Headgear assemblies and interface assemblies with headgear

Abstract

To provide a headgear system and / or an interface assembly incorporating a headgear system that is configured to transform from elasticated or "stretchy" behavior to "inelastic" behavior.SOLUTION: There is provided a headgear system and / or an interface assembly incorporating the headgear system. In some configurations, upon fitment to the head of a user, the system automatically adjusts toward or to an appropriate size. A headgear portion or assembly 1500 for use in combination with a breathing apparatus in some configurations is at least substantially inelastic and is three dimensional in shape. The headgear portion or assembly can comprise a plastic core and a textile casing. The headgear, or part thereof, may also have integrally molded labels, connectors, adjustment mechanisms and / or grips.SELECTED DRAWING: Figure 37

Description

[Technical Field]

[0001] Incorporation by reference of any priority application Any and all applications to which foreign or domestic priority is claimed in connection with this application are incorporated herein by reference and made part of this disclosure. [Background technology]

[0002] The present disclosure relates to headgear and interface assemblies used in respiratory therapy. More particularly, the present disclosure relates to substantially inelastic three-dimensional headgear, portions thereof, and processes for molding such headgear. Further applications of the molding process are also disclosed.

[0003] Treatment of respiratory diseases or conditions with therapies such as NIV, Bi-level, or CPAP requires the delivery of pressurized air to a person's airways via a conduit and breathing apparatus (e.g., a 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 does provide a delivery pathway for the delivery of supplemental breathing gas.

[0004] As a result of providing this "seal," the enclosed area of ​​the respirator, in combination with its internal pressure, creates a resulting force that tends to push the respirator away from the face. To counter this force, headgear is typically used, which includes a series of straps that pass around the back and / or top of the user's head. Such headgear is typically called a Breath-o-Prene TM The headgear is made from highly compliant materials such as nylon, nylon 6, nylon 7, nylon 8, nylon 9, nylon 10, nylon 11, and nylon 12. The use of such materials results in the headgear having a relatively small structure when not being worn. This lack of structure can lead to tangling of the headgear straps, which can make it difficult for a user to don the headgear and breathing apparatus.

[0005] The straps require some form of adjustment to account for variations in head size, and this adjustment mechanism is typically provided via adjustment loops between the mask body and the headgear. The adjustment loops can have hook-and-loop or similar fasteners that allow the ends of the straps to be threaded through attachment points on the mask or through clips attached to the mask and then attached to another portion of the strap. This configuration allows the headgear to be adjusted by positioning the ends of the straps at the desired locations on the other portion of the strap to change the size of the adjustment loop. Summary of the Invention [Problem to be solved by the invention]

[0006] This type of mechanism is one solution to providing an adjustment mechanism for the headgear, and thus the interface assembly. Such systems also require a moderate level of user interaction, and as a result are prone to being misused or incorrectly adjusted (e.g., over-tightened). In practice, fine tuning of such systems is difficult and time-consuming to achieve. Providing practical and less practical solutions to this has been the subject of considerable development effort from numerous organizations, resulting in numerous patents.

[0007] Furthermore, these conventional headgear are typically configured to have some elasticity, which can cause the headgear to stretch over the user's head and apply a clamping force to the user's head, which can be uncomfortable. It is desirable to create headgear and breathing apparatus that are easy to use and comfortable to wear, as this can improve user compliance with the treatment being provided. [Means for solving the problem]

[0008] The systems, methods, and apparatus described herein have innovative aspects, none of which is essential or solely responsible for their desirable attributes. Without limiting the scope of the claims, some of the advantageous features will now be outlined.

[0009] A headgear system and / or interface assembly incorporating a headgear system that automatically adjusts to the correct size when attached to a user's head and that changes characteristics from elasticated "stretchable" straps / straps to "non-elastic" straps / straps as they are used.

[0010] In some configurations, a headgear assembly supporting a respiratory interface on a user includes a rear headgear portion configured to contact a rear and / or upper 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 a unitary structure by adding molten plastic material within the textile casing. Each side of the rear headgear portion includes an attachment portion configured to be positioned in front of the user's ears in use. An interface connection mechanism is provided on the attachment portion of each side of the headgear assembly. Each interface connection mechanism is configured to be directly or indirectly coupled to the respiratory 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 fixed to one end of the elastic element. The core member passes through the limiting mechanism. The limiting mechanism is configured to selectively engage the core member to resist movement of the core member relative to the limiting mechanism.

[0011] In some configurations, the rear headgear portion does not have structure that passes under the user's ears to prevent upward removal of the rear headgear portion.

[0012] In some configurations, each of the interface connection mechanisms includes 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 on the mounting portion is adjustable.

[0014] In some configurations, each of the mounting portions includes a plurality of mounting locations for the first and second length adjustment mechanisms, the mounting locations being integrally formed with the plastic core.

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

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

[0017] In some configurations, the restraining mechanism is located in 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, the 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 limiting mechanism is located away from the end of the resilient element.

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

[0022] In some configurations, the elastic element comprises a non-elastic portion that limits the elastic element to a maximum length.

[0023] In some configurations, a headgear assembly supporting a respiratory interface on a user includes a rear headgear portion configured to contact a rear and / or upper portion of the user's head. The rear headgear portion includes a plastic core and a textile casing. The plastic core and textile casing are formed as a unitary structure by adding molten plastic material within the textile casing. An interface connection mechanism is provided on each side of the headgear assembly. Each interface connection mechanism is configured to couple directly or indirectly to the respiratory 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 relative to one end of the elastic element. The core member passes through the limiting mechanism. The limiting mechanism is configured to selectively engage the core member to resist movement of the core member relative to the limiting mechanism. The at least one limiting mechanism is located on the rear headgear portion.

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

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

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

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

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

[0029] In some configurations, the elastic element comprises a non-elastic portion that limits the elastic element to a maximum length.

[0030] A headgear system and / or interface assembly incorporating a headgear system that automatically adjusts to the correct size when attached to a user's head and that changes characteristics from elastic "stretchable" straps / straps to "non-elastic" straps / straps as they are used.

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

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

[0033] In some configurations, the at least one limiting mechanism is configured to provide a second resistance force against movement or attempted movement of the at least one filament in a direction that allows the inelastic rear portion and the inelastic front portion to move away from one another, the second resistance force being less than the first resistance force.

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

[0035] In some configurations, the inelastic forward portion is configured to be connected to a respiratory interface.

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

[0037] In some configurations, the first and second elastic side portions include end caps having an opening through which at least one filament passes. The end caps can be overmolded onto the first and second elastic side portions, respectively. The end caps can be bonded to the inelastic front portion.

[0038] In some configurations, the inelastic rear portion, the inelastic front portion, the first elastic side portion and the second elastic side portion define a closed loop perimeter.

[0039] In some configurations, the at least one filament comprises a first filament associated with the first elastic side portion and a second filament associated with the second elastic side portion, and the at least one restraining mechanism can comprise a first restraining mechanism associated with the first elastic side portion and a second restraining mechanism associated with the second elastic side portion.

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

[0041] In some configurations, the restricting mechanism includes a pair of locking jaws defining a space therebetween through which the filament passes, the locking jaws having a first relative position in which they engage the filament to provide a first resistive force and a second relative position in which they provide a second resistive force.

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

[0043] In some configurations, the headgear includes upper and lower elastic side portions, upper and lower filaments, and upper and lower restraining mechanisms on each side. In some such configurations, there are upper and lower collection passages. These upper and lower collection passages on each side of the headgear can be separate from one another.

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

[0045] In some configurations, the inelastic front portion is configured to connect to a number of different interfaces.

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

[0047] In some configurations, a headgear assembly supporting the respiratory interface on a user defines a perimeter that surrounds the user's head. The headgear assembly can include a first portion having a fixed length along the perimeter and a second portion having a fixed length along the perimeter. At least one elastic portion has a variable length along the perimeter, the at least one elastic portion having a first length and a second length greater than the first length. At least one filament is secured to one of the first and second portions and extends through the at least one elastic portion and into at least one collection passage in the other of the first and second portions. The at least one filament has a filament length greater than the second length of the at least one elastic portion. At least one limiting mechanism is configured to selectively engage the at least one filament to limit movement of the at least one filament relative to the at least one limiting mechanism. The at least one limiting mechanism is located at an entrance to the at least one collection passage.

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

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

[0050] In some configurations, the first portion defines at least one collection passage.

[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 a non-elastic element that defines a maximum length.

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

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

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

[0056] In some configurations, the restricting mechanism includes a pair of locking jaws defining a space therebetween through which the filament passes, the locking jaws having a first relative position in which they engage the filament to provide a first resistive force and a second relative position in which they provide a second resistive force.

[0057] In some configurations, the directional lock includes a housing defining an interior space, a first opening, and a second opening. Each of the first opening and the second opening communicates with the interior space. At least one locking element is pivotally coupled to the housing for rotation about a fixed pivot axis. The locking element has an aperture configured to receive the core element. The locking element is movable between a first position in which the aperture is aligned with the first opening and the second opening, and a second position in which the aperture is not aligned with the first opening and the second opening.

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

[0059] In some configurations, at least one of the first opening and the second opening is elongated in a direction perpendicular to the pivot axis, such that at least one of the first opening and the second opening can accommodate a core element passing through an aperture of the at least one locking element in both the first position and the second position.

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

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

[0062] In some configurations, a headgear assembly supporting the respiratory interface on a user includes a rear headgear portion configured to contact a rear and / or upper portion of the user's head. Each side of the rear headgear portion includes an attachment portion configured to be positioned in front of the user's ears in use. The rear headgear portion does not have structure that passes below the user's ears to prevent upward removal of the rear headgear portion. An interface connection mechanism is provided on the attachment portion on each side of the headgear assembly. Each interface connection mechanism is configured to be directly or indirectly coupled to the respiratory 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 secured to one end of the elastic element. The core member passes through the limiting mechanism. The limiting mechanism is configured to selectively engage the core member to resist movement of the core member relative to the limiting mechanism.

[0063] In some configurations, each of the interface connection mechanisms 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 on 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 on 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, the at least one connector includes at least one collection passage configured to receive a portion of the core member.

[0068] In some configurations, a single connector is configured to connect both interface connections to the respiratory interface.

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

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

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

[0072] In some configurations, the restricting mechanism includes a pair of locking jaws defining a space therebetween through which the core member passes, the locking jaws having a first relative position that engages the filament to provide a first level of resistance and a second relative position that provides a second level or resistance less than the first level.

[0073] In some configurations, a headgear assembly supporting a respiratory interface on a user includes at least one inelastic portion and at least one elastic portion having a first end and a second end. At least one filament extends through or along the at least one elastic portion. The first end of the at least one elastic portion is fixed relative to the at least one inelastic portion and the at least one filament. The second end of the at least one elastic portion is movable relative to the at least one inelastic portion and the at least one filament. The headgear assembly also includes at least one limiting mechanism. The at least one filament passes through the at least one limiting mechanism. The at least one limiting mechanism is configured to selectively engage the at least one filament to resist movement of the at least one filament relative to the at least one limiting mechanism. The at least one limiting mechanism is located away from each of the first and second ends of the at least one elastic portion.

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

[0075] In some configurations, the rear headgear portion comprises a top strap and the at least one restraining mechanism is located on the top strap.

[0076] In some configurations, the headgear assembly is configured so that the at least one restraining mechanism is located on top of the user's head in use.

[0077] In some configurations, the rear headgear portion comprises a rear strap, and the at least one restraining mechanism is located on the rear strap.

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

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

[0080] In some configurations, the restricting mechanism includes a pair of locking jaws defining a space therebetween through which the filament passes, the locking jaws having a first relative position in which they engage the filament to provide a first level of resistance and a second relative position in which they provide a second level or resistance less than the first level.

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

[0082] In some configurations, transformational locking behavior is provided by directional locking mechanisms.

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

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

[0085] In some configurations, the transformational locking behavior is provided by a set of directional locking mechanisms that move dependently on one another.

[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 the mask body.

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

[0089] Some configurations use a combination of a directional locking mechanism located on the mask body and a directional locking mechanism located on or in the headgear system.

[0090] In some configurations, the directional lock is located at a location proximal to the connection to the headgear.

[0091] In some configurations, the directional locks are located at the connection point to the headgear and at a distal location.

[0092] In some configurations, the directional lock incorporates a mechanism that allows for user attachment / detachment between it and the mask body.

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

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

[0095] In some configurations, the patient interface includes a body portion sized and shaped to provide a cannula-style gas delivery system within the nares. A fitting allows the patient interface to be coupled to the gas delivery system. A headgear system allows the body portion to be positioned and held on a user's head and allows the headgear system to transform from an elastic-type stretching behavior to a non-stretching type behavior when the interface system is in use.

[0096] In some configurations, the patient interface system includes a body portion sized and shaped to surround a user's nose and / or mouth and 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 body portion to be positioned and held on the user's head and allows the headgear system to transform from an elastic-type extensional behavior to a non-extensional behavior when the interface system is in use.

[0097] In some configurations, positional stability of the headgear system is achieved through two main sections: one section passing over or under the occipital prominence, and the other section passing loosely over the crown of the head at the crown position. The relative positions of these two sections are maintained by the shape retention of the headgear material.

[0098] In some configurations, positional stability of the headgear system is achieved through two main sections: one section passing over or under the occipital projection, and the other section passing loosely over the crown of the head at the crown of the head, the relative positions of these two being maintained by gussets or connecting members.

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

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

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

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

[0103] In some configurations, the non-stretch behavior of the main body portion of the headgear is achieved by constructing it from a plurality of thermosetting materials.

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

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

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

[0107] In some configurations, a headgear assembly for a respiratory interface includes a rear headgear portion, an interface coupling portion, and a length adjustment portion that adjusts the length of the headgear assembly or the circumference of the interface assembly when coupled to the respiratory interface. The headgear assembly exhibits elastic forces that tend to contract the headgear length or circumference and non-elastic locking forces that tend to prevent extension of the headgear length or circumference.

[0108] In some configurations, the headgear assembly comprises at least one support surface.

[0109] In some configurations, the headgear assembly comprises two support surfaces.

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

[0111] In some configurations, the retention surfaces converge in a direction moving from anterior to posterior.

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

[0113] In some configurations, the retention surfaces are separated from one another at the interface attachment location.

[0114] In some configurations, the support surfaces are generally parallel to one another.

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

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

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

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

[0119] In some configurations, the first and second portions are on opposite sides of the headgear assembly.

[0120] In some configurations, the interface coupling portion extends between the first portion and the second portion.

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

[0122] In some configurations, the interface coupling portion extends between the first portion and the second portion.

[0123] In some configurations, at least one core forms part of the headgear length or circumference and can be locked relative to another portion of the headgear assembly or interface assembly to prevent extension of the headgear length or circumference.

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

[0125] In some configurations, the length of the rear headgear portion is equal to or greater than the length of the core member.

[0126] In some configurations, the length of the rear headgear portion is equal to or greater than the length of the core member.

[0127] In some configurations, at least one collection portion accommodates, at any particular headgear length or circumference, excess portions of the core that do not form part of the headgear length or circumference.

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

[0129] In some configurations, the length of the rear headgear portion and the length of the core collection portion are fixed, and adjustment of the length of the length adjustment member provides substantially all of the length adjustment of the headgear length or circumference.

[0130] In some configurations, the nasal cannula system includes a nasal cannula and a headgear. At least one adjustment mechanism allows for adjustment of the perimeter 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 can engage the core member to hold the nasal cannula system at a desired adjusted perimeter.

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

[0132] In some configurations, the lock allows sliding of the core member above a threshold force, thereby increasing the perimeter beyond the desired adjusted perimeter.

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

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

[0137] In some configurations, the nasal cannula system includes at least one quick release mechanism that allows the peripheral loop to be quickly and easily broken, such as to remove or apply the nasal cannula system to a user.

[0138] In some configurations, the headgear is a single strap configuration or a two-strap configuration.

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

[0140] In some configurations, the excess portion of at least one core member that does not effectively define a portion of the perimeter is housed in either the nasal cannula or the headgear. In some such configurations, the excess portion is internal to the nasal cannula or the headgear. In some such configurations, the excess portion is housed in a circular reservoir.

[0141] In some configurations, multiple adjustment mechanisms are provided. In some such configurations, an adjustment mechanism is provided on each side of the nasal cannula system. In some such configurations, excess portions of the core member on each side are positioned above or below the nasal cannula.

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

[0143] In some configurations, the lock can maintain a desired adjusted circumference depending on normal or expected forces during use, such as, for example, the weight of the nasal cannula and hose tension.

[0144] In some configurations, the lock allows sliding of the core member above a threshold force, thereby increasing the perimeter beyond the desired adjusted perimeter.

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

[0148] In some configurations, the biasing element allows the nasal cannula to be self-fitting or automatically adjustable.

[0149] In some configurations, the nasal cannula system includes at least one quick release mechanism that allows the peripheral loop to be quickly and easily broken, such as to remove or apply the nasal cannula system to a user.

[0150] In some configurations, the headgear is a single strap configuration or a two-strap configuration.

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

[0152] In some configurations, an 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 internal to the headgear. In some such configurations, the excess portion is housed in a circular reservoir.

[0153] In some configurations, multiple adjustment mechanisms are provided. In some such configurations, an adjustment mechanism is provided 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 a core member or filament passing through the opening. The opening can vary in cross-sectional dimension between one side of the locking member and the other side of the locking member and / or the opening can have a tapered profile.

[0155] In some configurations, the side of the opening that defines the working edge of the locking member that engages 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 tapers towards 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 configured to engage a core member or filament passing through the aperture, and a motion transfer element that causes movement of the second locking member in response to movement of the first locking member.

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

[0159] In some configurations, the motion transfer element is a linkage that biases to allow the second locking member to move away from the first locking member.

[0160] In accordance with at least one embodiment disclosed herein, there is provided headgear including a top strap, a rear strap, a front strap, a yoke, and a connector, the headgear being configured to be substantially inelastic and three-dimensional in structure.

[0161] According to a further aspect, the headgear is constructed from a composite material, with a textile casing integrally formed around a plastic core.

[0162] According to a further aspect, the headgear includes integrally molded labels, connections and / or adjustment mechanisms.

[0163] According to a further aspect, the headgear component includes a grip molded into the textile strap.

[0164] According to a further aspect, the textile casing comprises a first portion covering an interior facing surface of the headgear.

[0165] According to a further aspect, the textile casing comprises a second portion covering the outwardly facing surface of the headgear.

[0166] According to a further aspect, the first and second portions of the textile casing meet at first and second edges.

[0167] According to a further aspect, the first and second portions are not connected to one another at the first and second edges.

[0168] According to a further aspect, the textile casing includes one or more retainer holes configured to engage with retaining pins of the mold.

[0169] According to a further aspect, the headgear includes at least one flexible joint that allows the strap to flex.

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

[0171] According to a further aspect, the headgear includes at least one bridge portion extending between the portions of the plastic core within the textile joint.

[0172] According to a further aspect, at least one bridge portion is integrally formed with said portion of the plastic core.

[0173] According to a further aspect, the headgear assembly includes a top strap, a rear strap connected to the top strap at an upper connection point located on the side of a user's forehead, and lower side straps connected to the top and rear straps at the upper connection point. The headgear assembly also includes a first length adjustment portion that adjusts the distance between the upper connection point and a frame of the respiratory interface, and a second length adjustment portion that connects to the lower side straps at a lower connection point located in front of the user's ears and approximately aligned with the user's mouth, the second adjustment mechanism adjusting the distance between the lower connection point and the frame of the respiratory interface.

[0174] According to a further aspect, the top strap and the rear strap are integrally formed as a one-piece structure.

[0175] According to a further aspect, the top strap, rear strap, and front strap are integrally formed as a one-piece structure.

[0176] According to a further aspect, the first length adjustment portion includes a fabric strap having a hook and loop fastener mechanism.

[0177] According to a further aspect, the second length adjustment portion includes a plurality of length adjustment mechanisms.

[0178] According to a further aspect, the headgear assembly includes 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 includes upper side straps connected to the top strap and the rear strap at the upper connection point and connected to the frame of the respiratory interface. The upper side straps extend between the user's ears and eyes and across the user's cheeks toward the frame of the respiratory interface. The headgear assembly further includes lower side straps connected to the rear strap at a rear connection point located behind the user's ears. The lower side straps extend below the user's ears and across the user's cheeks toward the frame of the respiratory interface. The headgear assembly further includes a first length adjustment portion connected to the lower side straps and the frame of the respiratory interface. The first length adjustment portion adjusts the distance between the lower side straps and the frame of the respiratory interface.

[0179] According to a further aspect, the top strap and the rear strap are integrally formed as a one-piece structure.

[0180] According to a further aspect, the top strap, rear strap, upper side straps and lower side straps are integrally formed as a one-piece structure.

[0181] According to a further aspect, the first length adjustment portion includes a one-way adjustment mechanism.

[0182] According to a further aspect, the headgear assembly further comprises a second length adjustment portion connected between the upper side straps and the frame of the breathing interface, the second length adjustment portion adjusting the distance between the upper side straps and the frame of the breathing interface.

[0183] According to a further aspect, the headgear assembly includes 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 and rear straps at the upper connection point and connected to the breathing interface, the front strap extending between the user's ears and eyes and toward the bottom of the user's nose.

[0184] According to a further aspect, the top strap and the rear strap are integrally formed as a one-piece structure.

[0185] According to a further aspect, the top strap, rear strap, and front strap are integrally formed as a one-piece structure.

[0186] According to a further aspect, the front strap extends across the front of the respiratory interface and forms part of the frame of the respiratory interface.

[0187] According to a further aspect, the headgear assembly further comprises a length adjustment portion connected between the front straps and the breathing interface, the length adjustment portion adjusting the distance between the front straps and the breathing interface.

[0188] According to a further aspect, the headgear assembly includes 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 the rear strap 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 ear. The headgear assembly also includes a first length adjustment portion connected to the lower strap at a first lower connection point, the first length adjustment portion adjusting the distance between the first lower connection point and a frame of the breathing interface. The first lower connection point is positioned in line with the user's ear, and the first length adjustment portion extends across the user's cheek directly below the user's eye. The headgear assembly further includes a second length adjustment portion connected to the lower strap at a second lower connection point, the second length adjustment portion adjusting 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 bottom of the user's nose, and the second length adjustment portion extends substantially horizontally across the user's cheek.

[0189] According to a further aspect, the top strap and the rear strap are integrally formed as a one-piece structure.

[0190] According to a further aspect, the top strap, rear strap and lower side strap are integrally formed as a one-piece structure.

[0191] According to a further aspect, 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 formed as a unitary structure by adding molten plastic material into the textile casing.

[0193] According to a further aspect, the textile casing comprises a first portion covering an interior facing surface of the headgear.

[0194] According to a further aspect, the textile casing comprises a second portion covering the outwardly facing surface of the headgear.

[0195] According to a further aspect, the first and second portions of the textile casing abut at first and second edges.

[0196] According to a further aspect, the first and second portions are not connected to one another at the first and second edges.

[0197] According to a further aspect, the textile casing includes one or more retainer holes configured to engage with retaining pins of the mold.

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

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

[0200] According to a further aspect, the headgear includes at least one bridge portion extending into the flexible joint between the portions of the plastic core.

[0201] According to a further aspect, at least one bridge portion is integrally formed with a portion of the plastic core.

[0202] According to at least one of the embodiments disclosed herein, a method of manufacturing headgear includes the steps of placing a textile casing in a mold, introducing 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] According to a further aspect, the step of placing the textile casing in the 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] According to a further aspect, the method further includes holding an end portion of each of the first and second textile portions while the molten plastic material is introduced into a holding feature of the mold.

[0205] According to a further aspect, the method further includes capturing at least one edge of the textile casing between separate first and second portions of the mold.

[0206] According to a further aspect, the method further includes engaging the opening of the textile casing with a retaining pin of the mold.

[0207] According to a further aspect, the method further comprises the step of fixing the textile casing in the mold before introducing the molten plastic material.

[0208] According to a further aspect, the step of securing the textile casing includes securing the textile casing by one or more of electrostatic charge, air pressure, holding the textile casing by another component inserted within the mold, or supporting strips of material forming the textile casing on each side of the mold that extend through the mold.

[0209] According to a further aspect, supporting the strip of material includes supporting one end on a roll and fixing the free end to a mold.

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

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

[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 cooperating 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 of manufacturing headgear includes the steps of placing a textile casing within a mold, introducing 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] According to a further aspect, 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 and the second strap defines a top strap.

[0215] According to a further aspect, 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 a respective one of the top strap and the rear strap.

[0216] According to a further aspect, one or both of the straps are constructed from a plastic core and a textile casing that are formed as a unitary structure by adding a molten plastic material over the textile casing.

[0217] According to at least one embodiment disclosed herein, the headgear includes an inner core, a first outer layer defining an inner surface of the headgear that faces a user in use, and a second outer layer defining an outer surface of the headgear that faces away from the user in use, the first and second layers having different colors, textures, or other indicia that allow tactile or visual distinction between the inner and outer surfaces.

[0218] According to further embodiments, the first outer layer or the second outer layer comprises one of polyurethane (imitation leather), patterned polyester, wool with mesh knit, continuous loop, nylon, a composite of spacer fabric and continuous loop, or a composite of foam continuous loop.

[0219] According to a further embodiment, an edge of one or both of the first and second outer layers extends beyond the inner core.

[0220] According to a further aspect, the inner core includes an internal cutout.

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

[0222] According to a further aspect, the first strap and the second strap are stacked vertically within the connector.

[0223] According to a further aspect, 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] According to a further aspect, the connector includes a front band portion and a rear band portion separated by a bridge portion, the bridge portion not entirely surrounding both the first strap and the second strap.

[0225] According to a further aspect, the connector includes a forward band portion and an aft gusset.

[0226] According to a further aspect, the front band portion and the rear gusset are separated by a bridge portion, the bridge portion not entirely surrounding both the first strap and the second strap.

[0227] According to at least one embodiment disclosed herein, a headgear strap comprises an inner core, at least one outer layer at least partially surrounding the inner core, and at least one air gap within the outer layer.

[0228] According to a further aspect, the at least one air gap comprises a first air gap at one side edge of the strap and a second air gap at an opposing side edge of the strap.

[0229] According to a further aspect, a portion of the inner core is exposed to the outside.

[0230] According to a further aspect, a conduit is disposed within the air gap.

[0231] According to a further aspect, the air gap is defined by the inner core.

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

[0233] According to a further aspect, the conduit is at least partially received within a recess in the inner core.

[0234] According to a further aspect, the conduit is completely enclosed within the inner core.

[0235] According to a further aspect, the at least one conduit comprises a first conduit and a second conduit.

[0236] According to a further aspect, the at least one conduit is defined by the core.

[0237] According to at least one embodiment disclosed herein, the straps of the headgear include an inner core, at least one outer layer, and at least one reinforcing member.

[0238] According to a further aspect, the reinforcing member is embedded within the core.

[0239] According to a further aspect, the reinforcing member is configured to hold opposing outer layers or opposing sides of the outer layers separated from one another prior to forming the inner core.

[0240] In accordance with at least one embodiment disclosed herein, the straps of the headgear comprise an inner core, at least one outer layer, and at least one cushioning layer.

[0241] According to a further aspect, a buffer layer surrounds the inner core.

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

[0243] In accordance with at least one embodiment disclosed herein, a headgear strap includes an inner core and an outer layer at least partially surrounding the inner core, the outer layer including a rim, the rim being embedded within the inner core.

[0244] According to further embodiments, the outer layer comprises two or more pieces or three or more pieces.

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

[0246] According to a further embodiment, a third piece of the outer layer is located on one edge of the strap and a fourth piece of the outer layer is located on an opposite edge of the strap.

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

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

[0249] According to a further aspect, the outer layer is ribbed or quilted.

[0250] According to a further aspect, the core is textured to impart texture to the outer layer.

[0251] According to at least one embodiment disclosed herein, the headgear, straps or other portions of the headgear have one or more features described herein, or methods of manufacturing such headgear, straps or other portions of the headgear.

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

[0253] [Figure 1] 1 is a graph showing an operating envelope illustrating the relationship between the force generated when the mask enclosure is pressurized and the range of possible patient headgear sizing. [Figure 2] 2 shows the operating envelope of FIG. 1 with the force curve of the elastic headgear system superimposed. [Figure 3] 2 shows the operating envelope of FIG. 1 with the force curves of the exemplary embodiment superimposed. [Figure 4] 1 is a graph of a force-deflection curve of an exemplary headgear arrangement. [Figure 4.1] 1 illustrates the position of an exemplary headgear arrangement when initially donned by a user. [Figure 4.2] 1 illustrates the position of an exemplary headgear arrangement at the start of a contraction. [Figure 4.3] 1 illustrates the position of an exemplary headgear arrangement at the end of wear. [Figure 5] 1 is a graph containing an exemplary "composite" force-deflection curve. [Figure 6] 1 is a force-area graph for maintaining an interface in sealing contact. [Figure 7] 1 is a three-dimensional graph of the relationship between headgear force, projected seal area and head size. [Figure 8A] 1 shows the force and elongation profiles of constant pressure treatment for elastic and non-elastic headgear systems. [Figure 8B]1 shows the force and extension profiles of variable pressure treatment for elastic and non-elastic headgear systems. [Figure 9] FIG. 10 is a side view of a nasal interface having a single retaining surface. [Figure 10] FIG. 10 is a side view of a nasal interface having two retaining surfaces. [Figure 11] FIG. 1 is a side view of a full face mask having two support surfaces. [Figure 12] FIG. 1 is a side view of a nasal mask having two retention surfaces. [Figure 13] FIG. 1 is a side view of a mask having two retaining surfaces that converge to a single point. [Figure 13.1] 1 is a table of stability of various headgear types. [Figure 13.2] 1 shows a single support surface interface assembly. [Figure 14] FIG. 1 is a side view of a full face mask with a forehead support having a directional locking mechanism located at the connection between the headgear and the mask. [Figure 15] FIG. 1 is a side view of a full face mask with a forehead support having a directional locking mechanism disposed within the headgear. [Figure 16] FIG. 1 is a side view of a nasal mask with a directional locking mechanism on a flat strap. [Figure 17] FIG. 12 is a side view of a nasal mask having a directional locking mechanism with a flexible core design. [Figure 18] 10 shows a module of an interface assembly configured to extend between a mask or other interface and a rear portion of headgear incorporating a directional locking mechanism. [Figure 19] 10 illustrates an alternative module of an interface assembly configured to extend between a mask or other interface and a rear portion of headgear incorporating a directional locking mechanism spaced from the biasing mechanism. [Figure 20] FIG. 1 is a side view of an exemplary interface assembly. [Figure 21]FIG. 1 is a side view of an exemplary full face mask. [Figure 22] FIG. 1 is a side view of an exemplary nasal pillows mask. [Figure 23] FIG. 1 is a rear perspective view of an exemplary headgear assembly positioned on a user. [Figure 24] FIG. 24 is a rear perspective view of the exemplary headgear assembly in FIG. 23. [Figure 25] FIG. 1 is a rear perspective view of an exemplary headgear assembly on a user. [Figure 26] 26 is a cross-sectional view of an exemplary headgear assembly taken along line 26-26 in FIG. 25. [Figure 27] 27 is a cross-sectional view of an exemplary headgear assembly taken along line 27-27 in FIG. 25. [Figure 28] 28 is a cross-sectional view of an exemplary headgear assembly taken along line 28-28 in FIG. 25. [Figure 29] FIG. 1 is a rear perspective view of an exemplary headgear assembly showing several portions of the exemplary headgear constructed from various material types. [Figure 30] 1 illustrates where an automatic adjuster may be located within an exemplary headgear assembly. [Figure 31] 10 illustrates possible locations for an automatic adjuster within an exemplary headgear assembly worn by a user. [Figure 32] 1 illustrates an exemplary strap adjustment mechanism in an assembled configuration. [Figure 33] FIG. 33 is a top view of the exemplary strap adjustment mechanism of FIG. 32 separated into a first portion and a second portion. [Figure 34] FIG. 33 is a perspective view of a second portion of the exemplary strap adjustment mechanism in FIG. 32. [Figure 35] 1A and 1B are cross-sectional views of a directional lock in a locked position and an unlocked position. [Figure 36] 1 shows the operating cycle for headgear incorporating directional locking. [Figure 37]FIG. 1 is a perspective view of an exemplary headgear assembly incorporating one or more directional locks. [Figure 38] FIG. 1 is a perspective view of an exemplary headgear assembly incorporating one or more directional locks. [Figure 39] FIG. 39 is a side view of an attachment member attached to a rear headgear portion of the exemplary headgear assembly in FIG. 38. [Figure 40] FIG. 1 is a perspective view of an exemplary interface assembly. [Figure 41] FIG. 10 is a left perspective view of an exemplary interface assembly attached to an interface coupling portion. [Figure 42] FIG. 1 is a side view of an exemplary interface assembly. [Figure 43] FIG. 10 is a perspective view of a frame element of an interface member attached to an interface coupling portion. [Figure 44] FIG. 10 is a front view of a frame element and an interface coupling portion of an interface member. [Figure 45] FIG. 10 is a front view of a frame element of an interface member attached to an interface coupling portion. [Figure 46] FIG. 10 is a right perspective view of an exemplary interface assembly attached to an interface coupling portion. [Figure 47] FIG. 10 is a top perspective view of an exemplary interface assembly attached to a second part of an interface coupling portion. [Figure 48] FIG. 10 is a top perspective view of a first part of the interface coupling portion. [Figure 49] FIG. 10 is a top perspective view of a second part of the interface coupling portion. [Figure 50] FIG. 1 illustrates a right perspective view of an exemplary interface assembly. [Figure 51] FIG. 1 is an exploded view of an exemplary interface assembly. [Figure 52] FIG. 1 is an exploded view of an exemplary interface coupling portion. [Figure 53]FIG. 1 is an exploded view of an exemplary interface coupling portion; [Figure 54] FIG. 1 is a top view of an exemplary folding headgear assembly. [Figure 55] FIG. 1 is a rear view of an exemplary folding headgear assembly. [Figure 56] FIG. 1 is a side view of an exemplary folding headgear assembly. [Figure 57] 1 illustrates an exemplary headgear assembly coupled to a full face mask interface. [Figure 58] 58 illustrates the exemplary headgear assembly of FIG. 57 coupled to a nasal mask. [Figure 59] 58 shows the exemplary headgear assembly of FIG. 57 coupled to a nasal pillows / prong mask. [Figure 60] 1 illustrates an exemplary headgear and interface assembly with a T-piece. [Figure 61] 1 illustrates an exemplary headgear and interface assembly without a T-piece. [Figure 62] 1 illustrates an exemplary headgear and interface assembly with an interface coupling portion removably attached to the interface. [Figure 63] 63 illustrates the exemplary interface assembly of FIG. 62 in a first position when worn. [Figure 64] 63 illustrates the exemplary interface assembly of FIG. 62 in a second position when worn. [Figure 65] 63 illustrates the exemplary interface assembly of FIG. 62 in a third position when worn. [Figure 66] 1 illustrates the perimeter of an adjustable interface assembly or headgear assembly at its minimum length. [Figure 67] 1 shows the circumference of an adjustable interface assembly or headgear assembly at its maximum length. [Figure 68A] FIG. 10 is a cross-sectional view of the directional lock in the locked position. [Figure 68B]FIG. 68B is a cross-sectional perspective view of the directional lock of FIG. 68A in a locked position. [Figure 68C] FIG. 68B is a cross-sectional view of the directional lock of FIG. 68A in an unlocked position. [Figure 68D] FIG. 68B is a cross-sectional perspective view of the directional lock of FIG. 68A in an unlocked position. [Figure 69A] 10A-10C illustrate a first assembly step of attaching a lock washer to a housing of an exemplary directional lock. [Figure 69B] FIG. 69B illustrates a second assembly step of attaching a lock washer to the housing of the exemplary directional lock of FIG. 69A. [Figure 70A] 10A-10C illustrate a first assembly step for attaching lock washers to the housings of several exemplary directional locks. [Figure 70B] 70B illustrates a second assembly step of attaching a lock washer to the housing of the exemplary directional lock of FIG. 70A. FIG. [Figure 71] 10A-10C illustrate assembly steps for attaching a lock washer to a housing of an exemplary directional lock. [Figure 72] 10A-10C illustrate assembly steps for attaching a lock washer to a housing of an exemplary directional lock. [Figure 73] FIG. 1 is a side view of an exemplary full face mask without a forehead support. [Figure 74] FIG. 10 is a side view of another exemplary full face mask without a forehead support. [Figure 75] FIG. 1 is a side view of an exemplary nasal mask. [Figure 76] 1 is an exemplary headgear system having a headgear rear portion and two support surfaces. [Figure 77] FIG. 10 is a front perspective view of another exemplary headgear. [Figure 78] FIG. 78 is a front view of the exemplary headgear system of FIG. 77. [Figure 79] FIG. 78 is a rear perspective view of the exemplary headgear system of FIG. 77. [Figure 80]FIG. 78 is a front view of the exemplary headgear system of FIG. 77 with a mating nasal mask device. [Figure 81] FIG. 1 is a front perspective view of an exemplary cushion module and frame assembly. [Figure 82] FIG. 10 is a front perspective view of a frame assembly connected to a housing of the headgear system. [Figure 83] FIG. 12 is a rear view of the frame assembly connected to the housing of the headgear system. [Figure 84] FIG. 10 is a rear view of the frame assembly removed from the headgear housing. [Figure 85] 1 shows a verification test of the functionality of a headgear device including at least one directional locking module. [Figure 86] 1 is a graph illustrating the relationship between force and extension of an exemplary headgear device that has been tested. [Figure 87] 10 is a force-extension graph showing the variation of force during extension after the transition. [Figure 88] FIG. 1 is a perspective view of a respiratory cannula incorporating a headgear apparatus of the present disclosure, which may include at least one directional locking mechanism. [Figure 89a] FIG. 10 is a perspective view of a further respiratory cannula incorporating a headgear assembly of the present disclosure, which may include at least one directional locking mechanism and a headgear quick release mechanism. [Figure 89b] FIG. 10 is a perspective view of a further respiratory cannula incorporating a headgear assembly of the present disclosure, which may include at least one directional locking mechanism and a headgear quick release mechanism. [Figure 89c] FIG. 10 is a perspective view of a further respiratory cannula incorporating a headgear assembly of the present disclosure, which may include at least one directional locking mechanism and a headgear quick release mechanism. [Figure 90] FIG. 10 is a perspective view of another respiratory cannula incorporating a headgear assembly of the present disclosure, which may include at least one directional locking mechanism. [Figure 91] FIG. 1 is a perspective view of a respiratory cannula incorporating a headgear apparatus of the present disclosure, which may include at least one directional locking mechanism and a headgear quick release mechanism. [Figure 92] FIG. 1 is a perspective view of a respiratory cannula incorporating a headgear apparatus of the present disclosure, which may include at least one directional locking mechanism. [Figure 93] FIG. 1 is a perspective view of a respiratory cannula incorporating a headgear apparatus of the present disclosure, which may include at least one directional locking mechanism and a headgear quick release mechanism. [Figure 94] FIG. 1 is a perspective view of a respiratory cannula incorporating a headgear apparatus of the present disclosure, which may include at least one directional locking mechanism. [Figure 95] FIG. 1 is a perspective view of a respiratory cannula incorporating a headgear apparatus of the present disclosure, which may include at least one directional locking mechanism and a headgear quick release mechanism. [Figure 96] FIG. 1 is a perspective view of a respiratory cannula incorporating a headgear apparatus of the present disclosure, which may include a pair of directional locking mechanisms and a pair of headgear quick release mechanisms. [Figure 97] FIG. 1 is a perspective view of a respiratory cannula incorporating a headgear apparatus of the present disclosure, which may include a pair of directional locking mechanisms and a pair of headgear quick release mechanisms. [Figure 98] FIG. 1 is a perspective view of a respiratory cannula incorporating a headgear apparatus of the present disclosure, which may include a pair of directional locking mechanisms and a headgear quick release mechanism. [Figure 99] FIG. 1 is a perspective view of a respiratory cannula incorporating a headgear apparatus of the present disclosure, which may include a pair of directional locking mechanisms and a headgear quick release mechanism. [Figure 100] FIG. 1 is a perspective view of a respiratory cannula incorporating a headgear apparatus of the present disclosure, which may include a pair of directional locking mechanisms and a pair of headgear quick release mechanisms. [Figure 101]FIG. 1 is a perspective view of a respiratory cannula incorporating a headgear apparatus of the present disclosure, which may include at least one directional locking mechanism and a pair of headgear quick release mechanisms. [Figure 102] FIG. 1 is a perspective view of a respiratory cannula incorporating a headgear assembly of the present disclosure, which may include a pair of directional locking mechanisms. [Figure 103] 1 is a perspective view of an elevated or controlled breathing pressure system with a breathing mask used in combination with a nasal high flow cannula, which may include one or more directional locking mechanisms. [Figure 104] FIG. 104 is a perspective view of the respiratory mask of FIG. 103. [Figure 105] FIG. 10 is a side view of the locking member and core member of the directional locking mechanism. [Figure 106] 10 is a graph of locking member edge sharpness versus locking member thickness illustrating a preferred operating envelope for the locking member. [Figure 107] FIG. 4 is an enlarged view of the locking member in the locked position. [Figure 108] FIG. 108 is an enlarged view of the locking member of FIG. 107 in an unlocked position. [Figure 109a] 1 shows several locking members having different possible cross-sectional opening shapes. [Figure 109b] 1 shows several locking members having different possible cross-sectional opening shapes. [Figure 110] FIG. 10 is a perspective view of a locking member having a tapered hole shape. [Figure 111a] 10 shows a locking member having an alternative tapered bore shape. [Figure 111b] 10 shows a locking member having an alternative tapered bore shape. [Figure 112] 10 is a force versus distance graph illustrating the gradual retention force profile of a tapered hole shape compared to a linear retention force profile. [Figure 113a]113a shows a directional locking mechanism comprising a pair of locking members and a motion-transmitting element that transmits motion between the locking members, with Fig. 113a showing the directional locking mechanism in the unlocked position and Fig. 113b showing the directional locking mechanism in the locked position. [Figure 113b] 113a shows a directional locking mechanism comprising a pair of locking members and a motion-transmitting element that transmits motion between the locking members, with Fig. 113a showing the directional locking mechanism in the unlocked position and Fig. 113b showing the directional locking mechanism in the locked position. [Figure 114a] Figure 114a shows an alternative directional locking mechanism comprising a pair of locking members and an alternative motion-transmitting element for transmitting 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] Figure 114a shows an alternative directional locking mechanism comprising a pair of locking members and an alternative motion-transmitting element for transmitting 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] 1 shows a respiratory mask system including a headgear assembly incorporating at least one directional locking mechanism, the directional locking mechanism being positioned behind the user's ears. [Figure 116] 10 shows possible locations for placing the directional locking mechanism on the user. [Figure 117] 10 illustrates a possible location for placing the directional lock behind the user's ear, with the placement area indicated relative to the skull. [Figure 118A] FIG. 1 is a side view of the headgear of the present disclosure being worn by a user. [Figure 118B] FIG. 1 is a perspective view of a headgear of the present disclosure. [Figure 119] 1 is a cross-sectional view of a strap forming part of the headgear disclosed herein. [Figure 120] FIG. 10 is a third angle orthographic view of one half of an injection mold configured to mold strap components similar to the headgear of the present disclosure. [Figure 121]FIG. 121 is an isometric view of a strap component produced by the injection mold of FIG. 120. [Figure 122] 121 is a cross-sectional view BB of the injection molding mold of FIG. 120 with a textile casing disposed therein. [Figure 123] FIG. 121 is an enlarged view of section AA of the injection molding mold of FIG. 120 with a textile casing disposed therein. [Figure 124A] FIG. 10 is a perspective view of a second embodiment of headgear of the present disclosure. [Figure 124B] FIG. 10 is an enlarged cross-sectional view of a size adjustment system of a second embodiment of headgear of the present disclosure. [Figure 125A] FIG. 124C is a cross-sectional view of a second embodiment of the sizing system of FIGS. 124A and 124B. [Figure 125B] 8B is a plan view of a first strap of the size adjustment system of FIG. 8A. FIG. [Figure 125C] FIG. 10 is a perspective view of a first strap of an alternative size adjustment system. [Figure 125D] 125D is a cross-sectional view of the connected first and second straps of the size adjustment system of FIG. 125C. [Figure 125E] 125D is a cross-sectional view of the disconnected first and second straps of the size adjustment system of FIG. 125C. FIG. [Figure 125F] FIG. 10 is an exploded perspective view of another alternative size adjustment system. [Figure 125G] FIG. 125F is a close-up exploded perspective view of the size adjustment system of FIG. [Figure 125H] FIG. 125F is a top view of the first strap of the size adjustment system of FIG. 125F. [Figure 125I] FIG. 125F is a cross-sectional view of a second strap of the size adjustment system of FIG. 125F. [Figure 126] FIG. 124C is a perspective view of a respiratory apparatus with a cushion pad connected using the size adjustment system of FIGS. 124A and 124B. [Figure 127A] FIG. 1 is a plan view of the connections between breathing apparatus components. [Figure 127B]FIG. 1 is a plan view of the connections between breathing apparatus components. [Figure 128] FIG. 1 is a plan view of a headgear component with a molded grip. [Figure 129] FIG. 129 is a cross-sectional view of a mold configured to form the headgear component of FIG. 128. [Figure 130] FIG. 1 is a side view of a headgear strap portion having a relatively inelastic core, a fabric casing on at least one side of the core, and flexible joints between portions of the core. [Figure 131] 14 is a cross-sectional view of the headgear strap portion of FIG. 130 taken along line 14-14 of FIG. 130. [Figure 132] FIG. 1 is a side view of a headgear strap portion having a relatively inelastic core, a fabric casing on at least one side of the core, and flexible joints between portions of the core, the flexible joints including flexible bridge portions extending between the portions of the core. [Figure 133] 16 is a cross-sectional view of the headgear strap portion of FIG. 132 taken along line 16-16 of FIG. 132. [Figure 134] 1 shows a system for forming headgear strap portions that utilizes static charges to hold a fabric casing in place within a mold. [Figure 135] 1 shows a system for forming headgear strap portions that utilizes air pressure to hold the fabric casing in place within the mold. [Figure 136] 1 illustrates a system for forming a headgear strap portion that utilizes one or more components to hold a fabric casing in place within a mold. [Figure 137] 1 shows a system for forming headgear strap portions that utilizes a roll of material to feed a fabric casing into a forming die. [Figure 138] 1 shows headgear having a first strap and a second strap. [Figure 139A] FIG. 10 is a cross-sectional view of a second strap. [Figure 139B] FIG. 4 is a cross-sectional view of a first strap. [Figure 139C] 10 is a cross-sectional view of an alternative strap in which the core of the strap includes a recess configured to receive a seam in a cover layer of the strap. [Figure 139D] FIG. 10 is a cross-sectional view of another alternative strap in which the core has one or more recesses occupying a substantial portion of the width of the core, and the seams of the cover layer are located within the recesses. [Figure 139E] FIG. 10 is a cross-sectional view of yet another alternative strap illustrating an alternative seam configuration in which the seam of the cover layer is folded over onto the surface of the cover layer. [Figure 140A] FIG. 10 is a view of the outer layer of the first strap. [Figure 140B] FIG. 10 is a view of the outer layer of the second strap. [Figure 141] 1 shows headgear having a first strap and a second strap. [Figure 142A] FIG. 4 is a cross-sectional view of a first strap. [Figure 142B] FIG. 10 is a cross-sectional view of a second strap. [Figure 143A] FIG. 10 is a view of the outer layer of the first strap. [Figure 143B] FIG. 10 is a view of the outer layer of the second strap. [Figure 144] 1 shows headgear having an inner core, a first outer layer and a second outer layer. [Figure 145] FIG. 145 is a cross-sectional view of a portion of the headgear of FIG. 144. [Figure 146A] FIG. 145 is a view of the first outer layer of the headgear of FIG. 144. [Figure 146B] FIG. 145 is a view of the second outer layer of the headgear of FIG. 144. [Figure 147] 1 shows headgear having an inner core, a first outer layer and a second outer layer. [Figure 148] FIG. 148 is a cross-sectional view of a portion of the headgear of FIG. 147. [Figure 149A] FIG. 148 is a view of the first outer layer of the headgear of FIG. 147. [Figure 148B] FIG. 148 is a view of the second outer layer of the headgear of FIG. 147. [Figure 150]1 shows headgear having an inner core, a first outer layer and a second outer layer. [Figure 151] FIG. 151 is a cross-sectional view of a portion of the headgear of FIG. 150. [Figure 152A] FIG. 151 is a view of the first outer layer of the headgear of FIG. 150. [Figure 152B] FIG. 151 is a view of the second outer layer of the headgear of FIG. 150. [Figure 153] 1 shows headgear having an inner core, a first outer layer and a second outer layer. [Fig. 154] FIG. 154 is a cross-sectional view of a portion of the headgear of FIG. 153. [Figure 155] 1 shows headgear having an inner core, a first outer layer and a second outer layer. [Figure 156] FIG. 156 is a cross-sectional view of a portion of the headgear of FIG. 155. [Figure 157A] FIG. 156 is a view of the first outer layer of the headgear of FIG. 155. [Figure 157B] FIG. 156 is a view of the second outer layer of the headgear of FIG. 155. [Figure 158] 1 is a cross-sectional view of a headgear strap arrangement having a core and one or more outer layers. [Figure 159] FIG. 159 is a side view of the core of the headgear strap device of FIG. 158. [Figure 160] 1 is a cross-sectional view of a headgear strap arrangement having a core and one or more outer layers. [Figure 161] FIG. 161 is a side view of the core of the headgear strap device of FIG. 160. [Figure 162] 1 is a cross-sectional view of a headgear strap arrangement having a core and one or more outer layers. [Figure 163] FIG. 163 is a side view of the core of the headgear strap device of FIG. 162. [Fig. 164] 1 is a cross-sectional view of a headgear strap arrangement having a core and one or more outer layers. [Figure 165] FIG. 165 is a side view of the core of the headgear strap device of FIG. 164. [Figure 166]1 is a cross-sectional view of a headgear strap arrangement having a core and one or more outer layers. [Figure 167] FIG. 167 is a side view of the core of the headgear strap device of FIG. 166. [Figure 168] 1 is a cross-sectional view of a headgear strap arrangement having a core and one or more outer layers. [Figure 169] FIG. 169 is a side view of the core of the headgear strap device of FIG. 168. [Figure 170] 1 is a cross-sectional view of a headgear strap arrangement having a core and one or more outer layers. [Figure 171] FIG. 171 is a side view of the core of the headgear strap device of FIG. 170. [Figure 172] 1 is a cross-sectional view of a headgear strap arrangement having a core and one or more outer layers. [Fig. 173] FIG. 173 is a side view of the core of the headgear strap device of FIG. 172. [Fig. 174] FIG. 1 is a perspective view of headgear having a first strap and a second strap. [Figure 175A] FIG. 175 is a cross-sectional view of a portion of the headgear of FIG. 174. [Figure 175B] 175 is a cross-sectional view of an alternative configuration of the straps of the headgear of FIG. 174. [Figure 175C] FIG. 175 is a cross-sectional view of another alternative configuration for the straps of the headgear of FIG. 174. [Figure 176] FIG. 1 is a perspective view of headgear having at least a first strap and a second strap. [Figure 177] FIG. 177 is an enlarged view of the headgear of FIG. 176 including a connecting mechanism that connects at least a first strap and a second strap. [Figure 178] 178 is a cross-sectional view of a portion of the headgear of FIG. 176 through the coupling mechanism of FIG. 177. [Figure 179] FIG. 1 is a perspective view of headgear having at least a first strap and a second strap. [Figure 180]FIG. 179 is an enlarged view of the headgear of FIG. 179 including a connecting mechanism that connects at least a first strap and a second strap. [Figure 181] 180. A cross-sectional view of a portion of the headgear of FIG. 179 through the coupling mechanism of FIG. [Figure 182] FIG. 1 is a perspective view of headgear having at least a first strap and a second strap. [Figure 183] FIG. 183 is an enlarged view of the headgear of FIG. 182 including a connecting mechanism that connects at least a first strap and a second strap. [Figure 187] 184 is a cross-sectional view of a portion of the headgear of FIG. 182 through the coupling mechanism of FIG. 183. [Figure 185] FIG. 1 is a perspective view of headgear having at least a first strap and a second strap. [Figure 186] FIG. 186 is an enlarged view of the headgear of FIG. 185 including a connecting mechanism that connects at least a first strap and a second strap. [Figure 187] 187 is a cross-sectional view of a portion of the headgear of FIG. 185 through the coupling mechanism of FIG. 186. [Figure 188] FIG. 1 is a perspective view of headgear having at least a first strap and a second strap. [Figure 189] FIG. 189 is an enlarged view of the headgear of FIG. 188 including a connecting mechanism that connects at least a first strap and a second strap. [Figure 190] 189 is a cross-sectional view of a portion of the headgear of FIG. 188 through the coupling mechanism of FIG. 189. [Figure 191] FIG. 1 is a perspective view of headgear having at least a first strap and a second strap. [Figure 192] FIG. 192 is an enlarged view of the headgear of FIG. 191 including a connecting mechanism that connects at least a first strap and a second strap. [Figure 193] 193 is a cross-sectional view of a portion of the headgear of FIG. 191 through the coupling mechanism of FIG. 192. [Figure 194]1 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] 1 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] FIG. 10 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] 1 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] FIG. 10 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] FIG. 1 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] FIG. 1 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] 201 is a cross-sectional view of the headgear strap of FIG. 200 in a first position relative to a surface. [Figure 201B] 201 is a cross-sectional view of the headgear strap of FIG. 200 in a second position relative to a surface. [Figure 202] 1 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 with a portion of the core exposed to the outside. [Figure 203] A cross-sectional view of another 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 204] FIG. 10 is an exploded view of the outer layer and reinforcing member of the headgear strap. [Figure 205] FIG. 205 is a cross-sectional view of a headgear strap incorporating the outer layer and reinforcing member of FIG. 204. [Figure 206]1 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 separating the outer layers prior to the introduction of the core material. [Figure 207] 1 is a cross-sectional view of a headgear strap having a core, a first outer layer, a second outer layer, and a reinforcing member encapsulated within the core. [Figure 208] FIG. 1 is a cross-sectional view of a headgear strap having a core, a cushioning layer, and an outer layer. [Figure 209] FIG. 10 is a cross-sectional view of another headgear strap having a core, a cushioning layer, and an outer layer, with a portion of the cushioning layer exposed to the outside. [Figure 210] FIG. 1 is a side view of a portion of headgear having several straps and a connector connecting two or more of the straps. [Figure 211] 211 is a cross-sectional view of one of the connectors and straps of FIG. 210. [Figure 212] 1 is a cross-sectional view of a headgear strap having a core and a single piece seamless outer layer. [Figure 213] 1 is a cross-sectional view of a headgear strap having a core and a single-piece outer layer with a seam, the edges of the outer layer being embedded within the core. [Figure 214] 10 is a cross-sectional view of another headgear strap having a core and a single-piece outer layer with a seam, the edges of the outer layer being embedded within the core. [Figure 215] 1 is a cross-sectional view of a headgear strap having a core and a two-piece outer layer with a pair of seams, the edges of the outer layer pieces being embedded within the core. [Figure 216A] FIG. 1 is a cross-sectional view of a two-piece outer layer without a core. [Figure 216B] FIG. 1 is a cross-sectional view of the two-piece outer layer after the core has been formed. [Figure 217] 1 is a cross-sectional view of a headgear strap having a core and a four-piece outer layer with four seams, the edges of the outer layer pieces being embedded within the core. [Figure 218]FIG. 10 is a cross-sectional view of another headgear strap having a core and a three-piece outer layer with three seams, with the edges of the outer layer pieces embedded within the core. [Figure 219] FIG. 1 is a perspective view of a headgear strap having a core and a textured outer layer, with a portion of the outer layer cut away to expose the core. [Figure 220] FIG. 1 is a perspective view of a headgear strap having a core and a quilted outer layer, with a portion of the outer layer cut away to expose the core. [Figure 221] FIG. 1 is a cross-sectional view of a headgear layer having a core and an outer layer, the core providing a textured shape to the outer layer. [Figure 222] FIG. 1 is a perspective view of headgear having a first strap and a second strap. [Figure 223] FIG. 223 is a cross-sectional view of a first strap of the headgear of FIG. 222. [Figure 224] FIG. 223 is a cross-sectional view of a second strap of the headgear of FIG. 222. [Figure 225] FIG. 1 is a perspective view of headgear having a first strap, a second strap, and a connection between the first strap and the second strap. [Figure 226] An enlarged view of a portion of the headgear of Figure 225 including the connection portion. [Figure 227] FIG. 227 is a cross-sectional view of the connection portion of FIG. 226. [Figure 228] FIG. 1 is a perspective view of headgear having a first strap, a second strap, and a connection between the first strap and the second strap. [Figure 229] This is an enlarged view of a portion including the connection portion of the headgear in Figure 228. [Figure 230] Several possible cross sections of the strap within the connection are shown. [Figure 231] A cross-sectional view of the second strap of the headgear of Figure 228. [Figure 232A] FIG. 1 is a top view of the front strap and bifurcated strap of the intra-molded bifurcated headgear. [Figure 232B] 232B is a perspective view of a first cover layer and a second cover layer joined together to form a strap of the molded bifurcated headgear of FIG. 232A. FIG. [Figure 232C] 232B is a cross-sectional view of a first cover layer and a second cover layer joined together to form a strap of the molded bifurcated headgear of FIG. 232A. [Figure 233] FIG. 232B is a perspective view of the molded bifurcated headgear of FIG. 232A having a partially rigid front strap. [Figure 234] 232B is a perspective view of the molded bifurcated headgear of FIG. 232A having a rigid front strap and a partially rigid bifurcated strap. FIG. [Figure 235] FIG. 232B is a perspective view of the molded bifurcated headgear of FIG. 232A having a rigid front strap and bifurcated straps. [Figure 236A] FIG. 236 is a perspective view of a mold configured to form the molded-in-mold bifurcated headgear configuration of FIGS. 232A-235. [Figure 236B] FIG. 236B is a cross-sectional view of the mold of FIG. 236A taken along line AA. [Figure 236C] FIG. 1 is a cross-sectional view of a mold configured to secure a fabric casing in place therein. [Figure 236D] FIG. 10 is a cross-sectional view of a mold having retaining spikes to secure the fabric casing in place therein. [Figure 236E] FIG. 236D is a partial perspective view of the mold of FIG. 236D showing the retaining spikes that secure the fabric casing in place inside. [Figure 236F] FIG. 236D is a cross-sectional view of the mold of FIG. 236D showing the retention spikes that pierce the fabric casing but do not extend through it. [Figure 236G] FIG. 236D is a cross-sectional view of the mold of FIG. 236D showing the retention spikes penetrating the fabric casing. [Figure 237A] FIG. 1 is a perspective view of a mold for forming headgear using a woven fabric casing. [Figure 237B] FIG. 237B is a cross-sectional view of the mold of FIG. 237A. [Figure 238]10 is a cross-sectional perspective view of an alternative structure of an in-mold molded strap having a core, a cover layer, and rails. FIG. [Figure 239A] 10A-10C are cross-sectional views of alternative constructions of molded straps having an air pocket core, a cover layer, and molded rails. [Figure 239B] FIG. 239B is a perspective view of the molded strap of FIG. 239A. [Figure 239C] FIG. 239B is a cross-sectional view of the molded strap of FIG. 239A as worn by a user. [Figure 240A] 10 is a cross-sectional perspective view of an alternative construction of an in-mold molded strap having a structured core. FIG. [Figure 240B] FIG. 240B is a cross-sectional view of a mold for constructing the structured core of the molded strap of FIG. 240A. [Figure 241A] 10A-10C are perspective views of alternative constructions of in-mold formed straps having complex 3D shapes with continuously varying shape and cross-section along their length. [Figure 241B] 241B is a cross-sectional view of the molded strap of FIG. 241A taken along line AA. [Figure 241C] FIG. 241B is a cross-sectional view of the molded strap of FIG. 241A taken along line BB. [Figure 242A] FIG. 10 is a cross-sectional perspective view of an alternative molded strap with an embossed brand logo. [Figure 242B] FIG. 10 is a cross-sectional perspective view of an alternative molded-in strap with a laser cut brand logo. [Figure 242C] FIG. 242C is a cross-sectional perspective view of the alternative molded strap of FIG. 242B. [Figure 242D] FIG. 10 is a cross-sectional perspective view of an alternative in-mold formed strap with the laser cut portion removed to expose the core material. [Figure 242E] FIG. 10 is a cross-sectional perspective view of an alternative in-mold molded strap having embossed indicia and protruding indicia formed from protruding exposed core material. [Figure 242F]FIG. 10 is a cross-sectional perspective view of an alternative in-mold molded strap having protruding gripping bumps with embossed features. [Figure 242G] FIG. 10 is a cross-sectional perspective view of an alternative in-mold molded strap having embossed protruding gripping bumps. [Figure 243A] FIG. 10 is a cross-sectional perspective view of an alternative in-mold molded strap with an overmolded brand logo. [Figure 243B] FIG. 10 is a cross-sectional perspective view of an alternative in-mold molded strap having overmolded grip bumps. [Figure 243C] FIG. 243C is a cross-sectional view of the alternative in-mold molded strap with overmolded gripping ledges of FIG. 243B taken along line AA. [Figure 244A] FIG. 16 is a rear perspective view of a molded headgear configuration having a single rear strap. [Figure 244B] FIG. 244B is a cross-sectional view of the molded headgear configuration of FIG. 244A taken along line AA. [Figure 245A] FIG. 10 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] FIG. 245B is a cross-sectional view of the molded headgear configuration of FIG. 245A taken along line AA. [Figure 245C] FIG. 245B is a side view of the molded headgear configuration of FIG. 245A. [Figure 246] FIG. 16 is a rear perspective view of a molded headgear configuration having rigid front straps and elastic rear and crown straps. [Figure 247A] FIG. 16 is a rear perspective view of a molded bifurcated headgear configuration having an in-mold variable knit. [Figure 247B] FIG. 247B is a cross-sectional view of the molded headgear configuration of FIG. 247A taken along line AA. [Figure 247C] FIG. 247B is a cross-sectional view of the molded headgear configuration of FIG. 247A taken along line BB. [Figure 247D]FIG. 247B is a mold for forming the molded headgear configuration of FIG. 247A. [Figure 248A] FIG. 16 is a side perspective view of a molded headgear configuration having fully integrated bifurcated rear and crown straps. [Figure 248B] FIG. 248B is a partially exploded perspective view of the molded headgear configuration of FIG. 248A. [Figure 248C] FIG. 248B is a cross-sectional perspective view of the molded headgear configuration of FIG. 248A taken along line AA. [Figure 249A] FIG. 10 is a side perspective view of a molded headgear configuration having a core material exposed and formed on the exterior surface of the outer cover. [Figure 249B] FIG. 248B is a cross-sectional perspective view of the molded headgear configuration of FIG. 248A having a core material disposed in a recess in the outer cover. [Figure 249C] FIG. 248B is a cross-sectional perspective view showing an alternative construction of the molded headgear configuration of FIG. 248A having a core material disposed on top of the outer cover without being disposed in a recess in the outer cover. [Figure 250] FIG. 1 is a side view of an exemplary molded headgear configuration for use in combination with a full face mask. [Figure 251] FIG. 10 is a side view of an exemplary molded headgear configuration having under-ear straps for use in combination with a nasal mask. [Figure 252] FIG. 12 is a side view of an exemplary molded-in-mold headgear configuration for use in combination with a nasal pillows mask. [Figure 253] FIG. 10 is a side view of an exemplary molded-in-mold headgear configuration for use in combination with a nasal mask. DETAILED DESCRIPTION OF THE INVENTION

[0254] Reference numerals may be reused throughout the drawings to indicate general correspondence between referenced elements. The drawings are provided to illustrate example embodiments described herein and are not intended to limit the scope of the present disclosure. Embodiments of systems, components, and methods of assembly and manufacturing will now be described with reference to the accompanying drawings. Like numerals refer to like or similar elements throughout the drawings. While several embodiments, examples, and illustrations are disclosed below, those skilled in the art will understand that the invention described herein extends beyond the scope of the specifically disclosed embodiments, examples, and illustrations and can include other uses of the present invention and obvious modifications and equivalents thereof. The terminology used in the description presented herein is not intended to be construed as limiting or restrictive in any way, but is merely used in connection with the detailed description of several specific embodiments of the present invention. Furthermore, embodiments of the present invention may include several novel features, and no single feature is solely responsible for its desirable attributes or is essential to practicing the invention described herein.

[0255] Certain terminology may be used in the following description for reference purposes only and, therefore, is not intended to be limiting. For example, the terms "upper" and "lower" refer to directions in the referenced drawings. Terms such as "front," "rear," "left," "right," "back," and "side" describe the orientation and / or location of a component or portion of an element within a consistent, but arbitrary, frame of reference that becomes apparent by reference to the text and associated drawings that describe the component or element being discussed. Furthermore, terms such as "first," "second," and "third" may be used to describe separate components. Such terminology may include the terms specifically mentioned above, derivatives thereof, and terms of similar import.

[0256] As used herein, the term "substantially inelastic" refers to the ability of headgear or material to resist stretching in response to loads to which it may be subjected. Thus, the 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 of load application by the treatment for which the headgear or material is intended. Substantially inelastic headgear or material can resist stretching that would compromise the seal of a respiratory mask in a sealed system under normal or expected conditions, for example. In a non-sealed system, the substantially inelastic headgear or material can resist stretching that would compromise proper placement of a respiratory interface in response to normal or expected conditions, such as hose tension or user movement. If the expected load force is relatively low, the load will not be sufficient to cause stretching, so 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 headgear systems, and / or interface assemblies incorporating headgear systems, that automatically adjust to the correct size when attached to a user's head and that change characteristics from elastic, "stretchable" straps / straps to "non-elastic" straps / straps when in use. 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 cooperate to define the perimeter of the interface assembly, the length of which decreases as a result of the contraction force toward a minimum perimeter. The perimeter is often referred to as the "circumference," although it is unlikely to be perfectly circular. Thus, in such a configuration, the interface assembly can be placed on a user's head and, similar to elastic or "stretchable" headgear, automatically contracts to or very close to the appropriate head size. The retraction force is preferably sufficient to support the weight of the interface assembly and at least substantially maintain the interface assembly in place on the user's head at the minimum head size or the minimum useful perimeter of the interface assembly (which may or may not coincide with the minimum perimeter). In some configurations, the retraction force may be sufficient to support the weight of a nasal cannula or other small interface, which may have a weight of, for example, 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 subrange therein). In other configurations, the retraction force may be insufficient to support the weight of the interface and may require manual assistance to move the interface into a sealing position on the user's face. However, preferably, the headgear is held in place once fully retracted, for example, by a directional lock. In some configurations, the retraction force is only sufficient, or configured to support, the weight of the headgear.

[0258] However, in at least some configurations, the retraction force is less than necessary to maintain the mask in sealing contact with the user's face during treatment / use. That is, the retraction force alone cannot resist blow-off forces. In some configurations, the retraction force is insufficient to resist blow-off forces throughout the range of usable perimeters or headgear sizes. Thus, the headgear and / or interface assembly also exhibit inelastic behavior in response to forces that tend to stretch the headgear or increase the perimeter of the interface assembly. The headgear and / or interface assembly can have a locking mode that can provide a locking force that tends to resist perimeter expansion, elongation, or extension. The locking force can be sufficient to resist perimeter extension, or at least any significant elongation, in response to the blow-off force. In some configurations, the locking force is sufficient to resist extension in response to the highest blow-off forces expected for various uses or therapies (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 extension in response to forces in addition to the blowing force, such as, for example, a hose pull force. These additional forces may be collectively referred to herein as "hose pull forces," and this additional resistance to extension may be referred to herein as a "reserve."

[0259] In some configurations, the headgear and / or interface assembly also exhibits a yield force beyond which perimeter expansion or elongation is permitted. Preferably, the yield force is greater than the expected blowout force. In some configurations, the yield force is greater than the expected blowout force and hose pull force. Thus, such headgear and / or interface assembly has a reserve force. Preferably, the yield force is set low enough that a user can at least relatively conveniently apply a stretching force to the headgear and / or interface assembly sufficient to exceed the yield force so that the interface assembly can be extended and applied to the user's head. As described above, the retraction force reduces the perimeter toward the appropriate head size.

[0260] In some configurations, the headgear and / or interface assembly automatically transitions between retracted, locked, and yielded modes depending on the presence or absence of an external force. For example, the headgear and / or interface assembly moves toward or to a minimum perimeter in the absence of an external extension or stretching force. An extension or expansion force greater than the yield force can be applied to increase the perimeter of the headgear and / or interface assembly to a length sufficient to allow the interface assembly to be positioned on the user's head. When the extension or expansion force is removed (or reduced to less than the retraction force), the retraction force acts to automatically reduce the perimeter to or substantially to an appropriate head size so that the interface assembly is supported on the user's head. When treatment begins (applied insufflation force) and / or hose tension is applied, the headgear and / or interface assembly transforms to a locked mode to resist extension or increase in perimeter, or at least to resist any significant extension or increase. At the end of treatment, or at any time as desired, a force beyond the yield force can be applied to the headgear and / or interface assembly to increase the circumference and allow the interface assembly to be removed from the user's head.

[0261] Advantageously, such a configuration allows fine adjustment of the circumference of the headgear and / or interface assembly to be achieved quickly and conveniently. For example, the mask can be manipulated to make fine adjustments to the circumference during treatment or use. For example, if there is a leak between the mask and the user's face, the mask can be shaken or otherwise moved to unadjust the circumference to address the leak. In some cases, the mask seal can be pressurized against the user's face, whereby the retraction force can automatically reduce the circumference. When the mask is released, the headgear and / or interface assembly locks at or very near the reduced circumference. Thus, such a configuration allows slight manipulation (e.g., shaking) of the mask to result in fine adjustment or movement of the headgear and / or interface assembly to an adjusted circumference. Manipulation of other parts of the interface assembly (e.g., the headgear or breathing tube / gas conduit) can similarly effect fine adjustment. Due to the nature of the human head and / or the conditions in which the interface assembly is used, quick and convenient fine adjustments 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 be in contact with a surface, such as a pillow or bed. Movement of the user's head relative to such a surface may cause the headgear to move, which may change the fit of the headgear. For example, hair may move or be "compressed" beneath the headgear, which may change the fit. Headgear straps may move upward, downward, or rotate on the head, which may change the fit. Such changes in fit may result in leakage between the mask and the user's face. The adjustment techniques described above may accommodate such changes in fit automatically or with slight manipulation of the mask or other portions of the interface assembly.Furthermore, the interface assembly can be removed and reapplied, automatically adjusting to or very nearly the appropriate headgear size. In contrast, if conventional non-retractable headgear is moved from its desired adjusted position, such as by mistake or as a result of cleaning, it can be difficult and time-consuming to re-establish the desired adjusted position. While conventional elastic headgear addresses the adjustment issue, because the retraction force must resist the highest anticipated blow-out force and hose pull force at the smallest usable headgear size, elastic headgear exerts relatively large pressures on the user's head that are only partially relieved by the application of blow-out force. Such pressures can be substantial for users with relatively large head sizes and low treatment pressures.

[0262] As described below with respect to specific directional locking mechanisms, in some configurations, the headgear and / or interface assembly experiences some amount of movement during the transition from the resilient mode to the locked mode. For example, some directional locking mechanisms may cause a slight increase in circumference during the transition from the resilient mode to the locked mode. In some cases, a compromise exists between increasing yield force and reducing circumference change during the transition. Thus, reference to any particular position or circumference of the headgear and / or interface assembly may include such slight length changes, if any, during the transition.

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

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

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

[0266] Figure 3 shows the operating envelope of Figure 1 overlaid with the performance of an example headgear system with the auto-adjustment technique described above. In the example shown, the force generated by the headgear and / or interface assembly is sufficient to balance the force generated by 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 a relatively low retraction force, and then provides a retention force "on demand" that matches the actual CPAP pressure. Thus, the example headgear system can automatically adjust to meet the needs of any possible point within the CPAP envelope.

[0267] FIG. 4 shows a graph of a force-deflection curve for an example headgear device or interface assembly including a headgear device. The deflection axis of the graph may represent the circumference or perimeter of the headgear device or interface assembly. The circumference or perimeter may then represent the head circumference of a particular user when the headgear device or interface assembly is attached to that user. FIGS. 4.1-4.3 show several distinct positions in which a user may don ("wear") and fine-tune the example interface assembly including a headgear device. The graph of FIG. 4 is described below with further reference to the wearing positions of FIGS. 4.1-4.3.

[0268] The graph in FIG. 4 also illustrates an operating envelope 10 for a headgear device or interface assembly, which may be the same operating envelope illustrated and described above with reference to FIGS. 1-3. The operating envelope 10 is illustrated as a rectangular area defined between a minimum and a maximum force applied to the headgear device or interface assembly as a result of therapy, and between a minimum and a maximum head size or head circumference / perimeter of the headgear device. The operating envelope 10 may be specific to a therapy (e.g., CPAP or bilevel PAP) or may cover multiple therapies. Similarly, the head size or head circumference / perimeter may be specific to a headgear device size or may cover multiple sizes. The operating envelope 10 may be used to establish functional or behavioral criteria for a particular headgear device and is utilized herein to illustrate the features or behavior of several disclosed embodiments.

[0269] Graphs are shown containing example force-deflection curves for an example headgear device or interface assembly (referred to as "headgear" for convenience in discussing the graph) for an example operating envelope 10. The curves occur at or near the origin of the graph, which may represent approximately zero force and a minimum circumference or perimeter of the headgear (referred to as "circumference" for convenience in discussing the graph). The minimum circumference is greater than zero, but is typically less than the minimum head circumference (considering the interface, if any) of the intended user or range of users.

[0270] As shown in Figure 4.1, to place the headgear 100 on a user, the headgear 100 is typically stretched to a circumference that is larger than the user's actual head circumference. Typically, the rear portion of the headgear 100 is placed behind the user's head, and the user grasps the front of the headgear 100 (e.g., a mask or other interface) and applies a pulling force to stretch the headgear 100, moving the mask or other interface over the top of the head and toward the face.

[0271] 4, an example force-deflection curve initially rises at a steeper rate, where the force increases a substantial amount 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 referred to as the initial extension portion 12a.

[0272] At any point beyond the maximum force of the operating envelope 10, the force-deflection curve transitions to a shallower pitch, where the circumference increases a substantial amount with a relatively small increase in force. This shallow pitch portion of the force-deflection curve can be related to the yield force of the retention mechanism of the headgear 100. Preferably, the shallow pitch portion, which can be referred to as extension portion 12b of the force-deflection curve, extends at or beyond the maximum force level of the operating envelope 10 along part or all of the circumferential range of the operating envelope 10. In some configurations, extension portion 12b extends beyond the maximum circumference level of the operating envelope 10. That is, the headgear 100 can be configured to achieve a circumference greater than the intended maximum head circumference, allowing the headgear 100 to be conveniently positioned on a user having the maximum head circumference of the operating envelope 10 of the headgear 100. In use, particularly for users with head sizes 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 stretching the headgear 100 to its maximum circumference, to a circumference exceeding the operating envelope 10, or to some other circumference sufficient to accommodate a user during use, the illustrated force-deflection curve drops sharply (initial contraction portion 14a) and then transitions to a relatively shallow portion where the circumference decreases substantially with relatively small changes in force. This shallow portion of the curve can be referred to as contraction portion 14b and is partially illustrated by FIG. 4.2. Preferably, in contraction portion 14b, the headgear 100 reduces its circumference at a relatively low force level until it reaches a circumference appropriate for fitting the user's head. The headgear 100 can be placed on the user's head at this low force level (the left end of contraction portion 14b, or "fit point 16") until treatment begins or another force is applied to stretch the headgear 100.

[0274] Advantageously, the relatively low force levels can make the headgear 100 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 is necessary or desirable to resist the minimum forces induced on the headgear 100 by treatment (e.g., low CPAP levels). Thus, even at low treatment levels, the headgear 100 can be configured to generate only sufficient retention force to resist the forces 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 described below, the contraction portion 14b of the force-deflection curve may be within the operating envelope 10. Such configurations can be said to exhibit “composite” behavior. However, preferably, the contraction portion 14b of the composite behavior headgear force-deflection curve remains below the maximum force level of the operating envelope 10.

[0275] When treatment begins or another extension force is applied to the headgear 100, the force-deflection curve rises relatively steeply from fit point 16 to a point within the operating envelope 10 where the holding force of the headgear 100 balances the forces caused by the treatment and / or other forces (e.g., hose pull) tending to extend the headgear 100. Such a point can be referred to as equilibrium fit point 18. The force-deflection curve between fit point 16 and equilibrium fit point 18 can have substantially the same slope as the initial extension portion 12a. The actual location of equilibrium fit point 18 can be anywhere within the operating envelope 10, depending on the actual forces caused by the treatment and the user's actual head size. In any particular case, the force in the headgear 100 applied as pressure against the user over a region related to the headgear size is substantially only that required to counter the forces 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 the particular level of treatment being utilized. The extension portion 12b of the force-deflection curve can be spaced above the maximum force level of the operating envelope 10 to provide a reserve force that allows for the application of additional force (e.g., hose pull) without elongation of the headgear 100. Elongation of the headgear 100 can occur when sufficient force is applied to the headgear 100 to reach the extension portion 12b of the force-deflection curve. However, the headgear 100 can be designed or configured to have a force-deflection curve that accommodates expected or normal treatment forces and hose pulls, or any combination thereof.

[0276] As noted above, in at least some configurations, a user can manipulate the headgear 100 to effect fine adjustments to the circumference. Advantageously, such configurations allow a user to, for example, address a leak or tighten or loosen the headgear 100 to a desired level (reduce the circumference) simply by grasping the mask or other interface and moving (e.g., shaking) the mask or other interface relative to the user's face and a rear portion of the headgear 100, as shown in FIG. 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 rotated (e.g., about a vertical or horizontal / lateral axis), as indicated by the arrows in FIG. 4.3. Movement toward the face can reduce the circumference or tighten the headgear 100 to achieve a fit, for example, toward the firmer end of the range of acceptable or desirable fit (which may be referred to as a "tight fit"). Movement away from the face can increase the circumference or loosen the headgear 100 to achieve a fit, for example, toward the looser end of the range of acceptable or desirable fit (which can be referred to as a "loose fit"). Rotational movement about a vertical axis can tighten one side of the headgear 100 while the other side remains the same or loosens. Rotation about a horizontal or lateral axis can tighten one of the top or bottom parts of the headgear 100 and loosen the other of the top or bottom parts.

[0277] As noted above, it is not necessary that the contraction portion 14b of the force-deflection curve be located below the minimum force level of the operating envelope 10 in all configurations. The headgear 100 can be designed or configured to position the contraction portion 14b of the force-deflection curve within the operating envelope 10 and at a level that provides a sufficient degree of comfort to the user. In some cases, a user may desire the headgear 100 to apply some force to provide some tactile feedback to the user that gives the feeling of comfort that the headgear 100 is holding the interface securely in place. Such forces applied by the headgear 100 may be within the operating envelope 10 of a particular treatment, depending on the user. Thus, with such a configuration, the contraction force of the headgear 100 may be sufficient to resist therapeutic forces for at least some lower treatment levels and / or some larger head sizes, at least under some conditions.

[0278] FIG. 5 shows a graph including an example "composite" force-deflection curve. For illustrative purposes, the graph shows an example elastic headgear force-deflection curve in addition to the composite force-deflection curve. The composite force-deflection curve can be substantially similar or identical to the force-deflection curve described above in connection with FIG. 4, except that the composite force-deflection curve places a 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 forces in the lower portion 20 below the contraction portion 14b of the force-deflection curve using headgear contraction forces, which can be provided by one or more elastic elements. Forces in the upper portion 22 above the contraction portion 14b of the force-deflection curve can be absorbed by headgear retention forces, which can be provided by one or more retention elements (e.g., locks), in a manner similar to that described above in connection with FIG. 4.

[0279] An example 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 upper and lower curve portions separated by a relatively small vertical distance representing internal friction losses or hysteresis within the headgear. The force required to extend the headgear is slightly greater than the headgear contraction force. Elastic headgear exhibiting the illustrated elastic force-deflection curve 15 can accommodate only applied therapeutic or other forces below the force-deflection curve 15. Application of forces above the force-deflection curve 15 will cause the elastic headgear to extend. Therefore, the force-deflection curve 15 of the elastic headgear must be positioned above the maximum force level of the operating envelope to avoid undesirable extension under at least some conditions (e.g., high therapeutic forces or small head sizes). 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 therapeutic forces or large head sizes).

[0280] In contrast, a composite force-deflection curve (or an equilibrium fit force-deflection curve as shown and described in connection with FIG. 4 ) exhibits a relatively large vertical distance between the upper portion 12 b of the curve and the lower portion 14 b of the curve. At least a portion of the operating envelope falls within the vertical space between the upper portion 12 b of the curve and the lower portion 14 b of the curve. Thus, headgear exhibiting such a force-deflection curve can resist relatively high forces while exerting relatively low forces or pressures on a user in the absence of treatment or other elongation forces. Furthermore, once treatment begins, the force or pressure exerted on the user remains the same (if below the contraction portion 14 b of the force-deflection curve in the composite configuration) or increases substantially only to the level required to resist the applied force.

[0281] The force applied by an interface to the headgear 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 than larger interfaces, such as full-face masks, and therefore provide less force. Some interfaces (e.g., nasal cannulas) may not provide a seal with the user's face, and therefore the force applied to the headgear may be primarily related to the weight of the interface. Figure 6 shows a graph of the force required to maintain an interface in sealing contact with 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 the interface in sealing contact with the user's face, and therefore the greater the force that must be resisted by the headgear. This force can be referred to as the headgear's retention force.

[0282] The graph in FIG. 6 includes two lines 24, 26 that define the upper and lower limits of a range of acceptable retention forces for interfaces with different protruding seal areas. The two lines 24, 26 are vertically spaced from each other and extend upward from left to right at a moderate slope. The lower line 24 can represent the minimum force necessary or desired to maintain a seal with the user's face. The upper line 26 can represent a desired maximum force, which may be greater than the force necessary to maintain a seal, but is preferably low enough to maintain user comfort or avoid excessive seal collapse. The space between the lower line 24 and the upper line 26 can represent a usable 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. Lower line 24 may include one or more relatively short, steep upward slopes representing transitions between interface types, such as from nasal pillows to a nasal mask and from a nasal mask to a full face mask. Upper line 26 is shown as a straight line, but may include steep slopes corresponding to those of lower line 24 to maintain a constant target adjustment range.

[0283] The graph in FIG. 6 also includes a flat or horizontal line 30 at a force level above the target range or target zone 28. This line 30 represents the force that will or may cause skin damage to a user over a relatively short period of continuous use of a particular headgear. This line 30 can be referred to as the maximum force line 30. Actual force values ​​may vary depending on specific headgear characteristics, such as 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 headgear force adjustment. As shown, the error range 32 is reduced for interfaces with large protruding seal areas, such as full-face masks, compared to interfaces with small protruding seal areas, such as nasal pillows or nasal masks. Therefore, it is desirable for headgear to be easily or conveniently adjustable to within or near the target zone 28, especially for interfaces with large protruding seal areas. Conventional non-elastic headgear incorporates relatively coarse adjustments, such as one or more adjustable loops secured with hook-and-loop fasteners. Such headgear can be difficult to adjust within the target zone 28, especially in environments where the wearer of the headgear is not the person making the adjustment, which often occurs, for example, in a hospital.

[0284] FIG. 7 shows a three-dimensional graph of the relationship between headgear force, projected seal area, and circumference. The graph in FIG. 7 is a combination of the graphs in FIG. 6 and FIG. 4. The graph in FIG. 7 shows the minimum force 24 (line 24 below target zone 28 in FIG. 6) that will create a seal between the interface and the user's face. Below the minimum force line 24, the headgear force may be insufficient to create or maintain a seal. The graph in FIG. 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 is a safe operating envelope for headgear force. The upper line of the target range has been omitted for clarity.

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

[0286] In at least some configurations, headgear exhibiting a balanced fit or compound force-deflection curve as 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 a suitable holding force within the safe operating envelope, preferably within a target zone. Thus, under- or over-tightening by the user or another person can be reduced or eliminated.

[0287] As described above, the example headgear system performs several functions in the process of donning, using, and removing an interface or mask system. For example, the headgear system expands in length so that it can be positioned over a user's head. The headgear system contracts in length during the "donning" process, providing 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 an elastic or stretchable behavior to an inelastic behavior. The headgear system also allows for fine adjustments to tighten or loosen the mask based on the user's preference during use. For removal, the headgear system expands in length so that it can be removed over the user's head. One or more combinations including all of these features provide a mask system that requires minimal user interaction for attachment and removal. This can eliminate the possibility of misuse and contribute to improved usability of the mask system. The example headgear system can also mitigate the effects of excessive pressure on the skin by reducing the likelihood or even likelihood of over-tightening the headgear. Exemplary headgear systems can improve overall compliance with treatment. A further feature of this is a high degree of positioning and stability, both during mask removal and reattachment and during use. Disclosed herein are one or more concepts for achieving repeatable and stable positioning of the headgear and associated interface assembly on the patient's or user's head. Also disclosed herein are one or more concepts for achieving a headgear system that supports variable behavior by providing portions that can be selectively elastic or inelastic and portions that provide inelastic behavior.

[0288] Figures 8A and 8B graphically illustrate the force profiles of constant and variable pressure treatments, respectively, for a full-face mask, along with the associated extension behavior of elastic and non-elastic headgear systems. Figure 8A includes two graphs of the force and extension, respectively, induced in the headgear over time by applying a constant pressure treatment, such as CPAP at 10 cm of HO. The top graph shows the force induced in the headgear by a combination of applied gas pressure and mask enclosing area, or simply mask area. While the treatment delivery pressure is constant, the force curve includes small oscillations caused by the user breathing, resulting in pressure changes within the mask. The bottom graph shows the resulting extension or movement within the headgear system, and therefore the mask body, as a result of the applied force. Two extension lines 34, 36 are shown in the bottom extension graph. The first line 34 shows the extension behavior of state-of-the-art elastic headgear, which extends in response to applied force. In the example shown, the elastic headgear stretches approximately 8 mm under CPAP pressure compared to its length without CPAP pressure. A second line 36 shows the stretch behavior of state-of-the-art non-elastic headgear. As shown, non-elastic headgear exhibits very little stretch in response to applied force.

[0289] FIG. 8B similarly includes graphs of the force and elongation, respectively, induced in the headgear over time by applying an oscillating or variable pressure therapy, such as NIV or bilevel PAP. For example, an exemplary therapy varies between a pressure of approximately 5 cm of HO (e.g., expiratory positive airway pressure—EPAP) and approximately 12 cm of HO (e.g., inspiratory positive airway pressure—IPAP). The top graph shows the force induced in the headgear by a combination of applied gas pressure and mask enclosure area, or simply mask area. The bottom graph shows the resulting elongation or displacement within the headgear system, and therefore the mask body, as a result of the applied force. Two elongation lines 34, 36 are shown in the elongation graph. The first line 34 shows the elongation behavior of state-of-the-art elastic headgear, which elongates and contracts with increasing and decreasing applied force. In the illustrated example, the elastic headgear elongates from approximately 4 mm to approximately 12 mm (at low and high pressures, respectively) in response to the variable force curve compared to its length without CPAP pressure. To reduce or prevent this movement, the typical practice is to overtighten the headgear system 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 wound care. The second line 36, similar to Figure 8A, shows the stretch behavior of state-of-the-art non-elastic headgear, which exhibits very little stretch but has the limitations and drawbacks discussed above.

[0290] As shown in the examples, a non-overtly constricted state-of-the-art headgear system used with a full-face mask will expand in length to move approximately 8 mm to approximately 12 mm during a change from peak inspiratory pressure to end-expiratory pressure in the case of NIV, or from IPAP to EPAP in the case of bilevel ventilation. In at least some configurations, the present directional locking headgear system behaves similarly to non-elastic headgear in response to the application of forces in a direction that tends to stretch the headgear. However, such configurations of directional locking headgear systems exhibit one or more advantages of elastic headgear (e.g., self-sizing or self-fit) without the disadvantages associated with non-elastic headgear (e.g., time-consuming and difficult adjustment). In at least some configurations, headgear systems incorporating directional locking mechanisms result in less than approximately 4 mm of headgear expansion or mask movement in response to applied forces during treatment, compared to the condition when applied to the user but without system pressure. In some configurations, headgear systems incorporating directional locking mechanisms provide less than about 4 mm of headgear extension or mask movement between high or maximum therapeutic pressure conditions and low or minimum therapeutic pressure conditions (e.g., between peak inspiratory pressure and end-expiratory pressure in the case of NIV).

[0291] The functional behavior of example headgear systems includes various headgear elements with extension characteristics at design-specific locations, allowing elastic or stretchable behavior to be switched on and off on demand, preferably with one or more of the directional locking and / or directional friction mechanisms disclosed herein. This can include various features of the headgear being configured to provide predetermined performance attributes at predetermined locations. For patient interfaces used in respiratory applications, the locations of these features can depend on the desired interface type and number of support surfaces. A support surface can be defined as one or more planes for resolving forces generated within the interface assembly.

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

[0293] FIG. 10 illustrates a nasal interface, such as a nasal pillow mask, nasal mask, or nasal cannula, having multiple (e.g., two) retention surfaces. As described with reference to FIG. 9, each retention surface is defined by a line on each side of the interface assembly, the lines extending between a point on the nasal interface and a point on the rear portion of the headgear. In the configuration of FIG. 10, the retention surfaces are offset from one another to define an angle in the anterior-posterior direction or from the side. In the configuration shown, the first retention surface extends through a relatively upper point on the nasal interface, and the second retention surface extends through a relatively lower point on the nasal interface. The first and second retention surfaces can extend through a single point on the rear portion of the headgear (or very close to one another), or can be spaced apart at the rear portion of the headgear, with the surfaces either bisecting (intersecting) each other between the nasal interface and the rear portion of the headgear, or spaced apart between the nasal interface and the rear portion of the headgear. In the illustrated configurations, the first support surface is positioned at or near the upper edge of the inlet, breathing tube connector, or gas conduit connector, and the second support surface is positioned at or near the lower edge of the inlet, breathing tube, or gas conduit. In some configurations, the support surface may extend along a physical portion of the headgear or interface assembly. However, in other configurations, the support surface may not extend along a physical portion of the headgear or interface assembly. That is, for example, the support surface may not be aligned with the straps of the headgear.

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

[0295] FIG. 12 shows a nasal mask with two support surfaces. Similar to the full-face mask of FIG. 11, the illustrated nasal 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, a first or upper support surface extends between the T-piece and an upper portion of the rear portion of the headgear. The upper support surface can extend above the user's eyes and ears. The upper support surface can be generally horizontal but can be angled somewhat in the front-to-back direction. For example, the upper support surface can be angled somewhat downward in the front-to-back direction, passing between the user's forehead and the center or rearmost point of the rear of the user's head. A second or lower support surface extends between the base of the mask and a lower portion of the rear portion of the headgear. The lower support surface can extend from a point around the user's nose to a point aligned with or below the user's ears. The lower support surface can be generally horizontal but can be angled somewhat in the front-to-back direction. For example, the lower support surface may be angled downward somewhat in the front-to-back direction. The upper support surface may extend along the upper strap of the headgear. The lower support surface may extend between the front and rear ends of the lower strap of the headgear. The illustrated lower strap may be curved to accommodate the user's ears so that the lower support surface does not overlap the middle portion of the lower strap. In either of the interface assemblies of FIGS. 11 and 12, the lower support surface may pass through (e.g., through or near) the inlet, breathing tube connector, or gas conduit connector of the interface.

[0296] FIG. 13 shows an alternative configuration applicable to either full-face or nasal masks, in which there are two retention surfaces that converge at a single point within the headgear system. The retention surfaces can be vertically spaced apart on the interface to provide some stability to the interface. For example, in a full-face mask, the upper retention surface can pass over or above the underside of the user's nose, and the lower retention surface can pass near or below the user's mouth. In a nasal mask, the upper retention surface can pass above the underside of the user's nose, and the lower retention surface can pass above the underside of the user's nose. The retention surfaces can intersect at a point generally above and / or in front of the user's ears. The portions of the interface assembly that connect the mask to the rear portion of the headgear can be separate or interconnected, potentially allowing a single adjustment to change the lengths of at least the upper and lower portions. The length ratio of the upper and lower portions can be easily adjusted by moving the interconnecting point located at the headgear connection point. The illustrated full-face mask does not include a forehead rest or "T-piece." However, in some configurations, a T-piece may be provided. If desired, an additional headgear element or strap may connect the rear portion of the headgear to the T-piece of the mask.

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

[0298] Generally, a highly stable headgear configuration may be universal or may provide at least an acceptable level of support for many or all interface types, or at least 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, at least without taking certain measures to increase the stability of the inherently less stable configuration. Generally, larger interfaces require or benefit from headgear that provides greater stability. For larger interfaces, such as full-face masks, it is often desirable or may be necessary to provide at least two support surfaces. It may be advantageous for the two support surfaces to be separated from each other vertically or heightwise at the interface (e.g., at the point of attachment to the interface). Generally, for a given headgear configuration, the greater the separation between the support surfaces at the interface, the more stable the configuration. In some configurations, it may be advantageous for at least one of the support surfaces to include an upward vector component.

[0299] One example headgear type provides a single retention surface. An example of such a configuration is discussed herein with reference to FIG. 9. Generally, single-retention-surface headgear may not be practical for use with full-face interface types because it does not provide a desirable level of stability for the mask. Thus, while the headgear may be able to secure the mask in place and maintain a seal, the mask may relatively easily shift and break the seal, or the interface assembly may be operable but not provide a reliable feel to the user. In some cases, single-retention-surface headgear may not provide an acceptable level of stability for the mask. However, some configurations of single-retention-surface headgear may be suitable for use with full-face masks. For example, single-retention-surface headgear utilizing rigid materials and / or configurations (e.g., shapes) may be suitable for use with full-face masks by providing resistance to rotation of the mask about a lateral axis. Additionally, the single-retention surface headgear may be suitable for use with a full-face mask by careful positioning of the single-retention surface relative to the full-face mask as shown in and described below with reference to Figure 13.2. The single-retention surface interface may be suitable or practical for use with a nasal interface, such as a nasal mask, nasal pillows, or prongs and cannula.

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

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

[0302] Distributed gravity can be summarized as a single point force ("gravity") acting on the mask and CPAP at the center of gravity, which may depend on the particular size and shape of the mask. In some configurations, the single support surface extends vertically between or passes through a point between the chin force and the insufflation force.

[0303] The distributed blowout force can be summarized as a single-point force ("blowout force") acting on the mask at a specific location, which may depend on the specific size and shape of the mask and / or the predetermined shape of the user's face. The blowout force may generally be located in the lower half of the mask height, such as at or near the mask's geometric center. Assuming a generally triangular mask, the blowout force may be located approximately one-third of the height from the bottom of the mask. In some configurations, the single support surface extends vertically between the chin force and the blowout force or passes through a point between them. Advantageously, such a configuration can provide a desired level of stability for a full-face mask with a single support surface. However, this configuration can be applied to multiple support surface configurations as well, with additional support surfaces providing additional stability.

[0304] The nasal bridge region can be a sensitive anatomical site, and it can be desirable to avoid excessive force or pressure in this area. Thus, when the nasal bridge force is zero or minimal, the headgear force can be the only force suppressing the insufflation force. If the headgear force passes through a point vertically higher than the insufflation force, the nasal bridge force increases, which is generally undesirable. If the headgear force is too low or too close to the chin force, it may not suppress the insufflation force or may provide an undesirably low level of suppression of the insufflation force, thereby compromising the sealing performance of the interface assembly. As described herein, the support surface preferably includes a directional locking mechanism that provides appropriate resistance to extension of the headgear in response to the insufflation force. In combination with the positioning of the support 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-support surface type headgear. As with the other headgear assemblies described herein, adequate stability can be achieved without excessive headgear tightening, which often occurs with prior art headgear devices.

[0305] Another example headgear type provides two support surfaces that converge in a forward position (i.e., toward or at the interface). The term "converging" as used herein in connection with Figure 13.1 is intended to describe support surfaces that are not substantially separated from one another at the interface or attachment point. While the support surfaces may meet at a single attachment point, converging headgear types could also include support surfaces attached adjacent to or close to one another. Two-support surface, forward-converging headgear types may be suitable or at least somewhat practical for use with full-face headgear because the additional support surface can provide sufficient additional stability relative to single-support surface headgear. As described with respect to single-support surface headgear types, two-support surface, forward-converging headgear types can employ rotation-resistant materials and / or configurations to provide improved performance with full-face masks. Two-support surface, forward-converging headgear types may also be suitable or practical for use with nasal interfaces, such as nasal masks, nasal pillows, or prongs and cannulas.

[0306] Yet another example headgear type provides two support surfaces that converge in a rearward position (i.e., away from the interface, such as at the rear portion of the headgear). Two-support surface, rearward-converging headgear types 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 shown and described herein in connection with FIGS. 10 and 13, which include nasal and full-face interfaces, respectively. Two-support surface, rearward-converging headgear types may be less practical for use with pillow or prong interface types because such interface types typically have a relatively small vertical or height dimension. The small height of pillow and prong interface types may limit the ability to space the attachment locations of the support surfaces on the interface and provide triangulation of the support surfaces, at least without increasing the height dimension beyond what is needed, which may be undesirable because pillows and prongs are often selected by users precisely because of their relatively small height dimension. Two-surface, backward-converging headgear types may not be practical for use with cannulas because they do not need to provide a sealing force against the cannula. Therefore, two-surface, backward-converging headgear types may be more than necessary for use with cannulas. Furthermore, two-surface, backward-converging headgear types may not be practical for use with cannulas for the same reasons as pillows and prongs. Cannulas generally have a smaller height dimension than pillows and prongs. However, at least in some configurations or under some circumstances, it may be practical or even desirable to use two-surface, backward-converging headgear types with pillows, prongs, or cannulas.

[0307] Yet another example headgear type provides two support surfaces that are separate and angled or non-parallel to each other. In some configurations, the upper support surface can be angled upward in the anterior-posterior direction. The lower support surface can be generally horizontal or angled. In other configurations, the lower support surface can be angled in either direction. The upper support surface can be generally horizontal or angled. Two-support 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-support 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 discussed above with respect to two-support surface, posteriorly converging headgear types. Similarly, two-support surface, separate / angled headgear types may be impractical for use with cannulas for the same reasons as pillow and prong interface types, as discussed above.

[0308] Another example headgear type provides two support surfaces that are generally or substantially horizontal or parallel to one another relative to one another. Examples of such two-support surface, parallel headgear types are shown and described in connection with FIGS. 11 and 12. Two-support 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-support surface, parallel 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 reasons described above with respect to two-support surface, backward-converging headgear types. Two-support surface, parallel headgear types may be impractical for use with cannulas for the same reasons as pillow and prong, for reasons described above with respect to two-support surface, backward-converging headgear types.

[0309] Positioned or otherwise configured to act along at least one of the support surfaces or lines is at least one mechanism or feature ("locking mechanism") capable of transforming the function of the headgear from an extensible to a non-extensible behavior. Along this surface, the directional locking feature can be configured to operate as a single mechanism for a given support surface, or preferably to provide two independent locking mechanisms. A single mechanism configuration can change the circumference or circumference 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 and right control for fine adjustment of the attachment of a mask or other interface. In other configurations, three or more locking mechanisms can be provided. In such configurations, multiple locking mechanisms can be provided on each side of the headgear or interface assembly. Alternatively, the locking mechanisms can be positioned in other ways (e.g., one on each side and additional mechanisms on the top and / or back), and the locking mechanisms can cooperate to allow adjustment of the circumference or circumference 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 a full-face mask 210 with a forehead support or T-piece as shown in FIGS. 14 and 15 , the mask 210 is connected to the rear portion of the headgear 220 on each side of the interface assembly 200 by upper and lower connection portions, for example, in the form of straps 230. The configurations of FIGS. 14 and 15 show examples of multiple locations where the locking feature or mechanism 240 can be located. In the illustrated configuration, the interface assembly 200 includes an elastic retraction feature 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 located at the connection between the headgear 220 and the mask 210, such as incorporated into an attachment fastener 260 (e.g., a clip) to the mask body as shown in Figure 14. Alternatively, the directional locking mechanism can be located in a suitable location within the headgear 220, such as between the rear portion of the headgear 220 and the strap portion 230 connecting the rear portion of the headgear 220 to the mask 210, as shown in Figure 15. In other configurations, similar configurations using multiple retention surfaces can be utilized.

[0311] In some configurations, the directional locking mechanism or module utilizes a lock coupled to or otherwise movable with one portion of the interface assembly and an adjustment member 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 circumference of the headgear or interface assembly. The adjustment member can be in the form of a core member, which can be a wire or filament, or can be a strap, for example. A portion of the adjustment member can be utilized to define a portion of the circumference or circumference at any given size adjustment of the interface assembly, while another portion can be excess or surplus length that is not utilized at the given adjustment size. The excess length changes as the circumference or circumference of the headgear or interface assembly changes. The accumulation of excess length can be accommodated in any suitable configuration, such as within an integral component within the mask frame or headgear system.

[0312] 16 and 17 show configurations applicable to nasal interfaces 300, such as nasal masks 310 (which may or may not have a forehead rest or T-piece, but often do not) or nasal cannulas. In these configurations, the directional locking mechanism 340 can be integrated onto or operate from the flat straps 330 or webs, as described above. The use of flat straps 330 is particularly beneficial in applications where the force vectors between the pressurized mask seal and the headgear are not aligned. This results in situations where moments are generated that are preferably sufficiently resolved by the stiffness within the headgear system. This can be achieved by selecting the torsional and bending stiffness characteristics of the headgear straps, which in combination provide a significantly increased level of rotational stability to the mask system.

[0313] In situations where a straight line between the headgear attachment points and the mask 410 attachment points provides an acceptable location for headgear components or components providing a connection between the mask and the rear portion of the headgear 420, use of a flexible core design 430, as shown in Figure 17, may be desirable. That is, unless constrained to an altered shape, the flexible core will assume a straight line between attachment points. Thus, the flexible core design is suitable for use in configurations where a straight line path for the directional locking mechanism 440 (e.g., between the rear portion of the headgear 420 and the mask 430) is the desired or acceptable location for the mechanism 440.

[0314] In some configurations, a combination of flat strap and flexible core configurations can be used, such as in applications where two or more support surfaces are desired or necessary. For example, the configurations of FIGS. 11 and 12 or the configurations of FIGS. 14 and 15 can utilize a flat strap configuration along one of the upper or lower support surfaces and a flexible core configuration along the other of the upper or lower support surfaces. In some configurations, the lower straps can be configured to utilize a flat strap configuration and the top straps can be configured to utilize a flexible core configuration. For example, as shown, the lower straps can have a curved shape along their length to provide space to pass under and accommodate the user's ears. However, the upper straps can be generally straight along their length. In some configurations, the upper straps can utilize a flat strap configuration and the lower straps can utilize a flexible core configuration. For example, the rear portion of the headgear can be configured to position the attachment points so that a straight line between the headgear attachment points and the mask attachment points is properly located. Additionally, as shown in Figures 18 and 20, flexibility with the positioning of the directional locking mechanism is possible by using flat or relatively rigid headgear sections to aid in torsional or bending stability along the sides of the user's head when connected in line with the flexible core configuration.

[0315] When either a high constant pressure waveform or a variable pressure waveform is used in conjunction with a respiratory ventilation pattern, such as non-invasive ventilation or bilevel ventilation, significant performance benefits of a directional-lock type headgear system or interface assembly arise because the headgear system does not stretch during use, or the circumference or perimeter of the interface assembly remains constant. As noted above, current state-of-the-art headgear devices can generally be categorized as elastic or non-elastic. As noted, non-elastic systems can accommodate high constant pressure or variable pressure, but they are prone to over-tightening and difficult and time-consuming to adjust. Current state-of-the-art elastic headgear systems tend to stretch in response to high constant pressure, or to stretch and contract in response to pressure waves in a variable pressure waveform. This stretching and contraction can cause the mask to move cyclically on the user's face, potentially resulting in leaks. Leaks, in turn, can lead to loss of therapy and / or false triggers of breathing due to the resulting volume and associated pressure changes within the mask. Additionally, the cyclical movement of the mask can result in abrasions and possible skin damage due to the movement or movement of the mask on the user's face.

[0316] FIGS. 18 and 19 show examples of interface assembly portions or modules configured to extend between a mask or other interface and a rear portion of 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 overall headgear system, including the module. The module includes an elastic section 520 extending between the removable clip 510 and a 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 can be of any suitable configuration, such as, for example, a braided member including one or more elastic elements. FIG. 18 shows a variation with the directional lock 530 located at the rear end of the elastic section 520 and / or at the connection between the module and the rear portion of the headgear, which positions the directional lock 530 spaced from the mask, such as in the positions shown in FIGS. 15 and 17.

[0317] FIG. 19 shows an alternative variation in which the directional lock 530 is located at a location spaced from the module and / or at the connection between the module and the rear portion of the headgear. Such a configuration may be referred to herein as a “remote” locking mechanism. In some configurations, the lock may be located elsewhere in the headgear system, such as within the rear portion of the headgear, with a hollow conduit bridging the distance between the connection between the module and the rear portion of the headgear and the location of the directional lock. Such a configuration may allow the directional lock to be located in a more suitable or desirable location within the headgear system, such as the location shown in FIG. 20.

[0318] 20 , interface assembly 600 includes a mask 610 or interface (such as a nasal interface in the illustrated configuration) and a headgear apparatus with a rear headgear portion 620 that engages with the rear and / or top of a user's head. Interface assembly 600 also includes an adjustment portion 630 that allows adjustment of the distance between mask 610 and the rear portion of headgear 620. Adjustment portion 630 may be part of the headgear apparatus, or part of the interface, or may be a separate component of the interface assembly.

[0319] In the illustrated configuration, the adjustment portion 630 includes an elastic material 640, which can be configured to return toward 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-elastic and elastic elements. The non-elastic elements can provide a hard stop or maximum stretch, and the elastic elements can provide a contraction force. In other configurations, the elastic elements 640 or other biasing mechanism can be positioned remote from the elastic material of the adjustment portion 630.

[0320] The illustrated interface assembly also includes a variable locking mechanism, such as a directional locking mechanism. The illustrated directional locking mechanism includes a directional lock 650, a filament core 660, and a filament guide 670 or housing (e.g., a conduit or tube). Such a configuration allows the directional lock 650 to be spaced or remote from an attachment location 680 between the adjustment portion 630 and the rear headgear portion 620. Furthermore, the filament configuration allows the directional lock 650 to be positioned in a non-linear configuration with the adjustment portion 630. In other words, the functional axis of the directional lock 650 can be offset or angled relative to the axis of the adjustment portion 630 and / or the holding surface of the interface assembly 600.

[0321] The filament housing 670 can extend between the directional lock 650 and an attachment location 680 between the adjustment portion 630 and the rear headgear portion 620. In the illustrated configuration, the filament housing 670 follows a curved path between the directional lock 650 and the attachment location 680 between the adjustment portion 630 and the rear headgear portion 620. For example, the directional lock 650 can be disposed on the crown strap 690 of the rear headgear portion 620, and the filament housing 670 can curve upward at a point on the crown strap 690 posterior to the attachment location 680. The directional lock 650 can be disposed at any desired point on the crown strap 690, including, for example, the side or the top or vertex. In other configurations, the directional lock 650 can be disposed on other portions or locations of the rear headgear portion 620, such as the side or rear of the rear strap of the rear headgear portion 620. Such a configuration allows the directional lock 650 to be located in a more desirable location than the attachment point between the adjustment portion 630 and the rear headgear portion 620 (referred to herein as a "remote" attachment). For example, locating the directional lock 650 at the top of the crown strap 690 can avoid contact with other objects (e.g., pillows) in many environments (e.g., when the user is sleeping on their back or side). The particular location of the directional lock 650 can be selected based on various relevant factors, such as comfort, clearance (e.g., for eyeglasses), filament length, etc., among others.

[0322] In some configurations, the filament housing 670 extends beyond the directional lock 650 to accommodate excess filament 660 not being utilized to support a load within the interface assembly 600. The portion of the filament housing 670 beyond the directional lock 650 may be referred to as an accumulation portion 700 or accumulation conduit. The portion of the filament housing 670 between the directional lock 650 and the attachment location 680 between the adjustment portion 630 and the rear headgear portion 620 may be referred to as a connection portion 710 or connection conduit. While shown herein as a tube, the filament housing 670 may be provided in other forms as well, such as, for example, a filament guide. The filament guide configuration may not completely enclose the filament but may simply provide a guide surface at a specific, discrete location to direct the filament along a desired path.

[0323] One or more adjustment portions and / or transformable locking mechanisms can be provided on each side of the interface assembly. The portions of the transformable locking mechanisms on both sides of the interface assembly can be integrated with each other or share components. For example, a storage portion of a filament housing can connect a directional lock on one side of the interface assembly with a directional lock on the other side of the interface assembly. In some configurations, a single housing can be provided on the top or rear of the interface assembly, which can house two separate locking mechanisms that interact with elements (e.g., filaments) associated with the transformable locking mechanisms on both sides of the interface assembly. Alternatively, the separate transformable or directional locking housings associated with the locking mechanisms on both sides of the interface assembly can be positioned near each other (longitudinally or laterally adjacent), for example, at the top or rear of the rear headgear portion.

[0324] Headgear systems incorporating the disclosed transformable mechanisms, which allow portions of the headgear to be selectively switched from a non-elastic to an elastic behavior to facilitate convenient attachment and detachment, offer numerous user advantages. Examples of mechanisms for achieving this behavior are disclosed herein and in applicant's PCT / NZ2014 / 000074, the entire contents of which are incorporated herein by reference. In some configurations, one or more of these advantages relate to the ability to provide automatic adjustment, self-sizing, or a more intuitive adjustment interaction for the user. Furthermore, in at least some configurations, headgear systems incorporating the disclosed transformable mechanisms can reduce or minimize unwanted mask body movement compared to state-of-the-art headgear systems, which are typically constructed from laminates of elastic material with stitched or sewn components or elastic knit structures. These conventional designs can result in mask movement caused by hose tension or the interaction of applied breathing pressure with the mask. Such migration can result in conditions ranging from leakage, loss of therapy, and incorrect breathing patterns due to resulting volume and pressure changes, to skin abrasions or possible skin damage. To counter this migration, a common practice is to overtighten the headgear (by applying high elastic forces in elastic systems or by manually overtightening in adjustable non-elastic systems) so that the force required to stretch the headgear is greater than the force generated by hose tension or through mask pressurization. The additional pressure exerted on the user as a result of this overtightening can result in user discomfort, skin irritation, or skin damage.

[0325] One or more features of the auto-fit or transformable headgear systems disclosed herein allow for elastic behavior to be constrained to predetermined regions of the headgear system, where the elastic behavior is selectively turned on or off depending on utility conditions rather than a global property of the headgear. This provides the opportunity to "engineer" the remainder of the headgear system to provide predetermined performance attributes. In at least some configurations, the primary result of the orchestrated transformable headgear system combination is to provide behavior with little or no mask body movement during use.

[0326] 21 and 22 show example headgear systems 800 for a full-face mask 810 (FIG. 21) and a nasal pillow mask 812 (FIG. 22). The illustrated region 840 indicates the currently preferred location for the portion where the selectable elastic / inelastic functionality resides. In each application, the selectable elastic / inelastic portion 830 is positioned between the mask 800 and the rear portion of the headgear system 820, extending 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 little elastic behavior within the range of forces encountered during normal or expected use. To achieve this behavior, both the headgear configuration and material construction have a significant impact in some configurations.

[0327] form 23 and 24, the use of top or crown straps 940 and straps that pass around the back of the user's head (rear straps 910) as disclosed herein takes advantage of the shape of the human head to provide repeatability through filament positioning and stability for the headgear 900 when in use. Additional design features can be added to this basic crown strap 940 and rear strap 910 configuration to further enhance these desirable properties, namely, the addition of a gusset 920 or web that connects the rear or lower strap 910 to the crown strap 940, as shown in FIGS. 23 and 24. The addition of a gusset 920 or web member reduces relative movement between the rear strap 910 and crown strap 940, resulting in a more laterally stable design.

[0328] The gusset 920 can be attached to the back strap 910 and the crown strap 940 at any suitable location. The attachment points 930, 960 of the gusset 930 on the back strap 910 and the crown strap 940 can be substantially equidistant or equidistant from a junction 950 between the back strap 910 and the crown strap 940, or can be spaced at different distances from the junction 950. In the illustrated configuration, the gusset 920 is attached to the crown strap 940 at a distance farther from the junction 950 than the distance from the junction 950 at which the gusset 920 is attached to the back strap 910. The distance from the junction 950 to the gusset 920 on the crown strap 940 can be approximately twice or more the distance from the junction 950 to the gusset 920 on the back 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 junction 950 at the crown strap 940 and the attachment point 960 of one of the gussets 920. That is, the length of the distance between the gussets 920 at the crown strap 940 is less than one-third of the total length of the crown strap 940. The rear straps 910 and / or crown straps 940 may be continuous or discontinuous. Sections of the discontinuous rear straps 910 or crown straps 940 may be connected by a suitable joint, which may be fixed length, elastic, or adjustable.

[0329] construction / manufacturing The overall shape of the headgear can be manufactured by 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 a single or multiple thermoplastic or thermoset materials. In some configurations, the headgear or head frame is constructed from a single material with various cross-sectional shapes that provide areas of increased or decreased torsional and / or bending stiffness to allow the headgear to smoothly conform to the human head shape, as shown in Figures 25-28. In other configurations, the headgear can be constructed by co-molding or multi-molding different materials in various sections to achieve the same or similar behavior, as shown in Figure 29.

[0330] Various portions of the headgear can be constructed to provide desired properties in desired portions or regions of the headgear. For example, for the portion extending over the user's ears (Section 1), it may be desirable to provide limited flexibility so that bending about a horizontal axis or twisting about a vertical axis is restricted. The rear portions of Section 1 (Sections 2 and 3) desirably conform closely to the shape of the human head. Desirably, each of Sections 1, 2, and 3 exhibits relatively inelastic behavior within the range of forces typically encountered or expected during use. Various combinations of materials can be used to achieve such behavior. In the illustrated example, thermoplastic elastomers or thermoplastic urethanes of various Shore hardnesses are used to achieve the desired behavior.

[0331] As discussed above, headgear can include various sections with varying cross-sectional dimensions to allow for varying headgear characteristics in different regions of the headgear. Referring to FIGS. 25-28 , a rear headgear section terminating generally in front of and above the user's ears is shown and is simply referred to as headgear 1000. Three vertical sections of headgear 1000 are shown. Section 1 is located at the portion of headgear 1000 that extends above and forward of the user's ears. Section 2 is located at the portion of headgear 1000 that is rearward of section 1 and can be positioned generally 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 located at a position on the headgear rearward of sections 1 and 2. In the illustrated configuration, section 3 is located at a rear position of the headgear 1000 that can contact the rear of the user's head.

[0332] Preferably, the portion including section 1 is relatively tall and provides resistance to vertical bending loads that tend 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 opposing the airflow force of the interface. As a result, it may be preferable to increase the area of ​​the rear portion by giving the rear portion 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. In other configurations, other dimensions can be used. For example, the dimensions can vary, and the headgear 1000 can maintain the same height ratio between each and every one of sections 1, 2, and 3. In other configurations, the 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 headgear 1000 varies gradually between sections 1, 2, and 3. The actual height at any point on headgear 1000 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 a reduced thickness from the front end to the rear end. For example, the portion including section 1 can have a thicker cross-section relative to the portions including sections 2 and 3, such that the portion including section 1 (the front end portion) has a greater resistance to torsional loads. Furthermore, the portion including section 2 can have a thicker cross-section relative to the portion including section 3. Thus, the portion including section 2 has a greater resistance to torsional loads than the portion including section 3. In some configurations, the difference in thickness between the portion including section 1 and the portion including section 2 is greater than the difference in thickness between the portion including section 2 and the portion including section 3. The reduced thickness of the portions including sections 2 and 3 allows these portions to flex laterally to better conform to the particular shape of the user's head. In the illustrated configuration, the thickness of section 1 is approximately 1.5 mm, the thickness of section 2 is approximately 1 mm, and the thickness of section 3 is approximately 0.8 mm. Other dimensions can be used in other configurations. For example, although the dimensions may vary, the headgear 1000 may maintain the same thickness ratio between each and every one of sections 1, 2, and 3. In other configurations, the dimensions may vary by a predetermined number (e.g., 0.1 mm, 0.2 mm, or 0.3 mm) or a percentage thicker or thinner than the illustrated dimensions. In some configurations, the thickness of the headgear 1000 varies gradually between sections 1, 2, and 3. The actual thickness at any point of the headgear 1000 may be selected to address appropriate performance parameters, such as resistance to torsional loads and lateral flexibility for improved fit.

[0334] Referring to FIG. 29 , as described above, the headgear 1100 may alternatively or additionally have different material types throughout the headgear 1100 to provide different properties in different portions of the headgear 1100. The headgear 1100 of FIG. 29 shows three sections taken at three different locations within the headgear 1100, which may be the same or substantially the same as the locations of the headgear 1100 of FIGS. 25-28. The portion including section 1 may be constructed from a first material or combination of materials, such as polypropylene. As with the headgear 1000 of FIGS. 25-28, the material selection for the portion including section 1 may take into account the desire to provide resistance to bending in the vertical direction. The material or combination of materials for the portion including section 2 may be different from the materials of one or both of the portions including sections 1 and 3. For example, the portion including section 2 may be constructed from a second material or combination of materials, such as a combination of thermoplastic polyurethane (TPU) and thermoplastic elastomer (TPE). The material or combination of materials for the portion including section 3 may be different from the material for one or both of the portions including sections 1 and 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 headgear 1100 may be the same or similar to the considerations described with respect to dimensional selection in Figures 25-28.

[0335] In some configurations, due to material selection, headgear 1100 has different durometers or hardnesses in different portions. For example, the portion including section 1 can have the highest durometer. In some configurations, the portion including section 1 can have a durometer of approximately 65 Shore D to 70 Shore D. The portion including section 2 can have a durometer less than the durometer of the portion including section 1. In some configurations, the portion including section 2 has the lowest durometer of the portions including sections 1, 2, and 3. For example, the portion including section 2 can have a durometer of approximately 70 Shore A. The portion including section 3 can have a durometer between the durometers of the portions including sections 1 and 2. For example, the portion including section 3 can have a durometer of approximately 40 Shore D. Considerations in selecting hardnesses for different portions of headgear 1100 can be the same as or similar to those discussed with respect to dimension selection in FIGS. 25-28. Variation in hardness can be achieved by other methods, such as material selection or material manipulation, for example.

[0336] Combinations of these techniques are also possible. For example, two or more of dimensions, materials, and hardness can be selected to vary the properties 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 the transformable locking mechanism.

[0337] The selection of materials for one or more portions of the headgear can include other considerations as well. For example, in some configurations, a portion or the entire headgear can include a material that exhibits little or no tendency to absorb moisture. In some configurations, a portion or the entire headgear can include a material that exhibits water vapor permeability. Advantageously, such a configuration allows the headgear to avoid or prevent absorption of moisture, such as sweat, or to allow moisture to migrate through the headgear material. Either configuration can improve comfort for the user.

[0338] The headgear can be further improved by incorporating textile lining or padding on either or both of the inner and outer surfaces to tailor the feel and / or tactical properties of the headgear. In some configurations, hair pulling and / or headgear edges perceived by the wearer are reduced or minimized. When the lining or padding is provided on only one side of the headgear (inner or outer surface) or the surfaces are otherwise distinguishable (e.g., the inner surface is a different color than the outer surface), that feature aids in the usability of the overall device by providing a visual cue to the user regarding the orientation of the headgear.

[0339] In some configurations, the headgear can include one or more adjusters that allow the size of the headgear to be adjusted. For example, adjusters can be provided on strap portions of the headgear to allow the length of the strap portions to be adjusted. Adjusters can also be provided between strap portions to allow the relative position of the strap portions to be adjusted. In some configurations, the adjuster is self-adjusting or allows for automatic adjustment of the headgear. As used herein, self-adjusting 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 can include a biasing element or mechanism. For example, the adjuster can include a biasing mechanism that tends to bias the strap portions in a first direction (e.g., toward a reduced length). Thus, the adjuster may simply allow the user to manipulate the headgear, thereby automatically locking it into a desired position, or the adjuster may help to move the headgear towards a proper fitting position, which then automatically locks in. Such an adjuster may comprise any of the variable locking mechanisms disclosed in applicant's application PCT / NZ2014 / 000074.

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

[0341] The automatic adjusters can be located at any one, any combination, or all of positions 1200A, 1200B, and 1200C, and / or elsewhere in the headgear. In some configurations, automatic adjusters are provided to allow the rear headgear portion to be adjusted to fit the user's head. Such automatic adjusters can therefore 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 rear headgear portion as well as apply an appropriate sealing or retaining force to the interface.

[0342] Referring to Figures 32-34, a particular strap adjustment mechanism 1300 is shown. The adjustment mechanism 1300 of Figures 32-34 is substantially similar to the flat strap adjustment or directional locking mechanism shown and described in connection with Figures 40-42 in applicant's PCT application PCT / NZ2014 / 000074. However, in some configurations, the strap adjustment mechanism 1300 of Figures 32-34 incorporates integral padding or backing, as described above. In some configurations, the components of the strap adjustment mechanism 1300 are constructed by molding a moldable material over a textile-based material.

[0343] FIGS. 32-34 illustrate the adjustable strap 1300 in assembled form and with portions of the adjustable strap separated in plan view to illustrate the various components of the adjustment mechanism. The adjustment mechanism 1300 includes a first portion 1310 that can be coupled to a second portion 1320 in multiple adjustment positions. In some configurations, the first portion 1310 and second portion 1320 can be infinitely adjustable within a provided adjustment range. The illustrated first portion 1310 and second portion 1320 are the first and second portions of an adjustable crown or parietal strap; however, adjustable straps can be provided in other positions, for example, as described in connection with FIGS. 30 and 31 . As discussed above, a biasing mechanism can be provided to bias the first portion 1310 and second portion 1320 toward one another, such as toward a retracted position.

[0344] Preferably, adjustment mechanism 1300 includes a directional lock 1330 that allows relative movement of first portion 1310 and 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 desired adjustment of first portion 1310 and second portion 1320.

[0345] The first portion 1310 of the adjustment mechanism 1300 can include a substantially flat strap 1312 that forms the male portion of the adjustment mechanism 1310. The second portion 1320 of the adjustment mechanism can include a receiver or lock housing 1322 that forms the female portion of the adjustment mechanism. The lock housing 1322 can include a space 1324 that receives a locking member, such as a lock washer. The flat strap 1312 is movable within the receiver 1322 and passes through the space 1324 that receives the lock washer. The flat strap 1312 also passes through the lock washer. The lock washer is movable within the space 1324 of the lock housing 1322 between an unlocked position and a locked position. In some configurations, the unlocked position is defined by the lock washer being oriented substantially perpendicular to the length of the flat strap 1312, and the locked position is defined by the lock washer being angled from the unlocked position's vertical orientation.

[0346] The position of the lock washer can be controlled by any suitable configuration, such as by being pressed into the 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 can have a vertical surface and the other end can have a sloped surface. When the flat strap 1312 moves toward the vertical surface, the lock washer is biased toward a vertical or unlocked position, allowing the flat strap 1312 to move relative to the lock housing 1322 with relatively little resistance. When the flat strap 1312 moves toward the sloped surface, the lock washer is biased toward a sloped or locked position, and relative movement between the flat strap 1312 and the lock housing 1322 is resisted by a yield force. The flat strap 1312 can include a gripping portion to facilitate movement of the lock washer. The gripping portion can be a high-friction material or a material with a high gripping force against the lock washer compared to the base material of the flat strap 1312.

[0347] In some configurations, the flat strap 1312 and lock housing 1322 are each constructed by molding material over the textile material of the respective first and second strap portions 1310, 1320. In the configuration shown, 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. Desirably, the portion of the flat strap 1312 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 throughout the adjustment range of the adjustment mechanism. The portion of the second strap portion 1320 that extends beyond the lock housing 1322 can be configured such that the textile material of the first strap portion 1310 abuts or overlaps the textile material of the second strap portion 1320 at the maximum or most separated location of the first and second portions 1310, 1320.

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

[0349] In the illustrated configuration, the strap portions 1310, 1320 are desirably relatively stiff in one direction (in the width direction to prevent bending) but remain flexible in another direction (in the thickness direction to allow the straps to bend and conform to the user's head). This can be achieved through 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 locations of the adjustment mechanism, other properties may be desirable. Therefore, other geometries and / or materials can be selected to impart the desired properties to the strap portions.

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

[0351] A textile material can be placed in a mold, the mold can be closed to capture a portion (e.g., an edge) of the textile material between separable portions (e.g., halves) of the mold, and a moldable material can be injected into the mold and over the textile material.

[0352] As disclosed in 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 inhibits or prevents relative movement between two portions of the headgear in a first direction at least below the yield force of the directional lock. The directional lock also allows relative movement between the two portions of the headgear in a second direction opposite the first direction. Preferably, movement in the second direction is permitted with only a relatively small amount of resistance.

[0353] Referring to FIG. 35 , in some configurations, a first portion of the headgear comprises a core member 1400. The core member 1400 can be a wire, wire-like element, or filament. A second portion of the headgear can comprise a housing 1410. The first and second portions of the headgear can be coupled to any suitable portion or component of the headgear that is movable relative to one another to change or adjust the circumference of the headgear. The housing 1410 can be an element or receptacle that defines a space 1412 that receives a locking mechanism 1420. The housing 1410 can be a separate component from the headgear or can be an integral component or part of the headgear. The locking mechanism 1420 can engage the core member 1400 to inhibit or prevent movement of the core member 1400 relative to the housing 1410 in a first direction that is at least below the yield force of the directional lock. The locking mechanism 1420 can also disengage the core member 1400 to allow movement of the core member 1400 relative to the housing 1410 in a second direction opposite the first direction.

[0354] The locking mechanism 1420 can include two or more locking elements movable between a first or locked position 1430 and a second or unlocked position 1440. The illustrated locking mechanism 1420 includes a pair of locking elements in the form of locking jaws 1422. Each of the locking jaws 1422 is a generally cylindrical member. The locking jaws 1422 cooperate to surround the core member 1400. The inner surface of each of the locking jaws 1422 facing the core member 1400 is concave. Each of the locking jaws 1422 includes an engagement portion 1424 that contacts the core member 1400 in the locked position 1430, thereby cooperatively engaging the core member 1400. In the illustrated configuration, the engagement portion 1424 is defined by the end of each of the locking jaws 1422.

[0355] The opposite end of each lock jaw 1422 extends through the housing 1410 and includes a radially extending flange 1426. The directional lock can include a biasing mechanism that, in some configurations, provides a relatively light biasing force that tends to move the locking mechanism toward the locked position, or toward the left of the page in FIG. 35 . The biasing mechanism can include a biasing element 1428, such as a spring, that acts against 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 FIG. 35 ). The lock jaw 1422 can move toward the unlocked 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 FIG. 35 ).

[0356] As described above, the housing 1410 defines a space or passageway that receives the lock jaws 1422 and through which the core member 1400 can pass. The passageway 1412 can define a chamfered, angled, or tapered surface 1416 that facilitates movement of the lock jaws 1422 between the locked position 1430 and the unlocked position 1440. One or more lock or roller elements 1418 can be disposed between each of the lock jaws 1422 and the housing 1410. Movement of the lock jaws 1422 along the longitudinal axis of the housing 1410 or passageway 1412 toward the locked position 1430 causes the roller elements 1418 to engage the tapered surfaces 1416, thereby moving the roller elements 1418, and therefore the lock jaws 1422, closer together, thereby clamping 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 is free to move 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 relatively without substantial resistance. This movement of the core member 1400 allows the lock jaw 1422 to move axially via friction 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 such that the directional lock applies a clamping force to the core member 1400 that substantially inhibits or prevents movement of the core member 1400 relative to the housing 1410 when a force less than the yield force acts on the core member 1400 to extend the headgear, and allows movement of the core member 1400 when a force greater than the yield force acts on the core member 1400 to extend the headgear. As described above, this configuration allows headgear incorporating one or more of the directional locks to resist normal or expected forces associated with treatment while also allowing extension of the headgear for attachment to or removal from a user. The directional lock can release the core member 1400 in response to movement of the core member 1400 to retract the headgear, allowing movement of the core member 1400 relative to the housing 1410 with relatively little resistance. Such a configuration allows headgear incorporating one or more of the directional locks to contract to fit a particular user's head size. The contraction force tending to contract the headgear can be provided by any suitable method or mechanism, including manual contraction or automatic contraction provided by an elastic configuration or element of the headgear.

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

[0359] While Figure 36 is described with reference to the directional lock structure described immediately above, 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 represents movement of the core member in a direction that tends to elongate the headgear as a result of application of a force that exceeds the directional lock's yield strength. The core member can therefore slide through the lock jaws, which are clamped against the core member by interaction of the roller elements with the tapered surfaces of the housing passages. Such force can be applied during application or removal of the headgear.

[0360] The next arrow in a clockwise direction represents a change in direction of the core member from expansion to contraction, which releases the clamping force on the core member.

[0361] The next arrow in a clockwise direction represents the retraction movement of the core member. Thus, movement of the core member can move the lock jaws so that the roller elements are no longer forced into the narrow portion of the tapered surface. This allows for relatively free retraction movement of the core member. This movement allows the headgear to fit a particular user or retract to a minimum circumference when not in use.

[0362] The next arrow in a clockwise direction represents a change in the orientation of the core member from contraction to extension. This change in orientation applies a clamping force to the core member. In each case of a change in orientation, some movement of the core member may occur or be fully reached before a change in clamping force or change in orientation lock position occurs. This cycle can repeat each time the headgear is applied to or removed from a user. In some cases, this cycle can occur when a user makes minor adjustments to the headgear.

[0363] 37-53 illustrate an example of a headgear assembly 1500 incorporating one or more directional locks 1510. The illustrated headgear assembly 1500 is configured to couple to a portion of an interface 1520. In particular, the illustrated headgear assembly 1500 includes a headgear rear portion 1530, an interface coupling portion 1540, and a length or circumference adjustment portion 1550 interposed between the headgear rear portion 1530 and the interface coupling portion 1540. The headgear rear portion 1530 is configured to contact a rear portion of a user's head during use. The interface coupling portion 1540 is configured to couple to the interface 1520 during use such that the headgear assembly 1500 can support the interface 1520 in an 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 headgear rear portion 1530 during use such that the headgear assembly 1500 can be adjusted to a particular user's head size. Thus, length or circumference adjustment portion 1550 allows for adjustment of the circumference or length of the headgear so that headgear assembly 1500 can fit a particular user's head size.

[0364] Although shown and described as a headgear assembly 1500, in some configurations, portions of the illustrated headgear assembly 1500 can be incorporated into any other suitable portion of the overall interface assembly. For example, the interface coupling portion 1540 can comprise a component or portion of an interface that is separate from and connectable to the headgear assembly 1500. The length or circumference adjustment portion 1550 can comprise a component or portion of an interface that is separate from and connectable to the headgear assembly 1500, or a component or portion of the headgear assembly 1500 that is separate from and connectable to the interface 1520. However, advantageously, as described further below, the illustrated headgear assembly 1500 can include a built-in, auto-fit headgear unit that exhibits balanced fit characteristics and can be coupled to at least one, and possibly multiple, types of interfaces. Thus, in at least some configurations, one type of illustrated headgear assembly 1500 can be utilized with multiple types of interfaces. Thus, a retailer can stock fewer unique products while offering the same interface options. Furthermore, a user can utilize a single headgear assembly and change interfaces as desired without having to manually adjust the headgear assembly when changing to a different interface.

[0365] In the illustrated configuration, the headgear rear portion 1530 includes at least one strap portion 1560 that contacts the user's head. Preferably, the at least one strap portion 1560 contacts the rear or back portion of the user's head to counteract forces induced in the headgear assembly 500 by interface compression during treatment. In some configurations, the strap portion 1560 extends laterally generally or substantially around the back of the user's head and has an end on each side of the user's head. Each end can be coupled to another portion of the headgear assembly 1500, such as, for example, the circumference adjustment portion 1550.

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

[0367] Preferably, the headgear rear portion 1530 engages the user's head and provides a relatively stable platform for interface connection, such as utilizing the interface coupling portion 1540 and the circumferential adjustment portion 1550. Thus, in at least some configurations, the headgear rear portion 1530 is substantially inelastic so as to retain its shape and effective length in response to applied forces within a range typical or expected for the intended use. In some configurations, the headgear rear portion 1530 can include a layer constructed 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 user-contacting surface of the rigid material layer. In some configurations, a fabric layer is provided on each side of the rigid material layer. Furthermore, in some configurations, the rigid material layer can be formed between the material layers, such as by injection molding the rigid material into the space between the two material layers in a mold. Examples of such headgear and methods of manufacturing such headgear are disclosed in commonly assigned US Provisional Patent Application No. 62 / 050,925, the entire contents of which are incorporated herein by reference.

[0368] The circumferential adjustment portion 1550 can include a pair of adjustment elements 1552, with one adjustment element 1552 located on each side of the headgear assembly 1500. In particular, each of the adjustment elements 1552 can couple one side of the headgear rear portion 1530 to one side of the interface coupling portion 1540. The adjustment elements 1552 can be coupled to or near the junction between the top strap 1564 and the rear strap 1562. In the illustrated configuration, the adjustment element 1552 is coupled to a forward extension of the headgear rear portion 1530 that extends forward from the junction of the top strap 1564 and the rear strap 1562. The adjustment element 1552 is adjustable in length between a retracted 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 adjustable elements 1552 can also include a resilient element or biasing mechanism that biases the adjustable element 1552 toward one of its retracted or extended lengths. Preferably, the adjustable elements 1552 are biased toward the retracted length, thereby biasing the headgear assembly 1500 toward its minimum circumference. This configuration allows the headgear assembly 1500 to extend and then automatically retract to fit a particular user under the biasing force of the resilient element or other biasing mechanism of the adjustable elements 1552. Additionally, preferably, the adjustable elements 1552 define a hard stop at the maximum extended length to limit the extension of the headgear 1500 and define the maximum circumference of the headgear 1500.

[0369] In some configurations, the adjustment element 1552 comprises a braided element 1554 that can expand or contract in length. The braided element 1554 can comprise one or more elastic elements parallel to the braided element 1554. The elastic elements can be separate from or incorporated into the braided element 1554. In some configurations, the elastic elements are contained within the interior spaces between the filaments of the braided element 1554. Examples of suitable braided elements are described in connection with Figures 46-54 of applicant's patent application PCT / NZ2014 / 000074. However, other suitable structures or configurations can also be used. Alternatively, an elastic or biasing element can be disposed within the interfacing portion and interact with the core member to draw it into the interfacing portion.

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

[0371] In some configurations, one or both of the core member 1570 and the adjusting element 1552 are secured to the headgear rear portion 1530 by encapsulating the core member 1570 and / or the adjusting element 1552 within the headgear rear portion 1530. For example, the core member 1570 and / or the adjusting element 1552 can be placed in a mold, and the rigid material portion of the headgear rear portion 1530 can be formed by injection molding to encapsulate the core member 1570 and / or the adjusting element 1552. In the configuration shown, the ends of the adjusting element 1552 and the ends of the core member 1570 are encapsulated within the rigid material portion of the headgear rear portion 1530. However, other suitable configurations may 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 applied 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 tension during the overmolding process. In some configurations, the adjustment element subassembly is then connected to the headgear rear portion 1530, such as by the overmolding process described above. Thus, the end cap portion 1556 of the adjustment element 1552 can be encapsulated by the headgear rear portion 1530.

[0373] The end cap portion 1556 of each of the adjusting elements 1552 opposing the headgear rear portion 1530 can be coupled to the interface coupling portion 1540 in any suitable configuration. In the illustrated configuration, the end cap portion 1556 of the adjusting element 1552 is coupled to a ferrule or socket 1580, which is coupled to the interface coupling portion 1540. For example, the end cap portion 1556 can be press-fit or otherwise secured within the socket 1580. The socket 1580 can include a neck portion 1582 that spaces a retaining portion 1584 from a body 1586 of the socket 1580. The neck portion 1582 can extend through an opening 1544 in the interface coupling portion 1540, and the retaining portion 1584 of the socket 1580 can prevent separation of the socket 1580 from the interface coupling portion 1540. In some configurations, the retaining portion 1584 of the socket 1580 can be integral with the housing 1512 of the directional lock 1510.

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

[0375] The collection space 1596 of the interfacing portion 1540, in the illustrated configuration, is configured as a reservoir to receive the end of the core member 1570 that is redundant or non-functional and does not form a working portion of the core member 1570. That is, the portion of the core member 1570 between the attachment point of the headgear rear portion 1530 and the housing 1512 of the directional lock 1510 (or at the locking element of the directional lock) is functional and forms part of the headgear circumference. This portion of the core member 1570 is placed under tension when a force that tends to elongate the headgear is applied. The lengths of the functional and non-functional core member portions change with the adjusted or instantaneous circumference change of the headgear assembly 1500. Thus, the collection space 1596 provides a place to accumulate and protect the non-functional portion of the core member 1570.

[0376] Desirably, the length of the collection space 1596 is at least as large as the telescoping distance (the distance between the extended and retracted lengths) of one of the adjustment members 1552. In other words, the telescoping distance of the adjustment member 1552 is preferably equal to or less than the length of the collection space 1596, such that there is enough space within the collection space 1596 for an excess core member portion of sufficient length to allow the adjustment member 1552 to move from the retracted position to the extended position with at least some excess core member 1570 length remaining within the collection space 1596, so that the core member 1570 is not pulled completely through the housing 1512 of the directional lock 1510. In some configurations, the collection space 1596 can comprise a separate space or channel for each of the core members 1570.

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

[0378] The interface member 1524 can be any portion of the interface 1520. For example, the interface member 1524 can be a relatively rigid portion of the interface 1520, such as a shell or frame element 1526. In the configuration shown, the interface member 1524 is a frame element 1526 that can directly or indirectly support a mask seal 1528, a cushion 1532, or other interface element. The frame element 1526 (or another portion of the interface) can support a conduit connector, such as an elbow 1534. In some configurations, the interface member 1524 can be configured to support several different types of mask seal 1528, cushion 1532, or other interface element. In some configurations, the interface member 1524 can be designed to be integrated with or used with a given mask seal 1528, cushion 1532, or other interface element, and a different interface member 1524 can be integrated with or associated with each type of mask seal 1528, cushion 1532, or interface element. In either case, in at least some configurations, the headgear assembly 1500 can be utilized with multiple types of mask seals 1528, cushions 1532, or other interface elements, including, for example, nasal cannulae, nasal pillows, nasal masks, or full face masks.

[0379] 54-56 illustrate an interface assembly incorporating a headgear assembly 1500, which can be the same or substantially the same as the headgear assembly 1500 described immediately above, or can be of another suitable configuration. In the illustrated configuration, the headgear rear portion 1530 is foldable. In some configurations, the headgear rear portion 1530 can be folded or bent from an extended configuration in which the headgear rear portion 1530 assumes a three-dimensional shape to a folded configuration in which it can lie relatively flat. In the illustrated configuration, one or both of the rear straps and the top straps include a hinge, joint, or fold. The hinge, joint, or fold 1536 can include a section of the headgear rear portion 1530 that is less stiff than other portions of the headgear rear portion 1530. The hinge, joint, or fold 1536 may comprise an area of ​​reduced thickness of the rigid headgear material, a separation between sections of rigid headgear material where one or more fabric layers define the hinge, joint, or fold 1536, or a connection, such as a sewn joint, between separate sections of the headgear rear portion 1530. Separate hinge members may be utilized to join several sections of the headgear rear portion.

[0380] Such a configuration allows the headgear to lay relatively flat, which can aid in packing the headgear if the user is traveling with the mask. The designed fold point or line allows the headgear unit to have shape-retaining behavior, but also results in a compact unit if it must be packed into a suitcase or the like. The fold or hinge line 1536 can be constructed by any suitable process, such as by using stitching or injection molding both the left and right sides of a rigid material section to that point, and then leaving one or more unlined sections of fabric to act as hinges.

[0381] 57-59 illustrate another headgear assembly 1600 that can be utilized with two or more interface types, at least in some configurations. For example, FIG. 57 illustrates the headgear assembly 1600 as forming a modular component of an interface assembly with a full-face mask-style interface 1650. The headgear assembly 1600 can include a portion 1602 that engages with the interface 1650 or can be otherwise coupled to the interface 1610. In some configurations, the engaging or coupling portion 1602 of the headgear assembly 1600 can engage or couple with at least one other type of interface. For example, FIG. 58 illustrates the headgear assembly 1600 of FIG. 57 (shown in dashed lines) supporting a nasal mask 1660, and FIG. 59 illustrates the headgear assembly 1600 of FIG. 57 (shown in dashed lines) supporting a nasal pillows / prong mask 1670. Thus, such a modular configuration allows a single headgear assembly to be utilized with multiple types of interfaces. Advantageously, the on-demand resistance features of the headgear assembly as described herein allow a single headgear assembly to operate suitably with different interface types. For example, the holding force provided by the headgear can automatically adjust to the force applied to the headgear by the particular interface being used. The engaging or coupling portion 1602 can be of any suitable configuration, such as, for example, the same as or similar to the configurations disclosed in connection with FIGS. 37-53.

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

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

[0384] The length or circumference adjustment portion 1606 may be of any suitable configuration, such as the same as or similar to any of those described herein or in applicant's application PCT / NZ2014 / 000074. The circumference adjustment portion 1606 may include two pairs of adjustment elements 1614, where one pair of adjustment elements 1614 is located on each side of the headgear assembly 1600. The illustrated headgear apparatus 1600 may therefore generally be described or classified as a two-supporting surface headgear type. The headgear apparatus 1600 may be described as a two-supporting surface, forward-converging headgear type, or in some cases as a hybrid of a two-supporting surface, forward-converging headgear type and a two-supporting surface, split / angled headgear type.

[0385] Each pair of adjustment elements 1614 can couple one side of the headgear rear portion 1604 to one side of the interface coupling portion 1602. The pair of adjustment elements 1614 on each side are coupled to the headgear rear portion 1604 at spaced apart locations. For example, one of the adjustment elements 1614 is coupled to the headgear rear portion 1604 at or near a portion of the top strap 1608, and the other of the adjustment elements 1614 is coupled to the headgear rear portion 1604 at or near a portion of the rear strap 1610. In the illustrated configuration, the upper adjustment element 1614 is coupled to a forward extension of the headgear rear portion 1604 that extends forward from a portion of the top strap 1608 at or near a position above the user's ears. The lower adjustment element 1614 is coupled to the end of the rear strap 1610 of the headgear rear portion 1604.

[0386] The adjustment elements 1614 are adjustable in length between a retracted length and an extended length. In some configurations, the adjustment elements 1614 cooperate to provide all or substantially all of the adjustment of the circumference of the headgear assembly 1600. Each of the adjustment elements 1614 can also include an elastic element or biasing mechanism that biases the adjustment element 1614 toward one of the retracted length or the extended length. Preferably, the adjustment elements 1614 are biased toward the retracted length, thereby biasing the headgear assembly 1600 toward its minimum circumference. Such a configuration allows the headgear assembly 1600 to extend and then automatically retract under the biasing force of the elastic element or other biasing mechanism of the adjustment elements 1614 to fit a particular user. Additionally, preferably, the adjustment elements 1614 define 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 includes a braided element that can expand or contract in length. The braided element can include one or more elastic elements parallel to the braided element. The elastic elements can be separate from or incorporated into the braided element. In some configurations, the elastic elements are housed in the interior spaces between the filaments of the braided element. Examples of suitable braided elements are described in connection with Figures 46-54 of applicant's patent application PCT / NZ2014 / 000074. However, other suitable structures or configurations can also be used. Alternatively, an elastic or biasing element can be disposed within the interfacing portion and interact with the core member to draw it into the interfacing portion.

[0388] The interface coupling portion 1602 of the headgear assembly 1600 can extend between a pair of adjustment elements 1614 comprising a circumferential adjustment portion 1606. In some configurations, the interface coupling portion 1602 can 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 connection of the headgear assembly 1600 to the interface. However, the interface coupling portion 1602 can also house at least a portion of one or more directional locks 1616. In the illustrated configuration, two pairs of directional locks 1616 are provided, one directional lock 1616 associated with each one of the adjustment elements 1614. A portion of the directional lock 1616 (e.g., a housing 1618) can be located on each of the interface coupling portions 1602. In some configurations, a core member 1620 associated with each directional lock 1616 is coupled to the headgear rear portion 1604 and extends along or through the adjustment element 1614, through the housing 1618 of the directional lock 1616, and into a collection space 1622. The collection space 1622 can be defined by a collection tube or conduit that can be a separate member from or incorporated into the interface coupling portion 1602. The housing 1620 of the directional lock 1616 can include one or more members or elements (e.g., lock washers or lock jaws) that interact with the core member 1618 to selectively allow retraction of the headgear assembly 1600 or lock the headgear assembly 1600 at a particular circumference, and inhibit or prevent extension of the headgear at least below the yield force provided by the directional lock. Further details of the operation of the directional locks 1616 are described above and in 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 stacked vertically or arranged side by side. Although the directional locks 1616 are illustrated as separate units, in some configurations, portions of the directional locks 1616 can be integrated. For example, a single housing can contain 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 (e.g., defined 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 complement 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 an elbow or other conduit connector of the mask 1650. Similarly, the interface coupling portion 1602 can be configured to complement or correspond to the shape of the body or shell portion of the nasal mask interface 1660. The central portion of the interface coupling portion 1602 can be located above an elbow or other conduit connector of the nasal mask 1660. The interface coupling portion 1602 can be configured to complement or correspond to the shape of the body of the nasal pillows / prong mask 1670. A central portion of the interface coupling portion 1602 can be located above the elbow or other conduit connector of the nasal pillows / prong mask 1670. In some configurations, the interface coupling portion 1602 can be located between the elbow or other conduit connector and the pillows / prongs of the nasal pillows / prong mask 1670.

[0391] FIG. 60 illustrates an interface assembly 1680 that is similar in many respects to other interface assemblies disclosed herein, such as the interface assemblies of FIGS. 37-53 and 57-59. The interface assembly 1680 of FIG. 60 includes a headgear assembly 1600 and an interface in the form of a full-face mask 1650 or a nasal mask. The headgear assembly 1600 generally includes a headgear rear portion 1604, a length or circumference adjustment portion 1606, and an interface coupling portion 1602. The headgear 1600 of FIG. 60 will be described with respect to its differences relative to the interface assemblies of FIGS. 37-53 and 57-59. Features or details not described may be the same or similar to corresponding features or details of the interface assemblies of FIGS. 37-53, 57-59, other interface assemblies disclosed herein or in applicant's application PCT / NZ2014 / 000074, or may be of any other suitable configuration.

[0392] The headgear assembly 1600 of FIG. 60 can be described or classified as a two-support-plane, parallel headgear type. The illustrated headgear rear portion 1604 includes a top strap 1608, a pair of upper straps 1624, and a pair of lower straps 1626. The headgear rear portion 1604 includes a vertically extending 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 a shell portion 1682 of a full-face or nasal mask. The shell portion 1682 and elbow 1684 or other conduit connector (collectively referred to as "elbow") can be directly or indirectly secured to the support frame 1630 by any suitable configuration. For example, the shell portion 1682 and the elbow 1684 can be separately coupled (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 a forehead rest or T-piece 1632. An upper pair of adjustment elements 1614 comprising cylindrical adjustment portions 1606 can be coupled to the T-piece 1632 such that the upper adjustment elements 1614 are positioned above the user's eyes and extend above the user's ears. A lower pair of adjustment elements 1614 comprising circumferential adjustment portions 1606 can be coupled (directly or through another member, such as a shell) to a lower portion of the support frame 1630 such that the lower adjustment elements 1614 are positioned below the user's eyes and ears. A collection space 1622 (e.g., defined by a collection tube or channel) for the upper adjustment elements 1614 can be curved and extend downward along the T-piece 1632 toward the elbow. An upper directional lock 1616 can be supported by the T-piece 1632. A lower directional lock 1616 can be supported (directly or indirectly) by a lower portion of the support frame 1630.

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

[0395] Figure 61 shows an interface assembly 1680 that is similar in many respects to other interface assemblies disclosed herein, such as the interface assemblies of Figures 37-53, 57-59, and 60. The headgear 1600 of Figure 61 will be described with respect to its differences relative to the interface assemblies of Figures 37-53, 57-59, and 60. Features or details not described may be the same or similar to corresponding features or details of the interface assemblies of Figures 37-53, 57-59, and 60, other interface assemblies disclosed herein or in applicant's application PCT / NZ2014 / 000074, or may be of any other suitable configuration.

[0396] The interface assembly 1680 of FIG. 61 includes a headgear assembly 1600 and an interface in the form of a full-face mask 1650 or a nasal mask. The headgear assembly generally includes a headgear rear portion 1604, a length or circumference adjustment portion 1606, and an interface coupling portion 1602. However, unlike the interface assembly of FIG. 60, the interface assembly 1680 of FIG. 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 interface at a lower position relative to the interface assembly 1680 of FIG. 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 of FIG. 61 can be described or characterized as a two-retaining surface, split / angled headgear type. The upper and lower adjustment elements 1614 can be spaced apart from each other on the mask 1650 to provide retention and stability to the mask 1650 in a spaced-apart vertical position. The headgear assembly 1600 can be coupled to the mask 1650 by separate interface coupling portions 1602, each of which can be substantially similar to the interface coupling portions 1602 described in connection with FIGS. 57-60. One of the interface coupling portions 1602 can be located in a lower portion (e.g., the lower half) of the mask 1650, and the other of the interface coupling portions 1602 can be located in an upper portion (e.g., the upper half) of the mask 1650. The lower interface coupling portion 1602 can pass over an elbow or other conduit connector. In some configurations, the upper and lower interface coupling portions 1602 can be coupled to one another or integral with one another. For example, a bridge portion can extend between and connect the upper and lower interface coupling portions 1602. The bridge portion can be separate from or integral with one or both of the interface coupling portions.

[0398] Figure 62 illustrates an interface assembly 1680 that is similar in many respects to other interface assemblies disclosed herein, such as the interface assemblies of Figures 37-53, 57-59, 60, and 61. The headgear 1600 of Figure 62 will be described with respect to its differences relative to the interface assemblies of Figures 37-53, 57-59, 60, and 61. Features or details not described may be the same or similar to corresponding features or details of the interface assemblies of Figures 37-53, 57-59, 60, and 61, other interface assemblies disclosed herein or in applicant's application PCT / NZ2014 / 000074, or may be of any other suitable configuration.

[0399] The interface assembly 1680 of FIG. 62 includes a headgear assembly 1600 and an interface in the form of, for example, a full-face mask 1650 or a nasal mask. The headgear assembly 1600 generally includes a headgear rear portion 1604, a length or circumference adjustment portion 1606, and an interface coupling portion 1602. However, unlike the interface assemblies 1680 of FIGS. 60 and 61 , for example, the interface coupling portion 1602 of the interface assembly 1680 of FIG. 62 does not extend between adjustment elements on opposite sides of the interface assembly 1680 or headgear assembly 1600. Instead, the interface coupling portion 1602 couples 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 and lower adjustment elements 1614 on one side of the interface assembly 1680 or headgear assembly 1600 to each other.

[0400] In the illustrated configuration, the interface coupling portion 1602 is a generally U-shaped member having an upper end 1634 coupled to the upper adjustment element 1614 and a lower end 1636 coupled to the lower adjustment element 1614. A 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 respective upper and lower ends 1634, 1636. Collection spaces 1622 (e.g., defined by collection tubes or other channels) can curve along a central curved body portion of the interface coupling portion 1602 and may overlap in some configurations.

[0401] In the configuration of FIG. 62 , the headgear assembly 1600 itself may not define the entire closure perimeter. Rather, the interface 1650 may form a portion of the closure perimeter, and thus a portion of the circumference or perimeter of the interface assembly 1680. Advantageously, with such a configuration, the interface assembly 1680 may optionally be configured to quickly and easily open the closure perimeter for donning or doffing the interface assembly 1680. That is, one (or both) of the interface coupling portions 1602 may be removably attached to the interface 1650 (such as by one or more clips), thereby allowing one (or both) of the interface coupling portions 1602 to be separated and the closure perimeter to be opened. In some configurations, only one side of the interface assembly may be provided with an automatic adjustment mechanism. Similarly, other interface or headgear assemblies disclosed herein or in applicant's application PCT / NZ2014 / 000074 may be one-sided or asymmetrical configurations that may provide an automatic adjustment mechanism on only one side.

[0402] FIGS. 63-65 illustrate a series of distinct positions or steps for donning the interface assembly 1680 of FIG. 62. FIG. 63 shows a 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 FIG. 64, the interface is oriented in place on the face, with the separated interface coupling portion 1602 oriented toward the interface 1680. FIG. 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 perimeter loop. Some or all of the movement between FIGS. 64 and 65 may be necessary to overcome the yield force of the directional lock, as described above. To remove or disconnect the interface assembly 1680, the procedure can be reversed.

[0403] 66 and 67 show the perimeter of automatically adjustable interface or headgear assembly 1700 in a first position (e.g., minimum perimeter) and a second position (e.g., maximum perimeter), respectively. As described with respect to the interface and headgear assemblies disclosed herein, the perimeter is defined by a length L defined by headgear rear portion 1704. rear In some configurations, L rear may be zero. In other words, the fixed length headgear rear portion 1704 may be omitted, and the rear section may be formed by a length adjustment portion or elastic component. Additionally, one or more of the multiple portions of the illustrated perimeter may be positioned in alternative locations or may be divided into multiple portions.

[0404] The outer periphery also has a length L defined by the circumference or length adjustment portion 1706. elastic17. The circumferential or length-adjustable portion 706 may also include a length L , which in the illustrated configuration is defined by a pair of elastic or adjustable elements 1714. However, in other configurations, the circumferential or length-adjustable portion 706 may be defined by one elastic or adjustable element 1714, or by three or more elastic or adjustable elements 1714, among other suitable configurations. As noted above, in some configurations, the length L rear The headgear rear portion 1704 defining the L can be omitted, and the length adjustment portion 1706 can extend through the entire perimeter portion from one end of the interface coupling portion 1702 to the other end of the interface coupling portion 1702. elastic The length includes the minimum length L min and maximum length L max Each relative position index is labeled.

[0405] The outer periphery has a collection length L collector , which can represent an individual or overall available length of the collection space 1722 that accommodates excess portions of the core element of the directional locking mechanism. As noted 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 perimeter. For example, in the interface assembly 1680 of FIG. 62 , the collection space 1622 does not extend between opposing adjustable elements 1614. Thus, in a physical sense, the interface coupling portion 1602, the interface 1650, or other structure can define a portion of the perimeter. However, in a conceptual sense, the elastic length L elastic (Minimum length L min and maximum length L max ) defines the length adjustable portion of the periphery of FIG. 66 and FIG. 67, and the remaining portion (headgear rear portion length L rear and the collection section length L collector ) is fixed length.

[0406] In the illustrated configuration, the perimeter is the rear length of the headgear L rear and the collection section length L collectorIn the illustrated configuration, two equal length adjustment elements 1714 are provided, so L elastic The total elastic length L is twice the elastic The total elastic length L at any time or for any particular position of the interface or headgear assembly 1700 can be determined by the sum of elastic is the maximum length L max and minimum length L min As described herein, the length L of each core member is equal to or between core is preferably the maximum length L of each adjustment element max Therefore, the total core member length L core is preferably the total maximum length L max This allows the headgear assembly to be extended to its maximum perimeter without pulling the core member completely through the directional locking elements. In other words, the directional locking elements can preferably engage a portion of the core member when the headgear assembly is extended to its maximum perimeter.

[0407] Furthermore, the collection section length L collector is preferably sufficient to accommodate the total excess or unused portion of the core member at the maximum and minimum perimeters of the headgear assembly. Thus, in at least some configurations, the individual or total core length L core is the individual or total maximum length L max the individual or total collection section length L collector In at least some configurations, the individual or total core length L core is the individual or total minimum length L max the individual or total collection section length L collector In some configurations, the individual or total maximum length L max is the individual or total maximum length L max the individual or total collection section length L collector The individual or total core length L is less than the sum of coreThe length of the directional locking mechanism is not specifically shown in the outer periphery, but is the length L of the rear part of the headgear. rear , elastic length L elastic or collection section length L collector In either case, the length of the directional locking mechanism is determined by the minimum length L of the core. core can be taken into consideration when determining

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

[0409] The perimeters in Figures 66 and 67 may represent the actual perimeter of an interface assembly or headgear assembly. That is, the perimeters in Figures 66 and 67 may represent the physical structure of a single support surface interface or headgear assembly, or the physical structure of one support surface in a multiple support surface interface or headgear assembly. However, as noted, the perimeters in Figures 66 and 67 may represent other interface or headgear types in a conceptual sense. The illustrated perimeters may represent, for example and without limitation, a single support surface (e.g., an upper support surface or a lower support surface) of a multiple support surface headgear type, or may represent the average of two or more support surfaces of a multiple support surface headgear type.

[0410] 68A-68D illustrate an embodiment of a directional lock comprising a housing 1810, first and second locking elements (e.g., washers 1820, 1822), and a core member 1830. The housing comprises a first chamber 1840 and a second chamber 1842, which are configured to accommodate the first and second lock washers 1820, 1822, respectively. In the illustrated configuration, the first and second chambers 1840, 1842 are separated by an interior wall 1812 of the housing 1810. However, in other configurations, the first and second chambers 1840, 1842 are not necessarily physically separate spaces and may be part of a single chamber. The housing 1810 has two end walls 1814, which, together with the inner wall 1812, define an elongated core opening 1860 through which the core member 1830 passes. The core openings 1860 are substantially aligned with one another. The core opening 1860 in the end wall 1814 shown on the right side of the figure is larger than the core openings in the inner wall 1812 and the end wall 1814 shown on the left side of the figure. This allows for maneuvering of the path of the core member 1830 through the housing 1810. The first chamber 1840 and the second chamber 1842 are each defined by the inner wall 1812, one of the end walls 1814, and a pair of side walls 1816 that extend 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 aligned with opposing sidewalls 1816 of the housing 1810. Each pair of washer retainers 1850 is configured to pivotally retain one of the first lock washer 1820 or the second lock washer 1822 within its respective first chamber 1840 or second chamber 1842. The washer retainers include a circular bushing 1852 and an elongated slot 1854, where the circular bushing 1852 intersects with 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 within the washer retainer 1850. The slot 1854 extends radially from the circular bushing 1852 toward the top of the housing 1810.

[0412] The first washer 1820 and the second washer 1822 each include 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 is tapered to fit within the first chamber 1840 and the second chamber 1842. In the illustrated configuration, the arm 1826 includes a first section 1872 and a second section 1874, where the first section 1872 extends radially or perpendicularly from the cylindrical shaft 1824 and the second section 1874 extends at an obtuse angle 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 so that the second section 1874 of one or both of the first washer 1820 and the second washer 1822 lies substantially flat against the corresponding wall of the housing 1810 (e.g., the interior wall 1812 and the end wall 1814, respectively) at one position of the washers 1820, 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 housed therein; i.e., the first chamber 1840 is smaller than the second chamber 1842 because the first washer 1820 is smaller than the second washer 1822.

[0413] The cylindrical shafts 1824 of the first and second lock washers 1820 and 1822 have substantially the same diameter as the circular bushing 1852 of the washer retainer 1850 and are configured to be received and retained by the circular bushing 1852 in a snap-fit ​​configuration. The snap-fit ​​configuration is provided by an entrance to the circular bushing 1852 that is narrower than the diameter of the cylindrical shaft 1824. The slots 1854 of the washer retainer 1850 are configured to flex to open the entrance, making it easier for the first and second lock washers 1820 and 1822 to be pushed through the entrance and assembled with the housing 1810. When assembled within the first and second chambers 1840 and 1842 of the housing 1810, the first and second washers 1820 and 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 apertures 1876 of the first and second washers 1820, 1822. Applying tension to the core member 1830 causes the first and second lock washers 1820, 1822 to pivot rearward and / or forward between locked and / or open positions. FIGS. 68A and 68B show the directional lock in a locked configuration in which a force is applied to the core member 1830 in a direction toward the left side of the figure (as indicated by the arrow). In this configuration, a force applied to the core member 1830 causes the first and second lock washers 1820, 1822 to pivot in a counterclockwise direction, thereby causing the path of the core member 1830 through the directional lock 1800 to be nonlinear or tortuous, limiting the movement of the core member 1830. 68C and 68D show the directional lock in an open configuration with a force being applied to the core member 1830 in a direction toward the right of the figure (as indicated by the arrow). In this configuration, the first lock washer 1820 and the second lock washer 1822 pivot in a clockwise direction, causing the circular aperture 1876 and the core opening 1860 to align in a substantially straight line. This provides a smooth path for the core member 1830 to be pulled substantially freely through the directional lock 1800. Further details of the operation of the directional lock 1800 are described above and in applicant's application PCT / NZ2014 / 000074.

[0415] 69A and 69B illustrate a non-limiting exemplary embodiment of a housing 1810 and a first and second lock washer 1820, 1822. The first and second lock washers 1820, 1822 are configured to be molded as a single component, as known in the art, where they are connected by a runner and gate system 1900. The runner and gate system is configured to be used as an assembly aid for the first and second lock washers 1820, 1822, where a person or machine can grasp the runner and gate system 1900 to align the first and second washers 1820, 1822 with the washer retainer 1850 of the housing 1810. A force (as indicated by the arrows) can be applied to the lock washers 1820, 1822 through the gate and runner system 1900 to cause relative movement between the housing 1810 and the lock washers 1820, 1822. Such relative movement can be used to engage the first and second lock washers 1820, 1822 with the housing 1810, such that the cylindrical shafts 1824 of the lock washers 1820, 1822 snap fit within the circular bushings 1852 of the washer retainer 1850.

[0416] As shown in FIG. 69B, once the first lock washer 1820 and second lock washer 1822 are assembled within the housing 1810, the gate and runner system 1900 can be separated or disconnected from the lock washers 1820, 1822. A force (indicated by the arrow) can be applied to the gate and runner system 1900 in a direction substantially perpendicular to the direction in which the assembly force is applied (arrow in FIG. 69) to remove the gate and runner system 1900 from the lock washers 1820, 1822. When the gate and runner system 1900 is removed, the lock washers 1820, 1822 remain assembled with the housing 1810. The gate 1910 of the gate and runner system 1900 can be designed to have a point of weakness that causes it to break as close as possible to the cylindrical shaft 1824 of the lock washers 1820, 1822 so that the range of pivoting of the lock washers 1820, 1822 is not restricted by excess gate material.

[0417] 70A and 70B show an embodiment in which multiple sets of first and second lock washers 1820, 1822 are molded onto a single gate and runner system 1900. This configuration allows multiple directional locks 1820, 1822 to be assembled at once 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 and second washers 1820, 1822 with their respective washer retainers 1850 on the housing 1810. A force (as indicated by the arrow) can be applied through the gate and runner system 1900 to engage the set of first and second lock washers 1820, 1822 with the housing 1810, causing the cylindrical shafts 1824 of the lock washers 1820, 1822 to snap fit within the circular bushing 1852 of the washer retainer 1850.

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

[0419] FIG. 72 shows a non-limiting exemplary embodiment of a directional lock. In this embodiment, washer retainers 1850 are positioned in an opposing arrangement, where a first washer retainer 1850 extends downward from the top of the housing and a 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, gripping tabs 1930 or a gate and runner system 1900, such as those described in connection with the embodiment of FIGS. 69a-71, can be used to aid in assembly of the lock washers 1820, 1822 to the housing 1810.

[0420] 73-80 show an interface with a headgear device configured to allow the interface to be donned and doffed like a baseball cap. Preferably, the headgear device does not include straps that pass under the user's ears. Thus, an interface with such a headgear device can be attached or donned 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 downward to place the interface on the user's face, or vice versa. The headgear device can include portions in front of the user's ears that can provide attachment locations for direct 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 inextensible.

[0421] 73 shows an alternative configuration for headgear system 2000 configured for use in combination with a full-face mask 2100 without a forehead support. However, headgear system 2000, or portions thereof, can also be used in combination with other types of interfaces, including interfaces with forehead support, if desired. Full-face mask 2100 is configured to seal around the user's nose and mouth, contacting the bridge of the nose, cheeks, and lower lip or chin area. Headgear system 2000 includes a headgear rear portion 2010, an upper support surface 2020, and a lower support surface 2030.

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

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

[0424] The two retention surfaces 2020, 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 retention surfaces 2020, 2030 may be spaced apart vertically from one another so that they are spaced apart more at the point where they connect to the headgear than where they contact the mask. This provides some stability to the interface. For example, the upper retention surface 2020 may pass from the tops of the user's ears and under or above the nose, and the lower retention surface 2030 may pass from the bottom of the user's ears to near or below the mouth.

[0425] Each of the two support surfaces 2020, 2030 can be provided by two directional locking modules 2060, one on each side of the headgear system 2000. The directional locking modules 2060 each include a directional lock 2062 and an elastic portion 2064, with one end connected to the directional lock 2062 and the other end connected to one of the multiple connectors 2014. The angle of the support surfaces 2020, 2030 can be adjusted by connecting the ends of the elastic portion 2064 to different connectors 2014 on the headgear arms 2012. The illustrated full face mask 2100 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 connect the rear portion of the headgear to the mask's T-piece.

[0426] FIG. 74 shows a headgear system apparatus 2000 including a headgear rear portion 2010 and two retention surfaces 2020, 2030 configured to secure the full-face mask 2100 to the user's face. In this configuration, the full-face mask 2100 is configured to seal under the user's nose and around the user's mouth, thereby preventing contact of the mask 2100 with the bridge of the nose. The different sealing location relative to the previous embodiment requires, or at least makes desirable, different angles for the retention surfaces 2020, 2030 to apply force to the mask in an optimal or desired direction. In FIG. 74, the two retention surfaces 2020, 2030 are shown vertically spaced apart and attached to an arm 2012 of the headgear rear portion 2010, resulting in an upper retention surface 2020 and a lower retention surface 2030 that are substantially parallel to one another. The upper retention surface 2020 is more horizontal and sits lower on the user's face than the upper retention surface 2020 of the previous embodiment. The angle of the retaining surfaces 2020, 2030 may be adjustable via multiple connectors 2014, such as those shown in the embodiment of FIG.

[0427] Each of the retention surfaces 2020, 2030 is shown to include a directional locking module 2060, which further includes a resilient portion 2064 and a directional lock 2062. In variations on this configuration, each directional locking module 2060 can include two or more directional locks 2062.

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

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

[0430] 77-79 show diagrams of a headgear system 2200 in accordance with the presently disclosed subject matter. The headgear system 2200 is a closed loop and includes a headgear 2210, two upper directional locking modules 2220, two lower directional locking modules 2230, and a housing 2240. The headgear rear portion 2250 includes a bifurcated molded plastic structure with an integrally formed fabric cover and a pair of arms 2252 configured to extend downwardly in front of the user's ears in use.

[0431] The upper directional locking module 2220 and the lower directional locking module 2230 include an elastic portion 2222, a core filament (not shown), and a directional lock 2224. The core filament is configured to extend partially or 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 locking modules 2220, 2230. The core filament and elastic portion 2222 are permanently joined to arms 2252 of the headgear 2210 by overmolded connections 2260, with the upper directional locking module 2220 joined to an upper region of the arm 2252 and the lower directional locking module 2230 joined to a lower region of the arm 2252. The elastic portion 2222 is permanently joined to the directional locks 2220, 2230 by the overmolded connections 2260. The directional locks 2220, 2230 are housed within a housing 2240. Two upper directional lock modules 2220 form an upper retention surface and two lower directional lock modules 2230 form a lower retention surface, which are substantially the same as in FIG.

[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 therebetween. Two directional lock brackets 2242 are disposed one above the other at each side end of the housing 2240. The directional lock brackets 2242 are configured to hold the 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 conduit 2244 and the lower conduit 2246 are configured to accommodate the free end of the core filament. The central opening 2248 formed between the upper conduit 2244 and the lower conduit 2246 is configured to receive a nasal mask device.

[0433] FIG. 80 illustrates the headgear assembly of FIG. 79 with a nasal mask apparatus 2270 configured to be assembled therewith. The nasal mask apparatus 2270 comprises a frame assembly 2280 and a cushion module 2290. The frame assembly 2280 includes a frame 2282, an elbow 2284, and a tubing connector 2286. The frame 2282 and the elbow 2284 are configured to be joined together by a ball-and-socket connection, with the frame 2282 including a socket 2410 and the elbow 2284 including a ball 2400. The frame 2282 comprises a nylon component shaped to provide a repeatably removable snap-fit ​​connection with 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 components do not stick to each other when assembled. This allows the elbow greater freedom of movement relative to the frame 2282 and reduces hose drag. It is contemplated that other material combinations may also be used.

[0434] The tube connector 2286 connects in a snap fit arrangement to the end of the elbow 2284 opposite the end that connects to the frame 2282. The tube connector 2286 can swivel or rotate about 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 of connecting the nasal mask device 2270 to a CPAP tube that provides a supply of pressurized air.

[0435] The cushion module 2290 comprises a sealing cushion 2292 integrally formed to a connector portion 2294 by means such as, but not limited to, overmolding. The sealing cushion 2292 comprises a highly compliant interface made from a flexible, resilient material such as, but not limited to, 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 a substantially rigid material such as, but not limited to, polycarbonate, and includes a circular opening 2296 facing the sealing cushion 2292. It is configured to provide a repeatable, removable connection between the cushion module 2290 and the frame assembly 2280. The cushion module 2290 and the frame assembly 2280 connect to each other such that an air passage is formed within the cushion module 2290 through the tube connector 2286 and the elbow 2284, as shown in FIG. 81 .

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

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

[0438] An advantage of the headgear adjustment system disclosed in the above-described embodiments is that it provides a quiet means of adjustment. Hook-and-loop fastening systems (such as Velcro) are commonly used in the art to allow size adjustment for headgear systems for respiratory masks. When adjustment of the headgear system's fastening is required, the hook-and-loop fastener components must be separated from one another. Separation of the hook-and-loop fastener components typically produces a tearing sound, which can be unpleasant for the mask user and, in some circumstances, may disturb the user's bed companion. The headgear system of the present disclosure is less likely to require the user to make manual adjustments to improve size and fit, and any adjustments required do not generate noise, or at least not a significant level of noise, thus improving ease of use and comfort for the user and the user's bed companion.

[0439] Headgear Test FIG. 85 illustrates a test setup for verifying the functionality of a headgear assembly 2500 including at least one directional locking module 2510. The headgear assembly 2500 being tested in FIG. 85 includes a headgear 2502 and a mask frame 2504 connected to each other by a pair of lateral directional locking modules 2510. The frame 2504 is configured to accept a nasal pillow seal. The end of the directional locking module 2510 connected to the headgear 2500 is held in a test fixture 2520 that secures the headgear assembly 2500 to a movable crosshead 2530 of a universal test machine. The mask frame 2504 is secured to a fixed crosshead 2540 of the universal test machine. The universal test machine is capable of conducting tests that simulate donning and wearing of a mask in several stages. It should be understood that this test setup can be modified to test headgear assembly configured for use with different mask types, such as full-face masks and nasal masks.

[0440] The first stage of the test simulates donning the mask and headgear assembly. The movable crosshead is programmed to pull the headgear away from the frame and extend the directional locking module until the headgear assembly is near its maximum circumference. The second stage of the test simulates attaching the mask and headgear assembly to a user's head. The universal tester is programmed to return the headgear toward the mask frame to a distance approximately halfway between the maximum and minimum circumferences of the headgear assembly. This simulates the point at which the circumference of the headgear assembly matches the circumference of the user's head. The third stage of the test involves extending the headgear assembly back to its maximum circumference, which simulates the application of CPAP pressure and use of the mask system. Force profiles are recorded during all three test stages.

[0441] During the first stage of testing, it is expected that the force-extension plot should show an initial steep rise in force as the locks of the directional locking mechanism engage during extension of the headgear assembly. 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 will activate. Following this steep rise in force, a transition point is reached at 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 an instantaneous release of the directional locking mechanism in the force-extension plot. The initial sudden drop in force indicates the instantaneous release of the retention of the washer (or other suitable locking mechanism) when the extension force is released from the headgear device. The return force is driven by the elastic component of the directional locking module; in this particular case, four strands of Lycra in a braided sleeve. The choice of material for the elastic component and its manufacturing method can control the return force. The return force should be less than the expected blow-out force, which varies depending on the type of mask (i.e., full face mask, nasal mask, or nasal pillows, etc.).

[0443] The third phase simulates use, in which the headgear is contracted to the head circumference of a hypothetical user. By applying CPAP pressure (insufflation force) to the mask, the force-extension plot should show a steep rise in force at substantially the same rate as the initial extension force before reaching the yield force. By applying CPAP pressure, a washer (or other locking mechanism) should be activated, showing a rapid rise in force for a short extension. The equilibrium fit of the mask and headgear assembly should fall somewhere along this force-extension curve, determined by the applied CPAP pressure. As the extension of the headgear assembly continues toward maximum circumference, the yield force is reached. This portion of the plot should follow or approximate the extension of the headgear after the yield point during the first phase of the test. Close overlap indicates a repeatable yield force.

[0444] Figures 86 and 87 show force-extension plots of two headgear device and mask samples obtained using the test setup described above. Both plots show that the tested headgear device and mask samples meet the desired criteria as described above. Both plots show a steep rise in force during initial extension 3000, followed by a drop in the rate of rise 3020 after reaching transition point 3010. In Figure 87, it can be seen that the force fluctuates during extension 3020 after transition point 3010. This may be the result of imperfect tolerances between the components of the directional locking module or imprecision in how the samples are held during testing. The two plots also show that both samples display a steep drop in force 3030 and low return force, indicating a momentary release of the directional locking mechanism. A steep rise in force 3040 was also shown for both samples during the third stage of simulating use. The force-extension curves after the yield force also closely aligned with the initial extension curves.

[0445] In both Figures 86 and 87, hesitation / extension 3050 can be seen approximately halfway through the steep rise in force. This corresponds to the design of the directional locking mechanism. In the tested sample, the directional locking mechanism included two washers, such as the embodiment in Figures 68A-68D. The hesitation occurs because the first washer, which has a lower yield force, allows a small amount of extension before the second washer engages and continues the steep slope.

[0446] 88-102 illustrate several nasal cannula systems incorporating the disclosed headgear device, which may include at least one directional locking mechanism. Several nasal cannula systems are described below, with emphasis on differences between the several systems. Parts, components, or features not specifically described may be the same or similar to corresponding parts, compo...

Claims

1. 1. A directional locking assembly for a respiratory mask headgear, comprising: Housing and first and second locking elements; a core member; the housing includes a first end wall, a second end wall, a first side wall, and a second side wall, the side wall extending between the end walls; The housing further includes first and second chambers configured to receive first and second locking elements, respectively; the first end wall, the second end wall, the first locking element, and the second locking element define an opening for passage of the core member, the openings in the first end wall and the second end wall being aligned with one another; the first and second chambers each having a pair of locking element retainers aligned with opposing side walls of the housing and configured to pivotally retain the first and second locking elements within the respective first or second chamber; the first and second locking elements are configured to pivot between a first position and a second position; each of the first and second locking elements comprises a shaft and an arm extending from the shaft, the arm having a first section and a second section, the first section extending radially or perpendicularly from the shaft and the second section extending at an obtuse angle from an end of the first section; Directional lock assembly.

2. The directional locking assembly of claim 1 , wherein the first and second locking elements are configured to pivot between first and second positions when tension is applied to the core member.

3. 3. The directional locking assembly of claim 1 or 2, wherein the first position is an open position and the second position is a locked position.

4. 4. The directional locking assembly of claim 1, wherein the first and second chambers are separated by an interior wall of the housing, the interior wall also including an opening for the passage of the core member therethrough, the opening in the interior wall and the openings in the first and second end walls being aligned with one another.

5. 5. The directional locking assembly of claim 4, wherein the first and second chambers separated by the interior wall are sized according to a size of a locking element contained within each chamber, thereby allowing the locking element to pivot between first and second positions.

6. The directional locking assembly of any one of claims 1 to 5, wherein the first and second locking elements comprise cylindrical shafts.

7. The directional locking assembly of any preceding claim, wherein the arms include openings configured to receive a core member.

8. The directional locking assembly of any preceding claim, wherein a first section of the arm of the first locking element is shorter than a first section of the arm of the second locking element.

9. 9. The directional locking assembly of claim 8, wherein an angle between a first section and a second section of an arm of the first locking element is greater than a corresponding angle of the second locking element.

10. The directional locking assembly of any one of claims 1 to 9, wherein the shaft is the same width as the housing and the arms are narrow to fit within the first and second chambers.

11. The directional locking assembly of any one of claims 1 to 10, wherein the locking element retainer comprises a circular bushing and an elongated slot, the circular bushing intersecting a bottom surface of the housing to form an entrance.

12. 12. The directional locking assembly of claim 11, wherein the shafts of the first and second locking elements are cylindrical and have a diameter the same as a diameter of a circular bushing of the locking element retainer and are configured to be received and retained by the circular bushing.

13. 13. The directional locking assembly of claim 11 or 12, wherein the slots of the locking element retainer are configured to allow the first and second locking elements to be received within a housing.

14. The directional locking assembly of any one of claims 11 to 13, wherein the locking element retainer slots extend radially from the circular bushing toward a top of the housing.

15. The directional locking assembly of any one of claims 1 to 14, wherein the first and second chambers are configured to open at one or both of the top and / or bottom of the housing.

16. 4. The directional lock assembly of claim 3, wherein in the first position, the first end wall, the second end wall, and the openings in the first and second locking elements are aligned, and in the second position, a path of the core member through the directional lock is non-linear or tortuous, configured to restrict movement of the core member through the directional lock.