Headgear for patient interface

Abstract

To provide an improved type of headgear.SOLUTION: A headgear for a patient interface includes at least one headgear member, and a pair of flexible joints adapted to connect said headgear member or headgear members to a patient interface and / or a pair of flexible joints connecting the headgear member to adjacent headgear members. Each flexible joint allows free relative movement between one or more headgear members and the patient interface or between the headgear member and the adjacent headgear members.SELECTED DRAWING: Figure 2A

Description

[Technical field]

[0001] The present disclosure relates generally to headgear for patient interfaces such as face masks, nasal masks, or nasal cannulas. [Background technology]

[0002] Patients may lose respiratory function during anesthesia or sedation, or more generally during a medical procedure. Prior to a medical procedure, the patient may be pre-oxygenated by a medical professional to a state of oxygen saturation reserve, and this pre-oxygenation and CO2 flushing / washout may be performed using high-flow therapy via a nasal cannula or other patient interface.

[0003] The patient interface may be held in place on the patient's face by headgear having a head strap that extends around the patient's or user's head to position and hold the patient interface in the correct position to provide respiratory gas to the patient. During application or removal of a nasal cannula or patient interface to a conscious or sedated patient, it may be necessary for the medical professional to manipulate the position of the patient's head to apply or remove head straps or the like. This may in turn impair the patient's posture and / or comfort to some extent, cause awkward or uncomfortable mechanical loads for the medical professional, disturb the patient's hairnet, and / or cause the duration of the medical procedure to be longer.

[0004] Furthermore, elastic and / or size-adjustable head straps may present disadvantages. It may be difficult for a medical professional to grasp or adjust the head strap - especially with gloved hands. When attempting to grasp an elastic head strap, the medical professional may try to pull the head strap away from the patient's head by slipping their fingers between the head strap and the patient's head, or pinch the head strap, or may drag the head strap over the patient's hair and skin. As a result, the medical professional may inadvertently push aside the patient's hair net or pull on the patient's hair or skin, or cause discomfort.

[0005] Where references are made in this specification to patents, other external documents, or other sources, this is generally for the purpose of providing material to explain features of the present invention. Unless specifically indicated otherwise, the reference to such external documents should not be construed as an admission in any jurisdiction that such documents, or such sources, are prior art or form part of the general knowledge common to the art. Summary of the Invention [Problem to be solved by the invention]

[0006] It is an object of the embodiments disclosed herein to provide improved headgear that may go at least some way towards addressing one or more of the above-mentioned disadvantages or provide a useful option for industry or the public. [Means for solving the problem]

[0007] When applying and removing the patient interface from the patient, it is desirable to avoid moving the patient's head and disturbing the patient's hairnet, as well as to improve handling and positioning of the patient interface.

[0008] According to at least one first aspect of the presently disclosed embodiment, the headgear comprises: At least one headgear member; and a pair of flexible joints adapted to connect the one or more headgear members to a patient interface, and / or a pair of flexible joints connecting the headgear members to a plurality of adjacent headgear members; Including, Each flexible joint allows for free relative movement between one or more headgear members and the patient interface, or between a headgear member and a number of adjacent headgear members, in at least two degrees of freedom.

[0009] According to at least one second aspect of the presently disclosed embodiments, the headgear comprises: At least one headgear member; and a pair of flexible joints adapted to connect the one or more headgear members to a patient interface, and / or a pair of flexible joints connecting the headgear members to a plurality of adjacent headgear members; Including, Each flexible joint allows relative free movement between one or more headgear members and a patient interface, or between a headgear member and a number of adjacent headgear members.

[0010] With respect to either or both of the first or second aspect, the following additional features or embodiments are provided:

[0011] In some embodiments, the flexible joint allows free relative movement between one or more headgear members and the patient interface, or between a headgear member and multiple adjacent headgear members, in at least two degrees of freedom.

[0012] In some embodiments, the flexible joint allows free relative movement between one or more headgear members and the patient interface, or between a headgear member and multiple adjacent headgear members, in at least one degree of freedom.

[0013] In some embodiments, the flexible joint is capable of stretching (which may be longitudinally or in a direction along at least one headgear member) to permit free relative movement between one or more headgear members and a patient interface, or between a headgear member and multiple adjacent headgear members.

[0014] In some embodiments, each flex joint includes a hinge, which may be a living hinge.

[0015] In some embodiments, the flexible joints are adapted to bend or fold transversely to a longitudinal axis of the end portions of said headgear members.

[0016] In some embodiments, the flexible joint is or includes a unitary member.

[0017] In some embodiments, the flex joint is a member formed from a soft, flexible material.

[0018] In some embodiments, the flexible joint is an elastomeric member.

[0019] In some embodiments, the flexible joint is a hollow or tubular member.

[0020] In some embodiments, the flexible joint, or at least one headgear member, comprises a connecting portion or connecting arrangement.

[0021] In some embodiments the connecting portion or connecting arrangement is configured to provide a connection with one or more of: an interface (or part of an interface), an arm adapted to connect to or form part of a patient interface.

[0022] In some embodiments the connecting portion or connecting arrangement is configured to provide a pivotal connection.

[0023] In some embodiments, the connecting portion or connecting arrangement includes a recess or aperture configured to receive a protrusion or boss, which may be located on the interface or part of the interface, and the recess or aperture may be located on the flexible joint.

[0024] In some embodiments, the connecting portion or connecting arrangement includes a protrusion or boss configured to be received by a recess or aperture, and the protrusion or boss may be located in the flexible joint and the recess or aperture may be located in the interface or part of the interface.

[0025] In some embodiments, at least one headgear member is integral with the flexible joint.

[0026] In some embodiments, the headgear and the interface, or a part of the interface, or an arm adapted to connect to or form part of the interface, may be integrally formed.

[0027] In some embodiments, the flexible joints deform elastically (without permanent deformation) under conditions of use.

[0028] In some embodiments, the flexible joint allows rotation of the headgear member relative to an adjacent headgear member about a longitudinal axis of the end portion of the headgear member attached to the adjacent headgear member.

[0029] In some embodiments, the headgear members are movably mounted to flexible joints to move relative to adjacent headgear members along the longitudinal axis of the headgear members.

[0030] In some embodiments, the headgear members are telescopically attached to the flexible joints.

[0031] In some embodiments, the headgear members are telescopically received in end portions of the flexible joints.

[0032] In some embodiments, the flexible joint includes at least one passageway (the flexible joint may be or may include a hollow or tubular member), and the at least one passageway is configured to allow a headgear member to pass therethrough.

[0033] In some embodiments, the headgear members are configured to move or slide in at least one passageway.

[0034] In some embodiments, the headgear member includes at least one stop that limits movement of the headgear member relative to the flexible joint and / or the at least one passageway, and the at least one stop may be located at an end of the headgear member.

[0035] In some embodiments, at least one stop comprises: i bump ii Recess iii. Barbed ends iv. Optionally, a local increase or decrease in thickness or cross-sectional area of ​​the headgear member relative to the size of at least one passageway. Contains one or more of the following:

[0036] In some embodiments, the headgear member includes one or more of a first stop and / or a second stop, the first stop providing a first limit of movement of the headgear member relative to the flexible joint and / or at least one passageway, and the second stop providing a second limit of movement of the headgear member relative to the flexible joint and / or at least one passageway.

[0037] In some embodiments, at least one headgear member is releasably attachable or connectable and removable or disconnectable to an adjacent headgear member and / or flexible joint.

[0038] In some embodiments, an end of at least one headgear member extends past or beyond the flexible joint.

[0039] In some embodiments, the headgear comprises at least one pair of said flexible joints, and each flexible joint of the pair engages a respective side of the user's head during use.

[0040] In some embodiments, the elastic modulus of at least one of the headgear members is at least about 0.5 GPa, or at least about 1 GPa, or at least about 1.5 GPa, or at least about 1.8 GPa, or at least about 2 GPa, or at least about 3 GPa.

[0041] In some embodiments, the elastic modulus of at least one of the headgear members is at least about 1 GPa, or at least about 1.5 GPa, or at least about 1.8 GPa, or at least about 2 GPa.

[0042] In some embodiments, the flexible joints are formed from a material with a modulus of elasticity of less than about 0.2 GPa, or less than about 0.1 GPa, or less than about 0.06 GPa.

[0043] In some embodiments, at least one of the headgear members is formed from a hard, resilient material and the flexible joint is formed from a soft, flexible material, the modulus of elasticity of the hard, resilient material being many times greater than the modulus of elasticity of the soft, flexible material.

[0044] In some embodiments, the modulus of elasticity of the hard resilient material is at least 10 times that of the soft flexible material, or at least 10, or 20, or 40, or 100, or 200 times that of the soft flexible material.

[0045] In some embodiments, the headgear includes at least one positioning tab connected to at least one said headgear member.

[0046] In some embodiments, the headgear includes at least one positioning tab or member connected to or forming part of at least one said headgear member.

[0047] In some embodiments, at least one positioning tab or member allows a user to apply and remove said headgear.

[0048] In some embodiments, the positioning tab or member is provided by or includes a substantially U-shaped portion.

[0049] In some embodiments, the positioning tab or member comprises: a first portion that, in use, extends outwardly from the headgear member (e.g., outwardly from the user's head); a second portion that, in use, extends toward the headgear member (e.g., toward the user's head); Including, The positioning tab or positioning member may include an intermediate portion located intermediate the first and second portions, the intermediate portion extending substantially parallel to the headgear member (e.g. parallel to the user's head) during use.

[0050] In some embodiments, at least one positioning tab or member is integrally formed with said headgear member.

[0051] In some embodiments, the headgear includes a pair of engagement portions, each engagement portion configured to engage the side of a user's head during use.

[0052] In some embodiments, the pair of flexible joints provide or include an engagement portion.

[0053] In some embodiments, the pair of flexible joints and / or at least one headgear member provide or include an engagement portion.

[0054] In some embodiments, the engagement portion comprises a textured surface, which may include one or more of: a knurled portion, a corrugated surface, a ribbed surface, a roughened surface, or may include micro- or nano-projections.

[0055] In some embodiments the headgear comprises: a resilient headband shaped to fit over a user's head with each end of the headband positioned on a respective side of the user's head; a pair of arms, each arm attached to a resilient headband, each arm adapted to connect to or be part of a patient interface; and Each arm is attached to the headband by a flex joint that allows the arm to move freely relative to the headband in at least two degrees of freedom.

[0056] In some embodiments, each arm is attached to an end or end portion of the headband.

[0057] In some embodiments, each arm is a resilient arm.

[0058] In some embodiments, the resilient headband is shaped to fit over the user's head, with each end of the headband positioned at and biased or biased against a respective side of the user's head.

[0059] In some embodiments, in the undeflected condition, the distance between the ends of the headband is less than the width of the user's head, such that flexing of the headband to fit the user's head biases the ends of the headband against the sides of the user's head.

[0060] In some embodiments, the headband is shaped to fit over the top of the user's head.

[0061] In some embodiments, the headband includes a central portion and one or more end portions, the one or more end portions being positioned at the or each side of the user's head, and the central portion may be angled relative to the one or more end portions to fit around the back of the user's head during use.

[0062] In some embodiments, the headband has a central portion and two end portions, the central portion being relatively stiff or stiffer or less flexible than the end portions.

[0063] In some embodiments, the central portion has a larger cross-sectional area than the end portions.

[0064] In some embodiments, the central portion is made of a first material and the end portions are made of a second material, the first material being relatively stiff or stiffer or less flexible than the second material.

[0065] In some embodiments the headgear includes a second headband.

[0066] In some embodiments, the second headband includes an elastic strap or band, which may be elastic and / or stretchable and / or extensible.

[0067] In some embodiments, the second headband may be engageable with the back of the user's head, and the second headband may be configured to engage with a portion of the user's head behind the top of the user's head.

[0068] In some embodiments, the second headband is adapted to be connected to the headband, which may include connection features adapted to allow the headband and the second headband to be connected and disconnected, which may include grooves, clips, or buckles.

[0069] In some embodiments, the headband is configured such that the flexible joints connecting the arms to the headband are such that, in use: i) adjacent to the user's temporal bone, such that when viewed in side profile, the flexible joint contours inward in front of the user's ear and above the cheekbone or zygomatic arch; or ii) In side profile, near the cheekbones and in front of the ears To be placed or shaped.

[0070] In some embodiments, in use, the headgear has a first lateral distance between the flexible joints, a second lateral distance between left and right side portions of the headband intermediate the flexible joints and a sagittal plane position of the headband, and a third lateral distance between the ends or between the ends of the arms attached or attachable to the patient interface; Each lateral distance is intersecting and perpendicular to the sagittal plane; and The first lateral distance is less than the second and third lateral distances.

[0071] In some embodiments, the headgear has a first lateral distance between the flexible joints, a second lateral distance between left and right side portions of the headband intermediate the flexible joints and a sagittal plane position of the headband, and a third lateral distance between the ends or between the ends of the arms attached or attachable to the patient interface; Each lateral distance is intersecting and perpendicular to the sagittal plane; and The first lateral distance is less than the second and third lateral distances.

[0072] In some embodiments, the second lateral distance is greater than the third lateral distance.

[0073] In some embodiments the arms are integrally formed with the patient interface.

[0074] In some embodiments, the patient interface and headgear form a continuous loop, including an upper and lower portion joined by a pair of flexible joints.

[0075] In some embodiments, the flexible joint, or the positioning tab, or the at least one headgear member includes at least one channel, which may extend from a front side of the flexible joint, or the at least one headgear member, to a rear side of the flexible joint, or the at least one headgear member, or an engaging portion or an engaging portion thereof.

[0076] According to at least one third aspect of the presently disclosed embodiments, a headgear for a patient interface includes: a resilient headband shaped to fit over a user's head with each end of the headband positioned on a respective side of the user's head; a pair of resilient arms, each arm attached to a resilient headband, each arm adapted to connect to or form part of a respective patient interface; and Each arm is attached to the headband by a flex joint that allows the arm to move freely relative to the headband in at least two degrees of freedom.

[0077] In some embodiments, each flex joint includes a hinge, which may be a living hinge.

[0078] In some embodiments, each arm is attached to an end or end portion of the headband.

[0079] In some embodiments, the flexible joint is adapted to bend transversely to a longitudinal axis of the end portion of the headband.

[0080] In some embodiments, the flexible joint is or includes a unitary member.

[0081] In some embodiments, the flex joint is a member formed from a soft, flexible material.

[0082] In some embodiments, the flexible joint is an elastomeric member.

[0083] In some embodiments, the flexible joint is a hollow or tubular member.

[0084] In some embodiments, the flexible joint, or at least one headgear member, comprises a connecting portion or connecting arrangement.

[0085] In some embodiments the connecting portion or connecting arrangement is configured to provide a connection with one or more of: an interface (or part of an interface), an arm adapted to connect to or form part of a patient interface.

[0086] In some embodiments the connecting portion or connecting arrangement is configured to provide a pivotal connection.

[0087] In some embodiments, the connecting portion or connecting arrangement includes a recess or aperture configured to receive a protrusion or boss, which may be located on the interface or part of the interface, and the recess or aperture may be located on the flexible joint.

[0088] In some embodiments, the connecting portion or connecting arrangement includes a protrusion or boss configured to be received by a recess or aperture, and the protrusion or boss may be located in the flexible joint and the recess or aperture may be located in the interface or part of the interface.

[0089] In some embodiments, at least one headgear member is integral with the flexible joint.

[0090] In some embodiments, the headgear and the interface, or part of the interface, or an arm adapted to connect to or form part of the interface, may be integrally formed.

[0091] In some embodiments, the flex joints deform elastically (without permanent deformation) during use, allowing the arms to move freely relative to the headband.

[0092] In some embodiments, the flex joint allows rotation of the arm relative to the headband about a longitudinal axis of the end portion of the arm that is attached to the headband.

[0093] In some embodiments, the arm is movably attached to a flexible joint and moves relative to the headband along a longitudinal axis of the arm.

[0094] In some embodiments, the arm is telescopically attached to a flexible joint.

[0095] In some embodiments, the arm is telescopically received in an end portion of the flexible joint.

[0096] In some embodiments, the flexible joint includes at least one passageway (the flexible joint may be or may include a hollow or tubular member), and the at least one passageway is configured to allow a headgear member to pass therethrough.

[0097] In some embodiments, the headgear members are configured to move or slide in at least one passageway.

[0098] In some embodiments, the headgear member includes at least one stop for limiting movement of the headgear member relative to the flexible joint and / or the at least one passageway, and the at least one stop may be located at an end of the headgear member.

[0099] In some embodiments, at least one stop comprises: i bump ii Recess iii. Barbed ends iv. Optionally, a local increase or decrease in thickness or cross-sectional area of ​​the headgear member relative to the size of at least one passageway. Contains one or more of the following:

[0100] In some embodiments, the headgear member includes one or more of a first stop and / or a second stop, the first stop providing a first limit of movement of the headgear member relative to the flexible joint and / or at least one passageway, and the second stop providing a second limit of movement of the headgear member relative to the flexible joint and / or at least one passageway.

[0101] In some embodiments, at least one headgear member is releasably attachable or connectable and removable or disconnectable to an adjacent headgear member and / or flexible joint.

[0102] In some embodiments, an end of at least one headgear member extends past or beyond the flexible joint.

[0103] In some embodiments, a flexible joint at or adjacent each end of the headband engages a respective side of the user's head during use.

[0104] In some embodiments, the elastic modulus of at least one of the headgear members is at least about 0.5 GPa, or at least about 1 GPa, or at least about 1.5 GPa, or at least about 1.8 GPa, or at least about 2 GPa, or at least about 3 GPa.

[0105] In some embodiments, the headband has a modulus of elasticity of at least about 1 GPa, or at least about 1.5 GPa, or at least about 1.8 GPa, or at least about 2 GPa.

[0106] In some embodiments, the elastic modulus of the arms is at least about 1 GPa, or at least about 1.5 GPa, or at least about 1.8 GPa, or at least about 2 GPa.

[0107] In some embodiments, the flexible joints are formed from a material with a modulus of elasticity of less than about 0.2 GPa, or less than about 0.1 GPa, or less than about 0.06 GPa.

[0108] In some embodiments, the headband, or the headband and arms, are formed from a hard, resilient material and the flexible joints are formed from a soft, flexible material, the modulus of elasticity of the hard, resilient material being many times greater than the modulus of elasticity of the soft, flexible material.

[0109] In some embodiments, the modulus of elasticity of the hard, resilient material is at least 10 times that of the soft, flexible material, or at least 20, or 40, or 100, or 200 times that of the soft, flexible material.

[0110] In some embodiments, the headgear includes at least one positioning tab connected to at least one said headgear member.

[0111] In some embodiments, the headgear includes at least one positioning tab or member connected to or forming part of at least one said headgear member.

[0112] In some embodiments, at least one positioning tab or member allows a user to apply and remove the headgear.

[0113] In some embodiments, the positioning tab or member is provided by or includes a substantially U-shaped portion.

[0114] In some embodiments, the positioning tab or member comprises: a first portion that, in use, extends outwardly from the headgear member (e.g., outwardly from the user's head); a second portion that, in use, extends toward the headgear member (e.g., toward the user's head); Including, The positioning tab or positioning member may include an intermediate portion located intermediate the first and second portions, the intermediate portion extending substantially parallel to the headgear member (e.g. parallel to the user's head) during use.

[0115] In some embodiments, at least one positioning tab or member is integrally formed with said headgear member.

[0116] In some embodiments, the headgear includes a pair of engagement portions, each engagement portion configured to engage the side of a user's head during use.

[0117] In some embodiments, the pair of flexible joints provide or include an engagement portion.

[0118] In some embodiments, the pair of flexible joints and / or at least one headgear member provide or include an engagement portion.

[0119] In some embodiments, the engagement portion comprises a textured surface, which may include one or more of: a knurled portion, a corrugated surface, a ribbed surface, a roughened surface, or may comprise micro- or nano-projections, which may be about 1×10-6 m and which may be about 1×10-9 m.

[0120] In some embodiments, the resilient headband is shaped to fit the user's head, with each end of the headband positioned at and biased against a respective side of the user's head.

[0121] In some embodiments, in the undeflected condition, the distance between the ends of the headband is less than the width of the user's head, so that flexing of the headband to fit the user's head biases the ends of the headband against the sides of the user's head.

[0122] In some embodiments, the headband is shaped to fit over the top of the user's head.

[0123] In some embodiments, the headband includes a central portion and one or more end portions, the one or more end portions being positioned at the or each side of the user's head, and the central portion may be angled relative to the one or more end portions to fit around the back of the user's head during use.

[0124] In some embodiments, the headband has a central portion and two end portions, the central portion being relatively stiff or stiffer or less flexible than the end portions.

[0125] In some embodiments, the central portion has a larger cross-sectional area than the end portions.

[0126] In some embodiments, the central portion is made of a first material and the end portions are made of a second material, the first material being relatively stiff or stiffer or less flexible than the second material.

[0127] In some embodiments the headgear includes a second headband.

[0128] In some embodiments, the second headband includes an elastic strap or band, which may be elastic and / or stretchable and / or extensible.

[0129] In some embodiments, the second headband may be engageable with the back of the user's head, and the second headband may be configured to engage with a portion of the user's head behind the top of the user's head.

[0130] In some embodiments, the second headband is adapted to be connected to the headband, which may include connection features adapted to allow the headband and the second headband to be connected and disconnected, which may include grooves, clips, or buckles.

[0131] In some embodiments, the headband is configured such that the flexible joints connecting the arms to the headband are such that, in use: i) adjacent to the user's temporal bone, such that when viewed in side profile, the flexible joint contours inward in front of the user's ear and above the cheekbone or zygomatic arch; or ii) In side profile, near the cheekbones and in front of the ears It is shaped in such a way that it can be placed.

[0132] In some embodiments, in use, the headgear has a first lateral distance between the flexible joints, a second lateral distance between left and right side portions of the headband intermediate the flexible joints and a sagittal plane position of the headband, and a third lateral distance between the ends or between the ends of the arms attached or attachable to the patient interface; Each lateral distance is intersecting and perpendicular to the sagittal plane; and The first lateral distance is less than the second and third lateral distances.

[0133] In some embodiments, the headgear has a first lateral distance between the flexible joints, a second lateral distance between left and right side portions of the headband intermediate the flexible joints and a sagittal plane position of the headband, and a third lateral distance between the ends or between the ends of the arms attached or attachable to the patient interface; Each lateral distance is intersecting and perpendicular to the sagittal plane; and The first lateral distance is less than the second and third lateral distances.

[0134] In some embodiments, the second lateral distance is greater than the third lateral distance.

[0135] In accordance with at least one fourth aspect of the presently disclosed embodiments, a patient interface assembly includes: Patient interface, A headgear according to any one of the first, second and third aspects above and as described below, the headgear being configured to position a patient interface on a patient's face in use. Includes.

[0136] According to at least one fifth aspect of the presently disclosed embodiments, a headgear for a patient interface includes: At least one headgear member; and At least one positioning member connected to or forming part of at least one said headgear member. Includes.

[0137] In some embodiments, at least one positioning member allows a user to apply and remove said headgear.

[0138] In some embodiments, the positioning member is provided by or includes a substantially U-shaped portion.

[0139] In some embodiments, the positioning member comprises: a first portion that, in use, extends outwardly from the headgear member (e.g., outwardly from the user's head); a second portion that, in use, extends toward the headgear member (e.g., toward the user's head); Including, The positioning member may include an intermediate portion located intermediate the first and second portions, the intermediate portion extending substantially parallel to the headgear member (e.g. parallel to the user's head) in use.

[0140] In some embodiments, at least one positioning member is integrally formed with said headgear member.

[0141] In some embodiments, the at least one positioning member is or includes a positioning tab.

[0142] In some embodiments, the flex joint is a member formed from a soft, flexible material.

[0143] In some embodiments, the positioning tabs or positioning members are integrally formed with the flex joint, and the flex joint and tabs may be or include a unitary member.

[0144] In some embodiments, the positioning tabs or members are visibly marked to indicate the direction in which to pull the tab to remove the headgear from the user's head.

[0145] In some embodiments, the positioning tabs or members project outwardly from the headgear member (eg outwardly from the user's head) during use.

[0146] In some embodiments, the headgear member is a headband, and the headgear includes a pair of positioning tabs or members, each positioning tab adjacent an end or end portion of the headband, positioned against the side of the user's head during use.

[0147] In some embodiments, the flexible joint, or at least one headgear member, and / or at least one positioning tab or member, and / or the or an engaging portion thereof comprises at least one channel.

[0148] In some embodiments, the channel extends from a front side of the flexible joint, or at least one headgear member, or at least one positioning tab or positioning member, or an engagement portion or portion thereof, to a rear side of the flexible joint, or at least one headgear member, or at least one positioning tab or positioning member, or an engagement portion or portion thereof.

[0149] In some embodiments, during use, the channel forms a channel passage between the flexible joint, or at least one headgear member, or at least one positioning tab, or the positioning member, or a surface of an engaging portion or an engaging portion thereof, and the patient's head.

[0150] In some embodiments, the channel is provided by a substantially U-shaped portion.

[0151] In some embodiments the headgear comprises: a resilient headband shaped to fit over a user's head with each end of the headband positioned on a respective side of the user's head; a pair of arms, each arm attached to a resilient headband, each arm adapted to connect to or be part of a patient interface; and At least one positioning tab is connected to the headband or to the arm.

[0152] In some embodiments, each arm is a resilient arm.

[0153] In some embodiments, each arm is attached to an end or end portion of the headband.

[0154] In some embodiments, the headgear includes a pair of engagement portions, each engagement portion configured to engage the side of a user's head during use.

[0155] In some embodiments, the headband includes a central portion and one or more end portions, the one or more end portions being positioned at the or each side of the user's head, and the central portion may be angled relative to the one or more end portions to fit around the back of the user's head.

[0156] In some embodiments the headgear comprises: a resilient headband shaped to fit over the top of the user's head with each end of the headband positioned on and biased against a respective side of the user's head; and a pair of engagement portions, each engagement portion configured to engage a side of a user's head; Including, In use, the headgear has a first lateral distance between the engagement portions, a second lateral distance between left and right side portions of the headband intermediate the engagement portions and a sagittal plane position of the headband, and a third lateral distance between an end or ends of the headgear attached or attachable to the patient interface; Each lateral distance is intersecting and perpendicular to the sagittal plane; and The first lateral distance is less than the second and third lateral distances.

[0157] In some embodiments, the patient interface and headgear form a continuous loop including an upper and lower portion joined by a pair of flexible joints.

[0158] According to at least one sixth aspect of the presently disclosed embodiment, a headgear for a patient interface includes: At least one headgear member; and At least one positioning tab connected to at least one of said headgear members. Includes.

[0159] In some embodiments, the headgear includes a pair of flexible joints adapted to connect the one or more headgear members to the patient interface, and / or the headgear includes a pair of flexible joints and a plurality of headgear members, the pair of flexible joints connecting the headgear members to a plurality of adjacent headgear members, each flexible joint allowing at least two degrees of freedom of relative free movement between the plurality of adjacent headgear members.

[0160] In some embodiments, the positioning tab is integrally formed with the flex joint, for example the flex joint and the tab are or include a unitary member.

[0161] In some embodiments, the positioning tabs are visibly marked to indicate the direction in which to pull the tab to remove the headgear from the user's head.

[0162] In some embodiments, the positioning tabs project outwardly from the headgear member (eg, outwardly from the user's head) during use.

[0163] In some embodiments, the headgear member is a headband, and the headgear includes a pair of positioning tabs, each positioning tab adjacent an end or end portion of the headband for positioning against the sides of the user's head during use.

[0164] In some embodiments, the flexible joint, or at least one headgear member, and / or at least one positioning tab or member, and / or the or an engaging portion thereof comprises at least one channel.

[0165] In some embodiments, the channel extends from a front side of the flexible joint, or at least one headgear member, or at least one positioning tab or positioning member, or an engagement portion or portion thereof, to a rear side of the flexible joint, or at least one headgear member, or at least one positioning tab or positioning member, or an engagement portion or portion thereof.

[0166] In some embodiments, during use, the channel forms a channel passage between the flexible joint, or at least one headgear member, or at least one positioning tab, or the positioning member, or a surface of an engaging portion or an engaging portion thereof, and the patient's head.

[0167] In some embodiments, the channel is provided by a substantially U-shaped portion.

[0168] In some embodiments the headgear comprises: a resilient headband shaped to fit over a user's head with each end of the headband positioned on a respective side of the user's head; a pair of arms, each arm attached to a resilient headband, each arm adapted to connect to or be part of a patient interface; and At least one positioning tab is connected to the headband or to the arm.

[0169] In some embodiments, each arm is a resilient arm.

[0170] In some embodiments, each arm is attached to an end or end portion of the headband.

[0171] In some embodiments, the headgear includes a pair of engagement portions, each engagement portion configured to engage the side of a user's head during use.

[0172] In some embodiments, the pair of flexible joints provide or include an engagement portion.

[0173] In some embodiments, the pair of flexible joints and / or at least one headgear member provide or include an engagement portion.

[0174] In some embodiments, the engagement portion comprises a textured surface, which may include one or more of: a knurled portion, a corrugated surface, a ribbed surface, a roughened surface, or may include micro- or nano-projections.

[0175] In some embodiments, the headband includes a central portion and one or more end portions, the one or more end portions being positioned at the or each side of the user's head, and the central portion may be angled relative to the one or more end portions to fit around the back of the user's head during use.

[0176] In some embodiments the headgear comprises: a resilient headband shaped to fit over the top of the user's head with each end of the headband positioned on and biased against a respective side of the user's head; and a pair of engagement portions, each engagement portion configured to engage a side of a user's head; Including, In use, the headgear has a first lateral distance between the engagement portions, a second lateral distance between left and right side portions of the headband intermediate the engagement portions and a sagittal plane position of the headband, and a third lateral distance between an end or ends of the headgear attached or attachable to the patient interface; Each lateral distance is intersecting and perpendicular to the sagittal plane; and The first lateral distance is less than the second and third lateral distances.

[0177] In some embodiments, the patient interface and headgear form a continuous loop, including an upper and lower portion joined by a pair of flexible joints.

[0178] According to at least one seventh aspect of the presently disclosed embodiments, the headgear comprises: At least one headgear member at least one sliding member movably attached to the headband and configured to slide relative to the headband; Includes.

[0179] In some embodiments, there is a pair of sliding members that may be located on each side of the headband.

[0180] In some embodiments, the at least one headgear member is a headband, which may be a single headband.

[0181] In some embodiments, the headband includes a central portion and one or more end portions, the one or more end portions being positioned at the or each side of the user's head, and the central portion may be angled relative to the one or more end portions to fit around the back of the user's head during use.

[0182] In some embodiments, the sliding member includes at least one passageway, the at least one passageway configured to allow passage of a headgear member.

[0183] In some embodiments, the headgear members are configured to move or slide in at least one passageway.

[0184] In some embodiments, the headgear member includes at least one stop to limit movement of the headgear member relative to the sliding member and / or the at least one passageway, and the at least one stop may be located at an end of the headgear member.

[0185] In some embodiments, at least one stop comprises: i bump ii Recess iii. Barbed ends iv. Optionally, a local increase or decrease in thickness or cross-sectional area of ​​the headgear member relative to the size of at least one passageway. Contains one or more of the following:

[0186] In some embodiments, the headgear member includes one or more of a first stop and / or a second stop, the first stop provided for a first limit of movement of the headgear member relative to the sliding member and / or at least one passageway, and the second stop provided for a second limit of movement of the headgear member relative to the sliding member and / or at least one passageway.

[0187] In some embodiments, at least one headgear member is releasably attachable or connectable and removable or disconnectable to an adjacent headgear member and / or to a sliding member.

[0188] In some embodiments, an end of at least one headgear member may extend past or beyond the sliding member, and the end of the at least one headgear member may be configured to rest against a portion of the patient's head or face during use.

[0189] In some embodiments, the sliding member, or at least one of the headgear members, includes a connecting portion or connecting arrangement.

[0190] In some embodiments, the connecting portion is located on one side of the slide member, and the connecting portion may be located away from the center of the slide member, or the passageway.

[0191] In some embodiments, the connecting portion is located on the side of the sliding member opposite the patient's face.

[0192] In some embodiments, the connecting portion is located at the bottom of the slide member.

[0193] In some embodiments the connecting portion or connecting arrangement is configured to provide a connection with one or more of: an interface (or part of an interface), an arm adapted to connect to or form part of a patient interface.

[0194] In some embodiments the connecting portion or connecting arrangement is configured to provide a pivotal connection.

[0195] In some embodiments, the headgear comprises an interface, and the headgear and the interface are configured between a storage configuration and an in-use configuration, in which the interface and headgear may be folded together (towards a common plane), and in which the interface may be positioned at an angle from the headgear.

[0196] In some embodiments, the connecting portion or connecting arrangement includes a recess or aperture configured to receive a protrusion or boss, which may be located on the interface or part of the interface, and the recess or aperture may be located on the sliding member.

[0197] In some embodiments, the connecting portion or connecting arrangement includes a protrusion or boss configured to be received by a recess or aperture, and the protrusion or boss may be located on the sliding member and the recess or aperture may be located on the interface or part of the interface.

[0198] In some embodiments, the sliding member includes at least one engagement portion, and the pair or each of the sliding members of a pair may include at least one engagement portion, and each engagement portion may be configured to engage the side of a user's head during use.

[0199] In some embodiments, each engagement portion is configured to engage the side of a user's head during use.

[0200] In some embodiments, the engagement portion comprises a textured surface, which may include one or more of: a knurled portion, a corrugated surface, a ribbed surface, a roughened surface, or may comprise micro- or nano-projections, which may be about 1×10-6 m, which may be about 1×10-9 m, and which may be about 1×10-9 m.

[0201] In some embodiments, the engagement portion includes an adhesive for engaging with a user's head.

[0202] In some embodiments, the adhesive is a biocompatible adhesive.

[0203] In some embodiments, the headgear includes a removable cover over the adhesive that is removed prior to use.

[0204] In some embodiments, the headgear includes a pair of flexible joints, each arm is attached to the headband by said flexible joints such that the arms are free to move with at least two degrees of freedom relative to the headband, and each flexible joint is said engagement portion.

[0205] According to at least one fourteenth aspect of the embodiment disclosed herein, a headgear for a patient interface comprises: a resilient headband shaped to fit over the top of the user's head with each end of the headband positioned on and biased against a respective side of the user's head; and a pair of engagement portions, each engagement portion configured to engage a side of a user's head; Including, In use, the headgear has a first lateral distance between the engagement portions, a second lateral distance between left and right side portions of the headband intermediate the engagement portions and a sagittal plane position of the headband, and a third lateral distance between an end or ends of the headgear attached or attachable to the patient interface; Each lateral distance is intersecting and perpendicular to the sagittal plane; and The first lateral distance is less than the second and third lateral distances.

[0206] In some embodiments, the second lateral distance is greater than the third lateral distance.

[0207] In some embodiments the headgear comprises: a pair of arms attached to ends of a resilient headband, each arm adapted to connect to or be part of a patient interface, and each arm attached to the headband by a flexible joint, the flexible joint allowing the arm to move freely with at least two degrees of freedom relative to the headband, and the flexible joint providing or including an engagement portion; Includes.

[0208] In some embodiments, the arms are resilient arms.

[0209] In some embodiments, the headband is shaped to fit over the top of the user's head.

[0210] In some embodiments, the headband has an engagement portion such that, in use: i) near the user's temporal bone, such that when viewed in side profile, the engagement portion contours inwardly in front of the user's ear and above the cheekbone or zygomatic arch; or ii) In side profile, near the cheekbones and in front of the ears It is shaped in such a way that it can be placed.

[0211] In some embodiments, the headgear includes at least one positioning tab connected to at least one said headgear member.

[0212] In some embodiments, the headgear includes at least one positioning member connected to at least one said headgear member.

[0213] In some embodiments, the patient interface and headgear form a continuous loop including an upper and lower portion joined by a pair of flexible joints.

[0214] According to at least one fifteenth aspect of the presently disclosed embodiment a headgear for a patient interface comprising: a plurality of headgear members interconnected together to form a continuous loop together with the patient interface during use; Including, The continuous loop includes an upper and lower portion, the upper end and the lower end being connected by a pair of flexible joints.

[0215] In some embodiments, the upper portion includes a resilient headband shaped to fit the user's head, with each end of the headband positioned on a respective side of the user's head; the lower portion includes a pair of arms, each arm attached to a resilient headband, each arm adapted to connect to or be part of a patient interface; Each arm is attached to the headband by one of a pair of flexible joints.

[0216] In some embodiments, the resilient headband is shaped to fit the user's head, with each end of the headband positioned at and biased against a respective side of the user's head.

[0217] In some embodiments, each arm is a resilient arm.

[0218] In some embodiments, the flexible joint provides an end portion of the lower portion with at least two degrees of freedom of movement relative to a respective end portion of the upper portion.

[0219] In some embodiments, the flexible joint is or includes a unitary member.

[0220] In some embodiments, the flex joint is a member formed from a soft, flexible material.

[0221] In some embodiments, at least one end portion of the lower portion is movably attached to an end portion of the upper portion such that there is relative movement therebetween along a longitudinal axis of the lower portion.

[0222] In some embodiments, the end portion of the lower portion is telescopically attached to the end of the upper portion.

[0223] In some embodiments, the end portion of the lower portion is telescopically received in the end portion of the flexible joint.

[0224] In some embodiments, the headgear includes at least one positioning tab connected to at least one of the upper and lower portions.

[0225] In some embodiments, the tab is integrally formed with the flexible joint.

[0226] In some embodiments, the headgear includes a pair of engagement portions, each engagement portion configured to engage the side of a user's head during use.

[0227] In some embodiments, the pair of flexible joints provide or include a pair of mating portions.

[0228] In some embodiments, in use, the headgear has a first lateral distance between the engagement portions, a second lateral distance between left and right side portions of the headband intermediate the engagement portions and a sagittal plane position of the headband, and a third lateral distance between the ends or ends of the arms attached or attachable to the patient interface; Each lateral distance is intersecting and perpendicular to the sagittal plane; and The first lateral distance is less than the second and third lateral distances.

[0229] In some embodiments, the second lateral distance is greater than the third lateral distance.

[0230] According to at least one sixteenth aspect of the embodiments disclosed herein, a method for donning a headgear and patient interface includes: i) applying a lateral force to each side or end of a resilient headband of the headgear against a bias provided by the resilient headband to cause the ends of the headband to deform outwardly; ii) positioning the headband over the top of the user's head and the interface over the user's nose, mouth, or nose and mouth; iii) removing lateral forces from each side or end of the resilient headband such that the bias of the headband presses the engagement portions of the headgear against the temples of the user's head to hold the headgear on the user's head; and iv) adjusting a relative position between the headband and the patient interface by manipulating a pair of flexible joints between the headband and the pair of arms of the headgear or between the headband and the patient interface to properly position the patient interface over the user's nose, mouth, or nose and mouth; Includes.

[0231] In some embodiments, in step (i), the method includes gripping and pulling a pair of positioning tabs to apply a lateral force to each side or end of the elastic headband against a bias provided by the elastic headband to outwardly deform both ends of the headband; and In step (iii), the method includes removing the lateral force from each positioning tab, biasing the headband to press engagement portions of the headgear against the temples of the user's head, thereby holding the headgear on the user's head and urging the patient interface to be in position over the user's nose, mouth, or nose and mouth.

[0232] In some embodiments, each flexible joint is or comprises said engaging portion, and in step (iii), the method comprises: Removing lateral forces from each side or end of the resilient headband such that the bias of the headband presses the flexible joints against the sides of the user's head to hold the headgear on the user's head. Includes.

[0233] In some embodiments, in step (iii), the method further comprises: a) near the user's temporal bone, such that when viewed in side profile, the engagement portion contours inwardly in front of the user's ear and above the cheekbone or zygomatic arch; or b) In side profile, near the cheekbone and in front of the ear This includes positioning so as to be positioned.

[0234] In some embodiments, the headband or arm is movably attached to a flexible joint for movement along a longitudinal axis of the headband or arm relative to the flexible joint, and the method comprises: c) adjusting the position of the headband or arms relative to the flexible joint to properly position the patient interface over the user's nose, mouth, or nose and mouth; Includes.

[0235] In some embodiments, the method includes applying the headband to the user's head without applying a secondary headband or strap behind the user's head.

[0236] In some embodiments, the method includes applying the headband to the user's head while the user's head is resting on a support (such as a pillow) and without lifting the user's head from the support.

[0237] In some embodiments, the method includes applying the headband to the user's head without moving the user's head.

[0238] In some embodiments, the headgear may be any of the first, second, third, fifth, sixth, seventh, eighth, ninth, tenth, eleventh, twelfth, thirteenth, fourteenth, fifteenth or sixteenth aspects of the headgear.

[0239] In accordance with at least one further aspect of the embodiments disclosed herein, in a method of wearing the headgear and patient interface, the headgear may be any of the headgear aspects described above.

[0240] It will be appreciated that any of the above described features may be combined with any of the other aspects of the invention.

[0241] In particular, any of the first, second, third, fourth, fifth, sixth, seventh, eighth, ninth, tenth, eleventh, twelfth, thirteenth, fourteenth, fifteenth or sixteenth aspects relating to the headgear or patient interface may be adapted to act interchangeably with any one of the headgear or patient interface of the first, second, third, fourth, fifth, sixth, seventh, eighth, ninth, tenth, eleventh, twelfth, thirteenth, fourteenth, fifteenth or sixteenth aspects.

[0242] Further, a connection arrangement or portion as defined in any one of the first, second, third or seventh aspects may be provided on the headgear as defined in any one of the first, second, third, fourth, fifth, sixth, seventh, eighth, ninth, tenth, eleventh, twelfth, thirteenth, fourteenth, fifteenth or sixteenth aspects to facilitate connection with a patient interface.

[0243] The term "resilient," in reference to a member or portion or material, is intended to mean that the member or portion or material is capable of bouncing or springing back to its original shape after bending or flexing under normal conditions of use without permanent deformation or failure, unless the context suggests otherwise. A resilient member or portion may be sufficiently rigid to resist bending or flexing under normal conditions of use, or it may be sufficiently flexible to bend or flex and to bounce or spring back to shape under normal conditions of use.

[0244] In this specification and in the claims, the term "comprising" means "at least in part." In this specification and in the claims, each statement containing the term "comprising" is to be interpreted such that there may be features other than the feature preceding the term. Related words such as "comprise" and "comprises" are to be interpreted in the same manner.

[0245] As referred to herein, use or reference of the term "living hinge" includes, but is not limited to, straight or flat living hinges and / or butterfly-type living hinges.

[0246] As referred to herein, use of or reference to the term "micro" (such as with respect to a protrusion or protrusions) means having a dimension of about 1 x 10-6 m in at least one dimension.

[0247] As referred to herein, use of or reference to the term "nano" (such as with respect to a protrusion or protrusions) means having a dimension of about 1 x 10-9 m in at least one dimension.

[0248] Reference to a numerical range disclosed herein (e.g., 1-10) also incorporates reference to every rational number within that range (e.g., 1, 1.1, 2, 3, 3.9, 4, 5, 6, 6.5, 7, 8, 9, and 10) and also to any range of rational numbers within that range (e.g., 2-8, 1.5-5.5, and 3.1-4.7), and therefore, every subrange of every range expressly disclosed herein is intended to be expressly disclosed herein. These are only examples of what is specifically intended, and all possible combinations of numerical values ​​between the lowest and highest values ​​recited shall be considered to be expressly set forth herein as well.

[0249] As used herein, the term "and / or" means "and" or "also," or both.

[0250] As used herein, the term "one or more" before a noun refers to the plural and / or the singular form of that noun.

[0251] The present invention may also be broadly described in terms of the parts, elements and features referred to or shown in the specification of this application, either individually or collectively, and in any or all combinations of any two or more of said parts, elements or features, and where specific integers known to be equivalent in the art to which the invention pertains are described herein, such known equivalents are intended to be incorporated herein as if individually set forth.

[0252] The present invention is as described above and also contemplates a number of configurations, which are given below by way of example only.

[0253] Embodiments will now be described, by way of example only, with reference to the drawings in which: [Brief description of the drawings]

[0254] [Figure 1] 1 shows a patient interface and headgear. [Figure 2A]2A shows a headgear similar to that shown in Fig. 1. Fig. 2A is a front, top, side perspective view. [Figure 2B] FIG. 2B shows a top view of headgear similar to that shown in FIG. [Figure 2C] 2A shows a headgear similar to that shown in Fig. 1. Fig. 2C is a front view. [Figure 2D] FIG. 2D shows a side view of a headgear similar to that shown in FIG. [Figure 3A] 2A-2D attached to a patient interface. FIG 3A is a front, top, and side perspective view. [Figure 3B] 2A-2D attached to the patient interface. FIG. 3B is a top view. [Figure 3C] 2A-2D attached to a patient interface. FIG 3C is a front view showing the elasticity of the headband of the headgear. [Figure 3D] 2A-2D attached to a patient interface. FIGURE 3D is a side view showing bending or flexing of the flexible joints between the headgear members. [Figure 4A] FIG. 13 illustrates a side view of a patient interface with headgear according to another embodiment. [Figure 4B] FIG. 13 illustrates a side view of a patient interface with headgear according to another embodiment. [Figure 5A] 13 illustrates a patient interface with headgear according to another embodiment. [Figure 5B] 13 illustrates a patient interface with headgear according to another embodiment. [Figure 5C] A headband and a second headband are shown. [Figure 6] 13 illustrates a patient interface with headgear according to another embodiment. [Figure 7A]7A shows headgear and a patient interface similar to that shown in Figures 3A-3D, worn by a user. Figure 7A is a view from the front left of the user. [Figure 7B] 7A shows headgear and a patient interface similar to that shown in Figures 3A-3D worn by a user. Figure 7B shows a left side view of the user. [Figure 7C] 7A-7D show headgear and a patient interface similar to that shown in Figures 3A-3D, worn by a user. [Figure 8] 2 shows a headgear similar to the headgear shown in FIG. 1 connected to a full-face mask. [Figure 9] 2 shows a headgear similar to that shown in FIG. 1 connected to a patient interface with nasal pillows. [Figure 10] FIG. 2 shows a headgear similar to the headgear shown in FIG. 1 connected to a nasal facemask. [Figure 11] 1 shows headgear according to another embodiment. [Figure 11A] 1 shows headgear according to another embodiment. [Figure 11B] 1 shows headgear according to another embodiment. [Figure 11C] 1 shows headgear according to another embodiment. [Figure 12A] 1 shows headgear according to another embodiment. [Figure 12B] 1 shows headgear according to another embodiment. [Figure 13A] 1 illustrates headgear according to various embodiments. [Figure 13B] 1 illustrates headgear according to various embodiments. [Figure 13C] 1 illustrates headgear according to various embodiments. [Figure 14A] Various connection portions or connection arrangements are shown. [Figure 14B] Various connection portions or connection arrangements are shown. [Figure 14C] Various connection portions or connection arrangements are shown. [Figure 14D] Various connection portions or connection arrangements are shown. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0255] Various embodiments are described below with reference to the drawings.

[0256] Throughout the drawings and the specification, the same reference numerals may be used to designate the same or similar components, and redundant descriptions thereof may be omitted.

[0257] FIG. 1 shows a patient interface 1 and headgear 10 according to some embodiments described herein.

[0258] Figures 3A-3D show similar headgear attached to an alternative patient interface, which is the same or similar to the interface described in U.S. Provisional Patent Application No. 62 / 399,893, the contents of which are incorporated herein by reference.

[0259] Patient interfaces and / or headgear as described herein may be used in a respiratory system such as that disclosed in PCT application WO 2016 / 157105, which is incorporated herein by reference.

[0260] A tube or conduit 2 provides the flow of breathing gas through interface 1 to the patient.

[0261] In some embodiments, the patient interface includes a tube 2. In the illustrated embodiment, the patient interface is a nasal cannula that includes a pair of nasal prongs 3. The nasal prongs interface with the patient's or user's nares to provide a flow of respiratory gas to the user.

[0262] In the illustrated embodiment, the prongs provide gas flow to the user without forming a seal with the nares or nasal cavities.

[0263] In some embodiments, the interface 1 may include a manifold section 5 that includes an inlet that receives gas from the tube 2 and one or more outlets, such as prongs 3. The manifold 5 directs the gas received by the manifold from the tube 2 to the prongs 3. Headgear may be attached to both sides of the patient interface. In some embodiments, the patient interface includes a side member or arm 4 on each side of the interface. For example, the illustrated example has a side arm 4 extending from each side of the manifold section 5.

[0264] In some embodiments, headgear is attached to each side arm 4, for example at an end or end portion of each side arm. A conduit portion may be formed within or integral with the side member or arm 4 of the cannula.

[0265] In some embodiments, the side member or arm 4 is a conduit for transporting the flow of gas from the patient conduit to the manifold section 5. In some embodiments, the side arm conduit 4 may include a collapsible portion. Substantially the entire length of the side arm conduit 4 may be configured to be collapsible, or only a portion of the length of the side arm conduit may be configured to be collapsible.

[0266] In some configurations, the patient interface may be adapted to provide high-flow therapy.

[0267] In this disclosure, "high flow therapy" may refer to the delivery of gas to a patient at a flow rate of about 10 liters per minute (10 LPM) or greater. In some configurations, "high flow therapy" may refer to the delivery of gas to a patient at a flow rate of about 10 LPM to about 100 LPM, or about 15 LPM to about 95 LPM, or about 20 LPM to about 90 LPM, or about 25 LPM to about 85 LPM, or about 30 LPM to about 80 LPM, or about 35 LPM to about 75 LPM, or about 40 LPM to about 70 LPM, or about 45 LPM to about 65 LPM, or about 50 LPM to about 60 LPM.

[0268] "High flow therapy" may also be, for example, according to various embodiments and configurations described herein, a flow rate of gas delivered or provided through a system, such as to an interface or through a flow path, including, but not limited to, a flow rate of at least about 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150 liters per minute (LPM) or more, and an effective range may be between any of these values ​​(e.g., about 40 LPM to about 80 LPM, or about 50 LPM to about 80 LPM, or about 60 LPM to about 80 LPM, or about 70 LPM to about 80 LPM). about 80 LPM, or about 5 LPM to about 150 LPM, or 10 LPM to about 150 LPM, or about 15 LPM to about 150 LPM, or about 20 LPM to about 150 LPM, or about 20 LPM to about 120 LPM, or about 30 LPM to about 120 LPM, or about 20 LPM to about 100 LPM, or about 20 LPM to about 90 LPM, or about 25 LPM to about 85 LPM, or about 30 LPM to about 80 LPM, or about 30 LPM to about 90 LPM, or about 35 LPM to about 75 LPM, or about 40 LPM to about 70 LPM, or about 45 LPM to about 65 LPM, or about 50 LPM to about 60 LPM).

[0269] The delivered gas may include a percentage of oxygen. In some configurations, the percentage of oxygen in the delivered gas may be about 20% to about 100%, or about 30% to about 100%, or about 40% to about 100%, or about 50% to about 100%, or about 60% to about 100%, or about 70% to about 100%, or about 80% to about 100%, or about 90% to about 100%, or about 100%, or 100%.

[0270] In some embodiments, the headgear 10 includes at least one headgear member, such as a headband 11, and a pair of flexible joints 13 adapted to connect an end or end portion of a headgear member or pair of headgear members to a patient interface. Each flexible joint 13 allows for relative movement between the headgear member and the patient interface in at least two degrees of freedom.

[0271] In some embodiments, each flexible joint 13 allows for relative free movement between the headgear member and the patient interface in at least two degrees of freedom.

[0272] Unless the context suggests otherwise, "free movement" or "freely moving" means that the flexible joint does not utilize mechanisms such as friction or mechanical indexing to impede movement or to set or lock the flexible joint in a particular position. The flexible joint may allow free movement in at least two degrees of freedom between both limits of movement. Both limits of movement may be provided by the headgear members, for example, by material selection and / or geometry.

[0273] In some embodiments, the headgear 10 includes multiple interconnected headgear members 11, 12. For example, the headgear may include a headband 11 and a pair of arms 12 attached to the headband. Each arm 12 may be adapted to connect to a patient interface 1. In the illustrated embodiment, each arm 12 facilitates connection of the headgear 10 to the patient interface. The arms 12 act as connecting structures between the interface 1 and the headband 11.

[0274] In some embodiments, the headband is a resilient headband.In some embodiments, the arms 12 are resilient arms.

[0275] Adjacent headgear members or adjacent headgear members 11 , 12 are attached or connected to each other by a flexible joint 13 .

[0276] In some embodiments, the headgear members are integral with the flexible joint 13 .

[0277] In some embodiments, at least one headgear member is releasably attachable or connectable and detachable or disconnectable to adjacent headgear members and / or flexible joints. In some embodiments, an end of at least one headgear member extends past or beyond the flexible joint 13, which may provide better contact and pressure distribution with the user's head during use.

[0278] As mentioned above, the flexible joint 13 allows one member (eg, arm 12) to move freely relative to the adjacent connected member (eg, headband 13).

[0279] In some embodiments, the flexible joints 13 allow for at least two degrees of freedom of relative movement between adjacent headgear members. For example, in Figure 3D, the headband 11 is shown moving in a direction relative to the arms 12, or in a front-to-back direction, and the flexible joints may also allow each arm 12 to move in a left-to-right direction (i.e., perpendicular to the page) relative to the headband, illustrating two degrees of freedom of relative movement between members 11 and 12.

[0280] In some embodiments, the flexible joints 13 may be located at or near either side of the user's head and / or at or near the top of the user's head.

[0281] In some embodiments, the flexible joint is located at or near a central portion of the headband.

[0282] In some embodiments, the flexible joints 13 allow for at least one degree of freedom of relative movement between adjacent headgear members. In some embodiments, for example as shown in Figures 11B-11C, the flexible joints 13 can optionally provide elongation in the vertical direction. The elongation allows for movement between adjacent headgear members away from each other. The elongation of the flexible joints 13 can assist in matching the headgear size to a particular patient.

[0283] 11B-11C, the flexible joint 13 may be provided by or may include a substantially U-shaped portion. The flexible joint may have a first portion that extends outwardly from the headgear member (e.g., outwardly from the user's head) in use, and a second portion that extends towards the headgear member (e.g., towards the user's head) in use.

[0284] In some embodiments, the flexible portion 13 may have an intermediate portion located intermediate the first and second portions, the intermediate portion extending substantially parallel to the headgear member (e.g. parallel to the user's head) during use.

[0285] In some embodiments, the flexible portion may be integrally formed as part of the headgear member and / or headband, as shown, for example, in FIGS. 11B-11C.

[0286] In some embodiments, the flexible portion may be formed of the same material as the adjacent headgear members, but may be geometrically shaped to be stiffer in one particular plane than in one or more other planes, hi some embodiments, the flexible joint is stiffer in the user's frontal plane, or in the plane of the headband, compared to the user's sagittal and median planes (or other orthogonal planes).

[0287] In some embodiments, as shown in, for example, FIG. 14D, flexible joint 13 may include a narrowed portion, which may form a hinge. The narrowed portion may include one or more rounded, angled, or substantially V-shaped portions to narrow at least one headgear member from a first cross-sectional area to a second cross-sectional area smaller than the first cross-sectional area.

[0288] In some embodiments, the flexible joints may include a relatively flexible material (i.e., rubber or silicone) compared to the headgear members, and / or a concertina or bellows section, and / or a spring section, to allow relative movement by stretching of the flexible joints, and preferably at least some relative movement of the connected headgear members away from each other.

[0289] In some embodiments, the flexible joints may allow for relative movement of about 5 mm to about 20 mm.

[0290] In some embodiments, the flexible joint may include at least one, or multiple, subsections.

[0291] In some embodiments, each subsection is a flexible joint as described elsewhere herein. In some embodiments, one or more of the subsections may provide flexibility or relatively free movement in one or more directions or degrees of freedom. For example, a flexible joint may include one or more living hinges, each living hinge providing flexibility or relatively free movement in one degree of freedom.

[0292] In some embodiments, one or more subsections may provide elongation (which may be longitudinally or in a direction along at least one headgear member) to allow relative free movement between one or more headgear members and a patient interface, or between a headgear member and multiple adjacent headgear members.

[0293] In some embodiments, the flexible joint may include one or more of: a living hinge, or a concertina or bellows type section, or a spring section.

[0294] In some embodiments, flexible joint 13 is adapted to bend or fold transversely to the longitudinal axis of the end portion of said headgear member, e.g. headband 11. The joint can bend or fold / flex (2 degrees of freedom) in either direction perpendicular to the longitudinal axis of the end portion of the headgear member. Flexible joint 13 may enable the headband to be folded over arm 12 to provide a folded, non-use configuration, e.g. in a packaging for sale.

[0295] In some embodiments, the flexible joint may be or include a flexible unitary member, such as a hollow member or a tubular member, such as a length of tubing. The flexible joint may be formed from a soft, flexible material, such as an elastomeric material. The flexible joint may be a length of elastomeric tubing, such as a silicone tube or tubular member. The flexible joint preferably deforms elastically (without permanent deformation) under normal use conditions, so that the joint may be flexed between different positions many times without changing its mechanical properties.

[0296] In some embodiments, the flexible joints may be over-molded to the headband 11 or may be assembled to the headband.

[0297] In some embodiments, the flexible joint is provided by a mechanical assembly or mechanism, such as a universal joint, or a two-way hinge assembly, allowing hinged movement about two perpendicular axes. The hinge may be a living hinge.

[0298] In some embodiments, the flexible joint allows rotation of said headgear member, e.g., arm 12, relative to an adjacent headgear member, e.g., band 11, about a longitudinal axis of an end portion of the headgear member 12 attached to the adjacent headgear member 11. This rotation may be effected by torsional elastic deformation of the flexible joint, e.g., twisting of the flexible joint. This torsional deformation provides an additional degree of freedom of movement, and in some embodiments the flexible joint provides three degrees of freedom of movement.

[0299] In some embodiments, the flexible joints simultaneously accommodate lateral bending / folding in two degrees of freedom and also torsional rotation, allowing the joints 13 to flex in multiple dimensions. The flexible joints 13 accommodate or allow for torsional forces and bending resulting from movement of the arms 12 and / or interface 1 relative to the headband 11.

[0300] In some embodiments, a flexible joint provides a bias against movement from an undeflected or "normal" position. For example, in some embodiments, a flexible joint is or includes a flexible member, such as an elastomeric member. The elastomeric member provides an undeflected shape or relative position between adjacent members interconnected by the flexible member. Movement between the connected members is achieved by deflecting the flexible member from the undeflected position, and the resiliency of the flexible member acts to bias the flexible joint to the undeflected position. A mechanical flexible joint may include a resilient member, such as a spring, to bias the joint to the undeflected position.

[0301] In some embodiments, the flexible joint may include a bellows or concertina section.

[0302] In some embodiments, the flexible joint 13 may be absent and the headband 11 may be a continuous, rigid headband. Such an arrangement is shown in Figures 11-11A and 13A-13C, which show a continuous headband 11. However, as described in more detail below, these arrangements may include a one-piece headband, a rigid or continuous headband with a flexible joint 13 (e.g., as shown in Figures 11B and 11C).

[0303] In some embodiments, the headgear includes at least one connecting portion or arrangement 20. The connecting portion or arrangement 20 may be disposed on or form part of one or more of the flexible joints 13, or at least one of the headgear members (e.g., band 11 or arm 12). The connecting portion or arrangement 20 may be configured to provide a connection with one or more of: an interface (e.g., interface 1, or any of the interfaces as shown in Figures 1, 3A-13C), or a part of an interface, an arm (e.g., side arm 4) adapted to connect to or form part of an interface.

[0304] Optionally, when connection arrangement 20 is positioned on at least one headgear member, connection arrangement 20 may be positioned away from an end of the at least one headgear member so that the headgear member extends past connection arrangement 20 and may be placed on the user's face.

[0305] 13B and 13C, and 14A-14B, the connecting portion or arrangement 20 may be configured to provide a pivotal connection, or a rigid or semi-rigid connection. The connecting portion or arrangement 20 may include a recess or aperture 21 configured to receive a protrusion or boss 21a, which may be located on the interface 1 or part of the interface, and which may be located on or part of the flexible joint 13, or on a sliding member 22 of the headgear 10.

[0306] In some embodiments, the protrusion or boss may include a first portion 35 that has a smaller diameter or cross-sectional area than a second portion 36. The second portion 36 may be configured to retain the protrusion or boss 21 within the recess or aperture 21.

[0307] Alternatively, the connecting portion or connecting arrangement 20 includes a protrusion or boss configured to be received in a recess or aperture. The protrusion or boss 21 a may be located on the flexible joint 13 or on a sliding member 22 of the headgear 10, and the recess or aperture may be located on the interface or part of the interface.

[0308] In some embodiments, the connecting portion or connecting arrangement 20 may include a slot 37 and a protrusion 38. The slot 37 or protrusion 38 may be disposed in or form part of one or more of the flexible joints 13, or at least one headgear member (e.g., band 11 or arm 12) with the remaining portion (i.e., protrusion 38 or slot 37) may be disposed in one or more of: an interface (e.g., interface 1, or any of the interfaces as shown in Figs. 1, 3A-13C), or a part of an interface, an arm (e.g., side arm 4) adapted to connect to or form part of an interface. Such a connecting arrangement 20 is shown in Figs. 14C and 14D. The slot 37 and protrusion 28 may be connected by one or more connecting features, or by any adhesive, or alternatively by overmolding.

[0309] In some embodiments, the connection portion or arrangement 20 may be one or more of: a snap fit, a lock / key arrangement, a male / female connection, or a socket arrangement.

[0310] In some embodiments, the arms of the interface, the flexible joints, and / or the sliding members of the headgear may include one or more corresponding connecting portions or arrangements. Multiple corresponding connecting portions or arrangements may be provided on the arms of the interface, the flexible joints, and / or the sliding members of the headgear to provide a range of sizes, such as adjustments along height, e.g., the distance from the chin to the level of the top of the user's head, and / or depth, e.g., from the front to the back of the user's head.

[0311] 11C-12B, connecting portion 20 is not shown, but examples of locations of connecting portion 20 are shown. It is understood that these embodiments can be modified to include connecting portion 20, as described above.

[0312] In some embodiments, the headgear and the interface, or part of the interface, or an arm adapted to connect to or form part of the interface, may be integrally formed.

[0313] In some embodiments, the headgear members 11, 12 are movably attached to a flexible joint so as to be movable relative to adjacent headgear members along the longitudinal axis of the end portions of the headgear members 11, 12 attached to the flexible joint.

[0314] In some embodiments, the headgear members are telescopically attached to the flexible joints. One or both arms 12 may be movably attached to a respective flexible joint 13 to allow the arms 12 to move along the longitudinal axis of the end portion of the arm attached to the flexible joint. The arms or members may be received in holes or recesses in the flexible joints and slide therein to form a telescopic engagement.

[0315] An embodiment of such a telescopic arrangement is shown in Figures 13A-13C, which show a sliding member 22 configured to slide relative to a headgear member (e.g. headband 11, or end 12a of elastic arm 12). In some embodiments, there may be a pair of sliding members 22. The sliding member 22 may be or include a flexible joint (as described above). The sliding member 22 may include at least one passageway 23. The sliding member 22 may be or include a hollow or tubular member, which may form said passageway 23. The at least one passageway 23 may be configured to allow a headgear member to pass through. The headgear member may be configured to move or slide relative to the sliding member 22.

[0316] In some embodiments, an end of at least one headgear member extends past or beyond the sliding member 22. In some embodiments, an end of at least one headgear member may be configured to rest against a portion of the patient's head or face during use.

[0317] As shown in FIG. 4A, in some embodiments, the flexible joint may include one or more openings, each opening (15 in FIG. 4A but hidden from view) allowing an end of the headband 11 or an end 12a of the elastic arm 12 to extend through a side of the flexible joint. The relative position of the headgear members may be adjusted by pushing the headgear members through the openings to position the flexible joint at a desired longitudinal position along the headgear members, or by positioning the arms within the flexible joints, as shown in FIG. 4B. The relative movement between the headgear members and the flexible joints allows for size adjustment of the headgear to accommodate users of different sizes. Size adjustment may be in the forward direction and / or in the upward or vertical direction.

[0318] 13A-13C, the headgear member may include at least one stop 24, 25 that limits movement of the headgear member relative to the sliding member 22 and / or the at least one passageway 23. The at least one stop may be located at or near an end of the headgear member (e.g., stop 24) and / or along the length of the headgear member (e.g., stop 25).

[0319] At least one stop must: i bump ii Recess iii) a barbed end (e.g., as shown by stop 24); iv. Optionally, a local increase or decrease in thickness or cross-sectional area of ​​the headgear member relative to the size of at least one passageway (e.g., as indicated by stop 25). may include one or more of:

[0320] In some embodiments, the headgear member (e.g., headband 11) includes one or more of: a first stop 24, and a second stop 25. The first stop 24 may provide a first limit of movement of the headgear member relative to the sliding member 22 (which may be a flexible joint) and / or the at least one passageway 23. The second stop 25 may provide a second limit of movement of the headgear member relative to the sliding member 22 (which may be a flexible joint).

[0321] In some embodiments, the flex joints may allow for relative movement (optionally by extension of the flex joints) of approximately or about 5 mm to approximately or about 20 mm. In some embodiments, each flex joint provides stepped telescopic movement in increments of approximately 5 mm, for example by engaging and disengaging notches in, along and / or at passage 23.

[0322] In some embodiments, the sliding member 22 includes a connecting portion 20 as described elsewhere herein. In some embodiments, the connecting portion 20 can be located on one side of the sliding member 22, and the connecting portion 20 may be located away from the center of the sliding member 22, or the passageway 23, as shown, for example, in Figures 13A-13C. The connecting portion 20 may be located on the side of the sliding member 22 opposite the patient's face. In some embodiments, the connecting portion is located on a lower portion of the sliding member.

[0323] The headgear may include an interface, and the headgear and interface may be configurable between a storage configuration and an in-use configuration.

[0324] In some embodiments, the interface may pivot and / or hinge about the headgear via the connecting portion 20 so that the headgear folds toward the headband 11, thereby providing a thinner profile or low profile storage configuration. In some embodiments, the interface may pivot and / or hinge about the headgear via the flexible joint 13 so that the headgear folds toward the headband 11. The headband 11 and the interface may fold toward a common plane so that in the storage configuration the interface and headgear may be folded in a common plane. The in-use position may be as shown in any of FIGS. 1-10, where the interface is angled from the headgear.

[0325] In some embodiments, the slide member 22 may include an engagement portion 33 as described below. The slide member 22 may have at least one engagement portion. In some embodiments, the pair or each of the slide members 22 has an engagement portion 33.

[0326] In some embodiments, the sliding member may be made of a stiffer material than the at least one headgear member and / or headband. In some embodiments, the sliding member may be made of a more flexible material than the at least one headgear member and / or headband.

[0327] In some embodiments, the sliding member may be configured to modify the profile of the headgear member passing through the passageway to provide a predetermined profile to a section of the headgear member in the area passing through the passageway, which may be a straight section or a curved section.

[0328] The longitudinal movement may be indexed or otherwise settable to set the longitudinal position of the headgear member relative to the flexible joint. In such an embodiment, the longitudinal position may be set such that the member is substantially not free to move relative to the flexible joint.

[0329] In some embodiments, the headgear members may include ridges or depressions (e.g., small indentations or grooves) that are received into corresponding depressions or ridges in the flexible joint to provide an indexing arrangement to set the longitudinal position of the members relative to the flexible joint.

[0330] In some embodiments, the headband and / or arms are marked with size markings that may be aligned with corresponding markings or other features on the flexible joint.

[0331] In some embodiments, each flexible joint of the pair of flexible joints engages a respective side of the user's head during use.

[0332] In some embodiments, the headband is shaped to fit over the top of the user's head, with each end of the headband positioned on a respective side of the user's head.

[0333] In some embodiments, headband 11 is a resilient headband shaped to fit the user's head, with each end of the headband positioned on a respective side of the user's head and each flexible joint attached to a respective end or end portion of the headband.

[0334] In some embodiments, the pair of flexible joints 13 provide or include a pair of engagement portions 33, each of which is configured to engage the side of the user's head during use.

[0335] As mentioned above, in some embodiments, the flexible joints may be adapted to attach directly to the patient interface or may interconnect adjacent headgear members, such as members 11 and 12 shown in Figure 1. In Figure 1, arms 12 are removably coupled to interface 1. Arms 12 couple directly to side arms 4 of interface 1, for example to the ends of arms 4. Each arm 12 couples to one outer end of the interface, and the outer ends are laterally opposite each other. In some embodiments, one or both arms 12 may be resilient arms.

[0336] In some embodiments, the headband is shaped to fit over the top of a user's head. In some embodiments, the headband is configured such that, in use, the flexible joints connecting the arms to the headband: i) adjacent to the user's temporal bone, such that when viewed in side profile, the flexible joint contours inward in front of the user's ear and above the cheekbone or zygomatic arch; or ii) In front of the ears near the cheekbones when viewed in side profile It is shaped in such a way that it can be placed.

[0337] 12 and 12A, headband 11 includes a central portion 30 and one or more end portions 31. In use, the end portion or portions may be positioned at one or each side of a user's head. The central portion 30 may be angled relative to the end portion or portions to fit around the back of the user's head in use. The central portion 30 adapted to fit around the back of the user's head in use allows the headband to be adapted to a wide range of user head sizes.

[0338] In some embodiments, the headband is a resilient band, for example a headband formed from a resilient material. One or both arms may be resilient arms and may be formed from the same resilient material as the headband material.

[0339] In some embodiments, the resilient headband is shaped to fit the user's head, with each end of the headband positioned at and biased against a respective side of the user's head.

[0340] In some embodiments, in a non-flexed condition, the distance between the ends of the headband is less than the width of the user's head, such that flexing of the headband to fit the user's head biases the ends of the headband against the sides of the user's head during use.

[0341] The headband is of sufficient length relative to its cross-section and is sufficiently flexible to allow the user to spread the ends of the headband apart and provide a comfortable amount of force against the sides of the user's head. The amount of bias provided by the headband provides a force on the user's head that is comfortable but helps maintain a correct position on the user's head.

[0342] In some embodiments, the geometry of the arm 12, for example its length and cross-sectional area, may prevent significant deflection of the arm during normal use.

[0343] Arm 12 is short enough relative to its cross-sectional area to resist lateral bending or twisting.

[0344] In at least the embodiment shown in Figures 1-6, the arms 12 may be made from the same material as the elastic headband 11, but are rigid (eg, do not substantially flex under normal use conditions).

[0345] In particular, when the interface is substantially soft and flexible as in the embodiment of Figures 3A-6, the arms 12 are rigid. The rigid arms 12 help to maintain a robust connection between the headband 11 and the interface 1, and the arms 12 act to efficiently transfer forces from the interface 1 to the flexible joint 13.

[0346] In some embodiments, the central portion 30 of the headband 11 is relatively stiff or stiffer or less flexible than the end portions 31. The central portion 30 may have a larger cross-sectional area than the end portions 31. The central portion 30 may have a different cross-sectional area than the end portions 31.

[0347] In some embodiments, the central portion 30 is made of a first material and the end portions 31 are made of a second material, and the first material is relatively stiff or stiffer or less flexible than the second material. In some embodiments, the relative stiffness of the central portion 30 with respect to the end portions 31 may be provided in a particular direction, for example, toward the user.

[0348] The elastic headband and / or the elastic arms may have a rectangular cross-section, a trapezoidal cross-section, a circular cross-section, or any other suitably shaped cross-section.

[0349] Preferably, a cross-section with a flat surface is employed to provide a sufficient contact area with the user's head so that there is sufficient friction to hold the headband in a desired position. The flat surface rests on the user's head and / or face. The cross-section of the headband and / or arms may vary along their length, e.g., widen or narrow, to provide greater or less force distribution around the patient's face and / or head area.

[0350] In some embodiments, the elastic modulus (Young's modulus) of at least one of the headgear members is at least about 0.5 GPa, or at least about 1 GPa, or at least about 1.5 GPa, or at least about 1.8 GPa, or at least about 2 GPa, or at least about 3 GPa. For example, the headband or the headgear and arms may be formed from polymers including, but not limited to, rubber (natural and synthetic) and plastics, such as acrylonitrile butadiene styrene (ABS), polyethylene terephthalate glycol (PETG), and polypropylene (PP), which have an elastic modulus of about 1 GPa to 3 GPa. In some embodiments, the headband or the headband and arms may be formed from a metallic material, such as high tensile steel. Thus, the Young's modulus of the headgear members may be 200 GPa or even higher.

[0351] In some embodiments, the headband, or the headgear and arms, may be formed from a resilient material that is substantially non-brittle.

[0352] In some embodiments, one or more of the headgear members, e.g., headband 11 and / or arms 12, may include a plastic core and a textile casing that are formed as a unitary structure by applying a molten plastic material to a textile or natural fiber casing or a composite of textile and natural fiber, e.g., as described in PCT application published as WO 2016 / 043603, the contents of which are incorporated herein by reference.

[0353] The textile may be a synthetic textile or a textile made from natural fibers. Examples of natural fibers include wool, jute, and flax. The plastic core of the headgear member may provide the elasticity, so the member is an elastic member. Additionally or alternatively, an elastic member, such as a metal band, may be provided within or together with the plastic core to provide sufficient elasticity.

[0354] In contrast to the headgear members, such as members 11 and 12, the flexible joints may be formed from a resilient material with a significantly lower modulus of elasticity. For example, the flexible joints may be formed from a material with a modulus of elasticity of less than about 0.2 GPa, or less than about 0.1 GPa, or less than about 0.06 GPa. An exemplary material is silicone rubber, whose Young's modulus may be 0.05 GPa or less. Thus, in some embodiments, the headgear members are formed from a relatively hard resilient material and the flexible joints are formed from a correspondingly relatively soft flexible material, the modulus of elasticity of the hard resilient material being many times higher than the modulus of elasticity of the soft flexible material. The soft flexible material is resilient and deforms without plastic deformation under normal conditions of use. However, it is much more flexible than the material of the headgear members.

[0355] In some embodiments, the modulus of elasticity of the hard resilient material of the headgear members is at least 10 times that of the soft flexible material of the flexible joints, or at least 20, or 40, or 100, or 200 times that of the soft flexible material.

[0356] In some embodiments, the flexible joint 13 isolates or separates the movement of the interface from the headband so that the headband may be less distributed on the user's head.

[0357] In some embodiments, the headgear is held on the user's head mostly by the headband, and the flexible joints 13 may serve to isolate the lower portion of the headgear and / or interface to avoid or reduce interference with the bias provided by the headband towards the sides of the user's head.

[0358] In some embodiments, at least one positioning tab 14 or positioning member 26 is connected to or forms part of at least one of the headgear members. For example, in some embodiments, the headgear has a pair of positioning tabs 14 or positioning members 26, each tab or member located at or near an end or end portion of the headband 11. At least one positioning tab or positioning member may allow a user to apply and remove the headgear.

[0359] In some embodiments, the tab or member may be positioned to be placed against the side of a user's head during use.

[0360] In some embodiments, a positioning tab or member 26 is provided on one of the aforementioned flexible joints 13. For example, the tab 14 or member 26 may be integrally formed with the flexible joint.

[0361] In some embodiments, at least one of the positioning tabs 14 or positioning members 26 is connected to or integrally formed with a headgear member. The flexible joint comprising the tabs 14 or members 26 may be a unitary member.

[0362] In some embodiments, the tabs 14 or members 26 include indicia that indicate the direction in which to pull the tab to remove the headgear from the user's head, for example the tabs or members may include an arrow attached or formed on the tab as shown in the drawings, the arrow indicating the direction to pull to remove the headgear. In some embodiments, the tabs or members may extend from the headgear members such that during use the tabs protrude or extend outwardly from the user's head.

[0363] 11-11C, in some embodiments, at least one positioning tab 14 or positioning member 26 may be provided by a substantially U-shaped portion. The positioning tab 14 or positioning member 26 may include a first portion 27 that extends outwardly from the headgear member (e.g., outwardly from the user's head) in use, and a second portion 28 that extends towards the headgear member (e.g., towards the user's head) in use.

[0364] In some embodiments, the positioning tab 14 or positioning member 26 includes an intermediate portion 29 located intermediate the first portion 27 and the second portion 28, which may extend substantially parallel to the headgear member (e.g., parallel to the user's head) during use. The geometry of the positioning member may provide for a channel 32, as described below.

[0365] 3C shows the deflection of the headgear 10 and patient interface 1 laterally relative to the sagittal plane of the user. A user or physician may apply and remove the headgear by pulling on the tabs, for example by grasping them between thumb and index finger. Once the headgear is placed on the user's head, a physician may use the tabs to reposition the headband, for example by adjusting the angle of the headband relative to the arms 12, to better support or position the patient interface and / or increase patient comfort.

[0366] In some embodiments, such as those shown in FIGS. 11B and 11C, the headband 11 may include one or more flexible joints 13. FIGS. 11B and 11C show the deflection of the headgear 10 in a direction along the frontal plane (i.e., perpendicular to the sagittal plane of the user). In other words, FIGS. 11B and 11C show the deflection of the headgear 10 in a direction from the patient's chin toward the forehead, or from the patient's forehead toward the chin. The solid line section 10″ shows the original undeformed shape of the headgear 10. The dashed line section 10′ shows the deformed shape of the headgear when it is stretched substantially in the frontal plane (e.g., when attached or worn by a user). The interface may be fitted to a user by stretching the flexible joints 13 to allow the headgear to deform to conform to the shape of the user's head. Once the stretching force is removed, the headgear may return toward its undeformed shape 10″ and engage the user's head.

[0367] In some embodiments, when a force is applied to the headgear to place the headgear and / or interface on the user's head, the shape of the headgear changes from a generally oblong shape to a rounded rectangular shape.

[0368] In some embodiments, positioning tabs 32 may be provided as part of or separate from flexible portion 32, which may assist the user in donning the headgear, as described elsewhere herein.

[0369] In some embodiments, a user pulls or twists the tab or member to apply a torsional force to the headgear member, twisting the headgear member to open the headgear (e.g., in a direction along the sagittal plane of the user's head during use) so that the headgear can be applied to or removed from the user's head. The headgear member and / or flexible joints may be configured to deform torsionally when a force is applied to the tab or member. Applying a force (e.g., pulling) to the tab or member may elastically deform the headgear (e.g., one or more flexible joints, headband, arms, or any other headgear member). Once the force is removed, the headgear may return toward an initial rest state, thereby engaging the user's head. In some embodiments, there may be no flexible joints (e.g., in Figures 11, 11A, 12, and 12A, where the headband 11 may be configured to connect directly to the patient interface), or the flexible joints may be configured to deform torsionally.

[0370] In some embodiments, the headband may be made from a material such as PETG (glycol-modified polyethylene terephthalate).

[0371] In some embodiments, the headgear includes a pair of engagement portions 33, each configured to engage the side of the user's head during use.

[0372] In some embodiments, each engagement portion 33 frictionally engages the side of the user's head. One or more of the engagement portions 33 may be integral with the headgear, or a portion thereof, and / or at least one flexible joint, and / or may be a separate, removable portion. The engagement portions 33 may provide friction pads to engage the user's head and enhance contact with the user's face. In some embodiments, the engagement portions 33 may include a textured surface to contact the user's head and enhance friction between the headgear and the user's head to help maintain the headgear in place on the user's head.

[0373] In some embodiments, the textured surface may include one or more of: knurled portions, corrugated surfaces, ribbed surfaces, rough surfaces, or may include micro- or nano-projections.

[0374] In some embodiments, the engagement portion 33 may include an adhesive for engaging with the user's head. The adhesive may be a biocompatible adhesive. The headgear may include a removable cover, e.g., a peelable layer, over the top of the adhesive to be removed prior to use.

[0375] In some embodiments, the pair of flexible joints 13 are or include a pair of engagement portions 33, each flexible joint of the pair of flexible joints configured to engage the side of a user's head during use. For example, a textured pad or surface may be provided on an inner surface of the flexible joint to engage the side of a user's head.

[0376] In some embodiments, the headgear members 11, 12 are interconnected to form a continuous loop together with the patient interface during use. Referring to FIG 1 as an example, the continuous loop is formed from the interface 1, around the loop, by the manifold section 5, the interface side arm 4, the headgear arm 12, the flexible joint 13, the headband 11, the flexible joint 13, the headgear arm 12 and the interface side arm 4. The continuous loop includes an upper and lower portion, the ends of the upper portion and the lower portion being interconnected by a pair of flexible joints 13.

[0377] In some embodiments, the upper portion is provided by the headband 11 and the lower portion is provided by the headgear arms 12 and the patient interface 1 .

[0378] As previously mentioned, in some embodiments, the arms and headband may be movably attached together for relative movement therebetween along the longitudinal axis of the end portions of the arms. Thus, in some embodiments, at least one end portion of the lower portion may be movably attached to an end of the upper portion for relative movement therebetween along the longitudinal axis of the end portion of the lower portion. This movement allows the length of the loop to be adjusted to accommodate the size of the user's head.

[0379] In some embodiments, the end portion of the lower portion is telescopically attached to the end of the upper portion, for example in a telescopic arrangement as described above. The positioning tab is preferably attached to the upper portion, for example to the upper side of the joint.

[0380] In some embodiments, at least one positioning tab is connected to at least one of the upper and lower portions. In some embodiments, headgear pieces that are interconnected to form a continuous loop may be connectable or disconnectable to one another to provide a point at which the continuous loop may be opened. This may be useful when the headgear needs to be removed from the user without interfering with other equipment that may be attached to the user.

[0381] In some embodiments, the continuous loop may be connectable and disconnectable between the headgear members and the interface (i.e., by the connection arrangement 20) and / or between adjacent headgear members. If the headgear is telescoping as described above, the sliding member 22 may be disconnectable from the headband 11 to break the continuous loop.

[0382] In some embodiments, the headgear may include a channel 32 that allows passage of an instrument or accessory (e.g., an arm of glasses) from one side of the headgear to the other. The channel 32 may be located in or form part of one or more of: the flexible joint 13, or the positioning tab 14, or the positioning member 26, or at least one headgear member, or the engagement portion 33.

[0383] In some embodiments, the channel may form a channel passage between a surface of the flexible joint, or at least one headgear member, or at least one positioning tab, or positioning member, or engagement portion 33, and the patient's head. The channel 32 may extend from the front side of the headgear to the rear side of the headgear. The channel 32 may extend from the front side of the flexible joint 13, or positioning tab 14, or positioning member 26, or at least one headgear member, or engagement portion 33 to the rear side of the flexible joint 13, or positioning tab 14, or positioning member 26, or at least one headgear member, or engagement portion 33.

[0384] 11-11C, the channel may be provided by a substantially U-shaped portion. The headgear may include an engagement portion disposed on one or both sides of the channel 32 for resting on the user's face during use. In some embodiments, the channel may be provided as part of the engagement portion 33.

[0385] 2D and 3D, headband 11 is curved and lies primarily in a plane, and arms 12 each extend primarily in a transverse plane to the plane of the headband. In the illustrated embodiment, each arm is curved and lies primarily in a transverse plane to the plane of the headband.

[0386] In some embodiments, a flexible joint may be provided such that each arm lies in a transverse plane relative to the plane of the headband, and / or the arms 12 may be curved and lie primarily in a transverse plane relative to the plane of the headband.

[0387] Referring to Figures 2C and 3C, in some embodiments, when the headgear is in use, e.g., positioned on a user's head to hold the interface 1 in place, and when viewed from the front (e.g., looking at the patient's face), the headgear forms a loop together with the interface 1, and the loop has a narrow portion 21 between the top 11c of the headgear 10 and the bottom 12a, 12b of the headgear.

[0388] In some embodiments, the headgear 10 has a first lateral distance 21 between the portions of the headgear that engage the user's head (e.g., the flexible joints 13 provide or form engagement portions for contacting the head), a second lateral distance 22 between the left and right side portions 11a and 11b of the headband 11 intermediate the engagement portions 13 and the sagittal plane position 11c of the headband, and a third lateral distance 23 between the ends or end portions 12a and 12b of the headgear that are attached or attachable to the patient interface 1. The lateral distances are across and perpendicular to the sagittal plane. In FIG. 2C, the sagittal plane is identified by reference numeral 24.

[0389] In some embodiments, the first lateral distance 21 is less than the second lateral distance 22 and the third lateral distance 23. In some embodiments, the second lateral distance 22 is greater than the third lateral distance 23. In use, the user's head is clamped between the engagement portions of the headgear located at the smallest lateral distance. These engagement portions are biased against the user's head by the headband 11, as previously described.

[0390] In some embodiments, this arrangement provides contact with the user's head at the engagement portion. The portion of the headgear between the engagement portion and the interface 1 may not contact, or may have minimal contact with, the user's head or face. For example, the arm 12 may not rest against the user's face, or may have minimal contact with the user's face. The arm 12 may support a side portion of the interface 1, such as the side arm 4, away from the user's face, or may support the interface, or may have minimal contact with the user's face.

[0391] As mentioned above, in some embodiments, the headgear arms 12 may be elastic, ie, formed from an elastic material.

[0392] In some embodiments, the arms may be stiff so as to resist significant bending under normal operating conditions.

[0393] In some embodiments, the arms may be curved in at least one center of curvature in front of the side arms in side view, for example as shown in Figures 2D and 3D. With the ends of the headband placed on the sides of the patient's head, the curvature of the arms 12 may help to provide correct positioning of the patient interface 1 on the user's face and / or reduce contact between the interface and the user's face. Correct positioning of the interface may also be provided by the flexible joints described above.

[0394] In some embodiments, the headgear may include a pair of flexible joints for attaching the headgear to the patient interface, or the patient interface may include a pair of flexible joints that connect to the headgear. For example, the arm 12 may be connected to the patient interface by a pair of flexible joints. The flexible joints that connect the headgear to the interface may be as described above. For example, in some embodiments, the arm 12 may be integrally formed with or part of the patient interface, and the headband 11 may be connected to a side arm of the patient interface via a flexible joint 13.

[0395] In some embodiments, as described in U.S. Provisional Patent Application No. 62 / 399,893 and shown in Figures 3A and 3B herein, one or both arms 12 may be integrally formed with a portion of the patient interface, such as the "plug" 708 and "conduit connector" 707 of the interface.

[0396] In some embodiments, the arms 12 may be integrally formed with the headband in a single continuous member.

[0397] In some embodiments, the headgear may include two pairs of flexible joints 13, one pair connecting between the headband 11 and the arms 12 and another pair connecting between the arms 12 and the patient interface 1.

[0398] In some embodiments, the or each arm 12 may be attached to the patient interface by a ball joint. As mentioned above, in some embodiments, the arms may be resilient. Alternatively, in some embodiments, the arms 12 may be formed from a soft, flexible material. For example, the arms 12 may be integrally formed with the flexible joint 13.

[0399] The integrally formed flexible joint and arm member may include a flexible section, for example provided by a hollow section, that forms the flexible joint, and a less flexible or stiffer section, for example provided by a solid cross section, that forms the arm 12.

[0400] The cannula or interface may be made of a flexible material so that the side arms 4 of the cannula or interface can flex relative to the prongs. This flexibility provides additional adjustability of the headgear relative to the prongs as the side arms of the cannula or interface move relative to the prongs.

[0401] In some embodiments, the resilient headband 11, the flexible joint 13 and / or the resilient arms 12 may be or include conduits. For example, the resilient headband conduits may provide a flow path for supplying inlet gas to the patient interface while at the same time securing the headgear to the patient's face and head. The arms 12, the flexible joints 13 and the headband conduits may be interconnected in fluid communication. For example, the ends of the arms and the ends of the headband may be received in the flexible joints.

[0402] 5A, 5B and 6, in some embodiments, a second headband 16 may be further provided to enhance fixation to the patient's head. The second headband 16 may be engageable with the back of the user's head, and the second headband may engage a portion of the user's head behind the top of the user's head. The second headband 16 may be elastic, flexible, with a reduced modulus of elasticity compared to the headband 11, or may be a stretchable strap or elastic cord. The second headband may be an elastic strap or band. The elastic strap or band may be elastic, and / or stretchable and / or extensible. The second headband may be detachable from the remaining headgear components. The second headband may be attached or releasably attached to the elastic headband 11 or the flexible joint 13. The flexible joint 13 may have a "Y" shape to accommodate both the first headband 11 and the second headband 16.

[0403] In some embodiments, as shown for example in FIG. 5C, headband 11 may include a groove or cavity to store the second headband when the second headband is not needed during use.

[0404] In some embodiments, the grooves or cavities may be scalloped or valleys and may be C-shaped. In a storage or non-use configuration, a second headband, e.g., an elastic strap, is held in a groove or channel in the outer surface of the elastic headband 11, as shown in FIG. 5A. The second headband may be removed from the groove or channel for use, as shown in FIG. 5B. Alternatively, the second headband 16 may be held by a retaining clip provided on the elastic headband 11.

[0405] In some embodiments, a second headband 16 may be provided on the headgear. The second headband may be secured to the headband or an arm or a flexible joint by a connection feature allowing the second headband to be connected to the headband. Such connection features may include, for example, clips, connectors, grooves, or buckles.

[0406] 6 shows a second headband 17 which is an elastic band, which may be attachable to the headgear by a connector 18. The strap may include a connector half, and the first headband, a flexible joint or arm may include a corresponding connector half.

[0407] Figures 7A-7C show headgear together with an interface similar to the headgear and interface shown in Figures 3A-3D. In Figures 7A-7C, the arms 12 of the headgear include a larger vertical dimension as compared to the arms 12 of the embodiment shown in Figures 3A-3D. In Figures 7A-7C, the arms may contact the user's face to help support and maintain the interface in the correct position on the user's face, as shown in Figure 7C. As shown in Figures 7B and 7C, the headgear may have a band or other feature 19 to secure the breathing conduit to the arms 12.

[0408] 11-11A show headgear connectable to the interface. The headgear 10 may include a headband including a positioning member 26.

[0409] In some embodiments, the positioning member 26 may perform the function of the flexible joint 13 .

[0410] In some embodiments, the positioning member 26 can be used to seat the headgear on a user by the user pulling or applying force to the positioning member 26. This can expand the profile of the headgear in the frontal plane of the user. The embodiment of Figures 11-11A also includes a channel 32 that provides a channel path between the user and the headgear 10.

[0411] 13A-13C show various headgears connectable with the interface. The headgear 10 comprises a pair of sliding members 22 configured to slide telescopically relative to the headgear member 11. The sliding members 22 comprise a connecting arrangement 20 for connecting the headgear to an associated interface. The sliding member 22 of FIG. 13A may have a flexible joint 34, allowing movement between the sliding member 22 and the connecting arrangement 20. The flexible joint 34 may be of a more flexible material than the remaining sliding members and / or the connecting arrangement, for example the flexible joint 34 may be made of a more flexible material (relative to the sliding member 22 and / or the connecting arrangement 20) and / or may have a locally reduced cross-sectional area (relative to the sliding member 22 and / or the connecting arrangement 20). The flexible joint 34 may be a living hinge.

[0412] In various embodiments, the slide member 22 includes a positioning tab or member as described elsewhere herein.

[0413] Various embodiments for the headgear described above are shown in Figures 1 and 3A-7C in conjunction with nasal cannulae. However, headgear according to the described embodiments may be used with other types of patient interfaces. For example, in Figure 8, headgear according to the embodiments described herein is shown in conjunction with a full face mask that covers the user's mouth and nose. The face mask includes a seal 6 for contacting the user's face and a body 7. Side arms 12 of the headgear may be connected to the body 7 by a connector or may be formed together with the body.

[0414] 9 shows headgear according to embodiments described herein along with a patient interface that includes nasal pillows that engage the user's nostrils. Other under-nose interfaces may also be used, such as interfaces that seal against or over the base of the user's nose.

[0415] Figure 10 shows headgear according to an embodiment described herein together with a nasal interface. The nasal interface includes a body 7 and a nose seal 6 that seals over the top of the user's nose.

[0416] The headgear may also be provided as part of an assembly that includes a patient interface (e.g., as described above), which may be a nasal cannula, a full face mask, a nasal pillows mask, a nasal mask, an endotracheal tube, or a breath collector / sampler for sampling gases.

[0417] In some embodiments, the interface may be a sealing or non-sealing interface.

[0418] In some embodiments, a method is provided for fitting headgear to a user's head. The method includes applying a lateral force to each side or end of a resilient headband 11 against an inward bias provided by the resilient headband to deform both ends of the headband outward. The method then includes positioning the headband over the top of the user's head and removing the lateral force from each side or end of the resilient headband to hold the headgear against the user's head such that the bias of the headband presses an engagement portion of the headgear (e.g., flexible joint 13) against the side of the user's head.

[0419] In some embodiments, the relative position between the headband and the patient interface is adjusted by flexing the flexible joint 13 to properly position the patient interface over the user's nose, mouth, or nose and mouth. The headband may be positioned over the top of the user's head and / or the engagement portion may be: a) near the user's temporal bone, such that when viewed in side profile, the engagement portion contours inwardly in front of the user's ear and above the cheekbone or zygomatic arch; or b) In front of the ear near the cheekbone when viewed in side profile It can be arranged.

[0420] In some embodiments, in a method for donning the headgear, the method includes grasping and pulling the pair of positioning tabs 14 to exert a lateral force on each side or end of the elastic headband of the headgear against the bias provided by the elastic headband, causing the ends of the headband to deform outwardly. The outward force is then removed to position the band correctly in place. The method may further include adjusting the position of the headband 11 or arms 12 relative to the flexible joint 13 to properly position the patient interface over the user's nose, mouth, or nose and mouth.

[0421] The method may further include applying the headband 11 to the user's head without applying a secondary headband or strap behind the user's head. The headband may be applied to the user's head while the user's head is resting on a support (such as a pillow) and without lifting the user's head from the support, and / or the headband may be applied to the user's head without moving the user's head.

[0422] When a patient is under anesthesia or sedated, rapid removal and application of a patient interface may be a higher priority than patient comfort, e.g., due to urgency. Furthermore, comfort is less important in short-term medical procedures compared to the use of a respiratory interface during sleep, e.g., overnight OSA treatment.

[0423] The embodiments described herein may allow for quick application and removal of the patient interface without disturbing the patient's hairnet or the position of the patient's head. The headgear configuration may distribute the weight of the interface and tube 2 across the top of the user's head.

[0424] In some embodiments, the medical professional may adjust the angle of the headband relative to the arms 12 to an optimal position to best distribute the weight of the patient interface and tubing. The headband may be tilted forward or backward to provide additional resistance and force it away from the face. Some embodiments may accommodate a wide range of head sizes, for example by varying the fit provided by the flexible joints 13 and / or by adjusting the longitudinal position between the headgear members. An additional advantage is that the patient interface is held in a stable position on the patient's face due to the resilient support from each side of the user's head.

[0425] The above description of the invention includes preferred forms thereof. Modifications can be made thereto without departing from the scope of the invention as defined by the appended claims.

Claims

1. At least one headgear member; and a pair of flexible joints adapted to connect the one or more headgear members to a patient interface, and / or a pair of flexible joints connecting the headgear members to a plurality of adjacent headgear members; Including, Headgear for a patient interface, wherein each flexible joint allows relative free movement between the one or more headgear members and the patient interface, or between the headgear member and multiple adjacent headgear members.

2. 2. The headgear of claim 1, wherein the flexible joint allows for at least two degrees of relative free movement between the one or more headgear members and the patient interface, or between the headgear member and multiple adjacent headgear members.

3. 2. The headgear of claim 1, wherein the flexible joint allows for at least one degree of relative free movement between the one or more headgear members and the patient interface, or between the headgear member and multiple adjacent headgear members.

4. A headgear according to any one of claims 1 to 3, wherein the flexible joint is extensible (which may be longitudinally or in a direction along the at least one headgear member) to enable relative free movement between the one or more headgear members and the patient interface, or between the headgear member and multiple adjacent headgear members.

5. Headgear according to any preceding claim, wherein each flexible joint includes a hinge, which may be a living hinge.

6. Headgear according to any preceding claim, wherein the flexible joints are adapted to bend or fold transversely to a longitudinal axis of the end portions of the headgear members.

7. Headgear according to any preceding claim, wherein the flexible joint is or includes a unitary member.

8. Headgear according to any one of claims 1 to 7, wherein the flexible joint is a member formed from a soft, flexible material.

9. Headgear according to any preceding claim, wherein the flexible joint is an elastomeric member.

10. Headgear according to any one of claims 1 to 9, wherein the flexible joint is a hollow or tubular member.

11. Headgear according to any preceding claim, wherein the flexible joint or the at least one headgear member comprises a connecting portion or arrangement.

12. 12. The headgear of claim 11, wherein the connection portion or connection arrangement is configured to provide connection with one or more of: an interface (or part of an interface), an arm adapted to connect to or form part of a patient interface.

13. 13. Headgear according to claim 11 or 12, wherein the connecting portion or arrangement is configured to provide a pivotal connection.

14. 14. Headgear according to any one of claims 11 to 13, wherein the connecting portion or connecting arrangement comprises a recess or aperture configured to receive a protrusion or boss, the protrusion or boss may be located in an interface or part of an interface, and the recess or aperture may be located in the flexible joint.

15. 15. A headgear as claimed in any one of claims 11 to 14, wherein the connecting portion or connecting arrangement comprises a protrusion or boss configured to be received by a recess or aperture, the protrusion or boss may be located in the flexible joint and the recess or aperture may be located in an interface or part of an interface.

16. Headgear according to any preceding claim, wherein the at least one headgear member is integral with the flexible joint.

17. Headgear according to any preceding claim, wherein the flexible joints deform elastically (without permanent deformation) under conditions of use.

18. A headgear according to any preceding claim, wherein the flexible joint allows rotation of the headgear member relative to an adjacent headgear member about a longitudinal axis of an end portion of the headgear member attached to the adjacent headgear member.

19. Headgear according to any preceding claim, wherein the headgear members are movably attached to the flexible joints for movement relative to adjacent headgear members along a longitudinal axis of the headgear member.

20. 20. Headgear according to claim 19, wherein the headgear members are telescopically attached to the flexible joints.

21. 21. Headgear according to claim 20, wherein the headgear members are telescopically received in end portions of the flexible joints.

22. A headgear as described in any one of claims 1 to 21, wherein the flexible joint includes at least one passageway (which may be or include a hollow or tubular member), and the at least one passageway is configured to allow the headgear member to pass therethrough.

23. 23. Headgear according to claim 22, wherein the headgear members are configured to move or slide within the at least one passageway.

24. 24. A headgear as described in claim 22 or 23, wherein the headgear member includes at least one stop for limiting movement of the headgear member relative to the flexible joint and / or the at least one passageway, and the at least one stop may be located at an end of the headgear member.

25. The at least one stop comprises: i bump ii. Recess iii. Barbed End iv. a local increase or decrease in thickness or cross-sectional area of ​​said headgear member, optionally related to the size of said at least one passageway.

25. The headgear of claim 24, comprising one or more of the following:

26. 26. A headgear as described in claim 24 or 25, wherein the headgear member includes one or more of a first stop and / or a second stop, the first stop providing a first limit of movement of the headgear member relative to the flexible joint and / or the at least one passageway, and the second stop providing a second limit of movement of the headgear member relative to the flexible joint and / or the at least one passageway.

27. A headgear as claimed in any preceding claim, wherein the at least one headgear member is releasably attachable or connectable to or from an adjacent headgear member and / or the flexible joint, and removable or disconnectable therefrom.

28. Headgear according to any preceding claim, wherein an end of the at least one headgear member extends past or beyond the flexible joint.

29. Headgear according to any one of claims 1 to 28, wherein the headgear includes at least one pair of the flexible joints, and each flexible joint of the pair of flexible joints engages, in use, a respective side of the user's head.

30. 30. A headgear according to any one of claims 1 to 29, wherein the at least one elastic modulus of the headgear member is at least about 0.5 GPa, or at least about 1 GPa, or at least about 1.5 GPa, or at least about 1.8 GPa, or at least about 2 GPa, or at least about 3 GPa.

31. Headgear according to any one of the preceding claims, wherein the flex joints are formed from a material having a modulus of elasticity of less than about 0.2 GPa, or less than about 0.1 GPa, or less than about 0.06 GPa.

32. Headgear as described in any one of claims 1 to 31, wherein at least one of the headgear members is formed from a hard, resilient material and the flexible joint is formed from a soft, flexible material, the elastic modulus of the hard, resilient material being many times greater than the elastic modulus of the soft, flexible material.

33. 33. Headgear according to claim 32, wherein the modulus of elasticity of the hard, resilient material is at least 10 times that of the soft, flexible material, or at least 10, or 20, or 40, or 100, or 200 times that of the soft, flexible material.

34. Headgear according to any preceding claim, including at least one positioning tab or member connected to or forming part of at least one said headgear member.

35. 35. Headgear according to claim 34, wherein the at least one positioning tab or member allows a user to apply and remove the headgear.

36. 36. Headgear according to claim 34 or 35, wherein the positioning tab or member is provided by or includes a substantially U-shaped portion.

37. The positioning tab or member may comprise: a first portion that, in use, extends outwardly from the headgear member (e.g., outwardly from the user's head); a second portion that, in use, extends toward a headgear member (e.g., toward the user's head); Including, Headgear as described in any one of claims 34 to 36, wherein the positioning tab or member may include an intermediate portion located intermediate the first and second portions, the intermediate portion extending substantially parallel to the headgear member (e.g. parallel to the user's head) in use.

38. Headgear according to any one of claims 34 to 37, wherein the at least one positioning tab or member is integrally formed with the headgear member.

39. Headgear according to any preceding claim, comprising a pair of engagement portions, each engagement portion configured to engage a side of the user's head in use.

40. 40. Headgear according to claim 39, wherein the pair of flexible joints and / or the at least one headgear member provide or include the engagement portion.

41. 41. The headgear of claim 39 or 40, wherein the engagement portion comprises a textured surface, which may include one or more of: a knurled portion, a corrugated surface, a ribbed surface, a roughened surface, or may include micro- or nano-projections.

42. A headgear according to any one of claims 1 to 41, wherein the flexible joint, a positioning tab or the positioning tab, or the at least one headgear member includes at least one channel, and the channel may extend from a front side of the flexible joint or the at least one headgear member to a rear side of the flexible joint or the at least one headgear member, or the engagement portion or a certain engagement portion.

43. The headgear comprises: a resilient headband shaped to fit over the user's head with each end of the headband positioned on a respective side of the user's head; a pair of arms, each arm attached to the elastic headband, each arm adapted to connect to or form part of a patient interface; and Headgear according to any one of claims 1 to 42, wherein each arm is attached to the headband by a flexible joint that allows the arm to move freely relative to the headband in at least two degrees of freedom.

44. 44. Headgear according to claim 43, wherein each arm is attached to an end or end portion of the headband.

45. 45. Headgear according to claim 43 or 44, wherein each arm is a resilient arm.

46. 46. ​​Headgear as claimed in any one of claims 43 to 45, wherein the resilient headband is shaped to fit a user's head with each end of the headband positioned against and biased against a respective side of the user's head.

47. 47. The headgear of claim 46, wherein in an unflexed condition, the distance between the ends of the headband is less than the width of a user's head such that flexing of the headband to conform to the user's head urges the ends of the headband against the sides of the user's head.

48. Headgear according to any one of claims 43 to 47, wherein the headband is shaped to fit over the top of a user's head.

49. Headgear as described in any one of claims 43 to 47, wherein the headband includes a central portion and one or more end portions, the one or more end portions being positioned at the or each side of the user's head, and the central portion may be angled relative to the one or more end portions to fit around the back of the user's head in use.

50. 50. Headgear according to claim 49, wherein the headband has a central portion and two end portions, the central portion being relatively stiff or stiffer or less flexible than the end portions.

51. 51. Headgear according to claim 49 or 50, wherein the central portion has a larger cross-sectional area than the end portions.

52. A headgear as described in any one of claims 49 to 51, wherein the central portion is made of a first material and the end portions are made of a second material, the first material being relatively stiff or stiffer or less flexible than the second material.

53. Headgear according to any one of claims 43 to 52, wherein the headgear includes a second headband.

54. 54. Headgear according to claim 53, wherein the second headband comprises an elastic strap or band, which may be elastic and / or stretchable and / or extensible.

55. 55. Headgear as described in claim 53 or 54, wherein the second headband is engageable with a back of a user's head, and the second headband may be configured to engage with a portion of the user's head behind the top of the head.

56. Headgear as described in any one of claims 53 to 55, wherein the second headband is adapted to be connected to the headband, and the headband may include connection features adapted to enable the headband and the second headband to be connected and disconnected, and the connection features may include grooves, clips or buckles.

57. The headband is configured such that the flexible joint connecting the arm to the headband, in use: i) adjacent to the user's temporal bone, such that when viewed in side profile, the flexible joint contours inward in front of the user's ear and above the cheekbone or zygomatic arch; or ii) in front of the ear near the cheekbone when viewed in side profile Headgear according to any one of claims 43 to 56, configured to position

58. the headgear having a first lateral distance between the flexible joints, a second lateral distance between left and right side portions of the headband intermediate the flexible joints and a sagittal plane position of the headband, and a third lateral distance between the ends or between the ends of the arms attached or attachable to the patient interface; each lateral distance is transverse to and perpendicular to said sagittal plane; and Headgear according to any one of claims 43 to 57, wherein the first lateral distance is less than the second and third lateral distances.

59. 60. Headgear according to claim 58, wherein the second lateral distance is greater than the third lateral distance.

60. 60. A patient interface and headgear according to any one of claims 43 to 59, wherein the arms are integrally formed with the patient interface.

61. A patient interface and headgear according to any one of claims 1 to 60, wherein the patient interface and headgear form a continuous loop including an upper portion and a lower portion joined by the pair of flexible joints.

62. Patient interface, 62. Headgear according to any one of the preceding claims, configured to position the patient interface on a patient's face in use. A patient interface assembly comprising:

63. 63. The patient interface of claim 62, wherein the patient interface is a nasal cannula, a full face mask, a nasal pillows mask, a nasal mask, an endotracheal tube, or a breath collector / sampler for sampling gases.

64. 60. A method for wearing headgear and a patient interface, said headgear being according to any one of claims 1 to 59.

Images