Directional adjustment mechanism for headgear of respiratory therapy mask or interface

Abstract

To provide improved components associated with such a headgear.SOLUTION: According to this disclosure, there is provided various embodiments of a directional adjustment unit for a headgear for a respiratory mask. The directional adjustment unit comprises: a housing; and at least one frictional engagement member. arranged to be movable with respect to the housing. The at least one frictional engagement member has an aperture extending therethrough for receiving a filament of a strap of the headgear therethrough. The at least one frictional engagement member in a first movable configuration provides a disengaged configuration with respect to the filament, and in a second movable configuration provides an engaged configuration with respect to the filament. Also disclosed herein are various headgear, yoke assemblies, mask assemblies, mask frames and headgear filaments, some of which are for use with such a directional adjustment unit.SELECTED DRAWING: Figure 1a

Description

[Technical Field]

[0001] The present disclosure relates to an orientation adjustment mechanism for headgear of a respiratory therapy mask or interface of a respiratory therapy system.

[0002]

[0001] This disclosure is related to the disclosures in the following prior patent applications: WO 2014 / 175752, filed April 24, 2014; WO 2016 / 043603, filed September 16, 2015; WO 2017 / 158544, filed March 16, 2017; WO 2017 / 160166, filed March 15, 2016; and U.S. Provisional Patent Application No. 62 / 644002, filed March 16, 2018, the entire contents of which are incorporated herein by reference. This application claims priority to U.S. Provisional Patent Application Nos. 62 / 755,766, filed November 5, 2018, 62 / 755,777, filed November 5, 2018, and 62 / 842,982, filed May 3, 2019, the entire contents of each of which are incorporated herein by reference. [Background technology]

[0003] Masks that provide a substantially airtight seal with the wearer are used in a variety of applications (e.g., gas masks, diving masks, respiratory therapy masks), etc. Some of these masks use headgear that includes one or more straps to secure the mask to the wearer's face.

[0004] Respiratory masks are used to provide respiratory therapy to the airways of individuals suffering from any of a number of respiratory diseases or conditions, including, but not limited to, continuous positive airway pressure (CPAP) therapy and non-invasive ventilation (NIV) therapy.

[0005] CPAP therapy can be used to treat obstructive sleep apnea (OSA), a condition in which a patient's airway becomes intermittently blocked during sleep, preventing the patient from breathing for periods of time. The cessation of breathing, or apnea, can awaken the patient. Repetitive and frequent apneas can result in patients rarely getting a full, restorative night's sleep.

[0006] CPAP therapy involves delivering a supply of continuous positive air pressure to a patient's airway via a breathing mask, which acts as a splint within the patient's airway, holding the airway in a patent position so that the patient's breathing and sleep are uninterrupted.

[0007] Respiratory masks typically include a patient interface and headgear, where the patient interface is configured to deliver a supply of continuous positive air pressure to the patient's airway via a seal or cushion that forms an airtight seal in or around the patient's nose and / or mouth. Respiratory masks are available in a variety of styles, including full face, nasal, direct nose, pillow, and mouth masks, that form an airtight seal with one or more nostrils, nose, and / or mouth. The seal or cushion is held in place on the patient's face by the headgear.

[0008] To maintain an airtight seal, the headgear must provide support for the patient interface so that it is held in a stable position against the patient's face during use. Such respiratory masks can also be used to deliver NIV and other therapies.

[0009] The inventors have previously proposed a headgear for a respiratory mask that includes at least one strap having a filament and a direction adjustment unit having an engagement and disengagement configuration for the filament. The direction adjustment unit allows the filament to be pulled in one direction through the unit to tighten the headgear, but resists movement of the filament in the opposite direction through the unit until the filament is released. Thus, the direction adjustment unit functions as a headgear tensioning device.

[0010] The inventors have also previously proposed a filament or elongated flexible member that can be received in and moved through a direction adjustment unit. The inventors have proposed a filament that includes a core member and a wider diameter outer braided sheath that acts as a stop and limits the amount that the filament can be pulled through the direction adjustment unit.

[0011] The inventors have also proposed an alternative orientation adjustment unit configured to generate a force profile similar to that of Figure 6a. Such an orientation adjustment unit comprises one or more movable frictional engagement members, each having an aperture through which a filament is fed, that tilt / engage as the filament fed into the aperture is pulled out of the unit. This imparts resistance to the system, thereby increasing the slip / pulling force that the user must overcome when extending the headgear.

[0012] When the filaments are retracted / pulled back and the headgear returns to its unactuated or neutral (e.g., balanced on the face) configuration, the frictional engagement members tilt back and release the filaments, thereby reducing the resistance force and causing the mask or patient interface to appear to spring back onto the user's face. Summary of the Invention [Problem to be solved by the invention]

[0013] One or more desirable features of such a direction adjustment unit include: The unit should be stretchy enough to be able to be pulled over the user's head; The unit is free to retract and further adjustable to the point where the user feels they can achieve a secure fit. When CPAP pressure is applied, the system becomes a non-elastic headgear, The unit should provide sufficient holding power to comfortably maintain the same seal position overnight. The unit should be able to be stretched over the user's head during removal; The forces generated by the elastic braid must be low enough that the directional adjustment unit functions as non-elastic headgear even at the lowest CPAP pressures. The unit should have sufficient working length to prevent over-tightening during normal bed use. [Means for solving the problem]

[0014] Aspects of the present disclosure can provide improved components associated with such headgear, such as any one or more of the yoke assembly, the directional adjustment unit, the filament, and the one or more straps.

[0015] Aspects of the present disclosure can provide improved orientation units and associated filament designs that, in use, reduce shear stress on the filaments, thereby reducing wear and tear on associated components. Such improved orientation units can form part of a respiratory mask.

[0016] In some configurations, this is achieved by providing the frictional engagement member of the direction adjustment unit with an aperture having a cross-sectional shape that forms at least one straight or substantially straight portion of the frictional engagement member that engages with a corresponding flat or substantially flat portion of the filament when the at least one frictional engagement member is in the engaged configuration.

[0017] According to one aspect of the present disclosure, there is provided a direction adjustment unit for a headgear for a respiratory mask. The direction adjustment unit includes a housing and at least one frictional engagement member movable relative to the housing, the at least one frictional engagement member having an aperture forming a cavity extending through the at least one frictional engagement member. The aperture is positioned to receive a filament of a strap of the headgear therethrough. The at least one frictional engagement member provides a disengaged configuration with respect to the filament in a first configuration and an engaged configuration with respect to the filament in a second configuration. The cavity forms an engagement surface area that is linear or substantially linear in cross section, and the engagement surface area is for engaging a flat or substantially flat portion of the filament when the at least one frictional engagement member is in the engaged configuration.

[0018] At least one frictional engagement member may be movable about a pivot axis, the first movably achieved configuration relating to a first pivot configuration and the second movably achieved configuration relating to a second pivot configuration.

[0019] The engagement surface area may be linear or substantially linear along a transverse axis that is parallel or substantially parallel to the pivot axis.

[0020] The aperture in the front surface of the at least one frictional engagement member may be non-round, non-circular, non-elliptical, or non-oval.

[0021] The aperture may be offset relative to the pivot axis and extend through the at least one frictional engagement member along an axis having a component perpendicular to the pivot axis.

[0022] The aperture may be quadrilateral, preferably rectangular, in front of the at least one frictional engagement member.

[0023] One side of the aperture may be parallel or substantially parallel to the pivot axis.

[0024] The aperture may have a quadrilateral cross section in a plane parallel to the pivot axis and in an axis perpendicular to the pivot axis.

[0025] The aperture may be triangular in shape in front of the at least one frictional engagement member.

[0026] One side of the triangular aperture may be parallel or substantially parallel to the pivot axis.

[0027] The triangular aperture may have an apex located closer to the pivot axis than a side that is parallel or substantially parallel to the pivot axis.

[0028] The aperture may have a triangular cross section in a plane parallel to the pivot axis or in an axis perpendicular to the pivot axis.

[0029] The aperture may extend through the at least one frictional engagement member perpendicular or substantially perpendicular to the pivot axis.

[0030] The aperture or cavity may extend through the at least one frictional engagement member symmetrically about the pivot axis.

[0031] The engagement surface region may form a portion of at least one internal cavity wall surface of the at least one frictional engagement member.

[0032] The engagement surface region may include at least one interior cavity wall surface of at least one frictional engagement member.

[0033] The cavity can have the shape of a rectangular elongate or prism.

[0034] The cavity may have the shape of a triangular elongate or prism.

[0035] At least one internal cavity sidewall surface can have a flat or substantially flat profile in one or more frontal planes, where each frontal plane intersects the central axis at a distinct location and includes a normal vector to the central plane at said distinct location.

[0036] At least one internal cavity sidewall surface can have a flat or substantially flat profile along one or more center plane normal vectors, each of which intersects the central axis at a different longitudinal location thereof.

[0037] At least one internal cavity sidewall surface may maintain said flat or substantially flat profile along a portion of the central axis.

[0038] The central axis can trace a straight line in space.

[0039] The central axis may have a curvature.

[0040] The at least one frictional engagement member may have a base member through which the pivot axis extends and at least a first section extending from the base member in a direction perpendicular to the pivot axis.

[0041] The at least one frictional engagement member may include a second section extending from an end of the first section in a direction away from the pivot axis, the second section being angularly disposed relative to the first section.

[0042] At least the first section may have a tapered cross-section in a plane perpendicular to the pivot axis.

[0043] At least the first section may have a rectangular cross-section in a plane perpendicular to the pivot axis.

[0044] The engagement surface region is capable of providing a frictional engagement to the filament in an engaged configuration in use.

[0045] The housing may include an exterior opening that, in use, slidably receives and / or accommodates a portion of the filament and / or strap.

[0046] The external opening may have a size that is smaller than the size of at least a portion of the transition region of the filament, in use.

[0047] At least a portion of the transition region of the filament can be received by the exterior opening of the housing.

[0048] At least a portion of the transition region of the filament can be received by a yoke assembly configured to connect the headgear to the respiratory mask.

[0049] The aperture may form a rounded edge on a front surface of the at least one frictional engagement member.

[0050] The rounded edge may have a curvature about an axis parallel to the pivot axis.

[0051] The aperture may have a polygonal cross section with three or more sides.

[0052] The central axis may be formed in a central plane having a normal vector parallel or substantially parallel to the pivot axis.

[0053] At least one cross-section may be perpendicular to the central axis.

[0054] According to a further aspect of the present disclosure, there is provided a headgear filament for a respiratory interface or mask, the filament can have a filament body extending along its longitudinal axis, the filament body having a core region having a first geometric shape and end regions having a second geometric shape, the filament body in the end regions can have at least one flat or substantially flat outer surface extending along its longitudinal axis, and a transition region disposed along the longitudinal axis between the core region and the end region, the transition region having a shape that transitions from the first geometric shape of the core to the second geometric shape of the end region over a longitudinal distance along the longitudinal axis of the filament body.

[0055] The transition region may have, at least in part, a dimension or cross section that, in use, is larger than the corresponding dimension of the external opening of the housing of the frictional engagement member of the orientation adjustment unit.

[0056] The transition region can be offset from the longitudinal axis of the filament.

[0057] The filament can have upper and lower elongate marginal edges extending along the longitudinal axis of the filament, the marginal edges tapering toward one another at least in the transition region. Both marginal edges can taper toward one another. Only one marginal edge can taper toward the other, the other marginal edge being substantially straight along its length. One marginal edge can have a continuous, substantially flat surface formed by the end region and the core region.

[0058] According to yet another aspect of the present disclosure, there is provided headgear for a respiratory mask, the headgear comprising a direction adjustment unit as disclosed herein and at least one filament comprising a filament body, the filament body having at least one flat or substantially flat outer surface extending along its longitudinal axis, such that in an engaged configuration, the substantially flat or flat outer surface of the filament body contacts an engagement surface area of ​​the direction adjustment unit.

[0059] The filament can further include a core region having a first geometric shape, end regions having a second geometric shape, and transition regions disposed longitudinally between the core region and the end regions, the transition regions having a shape that transitions from the first geometric shape of the core region to the second geometric shape of the end regions over a longitudinal distance along the longitudinal axis of the filament body.

[0060] The headgear may further comprise a yoke assembly configured to connect the headgear to the respiratory mask.

[0061] The orientation adjustment unit may be disposed on the yoke assembly.

[0062] The yoke assembly can include a central portion and at least one section extending from the central portion, and the at least one section can be configured to connect to at least one strap of the headgear.

[0063] According to another aspect, there is provided a respiratory mask, which may include a direction adjustment unit and headgear as disclosed herein.

[0064] According to yet another aspect of the present disclosure, a respiratory therapy system is provided that includes a respiratory mask.

[0065] In yet another aspect, a headgear for a respiratory mask is provided. The headgear includes a strap and a filament at least partially positioned within the strap. The headgear further includes a direction adjustment unit having at least one movable frictional engagement member. The frictional engagement member has an aperture forming a cavity extending through the at least one frictional engagement member, the aperture being positioned to receive the filament therethrough. The at least one frictional engagement member can provide a disengaged configuration with respect to the filament in a first configuration and an engaged configuration with respect to the filament in a second configuration. The at least one frictional engagement member can be movable between an engaged configuration and a disengaged configuration. The filament can include a filament body having a substantially flat outer surface portion extending along its longitudinal axis, such that in the engaged configuration, the substantially flat outer surface portion of the filament body contacts the at least one frictional engagement member.

[0066] According to another aspect of the present disclosure, there is provided a direction adjustment unit for headgear for a respiratory mask. The direction adjustment unit includes a housing and at least one frictional engagement member movably disposed relative to the housing. The at least one frictional engagement member has an aperture extending therethrough to receive a filament of a strap of the headgear. The at least one frictional engagement member provides a disengaged configuration with respect to the filament in a first movable configuration, and provides an engaged configuration with respect to the filament in a second movable configuration. The aperture defines an engagement surface of the frictional engagement member in cross section having a linear or substantially linear portion that engages with a corresponding linear or substantially linear portion of the filament when the at least one frictional engagement member is in the engaged configuration.

[0067] According to one aspect of the present disclosure, there is provided a direction adjustment unit for a headgear for a respiratory mask. The direction adjustment unit includes a housing and at least one frictional engagement member movable relative to the housing, the at least one frictional engagement member having an aperture forming a cavity extending through the at least one frictional engagement member. The aperture is positioned to receive a filament of a strap of the headgear therethrough. The at least one frictional engagement member provides a disengaged configuration with respect to the filament in a first configuration and an engaged configuration with respect to the filament in a second configuration. The cavity forms at least one engagement surface region of the frictional engagement member. The at least one engagement surface region includes at least one linear or substantially linear portion in at least one cross-section that engages with a linear or substantially linear portion of a corresponding cross-section of the filament when the at least one frictional engagement member is in the engaged configuration.

[0068] According to one aspect of the present disclosure, there is provided a direction adjustment unit for a headgear for a respiratory mask. The direction adjustment unit includes a housing and at least one frictional engagement member movable relative to the housing, the at least one frictional engagement member having an aperture forming a cavity extending through the at least one frictional engagement member. The aperture is positioned to receive a filament of a headgear strap therethrough. The at least one frictional engagement member provides a disengaged configuration with respect to the filament in a first configuration and an engaged configuration with respect to the filament in a second configuration. The cavity forms at least one frictional engagement surface area of ​​the frictional engagement member. The at least one engagement surface area includes at least one straight or substantially straight portion in at least one cross-section that engages with a straight or substantially straight portion of a corresponding cross-section of the filament when the at least one frictional engagement member is in the engaged configuration.

[0069] According to yet another aspect, there is provided a filament of headgear for a respiratory interface or mask, the filament comprising a filament body having at least one flat or substantially flat outer surface extending along a longitudinal axis thereof.

[0070] The flat outer surface of the filament may be positioned to engage an engagement surface area of ​​a frictional engagement member of the orientation adjustment unit.

[0071] The engagement surface region may comprise a linear portion in cross section.

[0072] A linear portion of the cross-section of the engagement surface region can correspond to a linear portion of the cross-section of the flat outer surface of the filament. A linear or substantially linear portion of the cross-section of the engagement surface region can refer to a portion that is linear or substantially linear along at least one dimension of said cross-section.

[0073] In some configurations, the term "linear" may be synonymous with "straight."

[0074] The systems, methods, and apparatus described herein have innovative aspects, none of which is essential or solely responsible for their desirable attributes. Without limiting the scope of the claims, some of the advantageous features will now be outlined.

[0075] In some configurations, headgear for a respiratory mask includes at least one strap having a filament and a direction adjustment unit having an engaging configuration and a disengaging configuration with respect to the filament.

[0076] In some configurations, the respiratory mask headgear comprises at least one strap comprising a filament and a direction adjustment unit configured to restrict movement of the filament in a direction until a minimal force in that direction is applied to the filament.

[0077] In some configurations, the headgear further comprises at least one strap that does not include a filament.

[0078] In some configurations, the mask comprises any of the headgear described above. The mask assembly further comprises a patient interface. The patient interface comprises a frame and a cushion module having a housing and a seal. The patient interface further comprises a connection arrangement configured to connect the cushion module to the frame. The connection arrangement comprises at least one protrusion located on one of the cushion module and the frame and at least one recess located on the other of the cushion module and the frame. The at least one protrusion is configured to engage with the at least one recess to secure the cushion module to the frame.

[0079] In some configurations, the headgear includes a yoke assembly configured to connect the headgear to the patient interface.

[0080] In some configurations, the orientation adjustment unit is disposed on the frame.

[0081] In some configurations, the orientation adjustment unit is located on the yoke assembly.

[0082] In some configurations, the yoke comprises a central portion and at least one section extending from the central portion, the at least one section configured to connect to at least one strap of the headgear.

[0083] Aspects of the present disclosure can provide improved components associated with such headgear, such as any one or more of the yoke assembly, the directional adjustment unit, the filament, and the one or more straps.

[0084] Aspects of the present disclosure may provide improved orientation units and associated filaments that provide a more defined and / or reliable and / or effective stop between the filament and the orientation unit. Such improved orientation units may form part of a respiratory mask or headgear.

[0085] The systems, methods, and apparatus described herein have innovative aspects, no single aspect of which is essential or solely responsible for their desirable attributes. Without limiting the scope of the claims, some of the advantageous features will now be summarized.

[0086] In some configurations, headgear for a respiratory mask includes at least one strap having a filament and a direction adjustment unit having an engaging configuration and a disengaging configuration with respect to the filament.

[0087] In some configurations, headgear for a respiratory mask comprises at least one strap comprising a filament and a direction adjustment unit configured to restrict movement of the filament in a direction until a force applied to the filament in said direction is minimized.

[0088] In some configurations, the headgear further comprises at least one strap that does not include a filament.

[0089] In some configurations, the mask comprises any of the headgear described above. The mask assembly further comprises a patient interface. The patient interface comprises a frame and a cushion module having a housing and a seal. The patient interface further comprises a connection device configured to connect the cushion module to the frame. The connection device comprises at least one protrusion located on one of the cushion module and the frame and at least one recess located on the other of the cushion module and the frame. The at least one protrusion is configured to engage with the at least one recess to secure the cushion module to the frame.

[0090] In some configurations, the headgear comprises a yoke configured to connect the headgear to the patient interface. In some configurations, a frame of the patient interface comprises the yoke.

[0091] In some configurations, the yoke can include a central portion and at least one section extending from the central portion, the at least one section configured to connect to at least one strap of the headgear.

[0092] According to one aspect of the present disclosure, there is provided a direction adjustment unit for headgear for a respiratory mask, the direction adjustment unit comprising: Housing and at least one frictional engagement member movably disposed relative to the housing, the at least one frictional engagement member having an aperture extending therethrough for receiving a filament of a headgear strap therethrough; Equipped with at least one frictional engagement member, in a first movable / first movably achieved configuration, provides a disengaged configuration with respect to the filament, and in a second movable / second movably achieved configuration, provides an engaged configuration with respect to the filament; The orientation adjustment unit includes an abutment feature configured to abut a stop on the filament to limit the range of movement of the filament relative to the orientation adjustment unit.

[0093] The aperture defines a cavity or bore or passageway that extends through at least one frictional engagement member.

[0094] In some configurations, the at least one frictional engagement member is disposed on the housing to pivot about a pivot axis, the at least one frictional engagement member providing a disengaged configuration with respect to the filament in a first pivoted configuration and an engaged configuration with respect to the filament in a second pivoted configuration.

[0095] The direction adjustment unit may further comprise a filament.

[0096] The abutment of the abutment feature and the stop can be configured to generate a sudden increase in force, while any increase in elongation of the filament is relatively low so that the abutment feature abuts the stop before the elongation of the filament is sufficient to yield. The stop and filament can be configured so that the onset of the elastic deformation region of the filament occurs at a lower force than the onset of the elastic deformation region of the stop of the filament.

[0097] The filament can have a length including a relatively large region and a length including a relatively small region. The ratio of the thickness of the larger region to the smaller region can be in the range of 2:1, preferably 1.5:1, and most preferably 1.4:1. The ratio of the cross-sectional area of ​​the larger region to the smaller region can be in the range of 10:1, preferably 7.5:1, and most preferably about 5:1. The ratio of the length of the larger region to the length of the smaller region can be in the range of 10:1, preferably 5:1, and most preferably 4:1. The ratio of the width of the larger region to the width of the smaller region can be in the range of 0.5:1, preferably 0.75:1, and most preferably about 1:1.

[0098] A filament support structure may be provided that is positioned between the housing and the headgear and includes an elongate support that extends along and restrains at least a portion of the filaments.

[0099] The filament support structure can have opposite ends, each end having an abutment feature configured to abut against a stop on the filament, the abutment features therebetween limiting the range of movement of the filament through the locking unit.

[0100] At least one abutment feature may comprise a collar defining a slot through which the filament extends and an abutment surface or face configured to abut against a stop on the filament. Each abutment feature may comprise a respective collar. The collar may taper inward toward the end of the filament support structure when viewed from the side. The abutment surface or face may comprise a protrusion protruding from the body of the collar. The protrusion may include a protruding bar or strip extending laterally across at least a portion of the collar and having a forward face against which the filament stop abuts when the filament is fully retracted into the direction adjustment unit. The abutment surface or face of the protrusion may be supported by upper and lower inclined walls extending from the collar. The abutment surface or face is planar and occupies a plane that is substantially, but not completely, perpendicular to the longitudinal axis of the flexible support structure, i.e., at an angle of 0 to 15°.

[0101] The filament support structure may include at least one elongate guide surface extending along the filament support structure parallel to the longitudinal axis of the filament support structure and constraining the filament against the filament support structure in a direction perpendicular to the longitudinal axis. A pair of elongate guide surfaces may be provided on opposite peripheral edges of the filament support structure. The elongate guide surfaces may be sloped upward from the body of the support structure to the collar.

[0102] The filament support structure can include a length along which the filament is exposed at least in part. At least a portion of this length of the filament support structure can include guide features extending along the support structure that constrain movement of the filament in at least one direction. The filament support structure can include multiple guide features such that movement of the filament is constrained in multiple directions.

[0103] The filament support structure can include an engagement feature at one end configured to engage with the housing to attach the filament support structure to the housing. The or each engagement feature can include at least one rib. The or each engagement feature can include at least one aperture.

[0104] The filament support structure can include at least one channel configured to receive a filament. The filament support structure can include multiple channels, each configured to receive a respective filament. The characteristics of one channel can be different from the characteristics of the other channels, such as: a) Width; b) height, c) cross-sectional area, d) Cross-sectional shape is selected from any of the following:

[0105] The or each channel may have any one or more of the following characteristics, configuration features: a) The width of one channel may be 1.1 to 2.5 times larger than the width of the other channel, preferably 1.1 to 1.5 times larger, and most preferably 1.1 to 1.3 times larger. b) The height of one channel may be 2 to 10 times greater than the height of the other channel, preferably 4 to 9 times greater, and most preferably 6 to 8 times greater. c) When viewed along the longitudinal axis of the filament support structure, channels can be stacked one on top of the other. d) One channel can be adjacent to another channel such that they are side-by-side when viewed along the longitudinal axis of the filament support structure.

[0106] The filament support structure may comprise an inner surface configured to contact the face of the user and an outer surface configured to face away from the user, one of the surfaces comprising at least one modified, strengthened or weakened region relative to the other surface. The modified, strengthened or weakened region may comprise: a) ribs, b) castellation, c) teeth, d) Recess Any one or more of the following may be included:

[0107] There may be multiple modifications or areas of strengthening or weakening.

[0108] The filament can have a length including a relatively larger region, a length including a relatively smaller region, and a length including a transition region between the larger and smaller regions, the transition region passing through the collar when the filament stop abuts the collar.

[0109] In some configurations, the orientation adjustment unit is disposed on the frame.

[0110] In some configurations, the orientation adjustment unit is located on the yoke assembly.

[0111] According to another aspect of the present disclosure, there is provided a filament for headgear for a respiratory interface or mask, comprising: a. a length that includes a relatively large area; b. a length that includes a relatively small area; c. a length including a transition region between the larger and smaller regions; a filament body comprising a plurality of regions including Equipped with The length including one of the regions includes a stop.

[0112] The stop and filament can be configured such that the initiation of the elastic deformation region of the filament occurs at a lower force than the initiation of the elastic deformation region of the stop on the filament.

[0113] The stop can include a protrusion projecting from the filament perpendicular to the longitudinal axis of the filament. The protrusion can be elongate and extend laterally across at least a portion of the larger region of the filament. The stop can be adjacent to the transition region.

[0114] The stop can have an abutment surface or face that is inclined relative to the longitudinal axis of the filament. The sloped or inclined abutment surface or face can be inclined at an angle of 5 to 90°, preferably 15 to 70°, and most preferably 20 to 45°, relative to the longitudinal axis of the filament. The stop can include an abutment surface or face that is undercut relative to the longitudinal axis of the filament. The abutment surface or face can be undercut at an angle of 5 to 90°, preferably 30 to 85°, and most preferably 60 to 80°, relative to the longitudinal axis of the filament.

[0115] The stopper is a) When viewed from the side, it has an obtuse trapezoidal shape, b) a pair of opposing abutment surfaces or faces; c) abutment surfaces or faces that are planar or include planar portions; d) abutment surfaces or faces that are arcuate or include arcuate portions; may include any one or more of:

[0116] The stops may be integrally formed with the filaments.

[0117] The filament may comprise a filament anchor, the filament anchor comprising a positioning and / or alignment feature configured to position and / or align the filament with the headgear to enable mating / connection of the filament anchor with the headgear.

[0118] The positioning and / or alignment feature may include: a) including any one or more of lugs and / or recesses and / or slots and / or apertures; b) It can be provided at the wide end of the filament forming the filament anchor.

[0119] The wide end can be substantially planar and extend laterally outward from the longitudinal axis of the filament. The positioning and / or alignment feature can also be generally planar and extend laterally away from the longitudinal axis of the filament. The tip of the filament anchor can comprise an elongated slot with an open distal edge such that the tip of the filament anchor is "U" shaped or forked when viewed from above. The filament anchor can comprise a single rectangular aperture. The filament can comprise an outer sheath or tube or cover, and the filament anchor also comprises at least one barb that retains a lateral end of the outer sheath or tube or cover.

[0120] According to another aspect of the present disclosure, there is provided headgear for a respiratory interface or mask, comprising: a) any one of the above-described orientation adjustment units; b) any one of the filaments described above; A headgear is provided comprising:

[0121] The headgear can include a yoke configured to connect the headgear to the breathing interface or mask. The orientation adjustment unit can be disposed in the yoke. The yoke can include a central portion and at least one section extending from the central portion, the at least one section configured to connect to at least one strap of the headgear.

[0122] According to another aspect of the present disclosure, there is provided headgear for a respiratory mask comprising a filament according to any one of the above descriptions.

[0123] According to another aspect of the present disclosure, there is provided headgear for a respiratory mask or interface, comprising: Strap and a filament located at least partially within the strap; A direction adjustment unit, At least one movable frictional engagement member having an aperture defining a cavity, bore, or passageway extending therethrough for receiving the filament therethrough; a direction adjustment unit comprising: Equipped with at least one frictional engagement member presents a disengaged configuration with respect to the filament in the first configuration and an engaged configuration with respect to the filament in the second configuration, the at least one frictional engagement member being movable between the engaged and disengaged configurations; Headgear is provided in which the orientation adjustment unit includes an abutment feature configured to abut a stop on the filament to limit the range of movement of the filament relative to the orientation adjustment unit.

[0124] According to another aspect of the present disclosure, there is provided a respiratory mask or interface comprising headgear according to any one of the above descriptions.

[0125] According to another aspect of the present disclosure, there is provided a respiratory therapy system comprising a respiratory mask or interface of any one of the above descriptions.

[0126] Respiratory therapy systems include: a flow generator; A humidifier and a breathing gas delivery conduit; The present invention may include any one or more of the following:

[0127] According to one aspect of the present disclosure, there is provided a direction adjustment unit for headgear for a respiratory mask, the direction adjustment unit comprising: Housing and at least one frictional engagement member movably disposed relative to the housing, the at least one frictional engagement member having an aperture defining a cavity extending therethrough for receiving a filament of a headgear strap therethrough; Equipped with the at least one frictional engagement member, in the first movable configuration, provides a disengaged configuration with respect to the filament, and in the second movable configuration, provides an engaged configuration with respect to the filament, wherein in the engaged configuration, the frictional engagement member frictionally engages the filament to resist movement of the filament through the aperture; The direction adjustment unit includes a friction adjustment device configured to adjust the degree of frictional engagement of the frictional engagement member with the filament when in the engaged configuration.

[0128] The direction adjustment unit may further comprise a filament.

[0129] The friction adjustment device may be configured to adjust the actual or effective aperture size of the frictional engagement member.

[0130] The friction adjusting device may be configured to adjust the movement characteristics of the friction engagement member relative to the housing. a) the position of the friction engagement member when in the first movable configuration; b) the position of the friction engagement member when in the second movable configuration; c) the degree, range, or magnitude of movement of the frictional engagement member between the first movable configuration and the second movable configuration Any one or more of the following may be included:

[0131] The friction adjustment device may be configured to adjust the position of the friction engagement member within the housing.

[0132] The friction adjustment device may be configured to adjust the minimum or maximum angle of inclination of the friction engagement member relative to the housing.

[0133] The friction engagement member may be pivotally mounted within the housing for movement about a pivot axis, the aperture being spaced from the pivot axis.

[0134] The friction adjuster may be configured to adjust the position of the pivot axis relative to the housing.

[0135] The friction engagement member may have a contact surface or face distal to the pivot axis, and the friction adjustment device is configured to contact the contact surface or face when the friction adjustment device is in the engaged configuration, and the position of at least a portion of the friction adjustment device is adjustable relative to the contact surface or face.

[0136] The position of at least a portion of the friction modifier may be adjustable relative to the contact surface or surface in a direction perpendicular to the pivot axis. The position of at least a portion of the friction modifier may be adjustable relative to the contact surface or surface in a direction parallel to the longitudinal axis of the filament.

[0137] The friction adjustment device may include an engagement formation configured to abut against the friction engagement member when in the engagement configuration to limit movement of the friction engagement member, and the relative position of the abutment member and the friction engagement member is adjustable.

[0138] The engagement formation may be movable relative to the frictional engagement member.The frictional engagement member may be movable relative to the engagement formation.

[0139] The housing may include at least one side wall and at least one end wall, and the engagement formation forms one of the side wall or end wall of the housing.

[0140] The friction adjusting device may comprise a movable portion of the housing, movement of which adjusts the minimum or maximum range of movement of the frictional engagement member relative to the housing.

[0141] The movable portion may include an upper sub-housing or a lower sub-housing, with the frictional engagement member attached to one of the sub-housings and the other sub-housing configured to engage the frictional engagement member.

[0142] The friction engagement member may be attached to or form part of the lower sub-housing.

[0143] The movable portion of the housing may be slidably movable relative to the other housing portion.

[0144] The friction adjustment device may include an actuator configured to allow adjustment of the degree of frictional engagement of the frictional engagement member with the filament.

[0145] The actuator is d) screws threaded into the housing; e) a slider slidably movable within the housing along the channel or slot or elongated opening; f) Movable buttons or contact pads; g) rotary dials or wheels; h) a switch or rocker; may include any one or more of:

[0146] The actuator can be directly connected to the engagement arrangement. The actuator can be integral with the engagement arrangement. The actuator can be configured to be a user actuator.

[0147] The engagement arrangement may comprise a cam configured to engage the frictional engagement member, the relative position of the cam and the frictional engagement member being adjustable. The cam may comprise a rotating cam having a rotatable contact surface that engages the frictional engagement member. The cam may comprise a linear cam configured for linear movement in or on the housing and having a cam surface that engages the frictional engagement member. The cam surface may comprise: i) Plane part, j) curved part; k) Curved part may include any one or more of:

[0148] The cam may be movable towards and away from the frictional engagement member to adjust the frictional force.

[0149] A plurality of friction engagement members may be provided.

[0150] The friction adjustment device may be configured to adjust the degree of frictional engagement with two or more filaments of the frictional engagement member.

[0151] The friction adjustment device may be configured to adjust the degree of frictional engagement with all but one of the filaments of the frictional engagement members.

[0152] According to another aspect of the present disclosure, there is provided headgear for a respiratory interface or mask, comprising: any one of the above-described direction adjustment units; A filament; A headgear is provided comprising:

[0153] The headgear may further comprise a yoke configured to connect the headgear to a patient interface or a mask. The orientation adjustment unit may be disposed in the yoke. The yoke may comprise a central portion and at least one section extending from the central portion, the at least one section configured to connect to at least one strap of the headgear.

[0154] According to another aspect of the present disclosure, there is provided headgear for a respiratory mask or interface, comprising: Strap and a filament located at least partially within the strap; A direction adjustment unit, At least one movable frictional engagement member having an aperture defining a cavity extending therethrough for receiving the filament therethrough. a direction adjustment unit comprising: Equipped with at least one frictional engagement member presents a disengaged configuration with respect to the filament in the first configuration and an engaged configuration with respect to the filament in the second configuration, the at least one frictional engagement member being movable between the engaged and disengaged configurations; A headgear is provided in which the orientation adjustment unit comprises a friction adjustment device configured to adjust the degree of frictional engagement with the filament of the frictional engagement member when in the engaged configuration.

[0155] According to a further aspect of the present disclosure, there is provided headgear for a respiratory interface, comprising: a housing defining an interior space, a first opening, and a second opening, each of the first opening and the second opening communicating with the interior space; a braking element defined by or supported by the housing; at least one rotating element disposed within the housing and having a rotation axis; a core element that passes through one or both of the first and second openings in the housing and engages with the rotating element such that movement of the core element relative to the housing causes rotation of the rotating element; Equipped with an axis of rotation of the rotating element movable relative to the housing between a first position providing a first level of resistance to rotation of the rotating element and a second position providing a second level of resistance to rotation of the rotating element, the second level of resistance being greater than the first level; the second level of resistance is provided, at least in part, by frictional engagement between the rotating element and the braking element; A headgear is provided, wherein the direction adjustment unit further comprises a friction adjustment device configured to adjust frictional engagement between the rotating element and the braking element when the rotating element is in the second position.

[0156] The rotating element may be a pinion. The core element may include a rack. The core element may include a filament.

[0157] According to another aspect of the present disclosure, there is provided a direction adjustment unit for headgear for a respiratory interface, the direction adjustment unit comprising: a housing defining an interior space, a first opening, and a second opening, each of the first opening and the second opening communicating with the interior space; A rack and pinion mechanism, a pinion positioned within the interior space and rotatable relative to the housing, the pinion also configured to move between a first displacement position and a second displacement position; a rack configured to engage the pinion and move through the first and second openings in the housing; a rack and pinion mechanism comprising: a brake mounted in or on or forming part of the housing; Equipped with the pinion is rotatable in a first pinion direction by moving the rack through the housing in a first rack direction when the pinion is in a first displacement position; the pinion frictionally engages the brake when in the second displacement position such that the brake prevents rotation of the pinion in the second pinion direction, thereby preventing movement of the rack through the housing in the second rack direction; An orientation adjustment unit is provided, wherein the orientation adjustment unit further comprises a friction adjustment device configured to adjust frictional engagement between the pinion and the brake when the pinion is in the second displacement position.

[0158] The friction adjuster may be configured to adjust the position of the brake relative to the housing.

[0159] The friction adjuster may be configured to adjust the position of the pinion relative to the housing.

[0160] The friction modifier may be configured to adjust the position of the brake or pinion relative to the housing by moving the brake or pinion toward or away from the other of the pinion or brake.

[0161] The actuator can be configured to control the brake adjuster. The actuator can include a user actuator. The actuator can include a rotary actuator configured to be movable relative to the housing. The rotary actuator can include an adjustment dial or wheel. The rotary actuator can include a threaded portion and an engagement portion, where rotation of the threaded portion adjusts the position of the engagement portion relative to the housing and engages the brake.

[0162] The brake adjuster may include a toothed portion on the housing and a toothed portion on the brake, and rotation of the rotary actuator rotates one of the toothed portions, causing the one toothed portion to move along the other toothed portion, and the relative movement of the toothed portions adjusts the relative position of the pinion and the brake.

[0163] The toothed portion of the housing may be linear and the toothed portion of the brake rotates.

[0164] The actuator may include a linear actuator configured to be linearly movable relative to the housing. The linear actuator may include a slider slidably mounted to the housing.

[0165] The actuator may include a cam configured to engage the brake or pinion, such that movement of the cam adjusts the position of the brake or pinion.

[0166] According to a further aspect of the present disclosure, there is provided a direction adjustment unit for headgear for a respiratory interface, comprising: a housing defining an interior space, a first opening, and a second opening, each of the first opening and the second opening communicating with the interior space; A rack and pinion mechanism, a pinion positioned within the interior space and rotatable relative to the housing; a rack configured to engage the pinion and move through the first and second openings in the housing; a rack and pinion mechanism comprising: a brake mounted in or on the housing; Equipped with the pinion is rotatable in a first pinion direction such that the rack moves through the housing in a first rack direction, and the pinion is also rotatable in a second pinion direction such that the rack moves through the housing in an opposite rack direction; The direction adjustment unit further includes a selective engagement unit configured to selectively engage the pinion with the brake, and configured such that when the pinion rotates in a first pinion direction, the pinion engages with the brake via the selective engagement unit, causing the brake to prevent rotation of the pinion and thereby preventing movement of the rack in the first rack direction, and when the pinion rotates in a second pinion direction, the direction adjustment unit does not engage with the brake or engagement with the brake is reduced.

[0167] The brake may include a rotary brake member and a friction brake member configured to frictionally engage the rotary brake member.

[0168] The rotary brake member may include a brake wheel or drum, and the friction brake member is configured to frictionally engage a surface of the wheel or drum that is coaxial with the axis of rotation of the brake wheel or drum.

[0169] The rotary brake member may include a brake disc, and the friction brake member is configured to frictionally engage a surface of the brake wheel or drum that is perpendicular to the axis of rotation of the wheel or drum.

[0170] The selective engagement unit can include a one-way mechanism configured to engage the pinion with the rotating member when the pinion rotates in a first pinion direction, and to disengage or reduce the engagement of the pinion from the rotating member to allow relative rotation therebetween when the pinion rotates in a second pinion direction.

[0171] The selective engagement unit may include, for example, a ratchet mechanism, a clutch mechanism, or a slipper clutch mechanism.

[0172] The selective engagement unit may include an electromechanical actuator configured to selectively engage the pinion with the brake in response to a control signal.

[0173] According to a further aspect of the present disclosure, there is provided a direction adjustment unit for headgear for a respiratory mask, the direction adjustment unit comprising: Housing and at least one frictional engagement member disposed so as to be movable relative to the housing, the at least one frictional engagement member having an aperture extending therethrough to receive a filament of a strap of the headgear therethrough, the at least one frictional engagement member providing a disengaged configuration with respect to the filament in a first movable configuration and providing an engaged configuration with respect to the filament in a second movable configuration; Equipped with The orientation adjustment unit includes an abutment feature configured to abut a stop on the filament to limit the range of movement of the filament relative to the orientation adjustment unit.

[0174] A filament support structure may be disposed between the housing and the headgear, the elongate support including an elongate support extending along and restraining at least a portion of the filaments, the elongate support having a longitudinal axis extending substantially parallel to the face of the user, a transverse or lateral axis extending away from the face of the user, and a vertical axis extending substantially parallel to the face of the user; At least a portion of the elongate support has bend-controlling structures configured to provide the elongate support with greater bending stiffness along a horizontal or lateral axis than along a vertical axis.

[0175] The bend control structure may comprise an apertured structure comprising a plurality of apertures spaced along the elongate support. The bend control structure may comprise a honeycomb structure. At least one aperture may have the following shape: a) circular, b) oval, c) triangle; d) quadrilateral, e) pentagon; f) hexagonal It can be any one of:

[0176] The bend control formation of the elongate support may extend over 50% of the length of the elongate support, preferably over 75% of its length, more preferably over 90% of its length.

[0177] The elongate support member may be hollow and include a lateral inner elongate support wall positioned to contact the user's face, a lateral outer wall spaced laterally from the elongate support wall, and upper and lower walls connecting the inner and outer walls, the walls therebetween defining a hollow space in which the elongate filament is received, and the bend control structure further includes the hollow space.

[0178] The laterally outer wall comprises upper and lower laterally outer sub-walls spaced apart to define a slot therebetween. At least one of the laterally outer wall, upper wall, and lower wall can comprise at least one cutout, which is a portion of the wall where wall material is absent or reduced. Multiple cutouts can be provided. Each of the laterally outer wall, upper wall, and lower wall can comprise a cutout. Each cutout can be a geometric shape, including regular lines and shapes. At least one of the outer wall, upper wall, and lower wall can comprise a cutout, and at least one wall is castellated or toothed, including a plurality of castellations or teeth, each pair of which is arranged so as to be separated by a respective cutout, and the bend control structure further comprises castellations or teeth.

[0179] According to a further aspect of the present disclosure, any one of the above-described direction adjustment units; A filament; A headgear for a breathing interface or mask is provided, comprising:

[0180] According to a further aspect of the present disclosure there is provided a respiratory mask or interface comprising headgear according to any one of the above descriptions.

[0181] According to a further aspect of the present disclosure, there is provided a respiratory therapy system comprising a respiratory mask or interface according to any one of the above descriptions.

[0182] Respiratory therapy systems include: a. a flow generator; b. a humidifier; c. a breathing gas delivery conduit; d. an expiratory circuit; The present invention may include any one or more of the following:

[0183] According to another aspect of the present disclosure, there is provided a respiratory mask or interface for use in a respiratory therapy system, comprising: Mask frame and a cushion attached to the frame and configured to seal with the user's face; Equipped with The mask frame a gas inlet configured to receive breathable gas from a gas supply Equipped with The mask frame Vent that releases exhaled gases from the mask Furthermore, A respiratory mask or interface is provided in which the vent is positioned above and behind the gas inlet when the mask or interface is viewed from the front and one side.

[0184] The respiratory mask or interface may further comprise a fitting above the gas inlet when the mask is viewed from the front in a direction along the central axis of the gas inlet, the fitting configured to attach a yoke assembly of the headgear to the mask frame, the yoke assembly connected or configured to be connected to side straps of the headgear, and the yoke assembly connecting the headgear to the mask frame when the yoke assembly is attached to the fitting.

[0185] According to another aspect of the present disclosure, there is provided a respiratory mask or interface for use in a respiratory therapy system, comprising: Mask frame and a cushion attached to the frame and configured to seal with the user's face; Equipped with The mask frame a gas inlet configured to receive breathable gas from a gas supply Equipped with The mask frame a vent for exhausting exhaled gases from the mask; a fitting above the gas inlet when the mask is viewed from the front in a direction along the central axis of the gas inlet, the fitting configured to attach a yoke assembly of a headgear to the mask frame, the yoke assembly being connected or configured to be connected to side straps of the headgear, the yoke assembly connecting the headgear to the mask frame when the yoke assembly is attached to the fitting; Furthermore, A respiratory mask or interface is provided in which the vent is positioned above and behind the fitting when the mask or interface is viewed from the front and one side.

[0186] The fixture may include a recess in which the yoke assembly is at least partially received.

[0187] The recess may be defined by a lower surface bounding the top of the gas inlet and at least one upper surface vertically spaced from the gas inlet.

[0188] The top surface may include a plurality of top surfaces spaced apart laterally when the mask is viewed from the front and provided on a plurality of outwardly projecting portions of the frame.

[0189] The frame can include at least one yoke retention feature configured to engage the yoke assembly to retain the yoke assembly on the fixture.

[0190] The yoke retention feature may include at least one snap fit connector.

[0191] The vent may include at least one vent aperture that slopes upwardly away from the axis of the inlet.

[0192] The vent may include at least one vent aperture that is angled laterally outwardly away from the axis of the inlet.

[0193] The vent may comprise an array of vent apertures.

[0194] The or each vent aperture may be laser drilled.

[0195] The vents may be provided on a vent surface of the mask frame, the vent surface being arcuate when viewed from the front of the mask.

[0196] The vents may be provided on a vent surface of the mask frame, the vent surface being arcuate when viewed from above the mask.

[0197] The vent surface may be elongated, with the width of the vent surface being greater than the height of the vent surface when viewed from the front.

[0198] The vent face may be oval when viewed from the front.

[0199] The vent surface may be configured to disperse exhaled gases radially outward away from the mask.

[0200] The vent surface may be convex when viewed from the front of the mask.

[0201] The vent surface can be curved about multiple axes such that the vent surface is curved in multiple dimensions.

[0202] The width of the vent face may be substantially equal to the width of the gas inlet.

[0203] The gas inlet may be provided in a boss that projects outward from the front face of the mask frame.

[0204] The bosses may be angled downward when the mask is viewed from the side.

[0205] The gas inlet is oval, Circular, Non-circular It can be any one of:

[0206] The respiratory mask or interface may include a gas inlet conduit connector configured to connect the frame to a gas delivery conduit.

[0207] The gas inlet conduit connector may be integral with the boss and protrudes outwardly from the boss.

[0208] A gas inlet conduit connector is removably attachable to the boss and projects outwardly from the boss.

[0209] The respiratory mask or interface may include at least one user grip portion on the mask frame adjacent the inlet.

[0210] The user grip portion may include a recessed portion.

[0211] The respiratory mask or interface may include a pair of user grip portions, one on each side of the inlet.

[0212] The or each user grip portion may be substantially below a central axis of the inlet.

[0213] The respiratory mask or interface may include a yoke assembly.

[0214] The yoke assembly may include a central portion and a pair of opposing side portions extending laterally outward from the central portion, each side portion configured to connect to a respective side strap of the headgear, and the central portion configured to attach to a mounting fixture on the mask frame.

[0215] At least one of the fixture and the yoke assembly may include a connector arrangement configured to engage the other of the fixture and the yoke assembly to attach the yoke assembly to the fixture.

[0216] The connector arrangement may include a snap-fit ​​connector arrangement.

[0217] 220. The respiratory mask or interface of claim 219, wherein the width of the yoke assembly from one lateral edge to the other lateral edge when viewed from the front is less than 80 mm, preferably less than 75 mm, more preferably less than 70 mm, and in one example 67 mm.

[0218] The thickness of the yoke assembly from front to back as measured from the center portion of the yoke assembly can be less than 8 mm, preferably less than 7 mm, and in one example is 6.7 mm.

[0219] The yoke assembly can include a front yoke member and a rear yoke member, the yoke members defining a filament guide path through the yoke assembly.

[0220] The yoke assembly can include a pair of filament guide paths extending therethrough, each guide path configured to guide a respective filament.

[0221] When the yoke assembly is viewed from the front, one guide path can intersect with the other guide path within the yoke assembly.

[0222] When the yoke assembly is viewed from above, one guide path can intersect with the other guide path within the yoke assembly.

[0223] One guide path can extend from a first vertical position at one lateral end of the yoke assembly to a different vertical position at the opposite lateral end of the yoke assembly, and the other guide path extends from a first vertical position at the opposite lateral end of the yoke assembly to a different vertical position at one lateral end of the yoke assembly.

[0224] The yoke assembly can include a pair of laterally spaced filament inlets and a pair of laterally spaced filament outlets.

[0225] The yoke assembly may have a pair of spaced apart lateral ends, with a filament inlet and a filament outlet positioned at each lateral end of the yoke assembly.

[0226] The filament inlet can be vertically spaced from the filament outlet.

[0227] The filament inlet can be positioned below the filament outlet.

[0228] The filament inlets can be positioned at the same height so that the filament inlet at one side end of the yoke assembly is at the same height as the filament inlet at the other side end of the yoke assembly.

[0229] The filament outlets can be positioned at the same height such that the filament outlet at one lateral end of the yoke assembly is at the same height as the filament outlet at the other lateral end of the yoke assembly.

[0230] The guide path, inlet and outlet can be configured so that the filament is force balanced across the yoke, meaning that the force required to move one filament through the yoke assembly is substantially equal to the force required to move the other filament through the yoke assembly.

[0231] The yoke assembly may be a two-piece structure including a front yoke member and a rear yoke member.

[0232] The yoke assembly may include a snap fit connection that attaches the front yoke member to the rear yoke member.

[0233] The front and rear yoke members can collectively define a filament guide path through the yoke assembly, and the rear yoke member can form an integral part of the mask frame.

[0234] The respiratory mask or interface may include a pair of filament support structures, each configured to be attached to a respective lateral end of the yoke assembly, each filament support structure including a pair of filament passages, each configured to receive a respective filament.

[0235] The cushion may include an outlet through which breathable gas is delivered to the patient, the outlet having a central axis extending through a center of the outlet in the direction of gas flow, the outlet aperture having an inverted trapezoidal shape when viewed along the central axis of the outlet, the outlet including an upper portion above the central axis and a lower portion below the central axis, the upper portion having a maximum width when viewed along the central axis of the outlet that is greater than a maximum width of the lower portion.

[0236] The respiratory mask or interface may comprise a direction adjustment unit for the headgear of the respiratory mask assembly, the direction adjustment unit comprising: a housing configured to be attached to a mask frame; at least one frictional engagement member movably disposed relative to the housing, the at least one frictional engagement member having an aperture defining a cavity extending therethrough for receiving a filament of a headgear strap therethrough; Equipped with The at least one frictional engagement member, in the first movable configuration, provides a disengaged configuration with respect to the filament, and in the second movable configuration, provides an engaged configuration with respect to the filament, wherein in the engaged configuration, the frictional engagement member frictionally engages the filament to resist movement of the filament through the aperture.

[0237] The orientation adjustment unit may include a yoke assembly configured to attach to the respiratory mask and hold the housing, the yoke assembly including a pair of laterally extending, opposing arms, each terminating at a respective lateral end of the yoke assembly.

[0238] According to another aspect of the present disclosure, there is provided a respiratory mask or interface for use in a respiratory therapy system, comprising: Mask frame and a cushion attached to the frame and configured to seal with the user's face; Equipped with The mask frame a gas inlet configured to receive breathable gas from a gas supply Equipped with A respiratory mask or interface is provided in which the cushion has an outlet through which breathable gas is delivered to the patient, the outlet having a central axis extending through the center of the outlet in the direction of gas flow, the outlet aperture having an upper portion above the central axis and a lower portion below the central axis, the upper portion having a maximum width, when viewed along the central axis of the outlet, that is greater than the maximum width of the lower portion.

[0239] The exit aperture may be in the shape of an inverted trapezoid when viewed along the central axis of the exit.

[0240] The outlet may be elongate, with the width of the outlet being greater than the height of the outlet when viewed along a central axis of the outlet.

[0241] The outlet may be oval.

[0242] The outlet may include at least one arcuate portion.

[0243] The arcuate portion may bend outwardly, away from the central axis of the outlet.

[0244] The outlet may include multiple arcuate portions.

[0245] The respiratory mask or interface may comprise a direction adjustment unit for the headgear of the respiratory mask assembly, the direction adjustment unit comprising: a housing configured to be attached to a mask frame; at least one frictional engagement member movably disposed relative to the housing, the at least one frictional engagement member having an aperture defining a cavity extending therethrough for receiving a filament of a headgear strap therethrough; Equipped with The at least one frictional engagement member, in the first movable configuration, provides a disengaged configuration with respect to the filament, and in the second movable configuration, provides an engaged configuration with respect to the filament, wherein in the engaged configuration, the frictional engagement member frictionally engages the filament to resist movement of the filament through the aperture.

[0246] The orientation adjustment unit may include a yoke assembly configured to attach to the respiratory mask and hold the housing, the yoke assembly including a pair of laterally extending, opposing arms, each terminating at a respective lateral end of the yoke assembly.

[0247] According to another aspect of the present disclosure, there is provided a direction adjustment unit for headgear for a respiratory mask, the direction adjustment unit comprising: Housing and at least one frictional engagement member movably disposed relative to the housing, the at least one frictional engagement member having an aperture defining a cavity extending therethrough for receiving a filament of a headgear strap therethrough; Equipped with the at least one frictional engagement member, in the first movable configuration, provides a disengaged configuration with respect to the filament, and in the second movable configuration, provides an engaged configuration with respect to the filament, wherein in the engaged configuration, the frictional engagement member frictionally engages the filament to resist movement of the filament through the aperture; The orientation adjustment unit may comprise a yoke assembly configured to attach to the respiratory mask and hold the housing, the yoke assembly comprising a pair of laterally extending arms, each terminating at a respective lateral end of the yoke assembly, the width of the yoke assembly extending from one lateral end to the other when viewed from the front being in the range of 60 to 85 mm, preferably 60 to 80 mm, more preferably 65 to 70 mm.

[0248] The width of the yoke assembly may be less than 80 mm.

[0249] The thickness of the yoke assembly from front to back, measured at the center portion of the yoke assembly, may range from 5 to 7 mm, preferably from 6 to 6.8 mm.

[0250] The thickness of the yoke assembly may be less than 7 mm.

[0251] At least a portion of the at least one friction engagement member may lie within the width of the yoke assembly.

[0252] When viewed from above, the depth of the yoke assembly from the front outer surface to the rear outer surface of the yoke assembly may be 25 to 35 mm.

[0253] When viewed from above, the depth of the yoke assembly from its outermost front surface to its outermost rear surface may be less than 30 mm.

[0254] When viewed from above, the ratio of the width of the yoke assembly to the depth of the yoke assembly from the forward-most outer surface to the rear-most outer surface of the yoke assembly may be less than 2.5:1, preferably less than 2:1, and more preferably less than 1.8:1.

[0255] The housing of any of the above orientation adjustment units may be formed by a yoke assembly. The yoke assembly of any of the above embodiments may be formed as part of the mask frame.

[0256] The yoke assembly can include a front yoke member and a rear yoke member, the yoke members defining a filament guide path through the yoke assembly.

[0257] The yoke assembly can include a pair of filament guide paths extending therethrough, each guide path configured to guide a respective filament.

[0258] When the yoke assembly is viewed from the front, one guide path can intersect with the other guide path within the yoke assembly.

[0259] When the yoke assembly is viewed from above, one guide path can intersect with the other guide path within the yoke assembly.

[0260] One guide path can extend from a first vertical position at one lateral end of the yoke assembly to a lower vertical position at the opposite lateral end of the yoke assembly, and the other guide path extends from the first vertical position at the opposite lateral end of the yoke assembly to a lower vertical position at one lateral end of the yoke assembly.

[0261] The yoke assembly can include a pair of laterally spaced filament inlets and a pair of laterally spaced filament outlets.

[0262] The yoke assembly may have a pair of spaced apart lateral ends, with a filament inlet and a filament outlet positioned at each lateral end of the yoke assembly.

[0263] The filament inlet can be vertically spaced from the filament outlet.

[0264] The filament inlet can be positioned below the filament outlet.

[0265] The filament inlets can be positioned at the same height so that the filament inlet at one side end of the yoke assembly is at the same height as the filament inlet at the other side end of the yoke assembly.

[0266] The filament outlets can be positioned at the same height such that the filament outlet at one lateral end of the yoke assembly is at the same height as the filament outlet at the other lateral end of the yoke assembly.

[0267] The guide path, inlet and outlet can be configured so that the filament is force balanced across the yoke, meaning that the force required to move one filament through the yoke assembly is substantially equal to the force required to move the other filament through the yoke assembly.

[0268] The yoke assembly may be a two-piece structure including a front yoke member and a rear yoke member.

[0269] The yoke assembly may include a snap fit connection that attaches the front yoke member to the rear yoke member.

[0270] The front and rear yoke members can collectively define a filament guide path through the yoke assembly.

[0271] The orientation adjustment unit can include a pair of filament support structures, each configured to be attached to a respective lateral end of the yoke assembly, each filament support structure including a pair of filament passages each configured to receive a respective filament.

[0272] The yoke assembly may have a pair of spaced apart lateral ends, with a filament inlet and a filament outlet positioned at each lateral end of the yoke assembly.

[0273] The orientation adjustment unit can include a pair of filament support members, each configured to be attached to a respective lateral end of the yoke assembly, each filament support member including a pair of filament passages each configured to receive a respective filament.

[0274] The yoke assembly may include a pair of laterally extending arms, each terminating at a respective lateral end of the yoke assembly, the width of the yoke assembly extending from one lateral end to the other when viewed from the front being in the range of 60 to 85 mm, preferably 60 to 80 mm, more preferably 65 to 70 mm, and in some cases less than 80 mm.

[0275] According to another aspect of the present disclosure, there is provided a yoke assembly for use in an orientation adjustment unit for headgear for a respiratory mask, the orientation adjustment unit configured to allow adjustment of filaments of the headgear; The yoke assembly is configured to attach to the respiratory mask and to hold the housing of the direction adjustment unit, the yoke assembly having a pair of laterally extending, opposing arms, each terminating at a respective lateral end of the yoke assembly, and when viewed from the front, the width of the yoke assembly extending from one lateral end to the other lateral end is less than 80 mm.

[0276] The yoke assembly may further include a direction adjustment unit, the direction adjustment unit comprising: Housing and at least one frictional engagement member movably disposed relative to the housing, the at least one frictional engagement member having an aperture defining a cavity extending therethrough for receiving a filament of a headgear strap therethrough; Equipped with The at least one frictional engagement member, in the first movable configuration, provides a disengaged configuration with respect to the filament, and in the second movable configuration, provides an engaged configuration with respect to the filament, wherein in the engaged configuration, the frictional engagement member frictionally engages the filament to resist movement of the filament through the aperture.

[0277] According to another aspect of the present disclosure, there is provided a direction adjustment unit for headgear for a respiratory mask, comprising: At least one movable frictional engagement member having an aperture forming a cavity extending therethrough for receiving a filament of a headgear strap therethrough; Equipped with at least one frictional engagement member, in the first movable configuration, presents a disengaged configuration with respect to the filament, and in the second movable configuration, presents an engaged configuration with respect to the filament, wherein in the engaged configuration, the frictional engagement member frictionally engages the filament to resist movement of the filament through the aperture; the orientation adjustment unit further comprising a yoke assembly attached to the respiratory mask and configured to engage the housing; A direction adjustment unit is provided in which a yoke assembly defines a filament guide path through the yoke assembly and is configured to receive a filament, the filament having an effective filament length that is a length over which the filament can move through at least one frictional engagement member, the effective filament length being greater than the length of the filament guide path.

[0278] The yoke assembly can include a front yoke member and a rear yoke member, the yoke members defining a filament guide path through the yoke assembly.

[0279] The yoke assembly can include a pair of filament guide paths extending therethrough, each guide path configured to guide a respective filament.

[0280] When the yoke assembly is viewed from the front, one guide path can intersect with the other guide path within the yoke assembly.

[0281] When the yoke assembly is viewed from above, one guide path can intersect with the other guide path within the yoke assembly.

[0282] One guide path can extend from a first vertical position at one lateral end of the yoke assembly to a lower vertical position at the opposite lateral end of the yoke assembly, and the other guide path extends from the first vertical position at the opposite lateral end of the yoke assembly to a lower vertical position at one lateral end of the yoke assembly.

[0283] The yoke assembly can include a pair of laterally spaced filament inlets and a pair of laterally spaced filament outlets.

[0284] The yoke assembly may have a pair of spaced apart lateral ends, with a filament inlet and a filament outlet positioned at each lateral end of the yoke assembly.

[0285] At least a portion of the at least one friction engagement member may lie within the width of the yoke assembly.

[0286] When viewed from above, the depth of the yoke assembly from the front outer surface to the rear outer surface of the yoke assembly may be 25 to 35 mm.

[0287] When viewed from above, the depth of the yoke assembly from its outermost front surface to its outermost rear surface may be less than 30 mm.

[0288] The ratio of the width of the yoke assembly to the depth of the yoke assembly from the front outermost surface to the rear outermost surface of the yoke assembly when viewed from above may be less than 2.5:1.

[0289] The ratio of the width of the yoke assembly to the depth of the yoke assembly from the front outermost surface to the rear outermost surface of the yoke assembly when viewed from above may be less than 2:1.

[0290] The ratio of the width of the yoke assembly to the depth of the yoke assembly from the forward-most outer surface to the rear-most outer surface of the yoke assembly when viewed from above may be less than 1.8:1.

[0291] The filament inlet can be vertically spaced from the filament outlet.

[0292] The filament inlet can be positioned below the filament outlet.

[0293] The filament inlets can be positioned at the same height so that the filament inlet at one side end of the yoke assembly is at the same height as the filament inlet at the other side end of the yoke assembly.

[0294] The filament outlets can be positioned at the same height such that the filament outlet at one lateral end of the yoke assembly is at the same height as the filament outlet at the other lateral end of the yoke assembly.

[0295] The guide path, inlet and outlet can be configured so that the filament is force balanced across the yoke, meaning that the force required to move one filament through the yoke assembly is substantially equal to the force required to move the other filament through the yoke assembly.

[0296] The yoke assembly may be a two-piece structure including a front yoke member and a rear yoke member.

[0297] The yoke assembly may include a snap fit connection that attaches the front yoke member to the rear yoke member.

[0298] The front and rear yoke members can collectively define a filament guide path through the yoke assembly.

[0299] The orientation adjustment unit can include a pair of filament support structures, each configured to be attached to a respective lateral end of the yoke assembly, each filament support structure including a pair of filament passages each configured to receive a respective filament.

[0300] The yoke assembly may include a pair of laterally extending, opposing arms, each terminating at a respective lateral end of the yoke assembly, the width of the yoke assembly extending from one lateral end to the other lateral end when viewed from the front being less than 75 mm.

[0301] The width of the yoke assembly may be in the range of 60 to 85 mm, preferably 60 to 80 mm, more preferably 65 to 70 mm, and in some cases is less than 80 mm.

[0302] The thickness of the yoke assembly from front to back as measured from a central portion of the yoke assembly may be less than 7 mm.

[0303] The orientation unit may comprise at least one filament.

[0304] The direction adjustment unit may comprise a pair of filaments.

[0305] According to another aspect of the present disclosure, there is provided a yoke assembly for use in an orientation adjustment unit for headgear for a respiratory mask, the orientation adjustment unit configured to allow adjustment of filaments of the headgear; The yoke assembly is attached to the respiratory mask and configured to hold a housing of the orientation adjustment unit, the yoke assembly defining a filament guide path that passes through the yoke assembly and is configured to receive a filament, the filament having an effective length that is a length that allows the filament to move through the housing, the filament effective length being greater than the length of the filament guide path.

[0306] The yoke assembly may include a direction adjustment unit, the direction adjustment unit comprising: Housing and at least one frictional engagement member movably disposed relative to the housing, the at least one frictional engagement member having an aperture defining a cavity extending therethrough for receiving a filament of a headgear strap therethrough; Equipped with The at least one frictional engagement member, in the first movable configuration, provides a disengaged configuration with respect to the filament, and in the second movable configuration, provides an engaged configuration with respect to the filament, wherein in the engaged configuration, the frictional engagement member frictionally engages the filament to resist movement of the filament through the aperture.

[0307] The housing may be at least partially defined by the yoke assembly.

[0308] The yoke assembly may be formed as part of the mask frame. The yoke assembly may include a front yoke member and a rear yoke member, the yoke members forming part of or comprising the mask frame.

[0309] According to another aspect of the present invention, there is provided headgear for a respiratory mask or interface, comprising: any one of the above-described direction adjustment units; any one of the filaments described above; A headgear is provided comprising:

[0310] According to another aspect of the present invention, there is provided headgear for a respiratory mask or interface, comprising: any one of the above-described direction adjustment units; A filament; A headgear is provided comprising:

[0311] The headgear may include a yoke assembly configured to connect the headgear to a respiratory mask or interface.

[0312] The orientation adjustment unit may be at least partially retained within the yoke assembly.

[0313] The yoke assembly includes a central portion and at least one side portion extending laterally outward from the central portion, the at least one side portion configured to connect to at least one strap of the headgear.

[0314] According to another aspect of the present invention there is provided headgear for a respiratory mask or interface comprising a filament according to any one of the above descriptions.

[0315] According to another aspect of the invention there is provided a respiratory mask or interface comprising headgear according to any one of the above descriptions.

[0316] According to another aspect of the present invention, there is provided a respiratory therapy system comprising a respiratory mask or interface according to any one of the above descriptions.

[0317] According to another aspect of the present invention, there is provided a respiratory therapy system comprising any one of the yoke assemblies described above.

[0318] According to another aspect of the present invention, there is provided a respiratory therapy system according to any one of the above descriptions, comprising: a flow generator; A humidifier and a breathing gas delivery conduit; An expiratory circuit; A respiratory therapy system is provided that also includes any one or more of:

[0319] Further aspects of the present disclosure, which should be considered in all its novel aspects, will become apparent from the following description.

[0320] Reference numerals may be reused throughout the drawings to indicate general correspondence between referenced elements. Referring now to the drawings, several embodiments of the present disclosure will now be described, by way of example only, in which: [Brief explanation of the drawings]

[0321] [Figure 1a] FIG. 10 is a cross-sectional view of the direction adjustment unit in an engaged configuration. [Figure 1b] 1b is a perspective cross-sectional view of the direction adjustment unit of FIG. 1a in an engaged configuration; [Figure 1c] FIG. 1b is a cross-sectional view of the direction adjustment unit of FIG. 1a in a disengaged configuration. [Figure 1d] 1b is a perspective cross-sectional view of the direction adjustment unit of FIG. 1a in a disengaged configuration; [Figure 2a] 1A-1C are perspective, front, side and rear perspective views of a mask assembly including headgear, a seal assembly and a frame assembly according to one embodiment. [Figure 2b] 1A-1C are perspective, front, side and rear perspective views of a mask assembly including headgear, a seal assembly and a frame assembly according to one embodiment. [Figure 2c] 1A-1C are perspective, front, side and rear perspective views of a mask assembly including headgear, a seal assembly and a frame assembly according to one embodiment. [Figure 2d] 1A-1C are perspective, front, side and rear perspective views of a mask assembly including headgear, a seal assembly and a frame assembly according to one embodiment. [Figure 3a] FIG. 1 is an exploded view of the seal assembly, frame assembly, and front portion of the headgear. [Figure 3b] FIG. 1 is an exploded view of one form of headgear according to one embodiment. [Figure 3c] 10 shows a front cross-sectional view illustrating the relevant contact surfaces between the filaments and the side walls of the frictional engagement member aperture. FIG. [Figure 4a] FIG. 1 is an exploded view of various components of a yoke assembly (end caps not shown) of headgear for a respiratory mask with a direction adjustment unit and filaments. [Figure 4b] FIG. 4b is a cutaway view of the yoke assembly of FIG. 4a. [Figure 4c] FIG. 4b is a cutaway view of the yoke assembly of FIG. 4a. [Figure 4d] FIG. 4b is a view of the yoke assembly of FIG. 4a in a partially assembled state (end caps and optional second direction adjustment unit not shown). [Figure 5a] 10 shows a front cross-sectional view illustrating the relevant contact surfaces between the filaments and the side walls of the frictional engagement member aperture. FIG. [Figure 5b] 10 shows a front cross-sectional view illustrating the relevant contact surfaces between the filaments and the side walls of the frictional engagement member aperture. FIG. [Figure 6] FIG. 10 is a cross-sectional view illustrating a direction adjustment unit having a rectangular aperture according to one embodiment assembled to a yoke assembly. [Figure 7a] 10A-10C each show different views of a housing sleeve that allows the housing of the orientation adjustment unit to be fixedly mounted within the yoke assembly, according to one embodiment. [Figure 7b] 10A-10C each show different views of a housing sleeve that allows the housing of the orientation adjustment unit to be fixedly mounted within the yoke assembly, according to one embodiment. [Figure 7c] 10A-10C each show different views of a housing sleeve that allows the housing of the orientation adjustment unit to be fixedly mounted within the yoke assembly, according to one embodiment. [Figure 7d]Show different views of a housing sleeve that enables the housing of an orientation adjustment unit according to an embodiment to be fixedly attached within a yoke assembly. [Figure 8a] Shows a notch perspective view of a filament having a rectangular cross-section accommodated through an aperture of a friction engagement member of an orientation adjustment unit, the aperture having a rectangular cross-section. [Figure 8b] Shows a notch perspective view of a filament having a rectangular cross-section accommodated through apertures of two friction engagement members of an orientation adjustment unit, the apertures having a rectangular cross-section. [Figure 8c] Shows an alternative notch perspective view of the configuration of FIG. 8b, in which the associated housing in which the friction engagement member is pivotally arranged is shown semi-transparent. [Figure 8d] Shows an alternative notch perspective view of the configuration of FIG. 8c. [Figure 9] Is a notch cross-sectional view of an orientation adjustment unit according to an embodiment in a plane having a normal vector parallel to the pivot axis of each friction engagement member, including two friction engagement members of the orientation adjustment unit and a filament extending through the associated friction engagement member aperture, and sharp edges are formed at the intersection of the front face and the aperture of each friction engagement member. [Figure 10] Is a notch cross-sectional view of an orientation adjustment unit according to an embodiment in a plane having a normal vector parallel to the pivot axis of each friction engagement member, including two friction engagement members of the orientation adjustment unit and a filament extending through the associated friction engagement member aperture, and rounded edges are provided at the upper intersection of the front face and the aperture of each friction engagement member. [Figure 11a] Is a notch cross-sectional view of an orientation adjustment unit according to an embodiment in a plane having a normal vector parallel to the pivot axis of each friction engagement member, including two friction engagement members of the orientation adjustment unit and a filament extending through the associated friction engagement member aperture, and rounded edges are provided at the upper intersection of the front face and the aperture of each friction engagement member and at the lower intersection of the rear face and the aperture of each friction engagement member. [Figure 11b] 11b is a cutaway perspective cross-sectional view of the arrangement of FIG. 11a, with a portion of the housing shown. [Figure 12a] FIG. 10 is a cross-sectional view illustrating an orientation adjustment unit having a triangular aperture according to one embodiment assembled to a yoke assembly. [Figure 12b] FIG. 11b is a perspective cross-sectional view of the direction adjustment unit of FIG. 11a; [Figure 12c] 11b is a cutaway perspective view of the direction adjustment unit of FIG. 11a, showing in semi-transparent form the associated housing in which the frictional engagement members are pivotally disposed; FIG. [Figure 13] 1 is a side view of a friction engagement member of an orientation adjustment unit according to one embodiment, the friction engagement member comprising two sections disposed at an angle relative to each other. [Figure 14] 10 is a side cross-sectional view of a friction engagement member of an orientation adjustment unit according to one embodiment, the friction engagement member comprising a single section. [Figure 15a] 1A-1C show respective cross-sectional side views of single-section friction engagement members. [Figure 15b] 1A and 1B show front views of respective single-section friction engagement members. [Figure 15c] 1A and 1B show perspective views of respective single-section friction engagement members. [Figure 16a] FIG. 2 shows a cross-sectional side view of a single-section friction engagement member. [Figure 16b] FIG. 1 shows a perspective view of a single-section friction engagement member. [Figure 16c] FIG. 10 shows a front view of a single-section friction engagement member identifying multiple adjustable dimensions. [Figure 16d] FIG. 1 illustrates a front view of a single-section friction engagement member having a first set of dimensions according to one embodiment. [Figure 16e] FIG. 10 shows a front view of a single section having a second set of dimensions of one embodiment. [Figure 17a] FIG. 10 is a cutaway side view of an orientation adjustment unit having two single-section friction engagement members with respective pivot axes extending parallel to a vertical axis. [Figure 17b]FIG. 17b is a cutaway top view of the direction adjustment unit of FIG. 17a. [Figure 18a] 1 shows a side view of one embodiment of a two-section frictional engagement member having a rounded edge formed at the upper intersection between the front surface of the frictional engagement member, i.e., the right surface in the figure, and the aperture. [Figure 18b] 18b shows an alternative side view of the two-section friction engagement member of FIG. 18a with cross-sectional aperture areas filled in for improved visualization. [Figure 18c] 18a and 18b show a profile side view of the two-section friction engagement member of FIG. 18a and FIG. [Figure 18d] 18a to 18c show side design views of the two-section friction engagement member. [Figure 18e] FIG. 18B is a front view of the two-section friction engagement member of FIGS. 18a to 18d. [Figure 18f] FIG. 18B is a rear view of the two-section friction engagement member of FIGS. 18a to 18e. [Figure 18g] FIG. 18B is a perspective cross-sectional view of the two-section friction engagement member of FIGS. 18a to 18f. [Figure 18h] FIG. 18 is a perspective view of the two-section friction engagement member of FIGS. 18a to 18g. [Figure 18i] FIG. 18 is a profile front perspective view of the two-section friction engagement member of FIGS. 18a-18h. [Figure 18j] FIG. 18 is a profile rear perspective view of the two-section friction engagement member of FIGS. 18a to 18i. [Figure 19a] FIG. 1 illustrates a perspective view of a filament according to one embodiment. [Figure 19b-c] Figure 19b shows a side view of the filament of Figure 19a. Figure 19c shows a top view of the filament according to one embodiment. [Figure 20a] FIG. 1 illustrates a cutaway side view of a yoke assembly with an orientation adjustment unit and a filament according to one embodiment. [Figure 20b] FIG. 20b shows an enlarged cutaway side view of the configuration of FIG. 20a highlighting the interaction of the filament with the yoke assembly. [Figure 21a]The ideal force spike is enclosed in a dashed box, showing the ideal performance of our conventional steering unit. [Figure 21b] 10 illustrates the force profile of an ideal mechanical stop in an orientation adjustment unit according to one embodiment. [Figure 22] 10 shows a force comparison between our conventional orientation adjustment unit and orientation according to one embodiment. [Figure 23a] 1 shows a cutaway view of our conventional direction adjustment unit. [Figure 23b] 1 shows a cutaway view of a direction adjustment unit according to the present disclosure. [Figure 23c] 23b shows an enlarged cutaway of the orientation adjustment of FIG. 23b. [Figure 24] FIG. 23B is a perspective view of the filament support structure of the direction adjustment unit of FIGS. 23B and 23C. [Figure 25] FIG. 25 is a perspective view of the medial end of the support structure of FIG. 24. [Figure 26] FIG. 25 is a perspective view of the medial end of the support structure of FIG. 24. [Figure 27] FIG. 27 is an enlarged perspective view of the central end of FIGS. 25 and 26 including a filament according to one embodiment. [Figure 28] FIG. 28 is a perspective view of the central end of a support structure including the filament of FIG. 27. [Figure 29] FIG. 28 is a perspective view of the center end of the filament-containing support structure of FIG. 27, showing the yoke cap of the orientation adjustment unit. [Figure 30] FIG. 25 is a perspective view of a lateral end of the support structure of FIG. 24. [Figure 31] FIG. 25 is a perspective view of a lateral end of the support structure of FIG. 24. [Figure 32] 1 is a top view of an orientation adjustment unit according to one embodiment. [Figure 33] FIG. 33 is an enlarged view of FIG. 32. [Figure 34] FIG. 10 is an enlarged side view of a stop of the direction adjustment unit according to one embodiment. [Figure 35]FIG. 10 is a perspective view of a filament having a modified stop. [Figure 36] FIG. 25 is an enlarged view of a lateral end of the filament support structure of FIG. 24. [Figure 37a] FIG. 37 is an enlarged perspective view of the side end of FIG. 36 including the filament. [Figure 37b] FIG. 37 is an enlarged perspective view of the side end of FIG. 36 including the filament. [Figure 37c] FIG. 37 is an enlarged perspective view of the side end of FIG. 36 including the filament. [Figure 38] FIG. 10 is a side perspective view of a stop, filament, and support structure according to another embodiment. [Figure 39] FIG. 39 is an end perspective view according to FIG. 38. [Figure 40] FIG. 40 is an enlarged view of the central end of the support structure of FIGS. 38 and 39. [Figure 41] FIG. 39 is an enlarged side view of a portion of the configuration of FIG. 38. [Figure 42] FIG. 42 is an enlarged perspective view of the central end of the support structure of FIGS. 31-41, with the filaments omitted. [Figure 43] FIG. 10 is a perspective view of a filament support structure according to a further embodiment. [Figure 44] 44 is a side view of the support structure of FIG. 43. [Figure 45] FIG. 45 shows a cross-sectional profile of the support structure of FIGS. 43 and 44. [Figure 46] FIG. 10 is an interior side view of a filament support structure according to another embodiment. [Figure 47] FIG. 10 is an exterior side view of a filament support structure according to another embodiment. [Figure 48] FIG. 10 is a top view of a filament support structure according to another embodiment. [Figure 49] FIG. 10 is an internal view of a central collar according to one embodiment. [Figure 50] FIG. 10 is an internal view of a side collar according to one embodiment. [Figure 51] FIG. 10 is a cross-sectional view along the length of a filament support structure at a central collar, according to one embodiment. [Figure 52] FIG. 52 is an enlarged perspective view of the exterior of the filament support structure of FIG. 51. [Figure 53a] FIG. 52 is an enlarged perspective view of the inside of the filament support structure of FIG. 51. [Figure 53b] FIG. 52 is an enlarged perspective view of the inside of the filament support structure of FIG. 51. [Figure 54] FIG. 10 is a perspective view of a filament having a modified stop. [Figure 55] FIG. 10 is a perspective view of filament anchors at the lateral ends of the filaments that secure the filaments to the headgear. [Figure 56] 1 illustrates a first embodiment of a friction modifier according to the present disclosure in a first state and a second state. [Figure 57] 57 shows a modification of the first embodiment of FIG. 56. [Figure 58a] 10 shows the force profile of a direction adjustment unit without a friction adjustment mechanism. [Figure 58b] 10 illustrates multiple force profiles of a direction adjustment unit having a friction adjustment device according to the present disclosure. [Figure 59] 3 shows a second embodiment of a friction adjusting device according to the present disclosure. [Figure 60] 10 shows a third embodiment of a friction adjusting device according to the present disclosure. [Figure 61] 10 illustrates a fourth embodiment of a friction adjusting device according to the present disclosure. [Figure 62] 10A) is a schematic diagram of a direction adjustment unit with a housing having an open end; and FIG. 10B) is a schematic diagram of a direction adjustment unit including a fifth embodiment of a friction adjustment device including a housing having an open end. [Figure 63a] FIG. 63 is a schematic diagram of an actuator of the friction adjusting device of FIG. 62. [Figure 63b] FIG. 63 is a schematic diagram of an actuator of the friction adjusting device of FIG. 62. [Figure 64a] 10 shows a sixth embodiment of a friction adjusting device according to the present disclosure. [Figure 64b] 10 shows a sixth embodiment of a friction adjusting device according to the present disclosure. [Figure 65a] 10 shows a seventh embodiment of a friction adjusting device according to the present disclosure. [Figure 65b] 10 shows a seventh embodiment of a friction adjusting device according to the present disclosure. [Figure 65c] 10 shows a seventh embodiment of a friction adjusting device according to the present disclosure. [Figure 65d] 10 shows a seventh embodiment of a friction adjusting device according to the present disclosure. [Figure 65e] 10 shows a seventh embodiment of a friction adjusting device according to the present disclosure. [Figure 66] 66 shows an alternative adjustment mechanism for the friction adjustment device of FIG. 65. [Figure 67] FIG. 66 is a plan view of the friction adjusting device of FIG. 65. [Figure 68a] 10 shows an eighth embodiment of a friction adjusting device according to the present disclosure. [Figure 68b] 10 shows an eighth embodiment of a friction adjusting device according to the present disclosure. [Figure 68c] 10 shows an eighth embodiment of a friction adjusting device according to the present disclosure. [Figure 68d] 10 shows an eighth embodiment of a friction adjusting device according to the present disclosure. [Figure 69] FIG. 10 is a perspective view of an elongated support that constitutes a part of the direction adjustment unit. [Figure 70] FIG. 1 is a view from one side of a modified elongate support according to an aspect of the present disclosure. [Figure 71] FIG. 71 is a view from the other side of the modified elongate support of FIG. 70. [Figure 72] FIG. 72 is a perspective view of the modified elongate support of FIGS. 70 and 71. [Figure 73] FIG. 72 is a perspective view of the modified elongate support of FIGS. 70 and 71. [Figure 74] FIG. 74 is a perspective view from a lateral end of the modified elongate support of FIGS. 70-73. [Figure 75] FIG. 1 is an exploded perspective view of a mask assembly including a front portion of headgear, a seal assembly, and a frame assembly, according to one embodiment. [Figure 76] FIG. 76 is a perspective view of the mask assembly of FIG. 75. [Figure 77] FIG. 76 is a side view of the mask assembly of FIG. 75. [Figure 78] FIG. 76 is an enlarged perspective view of the seal assembly and front of the headgear of the mask assembly of FIG. 75. [Figure 79] FIG. 76 is an exploded perspective view of the seal assembly of the mask assembly of FIG. 75. [Figure 80] FIG. 76 is a front view of the seal assembly of FIG. 75, including a filament support structure. [Figure 81] FIG. 81 is a perspective view of the seal assembly and filament support structure of FIG. 80; [Figure 82] FIG. 81 is an enlarged side view of the seal assembly and filament support structure of FIG. 80. [Figure 83] FIG. 81 is an enlarged front view of the seal assembly and filament support structure of FIG. 80. [Figure 84] FIG. 81 is an enlarged bottom view of the seal assembly and filament support structure of FIG. 80. [Figure 85] FIG. 81 is an enlarged side view of the seal assembly of FIG. 80. [Figure 86] FIG. 81 is an enlarged perspective view of the seal assembly of FIG. 80; [Figure 87] FIG. 81 is an enlarged front view of the seal assembly of FIG. 80. [Figure 88] FIG. 76 is an enlarged front view of the frame assembly of FIG. 75. [Figure 89] FIG. 76 is an enlarged side view of the frame assembly of FIG. 75. [Figure 90] FIG. 76 is an enlarged rear view of the frame assembly of FIG. 75. [Figure 91] FIG. 76 is an enlarged side cross-sectional view of the frame assembly of FIG. 75. [Figure 92] FIG. 76 is an enlarged bottom view of the frame assembly of FIG. 75. [Figure 93] FIG. 76 is an enlarged top view of the frame assembly of FIG. 75. [Figure 94] FIG. 76 is an enlarged rear perspective view of the frame assembly of FIG. 75. [Figure 95]FIG. 76 is an enlarged front view of another embodiment of the frame assembly of FIG. 75. [Figure 96] FIG. 96 is an enlarged front perspective view of the frame assembly of FIG. 95. [Figure 97] FIG. 96 is an enlarged side view of the frame assembly of FIG. 95. [Figure 98] FIG. 76 is a front exploded perspective view of the seal assembly of FIG. 75; [Figure 99] FIG. 99 is a side cross-sectional view of the seal assembly of FIG. 98 taken through the sagittal (median) plane. [Figure 100] FIG. 99 is a side cross-sectional view of the seal assembly of FIG. 98 taken through a parasagittal (offset from the midline) plane. [Figure 101] FIG. 99 is a rear perspective view of the seal assembly of FIG. 98, with a portion of the seal assembly removed. [Figure 102] 76 is a comparative front view of a) the yoke assembly of the mask assembly of FIG. 2 and b) the yoke assembly of FIG. 75. [Figure 103] 76 is a comparative top view of a) the yoke assembly of the mask assembly of FIG. 2 and b) the yoke assembly of FIG. 75. [Figure 104] 76A and 76B are comparative front views of a) the yoke assembly of FIG. 2 and b) the yoke assembly of FIG. 75, each attached to an elongate support. [Fig. 105a-b] 76A and 76B are front and rear views of the yoke assembly and attached elongate support of FIG. 75. [Figure 106] FIG. 76 is a cross-sectional view of the yoke assembly and mask frame of the mask assembly of FIG. 75. [Figure 107] FIG. 76 is an interior side view of the lateral end of the yoke assembly of FIG. 75, the side of the yoke assembly closest to the user's face, with an end cap attached to the lateral end. [Figure 108] FIG. 76 is an inner side view of a lateral end of the yoke assembly of FIG. 75 with the end cap removed. [Figure 109] 108 is an inner side view and a perspective view of the end cap of FIG. 107. FIG. [Figure 110] FIG. 108 is an exploded view corresponding to FIG. 107. [Figure 111] FIG. 76 is a partial perspective cross-sectional view of the yoke assembly and elongate support of the mask assembly of FIG. 75, showing the orientation adjustment unit. [Figure 112] FIG. 76 is an enlarged cross-sectional view of the yoke assembly and elongate support of the mask assembly of FIG. 75, showing the orientation adjustment unit. [Figure 113] 76a) is a front view of the front member of the yoke assembly of FIG. 75. FIG. 76b) is a rear view of the front member of the yoke assembly of FIG. [Figure 114] 76a) is a front view of the rear member of the yoke assembly of FIG. 75. FIG. 76b) is a rear view of the rear member of the yoke assembly of FIG. [Figure 115] FIG. 76 is a rear view of the front member of the yoke assembly of FIG. 75, showing a pair of direction adjustment units attached to the yoke assembly, and also showing a pair of filaments threaded through the front member. [Figure 116] 105a , further illustrating the variations in the internal cross section of the yoke assembly at various different locations along the length of the yoke assembly. [Figure 117] 76 is a schematic diagram of the yoke assembly of FIG. 3 and the yoke assembly of FIG. 75, respectively, in use with a patient resting on a bed or pillow. [Figure 118] FIG. 76 is a side view of the elongate support of the mask assembly of FIG. 75. [Figure 119] 116. a) is a cross-sectional view taken along line AA in FIG. 116. b) is a cross-sectional view taken along line BB in FIG. [Figure 120] 76A and 76B are comparative perspective views of a) the elongated support of FIG. 7 and b) the elongated support of FIG. [Figure 121] a) is a perspective view of the inside of the elongated support of Figure 75. b) is a perspective view of the outside of the elongated support of Figure 75. [Figure 122] FIG. 10 is a side view of another embodiment of a filament. [Figure 123] FIG. 10 is a side view of another embodiment of a filament. DETAILED DESCRIPTION OF THE INVENTION

[0322] Embodiments of systems, components, and methods of assembly and manufacturing will now be described with reference to the accompanying figures. Like numerals refer to like or similar elements throughout the figures. While several embodiments, examples, and illustrations are disclosed below, those skilled in the art will understand that the invention described herein goes beyond the scope of the specifically disclosed embodiments, examples, and illustrations and may include other uses of the invention as well as obvious modifications and equivalents of the invention. The terminology used in the description presented herein is not intended to be construed in any limiting or restrictive manner, merely because it is used in conjunction with the detailed description of several specific embodiments of the invention. Furthermore, embodiments of the invention may include several novel features, and no single feature is solely responsible for its desirable attributes or is essential to practicing the invention described herein.

[0323] In the following description, some terminology may be used merely for reference purposes and is therefore not intended to be limiting. For example, terms such as "top" and "bottom" refer to directions in the referenced drawings. Terms such as "horizontal," "vertical," "front," "rear," "left," "right," "back," and "side" describe the orientation and / or location of a component or some portion of an element in a consistent but arbitrary frame of reference that becomes clear by reference to the text and associated drawings describing the component or element under discussion, which, with respect to a patient interface, is often in a worn orientation with the user's head in an upright position. Furthermore, terms such as "first," "second," and "third" may be used to describe separate components. Such terminology may include the terms specifically mentioned above, their derivatives, and terms of similar importance.

[0324] Unless otherwise clearly required by context, throughout the specification and claims, words such as "comprise," "comprising," and the like should be interpreted in an inclusive sense, i.e., "including but not limited to," as opposed to an exclusive or exhaustive sense. In particular, conditional language used herein, such as "can," "could," "might," "may," "for example," and the like, is intended to generally suggest that some embodiments include certain features, elements, and / or conditions, while other embodiments do not, unless specifically stated otherwise or understood otherwise within the context in which it is used. Thus, such conditional language is generally not intended to suggest that features, elements, and / or conditions are in any way required by one or more embodiments, or that one or more embodiments necessarily include logic that determines whether or not those features, elements, and / or conditions should be included in or implemented in any particular embodiment, with or without authorial input or direction.

[0325] The term "substantially" means that the recited feature, parameter, or value need not be achieved exactly, and that deviations or variations, including, for example, tolerances, measurement errors, measurement accuracy limits, and other factors known to those skilled in the art, may occur in an amount that does not eliminate the effect that the feature is intended to provide.

[0326] Numerical data may be expressed or presented herein in a range format. It will be understood that such range format is used merely for convenience and brevity, and thus should be interpreted flexibly to include not only the numerical values ​​explicitly recited as the upper and lower limits of the range, but also to include all individual numerical values ​​or subranges subsumed within that range, as if each numerical value and subrange were explicitly recited. By way of illustration, a numerical range of "1 to 5" should be interpreted not only to include the explicitly recited values ​​of about 1 to about 5, but also to include each individual value and subrange within the stated range. Thus, included within this numerical range are individual values ​​such as 2, 3, and 4, as well as subranges such as "1 to 3," "2 to 4," and "3 to 5." This same principle should apply to ranges reciting only a single numerical value (e.g., "greater than 1"), regardless of the breadth or described characteristics of the range.

[0327] The term "alternatively" refers to the selection of one of two or more options and is not intended to limit the selection to only listed options at a time or to only one of the listed options, unless the context clearly dictates otherwise.

[0328] The present disclosure can be broadly said to consist in the parts, elements and features referred to or shown individually or collectively in the specification of this application, and in any or all combinations of two or more of said parts, elements or features.

[0329] In this disclosure, the term "outer" refers to the side facing away from the user's face, and the term "inner" refers to the side facing towards the user's face.

[0330] The present disclosure relates to various components of headgear for respiratory masks. In particular, the relevant components may relate to an orientation adjustment unit for the headgear for respiratory masks, a strap containing, comprising, or secured to a filament operatively coupled to the orientation adjustment unit, or a combination of the two, which may be combined with other components associated with the headgear for respiratory masks.

[0331] More particularly, the present disclosure relates to various components of a respiratory mask or interface system.

[0332] Direction Adjustment Unit 1a-1d show one embodiment of a directional adjustment unit 1800 from our prior U.S. Provisional Patent Application No. 62 / 644,002, including a housing 1810, first and second locking elements (e.g., frictional engagement members 1820, 1822), and a headgear strap filament 1830. The directional adjustment unit, or directional locking unit, or directional resistance unit, allows the headgear position to be adjusted relative to the housing. The frictional engagement members, in some embodiments, can be referred to as locking or adjustment washers with apertures through which the filaments extend. The frictional engagement members 1820, 1822 apply significantly higher resistance to movement to the filament in the direction of headgear extension relative to the direction of headgear retraction. The headgear strap includes elastic portions configured to bias the headgear in the direction of retraction when the headgear is extended. Therefore, the headgear must apply sufficient force to overcome the resistance to extension, including the bias of the elastic portions and the frictional force applied to the filament by the directional adjustment unit. When stretched, the bias of the elastic portions exerts a retraction force greater than any frictional force exerted on the filaments by the orientation unit. Thus, the stretched headgear automatically retracts due to the biasing force until any counter force equals the biasing force provided by the elastic portions. This counter force may include a counter force pressing the mask against the user's face.

[0333] The housing 1810 includes a first chamber 1840 and a second chamber 1842, which are configured to accommodate a first frictional engagement member 1820 and a second frictional engagement member 1822, respectively. The frictional engagement member 1820 can be made from a material that provides at least some resistance to wear from friction (e.g., polypropylene, high-density polyethylene, aluminum, steel). In the illustrated configuration, the first chamber 1840 and the second chamber 1842 are separated by an inner wall 1812 of the housing 1810. However, in other configurations, the first chamber 1840 and the second chamber 1842 are not necessarily physically separate spaces but can be, for example, portions of a chamber. The housing 1810 has two end walls 1814, which, together with the inner wall 1812, have an elongated outer opening 1860 that accommodates the filament 1830, or in other words, allows the filament to pass therethrough. The filament 1830 can be an elongated thread, fiber, string, wire, or filament, such as nylon, polyethylene, polypropylene fiber, or metal (e.g., aluminum, copper, silver) wire. Advantageously, materials can be selected that provide at least some resistance to friction, abrasion, fraying, and splaying. Other shapes or geometries can be used, including rectangular cross-sections (e.g., ribbons, bands, or belts), or multiple threads, fibers, strings, wires, or filaments (e.g., cables or braided or stranded wires). All of these can be referred to as filaments 1830.

[0334] One or more materials of the filament can be selected to be substantially inelastic, thereby allowing the filament 1830 to remain substantially the same length under elongation tension. The external housing openings 1860 can be substantially aligned with one another. The external opening 1860 in the housing end wall 1814, shown on the right side of the figure, can be larger than one or both of the internal wall 1812 and the end wall 1814, shown on the left side of the figure. This allows for manipulation or deflection of the path of the filament 1830 through the housing 1810. The first chamber 1840 and the second chamber 1842 are each bounded by the internal wall 1812, one of the end walls 1814, and a pair of side walls 1816, which extend between the end walls 1814 of the housing 1810. The first chamber 1840 and the second chamber 1842 are configured to be open at one or both of the top and bottom of the housing 1810.

[0335] Each of the first chamber 1840 and the second chamber 1842 has a pair of frictional engagement member retainers 1850 aligned with opposing sidewalls 1816 of the housing 1810. Each pair of frictional engagement member retainers 1850 is configured to pivotally retain one of the first frictional engagement member 1820 or the second frictional engagement member 1822 within the respective first chamber 1840 or second chamber 1842. The frictional engagement member retainers include a circular bushing 1852 and an elongated slot 1854, where the circular bushing 1852 intersects the bottom of the housing to form an entrance configured to allow the first frictional engagement member 1820 and / or the second frictional engagement member 1822 to be received within the frictional engagement member retainer 1850. The slot 1854 may extend radially from the circular bushing 1852 toward the top of the housing 1810.

[0336] 1a-1d, the first frictional engagement member 1820 and the second frictional engagement member 1822 each include a base 1824 forming a cylindrical shaft and an arm extending from their respective base 1824. The cylindrical shaft 1824 has substantially the same width W as the housing 1810, and the first arm 1872 is narrower to fit within the first chamber 1840 and the second chamber 1842. In the illustrated configuration, the arm includes a first section 1874 and a second section 1874, where the first section 1872 extends radially or perpendicularly from the cylindrical base 1824 and the second section 1874 extends at an obtuse angle from the end of the first section 1872. Thus, the first section 1872 and the second section 1874 generally extend in two different directions. Such obtuse angle double section or two section frictional engagement members will be referred to throughout this specification as two section frictional engagement members.

[0337] In this particular illustrated embodiment, the first section 1872 of the arm of the first frictional engagement member 1820 is shorter than the first section 1872 of the arm 1826 of the second frictional engagement member 1822. The angle between the first section 1872 and the second section 1874 of the arm of the first frictional engagement member 1820 is greater than the corresponding angle of the second frictional engagement member 1822. These angles can be selected such that the second section 1874 of one or both of the first frictional engagement member 1820 and the second frictional engagement member 1822 lies substantially flat against the corresponding wall of the housing 1810 (e.g., the inner wall 1812 and the end wall 1814, respectively) at one position of the frictional engagement members 1820, 1822. The second section 1874 of the arm includes an aperture 1876 configured to receive the filament 1830. The first chamber 1840 and the second chamber 1842 differ in size according to the size of the frictional engagement members housed therein; i.e., the first chamber 1840 is smaller than the second chamber 1842 because the first frictional engagement member 1820 is smaller than the second frictional engagement member 1822. Thus, in some configurations, the frictional engagement members of the direction adjustment units are different. In alternative embodiments, each frictional engagement member 1820 may be identical or have at least one identical property or characteristic; for example, the first section 1872 of each member 1820 may be the same length.

[0338] The cylindrical base 1824 of the first frictional engagement member 1820 and the second frictional engagement member 1822 has a diameter substantially the same as the diameter of the circular bushing 1852 of the frictional engagement member retainer 1850 and is configured to be received and retained by the circular bushing 1852 in a snap-fit ​​configuration. The snap-fit ​​configuration is provided by an entrance of the circular bushing 1852 that is narrower than the diameter of the cylindrical shaft 1824. The slot 1854 of the frictional engagement member retainer 1850 is configured to allow the entrance to open and flex, which improves the ease with which the first frictional engagement member 1820 and the second frictional engagement member 1822 can be pushed through the entrance and assembled to the housing 1810. When assembled within the first chamber 1840 and the second chamber 1842 of the housing 1810, the first frictional engagement member 1820 and the second frictional engagement member 1822 can pivot back and forth about a pivot axis extending through the cylindrical base 1824.

[0339] The filament 1830 can be configured to pass through the exterior opening 1860 of the housing 1810 and the apertures 1876 of the first frictional engagement member 1820 and the second frictional engagement member 1822 .

[0340] The general operation of the direction adjustment unit according to each of the embodiments disclosed herein will now be described with reference to the specific embodiment shown in Figures 1a-1d.

[0341] Applying tension to filament 1830 causes first frictional engagement member 1820 and second frictional engagement member 1822 to move rearward and / or forward between a locked or engaged position or configuration and / or an open or unlocked or disengaged position or configuration. In this example, the rearward and / or forward movement is a pivotal movement. Other forms of movement are contemplated. Figures 1a and 1b show an orientation adjustment in the locked or engaged configuration where a force is applied to filament 1830 in a direction toward the left side of the figure (as indicated by the arrow). In some embodiments, the force applied to the filament 1830 in this configuration causes the first frictional engagement member 1820 and the second frictional engagement member 1822 to pivot in a counterclockwise direction, causing the path of the filament 1830 through the direction adjustment 1800 to become non-linear or serpentine, and / or applying an increasing frictional force resisting movement of the filament 1830, for example, due to an increased contact area and increased contact pressure between the filament 1830 and the first frictional engagement member 1820 and the second frictional engagement member 1822.

[0342] 1c and 1d show the orientation adjustment in an open, unlocked, or disengaged configuration in which force is applied to the filament 1830 in a direction toward the right of the figure (as indicated by the arrow). In this configuration, the first frictional engagement member 1820 and the second frictional engagement member 1822 can pivot in a clockwise direction such that the aperture 1876 and the external opening 1860 are aligned on a substantially straight line. This provides a smooth, low-friction path and / or reduced contact pressure so that the filament 1830 can be pulled substantially freely through the orientation adjustment 1800. The amount of force required to move the filament 1830 through the orientation adjustment 1800 can be varied based on the different amounts of frictional force applied to the filament 1830 in the closed and open positions.

[0343] The illustrated embodiment of the directional adjustment 1800 utilizes a first frictional engagement member 1820 and a second frictional engagement member 1822, although fewer or more frictional engagement members can be used. The number of frictional engagement members, the type, length, and thickness of the filament 1830, and the geometry of the frictional engagement member 1820 are design parameters that can be varied to achieve a predetermined amount of force required to overcome the directional adjustment 1800 while in the engaged, closed, or locked configuration (the "yield force") and a second predetermined amount of force required to open, release, or move the directional adjustment member to the disengaged position (the "opening force").

[0344] In use, the friction engagement members 1820 are movable between a disengaged configuration (Figures 1c and 1d) and an engaged configuration (Figures 1a and 1b) in response to outward movement of the yoke.

[0345] When the frictional engagement member 1820 is allowed to move or pivot, movement of the filament 1830 in the extension direction can be limited (e.g., inhibited or prevented) by friction between the filament 1830 and the frictional engagement member 1820, as shown in Figures 1a and 1b. Conversely, when the frictional engagement member 1820 is oriented in the disengaged configuration, as shown in Figures 1c and 1d, friction between the filament 1830 and the frictional engagement member 1820 is reduced, and movement of the filament 1830 in the extension direction is easier compared to the engaged configuration.

[0346] Further details of the operation of the orientation adjustment 1800 are described above and in the applicant's earlier patent applications referenced in the first paragraph of this specification.

[0347] In some configurations, the minimum force of the orientation adjustment unit 1800 is approximately 2 Newtons to 8 Newtons. In some configurations, two or more orientation adjustments having a minimum force of 2 Newtons to 8 Newtons can be combined to provide an overall minimum force of 4 to 16 Newtons or 16 to 32 Newtons.

[0348] In some configurations, the minimum force of the orientation adjustment unit 1800 is approximately 4 Newtons to 6 Newtons. In some configurations, two or more orientation adjustments with a minimum force of 4 Newtons to 6 Newtons can be combined to provide an overall minimum force of 8 Newtons to 12 Newtons, or 16 to 32 Newtons.

[0349] For purposes of facilitating the understanding of this disclosure, the following definitions will be used throughout the specification. A plane having a normal vector parallel to the pivot axis may also be referred to as a side throughout this specification. A plane having a normal vector parallel to the pivot axis and intersecting the center line of the frictional engagement member may also be referred to as a center plane throughout this specification. The central plane may intersect the centre of mass of the frictional engagement member or may be provided laterally offset relative to the centre of mass of the frictional engagement member. The centerline is a line extending through the frictional engagement member along which the aperture is at least partially symmetrical.

[0350] headgear 2 and 3 , in one embodiment, a headgear 200 for a respiratory mask is provided. The headgear 200 includes at least one strap 208, at least one yoke assembly 21, and at least one filament 1830 extending through the at least one strap 208 and entering the yoke assembly 21. The headgear 200 also includes a direction adjustment unit 1800 according to any of the embodiments disclosed herein. The filament 1830 has at least one flat or substantially flat outer surface extending along its longitudinal axis such that, when in an engaged configuration, the substantially flat or flat outer surface of the filament 1830 contacts a substantially flat or flat region of at least one frictional engagement member 1820, 1822 of the direction adjustment unit 1800.

[0351] In some configurations, at least one strap 208 is flexible, resilient, and / or spring-like, and can extend from an idle length when the yoke assembly 21 is pulled outward by a user's hand, and can return to its idle length when the yoke assembly 21 is released. A filament 1830 can extend through the at least one strap 208. The at least one filament 1830 of the headgear further comprises a core region 181 having a first geometric shape. The filament 1830 further comprises end regions 183 having a second geometric shape. The filament 1830 further comprises a transition region 182 longitudinally disposed between the core region 181 and the end region 183. The transition region 182 has a shape that transitions from the first geometric shape of the core region 181 to the second geometric shape of the end region 183 over a longitudinal distance along the longitudinal axis of the filament 1830.

[0352] In some configurations, the yoke assembly 21 is positioned to connect the headgear to the respiratory mask.

[0353] In some configurations, at least one strap 208 defines a cavity therein that accommodates the filament 1830. At least a portion of the strap cavity can have a shape that matches the shape of the filament 1830. For example, in the case of a filament 1830 having a rectangular cross section, at least a portion of the strap cavity can be laterally rectangular with a slightly larger dimension to accommodate the rectangular filament 1830.

[0354] For a filament 1830 having a triangular cross-section, at least a portion of the strap cavity may be laterally triangular with a slightly larger dimension to accommodate the triangular filament 1830. Once assembled, the orientation adjustment unit 1800 can be placed within the yoke assembly 21. The housing 1810 of the orientation adjustment unit 1800 can include an exterior opening 1860 that, in use, slidably receives at least a portion of the filament 1830, e.g., a portion of the transition region 182 and / or the end region 183. In some configurations, the exterior opening 1860 has a size, i.e., at least one cross-sectional dimension, that is smaller than the size of the portion of the transition region 182 of the filament 1830 so as to prevent the transition region 182 from fully entering the orientation adjustment unit 1800, in use.

[0355] In some configurations, the yoke assembly 21 comprises a central portion and at least one section extending from the central portion, the at least one section configured to connect to at least one strap 208 of the headgear.

[0356] Respiratory Interface System 2 and 3 illustrate an example of a respiratory interface system 100 or respiratory mask system 100 for delivering respiratory therapy to a patient, according to one embodiment. The mask system 100 may include an interface, such as a mask 102. In the illustrated configuration, the mask 102 includes a seal or seal module and a frame, as described in further detail herein. The illustrated mask system 100 also includes headgear 200 (sometimes referred to herein as a "headgear assembly"). The mask 102 and headgear 200 may include a connection system that attaches the headgear 200 to the mask 102. Various forms of connection systems may be used to attach the headgear 200 to the mask 102. Similarly, the mask 102 may be coupled to at least one, and possibly multiple, different types of headgear.

[0357] 3c, the mask 102 may include a seal 104 and a frame 106. The seal 104 may be configured to seal around and / or under the patient's mouth and / or nose. In the illustrated configuration, the seal 104 is a nasal seal configured to deliver a flow of respiratory gas only to the user's nose. In particular, the illustrated seal 104 includes a pair of nasal pillows configured to form a seal with the user's nares and a secondary sealing portion that surrounds the nasal pillows and is configured to form a secondary seal with one or more of the underside of the user's nose, the sides of the user's nose, and the user's upper lip.

[0358] However, the features of the present disclosure may be implemented with other mask systems having other types of mask seals, such as, for example and without limitation, a full face seal.

[0359] The frame 106 is configured to support the seal 104 and to attach the seal 104 to the headgear 200. The frame 106 may also include a gas inlet 108, see FIG. 25 , configured to be attached to a gas conduit 110 that delivers a flow of breathing gas to the patient through the mask 102.

[0360] The seal 104 can include a mounting frame or clip 122, which in some configurations can include a first portion 122a and a second portion 122b that capture a rim of the seal 104 therebetween. The clip 122 is configured to selectively connect to the frame 106, such as by a snap fit, a friction fit, or other suitable configuration. The frame 106 can include a vent 140 configured to exhaust gas from the interior of the seal 104. The mask 102 can also include a vent insert or diffuser 152 that covers the vent 140 to control the exhaust flow.

[0361] The headgear 200 of the respiratory mask system 100 is used to hold the mask 102 on the patient's face. The headgear 200 is typically attached to the mask 102 and wraps around the back of the patient's head to hold the mask 102 in sealing contact with the patient's face.

[0362] In one form, the headgear 200 can include a yoke assembly 21 or collector configured to attach to the mask 102, as described in more detail herein.

[0363] The yoke assembly 21 can be configured to attach to straps of the headgear 200, the straps and yoke 20 cooperating to form a closed loop that encircles the user's head. In the illustrated embodiment, the headgear 200 comprises an assembly of straps including a rear strap 204 configured to wrap around the back of the patient's head, an upper strap 206 configured to wrap over the top of the patient's head, and a pair of front straps 208 (see FIG. 25 ) configured to extend along the user's cheeks during use.

[0364] In some configurations, for example as shown in Figures 3a and 3c, at least one filament 1830 comprises a core region 181, a transition region 183, and an end region 183, as described above.

[0365] In some configurations, each front strap 208 is attached to a rear strap 204 of the headgear assembly 200 by a rear connector 205, for example, to a free end 207 of the rear strap 204 or a connector coupled to the free end 207. In another form, the rear strap 204 includes side extensions that form a front strap that extends along the patient's cheek during use.

[0366] In one form, the headgear 200 can be adjustable (e.g., manually adjustable, automatically adjustable) and / or can incorporate one or more locks (e.g., the directional adjustment unit 1800 described above) that allow the headgear 200 to be reduced in length with a relatively low amount of resistance while resisting an increase in the length of the headgear 200. In some configurations, the locking force of the directional adjustment unit 1800 can be overridden to allow the headgear 200 to be lengthened to accommodate the interface assembly 100. In some forms, the yoke assembly 21 can form a collection for filaments used in an automatically adjustable headgear system. In this form, the yoke assembly 21 can incorporate one or more directional adjustments 1800, each of which can include one or more locking elements, which may be referred to herein as frictional engagement members or frictional engagement members. The frictional engagement members are configured to frictionally engage the filaments during extension of the headgear 200 but allow relatively frictionless movement during retraction of the headgear 200.

[0367] The frictional engagement members 1820, 1822 and / or the filament 1830 can have at least one flat or substantially flat region as described above.

[0368] In some configurations, the headgear 200 or interface assembly 100 includes a release mechanism or configuration that is configured to release or hold the directional adjustment 1800 open to allow low-friction movement while a control or other actuator is being operated by the user, and to provide high friction resistance when the control or actuator is not being actuated.

[0369] The orientation adjustment 1800 can be incorporated into the end of the yoke assembly or collector 20, and the body of the yoke assembly 21 or collector can be hollow enough to receive a filament therein. The headgear 200, or any portion thereof, can be configured according to any of the embodiments disclosed in applicant's U.S. Patent Application Publication No. 2016 / 0082217, U.S. Patent Application No. 14 / 856,193, filed September 16, 2015, and WO 2016 / 043603, all of which are incorporated herein by reference in their entireties.

[0370] 3a and 3b, the headgear 200 includes two filaments 1830, one for each front strap 208. However, any number of filaments may be used.

[0371] 3a and 3b, each front strap 208 can have a free end to which a connector 209 can be attached. Each connector 209 can mate with a complementary strap connector 203 located on the yoke assembly 21. Preferably, the yoke assembly 21 is substantially elongated, with the strap connectors 203 located at or near each end of the front and rear members 21a and 21b of the yoke assembly 21.

[0372] The connection between the front straps 208 and the yoke assembly 21 can be in any suitable form, such as a snap-fit ​​connection, a screw and thread type connection, an overmolded connection, or a hook connection. In one configuration, each strap connector 203 includes a cap 210 (not shown in FIGS. 3a-3c) located at each end of the yoke assembly 21. Each cap 210 can include an opening, such as an aperture or recess, configured to receive the connector 209 of the front strap 208 in a snap-fit ​​configuration to attach the yoke assembly to the front strap 208 of the headgear assembly 200.

[0373] Referring to FIG. 3b, the filament 1830 can be connected to the top strap 206 and / or the back strap 204 via a front strap connector 2081, thereby securing one end 1811 of the core region 181 of the filament 1830 to the front strap connector 2081.

[0374] This means that as the front strap 208 stretches, for example, as a result of pulling on the yoke assembly to which the strap 208 is connected in use, the stretching portion of the front strap 208 moves, e.g., slides, relative to the filament 1830 because both the front strap 208 and the core region end 1811 are connected together in or adjacent the front strap connector 2081. This causes the free end of the end region 183 of the filament 1830 to move closer to the connector 209 of the strap 208 to which it is attached. This causes relative movement of the end region 183 of the filament 1830 and the direction lock unit 1800 in which the filament 1830 is disposed. Because the yoke assembly 21, and indirectly the direction adjustment unit 1800, are also connected to the connector 209, the filament 1830 moves relative to the direction adjustment unit 1800. This relative movement causes the associated frictional engagement members 1820, 1822 to move from their disengaged position towards their engaged position due to friction between the filaments and the cavities in the frictional engagement members in which they are located.

[0375] The opposite occurs when the strap is allowed to return from its extended state to its unextended state, for example, when a user releases the yoke assembly 21 with their own hands. The spring resilience in the strap 208 acts to retract the strap 208 from its extended state to its unextended state. In this scenario, the distance between the free ends of the end region 183 of the filament 1830 moves further away from the connector 209 of the strap 208 to which the filament is attached. This causes relative movement between the end region 183 of the filament 1830 and the directional lock unit 1800 in which the filament 1830 is disposed. This relative movement causes the frictional engagement members 1820, 1822 to move from their engaged positions toward their disengaged positions due to friction between the filament and the cavity of the frictional engagement member in which the filament is attached.

[0376] 3b, the rightmost front strap 208 is connected to the leftmost directional adjustment unit 1800, and the leftmost front strap 208 is connected to the rightmost directional adjustment unit 1800. It should be understood that the directional lock unit 1800 having at least one frictional engagement member 1820, 1822 with an aperture forming a flat or substantially flat region that engages with a corresponding flat or substantially flat region of the filament 1830 can be provided in any headgear design, i.e., designs other than those disclosed herein. In such designs, the respective directional adjustment units 1800 and filaments 1830 can be oriented, positioned, or connected differently with respect to other components of the headgear while still allowing relative movement therebetween that triggers movement between the disengaged and engaged states.

[0377] As mentioned above, the yoke assembly 21 can also be configured to attach to the frame 106 of the mask 102. In one form, the frame 106 can include a recessed area configured to receive at least a portion of the yoke assembly 21 therein when the yoke assembly 21 and the frame 106 are attached to one another. A cover sleeve or front portion 222 can be configured to facilitate removable connection of the yoke assembly 21 to the frame 106.

[0378] 4a-4d show different views of a yoke assembly 20 of headgear for a respiratory mask according to one embodiment of the present disclosure.

[0379] 4a is an exploded view of the various components of a yoke assembly 20 (end caps not shown) of headgear for a respiratory mask. The yoke assembly 20 comprises a yoke housing 21 including a front member 21a and a rear member 21b. The front member 21a and the rear member 21b are permanently connected to one another by an interference fit to secure the direction adjustment unit within the yoke housing 21. A filament splitting insert 22 is disposed within the yoke housing 21.

[0380] The purpose of the filament splitting insert 22 is to guide the filament into position relative to the orientation unit of the yoke assembly 20 .

[0381] The filament splitting insert 22 includes a first guide channel 221 that slidably accommodates the first filament 1830. The first guide channel 221 has a first opening disposed at a first end of the filament splitting insert 22. The first opening of the first guide channel 221 is disposed at a first vertical level of the filament splitting insert 22. The first guide channel 221 further includes a second opening disposed at a second end of the filament splitting insert 22. The second opening of the first guide channel 221 can be disposed at a second vertical level of the filament splitting insert 22. The first vertical level and the second vertical level can relate to the same vertical level. The first vertical level can be different from the second vertical level. In some configurations, the first vertical level can be above or below the second vertical level when in use.

[0382] The yoke assembly 20 further includes an orientation adjustment unit 1800, such as that shown with reference to Figures 1a-1d. The orientation adjustment unit 1800 includes a housing 1810 and at least one frictional engagement member 1820, 1822 arranged to pivot on the housing 1810 about a pivot axis. The at least one frictional engagement member 1820, 1822 has an aperture 1876 extending therethrough that, in use, receives the filament 1830. The at least one frictional engagement member 1820, 1822 provides a disengaged configuration in a first pivoted configuration relative to the filament 1830. The at least one frictional engagement member 1820, 1822 further provides an engaged configuration in a second pivoted configuration relative to the filament 1830.

[0383] Figures 4b and 4c are cutaway views of the yoke assembly 20 of Figure 4a. In Figure 4b, the orientation adjustment unit housing 1810 has been removed to show how the apertures of at least one frictional engagement member 1820, 1822 operatively associate with the filament 1830 and the second channel 222 of the filament splitting insert 22, and Figure 4c shows the housing 1810 in which the frictional engagement members 1820, 1822 are pivotally disposed in use. Figure 4d is a view of the yoke assembly 20 of Figure 4a in a partially assembled state (end caps and optional second orientation adjustment unit not shown).

[0384] 4a-4d, aperture 1876 or the cavity formed by said aperture defines, in cross-section, at least one straight or substantially straight portion of at least one frictional engagement member 1820, 1822 that engages with a corresponding flat or substantially flat portion or outer surface of filament 1830 when at least one frictional engagement member 1820, 1822 is in an engaged configuration. In some configurations, the corresponding flat or substantially flat portion or outer surface of the filament has a straight or substantially straight portion in cross-section that corresponds to the straight or substantially straight portion of the engagement surface region.

[0385] Here, a "transverse" cross section means a cross section in which the entire aperture boundary can be observed. The transverse cross section may be parallel to the plane of the front view.

[0386] As described further below, the aperture forms a cavity extending through the frictional engagement member. In some configurations, the cavity extends along a central axis. Thus, a "cross-section" can refer to any cross-section that intersects the central axis or extension of the cavity and / or aperture. In some configurations, the cross-section is perpendicular to the central axis. In other configurations, the cross-section can be disposed at an angle relative to the central axis.

[0387] It should also be understood that the term "linear" may also be referred to as "straight" throughout this disclosure. It is believed that the filament design and corresponding frictional engagement member apertures having respective mating linear or flat surfaces or regions reduce shear forces acting on the filaments during use.

[0388] The inventors have found that a filament having a round shape, e.g., a circular cross-section, when operatively coupled to a frictional engagement member having a correspondingly larger round aperture surrounding the round filament in use, may not be able to withstand the loads generated by the natural movement of the mechanism, resulting in damage to the filament in the form of a kink. The reason for this may be that high local stress points cause deformation of the filament at the contact point between the frictional engagement member and the filament. This may permanently deform the round filament by changing the shape of its cross-section to an oval shape, thus preventing the filament from freely returning through the mechanism.

[0389] The stress (σ) acting on the filament during use can be defined using the following stress formula: σ=F / A where F relates to the force involved and A relates to the area of ​​the contact surface. Increasing the area of ​​the contact surface will reduce the stress for any given force.

[0390] The contact surface area between the round or circular filament and the slightly larger round or circular aperture is relatively small, and the local stresses in the contact surface area are relatively large.

[0391] The inventors have found that an increased contact surface area can be achieved by modifying the shape of the filaments and apertures (and / or the associated internal cavity sidewall surfaces of the cavities formed by the apertures through the frictional engagement member) so that a flat or substantially flat portion of each of the filaments engages a straight or substantially straight portion of a corresponding cross-section of the engagement surface region of the frictional engagement member.

[0392] The engagement surface region may include the interior wall or inner surface of the aperture, or the interior cavity surface of the cavity formed by the aperture.

[0393] The linear or substantially linear portion of the first cross-section of the first cross-section of the engagement surface region and the linear or substantially linear portion of the at least one second cross-section of the second cross-section of the engagement surface region can together form at least one flat or essentially flat engagement surface or region.

[0394] Straight or essentially straight portions of the cross section of the engagement surface area can extend the mutual contact surface area with the filament, thereby distributing forces more evenly across the associated contact surface.

[0395] This design ensures that when the filament engages the interior cavity wall surface of the frictional engagement member, the engagement or contact surface is flat, providing uniform pressure over a significantly larger area. These flat surfaces engage with each other, resulting in a repeatable and more consistent level of engagement, which in turn provides a more consistent level of friction to the orientation unit. Additionally, the increased contact surface minimizes stress on the filament, preventing permanent damage to the filament over its expected life cycle.

[0396] 5a and 5b show front cross-sectional views, respectively, illustrating the relevant contact surfaces between the filament 1830 and the sidewall of the frictional engagement member aperture 1876. In the example of FIG. 5a, both the filament and the frictional engagement member aperture 1876 are rectangular in cross-section, while in FIG. 5b, the filament and the frictional engagement member aperture are circular in cross-section, as previously disclosed by the inventors. Respective contact points are generally identified by arrows. As can be seen from FIG. 5a, by incorporating a rectangular filament, a significantly greater percentage of the total surface area of ​​the filament contacts the surface of the frictional engagement member aperture, significantly reducing stress in the filament, as opposed to a circular filament and aperture where only a small portion of the overlapping radius contacts each other. This increased contact area significantly reduces the stress generated in the filament when the same force is applied.

[0397] The contact surfaces of the filament and the frictional engagement member function with the greatest mechanical efficiency when they are perpendicular to one another and are able to fully engage as the frictional engagement member pivots.

[0398] As discussed above, with reference to FIGS. 1a-1d, each filament is configured to contact, in an engaged configuration, at least two surfaces of each frictional engagement member, for example, the interior cavity wall surfaces, i.e., the upper leading edge of the cavity formed by frictional engagement member aperture 1876 and the lower trailing edge of the cavity formed by frictional engagement member aperture 1876.

[0399] In some configurations, for example, referring to Figures 18e and 18f, the frictional engagement member aperture 1876 is non-round, non-circular, non-elliptical, or non-ovular in front view, i.e., in front of the at least one frictional engagement member 1820.

[0400] In some configurations, the linear or substantially linear portion of at least one cross-section of the engagement surface region of the frictional engagement member 1820 is linear along a transverse or lateral axis that is parallel or substantially parallel to the pivot axis and / or substantially perpendicular to the longitudinal axis of the filament 1830.

[0401] In some configurations, the frictional engagement member aperture 1876 can be provided offset relative to the pivot axis and extend through at least one frictional engagement member 1820, 1822 along an axis having a component perpendicular to the pivot axis.

[0402] In some configurations, as shown with reference to Figures 4a-4d, 5a and 5b, 6, 8a-8d, 15a-15c, 16a and 16b, and 18a-18j, the aperture is rectangular in shape on the front surface, e.g., the front face, of at least one friction engagement member 1820, 1822.

[0403] In some configurations, the front surface of the at least one frictional engagement member 1820, 1822 can be formed in a plane parallel to an outer surface of the first section or the second section of the at least one frictional engagement member.

[0404] In some configurations, the side edges of the rectangular aperture 1876 may be parallel or substantially parallel to the pivot axis.

[0405] In some configurations, the aperture 1876 has a rectangular cross-section in a plane parallel to the pivot axis and a longitudinal axis perpendicular to the pivot axis.

[0406] In some configurations, the aperture 1876 has a rectangular cross-section in a plane parallel to a front surface formed in a surface of the first section or the second section of the at least one friction engagement member.

[0407] FIG. 6 is a front cross-sectional view showing an orientation adjustment unit 1800 having a rectangular aperture 1876 in a cross-section, according to one embodiment of the present disclosure. In this view, the orientation adjustment unit 1800 is assembled to a yoke housing 21 comprising a front member 21a and a rear member 21b. A filament splitting insert 22 is shown behind the orientation adjustment unit 1800. In FIG. 6, an optional housing sleeve 1899 is shown to position and locate the orientation adjustment unit 1800 within the yoke housing 21. It should be understood that the housing sleeve 1899 may be preferred in some situations to allow for the possibility of using the same type or shape of orientation adjustment unit with yoke assembly designs of different sizes or shapes. However, in some configurations, the orientation adjustment unit housing 1810 is shaped to fit securely within the cavity formed by the yoke housing 21 without the need for the optional housing sleeve 1899.

[0408] 7a-7c each show different views of a housing sleeve 1899 that allows the housing of the orientation adjustment unit to be securely mounted within the yoke assembly 20 according to one embodiment.

[0409] FIG. 8a shows a cutaway perspective view of a filament 1830 having a rectangular cross-section received through an aperture 1876 of frictional engagement members 1820, 1822 of a direction adjustment unit 1800, where the aperture 1876 has a rectangular cross-section to slidably receive the rectangular filament 1830.

[0410] FIG. 8b shows a cutaway perspective view of a filament 1830 having a rectangular cross-section received through an aperture 1876 of a pair of frictional engagement members 1820, 1822 of a direction adjustment unit 1800, where the aperture 1876 has a rectangular cross-section.

[0411] Figure 8c shows an alternative cutaway perspective view of the configuration of Figure 8b, in which the associated orientation adjustment unit housing 1810 in which the frictional engagement members 1820, 1822 are pivotally arranged is shown in semi-transparent form. Figure 8d shows an alternative cutaway perspective view of the configuration of Figure 8c.

[0412] 9-11b show cutaway views of each of the orientation adjustment units 1800 in the engaged position, i.e., when the filament 1830 and the respective frictional engagement members 1820, 1822 are in frictional surface contact. As noted above, with reference to FIGS. 1a-1d, each filament 1830, in the engaged configuration, may contact at least two surfaces of each frictional engagement member, such as the interior cavity wall surfaces. These interior cavity wall surfaces are clearly shown in FIGS. 9-11b.

[0413] FIG. 9 is a cross-sectional cutaway side view (i.e., a view in a plane perpendicular to the pivot axis of each frictional engagement member 1820) of the orientation adjustment unit 1800 and associated filament 1830 according to one embodiment of the present disclosure. While not readily apparent from FIG. 9 , the aperture has a cross-sectional shape that forms at least one linear, substantially linear, or non-arcuate portion of at least one frictional engagement member 1820, 1822. Correspondingly, the filament 1830 has a corresponding flat or substantially flat portion of the cross-section. Compared to a circular or cylindrical filament and aperture cross-section, the contact area between the filament 1830 and the engagement surface area of ​​the frictional engagement member 1820, 1822 is increased during use, as described above, thereby reducing stress on the filament 1830. In this particular embodiment, the aperture 1876 forms a sharp edge at the intersection of the front face of each frictional engagement member 1820, 1822 with the aperture 1876. A cross section of the frictional engagement members 1820, 1822 shows the interaction that occurs between the filament 1830 and the frictional engagement members 1820, 1822 as the filament 1830 is pulled through a path formed between the frictional engagement members 1820, 1822 and the frictional engagement member housing 1810.

[0414] Sharp edges (E) formed at the intersection of the front faces of the frictional engagement members 1820, 1822 and the rectangular apertures 1876 that pass through the frictional engagement members 1820, 1822 can interfere with the filament 1830, and the contact points that are subject to high stresses can, in some circumstances, be permanently damaged, for example, by high levels of abrasion caused by contact between the sharp edges and the filament faces.

[0415] In some embodiments, at least one aperture edge is radiused or filleted to further reduce local stress on the filament 1830 and to further reduce or prevent damage or wear to the filament 1830 and / or frictional engagement members 1820, 1822 during use.

[0416] Thus, according to some embodiments, the aperture forms a rounded edge on a front surface of the at least one frictional engagement member 1820, 1822, which may be the forward surface.

[0417] FIG. 10 illustrates an example of a pair of frictional engagement members 1820, 1822 each having such rounded aperture edges. FIG. 10 shows a side cross-sectional view corresponding to that of FIG. 9 , in which the upper front aperture edge 81 formed at the upper intersection between the front surface of each frictional engagement member 1820, 1822 and the aperture 1876 is rounded. Here, the terms “front” and “rear” should be interpreted with respect to the front / forward direction of the arrow indicating the direction of movement of the filament when moving from the disengaged to engaged configuration. FIG. 10 illustrates the effect that rounding the upper front edges 81 of the frictional engagement member apertures 1820, 1822 has on their interaction with the filament 1830. In this particular embodiment, the lower rear edge 82 of each frictional engagement member aperture 1876 maintains a sharp edge that could potentially interfere with the filament 1830 in an undesirable manner. However, during the development of the present invention, it was discovered that this lower rear aperture edge 82 has less impact on filament wear and damage than the upper leading edge 81 .

[0418] Therefore, simply rounding the upper front aperture edge 81 may provide a more cost-effective solution while still increasing the expected life of the filament 1830.

[0419] In some configurations, the rounded edge has a curvature about an axis that is parallel to the pivot axis of the frictional engagement member.

[0420] However, it is contemplated that both the upper leading edge 81 and the lower trailing edge 82, i.e., the edges of diametrically opposite portions of the cavity formed by the aperture 1876, may be rounded.

[0421] Figure 11a is a cross-sectional cutaway side view of an orientation adjustment unit according to an alternative embodiment. Figure 11a shows a side cross-sectional view corresponding to that of Figures 9 and 10, in which both the upper front aperture edge 81 and the lower rear aperture edge 82 of each frictional engagement member 1820, 1822 are rounded. It can be said that Figure 11a shows the ideal cross-sectional profile of a frictional engagement member aperture with rounded upper and lower contact edges to eliminate any local high stress points during interaction between the frictional engagement members 1820, 1822 and the filament 1830.

[0422] Figure 11b is a cutaway perspective cross-sectional view of the configuration of Figure 11a, showing a portion of the housing and / or housing 1810. Figure 11b shows the interaction of rectangular filament 1830 with frictional engagement members 1820, 1822, where the frictional engagement members 1820, 1822 are in an engaged configuration and filament 1830 contacts the upper leading edge 81 and the lower trailing edge 82 of each frictional engagement member aperture, creating two contact areas, surfaces, or regions for each frictional engagement member 1820, 1822, resulting in a total of four contact areas, surfaces, or regions between filament 1830 and the two frictional engagement members 1820, 1822.

[0423] The rounded edges 81, 82 may have a consistent radius along their length.

[0424] In one embodiment, the aperture 1876 is triangular in front of the at least one frictional engagement member 1820, 1822, meaning that it has a triangular cross section. Similar to the rectangular apertures described above, the triangular aperture 1876 defines an engagement surface area of ​​the frictional engagement member having at least one linear or substantially linear portion in cross section. More specifically, the triangular aperture 1876 defines at least three linear or substantially linear or non-arcuate portions in cross section, each representing a sidewall of an associated triangle. Thus, when used with a triangular filament 1830 (in cross section), the triangular aperture 1876 provides the increased surface contact area described above, which reduces stress on the filament 1830 during use.

[0425] Thus, the aperture 1876 may have a triangular cross-section in a plane parallel to the pivot axis of the frictional engagement members 1820, 1822 and the longitudinal axis normal to the pivot axis.

[0426] In some configurations, the sides of the triangular aperture are parallel or substantially parallel to the pivot axis of the frictional engagement members 1820, 1822.

[0427] Such an arrangement is illustrated with reference to Figure 12a, which is a cross-sectional view similar to Figure 6, showing an orientation adjustment unit having a triangular aperture 1876 according to one embodiment. Figure 12b is a cross-sectional exploded perspective view of the orientation adjustment unit of Figure 12a. Figure 12c is an alternative cutaway perspective view of the orientation adjustment unit of Figure 11a, showing in semi-transparent form the associated housing 1810 in which the frictional engagement members 1820, 1822 are pivotally disposed.

[0428] 12a-12c, the triangular aperture has an apex that is located closer to the pivot axis of the frictional engagement members 1820, 1822 than the sides that are parallel or substantially parallel to the pivot axis. In other words, the apex of the triangular aperture points towards the pivot axis.

[0429] In some configurations, the triangular apertures can be oriented at any other angular orientation relative to the central axis about which the cross-sectional aperture shape is symmetrical. In other words, the triangular apertures can be oriented in any desired rotated orientation about the longitudinal axis of the filament 1830.

[0430] In some configurations, the aperture can have a polygonal cross-section having five or more sides, e.g., 5 to 12 sides, where the aperture has a cross-section that forms a polygon. The polygonal cross-section can be regular (i.e., all sides of the polygon are equal in length and all interior angles are equal), or irregular (i.e., any polygon that is not regular), or concave (i.e., has at least one interior angle greater than 180 degrees), or convex (i.e., has no interior angles greater than 180 degrees).

[0431] In one embodiment, the aperture 1876 extends through at least one of the frictional engagement members 1820, 1822 perpendicular or substantially perpendicular to the pivot axis of the frictional engagement members 1820, 1822.

[0432] In some configurations, the aperture 1876 can extend through at least one frictional engagement member 1820, 1822 symmetrically about a central aperture axis that is substantially perpendicular to the pivot axis, i.e., substantially aligned with the longitudinal axis of the filament 1830, and extending from the front surface of the frictional engagement member 1820, 1822. The aperture 1876 thus defines an entrance to a filament engagement cavity or bore that extends through the frictional engagement member 1820, 1822. The cavity or bore can include one or more straight or curved segments. In some configurations, the cavity or bore is substantially straight along its length. In some configurations where the central aperture axis has a spatial curvature, the cavity or bore is curved or arcuate, or has at least one curved or arcuate portion along its length.

[0433] In some configurations, the aperture extending through the at least one frictional engagement member 1820, 1822 forms a cavity or bore defined by at least one interior cavity wall surface of the at least one frictional engagement member 1820, 1822.

[0434] In some configurations, as shown in Figures 6, 12a, 15b, 16c-16e, and 18e, at least one internal cavity wall surface has a straight or substantially straight or non-arcuate profile or portion in one or more frontal planes, each frontal plane intersecting the central axis of the bore or cavity at a distinct location and containing a normal vector to the central plane at said distinct location. This means that such a flat profile of at least one internal cavity side wall surface can be maintained along the length or portion of the length of the cavity or bore in one or more regions between the front faces of the frictional engagement members 1820, 1822 and the rear faces of the frictional engagement members 1820, 1822.

[0435] In some configurations, at least one internal cavity or bore wall surface has a straight or flat, or substantially straight or substantially flat, profile along one or more center plane normal vectors, each center plane normal vector intersecting the central axis at a different longitudinal location thereof. Because the center plane normal vectors are parallel or substantially parallel to the pivot axis, at least one internal cavity wall surface will have a straight or flat, or substantially straight or substantially flat, profile along one or more transverse axes that are parallel or substantially parallel to the pivot axis of the frictional engagement members 1820, 1822, where each transverse axis intersects the central axis at a different longitudinal location thereof.

[0436] In other words, for any three orthogonal reference axes, at least one internal cavity wall surface can have a linear or substantially linear portion or profile along one of the reference axes, while being non-linear with respect to the remaining two orthogonal reference axes.

[0437] In some configurations, at least one internal cavity or bore wall maintains a straight or substantially straight portion or profile of said cross-section along a longitudinal portion of the central axis, i.e., for continuous cross-sections along the central axis.

[0438] In some configurations where the aperture 1876 has a rectangular cross section, the cavity or bore is cuboid.

[0439] In some configurations where the aperture 1876 has a triangular cross section, the cavity or bore has the shape of a triangular elongate or prism.

[0440] Further attention is now directed to the design of the frictional engagement members 1820, 1822.

[0441] In some configurations, at least one friction engagement member 1820, 1822 has a base member 1824 from which a pivot axis extends and at least a first section 1872 extending from the base member 1824 in a direction perpendicular to the pivot axis.

[0442] In some configurations, at least one frictional engagement member comprises a second section 1874 extending from a first section 1872 in a direction away from the pivot axis, where the second section 1874 is disposed at an angle relative to the first section. Such frictional engagement members are illustrated with reference to Figures 1a-1d, 4a, 8a-11b, 12b-12c, 13, 18a-18f, and 19.

[0443] 13, there is shown a side cross-sectional view of a friction engagement member of a direction adjustment unit 1800 according to one embodiment of our previous disclosure as summarized in the first paragraph of this specification. As can be seen from FIG. 13, a first section 1872 extends from a base member 1824 in a direction perpendicular to the pivot axis. A second section 1874, which may have a rectangular cross-section, extends from the first section 1872 at an angle relative to the first section 1872. A friction engagement member aperture 1876 is provided in the second section 1874 along the central axis and extends through the second section 1874.

[0444] The upright frictional engagement member position shown in FIG. 13 represents the frictional engagement member position in the disengaged configuration. In this disengaged configuration, the plane FFP including the front surface is disposed at a first vertical distance D1 from the pivot axis, and the plane RFP including the rear surface is disposed at a second vertical distance D2 from the pivot axis. As can be seen from FIG. 13, the first vertical distance D1 and the second vertical distance D2 are not equal, which means that the second section is not disposed symmetrically about the pivot axis. In FIG. 13, the front and rear surfaces of the second section 1874 are parallel to a plane including the vertical axis and the pivot axis. Considering the configuration of FIG. 13, when the frictional engagement member pivots clockwise from the disengaged configuration to the engaged configuration, the fixed point of the aperture 1876 follows a parabola or radius of curvature shown in FIG. 13 due to the symmetric offset of the second section 1874. In this configuration, the fixed points of the friction engagement members 1820, 1822 first move along an upwardly curved path and then move along a downwardly curved path.

[0445] FIG. 14 is a side cross-sectional view of frictional engagement members 1820, 1822, in which the frictional engagement members include a single section 1872. Accordingly, the associated aperture 1876 and cavity or bore are provided through the single section 1872. The frictional engagement members 1820, 1822 of FIG. 14 form non-angled or straight frictional engagement members or "flat" frictional engagement members, in which the single section 1872 extends from its base member 1824 along an axis perpendicular to the pivot axis, e.g., a vertical axis. In other words, the frictional engagement member of FIG. 14 consists of a single section and a base, and the single section 1872 in a plane having a normal vector parallel to the pivot axis extends from the base symmetrically along an axis perpendicular to the pivot axis. Thus, the single-section frictional engagement member does not further include a second section 1874.

[0446] The upright frictional engagement member position shown in FIG. 14 represents the frictional engagement member position in a disengaged configuration. In this disengaged configuration, the plane FFP containing the front surface is located a first vertical distance D1 from the pivot axis, and the plane RFP containing the rear surface is located a second vertical distance D2 from the pivot axis. As can be seen from FIG. 14, the first vertical distance D1 and the second vertical distance D2 are equal. In FIG. 14, the front and rear surfaces of the first section 1872 are parallel to a plane containing the vertical axis and the pivot axis. Considering the configuration of FIG. 14, as the frictional engagement member pivots clockwise from the disengaged configuration to the engaged configuration, the fixed point (A) of the aperture follows a parabola or curvature having a radius defined relative to the pivot axis shown in FIG. 14 because the first section 1872 is symmetrically aligned. In this configuration, the fixed points of the frictional engagement members 1820, 1822 initially move only along a downwardly curved path.

[0447] As can be seen in the embodiment of Figures 13 and 14, in the disengaged configuration, the central axis can be aligned with a horizontal plane. As can be seen from Figure 13, the center of the aperture is located horizontally rearward (i.e., to the left) from the pivot axis. The curvature is relative to the pivot axis, i.e., the curvature follows a radius defined between the pivot axis and the center of the aperture along an axis perpendicular to the pivot axis symmetrically along the first portion of the first section 1872. This means that the aperture first follows the curvature upward above the horizontal plane, and then follows the radius of curvature downward. In other words, in Figure 13, the intercept of the radius of curvature is located above a horizontal plane that intersects the central axis at the front of the frictional engagement member in the disengaged configuration. Due to the relative upward and downward movement while following the curvature, contact between the frictional engagement member and the filament occurs at different points throughout this movement. Thus, a frictional engagement member having the configuration of FIG. 13 may wear away at several points or locations along the interior cavity sidewall of the aperture. The situation is different in FIG. 14. Here, the frictional engagement member centers the aperture in line with and perpendicularly above the pivot axis, meaning that the aperture moves from the disengaged to engaged configuration only in a downward curvature. This results in a more consistent point of contact between the frictional engagement member and the filament. This may also result in a more consistent and repeatable frictional force generated by the frictional engagement member.

[0448] In some configurations, such as that shown with reference to Figure 13, at least the first section 1872 has a tapered cross-section in a plane perpendicular to the pivot axis. It should be understood that a tapered cross-section may similarly be provided in a single section 1872 friction engagement member configuration, for example, as shown in Figure 14. The tapered section may impart increased stiffness to the first section 1872.

[0449] In some configurations, such as that shown with reference to FIG. 14, at least one first section 1872 has a rectangular cross-section in a plane perpendicular to the pivot axis.

[0450] In some configurations, in the engaged configuration, a linear or substantially linear region of at least one cross section of the at least one frictional engagement member is arranged to frictionally engage a corresponding flat or substantially flat region of the filament, in use.

[0451] 15a-15c show side, front, and perspective views, respectively, of single-section frictional engagement members 1820, 1822. Similar to FIG. 14, the frictional engagement members may be symmetrical about a vertical axis when viewed from the side (see FIG. 15a). This allows the frictional engagement members 1820, 1822 to be inserted into the frictional engagement member housing 1810 in either orientation during assembly, thereby minimizing any issues in the assembly process.

[0452] Figures 16a and 16b show side and perspective views of a single-section frictional engagement member according to another embodiment. Compared to the embodiment shown in Figures 15a-15c, the frictional engagement member of Figures 16a and 16b has a shorter first section 1872. Additionally, the width of the first section is greater than that shown in Figures 15b and 15c. This provides a significantly wider aperture than the apertures of the frictional engagement members 1820, 1822 of Figures 15a-15c.

[0453] 16a and 16b may employ filaments that are significantly wider than those of the preceding embodiments. Wider filaments may provide benefits such as improved kink resistance by spreading force loads over a larger contact area. They may also resist twisting, thereby reducing the occurrence of twisting of the headgear during packaging / storage.

[0454] It should be appreciated that in some configurations, the frictional engagement members 1820, 1822 can be flipped or rotated 90 degrees so that the wide side of the filament 1830 extends parallel to the patient's face. Rotating the frictional engagement members 1820, 1822 can also allow the frictional engagement members to fit within existing yoke housings without requiring significant modifications.

[0455] In an alternative arrangement, the entire orientation adjustment unit, including the frictional engagement members and housing, can be reversed so that only the interior of the yoke where the frictional engagement members are located needs to be modified.

[0456] FIG. 16c shows a front view of single section friction engagement members 1820, 1822 identifying multiple adjustable dimensions.

[0457] Table 1 below identifies preferred ranges for the adjustable dimensions according to several configurations. However, these dimensions should not be considered limiting. Other dimensions may be used without departing from the scope of the invention.

[0458] [Table 1]

[0459] Figure 16d shows a front view of a single section frictional engagement member having a first set of dimensions of one embodiment where H1 is 20 mm. Figure 16e shows a front view of a single section having a second set of dimensions of one embodiment where H1 is 1 mm. Figures 16d and 16e show two examples at each end of example ranges of possible frictional engagement members 1820, 1822 that are within the scope of this disclosure.

[0460] FIG. 17a is a cutaway side view of an orientation adjustment unit 1800 having two single section 1872 friction engagement members 1820, 1822 with respective pivot axes extending parallel to a vertical axis.

[0461] FIG. 7b is a cutaway top view of the direction adjustment unit 1800 of FIG. 17a.

[0462] FIGS. 18a-18j show different views of a two-section / two-section frictional engagement member 1820, 1822 according to one embodiment of the present disclosure. FIG. 18a shows a side view of the two-section frictional engagement member, which has a rounded edge formed at the upper intersection of the front surface of the frictional engagement member 1820, 1822, i.e., the right side surface in the figure, and the aperture 1876. FIG. 18b shows an alternative side view of the two-section frictional engagement member 1820, 1822 of FIG. 18a, in which the aperture area is filled in for clarity. FIG. 18c shows a profile side view of the two-section frictional engagement member of FIGS. 18a and 18b. FIG. 18d shows a side design view of the two-section frictional engagement member of FIGS. 18a-18c. FIG. 18e shows a front view of the two-section frictional engagement member of FIGS. 18a-18d. Figure 18e shows a rear view of the two-section friction engagement member of Figures 18a-18e. Figure 18g shows a perspective cross-sectional view of the two-section friction engagement member of Figures 18a-18f. Figure 18h shows a perspective view of the two-section friction engagement member of Figures 18a-18g. Figure 18i shows a profiled front perspective view of the two-section friction engagement member of Figures 18a-18h. Figure 18j shows a profiled rear perspective view of the two-section friction engagement member of Figures 18a-18i.

[0463] 19a-19c show perspective, side, and top views, respectively, of a filament 1830 for headgear for a respiratory interface or mask according to one embodiment of the present disclosure. The filament 1830 comprises a filament body extending along its longitudinal axis. The filament body comprises a core region 181 having a first geometric shape. The filament body further comprises end regions 183 having a second geometric shape, where the filament 1830 at the end regions 183 have at least one flat or substantially flat outer surface extending along its longitudinal axis. It is this end region 183 of the filament 1830 that engages with the direction adjustment unit 1800 during use. The filament body further comprises a transition region 182 disposed longitudinally between the core region 181 and the end regions 183. The transition region 182 has a shape that transitions from the first geometric shape of the core to the second geometric shape of the end regions 183 over a longitudinal distance along the longitudinal axis of the filament body.

[0464] In some configurations, the transition region 182 has at least one cross-sectional dimension, at least in part, that is larger than the size of the external opening 1860 of the frictional engagement member housing 1810 during use. In this manner, the transition region 182, or at least the core region 181, is prevented from completely entering the frictional engagement member housing 1810. As shown with reference to FIG. 19b, the transition region 182 can have a first narrowed configuration 182a, which may have a curvature, in a side cross-sectional view, where the width decreases from the width of the core region to an intermediate width. The transition region 182 can further have an intermediate region 182b, where the width is substantially constant following the first narrowed configuration 182a. Further, following the intermediate region 182b, a second narrowed configuration 182c, which may have a further curvature, has a width that decreases from the width of the intermediate region 182b to the width of the end region 183 of the filament 1830.

[0465] FIG. 20a shows a cutaway side view of a yoke assembly 20 including a direction adjustment unit 1800 and the filament 1830 of FIGS. 20a and 20b according to one embodiment of the disclosure. A hard stop formed by the larger size of at least a portion of the transition region 182 of the yoke assembly 20 compared to the receiving structure of the yoke housing 211 of FIG. 20a restricts the strap from being inserted too far into the housing 1810. High bend resistance at this point minimizes the risk of the associated yoke assembly 20 twisting relative to the headgear in a relaxed state, where the transition region of the strap transitions, tapering, or curves toward the smaller-sized filament 1830 at the end to allow for snug insertion into the yoke housing. This provides high bend resistance that reduces the risk of the strap twisting and kinking when stowed or not in use.

[0466] FIG. 20b shows an enlarged cutaway side view of the configuration of FIG. 20a showing the strap together with the line track / yoke / friction engagement member housing 1810, where the transition region 182 provides a hard stop in its longitudinal position that limits the transition region 182 from being inserted too far inside the housing 1810, which could damage the directional adjustment unit 1800 and / or prevent it from functioning properly.

[0467] In one embodiment, the dimensions of the rectangular cross-section of filament 1830 (i.e., a cross-section perpendicular to the longitudinal axis of the filament) can be 0.85 mm (W) x 0.85 mm (H), meaning a cross-section that is 0.85 mm wide and 0.85 mm high. In such a configuration, the rectangular cross-section forms an equilateral rectangle, i.e., a square.

[0468] In other embodiments, the dimensions of the filament 1830 can be varied so that each side has a size ranging from 0.7 mm to 3 mm, meaning that the filament can have a 0.85 mm by 0.85 mm square, a 0.75 mm by 2.5 mm rectangle, a 3.00 mm by 3.00 mm square cross section, a triangular cross section with one 3.00 mm side and two 1.5 mm sides, or any other combination of dimensions.

[0469] Experiments have shown that a size of the filament 1830, e.g., in at least one cross-sectional dimension, that is 30 to 200 microns smaller than the size of the apertures in the frictional engagement members 1820, 1822 allows adequate clearance for the two components to function fully in the disengaged and engaged configurations.

[0470] In some configurations, the ratio of the area of ​​the cross section of the frictional engagement member aperture 1876 (as viewed from the front of the frictional engagement member) to the cross section of the filament 1830 can be in the range of 1:1.0201 to 1:1.3061.

[0471] Table 2 below identifies example dimension options, including example ratios, for apertures and filaments having rectangular cross sections. Thus, the ratio of A:F can range from 1:1 to 1:1.5.

[0472] [Table 2]

[0473] filament Referring to Figure 23a, the inventors have proposed a filament 1830 or elongated flexible member that is received within and engages with the direction adjustment unit 1800, which adjusts the tension (effective length) of the headgear in use.

[0474] Our conventional filament 1830 comprises a filament body extending along its longitudinal axis. The filament body comprises a core region having a first geometric shape and a relatively wide cross-section. The filament body further comprises end regions 183 of a narrower cross-section having a second geometric shape. It is the end regions 183 of the filament 1830 that engage with the direction adjustment unit 1800 in use. Additionally, the filament body comprises a transition region disposed longitudinally between the core region and the end regions. The transition region has a shape that transitions from the first geometric shape of the core to the second geometric shape of the end regions over a longitudinal distance along the longitudinal axis of the filament body.

[0475] Filaments in conventional designs were provided with an elastic braided outer sleeve within which the filament could move. The braided outer sleeve stretches as conventional filaments move within the orientation unit. The elastic limits of the braid provide a stop function that limits the amount the filament can slide into the orientation unit 1800. The braided outer sleeve can be, for example, a knit or woven fabric. The elasticity of the outer sleeve provided some return bias to the headgear as the outer sleeve was stretched.

[0476] The filaments of the present disclosure are provided with stops that are integral to the filament itself, eliminating the need for a braided outer sleeve as in conventional designs.

[0477] In some configurations, the transition region has, at least a portion thereof, a size, i.e., at least one cross-sectional dimension, that is larger than the size of the exterior opening 1860 of the frictional engagement member housing 1810 in use. In this way, the transition region, or at least the core region, is prevented from passing completely within the frictional engagement member housing.

[0478] A stop formed by at least a portion of the transition region being larger in size than the receiving structure of the yoke housing of the yoke assembly can help limit the strap from entering too far into the housing.

[0479] This stop resists the filament from being pulled too far into the direction adjustment unit 1800.

[0480] Referring to Figure 21a, the force spike contained within the dashed box in Figure 21a describes the ideal performance of the initial mechanical stop in the force profile: there is a sudden increase in the resulting force while the increase in braid elongation is relatively low.

[0481] The improved stop results in a force profile approximately similar to that shown in Figure 21b. The seal reaction force, which corresponds to the tensile force of the orientation unit (contributed by the frictional engagement members and the stretching of the filament braid), is constant until it becomes more gradual when the mechanical stop is activated.

[0482] In our previous design, there is a relatively large increase in elastic force before the braided outer sleeve reaches its maximum (elastic) elongation to provide a stop. The braided outer sleeve stop initially functions as described in Figure 21a, but gradually stiffens with each cycle as debris accumulates within it. Furthermore, users at the upper end of the fitting range, who require a large elongation of the braided outer sleeve for mask fitting, will experience high elastic forces. This causes the mechanism to effectively behave as a simple elastic mechanism.

[0483] Force characteristics and stops Aspects of the present disclosure provide mechanical stops on the filaments for the direction adjustment unit, where the mechanical stops are not formed by the braided outer cover. By using mechanical stops on the filaments themselves, the braided fabric or woven fabric does not enter the undesirable elongation range described above. Therefore, the user can obtain a balanced fit of the mechanism without large braid elastic forces pulling the headgear onto their face (i.e., without creating undesirable pressure). Furthermore, the user does not need to exert as much force when stretching the headgear to a sufficient length for mask fitting.

[0484] This improvement is illustrated by the modified force profile in Figure 5. The simple elastic mechanism of the braided outer cover (in solid line) operates at an extension of about 45 mm in this example, while the elastic mechanism of the mechanical stops on the filaments (in dashed line) according to the present disclosure operates at a longer extension length of about 58 mm in this example, which effectively increases the fitting range of the mechanism at a constant tensile force.

[0485] Comparison of Previous Filaments with the Filaments of the Present Disclosure 23a, our previous filaments had a relatively small cross section 1830B, e.g., a region of small or thin / narrow thickness or width or cross section along most of their length. This relatively small region is received by the direction adjustment unit 1800, as described above. A larger cross section 1830A, e.g., a region of larger or wider thickness or width or cross section, extends along the filament support structure and is secured to headgear.

[0486] 23b and 6c, a filament according to the present disclosure also features a relatively small cross-sectional filament length 1830B that passes through the frictional engagement member of the direction adjustment unit 1800, but its larger cross-sectional area 1830A extends along a greater portion of the entire filament length. The greater portion of the filament length that features a larger cross-section makes the filament 1830 overall more durable and stable. Additionally, because the length of the smaller area is reduced, the smaller area is less likely to buckle.

[0487] In one example, the larger region 1830A of the filament has a width of 3.5 mm, and the smaller region 1830B has a width of 0.86 mm. Between these two regions is a sloping transition region 1830C, where the thickness or width or cross-section of the filament 1830 tapers from the larger region 1830A to the smaller region 1830B. In one example, the length of the larger region 1830A is approximately 100 mm (including the transition region), and the length of the smaller region 1830B is approximately 95 mm. However, these lengths may vary depending on other features of the direction adjustment unit 1800, such as the yoke, the frictional engagement member, and the filament support structure 208. For example, the length of the yoke containing the smaller region 1830B of the filament can be reduced, thereby reducing the length of the smaller region 1830B of the filament 1830. The length must be small enough to be accommodated by the yoke, but also long enough so that the filament 1830 does not extend beyond the yoke as it is drawn. This is also determined by the location of the mechanical stops.

[0488] In one example, the thickness of the smaller region is approximately 0.86 mm and the thickness of the larger region is approximately 1.20 mm, as measured between the inner and outer surfaces of the filament 1830.

[0489] 23b and 23c, a locking assembly 1 according to the present disclosure includes a direction adjustment unit 1800 as described above, a filament support structure 208 as described above, and a filament 1830. The filament support structure 208 according to the present disclosure, further referring to FIG. 24, is elongated and rigid or semi-rigid, extending between the direction adjustment unit 1800 at a central end 208A and headgear at the other lateral end 208B. Each end 208A, 208B includes a hollow collar 208C, 208D through which the filament 1830 extends. The filament support structure 208 guides, but does not completely enclose, the filament 1830 along its length, while each collar 208C, 208D extends around and restrains the filament 1830. Each collar 208C, 208D acts as an end stop, limiting the range of movement or extendibility of the filament 1830.

[0490] As described above, filament 1830 includes larger region 1830A and smaller region 1830B having a smaller width, thickness, and / or cross-sectional area. Smaller region 1830B extends through direction adjustment unit 1800 and its frictional engagement member 1824. Filament 1830 is provided with mechanical stop feature 1830E in the form of a rigid structure that is a protrusion, lug, bar, or rib that projects radially outward from filament 1830, away from the longitudinal axis of the filament, in a region of filament 1830 adjacent transition region 1830C. Mechanical stop 1830E projects outward sufficiently to abut collars 208C, 208D as filament 1830 slides therethrough. 23b, the filament stop 1830E abuts the central end collar 208C, preventing the filament from being further pulled in the retraction direction through the direction adjustment unit 1800. This abutment creates a non-elastic limit to the amount the filament 1830 can extend through the direction adjustment unit 1800, i.e., a limit that is independent of any elastic properties of the filament itself. As the filament 1830 is released from the direction adjustment unit 1800, it moves in the extension direction away from the direction adjustment unit 1800, causing the stop 1830E to abut the side end collar 208D, thus limiting the amount the filament 1830 can be pulled from the direction adjustment unit 1800. The benefits of the mechanical stop 1830E and its abutment with the collars 208C, 208D are discussed above and below.

[0491] Filament Support Structure The filament 1830 is supported by a filament support structure or element 208, which is in the form of a sheath slightly wider than the larger region 1830B of the filament 1830 and includes collars 208C, 208D that hold the filament 1830 in close proximity to the filament support structure 208. The modified filament 1830 is routed through both collars 208C, 208D while supported by the support structure 208. The support structure 208 with collars 208C, 208D at both ends otherwise comprises a rectangular length of rigid material (e.g., plastic) in this example that supports the filament 1830 on only one side. In terms of orientation, the support structure 208 is positioned behind the filament 1830 and provides an interface or layer between the user's skin and the filament 1830. The collars 208C, 208D face outward, away from the user's face.

[0492] The lateral end collars 208D closer to the headgear 204 have a simple rectangular shape, while the central end collar 208C connected to the yoke of the direction adjustment unit 1800 has a rectangular shape (exposed on the outside of the yoke) but also includes an additional extension that is accommodated by the yoke (or yoke clip) and increases in width and thickness. This extension also features ribs / ridges 208E surrounding the periphery of the extension and apertures 208G on the outer surface (and / or inner surface) to achieve a strong anchoring / coupling of the support structure 208 within the lateral end of the yoke of the direction adjustment unit 1800. This can be done using an overmolding process. A sufficient anchor can be achieved in a variety of other ways, particularly in any shape that can achieve a mechanical connection between two components.

[0493] The support structure 208 itself is made from a material that is rigid enough to support the filament 1830, while preferably being somewhat flexible so that it can curve around and conform to the contours of the user's face / cheeks. It is preferably constructed from the same material as the filament 1830 (Pebax 7433).

[0494] The filament support structure 208 includes a pair of elongate guide surfaces 208F that extend parallel to the longitudinal axis of the filament support structure and constrain the filament against the filament support structure in a direction perpendicular to the longitudinal axis, and the elongate guide surfaces slope upward from the main body of the support structure 208 to each of the collars 208C, 208D.

[0495] Center end color 25-29, 36, and 37 show some further detail of the central end 208A and central end collar 208C of the filament support structure 208. The outer surface of the collar 208C is provided with a plurality of radially outwardly extending ribs 208E, which cause the central end 208A to increase in size and perimeter in a direction away from the main body of the filament support structure 208. These ribs 208E help to retain the central end 208A of the filament support structure in the yoke cap Y of the orientation adjustment unit 1800. The central end 208A also includes a centrally located oblong aperture 208F through which the filament 1830 is exposed.

[0496] These figures show some possible dimensions for the center end collar 208C. These dimensions are merely examples and are not limiting.

[0497] The shape and features of the central end collar 208C can be further seen in FIGS. 36 and 37. When viewed from the side, the collar 208C tapers inward toward the central end of the filament support structure 208. The portion of the collar 208C that abuts the filament stop 1830E comprises a protruding bar or strip 208G that extends across the width of the filament support structure 208 and is supported by upper and lower sloped walls 208I, with a forward surface 208H against which the filament stop 1830E abuts when the filament 1830 is fully retracted. Below the bar or strip 208F, the side of the filament support structure 208 slopes upward from the body to the central collar 208C. The forward surface 208G is planar and occupies a plane that is substantially, but not entirely, perpendicular to the longitudinal axis of the filament support structure 208.

[0498] As best seen in Figures 27 and 28, when the filament stop 1830E abuts the center end collar 208C, the transition region 1830C passes through the collar 208C and is located inside the yoke cap of the orientation adjustment unit 1800.

[0499] Side edge collar 30-35 show some further detail of side end 208B and side end collar 208D of filament support structure 208. Collar 208D has a similar structure to collar 208C except that rib 208E is absent, the exterior of collar 208 is smooth and flat, and the intersections of each face of collar 208 are chamfered.

[0500] Dimension example The channel or slot formed by the collars 208C, 208D through which the filament 1830 passes has a height (inside / outside direction) of 1.6 mm and a width (top / bottom direction) of 4 mm. The filament support structure 208 has a width (top / bottom direction) of 5.6 mm, a thickness (inside / outside direction) of 3.1 mm, and an overall length (medial / lateral direction) of 96 mm, including the anchor region. The distance between the collars 208C, 208D (medial / lateral direction) is 84 mm. The central collar 280C is approximately 0.75 mm thick (inside / outside direction). The inner and outer walls of the central collar 208C are flat, while the outer walls of the lateral end collars 208D are tapered to taper in thickness in the inside / outside direction. This provides a smoother thickness transition from the filament support structure 208 to the lateral ends of the filament 208 and the headgear filament attachment points. The lateral end collars 208D are approximately 0.72 mm thick (medial / lateral direction).

[0501] Manufacturing details example The filaments 1830 and filament support structure 208 may be covered by an elastic outer sheath or tube or cover (e.g., a braided cover of knitted or woven material) that is attached at the same points as the central end of the filament support structure 208 (the lateral ends of the yoke / yoke cap) and the lateral ends of the filaments 208 (the attachment points at the headgear halo formed by the straps 204, 206).

[0502] One, some, or all edges and corners are preferably rounded to achieve a smoother overall surface and further reduce the likelihood that any outer sheath or tube or cover (enclosing the filament 1830) will get caught on components and become damaged.

[0503] Filament stopper 32-35, filament stop 1830E can be seen in more detail. Stop 1830E, in this example, comprises a laterally extending protrusion, rib, or ridge that extends transversely across the longitudinal axis of filament 1830, adjacent transition region 1830C, and across the larger region of filament 1830A. Stop 1830E projects radially outward from filament 1830, away from the filament longitudinal axis. In this example, stop 1830E projects away from one side of filament 1830 in a direction perpendicular to the filament longitudinal axis.

[0504] The central edge of stop 1830E is, in one example, approximately 14 mm from the boundary dividing transition region 1830C and smaller region 1830A of filament 1830.

[0505] The stop 1830E has a beveled or angled abutment surface or face 1830F on its central side (toward the yoke Y of the directional control unit 1800) and an abutment surface or face 1830G on its lateral side (toward the headgear) that is an undercut 1830H. The beveled surface of the stop 1830 aids in assembly, particularly the insertion of the filament 1830 through the two collars 208C, 208D of the filament support structure 208. The edges and corners of the stop 1830 can be rounded to further facilitate these aspects and provide a smoother surface. Thus, when viewed from the side, the stop 1830 can take the form of an obtuse trapezoid. FIG. 34 shows example dimensions of the stop and example angles of the beveled surface 1830F and the undercut 1830G.

[0506] The abutment surface 1830G may alternatively be perpendicular to the outer surface of the filament 1830. However, experimentation has shown that the maximum pull-out force that the stop can withstand is increased by an abutment surface that engages the collar 208C that includes an angled undercut. This stop shape acts to bias the stop 1830E upwardly above the collar 208C when it contacts the collar 208C, instead of attempting to wedged under and pass under the collar 208C.

[0507] In one example, the mechanical stop 1830E has a maximum length (from center edge to side edge) of approximately 1.7 mm, and the distance between the center edge and the undercut corner is 1.6 mm. The beveled center surface of the stop is at a 30° angle relative to the flat outer surface of the filament. The height of the stop (in the inner / outer direction) is approximately 0.6 mm. The beveled surface of the undercut is at a 75° angle relative to the flat outer surface of the filament.

[0508] The lateral ends of the mechanical stop 1830 (i.e., the undercut abutment surfaces 1830G) interact with the central surfaces of the lateral end collars 208D of the filament support structure 208, while the central end of the stop 1830 (i.e., the sloped surfaces 1830F) interact with the central collars 208C of the filament support structure 208.

[0509] The profile of the mechanical stop 1830E can be modified to feature a more rounded edge on the center side and / or a deeper undercut, as shown in FIG. 35. The more rounded edge reduces the likelihood that the knitted tube surrounding the filament 1830 will get caught on the stop 1830E during retraction. A deeper undercut refers to either a greater distance between the location of the side edge and the undercut corner, or a smaller angle between the sloped surface of the undercut and the flat outer surface of the filament 1830. An example of the former is shown in FIG. 35. Together, these determine the headgear's extension limit / range, with the former determining the minimum length and the latter determining the maximum length.

[0510] The mechanical filament stop 1830E and collars 208C, 208D are designed to prevent the stop 1830E from rising above the collar and potentially wedging and passing under it. The height of the side end collar 208D is preferably approximately 0.72 m (inside / outside). This corresponds to a pull-out force of 96 N (the maximum load that can be applied before the stop 1830E and / or collar 208D yield and become inoperative). The larger area 1830B of the filament 1830 yields at a load of 70 N. A collar that is too small may cause the stop 1830E to rise above the outer wall of the collar and thus catch on the braid / braided tube covering the system during extension. The stop 1830E may also yield more easily, resulting in a lower pull-out force. A stop 1830E that is too small relative to the collar may easily slip under the collar (again, resulting in a lower pull-out force).

[0511] There are various advantages to introducing mechanical stops implemented on the filaments: This increases the reliability of the maximum extension length and reduces manufacturing complexity. One advantage is that the braided outer sleeve of conventional designs no longer needs to perform the stop function, allowing more convenient materials to be used. For example, the outer sleeve can be an elastomeric plastic or rubber or silicone material, or any other material that provides the desired aesthetic or tactile benefits. This separates the dual purpose of the braid as both a stop and an elastic return force, which reduces constraints on the braid and allows for experimentation with a wider variety of elastic materials. ·Parts are relatively easy to manufacture without complex tooling. The filaments have a sheath (support structure) that supports and protects the filaments, which can be particularly advantageous for users who wear the mask heavily. The filament has more guidance during return. There is more support to guide the returning filament. This mechanism is less prone to kinking, which effectively solves the current problem of the filament prematurely damaging and potentially stopping the return when the patient twists it.

[0512] Therefore, the size of the yoke of the direction adjustment unit 1800 can be reduced and / or the range of extension can be increased to protect the free ends of the filaments contained in the introduced channels and collars.

[0513] Filament support with two channels In a further example according to the present disclosure, a filament and filament support structure can be provided on each of the left and right sides of the mask. The free ends (i.e., smaller regions 1830A) of opposing filaments 1830 are routed through smaller channels 208J formed in the filament support structure 208. For example, the free end of the left filament 1830 passes through the smaller channel 208J in the filament support structure 208 on the right side of the yoke, and vice versa for the right filament and left filament support structure. The larger regions 1830b of each filament 1830 are routed through the larger channel 208K in the support structure 208. This means that each filament 1830 passes through the yoke assembly 21, which is located in the center of the mask, to reach the opposing filament support structure 208. This can be seen in FIGS. 3a, 3b, and 38-42.

[0514] Channel 208K, through which larger region 1830B of filament 1830 passes, is formed between elongated rim 208L and channel divider 208M, which separates two channels 208I, 208K. Rim 208J, located along the top edge of support structure 208 and channel divider 208M, which forms the bottom wall of larger channel 208K, resists vertical movement of filament 1830. This wider channel 208I is an open channel that is not completely enclosed, and the outer surface of filament 1830 is exposed.

[0515] The channel 208I through which the smaller region 1830A of the opposing filament 1830 passes completely encloses / surrounds the filament 1830. The upper wall of the smaller channel 208I is formed by the same channel divider 208M.

[0516] The central ends of these channels 208I, 208K are open as shown in Figure 40. As can be seen in Figure 39, the lateral ends of the larger / wider channel 208K are open, while the lateral ends of the smaller channel 208I are closed to limit the range of movement of the opposing filaments 1830 along the channel.

[0517] These modified filament support structures 208 can be configured so that the locations of the small channels 208H and large channels 208I alternate between the left and right sides of the mask assembly. For example, one filament 1830 passes through a large channel 208I positioned above a smaller channel 208H, while its narrow free end passes through the small channel 208H of the opposing filament support structure 208 positioned above the large channel 208I. In other words, the left side has a smaller channel 208H at the top and a larger channel 208I at the bottom, while the right side has a larger channel 208I at the top and a smaller channel 208H at the bottom (or vice versa). This allows the smaller region 1830A of one filament 1830 to pass through the opposing channel without interference from the other filament 1830. This is characterized by one channel for each filament being significantly smaller than the other channel, along with the channel corresponding to the opposing filament. The blue arrows indicate the movement of the opposing filaments, and the green arrows indicate the movement of the other filament. (b) is an internal view of the same component, showing the rim / lip feature that maintains the vertical position of the filaments. The rim / lip between the two filament channels also acts as a channel divider.

[0518] Ribbed Filament Support Structure 43-45, the smaller region 1830A of the filament 1830, along with the material properties of the filament 1830, allows the filament 1830 to be flexible enough to curve around and conform to the contours of the user's cheek. However, the thickening / widening of the filament support structure 208 and the filament 1830 can render the system inflexible. Therefore, the inventors propose a modified filament 1830 in which one major face or surface of the filament has an altered, strengthened, or weakened structure compared to the opposite major face or surface. Such a structure causes that major face or surface to exhibit different physical properties, such as stress or strain-related properties, stretchability, resilience to bending, and tensile or compressive strength, from the other major face or surface.

[0519] One form of such modified structure is a plurality of ribs, or castellations, or teeth or recesses 1830L. Having one surface / side / face of the filament support structure 208 ribbed allows the filament support structure 208 to curve or bend in one direction. For example, ribs on the outer surface of the support structure (away from the user's face) allow the support structure 208 to bend more easily around the contours of the user's face.

[0520] Filament support with two additional channels 46-53, a further two-part or two-filament embodiment is proposed. This embodiment features a different filament support structure 208, which includes two channels 208I, 208K, one for each opposing filament 1830, as described above. This embodiment differs from the previous embodiment in that the two channels 208I, 208K are stacked laterally in the medial / lateral direction, away from the user's face during use, rather than being stacked vertically. This results in the filament support structure 208 being thicker in the medial / lateral direction. The wider channel 208K is exposed throughout most of the length of the filament support structure 208, while the smaller channel 208I is covered. This can best be seen in FIGS. 51-53.

[0521] Because the thin channel divider 208M has a gap or slot 208N, the two channels are not completely separated as in the previous embodiment, which allows for easier manufacturing and reduces stiffness throughout the length of the filament support structure 208.

[0522] Like the prior two-channel embodiment, the filament support structure 208 is stiffer than the single-channel embodiment. The stiffness is uniform in the top / bottom direction, which is vertical in use, due to the symmetrical position of the channels, unlike the prior two-channel embodiment, which may be prone to twisting in one direction due to asymmetric stiffness.

[0523] Like the previous two-channel embodiment, this embodiment can also bend sufficiently to curve around and conform to the contours of the user's cheek without breaking. The filament support structure must curve around the user's cheek, i.e., one side of the support structure 208 curves with less stiffness to form a convex shape, thus forming the outer side of the component, i.e., the portion of the support structure 208 that faces radially outward from the user's face. This also means that the smaller channels are on the outer side than the wider channels.

[0524] The larger channel 208I is exposed as described above, but is also open at both ends, while the smaller channel 208H is open at its central end and closed at its lateral end. This introduces a limit to the length of the filament 1830 that can pass through the smaller channel 208H of the opposing filament support structure 208. The lateral ends of the filament support structure 208 taper in thickness toward the thickness of the wider region of the filament 1830. Because the outer wall thickness of the filament support structure 208 remains constant, the width of the smaller channel 208H tapers to zero, closing one end of the channel. The face-contacting side / surface / face of the support structure 208 remains unchanged, but the outer surface / face moves 1.6 mm closer to the lateral end from the face over a length of 15 mm in this example (see FIG. 48).

[0525] The top and bottom surfaces / faces of the side end collars 208 also taper from the width of the filament support structure 208 along the length of the exposed region of the filament 1830 to a smaller width that is closer in size to the width of the larger region 1830B of the filament 1830, as can be seen in FIG.

[0526] Example Filament Support Structure Dimensions for Additional Two-Channel Embodiments 49-51, the filament support structure 208, in one example, has an overall length (center / side direction) of 96 mm, with the center end collar having a width (top / bottom) of 7 mm and the side end collars having a minimum width of 5.6 mm. The center end collar has a thickness (inside / outside) of 4.2 mm and the side end collars have a thickness of 2.3 mm. The center end collar has a length of 8.1 mm while the side end collars have a length of 5 mm, which provides more space for attaching the filament support structure to the yoke cap, as can be seen in FIGS. 49 and 50. For both the center end and side end of the filament support structure 208, the (inside) side / surface / face / wall that contacts the face of the collar 208 is approximately 0.8 mm.

[0527] 51-53 show the features visible in cross section of the center end collar 208. In one example, the smaller channel has a width (top / bottom direction) of 2 mm and a depth (inside / outside direction) of 1.2 mm. The wider channel has a width of 4 mm and a depth of 1.5 mm. The channel divider has a thickness of 0.2 mm, and the gap forming the incomplete separation between the two channels is 0.5 mm wide. The center end collar 208 itself has a width (top / bottom direction) of 7 mm. In the center end collar 208, the larger channel 208I is not exposed, but is exposed along most of the length of the filament support structure 208.

[0528] Rounded stop 54, both the medial and lateral sides of stop 1830E can be radiused to further reduce the likelihood of the elastic outer tube catching on the stop (in both extension and retraction), which can also reduce damage to collar 208 when stop 1830 is abutted.

[0529] Filament Positioning / Alignment Features 30-55, the lateral ends of the filament 1830 include filament anchors or connectors or fittings 18301 that are used to securely attach / anchor the filament 1830 onto the headgear 200, in one example, to the crown portion of the headgear formed by straps 204, 206. These straps 204, 206 extend around the back of the user's head, forming a loop sometimes known in the art as a halo.

[0530] The filament anchor 1830I includes a plurality of positioning and / or alignment features 1830J for positioning and / or aligning the filament 1830 with the headgear 200 so that during manufacturing, in this example, during an overmolding process that secures the filament 1830 to the headgear 200 by overmolding, the mating / connection of the filament anchor 1830I with the headgear 200 can ensure accurate and precise alignment and orientation of the filament 1830.

[0531] The positioning and / or alignment features 1830J include a plurality of lugs, recesses, slots, and apertures that provide a plurality of unaligned edges, walls, and surfaces through which the overmolding material can flow to provide a strong bond between the filament and the headgear. These features 1830J are formed in the wide end of the filament 1830 that forms the filament anchor 1830I. The wide end is substantially planar and extends laterally outward from the longitudinal axis of the filament 1830. The lugs and recesses are also generally planar and extend laterally outward from the longitudinal axis of the filament 1830. The distal end of the filament anchor 1830I includes an elongated slot 1830K with an open distal edge such that the distal end of the filament anchor 1830I is "U" shaped or forked when viewed from above. In this embodiment, a single rectangular aperture 1830L is provided through which the overmolding material can flow during manufacturing.

[0532] In this embodiment, the filament anchor 1830I also includes a barb 1830K located more medially relative to the positioning feature 1830J to hold the lateral ends of an outer sheath or covering, such as an elastic tube, that covers the filament 1830 and the filament support structure 208.

[0533] Friction adjustment The amount of frictional force generated by the orientation adjustment unit 1800 described above is proportional to how far the frictional engagement member 1820 can be tilted (i.e., the angular limit of rotation of the frictional engagement member 1820 relative to the "free" position). The designs disclosed herein are focused on providing a friction adjustment device, which is a mechanism, assembly, or configuration of features arranged to change the angle at which the frictional engagement member 1820 can rotate using physical engagement formations shaped and positioned to prevent further rotation. The rotatable frictional engagement member 1820 is contained by a housing 1810, which in some examples can be modified to contact the free end of the frictional engagement member 1820 (when force is generated).

[0534] 56-64, the direction adjustment unit 1800 includes a friction adjustment device configured to adjust the degree of frictional engagement of the frictional engagement member 1820 with the filament 1830 when in the engaged configuration.

[0535] 56-64, the friction adjustment device is configured to constrain or control the degree of movement of the frictional engagement member 1820 relative to the housing 1810 and / or relative to the filament 1830. The relative movement adjusts the effective size of the aperture in the or each frictional engagement member 1820, and therefore the amount of friction between the aperture and the filament 1830, when viewed along the longitudinal axis of the filament 1830.

[0536] 56, the housing 1810 comprises an upper sub-housing 1810A and a lower sub-housing 1810B that are movably connected to one another. In this example, the upper sub-housing 1810A is slidably mounted to the lower sub-housing 1810B such that the upper sub-housing 1810A can move relative to the lower sub-housing 1810B in a direction parallel to the longitudinal axis of the filament 1830.

[0537] The upper sub-housing 1810A includes a plurality of downwardly directed engagement formations 2000, such as lugs or protrusions, that project downwardly into the housing interior from the top or side walls of the upper sub-housing 1810A, or from any other portion of the upper sub-housing 1810A that is spaced from the pivot 1824 of the frictional engagement members 1820. There is one engagement formation for each frictional engagement member 1820, i.e., two of each in this example. Each engagement formation 2000 is positioned to engage the upper free end of its respective frictional engagement member 1820, i.e., the portion of the frictional engagement member 1820 distal from the pivot 1824.

[0538] The degree of pivotal movement of each frictional engagement member 1820 relative to the housing 1810 is governed by the position of the upper sub-housing 1810A relative to the lower sub-housing 1810B.

[0539] 56a, with the upper sub-housing 1810A and the lower sub-housing 1810B aligned, the engagement formation 2000 is spaced a relatively large distance from the free end of the frictional engagement member 1820, thus allowing a relatively large degree of movement of the frictional engagement member 1820. Thus, when the frictional engagement member 1820 pivots to the extent necessary to abut the engagement formation 2000, the effective size of the aperture 1876 in the frictional engagement member 1820 is relatively small when the maximum friction or engagement force between the frictional engagement member 1820, and therefore the filament 1830, and the frictional engagement member 1820 is relatively high. This provides a relatively high degree of resistance to the user stretching the headgear straps.

[0540] A user can adjust this maximum friction or engagement force by moving the protrusions 2000 relative to the frictional engagement members 1820. In this example, this can be achieved by sliding the upper sub-housing 1810A relative to the lower sub-housing 1810B. As can be seen in FIGS. 56a and 56b, this causes the protrusions 2000 to move relative to the lower sub-housing 1810B in a direction parallel to the longitudinal axis of the filaments 1830, thus reducing the degree or range of movement permitted by each frictional engagement member 1820 relative to the housing 1810. Thus, when the frictional engagement members 1820 abut or engage with the protrusions 2000, the effective size of the apertures 1876 in the frictional engagement members 1820 is relatively large, and therefore the maximum friction or engagement force between the filaments 1830 and each frictional engagement member 1820 is relatively low. This provides a relatively low degree of resistance to the user stretching the headgear straps.

[0541] In this example, the friction adjustment device comprises an upper sub-housing 1810A and a lower sub-housing 1810B in combination with a protrusion 2000. This results in movement of the upper half of the housing, which features hard stops / barriers that contact the free ends of the individual friction engagement members (when in the frictional force generating configuration, angles α and β are greater than 0° (see FIG. 56)). This changes the maximum tilt angle of the friction engagement members 1820.

[0542] Such a friction adjustment device may be used with any number of friction engagement members 1820, including one, two, three or more.

[0543] 56, the friction adjustment device, in this example, comprises an actuator configured to control the friction adjustment device. In this example, the actuator comprises a user actuator configured to be moved or grasped by a user's hand or finger, and is in the form of an adjustment screw or set screw 2010, the end of which engages or at least abuts the upper sub-housing 1810A. The screw 2010, shown schematically in FIG. 57, is attached to the lower sub-housing 1810B such that rotation of the screw 2010 extends or retracts the screw 2010 relative to the sub-housings, thereby moving the upper sub-housing 1810A relative to the lower housing 1810B.

[0544] Referring to Figure 58, changing the maximum rotation angle of the friction engagement member 1820 affects the force profile of the orientation adjustment unit 1800, for example as shown in the second profile of Figure 58b. The original force profile of the orientation adjustment unit without the friction adjustment device is shown in the example force profile of Figure 58a.

[0545] The maximum force (i.e., friction / slip force) generated by the tilt of the friction engagement member 1820 increases or decreases depending on the tilt angle limit provided by the hard stop / barrier. This change in force profile applies to all components described herein, as they all change the friction force generated. The overall shape of the force profile is not changed.

[0546] 59, another embodiment of the friction adjustment device again comprises a split housing 1810 comprising an upper sub-housing 1810a and a lower sub-housing 1810b. In this embodiment, the engagement arrangement 2000 stands upright from the lower sub-housing 1810b, which forms the base of the housing 1810.

[0547] Referring to FIG. 60, another embodiment of a friction adjustment device includes a housing 1810 with an engagement formation 2000 projecting downward into the housing 1810 from the underside of the top of the housing 1810 .

[0548] In this embodiment, the frictional engagement members 1820 are mounted on a carriage 2020 that is movably mounted to the housing 1810. The carriage 2020 is movable relative to the housing 1810 in a direction parallel to the longitudinal axis of the filament 1830. Movement of the carriage 2020 adjusts the position of the pivotally mounted lower end 1824 of each frictional engagement member 1820 relative to the engagement arrangement 2000 and the housing 1810. Movement of the carriage 2020 adjusts the degree or range of movement of the frictional engagement members 1820 and, therefore, the effective size of the aperture 1876 in each of the filaments 1830 extensions.

[0549] In this embodiment, a user actuator 2010 is provided to move the carriage 2020 relative to the housing 1810. In this example, the user actuator 2010 includes a threaded shaft that threads into the carriage 2020, such that rotation of the shaft 2010 adjusts the amount that the shaft 2010 protrudes from the carriage 2020.

[0550] 61 , another friction adjustment device includes a movable engagement formation 2030 that is movably mounted to the housing 1810. The formation 2030 includes a wedge-shaped cam, in this example, with a cam surface or face 2040 that engages the upper or free end of the frictional engagement member 1820 when the frictional engagement member 1820 pivots to its maximum degree of movement. The maximum degree of movement is determined by the position of the formation 2030 in the housing 1810. By adjusting the position of the formation 2030 in the housing 2810, different portions of the cam surface 2040 engage the frictional engagement member 1820 to limit its movement. This adjusts the maximum degree of movement of the frictional engagement member 1820, and therefore the effective size of the extending aperture 1876 through which the filament 1830 extends.

[0551] In this embodiment, the formation 2030 is movable substantially vertically within the housing 1810 in a direction perpendicular to the longitudinal axis of the filament 1830, and the cam surface 2040 is inclined relative to that longitudinal axis. In this example, the cam surface 2040 is substantially planar, with the plane at a constant inclination angle. The cam surface 2040 is multi-faceted and includes multiple portions, e.g., multiple planar portions, each or some of which has a different inclination angle. The cam surface 2040 can include a single curved surface or multiple curved surfaces. By varying the inclination angle, and / or the planar portions, and / or any curved portions, the force profile generated by movement of the cam 2040 can be changed.

[0552] 62 , another friction adjustment device is provided in which the degree or range of movement of only one frictional engagement member 1820 is limited. In this embodiment, the movement of that or each other frictional engagement member 1820 is not or only less limited. This embodiment introduces the concept of being able to change the resistance to headgear extension provided by the direction adjustment unit 1800 by selecting the number of frictional engagement members 1820 that can be limited in movement, or by varying the degree or range of one frictional engagement member 1820 differently relative to another frictional engagement member 1820.

[0553] In this embodiment, a split housing configuration similar to the embodiment described above with respect to Figure 59 is provided, in which the lower sub-housing 1810B moves relative to the upper sub-housing 1810B, thereby adjusting the position of the pivot axis 1824 of the frictional engagement member 1820. In this example, the engagement formation 2000 is provided by an end wall 1810R of the upper sub-housing 1810A, which engages or abuts the free end of the frictional engagement member 1820 nearest to it, limiting its movement.

[0554] It will be appreciated that any number of frictional engagement members 1820 may be provided, and the movement of any one or more of these may be limited by a respective engagement arrangement 2000. For example, the movement of only one frictional engagement member 1820 may be limited by a respective engagement arrangement 2000, or the movement of only one frictional engagement member 1820 that is not limited by an engagement arrangement 2000.

[0555] 63, an example user actuator 2010 for use with any of the above-described embodiments is provided, which includes a button or slider slidably mounted to the upper sub-housing 1810a or the lower housing 1810b for sliding movement within a slot 2050 in the housing parallel to the longitudinal axis of the filament 1830. The button or slider 2010 protrudes from a sidewall of the housing 1810 and a) Upper sub-housing 1810a relative to lower sub-housing 1810b or vice versa b) one or more of the engagement arrangements 2000 relative to one or more of the friction engagement members 1820; c) pivoting the pivot shaft 1824 of the frictional engagement member 1820 relative to the engagement structure 2000 It can be configured to move.

[0556] The user actuator 2010 may be provided with indicia 2060 that indicate different maximum degrees or ranges of movement of the friction engagement members 1820 and therefore different levels of resistance to extension of the headgear.

[0557] The user actuator 2010 can be provided with friction features or configured to prevent free movement of the user actuator 2010 so that there is no unwanted movement of the button or slider. This can be achieved by controlling the tolerances of the slider or button 2010 and the slot 2050 within the housing 1810.

[0558] The user actuator 2010 can be directly connected to or integral with the upper sub-housing 1810a, the lower sub-housing 1810b, or the carriage 2020 to which the friction engagement member 1820 is attached. The user actuator 2010 can include a connector or connector mechanism configured to connect the user actuator 2010 to the upper sub-housing 1810a, the lower sub-housing 1810b, or the carriage 2020 and to transfer movement of the user actuator 2010 to movement of the upper sub-housing 1810a, the lower sub-housing 1810b, or the carriage 2020. The ratio of movement of the user actuator to movement of the upper sub-housing 1810a, the lower sub-housing 1810b, or the carriage 2020 can be 1:1. Alternatively, the connector mechanism can be configured to couple different amounts of movement of the upper sub-housing 1810a, the lower sub-housing 1810b, or the carriage 2020 depending on the amount of movement of the user actuator 2010.

[0559] Referring now to FIG. 64, the friction adjustment device can include a selector mechanism 2060 configured to allow a user to select how many of the friction engagement members 1820 have their movement restricted, and therefore how much the friction force generated by the friction engagement members 1820 in total can be varied.

[0560] The example selector mechanism 2060 includes an elongated selector body 2070 having multiple protrusions 2080 protruding from one side thereof. A button 2090 protrudes from the opposite side through an elongated slot 2100 in the housing 1810. Each protrusion 2080 protrudes into the housing 1810 adjacent to a respective frictional engagement member 1820, particularly into the space through which the frictional engagement member 1820 moves. Movement of the slider body 2070 using the button 2090 adjusts the position of the protrusions 2080 relative to the housing 1810 and the frictional engagement members 1820, thus controlling the degree or range of movement of some of the frictional engagement members 1820. In this example, the selector mechanism 2060 includes three protrusions 2080 and therefore controls the movement of three of the frictional engagement members 1820. When the slider body 2070 is moved to one end of its possible travel, the protrusions 2080 block all or substantially all movement of the respective frictional engagement members 1820, thus holding the frictional engagement members 1820 in a fully upright position where their frictional engagement with the filament 1830 is minimal. Thus, the amount of friction with which the frictional engagement members 1820 engage the filament 1830 is substantially controlled in this example by the one remaining frictional engagement member 1820, i.e., the frictional engagement member 1820 not engaged by the selector mechanism 2060.

[0561] Friction Adjustment - Rack and Pinion FIG. 65 shows a direction adjustment unit 2800 incorporating a rack and pinion mechanism as described in our earlier application, WO 2017 / 158544, the entire contents of which are incorporated herein by reference.

[0562] The unit 2800 may be incorporated into headgear or a headgear and patient interface, such as any of the headgear and interfaces of FIGS.

[0563] The unit 2800 includes a rack 2810 and a pinion 2820, which is housed within the housing 1810. As shown in FIG. 65 , the pinion 2820 includes a centrally located gear 2830 flanked on either side by circular flanges 2840 having a diameter larger than the outer diameter of the gear teeth 2850. A cylindrical shaft 2860 extends axially through the pinion 2820 and protrudes from the outer wall of the pinion 2820, providing a rotational linkage between the pinion 2820 and the housing 1810. The shaft 2860 and the pinion 2820 are configured for relative rotational movement therebetween.

[0564] The rack 2810 can function similarly to the filament 1830 described above. The rack 2810 is elongated and includes a plurality of teeth 2880 on one side configured to mesh with the teeth 2850 of the gear 2830 such that linear motion of the rack 2810 results in rotational motion of the pinion 2820. The rack 2810 has a free end 2810A and a fixed end 2810B. When assembled with the housing 1810, the fixed end 2810B is proximal to the brake 3000 and the free end 2810A is proximal to the pinion 2820. The fixed end 2810B is configured to be integrally formed with or permanently joined to another mask component, such as a frame or headgear assembly. The free end 2810A is configured to remain unattached so that it can move relative to the other mask component.

[0565] In some embodiments, the fixed end 2810B of the rack 2810 is integrally formed with or permanently joined to the headgear strap. This configuration provides a strap element for the headgear that can be lengthened or shortened relative to the frame or other mask component, including the housing, thus allowing for adjustment of headgear size. Alternatively, the fixed end of the rack 2810 can be integral with or permanently joined to the mask frame or other mask component, and the housing 1810 can be secured to the headgear strap.

[0566] The brake 3000 comprises an extrusion that is substantially rectangular in cross section but includes one concave side wall 3010. The concave side 3010 has a diameter that substantially matches the outer diameter of the flange 2840 of the pinion 2820. The concave side 3010 of the brake 3000 protrudes from the inner surface of the right wall 1810R of the housing 1810. The brake 3000 may be made from a soft, compressible material such as an elastomeric plastic or rubber.

[0567] In retracting the rack 2810, as shown in Figures 65b and 65c, the fixed end 2810B of the rack 2810 moves toward the housing 1810 and therefore the free end 2810A moves away from the housing 1810. This movement reduces the length of the headgear when assembled in the configuration described above.

[0568] During this retraction movement, the linear motion of the rack 2810 causes the teeth 2880 of the rack 2810 to mesh with the teeth 2850 of the gear 2830, rotating the pinion 2820 in a clockwise direction (relative to the page). This rotation also pushes the pinion 2820 toward the left side wall 1810L of the housing 1810, and the shaft 2860 is maintained within the housing 1810 at the left end of the elongated shaft aperture 2870. The inner surface of the left side wall 1810L is curved to substantially match the outer diameter of the pinion 2820. This reduces friction between the pinion 2820 and the housing 1810, allowing the rack 2810 to move freely through the housing 1810. In this position, there is clearance between the pinion 2820 and the concave wall 3010 of the brake 3000.

[0569] In some embodiments, the rack and pinion mechanism 2810, 2820 can be combined with a biasing means, such as an elastic strap, that provides a retraction force that biases the rack 2810 to move in the retraction direction without the user having to apply an external force.

[0570] In extending movement of the rack 2810, as shown in Figures 65d and 65e, the fixed end 2810B of the rack 2810 moves away from the housing 1810, and therefore the free end 2810A moves towards the housing 1810. This movement extends the length of the headgear when assembled in the configuration described above.

[0571] During this extension movement, the linear motion of the rack 2810 causes the teeth 2880 of the rack 2810 to mesh with the teeth 2850 of the gear 2830, rotating the pinion 2820 in a counterclockwise direction (as viewed along the axis of rotation of the pinion 2820 in FIG. 65 ). This rotation also pushes the pinion 2820 toward the right side wall 1810R of the housing 1810 and the brake 3000. The shaft 2860 slides toward the right side of the shaft aperture 2028 such that the flange 2840 of the pinion 2820 contacts the recessed wall 3010 of the brake 3000, compressing the brake 3000. This creates friction between the pinion 2820 and the brake 3000 that prevents the rack 2810 from moving freely through the housing 1810. The concave wall 3010 of the brake 3000 allows the pinion 2820 to continue to rotate in response to the linear motion of the rack 2810, but requires a higher force to cause this to occur.

[0572] When combined in a respiratory interface device, this provides resistance to extension of the headgear, requiring the user to intentionally apply enough force to overcome the friction between the pinion and brake in order to increase the size of the headgear.

[0573] 66-68, the direction adjustment unit 2800 includes a friction adjustment device configured to adjust the degree of frictional engagement of the brake 3000 with the flange 2840 when in the engaged configuration. This is similar to the embodiment of FIG. 65, except that the brake 3000 is adjustable. The position of the pinion 2820 can be toggled from one side of the slot to the other, providing two different levels of friction (i.e., no contact with the brake 3000 and contact with the brake 3000). The slip force can be further adjusted by adjusting the horizontal position of the brake 3000. Rotating the dial 4010 moves the brake 3000 horizontally toward or away from the pinion 2820. In the high-friction configuration depicted in (a), which corresponds to the configuration depicted in FIG. 65d, there is greater engagement between the pinion 2820 and the brake 3000, which has been moved to the left, and therefore greater friction force.

[0574] In the arrangement of Figure 66a, the housing is provided with a user actuator 4010 in the form of a dial 4020 whose axis of rotation is parallel to the axis of rotation of the pinion 2820. Rotation of the dial 4020 moves a brake 3000 within the housing 1810, as will be described in more detail below with reference to Figure 67.

[0575] In the configuration of FIG. 66b, the user actuator 4010 includes a set screw 4030 that is threaded within the housing 1810 for rotation about a set screw axis that is perpendicular to the axis of rotation of the pinion 1820. The set screw 4030 has a brake engagement end 4040 that abuts the brake 3000. Rotation of the set screw 4030 moves the brake 3000 toward or away from the pinion 2820 in a direction parallel to the longitudinal axis of the rack 2810. The relative position of the brake 3000 with respect to the pinion 2820 serves to adjust the friction between the two components when the pinion 2820 is driven into contact with the brake 3000.

[0576] 67, a dial 4020 is mounted on a shaft 4070, which is itself rotatably mounted to the brake 3000. A gear wheel 4050 is also mounted on the shaft and engages a matching gear profile 4060 in a slot 4070 in the side wall 1810S of the housing 1810. Rotation of the dial 4020 drives the gear wheel 4050 along the gear profile 4060, thus moving the brake 3000 toward or away from the pinion 2820 to adjust the frictional force between the pinion 1820 and the brake 3000.

[0577] 68, a further friction adjustment device for direction adjustment unit 2800 is similar to the embodiment of Figures 65-67, except that instead of brake 3000 having drum-type brake pads or blocks configured to engage flange 2840 in a radial direction perpendicular to the axis of rotation of pinion 2820, a brake disc 5000 is used and a brake caliper 5010 having axially opposed brake pads configured to receive brake disc 5000 therebetween and to frictionally engage brake disc 5000 in an axial direction, i.e., parallel to the axis of rotation of pinion 2820. In this embodiment, brake disc 5000 constitutes flange 2840 of pinion 2820, but could alternatively constitute separate or further components in addition to flange 2840.

[0578] A user actuator (not shown) may be provided to vary the frictional force exerted by the opposing brake pads on the disc 5000. The user actuator may be configured to move one or each brake pad axially towards or away from the disc 5000, for example via an adjustment screw or cam. Alternatively or additionally, the brake caliper 5010 comprises caliper halves movably mounted relative to one another, whereby the user actuator is configured to move one or both of the caliper halves towards or away from the other.

[0579] The brake disc 5000 and pinion 2820 are attached to one another via a selective engagement unit (not shown) configured to engage and rotate together when the brake disc 5000 and pinion 2820 rotate in a first direction, but disengage when the pinion 2820 rotates in the opposite direction, allowing relative rotation between the brake disc 5000 and pinion 2820. Thus, the selective engagement unit 5020 causes the frictional force generated by the brake pads and brake disc 5000 to resist movement of the rack 2810 in one direction (a direction that extends the headgear) but not resist, or at least reduce, movement of the rack 2810 in the opposite direction (a direction that retracts the headgear). As with all of the direction adjustment units 1800, 2800 described herein, the amount of force generated to resist headgear extension can be adjusted.

[0580] The selective engagement unit includes: a) a ratchet mechanism; b) Slipper clutch or one-way clutch may include any one or more of:

[0581] FIGS. 68b-68d show different configurations of the brake disc 5000 and brake caliper 5010. FIG. 68b is an end view of the configuration of FIG. 68a. However, in this example, the caliper 5010, or at least the brake pads, can be moved vertically toward the axis of rotation of the pinion wheel to adjust the engagement of the brake pads with the discs 5000. FIG. 68c uses two brake discs 5000 and a pair of brake pads, each configured to engage a respective disc 5000. Each brake pad engages the radially outer surface of the disc 5000. Again, the brake pads can be moved vertically to adjust the engagement. FIG. 68d includes a single brake pad or block configured to be positioned between a pair of spaced-apart brake discs 5000, such that the single brake pad engages both discs 5000. Again, the brake pad can be moved vertically to adjust the engagement. Thus, in these examples, the or each brake pad or block may have opposing inclined surfaces that increase their engagement with the brake disc 5000 as the disc moves up and down in a direction perpendicular to the axis of rotation of the disc 5000.

[0582] Honeycomb front strap According to the present disclosure, and with reference to FIGS. 70-74, a modified pair of front straps or filament support structures 208 are provided. The filament support structure 208, as described above, has the features shown in FIG. 69. Accordingly, the filament 1830 is supported by the filament support structure 208, which includes collars 208C, 208D in the form of a sheath slightly wider than the larger region 1830B of the filament 1830 and which hold the filament 1830 in close proximity to the filament support structure 208. The modified filament 1830 is fed through both collars 208C, 208D while supported by the support structure 208. The support structure 208, with collars 208C, 208D at both ends, otherwise includes an elongated support 208A, which in this example is a rectangular piece of rigid material (e.g., plastic) in the form of a sidewall that supports the filament 1830 on only one side. In terms of orientation, support structure 208 is positioned behind filaments 1830 and provides an interface or layer between the user's skin and filaments 1830. Collars 208C, 208D face outward, away from the user's face.

[0583] 70-74, the filament support structure 208 has a bending stiffness such that at least a portion of the elongate supports 208A has a greater bending stiffness along a horizontal axis (x-axis using the reference frame of FIG. 74) extending across the elongate supports 208A than along a vertical axis (y-axis using the reference frame of FIG. 74). Thus, the filament support structure is configured to bend more easily in the vertical direction (i.e., above and below the user's face) than in the horizontal direction (i.e., horizontally toward and away from the user's face). As can be seen with reference to the xyz coordinate system shown in FIG. 74, the modified filament support structure 208 has a structure that has a greater bending stiffness about the horizontal y-axis than about the vertical x-axis, i.e., that allows the honeycomb support structure to bend / curve laterally to conform to the shape of the user's neck, while still being stiff enough to support and maintain the vertical stability of the seal provided by the mask. Compared to solid-walled filament support structure designs, the entire structure is more flexible in both the x and y directions. In the x axis, this allows the structure to more easily conform to the shape of the user's face, but the effect of the modifications in the present disclosure is more pronounced in the y axis, i.e., the filament support structure can bend up and down much more easily allowing for easier adjustment of the mask seal angle and mask seal position.

[0584] The elongate support body 208A is provided with a bend control structure having one or more bend control structures configured to control bending of the elongate support 208A as described above. In this example, the bend control structures comprise a plurality of apertures 208H, cutouts 208J, and castellations 208K spaced apart along the length of the elongate support 208A.

[0585] In this example, the apertures 208H are each hexagonal in shape and are arranged in a regular array with regular spacing between the apertures 208H and a regular pattern / arrangement of the apertures 208H, which in this example causes the elongated support 208A to have a honeycomb-like structure.

[0586] The elongate support 208A may comprise at least one such aperture 208H, and the, or each, or any one of the apertures 208H may be any one of the following shapes: a.Circular, B. oval, c.triangle, d. Quadrilateral, e. Pentagon, f.Hexagon, g. Any other shape with multiple sides, where the sides may be straight or arcuate.

[0587] The filament support structure 208 includes a pair of elongate guide surfaces 208F extending along the filament support structure 208 parallel to the longitudinal axis of the filament support structure 208, which constrain the filament against the filament support structure in a direction perpendicular to the longitudinal axis. In this example, both elongate guide surfaces 208F are also provided with a bend control feature in the form of at least one cutout 208J, which is a portion of the elongate guide surface 208F that is free of or has reduced wall material. The elongate support 208A also includes such a cutout 208J when the filament support structure 208 is viewed perpendicular to its longitudinal axis, i.e., when viewed along the x-axis in FIG. 22 .

[0588] In this embodiment, multiple cutouts 208J are provided. Each cutout 208J is a geometric shape that includes regular lines and shapes in this example, in this case a half-hexagon. Any other multi-sided shape is contemplated, including cases where the cutout includes one or more straight portions and / or one or more curved portions. The cutouts 208J are arranged such that the elongated guide surface 208F and the elongated support 208A are castellated or toothed, with each pair including multiple castellations or teeth 208K separated by a respective cutout 208J.

[0589] In this embodiment, each elongate guide surface 208F has a cutout 208J at each of its upper and lower edges 208K, 208L, such that each elongate guide surface 208F has a wavy or zigzag profile when viewed from the side along the x-axis, the profile being defined by the cutout 208J and the castellations 208K.

[0590] 72 and 73, the apertures 208H are arranged along the length of the elongated support 208A in a repeating pattern or array of a single aperture, then a pair of vertically stacked apertures, then another single aperture, etc. The portion of the elongated support 208A in which each single aperture 208H is formed is aligned with a cutout 208J in the elongated guide surface 208F relative to the longitudinal axis of the elongated support 208A. Thus, each single aperture 208H is longitudinally aligned with a pair of cutouts 208J, while each portion of the elongated support 208A having a pair of apertures 208H does not have a cutout.

[0591] In this embodiment, the apertures 208H and cutouts 208J are located along substantially the entire length of the filament support structure 208. However, it is contemplated that the apertures 208H and cutouts 208J may be located along only a portion or portions of the length of the filament support structure 208. The apertures 208H and cutouts 208J may extend along 50% of the length of the elongate support, preferably 75% of the length, and more preferably 90% of the length.

[0592] The side having the elongated guide surface with no or reduced wall material is designed to face away from the user's face so that the internal components (filaments) do not come into contact with the skin.

[0593] The modified filament support structure 208 can be used with any of the orientation adjustment units 1800, 2800 described above.

[0594] 75-78, a further example of a respiratory interface system or respiratory mask system 2100 for delivering respiratory therapy to a patient is shown, according to another embodiment. The mask system 2100 is similar to the mask system 100 of FIGS. 2 and 3, with some differences as described below. The mask system 2100 may include an interface, such as a mask 2102. In the illustrated configuration, the mask 2102 includes a seal 2104 and a frame 2106, as described in further detail herein. The illustrated mask system 2100 also includes headgear 2200 (sometimes referred to herein as a "headgear assembly"). The mask 2102 and headgear 2200 may include a connection system that attaches the headgear 2200 to the mask 2102. Various forms of connection systems may be used to attach the headgear 2200 to the mask 2102. Similarly, the mask 2102 may be coupled to at least one, and possibly multiple, different types of headgear.

[0595] The seal 2104 can be configured to seal around and / or under the patient's mouth and / or nose. In the illustrated configuration, the seal 2104 is a nasal seal configured to deliver a flow of respiratory gas only to the user's nose. In particular, the illustrated seal 2104 includes a pair of nasal pillows configured to form a seal with the user's nares and a secondary sealing portion that surrounds the nasal pillows and is configured to create a secondary seal with one or more of the underside of the user's nose, the sides of the user's nose, and the user's upper lip.

[0596] However, features of the present disclosure may be implemented in other mask systems having other types of mask seals, such as, for example and without limitation, a full face seal.

[0597] The frame 2106 is configured to support the seal 2104 and to attach the seal 2104 to the headgear 2200. The frame 2106 may also include a gas inlet 2108 configured to attach to a gas conduit 2110 that delivers a flow of breathing gas to the patient through the mask 2102.

[0598] The headgear 2200 comprises at least one strap, which may include side straps, comprising or connected to a filament support structure 2208, at least one yoke assembly 2021, and at least one filament 1830 extending into the at least one filament support structure 2208 and entering the yoke assembly 2021. The headgear 2200 also comprises a direction adjustment unit 1800 according to any of the embodiments disclosed herein.

[0599] In system 2100, the yoke assembly 2021 is narrower than the yoke assembly 21 when viewed from the front along the central axis of the mask inlet 2108. The yoke assembly 2021 is narrower across a dimension W extending between two outermost lateral edges OM of the yoke assembly 21, as best seen in FIG. 83 . Like the yoke 21, the ends of opposing filaments 1830 enter the yoke 2021 from respective filament support structures 2208. However, in this embodiment, the ends of the opposing filaments are not contained within the yoke 2021 but instead pass through the yoke 2021 to enter the opposing filament support structure 2208. Thus, two longitudinally extending filament passages are provided in each filament support structure 2208 to simultaneously accommodate both the first filament 1830 entering the yoke assembly 2021 and the end of the other filament exiting the yoke assembly 2021. This modification means that the width of the yoke assembly 2021 can be smaller than the width of the yoke assembly 21, because the yoke assembly does not need to accommodate the filament 1830. As a result, the yoke assembly 2021 extends laterally across a smaller portion of the user's face. This generally results in improved user comfort, particularly when the user is lying down, allowing the user to rotate their head further before the yoke assembly 2021 contacts a pillow. This can best be seen in FIG. 117, where the dashed line connecting the yoke assembly to the user's face indicates the additional angle the user's head can rotate before the yoke assembly 2021 contacts the bed or pillow P. A yoke assembly that is narrower horizontally (i.e., shorter in length) makes side sleeping easier when the mask is in use. The yoke assembly 2021 extends horizontally beyond the lateral-most points of the mask frame 2106, thus forming the widest point of the rigid mask assembly. Thus, the narrower yoke assembly brings the lateral-most points of the mask assembly 102 as a whole further from the surface of the pillow P when the user is lying on their side.This allows a greater angular range of head rotation before the end of the yoke contacts the pillow P. Contact with the pillow P can cause the yoke assembly 2021, and therefore the mask assembly 2102, to be pushed away from the pillow and become dislodged, which can result in leakage and affect the delivery of CPAP therapy to the user, as well as discomfort to the user.

[0600] In system 2100, yoke assembly 2021 is a two-piece assembly including a front member 2021a and a rear member 2021b, which in this example are joined together by a snap-fit ​​engagement provided by interengaging formations on each member 2021a / b.

[0601] As can be seen most clearly from FIG. 106 above, the front and rear members 2021a, 2021b have guide structures on their inner surfaces. These guide structures define filament guide passages through the yoke assembly 2021 when the front and rear members 2021a, 2021b are secured together. Thus, the yoke assembly 2021 does not require the split insert 22 of the yoke assembly 2021. The guide passages are configured to allow the filaments 1830 to be guided past each other through the yoke assembly 2021 without interfering with each other. In the described example, the guide passages are configured so that the filaments 1830 cross each other at the center of the yoke assembly 2021, and each filament 1830 enters the yoke assembly 2021 at a first position, is guided downward into the yoke assembly 2021, and then exits the yoke assembly 2021 at a second, higher position. Additionally, one of the front member 2021a and the rear member 2021b is provided with a guide structure that spaces one of the filaments 1830 from the front of the yoke assembly 2021. This allows one of the filaments 1830 to take a path through the yoke assembly 2021 that is farther from the front of the yoke assembly 2021 than the other of the filaments 1830, thus allowing the filaments 1830 to cross within the yoke assembly 2021 without interfering with each other.

[0602] In system 2100, the housing 1810 of each orientation adjustment unit 1800 is received, or at least partially received, in a respective recess formed in a lateral end of the yoke assembly 2021. Each unit 1800 is held in place by a respective end cap 2209, which, in this example, retains the unit 1800 on the yoke assembly 2021 via a snap-fit ​​connection. The end caps 2209 also engage the ends of the elongated support members 2208 to retain the members 2208 on the yoke assembly 2021.

[0603] In system 2100, headgear 2200 is similar in construction to headgear 200, but with a knitted tube from which semi-rigid plastic is injection molded to form the core of the rear portion of the headgear. The side straps of the headgear are formed by elongate supports 208, which here receive the ends of filaments 1830, as described above.

[0604] 79-101, the mask 2102 is similar to the mask 102, but with some differences. The mask 2102 includes a flexible seal or cushion 2104, a more rigid mask frame 2106, and an intermediate clip 2122. The clip 2122 includes a first clip portion 2122a and a second clip portion 2122b that capture the rim of the seal 2104 therebetween. The clip 2122 is configured to selectively connect to the frame 2106, such as by a snap fit, friction fit, or other suitable configuration. The frame 2106 may include a vent 2140 configured to exhaust gases from the interior of the seal 104. The mask 2102 may include a vent insert or diffuser 2152 that covers the vent 2140 to control exhaust flow. In the mask 2102, the shape or configuration of the seal 2014 and frame 2106 has changed, the shape and location of the vent 2140 has changed, and the attachment of the yoke assembly 2021 to the mask frame 2106 has changed.

[0605] The frame 2106 comprises a gas inlet 2108 for connection to the gas conduit 110, which may be via a conduit connection portion 2108B comprising the inlet 2103D. The gas inlet 2108, in this embodiment, is provided in a lower portion of the frame 2106 when viewed from the front, on a protruding boss 2108A that protrudes outward from the front of the mask frame 2106 in a direction along the central axis of the gas inlet 2108. In this example, the boss 2108A is substantially oval, and the inlet 2108 is also oval. Notably, both the boss 2108A and the inlet 2108 are wider than they are tall, such that each extends laterally outward further from the axis of the inlet 2108 than they do vertically. This configuration reduces visibility of the mask 2102 on the user's face by minimizing any interference with the user's line of sight, and also minimizes interference with the user's mouth, as the reduced height spaces the mask 2102 from the mouth.

[0606] The top of boss 2108A includes a flat but arcuate surface 2106A that extends across the front of frame 2106 and defines a lower yoke mount in the form of a recess 2106B that receives yoke assembly 2021. The top of recess 2106B is defined by a pair of outwardly extending upper protrusions 2106C that overhang recess 2106B. Yoke assembly 2021 is retained within recess 2106B via snap fit formations 2106D at the lateral ends of recess 2106B that engage first member 2021A of yoke assembly 2021.

[0607] 85, 86, and 89, the front of the frame 2106 includes a pair of laterally spaced finger grip portions 2106E defined by recessed portions, one on each side of the inlet 2108, below the recess in which the yoke assembly 2021 mounts. These recessed portions provide an increased surface area for better gripping and a tactile indicator for grip position when adjusting the position of the seal 2104. These grip recesses may be located only on the front of the mask frame 2106, or may extend to the lower region of the inlet boss 2108A or the conduit connector portion 2108B extending from the inlet boss 2018A.

[0608] In this embodiment, the vent 2140 comprises a substantially convex, elliptical vent surface 2140A disposed above the recess 2106B and between a pair of outwardly extending upper protrusions 2106C. The vent 2140 comprises an array of vent apertures 2140B on the vent surface 2140A, which may be laser drilled, for example. The vent surface 2140A is angled upward relative to the axis of the inlet 2108 so that the axis of each vent aperture 2140B is directed upward or forward, away from the frame 2106. This configuration directs exhaled gases upward and forward, away from the frame 2106 and away from the user. The vent surface 2140A is an integral part of the front of the frame 2106. The vent surface 2140A is positioned rearward and upward of the yoke assembly 2021. The vent 2140 is configured so that the yoke assembly 2021 does not interfere with the path of the exhaust gases flowing through the vent 2140 .

[0609] 94, the rear of the frame 2106 includes an outlet collar 2106C that engages with a clip 2122 to attach the seal 2104 to the frame 2106. The outlet collar 2106C is D-shaped in that the upper portion of the outlet collar 2106C is wider than the lower portion of the outlet collar 2106C. Thus, the outlet collar 2106C tapers inward when viewed along the axis of the outlet collar 2106. Thus, the outlet collar 2106C comprises an inverted trapezoidal shape, albeit with the top, sides, and base being generally arcuate in this example. In this example, the top, sides, and base edges are arcuate and each curve outward, away from the axis of the outlet collar 2106C. The shape of the outlet collar 2106C allows for a larger surface area at the top of the frame 2106 on which the vent 2140 should be placed and which should be shaped and configured to achieve the desired directional flow of exhaled gas from the mask 2102.

[0610] The frame 2106 has a shorter vertical dimension when viewed along the axis of the inlet 2108 than the frame 106, but is similarly wider so as to still achieve the desired cross-sectional area for gas flow.

[0611] In this embodiment, the inlet boss 2108A has no vent holes, which means that the length of the boss 2108A can be minimized while still being long enough (in the direction along the axis of the inlet 2108) to allow the yoke assembly 2021 to be attached to the frame 2106.

[0612] In this embodiment, the mask frame inlet 2108 does not have ventilation apertures radially distributed around it as in the embodiment of FIG. 3c. The mask frame inlet 2108 has a ventilation aperture located in the ventilation hole surface 2140A above the recess 2106B and between two outwardly extending upper protrusions 2106C. The lower edge of the ventilation hole surface 2140A is generally aligned with the upper edge of the outwardly extending upper protrusion 2106C, and the upper edge of the ventilation hole surface 2140A extends upward beyond the upper edge of the outwardly extending upper protrusion 2106C. As described above, the ventilation hole surface 2140A is sloped so as to direct gas upward and forward, away from the face and away from the lower region of the mask 2102, which is typically a place where a user may tend to place their hand to adjust the mask position. This design change addresses the possible generation of noise when exhaled gas hits the user's face and causes noise. The ventilation hole surface 2140A extends across the same width as the outer surface of the mask frame inlet boss 2108A, as best seen by dashed line A in FIGS. 87 and 88. The ventilation hole surface 2140A requires a fluid connection between the mask frame outlet collars 2106C. Thus, the upper region of the outlet collar 2106C has a width that is at least the width of the ventilation hole surface 2140A.

[0613] Referring to FIG. 89, the inlet boss 2108A extends into the conduit connection portion 2108B, which can be a separate component attached to the inlet boss 2108A via, for example, a snap-fit connection, or can be integrated with the inlet boss 2108A. The conduit connection portion 2108B includes a gas inlet 2108C.

[0614] 95-97, further detailed modifications to the mask frame 2106 are shown in a modified mask frame 3106. The frame 3106 includes an inlet boss 2108A that does not protrude beyond the frame 2106, but has a longer, integral conduit connector 2108B with a larger finger grip portion 2106E that extends from below the recess 2106A along most of the length of the conduit connector 2108B, approximately to the tip of the conduit connector 2108B, when the frame 3106 is viewed from the side.

[0615] 98-101, the shape of the clip 2122 can be seen more clearly. The clip 2122 defines a gas flow aperture 2122C that is an inverted trapezoidal shape similar to the shape of the outlet collar in the frame 2106. Additionally, the first clip portion 2122a includes a triangular arrangement of connecting features 2122D / E, including one connecting feature 2122D at the top of the clip 2122 and a pair of laterally opposed connecting features 2122E on each side of the clip 2122 at the lower portion of the clip 2122. The second clip portion 2122b includes a similar triangular arrangement of connecting features 2122F / G, including one connecting feature 2122F at the top of the clip 2122 and a pair of laterally opposed connecting features 2122G on each side of the clip 2122 at the lower portion of the clip 2122. The seal 2104 includes correspondingly arranged connecting features 2104D / E. 98 indicates the pairing of connection features between the clip 122 and the seal 104. The connection features may include any suitable combination of protrusions, recesses, and / or snap fingers configured to interengage and attach one component to an adjacent component. The connection features may include snap-fit ​​features. The snap-fit ​​may be achieved, in part, through deformation of the clip 2122 and / or the seal 2104 when the components are attached to one another. The connection features may be configured to align the components when they are assembled together and ultimately connect the components together.

[0616] 102 and 103, there is a comparison of the shapes and external dimensions of yoke assemblies 21 and 2021. As can be clearly seen, yoke 2021 is narrower than yoke 21, providing the benefits outlined above of reducing the impact on the user's field of vision and allowing the user to rotate their head further before yoke 2021 contacts the user's bed or pillow, which may allow for better side sleeping.

[0617] By way of example only, yoke 2021 has a reduced lateral width (measured between the lateral-most points of the yoke) and a reduced thickness when viewed from above and measured between the front and rear yoke members, compared to yoke 21. This can be seen with reference to FIG. 103. The horizontal distance between the inner surfaces of the ends of the yoke is wider than the nose width of most typical users requiring OSA treatment, and therefore fits most of those users. This allows the yoke assembly to be used with a variety of seal sizes without requiring a different size yoke for each seal size. For comparison, example approximate dimensions of one example embodiment are as follows:

[0618] [Table 3]

[0619] Further example approximate dimensions for York 2021 include: Horizontal distance along the inner surface between the side edges of the yoke assembly: 58.5mm Depth of filament path from front yoke member 2021A at center of yoke assembly: 24.1 mm Distance between the center of the front face of the yoke assembly (i.e., the frontmost point) and the rearmost point of the yoke assembly (at the rear face of the yoke assembly at each side end): 29.15 mm Distance between the center of the rear face of the yoke assembly and the rearmost point of the yoke assembly (at the rear face of the yoke assembly at each side end): 22.45 mm

[0620] 104 and 105, the rear yoke member 2021A is provided with engagement features 2021H in the form of recesses that engage with the frame 2106 to hold the yoke assembly 2021 on the frame 2106. The front yoke member 2021A is not provided with engagement features, allowing the front of the front yoke member 2021A to have a smooth, uninterrupted outer surface.

[0621] 106, the mounting of the yoke assembly 2021 on the frame 2106 can be seen more clearly. The underside of the frame recess 2106B and the upper, outwardly extending frame protrusion are provided with yoke engaging lugs 2106C that are received in recesses 2021H in the yoke rear member 2021B. Together, these lugs 2106C and recesses 2021H can form a snap-fit ​​connection between the yoke assembly 2021 and the frame 2106.

[0622] FIGS. 107-110 show the engagement of the end caps 2209 with the side ends of the yoke assembly 2021. Each end cap 2209 is hollow and clips onto the side end of the yoke assembly, over a male portion 2021K that protrudes from the side end. The interior of each end cap 2209 has one portion of the snap-fit ​​connection, a slot 2209A that receives an angled protrusion 2021J on the male portion of the side end of the yoke assembly 2021. The angled protrusion 2021J deforms the end cap 2209 as it is pressed onto the yoke assembly 2021, and then springs back once the protrusion 2021J is received in the slot 2209A. These connection features facilitate alignment and engagement of the two parts. After assembly, the yoke end caps 2209 can be permanently attached by welding or other similar methods.

[0623] 111 , when the end cap 209 is attached to the yoke assembly 2021, the collar 2208C / D of the filament support structure 2208 is received within the end cap 209 and clamped between the end cap 2209 and the yoke assembly 2021, thereby mounting each filament support structure 2208 onto the yoke assembly 2021. This also serves to retain the housing 1810 of the friction adjustment unit 1800 on the yoke assembly 2021, with the housing 1810 being partially retained within the side ends of the yoke assembly 2021 and partially retained within the end cap 209.

[0624] As described above, there are two filaments 1830, each extending from a first filament support structure 2208, through the yoke assembly 2021 where the filament 1830 crosses, and to the other filament support structure 2208. Thus, one end of each filament 1830 is fixedly attached to one filament support structure 2208 and thus connected to the headgear 200. The opposite end of each filament 1830 is movably attached to the other filament support structure 2208. Thus, each filament support structure 2208 and yoke assembly 2021 define a pair of filament guide passages, one for each filament 1830.

[0625] As can be seen in FIGS. 110-112 and 116-119, each filament support structure 2208 includes a pair of vertically stacked filament guide passages 2208F / G. These passages 2208F / G can vary in cross-section along the length of the filament support structure 2208, with each passage being a different size to correspond to the size of the portion of the length of the filament 1830 accommodated within the passages 2208A / B. In this embodiment, the lower guide passage 2208G guides the filament 2830 through the friction adjustment unit 1800 and into the lower portion of the yoke assembly 2021. Inside the yoke assembly 2021, the filament 1830 passes upward through the yoke assembly 2021, exits the top of the opposite side end of the yoke assembly 2021, and is guided into the upper guide passage 2208F of the other filament support structure 2208 without passing through the direction adjustment unit 1800. The filament 1830 is free to move within the upper guide passage 2208F of the other filament support structure 2208.

[0626] 110 and 111, the entrance and exit paths to and from the yoke assembly 2021 can be seen. The protruding male portion 2021K at each side end of the yoke assembly is hollow and includes a ceiling and a base. Intermediate between the ceiling and the base is an upper guide surface 2021L through which the filament 1830 passes before exiting the yoke assembly 2021 and entering the upper passage 2208F of the filament support structure 2208. Also intermediate between the ceiling and the base is a lower guide surface 2021M that protrudes partway into the male portion 2021K. This lower guide surface 2021M is flush with the lower guide passage 2208G of the filament support structure 2208 and therefore receives the incoming filament 1830 from the filament support structure 2208. This lower guide surface also provides an abutment against which the housing 1810 of the direction adjustment unit 1800 abuts, and the unit 1800 is held in this position between the lower guide surface 2021M and the end collars 2208C / D of the filament support structure 2208.

[0627] It should be noted above that the two filaments 1830 are configured to enter the side ends of the yoke assembly 2021 at the same height. This helps ensure that the filaments 1830 experience the same force so that the forces are balanced across the yoke assembly 2021. Therefore, the left and right housings 1810 are oriented similarly to ensure that the interaction of the frictional engagement members 1824 with the filaments 1830 is the same on both sides. This results in equal force characteristics when extending and reducing the length of the side straps of the headgear 200.

[0628] 112, 113, 115, and 116, the path of each filament 1830 is indicated by reference to lines P1 and P2. In FIG. 116, one filament 1830 is shown as a filled circle and the other filament is shown as an open circle. Internal features of the front yoke member 2021A and the rear yoke member 2021B are configured to separate the paths of the filaments 1830 and prevent interference between the two components as they both pass through the yoke assembly 2021. The front yoke member 2021A includes a pair of guide surfaces 2021L / M, as described above. At its entrance to the yoke assembly 2021, each filament 1830 is guided along a path defined between the pair of guide surfaces 2021L / M. When the filament 1830 reaches the center of the yoke assembly 2021, it is guided upward and along an exit path defined between the upper guide surface 2021L and the ceiling of the yoke assembly 2021 so as to exit the yoke assembly 2021 at a location higher than its entry point into the yoke assembly 2021. The front yoke member 2021A also includes a raised guide surface 2021N on only one side of the yoke member, which projects up from the page in FIGS. 113 and 115. This guide surface 2021N spaces one filament 1830 from the other filament 1830 in a direction generally aligned with the axis of the inlet 108 (into and out of the page in FIGS. 113 and 115), allowing one filament 1830 to pass underneath the other without interfering with each other.

[0629] Referring to FIG. 114, the rear yoke member 2021B includes three elongated step structures 2021O / P / Q. The elongated step structure 2021O urges one filament into an exit path defined between the upper guide surface 2021L and the ceiling of the yoke assembly 2021. The elongated step structure 2021P urges the other filament into an exit path defined between the upper guide surface 2021L and the ceiling of the yoke assembly 2021. The middle guide step structure 2021Q serves to guide one of the filaments 1830 from the entrance path to an exit path within the yoke assembly 2021. For clarity, these step structures are also shown in FIG. 115. The dashed lines in FIG. 115 indicate where the filament 1830 is closer to the front of the yoke assembly 2021 than to the rear.

[0630] Thus, the combination of internal features of the front yoke member 2021A and the rear yoke member 2021B are configured to guide each filament 1830 from a lower entry point to a higher exit point when viewing the yoke assembly 2021 from the front. The combination of features is also configured to guide each filament 1830 toward or away from the front yoke members 2021A / B. This combination of guidance of the filaments 1830 up and down as well as toward and away from one or the other yoke member causes each filament 1830 to follow a 3D path through the yoke assembly 2021, thereby allowing the filaments 1830 to cross within the yoke assembly 2021 without interference. The filament crossings can be seen in FIG. 115 at the reference character X.

[0631] 116, for example, referring to the filament shown in the solid circle, it can be seen that the filament 1830 enters one side of the yoke assembly 2021 approximately aligned with the central axis of the yoke assembly 2021, then moves gradually toward the center of the yoke assembly 2021 toward the front yoke member 2021A, then moves upward and back toward the yoke assembly central axis, but spaced upward, before exiting the other side of the yoke assembly 2021. The other filament 1830 in the open circle follows the opposite path.

[0632] Thus, the yoke assembly 2021 provides a filament guide path from one lateral end of the yoke assembly 2021 to the other lateral end. The filament 1830 travels from the interior of one filament support structure 2208 through the yoke assembly 2021, and the free end of the filament 1830 exits the yoke assembly 2021 and is housed within the other, opposing filament support structure 2208. When assembled with the yoke assembly 2021, the filament support structure 2208, and the direction adjustment unit 1800 (one direction adjustment unit 1800 is provided for each filament 1830), the filament 1830 has an effective length, which is the distance the filament 1830 can be pulled through the direction adjustment unit 1800 before the hard stop 1830 of the filament 1830 prevents any further movement of the filament 1830. This effective length of the filament is configured to be longer than the filament guide path through the yoke assembly 2021. This helps ensure that the free end of the filament 1830 remains housed in the opposing filament support structure 2208. In one example, the guide path length through the yoke assembly 2021 is about 80 mm, so the effective filament length is greater than 80 mm.

[0633] 118-121, one embodiment of a filament support structure 2208 is similar to the filament support structure 208 described above, but with several different features. First of these features is that the central end collars 208C / D of the filament support structure 208 described above are modified so that the modified collars 2208C / D are oriented primarily downward, with the remainder of the collars 2208C / D being substantially flush with the filament support structure 2208. The previous embodiment 208 had collars 208C / D that were taller (upper and lower walls) and wider (inner and outer walls) than the distal opening of the end cap 209, which had the same dimensions as the main portion of the filament support structure 208. The updated filament support structure 2208 also has taller and wider collars 2208C / D. The upper wall is continuous with the main portion of the elongate support (inner sidewall) 2208A, while the lower wall projects downward. The shape of the downwardly projecting collars 2208C / D corresponds to the space provided in the yoke end cap 209 to retain the filament support structure 2208 in the yoke assembly 2021.

[0634] The filament support structure 208 described above has one outer surface without a wall that completely encloses both filaments 1830. The absence of one wall can reduce stiffness.

[0635] The inventors propose an alternative embodiment that includes an inner wall 2208A along with an outer wall 2208B. Both the outer and inner walls of the filament support structure 2208 include apertures 2208E spaced apart along the longitudinal length of the filament support structure 2208 in the main portion. The apertures 2208E serve the purpose of reducing the stiffness of the filament support structure 2208. This increased flexibility allows the component to curve around the patient's cheek, improving comfort. There is sufficient stiffness to support the position of the seal 2104 on the user's face. The apertures 2208E in the inner and outer walls 2208B and 2208A are not diametrically opposed to each other, but rather alternate in location along the length of the filament support structure 2208. This arrangement, as opposed to identical aperture placement in both walls 2208A / B, maintains some rigidity throughout the length of the filament support structure 2208 without introducing any significant weak spots that could damage or fail the structure and support. The alternating spacing of the apertures 2208E is most clearly seen in FIG.

[0636] 122 and 123, the components of the filament 1830 described above can be modified to provide a continuous (level) top edge between the thin region 1830B and the thick region 1830A. The thin region 1830B is the section of the filament 1830 that passes through the frictional engagement member 1824 and the housing 1810. The thick region 1830A provides some rigidity and stability to the filament 1830. The filament 1830 described above includes tapers on both the top and bottom sides of the filament 1830, as best seen in FIG. 23a. In modified embodiments, only the bottom edge tapers upward, forming the bottom edge of the thin region 1830B; this one-sided taper improves tooling precision, which may be particularly important for the thin region 1830B, which requires a relatively high degree of precision to achieve the desired interaction with the frictional engagement member 1824.

[0637] The lateral (tip) sides of the mechanical hard stops 1830E contact the central sides of the hard stop walls at the lateral ends of the filament support structure 2208 when the thin regions 1830B of the filaments 1830 are retracted to their maximum extent from the yoke assembly 2021. This determines the maximum length of the side straps of the headgear 200.

[0638] Below are some example filament dimensions: The thin area has a length of 107 mm and the thick area has a length of 103 mm. The thin area has a thickness of 0.86 mm and the thick area has a thickness of 1.22 mm. The thin region has a width of 1.00 mm and the thick region has a width of 3.50 mm. The length between the central end of the filament component and the locating feature is 214 mm. This provides a 4 mm length for the tapered width region between the thin and thick regions. The hard stop has a length (longitudinal) of 1.74 mm and a height of 0.66 mm.

[0639] For the avoidance of doubt, it is intended that features of any of the mask assemblies 100 and 2100 may be combined as desired. The features of the mask assembly 100 are not intended to be limited to only the mask assembly 100. In particular, the mask assembly 100 may include any one or more features of the mask frame 2106, the yoke assembly 2021, the filament support structure 2208, and the end caps 2209. Similarly, the mask assembly 2100 may include any one or more features of the mask frame 106, the yoke assembly 2021, the filament support structure 208, and the end caps 209. Similarly, either mask assembly 100, 2100 may be used with any of the filaments 1830 described herein. Furthermore, either mask assembly 100, 2100 may be used with any of the masks 104, 2104 described herein.

[0640] It will be understood that the yoke assembly 21, 2021 can comprise a separate assembly attached to the mask frame or can be integral with the frame 106, 2106. For example, with reference to FIGS. 113-115 , any or some of the filament guide paths P1, P2 and guide structures can be provided partially or completely by the frame 106, 2106. It is contemplated that the yoke assembly 21, 2021 can be formed in part by the frame 106, 2106. For example, the rear yoke member 21B, 2021B can be formed by the frame 106, 2106, and the front yoke member 21B, 2021B is attached directly to the frame 106, 2106.

[0641] In the described embodiment, the orientation adjustment unit 1800 is a separate assembly that is attached to and held by either the yoke assembly entirely, or the yoke assembly and end cap in combination. However, other configurations are possible. Thus, for example, it will be understood that the housing 1810 of the orientation adjustment unit 1800 can be integral with, or comprise components that are integral with, the yoke assembly 21, 2021 and / or the mask frame 106, 2106.

[0642] Throughout this specification, unless expressly required otherwise, the words "comprise," "comprising," and the like are to be construed in an inclusive sense, i.e., in the sense of "including but not limited to," as opposed to an exclusive or exhaustive sense.

[0643] While the present invention has been described by way of example and in terms of possible embodiments thereof, it should be understood that modifications or improvements can be made to such embodiments without departing from the scope of the invention. The invention can also be broadly described as consisting in any combination of two or more of the parts, elements, and features referred to or indicated in the specification of this application, individually or collectively. Furthermore, where reference is made to certain components or wholes of the invention that have known equivalents, such equivalents are incorporated herein as if individually set forth.

[0644] It should be noted that various variations and modifications to the presently preferred embodiments described herein will become apparent to those skilled in the art. Such variations and modifications can be made without departing from the spirit and scope of the present invention and without diminishing its attendant advantages. For example, various components can be rearranged as needed. Accordingly, such variations and modifications are intended to be included within the scope of the present invention. Moreover, not all features, aspects, and advantages are necessarily required to practice the present invention. Accordingly, the scope of the present invention is intended to be defined solely by the following claims.

[0645] Any discussion of prior art throughout this specification should in no way be taken as an admission that such prior art is widely known in the art or forms part of the common general knowledge.

Claims

1. 1. Headgear for a respiratory mask, comprising: Strap and a filament located at least partially within the strap; A direction adjustment unit, At least one movable frictional engagement member having an aperture forming a cavity extending therethrough, the aperture being positioned to receive a filament therethrough, the at least one frictional engagement member presenting a disengaged configuration with respect to the filament in a first configuration and an engaged configuration with respect to the filament in a second configuration, the at least one frictional engagement member being movable between the engaged and disengaged configurations. a direction adjustment unit comprising: Equipped with The headgear, wherein the filament comprises a filament body having a substantially flat outer surface portion extending along its longitudinal axis, such that in the engaged configuration, the substantially flat outer surface portion of the filament body contacts the at least one frictional engagement member.

2. The at least one friction engagement member is movable about a pivot axis. The headgear of claim 1 , wherein the first configuration is associated with a first pivot configuration and the second configuration is associated with a second pivot configuration.

3. The headgear of claim 2 , wherein the engagement surface area is linear or substantially linear along a transverse axis that is parallel or substantially parallel to the pivot axis.

4. The headgear of any one of claims 1 to 3, wherein the aperture is non-rounded, non-circular, non-elliptical or non-oval in front of the at least one frictional engagement member.

5. 3. Headgear as described in claim 2 or any claim dependent on claim 2, wherein the aperture is offset relative to the pivot axis and extends through the at least one frictional engagement member along an axis having a component perpendicular to the pivot axis.

6. 1. A filament for headgear for a respiratory interface or mask, comprising: a filament body extending along its longitudinal axis; a core region having a first geometric shape; an end region having a second geometric shape, the filament body in the end region having at least one flat or substantially flat outer surface extending along the longitudinal axis thereof; a transition region disposed along the longitudinal axis between the core region and the end region, the transition region having a shape that transitions from the first geometric shape of the core to the second geometric shape of the end region over a longitudinal distance along the longitudinal axis of the filament body; a filament body comprising: The filament comprises:

7. 7. The filament of claim 6, wherein the transition region has, in at least part thereof, a dimension or cross section that is greater than the corresponding dimension of an external opening of a housing of a frictional engagement member of a direction adjustment unit, in use.

8. The filament of claim 6 , wherein the transition region is offset from the longitudinal axis of the filament.

9. 7. The filament of claim 6, wherein the filament comprises upper and lower elongate marginal edges extending along the longitudinal axis of the filament, the marginal edges tapering toward one another at least in the transition region.

10. 10. The filament of claim 9, wherein the peripheral edges are tapered toward each other.

11. 10. The filament of claim 9, wherein only one edge is tapered toward the other edge, the other edge being substantially straight along its length.

12. 10. The filament of claim 9, wherein one peripheral edge comprises a continuous, substantially flat surface formed by the end regions and the core region.

13. 1. A direction adjustment unit for a headgear for a respiratory mask, comprising: Housing and at least one frictional engagement member movably disposed relative to the housing, the at least one frictional engagement member having an aperture extending therethrough to receive a filament of a strap of the headgear therethrough, the at least one frictional engagement member providing a disengaged configuration with respect to the filament in a first movable configuration and providing an engaged configuration with respect to the filament in a second movable configuration; Equipped with a direction adjustment unit comprising an abutment feature configured to abut a stop on the filament to limit a range of movement of the filament relative to the direction adjustment unit.

14. The direction adjustment unit of claim 13 further comprising the filament.

15. 15. The orientation adjustment unit of claim 13 or 14, wherein the abutment of the abutment feature and the stop is configured to generate a sudden increase in force, while any increase in elongation of the filament is relatively low such that the abutment feature abuts the stop before the elongation of the filament is sufficient to yield.

16. The direction adjustment unit according to any one of claims 13 to 15, wherein the stop and the filament are arranged such that the start of the elastic deformation region of the filament occurs at a lower force than the start of the elastic deformation region of the stop of the filament.

17. 17. A direction adjusting unit according to any one of claims 13 to 16, wherein the filament comprises a length comprising a relatively larger region and a length comprising a relatively smaller region, the ratio of the thickness of the relatively larger region to the relatively smaller region being in the range 2:1, preferably 1.5:1, most preferably 1.4:

1.

18. The direction adjustment unit of any one of claims 13 to 17, comprising a filament support structure positioned between the housing and the headgear and comprising an elongate support extending along and restraining at least a portion of the filament.

19. 20. The direction adjustment unit of claim 18, wherein the filament support structure includes opposite ends, each end including an abutment feature configured to abut the stop on the filament, the abutment features therebetween limiting the range of movement of the filament through the locking unit.

20. 20. The orientation adjustment unit of claim 19, wherein at least one abutment feature comprises a collar defining a slot through which the filament extends and an abutment surface or face configured to abut the stop on the filament.

21. 20. The orientation adjustment unit of claim 19, wherein each abutment feature comprises a respective collar.

22. 20. The direction adjustment unit of claim 19, wherein the collar tapers inwardly toward the end of the filament support structure when viewed from the side.

23. 20. The direction adjustment unit of claim 19, wherein the abutment surface or face comprises a protrusion that projects from the body of the collar.

24. 1. A respiratory mask or interface for use in a respiratory therapy system, comprising: Mask frame and a cushion attached to the frame and configured to seal with a user's face; Equipped with The mask frame is a gas inlet configured to receive breathable gas from a gas supply Equipped with The mask frame is a vent for exhausting exhaled gases from the mask; a mounting fixture above the gas inlet when the mask is viewed from the front in a direction along a central axis of the gas inlet, the mounting fixture configured to mount a yoke assembly of a headgear to the mask frame, the yoke assembly being connected or configured to be connected to side straps of the headgear, and the yoke assembly connecting the headgear to the mask frame when the yoke assembly is attached to the mounting fixture; Furthermore, A respiratory mask or interface wherein the vent is positioned above and behind the fitting when the mask or interface is viewed from the front and one side.

25. 25. A respiratory mask or interface according to claim 24, wherein the fitting comprises a recess into which the yoke assembly is at least partially received.

26. 26. A respiratory mask or interface according to claim 25, wherein the recess is defined by a lower surface bounding the top of the gas inlet and at least one upper surface vertically spaced from the gas inlet.

27. 27. A respiratory mask or interface according to claim 26, wherein the upper surface comprises a plurality of upper surfaces spaced laterally apart when the mask is viewed from the front and provided on a plurality of outwardly projecting portions of the frame.

28. 28. A respiratory mask or interface according to any one of claims 24 to 27, wherein the frame comprises at least one yoke retention feature configured to engage with the yoke assembly to retain the yoke assembly on the fitting.

29. 30. The respiratory mask or interface of claim 28, wherein the yoke retention feature comprises at least one snap fit connector.

30. 30. A respiratory mask or interface according to any one of claims 24 to 29, wherein the vent comprises at least one ventilation aperture that slopes upwardly away from the axis of the inlet.

31. A respiratory mask or interface according to any one of claims 24 to 30, wherein the vent comprises at least one ventilation aperture that is angled laterally outwardly away from the axis of the inlet.

32. 32. A respiratory mask or interface according to claim 30 or 31, wherein the vent comprises an array of ventilation apertures.

33. 1. A respiratory mask or interface for use in a respiratory therapy system, comprising: Mask frame and a cushion attached to the frame and configured to seal with a user's face; Equipped with The mask frame is a gas inlet configured to receive breathable gas from a gas supply Equipped with 1. A respiratory mask or interface, wherein the cushion includes an outlet through which breathable gas is delivered to a patient, the outlet having a central axis extending through a center of the outlet in a direction of gas flow, the outlet aperture including an upper portion above the central axis and a lower portion below the central axis, the upper portion having a maximum width, when viewed along the central axis of the outlet, that is greater than a maximum width of the lower portion.

34. 34. A respiratory mask or interface according to claim 33, wherein the outlet aperture is in the shape of an inverted trapezoid when viewed along the central axis of the outlet.

35. 35. The respiratory mask of claim 33 or 34, wherein the outlet is elongate, and the width of the outlet, when viewed along the central axis of the outlet, is greater than the height of the outlet.

36. A respiratory mask or interface according to any one of claims 33 to 35, wherein the outlet is oval.

37. A respiratory mask or interface according to any one of claims 33 to 35, wherein the outlet comprises at least one arcuate portion.

38. 38. A respiratory mask or interface according to claim 37, wherein the arcuate portion curves outwardly, away from the central axis of the outlet.

39. 1. A direction adjustment unit for headgear for a respiratory mask, comprising: At least one movable frictional engagement member having an aperture defining a cavity extending therethrough for receiving a filament of a strap of said headgear therethrough; Equipped with the at least one frictional engagement member, in a first movable configuration, presents a disengaged configuration with respect to the filament, and in a second movable configuration, presents an engaged configuration with respect to the filament, wherein in the engaged configuration, the frictional engagement member frictionally engages the filament to resist movement of the filament through the aperture; the orientation adjustment unit further comprising a yoke assembly configured to be attached to the respiratory mask; a direction adjustment unit, the yoke assembly defining a filament guide path therethrough and configured to receive the filament, the filament having an effective filament length that is a length over which the filament can move through the at least one frictional engagement member, the effective filament length being greater than a length of the filament guide path.

40. 40. The orientation adjustment unit of claim 39, wherein the yoke assembly comprises a front yoke member and a rear yoke member, the yoke members defining the filament guide path through the yoke assembly.

41. 40. The direction adjustment unit of claim 39, wherein the yoke assembly includes a pair of filament guide channels extending therethrough, each guide channel configured to guide a respective filament.

42. 42. The direction adjustment unit of claim 41, wherein one guide path intersects the other guide path within the yoke assembly when the yoke assembly is viewed from the front.

43. 43. The direction adjustment unit of claim 39, wherein the yoke assembly comprises a pair of spaced-apart lateral ends, and wherein a filament inlet and a filament outlet are positioned at each lateral end of the yoke assembly.

44. The direction adjustment unit according to any one of claims 39 to 43, wherein at least a portion of the at least one friction engagement member is within a width of the yoke assembly.

45. 45. The direction adjustment unit according to any one of claims 39 to 44, wherein the depth of the yoke assembly from the front outer surface to the rear outer surface of the yoke assembly when viewed from above is 25 to 35 mm.

46. 46. ​​The direction adjustment unit of claim 39, wherein the ratio of the width of the yoke assembly to the depth of the yoke assembly from the front outermost surface to the rear outermost surface of the yoke assembly when viewed from above is less than 2.5:

1.

47. 47. The direction adjustment unit of claim 39, wherein the filament inlets are positioned at the same height such that the filament inlet at one lateral end of the yoke assembly is at the same height as the filament inlet at the other lateral end of the yoke assembly.

48. 48. The direction adjustment unit of claim 39, wherein the filament outlets are positioned at the same height such that the filament outlet at one lateral end of the yoke assembly is at the same height as the filament outlet at the other lateral end of the yoke assembly.

49. 49. The orientation adjustment unit of claim 39, comprising a pair of filament support structures, each filament support structure configured to be attached to a respective lateral end of the yoke assembly, each filament support structure comprising a pair of filament passages each configured to receive a respective filament.

50. 50. The direction adjustment unit of claim 49, wherein the yoke assembly comprises a pair of laterally extending, opposing arms, each of the arms terminating at a respective lateral end of the yoke assembly, and wherein the width of the yoke assembly extending from one lateral end to the other lateral end when viewed from the front is less than 80 mm.

51. Headgear for a respiratory mask or interface, comprising a direction adjustment unit according to any one of claims 13 to 23 or 39 to 50 and a filament according to any one of claims 6 to 12.

52. Headgear for a respiratory mask or interface, comprising a direction adjustment unit according to any one of claims 13 to 23 or 39 to 50, and a filament.

53. 53. The headgear of claim 52, further comprising a yoke assembly configured to connect the headgear to the respiratory mask or interface.

54. 54. Headgear according to claim 53, wherein the direction adjustment unit is at least partially retained within the yoke assembly.

55. 55. Headgear as described in claim 53 or 54, wherein the yoke assembly comprises a central portion and at least one lateral portion extending laterally outward from the central portion, the at least one lateral portion configured to connect to the at least one strap of the headgear.

56. Headgear for a respiratory mask or interface, comprising a filament according to any one of claims 6 to 12.

57. A breathing mask or interface comprising headgear according to any one of claims 1 to 5.

58. A respiratory therapy system comprising a respiratory mask or interface according to any one of claims 24 to 38.

59. a flow generator; A humidifier and a breathing gas delivery conduit; An expiratory circuit; 57. The respiratory therapy system of claim 56, comprising any one or more of:

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