear that is movable relative to each other to change or adjust the circumference of the headgear. The housing 1410 may be an element or receptacle that defines a space 1412 that receives a locking mechanism 1420. The housing 1410 may be a separate component from the headgear, or it may be an integral component or part of the headgear. The locking mechanism 1420 can engage with the core member 1400 to prevent or block 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 mechanism 1420 can also disengage the core member 1400, allowing the core member 1400 to move relative to the housing 1410 in a second direction opposite to the first direction.

[0354] The locking mechanism 1420 may comprise two or more locking elements movable between a first position, i.e., a locked position 1430, and a second position, i.e., an unlocked position 1440. The illustrated locking mechanism 1420 comprises a pair of locking elements in the form of lock jaws 1422. Each of the lock jaws 1422 is generally cylindrical. The lock jaws 1422 cooperate to surround the core member 1400. The inner surface of each lock jaw 1422 facing the core member 1400 is concave. Each of the lock jaws 1422 comprises an engaging portion 1424 that contacts the core member 1400 in the locked position 1430, thereby allowing the lock jaws 1422 to cooperate to engage with the core member 1400. In the illustrated configuration, the engaging portion 1424 is defined by the respective ends of the lock jaws 1422.

[0355] Each opposite end of the lock jaw 1422 extends through the housing 1410 and includes a radially extending flange 1426. The directional lock may be equipped with a biasing mechanism, which in some configurations provides a relatively light biasing force that tends to move the locking mechanism toward the locked position, or toward the left in Figure 35. The biasing mechanism may include a biasing element 1428, such as a spring, acting on the flange 1426 of the lock jaw 1422 and the end face 1414 of the housing 1410. Preferably, the biasing mechanism provides a light biasing force that assists the initial movement of the lock jaw 1422 toward the locked position 1430 when the core member 1400 moves in a direction that tends to increase the circumference of the headgear (to the left in Figure 35). The lock jaw 1422 may move toward the released position 1440 against the biasing force of the biasing mechanism when the core member moves in a direction that tends to decrease the circumference of the headgear (to the right in Figure 35).

[0356] As described above, the housing 1410 defines a space or passage for receiving the lock jaws 1422 through which the core member 1400 can pass. The passage 1412 may define a chamfered, angled, or tapered surface 1416 that facilitates the movement of the lock jaws 1422 between a locked position 1430 and an unlocked position 1440. One or more lock or roller elements 1418 can be positioned between each of the lock jaws 1422 and the housing 1410. As the lock jaws 1422 move toward the locked position 1430 along the longitudinal axis of the housing 1410 or the passage 1412, the roller elements 1418 engage with the tapered surface 1416, thereby moving the roller elements 1418 and thus the lock jaws 1422 toward each other, thereby tightening the core member 1400 between the lock jaws 1422. As the lock jaw 1422 moves along the horizontal axis toward the release position 1440, the roller element 1418 moves freely radially away from the lock jaw 1422, thereby releasing the clamping force from the lock jaw 1422 and allowing the core member 1400 to move with relatively little resistance. This movement of the core member 1400 allows the lock jaw 1422 to move axially via the frictional force against the biasing force of the biasing mechanism.

[0357] The core member 1400, lock jaw 1422, tapered surface 1416, and / or roller element 1418 can be configured so that the directional lock applies a clamping force to the core member 1400, which substantially prevents or restricts the movement of the core member 1400 relative to the housing 1410 when a force below the yield force acts on the core member 1400 attempting to extend the headgear, and allows the movement of the core member 1400 attempting to extend the headgear when a force above the yield force acts on the core member 1400. As described above, such configurations allow a headgear incorporating one or more of the directional locks to resist normal or anticipated forces related to treatment, while also allowing the headgear to be extended for attachment to or removal from the user. The directional lock can release the core member 1400 in response to movement of the core member 1400 attempting to retract the headgear, allowing the core member 1400 to move relative to the housing 1410 with relatively little resistance. This configuration allows headgear incorporating one or more directional locks to contract to fit a particular user's head size. The contraction force that tends to contract the headgear can be provided by any preferred method or mechanism, including manual contraction or automatic contraction provided by the elastic configuration or elastic elements of the headgear.

[0358] Figure 36 shows the operating cycle for a headgear incorporating a directional lock, such as the directional lock described above, any other directional lock incorporated herein or by reference, or any other suitable directional lock. In the graphical operating cycle, the upward arrow component represents the extension of the headgear (increase in the circumference of the headgear), and the downward arrow component represents the contraction of the headgear (decrease in the circumference of the headgear). In Figure 36, the rightward arrow component represents the extension movement of the headgear, and the leftward arrow component represents the contraction movement of the headgear.

[0359] Figure 36 is illustrated with reference to the structure of the directional lock described above, but the basic concepts emphasized by the description are equally applicable to many or all of the other directional locks described or incorporated herein. The upper center arrow indicates that, as a result of applying a force exceeding the yield force of the directional lock, the core member moves in a direction that tends to extend the headgear. Thus, the core member can slide through the lock jaws, which are tightened against the core member by the interaction of the roller elements and the tapered surfaces of the passages in the housing. Such forces can be applied in the application or removal of the headgear.

[0360] The following arrows in the clockwise direction represent the change from extension to contraction in the direction of the core member. This change in direction releases the clamping force in the core member.

[0361] The following arrows in the clockwise direction represent the contraction movement of the core member. Therefore, the movement of the core member allows the lock jaws to be moved so that the roller elements are no longer pressed into the narrow portion of the tapered surface. As a result, relatively free contraction movement of the core member can occur. This movement allows the headgear to fit a particular user or to contract to its minimum circumference when not in use.

[0362] The following arrows in the clockwise direction represent a change from contraction to extension in the direction of the core member. These changes in direction apply a clamping force to the core member. In each case of a change in direction, some movement of the core member may occur, or be fully reached, before a change in clamping force or a change in the position of the directional lock occurs. This cycle can be repeated each time the headgear is fitted to or removed from the user. In some cases, this cycle may occur when the user makes fine adjustments to the headgear.

[0363] Figures 37 to 53 show examples of headgear assemblies 1500 incorporating one or more directional locks 1510. The illustrated headgear assembly 1500 is configured to connect to a portion of the interface 1520. In particular, the illustrated headgear assembly 1500 includes a rear headgear portion 1530, an interface coupling portion 1540, and a length or circumference adjustment portion 1550 inserted between the rear headgear portion 1530 and the interface coupling portion 1540. The rear headgear portion 1530 is configured to contact the rear portion of the user's head when in use. The interface coupling portion 1540 is configured to connect to the interface 1520 when in use so that the headgear assembly 1500 can support the interface 1520 in the appropriate position on the user's face. The length or circumference adjustment portion 1550 is configured to allow the position of the interface coupling portion 1540 to be adjusted relative to the rear headgear portion 1530 when in use, so that the headgear assembly 1500 can be adjusted to the head size of a particular user. Therefore, the length or circumference adjustment portion 1550 allows the circumference or length of the headgear to be adjusted so that the headgear assembly 1500 can fit the head size of a particular user.

[0364] Although illustrated and described as headgear assembly 1500, in some configurations, parts of the illustrated headgear assembly 1500 can be incorporated into any other suitable part of the entire interface assembly. For example, the interface coupling part 1540 may comprise an interface component or part that is separate from and connectable to the headgear assembly 1500. The length or circumference adjustment part 1550 may comprise an interface component or part that is separate from and connectable to the headgear assembly 1500, or a component or part of the headgear assembly 1500 that is separate from and connectable to interface 1520. However, advantageously, as will be further described later, the illustrated headgear assembly 1500 may comprise a built-in auto-fit headgear unit that exhibits balanced fit characteristics and can be coupled to at least one, and possibly more, types of interfaces. Thus, in at least some configurations, one type of illustrated headgear assembly 1500 can be used with multiple types of interfaces. Thus, vendors can stock fewer unique products while offering the same interface options. Furthermore, users can utilize a single headgear assembly and swap interfaces as needed without requiring manual adjustment of the headgear assembly when switching to a different interface.

[0365] In the illustrated configuration, the rear portion 1530 of the headgear comprises at least one strap portion 1560 that contacts the user's head. Preferably, at least one strap portion 1560 contacts the rear portion or posterior of the user's head so as to be able to restrain the force generated within the headgear assembly 500 by the pressurization of the interface during treatment. In some configurations, the strap portion 1560 extends laterally generally or substantially around the posterior of the user's head and has ends on each side of the user's head. Each end can be coupled to another part of the headgear assembly 1500, such as a circumferential adjustment portion 1550.

[0366] In some configurations, at least one strap portion 1560 comprises a first strap portion and a second strap portion. The first strap portion may be a posterior strap portion 1562 extending around the back of the user's head, and the second strap portion may be a vertex or upper strap portion 1564 extending over the top of the user's head. The posterior strap portion 1562 may be positioned to contact a portion of the user's head corresponding to one or both of the occipital bone or parietal bone. The vertex strap portion 1564 may be positioned to contact a portion of the user's head corresponding to one or both of the parietal bone or frontal bone. Thus, the vertex strap 1564 may be configured as either a vertex strap or a forehead strap, as such straps may be characterized in the art. Other preferred configurations may also be used.

[0367] Preferably, the rear portion 1530 of the headgear engages with the user's head and provides a relatively stable platform for interface connection, such as by utilizing the interface coupling portion 1540 and the circumferential adjustment portion 1550. Thus, in at least some configurations, the rear portion 1530 of the headgear is substantially inelastic so as to maintain its shape and effective length in response to forces applied within a range typical or predictable for the intended use. In some configurations, the rear portion 1530 of the headgear may comprise a layer made of a relatively rigid material, such as a plastic material, bonded to one or more layers of fabric material. Preferably, the fabric layer is provided at least on the side of the rigid material layer that is in contact with the user. In some configurations, the fabric layer is provided on each side of the rigid material layer. Furthermore, in some configurations, a rigid material layer can be formed between material layers, such as by injection molding the rigid material into the space between two material layers in a mold. Examples of such headgear and methods for manufacturing such headgear are disclosed in the applicant’s U.S. Provisional Patent Application No. 62 / 050,925, which is incorporated herein by reference in its entirety.

[0368] The circumferential adjustment section 1550 may comprise a pair of adjustment elements 1552, where one adjustment element 1552 is positioned on each side of the headgear assembly 1500. In particular, each of the adjustment elements 1552 can connect one side of the rear headgear section 1530 to one side of the interface connection section 1540. An adjustment element 1552 can be connected to or near the joint between the top strap 1564 and the rear strap 1562. In the illustrated configuration, the adjustment element 1552 is connected to the forward extension of the rear headgear section 1530 that extends forward from the joint between the top strap 1564 and the rear strap 1562. The length of the adjustment element 1552 is adjustable between a contracted length and an extended length. In some configurations, the adjustment elements 1552 cooperate to provide all or substantially all of the circumferential adjustment of the headgear assembly 1500. Each of the adjustment elements 1552 may also include an elastic element or biasing mechanism that biases the adjustment element 1552 toward either a contracted length or an extended length. Preferably, the adjustment element 1552 is biased toward the contracted length, thereby biasing the headgear assembly 1500 toward its minimum circumference. This configuration allows the headgear assembly 1500 to extend and then automatically contract to fit a particular user under the biasing force of the elastic element or other biasing mechanism of the adjustment element 1552. Furthermore, preferably, the adjustment element 1552 defines a hard stop at the maximum extended length to limit the extension of the headgear 1500 and defines the maximum circumference of the headgear 1500.

[0369] In some configurations, the adjustment element 1552 comprises a braided element 1554 whose length can be extended or contracted. The braided element 1554 may comprise one or more elastic elements parallel to the braided element 1554. The elastic elements may be separate from the braided element 1554 or incorporated into the braided element 1554. In some configurations, the elastic elements are housed within the internal space between the filaments of the braided element 1554. Examples of suitable braided elements are described in relation to Figures 46-54 of the present applicant's patent application PCT / NZ2014 / 000074. However, other suitable structures or configurations may also be used. Alternatively, an elastic or biasing element may be placed within the interface joint to interact with the core member and pull the core member into the interface joint.

[0370] The interface coupling portion 1540 of the headgear assembly 1500 may extend between a pair of adjustment elements 1552, each comprising a circumferential 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 the connection of the headgear assembly 1500 to the interface 1520. However, the interface coupling portion 1540 may also accommodate at least a portion of one or more directional locks 1510. In the illustrated configuration, a pair of directional locks 1510 are provided, with one directional lock 1510 associated with one of the pair of adjustment elements 1552. A portion of the directional lock 1510 (e.g., a housing 1512) may 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 rear portion 1530 of the headgear and extends along or through the adjustment element 1552 and through the housing 1512 of the directional lock 1510 into the collection space 1542 of the interface coupling portion 1540. The housing 1512 of the directional lock 1510 may include one or more members or elements (e.g., lock washers or lock jaws) that interact with the core member 1570 to selectively allow contraction of the headgear assembly 1500 or to lock the headgear assembly 1500 at a particular circumference and prevent or restrict extension of the headgear 1500 by a force less than the yield force provided by the directional lock 1510. Further details of the operation of the directional lock 1510 are described above and in the present applicant's patent application PCT / NZ2014 / 000074.

[0371] In some configurations, one or both of the core member 1570 and the adjustment element 1552 are fixed to the rear headgear portion 1530 by enclosing the core member 1570 and / or the adjustment element 1552 within the rear headgear portion 1530. For example, the core member 1570 and / or the adjustment element 1552 can be placed in a mold, and the rigid material portion of the rear headgear portion 1530 can be formed by injection molding to enclose the core member 1570 and / or the adjustment element 1552. In the illustrated configuration, the ends of the adjustment element 1552 and the ends of the core member 1570 are enclosed within the rigid material portion of the rear headgear portion 1530. However, other preferred configurations may also be used.

[0372] In some configurations, the adjustment element 1552 includes an end cap portion 1556 that connects the braided element 1554 to the elastic element. The end cap portion 1556 can be attached to the end of the adjustment element 1552 by an overmolding process. In particular, the braided element 1554 and the elastic element can be placed in a mold, and the end cap portion 1556 can be produced by injection molding over the ends of the braided element 1554 and the elastic element. In some configurations, the braided element 1554 and / or the elastic element are held in an elongated state during the overmolding process. In some configurations, the adjustment element subassembly is then connected to the rear headgear portion 1530 by the overmolding process described above, etc. Thus, the end cap portion 1556 of the adjustment element 1552 can be enclosed by the rear headgear portion 1530.

[0373] Each end cap portion 1556 of the adjustment element 1552, which faces the rear portion 1530 of the headgear, can be coupled to the interface coupling portion 1540 by any preferred configuration. In the illustrated configuration, the end cap portions 1556 of the adjustment element 1552 are coupled to a ferrule or socket 1580, and the ferrule or socket 1580 is coupled to the interface coupling portion 1540. For example, the end cap portions 1556 can be press-fitted into the socket 1580 or otherwise secured. The socket 1580 may include a neck portion 1582 that positions a retaining portion 1584 away from the body 1586 of the socket 1580. The neck portion 1582 may extend through an opening 1544 in the interface coupling portion 1540, and the retaining portion 1584 of the socket 1580 can prevent the socket 1580 from separating from the interface coupling portion 1540. In some configurations, the retaining portion 1584 of the socket 1580 can be integrated with the housing 1512 of the directional lock 1510.

[0374] In some configurations, the interface coupling portion 1540 can consist of multiple parts that work together to define the collection space. These multiple parts can also work together to define a space 1590 that receives the housing 1512 of each directional lock 1510. In the illustrated configuration, the interface coupling portion 1540 comprises a first part 1592 and a second part 1594, which, when connected, can define a collection space 1596 and a pair of spaces 1590 that receive the housings 1512 of the directional locks 1510. The first part 1592 and the second part 1594 can be an upper and lower part, respectively. In other configurations, the first part 1592 and the second part 1594 can be, for example, a front part and a rear part. Providing separate parts facilitates the assembly of the housing 1512 of the directional lock 1510, the core member 1570 and socket 1580 of the directional lock 1510 into the interface coupling portion 1540.

[0375] The collection space 1596 of the interface coupling portion 1540 is configured as a storage area that, in the illustrated configuration, receives the end of the core member 1570 that is superfluous or non-functional and does not form the working portion of the core member 1570. That is, the portion of the core member 1570 between the mounting point of the rear portion 1530 of the headgear and the housing 1512 of the directional lock 1510 (or in the locking element of the directional lock) is functional and forms part of the circumference of the headgear. These portions of the core member 1570 are placed under tension when a force is applied that tends to stretch the headgear. The lengths of the functional and non-functional portions of the core member change with the adjusted or instantaneous changes in the circumference of the headgear assembly 1500. Thus, the collection space 1596 provides a place to store and protect the non-functional portions of the core member 1570.

[0376] Preferably, the length of the collection space 1596 is at least the length of one of the extension distances (the distance between the extended and retracted lengths) of the adjustment member 1552. In other words, the extension distance of the adjustment member 1552 is preferably less than or equal to the length of the collection space 1596, so that there is sufficient space in the collection space 1596 for an extra core member portion of sufficient length to allow the adjustment member 1552 to move from the retracted position to the extended position while at least some extra length of core member 1570 remains in the collection space 1596, so that the core member 1570 is not completely pulled through the housing 1512 of the directional lock 1510. In some configurations, the collection space 1596 may have separate spaces or channels for each of the core members 1570.

[0377] A portion of the interface coupling portion 1540 can be configured to connect to interface 1520 or a portion of interface 1520. In some configurations, the interface coupling portion 1540 can be selectively coupled to interface 1520 or detachably coupled. In the illustrated configuration, a portion of the interface coupling portion 1540 defining the collection space 1596 is configured to be received within a receiving channel 1522 of the interface member 1524. The receiving channel 1522 may be a semi-cylindrical space defined by the interface member 1524 and configured to receive the interface coupling portion 1540 in a snap-fit ​​configuration. The central portion of the interface coupling portion 1540 defining the collection space 1542 may have an outer shape that is generally cylindrical or cylindrical. In the illustrated configuration, the central portion of the interface coupling portion 1540 is curved along its length.

[0378] The interface member 1524 can be any part of the interface 1520. For example, the interface member 1524 can be a relatively rigid part of the interface 1520, such as a shell or frame element 1526. In the illustrated configuration, the interface member 1524 is a frame element 1526 that can directly or indirectly support a mask seal 1528, cushion 1532, or other interface element. The frame element 1526 (or another part 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 designed to integrate with or be used with a given 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, such as nasal cannulas, nasal pillows, nasal masks, or full-face masks.

[0379] Figures 54–56 show interface assemblies incorporating the headgear assembly 1500, which may be the same as, substantially the same as, or another preferred configuration as, the headgear assembly 1500 described above. In the illustrated configurations, the rear headgear portion 1530 is foldable. In some configurations, the rear headgear portion 1530 can be folded or bent from an extended configuration in which the rear headgear portion 1530 takes on a three-dimensional shape to a folded configuration in which it can be positioned relatively flat. In the illustrated configurations, one or both of the rear strap and the top strap are provided with a hinge, joint or fold. The hinge, joint or fold 1536 may include a section of the rear headgear portion 1530 that is less rigid than the rest of the rear headgear portion 1530. The hinge, joint, or fold 1536 may include a portion of the rigid headgear material with reduced thickness, a separation between portions of the rigid headgear material such that one or more fabric layers define the hinge, joint, or fold 1536, or a connection between separate portions of the rear portion of the headgear 1530, such as a suture joint. Separate hinge members may be used to join several portions of the rear portion of the headgear.

[0380] This configuration allows the headgear to lie relatively flat, which can help pack the headgear when the user is moving with the mask. The presence of designed fold points or lines allows the headgear unit to have shape-retaining behavior, but it can also be a compact unit if it needs to be packed in a suitcase or the like. The fold line or hinge line 1536 can be constructed by any preferred process, such as sewing or injection molding both the left and right sides of the rigid material portion up to that point, and then leaving one or more unbacked pieces of fabric to act as a hinge.

[0381] Figures 57–59 show another headgear assembly 1600 that can be used with two or more interface types in at least some configurations. For example, Figure 57 shows the headgear assembly 1600 as forming a modular component of an interface assembly with a full-face mask type interface 1650. The headgear assembly 1600 may have a portion 1602 that engages with the interface 1650, or it may be coupled to the interface 1610 in other ways. In some configurations, the engaging or coupling portion 1602 of the headgear assembly 1600 may engage with or coupling to at least one other type of interface. For example, Figure 58 shows the headgear assembly 1600 of Figure 57 (shown by a dashed line) supporting a nose mask 1660, and Figure 59 shows the headgear assembly 1600 of Figure 57 (shown by a dashed line) supporting a nose pillow / prong mask 1670. Thus, such modular configurations allow a single headgear assembly to be used with multiple types of interfaces. Advantageously, the on-demand resistance function of the headgear assembly as described herein allows a single headgear assembly to suitably operate with different interface types. For example, the holding force provided by the headgear can be automatically adjusted to the force applied to the headgear by the particular interface used. The engaging or coupling portion 1602 may be any preferred configuration, such as being the same as or similar to the configuration disclosed in relation to Figures 37 to 53.

[0382] The headgear assembly 1600 may be generally similar to other headgear assemblies disclosed herein or in the applicant's application PCT / NZ2014 / 000074. In particular, the illustrated headgear assembly 1600 includes a rear headgear portion 1604, an interface coupling portion 1602, and a length or circumference adjustment portion 1606 inserted between the rear headgear portion 1604 and the interface coupling portion 1602. The rear headgear portion 1604 is configured to contact the rear portion of the user's head when in use. The interface coupling portion 1602 is configured to couple with the interface so that the headgear assembly 1600 can support the interface in the appropriate position on the user's face when in use. The length or circumference adjustment portion 1606 is configured to adjust the position of the interface coupling portion 1602 relative to the rear headgear portion 1604 so that the headgear assembly 1600 can be adjusted to the head size of a particular user when in use. Therefore, the length or circumference adjustment portion 1606 can be adjusted to allow the circumference or length of the headgear to be adjusted so that the headgear assembly 1600 can fit the head size of a particular user.

[0383] The rear headgear portion 1604 may be any preferred configuration, such as being the same as or similar to any of those described herein or in the applicant's application PCT / NZ2014 / 000074. Preferably, the rear headgear portion 1604 engages with the user's head and provides a relatively stable platform for interface connection, such as by utilizing the interface coupling portion 1602 and the circumferential adjustment portion 1606. Thus, in at least some configurations, the rear headgear portion 1604 is substantially inelastic, thereby maintaining its shape and effective length in response to applied forces that are typical or expected for the intended use. The rear headgear portion 1604 may include a top strap portion 1608 extending over the top of the user's head and a rear strap portion 1610 extending around the rear of the user's head. The top strap portion 1608 and the rear strap portion 1610 may be separate or connected in any preferred manner, such as by an intermediate connecting portion 1612.

[0384] The length or circumferential adjustment section 1606 may be any preferred configuration, such as being the same as or similar to any of those described herein or in the applicant's application PCT / NZ2014 / 000074. The circumferential adjustment section 1606 may comprise two pairs of adjustment elements 1614, where one pair of adjustment elements 1614 is positioned on each side of the headgear assembly 1600. Thus, the illustrated headgear device 1600 can generally be described or classified as a two-retaining-face headgear type. The headgear device 1600 can be described as a two-retaining-face, forward-converging headgear type, or, in some cases, a hybrid of a two-retaining-face, forward-converging headgear type and a two-retaining-face, separate / angled headgear type.

[0385] Each pair of adjustment elements 1614 can connect one side of the rear portion 1604 of the headgear to one side of the interface connection portion 1602. The pairs of adjustment elements 1614 on each side are connected to the rear portion 1604 of the headgear at spaced intervals. For example, one of the adjustment elements 1614 is connected to the rear portion 1604 of the headgear in or near part of the top strap 1608, and the other of the adjustment elements 1614 is connected to the rear portion 1604 of the headgear in or near part of the rear strap 1610. In the illustrated configuration, the upper adjustment element 1614 is connected to the forward extension of the rear portion 1604 of the headgear that extends forward from part of the top strap 1608 at or near the user's ears. The lower adjustment element 1614 is connected to the end of the rear strap 1610 of the rear portion 1604 of the headgear.

[0386] The adjustment element 1614 is adjustable in length between a contracted length and an extended length. In some configurations, the adjustment elements 1614 work together to provide all or substantially all of the adjustment of the circumference of the headgear assembly 1600. Each of the adjustment elements 1614 may also include an elastic element or biasing mechanism that biases the adjustment element 1614 toward either the contracted length or the extended length. Preferably, the adjustment element 1614 is biased toward the contracted length, thereby biasing the headgear assembly 1600 toward its minimum circumference. With such a configuration, the headgear assembly 1600 can extend and then automatically contract under the biasing force of the elastic element or other biasing mechanism of the adjustment element 1614 to fit a particular user. Furthermore, preferably, the adjustment element 1614 defines a hard stop at the maximum extended length to limit the extension of the headgear 1600 and define the maximum circumference of the headgear 1600.

[0387] In some configurations, each of the adjustment elements 1614 comprises a braided element whose length can be extended or contracted. The braided element may comprise one or more elastic elements parallel to the braided element. The elastic elements may be separate from the braided element or incorporated into the braided element. In some configurations, the elastic elements are housed in the internal space between the filaments of the braided element. Examples of suitable braided elements are described in relation to Figures 46 to 54 of the present applicant's patent application PCT / NZ2014 / 000074. However, other suitable structures or configurations may also be used. Alternatively, an elastic or biasing element may be placed within the interface joint that interacts with the core member to pull the core member into the interface joint.

[0388] The interface coupling portion 1602 of the headgear assembly 1600 may extend between a pair of adjustment elements 1614, each having a circumferential adjustment portion 1606. In some configurations, the interface coupling portion 1602 may be relatively rigid. In some configurations, the interface coupling portion 1620 is directly coupled to the adjustment elements 1614. As described above, the interface coupling portion 1602 can facilitate the connection of the headgear assembly 1600 to the interface. However, the interface coupling portion 1602 may also accommodate at least a portion of one or more directional locks 1616. In the illustrated configuration, two pairs of directional locks 1616 are provided, with one directional lock 1616 associated with each of the adjustment elements 1614. A portion of the directional lock 1616 (e.g., a housing 1618) may be located in each of the interface coupling portions 1602. In some configurations, a core member 1620 associated with each of the directional locks 1616 is coupled to the rear portion 1604 of the headgear and extends along or through the adjustment element 1614 and through the housing 1618 of the directional lock 1616 into a collection space 1622. The collection space 1622 can be defined by a collection tube or conduit, which may be a separate member from the interface coupling portion 1602 or may be incorporated therein. The housing 1620 of the directional lock 1616 may include one or more members or elements (e.g., lock washers or lock jaws) that interact with the core member 1618 to selectively allow contraction of the headgear assembly 1600 or lock the headgear assembly 1600 at a particular circumference, preventing or inhibiting extension of the headgear by a force less than the yield force provided by the directional lock. Further details of the operation of the directional lock 1616 are described above and in the applicant's patent application PCT / NZ2014 / 000074.

[0389] In the illustrated configuration, the directional locks 1616 on each side of the interface coupling portion 1602 are arranged either stacked vertically or side by side. Although the directional locks 1616 are illustrated as separate units, in some configurations, parts of the directional locks 1616 can be integrated. For example, a single housing may include individual locking elements that interact with separate core members of each adjustment element.

[0390] The interface coupling portion 1602 can be curved, and the collection space 1622 (defined, for example, by a collection tube or channel) can be curved along the interface coupling portion 1620. In the illustrated configuration, the central portion of the interface coupling portion 1602 is located above the ends of the interface coupling portion 1602. Furthermore, when viewed from the front, the sides of the interface coupling portion 1602 curve downward from the central portion. Thus, the interface coupling portion 1602 can interpolate or correspond to the shape of the body or shell portion of the full-face mask interface 1650. The central portion of the interface coupling portion 1602 can be located above the elbow or other conduit connector of the mask 1650. Similarly, the interface coupling portion 1602 can be configured to interpolate or correspond to the shape of the body or shell portion of the nasal mask interface 1660. The central portion of the interface coupling portion 1602 can be located above the 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 of the nasal pillow / prong mask 1670. The central portion of the interface coupling portion 1602 can be located above the 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.

[0391] Figure 60 shows an interface assembly 1680 that is in many respects similar to other interface assemblies disclosed herein, such as the interface assemblies in Figures 37-53 and 57-59. The interface assembly 1680 in Figure 60 comprises a headgear assembly 1600 and an interface in the form of a full-face mask 1650 or a nose mask. The headgear assembly 1600 generally comprises a rear headgear portion 1604, a length or circumference adjustment portion 1606, and an interface coupling portion 1602. Differences between the headgear 1600 in Figure 60 and the interface assemblies in Figures 37-53 and 57-59 are described below. Features or details not described may be the same as or similar to the corresponding features or details of the interface assemblies in Figures 37-53, 57-59, other interface assemblies disclosed herein or in the applicant's application PCT / NZ2014 / 000074, or any other preferred configuration.

[0392] The headgear assembly 1600 in Figure 60 can be described or classified as a two-retaining-face, parallel headgear type. The illustrated rear headgear portion 1604 comprises a top strap 1608, a pair of upper straps 1624, and a pair of lower straps 1626. The rear headgear portion 1604 comprises a vertically extended intermediate rear portion 1628 that extends between and connects 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 the shell portion 1682 of a full-face mask or nose mask. The shell portion 1682 and elbows 1684 or other conduit connectors (collectively referred to as “elbows”) can be fixed directly or indirectly to the support frame 1630 in any preferred configuration. For example, the shell portion 1682 and the elbow 1684 can be coupled separately (directly or indirectly) to the support frame 1630, the shell portion 1682 can be directly coupled to the frame 1630 and the elbow 1684 can be coupled to the shell portion 1682, or the elbow 1684 can be directly coupled to the frame 1630 and the shell portion 1682 can be coupled to the elbow 1684.

[0393] In the illustrated configuration, the interface coupling portion or support frame defines the forehead rest or T-piece 1632. The upper pair of adjustment elements 1614, each having a cylindrical adjustment portion 1606, can be coupled to the T-piece 1632 such that the upper adjustment element 1614 is positioned above the user's eyes and extends above the user's ears. The lower pair of adjustment elements 1614, each having a circumferential adjustment portion 1606, can be coupled (directly or through another member such as a shell) to the lower portion of the support frame 1630 such that the lower adjustment element 1614 is positioned below the user's eyes and ears. The collection space 1622 (defined, for example, by a collection tube or channel) relative to the upper adjustment element 1614 can be curved and extend downward along the T-piece 1632 toward the elbow. The upper directional lock 1616 can be supported by the T-piece 1632. The lower directional lock 1616 can be supported (directly or indirectly) by the lower portion of the support frame 1630.

[0394] The fine-tuning capability provided by the headgear assembly or interface assembly 1680 in Figure 60 is particularly advantageous in T-piece configurations because it allows for quick and easy adjustment of the fit around the bridge of the user's nose, which can be a particularly sensitive area. Each connection between the rear headgear portion 1604 and the interface coupling portion 1602 or interface is shown as an auto-adjusting configuration, although some configurations may utilize a combination of auto-adjusting and manual adjustment configurations. For example, the upper connection (e.g., to the T-piece 1632) can be manually adjustable (e.g., with a hook-and-loop fastening strap), while the lower connection can be automatically adjustable. Such a configuration allows the upper connection to be set and maintained in place throughout multiple fitting cycles, with the lower connection providing all the necessary extension to put on and take off ("doff") the headgear assembly or interface assembly 1600. Such a configuration can, for example, offer some of the benefits of auto-adjustment at a lower price point. Other suitable combinations can also be used, such as manual adjustment at the bottom and automatic adjustment at the top, or manual adjustment on one side and automatic adjustment on the other.

[0395] Figure 61 shows interface assembly 1680, which is in many respects similar to other interface assemblies disclosed herein, such as the interface assemblies in Figures 37-53, 57-59, and 60. Differences between the headgear 1600 in Figure 61 and the interface assemblies in Figures 37-53, 57-59, and 60 are described below. Any features or details not described herein may be the same as or similar to the corresponding features or details of the interface assemblies in Figures 37-53, 57-59, and 60, other interface assemblies disclosed herein or in the applicant's application PCT / NZ2014 / 000074, or any other preferred configuration.

[0396] The interface assembly 1680 in Figure 61 comprises a headgear assembly 1600 and an interface in the form of a full-face mask 1650 or a nose mask. The headgear assembly generally comprises a rear headgear portion 1604, a length or circumference adjustment portion 1606, and an interface coupling portion 1602. However, unlike the interface assembly in Figure 60, the interface assembly 1680 in Figure 61 does not include a forehead rest or T-piece 1632. As a result, each of the upper pair of adjustment elements 1614 connects to the interface coupling portion 1602 or the interface at a lower position relative to the interface assembly 1680 in Figure 60. For example, the upper adjustment elements 1614 can generally pass along the user's cheeks and below the eyes.

[0397] The headgear assembly 1600 in Figure 61 can be described or characterized as a two-retaining-face, separate / angle headgear type. The upper and lower adjustment elements 1614 are positioned spaced apart from each other in the mask 1650 to provide a retaining force to the mask 1650 in a spaced vertical position, thereby providing stability to the mask 1650. The headgear assembly 1600 can be coupled to the mask 1650 by separate interface coupling parts 1602, each of which may be substantially similar to the interface coupling parts 1602 described in relation to Figures 57-60. One interface coupling part 1602 may be located in the lower portion (e.g., lower half) of the mask 1650, and the other interface coupling part 1602 may be located in the upper portion (e.g., upper half) of the mask 1650. The lower interface coupling part 1602 may pass over an elbow or other conduit connector. In some configurations, the upper interface coupling portion 1602 and the lower interface coupling portion 1602 can be coupled to each other or integrated with each other. For example, a bridge portion can extend between and connect the upper interface coupling portion 1602 and the lower interface coupling portion 1602. The bridge portion may be separate from or integrated with one or both of the interface coupling portions.

[0398] Figure 62 shows interface assembly 1680, which is in many respects similar to other interface assemblies disclosed herein, such as the interface assemblies in Figures 37-53, 57-59, 60 and 61. Differences between the headgear 1600 in Figure 62 and the interface assemblies in Figures 37-53, 57-59, 60 and 61 are described below. Features or details not described herein may be the same as or similar to the corresponding features or details of the interface assemblies in Figures 37-53, 57-59, 60 and 61, other interface assemblies disclosed herein or in the applicant's application PCT / NZ2014 / 000074, or any other preferred configuration.

[0399] The interface assembly 1680 in Figure 62 comprises a headgear assembly 1600 and an interface, which is, for example, a full-face mask 1650 or a nose mask. The headgear assembly 1600 generally comprises a rear headgear portion 1604, a length or circumferential adjustment portion 1606, and an interface coupling portion 1602. However, unlike the interface assemblies 1680 in Figures 60 and 61, for example, the interface coupling portion 1602 of the interface assembly 1680 in Figure 62 does not extend between the adjustment elements on opposite sides of the interface assembly 1680 or headgear assembly 1600. Instead, the interface coupling portion 1602 couples the adjustment elements 1614 on the same side of the interface assembly 1680 or headgear assembly 1600. That is, each pair of interface coupling portions 1602 couples the upper adjustment element 1614 and the lower adjustment element 1614 on one side of the interface assembly 1680 or headgear assembly 1600 with each other.

[0400] In the illustrated configuration, the interface coupling portion 1602 is generally a U-shaped member, having an upper end 1634 coupled to an upper adjustment element 1614 and a lower end 1636 coupled to a lower adjustment element 1614. The curved portion of the interface coupling portion 1602 extends between the upper end 1634 and the lower end 1636. Directional locks 1616 for the upper and lower adjustment elements 1614 can be supported by the upper end 1634 and lower end 1636, respectively. The collection space 1622 (defined, for example, by a collection tube or other channel) can curve along the central curved body portion of the interface coupling portion 1602 and may overlap with each other in some configurations.

[0401] In the configuration shown in Figure 62, the headgear assembly 1600 itself may not define the entire closed periphery. Rather, the interface 1650 may form a portion of the closed periphery, and therefore a portion of the circumference or perimeter of the interface assembly 1680. Advantageously, such a configuration allows the interface assembly 1680 to be optionally configured to quickly and easily release the closed periphery in order to put on or take off the interface assembly 1680. That is, one (or both) of the interface coupling portion 1602 may be detachably attached to the interface 1650 (by one or more clips, etc.), thereby allowing one (or both) of the interface coupling portion 1602 to be separated and the closed periphery to be released. In some configurations, an automatic adjustment mechanism may be provided on only one side of the interface assembly. Similarly, other interface assemblies or headgear assemblies disclosed herein or in the applicant's application PCT / NZ2014 / 000074 may be one-sided or asymmetrical configurations in which an automatic adjustment mechanism may be provided on only one side.

[0402] Figures 63–65 show a series of distinct positions or steps for wearing the interface assembly 1680 of Figure 62. Figure 63 shows the user positioning the interface by attaching the interface coupling portion 1602 to one side of the head, looping the interface assembly 1600 around the back of the head, and pulling the separated interface coupling portion 1602 toward the face. In Figure 64, the interface is oriented in the correct position on the face, and the separated interface coupling portion 1602 is oriented toward the interface 1680. Figure 65 shows the interface 1680 in place on the user's face, and the user reconnecting the loosened or separated interface coupling portion 1602 to close the outer loop. Some or all of the movement between Figure 64 and Figure 65 may require overcoming the yield force of the directional lock, as described above. To remove or detach the interface assembly 1680, the procedure can be reversed.

[0403] Figures 66 and 67 show the outer periphery of the auto-adjustable interface assembly or headgear assembly 1700 in a first position (e.g., minimum periphery) and a second position (e.g., maximum periphery), respectively. As described with respect to the interface and headgear assemblies disclosed herein, the outer periphery is defined by a length L defined by the rear portion of the headgear 1704. rear It can include L rear This can be zero. In other words, the fixed-length rear portion 1704 of the headgear can be omitted, and the rear section can be formed by a length-adjustable portion or an elastic component. Furthermore, one or more of the multiple portions of the illustrated outer periphery can be placed in alternative positions or divided into multiple portions.

[0404] The outer periphery is also defined by the circumference or length adjustment portion 1706, which has a length L elasticcan also be included, which, in the illustrated configuration, is defined by a pair of elastic or adjustable elements 1714. However, in other configurations, there are other suitable configurations, particularly, the circumferential or length adjustment portion 706 can be defined by one elastic or adjustable element 1714, or three or more elastic or adjustable elements 1714. As described above, in some configurations, the length L rear of the rear portion 1704 of the headgear that defines can be omitted, and the length adjustment portion 1706 can extend through the entire outer peripheral portion from one end of the interface coupling portion 1702 to the other end of the interface coupling portion 1702. In FIGS. 66 and 67, L elastic for the length, there is a minimum length L min and a maximum length L max with their respective relative position indicators marked.

[0405] The outer peripheral portion can further include the collection portion length L collector which can represent the individual or overall available length of the collection space 1722 that receives the extra portion of the core element of the directional locking mechanism. As described above, the collection space 1722 does not necessarily extend from one adjustable element 1714 to the other adjustable element 1714, thereby defining a physical section of the circumferential length. For example, in the interface assembly 1680 of FIG. 62, the collection space 1622 does not extend between the opposing adjustable elements 1614. Thus, in a physical sense, the interface coupling portion 1602, the interface 1650 or other structures can define a part of the circumferential length. However, in a conceptual sense, the elastic length L elastic (minimum length L min and maximum length L[[ID=1,9]] max ) defines the length adjustable portion of the outer peripheral portion in FIGS. 66 and 67, and the remaining portions (the rear portion length L rear of the headgear and the collection portion length L collector ) are of fixed length.

[0406] In the illustrated configuration, the circumferential length is the rear portion length L rear of the headgear and the collection portion length L collectorAs shown in the diagram, two equal-length adjustment elements 1714 are provided, so L elastic The total elastic length L is twice that of elastic The total elastic length L at any point in time or at any specific position of the interface or headgear assembly 1700 is included in or can be defined by the sum of the following: elastic The maximum length is L max and minimum length L min It is equal to or between . As described herein, the length L of each core member core Preferably, the maximum length L of each adjustment element. max Therefore, the total core member length L is as stated above. core Preferably, the total maximum length L max As described above, this allows the headgear assembly to be stretched to its maximum circumference without completely pulling the core member through the directional locking element. In other words, it is preferable that the directional locking element can engage with a portion of the core member once the headgear assembly has been stretched to its maximum circumference.

[0407] Furthermore, the collection section length L collector It is preferable that the total excess or unused portion of the core member is sufficient to accommodate the maximum and minimum perimeter lengths of the headgear assembly. Therefore, in at least some configurations, the individual or total core length L is sufficient. core is the individual or total maximum length L max Individual or total collection section length L collector The sum of these values ​​is less than or equal to the total core length L. In at least some configurations, the individual or total core length L is less than or equal to the sum of the individual or total core length L. core The individual or total minimum length L max Individual or total collection section length L collector It is less than or equal to the sum of the values. In some configurations, the individual or total maximum length L max is the individual or total maximum length L max Individual or total collection section length L collector Individual or total core length L less than the sum of the values coreThe following applies: The length of the directional locking mechanism is not specifically indicated within the outer circumference, but the length L of the rear part of the headgear is not specified. rear , elastic length L elastic or collection section length L collector It can be considered to form part of any of these. In any case, the length of the directional locking mechanism is the minimum length L of the core. core This can be taken into consideration when determining the answer.

[0408] In at least some configurations, the individual or total core length L core The individual or total elastic length L elastic and collection section length L collector The sum of these may be greater. In at least some configurations, the individual or total core length L core is the individual or total maximum length L max and the length of the rear part of the headgear L rear It may be between, or the individual or total maximum length L max and the length L of the rear part of the headgear rear It may be equal to either one of the following.

[0409] The peripheries in Figures 66 and 67 can represent the actual periphery of an interface assembly or headgear assembly. That is, the peripheries in Figures 66 and 67 can represent the physical structure of a single-retaining-face interface or headgear assembly, or the physical structure of one retaining face in a multi-retaining-face interface or headgear assembly. However, as described, the peripheries in Figures 66 and 67 can represent other interface or headgear types in a conceptual sense. The illustrated peripheries can represent, for example and without limitation, a single retaining face (e.g., an upper or lower retaining face) of a multi-retaining-face headgear type, or the average of two or more retaining faces of a multi-retaining-face headgear type.

[0410] Figures 68A to 68D show an embodiment of a directional lock comprising a housing 1810, a first locking element and a second locking element (e.g., washers 1820 and 1822), and a core member 1830. The housing comprises a first chamber 1840 and a second chamber 1842, which are configured to accommodate a first locking washer 1820 and a second locking washer 1822, respectively. In the illustrated configuration, the first chamber 1840 and the second chamber 1842 are separated by the inner wall 1812 of the housing 1810. However, in other configurations, the first chamber 1840 and the second chamber 1842 may not necessarily be physically separate spaces but may be part of a single chamber. The housing 1810 has two end walls 1814, which, together with the inner wall 1812, have elongated core openings 1860 through which the core member 1830 passes. 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 inner wall 1812 and the end wall 1814 shown on the left side of the figure. This allows the path of the core member 1830 to be manipulated through the housing 1810. The first chamber 1840 and the second chamber 1842 are each bounded by the inner wall 1812, one of the end walls 1814, and a pair of side walls 1816, the side walls 1816 extending between the end walls 1814 of the housing 1810. The first chamber 1840 and the second chamber 1842 are configured to be open at one or both of the top and bottom of the housing 1810.

[0411] Each of the first chamber 1840 and the second chamber 1842 has a pair of washer retainers 1850 that are aligned with the opposing side walls 1816 of the housing 1810. Each pair of washer retainers 1850 is configured to pivotably hold either a first lock washer 1820 or a second lock washer 1822 within the respective first chamber 1840 or second chamber 1842. The washer retainer comprises a circular bush 1852 and an elongated slot 1854, the circular bush 1852 intersecting the bottom of the housing to form an entrance. The entrance is configured to allow the first lock washer 1820 and / or the second lock washer 1822 to be received into the washer retainer 1850. The slot 1854 extends radially from the circular bush 1852 toward the top of the housing 1810.

[0412] The first washer 1820 and the second washer 1822 each comprise a cylindrical shaft 1824 and an arm 1826 extending from the shaft 1824. The cylindrical shaft 1824 has substantially the same width W as the housing 1810, and the arm 1826 tapers to fit within the first chamber 1840 and the second chamber 1842. In the illustrated configuration, the arm 1826 comprises a first section 1872 and a second section 1874, the first section 1872 extending radially or perpendicularly from the cylindrical shaft 1824, and the second section 1874 extending obtusely from the end of the first section 1872. The first section 1872 of the arm 1826 of the first washer 1820 is shorter than the first section 1872 of the arm 1826 of the second washer 1822. The angle between the first section 1872 and the second section 1874 of the arm 1826 of the first washer 1820 is greater than the corresponding angle of the second washer 1822. The angles can be selected such that the second sections 1874 of one or both of the first washer 1820 and the second washer 1822 are substantially flat with respect to the corresponding walls of the housing 1810 (e.g., the inner wall 1812 and the end wall 1814, respectively) at one position of the washers 1820 and 1822. The second section 1874 of the arm 1826 includes a centrally located circular aperture 1876 configured to receive the core member 1830. The first chamber 1840 and the second chamber 1842 differ in size according to the size of the washers to be housed inside, i.e., the first washer 1820 is smaller than the second washer 1822, and therefore the first chamber 1840 is smaller than the second chamber 1842.

[0413] The cylindrical shafts 1824 of the first lock washer 1820 and the second lock washer 1822 have substantially the same diameter as the circular bush 1852 of the washer retainer 1850 and are configured to be received and held by the circular bush 1852 in a snap-fit ​​configuration. The snap-fit ​​configuration is provided by the fact that the entrance of the circular bush 1852 is narrower than the diameter of the cylindrical shaft 1824. The slot 1854 of the washer retainer 1850 is configured to flex so that the entrance is open, making it easier for the first lock washer 1820 and the second lock washer 1822 to be pushed through the entrance and assembled with the housing 1810. When assembled within the first chamber 1840 and the second chamber 1842 of the housing 1810, the first washer 1820 and the second washer 1822 can pivot back and forth about a central axis extending through the cylindrical shaft 1824.

[0414] The core member 1830 is configured to pass through the core opening 1860 of the housing 1810 and the aperture 1876 of the first washer 1820 and the second washer 1822. By applying tension to the core member 1830, the first lock washer 1820 and the second lock washer 1822 pivot backward and / or forward between the locked position and / or the open position. Figures 68A and 68B show a directional lock in a locked configuration where a force is applied to the core member 1830 in the direction toward the left of the figure (as indicated by the arrows). In this configuration, the force applied to the core member 1830 causes the first lock washer 1820 and the second lock washer 1822 to pivot counterclockwise, thereby making the passage of the core member 1830 through the directional lock 1800 nonlinear or winding, and restricting the movement of the core member 1830. Figures 68C and 68D show a directional lock in an open configuration in which force is applied to the core member 1830 in the direction toward the right in the figure (as indicated by the arrows). In this configuration, the first lock washer 1820 and the second lock washer 1822 pivot clockwise, thereby aligning the circular aperture 1876 and the core opening 1860 substantially in a straight line. This provides a smooth passage through which the core member 1830 is pulled substantially freely through the directional lock 1800. Further details of the operation of the directional lock 1800 are described above and in the applicant's application PCT / NZ2014 / 000074.

[0415] Figures 69A and 69B show exemplary, non-limiting embodiments of the housing 1810 and the first lock washer 1820 and the second lock washer 1822. The first lock washer 1820 and the second lock washer 1822 are configured to be molded as a single component, connected by a runner and gate system 1900, as is known in the art. The runner and gate system is configured to be used as an assembly aid for the first lock washer 1820 and the second lock washer 1822, in which a person or machine can grasp the runner and gate system 1900 to align the first washer 1820 and the second washer 1822 with the washer retainer 1850 of the housing 1810. Force can be applied to the lock washers 1820 and 1822 through the gate and runner system 1900 (as indicated by the arrows) to bring about relative movement between the housing 1810 and the lock washers 1820 and 1822. This relative movement can be used to engage the first lock washer 1820 and the second lock washer 1822 with the housing 1810, thereby snapping the cylindrical shafts 1824 of the lock washers 1820 and 1822 into the circular bushings 1852 of the washer retainer 1850.

[0416] As shown in Figure 69B, once the first lock washer 1820 and the second lock washer 1822 are assembled within the housing 1810, the gate and runner system 1900 can be separated or detached from the lock washers 1820 and 1822. The gate and runner system 1900 can be removed from the lock washers 1820 and 1822 by applying force (indicated by the arrow) to the gate and runner system 1900 in a direction substantially perpendicular to the direction in which the assembly force is applied (arrow in Figure 69). When the gate and runner system 1900 is removed, the lock washers 1820 and 1822 remain assembled with the housing 1810. The gate 1910 of the gate and runner system 1900 can be designed to have a weak point that fractures as close as possible to the cylindrical shaft 1824 of the lock washers 1820, 1822, thereby not limiting the pivot range of the lock washers 1820, 1822 by excess gate material.

[0417] Figures 70A and 70B show an embodiment in which multiple sets of first lock washers 1820 and second lock washers 1822 are molded on a single gate and runner system 1900. This configuration allows multiple directional locks 1820, 1822 to be assembled one at a time or sequentially, thus improving manufacturing efficiency. To assemble the sets of lock washers 1820, 1822 to the housing 1810, a person or machine can grasp the runner and gate system 1900 to align the first washers 1820 and second washers 1822 with their respective washer retainers 1850 in the housing 1810. By applying force through the gate and runner system 1900 (as indicated by the arrows), the pair of first lock washers 1820 and 1822 can be engaged with the housing 1810, thereby causing the cylindrical shafts 1824 of the lock washers 1820 and 1822 to snap into the circular bushings 1852 of the washer retainer 1850.

[0418] Figure 71 shows an exemplary, non-limiting configuration for assembling first lock washers 1820 and second lock washers 1822 into the housing 1810 of a directional lock 1800. This configuration includes a grip portion or element, such as a grip tab 1930, used to align the lock washers 1820, 1822 and apply assembly force to them. The grip tab 1930 is formed between the lock washers 1820, 1822 and the gate and runner system 1900 and may have a shape specifically configured for easy gripping by a person or machine. In some configurations, the gate and runner system 1900 is configured to be removed from the grip tab 1930 during the molding process. In a variation of this configuration (not shown), multiple pairs of first lock washers 1820 and second lock washers 1822 can be connected by a single grip tab 1930, and the single grip tab 1930 is used to assemble the directional lock in a single action.

[0419] Figure 72 shows an exemplary, non-limiting embodiment of the directional lock. In this embodiment, the washer retainers 1850 are positioned in an opposing arrangement, where the first washer retainer 1850 extends downward from the top of the housing and the second washer retainer 1850 extends upward from the bottom of the housing. The first lock washer 1820 and the second lock washer 1822 are assembled to the housing 1810 in opposite directions. For example, grip tabs 1930 or gate and runner systems 1900, as described in relation to the embodiments in Figures 69a to 71, can be used to assist in the assembly of the lock washers 1820 and 1822 to the housing 1810.

[0420] Figures 73–80 show interfaces with a headgear device configured to allow the interface to be worn and removed like a baseball cap. Preferably, the headgear device does not include straps that pass below the user's ears. Thus, interfaces with such a headgear device can be attached or worn by passing the interface over the user's head from above. The headgear device can be positioned behind the user's head, and then the interface mechanism can be rotated downwards to position the interface on the user's face, or vice versa. The headgear device may include a portion in front of the user's ears that can provide mounting positions for directional or indirect connection to the interface. In some configurations, the rear portion of the headgear device is relatively rigid (e.g., to maintain an open shape when resting on the user) and / or relatively non-stretchable.

[0421] Figure 73 shows an alternative configuration for the headgear system 2000 configured for use with a full-face mask 2100 without a forehead support. However, the headgear system 2000 or any part thereof may also be used in combination with other types of interfaces, including an interface having a forehead support, if desired. The full-face mask 2100 is configured to seal around the user's nose and mouth and to make contact with the bridge of the nose, cheeks, and lower lip or chin area. The headgear system 2000 comprises a rear headgear portion 2010, an upper retaining surface 2020, and a lower retaining surface 2030.

[0422] Preferably, the rear portion 2010 of the headgear engages with the user's head and provides a relatively stable platform for interface connection, such as by utilizing the interface coupling portion 2040 and the circumferential adjustment portion (e.g., the directional lock module 2060). Thus, in at least some configurations, the rear portion 2010 of the headgear is substantially inelastic, thereby maintaining its shape and effective length in response to forces applied within a range typical or predictable for the intended use. In some configurations, the rear portion 2010 of the headgear may comprise a layer made of a relatively rigid material, such as a plastic material, bonded to one or more layers of fabric material. Preferably, the fabric layer is provided on at least the side of the rigid material layer that is in contact with the user. In some configurations, the fabric layer is provided on each side of the rigid material layer. Furthermore, in some configurations, a rigid material layer can be formed between material layers, such as by injection molding the rigid material in the space between two material layers in a mold. Examples of such headgear and methods for manufacturing such headgear are disclosed in the applicant's U.S. Provisional Patent Application No. 62 / 050,925, which is incorporated herein by reference in its entirety.

[0423] The rear portion of the headgear 2010 includes an arm 2012 extending in front of the user's ears. The arm 2012 includes a plurality of vertically spaced connectors 2014 configured to provide a series of locations to which one or more directional lock modules 2060 can be connected. Full-face masks are generally larger and heavier than the direct nasal masks of previous embodiments. As a result, full-face masks may require two or more retaining surfaces to provide the desired or required level of stability to achieve a substantial airtight seal with the user's face.

[0424] The two retaining surfaces 2020 and 2030 converge toward a single point on the side or possibly the front of the full-face mask 2100, and they may or may not intersect. The retaining surfaces 2020 and 2030 can be positioned perpendicular to each other and spaced apart, thereby being spaced further apart where they connect to the headgear than where they contact the mask. This provides some stability to the interface. For example, the upper retaining surface 2020 may pass from the top of the user's ears, below or above the nose, and the lower retaining surface 2030 may pass from the bottom of the user's ears, near or below the mouth.

[0425] Each of the two retaining surfaces 2020, 2030 can be provided by two directional lock modules 2060, with one directional lock module 2060 located on each side of the headgear system 2000. Each directional lock module 2060 comprises a directional lock 2062 and an elastic portion 2064, the elastic portion 2064 having one end connected to the directional lock 2062 and the other end connected to one of several connectors 2014. The angles of the retaining surfaces 2020, 2030 can be adjusted by connecting the ends of the elastic portion 2064 to different connectors 2014 on the headgear arm 2012. The illustrated full-face mask 2100 does not include a forehead rest or "T-piece". However, in some configurations, a T-piece may be provided. If desired, additional headgear elements or straps can connect the rear portion of the headgear to the T-piece of the mask.

[0426] Figure 74 shows a headgear system device 2000 comprising a rear headgear portion 2010 and two retaining surfaces 2020, 2030 configured to secure a full-face mask 2100 to the user's face. In this configuration, the full-face mask 2100 is configured to seal below the user's nose and around the user's mouth, thereby preventing the mask 2100 from contacting the bridge of the nose. Due to the different sealing locations compared to the previous embodiment, the angles of the retaining surfaces 2020, 2030 need to be different, or at least desirable, to apply force to the mask in the optimal or desired direction. In Figure 74, the two retaining surfaces 2020, 2030 are shown to be vertically spaced apart and attached to the arm 2012 of the rear headgear portion 2010, thereby showing an upper retaining surface 2020 and a lower retaining surface 2030 that are substantially parallel to each other. The upper retaining surface 2020 is more horizontal than the upper retaining surface 2020 of the previous embodiment and is positioned lower on the user's face. The angles of the retaining surfaces 2020 and 2030 may be adjustable via multiple connectors 2014, as shown in the embodiment in Figure 73.

[0427] Each of the retaining surfaces 2020 and 2030 is shown to include a directional lock module 2060, which further comprises an elastic portion 2064 and a directional lock 2062. In a variation of this configuration, each directional lock module 2060 may include two or more directional locks 2062.

[0428] Figure 75 shows the headgear system 2000 of Figure 73 combined with a nasal mask 2110. The nasal mask 2110 is configured to seal around the user's nose and make contact with the bridge of the nose, cheeks, and upper lip. Two retaining surfaces 2020, 2030 are desirable or in some cases necessary to provide adequate stability to the mask 2110 when it is fitted to the user's face.

[0429] Figure 76 shows an exemplary, non-limiting embodiment of a headgear system 2000 comprising a rear headgear portion 2010 and two retaining surfaces 2020, 2030 configured to secure a nasal mask 2110 to the user's face. The rear headgear portion 2010 comprises a molded plastic structure 2016 with an integrally formed cloth cover having arms that extend downward in front of the user's ears. The upper retaining surface 2020 and the lower retaining surface 2030 are provided by directional locking modules 2060 at each side of the headgear. The upper retaining surface 2020 extends from the top of the arms 2012 to a location just above the tip of the user's nose. The lower retaining surface 2030 extends from the bottom of the arms 2012 to a location approximately below the user's nose. In the illustrated configuration, the directional lock module 2060 comprises a braided elastic portion, a core filament (not shown), and a directional lock, the braided elastic portion and the core filament being permanently bonded to the headgear arm 2012 and the directional lock 2060 by an overmolded connector. The angles of the retaining surfaces 2020 and 2030 are fixed by the overmolded connector 2016.

[0430] Figures 77–79 show illustrations of the headgear system 2200 according to the subject disclosed herein. The headgear system 2200 is a closed loop and comprises a headgear 2210, two upper directional locking modules 2220, two lower directional locking modules 2230, and a housing 2240. The rear portion of the headgear 2250 comprises 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 when in use.

[0431] The upper directional lock module 2220 and the lower directional lock module 2230 each comprise an elastic portion 2222, a core filament (not shown), and a directional lock 2224. The core filament is configured to extend partially or entirely through the length of the elastic portion 2222 and through the directional lock 2224. The directional lock 2224 is configured to interact with the core filament to automatically adjust the length of the directional lock modules 2220 and 2230. The core filament and the elastic portion 2222 are permanently bonded to the arm 2252 of the headgear 2210 by an overmolded connector 2260, with the upper directional lock module 2220 bonded to the upper region of the arm 2252 and the lower directional lock module 2230 bonded to the lower region of the arm 2252. The elastic portion 2222 is permanently bonded to the directional locks 2220 and 2230 by the overmolded connector 2260. The directional locks 2220 and 2230 are housed within the housing 2240. Two upper directional lock modules 2220 form the upper retaining surface, and two lower directional lock modules 2230 form the lower retaining surface, which are substantially the same as those in Figure 76.

[0432] The housing 2240 comprises a substantially rigid body having four directional lock brackets 2242, an upper conduit 2244, a lower conduit 2246, and a central opening 2248 formed between them. Two directional lock brackets 2242 are positioned vertically at each of the side ends of the housing 2240. The directional lock brackets 2242 are configured to hold directional locks 2224. The upper conduit 2244 extends laterally between the two upper lock brackets 2242, and the lower conduit 2246 extends laterally between the lower lock brackets 2242. The upper conduits 2244 and the lower conduits 2246 are configured to accommodate the free ends of the core filaments. The central opening 2248 formed between the upper conduits 2244 and the lower conduits 2246 is configured to receive a nasal mask device.

[0433] Figure 80 shows the headgear assembly of Figure 79 together with a nasal mask device 2270 configured to be assembled therewith. The nasal mask device 2270 comprises a frame assembly 2280 and a cushion module 2290. The frame assembly 2280 includes a frame 2282, an elbow 2284, and a tube connector 2286. The frame 2282 and the elbow 2284 are configured to be joined to each other by a ball-socket connection, with the frame 2282 including a socket 2410 and the elbow 2284 including a ball 2400. The frame 2282 comprises nylon components with a shape that provides a repeatedly removable snap-fit ​​connection to the housing 2240 of the headgear system 2200. In some configurations, the elbow is made from a different material than the frame 2282, such as polycarbonate, so that the two parts do not stick together when assembled. This can increase the degree of freedom that the elbow can move relative to the frame 2282, which can reduce hose drag. It is conceivable that other combinations of materials could also be used.

[0434] The tube connector 2286 connects in a snap-fit ​​configuration to the end of the elbow 2284 opposite to the end that connects to the frame 2282. The tube connector 2286 can pivot or rotate around the end of the elbow 2284. In some embodiments, the tube connector 2286 can be made from 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 that provides pressurized air supply.

[0435] The cushion module 2290 includes a sealing cushion 2292 integrally formed with the connector portion 2294 by means of, but not limited to, overmolding. The sealing cushion 2292 includes a high-compliance interface made from, but not limited to, a flexible elastic material such as silicone or a thermoplastic elastomer. It is configured to form a substantially airtight breathing chamber that seals around the user's nose. The connector portion 2294 is made from, but not limited to, a substantially rigid material such as polycarbonate and includes a circular opening 2296 facing the sealing cushion 2292. It 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 to each other so that an air passage is formed within the cushion module 2290 through the tube connector 2286 and the elbow 2284, as shown in Figure 81.

[0436] Figures 82 and 83 show how the frame assembly 2280 connects to the housing 2240 of the headgear system 2200. The elbow 2284 and tube connector 2286 are configured to pass through the central opening of the housing 2240 to connect the frame 2282 to the rear surface 2310 of the housing 2240. A portion of the frame 2282 extends through the central opening 2248 of the housing 2240 and is substantially coplanar with the front surface 2300 of the housing 2240.

[0437] Figures 83 and 84 show the rear surface 2320 of frame 2282. It can be seen that the rear surface 2320 of frame 2282 has a plurality of projections that form a circular inner cuff 2420 around the outer periphery of the socket of the ball 2400 and socket 2410 connection. The inner cuff 2420 has a plurality of cutouts 2430 that provide flexibility. A concave channel 2450 extends around the outer periphery of the inner cuff 2420. The concave channel 2450 holds the circular opening 2296 of the cushion module 2290 in a snap-fit ​​configuration. There is one or more (e.g., a pair) keying mechanisms 2440 located on the lower outer periphery of the concave channel 2450. The keying mechanisms 2440 are configured to interact with the corresponding mechanism on the connector portion 2294 of the cushion module 2290, thereby preventing rotation of the cushion module 2290.

[0438] The advantage of the headgear adjustment system disclosed in the embodiments described above is that it provides a quiet adjustment method. In the art, hook-and-loop fastening systems (such as Velcro) are commonly used to enable size adjustment for headgear systems for breathing masks. When adjustment of the tightness of the headgear system is required, the hook-and-loop fastener components must be separated from each other. Separation of the hook-and-loop fastener components usually produces a tearing sound, which can be unpleasant for the mask user and, depending on the environment, may disturb the user's bedmate. The headgear system of the disclosure is less likely to require the user to make manual adjustments to improve size and fit, and any necessary adjustments do not generate noise, or at least not at a significant level of noise, thus improving ease of use and comfort for the user and the user's bedmate.

[0439] Headgear Test Figure 85 shows a test setup for verifying the functionality of a headgear device 2500 including at least one directional lock module 2510. The headgear device 2500 being tested in Figure 85 comprises a headgear 2502 and a mask frame 2504 connected to each other by a pair of lateral directional lock modules 2510. The frame 2504 is configured to receive a nose pillow seal. The ends of the directional lock modules 2510 connected to the headgear 2500 are held within a test fixture 2520 that secures the headgear device 2500 to the movable crosshead 2530 of the general-purpose testing machine. The mask frame 2504 is secured to the fixed crosshead 2540 of the general-purpose testing machine. The general-purpose testing machine can perform tests that simulate mask wearing and fitting in several stages. It should be understood that this test setup can be modified to test headgear devices configured for use with different mask types, such as full-face masks and nose masks.

[0440] The first stage of the test simulates the wearing of the mask and headgear device. A movable crosshead is programmed to pull the headgear away from the frame and extend the directional lock module until the headgear device is near its maximum circumference. The second stage of the test simulates the attachment of the mask and headgear device to the user's head. A general-purpose test machine is programmed to pull the headgear back towards the mask frame to a distance where the circumference of the headgear device is approximately half the distance between its maximum and minimum circumferences. This simulates the point at which the circumference of the headgear device coincides with the circumference of the user's head. The third step of the test involves extending the headgear device back to its maximum circumference, which simulates the application of CPAP pressure and the use of the mask system. Force profiles are recorded throughout all three test stages.

[0441] During the first phase of the test, the force-extension plot is expected to show an initial steep increase in force as the directional locking mechanism engages during the extension of the headgear device. If the plot does not show this, there may be some slack in the headgear and fixture that needs to be removed before the directional locking mechanism engages. Following this steep increase in force, the transition point reaches or near a predetermined yield force. Once the yield force is reached, the rate of force increase decreases and remains substantially constant until the maximum headgear circumference is reached.

[0442] The second stage of the test is expected to show the instantaneous release of the directional locking mechanism in the force-extension plot. The initial sharp drop in force indicates the instantaneous release of the washer (or other suitable locking mechanism) when the extension force is released from the headgear device. The elastic component of the directional locking module drives the return force. In this particular case, four strands of Lycra in a braided sleeve. The return force can be controlled by the choice of material for the elastic component and its manufacturing method. The return force should be less than the expected blow force that will vary depending on the type of mask (i.e., full-face mask, nose mask, or nose pillow, etc.).

[0443] The third stage simulates use, where the headgear is contracted to the head circumference of a hypothetical user. By applying CPAP pressure (blow force) to the mask, the force-stretch plot should show a steep increase in force at substantially the same rate as the initial stretch force before reaching the yield force. Applying CPAP pressure should activate a washer (or other locking mechanism), showing a sharp increase in force for short stretches. The equilibrium fit of the mask and headgear device should fall somewhere along this force-stretch curve, determined by the applied CPAP pressure. As the stretch of the...

Claims

1. A headgear assembly for a breathing interface, Plastic core and Textile casing and, Equipped with, A headgear assembly in which the plastic core and the textile casing are formed as a single unit by adding molten plastic material into the textile casing.

2. The headgear assembly according to claim 1, wherein the textile casing comprises a first portion that covers the surface facing the inside of the headgear.

3. The headgear assembly according to claim 2, wherein the textile casing comprises a second portion that covers the surface facing the outside of the headgear.

4. The headgear assembly according to claim 3, wherein the first portion and the second portion of the textile casing are in contact at the first edge and the second edge.

5. The headgear assembly according to claim 4, wherein the first portion and the second portion are not connected to each other at the first edge and the second edge.

6. The headgear assembly according to any one of claims 1 to 5, wherein the textile casing comprises one or more retainer holes configured to engage with retaining pins of a mold.

7. The headgear assembly according to any one of claims 1 to 6, further comprising at least one flexible joint that allows the headgear to bend and / or fold.

8. The headgear assembly according to claim 7, wherein the at least one flexible joint includes a gap between a plurality of portions of the plastic core, and the textile casing extends into the gap to connect the portions of the plastic core.

9. The headgear assembly according to claim 8, further comprising at least one bridge portion extending within the flexible joint between the portions of the plastic core.

10. The headgear assembly according to claim 9, wherein the at least one bridge portion is integrally formed with the portion of the plastic core.

11. A headgear assembly that supports a breathing interface on the user, The substantially inelastic rear portion, The substantially inelastic forward portion, The first elastic lateral portion of the first side of the headgear assembly, The second elastic lateral portion of the second side of the headgear assembly, At least one filament extending through or along the first elastic lateral portion and the second elastic lateral portion, wherein at least one filament is coupled to one of the inelastic rear portion and the inelastic front portion, At least one limiting mechanism, Equipped with, A headgear assembly in which the at least one filament passes through the at least one limiting mechanism, and the at least one limiting mechanism is configured to selectively engage with the at least one filament to resist the movement of the at least one filament relative to the at least one limiting mechanism.

12. The headgear assembly according to claim 11, wherein the at least one limiting mechanism is configured to provide a first resistance force to the movement or attempt to move 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.

13. The headgear assembly according to claim 12, wherein the at least one limiting mechanism is configured to provide a second resistance force to the movement or attempt to move 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 force being less than the first resistance force.

14. The headgear assembly according to any one of claims 11 to 13, wherein the inelastic front portion is rigid.

15. The headgear assembly according to claim 14, wherein the inelastic front portion is configured to be connected to a breathing interface.

16. The headgear assembly according to claim 14 or 15, wherein the inelastic forward portion defines at least one collection passage for accommodating a portion of the at least one filament.

17. The headgear assembly according to any one of claims 11 to 16, wherein the first elastic lateral portion and the second elastic lateral portion each comprise an end cap having an opening through which at least one filament passes.

18. The headgear assembly according to claim 17, wherein the end cap is overmolded onto the first elastic lateral portion and the second elastic lateral portion, respectively.

19. The headgear assembly according to claim 17 or 18, wherein the end cap is coupled to the inelastic front portion.

20. The headgear assembly according to any one of claims 11 to 19, wherein the inelastic rear portion, the inelastic front portion, the first elastic lateral portion, and the second elastic lateral portion define a closed loop outer circumference.

21. A headgear assembly that supports a breathing interface on the user, A rear headgear portion configured to contact the rear and / or upper portion of the user's head, comprising a plastic core and a textile casing, wherein the plastic core and the textile casing are formed as a single unit by adding molten plastic material to the textile casing, and each side of the rear headgear portion is provided with mounting portions configured to be positioned in front of the user's ears when in use; Interface connection mechanisms provided on the mounting portion of each side of the headgear assembly, each configured to be directly or indirectly connected to the respiratory interface, At least one length adjustment mechanism, each comprising an elastic element, a core member, and a limiting mechanism, wherein the core member is associated with the elastic element and fixed to one end of the elastic element, the core member passes through the limiting mechanism, and the limiting mechanism is configured to selectively engage with the core member to resist movement of the core member relative to the limiting mechanism. An interface connection mechanism comprising, A headgear assembly equipped with the following features.

22. The headgear assembly according to claim 21, wherein the rear headgear portion does not have a structure that passes under the user's ears and prevents the rear headgear portion from being removed in an upward direction.

23. The headgear assembly according to claim 21 or 22, wherein each of the interface connection mechanisms comprises at least a first length adjustment mechanism and a second length adjustment mechanism.

24. The headgear assembly according to claim 23, wherein the position of at least one of the first length adjustment mechanism and the second length adjustment mechanism in the mounting portion is adjustable.

25. The headgear assembly according to claim 24, wherein each of the mounting portions is provided with a plurality of mounting positions for the first length adjustment mechanism and the second length adjustment mechanism, and the mounting positions are integrally formed with the plastic core.

26. The headgear assembly according to any one of claims 21 to 25, further comprising at least one connector configured to connect the interface connection mechanism to the respiratory interface.

27. The headgear assembly according to claim 26, wherein the at least one connector comprises at least one collection passage configured to receive a portion of the core member.

28. The headgear assembly according to any one of claims 21 to 26, wherein the limiting mechanism is located in the rear headgear portion.

29. The headgear assembly according to claim 28, wherein the rear headgear portion defines at least one collection passage configured to receive a portion of the core member.

30. The headgear assembly according to claim 29, wherein the at least one collection passage is defined by the plastic core or between the plastic core and the textile casing.

31. The headgear assembly according to claim 28, wherein the limiting mechanism is located away from the end of the elastic element.

32. The headgear assembly according to claim 31, further comprising a guide for the portion of the core member between the end of the elastic element and the limiting mechanism.

33. The headgear assembly according to any one of claims 21 to 32, wherein the elastic element comprises an inelastic portion that limits the elastic element to a maximum length.

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