H EADGEAR ASSEM BL I ES AND I NTERFACE ASSEM BL I ES WI TH H EADGEAR

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

[0001] Any and all applications for which a foreign or domestic priority claim is made in connection with the present application are hereby incorporated by reference and made a part of the disclosure.

BACKGROUND

Field

[0002] The present disclosure relates to headgear and interface assemblies for use in respiratoiy therapy. More particularly, the present disclosure relates to a substantially inelastic three dimensional headgear, portions thereof and a process for moulding such headgear. Further applications of the moulding process are also disclosed.

Description of Related Art

[0003] The treatment of respiratory ailments or conditions with therapies, such as NIV, Bi-level or CPAP, involves the delivery of pressurized air to the airways of a human via a conduit and a breathing apparatus (e.g., a mask or cannula). Typically, a mask creates at least a substantial "seal" on or around the nose and/or the mouth of a user while a cannula does not provide a seal but provides a delivery pathway for supplemental respiratoiy gas delivery.

[0004] A result of creating this "seal" is that the combination of the enclosure area of the breathing apparatus and its internal pressure creates a resulting force that attempts to push the breathing apparatus off of the face. To counteract this force, it is normal to use a headgear comprising a series of straps that pass around the back and/or top of a user's head. Headgear such as this are typically made from a compliant material, such as Breath-o-prene™. The use of such a material results in the headgear having relatively little structure when not being worn. This lack of structure can give rise to the straps of the headgear

becoming tangled, which in turn can make it difficult for a user to don the headgear and breathing apparatus.

[0005] The strap(s) require some form of adjustment to account for variation in head size, this adjustment mechanism is typically provided via an adjustment loop between the mask body and the head gear. The adjustment loop can have a hook-and-loop or similar fastener that permits an end of the strap to be passed through a mounting location on the mask or through a clip that attaches to the mask and then attached to another section of the strap. Such an arrangement permits adjustment of the headgear by positioning the end of the strap at a desired location on the other section of the strap to vary a size of the adjustment loop.

[0006] These types of mechanism are one solution to providing an adjustment mechanism for the headgear and, thus, the interface assembly. Such systems also require a reasonable level of user interaction and, as a result, is prone to misuse or mis-adjustment (e.g., over-tightening). As a practical matter, micro-adjustment of such systems is difficult and time-consuming to accomplish. The creation of practical and not so practical solutions to this has been the subject of considerable development effort from a number of organisations, which has resulted in numerous patents.

[0007] Further, these traditional headgear are usually configured to have some elasticity. This can result in the headgear stretching over, and applying pinching forces to, the user's head, which can be uncomfortable. It is desirable to make headgear and breathing apparatus that are easy to use and comfortable to wear because this may improve a user's compliance with the therapy being provided.

SUMMARY

[0008] The systems, methods and devices described herein have innovative aspects, no single one of which is indispensable or solely responsible for their desirable attributes. Without limiting the scope of the claims, some of the advantageous features will now be summarized.

[0009] A headgear system and/or an interface assembly incorporating a headgear system that upon fitment to the head of a user automatically adjusts to the correct size and, once in use, transforms in properties from an elasticated "stretchy" strap/strapping to an "inelastic" strap/strapping.

[0010] In some configurations, a headgear assembly for supporting a respiratory interface on a user comprises a rear headgear portion configured to contact the rearward and/or upper portions of a head of the user. The rear headgear portion comprises a plastic core and a textile casing. The plastic core and the textile casing are formed as an integral structure by the application of a molten plastic material into the textile casing. Each side of the rear headgear portion comprises a mounting portion configured to be located forwardly of an ear of the user in use. An interface connection arrangement is provided to the mounting portion on each side of the headgear assembly. Each interface connection arrangement is configured to be directly or indirectly coupled to the respiratory interface. Each interface connection arrangement includes at least one length adjusting arrangement. Each length adjusting arrangement comprises an elastic element, a core member and a restriction arrangement. 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 restriction arrangement. The restriction arrangement is configured to selectively engage the core member to resist movement of the core member relative to the restriction arrangement.

[0011] In some configurations, the rear headgear portion has no structure passing below the ear of the user that would inhibit removal of the rear headgear portion in an upward direction.

[0012] In some configurations, each of the interface connection arrangements comprises at least a first length adjusting arrangement and a second length adjusting arrangement.

[0013] In some configurations, a location of at least one of the first length adjusting arrangement and the second length adjusting arrangement on the mounting portion is adjustable.

[0014] In some configurations, each of the mounting portions comprises a plurality of mounting locations for the first length adjusting arrangement and the second length adjusting arrangement, wherein the mounting locations are unitarily formed with the plastic core.

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

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

[0017] In some configurations, the restriction arrangements are located on 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 members.

[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 restriction arrangements are located remotely from an end of the elastic element.

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

[0022] In some configurations, the elastic element comprises an inelastic portion that restricts the elastic element to a maximum length.

[0023] In some configurations, a headgear assembly for supporting a respiratory interface on a user comprises a rear headgear portion configured to contact the rearward and/or upper portions of a head of the user. The rear headgear portion comprises a plastic core and a textile casing. The plastic core and the textile casing are formed as an integral structure by the application of a molten plastic material into the textile casing. An interface connection arrangement is provided to each side of the headgear assembly. Each interface connection arrangement is configured to be directly or indirectly coupled to the respiratory interface. Each interface connection arrangement includes at least one length adjusting arrangement. Each length adjusting arrangement comprises an elastic element, a core member and a restriction arrangement. 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 restriction arrangement. The restriction arrangement is configured to selectively engage the core member to resist movement of the core member relative to the restriction arrangement. The at least one restriction arrangement is located on the rear headgear portion. [0024] In some configurations, the rear headgear portion has no structure passing below the ear of the user that would inliibit removal of the rear headgear portion in an upward direction.

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

[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 restriction arrangement is located remotely from the other end of the elastic element.

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

[0029] In some configurations, the elastic element comprises an inelastic portion that restricts the elastic element to a maximum length.

[0030] A headgear system and/or an interface assembly incorporating a headgear system that upon fitment to the head of a user automatically adjusts to the correct size and, once in use, transforms in properties from an elasticated "stretchy" strap/strapping to an "inelastic" strap/strapping.

[0031] In some configurations, a headgear assembly for supporting a respiratory interface on a user includes a substantially inelastic rear portion, a substantially inelastic front portion, a first elastic side portion on a first side of the headgear assembly, and a second elastic side portion of a second side of the headgear assembly. At least one filament extends through or along the first and second elastic side portions. The at least one filament coupled to one of the inelastic rear portion and the inelastic front portion, and at least one restriction arrangement. The at least one filament passes through the at least one restriction arrangement. The aL least one restriction arrangement 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 restriction arrangement.

[0032] In some configurations, the at least one restriction arrangement is configured to provide a first resistance force to movement or attempted movement of the at

least one filament in a direction that allows the inelastic rear portion and the inelastic front portion to move away from one another.

[0033] In some configurations, the at least one restriction arrangement is configured to provide a second resistance force to movement or attempted movement of the at least one filament in a direction that allows the inelastic rear portion and the inelastic front portion to move toward one another, wherein the second resistance force is less than the first resistance force.

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

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

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

[0037] In some configurations, each of the first and second elastic side portions comprises an end cap having an opening through which the at least one filament passes. The end cap can be overmolded onto the respective one of the first and second elastic side portions. The end cap can be coupled 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. The at least one restriction arrangement can comprise a first restriction arrangement associated with the first elastic side portion and a second restriction arrangement 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 restriction arrangement comprises a pair of lockjaws that define a space therebetween through which the filament passes. The lockjaws

have a first relative position engaging the filament to provide the first resistance force and a second relative position that provides the second resistance force.

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

[0043] In some configurations, the headgear comprises upper and lower elastic side portions on each side, upper and lower filaments and upper and lower restriction arrangements. In some such configurations, the there is an upper collection passage and lower collection passage. These upper and lower collection passages on each side of the headgear can be separate from one another.

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

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

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

[0047] In some configurations, a headgear assembly for supporting a respiratory interface on a user defines a perimeter that surrounds a head of the user. The headgear assembly can include a first portion having a fixed length along the perimeter and a second portion having a fixed length along the perimeter. At least one elastic portion has a variable length along the perimeter, wherein the at least one elastic portion has a first length and a second length that is greater than the first length. At least one filament is secured to one of the first portion and the second portion and extends through the at least one elastic portion and into at least one collection passage of the other of the first portion and the second portion. The at least one filament has a filament length that is greater than the second length of the at least one elastic portion. At least one restriction arrangement 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 restriction arrangement. The at least one restriction an-angement 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 the at least one collection passage.

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

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

[0053] In some configurations, the at least one elastic portion comprises a first elastic portion and a second elastic portion, wherein each of the first elastic portion and the second elastic portion extend 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. The at least one restriction arrangement comprises a first restriction arrangement associated with the first elastic side portion and a second restriction arrangement associated with the second elastic side portion.

[0055] 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.

[0056] In some configurations, the restriction arrangement comprises a pair of lockjaws that define a space therebetween through which the filament passes. The lock jaws have a first relative position engaging the filament to provide a first level of resistance and a second relative position that provides a second level or resistance that is lower that the first level.

[0057] In some configurations, a directional lock includes a housing defining an interior space, a first opening and a second opening. Each of the first and second openings communicates with the interior space. At least one lock element is pivotally coupled to the housing for rotation about a fixed pivot axis. The lock element has an aperture configured to receive a core element. The lock 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 lock element is a lock washer.

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

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

[0061] In some configurations, the housing comprises and internal wall positioned between the first lock element and the second lock element.

[0062] In some configurations, a headgear assembly for supporting a respiratory interface on a user includes a rear headgear portion configured to contact the rearward and/or upper portions of a head of the user. Each side of the rear headgear portion comprises a mounting portion configured to be located forwardly of an ear of the user in use. The rear headgear portion has no structure passing below the ear of the user that would inhibit removal of the rear headgear portion in an upward direction. An interface connection arrangement is provided to the mounting portion on each side of the headgear assembly. Each interface connection arrangement is configured to be directly or indirectly coupled to the respiratory interface. Each interface connection arrangement comprises at least one length adjusting arrangement. Each length adjusting arrangement comprises an clastic element, a core member and a restriction arrangement. 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 restriction arrangement. The restriction arrangement is configured to selectively engage the core member to resist movement of the core member relative to the restriction arrangement.

[0063] In some configurations, each of the interface connection arrangements comprises at least a first length adjusting an-angement and a second length adjusting arrangement.

[0064] In some configurations, the first length adjusting an-angement and the second length adjusting arrangement are spaced apart from one another on the mounting portion.

[0065] In some configurations, a location of at least one of the first length adjusting anangement and the second length adjusting anangement on the mounting portion is adjustable.

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

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

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

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

[0070] In some configurations, the connector is configured to connect to a plurality of 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 restriction anangement comprises a pair of lock jaws that define a space therebetween through which the core member passes. The lock jaws have a first relative position engaging the core member to provide a first level of resistance and a second relative position that provides a second level or resistance that is lower that the first level.

[0073] In some configurations, a headgear assembly for supporting a respiratory interface on a user comprises at least one inelastic portion and at least one elastic portion having a first end and a second end. At least one filament extends through or along the at least one elastic portion. The first end of the at least one elastic portion is fixed 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 comprises at least one restriction arrangement. The at least one filament passes through the at least one restriction arrangement. The at least one restriction aiTangement 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 restriction arrangement. The at least one restriction arrangement is located remotely from each of the first end and the second end of the at least one elastic portion.

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

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

[0076] In some configurations, the headgear assembly is configured such that the at least one restriction arrangement is located on the 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 restriction arrangement is located on the rear strap.

[0078] In some configurations, the headgear assembly is configured such that the at least one restriction arrangement is located behind the user's ear in use.

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

[0080] In some configurations, the restriction arrangement comprises a pair of lockjaws that define a space therebetween through which the filament passes. The lockjaws have a first relative position engaging the filament to provide a first level of resistance and a second relative position that provides a second level or resistance that is lower that the first level.

[0081] In some configurations, a patient interface system comprises a body portion sized and shaped to surround the nose and/or mouth of a user and adapted to create at least a substantial seal with the user's face. A coupling permits the patient interface to be coupled to a gas delivery system. A headgear system allows the body portion to be positioned and retained on an users head, with the head-gear system providing the ability to transform from an elastic type elongation behaviour to a non-elongating type behaviour when the interface system is in use.

[0082] In some configurations, the transformational locking behaviour is provided by a group of directional locking features.

[0083] In some configurations, the transformational locking behaviour is provided by a group of directional locking features which are located on retention planes.

[0084] In some configurations, the transformational locking behaviour is provided by a group of directional locking features which enable independent relative movement to each other.

[0085] In some configurations, the transformational locking behaviour is provided by a group of directional locking features which have dependent movement to each other.

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

[0087] In some configurations, the transformational locking behaviour is provided by a directional locking feature/s which are located on the mask body.

[0088] In some configurations, the transformational locking behaviour is provided by a directional locking feature/s which are located on or within the headgear system.

[0089] In some configurations, a combination of directional locking feature/s located on the mask body and located on or within the headgear system are used.

[0090] In some configurations, the directional lock is positioned in a location that is proximal with the connection point to the headgear.

[0091] In some configurations, the directional lock is positioned in a location that is distal with the connection point to the headgear.

[0092] In some configurations, the directional lock module incorporates a mechanism which enables user attachment/detachment between it and the mask body.

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

[0094] In some configurations, the non-stretch behaviour of the headgear system is such that there is less than 4mm of mask movement when the patient interface system is subjected to variable pressure waveform.

[0095] In some configurations, a patient interface system comprises a body portion sized and shaped to provide a cannulated gas delivery system into the nasal passages. A coupling permits the patient interface to be coupled to a gas delivery system. A headgear system allows the body portion to be positioned and retained on an users head, with the headgear system providing the ability to transform from an elastic type elongation behaviour to a non-elongating type behaviour when the interface system is in use.

[0096] In some configurations, a patient interface system includes a body portion sized and shaped to surround the nose and/or mouth of a user and adapted to create at least a substantial seal with the user's face. A coupling permits the patient interface to be coupled to a gas delivery system. A headgear system allows the body portion to be positioned and retained on an users head, with the head-gear system providing the ability to transform from an elastic type elongation behaviour to a non-elongating type behaviour when the interface system is in use.

[0097] In some configurations, the positional stability of the headgear system is achieved via two principal portions, one that passes on or below the occipital protruberance, the other passing over the top of the head in loosely the position of the crown of the head. The relative position of these two is maintained by the material of the headgear being shape sustaining.

[0098] In some configurations, the positional stability of the headgear system is achieved via two principal portions, one that passes on or below the occipital protuberance, the other passing over the top of the head in loosely the position of the crown of the head. The relative position of these two is maintained by the gusset or connecting member/s.

[0099] In some configurations, the non-stretch behaviour of the body portion of the headgear is achieved through constructing it from a single inelastic material and variable cross sectional geometry.

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

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

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

[0103] In some configurations, the non-stretch behaviour of the body portion of the headgear is achieved through constructing it from multiple thermoset materials.

[0104] In some configurations, the non-stretch behaviour of the body portion of the headgear is achieved through constructing it from multiple thermoplastic materials & variable cross sectional geometry.

[0105] In some configurations, the non-stretch behaviour of the body portion of the headgear is achieved through constructing it from thermoplastic material/s and an incorporated lining or padding.

[0106] hi some configurations, the non-stretch behaviour of the body portion of the headgear is achieved through constructing it from thermoset material/s and an incorporated lining 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 adjusting portion that adjusts a length of the headgear assembly or a perimeter length of the interface assembly when coupled to a respiratory interface. The headgear assembly exhibits an elastic force tending to contract the headgear length or the perimeter length and a non-elastic lock force tending to inhibit elongation of the headgear length or the perimeter length.

[0108] In some configurations, the headgear assembly comprises at least one retention plane.

[0109] In some configurations, the headgear assembly comprises two retention planes.

[0110] In some configurations, the retention planes converge in a direction moving from rearward to forward.

[0111] In some configurations, the retention planes converge in a direction moving from forward to rearward.

[0112] In some configurations, one of the retention planes is angled relative to the other retention plane.

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

[0114] In some configurations, the retention planes are generally parallel with one another.

[0115] In some configurations, the retention planes are generally horizontal.

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

[0117] In some configurations, the interface coupling portion can be connected to a plurality of types of interfaces.

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

[0119] In some configurations, the first portion and the second portion 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 member forms a portion of the headgear length or perimeter length and can be locked relative to another portion of the headgear assembly or interface assembly to inhibit elongation of the headgear length or perimeter length.

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

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

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

[0127] In some configurations, at least one core collector accommodates an excess portion of the core that, at any particular headgear length or perimeter length, does not form a portion of the headgear length or perimeter length.

[0128] In some configurations, a length of the core member is less than a combined length of the core collector and a maximum extended length of the length adjusting portion.

[0129] In some configurations, a length of the rear headgear portion and a length of the core collector is fixed, and adjustment of a length of the length adjusting member provides substantially all of a length adjustment of the headgear length or the perimeter length.

[0130] In some configurations, a nasal cannula system comprises a nasal cannula and a headgear. At least one adjustment arrangement allows adjustment of a perimeter length of the nasal cannula system. The at least one adjustment arrangement 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 retain the nasal cannula system in a desired adjusted perimeter length.

[0131] In some configurations, the lock can retain the desired adjusted perimeter length in response to normal or expected forces in use, such as the weight of the nasal cannula and hose pull forces, for example.

[0132] In some configurations, the lock allows slippage of the core member at forces above a threshold such that the perimeter length can be increased beyond the desired adjusted perimeter length.

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

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

[0135] In some configurations, at least one biasing element applies a force to the nasal cannula system tending to reduce the perimeter length.

[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 comprises at least one quick release arrangement that allows the perimeter loop to be quickly and easily broken, such as for removal or application of the nasal cannula system from or to a user.

[0138] In some configurations, the headgear is a single strap or a bifurcated strap arrangement.

[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, an excess portion of the at least one core member that is not actively defining a portion of the perimeter length is accommodated 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 accommodated in a circular accumulator.

[0141] In some configurations, multiple adjustment arrangements are provided. In some such configurations, an adjustment arrangement is provided on each side of the nasal cannula system. In some such configurations, the excess portions of the core members of each side are positioned above and below one another on or within the nasal cannula.

[0142] In some configurations, a nasal cannula system comprises a nasal cannula and a headgear. At least one adjustment arrangement allows adjustment of a perimeter length of the nasal cannula system. The at least one adjustment arrangement includes a core member coupled to one 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 retain the nasal cannula system in a desired adjusted perimeter length.

[0143] In some configurations, the lock can retain the desired adjusted perimeter length in response to normal or expected forces in use, such as the weight of the nasal cannula and hose pull forces, for example.

[0144] In some configurations, the lock allows slippage of the core member at forces above a thi'eshold such that the perimeter length can be increased beyond the desired adjusted perimeter length.

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

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

[0147] In some configurations, at least one biasing element applies a force to the nasal cannula system tending to reduce the perimeter length.

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

[0149] In some configurations, the nasal cannula system comprises at least one quick release arrangement that allows the perimeter loop to be quickly and easily broken, such as for removal or application of the nasal cannula system from or to a user.

[0150] In some configurations, the headgear is a single strap or a bifurcated strap arrangement.

[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 the at least one core member that is not actively defining a portion of the perimeter length is accommodated in the headgear. In some such configurations, the excess portion is internal to the headgear. In some such configurations, the excess portion is accommodated in a circular accumulator.

[0153] In some configurations, multiple adjustment arrangements are provided. In some such configurations, an adjustment arrangement is provided on each side of the nasal cannula system.

[0154] In some configurations, a directional lock includes a lock member having an aperture or opening and is configured to engage a core member or filament that passes through the opening. The opening can change cross-sectional dimensions between one side of the lock member and the other side of the lock member and/or the profile of the opening can be tapered.

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

[0156] In some configurations, the profile of the opening tapers towards a pivot axis of the lock member.

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

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

[0159] In some configurations, the motion transfer element is a link, which deflects to allow the second lock member to move away from the first lock member.

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

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

[0162] According to a further aspect, the headgear comprises integrally moulded labels, connections, and/or adjustment features.

[0163] According to a further aspect, a headgear component comprises a grip that is moulded to a textile strap.

[0164] According to a further aspect, the textile casing comprises a first portion that covers an inwardly-facing surface of the headgear.

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

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

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

[0168] According to a further aspect, the textile casing comprises one or more retainer holes configured to engage a retaining pin of a moulding tool.

[0169] According to a further aspect, the headgear comprises at least one flexible joint that permits the strap to bend.

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

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

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

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

[0174] According to a further aspect, the top strap and the rear strap are formed unitarily as an integral structure.

[0175] According to a further aspect, the top strap, the rear strap and the lower side strap are formed unitarily as an integral structure.

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

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

[0178] According to a further aspect, the headgear assembly comprises a top strap and a rear strap connected to the top strap at an upper connection point located on a side of a user's forehead. The headgear assembly also comprises an upper side strap connected to the top and rear straps at the upper connection point and connected to a frame of the respiratory interface. The upper side strap extends between the user's ear and eye and across the user's cheek towards the frame of the respiratory interface. The headgear assembly further comprises a lower side strap connected to the rear strap at a rear connection point located behind the user's ear. The lower side strap extends below the user's ear and across the user's cheek towards the frame of the respiratory interface. The headgear assembly additionally comprises a first length adjusting portion connected to the lower side strap and the frame of the respiratory interface. The first length adjusting portion adjusts the distance between the lower side strap and the frame of the respiratory interface.

[0179] According to a further aspect, the top strap and the rear strap are formed unitarily as an integral structure.

[0180] According to a further aspect, the top strap, the rear strap, the upper side strap and the lower side strap are formed unitarily as an integral structure.

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

[0182] According to a further aspect, the headgear assembly further comprises a second length adjusting portion connected between the upper side strap and the frame of the respiratory interface, wherein the second length adjusting portion adjusts the distance between the upper side strap and the frame of the respiratory interface.

[0183] According to a further aspect, the headgear assembly comprises a top strap, a rear strap connected to the top strap at an upper connection point located on a side of a user's forehead, and a front strap connected to the top and rear straps at the upper connection point and connected to the respiratory interface. The front strap extends between the user's ear and eye and towards a bottom of the user's nose.

[0184] According to a further aspect, the top strap and the rear strap are formed unitarily as an integral structure.

[0185] According to a further aspect, the top strap, the rear strap and the front strap are formed unitarily as an integral structure.

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

[0187] According to a further aspect, the headgear assembly further comprises a length adjusting portion connected between the front strap and the respiratory interface, wherein the length adjusting portion adjusts the distance between the front strap and the respiratory interface.

[0188] According to a further aspect, the headgear assembly comprises a top strap, a rear strap connected to the top strap at an upper connection point located on a side of a user's forehead, and a lower side strap connected to the top and rear straps at the upper connection point and extends away from the upper connection point in a substantially vertical direction. The lower strap is positioned in front of the user's ear. The headgear assembly also comprises a first length adjusting portion connected to the lower strap at a first lower connection point, the first length adjusting portion adjusting the distance between the first lower connection point and a frame of the respiratory interface. The first lower connection point is positioned in line with the user's eye and the first length adjusting portion extends across the user's cheeks just below the eyes. The headgear assembly further comprises a second length adjusting portion connected to the lower strap at a second lower connection point, the second length adjusting portion adjusting the distance between the second lower connection point and the frame of the respiratoiy interface. The second lower connection point is positioned approximately in line with a bottom of the user's nose and the second length adjusting portion extends substantially horizontally across the users cheek.

[0189] According to a further aspect, the top strap and the rear strap are formed unitarily as an integral structure.

[0190] According to a further aspect, the top strap, the rear strap and the lower side strap are formed unitarily as an integral structure.

[0191] According to a further aspect, at least one of the first or second length adjusting portions include a one-way adjusting mechanism.

[0192] In accordance with at least one of the embodiments disclosed herein, a headgear comprises a plastic core and a textile casing. The plastic core and the textile casing are formed as an integral structure by the application of a molten plastic material onto the textile casing.

[0193] According to a further aspect, the textile casing comprises a first portion that covers an inwardly-facing surface of the headgear.

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

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

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

[0197] According to a further aspect, the textile casing comprises one or more retainer holes configured to engage a retaining pin of a moulding tool.

[0198] According to a further aspect, the headgear comprises at least one flexible joint that permits the headgear to bend.

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

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

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

[0202] In accordance with at least one of the embodiments disclosed herein, a method of making a headgear comprises placing a textile casing within a moulding tool, introducing a molten plastic material into the moulding tool and into 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 placing of the textile casing into the moulding tool comprises placing a first textile portion and a second textile portion into the moulding tool, and the introducing the molten plastic material into the moulding tool comprises introducing the molten plastic material between the first and second textile portions.

[0204] According to a further aspect, the method further comprises retaining an end of each of the first and second textile portions at which the molten plastic material is introduced within a retaining feature of the moulding tool.

[0205] According to a further aspect, the method further comprises capturing at least one edge of the textile casing between first and second separable portions of a moulding tool.

[0206] According to a further aspect, the method further comprises engaging an opening of the textile casing with a retention pin of the moulding tool.

[0207] According to a further aspect, the method further comprises securing the textile casing within the moulding tool prior to the introduction of the molten plastic material.

[0208] According to a further aspect, the securing of the textile casing comprises securing the textile casing by one or more of a static electrical charge, air pressure, retaining the textile casing with another component inserted into the moulding tool, or supporting a strip of material that forms the textile casing extending through the moulding tool on each side of the moulding tool.

[0209] According to a further aspect, the supporting the strip of material comprises supporting one end on a roll and securing a free end relative to the moulding tool. [0210] According to a further aspect, the method further comprises forming a flexible joint by providing a gap in plastic core along a length of the headgear, and extending the textile casing along the gap.

[0211] According to a further aspect, the method further comprises 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 the opposite side of the gap- [0212] In accordance with at least one embodiment disclosed herein, a headgear comprises a first strap and a second strap, wherein the first strap and the second strap cooperate to form at least one of a top strap, a rear strap and a front strap of the headgear.

[0213] In accordance with at least one of the embodiments disclosed herein, a method of making a headgear comprises placing a textile casing within a moulding tool, introducing a molten plastic material into the moulding tool and into contact with an inside of the textile casing, and allowing the molten plastic material to solidify in the textile casing to form a plastic core.

[0214] According to a further aspect, the first strap and the second strap cooperate to form the rear strap, wherein the first strap and the second strap overlap one another within the rear strap, and wherein only one of the first strap and the second strap defines the top strap.

[0215] According to a further aspect, the first strap and the second strap cooperate to form the front strap, wherein the first strap and the second strap are stacked within the front strap, and wherein the first strap and the second strap alone defines 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 formed as an integral structure by the application of a molten plastic material onto the textile casing.

[0217] In accordance with at least one embodiment disclosed herein, a headgear includes an inner core, a first outer layer defining an inner surface of the headgear that faces the 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 layer and the second layer have different colors, textures or other indicia that permit tactile or visual differentiation of the inner surface and the outer surface.

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

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

[0220] According to a further aspect, the inner core comprises an interior cut-out.

[0221] In accordance with at least one embodiment disclosed herein, a headgear comprises a first strap, a second strap, and a connector that couples the first strap to the second strap, wherein the connector is formed by over-moulding onto the first strap and the second strap.

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

[0223] According to a further aspect, the connector includes a portion extending between and separating 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, wherein the bridge portion does not surround an entirety of both the first strap and the second strap.

[0225] According to a further aspect, the connector includes a front band portion and a rear gusset.

[0226] According to a further aspect, the front band portion and the rear gusset are separated by a bridge portion, wherein the bridge portion does not surround an entirety of both the first strap and the second strap.

[0227] In accordance with at least one embodiment disclosed herein, a strap of a headgear comprises an inner core, at least one outer layer that at least partially surrounds 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 lateral edge of the strap and a second air gap at the opposite lateral edge of the strap.

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

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

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

[0232] In accordance with at least one embodiment disclosed herein, a strap of a headgear comprises an inner core, at least one outer layer, and at least one conduit extending lengthwise along the strap and within the outer layer.

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

[0234] According to a further aspect, the conduit is completely encapsulated 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] In accordance with at least one embodiment disclosed herein, a strap of a headgear includes an inner core, at least one outer layer, and at least one reinforcement member.

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

[0239] According to a further aspect, the reinforcement member is configured to hold opposing outer layers or opposing sides of an outer layer apart from one another prior to the formation of the inner core.

[0240] In accordance with at least one embodiment disclosed herein, a strap of a headgear comprises an inner core, at least one outer layer, and at least one cushioning layer.

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

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

[0243] In accordance with at least one embodiment disclosed herein, a strap of a headgear comprises an inner core and an outer layer that at least partially surrounds the inner core, the outer layer comprising edges. The edges are embedded in the inner core.

[0244] According to a further aspect, the outer layer comprises more than one piece or more than two pieces.

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

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

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

[0248] In accordance with at least one embodiment disclosed herein, a strap of a headgear comprises an inner core and an outer layer, wherein the outer layer is textured.

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

[0250] According to a further aspect, the core is textured such that it imparts a texture to the outer layer.

WHAT IS CLAIMED IS:

1. A headgear assembly for a respiratory interface, comprising:

a plastic core; and

a textile casing;

wherein the plastic core and the textile casing are formed as an integral structure by the application of a molten plastic material into the textile casing.

2. The headgear assembly of Claim 1, wherein the textile casing comprises a first portion that covers an inwardly-facing surface of the headgear.

3. The headgear assembly of Claim 2, wherein the textile casing comprises a second portion that covers an outwardly-facing surface of the headgear.

4. The headgear assembly of Claim 3, wherein the first portion and the second portion of the textile casing meet at first and second edges.

5. The headgear assembly of Claim 4, wherein the first portion and the second portion are not connected to one another at the first and second edges.

6. The headgear assembly of any one of Claims 1-5, wherein the textile casing comprises one or more retainer holes configured to engage a retaining pin of a moulding tool.

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

8. The headgear assembly of Claim 7, wherein the at least one flexible joint comprises a gap between portions of the plastic core and wherein the textile casing extends within the gap to connect the portion of the plastic core.

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

10. The headgear assembly of Claim 9, wherein the at least one bridge portion is unitarily formed with the portions of the plastic core.

11. A headgear assembly for supporting a respiratory interface on a user, comprising:

a substantially inelastic rear portion;

a substantially inelastic front portion;

a first elastic side portion on a first side of the headgear assembly;

a second elastic side portion of a second side of the headgear assembly;

at least one filament that extends through or along the first and second elastic side portions, the at least one filament coupled to one of the inelastic rear portion and the inelastic front portion;

at least one restriction arrangement;

wherein the at least one filament passes through the at least one restriction arrangement, and wherein the at least one restriction arrangement 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 restriction arrangement.

12. The headgear assembly of Claim 11, wherein the at least one restriction arrangement is configured to provide a first resistance force to movement or attempted movement of the at least one filament in a direction that allows the inelastic rear portion and the inelastic front portion to move away from one another.

13. The headgear assembly of Claim 12, wherein the at least one restriction arrangement is configured to provide a second resistance force to movement or attempted movement of the at least one filament in a direction that allows the inelastic rear portion and the inelastic front portion to move toward one another, wherein the second resistance force is less than the first resistance force.

14. The headgear assembly of any one of Claims 1 1-13, wherein the inelastic front portion is rigid.

15. The headgear assembly of Claim 14, wherein the inelastic front portion is configured to be connected to a respiratory interface.

16. The headgear assembly of either one of Claims 14 or 15, wherein the inelastic front portion defines at least one collection passage that accommodates a portion of the at least one filament.

17. The headgear assembly of any one of Claims 11 -16, wherein each of the first and second elastic side portions comprises an end cap having an opening through which the at least one filament passes.

18. The headgear assembly of Claim 17, wherein the end cap is overmolded onto the respective one of the first and second elastic side portions.

19. The headgear assembly of either one of Claims 17 or 18, wherein the end cap is coupled to the inelastic front portion.

20. The headgear assembly of any one of Claims 11-19, wherein the inelastic rear portion, the inelastic front portion, the first elastic side portion and the second elastic side portion define a closed loop perimeter.

21. A headgear assembly for supporting a respiratory interface on a user, comprising:

a rear headgear portion configured to contact the rearward and/or upper portions of a head of the user, the rear headgear portion comprising a plastic core and a textile casing, wherein the plastic core and the textile casing are formed as an integral structure by the application of a molten plastic material into the textile casing, each side of the rear headgear portion comprising a mounting portion configured to be located forwardly of an ear of the user in use;

an interface connection arrangement provided to the mounting portion on each side of the headgear assembly, each interface connection arrangement configured to be directly or indirectly coupled to the respiratory interface, each interface connection arrangement comprising:

at least one length adjusting arrangement, each length adjusting arrangement comprising an elastic element, a core member and a restriction arrangement, wherein the core member is associated with the elastic element and is fixed relative to one end of the elastic element, wherein the core member passes through the restriction arrangement, and wherein the restriction arrangement is configured to selectively engage the core member to resist movement of the core member relative to the restriction arrangement.

22. The headgear assembly of Claim 21, wherein the rear headgear portion has no structure passing below the ear of the user that would inhibit removal of the rear headgear portion in an upward direction.

23. The headgear assembly of either of Claims 21 or 22, wherein each of the interface connection arrangements comprises at least a first length adjusting arrangement and a second length adjusting arrangement.

24. The headgear assembly of Claim 23, wherein a location of at least one of the first length adjusting arrangement and the second length adjusting arrangement on the mounting portion is adjustable.

25. The headgear assembly of Claim 24, wherein each of the mounting portions comprises a plurality of mounting locations for the first length adjusting arrangement and the second length adjusting arrangement, wherein the mounting locations are unitarily formed with the plastic core.

26. The headgear assembly of any one of Claims 21-25, further comprising at least one connector that is configured to connect the interface connection arrangements to the respiratory interface.

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

28. The headgear assembly of any one of Claims 21-26, wherein the restriction arrangements are located on the rear headgear portion.

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

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

31. The headgear assembly of Claim 28, wherein the restriction arrangements are located remotely from an end of the elastic element.

32. The headgear assembly of Claim 31, further comprising a guide for a portion of the core member between the end of the elastic element and the restriction arrangement.

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