Headgear and patient interface assembly for a respiratory support system

Abstract

A headgear is provided for use in securing a patient interface in a therapeutic position on the head of a patient for provision of respiratory support. The headgear includes a rear portion configured to engage a rear of the head of the patient, and a pair of side portions configured to engage respective sides of the head of the patient. The rear portion and the pair of side portions may be knitted. One or more inlaid elements are each mechanically inlaid with one or more of the rear portion or the pair of side portions. The inlaid elements may include tensile elements each configured to be coupled with a tensioner configured to control a tension in the headgear, or sleeves configured to receive the tensile elements.

Description

HEADGEAR AND PATIENT INTERFACE ASSEMBLY FOR A RESPIRATORY SUPPORTSYSTEMCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This applications claims the benefit of priority from United States Patent Application No. 63 / 716,138, filed on November 4, 2024, the disclosure of which is hereby incorporated by reference in its entirety.BACKGROUNDField

[0002] The disclosure relates to headgear and a patient interface assembly configured for use in a respiratory support system. Particularly, though not exclusively, the disclosure relates to a headgear including a knitted fabric with inlaid elements.Description of Related Art

[0003] In respiratory support systems, a flow of respiratory gases is supplied to a patient through a patient interface in gases communication with the patient's airway.

[0004] The patient interface is generally secured in position on the patient by headgear. The headgear may apply a sealing force to maintain a seal between the patient interface and the patient for respiratory therapy, e.g., for positive airway pressure (PAP) therapy or non-invasive ventilation (NIV). Together, the patient interface and the headgear may be referred to as a patient interface assembly.

[0005] Relevant factors in designing a patient interface assembly for a respiratory support system may include one or more of sealing, comfort, usability, manufacturability, cost, aesthetics, or sustainability, for example.

[0006] Obtaining an appropriate fit of the patient interface assembly with the patient may require a balance between sealing and comfort. An excessive sealing force may result in patient discomfort. And, over time, an excessive sealing force may contribute to pressure sores, e.g., where the patient interface engages sensitive parts of the patient's face such as the nasal bridge region. Conversely, an inadequate or misdirected sealing force may result in an uncontrolled leak of respiratory gases from the patient interface. An uncontrolled leak may impact the efficacy of the therapy or cause patient discomfort, e.g., jetting into the patient's eyes.

[0007] The optimum sealing force to be applied by the headgear may depend upon a number of different factors including one or more of the patient's facial geometry, the type of patient interface, the type of headgear, the pressure of the flow of respiratory gases, or the therapy period(s), for example.

[0008] To account for these factors, the headgear may be adjustable. The headgear may include one or more straps each configured to be adjustably coupled with the patient interface and / or each other. For example, side straps may loop through a slotted connector of the patient interface or a clip removably coupled with the patient interface, and adjustably couple back onto itself using a hook-and-loop fastener. The effective length of the side strap may be shortened to increase tension in the side strap, or lengthened to decrease tension in the side strap, when the patient interface assembly is donned by the patient.

[0009] Some patients, or their caregivers, may have difficulty adjusting the headgear precisely. For example, they may have difficulty with one or more of adjusting the tension at all (e.g., due to limited dexterity), adjusting the headgear with limited or no visual cues (e.g., due to poor vision, poor or no lighting, or the patient interface being donned), adjusting the tension symmetrically, or obtaining a suitable sealing force. There may be a tendency to overtighten adjustable headgear, e.g., to ensure an adequate sealing force. But this may come at the cost of long-term comfort.

[0010] Breathability of the headgear may also be a factor in patient comfort.

[0011] Headgear may be manufactured by cutting the headgear from a sheet of material. The sheet of material may be a composite material including at least a layer of foam, e.g., open-cell foam, sandwiched between two fabric layers (e.g., the Breath-o-prene™ composite material developed by Accu-Med Technologies, Inc).

[0012] The headgear may be formed as a single unitary piece from the sheet of material. But this may require compromises in the shape or properties (e.g., elasticity) of the headgear, impacting patient comfort. And it may result in excess waste material.

[0013] Alternatively, the headgear may be formed from two or more separate pieces joined to each other at one or more joints, e.g., by stitching or welding. But joining the pieces requires additional manufacturing steps, the joints may cause patient discomfort, and / or there may still be excess waste material.

[0014] Patient discomfort may result in a reduction in compliance, i.e., adherence to a prescribed therapy schedule.SUMMARY

[0015] In a first aspect, a headgear is provided for use in securing a patient interface in a therapeutic position on a head of a patient for provision of respiratory support. The headgear may include: a rear portion configured to engage a rear of the head of the patient, in use; a pair of side portions extending from the rear portion, the pair of side portions configured to engage respective sides of the head of the patient; and an inlaid element, the inlaid element mechanically inlaid with one or more of the rear portion or the pair of side portions.

[0016] The inlaid element may include a tensile element, the tensile element configured to be coupled with a tensioner configured to control a tension in the headgear. The tensile element may be non-knitted. Alternatively, the tensile element may be knitted.

[0017] The inlaid element may include a sleeve, the headgear may include a tensile element received within the sleeve, the tensile element configured to be coupled with a tensioner configured to control a tension in the headgear.

[0018] The sleeve may include a hollow tubular structure, the tensile element slidably received within the hollow tubular structure.

[0019] The sleeve may be non-knitted. Alternatively, the sleeve may be knitted, e.g., knitted simultaneously with at least part of one or more of the rear portion and the pair of side portions, e.g., in a complete garment process.

[0020] The headgear may further include the tensioner.

[0021] The tensioner may include: an automatic tensioner configured to automatically adjust the headgear to an appropriate size and / or tension when the headgear is donned by the patient; a headgear adjustment assembly operable, e.g., rotatable, by the patient to adjust an effective length of the tensile element and / or to control a tension in the headgear; or a resilient member configured to control the tension in the headgear by elastic deformation.

[0022] The headgear may include a further inlaid element, the further inlaid element including : a shaping element; and / or a cushioning element.

[0023] The cushioning element may be non-knitted. Alternatively the cushioning element may be knitted, e.g., knitted simultaneously with at least part of one or more of the rear portion and the pair of side portions, e.g., in a complete garment process.

[0024] The inlaid element may include a curved path when the headgear is laid flat.

[0025] The inlaid element may emerge from a distal end of one or each of the pair of side portions.

[0026] Movement of the inlaid element with respect to one or more of the rear portion and the pair of side portions may be: relatively uninhibited in a longitudinal direction of the inlaid element; and / or relatively inhibited in a lateral direction.

[0027] The inlaid element may be anchored to one or more of the rear portion or the pair of side portions.

[0028] The inlaid element may be configured to move within one or more of the rear portion or the pair of side portions., e.g., in one or more of a lateral direction and a longitudinal direction.

[0029] The inlaid element may be: relatively inextensible compared to one or more of the rear portion or the pair of side portions; and / or substantially inextensible when subjected to tensile forces typically encountered during normal use of headgear in a respiratory support system.

[0030] One or more of the rear portion or the pair of side portions may include a knit structure, the knit structure preferably including : an inner layer configured to engage the head of the patient when the headgear is donned by the patient; and an outer layer configured to face outwardly when the headgear is donned by the patient, wherein an interior space is formed between the inner layer and the outer layer.

[0031] The inlaid element may be mechanically inlaid : through the inner layer; through the outer layer; and / or within the interior space.

[0032] The inner layer may be joined with the outer layer by a knit structure, e.g., a double knit stitch structure, an interlock stitch structure, or a rib stitch structure.

[0033] One or more of the rear portion or the pair of side portions may include a moisture absorbent yarn or a wicking yarn.

[0034] One or more of the rear portion or the pair of side portions may include a heat-set yarn.

[0035] The rear portion may include a panel; and / or the pair of side portions may include: a left upper side strap configured to pass above a left ear of the patient, and a right upper side strap configured to pass above a right ear of the patient; and / or a left lower side strap configured to pass below a left ear of the patient, and a right lower side strap configured to pass below a right ear of the patient.

[0036] The left upper side strap may be configured to pass below a left eye of the patient. The right upper side strap may be configured to pass below a right eye of the patient.

[0037] The inlaid element may be mechanically inlaid with: the rear portion and each of the pair of side portions, e.g. : a left upper side strap, the rear portion, and a right lower side strap; a right upper side strap, the rear portion, and a left lower side strap; the left upper side strap, the rear portion, and the right upper side strap; or the left lower side strap, the rear portion, and the right lower side strap; or the rear portion and one of the pair of side portions, e.g. : the left upper side strap, the rear portion, and the left lower side strap; or the right upper side strap, the rear portion, and the right lower side strap.

[0038] The headgear may include: a first inlaid element mechanically inlaid with the left upper side strap, the rear portion, and the right lower side strap; and a second inlaid element mechanically inlaid with the right upper side strap, the rear portion, and the left lower side strap.

[0039] The inlaid element may be mechanically inlaid with the left upper side strap, the rear portion, and the right upper side strap.

[0040] The headgear may include a second inlaid element mechanically inlaid with the left lower side strap, the rear portion, and the right lower side strap.

[0041] One or more of the rear portion or the pair of side portions may include a flattened tubular structure.

[0042] The rear portion may include a panel, the panel including an upper section, a central section, and a lower section, one or more of the upper section, the central section, or the lower section including a flattened tubular structure.

[0043] The left upper side strap, the upper section, and the right upper side strap together may include a continuous flattened tubular structure; and / or the left lower side strap, thelower section, and the right lower side strap together may include a continuous flattened tubular structure.

[0044] One or more of the pair of side portions may include a knitted strap, the knitted strap including a distal region distal of the rear portion and a proximal region proximal to the rear portion, the distal region including a first yarn and the proximal region including a second yarn, wherein the first yarn is different to the second yarn.

[0045] The first yarn, e.g., elastane, may be more extensible or more elastic than the second yarn, e.g., nylon.

[0046] The distal region may be formed predominantly or entirely from the first yarn. The proximal region may be formed predominantly or entirely from the second yarn.

[0047] The inlaid element may include a first tensile element. The headgear may further include a second tensile element.

[0048] In a second aspect, a headgear is provided for use in securing a patient interface in a therapeutic position on a head of a patient for provision of respiratory support. The headgear may include: a rear portion configured to engage a rear of the head of the patient; a pair of side portions extending from the rear portion, the pair of side portions configured to engage respective sides of the head of the patient; and one or more tensile elements each configured to be coupled with a tensioner configured to control an effective length and / or tension of the one or more tensile elements, wherein one or more of the rear portion and the pair of side portions include a knit structure, and the one or more tensile elements are mechanically inlaid with the knit structure.

[0049] In a third aspect, a headgear is provided for use in securing a patient interface in a therapeutic position on a head of a patient for provision of respiratory support. The headgear may include: a rear portion configured to engage a rear of the head of the patient; a pair of side portions extending from the rear portion, the pair of side portions configured to engage respective sides of the head of the patient; one or more sleeves each coupled with one or more of the rear portion or the pair of side portions; and one or more tensile elements extending through the one or more sleeves, the one or more tensile elements configured to be coupled with one or more tensioners configured to control an effective length and / or tension of the one or more tensile elements.

[0050] One or more of the rear portion or the pair of side portions may include a knit structure. The one or more sleeves may be mechanically inlaid with the knit structure.

[0051] The one or more sleeves may be knitted with one or more of the rear portion or the pair of side portions, e.g., as part of a complete garment process.

[0052] The one or more sleeves may comprise a knitted sleeve.

[0053] The one or more tensile elements may comprise a knitted tensile element.

[0054] In a fourth aspect, a headgear is provided for use in securing a patient interface in a therapeutic position on a head of a patient for provision of respiratory support. The headgear may include: a rear portion configured to engage a rear of the head of the patient; and a pair of side portions extending from the rear portion, the pair of side portions configured to engage respective sides of the head of the patient, one or more of the rear portion and the pair of side portions including a curved portion, the curved portion knitted with a plurality of courses, the curved portion including : a first region including one or more of the plurality of courses; and a second region adjacent to the first region, the second region including one or more of the plurality of courses, wherein one or more of a yarn tension or a gauge of the plurality of courses is varied between the first region and the second region.

[0055] The headgear may include a third region adjacent to the second region, the third region including one or more of the plurality of courses. One or more of the yarn tension or the gauge of the plurality of courses may be varied between the second region and the third region.

[0056] One or more of the yarn tension or the gauge of the plurality of courses may be varied between each of the first region, the second region, and the third region.

[0057] The yarn tension of the plurality of courses may be greater: in the first region than in the second region and / or the third region; and / or in the second region than the third region.

[0058] The gauge of the plurality of courses may be greater: in the second region than in the first region; and / or in the third region than in the second region and / or the first region.

[0059] The plurality of courses may be knitted at: half gauge or less in the first region, and full gauge in the second region; or quarter gauge or less in the first region, half gauge or less in the second region, and full gauge in the third region.

[0060] The headgear may include one or more inlaid elements mechanically inlaid with one or more of the rear portion and the pair of side portions, e.g., the curved portion.

[0061] The one or more inlaid elements may include one or more tensile elements each configured to be coupled with one or more tensioners configured to control an effective length and / or a tension of the one or more tensile elements.

[0062] One or more of the rear portion or the pair of side portions may be knitted in a complete garment process.

[0063] One or more of the rear portion or the pair of side portions may be knitted in a complete garment process with the inlaid element / one or more tensile elements.

[0064] Each of the rear portion and the pair of side portions may be knitted together in a complete garment process.

[0065] In a fifth aspect, a patient interface assembly is provided for provision of respiratory support to a patient. The patient interface assembly may include: a patient interface configured to receive a flow of respiratory gases and supply the flow of respiratory gases to the patient; the headgear according to any one of the first to fourth aspects, the headgear configured to secure the patient interface in a therapeutic position on the head of the patient; and one or more tensioners configured to cooperate with the one or more inlaid elements and / or the one or more tensile elements to control a tension in the headgear.

[0066] The headgear may include one or more tensile elements. The one or more tensioners may include a headgear adjustment assembly operable, e.g., rotatable, to adjust an effective length and / or a tension of the one or more tensile elements.

[0067] The headgear adjustment assembly may include: a rack-and-pinion or a reel, the rack-and-pinion or reel coupled with the one or more tensile elements; a rotatable dial coupled with the rack-and-pinion or reel and operable to rotate the rack-and-pinion or reel in a first direction to adjust one or more of an effective length or a tension of the one or more tensile elements.

[0068] The headgear adjustment assembly may include: a locking mechanism configured to inhibit rotation of the rack-and-pinion or the reel in a second direction; and a release mechanism configured to selectively and at least partially disengage the locking mechanism so that rotation of the rack-and-pinion or the reel in the second direction is relatively uninhibited.

[0069] The headgear may include one or more tensile elements. The one or more tensioners may include one or more resilient members configured to control the tension in the one or more tensile elements by elastic deformation.

[0070] The patient interface assembly may include a compact full-face mask configured to seal with, or about, the patient's nares and mouth, e.g., without engaging an upper part of the patient's nasal region such as one or more of the patient's nasion, rhinion, or supratip.

[0071] The patient interface patient interface may include: a frame; a cushion, the cushion coupled with the frame, e.g., permanently coupled by overmolding; and a bracket, the bracket permanently or removably coupled with the frame and the one or more tensioners.

[0072] In a sixth aspect, a respiratory support system is provided for provision of respiratory support to a patient. The respiratory support system may include: a gases source configured to supply a flow of respiratory gases; an inspiratory conduit configured to receive and convey the flow of respiratory gases from the gases source; and the patient interface assembly according to the fifth aspect, the patient interface assembly configured to receive the flow of respiratory gases from the inspiratory conduit and supply the flow of respiratory gases to the patient.

[0073] In a seventh aspect, a method is provided for forming at least a portion of a headgear configured for use in securing a patient interface in position on a head of a patient for provision of respiratory support. The method may include: knitting one or more of: a rear portion configured to engage a rear of the head of the patient; or a side portion configured to engage a side of the head of the patient; and mechanically inlaying one or more inlaid elements with one or more of the rear portion and the side portion as it is knitted.

[0074] The one or more inlaid elements may include one or more tensile elements, the one or more tensile elements each configured to be coupled with one or more tensioners to control a tension in the headgear.

[0075] The one or more inlaid elements may include one or more sleeves, the one or more sleeves configured to receive one or more tensile elements, the tensile elements each configured to be coupled with one or more tensioners to control a tension in the headgear.

[0076] The method may include mechanically inlaying the one or more sleeves with one or more of the rear portion and the pair of side portions, with the one or more tensile elements in situ within the one or more sleeves.

[0077] The method may include: mechanically inlaying the one or more sleeves with one or more of the rear portion and the pair of side portions; and inserting the one or more tensile elements into the one or more sleeves.

[0078] The method may include coupling the one or more tensile elements with the one or more tensioners, e.g., by winding a tensile element onto a reel of a headgear adjustment assembly.

[0079] The one or more inlaid elements may be carried by a yarn carrier of a knitting machine.

[0080] The method may include: inlaying at least one of the one or more inlaid elements along an edge, preferably an entirety of the edge, of the headgear; and pulling the at least one of the one or more inlaid elements out from the edge.

[0081] The method may comprise simultaneously knitting an inner knitted element and an outer knitted element, e.g., in a complete garment process.

[0082] In an eighth aspect, a method is provided for forming at least a portion of a headgear configured for use in securing a patient interface in a therapeutic position on a head of a patient for provision of respiratory support. The method may include: knitting a first region, the first region including one or more courses knitted with one or more of: a first yarn tension; and / or a first gauge; and knitting a second region adjacent to the first region, the second region including one or more courses knitted with one or more of: a second yarn tension different to the first yarn tension; and / or a second gauge different to the first gauge.

[0083] The method may include: knitting a third region adjacent to the second region, the third region including one or more courses knitted with one or more of: a third yarn tension different to the first yarn tension and the second yarn tension; and / or a third gauge different to the first gauge and the second gauge.

[0084] The first yarn tension may be greater than the second yarn tension; and / or the second yarn tension may be greater than the third yarn tension.

[0085] The third gauge may be greater than the second gauge; and / or the second gauge may be greater than the first gauge.

[0086] The second gauge may be a full gauge and the first gauge may be a half gauge; or the third gauge may be a full gauge, the second gauge may be a half gauge, and the first gauge may be a quarter gauge.

[0087] In a ninth aspect, a headgear is provided, the headgear configured for use in securing a patient interface in a therapeutic position on a head of a patient for provision of respiratory support. The headgear may be formed, at least in part, according to the method of the seventh aspect or the eighth aspect.

[0088] Further aspects, novel features and advantages of the present technology will be apparent in light of any one or more of the illustrative examples set out in the accompanying detailed description and drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0089] A number of non-limiting examples of the technology are described below with reference to the accompanying drawings, in which:

[0090] FIG. 1 is a plan view of an example headgear, laid flat.

[0091] FIG. 2 is a detailed plan view of a panel and portions of four side straps of the example headgear of FIG. 1.

[0092] FIG. 3 is a detailed plan view of one of the side straps of the example headgear of FIG. 1.

[0093] FIG. 4 is a schematic cross-section through another example side strap which may be used in the headgear of FIG. 1.

[0094] FIG. 5 is a schematic cross-section through another example side strap which may be used in the headgear of FIG. 1.

[0095] FIG. 6 is a schematic cross-section through another example side strap which may be used in the headgear of FIG. 1.

[0096] FIG. 7 is a schematic cross-section through another example side strap which may be used in the headgear of FIG. 1.

[0097] FIG. 8 is a schematic cross-section through another example side strap which may be used in the headgear of FIG. 1.

[0098] FIG. 9 is a schematic cross-section through an example side strap which may be used in the headgear of FIG. 1.

[0099] FIG. 10 is a schematic cross-section through another example side strap which may be used in the headgear of FIG. 1.

[0100] FIG. 11 is a perspective view of a knitted structure having an inner knitted element and an outer knitted element.

[0101] FIG. 12 is a schematic diagram of an example of a knitting program according to the present technology.

[0102] FIG. 13 is a schematic cross-section through the rear portion of the example headgear of FIG. 1.

[0103] FIG. 14 is a schematic cross-section through a side strap of the example headgear of FIG. 1.

[0104] FIG. 15 is a schematic diagram of a double knit stitch structure which may be used in the example headgear of FIG. 1.

[0105] FIG. 16 is a schematic diagram of an interlock stitch structure which may be used in the example headgear of FIG. 1.

[0106] FIG. 17 is a schematic diagram of a rib stitch structure which may be used in the example headgear of FIG. 1.

[0107] FIG. 18 is a schematic diagram of an alternative rib stitch structure which may be used in the example headgear of FIG. 1.

[0108] FIG. 19 is a schematic plan view showing hidden details of a variant of the example headgear of FIG. 1.

[0109] FIG. 20 is a schematic plan view showing hidden details of another variant of the example headgear of FIG. 1.

[0110] FIG. 21 is a schematic plan view showing hidden details of another variant of the example headgear of FIG. 1.

[0111] FIG. 22 is a schematic plan view showing hidden details of another variant of the example headgear of FIG. 1.

[0112] FIG. 23 is a detailed plan view of the left half of the headgear of FIG. 22.

[0113] FIG. 24 is perspective view of portions of eight examples, labelled (a)-(h), of tensile elements which may be suitable for use in headgear according to the present technology.

[0114] FIG. 25 is a perspective view of a spool of a tensile element as shown in FIG. 24.

[0115] FIG. 26 is a schematic plan view showing hidden details of another variant of the headgear of FIG. 1.

[0116] FIG. 27 is a schematic plan view showing hidden details of another variant of the headgear of FIG. 1.

[0117] FIG. 28 is a schematic plan view showing hidden details of another variant of the headgear of FIG. 1.

[0118] FIG. 29 illustrates a potential tensile element configuration.

[0119] FIG. 30 illustrates another potential tensile element configuration.

[0120] FIG. 31 illustrates another potential tensile element configuration.

[0121] FIG. 32 illustrates another potential tensile element configuration.

[0122] FIG. 33 illustrates another potential tensile element configuration.

[0123] FIG. 34 illustrates another potential tensile element configuration.

[0124] FIG. 35 illustrates another potential tensile element configuration.

[0125] FIG. 36 illustrates another potential tensile element configuration.

[0126] FIG. 37 illustrates another potential tensile element configuration.

[0127] FIG. 38 illustrates another potential tensile element configuration.

[0128] FIG. 39 illustrates another potential tensile element configuration.

[0129] FIG. 40 illustrates another potential tensile element configuration.

[0130] FIG. 41 illustrates another potential tensile element configuration.

[0131] FIG. 42 illustrates another potential tensile element configuration.

[0132] FIG. 43 illustrates another potential tensile element configuration.

[0133] FIG. 44 illustrates another potential tensile element configuration.

[0134] FIG. 45 illustrates another potential tensile element configuration.

[0135] FIG. 46 illustrates another potential tensile element configuration.

[0136] FIG. 47 illustrates another potential tensile element configuration.

[0137] FIG. 48 illustrates another potential tensile element configuration.

[0138] FIG. 49 illustrates another potential tensile element configuration.

[0139] FIG. 50 illustrates another potential tensile element configuration.

[0140] FIG. 51 illustrates another potential tensile element configuration.

[0141] FIG. 52 is a schematic plan view showing hidden details of another variant of the headgear of Fig. 1.

[0142] FIG. 53 is a detailed plan view of a curved portion of the headgear of FIG. 52.

[0143] FIG. 54 is a detailed plan view of part of the curved portion of FIG. 52.

[0144] FIG. 55 is a schematic plan view of the headgear of FIG. 52 including tensioners and clips.

[0145] FIG. 56 is a schematic exploded view of the tensioner of the patient interface assembly of FIG. 68.

[0146] FIG. 57 is a schematic cross-sectional view of the tensioner of FIG. 56.

[0147] FIG. 58 is a flow diagram for an example method for forming the headgear of FIG. 21.

[0148] FIG. 59 is a schematic plan view illustrating a step in the example method of FIG.58.

[0149] FIG. 60 is a schematic plan view illustrating another step in the example method of FIG. 58.

[0150] FIG. 61 is a schematic plan view illustrating yet another step in the example method of FIG. 58.

[0151] FIG. 62 is a schematic plan view illustrating yet another step in the example method of FIG. 58.

[0152] FIG. 63 is a diagram illustrating yet another step in the example method of FIG. 58.

[0153] FIG. 64 is a schematic plan view illustrating yet another step in the example method of FIG. 58.

[0154] FIG. 65 is a schematic plan view illustrating yet another step in the example method of FIG. 58.

[0155] FIG. 66 is a schematic plan view illustrating yet another step in the example method of FIG. 58.

[0156] FIG. 67 is a schematic plan view illustrating yet another step in the example method of FIG. 58.

[0157] FIG. 68 is a schematic isometric view of an example patient interface assembly including headgear according to another example.

[0158] FIG. 69 is a schematic front view of the patient interface assembly of FIG. 68.

[0159] FIG. 70 is a schematic side view of an example patient interface assembly including headgear (illustrating hidden details) according to another example, donned by a patient.

[0160] FIG. 71 is a schematic side view of a patient interface assembly including a variant of the example headgear of FIG. 70.

[0161] FIG. 72 is a schematic side view of a patient interface assembly including another variant of the example headgear of FIG. 70.

[0162] FIG. 73 is a schematic diagram of an example respiratory support system which may include a patient interface assembly and / or headgear of the present technology.DETAILED DESCRIPTIONHeadgear

[0163] FIG. 1 shows a headgear 100 according to a first example. The headgear 100 is shown laid flat in plan view, i.e., showing the outer surface of the headgear 100 which would be visible to others when the headgear 100 is donned by a patient. An opposing inner surface, not shown in FIG. 1, is configured to engage the patient's head when the headgear 100 is donned .

[0164] The headgear 100 is shown in an incomplete form, e.g., in an intermediate state between knitting of the headgear 100 and attachment of further components such as the clips and headgear adjustment assembly as described in further detail below with reference to FIG. 55 and FIG. 68, for example.Rear portion / Panel

[0165] The headgear 100 may include a rear portion 102 configured to be positioned at a rear of a patient's head, when the headgear 100 is donned. The rear portion may be configured to overlie one or more of the patient's parietal bone or occipital bone.

[0166] In some examples, as shown in FIG. 1 and in further detail in FIG. 2, the rear portion 102 may include a panel 106. The panel 106 may be configured to overlie one or more of the patient's parietal bone or occipital bone, when the headgear 100 is donned.

[0167] In other examples, the rear portion 102 may be formed from a plurality of straps and / or include one or more apertures. Apertures may improve breathability of the headgear. Improved breathability may improve patient comfort.

[0168] The panel 106 may have one or more of an upper section 202, a central section 204 or a lower section 206 as described in further detail below.

[0169] The panel 106 may have a panel upper edge 108, a panel lower edge 110, and panel side edges 112.

[0170] When the headgear 100 is detached from a patient interface and laid flat as shown in FIG. 1, the panel upper edge 108 may be configured to be substantially linear. The panellower edge 110 may be configured to be curved, e.g., concave. The curvature of the panel lower edge 110 may be configured to reduce or avoid contact with the patient's neck. Avoiding contact with the patient's neck may improve patient comfort and / or mitigate changes in tension in the headgear as the patient turns their head.

[0171] The panel side edges 112 may be curved, e.g., concave. The panel side edges 112 may have a greater degree of curvature than the panel lower edge 110. The panel side edges 112 may be configured to curve around the patient's ears, when the headgear 100 is donned. The curvature may be configured to mitigate or avoid contact with the ears, in use, which can cause discomfort.Side portions / side straps

[0172] The headgear 100 may include a pair of side portions 104 configured to be positioned at respective sides of the patient's head, when the headgear 100 is donned. For example, at one or more of the temporal regions, frontal region, auricular regions, zygomatic regions, parotideomasseteric regions, or buccal regions. The side portions 104 may be configured to overlie one or more of the patient's temporal bone, frontal bone, sphenoid bone, maxilla, zygomatic bone, or mandible.

[0173] In some examples, each of the side portions 104 may include one or more side straps, e.g., two side straps as shown in FIG. 1 and in further detail in FIG. 3. With the headgear 100 donned by a patient, the side straps may be configured to extend forwardly from the rear portion, e.g., panel 106, towards a patient interface. The side straps may be coupled with the patient interface, e.g., via a clip configured to removably couple with the patient interface.

[0174] In some examples, as shown in FIG. 1, the headgear 100 may be a four-point headgear. The headgear 100 may include four side straps each configured to be coupled with the patient interface. The headgear may include a left upper side strap 114, a right upper side strap 116, a left lower side strap 118 and a right lower side strap 120. The side straps 114, 116, 118, 120 may each be configured to be coupled with the patient interface.

[0175] A four-point headgear may provide a relatively more secure fit and / or greater adjustability, e.g., compared to a two-point headgear. A four-point headgear may be better suited for nasal masks, compact nasal mask, full-face masks, and / or compact full-face masks, for example.

[0176] In other examples, the headgear may be a two-point headgear. Each side portion 104 may include a single side strap. The side strap may be configured to extend forwardly, and optionally downwardly, from the rear portion 102 towards the patient interface, e.g., to pass between the patient's eye and ear. In some examples, the side portions of the two- point headgear may be formed by a single continuous strap. For example, a continuous strap configured to pass from one side of the patient interface, around the rear of the patient's head, to the other side of the patient interface. The pair of side portions and the rear portion may be formed by a single continuous strap. The continuous strap may be bifurcated in the rear portion, e.g., split into an upper rear strap portion and a lower rear strap portion. A bifurcated rear portion 102 may cradle an upper rear of the patient's head when the headgear 100 is donned. An inlaid element, described in further detail below, may pass through either or both of the upper rear strap portion and the lower rear strap portion. In other examples, the side straps may be formed separately and joined to each other and / or a separately-formed rear portion. In some examples, the pair of side portions may be formed by a single continuous strap configured to pass from one side of the rear portion, over or around the patient interface, to the other side of the rear portion.

[0177] A two-point headgear may be relatively inexpensive, quicker and / or easier to don, and / or less intimidating to patients, e.g., compared to a four-point headgear. A two-point headgear may be better suited for use with a compact nasal mask, nasal pillows interface, or nasal cannula, for example.

[0178] The left upper side strap 114 and the right upper side strap 116 may extend from respective lateral sides of the panel 106, e.g., the upper section 202 of the panel 106, at respective joints 128. The left lower side strap 118 and the right lower side strap 120 may extend from respective lateral sides of the lower section 206 of the panel 106, e.g., at respective joints 128.

[0179] In some examples, the left upper side strap 114 and the right upper side strap 116 may each be configured to extend forwardly and downwardly from the rear portion towards the patient interface, passing between the patient's eye and ear on respective sides of the patient's head, when the headgear 100 is donned. The left upper side strap 114 and right upper side strap 116 may be configured to couple with the patient interface at or near one or more of the patient's zygomatic regions, infraorbital regions, or temporal regions (e.g., via respective rearwardly-extending rigid or semi-rigid arms of the patient interface).

[0180] In other examples, the left upper side strap 114 and the right upper side strap 116 may be configured to extend above the patient's eye on respective sides of the patient'shead. The left upper side strap 114 and right upper side strap 116 may couple with the patient interface, e.g., a forehead support of the patient interface, each other, or other coupling or adjustment components (the clips and headgear adjustment assembly as described in further detail below with reference to FIG. 55 and FIG. 68, for example). For example, at the patient's frontal region. In some examples, e.g., where the left upper side strap 114 and right upper side strap 116 couple with a forehead support at the patient's frontal region, the left upper side strap 114 and the left lower side strap 118 may be substantially parallel with each other when the headgear 100 is donned. Similarly, the right upper side strap 116 and the right lower side strap 120 may be substantially parallel with each other when the headgear 100 is donned.

[0181] In some examples, the left lower side strap 118 and the right lower side strap 120 may be configured to extend below the patient's ear on respective sides of the patient's head when the headgear 100 is donned, e.g., to couple with the patient interface at or near one or more of the patient's buccal regions or parotideomasseteric regions.

[0182] The left upper side strap 114 and the left lower side strap 118 may be configured to converge towards each other in the forward direction, when the headgear 100 is donned. The right upper side strap 116 and the right lower side strap 120 may be configured to converge towards each other in the forward direction, when the headgear 100 is donned. In other examples, the left upper side strap 114 and the left lower side strap 118, and the right upper side strap 116 and the right lower side strap 120, may be configured to be parallel when the headgear 100 is donned. In some examples, the upper side straps 114, 116 and / or lower side straps 118, 120 may be parallel with the patient's Frankfort horizontal.

[0183] A detailed plan view of the left upper side strap 114 of FIG. 1 is shown in FIG. 3. Except as described, illustrated or otherwise apparent from the context, the description of the left upper side strap 114 throughout the specification may apply equally to any one or more other straps, e.g., one or more of right upper side strap 116, left lower side strap 118, or right lower side strap 120, with necessary modifications.

[0184] FIG. 4 to FIG. 10 schematically illustrate cross-sections through seven different straps which may form the left upper side strap 114.Crown straps

[0185] In some examples the headgear 100 may include a crown strap. The crown strap may be configured to extend across a top of the patient's head, from one side to the other. A crown strap may inhibit the headgear 100 from slipping down the patient's head.

[0186] In some examples, as shown in FIG. 22, the crown strap may include a pair of crown strap portions, e.g., left crown strap portion 2202 and right crown strap portion 2204. The left crown strap portion 2202 may be configured to extend upwardly from the left side portion 104, e.g., left upper side strap 114. The right crown strap portion 2204 may be configured to extend upwardly from the right side portion 104, e.g., right upper side strap 116. The left crown strap portion 2202 and right crown strap portion 2204 may be configured to be adjustably coupled with each other, e.g., at or near the top of the patient's head. The left crown strap portion 2202 and / or right crown strap portion 2204 may include complementary fasteners, e.g., one or more of a hook-and-loop fastener, buckle, buttons, studs, or other couplings for adjustably coupling the crown strap portions to each other to adjust an effective length of the crown strap.

[0187] In other examples, one end of a single adjustable crown strap may be permanently coupled, e.g., integrally formed or joined, with the headgear 100, e.g., one of the left upper side strap 114 or right upper side strap 116. The other end may be configured to be adjustably coupled with the headgear 100, e.g., the other of the left upper side strap 114 and right upper side strap 116. In yet other examples, the crown strap may be non- adjustable. A single non-adjustable crown strap, e.g., an elastic crown strap, may be permanently coupled with the headgear 100, e.g., the left upper side strap 114 and right upper side strap 116, at respective ends of the crown strap.Knitting

[0188] At least a portion of the headgear 100 may be knitted, e.g., weft knitted. For example, one or more of the rear portion, pair of side portions, or crown strap. Or one or more of the panel 106, left upper side strap 114, right upper side strap 116, left lower side strap 118, right lower side strap 120, left crown strap portion 2202, or right crown strap portion 2204. The portion, or portions, may include a knit structure, e.g., a weft knit structure or a warp knit structure.

[0189] In some examples, one or more of the side straps may be knitted, at least in part. In one example, each of the side straps may be knitted, e.g., all four of the left upper side strap 114, the right upper side strap 116, the left lower side strap 118 and the right lowerside strap 120. In some examples, the panel 106 may be knitted. In some examples, each of the panel 106, the left upper side strap 114, the right upper side strap 116, the left lower side strap 118 and the right lower side strap 120 may be knitted.

[0190] In some examples, the headgear 100, or one or more portions of the headgear 100, may be formed in a "cut and sew" process, a "fully fashioned" process, and / or "complete garment" process (e.g., using a WHOLEGARMENT™ knitting machine available from Shima Seiki Mfg., Ltd. of Wakayama, Japan).

[0191] In a "cut and sew" process, component pieces are cut from a swathe of knitwear fabric and then sewn together to form the headgear 100 or portion of the headgear 100. In a "fully fashioned" process, the component pieces are knitted to shape, e.g., including a selvage to keep the edges from unravelling, then sewn together in a subsequent step to form the headgear 100 or portion of the headgear 100. In a "complete garment" process, the headgear 100 (or part of the headgear 100, e.g., including two or more of the panel 106, left upper side strap 114, right upper side strap 116, left lower side strap 118, right lower side strap 120, left crown strap portion 2202, or right crown strap portion 2204) is formed in one entire piece directly on the knitting machine.

[0192] "Fully fashioned" and "complete garment" processes may result in less waste material than the "cut and sew" process. The "complete" garment" process may further reduce the need for post-production labor, and may reduce or eliminate seams which may cause patient discomfort or facial marking.

[0193] In some examples, at least the rear portion, the pair of side portions, and the inlaid elements described below may be formed together in a complete garment process. For example, the headgear 100 illustrated in FIG. 1 may be formed in one entire piece on a flatbed knitting machine. The headgear 100 may then be completed by adding any further components, e.g., non-knitted components, such as the clips and headgear adjustment assembly as described in further detail below with reference to FIG. 55 and FIG. 68, for example.

[0194] The stretch of different headgear portions, e.g., one or more of the panel 106, left upper side strap 114, right upper side strap 116, left lower side strap 118, right lower side strap 120, left crown strap portion 2202, or right crown strap portion 2204, may be varied. For example, by varying the knit structure. In some examples, the different knit structures may include any two or more of a double knit stitch structure, interlock stitch structure, rib stitch structure, tuck stitches, and / or missed stitches. In some examples, the different knit structures may include a different yarn tension or gauge.

[0195] In some examples, the left upper side strap 114 and the right upper side strap 116 may have a different stretch to the left lower side strap 118 and the right lower side strap 120, e.g., in the longitudinal direction. The left upper side strap 114 and the right upper side strap 116 may have a different knit structure to the left lower side strap 118 and the right lower side strap 120. The left upper side strap 114 and the right upper side strap 116 may be configured to stretch more, in absolute and / or relative terms, than the respective left lower side strap 118 and right lower side strap 120.

[0196] One or more of the side straps may have a different knit structure to the rear portion. For example, the left upper side strap 114 and the right upper side strap 116 may be configured to stretch more, in absolute or relative terms, than the panel 106. The left lower side strap 118 and the right lower side strap 120 may be configured to stretch more, in absolute or relative terms, than the panel 106.

[0197] In some examples, one or more portions of the headgear 100 may include two or more different knit structures, e.g., one or more of the panel 106, left upper side strap 114, right upper side strap 116, left lower side strap 118, right lower side strap 120, left crown strap portion 2202, or right crown strap portion 2204.

[0198] In some examples, one or more portions of the headgear 100 may include only one knit structure, e.g., one or more of the panel 106, left upper side strap 114, right upper side strap 116, left lower side strap 118, right lower side strap 120, left crown strap portion 2202, or right crown strap portion 2204.

[0199] At least a portion of the headgear 100, e.g., one or more of the panel 106, left upper side strap 114, right upper side strap 116, left lower side strap 118, right lower side strap 120, left crown strap portion 2202, or right crown strap portion 2204, may have a weft knit structure. The weft knit structure may have a plurality of courses and a plurality of wales. The weft knit structure may be formed on a flat bed knitting machine. The flat bed knitting machine may include a front needle bed and a back needle bed. In some examples, at least a portion of the headgear 100 may have a warp knit structure.

[0200] The weft knit structure may be formed such that the courses are orientated along a length of one or more of the left upper side strap 114, right upper side strap 116, left lower side strap 118, or right lower side strap 120, i.e., oriented in the longitudinal direction of the strap. In some examples, the courses of the weft knit structure may be oriented along a length of each of the left upper side strap 114, right upper side strap 116, left lower side strap 118, and right lower side strap 120. The courses may be oriented in a substantially horizontal direction as illustrated in FIG. 1, i.e., with the headgear 100detached from the patient interface and laid flat as shown. The courses may be oriented to extend around the patient's head when the headgear 100 is donned.

[0201] The weft knit structure may be formed such that its wales are orientated substantially orthogonally to the courses. The wales may be oriented in a substantially vertical direction as illustrated in FIG. 1, i.e., with the headgear 100 detached from the patient interface and laid flat as shown. The wales may be oriented to extend up the patient's head, when the headgear 100 is donned.

[0202] The weft knit structure may include one or more of a plain, rib, interlock, or purl knit structure. A plain knit structure may be knitted on a single needle bed. Layers of plain knit structures may be produced simultaneously or sequentially on separate needle beds. Rib, interlock and purl knit structures may be knitted on two needle beds, e.g., a front needle bed and a back needle bed.

[0203] Knitting at least a portion of the headgear 100 may result in a fabric with a relatively open structure. The porosity of the open structure may improve breathability of the headgear, e.g., with respect to a corresponding headgear portion including a layer of foam, such as the Breath-O-Prene™ laminated fabric and foam composite material.

[0204] In some examples, the headgear 100, or one or more of the panel 106 or side straps 114, 116, 118, 120, does not include a foam material.Yarns

[0205] The headgear 100, or a portion of the headgear 100, may include two or more different types of yarns, e.g., in two or more different regions of the headgear 100 or portion of the headgear 100.

[0206] At least a part of one or more of the straps, e.g., left upper side strap 114, right upper side strap 116, left lower side strap 118, or right lower side strap 120, may be configured to stretch, e.g., resiliently stretch, in a longitudinal direction. In some examples, one or more of the straps 114, 116, 118, 120 may have two or more different degrees of stretch along their length. Referring to FIG. 3 for example, a distal region 302 of the left upper side strap 114 may have a greater degree of stretch than a proximal region 304. The distal region 302 may be formed, at least in part, from a first yarn. The proximal region 304 may be formed, at least in part, from a second yarn. The first yarn may be absent from the proximal region 304. The second yarn may be absent from the distal region. The first yarn and the second yarn may be different. In some examples, the firstyarn may be a relatively extensible or relatively elastic yarn, e.g., a yarn including elastane and / or silicone. The second yarn may be a relatively inextensible or relatively inelastic yarn, e.g., a nylon yarn. Alternatively, or additionally, different knit structures could be used to vary the extensibility of the headgear 100 in different regions.

[0207] In some examples, the panel 106 may include the same yarn as the proximal region 304 of one or more of the left upper side strap 114, right upper side strap 116, left lower side strap 118, or right lower side strap 120, e.g., the second yarn. In other examples, the panel 106 may be formed from a different yarn, e.g., the first yarn or a third yarn.

[0208] In some examples, the headgear 100 may include a moisture absorbent yarn or a wicking yarn. For example, in at least a region of one or more of the panel 106, left upper side strap 114, right upper side strap 116, left lower side strap 118, right lower side strap 120, left crown strap portion 2202, or right crown strap portion 2204.

[0209] The moisture absorbent yarn or wicking yarn may be provided on at least an inner layer of the headgear 100, i.e., the layer configured to engage the patient's head when the headgear 100 is donned. A moisture absorbent yarn or wicking yarn may improve patient comfort by dissipating moisture away from the patient's skin.

[0210] Joints 128 may be provided between adjacent regions of different yarn. The joints 128 may include particular stitch structures. For example, the joints 128 may include one or more tuck stitches. The joints 128 may each be configured to join respective layers of different portions of the headgear, e.g., to provide a continuous interior space between the panel 106 and one of the side straps, as described in further detail below. The location of the joints 128 along the side straps may define the relative ends of the distal region 302 and the proximal region 304 of the side strap. In some examples, a joint 128 between the panel 106 and the side strap may be configured to be positioned forward of the patient's ear when the headgear 100 is donned. In other examples, the joint 128 may be configured to be positioned above / below or rearward of the patient's ear.

[0211] In some examples, one or more edges of the headgear 100 may be formed by casting off the yarns. A double knit stitch structure, interlock stitch structure, rib stitch structure, or any other knit structure that passes between the front needle bed and the rear needle bed, may extend along or adjacent to the edge. An edge formed by casting off may provide a relatively soft edge, improving patient comfort and / or mitigating facial marking.

[0212] In some examples, the headgear 100 may include a heat-set yarn. For example, in at least a region of one or more of the panel 106, left upper side strap 114, right upper side strap 116, left lower side strap 118, right lower side strap 120, left crown strap portion 2202, or right crown strap portion 2204.

[0213] The heat-set yarn may be at least partially melted, e.g., after the headgear 100, or the relevant portion or region, is knitted. The melted heat-set yarn may fuse with another yarn as it solidifies. In some examples, one or more of the side straps 114, 116, 118, 120 may include a heat-set yarn. In some examples, the heat-set yarn 308 may extend along an edge of the side strap 114, 116, 118, 120.

[0214] Referring to FIG. 3, for example, a side strap upper edge 306 may include a heatset yarn 308. In some examples, as shown, the heat-set yarn 308 may extend along the side strap upper edge 306, e.g., along an entire length of the side strap upper edge 306. The heat-set yarn 308 may join an inner layer and an outer layer of the strap. In some examples, the heat-set yarn 308 may join an inner layer and an outer layer of the strap following the application of heat. In such examples, the heat-set yarn 308 may advantageously provide a convenient way of joining layers, e.g., without the need for casting off.

[0215] In some examples, the panel 106, e.g., panel upper edge 108, may include a heatset yarn.

[0216] In one example, as shown in FIG. 1 to FIG. 3, at least the upper edges 108, 306 of each of the panel 106 and side straps 114, 116, 118, 120 may include a heat-set yarn.Interior space

[0217] At least a portion of the headgear 100, may include two or more layers, e.g., an inner layer and an outer layer. For example, one or more of the panel 106, left upper side strap 114, right upper side strap 116, left lower side strap 118, right lower side strap 120, left crown strap portion 2202, or right crown strap portion 2204. The inner layer may be configured to engage the patient's head when the headgear 100 is donned by the patient. The outer layer may be configured to face outwardly when the headgear 100 is donned by the patient. In some examples, the inner layer and the outer layer may be formed as a flattened tubular structure. In other examples, the inner layer and the outer layer may be joined together at one or more edges.

[0218] One or more interior spaces may be formed between the two or more layers, e.g., between the inner layer and outer layer. The one or more side straps may include an opening 122 to the interior space, e.g., at their distal ends 310.

[0219] FIG. 13 shows a schematic cross-section through the sagittal plane of an example panel 106 is shown. The panel 106 includes an inner layer 504 and an outer layer 208. An interior space 1304 is formed between the inner layer 504 and the outer layer 208. In some examples, the interior space 1304 may accommodate inlaid elements, e.g., one or more tensile elements 124, 126, as described in further detail below. The inner layer 504 and the outer layer 208 may be joined by one or more stitch structures 1302, e.g., double knit stitch structures, interlock stitch structures, and / or rib stitch structures, as described in further detailed below. In some examples, the stitch structures 1302 may help position the inlaid elements within the interior space 1304, as described in further detail below.

[0220] FIG. 14 shows a schematic cross-section of an example left upper side strap 114. The left upper side strap 114 includes an inner layer 504 and an outer layer 208. In some examples, the interior space 1304 may accommodate inlaid elements, e.g., tensile element 124, as described in further detail below. The inner layer 504 and the outer layer 208 may be joined by one or more stitch structures 1302, e.g., double knit stitch structures, interlock stitch structures, or rib stitch structures, as described in further detailed below.

[0221] FIG. 4 to FIG. 10 show cross-sections through seven different left upper side straps 114 each including one or more interior spaces 1304. In some examples, as shown in each of FIG. 4 to FIG. 10, the interior spaces 1304 may extend in the longitudinal direction of the left upper side strap 114. In some examples, again as shown in each of FIG. 4 to FIG. 10, the side strap may include a plurality of distinct interior spaces 1304, e.g., three, four, or five interior spaces 1304. The plurality of distinct interior spaces 1304 may be parallel to each other. In some examples, as shown in each of FIG. 4 to FIG. 8, two or more of the plurality of distinct interior spaces 1304 may differ in size, e.g., include a relatively larger central interior space 1304 flanked by one or more smaller lateral interior spaces 1304. The lateral interior spaces 1304 may provide the strap with rounded edges, which may improve patient comfort and / or mitigate facial marking. The central interior space 1304 may accommodate one or more inlaid elements, as shown in FIG. 4 to FIG. 6 and FIG. 8, for example. One or more of the lateral interior spaces 1304 may accommodate an inlaid element as shown in FIG. 7, for example. In some examples, the left upper side strap 114 may include a plurality of interior spaces 1304 of about equal size, as shown in FIG. 9 and FIG. 10 for example. Inlaid elements may be accommodated by some or each of theplurality of interior spaces 1304, e.g., the central interior space or interior spaces 1304 as shown in FIG. 9, or each of the interior spaces 1304 as shown in FIG. 10.

[0222] In some examples, the interior space 1304 of a strap or panel 106 may accommodate an isolator 502. The isolator 502 may be disposed between the inner layer and the tensile element 124 or sleeve, described in further detail below. The isolator 502 may be configured to cushion and / or distribute forces from the first tensile element 124 or sleeve. The isolator 502 may improve patient comfort and / or mitigate facial marking. In some examples, the isolator 502 may be a separate from the knit structure. In other examples, the isolator 502 may be integral with the knit structure. In some examples, the isolator 502 itself may be knitted. In other examples, the isolator 502 may be formed from a plastic or foam material. In some examples, the isolator 502 may be a rigid or semirigid, e.g., relatively rigid compared to the knit structure of the strap or panel. In other examples, the isolator 502 may be flexible and / or compressible. The isolator 502 may reduce friction between the tensile element 124 and other components of the headgear 100, e.g., the knit structure. The isolator 502 may be mechanically inlaid with the headgear 100. Or the isolator 502 may be inserted into the headgear through an opening 122 after the headgear 100 is knitted or otherwise formed.

[0223] An interior space 1304 may extend continuously through the rear portion 102 and one or each of the pair of side portions 104. In some examples, the panel 106 may form one or more continuous interior spaces with one or more of the left upper side strap 114, right upper side strap 116, left lower side strap 118, or right lower side strap 120.

[0224] The central section 204 of the panel 106 may form a continuous interior space with one or more of the upper section 202 or the lower section 206.

[0225] In one example, the panel 106, left upper side strap 114, right upper side strap 116, left lower side strap 118 and right lower side strap 120 may form a single continuous interior space. In other examples, the headgear 100 may include two or more distinct interior spaces. In some examples, the two or more distinct interior spaces may be continuous between two or more of the openings 122 at distal ends 310 of two or more of the side straps.

[0226] In one example, the headgear 100 may include a first continuous interior space between respective openings 122 of the left upper side strap 114 and the right upper side strap 116, and a second continuous interior space between respective openings 122 of the left lower side strap 118 and the right lower side strap 120.

[0227] In another example, the headgear 100 may include a first continuous interior space between respective openings 122 of the left upper side strap 114 and the left lower side strap 118, and a second continuous interior space between respective openings 122 of the right upper side strap 116 and the right lower side strap 120.

[0228] The first and second continuous interior spaces may be partially or entirely separated by a stitch structure between the inner layer and the outer layer, e.g., a double knit stitch structure, an interlock stitch structure, or a rib stitch structure. For example, in one or more of the upper section 202, the central section 204 or the lower section 206 of the panel 106.

[0229] One or more of the side straps, e.g., the left upper side strap 114 as shown in FIG. 14, may be formed as a flattened tubular structure.

[0230] FIG. 11 shows a portion of some examples of an inner knitted element 1102 and an outer knitted element 1104.

[0231] In some examples, the inner knitted element and outer knitted element may be knitted simultaneously, as described below with reference to FIG. 12.

[0232] In some examples, the isolator 502 may be knitted. The isolator 502 may be knitted with one or more of the panel 106 or side straps 114, 116, 118, 120, e.g., as part of a complete garment process. With reference to FIGs. 5 and 11, the isolator 502 may be the inner knitted element 1102, and one or more of the panel 106 or side straps may be the outer knitted element 1104. The tensile element 124 (not shown in FIG. 11) may be mechanically inlaid adjacent to the inner knitted element 1102 (e.g., isolator 502). The inner knitted element 1102 may be tubular, as shown in FIG. 11, or a single layer.

[0233] In some examples, the one or more sleeves 602 may be knitted. The one or more sleeves 602 may be knitted simultaneously with one or more of the panel 106 or side straps 114, 116, 118, 120, e.g., as part of a complete garment process. With reference to FIGs. 6 and 11, the sleeve 602 may be the inner knitted element 1102 of FIG. 11, and one or more of the panel 106 or side straps 114, 116, 118, 120 may be the outer knitted element 1104. The tensile element 124 (not shown in FIG. 11) may be mechanically inlaid within the inner knitted element 1102 (e.g., sleeve 602) as it is knitted.

[0234] In some examples, the tensile element 124 may be knitted. The tensile element 124 may be knitted simultaneously with one or more of the panel 106 or side straps 114, 116, 118, 120, e.g., as part of a complete garment process. With reference to FIGs. 4 and11, the tensile element 124 may be the inner knitted element 1102 of FIG. 11, and one or more of the panel 106 or side straps 114, 116, 118, 120 may be the outer knitted element 1104. The inner knitted element 1102 may be tubular, as shown in FIG. 11, or a single layer.

[0235] In some examples, the inner knitted element 1102 may be attached to the outer knitted element 1104. The inner knitted element 1102 may be attached to the outer knitted element 1104 continuously or at one or more discrete locations. For example, the sleeve 602 or cushioning element, e.g., isolator 502, may be attached to one or more of the outer layer 208 and inner layer 504. Attachment may inhibit or prevent relative movement, e.g., in one or more of the lateral and longitudinal directions, between the inner knitted element 1102 and the outer knitted element 1104.

[0236] In other examples, the inner knitted element 1102 is not attached to the outer knitted element 1104. For example, the sleeve 602, isolator 502, or tensile element 124 is not attached to either of the outer layer 208 or inner layer 504 of the panel 106 or side straps 114, 116, 118, 120. In such examples, the sleeve 602 or cushioning element, e.g., isolator 502, may be able to move freely within the headgear, e.g., in one or more of the lateral and longitudinal directions.

[0237] In some examples, the inner knitted element 1102 may be longer than the outer knitted element 1104. For example, the sleeve 602, e.g., isolator 502, or tensile element 124, may be longer than the respective panel 106 or side strap 114, 116, 118, 120. This may allow the inner knitted element 1102, e.g ., the sleeve 602, isolator 502, or tensile element 124 to accumulate or move within the outer knitted element 1104, e.g, the panel 106 or side straps 114, 116, 118, 120.

[0238] FIG. 12 depicts an example of a knitting program 1200. The knitting program 1200 may be suitable for knitting the inner knitted element 1102 and outer knitted element 1104 of FIG. 11, for example. The knitting program 1200 may be suitable for use with the Shima Seiki Mfg., Ltd. SWG 061 N2 knitting machine of Wakayama, Japan, for example. The knitting program 1200 may be applied to other knitting machines, such as one or more of the Shima Seiki SWG 021 N2, 041 N2, and 091 N2 knitting machines. In other examples, a knitting program may be configured for use in a knitting machine including four needle beds.

[0239] The knitting program 1200 shown is for knitting on a knitting machine having two needle beds. The two needle beds may be referred to as a first needle bed 1212, e.g., the front needle bed, and a second needle bed 1214, e.g., the back needle bed. Each needlebed 1212, 1214 may form two rows of stitches. The first needle bed 1212 may form the first row 1202 and the second row 1204. The second needle bed 1214 may form the third row 1206 and the fourth row 1208.

[0240] The first row 1202 and the fourth row 1208 of the knitting program 1200 may be configured to knit the outer knitted element 1104 of FIG. 11, for example. The first row 1202 and fourth row 1208 may correspond to the outer knitted element 1104, e.g., either of the inner layer 504 and outer layer 208, respectively, of one or more of the panel 106 or side straps 114, 116, 118, 120.

[0241] The second row 1204 and the third row 1206 of the knitting program 1200 may be configured to knit the inner knitted element 1102 of FIG. 11, for example. The second row 1204 and third row 1206 may correspond to the inner knitted element 1102, e.g., the sleeve 602, isolator 502, or tensile element 124.

[0242] Each row 1202, 1204, 1206, 1208 of stitches 1210a, 1210b, 1210c, 1210d may be formed on every third needle of the respective needle bed.

[0243] The knitting program 1200 is configured to knit in y3gauge, i.e., on every third needle.

[0244] In the illustrated example knitting program 1200, in the first row 1202, a first stitch 1210a may be formed on the first needle, then a second stitch 1210a on the fourth needle, then a third stitch 1210a on the seventh needle, and so on, of the first needle bed 1212. A first yarn carrier may be used for the first row 1202.

[0245] In the second row 1204, a first stitch 1210b may be formed on the second needle, then a second stitch 1210b on the fifth needle, then a third stitch 1210b on the eighth needle, and so on, of the first needle bed 1212. A second yarn carrier may be used for the second row 1204. The second row 1204 may be knitted in either the same direction, or opposite direction to the first row 1202. No stitches are formed on the third needle, the sixth needle, the ninth needle, and so on, of the first needle bed 1212. These needles may be left free so that stitches from the second needle bed 1214 can later be transferred to them.

[0246] In the third row 1206, a first stitch 1210c may be formed on the third needle, then a second stitch 1210c on the sixth needle, then a third stitch 1210c on the ninth needle, and so on, of the second needle bed 1214. The third row 1206 may be knitted in either the same direction, or opposite direction of the second row 1204. In examples where the thirdrow 1206 is knitted in the opposite direction to the second row 1204, the second yarn carrier may be shared by the second row 1204 and the third row 1206, as the second yarn carrier may form the second row 1204 and the third row 1206 in a circular direction. In examples where the third row 1206 is knitted in the same direction to the second row 1204, a third yarn carrier may be used for the third row 1206.

[0247] In the fourth row 1208, a first stitch 1210d may be formed on the first needle, then a second stitch 1210d on the fourth needle, then a third stitch 1210d on the seventh needle, and so on, of the second needle bed. In examples where the second row 1204 and third row 1206 share the second yarn carrier, a third yarn carrier may be used for the fourth row 1208. In examples where the second row 1204 and third row 1206 use the second yarn carrier and third yarn carrier respectively, a fourth yarn carrier may be used for the fourth row 1208.

[0248] The knitting program 1200 may use three or four yarn carriers.

[0249] Each row 1202, 1204, 1206, 1208 of stitches 1210a, 1210b, 1210c, 1210d may be formed completely before the next row is begun. Completing each row before beginning the next row may keep the inner knitted element 1102 separate from the outer knitted element 1104, where necessary.

[0250] As shown in FIG. 12, the knitting program 1200 follows a repeating knit pattern. The repeating knit pattern may include the following sequence:• knitting the first row 1202 on the first needle bed 1212• knitting the second row 1204 on the first needle bed 1212• knitting the third row 1206 on the second needle bed 1214• transferring the stitches from the third row 1206 to the opposing empty needles of the first needle bed 1212• knitting the fourth row 1208 on the second needle bed 1214, and• transferring the stitches from the second row 1204 and the third row 1206 to the opposing empty needles of the second needle bed 1214.

[0251] By repeating the knit pattern, each of the inner knitted element 1102 and outer knitted element 1104 of FIG. 11 may be progressively formed. The tensile element maybe mechanically inlaid at the same time. For example, with reference to FIG. 5, within the outer knitted element 1104 (in this example, left upper side strap 114) and adjacent to the inner knitted element 1102 (in this example, isolator 502). In another example, with reference to FIG. 6, within the inner knitted element 1102 (i.e., sleeve 602).

[0252] Referring again to FIG. 1, in some examples the left upper side strap 114, upper section 202 of the panel 106, and the right upper side strap 116 may be formed as a continuous flattened tubular structure. In some examples, the central section 204 of the panel 106 may be formed as a flattened tubular structure. In some examples, the left lower side strap 118, lower section 206 of the panel 106, and the right lower side strap 120 may be formed as a continuous flattened tubular structure.

[0253] In one example, the left upper side strap 114, upper section 202 of the panel 106, and the right upper side strap 116 may be formed as a first flattened tubular structure; the central section 204 may be formed as a second flattened tubular structure; and the left lower side strap 118, lower section 206 of the panel 106, and the right lower side strap 120 may be formed as a third flattened tubular structure. The second flattened tubular structure may be oriented substantially orthogonally to the first flattened tubular structure and the third flattened tubular structure. The flattened tubular structures may be joined to form, at least in part, the headgear 100.

[0254] In one example, the upper section 202 and the lower section 206 of the panel 106 may each be formed as a flattened tubular structure including a plurality of courses joined at the panel upper edge 108 and the panel lower edge 110 by one or more courses of double knit stitch structure, interlock stitch structure, or other stitches that transfer between needle beds. The central section 204 may be formed as a flattened tubular structure, joined together at left and right panel side edges 112 (e.g., at ends of the courses). The left panel side edge 112 and the right panel side edge 112 may be formed by transferring yarn between a front needle bed and a back needle bed. Alternatively, or additionally, the left panel side edge 112 and / or right panel side edge 112 may include a stich structure, e.g., a double knit stitch structure, an interlock stitch structure, or a rib stitch structure, as described in further detail below. The central section 204 may be joined to the upper section 202 and / or the lower section 206 by a plurality of stitches.

[0255] In some examples, the left upper side strap 114, right upper side strap 116, left lower side strap 118, right lower side strap 120 may each have the same arrangement of interior spaces 1304, e.g., the same cross-section. In other examples, the left upper side strap 114 and right upper side strap 116 may each have the same arrangement of interiorspaces 1304, e.g., the same cross-section. The left lower side strap 118 and the right lower side straps 120 may each have the same arrangement of interior spaces 1304, e.g., the same cross-section. But the upper side straps 114, 116 and lower side straps 118, 120 may have different arrangements of interior spaces 1304, e.g., different cross-sections.Stitch structures

[0256] The headgear 100 may include one or more of a number of different stitch structures between layers, e.g., between the inner layer 504 and the outer layer 208.

[0257] In some examples, at least a portion of the headgear 100 may include a double knit stitch structure.

[0258] Referring briefly to FIG. 15, a double knit stitch structure may be knitted using a yarn 1502 on a pair of needle beds 1504, 1506. The needle beds 1504, 1506 may each include a number of needles 1508 (not all of which are labelled in the diagram, for clarity). The needles 1508 of the respective needle beds 1504, 1506 may be laterally offset from each other. Loops 1510 (not all of which are labelled in the diagram, for clarity) may be formed in the yarn 1502 on every needle 1508, alternating between the two needle beds 1504, 1506.

[0259] In some examples, at least a portion of the headgear 100 may include an interlock stitch structure.

[0260] Referring briefly to FIG. 16, an interlock stitch structure may be knitted using a yarn 1602 on a pair of needle beds 1604, 1606. The needle beds 1604, 1606 may each include a number of needles 1608 (not all of which are labelled, for clarity). The needles 1608 of the respective needle beds 1604, 1606 may be laterally aligned with each other. Corresponding needles 1608 of the needle bed 1604 and needle bed 1606 may form opposing pairs of needles. The yarns 1602 may alternate between the needle beds 1604, 1606. Loops 1610 (not all of which are labelled in the diagram, for clarity) may be formed in the yarns 1602 on every other needle 1608 of each needle bed 1604, 1606, in each pass direction. For example, on the odd needles 1608 of the front needle bed 1604 and the even needles 1608 of the back needle bed 1604 in a first pass direction 1612, and on the even needles 1608 of the front needle bed 1604 and the odd needles 1608 of the back needle bed 1604 in a second pass direction 1614.

[0261] An interlock stitch structure may provide less extensibility in the direction of the courses (the horizontal direction, as illustrated in FIG. 15 and FIG. 16), compared to a double knit stitch structure.

[0262] In some examples, at least a portion of the headgear 100 may include a rib stitch structure.

[0263] Referring briefly to FIG. 17, a rib stitch structure may be knitted using a yarn 1702 on a pair of needle beds 1704, 1706. The needle beds 1704, 1706 may each include a number of needles 1708 (not all of which are labelled, for clarity). The needles 1708 of the respective needle beds 1704, 1706 may be laterally aligned with each other. Corresponding needles 1708 of the needle bed 1704 and needle bed 1706 may form opposing pairs of needles. In some examples, the yarn 1702 may alternate between the needle beds 1704, 1706. The resulting rib stitch structure may be referred to as a 1x1 rib stitch structure. Loops 1710 (not all of which are labelled in the diagram, for clarity) may be formed in the yarn 1702 on every other needle 1708 of each needle bed 1704, 1706, in a single pass direction. For example, on the even needles 1708 on the front needle bed 1704 and the odd needles 1708 of the back needle bed 1604.

[0264] FIG. 18 illustrates another rib stitch structure. Loops 1710 may be formed in the yarn 1702 on adjacent pairs of needle 1708 on one needle bed 1704, and a single needle 1708 of the other needle bed 1706. The resulting rib stitch structure may be referred to as a 2x1 rib stitch structure. The description of FIG. 17 otherwise applies equally to FIG. 18. Alternatively, or additionally, other rib stitch structures may be used.

[0265] In some examples, a stitch structure between layers of the headgear 100 may form one or more edges of at least a portion of the headgear 100. For example, an edge of one or more of the panel 106, left upper side strap 114, right upper side strap 116, left lower side strap 118, right lower side strap 120, left crown strap portion 2202, or right crown strap portion 2204. A stitch structure may join the inner layer and the outer layer to define an edge of the interior space. For example, the inner layer and the outer layer 208 of the panel 106 may be joined at one or more of the panel upper edge 108, panel lower edge 110, or panel side edges 112 by a stitch structure, e.g., a double knit stitch structure, an interlock stitch structure, or a rib stitch structure. The panel side edges 112 may be formed by yarn transferring between the inner layer and the outer layer 208.

[0266] In some examples, one or more regions of double knit stitch structure may be provided at a peripheral region of the headgear 100. For example, at a peripheral region of the panel 106, e.g., adjacent one or more of the panel upper edge 108, the panel sideedges 112, or the bottom panel lower edge 110. A double knit stitch structure at a peripheral region of the headgear 100 may provide cushioning. The cushioning may improve patient comfort and / or mitigate facial marking.

[0267] In some examples, an interior space 1304 within the panel 106 may be continuous with an interior space within one or more of the left upper side strap 114, right upper side strap 116, left lower side strap 118, right lower side strap 120, left crown strap portion 2202, and right crown strap portion 2204, e.g., both the left upper side strap 114 and the right upper side strap 116, both the left lower side strap 118 and the right lower side strap 120, or all of the side straps 114, 116, 118, 120. The joint 128 between the panel 106 and the (or each) side strap may be a knitted joint between the respective inner layers and outer layers 208 of the panel 106 and the side strap. The joint 128 may be configured to provide a passage between the respective interior spaces 1304 of the side strap and the panel 106 to form the continuous interior space.

[0268] In some examples, the panel 106 and / or side straps may include one or more stitch structures joining portions of the inner layer and the outer layer 208 together inwardly of the edges and / or the peripheral region, e.g., substantially centrally or at intervals. For example, in one or more of the upper section 202, central section 204, or lower section 206 of the panel 106. The stitch structures, e.g., double knit stitch structure, interlock stitch structure, or rib stitch structure, may define divisions between two or more interior spaces 1304 of the panel 106. The stitch structure may help maintain the shape of the headgear 100, and / or may be configured to locate or retain components of the headgear, e.g., one or more of the tensile elements, sleeves, shaping elements, or cushioning elements described below, as shown in FIG. 9 and FIG. 10, for example.

[0269] In other examples, the central section 204 may have an inner layer and an outer layer formed together as a flattened tubular structure, e.g., by a circular knitting machine. The inner layer and the outer layer may be joined, e.g., seamlessly joined, at the panel side edges 112. The central section 204 may have an upper opening and a lower opening. One or more of the upper opening or the lower opening of the central section 204 may join with an opening of the upper section 202 or the lower section 206, respectively, to provide a continuous interior space.Inlaid elements

[0270] The headgear 100 may include one or more inlaid elements. The inlaid elements may be mechanically inlaid through a knit structure as it is knitted. The inlaid element is non-knitted. The inlaid elements may be relatively linear with respect to the yarn of theknit structure, i.e., the loops of the courses. An inlaid element which is mechanically inlaid with a knit structure may, for example, be:• accommodated between layers of the knit structure, e.g., within the interior space between the 504 and the outer layer 208 as described above, or• woven through the knit structure, e.g., the inner layer 504 and / or the outer layer 208.

[0271] The inlaid elements may be outwardly visible if, for example, the inlaid element is mechanically inlaid, e.g., woven, through the outer layer 208. Or the inlaid elements may be substantially concealed if, for example, the inlaid element is mechanically inlaid so that it is accommodated within the interior space 1304 or woven through the inner layer 504.

[0272] In some examples, as in the tensile elements and / or sleeves described in further detail below, the inlaid elements may be included for functional rather than purely aesthetic reasons.

[0273] In some examples, as shown in FIG. 1, the inlaid elements may include one or more tensile elements, e.g., a first tensile element 124 and a second tensile element 126. The tensile elements may be configured to cooperate with a tensioner to control, e.g., maintain, limit, and / or adjust, a tension in the headgear 100, e.g., one or more of the panel 106, left upper side strap 114, right upper side strap 116, left lower side strap 118, right lower side strap 120, left crown strap portion 2202, or right crown strap portion 2204.

[0274] In some examples, the inlaid elements may be provided, at least in part, within one or more of the interior spaces described above, e.g., in one or more of the panel 106, left upper side strap 114, right upper side strap 116, left lower side strap 118, right lower side strap 120, left crown strap portion 2202, or right crown strap portion 2204. The inlaid elements may emerge from an opening 122 at a distal end 310 of one or more of the left upper side strap 114, right upper side strap 116, left lower side strap 118, or right lower side strap 120. Or the inlaid elements may emerge between loops in the knit structure of the headgear 100.

[0275] In some examples, the headgear 100 may be configured so that the one or more inlaid elements, e.g., tensile elements, may move within the interior space of the headgear 100, e.g., slide in a longitudinal direction. In some examples, the tensile elements may be configured to slide with respect to one or more of the panel 106, left upper side strap 114, right upper side strap 116, left lower side strap 118, or right lower side strap 120. In someexamples, the headgear 100 may be configured so that the one or more inlaid elements are inhibited from moving in at least a lateral direction, in use, e.g., by being woven through a knitted fabric, or between knit structures as described in further detail below. In some examples, the headgear 100 may be configured so that the inlaid elements, e.g., tensile elements, may slide along a substantially curved path, e.g., a serpentine path.

[0276] The one or more tensile elements may be relatively inextensible. The one or more tensile elements may be less extensible than one or more of the panel 106, left upper side strap 114, right upper side strap 116, left lower side strap 118, right lower side strap 120, left crown strap portion 2202, or right crown strap portion 2204 of the headgear 100. A tensile element may be less extensible than each of the portions of the headgear 100 through which the tensile element passes. The tensile elements may be configured to be substantially inextensible, e.g., when subjected to a tensile forces typically encountered during normal use of headgear in a respiratory support system.

[0277] In other examples, the tensile elements may be extensible, e.g., elastically extensible, or may include an extensible portion.

[0278] In some examples, the tensile element may have a substantially circular crosssection, as shown in FIG. 4 for example. In other examples, the tensile element may have a substantially elliptical or rectangular cross-section, among other possibilities.

[0279] In some examples, the inlaid elements, e.g., the tensile elements, may each be a yarn. In other examples, the tensile element may be a monofilament or a multifilament. The multifilament may be braided or twisted.

[0280] The inlaid elements may be mechanically inlaid with one or more knitted portions of the headgear 100. In various examples, the inlaid elements may be mechanically inlaid, at least in part:• within the interior space between layers, e.g., the inner layer and the outer layer;• through the single knit stitch structure of the outer layer;• through the single knit stitch structure of the inner layer; and / or• within a double knit stitch structure, interlock stitch structure, or rib stitch structure, e.g., along an edge of a side strap and / or panel.

[0281] Each of the above options may be associated with different benefits, and suited to different applications. For example, an inlaid element mechanically inlaid through the inner layer 504 and / or the outer layer 208 may advantageously limit extensibility of the knitted fabric of the headgear 100, e.g., in a side strap. An inlaid element mechanically inlaid through the outer layer 208 may advantageously provide additional cushioning (i.e., at least the inner layer 504) between the inlaid element and the patient's face. An inlaid element mechanically inlaid through the inner layer 504 may conceal the tensile element when the headgear 100 is donned. An inlaid element mechanically inlaid within the interior space may advantageously allow the inlaid element, e.g., tensile element, to move relatively freely with relatively little friction, and / or provide a balance between comfort and concealment.

[0282] The inlaid elements, e.g., tensile elements, may be configured to be handled by a flat bed knitting machine, e.g., by being sufficiently flexible and narrow. With reference to FIG. 25, the inlaid elements may be configured to be supplied to the knitting bed from a spool. The inlaid elements may be configured to be manipulated by mechanical yarn carriers. Mechanically inlaying the inlaid elements as the headgear 100 is formed may be simpler and / or more efficient than providing the inlaid elements to the headgear 100, e.g., within the interior space, after the knitted portions of the headgear 100 are formed.

[0283] The tensile elements may be configured to have a low coefficient of friction. A low coefficient of friction may reduce one or more of friction, abrasion or catching between the tensile element and one or more of the panel 106, left upper side strap 114, right upper side strap 116, left lower side strap 118, right lower side strap 120, left crown strap portion 2202, right crown strap portion 2204, or sleeves (described below). The tensile elements may have a smooth outer surface. The tensile elements may at least in part formed from, e.g., coated with, a low-friction material such as polytetrafluoroethylene (PTFE). In some examples, one or more of the inner layer 504 or outer layer 208 of the headgear 100 may include a yarn having a smooth surface or formed at least in part from a low-friction material.

[0284] The inlaid elements, e.g., tensile elements, may be flexible. The inlaid elements may be configured to have, or adopt, a curved, e.g., serpentine, shape. The inlaid elements may be configured to conform to the shape of the patient's head when the headgear 100 is donned.

[0285] In some examples, both free ends of an inlaid element, e.g., tensile element, may emerge from the headgear 100. For example, from any two of the left upper side strap 114, right upper side strap 116, left lower side strap 118, right lower side strap 120.

[0286] In some examples, an inlaid element, e.g., tensile element, may terminate within the headgear 100. For example, within the interior space of the panel 106, left upper side strap 114, right upper side strap 116, left lower side strap 118, or right lower side strap 120.

[0287] In some examples, an inlaid element, e.g., tensile element, may be fixedly attached to the headgear 100, e.g., to one or more of the panel 106, left upper side strap 114, right upper side strap 116, left lower side strap 118, or right lower side strap 120 at one or more discrete locations. Attachment may inhibit or prevent the inlaid element being inadvertently pulled out of the headgear, partially or entirely. In some examples, the inlaid element may be anchored by one or more of an adhesive, ultrasonic welding, radio frequency (RF) welding, stitching, heat setting, a clip, a hook-and-loop fastener, or a tortuous path. The inlaid element may be anchored to one or more of the rear portion or the pair of side portions within an interior space of the headgear 100 and / or attached to a layer of the headgear, e.g., inner layer or outer layer. In some examples, the inlaid element may be permanently attached to the headgear 100.

[0288] The one or more inlaid elements may extend through the headgear 100 in a variety of different configurations.

[0289] In some examples, each inlaid element may extend through a pair of side straps and the panel 106.

[0290] As best illustrated in FIG. 19, in some examples one or more inlaid elements may each extend through a pair of side straps on opposing sides of the headgear 100. A first tensile element 124 may extend through the left upper side strap 114, panel 106 (e.g., upper section 202), and right upper side strap 116. A second tensile element 126 may extend through the left lower side strap 118, panel 106 (e.g., lower section 206), and right lower side strap 120. In such examples, the central section 204 of the panel 106 may not necessarily include an interior space. The central section 204 may be formed as a single layer.

[0291] As best illustrated in FIG. 20, in some examples one or more inlaid elements may each extend through a pair of diagonally opposed side straps. A first tensile element 124 may extend through the left upper side strap 114, panel 106 (e.g., the upper section 202,central section 204, and lower section 206), and right lower side strap 120. A second tensile element 126 may extend through the left lower side strap 118, panel 106 (e.g., the upper section 202, central section 204, and lower section 206), and right upper side strap 116. The first tensile element 124 and the second tensile element 126 may intersect within the panel 106, e.g., at about a center of the central section 204 and / or in the sagittal plane. In such examples, each of the upper section 202, central section 204, and lower section 206 of the panel 106 may include an interior space. The upper section 202, central section 204, and lower section 206 may define a continuous interior space.

[0292] As best illustrated in FIG. 22, in some examples one or more inlaid elements may each extend through a pair of side straps on the same side of the headgear 100. A first tensile element 124 may extend through the left upper side strap 114, panel 106 (e.g., the upper section 202, central section 204, and lower section 206), and left lower side strap 118. A second tensile element 126 may extend through the right upper side strap 116, panel 106 (e.g., the upper section 202, central section 204, and lower section 206), and right lower side strap 120. In such examples, the headgear 100, including the tensile elements (with the possible exception of the coupling of the tensile elements with a tensioner, as described in further detail below), may be substantially symmetric about a sagittal plane 2206, e.g ., when the headgear 100 is laid flat and / or donned by a patient. And the headgear 100 may be formed in two halves, e.g., a left half 2208 and a right half 2210, which may be subsequently joined together. FIG. 23 shows the left half 2208 in further detail.

[0293] Seven possible tensile elements configurations are illustrated in FIG. 24. In some examples, the illustrated tensile element configurations may form the entirety of the tensile element of the headgear 100. In other examples, the illustrated tensile element configurations may form an end portion or end portions of a tensile element, e.g., to engage a headgear adjustment assembly. A remainder of the tensile element, e.g., configured to extend through the rear portion of the headgear 100, may include a monofilament or multifilament, for example.

[0294] In one example, as shown in FIG. 24(a), the tensile element may include opposing undulating surfaces, e.g., sinusoidal surfaces. In another example, as shown in FIG. 24(b), the first tensile element 124 may include a single undulating surface. In another example, as shown in FIG. 24(c), the first tensile element 124 may include a notched surface, e.g., opposing an undulating surface. In yet another example, as shown in FIG. 24(d), the first tensile element 124 may include a notched surface adjacent an undulating surface. In another example, as shown in FIG. 24(e), the tensile element may include a plurality ofannular ribs. In another example, as shown in FIG. 24(f), the tensile element may include beads, e.g., a plurality spherical beads threaded upon a string. In yet another example, as shown in FIG. 24(g), the tensile element may include a chain, e.g., a plurality of articulated chain links. One or more of the undulating surfaces, notched surfaces, annular ribs, beads, or the like, may be configured to engage a headgear adjustment assembly.

[0295] In yet another example, as shown in FIG. 24(h), the tensile element may comprise an elongate band 2404. The elongate band 2404 may be wider than it is thick, as illustrated in FIG. 25. In some examples, a width :thickness ratio of the elongate band 2404 may be greater than 10: 1, or greater than 100: 1. The elongate band 2404 may increase contact area and reduce forces on the patient's head, e.g., compared to a tensile element with a circular cross-section, improving patient comfort and / or mitigating facial marking.

[0296] The elongate band 2404 may have a textured finish. In some examples, the texture of the elongate band 2404 may reduce friction between the outer layer 208, the inner layer 504, isolator 502 or the sleeve 602, e.g., compared to a smooth finish.

[0297] In some examples, the elongate band 2404 may be formed from a textile. In some examples, the elongate band 2404 may be formed from a plastic material.

[0298] As shown in FIG. 25, the tensile element, e.g., elongate band 2404, may be supplied to the knitting machine from a spool 2502.

[0299] In some examples, a tensile element may be configured to be relatively rigid in one direction, and relatively flexible in another direction, e.g., an orthogonal direction. The tensile element may be arranged within the headgear 100 so that it can readily conform around the head of the patient when the headgear 100 is donned.

[0300] In some examples, at least part of a length, e.g., at least 50%, of the tensile elements may have an outside width, e.g., diameter, of between about 0.25 mm and 5.00 mm, or between about 0.5 mm and 2.0 mm. But other diameters may be used, and may depend on one or more of the function of the tensile element, anticipated tensile loads, or the particular knitting machine used, for example.

[0301] In some examples, the tensile elements may have a smaller diameter than the knitted yarns.

[0302] In some examples, as shown in FIG. 7 to FIG. 10, two or more tensile elements may be provided in parallel through one or more portions of the headgear 100, e.g., leftupper side strap 114. Parallel tensile elements may increase a contact area and reduce forces on the patient's head, improving patient comfort and / or mitigating facial marking.

[0303] In some examples, the inlaid elements may include one or more sleeves. The sleeve may define a passage configured to receive a tensile element, as shown in FIG. 6. The sleeve may have a hollow tubular structure. A tensile element may be movably, e.g., slidably, received within a sleeve.

[0304] Referring to FIG. 26 to FIG. 28, the sleeves may extend between openings 122 at distal ends of two side straps. In some examples, the sleeves may emerge from the openings 122.

[0305] The sleeves may be curved, e.g., serpentine. The sleeves may be configured to impart a curved shape, e.g., a serpentine shape, upon the tensile element received by the sleeve. The sleeves may be more rigid than the tensile elements.

[0306] The sleeves may be configured so that the tensile elements may slide freely within them. The sleeves may be configured to have a low coefficient of friction. In some examples, the sleeves may have a substantially smooth inner surface. In some examples, the sleeves may be at least in part formed from, e.g., coated with, a low-friction material such as PTFE.

[0307] The sleeves may be formed at least in part from an extensible and / or compressible material. For example, an elastomer such as silicone. Such materials may provide cushioning between the tensile element and the patient's face. In some examples, the sleeves may be knitted as described in further detail with reference to FIG. 6 and FIG. 11.

[0308] The sleeves may be mechanically inlaid with one or more knitted portions of the headgear 100, e.g., one or more of the panel 106 or side straps, as described above.

[0309] In some examples, the sleeves may be secured (e.g., by adhesive, welding, heatset yarn, or mechanical clip) within the headgear 100. For example, fixedly attached to one or more of the panel 106 or side straps 114, 116, 118, 120. Securing the sleeves may inhibit the sleeves from moving in the longitudinal direction and / or lateral direction. But the tensile elements within the sleeves may be able to slide relatively freely with respect to the sleeves and one or more of the panel 106, left upper side strap 114, right upper side strap 116, left lower side strap 118, right lower side strap 120, left crown strap portion 2202, or right crown strap portion 2204.

[0310] In some examples, the sleeves may be mechanically inlaid with the headgear 100 and the tensile elements may be provided to, e.g., threaded through, the sleeves in a subsequent step. In other examples, the sleeves may be inlaid with the headgear 100 with the tensile elements in situ within the sleeves.

[0311] The sleeves may extend through the headgear 100 in a variety of different configurations. In some examples, each sleeve may extend through a pair of side straps and the panel 106.

[0312] In some examples, as shown in FIG. 26 and FIG. 27, a sleeve may pass through the rear portion 102 and both side portions 104.

[0313] As shown in FIG. 26, one or more sleeves may each extend through a corresponding pair of side straps (e.g., upper side straps or lower side straps) on opposing sides of the headgear 100. As indicated by the dashed lines, the first sleeve 602 may extend through the left upper side strap 114, panel 106 (e.g., upper section 202), and right upper side strap 116. A second sleeve 2602 may extend through the left lower side strap 118, panel 106 (e.g., lower section 206), and right lower side strap 120.

[0314] As shown in FIG. 27, one or more sleeves may each extend through a pair of diagonally opposed side straps. As indicated by the dashed lines, a first sleeve 602 may extend through the left upper side strap 114, panel 106 (e.g., the upper section 202, central section 204, and lower section 206), and right lower side strap 120. A second sleeve 2602 may extend through the left lower side strap 118, panel 106 (e.g., the upper section 202, central section 204, and lower section 206), and right upper side strap 116. The first sleeve 602 and the second sleeve 2602 may cross over each other, e.g., in the central section 204 of the panel 106.

[0315] In some examples, as shown in FIG. 28, a sleeve may pass through a single side portion 104 and, optionally, the rear portion 102.

[0316] As shown in FIG. 28, one or more sleeves may each extend through a pair of side straps on the same side of the headgear 100. As indicated by the dashed lines, a first sleeve 602 may extend through the left upper side strap 114, panel 106 (e.g., the upper section 202, central section 204, and lower section 206), and left lower side strap 118. A second sleeve 2602 may extend through the right upper side strap 116, panel 106 (e.g., the upper section 202, central section 204, and lower section 206), and right lower side strap 120.

[0317] The sleeves may mitigate friction between the tensile elements and one or more of the panel 106, left upper side strap 114, right upper side strap 116, left lower side strap 118, right lower side strap 120, left crown strap portion 2202, or right crown strap portion 2204. The sleeves may mitigate the risk of the tensile elements catching on, or abrading, the knit fabric. The sleeves may mitigate friction between the first tensile elements and the patient's face. And mitigate facial marking and / or discomfort, e.g., from the narrower tensile elements digging into the patient's skin.

[0318] The sleeves, in cross-section, may have a symmetric outer profile. For example, one or more of a rotational symmetry or reflective symmetry. In other examples, the sleeves may have an asymmetric outer profile. For example, neither rotational nor reflective symmetry. The sleeves may have a circular, square, rectangular, or elliptical outer profile, in cross-section. The passage may have a circular, square, rectangular, or elliptical profile in cross-section. In some examples, the outer profile of the sleeve and the profile of the passage may be geometrically similar, e.g., both circular. In other examples, the profiles may be dissimilar.

[0319] In some examples, a width of the sleeve may be configured to be at least two, preferably at least three, and more preferably at least three times the width of the passage and / or the tensile element. A relatively large and / or broad sleeve may aid in distributing forces from the tensile elements against the patient's face.

[0320] In some examples, the sleeves may have a passage width (e.g., inside diameter) about equal to, or greater than, a width (e.g., outside diameter) of the tensile elements. The sleeves may have a passage width of between about between about 0.25 mm and 5.00 mm, or between about 0.5 mm and 2.0 mm, or between about 0.5 mm and 5.0 mm, or between about 2 mm and 4 mm, e.g., about 3 mm.

[0321] In some examples, the sleeves may be formed at least in part from a soft material, e.g., an elastomeric material, to cushion the tensile elements from the patient's face.

[0322] A number of different potential configurations for the inlaid elements, e.g., sleeves and / or tensile elements, are shown in FIG. 29 to FIG. 51. In each of the examples of FIG. 29 to FIG. 51, the free ends of the inlaid elements, represented by a dot, may be connected, or configured to connect, to a headgear adjustment assembly.

[0323] In FIG. 29, one tensile element 124 extends through both side portions, the rear portion, and a crown strap portion. The tensile element crosses over itself in the rear portion and in the crown strap portion. The tensile element passes above and below eachof the patient's ears. The tensile element passes over the parietal region or frontal region of the patient, e.g., across the top of the patient's head. The tensile element, e.g., a midpoint of the tensile element, passes across the patient's face between the nose and mouth, e.g., across one or more of the philtrum or nasolabial sulci above the mouth. Opposing ends of the tensile element emerge in the patient's oral region or mental region, e.g., below the mouth. This configuration may allow all straps to be tightened from one location.

[0324] In FIG. 30, one tensile element 124 extends through both side portions and the rear portion. The tensile element crosses over itself in the rear portion. The tensile element, e.g., a midpoint of the tensile element, passes across the front of the patient's face, e.g., across one or more of the philtrum or nasolabial sulci between the nose and mouth. Opposing ends of the tensile element emerge in the patient's oral region or mental region, e.g., below the mouth. This configuration may have less friction than that of FIG. 29. The crown strap, if any, may be adjusted separately, or may be non-adjustable.

[0325] In FIG. 31, one tensile element extends through both side portions. The tensile element loops around each of the patient's ears. The tensile element, e.g., a midpoint of the tensile element, passes across the front of the patient's face, e.g., across one or more of the philtrum or nasolabial sulci between the nose and mouth. Opposing ends of the tensile element emerge in the patient's oral region or mental region, e.g., below the patient's mouth. The crown strap, if any, may be adjusted separately, or may be non- adjustable. The rear portion, if any, may be separately adjustable, or may be non- adjustable.

[0326] In FIG. 32, one tensile element extends through both side portions. The tensile element loops around each of the patient's ears. The tensile element crosses over itself in each side portion, e.g., in the zygomatic region, parotideomasseteric region, or buccal region. The tensile element, e.g., a midpoint of the tensile element, passes across the front of the patient's face, e.g., across the mental region or between the lower lip and mental protuberance below the mouth. Opposing ends of the tensile element emerge in the patient's oral region or nasal region, e.g., between the patient's nose and mouth. The crown strap, if any, may be adjusted separately, or may be non-adjustable. The rear portion, if any, may be separately adjustable, or may be non-adjustable.

[0327] In FIG. 33, a pair of tensile elements extend through respective side portions. The tensile elements loop around respective ears of the patient. The crown strap, if any, maybe adjusted separately, or may be non-adjustable. The rear portion, if any, may be separately adjustable, or may be non-adjustable.

[0328] As indicated by the dashed lines in FIG. 33 (but also applicable in other examples), the headgear may include an elongation assembly 3302. The elongation assembly may facilitate controlled elongation of the loop defined by the patient interface assembly, e.g., the headgear or the combination of the headgear and patient interface. The elongation assembly may allow the loop to expand sufficiently for the headgear to easily slide into position around the head of the patient. In some examples, the elongation assembly may provide between about 0 and 200 mm, or between about 0 and 200 mil, of elongation. The elongation assembly may return to the original position, e.g., a use length, once the patient interface assembly has been properly donned. In some examples, the elongation assembly may return automatically once the patient interface assembly has been donned. Details of suitable elongation assemblies are disclosed in further detail as a "break-fit assembly" in International Patent Publication No. WO 2014 / 025267 Al, the entire content of which is incorporated herein by reference. In some examples, the elongation assembly may be integrated with the headgear adjustment assembly.

[0329] In FIG. 34, one tensile element extends through both side portions. The tensile element loops back towards the patient interface forward of the patient's ears. The tensile element, e.g., a midpoint of the tensile element, passes across the front of the patient's face, e.g., across one or more of the philtrum or nasolabial sulci between the nose and mouth. Opposing ends of the tensile element emerge in the patient's oral region or mental region, e.g., below the patient's mouth. The tensile element may be mechanically inlaid in a single wide side strap or panel on each side of the patient's head. The crown strap, if any, may be adjusted separately, or may be non-adjustable. The rear portion, if any, may be separately adjustable, or may be non-adjustable.

[0330] In FIG. 35, one tensile element extends through each of the side portions and the rear portion once. The tensile element curves over the patient's ears, e.g., curves downwardly from above the ear in one or more of the forward direction or rearward direction. The tensile element extends rearwardly from the patient interface, then upwardly forward of the patient's ears. The tensile element passes between the patient's eye and ear on opposing sides of the patient's head. Opposing ends of the tensile element emerge in the patient's oral region or mental region, e.g., below the patient's mouth. The crown strap, if any, may be adjusted separately, or may be non-adjustable.

[0331] In FIG. 36, one tensile element extends through both side portions. The tensile element may extend upwardly and rearwardly from the patient interface to pass between the eye and the ear on respective sides of the patient's head. The tensile element, e.g., a midpoint of the tensile element, passes across the front of the patient's face, e.g., across one or more of the philtrum or nasolabial sulci between the nose and mouth. Opposing ends of the tensile element emerge in the patient's respective temporal regions or auricular regions, e.g., above and / or forward of the patient's ears.

[0332] In FIG. 37, one tensile element extends through both side portions and the rear portion once. The tensile element may extend upwardly and rearwardly from the patient interface to pass between the eye and the ear on respective sides of the patient's head. Opposing ends of the tensile element emerge in the patient's oral region or nasal region, e.g., between the nose and mouth. This configuration may have relatively little friction. This configuration may be best suited for two-point headgear for compact nasal masks, nasal pillows, or nasal cannula interfaces.

[0333] In FIG. 38, one tensile element extends through both side portions, the rear portion, and a crown strap portion. The tensile element passes over the parietal region or frontal region of the patient, e.g., across the top of the patient's head. The tensile element, e.g., a midpoint of the tensile element, passes across the front of the patient's face, e.g., across one or more of the philtrum or nasolabial sulci between the nose and mouth. Opposing ends of the tensile element may emerge in the patient's oral region or mental region, e.g., below the patient's mouth.

[0334] In FIG. 39, one tensile element extends through both side portions, the rear portion, and a crown strap portion. The tensile element crosses over itself in the rear portion and in the side portions or crown strap. The tensile element passes over the parietal region or frontal region of the patient, e.g., across the top of the patient's head. The tensile element, e.g., a midpoint of the tensile element, passes across the front of the patient's face, e.g., across one or more of the philtrum or nasolabial sulci between the nose and mouth. The tensile element may extend upwardly and rearwardly from the patient interface to pass between the eye and the ear on respective sides of the patient's head. Opposing ends of the tensile element emerge in the patient's auricular region, temporal region, or parietal region, e.g., above respective ears of the patient.

[0335] In FIG. 40, a pair of tensile elements each extend through both side portions and the rear portion. The pair of tensile elements cross over each other in the rear portion. The crown strap portion, if any, may be adjusted separately, or may be non-adjustable.One end of each of the tensile elements emerges in the patient's oral region or nasal region, e.g., above the patient's mouth. The other end of each of the tensile elements emerges in the patient's oral region or mental region, e.g., below the patient's mouth.

[0336] In FIG. 41, a pair of tensile elements extend through a respective side portion and the crown strap portion. One end of each of the tensile elements emerges in the patient's respective mastoid region or occipital region, e.g., behind and / or below the ear. The other end of each of the tensile elements emerges in the patient's parietal region or frontal region, e.g., at or near the top of the patient's head.

[0337] In FIG. 42, one tensile element extends through both side portions, the rear portion, and the crown strap portion. The tensile element passes between the eye and ear, and below the ear, on respective sides of the patient's head. The tensile element, e.g., a midpoint of the tensile element, passes across the rear of the patient's head, e.g., across the occipital region. Opposing ends of the tensile element emerge in the patient's parietal region or frontal region, e.g., at or near the top of the patient's head. A portion of the tensile element extends in a substantially vertical direction adjacent lateral sides of the patient's mouth. The tensile element does not extend across the front of the patient's face.

[0338] FIG. 43 shows a variant of the configuration of FIG. 30, with opposing ends of the tensile element emerging in the nasal region or the oral region, e.g., above the patient's mouth. The tensile element, e.g., a midpoint of the tensile element, passes across the front of the patient's face, e.g., across the mental region or between the lower lip and mental protuberance below the mouth. A tensioner may apply a relatively greater force to an upper portion of the patient interface, compared to the configuration of FIG. 30.

[0339] FIG. 44 shows a variant of the configuration of FIG. 31, with opposing ends of the tensile element emerging in the nasal region or the oral region, e.g., above the patient's mouth. The tensile element, e.g., a midpoint of the tensile element, passes across the front of the patient's face, e.g., across the mental region or between the lower lip and mental protuberance below the mouth. A tensioner may apply a relatively greater force to an upper portion of the patient interface, compared to the configuration of FIG. 31.

[0340] FIG. 45 shows a variant of the configuration of FIG. 34, with opposing ends of the tensile element emerging in the nasal region or the oral region, e.g., above the patient's mouth. The tensile element, e.g., a midpoint of the tensile element, passes across the front of the patient's face, e.g., across the mental region or between the lower lip and mental protuberance below the mouth. A tensioner may apply a relatively greater force to an upper portion of the patient interface, compared to the configuration of FIG. 34.

[0341] In FIG. 46, a pair of tensile elements extend through respective side portions. The tensile elements loop back forward of the patient's ears. One end of each of the tensile elements emerges in the nasal region or the oral region, e.g., above the patient's mouth. The other end of each of the tensile elements emerges in the mental region or the oral region, e.g., below the patient's mouth.

[0342] In FIG. 47, a pair of tensile elements extend through respective side portions. The tensile elements loop around the patient's respective ears. One end of each of the tensile elements emerges in the nasal region or the oral region, e.g., above the patient's mouth. The other end of each of the tensile elements emerges in the mental region or the oral region, e.g., below the patient's mouth.

[0343] In FIG. 48, a pair of tensile elements each extend through the side portions, the rear portion, and the crown strap portion. Opposing ends of each of the tensile elements emerge adjacent to each other in the patient's parietal region or frontal region, e.g., at the top of the patient's head. The pair of tensile elements cross over each other in the rear portion and at the front of the patient's face, e.g., in the patient's nasal region, oral region, or mental region.

[0344] In FIG. 49, a pair of tensile elements each extend through a respective side portion, the rear portion, and the crown strap portion. Opposing ends of each of the tensile elements emerge in the patient's parietal region or frontal region, e.g. opposite to each other at or near the top of the patient's head. Unlike the configuration of FIG. 48, for example, the tensile elements do not cross over each other at the front of the patient's face, e.g., in the patient's nasal region, oral region, or mental region.

[0345] In FIG. 50, a pair of tensile elements each extend through the side portions, the rear portion, and the crown strap portion. Opposing ends of each of the tensile elements emerge opposite to each other in the patient's parietal region or frontal region, e.g., at or near the top of the patient's head. Unlike the configuration of FIG. 48 and FIG. 49, for example, the tensile elements do not cross over each other in the rear portion.

[0346] In FIG. 51, one tensile element extends through both side portions, the rear portion, and the crown strap portion. Opposing ends of the tensile element emerge in the patient's nasal region or oral region, e.g., above the patient's mouth. The tensile element extends rearwardly from the patient interface, passing below the patient's ears. The tensile element crosses over itself in the rear portion. The tensile element passes up, around, and over one or more of the occipital region or parietal region of the patient, e.g., so that a midpoint of the tensile element is positioned at or near the top of the patient's head.

[0347] The headgear 100 may include one or more other inlaid elements, e.g., within the interior space(s) or through an inner layer 504, outer layer 208, or edge of the headgear 100.

[0348] In some examples, the inlaid elements may include a shaping element. The shaping element may be configured to give a three-dimensional, e.g., curved, shape to the corresponding portion(s) of the headgear 100, e.g., one or more of the panel 106, left upper side strap 114, right upper side strap 116, left lower side strap 118, right lower side strap 120, left crown strap portion 2202, or right crown strap portion 2204. In one example, a shaping element may be configured to give the panel 106 a three-dimensional shape configured to cradle a rear or upper-rear portion of the patient's head. The three- dimensional shape may provide a visual cue assisting in correctly coupling the headgear with the patient interface and / or donning of the patient interface assembly. For example, with the inner layer facing inwards to engage the patient's head. The three-dimensional shape may improve patient comfort. In some examples, the shaping element may be relatively resilient or rigid, e.g., with respect to one or more of the panel 106, left upper side strap 114, right upper side strap 116, left lower side strap 118, or right lower side strap 120. In some examples, the shaping element may be malleable.

[0349] The inlaid elements may include a cushioning element. For example, including a bulkier yarn, a foam material, or a gel material. An example is shown in FIG. 5 in the form of the isolator 502, which may be a foam or gel pad. The cushioning element may improve patient comfort, e.g., cushioning one or more of the tensile elements, sleeves, or shaping elements.

[0350] The inlaid elements may be permanently coupled with the headgear 100, e.g., one or more of the panel 106, left upper side strap 114, right upper side strap 116, left lower side strap 118, right lower side strap 120, left crown strap portion 2202, or right crown strap portion 2204. In some examples, the inlaid elements may be permanently coupled with the headgear 100 by being inlaid within a tight knit structure, so that friction inhibits movement. In some examples, the inlaid elements may be permanently coupled with the headgear 100 by secondary process steps, e.g ., adhesive, welding, mechanical clips, or heat setting. Permanent coupling may better retain the inlaid elements in a particular location of the headgear. In other examples, the inlaid element is not permanently coupled with any of the panel 106, left upper side strap 114, right upper side strap 116, left lower side strap 118, or right lower side strap 120.Guide portions

[0351] The headgear 100, e.g., the panel 106, may include one or more guide portions. The guide portions may be configured to aid in maintaining one or more of a shape and position of one or more of the inlaid elements. The guide portions may impart a curved shape on the tensile elements.

[0352] In some examples, one or more guide portions may be provided in the rear portion of the headgear 100. The guide portions may be provided as the panel 106, e.g., central section 204, is formed. The guide portions may include a stitch structure, e.g., a double knit, interlock, or rib stitch structure, joining the inner layer and the outer layer 208 together. The guide portions may be a unitary part of the panel 106. In other examples, the guide portions may include stitches, pins, rivets, buttons, or the like. The stitches, pins, rivets, buttons, or the like may be added after the panel 106, e.g., central section 204, is otherwise formed. Or as it is formed.

[0353] As shown in FIG. 21 and FIG. 27, the headgear 100 in some examples may include an upper guide portion 2102 and a lower guide portion 2104. In other examples, the headgear 100 may include a left guide portion and a right guide portion. The upper guide portion 2102 and the lower guide portion 2104 may be provided in the central section 204 of the panel 106. The upper guide portion 2102 and the lower guide portion 2104 may be substantially parallel. A pathway 2106 may be defined between the upper guide portion 2102 and the lower guide portion 2104. The pathway 2106 may be substantially linear. The pathway 2106 may be substantially horizontal. In other examples, the pathway may be substantially vertical. Alternatively, or additionally, the upper guide portion 2102 and the lower guide portion 2104 may define a curved pathway. In some examples, a length of the pathway may be between about 3 and 20 millimeters (mm). In some examples, a width of the pathway may be between 3 and 20 mm. One or more of the first tensile element 124, second tensile element 126, first sleeve 602, or second sleeve 2602 may be configured to pass, at least in part, between the upper guide portion 2102 and the lower guide portion 2104, e.g., along the pathway 2106. The guide portions may inhibit movement of at least a portion of the tensile elements or the sleeves, in use, e.g., laterally with respect to the tensile element or sleeve. In some examples, the first tensile element 124 and second tensile element 126, and optionally the first sleeve 602 and second sleeve 2602, may cross over each other within the pathway 2106.

[0354] In other examples, the headgear 100 may include a guide portion formed as a double knit or interlock stitch structure in a single course, with a tensile element or sleeve inlaid within the loop structure of the stitches.

[0355] The guide portions may assist in forming the headgear, e.g., by retaining inlaid tensile elements or other inlaid elements in position as the headgear is formed. For example, as the panel 106, e.g., central section 204, is formed, a first set of double knit, interlock, or other stitches joining the inner layer and the outer layer 208 may be knitted between the front needle bed and back needle bed, e.g., approximately at the center of the panel 106. Yarn carriers may then carry the tensile elements in opposite directions across the panel 106, and may switch positions immediately after, e.g., above, the first set of interlock stitches. After the tensile elements have crossed over, a second set of interlock stitches may be knitted, e.g., directly above the tensile elements.Curved portions

[0356] In some examples the headgear 100 may include one or more curved portions. The curved portions may be knitted with a preformed curvature. A curved portion may better conform to a patient's head and / or improve patient comfort, e.g., by curving around the patient's ear.

[0357] FIG. 52 shows a variant of the headgear 100 of FIG. 1 with a rear portion 102 including two curved portions 5202, 5204.

[0358] In some examples, a curved portion may include two or more regions each knitted with a different gauge and / or tension. Each region may include one or more courses. The gauge and / or tension of each region may successively increase or decrease, e.g., from one edge to the other.

[0359] In some examples, an upper side strap and a lower side strap may be joined by, e.g., integrally knitted with, an intermediate curved portion. The intermediate curved portion may be configured to extend partially around, e.g., behind, the patient's ear, when the headgear 100 is donned.

[0360] In some examples, a curved portion may form at least part of any one or more of the panel 106, left upper side strap 114, right upper side strap 116, left lower side strap 118, or right lower side strap 120.

[0361] In some examples, as shown in FIG. 52, the headgear 100 may include two or more curved portions. The curved portions may form at least part of the panel 106. In some examples, the curved portions may include a left curved portion 5202 and a right curved portion 5204. A remainder of the panel 106 may extend between the left curved portion 5202 and the right curved portion 5204. In some examples, the headgear 100 may include one or more of an upper curved portion or a lower curved portion, e.g., along the panel upper edge 108 or the panel lower edge 110. In some examples, as shown in FIG. 52, the curved portions may define lateral panel side edges 112.

[0362] FIG. 53 shows the left curved portion 5202 in detail. The right curved portion 5204 may be a mirror-image of the left curved portion 5202. The description of the left curved portion 5202 is intended to apply equally to the right curved portion 5204 (or other curved portions), with any necessary modifications (e.g., substitution of the "right upper side strap 116" for the "left upper side strap 114").

[0363] As shown, the left curved portion 5202 may be joined to, or formed integrally with, the left upper side strap 114 and the left lower side strap 118. In some examples, as shown in FIG. 53, the left curved portion 5202 may be joined to, or formed integrally with, the left upper side strap 114 and the left lower side strap 118 before the panel 106 is joined with the left curved portion 5202.

[0364] The left curved portion 5202 may include one or more of an inner layer, an outer layer, or an interior space as described in further detail above. In some examples, as shown in FIG. 52, the remainder of the rear portion between the left curved portion 5202 and the right curved portion 5204 may be a single layer. In other examples, e.g., where an interior space is not required, the curved portions may be a single layer. One or more of the inner layer, the outer layer, or the single layer may be knitted, e.g., formed from a single knit stitch structure or a double knit stitch structure.

[0365] The left curved portion 5202 may be formed as a flattened tubular structure. In some examples, the left upper side strap 114, left curved portion 5202, and left lower side strap 118 may be integrally formed as a continuous flattened tubular structure.

[0366] The curved portions may include one or more inlaid elements, e.g., one or more of the first tensile element 124 or first sleeve 602, as described above. One or more of the tensile element, sleeve, or other inlaid elements may be inlaid in an interior space of the curved portion, or through the inner layer or the outer layer. In some examples, as shown in FIG. 52, the tensile element or sleeve may extend continuously through the left upper side strap 114, left curved portion 5202, and left lower side strap 118.

[0367] FIG. 54 shows part of the left curved portion 5202 of FIG. 52 and FIG. 53 in further detail.

[0368] The left curved portion 5202 has an inner edge 5402 and an outer edge 5404. One or more of the inner edge 5402 or the outer edge 5404 may be formed as a double knit stitch structure, interlock stitch structure, or rib stitch structure.

[0369] The left curved portion 5202 may include a plurality of courses. The courses may run along the length of the left curved portion 5202. The wales may run laterally.

[0370] Curvature may be induced in the curved portions by varying the yarn tension of the courses. Increasing yarn tension in a course may result in a greater force pulling adjacent stitches together. A course knitted at higher yarn tension may be shorter than a course including the same number of stitches knitted at a lower yarn tension.

[0371] In some examples, yarn tension can be increased by directly increasing the yarn tension applied to the yarn by the knitting machine. In some examples, the yarn tension may be applied to the yarn during the knitting process, such as by a tension mast of the knitting machine.

[0372] In some examples, yarn tension in a section can be modified by a selection of a particular stitch structure for that section that inherently increases or decreases yarn tension relative to adjacent knitted sections.

[0373] The curvature in the curved portion may be along the length of the courses. The curvature of the curved portions may be provided by an interaction between a first region including courses which have a first yarn tension, and a second region including courses which have a second yarn tension. The first yarn tension and the second yarn tension may be dissimilar. Each of the courses in the first region and the second region may be substantially parallel to each other. The first region and the second region may be substantially similar in length. In a knitted fabric including one or more courses of relatively greater yarn tension adjacent one or more courses of relatively lesser yarn tension, the courses in the knitted fabric will generally curve towards the courses of relatively greater yarn tension.

[0374] Referring particularly to FIG. 54, the left curved portion 5202 may include a first region 5406 of one or more courses with a first yarn tension.

[0375] Adjacent to the first region 5406 may be a second region 5408 of one or more courses with a second yarn tension. A course of the second region may be interlooped with a course of the first region. The first yarn tension may be greater than the second yarn tension. The curved portion may curve towards the region with the greater yarn tension, i.e., the first region 5406.

[0376] The left curved portion 5202 may include a third region 5410 of one or more courses with a third yarn tension, adjacent to the second region. The left curved portion 5202 may further include additional regions of one or more courses each having their own yarn tensions.

[0377] Demarcation of the first region 5406, second region 5408, and third region 5410 in the example left curved portion 5202 in FIG. 54 is generally indicated by the dashed lines.

[0378] The courses of one or more of the first region 5406 or the second region 5408 may be sequentially knitted on a knitting machine.

[0379] In other examples, a curved portion may include one or more further regions with different yarn tensions.

[0380] The yarn tension may successively decrease from the first region to the second region, from the second region to the third region, and so on. The third yarn tension (and any successive yarn tensions in the courses of additional regions) may be selected such that the left curved portion 5202 has a tension gradient 5412, i.e., the yarn tension may increase between adjacent regions in the direction of the arrow. The tension gradient may induce the curvature along the length of the courses in the first region, second region and / or third region. The tension gradient 5412 may be orthogonal to the direction of the courses in the first region, second region and third region. For example, the first yarn tension may be greater than the second yarn tension, and the second yarn tension may be greater than the third yarn tension.

[0381] In some examples, curvature and / or tensions tension gradient may be induced by varying the knit gauges of the courses. The gauge of knitting a course may be related to the yarn tension in the course. Courses knitted at less than full gauge may have a greater yarn tension than a course knitted at full gauge. As the gauge is reduced, the yarn tension may increase.

[0382] In some examples, a curved portion may include two or more regions which are knitted at a different gauge to each other. Referring particularly to FIG. 54, the first region 5406 may include one or more courses that are knitted at a first gauge. The second region 5408 may include one or more courses that are knitted at a second gauge. The second gauge may be different to the first gauge. The second gauge may be greater than the first gauge. The third region 5410 may include one or more courses that are knitted at a third gauge. The third gauge may be different to the second gauge. The third gauge may be greater than the second gauge. The third gauge may be different to the first gauge and the second gauge. The third gauge may be greater than the first gauge and the second gauge.

[0383] The first gauge, the second gauge, and the third gauge may be selected so that the gauge successively increases from the first region to the second region, and from the second region to the third region, and so on. For example, the first gauge may be quarter gauge (knitting on every fourth needle), the second gauge may be half gauge (knitting on every second needle), and the third gauge may be full gauge (knitting on every needle).

[0384] In some examples the left curved portion 5202 may include two or more of a quarter gauge region, a half gauge region, and a full gauge region. The half gauge region may be between the quarter gauge region and the full gauge region.

[0385] Each of the first region 5406, second region 5408 and third region 5410 may include one or more courses. Curvature may be imparted to the left curved portion 5202 by virtue of relatively higher tension in the loops of the first region 5406. This relatively higher tension may result in the individual stitches being pulled closer together. One or more of the first region 5406 or the second region 5408 may include a plurality floats. The number of floats per full course in the first region 5406 may be greater than the number of floats per full course in the second region 5408. In other examples, the left curved portion 5202 may include one or more of 1 / 3 gauge (knitting on every third needle), 1 / 5 gauge (knitting on every fifth needle), or 1 / 6 gauge (knitting on every sixth needle) courses.

[0386] In some examples, the first region 5406 may be adjacent to, e.g., form, a concave inner edge 5402 of the left curved portion 5202. The outermost region, e.g., the third region 5410, may be adjacent to, e.g., form, a convex outer edge 5404 of the left curved portion 5202. The inner edge 5402 and / or the outer edge 5404 of the left curved portion 5202 may include one or more courses of a double knit stitch structure, interlock stitch structure, or rib stitch structure.

[0387] The left curved portion 5202 may be formed on a flat bed knitting machine. In some examples, the left curved portion 5202 may be formed beginning with the outer edge 5404. The outer edge 5404 may be adjacent, or formed by, the third region 5410. In other examples, the left curved portion 5202 may be formed beginning with the inner edge 5402. The inner edge 5402 may be adjacent, or formed by, the first region 5406. In either case, the left curved portion 5202 may be completed by sequentially knitting the remaining regions.

[0388] In some examples, a thickness of the left curved portion 5202 may be varied. The left curved portion 5202 may include two or more regions including different thicknesses. A relatively greater thickness may be imparted to a region by increasing the number of lengths of yarn in each course. For example, by decreasing the knitting gauge. Courses knitted at less than full gauge may include multiple yarn traverses in each course. Increasing the number of yarn traverses in a course may increase the thickness of the course. For example, the first region 5406 may have a greater thickness than the second region 5408. The second region 5408 may have a greater thickness than a third region 5410. Each quarter gauge course may be formed by four yarn carrier traverses and include four separate lengths of yarn traversing the same course. Each half gauge course may be formed by two yarn carrier traverses and include two separate lengths of yarn traversing the same course.

[0389] In some examples, a region of greater thickness may be located at, or adjacent, the inner edge 5402 of the left curved portion 5202. This may provide more cushioning against more sensitive parts of the patient's head. Or where discomfort is most likely to occur. For example, at or adjacent the patient's ears.Tensioner

[0390] The one or more tensile elements may be configured to be coupled with one or more tensioners of the patient interface assembly.

[0391] A tensioner may be configured to control, e.g., maintain, limit, and / or adjust, tension in the tensile element. The tensioner may be configured to control, e.g., maintain, limit, and / or adjust, an effective length of the tensile element.

[0392] In some examples, the tensioner may allow for manual adjustment, e.g., by the patient, of one or more of the tension or the effective length of the one or more tensile elements.

[0393] In other examples, the tensioner may be configured to automatically apply a predetermined tension to the one or more tensile elements. The predetermined tension may be configured to be substantially constant. Or the predetermined tension may be dependent on the effective length, i.e., extension and / or retraction, of the tensile element. The tension may be linear or non-linear.

[0394] In some examples, the tensioner may be an integral part of, e.g., permanently coupled with, the headgear 100. In some examples, the tensioner may be an integral part of, e.g., permanently coupled with, the patient interface. In some examples, the tensioner may be configured to be removably coupled with one or more of the headgear, e.g., tensile elements, or the patient interface, e.g., a frame or bracket.

[0395] In some examples the tensioner may include one or more resilient members 5502, as shown schematically in FIG. 55. A resilient member 5502 may be configured to be coupled with, e.g., between, a tensile element and the patient interface.

[0396] The resilient members 5502 may be resiliently extensible. The headgear 100 may be configured so that the resilient member 5502 is in tension when a patient interface assembly including the headgear 100 is properly fitted to a patient. Or to any one of a subset of patients (e.g., adult patients, or small adult patients). A length of one or more of the resilient members 5502 and / or the associated tensile elements may be selected so that they are in tension when the headgear 100 is property fitted to the patient.

[0397] In some examples, the resilient member 5502 may include a spring, e.g., an extension spring. In other examples, the resilient member 5502 may include an elastic material, e.g., an elastomeric material.

[0398] The resilient member 5502 may control tension in the headgear by elastic deformation. The tensile force in the tensile element may at least in part be determined, e.g., limited, by a restoring force of the resilient member 5502. A resilience, e.g., elasticity, of the resilient members 5502 may be selected so that an appropriate force is applied to the patient interface when the patient interface assembly is properly fitted to the patient. The force may be selected to be high enough to maintain an appropriate sealing force between the patient interface and the patient's face. The force may be selected to be high enough to mitigate or eliminate leaks during delivery of respiratory support. For example, during delivery of a flow of respiratory gases at pressures of up to about 20 cmH2O. The force may be selected to be low enough to mitigate or eliminate one or more of facial marking, patient discomfort, or pressure sores.

[0399] In some examples, the resilient members 5502 may be identical, e.g., have the same resilience and / or extensibility. In other examples, any two or more of the resilient members 5502 may differ from each other. For example, some of the resilient members 5502 may be selected to apply a greater tensile force and / or provide less extensibility to a lower part of the headgear, e.g., the left lower side strap 118 and the right lower side strap 120. A greater tensile force and / or less extensibility at a lower part of the patient interface assembly may improve sealing and / or patient comfort, e.g., mitigate mask "bounce" due to variations in gas pressure within the patient interface between inspiratory and expiratory phases. The lower resilient members 5502, e.g., associated with the lower side straps 118, 120, may be configured to provide a greater restoring force, e.g., have a greater spring constant or elastic modulus, and / or less extensibility than the upper resilient members 5502, i.e., associated with the upper side straps 114, 116.

[0400] In some examples, the resilient members 5502 may be user-replaceable, e.g., with a resilient member 5502 of different resilience. In other examples, the resilient member 5502 may be permanently coupled with a tensile element. A range of headgear 100 including resilient members 5502 of different size and / or resilience may be provided, e.g., small and large adult sizes, pediatric and adult sizes, and / or low tension and high tension headgear. Low tension headgear may improve patient comfort for respiratory support at relatively lower treatment pressures, e.g., less than about 10 centimeters of water (cmHzO), or less than about 8 cmHzO. High tension headgear may improve sealing at relatively higher treatment pressures, e.g., greater than 10 cmH2O, or greater than 12 cmH2O. Or the headgear 100 may be made available in a single size, e.g., one-size-fits- all. In some examples, a kit may include a plurality, e.g., a complete set, of resilient members 5502 of the same size and / or resilience. In other examples, the kit may include two or more resilient members 5502 of different size and / or resilience. For example, different size and / or resilience for the upper side straps and lower side straps, respectively. Or a complete set of resilient members 5502 in two or more difference sizes and / or resilience. In some examples, the kits may also include the headgear.

[0401] In some examples, as shown in FIG. 55, a resilient member 5502 may be provided at each end of a tensile element, e.g., first tensile element 124 and / or second tensile element 126. In other examples, a resilient member 5502 may be provided at a single end of a tensile element.

[0402] The headgear 100 may include one or more clips 5504. The clips 5504 may be configured to removably couple the headgear 100, e.g., the resilient members 5502, with one or more of the patient interface or a headgear adjustment assembly. The clips 5504may allow convenient assembly and / or disassembly of the headgear 100 and patient interface.

[0403] In some examples, as shown in FIG. 55, a clip 5504 may be provided at, or near, each end of a tensile element, e.g., first tensile element 124 and / or second tensile element 126. In other examples, a clip 5504 may be provided at a single end of a tensile element.

[0404] In some examples, the resilient members 5502 may be coupled with a tensile element after the headgear 100 is otherwise formed as described above. This may assist inlaying of the tensile elements as the headgear 100 is knitted. For example, as shown in FIG. 25, the tensile elements may be supplied to the knitting machine as a continuous length from a spool, cut to length after the knitted portions of the headgear are fully formed, and the resilient member 5502 then attached to the cut ends of the tensile elements.

[0405] In some examples, the tensioner may be an automatic tensioner.

[0406] The automatic tensioner may be configured, upon fitment to the head of the patient, to automatically adjust to the correct size. Once in use, a patient interface assembly including the automatic tension may transform in properties from an elasticated "stretchy" headgear or strap to an "inelastic" headgear or strap. The patient interface assembly may exhibit a relatively small contraction force that tends to shorten the headgear. The patient interface assembly can be positioned on the patient's head and may automatically contract to or near a proper head size, in a manner similar to elasticated headgear.

[0407] In some examples, the contraction force may be sufficient to support the weight of the patient interface assembly. And optionally maintain the patient interface assembly in place on the patient's head during therapy. In other examples, the contraction force may be less than is necessary to maintain the mask in sealed contact with the patient's face, e.g., during therapy. For example, the contraction force alone may be insufficient to resist a blow-off force from pressurization of the patient interface.

[0408] The automatic tensioner may also exhibit an inelastic behavior in response to forces tending to elongate the headgear. The automatic tensioner may have a locked mode that can produce a locking force tending to resist elongation of the headgear 100. The locking force may be sufficient to resist elongation, or at least any significant elongation, of the headgear 100 in response to blow-off forces. The locking force may be sufficient to resist elongation of the headgear 100 in s response to forces in addition to blow-off forces, such as hose pull forces for example.

[0409] The automatic tensioner may exhibit a yield force. The automatic tensioner may be configured to permit elongation of the headgear 100 when subject to a force exceeding the yield force. The yield force may be greater than the expected blow-off force and / or greater hose pull force. The yield force may be low enough that the patient can relatively conveniently apply an elongation force exceeding the yield force, e.g., to intentionally elongate the headgear 100 for donning or doffing.

[0410] The automatic tensioner may be configured to automatically transition between a contraction mode, a locked mode, and a yield mode in response to the presence or absence of external forces.

[0411] For example, the headgear 100, in a contraction mode, may contract towards a predetermined minimum length in the absence of an external elongating force. The headgear 100, in a yield mode, may be elongated to a length sufficient to permit the patient interface assembly to be positioned on the patient's head when subject to a elongating force exceeding the yield force. The headgear 100, in a contraction mode, may contract to conform to the size of the patient's head when the elongating force is removed. The headgear 100, in a contraction mode and / or a locked mode, may resist elongation, or any significant elongation, when subject to a blow-off force and / or hose pull force, e.g., upon commencement of therapy. The headgear 100, in a yield mode, may be elongated to permit doffing of the patient interface assembly.

[0412] In some examples, the automatic tensioner and / or patient interface assembly may include a directional lock.

[0413] Further details and examples of automatic tensioners and directional locks are disclosed in International Patent Application Publication No. WO 2016 / 043603 Al and No. WO 2019 / 175814 Al, both assigned to Fisher &. Paykel Healthcare Limited, the entire contents of which are incorporated herein by reference.

[0414] In some examples, the tensioner may include a headgear adjustment assembly. The headgear adjustment assembly may be configured to control, e.g., maintain, limit, and / or adjust, tension in the headgear 100. The headgear adjustment assembly may be configured to one or more of shorten, maintain, or lengthen an effective length of one or more of the tensile elements of the headgear 100. The headgear adjustment assembly may be configured to apply, maintain, and / or release tension in one or more of the tensile elements of the headgear 100.

[0415] In some examples, the headgear adjustment assembly may include a reel. The tensile elements may be, in part, wound onto the reel. Rotating the reel in a first direction may further wind the tensile elements onto the reel. Winding the tensile elements onto the reel may shorten an effective length ( I . e. , the length of the tensile element not wound onto the reel) and / or increase tension in the tensile elements. Rotating the reel in a second direction may unwind the tensile elements from the reel. Unwinding the tensile elements from the reel may lengthen an effective length and / or decrease tension in the tensile elements.

[0416] In some examples, the headgear adjustment assembly may include an actuator, e.g., a rotatable dial, which can be manipulated by the patient or other user to adjust an effective length and / or tension of the headgear 100. For examples, by rotating the rotatable dial in a first direction to increase a sealing force between the patient interface and the patient's face. The actuator may be coupled with the reel, e.g., to rotate the reel in the same direction.

[0417] The headgear adjustment assembly may include a torque transfer mechanism configured to communicate torque between the actuator and the reel. In some examples, the torque transfer mechanism may be configured to inhibit or prevent overtightening of the headgear. The torque transfer mechanism may be configured to decouple the actuator and the reel if the force exceeds a threshold.

[0418] In some examples, one of the rotatable dial and the reel may include a ratchet wheel. The other of the rotatable dial and the reel may include a pawl configured to engage the ratchet wheel. The pawl may be resiliently biased towards the ratchet wheel. In one example, the ratchet wheel may be integrated in an inner surface of the reel.

[0419] The headgear adjustment assembly may include a locking mechanism, e.g., a ratchet mechanism, to maintain a desired effective length and / or tension of the headgear. The locking mechanism may be configured to inhibit or prevent rotation of the reel in the second direction (i.e., unwinding).

[0420] In some examples, the locking mechanism may be configured to inhibit or prevent rotation of the reel in the second direction unless, or until, a force upon the headgear adjustment assembly, e.g., from actuation or tension in the tensile elements, exceeds a threshold. The locking mechanism may be configured, e.g., the threshold selected, so that the reel does not unintentionally rotate in the second direction during normal use. The locking mechanism may be configured, e.g., the threshold selected, so that the reel is relatively easily rotated in the second direction by active adjustment or doffing of theheadgear. For example, by actuating the reel, pulling the patient interface away from the patient's face, or pulling on the headgear 100, e.g., tensile elements, side straps, or rear portion, when the headgear 100 needs to be loosened for donning or doffing.

[0421] The ratchet mechanism may include a plurality of teeth on the reel and a plurality of complementary teeth on a base of the headgear adjustment assembly. Or vice versa. The plurality of teeth and the plurality of complementary teeth may be configured to normally engage each other, e.g., in an interference fit. The reel, e.g., the plurality of teeth, and the base, e.g., the plurality of complementary teeth, may be biased towards each other, e.g., by a spring.

[0422] The locking mechanism may include a release mechanism. The release mechanism may be actuated by the user to selectively disengage the locking mechanism. When disengaged, the reel may be rotated, e.g., freely rotated with little or no resistance from the locking mechanism, in the second direction to lengthen an effective length and / or decrease tension in the tensile elements. For example, as the patient interface assembly is doffed.

[0423] An example headgear adjustment assembly 5600 is shown in detail in FIG. 56 and FIG. 57. The example headgear adjustment assembly 5600 includes a cap 5602, an actuator 5604 comprising an outer part 5606 and an inner part 5608, a biasing member 5610, a torque transfer element 5612, a rotatable member 5614, and a base 5616.

[0424] In use, a patient may rotate the outer part 5606 of the actuator 5604 to adjust the headgear 100. The outer part 5606 is coupled with the inner part 5608. The inner part 5608 includes internal contours that engage pawls of the torque transfer element 5612. The torque transfer element 5612 is coupled with the rotatable member 5614. Rotation of the rotatable member 5614 in the first direction winds the tensile elements onto the rotatable member 5614, decreasing an effective length and / or increasing tension in the tensile elements. Teeth of the rotatable member 5614 engage corresponding teeth of the base 5616 to inhibit or prevent the rotatable member 5614 from rotating in the second direction. The biasing member 5610 biases the torque transfer element 5612 and rotatable member 5614 towards the base 5616.

[0425] In some examples, the headgear adjustment assembly 5600 may be provided on the patient interface. In other examples, the headgear adjustment assembly 5600 may be provided on the headgear 100, e.g., on the crown strap 6802.

[0426] In some examples, the headgear adjustment assembly may be coupled with one or more tensile elements in a rack-and-pinion configuration. The headgear adjustment assembly may include a rotatable pinion. At least a portion of the tensile element, e.g., an end portion, may include one or more protrusions 2402 configured to engage the pinion or reel, e.g., two or more protrusions forming a rack.

[0427] Further details and examples of headgear adjustment assemblies are disclosed in International (PCT) Patent Publication Nos. WO 2014 / 025267 Al, WO 2015 / 151019 Al, WO 2022 / 173314 Al, and WO 2024 / 102001 Al, each assigned to Fisher & Paykel Healthcare Limited, the entire content of each of which is incorporated herein by reference.

[0428] Since headgear tension may be determined by the one or more tensioners and the tensile elements, the side straps of the headgear 100 in some examples may be non- adjustably coupled with the patient interface. In some examples, the side straps may be configured to bunch up as the headgear is tightened, and / or stretch as the headgear is loosened. In other examples, the side straps may not be directly coupled with the patient interface at all. The side straps may be configured to cushion the patient's face against the tensile elements and / or conceal the tensile elements.Forming the headgear

[0429] In some examples, the headgear 100 may be progressively formed course by course, e.g., beginning at the lower edges or the upper edges.

[0430] The headgear 100 of FIG. 1 in one example may be knitted according to the process shown in FIG. 58. The process is described below with further reference to the headgear diagrams of FIG. 59 to FIG. 67.

[0431] In first step 5802, a panel lower edge of headgear 100, e.g., the side strap lower edge 314 of the left lower side strap 118, the panel lower edge 110 of the panel 106, and the side strap lower edge 314 of the right lower side strap 120, may be knitted. For example, as two or more courses of double knit stitch structures, interlock stitch structure, or any other knit structure that extends between the needle beds.

[0432] The second tensile element 126 may be inlaid with the panel lower edge, e.g., along the entire length of the panel lower edge of the headgear 100. FIG. 59 shows the direction of movement of the yarn carrier inlaying the second tensile element 126 according to the example method. But it will be appreciated that the direction could be reversed in other examples.

[0433] Inlaying the second tensile element 126 into the panel lower edge may be an optional step. The second tensile element 126 may be pulled out from the panel lower edge once the headgear 100 is formed. But forming the headgear 100 with a length of second tensile element 126 initially inlaid into the panel lower edge may allow forming headgear with a relatively longer tensile element, e.g., longer than a width of the knitting machine.

[0434] In second step 5804, the inner layer and the outer layer 208 of the left lower side strap 118, panel 106 (e.g., lower section 206), and the right lower side strap 120 may be knitted. The inner layer and the outer layer may be simultaneously or sequentially knitted on respective front needle bed and back needle bed. The left lower side strap 118, lower section 206 of the panel 106, and right lower side strap 120 may be formed as a flattened tubular structure defining an interior space as indicated by the dashed lines in FIG. 60. The openings 122 may be formed by not transferring yarn between the front needle bed and the back needle bed at ends of the one or more courses. The second tensile element 126 may be inlaid back in the opposite direction between the inner layer and the outer layer 208, within the interior space as shown in FIG. 60. The first tensile element 124 may be inlaid into the headgear 100 between the inner layer and the outer layer, e.g., during knitting of the right lower side strap 120. A loop 6002 may be formed by the second tensile element 126 beyond the distal end of the left lower side strap 118.

[0435] In third step 5806, the side strap upper edges 306 of the left lower side strap 118 and right lower side strap 120 may be knitted, e.g., with one or more courses of a double knit or interlock stitch structure, as shown in FIG. 61. Stitches may be cast off to finish the edges. Alternatively, or additionally, a heat-set yarn may be introduced. Heat may be applied to the heat-set yarn to fuse the knit together and securely seal the side strap. The heat may optionally be applied after the knitting process is completed.

[0436] In fourth step 5808, the central section 204 of the panel 106 may be knitted. The central section 204 may be formed as a flattened tubular structure, e.g., including an inner layer and an outer layer of plain knit structure. The central section 204 may have an interior space which is continuous with the interior space of the lower section 206. Respective ends of the first tensile element 124 and the second tensile element 126 may be secured adjacent the lower section 206 of the panel 106, as shown in FIG. 62. And then fed into the interior space of the central section 204 as it is knitted. The ends may be held in place by the carriers as described below with reference to the sixth step 5812, as well as the interlock stitches of the side strap upper edges 306. The central section 204 may be formed as a flattened tubular structure to provide panel side edges 112.

[0437] In fifth step 5810, guide portions may be formed . A lower guide portion 2104 may be formed, e.g., from one or more double knit, interlock, or rib stitch structures. The double knit stitch structures may be knitted at about a center of the central section 204. Yarn carriers may then carry the first tensile element 124 and the second tensile element 126 in opposite directions across the panel 106. The first tensile element 124 and the second tensile element 126 may be crossed over each other, e.g., to intersect each other above the lower guide portion 2104, as shown in FIG. 63. An upper guide portion 2102 may then be formed. The upper guide portion 2102 may include one or more double knit, interlock, or rib stitches. The upper guide portion 2102 may be formed above the intersection between the first tensile element 124 and the second tensile element 126. A remainder of the panel 106 above the upper guide portion 2102 may then be knitted.

[0438] In sixth step 5812, the side strap lower edges 314 of the left upper side strap 114 and the right upper side strap 116, and the lower edge of the upper section 202 of panel 106, may be knitted. The first tensile element 124 and second tensile element 126 may be held stationary by the respective yarn carriers, e.g., in the locations shown in FIG. 64. The side strap lower edges 314 may be formed by merging an outer layer 208 and inner layer with double knit stitch structures or an interlock stitch structure. The left upper side strap 114, upper section 202, and right upper side strap 116 may be formed as a flattened tubular structure from single knit outer layer 208 and single knit inner layer extending from the panel lower edges.

[0439] In seventh step 5814, the inner layer and the outer layer 208 of the left upper side strap 114, panel 106 (e.g., upper section 202), and the right upper side strap 116 may be knitted. The first tensile element 124 and the second tensile element 126 may be inlaid between the outer layer and the inner layer of the left upper side strap 114 and the right upper side strap 116, respectively, as shown in FIG. 65. Openings 122 may be formed at the free ends of each of the left upper side strap 114 and the right upper side strap 116, e.g., by not transferring yarn between beds at ends of the courses. The first tensile element 124 may emerge from the opening 122 at the free end of the left upper side strap 114. The second tensile element 126 may emerge from the opening 122 at the free end of the right upper side strap 116.

[0440] In eighth step 5816, the side strap upper edges 306 of the left upper side strap 114 and right upper side strap 116, and the panel upper edge 108 of the panel 106, may be knitted, as shown in FIG. 66. The side strap upper edges 306 and panel upper edge 108 may be knitted with a double knit stitch structure or an interlock stitch structure. The panel upper edge 108 and side strap upper edges 306 may join the outer layer 208 and the innerlayer of the upper side straps and the panel, e.g., upper section 202. The panel upper edge 108 and the side strap upper edge 306 may be cast off. Alternatively, of additionally, a heat-set yarn may be introduced. Heat may be applied to fuse the knit together and securely seal the upper side straps.

[0441] A portion of the first tensile element 124 may emerge from the opening 122 of the left upper side strap 114 and optionally loop back into the left upper side strap 114 to be inlaid with the interlock structure or double knit stitch structure of the side strap upper edges 306 of the left upper side strap 114, the panel upper edge 108 of the panel 106, and the right upper side strap 116, as shown in FIG. 66.

[0442] In ninth step 5818, the inlaid portions of the first tensile element 124 and the second tensile element 126 may be pulled out of the double knit stitch structures so that, in this example, free ends of each of the tensile elements emerge from diagonally opposed side straps, with the tensile elements intersecting within the panel 106 as shown in FIG. 67. This step may mitigate or avoid the need for long lengths of the tensile elements hanging from the openings 122 as the headgear 100 is knitted. The additional length of the tensile elements 124, 126 may be beneficial in patient interface assemblies in which the tensile elements are configured to be wound onto a reel, for example.Patient Interface Assembly

[0443] FIG. 68 to FIG. 72 show an example patient interface assembly 6800, and variants.Headgear

[0444] The patient interface assembly 6800 may include a headgear 100. Aside from the differences described below or otherwise apparent from the drawings, the headgear 100 may be similar to the headgear and / or variants described above.

[0445] In some examples, the headgear 100 may be configured to be substantially symmetric about a sagittal plane. The following description of the left side of the headgear 100 may apply equally to the right side of the headgear 100 (with any necessary modifications).

[0446] The headgear 100 may include a crown strap 6802. The crown strap 6802 may be configured to extend over the top of the patient's head, e.g., from a left side of the patient's head to a right side of the patient's head. In some examples, the crown strap 6802 may extend from the left upper side strap 114 to the right upper side strap 116. The crownstrap 6802 may be configured to inhibit or prevent the headgear 100, e.g., upper side straps 114, 116 from slipping down the patient's head. The crown strap 6802 may be configured to inhibit or prevent the headgear 100, e.g., upper side straps 114, 116, from engaging the patient's ears. In some examples, the crown strap 6802 may extend upwardly from the left upper side strap 114 and the right upper side strap 116 in the vicinity of the patient's respective ears, e.g., directly above the patient's respective ears, as shown in FIG. 70. In other examples, the crown strap 6802 may be configured to be at least partially forward or rearward of the patient's ears.

[0447] The crown strap 6802 may be integral with the left upper side strap 114 and / or right upper side strap 116. The crown strap 6802 may be part of the knitted structure of the headgear. In some examples, the crown strap 6802 may be integrally knitted with the left upper side strap 114 and / or the right upper side strap 116.

[0448] In other examples, as shown in FIG. 68, the crown strap 6802 may be non- adjustable. The crown strap 6802 may be formed as a single integral strap. In other examples, the crown strap 6802 may be adjustable.

[0449] In some examples, as shown in FIG. 70, the side portions of the headgear 100 may include a side panel 7002. The side panel 7002 may span between respective portions of the left upper side strap 114 and the left lower side strap 118 (or the right upper side strap and the right lower side strap). In some examples, the (or each) side panel 7002 may be configured to be located entirely forward of the patient's ear. The side panels 7002 may be configured to overlie, e.g., engage, at least part of one or more of the buccal region, zygomatic region, temporal region, parotideomasseteric region, or auricular region of the patient's head, when the headgear 100 is donned.

[0450] In other examples, the headgear 100 may include a pair of side panels in place of the side straps. That is, one or more of the side straps may be omitted.

[0451] As shown in FIG. 70, the headgear 100 may include an ear aperture 7004. The ear aperture 7004 may be defined by one or more of the panel 106, left upper side strap 114, left lower side strap 118, or side panel 7002. In other examples, one or more of the side panel 7002 or the panel 106 may be configured to cover the patient's ear.

[0452] The side panel 7002 may assist in maintaining a spacing between the left upper side strap 114 in the left lower side strap 118. The side panel 7002 may inhibit or prevent at least portions of the left upper side strap 114 and the left lower side strap 118 from moving apart from each other, e.g., the left upper side strap 114 slipping upwards and / orthe left lower side strap 118 slipping downwards. In some examples, the side panel 7002 may inhibit at least portions of the left upper side strap 114 and the left lower side strap 118 from moving towards each other, e.g., the left upper side strap 114 slipping downwards and / or the left lower side strap 118 slipping upwards. In some examples, the side panel 7002 may include a rigid or semi-rigid material configured to impede buckling of the side panel 7002. The rigid or semi-rigid material may be a solid polymer material, for example. The rigid or semi-rigid material may be substantially inextensible, in use. The semi-rigid material may be resilient and / or flexible to conform with the shape of the patient's head. The rigid or semi-rigid material may extend from the left upper side strap 114 to the left lower side strap 118. The rigid or semi-rigid material may be configured to be positioned adjacent one or more of the patient's zygomatic region, parotideomasseteric region, or buccal region. In one example, the rigid or semi-rigid material may be configured to overlie at least the zygomatic region and parotideomasseteric region of the patient's head. The rigid or semi-rigid material may be provided adjacent the ear aperture 7004. The rigid or semi-rigid material may be cushioned, e.g., by one or more layers of fabric, e.g., the inner layer, and / or foam material. Cushioning the rigid or semi-rigid material may improve patient comfort and / or inhibit facial marking. In some examples, the rigid or semi-rigid material may be encapsulated within the side panel 7002.

[0453] In some examples, the side panel 7002 may inhibit the left upper side strap 114 and the left lower side strap 118 from both moving apart and moving towards each other, in use.

[0454] The side panels 7002 may be formed, at least in part, from an elastic material, such as elastane.

[0455] In some examples, one or more of the left upper side strap 114, side panel 7002, or left lower side strap 118 may be configured to engage, e.g., press upon, the patient interface, in use. Such engagement may be configured to aid sealing of the patient interface against the patient's head.

[0456] The headgear 100 may include one or more sleeves as described above. One or more tensile elements, e.g., first tensile element 124 and second tensile element 126, may be provided within the one or more sleeves. In other examples, the headgear 100 may include tensile elements without sleeves.

[0457] In some examples, as shown in FIG. 68 and FIG. 69, the headgear may include a first tensile element 124 mechanically inlaid with the pair of side portions and the rear portion, e.g., left upper side strap 114, panel 106, and right upper side strap 116. And asecond tensile element 126 mechanically inlaid with the pair of side portions and the rear portion, e.g., left lower side strap 118, panel 106, and right lower side strap.

[0458] In some examples, as shown in FIG. 70, the headgear 100 may include a first sleeve 602 mechanically inlaid with a pair of side straps on the same side of the headgear 100. The first sleeve 602 may extend through the left upper side strap 114, panel 106, and left lower side strap 118. The headgear 100 may include a corresponding second sleeve (not shown in FIG. 70) on the right hand side of the headgear.

[0459] In some examples, as shown in FIG. 71, the headgear 100 may include a first sleeve 602 mechanically inlaid with the left upper side strap 114, panel 106 and right lower side strap (not visible in FIG. 71). The headgear 100 may include a second sleeve 2602 mechanically inlaid with the left lower side strap 118, panel 106, and right upper side strap (not visible in FIG. 71). The first sleeve 602 and the second sleeve 2602 may cross over each other in the rear portion of the headgear 100.

[0460] In some examples, as shown in FIG. 72, the headgear 100 may include one or more of a first sleeve 602 mechanically inlaid with the left upper side strap 114, panel 106, and right upper side strap (not visible in FIG. 72), or a second sleeve 2602 mechanically inlaid with the left lower side strap 118, panel 106 and right lower side strap (not visible in FIG. 72).Patient interface

[0461] The example patient interface assembly 6800 includes a patient interface 6810.

[0462] The patient interface 6810 may be a non-invasive interface. In some examples, as illustrated, the patient interface 6810 may be a compact full-face mask. The compact full-face mask may be configured to seal with, or about, the patient's nares and mouth, e.g., without engaging an upper part of the patient's nasal region such as one or more of the nasion, rhinion, or supratip. Such a compact full-face mask may allow the patient to wear spectacles, reduce obstruction of the patient's vision, and / or reduce pressure sores, e.g., when compared with a traditional full-face mask configured to engage the patient's nasion.

[0463] In other examples, the patient interface 6810 may be a full-face mask (e.g., configured to seal about the nasal region and the oral region, optionally engaging the nasion), a nasal mask (e.g., configured to seal about the nasal region, optionally engaging the nasion), a compact nasal mask (e.g., configured to seal about the nares), a nasal pillowsinterface (e.g., including a pair of pillows each configured to seal with a respective one of the patient's nares), a nasal cannula (e.g., including a pair of non-sealing prongs each configured to extend into a respective one of the patient's nares), an oral mask (e.g., configured to seal about, the patient's mouth), an intra-oral interface (e.g., configured to extend into, and seal with and / or about the patient's mouth), or an integral, modular, or juxtaposed combination of any one of a nasal mask, compact nasal mask, nasal pillows interface or nasal cannula with an oral mask or intra-oral interface, for example. In yet other examples, the patient interface may be an invasive interface such as an endotracheal interface or a tracheostomy interface.

[0464] Referring again to FIG. 70, the patient interface 6810 may include a cushion 6812. The cushion 6812 may be formed from an elastomeric material such as liquid silicone rubber (LSR). The cushion 6812 may be injection molded.

[0465] The cushion 6812 may include a nasal sealing portion 6814 configured to seal with and / or around the patient's external nares. The nasal sealing portion 6814 may be configured to seal against the nasal region of the patient's face, e.g., at least an underside of the patient's nose. The nasal sealing portion 6814 may be further configured to seal with one or more of the oral region (e.g., upper lip) or zygomatic region of the patient's face, for example.

[0466] The nasal sealing portion 6814 may include a single nasal aperture through which a flow of respiratory gases may be supplied to both of the patient's nares. In other examples, the nasal sealing portion 6814 may include a pair of nasal apertures through each of which the flow of respiratory gases may be supplied to a respective one of the patient's nares. In one example, the pair of nasal apertures may be defined in part by a columella region of the nasal sealing portion 6814. The columella region may be configured to engage, or seal with, the columella of the patient's nasal region, in use.

[0467] In some examples, the cushion 6812 does not engage, or seal against, one or more of the dorsum, nasion, rhinion, or supratip of the nasal region. In some examples, the cushion 6812 does not engage, or seal against, the orbital region of the patient's head. In some examples, as shown in FIG. 70, one or more of the cushion 6812 or the patient interface 6810 may be configured to be entirely below the patient's orbital region, in use.

[0468] The cushion 6812 may include an oral sealing portion 6816 configured to seal around the patient's mouth. The oral sealing portion 6816 may be configured to seal against at least the oral region of the patient's head. The oral sealing portion 6816 maybe further configured to seal with one or more of the buccal region or the mental region, for example.

[0469] The oral sealing portion 6816 may include a single oral aperture, distinct from the single nasal aperture or pair of nasal apertures, through which the flow of respiratory gases may be supplied to the patient's mouth. In other examples, the cushion 6812 may have a single contiguous aperture configured to encompass the patient's nares and mouth.

[0470] In some examples, the apertures of the nasal sealing portion 6814 and the oral sealing portion 6816 may be in gases communication with a common plenum chamber within the patient interface 6810. In other examples, the aperture or apertures of the nasal sealing portion 6814 may be in gases communication with a nasal plenum chamber, and the aperture of the oral sealing portion 6816 may be in gases communication with an oral plenum chamber. The nasal plenum chamber and the oral plenum chamber may be in gases communication with each other, so that they are each configured to be supplied with the flow of respiratory gases via a single inlet. The nasal plenum chamber and the oral plenum chamber may be defined, in part, by a dividing wall within the patient interface 6810.

[0471] The patient interface 6810 may include a frame 6818. The frame 6818 may be configured to support the cushion 6812. The cushion 6812 and frame 6818 together may form a cushion module. The frame 6818 may, in part, define the common plenum chamber, or one or more of the nasal plenum chamber or oral plenum chamber. The frame 6818 may be relatively rigid compared to the cushion 6812. The frame 6818 may be formed from a polymer material, e.g., a thermoplastic polymer material such as polycarbonate. In other examples, the frame 6818 may be formed from an elastomeric material. An elastomeric frame may be relatively thicker than the nasal sealing portion 6814 and the oral sealing portion 6816. An elastomeric frame may be formed from a different elastomeric material than the nasal sealing portion 6814 and the oral sealing portion 6816. An elastomeric frame may be formed from a material with a different (e.g., higher) Shore A hardness than the nasal sealing portion 6814 and the oral sealing portion 6816.

[0472] In some examples, the cushion 6812 may be permanently coupled with the frame 6818. The cushion 6812 may be overmolded to the frame 6818. The frame 6818 may include a plurality of through-holes or protrusions about its perimeter. The cushion 6812 may be mechanically interlocked with the frame 6818, e.g., the through-holes or protrusions. The cushion 6812 may be chemically bonded with the frame 6818.

[0473] The frame 6818 may include an inlet 6820 configured to receive the flow of respiratory gases from a gases source, e.g., via an inspiratory conduit. The inlet 6820 may be integrally formed as part of the frame 6818. In some examples, the inlet 6820 may have an axis which is substantially vertical, or inclined at an acute angle with respect to the vertical direction.

[0474] The inlet 6820 may be configured to be coupled with a connector, e.g., a swivel connector. The connector may be part of an inspiratory conduit. In some examples, the patient interface 6810 may include a flexible inlet tube 6824, e.g., permanently or removably coupled with the inlet 6820. The inlet tube 6824 may be configured to be coupled with the connector of the inspiratory conduit. The inlet tube 6824 may include a swivel connector at one or more of the distal end or proximal end of the inlet tube. Swivel connectors on the inlet tube 6824 may decouple rotational forces as the inlet tube 6824 and / or inspiratory conduit, e.g., a helically-wound inlet tube, is stretched and / or compressed. The inlet tube 6824 may be more flexible than the inspiratory conduit. In some examples, the inlet 6820 may include, or be configured to couple with, an elbow, e.g., a swivel elbow. The elbow may have one, two, or three degrees of freedom. The elbow and / or inlet 6820 may include one or more of a rotary joint, a pivot joint, an ellipsoid joint, or a spheroid joint.

[0475] The frame 6818 and the cushion 6812, in combination, may at least in part define the common plenum chamber (or one or more of the nasal plenum chamber or oral plenum chamber). In use, the flow of respiratory gases may be received by one or more of the common plenum chamber, nasal plenum chamber, and oral plenum chamber through the inlet 6820. Then supplied to the patient's upper airway through one or more of the nasal aperture, pair of nasal apertures, oral aperture, or single contiguous aperture of the cushion 6812.

[0476] The patient interface 6810, e.g., one or more of the cushion 6812, the frame 6818, or the elbow, may include a vent. The vent may include a one or more vent holes. The vent holes may provide a flow path from an interior of the patient interface 6810 (i.e., the common plenum chamber, nasal plenum chamber, or oral plenum chamber) and ambient air, e.g., for venting expiratory gases from the patient interface 6810. The vent holes may be tapered, e.g., taper in the direction of vent flow (i.e., from an interior of the patient interface 6810 to ambient). In some examples, the vent may include a diffuser. The diffuser may include a porous media. The diffuser may be spaced from an outlet end of each of the vent holes. In some examples, one or more of the vent or the diffuser may be removable from another component of the patient interface 6810. The vent and / or diffusermay be retained on the patient interface 6810 by a vent clip. The vent clip may be configured to be removably coupled with another component of the patient interface 6810, e.g., the frame 6818 or the elbow, with a snap-fit.

[0477] In other examples, the patient interface 6810 does not have a vent. Such a patient interface may be suitable for provision of non-invasive ventilation. The respiratory support system may include a dual-limb breathing circuit. The dual-limb breathing circuit may include an expiratory conduit configured to convey the expiratory gases back to the gases source, e.g., a gases return inlet of a ventilator. Or a separate vent may be coupled with the patient interface 6810, e.g., to the inlet 6820, connector, elbow, or a Y-piece, by a medical professional before the patient interface 6810 is fitted to the patient.

[0478] The patient interface 6810, e.g., one or more of the frame 6818 or the elbow, may include an anti-asphyxiation valve 6822. The anti-asphyxiation valve may be configured to selectively provide a flow path for ambient air into the patient interface 6810, e.g., one or more of the common plenum chamber, nasal plenum chamber, or oral plenum chamber. The anti-asphyxiation valve may include a flap valve. The flap valve may be configured to open if a pressure of the respiratory gases within patient interface 6810 drops below a threshold, e.g., if the gases source fails or the inspiratory conduit is partially or completely occluded.

[0479] In some examples, the frame 6818 may be coupled, e.g., removably coupled, with one or more of the headgear 100 or the one or more tensioners such as the headgear adjustment assembly 5600.

[0480] In other examples, the frame 6818 may be coupled, e.g., removably coupled or permanently coupled, with a bracket, e.g., by snap-fit, friction fit, adhesive, or welding. The bracket may be configured to couple with, e.g., within or about, the inlet 6820. In some examples, the elbow may couple directly with the bracket. In other examples, the elbow may couple directly with the frame 6818, e.g., through an aperture in the bracket. In such examples, the coupling between the elbow and the frame 6818 may be configured, at least in part, to retain the bracket with the frame 6818. Alternatively, the bracket may attach to the frame without being around the inlet. For example, the bracket may be adjacent the inlet, or above the inlet.

[0481] The bracket may be more rigid than the cushion 6812, e.g., at least the nasal sealing portion 6814 and / or the oral sealing portion 6816. In some examples, the bracket may be formed, at least in part, from a thermoplastic polymer such as polycarbonate.

[0482] The bracket may be coupled, e.g., removably coupled, with one or more of the headgear 100 or a headgear adjustment assembly 5600. The bracket may be configured to allow the cushion module, i.e., the combination of the cushion 6812 and frame 6818, to be assembled with and / or disassembled from the bracket (and optionally one or more of the tensioner, elbow, or headgear), as a single unit. Such convenient assembly and disassembly may help facilitate regular cleaning or replacement of the cushion module.

[0483] The patient interface assembly 6800 may include one or more tensioners, e.g., a headgear adjustment assembly 5600 as described above. The headgear adjustment assembly 5600 may be coupled with the tensile elements 124, 126, to allow adjustment of the effective length and / or tension of the tensile elements.

[0484] In some examples, as shown in FIG. 68 to FIG. 72, the headgear adjustment assembly 5600 may be configured to be positioned in front of the patient interface 6810, when the patient interface assembly 6800 is donned. This position may be conveniently adjacent, and between, the openings 122 in the headgear 100, e.g., one or more of the left upper side strap 114, right upper side strap 116, left lower side strap 118, or right lower side strap 120, from which the tensile elements 124, 126 emerge to be wound onto the reel. The headgear adjustment assembly 5600 may be coupled with the frame 6818 or the bracket.

[0485] The headgear adjustment assembly 5600 may be permanently to a bracket. The bracket and headgear adjustment assembly 5600 may be supplied with the headgear 100, e.g., replacement headgear. This may allow for simple replacement of the headgear 100 without the need for engaging the individual tensile elements with the headgear adjustment assembly 5600.

[0486] In other examples, a headgear adjustment assembly 5600 may be located on the headgear 100. In one example, the headgear adjustment assembly 5600 may be coupled with a crown strap 6802. Positioning the headgear adjustment assembly 5600 on the crown strap 6802, e.g., at or near a top of the patient's head, may reduce the likelihood of patient discomfort, e.g., from lying upon the headgear adjustment assembly and / or the headgear adjustment assembly tangling with bedding. In other examples, e.g., for patients who tend to sleep on their side, the headgear adjustment assembly 5600 may be located on the rear portion of the headgear 100.

[0487] The headgear adjustment assembly 5600 may improve usability of the headgear 100 and / or patient interface assembly 6800. The headgear adjustment assembly 5600 may be intuitive to operate, even with impeded vision and / or limited dexterity. Adjustmentscan be made quickly and conveniently. And in at least some examples, the headgear adjustment assembly 5600 may inhibit or prevent overtightening of the headgear.Respiratory support system

[0488] FIG. 73 schematically illustrates an example respiratory support system 7300 which may include headgear 100 and / or a patient interface assembly 6800 as described above.

[0489] The respiratory support system 7300 may be configured to supply a flow of respiratory gases to a patient (not shown), in use. The respiratory support system 7300 may be configured to control a pressure of the flow of respiratory gases. In some examples, the respiratory support system 7300 may be configured to provide positive airway pressure (PAP) therapy, e.g., one or more of continuous positive airway pressure (CPAP) therapy, bi-level positive airway pressure (BPAP) therapy, or automatic positive airway pressure (APAP) therapy. In some examples, the respiratory support system 7300 may be configured to provide non-invasive ventilation (NIV) therapy.

[0490] The respiratory support system 7300 may include a gases source 7302. In some examples, as illustrated, the gases source 7302 may include a blower 7304. The blower 7304 may be configured to generate a flow of respiratory gases from ambient air, e.g., received via an ambient air inlet 7306. The ambient air inlet 7306 may include an air filter 7328 configured to filter particulates from the ambient air.

[0491] The respiratory support system 7300 may include a humidifier 7308. The humidifier 7308 may be configured to heat and humidify the flow of respiratory gases. In some examples, as shown in FIG. 73, the gases source 7302 and humidifier 7308 may be integrated within a single housing 7310. In other examples, the gases source 7302 and humidifier 7308 may be provided in separate housings and coupled by a humidifier supply conduit. The humidifier 7308 may include a humidification chamber 7312 configured to contain a volume of a humidification liquid, e.g., water. The humidification chamber 7312 may be removable. The humidifier 7308 may include a heat source, e.g., a heater plate 7314. The heater plate 7314 may be configured to heat the humidification chamber 7312 by thermal conduction. The humidification chamber 7312 may be removable from the heater plate 7314, e.g., for one or more of filling, cleaning or replacement. In some examples, the humidification chamber 7312 may be positioned outside the housing 7310. In other examples, the humidification chamber 7312 may be positioned within, or at least partially within, the housing 7310, e.g., within a humidifier compartment. The humidifier compartment may be configured to be enclosed by a lid, e.g., by a hinged lid, sliding lid,or rotatable lid. The lid may be secured in a closed position by a latch or thread, for example. The humidifier compartment may be configured to be pressurized by the flow of respiratory gases.

[0492] The respiratory support system 7300 may include an inspiratory conduit 7316. The inspiratory conduit 7316 may convey the flow of respiratory gases towards the patient. In some examples, the inspiratory conduit 7316 may include a conduit heater, e.g., one or more heater wires. The heater wires may be provided be within the lumen of the inspiratory conduit 7316, embedded within a wall of the inspiratory conduit 7316, or wound around the inspiratory conduit 7316, for example. The conduit heater may be configured to inhibit one or more of cooling or condensation of the flow of respiratory gases as the gases pass along the length of the inspiratory conduit 7316.

[0493] In some examples, the respiratory support system 7300 may include an expiratory conduit. The expiratory conduit may convey respiratory gases from the patient to the gases source 7302, e.g., a gases return inlet. The expiratory conduit may include a conduit heater, e.g., one or more heater wires, as described above with respect to the inspiratory conduit 7316.

[0494] The respiratory support system 7300 may include a controller 7318. The controller 7318 may be configured to control operation of at least part of the respiratory support system 7300, e.g., one or more of the gases source 7302, humidifier 7308, conduit heater of the inspiratory conduit 7316, or conduit heater of the expiratory conduit. The controller 7318 may be configured to control one or more of the flow rate, pressure, temperature, or humidity of the flow of respiratory gases.

[0495] The controller 7318 may include one or more sensors configured to sense one or more properties of the respiratory support system 7300, e.g., temperature, flow rate, humidity or pressure.

[0496] The controller 7318 may include one or more processors and a machine-readable medium, e.g., a non-transitory machine-readable medium such as a non-volatile flash memory. The machine-readable medium may be programmed with instructions which, when executed by the one or more processors, cause the respiratory support system 7300, or any one or more components of the respiratory support system 7300, to operate as described.

[0497] The respiratory support system 7300 may include a patient interface assembly 6800. The patient interface assembly 6800 may include a patient interface 6810 and a headgear 100.

[0498] The patient interface 6810 may be configured to receive the flow of respiratory gases from the gases source 7302, e.g., via the humidifier 7308 and the inspiratory conduit 7316. And deliver the flow of respiratory gases to the patient's airway, e.g., via one or more of the patient's nose or mouth.

[0499] The patient interface 6810 may include a cushion. The cushion may be formed, at least in part, from an elastomeric material such as liquid silicone rubber.

[0500] The patient interface 6810 may include a frame. The frame may be more rigid than the cushion. In some examples, the frame may be formed, at least in part, from a thermoplastic polymer such as polycarbonate. The cushion and frame in combination may be configured to form a plenum chamber when the patient interface assembly is donned by the patient. The frame may include an inlet configured to receive the flow of respiratory gases, in use.

[0501] In some examples, the patient interface 6810 may include a bracket 7320. The bracket may be configured to be removably coupled with the frame. The bracket 7320 may include one or more headgear connectors configured to couple with the headgear 4, e.g., side straps or clips. In some examples, the frame may alternatively, or additionally, include one or more headgear connectors. The bracket 7320 may include, or be configured to be coupled with, a headgear adjustment assembly. The headgear adjustment assembly may be configured to couple with the tensile elements of the headgear 100.

[0502] In some examples, the bracket 7320 may include a forehead support 7322. The forehead support 7322 may be configured to engage, e.g., directly engage, a frontal region of the patient's head. In other examples, the bracket 7320 does not include a forehead support. In yet other examples, the bracket 7320 may be omitted.

[0503] The patient interface 6810, e.g., the bracket 7320, may include an elbow 7324 as described above. The elbow 7324 may be configured to couple with a connector 7326 of the inspiratory conduit 7316 to receive the flow of respiratory gases from the gases source 7302.

[0504] The headgear 100 may be configured to secure the patient interface 6810 in position on the patient's head. The headgear 100 may be configured to couple with thepatient interface 6810 with a two-point connection or, as shown in FIG. 73, a four-point connection, for example. In some examples, the headgear 100 may include upper side straps configured to couple with the forehead support. The upper side straps may be configured to extend rearwardly from the forehead support, above the patient's eye and ear to a rear portion of the headgear. In other examples, the upper side straps may be configured to extend upwardly and rearwardly from the patient interface, between the patient's eye and ear. The headgear 100 may include lower side straps configured to extend rearwardly from the patient interface 6810, below the patient's ear, to the rear portion of the headgear 100.

[0505] The headgear 100 may be configured to removably couple with the patient interface 6810, e.g., by one or more of clips, magnets, or hook-and-loop fasteners. The headgear 100 may be configured to couple with one or more of the bracket, the frame, or the cushion.

[0506] In some examples, the headgear 100 may be any one of the examples or variants of the headgear described above, or include any one or more features of that headgear.Glossary

[0507] "Mechanically inlaid," "laid-in," or simply "inlaid" refers to the process by which an inlaid element is incorporated into a knitted fabric as it is knitted, and / or the resulting structure of the inlaid element within, or through, the knitted fabric. The inlaid element may be non-knitted. "Inlaid fabric" refers to a fabric including a base structure of a knitted yarn that holds an inlaid element incorporated into the base structure as it was knitted. In some examples, the inlaid element may be unable to be knitted, and / or the inlaid element may provide properties which are challenging or impossible to achieve from the knit alone.

[0508] "Complete garment process" refers to a method by which an entire product, or at least the knitted portion of the product, is knitted in one continuous, integrated manufacturing operation, rather than by separately creating and subsequently joining multiple knitted components. The process typically involves forming the product in a seamless or near-seamless manner. A "complete garment" or "complete headgear" is a product resulting from such a process, requiring little or no post-production assembly (only adding a headgear adjustment assembly, for example), thereby reducing production time, material waste and labor.

[0509] Unless the context clearly requires otherwise, throughout the description and claims the terms "comprising," "including," "having," and the like, are to be construedinclusively rather than exclusively. That is, such terms are to be construed in the sense of "including, but not limited to" rather than "consisting solely of." Similarly, the terms "a," "the," and singular nouns are to be construed inclusively rather than exclusively.

[0510] The term "substantially," unless otherwise defined or apparent from the context, is intended to encompass variations, e.g., of up to ± 10%, ±5% or ±1% in number, length, or equality, and so on.

[0511] References to "first," "second," and so on, is for convenience only. Unless explicitly stated or otherwise apparent from the context, such references are not intended to imply any specific number or order. Or the need for any other similar succeeding or preceding features. For example, reference to a "second" feature is not intended to imply that a "first" feature, or two such features, are necessarily essential.

[0512] Directional or positional terms such as "upper," "lower," "left," "right," "above," "below," "top," "bottom" and the like, are used in a relative sense rather than an absolute sense, and with reference to the orientations illustrated in the accompanying drawings. The drawings generally depict the subject in an upright orientation, but the headgear and / or patient interface assembly, in use, may be oriented in a generally horizontal orientation corresponding to with the reclined, supine, or lateral recumbent position of the patient.

[0513] Unless the context requires otherwise, references to one or more of a pair of features, alone or listed with other features, is intended to encompass both: i) one of the pair of features, and ii) both of the pair of features. For example, references to one or more of the rear portion or the pair of side portions of the headgear is intended to encompass any of: i) the rear portion alone, II) one of the pair of side portions alone, ill) both of the pair of side portions, iv) the rear portion in combination with one of the pair of side portions, and v) the rear portion in combination with both of the pair of side portions.LISTING OF DRAWING ELEMENTS100 headgear102 rear portion104 side portion106 panel108 panel upper edge110 panel lower edge112 panel side edge114 left upper side strap116 right upper side strap118 left lower side strap120 right lower side strap122 opening124 first tensile element126 second tensile element128 joint 02 upper section 04 central section206 lower section208 outer layer302 distal region304 proximal region306 side strap upper edge308 heat-set yarn310 distal end312 proximal end314 side strap lower edge502 isolator504 inner layer602 first sleeve1102 stitch structure1104 interior space1302 yarn1304 needle bed1306 needle bed1308 needle1310 loop1402 yarn1404 needle bed1406 needle bed1408 needle1410 loop1412 first pass direction1414 second pass direction1502 yarn1504 needle bed1506 needle bed1508 needle1510 loop1602 yarn1604 needle bed1606 needle bed1608 needle1610 loop1612 loop1902 upper guide portion1904 lower guide portion1906 pathway2002 left crown strap portion2004 right crown strap portion2006 sagittal plane2008 left half2010 right half2202 protrusion2302 second sleeve3002 elongation assembly4902 left curved portion4904 right curved portion5102 inner edge5104 outer edge5106 first region5108 second region5110 third region5112 tension gradient5202 resilient member5204 clip5300 headgear adjustment assembly5302 cap5304 actuator5306 outer part5308 inner part5310 biasing member5312 torque transfer element5314 rotatable member5316 base5502 first step5504 second step5506 third step5508 fourth step5510 fifth step5512 sixth step5514 seventh step5516 eighth step5518 ninth step5702 loop6500 patient interface assembly6502 crown strap6510 patient interface6512 cushion6514 nasal sealing portion6516 oral sealing portion6518 frame6520 inlet6522 anti-asphyxiation valve6524 inlet tube6702 side panel6704 ear aperture7000 respiratory support system7002 gases source7004 blower7006 ambient air inlet7008 humidifier7010 housing7012 humidification chamber7014 heater plate7016 inspiratory conduit7018 controller7020 bracket7022 forehead support7024 elbow7026 connector7028 air filter7102 elongate band7202 spool7400 knitting program7402 first row7404 second row7406 third row7408 fourth row7410 first stitch7412 second stitch7414 third stitch7416 fourth stitch

Claims

CLAIMSWhat is claimed is:

1. A headgear for use in securing a patient interface in a therapeutic position on a head of a patient for provision of respiratory support, the headgear comprising : a rear portion configured to engage a rear of the head of the patient, in use; a pair of side portions extending from the rear portion, the pair of side portions configured to engage respective sides of the head of the patient; and an inlaid element, the inlaid element mechanically inlaid with one or more of the rear portion or the pair of side portions.

2. The headgear of claim 1, the inlaid element comprising a tensile element, the tensile element configured to be coupled with a tensioner configured to control a tension in the headgear.

3. The headgear of claim 2, wherein the tensile element is knitted.

4. The headgear of claim 1, the inlaid element comprising a sleeve, the headgear comprising a tensile element received within the sleeve, the tensile element configured to be coupled with a tensioner configured to control a tension in the headgear.

5. The headgear of claim 4, the sleeve comprising a hollow tubular structure, the tensile element slidably received within the hollow tubular structure.

6. The headgear of claim 5, wherein the sleeve is knitted.

7. The headgear of any one of claims 4 to 6, further comprising the tensioner.

8. The headgear of any one of claims 2 to 7, the tensioner comprising: an automatic tensioner configured to automatically adjust the headgear to an appropriate size and / or tension when the headgear is donned by the patient; a headgear adjustment assembly operable, e.g., rotatable, by the patient to adjust an effective length of the tensile element and / or to control a tension in the headgear; ora resilient member configured to control the tension in the headgear by elastic deformation.

9. The headgear of any one of claims 1 to 8, comprising a further inlaid element, the further inlaid element comprising: a shaping element; and / or a cushioning element.

10. The headgear of claim 9, wherein the cushioning element is knitted.

11. The headgear of any one of claims 1 to 10, the inlaid element comprising a curved path when the headgear is laid flat.

12. The headgear of any one of claims 1 to 11, the inlaid element emerging from a distal end of one or each of the pair of side portions.

13. The headgear of any one of claims 1 to 12, wherein movement of the inlaid element with respect to one or more of the rear portion and the pair of side portions is: relatively uninhibited in a longitudinal direction of the inlaid element; and / or relatively inhibited in a lateral direction.

14. The headgear of any one of claims 1 to 13, wherein the inlaid element is anchored to one or more of the rear portion or the pair of side portions.

15. The headgear of any one of claims 1 to 13, wherein the inlaid element is configured to move within one or more of the rear portion or the pair of side portions.

16. The headgear of any one of claims 1 to 15, wherein the inlaid element is: relatively inextensible compared to one or more of the rear portion or the pair of side portions; and / or substantially inextensible when subjected to tensile forces typically encountered during normal use of headgear in a respiratory support system.

17. The headgear of any one of claims 1 to 16, one or more of the rear portion or the pair of side portions comprising a knit structure, the knit structure preferably comprising :an inner layer configured to engage the head of the patient when the headgear is donned by the patient; and an outer layer configured to face outwardly when the headgear is donned by the patient, wherein an interior space is formed between the inner layer and the outer layer.

18. The headgear of claim 17, the inlaid element is mechanically inlaid: through the inner layer; through the outer layer; and / or within the interior space.

19. The headgear of claim 18, wherein the inner layer is joined with the outer layer by a knit structure, e.g., a double knit stitch structure, an interlock stitch structure, or a rib stitch structure.

20. The headgear of any one of claims 1 to 19, one or more of the rear portion or the pair of side portions comprising a moisture absorbent yarn or a wicking yarn.

21. The headgear of any one of claims 1 to 20, one or more of the rear portion or the pair of side portions comprising a heat-set yarn.

22. The headgear of any one of claims 1 to 21: the rear portion comprising a panel; and / or the pair of side portions comprising: a left upper side strap configured to pass above a left ear of the patient, and a right upper side strap configured to pass above a right ear of the patient; and / or a left lower side strap configured to pass below a left ear of the patient, and a right lower side strap configured to pass below a right ear of the patient.

23. The headgear of claim 22, the left upper side strap configured to pass below a left eye of the patient, and the right upper side strap configured to pass below a right eye of the patient.

24. The headgear of any one of claims 1 to 23, the inlaid element mechanically inlaid with:the rear portion and each of the pair of side portions, e.g. : a left upper side strap, the rear portion, and a right lower side strap; a right upper side strap, the rear portion, and a left lower side strap; the left upper side strap, the rear portion, and the right upper side strap; or the left lower side strap, the rear portion, and the right lower side strap; or the rear portion and one of the pair of side portions, e.g. : the left upper side strap, the rear portion, and the left lower side strap; or the right upper side strap, the rear portion, and the right lower side strap.

25. The headgear of claim 24, comprising: a first inlaid element mechanically inlaid with the left upper side strap, the rear portion, and the right lower side strap; and a second inlaid element mechanically inlaid with the right upper side strap, the rear portion, and the left lower side strap.

26. The headgear of claim 24, the inlaid element mechanically inlaid with the left upper side strap, the rear portion, and the right upper side strap.

27. The headgear of claim 26, comprising a second inlaid element mechanically inlaid with the left lower side strap, the rear portion, and the right lower side strap.

28. The headgear of any one of claims 1 to 27, one or more of the rear portion or the pair of side portions comprising a flattened tubular structure.

29. The headgear of claim 28, the rear portion comprising a panel, the panel comprising an upper section, a central section, and a lower section, one or more of the upper section, the central section, or the lower section comprising a flattened tubular structure.

30. The headgear of claim 28 or 29, the left upper side strap, the upper section, and the right upper side strap together comprising a continuous flattened tubular structure; and / orthe left lower side strap, the lower section, and the right lower side strap together comprising a continuous flattened tubular structure.

31. The headgear of any one of claims 1 to 30, one or more of the pair of side portions comprising a knitted strap, the knitted strap comprising a distal region distal of the rear portion and a proximal region proximal to the rear portion, the distal region comprising a first yarn and the proximal region comprising a second yarn, wherein the first yarn is different to the second yarn.

32. The headgear of claim 31, wherein the first yarn, e.g., elastane, is more extensible or more elastic than the second yarn, e.g., nylon.

33. The headgear of claim 31 or 32, wherein the distal region is formed predominantly or entirely from the first yarn, and the proximal region is formed predominantly or entirely from the second yarn.

34. The headgear of any one of claims 1 to 33, the inlaid element comprising a first tensile element and the headgear further comprising a second tensile element.

35. A headgear for use in securing a patient interface in a therapeutic position on a head of a patient for provision of respiratory support, the headgear comprising : a rear portion configured to engage a rear of the head of the patient; a pair of side portions extending from the rear portion, the pair of side portions configured to engage respective sides of the head of the patient; and one or more tensile elements each configured to be coupled with a tensioner configured to control an effective length and / or tension of the one or more tensile elements, wherein one or more of the rear portion and the pair of side portions comprise a knit structure, and the one or more tensile elements are mechanically inlaid with the knit structure.

36. A headgear for use in securing a patient interface in a therapeutic position on a head of a patient for provision of respiratory support, the headgear comprising : a rear portion configured to engage a rear of the head of the patient;a pair of side portions extending from the rear portion, the pair of side portions configured to engage respective sides of the head of the patient; one or more sleeves each coupled with one or more of the rear portion or the pair of side portions; and one or more tensile elements extending through the one or more sleeves, the one or more tensile elements configured to be coupled with one or more tensioners configured to control an effective length and / or tension of the one or more tensile elements.

37. The headgear of claim 36, wherein one or more of the rear portion or the pair of side portions comprise a knit structure, and the one or more sleeves are mechanically inlaid with the knit structure.

38. The headgear of claim 36 or 37, wherein the one or more sleeves are knitted with one or more of the rear portion or the pair of side portions as part of a complete garment process.

39. The headgear of claim 36 or 37, wherein the one or more sleeves comprise a knitted sleeve.

40. The headgear of any one of claims 36 to 39, wherein the one or more tensile elements comprise a knitted tensile element.

41. A headgear for use in securing a patient interface in a therapeutic position on a head of a patient for provision of respiratory support, the headgear comprising: a rear portion configured to engage a rear of the head of the patient; and a pair of side portions extending from the rear portion, the pair of side portions configured to engage respective sides of the head of the patient, one or more of the rear portion and the pair of side portions comprising a curved portion, the curved portion knitted with a plurality of courses, the curved portion comprising: a first region comprising one or more of the plurality of courses; and a second region adjacent to the first region, the second region comprising one or more of the plurality of courses, wherein one or more of a yarn tension or agauge of the plurality of courses is varied between the first region and the second region.

42. The headgear of claim 41, comprising a third region adjacent to the second region, the third region comprising one or more of the plurality of courses, wherein one or more of the yarn tension or the gauge of the plurality of courses is varied between the second region and the third region.

43. The headgear of claim 42, wherein one or more of the yarn tension or the gauge of the plurality of courses is varied between each of the first region, the second region, and the third region.

44. The headgear of any one of claims 41 to 43, wherein the yarn tension of the plurality of courses is greater: in the first region than in the second region and / or the third region; and / or in the second region than the third region.

45. The headgear of any one of claims 41 to 44, wherein the gauge of the plurality of courses is greater: in the second region than in the first region; and / or in the third region than in the second region and / or the first region.

46. The headgear of any one of claims 41 to 45, the plurality of courses knitted at: half gauge or less in the first region, and full gauge in the second region; or quarter gauge or less in the first region, half gauge or less in the second region, and full gauge in the third region.

47. The headgear of any one of claims 41 to 46, comprising one or more inlaid elements mechanically inlaid with one or more of the rear portion and the pair of side portions, e.g., the curved portion.

48. The headgear of claim 47, the one or more inlaid elements comprising one or more tensile elements each configured to be coupled with one or more tensioners configured to control an effective length and / or a tension of the one or more tensile elements.

49. The headgear of any one of claims 41 to 48, wherein one or more of the rear portion or the pair of side portions is knitted in a complete garment process.

50. The headgear of claim 49, wherein one or more of the rear portion or the pair of side portions is knitted in a complete garment process with the inlaid element I one or more tensile elements.

51. The headgear of claim 49 or 50, wherein each of the rear portion and the pair of side portions are knitted together in a complete garment process.

52. A patient interface assembly for provision of respiratory support to a patient, the patient interface assembly comprising : a patient interface configured to receive a flow of respiratory gases and supply the flow of respiratory gases to the patient; the headgear according to any one of claims 1 to 51, the headgear configured to secure the patient interface in a therapeutic position on the head of the patient; and one or more tensioners configured to cooperate with the one or more inlaid elements and / or the one or more tensile elements to control a tension in the headgear.

53. The patient interface assembly of claim 52, the headgear comprising one or more tensile elements, and the one or more tensioners comprising a headgear adjustment assembly operable, e.g., rotatable, to adjust an effective length and / or a tension of the one or more tensile elements.

54. The patient interface assembly of claim 52 or 53, the headgear adjustment assembly comprising : a rack-and-pinion or a reel, the rack-and-pinion or reel coupled with the one or more tensile elements; a rotatable dial coupled with the rack-and-pinion or reel and operable to rotate the rack-and-pinion or reel in a first direction to adjust one or more of an effective length or a tension of the one or more tensile elements.

55. The patient interface assembly of claim 54, the headgear adjustment assembly comprising :a locking mechanism configured to inhibit rotation of the rack-and-pinion or the reel in a second direction; and a release mechanism configured to selectively and at least partially disengage the locking mechanism so that rotation of the rack-and-pinion or the reel in the second direction is relatively uninhibited.

56. The patient interface assembly of claim 52, the headgear comprising one or more tensile elements, and the one or more tensioners comprising one or more resilient members configured to control the tension in the one or more tensile elements by elastic deformation.

57. The patient interface assembly of any one of claims 52 to 56, the patient interface assembly comprising a compact full-face mask configured to seal with, or about, the patient's nares and mouth, e.g., without engaging an upper part of the patient's nasal region such as one or more of the patient's nasion, rhinion, or supratip.

58. The patient interface assembly of any one of claims 52 to 57, the patient interface comprising: a frame; a cushion, the cushion coupled with the frame, e.g., permanently coupled by overmolding; and a bracket, the bracket permanently or removably coupled with the frame and the one or more tensioners.

59. A respiratory support system for provision of respiratory support to a patient, the respiratory support system comprising : a gases source configured to supply a flow of respiratory gases; an inspiratory conduit configured to receive and convey the flow of respiratory gases from the gases source; and the patient interface assembly according to any one of claims 52 to 58, the patient interface assembly configured to receive the flow of respiratory gases from the inspiratory conduit and supply the flow of respiratory gases to the patient.

60. A method for forming at least a portion of a headgear configured for use in securing a patient interface in position on a head of a patient for provision of respiratory support, the method comprising : knitting one or more of: a rear portion configured to engage a rear of the head of the patient; or a side portion configured to engage a side of the head of the patient; and mechanically inlaying one or more inlaid elements with one or more of the rear portion and the side portion as it is knitted.

61. The method of claim 60, the one or more inlaid elements comprising one or more tensile elements, the one or more tensile elements each configured to be coupled with one or more tensioners to control a tension in the headgear.

62. The method of claim 60, the one or more inlaid elements comprising one or more sleeves, the one or more sleeves configured to receive one or more tensile elements, the tensile elements each configured to be coupled with one or more tensioners to control a tension in the headgear.

63. The method of claim 62, comprising mechanically inlaying the one or more sleeves with one or more of the rear portion and the pair of side portions, with the one or more tensile elements in situ within the one or more sleeves.

64. The method of claim 62, comprising : mechanically inlaying the one or more sleeves with one or more of the rear portion and the pair of side portions; and inserting the one or more tensile elements into the one or more sleeves.

65. The method of any one of claims 61 to 64, the method comprising coupling the one or more tensile elements with the one or more tensioners, e.g., by winding a tensile element onto a reel of a headgear adjustment assembly.

66. The method of any one of claims 60 to 65, the one or more inlaid elements each being carried by a yarn carrier of a knitting machine.

67. The method of any one of claims 60 to 66, comprising :inlaying at least one of the one or more inlaid elements along an edge, preferably an entirety of the edge, of the headgear; and pulling the at least one of the one or more inlaid elements out from the edge.

68. The method of any one of claims 60 to 67, comprising simultaneously knitting an inner knitted element and an outer knitted element.

69. A method for forming at least a portion of a headgear configured for use in securing a patient interface in a therapeutic position on a head of a patient for provision of respiratory support, the method comprising: knitting a first region, the first region comprising one or more courses knitted with one or more of: a first yarn tension; and / or a first gauge; and knitting a second region adjacent to the first region, the second region comprising one or more courses knitted with one or more of: a second yarn tension different to the first yarn tension; and / or a second gauge different to the first gauge.

70. The method of claim 69, comprising: knitting a third region adjacent to the second region, the third region comprising one or more courses knitted with one or more of: a third yarn tension different to the first yarn tension and the second yarn tension; and / or a third gauge different to the first gauge and the second gauge.

71. The method of claim 69 or 70, wherein: the first yarn tension is greater than the second yarn tension; and / or the second yarn tension is greater than the third yarn tension.

72. The method of any one of claims 69 to 71, wherein: the third gauge is greater than the second gauge; and / or the second gauge is greater than the first gauge.

73. The method of any one of claims 69 to 72, wherein: the second gauge is a full gauge and the first gauge is a half gauge; or the third gauge is a full gauge, the second gauge is a half gauge, and the first gauge is a quarter gauge.

74. A headgear configured for use in securing a patient interface in a therapeutic position on a head of a patient for provision of respiratory support, the headgear formed, at least in part, according to the method of any one of claims 60 to 67.

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