Headgear with directional adjustment mechanism
The direction adjustment unit with a movable frictional coordination member and filament guide addresses the issue of wear and tear in respiratory masks, ensuring a stable fit and reducing discomfort by minimizing filament damage, thus enhancing the effectiveness of therapies like CPAP and NIV.
Patent Information
- Application Number
- JP2024188606
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2019-11-14
- Filing Date
- 2024-10-25
- Publication Date
- 2025-01-28
AI Technical Summary
Existing respiratory masks face challenges in maintaining an airtight seal due to the wear and tear of headgear components, leading to discomfort and reduced effectiveness during respiratory therapies like CPAP and NIV.
The introduction of a direction adjustment unit with a movable frictional coordination member and filament guide that reduces filament damage by providing a stable and secure fit through a design with linear or substantially flat parts, allowing for controlled movement and engagement with the headgear straps.
This design enhances the longevity of the headgear components, maintains an airtight seal, and reduces discomfort by minimizing filament damage, thereby improving the effectiveness and comfort of respiratory therapies.
Smart Images

Figure 2025013987000001_ABST
Abstract
Description
[Technical field]
[0001] The present disclosure relates to respiratory therapy systems. In particular, the present disclosure relates to various components of respiratory mask systems.
[0002] 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. Patent Application No. 62 / 644002, filed March 16, 2018, the entire contents of which are incorporated herein by reference. This application also incorporates by reference the entire contents of U.S. Patent Application Nos. 62 / 755766, filed November 5, 2018, 62 / 755777, filed November 5, 2018, and 62 / 842982, filed May 3, 2019, and PCT / NZ Patent Application Publication No. 2019 / 050147, filed November 5, 2019, the entire contents of each of which are incorporated herein by reference. This application claims priority from U.S. Patent Application No. 62 / 935539, filed November 14, 2019, the entire contents of which are also 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, causing the patient to be unable to breathe for periods of time. The cessation of breathing, or apnea, causes the patient to awaken. Recurrent and frequent apneas can result in the patient rarely getting a full, restorative night's sleep.
[0006] CPAP therapy involves the delivery of 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 it in an open position so that the patient can breathe and sleep 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 to 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 pressure or flow related therapies. Summary of the Invention [Means for solving the problem]
[0009] Aspects of the present disclosure can provide improved components associated with such headgear, such as any one or more of the yoke assembly, the orientation adjustment unit, the filament, and the strap or straps.
[0010] 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 during use. Such improved orientation units can form part of a respiratory mask.
[0011] In some configurations, this is accomplished by providing the frictional engagement members of the orientation adjustment unit with apertures having a cross-sectional shape that forms at least one straight or substantially straight portion of the frictional engagement member that engages a corresponding flat or substantially flat portion of the filament when the at least one frictional engagement member is in an engaged configuration.
[0012] In some configurations, the term "linear" may be synonymous with "straight."
[0013] The systems, methods, and devices 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 advantageous features will now be outlined.
[0014] According to one aspect of the present disclosure, there is provided a direction adjustment unit for headgear for a respiratory mask, comprising: a) a movable frictional engagement member including an aperture forming a cavity extending therethrough, the aperture being arranged to receive a filament of a strap of the headgear therethrough, the frictional engagement member providing a disengaged configuration for the filament in a first configuration and providing an engaged configuration for the filament in a second configuration; Including, b) a direction adjustment unit is provided, further comprising a filament guide configured to guide the filament as it passes through the direction adjustment unit, the filament guide configured to engage the filament to constrain the filament against bending of the filament within the direction adjustment unit.
[0015] Filament guides may be provided at the filament inlet and / or outlet of the direction adjustment unit.
[0016] The filament guide may be adjacent to the aperture of the frictional engagement member.
[0017] The orientation unit may include a plurality of filament guides.
[0018] A frictional engagement member may be disposed between the pair of filament guides.
[0019] The orientation adjustment unit may include at least two friction engagement members.
[0020] The filament guide may be provided at a location intermediate the two frictional engagement members.
[0021] The or each aperture of the or each frictional engagement member may include a cavity forming an engagement surface that is linear or substantially linear in transverse cross-section, the engagement surface for engaging a flat or substantially flat portion of the filament when the at least one frictional engagement member is in an engaged configuration.
[0022] The or each frictional engagement member may be movable about a respective pivot axis, the first configuration including a first pivot configuration and the second configuration including a second pivot configuration.
[0023] The pivot axis may be movable relative to the orientation adjustment unit.
[0024] The orientation adjustment unit may include a base, with each pivot axis being movable toward and away from the base of the orientation adjustment unit.
[0025] Each pivot axis may be movable independently of the other pivot axes.
[0026] The filament guide may include at least one guide surface that is engaged by the filament in use.
[0027] The guide surface can be positioned to engage at least a top surface of the filament.
[0028] The guide surface may be positioned to engage at least a lower surface of the filament.
[0029] The guide surface may be straight or substantially straight in transverse cross-section for slidably engaging a flat or substantially flat portion of the filament, in use.
[0030] The orientation adjustment unit may include a plurality of filament guides, each including a guide surface configured to guide and engage a filament, the guide surfaces being aligned along a longitudinal axis of the orientation adjustment unit when the unit is viewed from the side.
[0031] The orientation adjustment unit may include a plurality of filament guides, each including a guide surface configured to guide and engage a filament, the guide surfaces being aligned along a longitudinal axis of the orientation adjustment unit when the unit is viewed from above.
[0032] The filament guide may include an opening through which the filament passes.
[0033] The orientation adjustment unit may include at least one housing, the or each frictional engagement member being contained in and movable relative to the at least one housing.
[0034] The orientation adjustment unit may include at least two frictional engagement members, the frictional engagement members being received in the housing and movable relative thereto.
[0035] The orientation adjustment unit may include at least two frictional engagement members and a plurality of housings, each frictional engagement member contained within and movable relative to a respective housing.
[0036] The or each housing may include a base and a top and an opposing end between the base and the top, and an aperture of the or each frictional engagement member is movable generally toward and away from the opposing end between a disengaged configuration and an engaged configuration.
[0037] The filament guide may include or be provided in an intermediate wall of the housing between and spaced from the opposing ends of the housing.
[0038] The filament guide may include or be provided in at least one of the opposing ends of the housing.
[0039] The opposing ends of the housing may include end walls of the housing.
[0040] The guide surface of the filament guide may be substantially straight in transverse cross-section for slidably engaging a flat or substantially flat portion of the filament, in use.
[0041] The filaments may be of square cross section and may be of rectangular cross section.
[0042] The orientation adjustment unit may include a plurality of filament guides, each including a guide surface configured to guide and engage a filament, the guide surfaces being aligned along a longitudinal axis of the orientation adjustment unit when the unit is viewed from the side.
[0043] The orientation adjustment unit may include a plurality of filament guides, each including a guide surface configured to guide and engage a filament, the guide surfaces being aligned along a longitudinal axis of the orientation adjustment unit when the unit is viewed from above.
[0044] The or each frictional engagement member may include a base member through which the pivot axis extends.
[0045] The orientation adjustment unit may include a mounting slot that includes a retention space for movably retaining a follower for movably retaining the friction engagement member on or within the orientation adjustment unit.
[0046] The or each frictional engagement member may have a base member and the aperture may be spaced from the base member.
[0047] The base member may include a follower.
[0048] The orientation adjustment unit may include at least two mounting slots, each mounting slot having a retaining space for movably retaining a respective portion of the base member of the friction engagement member.
[0049] Each retention space may be sized to permit translational movement of the follower within the retention space along a predetermined path while being retained.
[0050] The mounting slot may be elongated when the orientation adjustment unit is viewed from the side.
[0051] The mounting slots may extend in a substantially vertical direction when the orientation adjustment unit is viewed from the side.
[0052] The retention space may include at least one narrowed section to resist movement of the base member beyond said narrowed section.
[0053] Each retention space may be sized to allow the follower to pivot about its pivot axis within the retention space.
[0054] The or each friction engagement member is Pivotal movement relative to the orientation adjustment unit about the pivot axis; and a translational movement relative to the orientation adjustment unit in a direction perpendicular to the pivot axis along a predetermined elongated path extending away from the pivot axis when the unit is viewed along the pivot axis; The or each friction engagement member may be mounted in or on the orientation adjustment unit for both the pivot shaft itself moving along a predetermined elongate path and the or each friction engagement member may be pivoted about the pivot shaft simultaneously.
[0055] The predetermined elongated path may include an elongated slot in one of the frictional engagement member of the orientation adjustment unit and the housing, and a follower in the other of the frictional engagement member of the orientation adjustment unit and the housing, the follower being received in the slot.
[0056] The guide surface may include a planar portion when viewed in a direction substantially parallel to the pivot axis of the frictional engagement member.
[0057] The guide surface may be straight or substantially straight when viewed in a direction substantially parallel to the pivot axis of the frictional engagement member.
[0058] The aperture is a) non-circular, b) non-elliptical, c) rectangle; d) at least one linear portion; e) at least one arcuate portion; f) at least one portion substantially parallel to the pivot axis of the frictional engagement member; g) triangle It may be or may include any of the following:
[0059] The aperture may be offset from the pivot axis when the orientation adjustment unit is viewed from the side.
[0060] The cavity may extend through the at least one frictional engagement member in a direction substantially perpendicular to the pivot axis.
[0061] The engagement surface may form a portion of at least one interior cavity wall surface of the at least one frictional engagement member.
[0062] The cavity may have the shape of a rectangular elongated body or a prism or cube.
[0063] The cavity may have the shape of a triangular elongated body or a prism or cube.
[0064] At least a portion of the interior cavity sidewall surface may have a flat or substantially flat profile when the orientation unit is viewed from the side.
[0065] The cavity may be substantially straight when the frictional engagement member is viewed from the side.
[0066] The cavity may be substantially arcuate when the frictional engagement member is viewed from the side.
[0067] The at least one frictional engagement member may include a base member through which the pivot axis extends and at least one arm member extending from the base member, the aperture being provided in the arm member.
[0068] The arm member may extend away from the base member and the pivot axis.
[0069] The arm member may include a plurality of arm member portions, at least one arm member portion being angled relative to another arm member portion.
[0070] The arm member may be tapered along at least a portion of its length.
[0071] The arm members may be of rectangular cross-section along at least a portion of their length.
[0072] The orientation adjustment unit may be configured such that, in use, at least in the engaged configuration, the frictional engagement member frictionally engages the filament.
[0073] The orientation adjustment unit may be configured such that when the, or each, frictional engagement member is in a disengaged configuration with respect to the filament, the filament can move through the orientation adjustment unit with a first resistance to its movement between the filament and the frictional engagement member, and when each frictional engagement member is in an engaged configuration with the filament, the filament can move through the orientation adjustment unit with a second resistance to its movement between the filament and the frictional engagement member, the second resistance being greater than the first resistance.
[0074] The filament guide can include an opening through which the filament passes, the opening being smaller than at least a portion of the filament such that said at least a portion of the filament cannot pass through the opening.
[0075] At least a portion of at least one edge of the aperture of the at least one frictional engagement member may be chamfered.
[0076] The entire perimeter of the edge of the aperture may be chamfered, or only the portion of the edge that directly engages the filament may be chamfered.
[0077] The aperture may include three or more sides when viewed along the longitudinal axis of the filament.
[0078] 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: a) a movable frictional engagement member having an aperture forming a cavity extending therethrough, the aperture being arranged to receive a filament of a strap of the headgear therethrough such that the filament follows a filament path through the direction adjustment unit, the frictional engagement member providing a disengaged configuration for the filament in a first configuration and providing an engaged configuration for the filament in a second configuration; Including, b) a filament guide configured to guide the filament as it passes through the direction adjustment unit, the filament guide configured to engage the filament to constrain the filament against bending of the filament within the direction adjustment unit at a location where the filament guide engages the filament; c) an orientation adjustment unit is provided, wherein the frictional engagement members are mounted to the orientation adjustment unit such that when the at least one frictional engagement member moves from a disengaged configuration to an engaged configuration, the frictional engagement member can move relative to the orientation adjustment unit along a predetermined elongated path extending perpendicular to the filament path.
[0079] 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: a) at least one movable frictional engagement member having an aperture forming a cavity extending therethrough, the aperture being arranged to receive a filament of a strap of the headgear therethrough such that the filament follows a filament path through the direction adjustment unit, the frictional engagement member providing a disengaged configuration for the filament in a first configuration and providing an engaged configuration for the filament in a second configuration; and b) a filament guide configured to guide the filament as it passes through the direction adjustment unit, the filament guide configured to engage the filament to constrain the filament against bending of the filament within the direction adjustment unit at a location where the filament guide engages the filament; c) an orientation adjustment unit is provided, wherein the frictional engagement members are movable relative to the orientation adjustment unit with at least two degrees of freedom when at least one frictional engagement member moves from a disengaged configuration to an engaged configuration;
[0080] One of the two degrees of freedom can include a pivotal movement of the frictional engagement member such that the frictional engagement member pivots along the filament path.
[0081] One of the two degrees of freedom may include translational movement of the frictional engagement member along a predetermined elongated path extending perpendicular to the filament path.
[0082] According to another aspect of the present disclosure, there is provided headgear for a respiratory mask, the headgear comprising: Any of the above-described orientation adjustment units, and At least one filament A headgear including:
[0083] The headgear is the aperture of the frictional engagement member includes a cavity that defines an engagement surface that is linear or substantially linear in transverse cross-section; and The filament includes a filament body having at least one flat or substantially flat outer surface extending along its longitudinal axis that is contacted with the engagement surface of the orientation adjustment unit when in the engagement configuration. It can be configured as follows.
[0084] The filament is a) a body portion having a first shape and / or size; b) an end portion having a second shape and / or size; and c) a transition portion provided longitudinally between the body portion and the end portion, the transition portion having a shape and / or size that transitions from the shape and / or size of the body portion to the shape and / or size of the end portion; It may further include.
[0085] The headgear may include a yoke assembly configured to connect the headgear to the respiratory mask.
[0086] The orientation adjustment unit may be disposed at least partially within the yoke assembly.
[0087] The yoke assembly may include a central portion and at least one laterally extending portion extending from the central portion, the at least one laterally extending portion configured to connect to at least one strap of the headgear.
[0088] The headgear may include a frame configured to connect the headgear to the respiratory mask.
[0089] The orientation adjustment unit may be disposed at least partially within the frame.
[0090] 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: a movable frictional engagement member including an aperture forming a cavity extending through at least one of the frictional engagement members, the aperture being positioned to receive a filament of a strap of the headgear therethrough, the frictional engagement member being movable between a first configuration and a second configuration relative to the filament; Including, The first configuration provides a pre-actuated configuration in which the frictional engagement member engages the filament with a first frictional force between the frictional engagement member and the filament; The second configuration provides an engagement configuration in which the frictional engagement member engages with the filament with a second frictional force between the frictional engagement member and the filament; An orientation adjustment unit is provided, where the second friction force is greater than the first friction force.
[0091] 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: a movable frictional engagement member including an aperture forming a cavity extending through at least one of the frictional engagement members, the aperture being positioned to receive a filament of a strap of the headgear therethrough, the frictional engagement member being movable between a first configuration and a second configuration relative to the filament; Including, A frictional engagement member frictionally engages the filament to resist movement of the filament through the aperture when in both configurations, the resistance to movement being different for each configuration, and a direction adjustment unit is provided.
[0092] When in the first configuration, a central axis through the aperture may be inclined at a first oblique angle relative to the housing.
[0093] When in the second configuration, the central axis of the aperture can be tilted at a second tilt angle relative to the longitudinal axis of the filament, the second tilt angle being greater than the first tilt angle.
[0094] The orientation adjustment unit may include a housing, with the frictional engagement member movably mounted within the housing.
[0095] The housing may include a vertical housing axis substantially perpendicular to the filament, with the central axis through the aperture being inclined at an oblique angle relative to the vertical housing axis.
[0096] The housing can include an entrance opening through which the filament extends into the housing, the entrance opening including a central entrance opening axis that is non-parallel to the aperture central axis.
[0097] The central inlet opening axis may be inclined at an oblique angle relative to the aperture central axis when the frictional engagement member is in the first configuration.
[0098] The aperture central axis may be tilted relative to the central inlet opening axis when the frictional engagement member is in the first configuration.
[0099] The frictional engagement member may be elongate and include a longitudinal axis that is non-parallel to the vertical axis of the housing when in both the first and second configurations.
[0100] The first tilt angle may be between 0 and 10°, or between 0.5 and 8°, or between 1 and 6°, or is about 3°.
[0101] The second tilt angle may be less than 25°.
[0102] The tilt angle may increase between the first configuration and the second configuration.
[0103] The maximum tilt angle when in the second configuration may increase by 1 to 30°, or 2 to 25°, or is about 6°.
[0104] The housing may include a filament path through the entrance opening and the aperture in the frictional engagement member, the filament path being non-linear or including at least a non-linear portion when the frictional engagement member is in the first configuration.
[0105] The inlet opening can have a vertical dimension and the filaments have a vertical dimension, the vertical dimension of the inlet opening being 10-50% or 15-40% greater than the vertical dimension of the filaments, or about 25% greater.
[0106] According to another aspect of the present invention there is provided a direction adjustment unit for headgear for a respiratory mask, comprising: housing, a movable frictional engagement member including an aperture forming a cavity extending through at least one of the frictional engagement members, the aperture being positioned to receive a filament of a strap of the headgear therethrough, the frictional engagement member being movably mounted within the housing; Includes the frictional engagement member provides an engagement configuration for the filament in the second configuration; The housing includes a housing wall against which the frictional engagement member abuts when the housing is in the first configuration, the housing wall restricting movement of the frictional engagement member; An orientation adjustment unit is provided in which at least one of the frictional engagement member and the housing wall is configured to provide a discrete contact area between the frictional engagement member and the housing wall, the discrete contact area being smaller than an area of the housing wall.
[0107] The discrete contact areas may be defined by surface features on the housing wall and / or the frictional engagement member.
[0108] The surface features may include protruding portions configured to provide discrete contact areas between the frictional engagement member and the housing wall.
[0109] The protruding portion may include an edge of the housing wall.
[0110] The housing wall may be angled so that the edges protrude into the housing.
[0111] The edge may be a lower edge of a housing wall that protrudes into the housing.
[0112] The edge may be an upper edge of a housing wall that protrudes into the housing.
[0113] The protruding part is a) elongated ribs; b) a linear feature; c) an arc-shaped portion; d) a triangular shaped portion; e) Dome-shaped section Includes one or more of the following.
[0114] The surface features may include recesses configured to provide discrete non-contact areas, and the discrete contact areas between the frictional engagement member and the housing wall may be defined by one or more areas adjacent the recesses.
[0115] The orientation adjustment unit may include a plurality of discrete contact areas.
[0116] The housing may include discrete contact areas.
[0117] The frictional engagement members may include discrete contact areas.
[0118] The frictional engagement member, when in the first configuration, may provide a disengaged configuration for the filament.
[0119] The frictional engagement member, when in the first configuration, may provide a pre-activated configuration in which the frictional engagement member engages the filament with a first frictional force between the frictional engagement member and the filament; The second configuration provides an engagement configuration in which the frictional engagement member engages with the filament with a second frictional force between the frictional engagement member and the filament; The second frictional force is greater than the first frictional force.
[0120] The frictional engagement member frictionally engages the filament to resist movement of the filament through the aperture when in both configurations, the resistance to movement being different for each configuration.
[0121] According to another aspect of the present disclosure, there is provided headgear for a respiratory mask, the headgear comprising: a) the filaments of the headgear straps, and b) an orientation adjustment unit including at least one movable frictional engagement member having an aperture forming a cavity extending therethrough, the aperture being positioned to receive the filament therethrough, the frictional engagement member providing a disengaged configuration for the filament in a first configuration and providing an engaged configuration for the filament in a second configuration, the frictional engagement member being movable between the engaged and disengaged configurations; Including, c) the direction adjustment unit further includes a filament guide configured to guide the filament as it passes through the direction adjustment unit, the filament guide being configured to engage the filament to constrain the filament against bending of the filament within the direction adjustment unit at a position where it engages the filament. Headgear is provided.
[0122] According to another aspect of the present disclosure, there is provided headgear for a respiratory mask, the headgear comprising: a) the filaments of the headgear straps, and b) Direction Adjustment Unit The direction adjustment unit includes: c) a movable frictional engagement member having an aperture forming a cavity extending through at least one of the frictional engagement members, the aperture being arranged to receive a filament of a strap of the headgear therethrough, the frictional engagement member providing a disengaged configuration for the filament in a first configuration and providing an engaged configuration for the filament in a second configuration; Including, d) the orientation unit further includes a filament guide configured to guide the filament as it passes through the orientation unit, the filament guide configured to engage the filament to constrain the filament against bending of the filament within the orientation unit at a location where it engages the filament; e) a headgear is provided, wherein the at least one frictional engagement member is attached to the direction adjustment unit such that when the at least one frictional engagement member moves from a disengaged configuration to an engaged configuration, the frictional engagement member can move relative to the direction adjustment unit along a predetermined elongated path extending in a direction perpendicular to the filament path.
[0123] According to another aspect of the present disclosure, there is provided headgear for a respiratory mask, the headgear comprising: a) the filaments of the headgear straps, and b) Direction Adjustment Unit The direction adjustment unit includes: c) at least one movable frictional engagement member having an aperture forming a cavity extending therethrough, the aperture being arranged to receive a filament of a strap of the headgear therethrough, the frictional engagement member providing a disengaged configuration for the filament in a first configuration and providing an engaged configuration for the filament in a second configuration; Including, d) the orientation unit further includes a filament guide configured to guide the filament as it passes through the orientation unit, the filament guide configured to engage the filament to constrain the filament against bending of the filament within the orientation unit at a location where it engages the filament; e) headgear is provided, wherein the frictional engagement members are movable with respect to at least two degrees of freedom when at least one frictional engagement member moves from a disengaged configuration to an engaged configuration.
[0124] According to another aspect of the present disclosure, there is provided headgear for a respiratory mask, the headgear comprising: Filaments in the straps of the headgear, and Direction Adjustment Unit The direction adjustment unit includes: a movable frictional engagement member including an aperture forming a cavity extending through at least one of the frictional engagement members, the aperture being positioned to receive a filament of a strap of the headgear therethrough, the frictional engagement member being movable between a first configuration and a second configuration relative to the filament; Including, The first configuration provides a pre-actuated configuration in which the frictional engagement member engages the filament with a first frictional force between the frictional engagement member and the filament; The second configuration provides an engagement configuration in which the frictional engagement member engages with the filament with a second frictional force between the frictional engagement member and the filament; Headgear is provided, where the second frictional force is greater than the first frictional force.
[0125] According to a further aspect of the present disclosure, there is provided headgear for a respiratory mask, comprising: Filaments in the straps of the headgear, and Direction Adjustment Unit The direction adjustment unit includes: a movable frictional engagement member including an aperture forming a cavity extending through at least one of the frictional engagement members, the aperture being positioned to receive a filament of a strap of the headgear therethrough, the frictional engagement member being movable between a first configuration and a second configuration relative to the filament; Including, Frictional engagement members frictionally engage the filaments to resist movement of the filaments through the apertures when in both configurations, the resistance to movement being different for each configuration, and headgear is provided.
[0126] According to another aspect of the present disclosure, there is provided headgear for a respiratory mask, the headgear comprising: Filaments in the straps of the headgear, and Direction Adjustment Unit The direction adjustment unit includes: housing, a movable frictional engagement member including an aperture forming a cavity extending through at least one of the frictional engagement members, the aperture being positioned to receive a filament of a strap of the headgear therethrough, the frictional engagement member being movably mounted within the housing; Including, the frictional engagement member provides an engagement configuration for the filament in the second configuration; The housing includes a housing wall against which the frictional engagement member abuts when the housing is in the first configuration, the housing wall restricting movement of the frictional engagement member; At least one of the frictional engagement member and the housing wall is configured to provide a discrete area of contact between the frictional engagement member and the housing wall, the discrete area of contact being smaller than an area of the housing wall, and headgear is provided.
[0127] According to another aspect of the present disclosure there is provided a respiratory mask including a direction adjustment unit according to any one of the above descriptions and headgear.
[0128] According to another aspect of the present disclosure, there is provided a respiratory therapy system including a respiratory mask as described above.
[0129] 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: a movable frictional engagement member having an aperture forming a cavity extending through at least one of the frictional engagement members, the aperture being arranged to receive a filament of a strap of the headgear therethrough, whereby the filament follows a filament path through the direction adjustment unit, the frictional engagement member providing a disengaged configuration for the filament in a first configuration, and providing an engaged configuration for the filament in a second configuration; Including, An orientation adjustment unit is provided, wherein the frictional engagement members are attached to the orientation adjustment unit such that when the at least one frictional engagement member moves from a disengaged configuration to an engaged configuration, the frictional engagement member can move relative to the orientation adjustment unit in a direction perpendicular to the filament path.
[0130] The friction engagement member is Pivotal movement relative to the orientation adjustment unit about the pivot axis; and Translational movement relative to the orientation adjustment unit in a direction perpendicular to the pivot axis The direction adjustment unit can be attached for both.
[0131] The frictional engagement member is movable from a disengaged configuration to an engaged configuration such that the frictional engagement member moves from a non-pivoted state to a pivoted state about the pivot axis and also moves from a non-translationally displaced state to a translationally displaced state in a direction perpendicular to the pivot axis.
[0132] The orientation adjustment unit may include a filament guide configured to guide the filament as it passes through the orientation adjustment unit, the filament guide configured to engage the filament to constrain the filament against bending of the filament within the orientation adjustment unit.
[0133] The aperture can define a cavity forming an engagement surface that is linear or substantially linear in cross-section, the engagement surface for engaging a flat or substantially flat portion of the filament when the at least one frictional engagement member is in an engaged configuration.
[0134] Further aspects of the present disclosure, which should be considered in all its novel aspects, will become apparent from the following description.
[0135] Reference numerals may be reused throughout the drawings to indicate general correspondence between referenced elements.With reference now to the drawings, several embodiments of the present disclosure are described, by way of example only, in which: [Brief description of the drawings]
[0136] [Figure 1a] FIG. 13 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] FIG. 1 is an exploded view of various components of a yoke assembly (end caps not shown) of headgear for a respiratory mask including an orientation adjustment unit and filaments. [Figure 2b-c] FIG. 2b is a cutaway view of the yoke assembly of FIG. 2a. [Figure 2d] FIG. 2b is a diagram of the yoke assembly of FIG. 2a in a partially assembled state (end caps and optional second orientation adjustment unit are not shown). [Figure 3a-b] 1A and 1B show front cross-sectional views illustrating the relative contact surfaces between the filaments and the side walls of the frictional engagement member apertures, respectively. [Figure 4] FIG. 13 is a cross-sectional view illustrating a direction adjustment unit having a rectangular aperture according to one embodiment assembled to a yoke assembly. [Figure 5a-d] 11A-11D 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 6a] 1 illustrates a cutaway perspective view of a filament having a rectangular cross-section received through an aperture of a frictional engagement member of a direction adjustment unit, the aperture having a rectangular cross-section. [Figure 6b] 1 illustrates a cutaway perspective view of a filament having a rectangular cross-section received through apertures of two frictional engagement members of a direction adjustment unit, the apertures having a rectangular cross-section. [Figure 6c]Figure 6b shows an alternative cutaway perspective view of the configuration, where the associated housing in which the friction engagement member pivots is shown in translucent form. [Figure 6d] Figure 6c shows an alternative cutaway perspective view of the configuration. [Figure 7] A cutaway cross-sectional view of the direction adjustment unit according to one 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 direction adjustment unit and a filament extending through the associated friction engagement member aperture, where a sharp edge is formed at the intersection of the front face of each friction engagement member and the aperture. [Figure 8] A cutaway cross-sectional view of the engagement form of the direction adjustment unit according to one 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 direction adjustment unit and a filament extending through the associated friction engagement member aperture, where a rounded edge is provided at the upper intersection of the front face of each friction engagement member and the aperture. [Figure 9a] A cutaway cross-sectional view of the disengagement form of the direction adjustment unit according to one 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 direction adjustment unit and a filament extending through the associated friction engagement member aperture, where rounded edges are provided at the upper intersection of the front face of each friction engagement member and the aperture and at the lower intersection of the rear face of each friction engagement member and the aperture. [Figure 9b] A cutaway perspective cross-sectional view of the configuration of Figure 9a, where a part of the housing is shown. [Figure 9c] A cross-sectional broken view of the arrangement of Figure 9a with the filament removed. [Figure 9d] A cross-sectional broken view of the direction adjustment unit in the engagement form according to one embodiment, having two friction engagement members of the direction adjustment unit and a filament extending through the associated friction engagement member aperture in a plane having a normal vector parallel to the pivot axis of each friction engagement member, where a rounded edge is provided at the upper intersection between the front face of each friction engagement member and the aperture. [Figure 9e]FIG. 9c is a cutaway perspective cross-sectional view of the arrangement of FIG. 9d. [Figure 9f] FIG. 9c is a cross-sectional cutaway view of the arrangement of FIG. 9d with the filament removed. [Figure 10a] FIG. 13 is a cross-sectional view showing a direction adjustment unit having a triangular aperture according to one embodiment assembled to a yoke assembly. [Figure 10b] FIG. 10b is a perspective cross-sectional view of the direction adjustment unit of FIG. 10a. [Figure 10c] FIG. 10b is a cutaway perspective view of the orientation adjustment unit of FIG. 10a, with the associated housing in which the frictional engagement members are arranged to pivot, shown semi-transparently; [Figure 11] 1 is a side view of a friction engagement member of a direction adjustment unit according to one embodiment, the friction engagement member including two arm portions disposed at an angle relative to each other. [Figure 12] 1 is a cross-sectional side view of a friction engagement member of an orientation adjustment unit according to one embodiment, the friction engagement member including a single arm portion. [Figure 13a-c] 1A-1C are a side cross-sectional view, a front view, and a perspective view of a single arm partial friction engagement member, respectively. [Figure 14a-b] 1A and 1B show side cross-sectional and perspective views of a single arm partial friction engagement member. [Figure 14c] FIG. 13 illustrates a front view of a single arm portion friction engagement member identifying multiple adjustable dimensions. [Figure 14d] FIG. 2 illustrates a front view of a single arm portion friction engagement member having a first set of dimensions according to one embodiment. [Figure 14e] FIG. 13 shows a front view of a single arm portion having a second set of dimensions of one embodiment. [Figure 15a] FIG. 13 is a cutaway side view of a direction adjustment unit having two single arm portion friction engagement members with respective pivot axes extending parallel to a vertical axis. [Figure 15b] FIG. 18B is a cutaway top view of the direction adjustment unit 1800 of FIG. 15a. [Figure 16a]1 shows a side view of a two-arm portion frictional engagement member of one embodiment 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 16b] 16b shows an alternative side view of the two-arm portion friction engagement member of FIG. 16a with cross-sectional aperture volumes filled in for improved visualization. [Figure 16c] 16a and 16b show profile side views of the two-arm partial friction engagement member; [Figure 16d] 16a to 16c show side design views of the two-arm partial friction engagement member. [Figure 16e] FIG. 16B is a front view of the two-arm friction engagement member of FIGS. 16a to 16d. [Fig. 16f] FIG. 16B is a rear view of the two-arm partial friction engagement member of FIGS. 16a to 16e. [Figure 16g] FIG. 16b is a perspective cross-sectional view of the two-arm friction engagement member of FIGS. 16a to 16f. [Figure 16h] FIG. 16B is a perspective view of the two-arm partial friction engagement member of FIGS. 16a to 16g. [Figure 16i] FIG. 16B is a profile front perspective view of the two-arm portion friction engagement member of FIGS. 16a to 16h. [Figure 16j] FIG. 16 is a profile rear perspective view of the two-arm portion friction engagement member of FIGS. 16a to 16i. [Figure 17a] FIG. 1 illustrates a perspective view of a filament according to one embodiment. [Figure 17b] FIG. 17b shows a side view of the filament of FIG. 17a. [Figure 17c] FIG. 1 illustrates a top view of a filament according to one embodiment. [Figure 18a] FIG. 1 illustrates a cutaway side view of a yoke assembly including an orientation adjustment unit and a filament according to one embodiment. [Figure 18b] FIG. 18b shows an enlarged cutaway side view of the configuration of FIG. 18a highlighting the interaction of the filament with the yoke assembly. [Figure 19] FIG. 1 is a perspective view of a mask assembly including headgear, a seal assembly and a frame assembly according to one embodiment. [Figure 20-22] 20A-20C are front, side and rear perspective views, respectively, of the mask assembly of FIG. 19. [Figure 23] FIG. 2 is an exploded view of the seal assembly, frame assembly and front portion of the headgear. [Figure 24] FIG. 24 is a further exploded view of one form of headgear corresponding to FIG. 23. [Diagram 25] FIG. 1 is an exploded perspective view of a respiratory mask according to one embodiment. [Figure 26a] FIG. 2 is a cross-sectional cutaway view of the housing of the direction adjustment unit. [Figure 26b] FIG. 26b is a cutaway perspective cross-sectional view of the housing of FIG. 26a. [Figure 26c] FIG. 26b is a perspective cross-sectional view of the housing of FIG. 26a. [Figure 26d] FIG. 26b is a perspective cross-sectional view of the housing of FIG. 26a taken from above that of FIG. 26c. [Figure 26e] FIG. 26b is a front view of the housing of FIG. 26a. [Fig. 26f] FIG. 26b is a rear view of the housing of FIG. 26a. [Figure 26g] FIG. 26b is a top view of the housing of FIG. 26a having frictional engagement members. [Figure 26h] FIG. 26b is a bottom view of the housing of FIG. 26a having frictional engagement members. [Figure 27] FIG. 11 is a cross-sectional cutaway view showing the orientation, in terms of pivoting and vertical displacement, of the direction adjustment unit in several or arbitrarily selected different stages of moving from a disengaged configuration to an engaged configuration, where either the initial stages 1-3 and / or the final stages 5-7 can be omitted. [Figure 28a] FIG. 1 is a side view of the headgear, the yoke of the patient interface (note that the seal / cushion of the patient interface is not shown) and the orientation adjustment unit according to the present disclosure, with the headgear extended and the frictional engagement member of the orientation adjustment unit actuated, i.e., resisting extension of the headgear. [Figure 28b]FIG. 2 is a side view of a headgear including a yoke and a direction adjustment unit according to the present disclosure, with the headgear retracted and the frictional engagement members of the direction adjustment unit deactivated, i.e., not resisting retraction of the headgear. [Figure 29] 13 is a cross-sectional side view of another embodiment of an orientation adjustment unit according to the present disclosure having a modified housing and a modified friction engagement member; FIG. [Figure 30a] FIG. 29 is a perspective view of the headgear of FIG. [Figure 30b] FIG. 30b is an enlarged cross-sectional view of the inner feature of the rectangle of FIG. 30a, showing the friction engagement members of the orientation adjustment unit actuated as in FIG. 28a. [Figure 31a] FIG. 29 is a perspective view of the headgear of FIG. [Figure 31b] FIG. 31b is an enlarged cross-sectional view of the inner feature of the rectangle of FIG. 31a, showing the friction engagement member of the orientation adjustment unit deactivated as in FIG. 28b. [Diagram 32] FIG. 30 is a cross-sectional side view of the housing and frictional engagement member of FIG. 29, showing the frictional engagement member in a pre-actuated state or in a deactuated state as in FIG. 28b. [Diagram 33] 29A is a cross-sectional side view of the housing and frictional engagement member of FIG. 29, showing the frictional engagement member in an actuated state according to FIG. 28A. [Fig. 34a-34b] FIG. 34 is an end view of the housing of FIGS. 28-33 taken along the longitudinal axis of the filament. [Diagram 35] FIG. 35 is a CT scan of the direction adjustment unit of FIGS. 28-34 with the friction engagement members in an actuated state. [Diagram 36] 9b is an enlarged schematic side view of a friction engagement member contacting a contact surface of a housing of the direction adjustment unit of FIG. 9a; FIG. [Figure 37] FIG. 36 is a cross-sectional side view of the orientation adjustment unit of FIGS. 28-35, illustrating further features of the unit. [Fig. 38a-38c] FIG. 37 is a view corresponding to FIG. 36, showing a modified contact surface of the housing. [Figure 39] FIG. 39 is a cross-sectional side view of the orientation adjustment unit of FIGS. 28-38, illustrating further features of the unit. [Fig. 40a-40e] 1A-1C show a first end view, a second end view, a side view, a bottom view and a top view of the direction adjustment unit housing, respectively. [Fig. 41a-41d] 28 to 40. FIG. 41 shows a plan view, a front view, a side view and a rear view of the friction adjustment member of the direction adjustment unit of FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0137] Now, with reference to the attached figures, embodiments of the system, components, and assembly and manufacturing methods will be described. Throughout the figures, like numerals refer to like or similar elements. In the following, several embodiments, examples, and illustrations are disclosed, but those skilled in the art will understand that the invention described herein can go beyond the scope of the specifically disclosed embodiments, examples, and illustrations and include other uses of the invention and obvious modifications and equivalents of the invention. The terms used in the description presented herein are not intended to be interpreted in any restrictive or limiting manner, only because they are used in conjunction with the detailed description of several specific embodiments of the invention. Furthermore, the embodiments of the invention can include several novel features, and no single feature is solely responsible for its desirable attributes, nor is it essential to practice the invention described herein.
[0138] In the following description, some terms may be used for reference purposes only and are therefore not intended to be limiting. For example, terms such as "top" and "bottom" refer to directions in the drawings to which they refer. Terms such as "horizontal", "vertical", "front", "rear", "left", "right", "rear" and "side" describe the orientation and / or location of some parts of a component or element in a consistent but arbitrary frame of reference that becomes clear by reference to the text and associated drawings that describe the component or element under consideration, which, with respect to the patient interface, is often in a worn orientation with the user's head in an upright orientation. Furthermore, terms such as "first", "second", "third" and the like may be used to describe separate components. Such terms may include the terms specifically mentioned above, their derivatives and terms of similar importance.
[0139] Unless otherwise clearly required by context, throughout this specification and claims, words such as "comprises," "including," 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 "may," "could," "could be," "may be," "for example," and the like, is intended to generally suggest that some embodiments include some features, elements, and / or conditions but not other embodiments, 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 for 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 or implemented in any particular embodiment, with or without the input or direction of the author.
[0140] 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 of ordinary skill in the art, may occur in an amount that does not eliminate the effect that the feature is intended to provide.
[0141] Numerical data may be expressed or presented in a range format in this specification. It will be understood that such range formats are 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 the range as if each numerical value and subrange were explicitly recited. By way of illustration, a numerical range of "1 to 5" should not be interpreted to include only the explicitly recited values of about 1 to about 5, but also to include each value and subrange within the range set forth. Thus, included in this numerical range are individual values such as 2, 3, and 4, and subranges such as "1 to 3," "2 to 4," and "3 to 5." This same principle should be applied to ranges reciting only one numerical value (e.g., "greater than 1"), regardless of the breadth of the range or the characteristics described.
[0142] The term "alternatively" refers to a selection of one of two or more options and is not intended to limit the selection to only those options listed at a time or to only one of the listed options, unless the context clearly dictates otherwise.
[0143] The present disclosure can also be broadly stated to include any or all combinations of two or more of the components, elements and features referred to or shown individually or collectively in this specification of the application.
[0144] The present disclosure relates to various components of headgear for a respiratory mask. In particular, the relevant components may relate to an orientation adjustment unit for the headgear for the respiratory mask, a strap that houses a filament operatively coupled to the orientation adjustment unit, or a combination of the two that may be combined with other components associated with the headgear for the respiratory mask.
[0145] The directional adjustment unit, sometimes referred to as a directional lock unit or directional resistance unit, allows for adjustment of the position of the headgear relative to the housing. The frictional engagement member in some embodiments is in the form of a washer, such as a lock washer or an adjustment washer, and includes an aperture through which the filament extends.
[0146] 1a-1d show an embodiment of a direction adjustment unit 1800 of our prior application US Patent Application No. 62 / 644002, including a housing 1810, first and second locking elements (e.g., frictional engagement members 1820, 1822), and a filament 1830 of a headgear strap. The housing 1810 includes a first chamber 1840 and a second chamber 1842 configured to accommodate the first frictional engagement member 1820 and the second frictional engagement member 1822, respectively. The frictional engagement member 1820 can be made of a material that provides at least some resistance to wear and tear 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 may 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 external opening 1860 that accommodates the filament 1830, or in other words allows the filament to pass through. The filament 1830 may 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 may be selected that provide at least some resistance to friction, abrasion, fraying, and spreading. Other shapes or geometries may 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 may be referred to as filaments 1830.
[0147] The material or materials of the filament can be selected to be substantially inelastic, so that the filament 1830 can remain substantially the same length under elongation tension. The exterior housing openings 1860 can be substantially aligned with one another. The exterior opening 1860 of the housing end wall 1814 shown on the right side of the figure can be larger than one or both of the interior wall 1812 and the exterior opening 1860 of 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 interior 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 .
[0148] 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 1850 include a circular bushing 1852 and an elongated slot 1854, where the circular bushing 1852 intersects with the bottom of the housing 1810 such that an entrance is formed. The entrance is 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 slots 1854 may extend radially from the circular bushing 1852 toward the top of the housing 1810 .
[0149] 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 is substantially the same width W as the housing 1810, and the arms are narrower to fit within the first chamber 1840 and the second chamber 1842. In the illustrated configuration, the arms include a first arm portion 1872 and a second arm portion 1874, where the first arm portion 1872 extends radially or perpendicularly from the cylindrical base 1824 and the second arm portion 1874 extends at an obtuse angle from the end of the first arm portion 1872. Thus, the first arm portion 1872 and the second arm portion 1874 generally extend in two different directions. Such obtuse angled two arm portion or two arm portion frictional engagement members will be referred to throughout this specification as two arm portion frictional engagement members.
[0150] In this particular illustrated embodiment, the first arm portion 1872 of the arm of the first frictional engagement member 1820 is shorter than the first arm portion 1872 of the arm of the second frictional engagement member 1822. The angle between the first arm portion 1872 and the second arm portion 1874 of the arm of the first frictional engagement member 1820 is greater than the corresponding angle of the arm of the second frictional engagement member 1822. These angles can be selected such that the second arm portion 1874 of one or both of the first frictional engagement member 1820 and the second frictional engagement member 1822 lies substantially flat against a corresponding wall of the housing 1810 (e.g., the inner wall 1812 and the end wall 1814, respectively) at one location of the frictional engagement members 1820, 1822. The second arm portion 1874 of the arm includes an aperture 1876 configured to receive the filament 1830. The aperture 1876 forms an entrance to an associated elongated cavity through the second arm portion 1874, through which the filament 1830 extends. The first and second chambers 1840, 1842 are sized depending on the size of the frictional engagement members to be contained 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. Each frictional engagement member 1820, 1822 can be configured to move independently of the other.
[0151] Thus, in some configurations, the frictional engagement members of the orientation adjustment units may be different, however, it should be understood that in other configurations, such as that described in FIG.
[0152] The cylindrical base 1824 of the first frictional engagement member 1820 and the second frictional engagement member 1822 have a diameter substantially the same as a diameter of the circular bushing 1852 of the frictional engagement member retainer 1850 and are configured to be received and held by the circular bushing 1852 in a snap-fit or interference fit configuration. The snap-fit configuration is provided by an inlet of the circular bushing 1852 being narrower than the diameter of the cylindrical shaft 1824. The slot 1854 of the frictional engagement member retainer 1850 is configured to allow the inlet to open and flex to improve the ease with which the first frictional engagement member 1820 and the second frictional engagement member 1822 can be pushed through the inlet and assembled to the housing 1810. When assembled into 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.
[0153] The filament 1830 can be configured to pass through an exterior opening 1860 of the housing 1810 and through an aperture 1876 in the first frictional engagement member 1820 and the second frictional engagement member 1822 .
[0154] The general operation of the orientation 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.
[0155] Applying tension to the filament 1830 causes the first and second frictional engagement members 1820, 1822 to pivot back and forth between a locked position or configuration, also referred to as an engaged position or configuration, and / or an open position or configuration, also referred to as a disengaged position or configuration. FIGS. 1a and 1b show the direction adjustment unit in an engaged configuration, where a force is applied to the filament 1830 in a direction toward the left side of the figure (as indicated by the arrow). In some embodiments, a force applied to the filament 1830 in this configuration causes the first and second frictional engagement members 1820, 1822 to pivot in a counterclockwise direction (when viewed from the orientation shown in FIGS. 1a and 1b), such that the path of the filament 1830 through the direction adjustment unit 1800 is non-linear or serpentine, and / or an increased frictional force is applied to resist movement of the filament 1830, e.g., due to an increased contact area and / or increased contact pressure between the filament 1830 and the first and second frictional engagement members 1820, 1822.
[0156] 1c and 1d show the orientation adjustment unit in an open, i.e., disengaged or unlocked, configuration in which a force is applied to the filament 1830 in a direction toward the right side of the figure (as indicated by the arrow). In this configuration, the first and second frictional engagement members 1820, 1822 can be pivoted in a clockwise direction (when viewed in the orientation shown in FIGS. 1c and 1d) such that the aperture 1876 and the exterior opening 1860 are substantially linearly aligned. This provides a smooth, non-tortuous, low-friction path and / or reduced contact pressure for the filament 1830 to be pulled substantially freely through the orientation adjustment unit 1800. The amount of force required to move the filament 1830 through the orientation adjustment unit 1800 can be varied based on the different amounts of frictional force exerted on the filament 1830 by the first and second frictional engagement members 1820, 1822 in the closed and open positions.
[0157] The illustrated embodiment of the orientation adjustment unit 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 members 1820 are design parameters that can be varied to achieve a predetermined amount of force required to overcome the orientation adjustment unit 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 orientation adjustment members into the disengaged position / configuration (the "opening force").
[0158] In use, the frictional engagement members 1820 can move between a disengaged configuration (FIGS. 1c and 1d) and an engaged configuration (FIGS. 1a and 1b) in response to outward movement of the associated yoke assembly 20 or other headgear components. Such movement of the frictional engagement members 1820 between the disengaged and engaged configurations can also occur in response to an increase in the circumferential size of the headgear.
[0159] 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 a 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 becomes easier compared to the engaged configuration.
[0160] Further details of the operation of the direction adjustment unit 1800 are provided in the applicant's prior patent applications referenced above and in the first paragraph of this specification.
[0161] In some configurations, the minimum force of the orientation adjustment unit 1800 is about 2 Newtons to 8 Newtons. In some configurations, two or more orientation adjustment units 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.
[0162] In some configurations, the minimum force of the orientation adjustment unit 1800 is about 4 Newtons to 6 Newtons. In some configurations, two or more orientation adjustment units having 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.
[0163] For purposes of facilitating the understanding of this disclosure, the following definitions will be used throughout the specification.
[0164] A plane having a normal vector parallel to the pivot axis may also be referred to as a side throughout this specification.
[0165] A plane having a normal vector parallel to the pivot axis and intersecting the centerline of the frictional engagement member may also be referred to as a center plane throughout this specification.
[0166] 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.
[0167] The centerline is a line extending through the frictional engagement member along which the aperture is at least partially symmetrical.
[0168] 2a-2d show different views of a yoke assembly 20 of headgear for a respiratory mask according to one embodiment of the present disclosure.
[0169] 2a is an exploded view of various components of a yoke assembly 20 (end caps not shown) of headgear for a respiratory mask. The yoke assembly 20 includes 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 with an interference fit to secure the orientation adjustment unit within the yoke housing 21. A filament splitting insert 22 is disposed within the yoke housing, or alternatively, a filament splitter may be integrated with the yoke housing such that no insert is required.
[0170] 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.
[0171] 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, in use, the first vertical level can be above or below the second vertical level.
[0172] The yoke assembly 20 further includes a direction adjustment unit 1800, such as that shown with reference to Figures la-id. The direction 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 defining a cavity extending therethrough that receives the filament 1830 in use. The at least one frictional engagement member 1820, 1822 provides a disengaged configuration in a first pivot configuration with respect to the filament 1830. The at least one frictional engagement member 1820, 1822 further provides an engaged configuration in a second pivot configuration with respect to the filament 1830.
[0173] 2b and 2c are cutaway views of the yoke assembly 20 of FIG. 2a. In FIG. 2b, the orientation adjustment unit housing 1810 has been removed to show how the apertures of the at least one frictional engagement member 1820, 1822 operatively associate with the filament 1830 and the filament splitting insert 22, while FIG. 2c shows the housing 1810 in which the frictional engagement members 1820, 1822 are pivotally disposed in use. It should also be appreciated that in some embodiments, it is not necessary to have a separate housing component, but instead the yoke itself can provide a housing for the at least one frictional engagement member. FIG. 2d is a view of the yoke assembly 20 of FIG. 2a in a partially assembled state (end caps and optional second orientation adjustment unit are not shown).
[0174] 2a-d, the aperture 1876 or cavity formed by said aperture forms, in cross-section, at least one straight or substantially straight portion of the at least one frictional engagement member 1820, 1822 that engages a corresponding flat or substantially flat portion or outer surface of the filament 1830 when the 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.
[0175] Here, a "transverse" section means a section in which the entire aperture boundary can be observed. The transverse section may be parallel to the plane of the front view.
[0176] As described further below, the apertures form cavities that extend through the frictional engagement members. In some configurations, the cavities extend along a central axis. Thus, a "cross section" can refer to any cross section that intersects the central axis or an 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 to the central axis.
[0177] It should also be understood that the term "straight" 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 straight or flat surfaces or regions reduce shear forces acting on the filaments during use.
[0178] 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 corresponding round aperture of somewhat larger size that surrounds the round filament in use, may not be able to withstand the loads generated by the natural movement of the mechanism, which would result in damage to the filament in the form of kinking or permanent deformation. The reason for this may be that high local stress points cause deformations in the filament at the contact points 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 moving freely back through the mechanism.
[0179] The stress (σ) acting on the filament during use is given by the following stress formula: σ= / A where F is the force involved and A is the area of the contact surface. Increasing the area of the contact surface will reduce the stress for any given force.
[0180] The surface area of contact between a round or circular filament and a slightly larger round or circular aperture is relatively small, and the local stresses in the surface area of contact are relatively large.
[0181] Applicant has determined that an increased area of contact surface may 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) such that respective flat or substantially flat portions of the filaments engage straight or substantially straight portions of the corresponding cross-sectional areas of the engagement surface of the frictional engagement member.
[0182] The engagement surface may include an interior wall or surface of an aperture or an interior cavity surface of a cavity formed by the aperture.
[0183] The linear or substantially linear portion of the first cross-section of the engagement surface and the linear or substantially linear portion of at least one second cross-section of the second cross-section of the engagement surface may together form at least one flat or essentially flat engagement surface or region.
[0184] Straight or essentially straight portions of the cross-section of the engagement surfaces can extend the mutual contact surface area with the filaments, thereby distributing forces more evenly across the associated contact surfaces.
[0185] Such a design can ensure that when the filament engages the internal cavity wall surface of the frictional engagement member, the engagement or contact surface is flat and provides uniform pressure over a significantly larger area. These flat surfaces engage with one another to provide 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 area minimizes stress applied to the filament, preventing permanent damage to the filament during its expected life cycle.
[0186] 3a and 3b show front cross-sectional views, respectively, illustrating the relevant contact surfaces between the filament 1830 and the sidewalls of the frictional engagement member aperture 1876. In the example of FIG. 3a, both the filament and the frictional engagement member aperture 1876 are rectangular in cross-section, while in FIG. 3b, the filament and the frictional engagement member aperture are circular in cross-section as per our prior disclosure. The respective contact points are generally identified by arrows. As can be seen from FIG. 3a, 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 the 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.
[0187] 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.
[0188] As described above, with reference to FIGS. 1a-1d, in the engaged configuration, each filament is configured to contact at least two surfaces of each frictional engagement member, such as the interior cavity wall surfaces, i.e., an upper leading edge of the cavity formed by frictional engagement member aperture 1876 and a lower trailing edge of the cavity formed by frictional engagement member aperture 1876.
[0189] In some configurations, for example, referring to FIGS. 16e and 16f, the frictional engagement member aperture 1876 is non-round, non-circular, non-elliptical, or non-oval in front view, i.e., in front of the at least one frictional engagement member 1820.
[0190] In some configurations, a straight or substantially straight portion of at least one cross-section of the engagement surface of the frictional engagement member 1820 is parallel or substantially parallel to the pivot axis and / or is straight along a lateral or transverse axis that is substantially perpendicular to the longitudinal axis of the filament 1830.
[0191] In some configurations, the frictional engagement member aperture 1876 can be provided offset relative to the pivot axis and extend through at least one of the frictional engagement members 1820, 1822 along an axis having a component perpendicular to the pivot axis.
[0192] In some configurations, as shown with reference to Figures 2a-2d, 3a-3b, 4, 6a-6d, 13a-13c, 14a-14b, and 16a-16j, the aperture is rectangular in front, e.g., the front surface, of at least one frictional engagement member 1820, 1822.
[0193] 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 arm portion or the second arm portion of the at least one frictional engagement member.
[0194] In some configurations, the side edges of the rectangular aperture 1876 may be parallel or substantially parallel to the pivot axis.
[0195] 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.
[0196] 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 arm portion or the second arm portion of the at least one frictional engagement member.
[0197] FIG. 4 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 disclosure. In this view, the orientation adjustment unit 1800 is assembled to a yoke housing 21 including a front member 21a and a rear member 21b. A filament splitting insert 22 is shown behind the orientation adjustment unit 1800. In FIG. 4, 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 circumstances to allow the possibility of using the same type or shape of orientation adjustment unit in 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.
[0198] 5a-5c 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.
[0199] FIG. 6a 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.
[0200] FIG. 6b 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.
[0201] FIG. 6c shows an alternative cutaway perspective view of the arrangement of FIG. 6b, with the associated orientation adjustment unit housing 1810 in which the frictional engagement members 1820, 1822 are slidably and pivotably arranged via slots or retaining spaces 84 shown in semi-transparent. FIG. 6d shows an alternative cutaway perspective view of the arrangement of FIG. 6c. Each slot 84 is vertically elongated extending away from the pivot axis of the frictional engagement members 1820, 1822 so as to define a predetermined elongated path along which the frictional engagement members 1820, 1822 can move during use while still being able to pivot about the pivot axis. In other words, the pivot axis can itself move along a predetermined elongated path from an initial pivot axis position to another pivot axis position while the frictional engagement members 1820, 1822 pivot about the pivot axis. Each frictional engagement member 1820, 1822 is thus configured to be capable of translationally moving away from a first pivot axis location to a second pivot axis location. The predetermined elongate path, in this example, extends away from the base of the housing 1810 and generally toward the top of the housing 1810. Each frictional engagement member 1820, 1822 is thus configured to be capable of moving with respect to at least two degrees of freedom - in this example, pivotally about the pivot axis and translationally away from the pivot axis - with this mounting arrangement.
[0202] In the example described herein, the slot 84 is formed in the housing 1810 and the frictional engagement members 1820, 1822 include followers that are received in the slot 84. In this example, an outwardly projecting base member of the frictional engagement members 1820, 1822 forms each follower. In alternative embodiments, a slot can be provided in the frictional engagement members 1820, 1822 with the followers provided on the housing, for example, as a protrusion that projects outwardly from a wall of the housing 1810.
[0203] 7, 8 and 9d-e show respective cutaway views of the orientation adjustment unit 1800 in an engaged configuration, ie, when the filament 1830 and respective frictional engagement members 1820, 1822 are in frictional surface contact.
[0204] As mentioned above, referring to Figures 1a-1d, in the engaged configuration, each filament 1830 may contact at least two surfaces, such as the internal cavity wall surfaces, of each frictional engagement member. These internal cavity wall surfaces E, 81, 82 are clearly shown in Figures 7, 8 and 9a-9f.
[0205] FIG. 7 is a cross-sectional cutaway side view (i.e., in a plane perpendicular to the pivot axis of each frictional engagement member 1820) of the orientation adjustment unit 1800 and the associated filament 1830 according to one embodiment of the present disclosure. Although not readily apparent from FIG. 7, the aperture has a cross-sectional shape that forms at least one linear or 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 of the frictional engagement member 1820, 1822 is increased in 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 surface of each frictional engagement member 1820, 1822 with the aperture 1876. A cross section of the frictional engagement members 1820, 1822 illustrates 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.
[0206] Sharp edges (E) formed at the intersection of the front faces of the frictional engagement members 1820, 1822 with the rectangular apertures 1876 through the frictional engagement members 1820, 1822 can interfere with the filament 1830 and the contact points exposed to high stresses can potentially be permanently damaged, for example, due to high levels of abrasion caused by contact between the sharp edges and the filament faces.
[0207] To further reduce local stresses 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, in some embodiments, at least one aperture edge is radiused, chamfered or filleted.
[0208] Thus, according to some embodiments, the aperture forms a rounded edge on a front surface of at least one frictional engagement member 1820, 1822, which may be a forward surface.
[0209] Figures 9a-9f show a pair of frictional engagement members 1820, 1822 each including such rounded aperture edges according to one embodiment. Figure 9d shows a cross-sectional side view corresponding to Figure 7, 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 reference to the front-to-rear direction of arrow A (see Figure 7), which indicates the direction of filament movement when moving from a disengaged to an engaged configuration, with "front" toward the right and "rear" toward the left in these figures.
[0210] 8 illustrates the effect of rounding the upper leading edge 81 of the frictional engagement member apertures 1820, 1822 on their interaction with the filament 1830. In this particular embodiment, the lower trailing edge 82 of each frictional engagement member aperture 1876 maintains a sharp edge that may interfere with the filament 1830 in an undesirable manner. However, during the development stage of the present invention, it was found that this lower trailing aperture edge 82 has a lower effect on filament wear and damage than the upper leading edge 81. Thus, rounding only the upper leading aperture edge 81 may provide a more cost-effective solution while still increasing the expected life of the filament 1830. However, it is contemplated that both the upper leading edge 81 and the lower trailing edge 82, i.e., the edges on diametrically opposite portions of the cavity formed by the apertures 1876, may be rounded.
[0211] In the embodiment of Figures 9a-9f, both the front upper aperture edge and the rear lower aperture edge are rounded, as is shown in part of the housing 1810.
[0212] 9a-9c show respective cutaway views of the orientation adjustment unit 1800 in a disengaged configuration, while FIGS. 9d-9f show respective cutaway views of the orientation adjustment unit 1800 in an engaged configuration.
[0213] Figure 9b is a cutaway perspective cross-sectional view of the configuration of Figure 9a. Figures 9d and 9e show the interaction of the rectangular filament 1830 with the frictional engagement members 1820, 1822, where the frictional engagement members 1820, 1822 are in an engaged configuration and the filament 1830 contacts the upper leading edge 81 and the lower trailing edge 82 of each frictional engagement member aperture to create two contact areas, faces or regions for each frictional engagement member 1820, 1822, resulting in a total of four contact areas, faces or regions between the filament 1830 and the two frictional engagement members 1820, 1822. The rounded edges 81, 82 may have a constant radius along their lengths.
[0214] In some configurations, the rounded edges have a curvature about an axis of curvature that is parallel to the pivot axis of the frictional engagement member. The rounded edges 81, 82 may have a curved cross-sectional profile about the axis of curvature such that a fillet is formed that is non-circular or does not have a constant radius.
[0215] The embodiment of Figures 9a-9f can be said to exhibit an ideal cross-sectional profile of a frictional engagement member aperture having rounded upper and lower contact edges to eliminate localized points of high stress during interaction between the frictional engagement members 1820, 1822 and the filament 1830.
[0216] In another embodiment, the aperture 1876 is triangular in front of at least one frictional engagement member 1820, 1822, meaning that the cross section is triangular. The triangular aperture 1876, like the rectangular aperture described above, forms an engagement surface of the frictional engagement member having at least one straight or substantially straight portion in cross section. More specifically, the triangular aperture 1876 forms at least three straight or substantially straight or non-arcuate portions in cross section, each of which represents a sidewall of an associated triangle. Thus, when used with a triangular (cross section) filament 1830, the triangular aperture 1876 provides the increased surface contact area described above, which reduces stress on the filament 1830 in use.
[0217] 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.
[0218] 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.
[0219] Such an arrangement is illustrated with reference to Figure 10a, which is a cross-sectional view similar to Figure 4, showing an orientation adjustment unit having a triangular aperture 1876 according to one embodiment. Figure 10b is a cross-sectional exploded perspective view of the orientation adjustment unit of Figure 10a. Figure 10c is an alternative cutaway perspective view of the orientation adjustment unit of Figure 9, showing in semi-transparent form the associated housing 1810 in which the frictional engagement members 1820, 1822 are pivotally disposed.
[0220] 10a-10c, the triangular aperture has an apex that is located closer to the pivot axis of the frictional engagement members 1820, 1822 than a side that is parallel or substantially parallel to the pivot axis. In other words, the apex of the triangular aperture points to the pivot axis.
[0221] In some configurations, the triangular apertures can be disposed at any other angular orientation relative to the central axis about which the cross-sectional aperture shape is provided symmetrically. In other words, the triangular apertures can be oriented in any desired rotated orientation about the longitudinal axis of the filament 1830.
[0222] In some configurations, the apertures may have a polygonal cross-section having five or more sides, for example between 5 and 12 sides, where the apertures form a polygon in cross-section. A polygonal cross-section may 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), 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).
[0223] 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.
[0224] In some configurations, the aperture 1876 can extend through at least one of the frictional engagement members 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 extends from the front face of the frictional engagement members 1820, 1822. The aperture 1876 thus defines an entrance to a filament engagement cavity or bore that extends through the frictional engagement members 1820, 1822. The cavity or bore can include one or more straight or curved portions. In some configurations, the cavity or bore is substantially straight along its length. In some configurations, the cavity or bore is curved or arcuate, or has at least one curved or arcuate portion along its length.
[0225] 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 of the at least one frictional engagement member 1820, 1822.
[0226] As shown in Figures 4, 10a, 13b, 14c-14e, and 16e, in some configurations, at least one interior cavity wall surface has a straight or substantially straight or non-arcuate profile or portion that is maintained along the length or portion of the length of the cavity or bore between the front surface of the frictional engagement member 1820, 1822 and the rear surface of the frictional engagement member 1820, 1822.
[0227] With respect to any three orthogonal reference axes, at least one internal cavity wall surface may 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.
[0228] In some configurations where the aperture 1876 has a rectangular cross-section, the cavity or bore is a cube or rectangular prism.
[0229] In some configurations where the aperture 1876 has a triangular cross-section, the cavity or bore has the shape of a triangular elongated body or prism.
[0230] The frictional engagement members 1820, 1822 are further described below.
[0231] In some configurations, at least one frictional engagement member 1820, 1822 has a base member 1824 through which the pivot axis extends and an arm extending away from the base member 1824. At least a first arm portion 1872 extends from the base member 1824 in a direction perpendicular to the pivot axis. The base member 1824 in this example includes at least one protruding portion that protrudes outwardly from the frictional engagement member 1820, 1822 and forms a follower that is received in the slot 84 of the housing 1810. Each base member 1824 may form a pair of such followers.
[0232] In some configurations, at least one frictional engagement member includes a second arm portion 1820 extending from an end of the first arm portion 1872 away from the pivot axis, the second arm portion 1820 being angled relative to the first arm portion 1872 such that the arm is bent along its length. Such frictional engagement members are illustrated with reference to Figures 1a-1d, 2a, 6a-9b, 10b-10c, 11, 16a-16f and 17.
[0233] 11, a cross-sectional side view of a frictional engagement member of a direction adjustment unit 1800 is shown according to one embodiment. As can be observed from FIG. 11, a first arm portion 1872 extends from a base member 1824 in a direction perpendicular to the pivot axis. A second arm portion 1820, optionally having a substantially rectangular cross-section, extends from the first arm portion 1872 at an angle relative to the first arm portion 1872. A frictional engagement member aperture 1876 is provided in the second arm portion 1820 and extends through the second arm portion 1820 along a central axis.
[0234] In some embodiments, the lateral cross-sectional shape of the base member 1824, when viewed along the pivot axis, can be at least partially circular or at least arcuate. The base member 1824 in lateral cross-section can have a constant diameter or at least a portion of a constant diameter. The base member 1824 can pivot about its pivot axis and can translate within the slot 84 between the disengaged and engaged configurations, where in this example the slot 84 of the housing 1810 has a constant width.
[0235] In Figure 11, the lateral cross-sectional shape of the base member 1824 is a partial circular cross-section having two flat edges, i.e., two opposing arcuate portions joined by two opposing linear portions. In Figure 11, the two flat edges are parallel.
[0236] The upright frictional engagement member position shown in Fig. 11 represents the frictional engagement member position in a disengaged configuration. In this disengaged configuration, the plane FFP constituting the front surface is provided at a first vertical distance D1 from the pivot axis, and the plane RFP constituting the rear surface is provided at a second vertical distance D2 from the pivot axis. As can be seen from Fig. 11, the first distance D1 and the second vertical distance D2 are not equal, i.e. the second arm portion is not provided symmetrically with respect to the pivot axis. In Fig. 11, the front and rear surfaces of the second arm portion 1820 are parallel to a plane including the vertical axis and the pivot axis. Considering an embodiment in which the frictional engagement member is permitted to pivot only about its pivot axis, which is fixed relative to the housing, as the frictional engagement member pivots clockwise (e.g., when viewed in the orientation shown in FIG. 11 ) from the disengaged configuration to the engaged configuration, the symmetrically offset second arm portion 1820 causes the fixed point of the aperture 1876 to trace a parabola or radius of curvature A shown in FIG. 11 . In this configuration, the fixed point of the frictional engagement member 1820, 1822 first travels along an upwardly curved path and then travels along a downwardly curved path. As will be made clear in more detail below, and particularly with consideration of FIG. 27 , in an alternative embodiment in which the frictional engagement member is permitted to pivot about its pivot axis, but is also permitted to move vertically within the housing by the slot 84, the fixed point of the aperture 1876 will trace a different parabola.
[0237] In some embodiments, the lateral cross-sectional shape of the base member 1824 can be circular, as shown in Figures 10b-10c, 12, and 13a-14b.
[0238] FIG. 12 is a cross-sectional side view of frictional engagement members 1820, 1822, where the frictional engagement members include a single straight arm portion 1872. As such, the associated aperture 1876 and cavity or bore are provided through the single arm portion 1872. The frictional engagement members 1820, 1822 of FIG. 12 form non-angled or straight frictional engagement members, i.e., "flat" frictional engagement members, where the single arm portion 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. 12 consists of a single arm portion and a base, where the single arm portion 1872 extends symmetrically from the base along an axis perpendicular to the pivot axis in a plane having a normal vector parallel to the pivot axis. As such, the single arm portion frictional engagement member does not further include a second arm portion 1820.
[0239] The upright frictional engagement member position shown in FIG. 12 shows the frictional engagement member position in a disengaged configuration. In this disengaged configuration, a plane FFP including the front surface is provided at a first vertical distance D1 from the pivot axis, and a plane RFP including the rear surface is provided at a second vertical distance D2 from the pivot axis. As can be seen from FIG. 12, the first vertical distance D1 and the second vertical distance D2 are equal. In FIG. 12, the front and rear surfaces of the first arm portion 1872 are parallel to a plane including the vertical axis and the pivot axis. Considering the configuration of FIG. 12, when the frictional engagement member is pivoted clockwise from the disengaged configuration to the engaged configuration, the first arm portion 1872 is aligned symmetrically, so that the fixed point 1876 of the aperture follows a parabola or curvature (A) having a radius defined with respect to the pivot axis shown in FIG. 12. In this configuration, the fixed points of the frictional engagement members 1820, 1822 initially move only along a downwardly curved path.
[0240] As can be seen in the embodiment of Figures 11 and 12, in the disengaged configuration, the central axis of the aperture 1876 may be aligned with a horizontal plane and may be parallel to the base and / or top of the housing 1810. As can be observed from Figure 11, the center of the aperture 1876 is located horizontally rearward (i.e., to the left) from the pivot axis. In an embodiment where the pivot axis remains fixed relative to the housing 1810, i.e., for all relative orientations between the frictional engagement members 1820, 1822 and the housing 1810, the curvature follows a radius defined between the pivot axis and the center of the aperture 1876 when the curvature is referenced to the pivot axis. This means that the aperture 1876 first follows the curvature above the horizontal plane before following the radius of curvature downward. In other words, in Figure 11, a segment of the radius of curvature is located above the horizontal plane that intersects the central axis in the face of the frictional engagement member in the disengaged configuration. Due to the associated upward and downward movement while following the curvature, contact between the frictional engagement members 1820, 1822 and the filament 1830 occurs at different points throughout this movement. Thus, a frictional engagement member having the configuration of FIG. 11 may experience wear at several points or locations along the inner hollow sidewall surface of the aperture. The different frictional engagement members 1820, 1822 can be seen in FIG. 12. Here, the frictional engagement members 1820, 1822 position the center of the aperture vertically above the pivot axis in line with the pivot axis, which means that the aperture only moves into a downward curvature on its way from the disengaged configuration to the engaged configuration. This may result in a more consistent contact point between the frictional engagement members 1820, 1822 and the filament 1830 in some circumstances. This may also therefore result in a more consistent and repeatable frictional force generated by the frictional engagement members 1820, 1822.
[0241] In some configurations, such as shown with reference to Figure 11, at least the first arm portion 1872 has a tapered cross-section in a plane perpendicular to the pivot axis. It should be appreciated that a tapered cross-section may also be provided in the friction engagement member configuration of a single arm portion 1872, for example as shown in Figure 12. The tapered cross-section may provide increased stiffness to the first arm portion 1872 by providing additional material proximate the pivot axis where the applied torque force is highest.
[0242] In some configurations, such as shown with reference to FIG. 12, at least the first arm portion 1872 has a rectangular cross-section in a plane perpendicular to the pivot axis.
[0243] In some configurations, in the engaged configuration, a linear or substantially linear region of at least one cross-section of at least one frictional engagement member 1820, 1822 is arranged to frictionally engage, in use, a corresponding planar or substantially planar region of the filament 1830. The shape of the portion of the filament 1830 that engages the frictional engagement member 182, 1822 can be configured to be similar or similar to the shape of the portion of the wall of the aperture 1876 that engages the filament 1830.
[0244] 13a-c show side, front and perspective views, respectively, of single arm portion frictional engagement members 1820, 1822. As with FIG. 12, the frictional engagement members may be symmetrical about a vertical axis when viewed from the side (see FIG. 13a). This allows the frictional engagement members 1820, 1822 to be inserted into the frictional engagement member housing 1810 in either orientation during assembly, which may simplify the assembly process.
[0245] Figures 14a-b show side and perspective views of a frictional engagement member according to another embodiment. Compared to the embodiment shown in Figures 13a-c, the frictional engagement member in Figures 14a and 14b has a shorter first arm portion 1872. Furthermore, the width of the first arm portion 1872 is made larger than that shown in Figures 13b and 13c. This results in an aperture 1876 that is significantly wider than that of the frictional engagement members 1820, 1822 in Figures 13a-c, which aperture 1876 is of rectangular cross section in this example.
[0246] Thus, the frictional engagement members 1820, 1822 of Figures 14a and 14b may employ a filament 1830 that is significantly wider than the filaments of the previous embodiments. The wider filament 1830 may provide benefits such as improved kink resistance by spreading the force load over a larger contact area. It may also resist twisting, thereby reducing the occurrence of twisting of the headgear during packaging / storage.
[0247] It will be appreciated that in some configurations, the frictional engagement members 1820, 1822 may be flipped or rotated 90 degrees such that the splayed side of the filament 1830 extends parallel to the patient's face parallel to that side of the housing 1810. By rotating the frictional engagement members 1820, 1822, it may also be possible to fit the frictional engagement members into current yoke housings without requiring significant modifications.
[0248] In an alternative configuration, the entire orientation adjustment unit 1800, including the frictional engagement members 1820, 1822 and the housing 1810, can be inverted so that only the interior of the yoke where the frictional engagement members are located needs to be modified.
[0249] FIG. 14c illustrates a front view of a single arm portion friction engagement members 1820, 1822 defining multiple adjustable dimensions.
[0250] 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.
[0251] [Table 1]
[0252] Figure 14d shows a front view of a single arm portion friction engagement member having a first set of dimensions of an embodiment where H1 is 20 mm. Figure 14e shows a front view of a single arm portion having a second set of dimensions of an embodiment where H1 is 1 mm. Figures 14d and 14e show two examples at each end of an exemplary grouping of the possible range of friction engagement members 1820, 1822 within the scope of the present disclosure.
[0253] FIG. 15a is a cutaway side view of a direction adjustment unit 1800 having two frictional engagement members 1820, 1822 with respective pivot axes.
[0254] FIG. 15b is a cutaway top view of the direction adjustment unit 1800 of FIG. 15a.
[0255] 16a-16j show different views of a two-arm portion / two arm portion frictional engagement member 1820, 1822 according to one embodiment of the present disclosure. FIG. 16a shows a side view of the frictional engagement member 1820, 1822 having first and second angled arm portions 1872, 1874 and having a rounded or chamfered edge formed at the upper intersection between the front surface of the frictional engagement member 1820, 1822, i.e., the right side surface in the figure, and an aperture 1876. FIG. 16b shows an alternative side view of the frictional engagement member 1820, 1822 of FIG. 16a, where the aperture volume is filled in for clarity. FIG. 16c shows a profile side view of the frictional engagement member of FIGS. 16a and 16b. FIG. 16d shows a side design view of the frictional engagement member of FIGS. 16a-16c. FIG. 16e shows a front view of the frictional engagement member of FIGS. 16a to 16d. FIG. 16e shows a rear view of the frictional engagement member of FIGS. 16a to 16e. FIG. 16g shows a perspective cross-sectional view of the frictional engagement member of FIGS. 16a to 16f. FIG. 16h shows a perspective view of the frictional engagement member of FIGS. 16a to 16g. FIG. 16i shows a perspective profile front view of the frictional engagement member of FIGS. 16a to 16h. FIG. 16j shows a perspective profile rear view of the frictional engagement member of FIGS. 16a to 16i. In FIGS. 16a to 16i the base member has the same shape as that of FIG. 11, i.e. it is at least partially circular in transverse cross section.
[0256] In some embodiments, the base member 1824 can project laterally outward in a transverse plane from the first arm portion 1872 in the direction of the pivot axis such that the outer lateral end of the base member 1824 can form a follower that is received in the slot 84 of the housing 1810 while allowing the first arm portion 1872 and / or the second arm portion 1820 of the friction engagement members 1820, 1822 to move within cavities formed in the housing 1810.
[0257] 17a-c 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 body portion 181 having a first shape and size. The filament body further comprises an end portion 183, in this example having the same shape but a smaller size, the filament 1830 of the end portion 183 having at least one flat or substantially flat outer surface extending along its longitudinal axis. It is this end portion 183 of the filament 1830 that engages the frictional engagement members 1820, 1822 in use. Furthermore, the filament body comprises a transition portion 182 provided longitudinally between the body portion 181 and the end portion 183. Transition portion 182 has a shape and / or size that transitions from a first geometric shape and / or size of body portion 181 to the shape and / or size of end portion 183 over a longitudinal distance along the longitudinal axis of filament 1830.
[0258] In some configurations, the transition portion 182, or at least a portion thereof, has a size, i.e., at least one cross-sectional dimension, that is greater than the size of the external opening 1860 of the frictional engagement member housing 1810 in use. In this way, the transition portion 182, or at least the body portion 181, is prevented from completely entering the frictional engagement member housing 1810. As shown with reference to FIG. 17b, the transition portion 182, in a side cross-sectional view, can include a first narrow configuration 182a, which can have a curvature, where the width decreases from the width of the body portion to an intermediate width. The transition portion 182 can further include an intermediate portion 182b, where the width is substantially constant following the first narrow configuration 182a. Furthermore, following the intermediate portion 182b, a second narrow configuration 182c, which can have a further curvature, has a width that decreases from the width of the intermediate portion 182b to the width of the end portion 183 of the filament 1830.
[0259] FIG. 18a shows a cutaway side view of a yoke assembly 20 including a direction adjustment unit 1800 and the filament 1830 of FIGS. 18a and 18b according to one embodiment of the disclosure. A hard stop formed by the size of at least a portion of the transition portion 182 of the yoke assembly 20 being larger than the receiving structure of the yoke housing 211 of FIG. 18a limits the strap from being inserted too far into the housing 1810. High bending resistance at this point minimizes the risk of the associated yoke assembly 20 twisting against the headgear in a relaxed state, where the transition portion of the strap transitions and tapers or curves towards the smaller sized filament 1830 at the end to allow for a tight insertion into the yoke housing. This provides high bending resistance that reduces the risk of the strap twisting and kinking when stowed or not in use.
[0260] FIG. 18b shows an enlarged cutaway side view of the configuration of FIG. 18a showing the strap with the line track / yoke / friction engagement member housing 1810, where the transition portion 182 provides a hard stop in its longitudinal position that limits the transition portion 182 from being inserted too far inside the housing 1810, which could damage the directional adjustment unit 1800 and / or prevent the directional adjustment unit 1800 from functioning properly.
[0261] In one embodiment, the dimensions of the rectangular cross-section of filament 1830 (i.e., the cross-section perpendicular to the longitudinal axis of the filament) may be 0.85 mm (W) by 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.
[0262] In other embodiments, the dimensions of the filament 1830 can be varied to have sides ranging in size from 0.7 mm to 3 mm, meaning 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 triangle with one 3.00 mm side and two 1.5 mm sides, or any other combination of dimensions.
[0263] Experimentation has shown that a size of the filament 1830, for example in at least one cross-sectional dimension, between 30 and 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.
[0264] In some configurations, the ratio of the area of the frictional engagement member aperture 1876 cross-section (as viewed at the front of the frictional engagement member) to the filament 1830 cross-section can be in the range of 1:1.0201 to 1:1.3061.
[0265] 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.
[0266] [Table 2]
[0267] In one embodiment, a headgear 200 for a respiratory mask is provided. The headgear 200 includes at least one strap 208 and at least one yoke assembly 20. The strap 208 includes a filament guide and at least one filament 1830 that extends into the filament guide and enters the yoke assembly 20, as described further below. A sheath, such as an elastic sheath, may be provided around the strap 208, i.e., around the filament 1830 and the filament guide. 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 in an engaged configuration, at least a flat or substantially flat portion of the substantially flat or flat outer surface of the filament 1830 is contacted by a substantially linear or linear portion of a cross section of at least one engagement surface of the frictional engagement member 1820, 1822 of the direction adjustment unit 1800.
[0268] In some configurations, the sheath around the at least one strap 208 is flexible, resilient and / or spring-elastic, allowing the yoke assembly 20 to extend from an idle length when the yoke assembly 20 is pulled outward by the user's hand, while attempting to return to its idle length when the yoke assembly 20 is released. A filament 1830 may extend through the sheath. The at least one filament 1830 of the headgear further includes a core portion 181 having a first geometric shape. The filament 1830 further includes an end portion 183 having a second geometric shape. The filament 1830 further includes a transition portion 182 provided longitudinally between the core portion 181 and the end portion 183. The transition portion 182 has a shape that transitions from the first geometric shape of the core portion 181 to the second geometric shape of the end portion 183 over a longitudinal distance along the longitudinal axis of the filament 1830.
[0269] In some configurations, the yoke assembly 20 is positioned to connect the headgear to a respiratory mask.
[0270] In some configurations, at least one strap 208 forms a cavity therein for receiving 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 transversely rectangular cross-section, at least a portion of the strap cavity can be transversely rectangular with a slightly larger dimension to fit the rectangular filament 1830.
[0271] In the case of a filament 1830 having a transversely triangular cross-section, at least a portion of the strap cavity may be transversely triangular with a slightly larger dimension to accommodate the triangular filament 1830.
[0272] The orientation adjustment unit 1800, when assembled, can be disposed within the yoke assembly 20. The housing 1810 of the orientation adjustment unit 1800 can include an exterior opening 1860 for slidably receiving at least a portion of the filament 1830, such as a portion of the transition portion 182 and / or the end portion 183, during use. In some configurations, the exterior opening 1860 has a size, i.e., at least one cross-sectional dimension, smaller than the portion of the transition portion 182 of the filament 1830 during use, so as to prevent the transition portion 182 from entering the orientation adjustment unit 1800 completely.
[0273] In some configurations, the yoke assembly 20 includes 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.
[0274] 19-25 illustrate an example of a respiratory interface system 100 or respiratory mask system 100 for providing 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 arrangement, 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 for attaching 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.
[0275] 25, 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 configuration shown, 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 configured to surround the nasal pillows and 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.
[0276] 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, full face seals, such as a nasal seal, a full face above-the-nose seal, a full face below-the-nose seal, etc.
[0277] 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.
[0278] 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, 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. Optionally, the mask 102 can include a vent insert or diffuser 152 that covers the vent 140 to control the exhaust flow.
[0279] 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.
[0280] In one form, the headgear 200 may include a yoke assembly 20 or collector configured to attach to the mask 102, as described in more detail herein.
[0281] The yoke assembly 20 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 includes an assembly of straps including rear straps 204 configured to wrap around the rear of the patient's head, top straps 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. In some configurations, the top straps 206 may not be necessary.
[0282] In some configurations, for example as shown in Figures 23 and 24, at least one filament 1830 includes a core portion 181, a transition portion 183, and an end portion 183, as described above.
[0283] In some configurations, each front strap 208 is attached to a rear strap 204 of the headgear assembly 200, such as by a rear connector 205 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 in use.
[0284] In one form, the headgear 200 may be adjustable (e.g., manually adjustable, automatically adjustable) and / or may incorporate one or more directional adjustment units 1800 as 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 may be overridden so that the headgear 200 may be lengthened to accommodate the interface assembly 100. In some forms, the yoke assembly 20 may form a collection for the filaments used in an automatically adjustable headgear system. In this form, the yoke assembly 20 may incorporate one or more directional adjustments 1800, each of which may include one or more locking elements, which may be referred to herein as frictional engagement members 1820, 1822. The frictional engagement members 1820, 1822 are configured to frictionally engage the filaments 1830 during extension of the headgear 200, but allow relatively frictionless movement during contraction of the headgear 200.
[0285] The frictional engagement members 1820, 1822 and / or filament 1830 may have at least one flat or substantially flat portion or region or outer surface as described above.
[0286] The direction adjustment unit 1800 can be incorporated into the end of the yoke assembly or collector 20, and the body of the yoke assembly 20 or collector can be hollow enough to receive the 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 Publication No. 14 / 856,193, filed September 16, 2015, and WO 2016 / 043603, all of which are incorporated herein by reference in their entireties.
[0287] 23 and 24, the headgear 200 includes two filaments 1830, one for each front strap 208. However, any number of filaments may be used.
[0288] 23 and 24 , each front strap 208 may include a free end to which a connector 209 may be attached. Each connector 209 may engage a complementary strap connector 203 located on the yoke assembly 20. Preferably, the yoke assembly 20 is substantially elongated and includes a strap connector 203 located at or near each end of the front member 21 a and rear member 21 b of the yoke assembly 20.
[0289] Optionally, the front straps may be overmolded onto connectors located on the yoke assembly. The connection between the front straps 208 and the yoke assembly 20 may be any suitable form of connection, 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. 23-24 ) located on each end of the yoke assembly 20. Each cap 210 may 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.
[0290] Referring to FIG. 24, the filament 1830 can be connected to the top strap 206 and / or the rear strap 204 via a front strap connector 2081, thereby securing one end 1811 of the core portion 181 of the filament 1830 to the front strap connector 2081.
[0291] This means that when 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 stretched portion of the front strap 208 moves, e.g. slides, relative to the filament 1830 because both the front strap 208 and the core portion end 1811 are connected together in or adjacent the front strap connector 2081. This causes the free end of the end portion 183 of the filament 1830 to move closer to the connector 209 of the strap 208 to which it was provided. This causes relative movement of the end portion 183 of the filament 1830 and the orientation adjustment unit 1800 in which the filament 1830 is disposed. The filament 1830 moves relative to the orientation adjustment unit 1800 because the yoke assembly 20 and indirectly the orientation adjustment unit 1800 are also connected to the connector 209. This relative movement causes the associated frictional engagement members 1820, 1822 to move from their disengaged configuration toward their engaged configuration due to friction between the filament 1830 and the cavity of the frictional engagement member in which it is provided.
[0292] For example, when a user releases the yoke assembly 20 with his or her own hand, the opposite phenomenon occurs if the strap 208 is allowed to return from its extended state to its unextended state. The spring resilience in the strap 208 acts to retract the strap 208 from its extended state to its unactuated state. In this scenario, the distance between the free ends of the end portion 183 of the filament 1830 moves further away from the connector 209 of the strap 208 to which the filament 1830 is provided. This causes a relative movement between the end portion 183 of the filament 1830 and the orientation adjustment unit 1800 in which the filament 1830 is disposed. This relative movement causes the frictional engagement members 1820, 1822 to move from their engaged configuration toward their disengaged configuration due to friction between the filament 1830 and the cavity of the frictional engagement members in which the filament is provided.
[0293] It should be understood that a direction adjustment unit 1800 having at least one frictional engagement member 1820, 1822 with an aperture forming an engagement surface of the frictional engagement member having a linear or substantially linear portion that, in cross section, engages a corresponding flat or substantially flat portion of the filament 1830, can be provided in any headgear design, i.e., designs other than those disclosed herein, in which the respective direction 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 disengaged and engaged states.
[0294] As mentioned above, the yoke assembly 20 may also be configured to attach to a frame 106 of the mask 102. In one form, the frame 106 may include a recessed area or alignment feature configured to receive at least a portion of the yoke assembly 20 therein when the yoke assembly 20 and the frame 106 are attached to one another. The cover sleeve or front portion 22 may be configured to facilitate removable connection of the yoke assembly 20 to the frame 106.
[0295] 26a-26h, a housing 1810 of a direction adjustment unit 1800 according to one embodiment is shown. In this embodiment, the housing 1810 is adapted to hold two frictional engagement members 1822, 1820 in a single housing. However, it should be understood that the housing 1810 may be adapted to hold any predetermined number of frictional engagement members according to other embodiments. Thus, any predetermined number of frictional engagement members may be arranged in series, i.e., one behind the other, in the housing according to some embodiments. Similarly, the direction adjustment unit 1800 may include multiple housings in series, where each housing includes a single frictional engagement member 1820, 1822. For example, the direction adjustment unit 1800 may include a single housing including two frictional engagement members 1820, 1822, or the direction adjustment unit 1800 includes two housings, where each housing includes a single frictional engagement member. The filament guide features in each housing substantially decouple the operation of the frictional engagement members such that an orientation adjustment unit including a single housing containing two frictional engagement members will provide substantially similar performance as an orientation adjustment unit including two housings each containing a single frictional engagement member.
[0296] 26a is a cross-sectional cutaway view of the housing 1810 of the orientation adjustment unit. The housing 1810 includes a filament guide 831 having a first opening 8311 for slidably retaining a filament (not shown) in use. The filament guide 831 may form an intermediate wall or structure of the housing 1810 or at least an intermediate structure disposed between adjacent frictional engagement members 1820, 1822. The purpose of the filament guide 831 is to allow the filament to be aligned in a correct or desired vertical position between the two frictional engagement members 1820, 1822. In particular, the filament guide 831 restrains the filament 1830 in a direction perpendicular to the axis of the filament 1830, resists movement toward or away from the pivot axis of the frictional engagement members 1820, 1822, and provides restraint of the filament relative to the inlet and outlet apertures 8321, 8331 in the housing 1810. This helps to constrain the filament along a desired filament path through the housing 1810, minimizes or at least controls bending of the filament within the housing 1810 or relative to the or each frictional engagement member 1820, 1822, and at least partially isolates the operation of one frictional engagement member from the other, thereby allowing the two frictional engagement members to operate substantially independently. In this manner, the configuration of a first frictional engagement member 1820, 1822 in a series will not significantly affect a subsequent frictional engagement member 1820, 1822 in the series, because the filament enters each frictional engagement member 1820, 1822 in substantially the same or more closely the same orientation. The constraint of the filament between adjacent frictional engagement members also serves to minimize, but not necessarily completely eliminate, bending of the filament 1830 as it enters and exits the housing 1810, thus minimizing, but not necessarily eliminating, undesirable bending of the filament 1830 within the housing 1810 and relative to each frictional engagement member 1820. Such bending of the filament 1830 can be seen, for example, in Figures 1a and 8. An undesirable bend can be described as a bend of the filament 1830 that opposes the action of the frictional engagement members. This undesirable bend of the filament 1830 typically occurs when entering or exiting the housing 1810 or between the frictional engagement members.
[0297] Thus, the filament guide 831 when intermediate the frictional engagement members 1820, 1822 helps to ensure that pivoting of one frictional engagement member 1820, 1822 has a reduced effect on pivoting of another frictional engagement member 1820, 1822 by aligning, or at least improving, the filament along the longitudinal axis after it exits one frictional engagement member 1820 and before it enters the next frictional engagement member 1820. Thus, the filament guide 831 can be said to act to unbend or straighten the filament 1830 between the frictional engagement members 1820. Thus, the filament guide at least partially decouples the movement of one frictional engagement member 1820 from another.
[0298] As discussed above, the housing 1810 further includes at least one mounting slot 84 that provides a retention space for slidably retaining the base member 1824 of each frictional engagement member 1820, 1822. The slot 84 is configured to permit the frictional engagement members 1820, 1822 to pivot relative to the housing 1810 as discussed above, and to slide or translate toward or away from the base of the housing 1810, with the range of such movement being limited by the frictional engagement members 1820 abutting the ends of the slot 84. Each slot 84 thus defines a predetermined elongated path along which the frictional engagement members 1820, 1822 may move in addition to pivoting about a pivot axis. This translational movement of the frictional engagement members 1820, 1822 allows the position of the aperture 1876 to follow the path of the filament, such as, but not limited to, moving vertically in response to the vertical movement of the position of the filament as it bends inside the housing 1810, moving with the filament as each frictional engagement member 1820, 1822 moves from a disengaged position to an engaged position, etc.
[0299] Each slot 84 may form a portion of a side wall 85 of the housing. Each frictional engagement member 1820, 1822 may be attached to the housing 1810 using two laterally opposed slots 84 of the housing 1810. The two laterally opposed slots 84 may be formed in two laterally opposed side walls of the housing 1810.
[0300] However, it should be understood that in alternative embodiments, only a single slot 84 may be required to attach each frictional engagement member 1820, 1822 to the housing 1810. Such a single slot 84 may be formed, for example, in a solid base or lower region of the housing 1810. The frictional force between the outer periphery of the base member 1824 and the slot surface 842 can be desirably kept to a minimum or at least reduced, for example, by designing the slot surface and / or the base member 1824 to be smooth, and / or by selection of appropriate materials / material coatings, and / or by appropriate tolerances between the components. Thus, by adjusting the shape and surface of the dual or single slot 84, the frictional force between the outside of the base member 1824 and the slot surface can be maintained at a desired relatively low level.
[0301] The retention space formed by each slot 84 may be sized to permit the retained base member 1824 to pivot about its pivot axis within that retention space. In other words, the retention space is large enough relative to the base member 1824 to permit the base member 1824 to be translationally displaced along the slot 84 away from the base of the housing 1810 such that the pivot axis can be translationally displaced along the slot 84.
[0302] In some embodiments, the slot 84 can have a transverse cross-sectional shape similar to, but larger than, the transverse cross-sectional shape of the base member 1824 when viewed along the pivot axis of the base member 1824. The size of the slot 84 or the size of the dimensions of the slot 84 can be configured to allow a predetermined or desired maximum amount of movement of the base member 1824 relative to the slot 84.
[0303] In embodiments where the base member 1824 has a circular transverse cross-sectional shape, the slot 84 may have a corresponding, but larger circular shape or at least partially circular or arcuate ends such that the base member 1824 can be movably retained within the circular slot 84. In such embodiments, the pivot axis of the base member 1824 will remain substantially fixed relative to the housing 1810 as the frictional engagement members 1820, 1822 move from the disengaged to the engaged configuration. Thus, the apertures of each frictional engagement member 1820, 1822 will move along an arc similar to that shown in FIGS. 11 and 12 as the pivot axis remains substantially fixed relative to the housing 1810.
[0304] Applicant has appreciated that each and / or any combination of the pivot angle of the frictional engagement members 1820, 1822 relative to the housing 1810, the position of the filament into and out of the housing 1810, and the position of the filament 1830 between the frictional engagement members 1820, 1822, are related to the amount of frictional force exerted between the frictional engagement members 1820, 1822 and the filament 1830 as the frictional engagement members 1820, 1822 move from a disengaged position to an engaged position.
[0305] In one embodiment, the pivot axis of the frictional engagement members 1820, 1822 is fixed relative to the housing 1810 and the filament 1830 is partially constrained or largely unconstrained in the "vertical" direction as it enters or exits the housing 1810, for example, this configuration is shown in Figures 1, 7, 8, 10-12. In other words, the distance between the filament 1830 and the base of the housing 1810 is unconstrained. In this embodiment, because there is limited constraint on the filament 1830 as it enters or exits the housing 1810, the pivot angle of the frictional engagement members 1820, 1822 relative to the housing 1810 will greatly affect the tortuous path that the filament 1830 takes through the housing 1810. The filament 1830 will tend to bend or flex within the housing due to the material properties of the filament 1830 and the forces exerted by the engagement of the filament 1830 with the frictional engagement members 1820, 1822. Because there are no constraints on the filament 1830 other than the positioning of the frictional engagement members 1820, 1822, it can be said that the pivot angle largely determines the bend or kink that is formed in the filament 1830 as it passes through the housing 1810, and therefore largely determines the frictional force acting between the frictional engagement members 1820, 1822 and the filament 1830.
[0306] In a further embodiment, the pivot axis of the frictional engagement members 1820, 1822 is fixed relative to the housing 1810, and the filament guide 831 of the housing 1810 largely restrains the filament 1830 at a location within the housing 1810. In this embodiment, the pivot angle of the frictional engagement members 1820, 1822 relative to the housing 1810, along with the filament guide 831, will determine the serpentine path formed therein and therefore the bend or kink formed in the filament 1830. Due to the stiffness of the filament 1830, the pivot angle of the frictional engagement members 1820, 1822 may be limited. In this situation where the pivot axis is fixed, the bend or kink of the filament 1830 will be limited by the ability of the filament 1830 to extend through the aperture 1876 of the or each frictional engagement member 1820, 1822 and through the aperture 8331 of the filament guide 831. The ability of the filament 1830 to extend through these apertures 1876, 8331 (and the serpentine path that is formed) will be limited by the stiffness of the filament 1830. Thus, by including a filament guide 831 in the housing 1810 to which the pivot axes of the frictional engagement members 1820, 1822 are fixed, the pivot angle and the bends or kinks formed in the filament 1830 may be limited by the filament path taken by the filament 1830 being constrained by the filament guide, and thus the amount of frictional force between the filament 1830 and the frictional engagement members 1820, 1822 may be limited in an undesirable manner.
[0307] Applicant has recognized that by movably mounting the frictional engagement members 1820, 1822 to the housing 1810 to permit relative movement therebetween, particularly in a direction perpendicular to the pivot axis of the frictional engagement members 1820, 1822 and particularly in a direction in which the pivot axis can move generally perpendicularly upwardly relative to the housing 1810 and away from the base of the housing 1810, the filament 1830 can extend through the aperture 1876 of the or each frictional engagement member 1820, 1822 and through the aperture 8331 of the filament guide 831 fully or at least in a more engaged position without being restricted, or less restricted, by the stiffness of the filament 1830.
[0308] In addition to the base member 1824 being pivotally held, by designing the slot 84 to be allowed to be displaced, e.g., vertically translated, relative to the housing 1810, the frictional engagement members 1820, 1822 are allowed to pivot while being displaced vertically, allowing one or more of the frictional engagement members 1820, 1822 to engage a sharp curve in the filament 1830. This sharp bend, curve or kink in the filament 1830 is formed in part due to the addition of the filament guide 831, whereby as the filament exits one or more apertures 1876 in the engagement members 1820, 1822 and enters an aperture 8331 in the filament guide 831, the aperture 8331 restrains the filament 1830, thus causing the sharp bend, curve or kink to be formed. By allowing the pivot axis of the frictional engagement members 1820, 1822 to be displaced, the pivot axis is no longer fixed relative to the housing 1810. In this manner, the housing 1810 and the frictional engagement members 1820 , 1822 are configured to allow the pivot axis of the frictional engagement members 1820 , 1822 to be floatable, translatable or movable relative to the housing 1810 .
[0309] Also, by allowing the frictional engagement members 1820, 1822 to be slidably vertically displaced relative to the housing 1810, it may be possible to allow the vertical displacement of the aperture 1876 of each frictional engagement member for a given pivot angle to more closely follow an imaginary line through the central axis of the aperture 8331 of the filament guide 831 when in the disengaged position. This may mean that the frictional force between the frictional engagement members 1820, 1822 and the filament 1830 only increases linearly when moving from the disengaged to the engaged configuration.
[0310] 9a-9f and 26a-26f has slots 84 designed to allow the base member 1824 of each frictional engagement member to be vertically displaceable as well as pivotable relative to the housing 1810. Thus, the slots 84 are designed to allow the pivot axis of the base member 1824 to be displaced or moveable relative to the housing 1810.
[0311] In Fig. 26a the longitudinal axis of the housing 1810 is shown. The longitudinal axis is depicted symmetrically through the opening 8311 of the filament guide 831. A "vertical" axis, perpendicular to the longitudinal axis, is also shown. As can be observed from Figs. 26a-d, the slot 84 is clearly shown. The slot 84 forms a holding space for the base member 1824 (see Figs. 9a-9f).
[0312] As can be observed from Figures 9a-9f, the retention space can have a width in a transverse cross-section, e.g., extending along a longitudinal axis, that is greater than the cross-sectional width of the base member 1824 so that the base member 1824 (and its pivot axis) can move within the retention space.
[0313] The retention space may be sized such that the retained base member 1824 can move to some extent within the retention space in a direction perpendicular to the pivot axis.
[0314] 26a-26c, the slot 84 forms an elongated, oval or elliptical shape. The slot 84 extends along a vertical axis. As can be seen, at least a portion of the slot 84 is formed by two opposing parallel surfaces 842 of the side wall 85 of the housing 1810. In Figs. 26a-26d, the two opposing parallel surfaces 842 are parallel to the vertical axis. When viewed along the pivot axis, the elliptical slot 84 has a vertical length greater than its horizontal width and has a rounded end. The lower rounded end is open but includes a narrowed portion in the form of a jaw 841, which is narrower than the base member 1824 and holds the base member 1824 in the slot 84.
[0315] However, it should be understood that the two opposing parallel surfaces 842 may be oriented by and aligned with any other axis having at least a component along the vertical axis, e.g., any axis perpendicular to the pivot axis, so that the base member 1824 can be displaced away from the base of the housing 1810.
[0316] 26a-d and 9a-f, the transverse cross-sectional slot 84 has a length extending along a vertical axis that is greater than its width, for example, to allow the base member 1824 to move in a direction perpendicular to the pivot axis. Thus, the length of the retention space can extend substantially vertically away from the base of the housing 1810, generally in a direction toward the filament 1830.
[0317] In some embodiments, the length of the slot 84 extends parallel or substantially parallel to at least a portion of the filament guide 831.
[0318] In some embodiments, the slot 84 has end portions having an arcuate shape that at least partially matches the at least partially arcuate shape of the base member 1824 .
[0319] 26a-d and 26h, the slot 84 may have at least one narrowed section 841 to prevent the base member 1824 from moving beyond said narrowed section, thereby retaining it within the slot 84 of the housing 1810. The frictional engagement members 1820, 1822 are attached to the housing 1810 by elastically deforming the jaws 841 to force the base member 1824 into the slot 84, which snaps back when the base member 1824 is fully received within the slot 84.
[0320] The housing 1810 may further include one or more additional filament guides for guiding the filament 1830. Each filament guide includes a guide surface configured to contact at least the filament. In a preferred embodiment, at least one filament guide includes an opening through which the filament extends. For example, the housing may further include a second filament guide 832 having a second opening 8321 for slidably guiding the filament 1830 in use. The filament guide 832 may form a first end wall of the housing 1810. Referring to Figures 9a-9d, at least one frictional engagement member is disposed between the first filament guide 831 and the second filament guide 832 of the housing.
[0321] The housing 1810 may further include a third filament guide 833 having a third opening 8331 for slidably guiding the filament 1830, in use. The third filament guide 833 may form a second end wall of the housing 1810, the second end wall being opposite that of the first end wall.
[0322] Applicant has found that in embodiments in which the housing 1810 includes a first filament guide 831 having a first opening 8331 for slidably guiding the filament 1830, a second filament guide 832 having a second opening 8321 for slidably guiding the filament 1830, and a third filament guide 833 having a third opening 8331 for slidably guiding the filament 1830, the ability of the pivot axes of the frictional engagement members 1820, 1822 to translate can be useful.
[0323] Applicants propose to provide a pair of filament guides for a single frictional engagement member 1820, 1822, and then provide an additional filament guide for each additional frictional engagement member 1820, 1822, with each frictional engagement member 1820, 1822 located intermediate two filament guides. Thus, in a housing 1810 including a single frictional engagement member 1820, 1822, two filament guides would be provided. In a housing 1810 including two frictional engagement members 1820, 1822, three filament guides would be provided, and in a housing 1810 including three frictional engagement members 1820, 1822, four filament guides would be provided.
[0324] In such an embodiment having two frictional engagement members, the filament 1830 is constrained, i.e., slidably guided, at multiple positions. The filament 1830 is constrained at the inlet and outlet of the housing 1810 by the second filament guide 832 and the third filament guide 833, respectively, and within the housing 1810 by the first filament guide 831. These three filament guides constrain the filament 1830 at a predetermined "vertical" position, or stated differently, constrain the filament 1830 to be substantially horizontal at multiple positions, for example, as viewed in FIG. 9d. As the engagement members 1820, 1822 pivot in response to lateral movement of the filament 1830, they begin to engage the filament 1830 with the front and rear aperture edges 81 and 82, forming a serpentine path defined by the cavity provided by the three filament guides 831, 832, 822 and the aperture 1876 of the or each frictional engagement member 1820, 1822. This contact of the filament 1830 with the front and rear aperture edges 81 and 82 causes the filament 1830 to bend or kink between the first filament guide 831 and one of the second filament guide 832 or the third filament guide 833. The stiffness of the filament 1830 and the constraints at the exit and entrance of the housing 1810 mean that the filament must bend or kink above a horizontal axis defined in the rest position. Thus, the pivot axis of the engagement members 1820, 1822 translates vertically to allow the engagement members 1820, 1822 to fully pivot and engage the filament 1830 with sufficient frictional force.
[0325] In some embodiments, when the orientation adjustment unit includes three or more frictional engagement members 1820, 1822 attached to the housing 1810, the third filament guide 833 may form a further intermediate wall of the housing 1820. A filament guide having an opening may be provided between each adjacent pair of frictional engagement members 1820, 1822.
[0326] 26b-d, the first opening 8311, the second opening 8321 and / or the third opening 8331 in the housing 1810 may have a filament engagement surface that is straight or substantially straight in cross section when the housing 1810 is viewed in the direction of the pivot axis of the frictional engagement members 1820, 1822. Each engagement surface slidably engages a flat or substantially flat portion of the filament, in use.
[0327] 26d, in a cross-sectional plane, the first opening 8311, the second opening 8321, and / or the third opening 8331 can be aligned with a longitudinal axis extending through the housing 1810. In other words, the longitudinal axis passes through the center of each of the first opening 8311, the second opening 8321, and / or the third opening 8331.
[0328] Figures 26e and 26f show front and rear views, respectively, of a housing 1810 according to one embodiment. Figure 26e shows a front view of the housing 1810 according to one embodiment, identifying the third filament guide / end wall 833, the third opening 8331, and the side wall 85. Figure 26f shows a rear view of the housing 1810 according to one embodiment, identifying the second filament guide / end wall 833, the second opening 8321, and the side wall 85.
[0329] As can be observed from Figures 26e and 26f, each end wall can include a draft angle 261 that allows for improved tooling.
[0330] It can also be observed that a step 262 is provided between each side wall 85 and end wall 833, 832. This may allow for improved multi-core tool design.
[0331] Referring to Fig. 26g, a top view of the housing of Fig. 26a is shown with two retained frictional engagement members 1822, 1820. The frictional engagement members are now shown in a disengaged configuration. In this embodiment, the housing 1810 defines an open cavity between each of the first, second and third filament guides 831, 832, 833 and each of the side walls 85 within which each of the frictional engagement members 1822, 1820 is permitted to move.
[0332] FIG. 26h is a bottom view of the arrangement of FIG. 26g, in which it can be clearly seen that the base members 1824 of each frictional engagement member 1822, 1820 are retained within their respective slots 84 by the narrowed sections 841. FIG.
[0333] 27 is a cross-sectional schematic diagram illustrating the orientation of a frictional engagement member 1820 with respect to pivotal and vertical translational displacement, which is held in a housing 1810 having a slot 84 that allows the pivot axis of the frictional engagement member 1820 to move relative to the housing 1810 when a filament (not shown) is pulled and moved, e.g., to the right, relative to the filament guides 821, 832, 833 and / or the frictional engagement member 1820. It is this relative movement between the filament and the housing 1810 in which the frictional engagement member 1820 is held, that changes the orientation of the frictional engagement member 1820. Without an assembled filament, the only force acting against the frictional engagement member is the force of gravity.
[0334] More specifically, FIG. 27 shows examples of the relative movement of the frictional engagement member 1820 with respect to the longitudinal axis of the housing 1810 (located symmetrically along the openings 8311, 8321, 8331) and the original vertical position of the pivot axis (in the disengaged position as shown by the leftmost frictional engagement member 1820 in FIG. 27) assumed at different pivot angles when moving from the disengaged to the engaged configuration.
[0335] As the frictional engagement member 1820 moves from the disengaged configuration towards the engaged configuration, the vertical position of the pivot axis changes for a given pivot angle. Also, from a relative standpoint, it can be observed that the aperture 1876 of the frictional engagement member 1820 remains more centered with respect to the openings 8311, 8321, 8331 of the housing 1810 than would be the case with a fixed pivot axis solution as shown in Figures 11 and 12. In other words, the vertical displacement of the aperture 1876 with respect to the longitudinal axis of the housing 1810 is reduced in this embodiment. This is primarily because the filament 1830 is constrained by the aperture 8311 of the first filament guide 831. This constraint resists the tendency of the filament 1830 to bend within the housing 1810 between the housing entrance and exit apertures, and more importantly, at least partially minimizes the curvature of the filament 1830 shown in Figures la and 8 between the first and second engagement members 1820, 1822. The constraint of the filament 1830 by the or each filament guide 831, 832, 833 causes the aperture 1876 of each frictional engagement member 1820 to want to translate within the housing 1810 to follow the curvature of the filament 1830. The stiffness of the filament 1830 means that when a bend or kink forms, the filament will lift the frictional engagement members 1820, 1822 upwards, away from the base of the housing 1810, because the filament is constrained on the left and right and therefore must bend upwards. To allow for this, the pivot axis of each frictional engagement member 1820 is vertically displaceable relative to the housing 1810 along a predetermined elongated path defined by the slot 84. Thus, each frictional engagement member 1820 can float or move relative to the housing 1810 to at least partially follow the path of the filament 1830.
[0336] The general alignment of the aperture 1876 with respect to the longitudinal axis of the housing depends on many factors, such as the size and shape of the frictional engagement member aperture 1876 with respect to the filament 1830, the relative size, location, relative orientation and alignment of the adjacent openings 8311, 8321, 8331 in the housing 1810, the longitudinal distance between the center of the left side of the aperture 1876 and the nearest filament guides 831, 832, 833, the longitudinal distance between the center of the right side of the aperture 1876 and the nearest filament guides 831, 832, 833, and / or the weight of the frictional engagement member 1820 with respect to the required pulling force of the filament 1830. Another factor relates to the material properties or other material properties of the filament 1830 in terms of the resistance to bending or relative resistance to bending of the frictional engagement member 1820 with respect thereto. Thus, the filament 1830 being able to bend more or less will affect the vertical displacement of the frictional engagement member 1820 when moved from a disengaged to an engaged configuration.
[0337] To this extent, FIG. 27 should be viewed solely as an example arrangement of how a frictional engagement member 1820 having a pivot axis that is vertically displaceable relative to the housing 1810 may generally move between a disengaged configuration and an engaged configuration. In FIG. 27, the openings 8311, 8321, 8331 on either side of the frictional engagement member 1820 are arranged along a longitudinal axis such that the longitudinal axis extends along the center of each opening. The center of the aperture 1876 of the frictional engagement member 1820 is identified by a circle. Similarly, the pivot axis of the frictional engagement member 1820 is also identified by a circle. The center of the right side of the aperture 1876, i.e., halfway between the edges of the right side, is identified by a square. Similarly, the center of the left side of the aperture 1876, i.e., halfway between the edges of the right side, is also identified by a square. These locations are highlighted in FIG. 27 so that the paths of the different portions of the frictional engagement member 1820 can be more easily seen.
[0338] In this embodiment, the aperture 8311 of the first filament guide 831 closely resembles in cross-section the size and shape of the filament 1830 in cross-section, such that there is only minimal clearance between the filament 1830 and the aperture 8311. Similarly, the inlet and outlet openings 8321, 8331 of the housing 1810 can be similarly closely similar to the filament 1830. This close tolerance between the filament 1830, the aperture 831, and the openings 8321, 8331 assists in precisely guiding the filament 1830 along a desired path through the housing 1810. Control of the path of the filament 1830 through the housing 1810 assists in achieving precise and desired control of the movement of the frictional engagement member 1820, and thus the frictional engagement between the frictional engagement member 1820 and the filament 1830. This also ensures that the filament 1830 moving in and out of the housing 1810 does so in a more straight or horizontal trajectory, as seen in FIG. 9d, for example, minimizing the tendency for it to move in and out of the housing 1810 in a curved or bent trajectory.
[0339] Seven different orientations of the frictional engagement members are shown in Figure 27. The number of orientations shown is arbitrary and is included for purposes of illustration. The frictional engagement members 1820, 1822 may move to a greater or lesser extent than is shown in Figure 27.
[0340] Orientation number 1 corresponds to a disengaged configuration. In orientation number 1, the center of the aperture 1876 on the left side of the frictional engagement member 1820 intersects the longitudinal axis. Orientation number 7 corresponds to an engaged configuration. In orientation number 7, the center of the aperture 1876 on the right side of the frictional engagement member 1820 intersects the longitudinal axis. Orientations numbers 2-6 correspond to intermediate stages between the disengaged and engaged configurations, respectively. Orientation number 4 indicates a stage where the longitudinal distance between the center of the left side face and the housing opening closest to the left side is equal to the longitudinal distance between the center of the right side face and the housing opening closest to the right side. The center of the aperture 1876 is located on or very close to the longitudinal axis. In this orientation, the filament 1830 can bend relatively evenly on both sides of the frictional engagement member 1820.
[0341] From Fig. 27, it can be observed that the center of the aperture 1876 does not move along the same arc as shown in Fig. 11 or 12. Instead, between orientation numbers 1 and 4, the center of the aperture 1876 remains relatively close to the longitudinal axis (as translational movement of the pivot axis along a predetermined elongated path is permitted), and thereafter, the vertical distance between the center of the aperture 1876 and the longitudinal axis steadily increases. Thus, by allowing the frictional engagement member 1820 to move vertically within the slot 84, the center of the aperture 1876 can be maintained relatively close to the longitudinal axis during the initial stages between the disengaged and engaged configurations.
[0342] It can also be observed that the pivot axis moves vertically slightly downward from orientation number 1, finds its lowest vertical level at orientation number 2, and then moves vertically upward to intersect with the original pivot axis level between orientation numbers 3 and 4, after which the vertical level can be seen to steadily increase until it reaches its maximum value at orientation number 7.
[0343] The above-described arrangement is configured to allow the aperture 1876 to move about a pivot axis that is not fixed. In other words, the aperture 176 is configured to move relative to the housing 1810 according to multiple degrees of freedom, specifically pivoting about the pivot axis and translational movement in which the pivot axis itself moves relative to the housing 1810. This allows the or each frictional engagement member 1820, 1822 to follow the filament 1830 as it moves through the housing 1810 while being constrained by the aperture of the housing 1810 through which the filament 1830 passes. Furthermore, this arrangement still allows the orientation of each aperture 1876 to pivot relative to the housing 1810 to change the frictional engagement between the or each frictional engagement member 1820, 1822 and the filament 1830 as the filament 1830 moves through the housing. This allows the or each frictional engagement member 1820 to engage the filament 1830 such that if the filament 1830 bends or kinks, the bend or kink raises a section of the filament 1830 above its horizontal position where it is disposed in the disengaged configuration.
[0344] Referring to FIG. 28, the headgear 200 can be seen in an extended / extended position and a retracted / retracted position. Note that in FIG. 28, only the yoke 21 is shown. The cushions / seals of the patient interface 102 are omitted for clarity. In the extended position, the headgear 200 is extended such that the patient interface 102 is moved away from the user's face. This is undesirable in use, as the patient interface 102 should be in contact with the user's face in order for breathing gas to be effectively delivered to the user. FIG. 28a shows an extreme degree of extension, where it is undesirable that the patient interface 102 could move away from the user's face. When the headgear 200 is extended, and as shown in FIG. 28a, the orientation adjustment unit 1810 transitions from an actuated state in which the frictional engagement members 1820, 1822 have moved within the housing 1810 to a second state in which the frictional engagement members 1820, 1822 frictionally engage the filament 1830 and resist extension of the headgear. In other words, when the orientation adjustment unit 1810 is in an actuated state, movement of the patient interface 102 away from the user's face is resisted. The position of the frictional engagement members 1820, 1822 when the orientation adjustment unit 1810 is engaged can also be seen with reference to FIG. 30 when the headgear is subjected to a tensile extension force in the direction of arrow A. In this position, the frictional engagement members 1820, 1822 are tilted relative to the housing 1810 and / or the filament 1830, for example relative to an assumed vertical axis of the housing 1810.
[0345] When the headgear 200 is retracted towards the position shown in FIG. 28b where the patient interface 102 contacts the user's face, the orientation adjustment unit is deactivated and the frictional engagement members 1820, 1822 move to a position within the housing 1810 where the frictional force applied to the filament 1830 is reduced and the filament 1830 can move relatively freely through the orientation adjustment unit. The position of the frictional engagement members 1820, 1822 when the orientation adjustment unit 1810 is disengaged can also be seen with reference to FIG. 31 where the headgear is subjected to a retraction force in the direction of arrow B. In this position, the frictional engagement members 1820, 1822 are less tilted relative to the housing 1810 and / or the filament.
[0346] 29-41, another orientation adjustment unit 1800 is disclosed that includes additional or modified features. These features may include any one or more of the following, which can be seen initially with reference to FIG. 29: a) The frictional engagement members 1820, 1822 can be pre-actuated, i.e., positioned within the housing 1810, such that the frictional engagement members 1820, 1822 always frictionally engage the filament 1830, regardless of whether the headgear 200 is under tension or not, to prevent or at least reduce slippage of the filament 1830 through the housing 1810. Thus, the frictional engagement members 1820, 1822 always frictionally engage the filament 1830, regardless of their position or whether the headgear 200 is under tension or not. However, the amount of frictional engagement still varies depending on the position of the frictional engagement members 1820, 1822 relative to the housing 1810 and filament 1830. One example of how to achieve this is to angle the frictional engagement members 1820, 1822 with respect to the vertical axis of the housing 1810 and / or with respect to the filament 1830 to prevent or at least reduce unwanted slippage of the filament 1830 through the housing 1810. b) The filament inlet and outlet openings 1876 can be larger vertically to allow the filament 1830 to buckle during pre-actuation. c) One or more internal contact surfaces within the housing 1810 may be modified to reduce surface tension between the frictional engagement members 1810, 1822 and the contact surfaces. Surface tension may be present when the contact surfaces are wet or have contaminants on the surfaces. This may help to avoid or reduce the frictional engagement members 1820, 1822 from sticking at a given position within the housing 1830. d) Modifications to the housing 1810 to facilitate correct positioning of the friction engagement members 1820, 1822 within the housing 1810 during assembly.
[0347] Any one or more of these figures may be combined with any of the features of the direction adjustment unit 1800 of Figures 1-28.
[0348] 32, one can see the pre-actuation feature of the frictional engagement members 1820, 1822. This pre-actuation ensures that before the headgear 200 is extended, the frictional engagement members 1820, 1822 frictionally engage the filament 1830 to a predetermined degree before transitioning to the second condition.
[0349] This is accomplished by configuring the frictional engagement members 1820, 1822 and housing 1810 such that the central axis of the opening 1876 is not parallel to the central axis of the housing entrance opening 1860. In other words, the frictional engagement members 1820, 1822 and housing 1810 are configured such that the filament path entering the housing 1810 through opening 1860 and through opening 1876 is non-linear or serpentine.
[0350] The frictional engagement members 1820, 1822 each include an upper arm portion 1874 whose axis 1874A is inclined relative to the vertical axis VA of the housing 1810 when the frictional engagement members 1820, 1822 are in the pre-actuated state. As can be seen in FIG. 32 , the central axis 1876A of the opening 1876 is non-parallel to the central axis 1860A of the housing entrance opening 1860. Thus, before a pulling force is applied to the filament 1830 during or during resisting elongation of the headgear 200, the upper arm portion 1874 is inclined relative to the vertical axis VA of the housing 1810, i.e., relative to an axis perpendicular to the longitudinal axis of the filament. It will be appreciated that as the filament 1830 extends through the housing 1810, the filament longitudinal axis moves and / or bends. We note here that the assumed filament axis is the line connecting the central axis 1860A of the housing inlet opening and the corresponding central axis of the housing outlet opening 1860. The central axis 1876A of the frictional engagement member 1820 will have an inclination angle relative to the central axis 1860A of the housing inlet opening 1860. In this example, the central axis 1876A of the frictional engagement member 1820 will have an inclination angle relative to the base of the housing 1810. This inclination angle, or pre-actuation angle PA, is such that the filament path through the aperture 1876 is not perfectly aligned with the filament longitudinal axis, and thus the aperture 1876 frictionally engages the filament 1830 to some degree. A pre-actuation angle PA of 0 to 4° is determined to be acceptable. A pre-actuation angle PA of about 3° is believed to be preferred. The pre-actuation angle PA may be measured relative to the longitudinal axis of the filament 1830. It can also be seen that this pre-actuation angle is such that the longitudinal axis of filament 1830 and the central axis CA of filament aperture 1876 are tilted or non-parallel.
[0351] With reference to FIG. 33, the angle of the upper arm portion 1874, i.e., the portion of the arm including the filament aperture 1876, increases from a pre-actuation angle PA to an actuation angle AA when a pulling force is applied to the headgear 200. Such a pulling force may be applied before headgear extension occurs, such as while the frictional engagement members 1820, 1822 are reassembling headgear extension and / or during headgear extension. The actuation angle AA may increase the pre-actuation angle by 1-30°. In one example, the actuation angle AA may be up to 25°. In the example of FIG. 33, the actuation angle AA is about 9°, i.e., the frictional engagement members 1820, 1822 pivot about 6° from the pre-actuation angle PA.
[0352] Providing the frictional engagement members 1820, 1822 with a pre-actuation angle PA can have the effect of buckling the filament 1830 within the housing 1810 and as the filament 1830 enters and exits the housing 1810 through the inlet and outlet apertures 1860. With reference to Figures 29 and 34, the vertical dimension 1860H of the filament inlet and outlet apertures 1860 within the housing 1810 is increased to accommodate buckling of the filament 1830 in a generally vertical direction.
[0353] The vertical dimension 1860H of the entrance and exit apertures 1860 in the housing 1810 is preferably 10-50% larger than the vertical dimension of the filament 1830. The required vertical dimension of the entrance and exit apertures 1860 is proportional to the pre-actuation angle PA, with larger pre-actuation angles PA requiring apertures 1860 having larger vertical dimensions.
[0354] In one example, a square filament 1830 may be provided, for example having a square cross-section of 1 mm by 1 mm. In this example, the inlet and outlet apertures 1860 have a vertical dimension of about 1.25 mm, i.e., about 25% larger than the vertical dimension of the filament. In this example, the inlet and outlet apertures 1860 have a transverse dimension of about 1.1 mm.
[0355] Referring to FIG. 29 and FIG. 35, a) Entrance aperture 1860 - top surface 1860T engages filament 1830. b) The exit aperture 1860--the bottom surface 1860B engages the filament 1830.
[0356] FIG. 35 is a line drawing of a CT scan of the orientation adjustment unit 1820 with the frictional engagement members 1820, 1822 in an actuated state, illustrating the state in which the filament 1830 is buckled by the actuation angle AA of the frictional engagement members 1820, 1822.
[0357] 36, this figure illustrates generally the assumed contact area CR between the inner wall W of the housing 1810 against which the upper arm portions 1874 of the frictional engagement members 1820, 1822 abut when the frictional engagement members 1820, 1822 are in an unactuated state. The abutment between the frictional engagement members 1820, 1822 and the wall W serves to limit the range of movement of the frictional engagement members 1820, 1822 within the housing 1810.
[0358] 36 , the inner wall W of the housing 1810 is substantially planar, providing a relatively large contact area CR against which the planar surface of the upper arm portion 1874 rests. This relatively large contact area CR may provide surface tension forces acting between the frictional engagement members 1820, 1822 and the adjacent inner wall W of the housing 1810, for example, when the orientation adjustment unit 1800 becomes wet during use, or after cleaning, or when exposed to other contaminants. This surface tension may undesirably impede movement of the frictional engagement members 1820, 1822 between the non-activated / pre-activated state and the activated state, such that the frictional engagement members 1820, 1822 may stick in the non-activated / pre-activated state.
[0359] The inner wall W and / or the upper arm portion 1874 of the frictional engagement members 1820 , 1822 may be modified to provide a smaller contact area between the inner wall W and the upper arm portion 1874 .
[0360] Examples of how this reduced contact area can be achieved include any one or more of the following: a) positioning the inner wall W such that a portion of the inner wall W protrudes further into the housing 1810 than a remainder of the inner wall W; b) providing one or more discrete surface features on the inner wall W and / or the frictional engagement members 1820, 1822 which help define a smaller contact area CR and therefore reduce sticking of the frictional engagement members 1820, 1822;
[0361] The one or more discrete surface features may include: a) one or more protruding portions protruding from the inner wall W and / or the frictional engagement members 1820, 1822; b) Providing one or more recesses in the inner wall W and / or the frictional engagement members 1820, 1822.
[0362] In the described example, it is the upper portions, i.e., upper arm portions 1874, of the frictional engagement members 1820, 1822 that contact the inner wall W of the housing 1810. However, it is envisioned that any other portion of the frictional engagement members 1820, 1822 may be configured to contact the inner wall W of the housing 1810.
[0363] Similarly, the inner wall W of the housing 1810 may be any interior surface of the housing 1810 against which the frictional engagement members 1820, 1822 abut when in the first configuration.
[0364] 37, in this example, one or both of the inner walls W include a protruding portion P that protrudes from the plane of the inner wall W into the housing 1810 in the direction of the frictional engagement members 1820, 1822. The protruding portion P provides a relatively small surface area abutment surface against which the frictional engagement members 1820, 1822 abut when in the unactuated / pre-actuated state. This relatively small protruding portion P reduces any surface tension compared to the example of FIG.
[0365] 37, the protruding portion P is provided by inclining the inner wall W with respect to the vertical axis VA of the housing 1810 such that a lower portion of the inner wall W protrudes into the housing 1810. In particular, the lower edge of the inner wall W protrudes into the housing. The inclination of the inner wall W is indicated by the line L.
[0366] In this example, a further effect of the inclination of the inner wall W is that it forces the frictional engagement members 1820, 1822 into the pre-actuated position described above. The orientation adjustment unit 1800 thus includes a housing 1810 and a pair of frictional engagement members 1820, 1822 through which the filament 1830 passes, the housing 1820 including at least one inner surface on which one of the frictional engagement members 1820, 1822 rests, the inner surface being inclined such that when the frictional engagement members 1820, 1822 are at rest, they are inclined relative to the filament and / or the base of the housing 1810, such that the frictional engagement members 1820, 1822 frictionally engage the filament 1830 before leaving the rest state, for example when a pulling force is applied to the filament 1830.
[0367] In another example, the inner wall W can be angled such that the top of the inner surface protrudes into the housing 1810.
[0368] In another example, only one inner wall W of the housing 1810 includes the protruding portion P. This may be sufficient to reduce any surface tension. However, it is envisioned that both inner walls W of the housing 1810 may include the protruding portion P.
[0369] 38, further examples of protruding portions P are disclosed. In these examples, the protruding portions P include discrete protruding features that protrude from a planar inner wall W. In this manner, the wall W can be substantially parallel or inclined to the housing vertical axis VA.
[0370] In the example of Fig. 38a, the protruding portion P is provided by a triangular protrusion that provides a discrete contact edge PE against which the frictional engagement members 1820, 1822 rest when in the disengaged state. Such discrete contact edge PE has a relatively small contact area.
[0371] In the example of Fig. 38b, the protruding portion P is provided by a protrusion that includes a dome having a curved outer surface. The protruding portion P in this example is hemispherical. The frictional engagement members 1820, 1822 contact the protruding portion P tangentially in this example, and again the contact area CR is relatively small.
[0372] 38c, the protruding portion P is provided by a rib extending along at least a portion of the inner wall W. The rib may extend along the entire width of the inner wall W, along the entire width of the frictional engagement members 1820, 1822, or along only a portion of the width of the inner wall W or the frictional engagement members 1820, 1822.
[0373] The ribs may be substantially straight or arcuate or a combination thereof.
[0374] The or each inner wall W may be provided with a plurality of protruding portions P. The protruding portions may be equally spaced apart.
[0375] The features on the inner wall W may include one or more adjacent recesses. The recesses also serve to reduce the surface area of the inner wall W that contacts the upper arm portions 1874 of the frictional engagement members 1820, 1822. The recesses may include slots or dimples, for example. The recesses may include larger / wider grooves or channels.
[0376] Alternatively or additionally, the frictional engagement members 1820, 1822 may be provided with one or more protruding portions P or one or more recesses. In particular, the upper arm portion 1874 may be so provided.
[0377] It is also envisioned that both the frictional engagement members 1820, 1822 and the inner wall W may be provided with one or more protruding portions P and / or one or more recesses.
[0378] The protruding portion may be provided by the entire inner wall W being convex or concave. When the inner wall W is convex, only the central apex portion of the inner wall W contacts the frictional engagement members 1820, 1822. When the inner wall W is concave, only the peripheral portion of the inner wall W contacts the frictional engagement members 1820, 1822.
[0379] As described above, the frictional engagement members 1820, 1822 are inserted into the housing 1810 through the base of the housing 1810 during assembly. With reference to FIG. 39, the insertion direction is indicated by arrow A. To aid in this portion of the assembly process, the tops of the two housing cavities C1, C2 into which the frictional engagement members 1820, 1822 are inserted may include a sloped transition portion TP. In this example, each transition portion TP is arc-shaped. Each transition portion TP may be linear and / or planar. As the upper arm portion 1874 of the frictional engagement members 1820, 1822 moves upward into the respective housing cavity C1, C2, the sloped transition portion TP helps guide the upper arm portion 1874 into the narrow upper portion of the housing 1810 such that the apertures 1876 of the frictional engagement members 1820, 1822 are fully inserted into the cavities C1, C2 and aligned with the inlet and outlet apertures 8321, 8331 of the housing 1810. The angled transition portion TP acts to direct the upper arm portion 1874 away from the walls of the cavities C1, C2 and toward the center of the cavities C1, C2 when the frictional engagement members 1820, 1822 are inserted into the housing 1810.
[0380] Figure 40 shows a view of a housing 1810 in accordance with the features of Figures 28-39. Figure 40e also shows an opening O in the top surface of the housing 1810 connecting two cavities that house the friction engagement members 1820, 1822. This allows for easy access for tooling during manufacturing.
[0381] It will be appreciated that the orientation adjustment unit 1810 of Figures 28-41 may include any one or any combination of the features described above. For example, the orientation adjustment unit 1810 may be configured such that the frictional engagement members 1820, 1822 have a pre-actuation angle but do not have a surface tension reducing feature.
[0382] It will be appreciated that in general, the above embodiments have been described with reference to multiple frictional engagement members 1820, 1822. It is also envisioned that some or all of the above-mentioned advantages may still be provided to an orientation adjustment unit including only one frictional engagement member 1820, 1822. Similarly, any number of frictional engagement members 1820, 1822 greater than or equal to two may also be provided.
[0383] When multiple frictional engagement members 1820, 1822 are provided, the movement of each frictional engagement member 1820, 1822 may be independent of the movement of the other frictional engagement members 1820, 1822. For example, in the orientation of the figures herein, the left frictional engagement member 1820 may move independently from the right frictional engagement member 1822. The independence of movement may be independent pivotal movement and / or independent translational movement relative to the housing 1810. The pivot axis of one frictional engagement member 1820, 1822 may move independently from the pivot axis of the other.
[0384] Further, any number of filament guides may be provided. It may be sufficient to provide filament guides only at the inlet and outlet of the housing 1810. It may also be sufficient to provide filament guides between each pair of frictional engagement members 1820, 1822 or between or adjacent only one or a portion of the frictional engagement members 1820, 1822.
[0385] In instances where the yoke itself can provide a housing 1810 for at least one frictional engagement member 1820, 1822, any or all of the features of the housing 1810 can be provided on the yoke, such as the slots 84, the filament guides and any or all of the base, sides and top of the housing, as well as any intermediate walls.
[0386] Unless expressly required otherwise throughout this specification, the words "include", "including", and the like are to be interpreted in an inclusive sense, i.e., "including but not limited to," as opposed to an exclusive or exhaustive sense.
[0387] Although the present invention has been described by way of example and with respect to possible embodiments thereof, it should be understood that modifications or improvements to such embodiments may be made without departing from the scope of the present invention. The present invention may also be broadly described as including any combination of two or more of the parts, elements or features mentioned or indicated in this specification of the present application, either individually or collectively. Furthermore, when reference is made to certain components or wholes of the present invention that have known equivalents, such equivalents are incorporated herein as if individually set forth.
[0388] 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 repositioned as needed. Thus, such variations and modifications are intended to be included within the scope of the present invention. Moreover, not all of the features, aspects and advantages are necessarily required to implement the present invention. Thus, the scope of the present invention is intended to be defined solely by the following claims.
[0389] 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. A direction adjustment unit for headgear for a respiratory mask, comprising: a movable frictional engagement member including an aperture forming a cavity extending through the at least one frictional engagement member, the aperture being arranged to receive a filament of a strap of the headgear therethrough, the frictional engagement member providing a disengaged configuration for the filament in a first configuration and providing an engaged configuration for the filament in a second configuration; Including, a filament guide configured to guide the filament as it passes through the direction adjustment unit, the filament guide configured to engage the filament to constrain the filament against bending of the filament within the direction adjustment unit.
2. The direction adjusting unit of claim 1 , wherein the filament guide is provided at a filament inlet of the direction adjusting unit.
3. The direction adjusting unit of claim 1 , wherein the filament guide is provided at a filament outlet of the direction adjusting unit.
4. The orientation adjustment unit of claim 1 including a filament guide adjacent the aperture of the frictional engagement member.
5. The direction adjustment unit according to any one of claims 1 to 4, comprising a plurality of filament guides.
6. The orientation adjustment unit of claim 5 , wherein the frictional engagement member is disposed between the pair of filament guides.
7. The direction adjustment unit according to any one of claims 1 to 6, comprising at least two frictional engagement members.
8. The orientation adjustment unit according to claim 7 , wherein the or at least one filament guide is provided at a position intermediate the two frictional engagement members.
9. 9. A direction adjustment unit as claimed in any one of claims 1 to 8, wherein the aperture of the or each frictional engagement member comprises a cavity forming an engagement surface that is linear or substantially linear in transverse cross-section, the engagement surface being for engaging a flat or substantially flat portion of the filament when the at least one frictional engagement member is in the engaged configuration.
10. 10. A direction adjustment unit as claimed in any preceding claim, wherein the or each frictional engagement member is movable about a respective pivot axis, the first configuration comprising a first pivot configuration, and the second configuration comprising a second pivot configuration.
11. The orientation adjustment unit of claim 10 , wherein each pivot axis is moveable relative to the orientation adjustment unit.
12. The direction adjustment unit of claim 11 , wherein each pivot axis is movable independently of the other pivot axes.
13. 13. An orientation adjustment unit according to claim 11 or 12, including a base, each pivot axis being movable towards and away from the base of the orientation adjustment unit.
14. An orientation adjustment unit according to any preceding claim, wherein the filament guide comprises at least one guide surface which, in use, is engaged by the filament.
15. The orientation adjustment unit of claim 14 , wherein the guide surface is positioned to engage at least a top surface of the filament.
16. 16. The orientation adjustment unit of claim 14 or 15, wherein the guide surface is arranged to engage at least a lower surface of the filament.
17. 15. The orientation adjustment unit of claim 14, wherein the guide surface of the filament guide is straight or substantially straight in transverse cross-section for slidably engaging a flat or substantially flat portion of the filament, in use.
18. 18. The orientation adjustment unit of claim 14, comprising a plurality of filament guides, each filament guide including a guide surface configured to guide and engage the filament, the guide surfaces being aligned along a longitudinal axis of the orientation adjustment unit when the unit is viewed from the side.
19. 19. The orientation adjustment unit of claim 14, comprising a plurality of filament guides, each filament guide including a guide surface configured to guide and engage the filament, the guide surfaces being aligned along a longitudinal axis of the orientation adjustment unit when the unit is viewed from above.
20. The direction adjustment unit according to any one of claims 1 to 19, wherein the filament guide comprises an opening through which the filament passes.
21. An orientation adjustment unit as claimed in any preceding claim, including at least one housing, the or each frictional engagement member being received in and moveable relative to the housing.
22. 22. The orientation adjustment unit of claim 21, including at least two frictional engagement members, said frictional engagement members received in and movable relative to said housing.
23. 23. The orientation adjustment unit of claim 22, including at least two frictional engagement members and a plurality of housings, each frictional engagement member contained within and movable relative to a respective housing.
24. 24. A direction adjustment unit as claimed in any one of claims 21 to 23, wherein the or each housing includes a base and a top and an opposing end between the base and top, and the aperture of each frictional engagement member is movable generally towards and away from the opposing end between the disengaged and engaged configurations.
25. 25. An orientation adjustment unit according to any one of claims 21 to 24, wherein the or at least one filament guide comprises or is provided in an intermediate wall of the housing between and spaced from the opposing ends of the housing.
26. An orientation adjustment unit according to any one of claims 21 to 25, wherein the or at least one filament guide comprises or is provided at at least one of the opposing ends of the housing.
27. 25. The orientation adjustment unit of claim 24, wherein the opposing ends of the housing include end walls of the housing.
28. 28. A direction adjustment unit as claimed in any one of claims 1 to 27, comprising a mounting slot, the mounting slot including a retaining space for movably retaining a follower for movably retaining the friction engagement member on or in the direction adjustment unit.
29. 29. An orientation adjustment unit according to claim 28, wherein the or each frictional engagement member has a base member, and the aperture is spaced from the base member.
30. 30. The orientation adjustment unit of claim 29, wherein the base member includes the follower.
31. The direction adjustment unit according to any one of claims 28 to 30, comprising at least two mounting slots, each mounting slot having a retaining space for movably retaining a respective portion of the base member of the friction engagement member.
32. An orientation adjustment unit as claimed in any one of claims 28 to 31, wherein each mounting slot is sized to permit translational movement of the follower within the mounting slot along a predetermined path whilst retained.
33. An orientation adjustment unit according to any one of claims 28 to 32, wherein the mounting slot is elongated when the orientation adjustment unit is viewed from the side.
34. 34. The orientation adjustment unit of claim 33, wherein the mounting slots extend in a substantially vertical direction when the orientation adjustment unit is viewed from the side.
35. The orientation adjustment unit of any one of claims 28 to 34, wherein the mounting slot includes at least one narrowed section to resist movement of the base member beyond the narrowed section.
36. An orientation adjustment unit as claimed in any one of claims 28 to 35, wherein each mounting slot is sized to allow the follower to pivot within the slot about its pivot axis.
37. The or each friction engagement member is a. a pivoting movement relative to the orientation adjustment unit about a pivot axis; and b. A translational movement relative to the orientation adjustment unit in a direction perpendicular to the pivot axis along a predetermined elongated path extending away from the pivot axis when the unit is viewed along the pivot axis. An orientation adjustment unit according to any one of claims 1 to 36, mounted within the orientation adjustment unit for both.
38. 38. The directional adjustment unit of claim 37, wherein the predetermined elongated path is defined by an elongated mounting slot on one of the frictional engagement member and housing of the directional adjustment unit and a follower on the other of the frictional engagement member and housing of the directional adjustment unit, the follower being received within the mounting slot.
39. The orientation adjustment unit according to claim 14 , wherein the guide surface is straight or substantially straight when viewed in a direction substantially parallel to the pivot axis of the frictional engagement member.
40. The aperture is a. Non-circular; b. Non-elliptical; c. square, d. rectangle, e. at least one linear portion; f. at least one arcuate portion; g. at least one portion substantially parallel to the pivot axis of the frictional engagement member; h. triangle The direction adjustment unit according to any one of claims 1 to 39, which is or comprises:
41. The orientation adjustment unit of claim 10 , wherein the aperture is offset from the pivot axis when the orientation adjustment unit is viewed from the side.
42. The orientation adjustment unit of claim 9 , wherein the cavity extends through the at least one frictional engagement member in a direction substantially perpendicular to the pivot axis.
43. The orientation adjustment unit of claim 9 , wherein the engagement surface forms a portion of at least one internal cavity wall surface of the at least one frictional engagement member.
44. 44. An orientation adjustment unit according to claim 42 or 43, wherein the cavity has the shape of a rectangular elongated body or a prism or cube.
45. 44. An orientation adjustment unit according to claim 42 or 43, wherein the cavity has the shape of a triangular elongated body or a prism or cube.
46. 46. An orientation adjustment unit according to any one of claims 42 to 45, wherein at least a portion of an internal cavity side wall surface has a flat or substantially flat profile when the orientation adjustment unit is viewed from the side.
47. The direction adjustment unit according to claim 9 , wherein the cavity is substantially straight when the frictional engagement member is viewed from the side.
48. The direction adjustment unit according to claim 9 , wherein the cavity is substantially arcuate when the frictional engagement member is viewed from the side.
49. 11. The orientation adjustment unit of claim 10, wherein the at least one frictional engagement member comprises a base member through which the pivot axis extends and at least one arm member extending from the base member, the aperture being provided in the arm member.
50. 50. The orientation adjustment unit of claim 49, wherein the arm member extends away from the base member and the pivot axis.
51. 51. A direction adjustment unit according to claim 49 or 50, wherein the arm member comprises a plurality of arm member portions, at least one arm member portion being angled relative to another arm member portion.
52. A direction adjustment unit according to any one of claims 49 to 51, wherein the arm member is tapered along at least a portion of its length.
53. A direction adjustment unit as claimed in any one of claims 49 to 52, wherein the arm member is of rectangular cross-section along at least part of its length.
54. A direction adjustment unit according to any one of claims 1 to 53, wherein, in use, at least in the engaged configuration, the frictional engagement member frictionally engages the filament.
55. 55. A direction adjustment unit as described in any one of claims 1 to 54, wherein when the or each frictional engagement member is in the disengaged configuration with respect to the filament, the filament can move through the direction adjustment unit with a first resistance to its movement between the filament and the frictional engagement member, and when each frictional engagement member is in the engaged configuration with the filament, the filament can move through the direction adjustment unit with a second resistance to its movement between the filament and the frictional engagement member, the second resistance being greater than the first resistance.
56. 56. The direction adjustment unit of any one of claims 1 to 55, wherein the filament guide includes an opening through which the filament passes, the opening being smaller than at least one portion of the filament such that the at least one portion of the filament cannot pass through the opening.
57. An orientation adjustment unit according to any one of the preceding claims, wherein at least a portion of an edge of at least one of the apertures of at least one frictional engagement member is chamfered.
58. The direction adjusting unit of any one of claims 1 to 57, wherein the aperture comprises three or more sides when viewed along a longitudinal axis of the filament.
59. 1. A direction adjustment unit for headgear for a respiratory mask, comprising: a movable frictional engagement member having an aperture forming a cavity extending therethrough, the aperture being arranged to receive a filament of a strap of the headgear therethrough such that the filament follows a filament path through the direction adjustment unit, the frictional engagement member providing a disengaged configuration for the filament in a first configuration and providing an engaged configuration for the filament in a second configuration; Including, a filament guide configured to guide the filament as it passes through the orientation unit, the filament guide configured to engage the filament to constrain the filament against bending of the filament within the orientation unit at a location where the filament guide engages the filament; The frictional engagement members are attached to the orientation adjustment unit such that when at least one frictional engagement member moves from the disengaged configuration to the engaged configuration, the frictional engagement member can move relative to the orientation adjustment unit along a predetermined elongated path extending perpendicular to the filament path.
60. 1. 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, the aperture being arranged to receive a filament of a strap of the headgear therethrough such that the filament follows a filament path through the direction adjustment unit, the frictional engagement member providing a disengaged configuration for the filament in a first configuration and providing an engaged configuration for the filament in a second configuration; and a filament guide configured to guide the filament as it passes through the orientation unit, the filament guide configured to engage the filament to constrain the filament against bending of the filament within the orientation unit at a location where the filament guide engages the filament; An orientation adjustment unit, wherein the frictional engagement member is movable relative to the orientation adjustment unit with at least two degrees of freedom when the at least one frictional engagement member moves from the disengaged configuration to the engaged configuration.
61. 61. The orientation adjustment unit of claim 60, wherein one of the two degrees of freedom includes a pivotal movement of the frictional engagement member such that the frictional engagement member pivots along the filament path.
62. 62. The orientation adjustment unit of claim 60 or 61, wherein one of the two degrees of freedom includes translational movement of the frictional engagement member along a predetermined elongated path extending perpendicular to the filament path.
63. 1. A direction adjustment unit for headgear for a respiratory mask, comprising: a movable frictional engagement member including an aperture forming a cavity extending through the at least one frictional engagement member, the aperture being positioned to receive a filament of a strap of the headgear therethrough, the frictional engagement member being movable between a first configuration and a second configuration relative to the filament; Including, the first configuration provides a pre-actuated configuration in which the frictional engagement member engages the filament with a first frictional force between the frictional engagement member and the filament; the second configuration provides an engagement configuration in which the frictional engagement member engages with the filament with a second frictional force between the frictional engagement member and the filament; The second friction force is greater than the first friction force.
64. 1. A direction adjustment unit for headgear for a respiratory mask, comprising: a movable frictional engagement member including an aperture forming a cavity extending through the at least one frictional engagement member, the aperture being positioned to receive a filament of a strap of the headgear therethrough, the frictional engagement member being movable between a first configuration and a second configuration relative to the filament; Including, A direction adjustment unit, the frictional engagement member frictionally engages the filament to resist movement of the filament through the aperture when in both configurations, the resistance to movement being different for each configuration.
65. 65. The orientation adjustment unit of claim 63 or 64, wherein when in the first configuration, a central axis through the aperture is inclined at a first oblique angle relative to the housing.
66. 66. The orientation adjustment unit of claim 65, wherein when in the second configuration, the central axis of the aperture is tilted at a second tilt angle relative to the housing, the second tilt angle being greater than the first tilt angle.
67. 67. A direction adjustment unit according to any one of claims 63 to 66, including a housing, the frictional engagement member being movably mounted within the housing.
68. 68. The orientation adjustment unit of claim 67, wherein the housing includes a vertical housing axis substantially perpendicular to the filament, and the central axis through the aperture is inclined at an oblique angle relative to the vertical housing axis.
69. 68. The direction adjustment unit of claim 67, wherein the housing includes an entrance opening through which the filament extends into the housing, the entrance opening including a central entrance opening axis that is non-parallel to the aperture central axis.
70. 70. The orientation adjustment unit of claim 69, wherein the central inlet opening axis is inclined at an oblique angle relative to the aperture central axis when the frictional engagement member is in the first configuration.
71. 70. The orientation adjustment unit of claim 69, wherein the aperture central axis is tilted relative to the central inlet opening axis when the frictional engagement member is in the first configuration.
72. 68. The orientation adjustment of claim 67, wherein the frictional engagement member is elongated and includes a longitudinal axis, the longitudinal axis being non-parallel to a vertical axis of the housing when in both the first and second configurations.
73. The direction adjusting unit according to any one of claims 65 to 72, wherein the first tilt angle is between 0 and 10°, or between 0.5 and 8°, or between 1 and 6°, or is about 3°.
74. 73. A direction adjustment unit according to any one of claims 65 to 72, wherein the second tilt angle is less than 25°.
75. 73. The orientation adjustment unit of claim 72, wherein the tilt angle increases between the first configuration and the second configuration.
76. A direction adjustment unit, wherein the maximum tilt angle when in the second configuration increases by 1-30°, or 2-25°, or is about 6°.
77. 68. The orientation adjustment unit of claim 67, wherein the housing includes a filament path through the entrance opening and the aperture in the frictional engagement member, the filament path being non-linear or including at least a non-linear portion when the frictional engagement member is in the first configuration.
78. 68. The direction adjustment unit of claim 67, wherein the entrance opening has a vertical dimension and the filament has a vertical dimension, the vertical dimension of the entrance opening being 10-50%, or 15-40% greater than the vertical dimension of the filament, or about 25% greater.
79. 1. A direction adjustment unit for headgear for a respiratory mask, comprising: housing, a movable frictional engagement member including an aperture forming a cavity extending through said at least one frictional engagement member, said aperture being positioned to receive a filament of a strap of said headgear therethrough, said frictional engagement member being movably mounted within said housing; Includes the frictional engagement member provides an engagement configuration for the filament in a second configuration; the housing includes a housing wall against which the frictional engagement member abuts when the housing is in the first configuration, the housing wall restricting movement of the frictional engagement member; An orientation adjustment unit, wherein at least one of the frictional engagement member and the housing wall is configured to provide a discrete contact area between the frictional engagement member and the housing wall, the discrete contact area being smaller than an area of the housing wall.
80. 80. The orientation adjustment unit of claim 79, wherein the discrete contact areas are defined by surface features on the housing wall and / or the frictional engagement members.
81. 81. The orientation adjustment unit of claim 80, wherein the surface features include protruding portions configured to provide the discrete contact areas between the frictional engagement members and the housing wall.
82. 82. The direction adjustment unit of claim 81, wherein the protruding portion includes an edge of the housing wall.
83. 83. The orientation adjustment unit of claim 82, wherein the housing wall is inclined so that the edge protrudes into the housing.
84. 84. A direction adjustment unit according to claim 82 or 83, wherein the edge is a lower edge of the housing wall that protrudes into the housing.
85. 84. A direction adjustment unit according to claim 82 or 83, wherein the edge is an upper edge of the housing wall that protrudes into the housing.
86. The protruding portion is a. Elongated ribs; b. A linear feature; c. An arcuate shape; d. triangular features; e. Dome-shaped portion 82. The direction adjustment unit of claim 81, comprising one or more of:
87. 81. The orientation adjustment unit of claim 80, wherein the surface feature includes a recess configured to provide a discrete non-contact area, and the discrete contact area between the friction engagement member and the housing wall is defined by one or more areas adjacent the recess.
88. An orientation adjustment unit according to any one of claims 79 to 87, comprising a plurality of discrete contact areas.
89. An orientation adjustment unit according to any one of claims 79 to 88, wherein the housing includes the discrete contact areas.
90. The direction adjustment unit according to any one of claims 79 to 89, wherein the frictional engagement member comprises the discrete contact areas.
91. The orientation adjustment unit of any one of claims 79 to 90, wherein the frictional engagement member, when in a first configuration, provides a disengaged configuration for the filament.
92. the frictional engagement member, when in a first configuration, provides a pre-activated configuration in which the frictional engagement member engages the filament with a first frictional force between the frictional engagement member and the filament; the second configuration provides an engagement configuration in which the frictional engagement member engages with the filament with a second frictional force between the frictional engagement member and the filament; The direction adjustment unit according to any one of claims 79 to 90, wherein the second friction force is greater than the first friction force.
93. 91. The direction adjustment unit of any one of claims 79 to 90, wherein the frictional engagement member frictionally engages the filament to resist movement of the filament through the aperture when in both configurations, the resistance to movement being different for each configuration.
94. 1. Headgear for a respiratory mask, comprising: a. a direction adjustment unit according to any one of claims 1 to 93, and b. at least one filament Including headgear.
95. a. the aperture of the frictional engagement member includes a cavity that defines an engagement surface that is linear or substantially linear in transverse cross-section; and 95. The headgear of claim 94, wherein the filament comprises a filament body having at least one flat or substantially flat outer surface extending along its longitudinal axis that is contacted with the engagement surface of the direction adjustment unit when in the engaged configuration.
96. The filament is i. a body portion having a first shape and / or size; ii. an end portion having a second shape and / or size; and iii. a transition portion provided longitudinally between the body portion and the end portion, the transition portion having a shape and / or size that transitions from the shape and / or size of the core portion to the shape and / or size of the end portion; 96. The headgear of claim 95, further comprising:
97. 98. Headgear according to any one of claims 94 to 97, further comprising a yoke assembly configured to connect the headgear to the respiratory mask.
98. 98. Headgear according to claim 97, wherein the direction adjustment unit is disposed at least partially within the yoke assembly.
99. 99. Headgear as described in claim 97 or 98, wherein the yoke assembly includes a central portion and at least one laterally extending portion extending from the central portion, the at least one laterally extending portion configured to connect to the direction adjustment unit.
100. 100. Headgear according to any one of claims 94 to 99, further comprising a frame configured to connect the headgear to the respiratory mask.
101. 101. The headgear of claim 100, wherein the direction adjustment unit is disposed at least partially within the frame.
102. 1. Headgear for a respiratory mask, comprising: filaments of the straps of the headgear; and a direction adjustment unit including at least one movable frictional engagement member having an aperture forming a cavity extending therethrough, the aperture being positioned to receive the filament therethrough, the frictional engagement member providing a disengaged configuration for the filament in a first configuration and providing an engaged configuration for the filament in a second configuration, the frictional engagement member being movable between an engaged configuration and a disengaged configuration; Including, The headgear, wherein the direction adjustment unit further includes a filament guide configured to guide the filament as it passes through the direction adjustment unit, the filament guide configured to engage the filament to constrain the filament against bending of the filament within the direction adjustment unit at a position where it engages the filament.
103. 1. Headgear for a respiratory mask, comprising: filaments of the straps of the headgear; and Direction Adjustment Unit The direction adjustment unit includes: a movable frictional engagement member having an aperture forming a cavity extending through said at least one frictional engagement member, said aperture being arranged to receive a filament of a strap of said headgear therethrough, said frictional engagement member providing a disengaged configuration for said filament in a first configuration and providing an engaged configuration for said filament in a second configuration; Including, the orientation adjustment unit further includes a filament guide configured to guide the filament as it passes through the orientation adjustment unit, the filament guide configured to engage the filament to constrain the filament against bending of the filament within the orientation adjustment unit at a location where it engages the filament; At least one frictional engagement member is attached to the direction adjustment unit such that when the at least one frictional engagement member moves from the disengaged configuration to the engaged configuration, the frictional engagement member can move relative to the direction adjustment unit along a predetermined elongated path extending perpendicular to the filament path.
104. 1. Headgear for a respiratory mask, comprising: filaments of the straps of the headgear; and Direction Adjustment Unit The direction adjustment unit includes: at least one movable frictional engagement member having an aperture forming a cavity extending therethrough, the aperture being arranged to receive a filament of a strap of the headgear therethrough, the frictional engagement member providing a disengaged configuration for the filament in a first configuration and providing an engaged configuration for the filament in a second configuration; Including, the orientation adjustment unit further includes a filament guide configured to guide the filament as it passes through the orientation adjustment unit, the filament guide configured to engage the filament to constrain the filament against bending of the filament within the orientation adjustment unit at a location where it engages the filament; The frictional engagement member is movable with respect to at least two degrees of freedom when the at least one frictional engagement member moves from the disengaged configuration to the engaged configuration.
105. 1. Headgear for a respiratory mask, comprising: filaments of the straps of the headgear; and Direction Adjustment Unit The direction adjustment unit includes: a movable frictional engagement member including an aperture forming a cavity extending through the at least one frictional engagement member, the aperture being positioned to receive a filament of a strap of the headgear therethrough, the frictional engagement member being movable between a first configuration and a second configuration relative to the filament; Including, the first configuration provides a pre-actuated configuration in which the frictional engagement member engages the filament with a first frictional force between the frictional engagement member and the filament; the second configuration provides an engagement configuration in which the frictional engagement member engages with the filament with a second frictional force between the frictional engagement member and the filament; The second frictional force is greater than the first frictional force.
106. 1. Headgear for a respiratory mask, comprising: filaments of the straps of the headgear; and Direction Adjustment Unit The direction adjustment unit includes: a movable frictional engagement member including an aperture forming a cavity extending through the at least one frictional engagement member, the aperture being positioned to receive a filament of a strap of the headgear therethrough, the frictional engagement member being movable between a first configuration and a second configuration relative to the filament; Including, The frictional engagement member frictionally engages the filament to resist movement of the filament through the aperture when in both configurations, the resistance to movement being different for each configuration.
107. 1. Headgear for a respiratory mask, comprising: filaments of the straps of the headgear; and Direction Adjustment Unit The direction adjustment unit includes: housing, a movable frictional engagement member including an aperture forming a cavity extending through said at least one frictional engagement member, said aperture being positioned to receive a filament of a strap of said headgear therethrough, said frictional engagement member being movably mounted within said housing; Including, the frictional engagement member provides an engagement configuration for the filament in a second configuration; the housing includes a housing wall against which the frictional engagement member abuts when the housing is in the first configuration, the housing wall restricting movement of the frictional engagement member; At least one of the frictional engagement member and the housing wall is configured to provide a discrete contact area between the frictional engagement member and the housing wall, the discrete contact area being smaller than an area of the housing wall.
108. A respiratory mask comprising a direction adjustment unit according to any one of claims 1 to 93 and a headgear according to any one of claims 94 to 107.
109. 109. A respiratory therapy system including the respiratory mask of claim 108.
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