Headgear for a 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 generally relates to headgear for patient interfaces such as face masks, nasal masks, or nasal cannulas.

Background Art

[0002] A patient may lose their respiratory function during anesthesia, or during sedation, or more generally during a medical procedure. Prior to a medical procedure, a patient can be pre-oxygenated by a medical professional to a state with a store of oxygen saturation, and this pre-oxygenation and flushing / washing out of CO 2 can be carried out using high-flow therapy via a nasal cannula or other patient interface.

[0003] The patient interface can be held in place on the patient's face by headgear. The headgear has head straps that extend around the patient's or user's head to position and hold the patient interface in the correct position and to provide breathing gas to the patient. During the attachment or removal of a nasal cannula or patient interface to an awake or sedated patient, it may be necessary for a medical professional to manipulate the position of the patient's head in order to apply or remove head straps or the like. As a result, this can somewhat compromise the patient's posture and / or comfort, impose an awkward or uncomfortable mechanical load on the medical professional, disrupt the patient's hairnet, and / or cause the medical procedure to take longer.

[0004] Furthermore, an elastic and / or size-adjustable head strap may present disadvantages. It can 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 slide a finger between the head strap and the patient's head, or pull the head strap away from the patient's head by pinching it, or try to drag the head strap across the patient's hair and skin. As a result, the medical professional may accidentally displace the patient's hairnet, or pull on the patient's hair or skin, or cause discomfort.

[0005] References in this specification to patent specifications, other external documents, or other information sources are provided generally to illustrate the features of the invention. Unless specifically indicated otherwise, such references to external documents in any jurisdiction should not be construed as an admission that such documents, or such information sources, are prior art, or form part of the common general knowledge in the art.

Summary of the Invention

Problems to be Solved by the Invention

[0006] An object of the embodiments disclosed in this specification is to provide an improved headgear that can at least somewhat help address one or more of the above disadvantages, or provide useful alternatives for industry or the general public.

Means for Solving the Problems

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

[0008] According to at least one first aspect of the embodiments disclosed herein, 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 for connecting the headgear member to a plurality of adjacent headgear members and, each flexible joint enables relative free movement between one or more headgear members and a patient interface, or between a headgear member and a plurality of adjacent headgear members with at least two degrees of freedom.

[0009] According to at least one second aspect of the embodiments disclosed herein, 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 for connecting the headgear member to a plurality of adjacent headgear members and, each flexible joint enables relative free movement between one or more headgear members and a patient interface, or between a headgear member and a plurality of adjacent headgear members.

[0010] For one or both of the first or second aspects, the following additional features or embodiments are provided:

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

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

[0013] In some embodiments, the flexible joint allows for relative free movement between one or more headgear members and the patient interface, or between a headgear member and a plurality of adjacent headgear members, such that it can be extended (which may be in the longitudinal direction or at least in a direction along one of the headgear members).

[0014] In some embodiments, each flexible joint includes a hinge, which may be an integral hinge.

[0015] In some embodiments, the flexible joint is adapted to bend or fold laterally with respect to the longitudinal axis of the end portion of the headgear member.

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

[0017] In some embodiments, the flexible 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, includes a connection portion or connection arrangement.

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

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

[0023] In some embodiments, the connection portion or connection arrangement configuration includes a recess or aperture configured to receive a protrusion or boss, which may be disposed at an interface or a part of the interface, and the recess or aperture may be disposed in the flexible joint.

[0024] In some embodiments, the connection portion or connection arrangement configuration includes a protrusion or boss configured to be received by a recess or aperture, which may be disposed in the flexible joint, and the recess or aperture may be disposed at an interface or a 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 a part of the interface may be integrally formed.

[0027] In some embodiments, the flexible joint elastically deforms (without permanent deformation) under use conditions.

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

[0029] In some embodiments, the headgear member is movably attached to the flexible joint and moves relative to an adjacent headgear member along the longitudinal axis of the headgear member.

[0030] In some embodiments, the headgear member is telescopically attached to the flexible joint.

[0031] In some embodiments, the headgear member is telescopically received at the end portion of the flexible joint.

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

[0033] In some embodiments, the headgear member is configured to move or slide within the at least one passage.

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

[0035] In some embodiments, the at least one stop includes: i a protrusion ii a recess iii an abutting end iv optionally, a local increase or decrease in the thickness or cross-sectional area of the headgear member with respect to the size of the at least one passage and includes one or more of the above.

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

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

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

[0039] In some embodiments, the headgear includes at least one pair of the flexible joints, and each flexible joint of the pair of flexible joints engages the respective temple of the user 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 joint is formed from a material having an elastic modulus 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 elastic material and the flexible joint is formed from a soft flexible material, and the elastic modulus of the hard elastic material is many times higher than the elastic modulus of the soft flexible material.

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

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

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

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

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

[0049] In some embodiments, the positioning tab or positioning member: a first portion that extends outwardly from the headgear member (e.g., outwardly from the user's head) during use, a second portion that extends toward the headgear member (e.g., toward the user's head) during use and includes The positioning tab or positioning member may include an intermediate portion located between the first portion and the second portion, and the intermediate portion extends 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 positioning member is integrally formed with the headgear member.

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

[0052] In some embodiments, a pair of flexible joints provides or includes the engagement portions.

[0053] In some embodiments, the pair of flexible joints and / or at least one headgear member provides or includes the engagement portions.

[0054] In some embodiments, the engaging portion includes a textured surface, which may include one or more of: a serrated portion, a corrugated surface, a ribbed surface, a rough surface, or may include micro or nano protrusions.

[0055] In some embodiments, the headgear is: An elastic headband shaped to fit the user's head with each end of the headband positioned on each respective temple of the user. A pair of arms, each arm being attached to the elastic headband and each arm being adapted to connect to or be part of the patient interface. Including, and Each arm is attached to the headband by the flexible joint, which allows the arm to move freely with at least two degrees of freedom with respect to the headband.

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

[0057] In some embodiments, each arm is an elastic arm.

[0058] In some embodiments, the elastic headband is shaped to fit the user's head with each end of the headband disposed on each respective temple of the user and biased or urged against it.

[0059] In some embodiments, under non-flexing conditions, the distance between the ends of the headband is less than the width of the user's head, so that the flexure of the headband to fit the user's head biases the ends of the headband against the user's temples.

[0060] In some embodiments, the headband is shaped to fit the user's crown.

[0061] In some embodiments, the headband includes a central portion and one or more end portions, the one or more end portions are disposed on one or each of the user's temples, and the central portion may be angled with respect to the one or more end portions so as to fit around the user's occipital region during use.

[0062] In some embodiments, the headband has a central portion and two end portions, and the central portion is relatively hard, or harder 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, and the first material is relatively hard, or harder 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, and the elastic strap or band may be elastic and / or stretchable and / or extensible.

[0067] In some embodiments, the second headband is engageable with the user's occipital region, and the second headband may be configured to engage 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, and the headband may include connection features adapted to connect and disconnect the headband and the second headband, and the connection features may include grooves, clips or buckles.

[0069] In some embodiments, the headband has a flexible joint connecting the arm to the headband, during use: i) near the user's temporal bone, or such that, when viewed in a side profile, the flexible joint occupies an inward contour above the front side of the user's ear and the cheekbone or zygomatic arch, or ii) in front of the ear near the cheekbone, when viewed in a side profile is shaped to be positioned.

[0070] In some embodiments, during use, the headgear has a first lateral distance between the flexible joints, a second lateral distance between the left and right side portions of the headband, intermediate the sagittal plane position of the flexible joints and the headband, and a third lateral distance between the ends or end portions of the arms attached to or attachable to the patient interface, each lateral distance is transverse to 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 the left and right side portions of the headband, intermediate the sagittal plane position of the flexible joints and the headband, and a third lateral distance between the ends or end portions of the arms attached to or attachable to the patient interface, each lateral distance is transverse to 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 arm is integrally formed with the patient interface.

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

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

[0076] According to at least a third aspect of the embodiments disclosed herein, a headgear for a patient interface is: An elastic headband shaped to fit the user's head with each end of the headband positioned on each respective temple of the user. A pair of elastic arms, each arm being attached to the elastic headband and each arm being adapted to connect to or form part of each patient interface. including, and each arm is attached to the headband by a flexible joint, and the flexible joint allows the arm to move freely with at least two degrees of freedom with respect to the headband.

[0077] In some embodiments, each flexible joint includes a hinge, and the hinge may be a one-piece rivet.

[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 laterally with respect to the longitudinal axis of the end portion of the headband.

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

[0081] In some embodiments, the flexible 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, includes a connection portion or connection arrangement.

[0085] In some embodiments, the connection portion or connection arrangement is configured to provide a connection to 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 connection portion or connection arrangement is configured to provide a pivotal connection.

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

[0088] In some embodiments, the connection portion or connection arrangement includes a protrusion or boss configured to be received by a recess or aperture, which may be disposed on the flexible joint, and the recess or aperture may be disposed on 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 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 flexible joint elastically deforms (without permanent deformation) during use to allow the arm to move freely with respect to the headband.

[0092] In some embodiments, the flexible joint allows rotation of the arm with respect to the headband about the longitudinal axis of the end portion of the arm attached to the headband.

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

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

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

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

[0097] In some embodiments, the headgear member is configured to move or slide within at least one passage.

[0098] In some embodiments, the headgear member includes at least one stop for restricting movement of the headgear member with respect to the flexible joint and / or at least one passage, and at least one stop may be disposed at an end of the headgear member.

[0099] In some embodiments, the at least one stop is: i a protrusion ii a recess iii an abutting end iv Optionally, a local increase or decrease in the thickness or cross-sectional area of the headgear member with respect to the size of at least one passageway including one or more of the foregoing.

[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 to the movement of the headgear member with respect to the flexible joint and / or at least one passageway, and the second stop providing a second limit to the movement of the headgear member with respect to the flexible joint and / or at least one passageway.

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

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

[0103] In some embodiments, the flexible joints at or adjacent to each end of the headband engage the respective temples of the user during use.

[0104] In some embodiments, the elastic modulus of at least one 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.

[0105] In some embodiments, the elastic modulus of the headband 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.

[0106] In some embodiments, the elastic modulus of the arm 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 joint is 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.

[0108] In some embodiments, the headband, or the headband and the arm, are formed from a hard elastic material, and the flexible joint is formed from a soft flexible material, and the modulus of elasticity of the hard elastic material is many times greater than the modulus of elasticity of the soft flexible material.

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

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

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

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

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

[0114] In some embodiments, the positioning tab or positioning member comprises: a first portion extending outwardly from the headgear member (e.g., outwardly from the user's head) during use, a second portion extending towards the headgear member (e.g., towards the user's head) during use and includes. The positioning tab or positioning member may include an intermediate portion located between the first portion and the second portion, and the intermediate portion extends 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 positioning member is formed integrally with the headgear member.

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

[0117] In some embodiments, the pair of flexible joints provides or includes the engagement portion.

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

[0119] In some embodiments, the engagement portion includes a textured surface, and the textured surface may include one or more of: a grooved portion, a corrugated surface, a ribbed surface, a rough surface, or may include micro or nano protrusions, the micro protrusions may be about 1×10-6m, and the nano protrusions may be about 1×10-9m.

[0120] In some embodiments, the elastic headband is shaped to fit the user's head with each end of the headband disposed on and biased against the user's respective temple.

[0121] In some embodiments, under non-flexing conditions, 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 user's temples.

[0122] In some embodiments, the headband is shaped to fit 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 are disposed on one or each side of the user's head, and the central portion may be angled with respect to the one or more end portions so as 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, and the central portion is relatively hard, or harder 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, and the first material is relatively hard, or harder 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, and the elastic strap or band may be elastic and / or stretchable and / or extensible.

[0129] In some embodiments, the second headband is engageable with the back of the user's head, and the second headband may be configured to engage 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 connect and disconnect the headband and the second headband, and the connection features may include grooves, clips or buckles.

[0131] In some embodiments, the headband has a flexible joint for connecting the arm to the headband, and during use: i) when viewed in a side profile, the flexible joint is near the user's temporal bone or above the zygomatic bone or zygomatic arch so as to occupy an inward contour in front of the user's ear, or ii) when viewed in a side profile, it is shaped to be disposed in front of the ear near the zygomatic bone.

[0132] In some embodiments, during use, the headgear has a first lateral distance between the flexible joints, a second lateral distance between the left and right side portions of the headband, intermediate the sagittal plane position of the flexible joints and the headband, and a third lateral distance between the ends or end portions of the arms attached or attachable to the patient interface, each lateral distance is transverse to 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 the left and right side portions of the headband, intermediate the sagittal plane position of the flexible joints and the headband, and a third lateral distance between the ends or end portions of the arms attached or attachable to the patient interface, each lateral distance is transverse to 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] According to at least one fourth aspect of the embodiments disclosed herein, a patient interface assembly comprises: a patient interface, a headgear according to any one of the above-described first, second, and third aspects and a headgear described below, the headgear being configured to position the patient interface on a patient's face during use. and includes.

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

[0137] In some embodiments, the at least one positioning member enables a user to apply and remove the 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 extending outwardly from the headgear member (e.g., outwardly from the user's head) during use, a second portion extending toward the headgear member (e.g., toward the user's head) during use and includes, the positioning member may include an intermediate portion located between the first portion and the second portion, the intermediate portion extending substantially parallel to the headgear member (e.g., parallel to the user's head) during use.

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

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

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

[0143] In some embodiments, the positioning tab or positioning member is integrally formed with the flexible joint, and the flexible joint and tab may be or include a unitary member.

[0144] In some embodiments, the positioning tab or positioning member is 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 tab or positioning member projects outwardly from the headgear member during use (e.g., outwardly from the user's head).

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

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

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

[0149] In some embodiments, during use, the channel forms a channel passage between a flexible joint, or at least one headgear member, or at least one positioning tab, or a positioning member, or an engaging portion thereof or a surface of an engaging portion, 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 is: An elastic headband shaped to fit the user's head with each end of the headband positioned on each respective temple of the user. A pair of arms, each arm being attached to the elastic headband and each arm being adapted to connect to or be part of the patient interface. including, and At least one positioning tab is connected to the headband or the arm.

[0152] In some embodiments, each arm is an elastic 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 engaging portions, each engaging portion being configured to engage the user's temple 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 disposed on one temple or each respective temple of the user, and the central portion may be angled with respect to the one or more end portions to fit around the user's occiput.

[0156] In some embodiments, the headgear is: An elastic headband shaped to fit the user's crown, with each end of the headband disposed on and biased against the user's respective temple, and a pair of engagement portions, each engagement portion being configured to engage the user's temple comprising During use, the headgear has a first lateral distance between the engagement portions, a second lateral distance between the left and right side portions of the headband, intermediate the engagement portion and the sagittal plane position of the headband, and a third lateral distance between the ends or end portions of the headgear that are attached or attachable to the patient interface, each lateral distance being transverse to and perpendicular to the sagittal plane, and the first lateral distance being less than the second and third lateral distances.

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

[0158] According to at least one sixth aspect of the embodiments disclosed herein, a headgear for a patient interface comprises: at least one headgear member, and at least one positioning tab connected to at least one of the at least one headgear member comprising

[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 relative free movement between the plurality of adjacent headgear members in at least two degrees of freedom.

[0160] In some embodiments, the positioning tab is integrally formed with the flexible joint, e.g., the flexible joint and the tab are a unitary member or include it.

[0161] In some embodiments, the positioning tab is 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 tab projects outwardly from the headgear member (e.g., 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, and each positioning tab adjacent to an end or end portion of the headband is disposed at the user's temple during use.

[0164] In some embodiments, the flexible joint, or at least one headgear member, and / or at least one positioning tab or positioning member, and / or its engagement portion or a certain engagement portion thereof includes at least one channel.

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

[0166] In some embodiments, during use, the channel forms a channel passage between the surface of the flexible joint, or at least one headgear member, or at least one positioning tab, or positioning member, or its engagement portion or a certain engagement 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: An elastic headband shaped to fit the user's head with each end of the headband positioned on each respective temple of the user; A pair of arms, each arm being attached to the elastic headband and each arm being adapted to connect to or be part of the patient interface; and At least one positioning tab is connected to the headband or the arm.

[0169] In some embodiments, each arm is an elastic 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 being configured to engage the user's temple during use.

[0172] In some embodiments, a pair of flexible joints provides or includes the engagement portion.

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

[0174] In some embodiments, the engagement portion includes a textured surface, the textured surface may include one or more of: a knurled portion, a wavy surface, a ribbed surface, a rough surface, or may include micro or nano protrusions.

[0175] In some embodiments, the headband includes a central portion and one or more end portions, the one or more end portions are disposed on one or each of the user's temples, and the central portion may be angled with respect to the one or more end portions so as to fit around the user's occipital region during use.

[0176] In some embodiments, the headgear is: An elastic headband shaped to fit over the user's crown with each end of the headband disposed on and biased against each of the user's temples, and A pair of engagement portions, each engagement portion being configured to engage the user's temple. comprising During use, the headgear has a first lateral distance between the engagement portions, a second lateral distance between the left and right side portions of the headband, intermediate the engagement portions and the sagittal plane position of the headband, and a third lateral distance between the ends or end portions of the headgear that are or can be attached to the patient interface, each lateral distance is transverse 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 the headgear form a continuous loop including upper and lower portions joined by a pair of flexible joints.

[0178] According to at least a seventh aspect of one or more of the embodiments disclosed herein, the headgear is: at least one headgear member at least one sliding member movably attached to and configured to slide with respect to the headband. comprising

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

[0180] In some embodiments, 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 are disposed on one or each of the user's lateral heads, and the central portion may be angled with respect to the one or more end portions so as to fit around the user's occipital head during use.

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

[0183] In some embodiments, the headgear member is configured to move or slide within at least one passageway.

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

[0185] In some embodiments, the at least one stop includes: i a protrusion ii a recess iii a hooked end iv optionally, a local increase or decrease in the thickness or cross-sectional area of the headgear member with respect to the size of at least one passageway and includes one or more of the above.

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

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

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

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

[0190] In some embodiments, the connection portion is disposed on one side of the sliding member, and the connection portion may be disposed at the center of the sliding member or away from the passage.

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

[0192] In some embodiments, the connection portion is disposed at the lower part of the sliding member.

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

[0194] In some embodiments, the connection portion or connection 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 storage configuration, the interface and the headgear may be folded together (may be directed towards a common plane), and in which in-use configuration, the interface may be arranged at an angle from the headgear.

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

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

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

[0199] In some embodiments, each engagement portion is configured to engage with the user's temple during use.

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

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

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

[0203] In some embodiments, the headgear includes a removable cover that covers the upper side of the adhesive and is removed before use.

[0204] In some embodiments, the headgear includes a pair of flexible joints, each arm is attached to the headband by the flexible joint, enabling the arm to move freely with at least two degrees of freedom with respect to the headband, and each flexible joint is the engagement portion.

[0205] According to at least a fourteenth aspect of at least one of the embodiments disclosed herein, a headgear for a patient interface is: An elastic headband shaped to fit the user's crown with each end of the headband disposed on and biased against each respective temple of the user, and A pair of engagement portions, each engagement portion being configured to engage with the user's temple. Including, During use, the headgear has a first lateral distance between the engagement portions, a second lateral distance between the left and right side portions of the headband intermediate the sagittal plane position of the engagement portion and the headband, and a third lateral distance between the ends or end portions of the headgear that are attached to or attachable to the patient interface. Each transverse distance is transverse to and perpendicular to the sagittal plane, and The first transverse distance is less than the second and third transverse distances.

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

[0207] In some embodiments, the headgear is: A pair of arms attached to the ends of an elastic headband, each arm being adapted to connect to or be part of a patient interface, and each arm being attached to the headband by a flexible joint that allows the arm to move freely with at least two degrees of freedom with respect to the headband, and the flexible joint providing or including an engagement portion, a pair of arms including.

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

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

[0210] In some embodiments, the headband is such that the engagement portion, during use: i) When viewed in a side profile, the engagement portion occupies an inward contour near the user's temporal bone such that it is in front of the user's ear and above the zygomatic bone or zygomatic arch, or ii) When viewed in a side profile, in front of the ear near the zygomatic bone is arranged in such a shape.

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

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

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

[0214] According to at least a fifteenth aspect of the embodiments disclosed herein, the headgear for a patient interface is: a plurality of headgear members interconnected to form a continuous loop with the patient interface during use and the continuous loop includes an upper portion and a lower portion, and the upper end portion and the lower end portion are connected by a pair of flexible joints.

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

[0216] In some embodiments, the elastic headband is shaped to fit the user's head with each end of the headband disposed on respective sides of the user's head and biased against it.

[0217] In some embodiments, each arm is an elastic arm.

[0218] In some embodiments, the flexible joint provides a lower end portion and is free to move relative to each respective end portion of the upper portion with at least two degrees of freedom.

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

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

[0221] In some embodiments, at least one end portion of the lower part is movably attached to the upper end portion so that there is relative movement between them along the longitudinal axis of the lower part.

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

[0223] In some embodiments, the end portion of the lower part 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 parts.

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

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

[0227] In some embodiments, a pair of flexible joints provides or includes a pair of engagement portions.

[0228] In some embodiments, during use, the headgear has a first lateral distance between the engagement portions, a second lateral distance between the left side portion and the right side portion of the headband, intermediate the engagement portions and the sagittal plane position of the headband, and a third lateral distance between the ends or end portions of the arms attached to or attachable to the patient interface, each lateral distance being transverse to and perpendicular to the sagittal plane, and the first lateral distance being 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 a sixteenth aspect of the embodiments disclosed herein, a method for wearing a headgear and a patient interface is: i) Applying a lateral force to each side or end of the elastic headband of the headgear against the bias provided by the elastic headband to deform both ends of the headband outward; ii) Positioning the headband at the top of the user's head and the interface at the user's nose, mouth, or nose and mouth; iii) Removing the lateral force from each side or end of the elastic headband and allowing the bias of the headband to press the engagement portion of the headgear against the user's temples to hold the headgear on the user's head, and iv) Operating a pair of flexible joints between the headband and a pair of arms of the headgear or between the headband and the patient interface to adjust the relative position between the headband and the patient interface to correctly position the patient interface at the user's nose, mouth, or nose and mouth. Including.

[0231] In some embodiments, in step (i), the method includes grasping and pulling a pair of positioning tabs to apply a lateral force to each side or end of the elastic headband against the bias provided by the elastic headband to deform both ends of the headband outward, and In step (iii), the method includes removing the lateral force from each positioning tab and allowing the bias of the headband to press the engagement portion of the headgear against the user's temples to hold the headgear on the user's head and to position the patient interface in place at the user's nose, mouth, or nose and mouth.

[0232] In some embodiments, each flexible joint is or includes the engagement portion, and in step (iii), the method is: Except for the lateral forces from each side or end of the elastic headband, the headgear is held on the user's head by biasing the headband to press the flexible joint against the user's temporal head region. comprises.

[0233] In some embodiments, in step (iii), the method comprises positioning the engaging portion: a) near the user's temporal bone, or such that, when viewed in a side profile, the engaging portion occupies an inward profile above the front side of the user's ear and the zygomatic bone or zygomatic arch, or b) in front of the ear near the zygomatic bone, when viewed in a side profile. be positioned so as to be arranged.

[0234] In some embodiments, the headband or arm is movably attached to the flexible joint and moves relative to the flexible joint along the longitudinal axis of the headband or arm, and the method comprises: c) adjusting the position of the headband or arm relative to the flexible joint to correctly position the patient interface on the user's nose, mouth, or both the nose and mouth. comprises.

[0235] In some embodiments, the method comprises 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 comprises applying the headband to the user's head with the user's head resting on a support (such as a pillow) and without lifting the user's head from the support.

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

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

[0239] According to at least one other aspect of the embodiments disclosed herein, in a method of wearing a headgear and a patient interface, the headgear can be the headgear of any of the above-described aspects.

[0240] It is understood that any of the above features can be combined with any of the other aspects of the present 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 regarding the headgear or the patient interface can be made to act interchangeably with any one of the headgears or patient interfaces of any of the first, second, third, fourth, fifth, sixth, seventh, eighth, ninth, tenth, eleventh, twelfth, thirteenth, fourteenth, fifteenth, or sixteenth aspects.

[0242] Furthermore, a connection arrangement configuration or part as defined in any one of the first, second, third, or seventh aspects can be provided to a 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 the patient interface.

[0243] As used herein, the term "elasticity" with respect to a member or portion or material, unless the context otherwise suggests, is intended to mean that the member or portion or material, after being bent or flexed, will spring back or spring return to its original shape without permanent deformation or breakage under normal use conditions. An elastic member or portion may be sufficiently hard to resist bending or flexing under normal use conditions, or may be sufficiently flexible to bend or flex and spring back or spring return to its shape under normal use conditions.

[0244] As used in this specification and the claims, the term "comprising" means "including at least in part". When interpreting each statement that includes the term "comprising" in this specification and the claims, features other than those that come before this term may also exist. Related terms such as "comprise" and "comprises" are interpreted in the same way.

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

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

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

[0248] References to numerical ranges disclosed herein (e.g., 1 to 10) also incorporate references to all rational numbers within that range (e.g., 1, 1.1, 2, 3, 3.9, 4, 5, 6, 6.5, 7, 8, 9, and 10) and also any range of rational numbers within that range (e.g., 2 to 8, 1.5 to 5.5, and 3.1 to 4.7), and thus all sub-ranges of all ranges expressly disclosed herein are intended to be expressly disclosed herein. These are merely examples of what is specifically intended, and it is to be assumed that all possible combinations of numerical values between the recited minimum value and the maximum value are likewise expressly stated herein.

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

[0250] As used herein, "one or more" coming before a noun means the plural and / or singular of that noun.

[0251] The present invention can also be broadly described in relation to the parts, elements, and features referred to or shown in the specification of this application, individually or in combination, and in any combination of any two or more of said parts, elements, or features, and where specific integers known to be equivalent in the field to which the present invention pertains are described herein, such known equivalents are to be incorporated herein as if individually recited.

[0252] The present invention is as described above and also contemplates a plurality of structures, which are only given as examples below.

[0253] Embodiments are described by way of example only with reference to the drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0254]

Figure 1

Figure 2A

Figure 2B

Figure 2C

Figure 2D

Figure 3A

Figure 3B

Figure 3C

Figure 3D

Figure 4A

Figure 4B

Figure 5A

Figure 5B

Figure 5C

Figure 6

Figure 7A

Figure 7B

Figure 7C

Figure 8

Figure 9

Figure 10

Figure 11

Figure 11A

Figure 11B

Figure 11C

Figure 12A

Figure 12B

Figure 13A

Figure 13B

Figure 13C

Figure 14A

Figure 14B

Figure 14C

Figure 14D

Best Mode for Carrying Out the Invention

[0255] With reference to the drawings, various embodiments will be described below.

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

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

[0258] FIGS. 3A - 3D show similar headgears attached to alternative patient interfaces. The patient interfaces shown in FIGS. 3A - 3D are the same as or similar to the interface described in U.S. Provisional Patent Application No. 62 / 399,893, the content of which is incorporated herein by reference.

[0259] A patient interface and / or headgear as described herein may be used in a respiratory system as disclosed in PCT Application, International Publication No. 2016 / 157105 (which is incorporated herein by reference).

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

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

[0262] In the illustrated embodiment, the prong provides a flow of gas to the user without forming a seal with the nostril or nasal cavity.

[0263] In some embodiments, the interface 1 may include a manifold section 5 having an inlet for receiving gas from the tube 2 and one or more outlets, such as a prong 3. The manifold 5 directs the gas received from the tube 2 by the manifold towards the prong 3. The headgear may be attached to both sides of the patient interface. In some embodiments, the patient interface includes side members or arms 4 on each side of the interface. For example, the illustrated example has side arms 4 extending from each side of the manifold section 5.

[0264] In some embodiments, the headgear is attached to each side arm 4, for example at the end or end portion of each side arm. A conduit portion may be formed within or integrally 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. The substantially entire length of the side arm conduit 4 may be configured to collapse or a portion of the length of the side arm conduit may be configured to collapse.

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

[0267] In the present 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 more per minute. 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, for example, according to various embodiments and configurations described herein, be a flow of gas supplied or provided to an interface or through a system such as through a flow path, which is not limited to, but may be at least about 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150 L / min (LPM) or more, and the effective range may be selected 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, 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 contain a certain proportion of oxygen. In some configurations, the proportion of oxygen in the delivered gas may be from about 20% to about 100%, or from about 30% to about 100%, or from about 40% to about 100%, or from about 50% to about 100%, or from about 60% to about 100%, or from about 70% to about 100%, or from about 80% to about 100%, or from 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 the ends or end portions of the headgear member or a pair of headgear members to the patient interface. Each flexible joint 13 allows relative movement between the headgear member and the patient interface with at least two degrees of freedom.

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

[0272] Unless the context indicates otherwise, "free movement" or "moves freely" means that the flexible joint does not utilize a mechanism 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 between both limits of movement with at least two degrees of freedom. The both limits of movement may be provided by the headgear member, for example, by material selection and / or geometry.

[0273] In some embodiments, the headgear 10 includes a plurality of headgear members 11, 12 that are interconnected. 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 the patient interface 1. In the illustrated embodiment, each arm 12 facilitates the connection of the headgear 10 to the patient interface. The arm 12 functions as a connection structure between the interface 1 and the headband 11.

[0274] In some embodiments, the headband is an elastic headband. In some embodiments, the arm 12 is an elastic arm.

[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 member is integral with the flexible joint 13.

[0277] In some embodiments, at least one headgear member is removably attachable or connectable and detachable or disconnectable with respect to an adjacent headgear member and / or a flexible joint. In some embodiments, an end of at least one headgear member extends through or beyond the flexible joint 13, thereby enhancing contact with the user's head and improving pressure distribution when in use.

[0278] As described above, the flexible joint 13 allows one member (e.g., the arm 12) to move freely with respect to an adjacent connected member (e.g., the headband 13).

[0279] In some embodiments, the flexible joint 13 allows relative movement between adjacent headgear members with at least two degrees of freedom. For example, in FIG. 3D, the headband 11 is shown to move in a certain direction with respect to the arm 12, or in the front - to - back direction, and the flexible joint may also allow each arm 12 to move in a direction from the left side to the right side with respect to the headband (i.e., perpendicular to the plane of the paper), showing a relative movement with two degrees of freedom between the members 11 and 12.

[0280] In some embodiments, the flexible joint 13 can be disposed on or near both sides of the user's head and / or on or near the user's crown.

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

[0282] In some embodiments, the flexible joint 13 allows relative movement between adjacent headgear members with at least one degree of freedom. In some embodiments, for example, as shown in FIGS. 11B - 11C, the flexible joint 13 can optionally result in elongation in the longitudinal direction. The elongation allows movement in a direction away from each other between adjacent headgear members. The elongation of the flexible joint 13 can assist in sizing the headgear to a particular patient.

[0283] In some embodiments, for example, as shown in FIGS. 11B - 11C, the flexible joint 13 can be provided by or include a substantially U - shaped portion. The flexible joint can have a first portion that extends outwardly from the headgear member (e.g., outwardly from the user's head) during use and a second portion that extends toward the headgear member (e.g., toward the user's head) during use.

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

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

[0286] In some embodiments, the flexible portion may be formed of the same material as the adjacent headgear member, but may be in a geometric shape such that the rigidity in one particular plane is higher than that in one or more other planes. In some embodiments, the flexible joint is stiffer in the sagittal and midsagittal planes (or other orthogonal planes) of the user compared to the frontal plane of the user or the plane of the headband.

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

[0288] In some embodiments, the flexible joint includes a relatively flexible material (i.e., rubber or silicon) compared to the headgear member, and / or a concertina or bellows section, and / or a spring section, and may allow relative movement due to the extension of the flexible joint and preferably at least some relative movement such that the connected headgear members move apart from each other.

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

[0290] In some embodiments, the flexible joint may include at least one, or a plurality of sub - sections.

[0291] In some embodiments, each sub-section is a flexible joint as described elsewhere herein. In some embodiments, one or more sub-sections can provide flexibility or relatively free movement in one or more directions or degrees of freedom. For example, the flexible joint can include one or more integral hinges, each integral hinge providing flexibility or relatively free movement in one degree of freedom.

[0292] In some embodiments, one or more sub-sections can provide elongation (which can be in a longitudinal direction or at least in a direction along one or more headgear members), enabling relatively free movement between one or more headgear members and a patient interface, or between a headgear member and a plurality of adjacent headgear members.

[0293] In some embodiments, the flexible joint can include one or more: integral hinges, or bellows or bellow-style sections, or spring sections.

[0294] In some embodiments, the flexible joint 13 is adapted to bend or fold laterally with respect to the longitudinal axis of an end portion of the headgear member, such as the headband 11. The joint can bend or fold / flex in either direction perpendicular to the longitudinal axis of the end portion of the headgear member (two degrees of freedom). The flexible joint 13 can enable the headband to be folded over the arm 12, providing a folded, non-use configuration, for example, within a sales package.

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

[0296] In some embodiments, the flexible joint may be over-moulded onto the headband 11 or 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 bi-directional hinge assembly, allowing it to pivot about two perpendicular axes. The hinge may be an integral hinge.

[0298] In some embodiments, the flexible joint allows rotation of the headgear member, such as arm 12, about the longitudinal axis of the end portion of the headgear member 12 attached to the adjacent headgear member, such as band 11, relative to the adjacent headgear member. This rotation can be provided by torsional elastic deformation of the flexible joint, such as twisting of the flexible joint. This torsional deformation provides an additional degree of freedom of movement, such that in some embodiments the flexible joint provides three degrees of freedom of movement.

[0299] In some embodiments, the flexible joint simultaneously accommodates lateral bending / folding in two degrees of freedom and also torsional rotation, allowing the joint 13 to flex in multiple dimensions. The flexible joint 13 incorporates or allows torsional forces and bending resulting from the movement of the arm 12 and / or interface 1 with respect to the headband 11.

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

[0301] In some embodiments, the flexible joint may include a bellows or bellows 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 FIGS. 11-11A and FIGS. 13A-13C, which show a continuous headband 11. However, as will be described in more detail below, these arrangements may include an integrally formed headband, a rigid or continuous headband with a flexible joint 13 (e.g., as shown in FIGS. 11B and 11C).

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

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

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

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

[0307] Alternatively, the connection portion or connection arrangement configuration 20 may include a protrusion or boss configured to be received within a recess or aperture. The protrusion or boss 21a may be disposed on the flexible joint 13 or on the sliding member 22 of the headgear 10. The recess or aperture may be disposed on the interface or a part of the interface.

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

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

[0310] In some embodiments, the interface arm, the flexible joint, and / or the sliding member of the headgear may include one or more corresponding connection portions or arrangement configurations. The plurality of corresponding connection portions or arrangement configurations may be provided on the interface arm, the flexible joint, and / or the sliding member of the headgear, and may provide adjustment along various size spreads, such as height, e.g., the distance from the jaw tip to the level of the user's crown, and / or depth, e.g., from the front to the back of the user's head.

[0311] In FIGS. 11C - 12B, although the connection portion 20 is not shown, it is understood that examples of the location of the connection portion 20 are shown. It is understood that these embodiments may be modified to include the connection portion 20 as described above.

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

[0313] In some embodiments, the headgear members 11, 12 are movably attached to the flexible joint and can move with respect 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 member is telescopically attached to the flexible joint. One arm or both arms 12 may be movably attached to their respective flexible joints 13 such that the arm 12 can move along the longitudinal axis of the end portion of the arm attached to the flexible joint. The arm or member may be received in a hole or recess of the flexible joint and slide therein to form a telescopic engagement.

[0315] Embodiments of such telescoping arrangements are shown in FIGS. 13A - 13C, which illustrate sliding members 22 configured to slide with respect to a headgear member (e.g., the headband 11 or the end 12a of the 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 passage 23. The sliding member 22 may be or include a hollow or tubular member, which may form the passage 23. At least one passage 23 may be configured to allow the 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, the end of at least one headgear member extends past or beyond the sliding member 22. In some embodiments, the end of at least one headgear member may be configured to rest on a patient's head or part of the 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, although hidden from view) allowing the end of the headband 11 or the end 12a of the elastic arm 12 to extend through the side of the flexible joint. The relative position of the headgear member can be adjusted by pushing the headgear member through the opening to position the flexible joint at a desired longitudinal position along the headgear member, or, as shown in FIG. 4B, by positioning the arm within the flexible joint. The relative movement between the headgear member and the flexible joint allows for adjustment of the size of the headgear to accommodate users of different sizes. The size adjustment can be in the forward direction and / or in the upward or vertical direction.

[0318] As shown in FIGS. 13A to 13C, the headgear member may include at least one stop 24, 25 that limits the movement of the headgear member relative to the sliding member 22 and / or at least one passage 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] The at least one stop may include: i a protrusion ii a recess iii a hooked end (e.g., as shown by stop 24) iv optionally, a local increase or decrease in the thickness or cross-sectional area of the headgear member with respect to the size of at least one passage (e.g., as shown by stop 25) and may include one or more of the above.

[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 to the movement of the headgear member with respect to the sliding member 22 (which may be a flexible joint) and / or at least one passage 23. The second stop 25 may provide a second limit to the movement of the headgear member with respect to the sliding member 22 (which may be a flexible joint).

[0321] In some embodiments, the flexible joint may allow for a relative movement of approximately or about 5 mm to approximately or about 20 mm (optionally by elongation of the flexible joint). In some embodiments, each flexible joint provides a stepwise telescoping movement in increments of about 5 mm, e.g., by engagement and disengagement of notches within, along, and / or at the passage 23.

[0322] In some embodiments, the sliding member 22 includes a connection portion 20 as described elsewhere in this specification. In some embodiments, for example, as shown in FIGS. 13A - 13C, the connection portion 20 may be disposed on one side of the sliding member 22, and the connection portion 20 may be disposed away from the center of the sliding member 22 or the passage 23. The connection portion 20 may be disposed on the side of the sliding member 22 opposite to the patient's face. In some embodiments, the connection portion is disposed at the lower part of the sliding member.

[0323] The headgear may comprise an interface, and the headgear and the interface may be configurable between a storage configuration and a configuration during use.

[0324] In some embodiments, the interface can pivot around the headgear via the connection portion 20, so that the headgear folds towards the headband 11. This provides a thinner profile or a thin storage configuration. In some embodiments, the interface can pivot around the headgear via the flexible joint 13 and / or can move with a hinge, so that the headgear folds towards the headband 11. Since the headband 11 and the interface can be folded towards a common plane, in the storage configuration, the interface and the headgear can be folded in a common plane. The position during use may be as shown in any of FIGS. 1 - 10, where the interface is disposed at an angle from the headgear.

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

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

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

[0328] The longitudinal movement may be indexed or otherwise set to set the longitudinal position of the headgear member relative to the flexible joint. In such embodiments, the longitudinal position may be set such that the member does not move substantially freely relative to the flexible joint.

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

[0330] In some embodiments, the headband and / or the arm are sized and may be aligned with corresponding indicia or other features of the flexible joint.

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

[0332] In some embodiments, the headband is shaped to fit over the user's crown with each end of the headband disposed at the user's respective temple.

[0333] In some embodiments, the headband 11 is an elastic headband shaped to fit the user's head with each end of the headband disposed on the respective temporal sides of the user and each flexible joint attached to the respective end or end portion of the headband.

[0334] In some embodiments, the pair of flexible joints 13 provides or includes a pair of engagement portions 33, each engagement portion 33 being configured to engage the user's temporal side during use.

[0335] As described above, in some embodiments, the flexible joint can be adapted to attach directly to the patient interface or can connect adjacent headgear members to each other, such as the members 11 and 12 shown in FIG. 1. In FIG. 1, the arm 12 is removably coupled to the interface 1. The arm 12 is directly coupled, for example, to the end of the side arm 4 of the interface 1. Each arm 12 is coupled to one outer end of the interface, and both outer ends face each other left and right. In some embodiments, one or both arms 12 can be elastic arms.

[0336] In some embodiments, the headband is shaped to fit the user's crown. In some embodiments, the headband has a flexible joint connecting the arm to the headband that, during use: i) when viewed in a side profile, occupies an inward profile near the user's temporal bone, above the user's ear and zygomatic bone or zygomatic arch, or ii) in front of the ear near the zygomatic bone when viewed in a side profile is shaped to be disposed.

[0337] Referring now to FIGS. 12 and 12A, the headband 11 includes a central portion 30 and one or more end portions 31. In use, the one or more end portions can be disposed on one or each of the user's temples. The central portion 30 may be angled relative to the one or more end portions such that, in use, it fits around the user's occipital region. In use, the central portion 30, which is adapted to fit around the user's occipital region, enables the headband to be sized to fit a wide range of user head sizes.

[0338] In some embodiments, the headband is an elastic band, such as a headband formed from an elastic material. One or both arms can be elastic arms and can be formed from the same elastic material as the material of the headband.

[0339] In some embodiments, the elastic headband is shaped to fit the user's head with each end of the headband disposed on and biased against each of the user's temples.

[0340] In some embodiments, under non-flexed conditions, the distance between the ends of the headband is shorter than the width of the user's head, such that flexure of the headband to fit the user's head biases the ends of the headband against the user's temples during use.

[0341] The headband is of sufficient length relative to its cross-section and is sufficiently flexible such that the user can spread the ends of the headband and exert a comfortable amount of force against the user's temples. The amount of bias provided by the headband provides a force to the user's head that is comfortable but aids in maintaining the head in the correct position.

[0342] In some embodiments, the geometry of the arm 12, such as length and cross-sectional area, can prevent significant flexure of the arm during normal use.

[0343] The arm 12 is sufficiently short with respect to its cross-sectional area and can resist lateral bending or torsion.

[0344] In at least the embodiments shown in FIGS. 1 - 6, the arm 12 can be made of the same material as the elastic headband 11, but is rigid (e.g., does not substantially bend under normal use conditions).

[0345] In particular, when the interface is substantially soft and flexible as in the embodiments of FIGS. 3A - 6, the arm 12 is rigid. The rigid arm 12 helps to maintain a robust connection between the headband 11 and the interface 1, and the arm 12 serves to efficiently transmit force from the interface 1 to the flexible joint 13.

[0346] In some embodiments, the central portion 30 of the headband 11 is relatively hard, or harder or less flexible than the end portions 31. The central portion 30 can have a larger cross-sectional area than the end portions 31. The central portion 30 can 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 hard, or harder or less flexible than the second material. In some embodiments, the relative rigidity of the central portion 30 with respect to the end portions 31 can be provided in a particular direction, e.g., the direction towards the user.

[0348] The elastic headband and / or the elastic arm can have a cross-section in the shape of a rectangle, trapezoid, circle, or any other suitable shape.

[0349] Preferably, the cross-section with a flat surface is adopted to provide sufficient contact area with the user's head, so that sufficient friction exists to hold the headband in the desired position. The flat surface is placed on the user's head and / or face. The cross-section of the headband and / or arm varies along its length to provide greater or less force distribution around the area of the patient's face and / or head, and may, for example, flare out or narrow down.

[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 arm can 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 arm, can be formed from a metallic material such as high-tensile steel. Therefore, the Young's modulus of the headgear member can be 200 GPa or even higher.

[0351] In some embodiments, the headband, or the headgear and arm, can be formed from an elastic material that is not substantially brittle.

[0352] In some embodiments, one or more of the headgear members, such as the headband 11 and / or the arm 12, can include a plastic core and a textile case, and the plastic core and the textile case are formed as an integral structure by applying a molten plastic material to a textile or natural fiber case or a composite of textile and natural fiber, as described in, for example, the PCT application published as WO 2016 / 043603 (the content of which is incorporated herein by reference).

[0353] The textile can be a synthetic textile or a textile made of natural fibers. Examples of natural fibers include wool, jute, and linen. Since the plastic core of the headgear member can provide elasticity, the member is an elastic member. In addition or alternatively, an elastic member such as a metal band can 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 joint can be formed from an elastic material having a significantly low modulus of elasticity. For example, the flexible joint can be 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. An exemplary material is silicone rubber, and its Young's modulus can be 0.05 GPa or less. Therefore, in some embodiments, the headgear member is formed from a relatively hard elastic material, and the flexible joint is correspondingly formed from a relatively soft flexible material, and the modulus of elasticity of the hard elastic material is many times higher than the modulus of elasticity of the soft flexible material. The soft flexible material is elastic and deforms without plastic deformation under normal use conditions. However, it is much more flexible than the material of the headgear member.

[0355] In some embodiments, the modulus of elasticity of the hard elastic material of the headgear member is at least 10 times, or at least 20, or 40, or 100, or 200 times the modulus of elasticity of the soft flexible material of the flexible joint.

[0356] In some embodiments, the flexible joint 13 isolates or separates the movement of the interface from the headband, so that the headband may not be well distributed on the user's head.

[0357] In some embodiments, the headgear is held almost on the user's head by the headband. The flexible joint 13 can function to isolate the lower part and / or the interface of the headgear to avoid or reduce the interference of the biasing force towards the user's temples caused by the headband.

[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, and each tab or member is disposed at or near an end or end portion of the headband 11. At least one positioning tab or positioning member may enable a user to apply and remove the headgear.

[0359] In some embodiments, the tab or member may be arranged to be disposed on the user's temple during use.

[0360] In some embodiments, the positioning tab or positioning 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 positioning tab 14 or positioning member 26 is connected to or integrally formed with the headgear member. The flexible joint comprising the tab 14 or member 26 may be a unitary member.

[0362] In some embodiments, the tab 14 or member 26 comprises an indication of the direction in which to pull the tab to remove the headgear from the user's head. For example, the tab or member may include an arrow attached to or formed on the tab, as shown in the drawing, and the arrow indicates the direction to pull to remove the headgear. In some embodiments, the tab or member may extend from the headgear member, such that during use, the tab projects or extends outwardly from the user's head.

[0363] As shown in FIGS. 11 to 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) during use and a second portion 28 that extends toward the headgear member (e.g., toward the user's head) during use.

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

[0365] FIG. 3C shows the deflection of the headgear 10 and the patient interface 1 in a direction transverse to the sagittal plane of the user. The user or physician may pull the tab, for example, by grasping the tab between the thumb and forefinger, to apply and remove the headgear. Once the headgear is placed on the user's head, the physician may use the tab to reposition the headband, for example, by adjusting the angle of the headband relative to the arm 12, to better support or position the patient interface and / or enhance the comfort of the patient.

[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 flexure of the headgear 10 in a direction along the forehead plane (i.e., perpendicular to the sagittal plane of the user). In other words, FIGS. 11B and 11C show the flexure of the headgear 10 in a direction from the patient's jaw towards the forehead or from the patient's forehead towards the jaw. 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 the headgear is substantially extended in the forehead plane (e.g., when attached or worn by the user). The interface may be worn by the user by extending the flexible joint 13 to deform the headgear to conform to the shape of the user's head. Once the stretching force is removed, the headgear returns to its undeformed shape 10” and can engage the user's head.

[0367] In some embodiments, when a force is applied to the headgear to attach the headgear and / or interface to the user's head, the shape of the headgear changes from an overall oval shape to a rounded rectangular shape.

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

[0369] In some embodiments, the user pulls or twists a tab or member to apply a torsional force to the headgear member, and twists 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 the flexible joint may be configured to deform with torsion when a force is applied to the tab or member. By applying a force (e.g., pulling) to the tab or member, the headgear (e.g., one or more flexible joints, headband, arm, or any other headgear member) can be elastically deformed. Once the force is removed, the headgear returns to its initial rest state, thereby enabling it to engage the user's head. In some embodiments, there may be no flexible joint (e.g., in FIGS. 11, 11A, 12, and 12A, where the headband 11 may be configured to connect directly to the patient interface), or the flexible joint may be configured to deform with torsion.

[0370] In some embodiments, the headband can 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 engagement portion 33 being configured to engage the user's temples during use.

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

[0373] In some embodiments, the textured surface may include one or more of: scored portions, wavy surfaces, ribbed surfaces, rough surfaces, or may include micro or nano protrusions.

[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, such as a peelable layer, to be removed before use, overlying the adhesive.

[0375] In some embodiments, the pair of flexible joints 13 is or includes the pair of engagement portions 33, and each flexible joint of the pair of flexible joints is configured to engage with the user's temple during use. For example, a textured pad or surface may be provided on the inner surface of the flexible joint to engage with the user's temple.

[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 travels around the loop from the interface 1, through 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 portion and a lower portion, and the upper end and the lower end are interconnected by the 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 arm 12 and the patient interface 1.

[0378] As described above, in some embodiments, the arm and the headband can be movably attached together along the longitudinal axis of the end portion of the arm so as to move relative to each other therebetween. Therefore, in some embodiments, at least one end portion of the lower part can be movably attached to the upper end portion and can move relative to each other therebetween along the longitudinal axis of the lower end portion. This movement enables adjustment of the length of the loop to accommodate the size of the user's head.

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

[0380] In some embodiments, at least one positioning tab is connected to at least one of the upper and lower parts. In some embodiments, the headgear members that are interconnected to form a continuous loop can be connectable or disconnectable from each other to provide a location where the continuous loop can be opened. This can be useful when it is necessary to remove the headgear from the user without interfering with other devices that may be attached to the user.

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

[0382] In some embodiments, the headgear can include a channel 32 that allows a device or accessory (such as an arm of glasses) to pass from one side of the headgear to the other side. The channel 32 can be disposed in or form a 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 the flexible joint, or at least one headgear member, or at least one positioning tab, or positioning member, or the surface of the engaging 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 the positioning tab 14 or positioning member 26, or at least one headgear member, or the engaging portion 33 to the rear side of the flexible joint 13, or the positioning tab 14 or positioning member 26, or at least one headgear member, or the engaging portion 33.

[0384] As shown in FIGS. 11 to 11C, the channel may be provided by a substantially U-shaped portion. The headgear may include an engaging portion disposed on one or both sides of the channel 32 so as to be placed on the user's face during use. In some embodiments, the channel may be provided as part of the engaging portion 33.

[0385] Referring to the drawings, particularly FIGS. 2D and 3D, the headband 11 is curved and is mainly in a plane, and the arms 12 each extend mainly in a cross-section with respect to the plane of the headband. In the illustrated embodiment, each arm is curved and is mainly in a cross-section with respect to the plane of the headband.

[0386] In some embodiments, the flexible joint may be provided such that each arm is in a cross-section with respect to the plane of the headband, and / or the arm 12 may be curved and mainly in a cross-section with respect to the plane of the headband.

[0387] Referring to FIGS. 2C and 3C, in some embodiments, when the headgear is in use, for example, when positioned on the 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 portions of the headgear that engage the user's head (e.g., the flexible joint 13 provides or forms an engaging portion for contacting the head), a second lateral distance 22 between the left side portion 11a and the right side portion 11b of the headband 11, intermediate the engaging portion 13 and the sagittal plane position 11c of the headband, and a third lateral distance 23 between the end or end portions 12a and 12b of the headgear that are attached to or attachable to the patient interface 1. The lateral distances are transverse to 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 shorter than the second lateral distance 22 and the third lateral distance 23. In some embodiments, the second lateral distance 22 is longer than the third lateral distance 23. In use, the user's head is clamped between the engaging portions disposed at the minimum lateral distance of the headgear. These engaging portions are biased against the user's head by the headband 11 as described above.

[0390] In some embodiments, this arrangement results in contact with the user's head at the engaging portions. The portion of the headgear between the engaging portions and the interface 1 may not contact or may minimally contact the user's head or face. For example, the arm 12 may not approach or may minimally contact the user's face. The arm 12 may support the 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 minimally contact the user's face.

[0391] As described above, in some embodiments, the arm 12 of the headgear can be elastic, i.e., can be formed from an elastic material.

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

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

[0394] In some embodiments, the headgear can include a pair of flexible joints for attaching the headgear to the patient interface, or the patient interface can include a pair of flexible joints for connecting to the headgear. For example, the arm 12 can be connected to the patient interface by a pair of flexible joints. The flexible joints for connecting the headgear to the interface can be as described above. For example, in some embodiments, the arm 12 can be integrally formed with or be part of the patient interface, and the headband 11 can be connected to the 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 / 399893 and shown in FIGS. 3A and 3B of the present application, one or both arms 12 can be integrally formed with a part of the patient interface, such as the "plug" 708 and the "duct connector" 707 of the interface.

[0396] In some embodiments, the arm 12 can be integrally formed with the headband as a single continuous member.

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

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

[0399] The integrally formed flexible joint and arm member can include a flexible section forming the flexible joint, provided by, for example, a hollow section, and a less flexible or harder section forming the arm 12, provided by, for example, a solid cross-section.

[0400] Since the cannula or interface can be made of a flexible material, the side arm 4 of the cannula or interface can flex relative to the prong. This flexibility provides additional adjustability of the headgear relative to the prong as the side arm of the cannula or interface moves relative to the prong.

[0401] In some embodiments, the elastic headband 11, the flexible joint 13 and / or the elastic arm 12 can be or include a conduit. For example, the elastic headband conduit can provide a flow path for supplying inflow gas to the patient interface while simultaneously securing the headgear to the patient's face and head. The conduits of the arm 12, the flexible joint 13 and the headband can be interconnected to be in fluid communication. For example, the ends of the arm and the ends of the headband can be received in the flexible joint.

[0402] Referring to FIGS. 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, have a reduced modulus of elasticity compared to the headband 11, or be an elastic strap or rubber string. 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 removable from the remaining headgear components. The second headband may be attached or removably attached to the elastic headband 11 or the flexible joint 13. The flexible joint 13 has a "Y" shape and may be adapted to both the first headband 11 and the second headband 16.

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

[0404] In some embodiments, the groove or cavity may be a scallop or valley and may be C-shaped. In a storage or non-use configuration, the second headband, such as a rubber string, is held in a groove or channel on 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, the second headband 16 may be provided to the headgear. The second headband may be fixed to the headband or the arm or the flexible joint by a connection feature so that the second headband can be connected to the headband. Such connection features may include, for example, clips, connectors, grooves, or buckles.

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

[0407] FIGS. 7A-7C show a headgear together with an interface similar to the headgear and the interface shown in FIGS. 3A-3D. In FIGS. 7A-7C, the arm 12 of the headgear includes a greater vertical dimension compared to the arm 12 of the embodiment shown in FIGS. 3A-3D. In FIGS. 7A-7C, the arm may contact the user's face, as shown in FIG. 7C, to assist in supporting and maintaining the correct position of the interface on the user's face. As shown in FIGS. 7B and 7C, the headgear may have a band or other feature 19 to secure the breathing conduit to the arm 12.

[0408] FIGS. 11-11A show a headgear connectable to an 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 may be used to attach the headgear to the user by the user pulling or applying force to the positioning member 26. Thereby, the profile of the headgear can be extended on the user's forehead. The embodiment of FIGS. 11-11A also includes a channel 32 that provides a channel path between the user and the headgear 10.

[0411] Figures 13A - 13C show various headgears connectable to an interface. The headgear 10 includes a pair of sliding members 22 configured to slide telescopically with respect to a headgear member 11. The sliding member 22 includes a connection arrangement 20 for connecting the headgear to an associated interface. The sliding member 22 of Figure 13A may have a flexible joint 34 that allows movement between the sliding member 22 and the connection arrangement 20. The flexible joint 34 may be made of a more flexible material than the remaining sliding members and / or connection arrangements. For example, the flexible joint 34 may be made of a more flexible material (with respect to the sliding member 22 and / or the connection arrangement 20) and / or may have a locally reduced cross-sectional area (with respect to the sliding member 22 and / or the connection arrangement 20). The flexible joint 34 may be an integral hinge.

[0412] In various embodiments, the sliding 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 together with a nasal cannula. However, the headgear according to the described embodiments may be used with other types of patient interfaces. For example, in Figure 8, the headgear according to the embodiments described herein is shown together 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. The side arms 12 of the headgear may be connected to the body 7 by a connector or may be formed integrally with the body.

[0414] Figure 9 shows the headgear according to the embodiments described herein together with a patient interface that includes a nasal pillow engaging the user's nostrils. Other under - nose interfaces, such as an interface that seals against or covers the upper side of the base of the user's nose, may be used.

[0415] Figure 10 shows a headgear according to an embodiment described herein, together with a nasal interface. The nasal interface includes a body 7 and a nasal seal 6 that covers and seals the upper side 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). The patient interface may be a nasal cannula, a full face mask, a nasal pillow mask, a nasal mask, an endotracheal tube, or a respiratory collector / sampler for sampling gas.

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

[0418] In some embodiments, a method is provided for wearing the headgear on a user's head. The method includes applying a lateral force to each side or end of the elastic headband 11 against the inward biasing provided by the elastic headband to deform both ends of the headband outward. Thereafter, the method includes positioning the headband over the upper side of the user's crown and, except for the lateral force from each side or end of the elastic headband, pressing the engagement portion (e.g., the flexible joint 13) of the headgear against the user's temple by the biasing of the headband to hold the headgear against 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 so as to correctly position the patient interface relative to the user's nose, mouth, or both nose and mouth. The headband may be positioned over the user's crown and / or the engagement portion may be: a) near the user's temporal bone such that, when viewed in a side profile, the engagement portion occupies an inward contour 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 a side profile and may be arranged.

[0420] In some embodiments, for a method of donning a headgear, the method includes grasping and pulling on the pair of positioning tabs 14 to apply a lateral force to each side or end of the elastic headband of the headgear against the biasing provided by the elastic headband, deforming both ends of the headband outwardly. Thereafter, the outward force is removed to position the band correctly in place. The method may further include adjusting the position of the headband 11 or arm 12 relative to the flexible joint 13 to correctly position the patient interface on 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 with the user's head 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 the patient is under anesthesia or sedated, rapid removal and application of the patient interface may be of higher priority than the patient's comfort, for example due to an emergency. Further, comfort may be less important in short medical procedures compared to use of a respiratory interface during sleep, for example overnight OSA treatment.

[0423] The embodiments described herein may enable rapid 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 user's crown.

[0424] In some embodiments, a medical professional can adjust the angle of the headband with respect to the arm 12 to an optimal position, best distributing the weight of the patient interface and the tube. The headband can be tilted forward or backward to provide additional resistance and be forced away from the face. Some embodiments can accommodate a wide range of head sizes, for example, by the change in fit provided by the flexible joint 13 and / or adjustment of the longitudinal position between the headgear members. A further advantage is that the patient interface is held in a stable position on the patient's face due to being resiliently supported from each side of the user's head.

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

Claims

1. At least one headgear member, the headgear member comprising an elastic headband, the elastic headband being shaped to fit the crown of the user's head, at least one headgear member; A pair of positioning tabs or positioning members connected to the at least one headgear member, each tab or positioning member being adjacent to an end of the elastic headband such that it is positioned at the user's temple during use, a pair of positioning tabs or positioning members; A pair of flexible joints adapted to connect the at least one headgear member to a patient interface and / or a pair of flexible joints for connecting at least one of the headgear members to an adjacent headgear member; comprising, each of the pair of flexible joints allowing relative free movement between the at least one headgear member and the patient interface or between the adjacent headgear members; the elastic headband being shaped to fit the user's head with each end of the elastic headband disposed at the user's respective temple and biased against the user's respective temple; the headgear further comprising a pair of arms, each arm being attached to the elastic headband, each arm being adapted to connect to or form part of a patient interface, a pair of arms; including, and each arm being attached to the elastic headband by a respective flexible joint of the pair of flexible joints, each respective flexible joint allowing the arm to move freely with respect to the elastic headband in at least two degrees of freedom; each arm being attached to an end or end portion of the elastic headband; each arm being an elastic arm; A headgear for a patient interface.

2. The headgear according to claim 1, wherein the pair of positioning tabs or positioning members enable the user to apply and remove the headgear.

3. The headgear according to claim 1 or 2, wherein each of the pair of positioning tabs or positioning members is provided by or includes a substantially U-shaped portion.

4. Each of the pair of positioning tabs or positioning members: A first portion extending outwardly from the at least one headgear member during use; a second portion extending towards the at least one headgear member during use; comprising; The headgear according to any one of claims 1 to 3.

5. Each of the pair of positioning tabs or positioning members includes an intermediate portion located between the first portion and the second portion, and the intermediate portion extends substantially parallel to the at least one headgear member during use. The headgear according to claim 4.

6. The headgear according to claim 1, wherein the pair of positioning tabs or positioning members are integrally formed with the at least one headgear member.

7. Each of the pair of flexible joints enables relative free movement between the at least one headgear member and the patient interface, or between a plurality of adjacent headgear members, with at least one degree of freedom or two degrees of freedom, and / or Each of the pair of flexible joints is made extensible to enable relative free movement between the at least one headgear member and the patient interface, or between a plurality of adjacent headgear members. The headgear according to claim 1.

8. Each of the pair of flexible joints includes a hinge in the form of an integral hinge, and / or Each of the pair of flexible joints is adapted to bend or fold transversely with respect to the longitudinal axis of the end portion of the at least one headgear member. The headgear according to claim 1.

9. Each of the pair of flexible joints is a unitary member or includes one, and / or Each of the pair of flexible joints is a member formed from a soft flexible material, and / or Each of the pair of flexible joints is an elastomeric member, and / or Each of the pair of flexible joints is a hollow or tubular member. The headgear according to claim 1.

10. Each of the pair of flexible joints, or the at least one headgear member, includes a connection portion or connection arrangement configuration, The connection portion or connection arrangement configuration is configured to provide a connection with one or more of: an interface or a part of an interface, an arm adapted to connect to or form part of a patient interface, and / or The connection portion or connection arrangement configuration is configured to provide a pivotal connection, and / or The connection portion or connection arrangement configuration includes a recess or aperture configured to receive a protrusion or boss, the protrusion or boss being disposed at an interface or a part of the interface, the recess or aperture being disposed at one of the pair of flexible joints, and / or The connection portion or connection arrangement configuration includes a protrusion or boss configured to be received by a recess or aperture, the protrusion or boss being disposed at one of the pair of flexible joints, the recess or aperture being disposed at an interface or a part of the interface, the headgear according to claim 1.

11. The headgear according to claim 1, wherein the at least one headgear member is integral with the pair of flexible joints.

12. Each of the pair of flexible joints is elastically deformable under use conditions, and / or The headgear according to claim 1, wherein each of the pair of flexible joints enables rotation of the at least one headgear member with respect to an adjacent headgear member about a longitudinal axis of an end portion of the at least one headgear member attached to the adjacent headgear member.

13. The headgear according to claim 1, wherein the at least one headgear member is movably attached to the pair of flexible joints and moves with respect to an adjacent headgear member along a longitudinal axis of the at least one headgear member.

14. The at least one headgear member is telescopically attached to the pair of flexible joints, and / or The headgear according to claim 13, wherein the at least one headgear member is telescopically received at respective end portions of the pair of flexible joints.

15. Each of the pair of flexible joints includes at least one passage, the at least one passage being configured to allow passage of the at least one headgear member, The at least one headgear member is configured to move or slide within the at least one passage, and / or The at least one headgear member includes at least one stop for restricting movement of the at least one headgear member with respect to the pair of flexible joints and / or the at least one passage, the at least one stop being disposed at an end of the at least one headgear member, and the at least one stop being: i. a protrusion ii. a recess iii. a hooked end iv. a local increase or decrease in the thickness or cross-sectional area of the at least one headgear member with respect to the size of the at least one passage including one or more of: The at least one headgear member includes one or more of a first stop and / or a second stop, the first stop providing a first limit to movement of the at least one headgear member with respect to the pair of flexible joints and / or the at least one passage, and the second stop providing a second limit to movement of the at least one headgear member with respect to the pair of flexible joints and / or the at least one passage. The headgear according to claim 1.

16. The at least one headgear member is removably attachable or connectable to and removable or disconnectable from an adjacent headgear member and / or the pair of flexible joints. The headgear according to claim 1.

17. Each end of the at least one headgear member extends past or beyond each flexible joint of the pair of flexible joints. The headgear according to claim 1.

18. Each flexible joint of the pair of flexible joints engages a respective temple of the user during use. The headgear according to claim 1.

19. The modulus of elasticity of the at least one 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, and each of the pair of flexible joints is 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. The headgear according to claim 1.

20. The at least one headgear member is formed from a hard elastic material, and each of the pair of flexible joints is formed from a soft flexible material, and the elastic modulus of the hard elastic material is many times higher than the elastic modulus of the soft flexible material. The elastic modulus of the hard elastic material is at least 10 times, or at least 10, or 20, or 40, or 100, or 200 times the elastic modulus of the soft flexible material, the headgear according to claim 1.

21. Including a pair of engaging portions, each engaging portion being configured to engage the user's temples during use. The pair of flexible joints and / or the at least one headgear member provides or includes the pair of engaging portions. The pair of engaging portions includes a textured surface, the textured surface including one or more of: scored portions, wavy surfaces, ribbed surfaces, rough surfaces, or micro or nano protrusions, the headgear according to claim 1.

22. Each of the pair of flexible joints, each of the pair of positioning tabs, or the at least one headgear member includes at least one channel that extends from the front side of the flexible joint or the at least one headgear member to the rear side of the flexible joint or the at least one headgear member, or the engaging portion or one of the engaging portions, the headgear according to claim 1.

23. Due to the deflection of the elastic headband for fitting the user's head, the distance between the ends of the elastic headband is less than the width of the user's head under non-deflected conditions so as to bias the ends of the elastic headband against the temples, the headgear according to claim 1.

24. The elastic headband includes a central portion and one or more end portions, the one or more end portions being disposed on one or each of the user's temple regions, and the central portion being angled with respect to the one or more end portions so as to fit around the user's occipital region during use. The elastic headband has a central portion and two end portions, the central portion being relatively hard, or harder than the end portions, or less flexible, the central portion having a larger cross-sectional area than the end portions, the central portion being made of a first material, and the end portions being made of a second material, the first material being relatively hard, or harder than the second material, or less flexible. The headgear includes a second headband, the second headband including an elastic strap or band, the elastic strap or band being elastic and / or stretchable and / or extensible, the second headband being engageable with the user's occipital region, the second headband being configured to engage a portion of the user's head behind the top of the user's head, the second headband being adapted to be connected to the elastic headband, the elastic headband including connection features adapted to connect and disconnect the elastic headband and the second headband, the connection features including grooves, clips or buckles, the headgear according to claim 1 or 23.

25. The elastic headband, wherein the pair of flexible joints connecting the pair of arms to the elastic headband are, during use: i) shaped such that, when viewed in a side profile, the pair of flexible joints occupy an inward profile near the user's temporal bone, or above the user's ear and zygomatic bone or zygomatic arch, or ii) in front of the ear near the zygomatic bone when viewed in a side profile. The headgear according to claim 1, wherein the headgear is shaped to be positioned as described above.

26. The headgear has a first lateral distance between the pair of flexible joints, a second lateral distance between the left and right side portions of the elastic headband, and a third lateral distance between the ends or end portions of the pair of arms attached to or attachable to the patient interface. The first lateral distance, the second lateral distance, and the third lateral distance are transverse to and perpendicular to the sagittal plane position of the elastic headband, The headgear according to claim 1, wherein the first lateral distance is less than the second and third lateral distances. **Claim 27** The headgear according to claim 1, wherein the pair of arms are integrally formed with the patient interface. **Claim 28** The headgear according to claim 1, wherein the patient interface and the headgear form a continuous loop including upper and lower portions joined by the pair of flexible joints.

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