Respiratory Mask Assembly

Abstract

To provide a headgear assembly for a full-face under-nose respiratory mask.SOLUTION: A headgear assembly comprises a strap assembly including a rear panel, a crown strap 2808, a pair of opposing upper side straps 2804, and a pair of opposing lower side straps 2802. The assembly further comprises a flexible headgear connector element, where a free end of each of the upper straps is coupled to the headgear connector element, and where the headgear connector element is configured to extend laterally across, and be removably fastened to a frame 2178 of the respiratory mask below a tip of a user's nose.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present disclosure relates to an interface assembly for respiratory therapy, and in particular to an under-the-nose interface assembly that does not cover the bridge of a user's nose. [Background technology]

[0002] In patients with obstructive sleep apnea (OSA), the muscles that normally keep the upper airway open relax to the point where the airway becomes constricted or completely blocked during sleep, a phenomenon that often manifests as snoring. If this occurs over a period of time, the patient's brain typically recognizes the signs of hypoxia and partially awakens the patient to open the airway so that normal breathing can resume. Patients may not be aware of these awakening episodes, which may occur hundreds of times per sleep session. These partial awakenings can significantly reduce the patient's sleep quality and, over time, can lead to a variety of symptoms, including excessive daytime sleepiness, chronic fatigue, elevated heart rate, elevated blood pressure, weight gain, headaches, irritability, depression, and anxiety.

[0003] Obstructive sleep apnea is commonly treated by applying positive airway pressure (PAP) therapy. PAP therapy involves delivering a flow of gas to a patient at a therapeutic pressure above atmospheric pressure, which reduces the frequency and / or duration of apneas, hypopneas, and / or flow limitation. This therapy is often implemented using a positive airway pressure device to deliver a pressurized flow of air to the patient through a conduit and a patient interface or mask positioned on the patient's face. Summary of the Invention [Problem to be solved by the invention]

[0004] One common type of patient interface assembly used in PAP therapy or other respiratory therapies involving the administration of gases includes a seal that contacts the bridge of the user's nose. The bridge of the nose is sensitive to pressure exerted by the seal of the interface assembly. More recently, interface assemblies that do not contact the bridge of the nose have become available. These interface assemblies are sometimes referred to as "under-the-nose" interface assemblies. There is a need to provide an improved under-the-nose interface assembly with improved comfort and / or sealing performance, or to provide the public with a useful option. [Means for solving the problem]

[0005] The systems, methods, and apparatus described herein have innovative aspects, none of which is individually essential or solely responsible for their desirable attributes. Without limiting the scope of the claims, some of the more advantageous features will now be summarized.

[0006] A preferred embodiment includes a headgear assembly for a full-face under-the-nose respirator. The headgear assembly includes a strap assembly including a back panel, a crown strap, a pair of opposing upper side straps, and a pair of opposing lower side straps. The headgear assembly includes a flexible headgear connector element. A free end of each of the upper straps is coupled to the headgear connector element. The headgear connector element extends laterally across a frame of the respirator below the tip of the user's nose and is configured to be removably fastened to the frame.

[0007] In some configurations, the pair of upper side straps, the headgear connector element and the crown strap form a closed loop when the headgear connector element is detached from the frame.

[0008] In some configurations, the upper strap is adjustably coupled to the headgear connector element, allowing a user to adjust the length of the upper strap once it is coupled to the headgear connector element.

[0009] In some configurations, the headgear connector element is configured to be coupled to and detached from the frame without detaching the upper strap from the headgear connector element.

[0010] In some configurations, the headgear connector elements include one or more apertures each configured to receive and removably retain a post on the frame.

[0011] In some configurations, the headgear connector element further includes a thickened portion at least partially surrounding each of the apertures.

[0012] In some configurations, the headgear connector elements include a flexible material that allows the headgear connector elements to conform to the curvature of the frame when removably fastened to the frame.

[0013] In some configurations, the headgear connector elements include an elastomeric material.

[0014] In some configurations, the headgear connector elements comprise a thermoplastic elastomer material.

[0015] In some configurations, the headgear connector elements have a substantially upwardly facing concave shape.

[0016] In some configurations, the headgear connector element includes a pair of strap loops each configured to retain one of the upper straps.

[0017] A preferred embodiment includes a respiratory mask assembly. The respiratory mask assembly includes a frame, a cushion module carried by the frame, and a headgear assembly. The cushion module includes a seal and a housing. The seal includes a nose portion and a mouth portion having pairs of upward extensions extending upward from opposite sides of a central sealing surface. The upward extensions may be referred to as paddles. The headgear assembly includes a back panel, a crown strap, a pair of opposing upper side straps, and a pair of opposing lower side straps. The headgear assembly includes a flexible headgear connector element. The free ends of each of the upper straps are coupled to the headgear connector element. The headgear connector element extends laterally across the frame below the upward extensions of the seal and is configured to be removably fastened to the frame.

[0018] In some configurations, the frame is removably connectable to the cushion module.

[0019] In some configurations, the pair of upper side straps, the headgear connector element and the crown strap form a closed loop when the headgear connector element is detached from the frame.

[0020] In some configurations, the upper strap is adjustably coupled to the headgear connector element, allowing a user to adjust the length of the upper strap once it is coupled to the headgear connector element.

[0021] In some configurations, the respiratory mask assembly further includes an inlet tube connected to the frame.

[0022] In some configurations, the headgear connector element is configured to be removably connected to the frame above the inlet tube.

[0023] In some configurations, the headgear connector elements include one or more apertures each configured to receive and removably retain a post on the frame.

[0024] In some configurations, the post includes an enlarged head having a cross-sectional area greater than the cross-sectional area of ​​the aperture in the headgear connector element.

[0025] In some configurations, the headgear connector elements comprise a flexible material that allows the headgear connector elements to conform to the curvature of the frame when removably connected to the frame.

[0026] A preferred embodiment includes a headgear connector element for connecting a headgear assembly to a respiratory mask assembly. The headgear connector element includes an elongated flexible body having a first end and a second end. The headgear connector element includes a pair of strap loops. A first strap loop of the pair of strap loops is attached to the first end of the body, and a second strap loop of the pair of strap loops is attached to the second end of the body. Each of the strap loops is configured to adjustably receive a strap of the headgear assembly. The headgear connector element includes at least one aperture extending through the body of the headgear connector element. The aperture is configured to receive and removably retain a post of a frame of the mask assembly. The body further includes a thickened portion at least partially surrounding the at least one aperture.

[0027] In some configurations, the thickened portion is integrally formed with the body.

[0028] In some configurations, the thickened portion is constructed from the same material as the main body.

[0029] In some configurations, the thickened portion is overmolded onto the body.

[0030] In some configurations, the strap loop and the body are constructed of different materials.

[0031] In some configurations, the body is constructed from a thermoplastic elastomeric material, such as, for example, silicone.

[0032] In some configurations, the strap loop is constructed from nylon.

[0033] In some configurations, each of the strap loops includes a tab, and the body is overmolded over the tab.

[0034] In some configurations, the strap loop and body are attached by a welded joint.

[0035] In some configurations, the headgear connector element further includes a concave portion along a central portion of a lower edge of the headgear connector element.

[0036] In some configurations, the headgear connector element is substantially flat when the headgear connector element is not coupled to the mask assembly.

[0037] A preferred embodiment includes a seal for a respiratory mask. The seal includes a mouth sealing portion configured to seal around a user's mouth. The seal includes a nose sealing portion configured to seal against the underside of the user's nose and to be positioned completely below the bridge of the user's nose. The nose sealing portion includes first and second upward extensions extending upward from opposite sides of a central sealing surface. Each of the first and second upward extensions has an inner wall configured to engage the side of the user's nose and an outer wall configured to provide structure to the nose sealing portion, the inner and outer walls being joined along an upper edge of the seal. The outer wall includes a pocket having a wall thickness less than the surrounding wall thickness.

[0038] In some configurations, the outer wall further includes a thickened rib extending along an upper portion of the outer wall. The thickened rib is proximate to but spaced from an upper edge of the seal. The thickened rib has a wall thickness that is greater than the surrounding wall thickness. The thickened rib extends from a rear end of the outer wall toward a front of the seal.

[0039] In some configurations, the thickened rib narrows at opposite ends.

[0040] In some configurations, the thickened rib has a curved or serpentine shape along its length.

[0041] In some configurations, the pocket is at least partially defined by a thickened rib.

[0042] In some configurations, the pocket is substantially teardrop shaped.

[0043] In some configurations, the pocket is located on the interior surface of the outer wall.

[0044] In some configurations, the thickened ribs are located on the inner surface of the outer wall.

[0045] In some configurations, the thickened rib has a thickness that varies along its length.

[0046] According to one aspect of the present disclosure, there is provided a respiratory mask assembly comprising: a mask frame and a cushion module, the mask frame including a respiratory gas inlet configured to receive a supply of breathable gas and deliver the breathable gas to the cushion module, the cushion module configured to form a seal with a user's face; a bias vent on the mask frame and in communication with the cushion module, the bias vent configured to allow air to be exhausted from the cushion module through the bias vent; Including, a diffuser including a diffuser material configured to extend over the bias vent, the diffuser material providing a tortuous air path from the bias vent through the diffuser; a headgear connector element configured to be removably attached to a front of the mask frame to define opposed distal ends extending laterally across the mask frame and each end configured to be connected to a headgear, the headgear connector element including at least one aperture that aligns with the bias vent when the headgear connector element is attached to the mask frame; A respiratory mask assembly is provided which further includes:

[0047] The diffuser may be positioned between the mask frame and the headgear connector element. The diffuser may be positioned on the headgear connector element. The diffuser may be positioned on a front surface of the headgear connector element, i.e., a surface of the headgear connector element that does not face the mask frame. At least a portion of the diffuser may be spaced apart from the bias vent, such that a portion of the bias vent is not in direct contact with the bias vent. The diffuser may be provided on the headgear connector element and spaced apart from the mask frame by the headgear connector element. The diffuser may be provided on the mask frame.

[0048] The diffuser may include a diffuser frame configured to be attached to the mask frame, and the diffuser material may be held by the diffuser frame. The diffuser material can be held by the diffuser frame so that it is spaced from the bias vent, such that a portion of the bias vent is not in direct contact with the bias vent. The diffuser frame and / or the diffuser material can include at least one raised portion and at least one recessed portion, the raised portion configured to space the recessed portion from the bias vent. Multiple raised portions and / or multiple recessed portions can be provided.

[0049] The diffuser may be substantially the same shape and size as the bias vent.

[0050] The diffuser may be removably attached to the mask assembly.

[0051] The diffuser may be removably attached to the headgear connector element.

[0052] The diffuser may be removably attached to the mask frame via clips that engage on one of the diffuser and the mask frame with the other of the diffuser and the mask frame.

[0053] The diffuser may be permanently attached to the mask assembly.

[0054] The headgear connector element may include a plurality of apertures, which may be arranged in a U-shaped or V-shaped vent array symmetrically about a vertical centerline of the mask frame when the mask frame is viewed from the front, and the or each aperture in the headgear connector element may be located above the respiratory gas inlet when the headgear connector element is attached to the mask frame.

[0055] The bias vent may include multiple vents. The multiple vents may be arranged in a vent array. There may be multiple vent arrays. The vent arrays may be arranged symmetrically about a vertical centerline of the mask frame when viewed from the front.

[0056] The headgear connector element can include an elongated flexible member that connects an upper side strap of the headgear to the frame, and when connected to the mask frame, the headgear connector element can extend laterally across the mask frame below the tip of the user's nose.

[0057] The headgear connector element can include a central body portion and a pair of opposing, laterally extending arms extending from the central body portion, the arms terminating at opposite distal ends for connection to the headgear, with apertures provided in the central body portion. The central body portion can be arcuate to extend downward from the arms in a U- or V-shape. The headgear connector element can include laterally extending brace elements extending above the central body portion and between the laterally extending arms. The laterally extending arms can be angled upward, away from the central body portion.

[0058] The mask assembly may include a positioning feature configured to position the headgear connector element relative to the mask frame to resist movement of the headgear connector element relative to the mask frame. The positioning feature may be configured to position the headgear connector element relative to the mask frame to resist vertical movement of the headgear connector element relative to the mask frame in a direction generally aligned with a vertical centerline of the mask frame when viewed from the front. The positioning feature may include a recess or protrusion in the mask frame against which the headgear connector element abuts or otherwise engages.

[0059] According to another aspect of the present disclosure, there is provided a respiratory mask assembly comprising: a mask frame and a cushion module, the mask frame including a respiratory gas inlet configured to receive a supply of breathable gas and deliver the breathable gas to the cushion module, the cushion module configured to form a seal with a user's face; a bias vent on the mask frame and in communication with the cushion module, the bias vent configured to allow air to be exhausted from the cushion module through the bias vent; Including, a diffuser including a diffuser frame holding a diffuser material configured to extend over the bias vent, the diffuser material providing a tortuous air path from the bias vent through the diffuser, the diffuser frame being attached to a front surface of the mask frame; A respiratory mask assembly is provided, further comprising:

[0060] According to a further aspect of the present disclosure, there is provided a respiratory mask assembly comprising: a mask frame and a cushion module, wherein the mask frame includes a respiratory gas inlet configured to receive a supply of breathable gas and deliver the breathable gas to the cushion module, the cushion module configured to form a seal with a user's face, and the mask frame is connected to the cushion module via a cushion connector including a gas flow duct extending from the mask frame into the cushion module and arranged to deliver the breathable gas from the respiratory gas inlet to the cushion module; a bias vent in communication with the cushion module, the bias vent configured to allow air to be exhausted from the cushion module through the bias vent; Including, A respiratory mask assembly is provided in which a bias vent is provided in a gas flow duct.

[0061] The mask assembly may include a diffuser including a diffuser material configured to extend over the bias vent, the diffuser material providing a tortuous air path from the bias vent through the diffuser. The diffuser may be arcuate and configured to extend around a portion of the exterior of the gas flow duct. The diffuser may be configured to be concentrically attached to the gas flow duct. The diffuser may be arranged as a ring of diffuser material configured to receive the gas flow duct.

[0062] The bias vent may include a plurality of vent holes. The vent holes may be spaced around at least a portion of the periphery of the gas flow duct when viewed along the longitudinal axis of the gas flow duct. The vent holes may be spaced around an upper portion of the periphery of the gas flow duct. The vent holes may be provided only in the upper half of the gas flow duct when viewed along the longitudinal axis of the gas flow duct. In some examples, vent holes may not be provided around a lower portion of the periphery of the gas flow duct. The vent holes may be evenly spaced. The mask assembly may include at least 10 vent holes, preferably at least 15 vent holes, and more preferably at least 20 vent holes. The vent holes may be arranged in a row, the row extending around at least a portion of the periphery of the gas flow duct. The row of vent holes may be spaced along the longitudinal axis of the gas flow duct so as to be spaced from the inner surface of the cushion module. A plurality of rows of vent holes may be provided, each row spaced apart along the longitudinal axis of the gas flow duct.

[0063] The vents may each include an inlet and an outlet and a bore extending between the inlet and the outlet through the wall of the gas flow duct, with the vent axis defined between the center of the vent inlet and the center of the vent outlet, and the vent axis being inclined with respect to the longitudinal axis of the gas flow duct. The vent axis may be angled from the longitudinal axis of the gas flow duct by 10 to 85 degrees. The vent axis angle of all vents may be the same. The vent axis angle of at least one vent may be different from the vent axis angle of at least one other vent. Bias vents may be provided in a portion of the gas flow duct that is in the space between the mask frame and the cushion module.

[0064] A bias vent channel may be defined for each vent between the inner surface of the mask frame and the outer surface of the cushion module. The bias vent channel may extend radially outward from the longitudinal axis of the gas flow duct. The bias vent channel may be angled relative to the longitudinal axis of the gas flow duct when the mask assembly is viewed from the side.

[0065] According to a further aspect of the present disclosure, there is provided a respiratory mask assembly comprising: a mask frame and a cushion module, the mask frame including a respiratory gas inlet configured to receive a supply of breathable gas and deliver the breathable gas to the cushion module, the cushion module configured to form a seal with a user's face; Including, the cushion module includes a bias vent in communication with the cushion module, the bias vent configured to allow air to be exhausted from the cushion module through the bias vent; the mask frame is connected to the cushion module via a cushion connector including a gas flow duct extending from the mask frame into the cushion module and positioned to deliver breathable gas from the breathing gas inlet to the cushion module; The mask assembly is a diffuser including a diffuser frame and a diffuser material supported by the diffuser frame and configured to extend over a bias vent, the diffuser material providing a tortuous air path from the bias vent through the diffuser, the diffuser frame including a mounting portion configured to be attached to a cushion connector; A respiratory mask assembly is provided, further comprising:

[0066] The cushion module may include a mounting aperture configured to receive the gas flow duct of the cushion connector, and the mounting portion of the diffuser frame includes a mounting ring configured to be attached to the cushion module concentrically with the mounting aperture.

[0067] The cushion module may include an annular recess concentric with and extending around the periphery of the mounting aperture, the mounting ring of the diffuser frame being received within the annular recess.

[0068] The bias vent may be located below the mounting aperture when the cushion module is viewed along the axis of the inlet aperture.

[0069] The bias vent may include multiple vents. The multiple vents may be arranged in a vent array. Multiple vent arrays may be provided. The vent arrays may be arranged symmetrically about a vertical centerline of the cushion module when viewed from the front. Each vent array may be laterally spaced from the vertical centerline of the cushion module. Each vent array may be adjacent to a respective side of an inlet aperture of the cushion module. Each vent array may be adjacent to a respective side of a valve recess of the cushion module, the valve recess being an area below the inlet aperture that is recessed to receive a portion of a gas delivery inlet tube or connector assembly.

[0070] The diffuser frame can include a plurality of subframes, each holding a respective portion of the diffuser material, and each subframe being aligned with a respective vent array when the diffuser is attached to the cushion module. The subframes can extend laterally outward from the mounting portion. The subframes can extend laterally outward from a lower portion of the mounting portion. The diffuser can include a brace element extending between the subframes below the mounting portion. The mounting portion and the sub-frame may together define an omega shape. The sub-frame may be substantially triangular.

[0071] The diffuser may be permanently or removably attached to the cushion module. The diffuser may be retained on the cushion module by frictional engagement with the cushion module. The diffuser may be retained on the cushion module by a cushion connector, i.e., sandwiched between the mask frame and the cushion module.

[0072] The diffuser can include a rear surface that is shaped such that when the diffuser is attached to the cushion module, the rear surface is complementary to the front surface of the cushion module adjacent to the diffuser.

[0073] The diffuser frame and / or mounting portion may be at least partially hollow and / or at least partially solid.

[0074] The diffuser material may be permanently or removably attached to the diffuser frame.

[0075] The diffuser frame and / or diffuser material may be shaped to define at least one recess that forms an alternate gas flow path through the diffuser.

[0076] The diffuser mounting portion can include a diffuser frame that holds the diffuser material, the diffuser frame being attached to the cushion module.

[0077] The diffuser frame and / or the cushion module may include mounting features configured to attach the diffuser frame to the cushion module to retain the diffuser frame on the cushion module.

[0078] According to another aspect of the present disclosure, there is provided a respiratory mask assembly comprising: a mask frame and a cushion module, the mask frame including a respiratory gas inlet configured to receive a supply of breathable gas and deliver the breathable gas to the cushion module, the cushion module configured to form a seal with a user's face, the cushion module including an attachment aperture; Including, the mask frame is connected to the cushion module via a cushion connector including a gas flow duct extending from the mask frame through the mounting aperture and into the cushion module and positioned to deliver breathable gas from the breathing gas inlet to the cushion module; the cushion module includes a bias vent in communication with the cushion module, the bias vent configured to allow air to be exhausted from the cushion module through the bias vent; A respiratory mask assembly is provided in which the cushion module includes a recess adjacent the mounting aperture, the recess forming a cavity defined between the cushion module and the mask frame when the mask frame is connected to the cushion module, and the bias vent includes at least one vent hole located within the recess.

[0079] The recess may be an annular recess, extending around the periphery of the mounting aperture and being concentric with the mounting aperture.

[0080] The vent may include an inlet and an outlet and a bore extending between the inlet and the outlet through the wall of the recess, wherein a vent axis is defined between a center of the vent inlet and a center of the vent outlet, the vent axis extending substantially in the direction of the longitudinal axis of the mounting aperture of the cushion module.

[0081] The vent axis may be substantially parallel to the longitudinal axis of the mounting aperture of the cushion module.The vent axis may be tilted relative to the longitudinal axis of the mounting aperture of the cushion module.

[0082] The or each vent bore may include a sidewall that is inclined relative to the longitudinal axis of the mounting aperture of the cushion module when the vent is viewed in cross section. The radially outer and / or radially inner portions of the sidewall of the bore may be tapered.

[0083] The vent may include an inlet and an outlet and a bore extending between the inlet and the outlet through the wall of the recess, wherein a vent axis is defined between a center of the vent inlet and a center of the vent outlet, and wherein the vent axes extend substantially perpendicular to the longitudinal axis of the mounting aperture of the cushion module, whereby each vent axis extends radially outward from the mounting aperture, and wherein the gas flow duct of the cushion connector also includes at least one vent hole that is aligned with the vent hole of the recess, whereby air can be discharged from the cushion connector and into the recess through the aligned vent hole.

[0084] The mask assembly may include a diffuser, the diffuser including an annular body of diffuser material configured to be received within the annular recess so as to cover the or each vent of the bias vent.

[0085] The cavity may be defined by a recess between the mask frame and the cushion module and has a cavity volume, and the volume of the diffuser is smaller than the cavity volume.

[0086] The diffuser may be shaped and sized such that when received within the cavity, the diffuser is substantially incompressible and does not substantially deform.

[0087] The diffuser material and recesses may be configured such that the diffuser material is spaced from the vent.

[0088] An abutment feature may be provided that abuts when the diffuser is installed in the recess, the abutment feature limiting movement of the diffuser material towards the vent hole.

[0089] The bias vent may include a plurality of vent holes. The bias vent holes may extend around the entire periphery of the mounting aperture. The bias vent holes may be evenly spaced.

[0090] A bias vent channel may be defined for the or each vent between the inner surface of the mask frame and the outer surface of the cushion module. The bias vent channel may extend radially outward from the longitudinal axis of the mounting aperture. The bias vent channel may be angled relative to the longitudinal axis of the mounting aperture when the mask assembly is viewed from the side.

[0091] According to another aspect of the present disclosure, there is provided a respiratory mask assembly comprising: a mask frame and a cushion module, the mask frame including a respiratory gas inlet configured to receive a supply of breathable gas and deliver the breathable gas to the cushion module, the cushion module including a housing and a cushion seal configured to form a seal with a user's face; a bias vent on the mask frame or cushion module configured to allow air to be exhausted from the cushion module through the bias vent, the bias vent including a plurality of vents arranged in at least one vent array; Including, the mask frame is removably connected to the cushion module via a cushion connector including a gas flow duct extending from the mask frame into the cushion module and positioned to deliver breathable gas from the breathing gas inlet to the cushion module; The mask assembly is a diffuser including a diffuser material configured to extend over the bias vent, the diffuser material providing a tortuous air path from the bias vent through the diffuser, the diffuser being a shape complementary to the vent array; a headgear connector element configured to be removably attached to a front of the mask frame so as to define opposed distal ends extending laterally across the mask frame and each end being configured to be connected to the headgear; further comprising A respiratory mask assembly is provided in which the diffuser is attached to one or more of the mask frame, cushion module, cushion connector, and headgear connector element.

[0092] According to a further aspect of the present disclosure, there is provided a respiratory mask assembly comprising: a mask frame and a cushion module, the mask frame including a respiratory gas inlet configured to receive a supply of breathable gas and deliver the breathable gas to the cushion module, the cushion module configured to form a seal with a user's face; a bias vent in communication with the cushion module, the bias vent configured to allow air to be exhausted from the cushion module through the bias vent; Including, the mask frame is connected to the cushion module via a cushion connector including a gas flow duct extending from the mask frame into the cushion module and positioned to deliver breathable gas from the breathing gas inlet to the cushion module; The mask assembly is a diffuser including a diffuser material configured to extend over the bias vent, the diffuser material providing a tortuous air path from the bias vent through the diffuser; further comprising A respiratory mask assembly is provided, wherein the diffuser is located between the mask frame and the cushion module.

[0093] According to another aspect of the present disclosure, there is provided a respiratory mask assembly comprising: a mask frame and a cushion module, the mask frame including a respiratory gas inlet configured to receive a supply of breathable gas and deliver the breathable gas to the cushion module, the cushion module configured to form a seal with a user's face; a bias vent in communication with the cushion module, the bias vent configured to allow air to be exhausted from the cushion module through the bias vent; Including, the mask frame is connected to the cushion module via a cushion connector including a gas flow duct extending from the mask frame into the cushion module and positioned to deliver breathable gas from the breathing gas inlet to the cushion module; The mask assembly is a diffuser including a diffuser material configured to extend over the bias vent, the diffuser material providing a tortuous air path from the bias vent through the diffuser; further comprising A respiratory mask assembly is provided in which the diffuser is located between the mask frame and another component of the front mask assembly.

[0094] The mask assembly may further include a headgear assembly. The headgear assembly may include a strap assembly including at least a pair of opposing side straps, a rear strap or panel, and / or a crown strap. The pair of opposing side straps may be a pair of opposing upper side straps, and the mask assembly may further include a pair of opposing lower side straps. A free end of each of the upper straps may be coupled to a headgear connector element or the headgear connector element. A free end of each of the lower side straps may be coupled to the mask frame.

[0095] The cushion module can include a cushion seal and a cushion housing. The cushion seal can include a nose portion having a pair of upward extensions extending upward from opposite sides of a central sealing surface, and a mouth portion.

[0096] The mask assembly is a) a tube connector for connecting a respiratory gas delivery tube to the respiratory gas inlet; b) Respiratory gas delivery tube The composition may further include any one or more of:

[0097] The respiratory gas delivery tube is a) Tube heater wire, and / or b) sensor wires, and / or c) a connector cuff at the end of said tube may include:

[0098] Reference numbers may be reused throughout the drawings to indicate general correspondence between referenced elements. The drawings are provided to illustrate example embodiments described herein and are not intended to limit the scope of the present disclosure. [Brief explanation of the drawings]

[0099] [Figure 1] 1A and 1B are front and top perspective views of a mask assembly. [Figure 2A] 1A-1C are front, top and side perspective views of a mask assembly with the headgear omitted and the air delivery conduit shown in its entirety; [Figure 2B] 2B is a rear, top, and side perspective close-up view of the mask assembly of FIG. 2A. [Figure 3A] FIG. 2B is a front view of the frame of the mask assembly of FIG. 2A. [Figure 3B] FIG. 2B is a rear view of the frame of the mask assembly of FIG. 2A. [Figure 4] FIG. 2B is a side view of the frame of the mask assembly of FIG. 2A. [Figure 5]5 is a side cross-sectional view of the frame of the mask assembly of FIG. 2A taken along line 5-5 of FIG. 3A. [Figure 6] 6 is a side cross-sectional view of the frame of the mask assembly of FIG. 2A taken along line 6-6 of FIG. 3A. [Figure 7] 7 is a front cross-sectional view of the frame of the mask assembly of FIG. 3A taken along line 7-7 of FIG. 4. [Figure 8] FIG. 2B is a bottom view of the frame of the mask assembly of FIG. 2A. [Figure 9] 2B is a front, bottom, and side perspective exploded view of the frame of the mask assembly of FIG. 2A. [Figure 10] 2B is a rear, bottom, and side perspective exploded view of the frame of the mask assembly of FIG. 2A. [Figure 11] 2B is a side cross-sectional view of the frame of the mask assembly of FIG. 2A showing the inlet axis and the cushion connector axis. [Figure 12] 2B is a front, top, and side perspective view of the cushion module of the mask assembly of FIG. 2A. [Figure 13] FIG. 2B is a rear view of the cushion module of the mask assembly of FIG. 2A. [Figure 14] FIG. 2B is a front view of the cushion module of the mask assembly of FIG. 2A. [Figure 15] FIG. 2B is a side view of the cushion module of the mask assembly of FIG. 2A. [Figure 16] 2B is a side cross-sectional view of the cushion module of the mask assembly of FIG. 2A. [Figure 17] 2B is a close-up rear view of the mask seal portion of the cushion module of the mask assembly of FIG. 2A. [Figure 18] 2B is a top view of a mask seal of the cushion module of the mask assembly of FIG. 2A. [Figure 19A] 19A is a rear cross-sectional view of the mask seal of the mask assembly of FIG. 2A taken along line 19A-19A of FIG. 18. [Figure 19B] 19B is a rear cross-sectional view of the mask seal of the mask assembly of FIG. 2A taken along line 19B-19B of FIG. 18. [Figure 19C] 19C is a rear cross-sectional view of the mask seal of the mask assembly of FIG. 2A taken along line 19C-19C of FIG. 18. [Figure 19D] 19D is a rear cross-sectional view of the mask seal of the mask assembly of FIG. 2A taken along line 19D-19D of FIG. 18. [Figure 19E] 19E is a rear cross-sectional view of the mask seal of the mask assembly of FIG. 2A taken along line 19E-19E of FIG. 18. [Figure 19F] 19F is a rear cross-sectional view of the mask seal of the mask assembly of FIG. 2A taken along line 19F-19F of FIG. 18. [Figure 20A] 2B and 2C are front and side perspective views of a cushion module similar to the cushion module of the mask assembly of FIG. 2A. [Figure 20B] 20B is another version of a front and side perspective view of the cushion module of the mask assembly of FIG. 20A, with the transition or boundary between sections of different thicknesses outlined. [Figure 21A] FIG. 20B is a front view of the cushion module of the mask assembly of FIG. 20A. [Figure 21B] FIG. 20B is an enlarged view of an upper portion of the cushion module of the mask assembly of FIG. 20A. [Figure 21C] FIG. 20B is a side view of the cushion module of the mask assembly of FIG. 20A. [Figure 21D] FIG. 20B is a top view of the cushion module of the mask assembly of FIG. 20A. [Figure 21E] 21A is a rear cross-sectional view of the cushion module of the mask assembly of FIG. 20A taken along line 21A-21A of FIG. 21D. [Figure 21F] 21B is a side cross-sectional view of the cushion module of the mask assembly of FIG. 20A taken along line 21B-21B of FIG. 21D. [Figure 22A] FIG. 20B is a front view of the cushion module of the mask assembly of FIG. 20A in a neutral position. [Figure 22B] FIG. 20B is a front view of the cushion module of the mask assembly of FIG. 20A when a lateral outward force is applied to each side of the nasal seal surface. [Figure 22C] FIG. 20B is a front view of the cushion module of the mask assembly of FIG. 20A when a downward force is applied to the nose seal surface. [Figure 23] FIG. 2B is a side view of the mask assembly of FIG. 2A. [Figure 24] 2B is a side cross-sectional view of the mask assembly of FIG. 2A. [Figure 25] FIG. 2B is a front view of the mask assembly of FIG. 2A. [Figure 26] FIG. 2B is a bottom view of the mask assembly of FIG. 2A. [Figure 27A] 2B is a top cross-sectional view of the mask assembly of FIG. 2A. [Figure 27B] FIG. 2B is a bottom view of the mask assembly of FIG. 2A. [Figure 28] FIG. 10 is a side view of the interface assembly showing the headgear assembly. [Figure 29] FIG. 29 is an exterior view of the headgear assembly of FIG. 28 in a horizontal, flat orientation. [Figure 30] FIG. 29 is an interior view of the headgear assembly of FIG. 28 in a horizontal, flat orientation. [Figure 31A] 1A-1C are front, top, and side perspective views of an interface assembly including a mask assembly and a headgear assembly along with a yoke. [Figure 31B] 31B is a front and top perspective view of the interface assembly of FIG. 31A. [Figure 32] FIG. 31B is a front view of the mask assembly of the interface assembly of FIG. 31A including a yoke. [Figure 33A] 31B is a front and side perspective view of a headgear assembly of the interface assembly of FIG. 31A including a yoke. [Figure 33B] FIG. 33B is a side view of the headgear assembly of FIG. 33A. [Figure 33C] FIG. 33B is a front view of the headgear assembly of FIG. 33A. [Figure 34A] FIG. 31B is a front view of the yoke of the interface assembly of FIG. 31A. [Figure 34B]FIG. 31B is a rear view of the yoke of the interface assembly of FIG. 31A. [Figure 34C] FIG. 31B is a side view of the yoke of the interface assembly of FIG. 31A. [Figure 34D] FIG. 31B is a view of the yoke of the interface assembly of FIG. 31A, shown partially in outline form to illustrate the underlying structure. [Figure 34E] FIG. 31B is a bottom view of the yoke of the interface assembly of FIG. 31A. [Figure 34F] FIG. 34B is an enlarged view of a portion of the bottom of the yoke of the interface assembly of FIG. 31A as identified in FIG. 34E. [Figure 34G] 34G is an enlarged view of a portion of the bottom cross-sectional view of the yoke of the interface assembly of FIG. 32A taken along line 34G-34G of FIG. 34D. [Figure 35A] 31B is a front and side perspective view of the frame of the interface assembly of FIG. 31A. [Figure 35B] FIG. 35B is an enlarged cross-sectional view of a portion of the frame of FIG. 35A. [Figure 36] 31B is a close-up cross-sectional view of a portion of the yoke and mask assembly of the interface assembly of FIG. 31A. [Figure 37A] FIG. 31B is a front view of a yoke similar to the yoke of the interface assembly of FIG. 31A. [Figure 37B] FIG. 37B is a rear view of the yoke of FIG. 37A. [Figure 38] FIG. 12 is a front view of a mask frame of an interface assembly according to aspects of the present disclosure. [Figure 39] FIG. 39 is a perspective view of the mask frame of FIG. 38. [Figure 40] FIG. 40 is a side view of the mask frame of FIGS. 39 and 39. [Figure 41] FIG. 41 is a front perspective view of the mask frame and yoke of FIGS. 38-40, with the diffuser material omitted. [Figure 42] FIG. 41 is a front perspective view of the mask frame and further yoke of FIGS. 38-40, with the diffuser material shown. [Figure 43]FIG. 43 is a front view of the yoke of FIG. 42. [Figure 44] FIG. 43 is a front view of the yoke of FIG. 42, showing the diffuser material. [Figure 45] FIG. 10 is a front view of another mask frame of an interface assembly according to aspects of the present disclosure. [Figure 46] A perspective view of the mask frame of Figure 45, omitting the yoke and diffuser material. [Figure 47] FIG. 47 is a front perspective view of the mask frame of FIGS. 45 and 46, showing the diffuser material. [Figure 48] FIG. 47 is a front perspective view of the mask frame of FIGS. 45 and 46, with the diffuser and diffuser material removed from the mask frame. [Figure 49] 49 is a cross section of the diffuser of FIG. 48. [Figure 50] FIG. 47 is a cross-sectional side view of the mask frame of FIGS. 45 and 46, with the diffuser and diffuser material removed from the mask frame. [Figure 51] FIG. 12 is a rear perspective view of a mask frame and mask seal according to aspects of the present disclosure. [Figure 52] FIG. 52 is a rear perspective view of the mask frame of FIG. 51. [Figure 53] FIG. 52 is a cross-sectional side view of the mask frame and mask seal of FIG. 51. [Figure 54] FIG. 52 is a rear perspective view of the mask frame and mask seal of FIG. 51. [Figure 55] FIG. 51 is a front perspective view of the mask frame and mask seal of FIG. 50. [Figure 56] FIG. 51 is a rear view of the mask frame and mask seal of FIG. 50. [Figure 57] FIG. 51 is a front view of the mask frame and mask seal of FIG. 50. [Figure 58] FIG. 51 is a rear perspective view of the mask frame and mask seal of FIG. 50. [Figure 59] FIG. 51 is a rear perspective view of the mask frame and mask seal of FIG. 50. [Figure 60] FIG. 51 is a side view of the mask frame and mask seal of FIG. 50. [Figure 61] FIG. 10 is a front perspective view of another mask frame and mask seal according to aspects of the present disclosure. [Figure 62] FIG. 62 is a bottom view of the mask frame and mask seal of FIG. 61. [Figure 63] FIG. 63 is a front view of the mask seal of FIG. 62. [Figure 64] FIG. 63 is a perspective view of the mask seal of FIG. 62. [Figure 65] FIG. 63 is a perspective view of the mask seal of FIG. 62. [Fig. 66a-b] 62A and 62B are front and rear views of a diffuser for use with the mask seal of FIG. 61. [Fig. 67a-b] 67A and 67B are top and bottom views of the diffuser of FIG. 66. [Figure 68] FIG. 69 is a rear perspective view of the diffuser of FIG. 68. [Figure 69] FIG. 69 is a front perspective view of the diffuser of FIG. 68. [Figure 70] FIG. 69 is a front perspective view of the diffuser of FIG. 68. [Figure 71] FIG. 69 is a front view of the diffuser and mask seal of FIG. 68. [Figure 72] FIG. 63 is a front view of an alternative diffuser for use with the mask seal of FIG. 62. [Figure 73] FIG. 73 is a perspective front view of the diffuser and mask seal of FIG. 72. [Figure 74] FIG. 10 is a perspective front view of another diffuser and mask seal. [Fig. 75a-b] FIG. 75 is a front view of the mask seal of FIG. 74. [Figure 76] FIG. 76 is a cross-sectional top view of the mask seal of FIG. 75. [Figure 77] FIG. 76 is a cross-sectional front view of the mask seal of FIG. 75. [Fig. 78a-b] 77 is an enlarged cross-sectional top view of a portion of the mask seal of FIG. 75 shown in Box A of FIG. 76. [Fig. 79a-b]FIG. 76 is an enlarged cross-sectional top view of the mask seal of FIG. 75, including first and second vent configurations. [Fig. 79c-d] FIG. 79 is a view similar to FIGS. 79a and 79b, but including a wider recess and diffuser. [Figure 80] FIG. 76 is an enlarged cross-sectional top view of the mask seal of FIG. 75. [Figure 81] FIG. 76 is an enlarged cross-sectional top view of the mask seal of FIG. 75. [Figure 82] FIG. 88 is an enlarged cross-sectional side view of the mask seal of FIG. 87. DETAILED DESCRIPTION OF THE INVENTION

[0100] Embodiments of systems, components, and methods of assembly and manufacturing are now described with reference to the accompanying figures, in which like reference numerals refer to like or similar elements throughout. While several embodiments, examples, and figures are disclosed below, those skilled in the art will understand that the invention described herein extends beyond the specifically disclosed embodiments, examples, and figures and may include other uses of the invention as well as obvious modifications and equivalents. The terminology used in the description presented herein is not intended to be construed as limiting or restrictive in any way, as it is used solely in conjunction with the detailed description of several specific embodiments of the invention. Furthermore, embodiments of the invention may include several novel features, and no single feature is solely responsible for its desirable attributes or is essential to practicing the invention described herein.

[0101] In the following description, some terms may be used merely for reference purposes and are therefore not intended to be limiting. For example, terms such as "top" and "bottom" refer to directions in the referenced drawings. Terms such as "front," "back," "left," "right," "rear," and "side" describe the orientation and / or location of a component or portion of an element within a consistent, but arbitrary, frame of reference that becomes clear by reference to the text and associated drawings that describe the component or element being discussed. For example, as the context may dictate, the terms "front" and / or anterior may be used with respect to components described herein that are positioned relatively or entirely distal to a user's face when a mask assembly as described herein is worn by a user. As the context may dictate, the terms "rear" and / or "back" may be used with respect to components described herein that are positioned relatively or entirely proximal to a user's face and / or components that are in front of or in front of the mask assembly when a mask assembly as described herein is worn by a user. Furthermore, terms such as "first," "second," "third," etc. may be used to describe separate components. Such terminology may include the words specifically mentioned above, derivatives thereof and phrases of similar importance.

[0102] One or more of the embodiments described herein address the problem of sealing and conforming to various facial (e.g., nasal) shapes that may arise with face masks. In particular, at least some of the embodiments relate to patient interfaces, such as face masks that seal below the bridge of a user's nose and around the nares. However, the embodiments disclosed herein may also be compatible with other full face masks (e.g., those that partially cover and / or seal over the bridge of a patient's nose) or under-the-nose nasal masks.

[0103] One or more of the embodiments described herein address the problem of providing an adequate seal on various facial shapes with an under-the-nose seal. Compared to traditional nasal masks or full-face masks that contact the bridge of the nose, under-the-nose nasal masks or combined nose and mouth masks have a reduced attachment area on the user's face, which can make maintaining a seal with the user's face and configuring them to fit various facial shapes more difficult. Sealing around and under the nose can present challenges due to variations in facial shapes between users. One or more of the exemplary embodiments described herein can allow the nose portion of the mask seal to expand, for example, depending on fit for a particular user or pressure within the mask seal. In some configurations, the nose portion of the mask seal can be configured to allow relatively low resistance to width increase. Such a configuration allows a single mask seal to provide an adequate seal with users with relatively narrow and relatively wide noses. For example, when used with a user with a relatively narrow nose, the width of the nose portion may not expand or increase, or may only expand or increase slightly. When used with users with relatively wide noses, the width of the nose portion can expand or increase significantly or maximally. However, in at least some configurations, even when expanded, the nose portion does not exert an uncomfortable level of force against the user's nose. Such a configuration advantageously maintains an adequate seal between the user's face and the mask seal. One example of such a configuration is disclosed in applicant's PCT application PCT / IB2017 / 056146, the entire contents of which are incorporated herein by reference.

[0104] 1-28 show a mask assembly 2100 and its components both in place on a user's face and separated from the user's face. The illustrated mask assembly 2100 includes a cushion module 2150, which is a combined nose and mouth cushion module; herein, the mask assembly 2100 may be referred to as a nose-mouth or mouth-nose mask. The illustrated cushion module 2150 is designed to seal under the user's nose, along the portion of the face extending laterally up to the nose, and around the user's mouth. Advantageously, the cushion module 2150 need not contact the bridge of the user's nose. In the illustrated configuration, the cushion module 2150 does not extend over the bridge of the user's nose. More particularly, the illustrated cushion module 2150 does not contact the bridge of the user's nose. Even more particularly, the illustrated cushion module 2150 does not contact the forward-facing portion of the bridge of the user's nose. In some configurations, the cushion module 2150 does not contact the face in an area vertically higher than a generally horizontal plane extending along the lower edges of the user's eyes. The cushion module 2150 may or may not extend over the tip of the user's nose. Thus, in some configurations, the cushion module 2150 covers the tip of the nose. In some configurations, the seal of the cushion module 2150 covers the tip of the nose. In some configurations, the illustrated cushion module 2150 preferably does not obscure the tip of the user's nose. In some configurations or with some face shapes, the tip of the user's nose extends over an adjacent portion of the cushion module 2150.

[0105] As shown, the cushion module 2150 is preferably adapted to extend around and seal on the nasal wings or alars, which flare to form rounded ridges around the nostrils. The illustrated cushion module 2150 is adapted to seal around the surfaces defining the openings to the nostrils, which may include part or all of the thick outer end of the nasal septum, sometimes referred to as the columella. In some configurations, the cushion module 2510 is adapted to extend upward to seal along at least a portion of the left and right dorsal walls of the user's nose. In some configurations, the cushion module 2150 is adapted to extend upward along at least a portion of the left and right dorsal walls without extending upward to the area of ​​the user's nasal bridge. In some configurations, the first sealing surface of the cushion module 2150 contacts the underside of the user's nose, possibly along the upper lip and / or the transition region between the underside of the nose and the upper lip. The second sealing surface of the mask can contact the sides of the user's nose, possibly along with the cheeks in a location near the nose. While these primary and secondary sealing surfaces may not contact all users' faces, this configuration can provide a suitable seal with a relatively wide range of facial shapes. The cushion module 2150 also preferably seals around at least a portion of the user's mouth. The cushion module 2150 may or may not be adapted to seal between the user's mouth and nose.

[0106] As shown, the cushion module 2150 includes a support structure. In some configurations, the support structure is a mask shell or housing 2102. The mask seal or cushion 2104 can be attached to the housing 2102 such that the housing 2102 provides some amount of support for the mask seal 2104. However, in other configurations, the mask seal 2104 may not include a support portion and may be adapted to be directly assembled to another component of an associated interface assembly. In some configurations, the housing 2102 can be substantially smaller than the housing 2102 shown. For example, the housing 2102 may define an opening that allows the cushion module 2150 to be attached to another component, such as a frame and / or conduit connector (e.g., elbow), and the housing 2102 can be localized to the opening without providing direct support to other portions of the cushion module 2150.

[0107] The housing 2102 can be formed from any suitable material. In some configurations, the housing 2102 is formed from a relatively rigid material. In some configurations, the housing 2102 is formed from a rigid plastic material, such as a polycarbonate material. In some configurations, the mask assembly 2100 can include a mask seal that is separate from the housing but includes a mask seal clip that is attachable to the housing. In such configurations, the mask seal clip connects the mask seal 2104 to the housing 2102. In such configurations, the mask seal and mask seal clip can be formed separately and secured together, or the mask seal and mask seal clip can be integrated into a single component. In some configurations, the mask seal can be overmolded onto the mask seal clip, and in some configurations, the mask seal 2104 can be overmolded directly onto the housing 2102, which can include, for example, chemical and / or mechanical overmolding.

[0108] In some configurations, the housing 2102 comprises a substantial portion of the anterior wall of the cushion module 2150. Such a configuration provides an advantageous level of support for the mask seal 2104. For example, the housing 2102 comprises a substantial portion of the mouth portion of the anterior wall of the cushion module 2150 or mask assembly 2100. In some configurations, the housing 2102 is generally restricted to the mouth portion of the cushion module 2150 or mask assembly 2100 and does not extend into the nose portion of the cushion module 2150 or mask assembly 2100, at least to a significant extent. Such a configuration can provide support for the mask seal 2104 while advantageously allowing movement or deformation of the nose portion of the mask seal 2104. In other configurations, the housing 2102 can extend into the nose portion to provide additional support to the nose portion, if desired.

[0109] The mask seal 2104 is designed to seal against the face of a user. The mask seal 2104 is preferably formed from a soft material such as, for example, without limitation, silicone. In some configurations, at least a portion of the mask seal 2104 may be textured to improve comfort for the user. For example, in some configurations, at least a portion of the mold used to form the illustrated mask seal 2104 may be bead blasted to impart a surface texture to at least the area of ​​the mask seal 2104 that contacts the user's skin. Other techniques for texturing one or more surfaces of the mask seal 2104 may be used. In some configurations, it may be desirable to avoid surface texturing and impart a smooth surface texture to at least the face-contacting surface of the mask seal 2104, which may increase the grip of the mask seal 2104 on the user's face and improve sealing properties.

[0110] The cushion module 2150 may engage with or otherwise be supported by a headgear connector or frame 2178 that allows connection to a head strap or headgear 2180 of any suitable configuration. The frame 2178 may therefore be considered a component of the mask assembly 2100. The mask assembly 2100 may also include, among other possible components, an inlet tube such as a gas supply conduit 2520A connected to the frame 2178. The frame 2178 may be adapted to allow assembly of the cushion module 2150 only in the correct orientation. The headgear assembly 2180 may include, among other components, straps such as one or more upper side straps 2804, one or more lower side straps 2802, and / or a crown strap 2808 (see FIGS. 25-27). In some configurations, the head strap or headgear 2180 may be directly coupled to the cushion module 2150, and the frame 2178 may be utilized for other purposes or omitted. In such a configuration, a head strap or headgear 2180 can be coupled to the housing 2102. The frame 2178 and headgear 2180 can together support the cushion module 2150 in place on the user's face. The cushion module 2150, frame 2178, gas delivery conduit 2520A, and headgear 2180 can collectively be referred to as an interface assembly. While the illustrated mask assembly 2100 includes a cushion module 2150 that supports the seal 2104 and a frame 2178 that connects to the headgear 2180, in other configurations, a single integrated structure can support the seal 2104 and connect to the headgear 2180. For example, the housing 2102 and frame 2178 of the cushion module 2150 can be formed as a single integrated structure, which can be simplified compared to the illustrated configuration. Such a single integrated structure is often referred to as a "frame."Thus, references in this disclosure to separate cushion module 2150 / housing 2102 and frame 2178 may also be referred to as an integrated structure unless otherwise indicated.

[0111] As shown in the illustrated example and described in more detail below, the frame 2178 can include an anti-asphyxiation (AA) valve assembly 2522 (referred to herein as "AA valve 2522"). In some configurations, the AA valve 2522 can be received by a valve recess 2726 of the cushion module 2150, as described below. As described in more detail below, the AA valve 2522 can include a valve housing. The AA valve 2522 can be integrally formed with the frame 2178. As described below, the AA valve 2522 can include, among other possible components, at least a portion of the frame 2178, a valve element or member such as a valve flap 2524, and / or a tube connector 2711. The AA valve 2522 can be located adjacent to the air supply conduit 2520A within the frame 2178. In some embodiments, the AA valve 2522 can include an inlet tube positioned rearward of the front wall of the frame 2178. In some embodiments, the inlet tube can define at least a portion of the gas flow path. In some configurations, incorporating the AA valve 2522 within the frame 2178 allows the air delivery conduit 2520A to extend in a generally downward direction from the lower front portion of the frame 2178. Such a configuration may reduce the overall bulk of the patient interface. For example, such a configuration may allow the conduit 2520A to be positioned closer to the user during use. A gas flow path is provided by the gas delivery conduit 2520A, the AA valve 2522, and the cushion connector 2708. The gas flow path provides a passageway for pressurized gas to be delivered through the mask assembly 2100 to the user's nose and / or mouth.

[0112] 2A and 2B show an example of a mask assembly 2100. As mentioned above, the cushion module 2150 of the mask assembly 2100 may include a mask seal 2104 and a housing 2102, which, among other components, is assembled to a frame 2178 and / or an air delivery conduit 2520A. The frame 2178 may be generally curved laterally and / or vertically.

[0113] In some embodiments, the frame 2178 can be provided on the front side of the cushion module 2150. In some embodiments, the frame 2178 can cover a substantial portion of the front side of the cushion module 2150, such as a substantial portion of the housing 2102 of the cushion module 2150. In some embodiments, the frame 2178 is centered laterally along the front side of the cushion module 2150. For example, the entire front side of the frame 2178 can be positioned in front of the cushion module 2150.

[0114] 3A-11 show embodiments of a frame 2178. In some embodiments, the frame 2178 can include a cushion connector 2708, an inlet or inlet opening 2706, a valve 2522, at least one upper strap connector 2702, at least one lower strap connector 2704, and / or an upwardly extending support 2179. The upwardly extending supports may be referred to as wings or paddles.

[0115] In some embodiments, the cushion connector 2708 can be positioned on the rear side of the frame 2178. In some embodiments, the cushion connector 2708 is integral with the frame 2178 and extends rearward from the rear surface of the front wall 2701 of the frame 2178. The cushion connector 2708 can provide a fluid connection between the inlet 2706 and the cushion module 2150.

[0116] In some embodiments, the cushion connector 2708 can be shaped to fit within at least a portion of the cushion module 2150 to connect the frame 2178 to the cushion module 2150. For example, the cushion connector 2708 can fit within at least a receiving portion of the mask housing 2102, such as the frame connector 2730. The cushion connector 2708 can include a somewhat rounded "D" shape, a rounded trapezoidal shape, a circular shape, an elliptical shape, and / or an oval shape, among other possible shapes.

[0117] In some embodiments, the cushion connector 2708 is in the form of a protruding wall that forms a cuff or collar. The protruding wall can extend rearward and / or upward from the rear side of the front wall portion 2701 of the frame 2178. The cushion connector 2708 can be positioned above the AA valve 2522 along the rear side of the frame 2178. The cushion connector 2708 can be positioned adjacent to the AA valve 2522 along the rear side of the frame 2178. In some configurations, the inlet 2706, the AA valve 2522, and the cushion connector 2708 cooperate to form a gas flow path defined by the frame 2178. In the illustrated configuration, the inlet 2706, the AA valve 2522, and the cushion connector 2708 each include a substantially enclosed space (e.g., except for predetermined and intentional openings) that defines a portion of the overall gas flow path. In some configurations, the front wall portion 2701 of the frame 2178 defines at least a portion of the gas flow path. In the illustrated configuration, the front wall portion 2701 of the frame 2178 defines a portion of the gas flow path at one or both of the AA valve 2522 and the cushion connector 2708. Such a configuration allows the frame 2178 to have a reduced depth compared to designs in which the entire gas flow path is defined by a dedicated structure.

[0118] In some embodiments, the cushion connector 2708 may include an alignment feature such as an alignment notch 2710. The alignment notch 2710 may be formed in a portion of the cushion connector 2710. For example, the alignment notch 2710 may be formed in a top wall portion of the cushion connector 2708. The alignment notch 2710 may guide the connection between the frame 2178 and the mask assembly 2100. For example, the alignment notch 2710 may correspond to a feature on the mask assembly 2100 so that the frame 2178 and the mask assembly 2100 can be connected in the proper orientation. In some embodiments, the alignment notch 2710 has a generally trapezoidal, rectangular, and / or square shape, among other possible shapes. In some embodiments, the alignment notch 2710 may have a width at the rear edge of the top wall of the cushion connector 2708 that is wider than the width of the alignment notch 2710 located closer to the rear of the frame 2178.

[0119] In some embodiments, the frame 2178 may carry or otherwise include an inlet 2706. The inlet 2706 may be defined by a tube connector 2711, which may be a separate structure coupled to the frame 2178. In some embodiments, the inlet 2706 may provide a fluid or gas flow path through which pressurized air may be provided to the mask assembly 2100. In some embodiments, the pressurized air may be provided to the mask assembly 2100 through the inlet 2706 and via or through the AA valve 2522. As will be described in more detail below, the AA valve 2522 may allow access to the atmosphere in the absence of a pressurized air source or when the pressure within the mask assembly 2100 drops below atmospheric pressure for other reasons.

[0120] In some embodiments, the frame 2178 can include at least one upper strap connector 2702 and at least one lower strap connector 2704. In the illustrated configuration, the frame 2178 includes a pair of upper strap connectors 2702 and a pair of lower strap connectors 2704. Each of the pairs of upper strap connectors 2702 and lower strap connectors 2704 can be positioned on opposite sides of the frame 2178. In some embodiments, the upper strap connectors 2702 can slidably receive corresponding upper headgear straps 2804 of the headgear 2180 (see, for example, FIG. 1). With reference to FIG. 4, the upper headgear connector 2702 can include a post 2703A and an aperture 2703B. The post 2703A can be spaced from the front of the frame 2178. The post 2703A can be positioned approximately in the center of the aperture 2703B. In some embodiments, the post 2703A can be positioned off-center of the aperture 2703B. In some embodiments, the post 2703A can be offset forward of the front wall of the frame 2178.

[0121] 1 and 28, the posts 2703A can serve to secure the upper side straps 2804 to the upper headgear connectors 2702. In some embodiments, the posts 2703A, together with the front surface of the frame 2178, can define slots through which the corresponding upper side straps 2804 can pass. For example, the upper side strap 2804 can pass through a slot formed between the post 2703A and the aperture 2703B. Once the upper side strap 2804 passes through the slot, the upper side strap 2804 can be wrapped around the outside of the post 2703A and folded over on itself, for example. In some embodiments, the aperture 2703B can provide additional space to allow the upper side strap 2804 to pass behind the post 2703A. In some configurations, the aperture 2703B can help reduce the distance between the post 2703A and the front of the frame 2178 required to accommodate the thickness of the strap 2804. In some embodiments, the upper strap connector 2702 can secure, such as removably secure, a headgear clip that can be attached to the upper side strap 2804.

[0122] In some embodiments, the lower strap connector 2704 can receive and / or secure the lower side strap 2802 and / or the lower headgear clip 2600 (see FIG. 1 ). As clarified in FIG. 4 , the lower strap connector 2704 can include a lower post 2705A. The lower post 2705A can be positioned along a side edge of the frame 2178. The lower post 2705A can be spaced from a portion of the frame 2178 to define an aperture 2705B. In some embodiments, the lower post 2705A forms a lower side edge of the frame 2178. In some embodiments, the aperture 2705B can be shaped to receive at least a portion of the lower headgear clip 2600. In some embodiments, the aperture 2705B can be substantially D-shaped, among other possible shapes. In some embodiments, the post 2705A can be received within and / or retain a portion of a corresponding lower headgear clip 2600, such as a hook portion of the clip 2600. The aperture 2705B can be sized and shaped to accommodate the hook portion of the clip 2600. The lower post 2705A can allow for a removable connection between the lower side strap 2804 and the frame 2178 and / or between the lower headgear clip 2600 and the frame 2178.

[0123] In some embodiments, the frame 2178 can include upwardly extending supports 2179. The upwardly extending supports 2179 extend upwardly from either side of a central portion of the frame 2178. The upwardly extending supports can be referred to as "frame paddles." As described above, the upwardly extending supports 2179 can define an upper support member that, when assembled, provides support to the forward-facing side of the nasal region 2168 of the mask seal 2104 (the upwardly extending portion 2126 of the seal 2104). The upwardly extending supports 2179 can help minimize deflection of the mask seal 2104. In some embodiments, the upwardly extending supports 2179 can help maintain contact between the nasal region 2168 and the user's nose. For example, the upwardly extending supports 2179 can help prevent the nasal region 2168 and the upwardly extending portion 2126 of the mask seal 2104 from bulging away from and / or disengaging from the user's nose, while allowing the inner wall of the upwardly extending portion 2126 to flex outward. The upwardly extending supports 2179 each have a curved upper edge. The upwardly extending supports 2179 each form a semicircular or D-shaped panel. The panels, in use, lie below and on either side of the wearer's nose. A curved trough is formed at the upper edge of the frame 2178 between the upwardly extending supports 2179.

[0124] 4-10 show certain portions of the valve 2522 in more detail. As shown in at least FIGS. 4-6, 9, and 10, the valve 2522 can include a valve element or member, such as a valve flap 2524. The valve 2522 can also include a tubing connector 2711, among other possible components. In some embodiments, the valve 2522 can include a vent passage 2722 and / or an outlet 2720. As shown, at least a portion or some components of the valve 2522 can be integrally formed with the frame 2178. For example, the body portion of valve 2522 that defines the gas flow path may be integrally formed with frame 2178. Some configurations may desirably reduce assembly time and / or the number of components required to manufacture, clean, and / or replace. Some such configurations may desirably reduce the likelihood of pressurized air leaking from the assembly.

[0125] 5 and 6 show side cross-sectional views of the frame 2178 taken along lines 5-5 and 6-6, respectively, as shown in FIG. 3A. FIG. 7 shows a front cross-sectional view of the frame 2178 taken along line 7-7 as shown in FIG. 4. As shown, the frame 2178 can house the valve flap 2524. In some embodiments, the frame 2178 completely surrounds the periphery of the movable portion of the valve flap 2524. Thus, the movable portion of the valve flap 2524 can be positioned to fit within the gas flow path of the valve 2522 of the frame 2178.

[0126] In some embodiments, the tube connector 2711 can define an inlet opening 2706 that directs pressurized air through the valve 2522, through the mask assembly 2100, and to the user. In some embodiments, the tube connector 2711 can be elliptical, circular, and / or oval, among other shapes. Preferably, the dimension of the inlet 2706 in the anterior-posterior direction is smaller than the dimension of the inlet 2706 in the lateral direction. Thus, additional space is provided in the anterior-posterior direction to accommodate the valve 2522, as compared to designs in which the inlet 2706 is circular, without increasing the anterior-posterior dimension of the frame 2178 or moving the inlet 2706 further away from the user's face.

[0127] The tube connector 2711 can include a male component that is received by a corresponding female connector, which can be attached to the conduit 2520A. In some embodiments, the tube connector 2711 can allow for disconnection of the conduit 2520A by twisting the conduit 2520A relative to the frame 2178 and / or the tube connector 2711. In some embodiments, the conduit 2520A is connected to the tube connector 2711 via a snap-fit ​​arrangement, among other possible configurations. For example, the tube connector 2711 can include one or more tube connector notches 2712. The tube connector notches 2712 can engage with corresponding features on the conduit 2520A via the snap-fit ​​arrangement.

[0128] In some embodiments, the valve flap 2524 can be secured within the frame 2178 by a tube connector 2711. In some embodiments, the tube connector 2711 can be permanently coupled to the bottom end of the frame 2178 defining the valve 2522 by a variety of configurations, such as welding, adhesives, and / or snap-fit ​​configurations, among other possible configurations. In some embodiments, the tube connector 2711 can surround a tab of the valve flap 2524 and / or secure the tab of the valve flap 2524 between the bottom end of the frame 2178 and a flange of the tube connector 2711. In some embodiments, the valve flap 2524 can be positioned within the frame 2178 adjacent an inner end of the tube connector 2711. In some embodiments, the valve flap 2524 can be constructed, in whole or in part, from a flexible elastomer, such as silicone, among other materials.

[0129] The valve flap 2524 can open and close different flow paths within the valve 2522 to allow air to flow through desired ones of the different flow paths of the valve 2522. For example, when the flow generator supplies positive pressure air to a user through the mask assembly 2100, the valve flap 2524 can pivot about a hinge or otherwise move in response to pressurized air entering the inlet 2706. In this position, the valve flap 2524 is open to the inlet 2706 of the tube connector 2711 and closed to the valve 2522 and / or the air passage 2722 of the valve 2522. Some configurations can help ensure that little or no airflow leaks out of the air passage 2722 of the valve 2522, and that all or substantially all of the positive pressure airflow is directed toward the user. When the flow generator does not provide airflow to the mask assembly 2100 or the pressure within the mask assembly 2100 drops below atmospheric pressure for other reasons, the valve flap 2524 closes against the inlet 2706 of the tube connector 2711 and the air passage 2722 of the AA valve 2522 is opened to allow the user to inhale ambient air through the valve 2522.

[0130] The tube connector 2711 can support the valve flap 2524 in an operable position relative to the valve 2522 portion of the frame 2178. In some configurations, the tube connector 2711 defines a stop that prevents the valve flap 2524 from inverting or expanding downwardly out of the inlet 2706 of the frame 2178 (see, for example, FIG. 5). In some configurations, the tube connector 2711 can include a flap support 2724. In some configurations, the tube connector 2711 can include at least three flap supports 2724 (see FIG. 8). In some embodiments, the tube connector 2711 can include at least two, three, four, five, six, or more flap supports 2724. The flap supports 2724 can extend radially inward from the inner surface of the peripheral wall of the tube connector 2711 into the inlet 2706 of the tube connector 2711. In some embodiments, the flap support 2724 can be positioned adjacent the top edge of the tube connector 2711. In some configurations, the flap support 2724 can prevent the valve flap 2524 from inverting or spreading downward into the inlet 2706.

[0131] 7, the valve 2522 can include various air passages and valve outlets that allow air to flow into and out of the mask assembly 2100 when the valve flap 2524 (alone or in combination with the frame 2178) is in the closed position. For example, in some embodiments, a flow path is provided through the air passages 2722 and valve outlets 2720 of the valve assembly 2522. In some embodiments, the valve 2522 can include at least two air passages 2722 and / or at least two lateral valve outlets 2720.

[0132] In some embodiments, the air passage 2722 can extend rearward, away from the inlet 2706, towards the outlet 2720. In some embodiments, the air passage 2722 can extend through an inner wall of the valve 2522 towards the outlet 2720. In some embodiments, the air passage 2722 can extend through an inner wall of the valve 2522 towards the outlet 2720. In some embodiments, the air passage 2722 can extend rearward and downward into the outlet 2720. In some embodiments, the central axis of the air passage 2722 forms an acute angle with the central axis 2706A (as shown in FIG. 11 ) of the inlet 2706.

[0133] In some embodiments, the outlet 2720 can define an opening that allows exhausted air to exit the patient interface or inhaled air to enter the patient interface via the airway 2722 when the valve flap 2524 is in a closed position relative to the inlet 2706. As shown in FIG. 6 , the valve 2522 can include a rear wall 2523 that is spaced rearward from the outlet of the airway 2722 beside the outlet 2720 and defines a rear extent of the outlet 2720. Such a configuration can provide space to direct the exhausted air laterally, as indicated by the arrows shown in FIG. 3B . The rear wall 2523 of the valve 2522 can direct the exhausted air away from the user. In some embodiments, venting air laterally can help minimize contact between the exhausted air and the user. Some configurations can help reduce discomfort caused to the patient by the exhausted air. In some embodiments, the outlet 2720 can extend below the underside of the housing 2102 of the cushion module 2150 when assembled (see FIGS. 23 and 24). In such a configuration, the exhaust air cannot be blocked by the housing 2102.

[0134] 9 and 10 show exploded views of the frame 2178 showing a portion of the valve 2522. In some embodiments, the valve flap 2524 can include a perimeter 2524A and an inner rib 2524B. The perimeter 2524A can include a lip. The lip can define a thickened region extending along the perimeter 2524A. In some embodiments, the rib 2524B can be positioned along the underside of the valve flap 2524. The rib 2524B can be positioned approximately along the central axis of the valve flap 2524. In some embodiments, the rib 2524B can be positioned along the underside of the valve flap 2524. The rib 2524B can be positioned approximately along the central axis of the valve flap 2524. In some embodiments, the rib 2524B can define a thickened region along the center of the valve flap 2524. In some embodiments, the perimeter 2524A and / or ribs 2524B can provide rigidity to the valve flap 2524. The perimeter 2524A and / or ribs 2524B can help prevent expansion and / or deformation of the valve flap 2524 caused by pressurized air during use. Some configurations can help provide an effective seal around the air passage 2722 when the valve 2522 is in an open position relative to the inlet 2706.

[0135] In some embodiments, the tube connector 2711 can define an inlet 2706 that directs a source of pressurized air through the valve 2522 and into the breathing chamber of the cushion module 2150. The inlet 2706 can be angled downward during use. For example, as shown in FIG. 11 , the central axis 2706A of the inlet 2706 can form an angle with the central axis 2708A of the cushion connector 2708. In some embodiments, this angle is approximately 125 degrees. In some embodiments, this angle is greater than or less than 125 degrees. In some embodiments, this angle is approximately 124.4 degrees. In some embodiments, this angle is greater than or less than 124.4 degrees. Some configurations can help keep the conduit 2520A away from the user. Some configurations can desirably minimize the bulk of the patient interface, such as at the front of the mask assembly 2100.

[0136] 12 and 14 show the front of the cushion module 2150 showing the housing 2102. In some embodiments, the housing 2102 can include one, two, three, four, five, or more bias vents 2502. The bias vents 2502 can be positioned in a bottom region of the housing 2102. In some embodiments, the bias vents 2502 can be positioned on a generally forward-facing surface of the housing 2102. For example, the bias vents 2502 can be positioned adjacent to the bottom edge of the housing 2102. In some configurations, the bias vent 2502 holes can be positioned near and / or adjacent to the bottom edge of the frame 2178 when assembled. Preferably, the bias vents 2502 are positioned below the bottom edge of the frame 2178. Such a configuration can minimize contact between the exhaust air and the frame 2178. Such a configuration can help reduce noise and / or unwanted airflow or leakage.

[0137] FIG. 14 illustrates an example of a housing 2102 including two bias vents 2502. The bias vents 2502 can include multiple holes. The multiple holes can be arranged in a generally triangular pattern, among other possible patterns. The bias vents 2502 can be positioned on either side of the inlet 2732 and / or the valve recess 2726 of the cushion module 2150. In some embodiments, at least a portion of the bias vent 2502 is positioned below at least a portion of the inlet 2732, and at least a portion of the bias vent 2502 is positioned beyond a side of the inlet 2732. In such a configuration, only a portion of the bias vent 2502 is positioned laterally beyond the inlet 2732. In some embodiments, the bias vent 2502 is positioned completely beyond a side of the inlet 2732. The bias vents 2502 can be configured to help disperse exhaust air. Such a configuration may reduce disturbances, such as drafts and / or noise, caused by the exhaust air to the occupant and / or their bed companions.

[0138] In some embodiments, the bias vents 2502 are positioned such that air is exhausted below the frame 2178 (see FIGS. 23-25). For example, the bias vents 2502 are positioned directly below and / or adjacent to the bottom edge of the frame 2178. Such a configuration allows the exhaust air to pass through the frame 2178 with little or minimal obstruction to the airflow. As discussed above, such a configuration can help to disperse the exhaust air, reduce noise, and / or reduce obstructions caused by the exhaust air.

[0139] In some embodiments, the housing 2102 includes a valve recess 2726. The valve recess 2726 can define a concave area. The concave area can be positioned below and / or adjacent to the inlet 2732. In some embodiments, the valve recess 2726 can have a width that is less than the maximum width of the inlet 2732.

[0140] As described above, the valve recess 2726 can receive at least a portion of the AA valve 2522, such as the rear portion of the AA valve 2522 and / or the valve outlet 2720. In some embodiments, the valve recess 2726 has a curved surface that includes a curvature that accommodates or matches the curvature of the rear surface / rear wall 2523 of the AA valve 2522. In at least some embodiments, the valve recess 2726 can recess the AA valve 2522 within the cushion module 2150 and / or position the AA valve 2522 below at least a portion of the mask seal 2104, such as the anterior upper portion and / or nasal region 2168 of the mask seal 2104. In at least some embodiments, the valve recess 2726 and / or the AA valve 2522 can desirably reduce the overall depth of the patient interface. This can help make the patient interface less intrusive to the user and reduce strain on hoses. In at least some embodiments, the valve recess 2726 and / or the AA valve 2522 may allow the AA valve 2522 to be positioned higher relative to the bottom of the mask seal 2104 and / or the inlet 2732 to be shorter, which may help reduce the overall size of the mask assembly 2100.

[0141] As described above, the housing 2102 can include a frame connector 2730. As shown in FIG. 12 , the frame connector 2730 can form a collar. The collar can protrude inward from the front of the housing 2102 toward or into the interior of the cushion module 2150. The frame connector 2730 can extend around all or part of the periphery of the inlet 2730. In some embodiments, the frame connector 2730 can receive and / or retain the cushion connector 2708 of the frame 2178.

[0142] In some embodiments, the frame connector 2730 can include a securing feature that engages with the cushion connector 2708 of the frame 2178. For example, the frame connector 2730 can include at least one connector bump 2734 (e.g., a pair of connector bumps 2734) or other retention or alignment feature. The connector bump 2734 can be positioned along a portion of the inner surface of the frame connector 2730. The connector bump 2734 can engage with a corresponding engagement feature 2715 of the cushion connector 2708. The engagement feature 2715 can include a notch, recess, or other engagement feature. The engagement feature 2715 can be positioned on the outer surface of the cushion connector 2708. In some embodiments, the connector bump 2734 can engage with the engagement feature 2715 of the cushion connector 2708 in a snap-fit ​​configuration, among other engagement configurations. In some embodiments, the cushion connector 2708 includes a pair of laterally opposed recesses 2715 configured to receive and / or retain a pair of corresponding connector bumps 2734 on the frame connector 2730. Such a configuration can secure the frame 2178 to the cushion module 2150.

[0143] 16 and 24 , in some embodiments, the frame connector 2730 can include a lip 2738. The lip 2738 can define an upper wall of the valve recess 2726. In some configurations, the lip 2738 can be recessed relative to the front side of the housing 2102. In some embodiments, the lip 2738 can form at least a portion of the frame connector 2730 and / or the inlet 2732. When assembled, the lip 2738 can be positioned above the valve outlet 2720.

[0144] As described above, the frame connector 2730 may include an alignment feature 2714. The alignment feature 2714 may protrude radially into the inlet and / or forward of the trailing edge of the frame connector 2730. The alignment feature 2714 may engage with an alignment notch 2710 in the cushion connector 2708 of the frame 2178. Such a configuration may help to align and / or secure the frame 2178 to the mask seal 2104.

[0145] In some embodiments, the mask seal 2104 is substantially elastic. In some embodiments, the mask seal 2104 can include a nasal region 2168 and a mouth sealing portion. The nasal region 2168 can include nasal openings 2124 and right and left nasal sealing surfaces 2124A, 2124B. The right and left nasal sealing surfaces 2124A, 2124B can extend outward from the nasal openings 2124. In some embodiments, the mouth sealing portion can include a mouth opening 2122 (see FIG. 13 ).

[0146] As shown in at least FIGS. 13 and 14 , the cushion module 2150 can include an inlet 2732. The inlet 2732 can form an opening in the cushion module 2150 that allows air to flow into the breathing chamber. In some embodiments, the inlet 2732 can include a non-circular perimeter. In some embodiments, the perimeter of the inlet 2732 is generally oval, elliptical, square, and / or rectangular, among other shapes. In some embodiments, the inlet 2732 includes a generally rounded "D" shape and / or a rounded trapezoid, among other shapes. An inlet 2732 having a non-circular perimeter can desirably help to more easily assemble and / or align the frame 2178 and cushion module 2150. Such a configuration can help prevent imprecise assembly of the seal 2104 to the frame 2178. Such a configuration can help prevent or limit rotation of the frame 2178 relative to the cushion module 2150 once assembled. In some embodiments, the non-circular perimeter of the inlet 2732 allows at least a portion of the valve 2522 to be positioned closer to the center of the inlet 2732 than in designs having a circular inlet 2732 because such a non-circular configuration of the inlet 2732 has a smaller height than the circular inlet 2732. Such a non-circular configuration can desirably provide additional space for the valve 2522, thereby reducing the overall size (e.g., height) of the mask assembly 2100 when assembled compared to a mask having a circular inlet.

[0147] As described above, the mask seal 2104 can include a nasal region 2168. The nasal region 2168 can include a left sealing surface 2124B and a right sealing surface 2124A. In some embodiments, the left sealing surface 2124B and the right sealing surface 2124A can each define a convex surface region. As described herein above, the left sealing surface 2124B and the right sealing surface 2124A cooperate to define a concave surface region configured to receive the user's nose. The convex surface regions of the left sealing surface 2124B and the right sealing surface 2124A can be generally flattened. For example, the flattened convex surface regions can extend from the tops of the left sealing surface 2124B and the right sealing surface 2124A toward the nasal openings 2124. As the left sealing surface 2124B and the right sealing surface 2124A extend from their uppermost points toward the nasal openings 2124, the flattened convex surface regions can have a generally linear contour. The flattened sealing surfaces 2124B, 2124A can help to prevent or limit the formation of folds in the sealing surfaces 2124B, 2124A, for example, when the nose region 2168 engages the user's nose in use. Some configurations can help to minimize leakage around the user's nose in use.

[0148] 17 shows a close-up rear view of a portion of the nasal region 2168. While the left nasal sealing surface 2124B is shown and described, the right nasal sealing surface 2124A can include similar features and is preferably a mirror image of the left nasal sealing surface 2124B. As shown, the nasal sealing surface 2124B can be relatively flat laterally adjacent the nasal opening 2124. In some embodiments, the nasal sealing surface 2124B can have a relatively low curvature (e.g., approximately linear) as it extends radially outward from the nasal opening 2124 toward the uppermost point of the nasal sealing surface 2124B. In some embodiments, the curvature of the nasal sealing surface 2124B can be relatively low as the nasal sealing surface 2124B extends radially outward from the nasal opening 2124 to approximately the midpoint 2725 of the nasal sealing surface 2124B, as shown by lines of curvature 2727A, 2727B, 2727C, 2727D, 2727E. In some embodiments, the curvature of the nasal sealing surface 2124B increases as the nasal sealing surface 2124B extends radially outward beyond the midpoint 2725 (e.g., in the outer nasal sealing surface region).

[0149] As shown by curve plot 2728 and as described in more detail below, the radius of curvature of the outer nasal sealing surface region decreases in a posterior to anterior direction along the surface of the outer nasal sealing surface region. For example, in some embodiments, the radius of curvature of the outer nasal sealing surface region at the posterior portion of the nasal sealing surface 2124B is greater than the radius of curvature of the outer nasal sealing surface region at the anterior portion of the nasal sealing surface 2124B, i.e., the nasal sealing surface 2124B can go from less curvature to more curvature going in the posterior-to-anterior direction.

[0150] FIG. 18 shows a top view of the mask seal 2104. FIGS. 19A-19F are cross-sectional views of the mask seal 2104 from a rear view. As shown, in some embodiments, the left and right nasal sealing surfaces 2124B, 2124A can be angled from one another in at least two dimensions. For example, when viewed from the front or rear, the left and right nasal sealing surfaces 2124B, 2124A can extend upwardly, away from the nasal region 2168, at an angle that generally forms a V-shape. In some embodiments, when viewed from above, the left and right nasal sealing surfaces 2124B, 2124A can be angled away from one another in a direction from the front 2740 to the rear 2742 of the mask seal 2104 or seal assembly 2100. In such a configuration, the nasal region 2168, including the left and right nasal sealing surfaces 2124B, 2124A, can form a generally triangular shape. Such a configuration can desirably adapt to or generally conform to the shape of the user's nose, which can provide more stability and / or comfort to the user, and can help reduce air leakage through the mask seal 2104.

[0151] FIG. 19A shows a rear cross-sectional view taken along line 19A-19A in FIG. 18. FIG. 19B shows a rear cross-sectional view taken along line 19B-19B in FIG. 18. FIG. 19C shows a rear cross-sectional view taken along line 19C-19C in FIG. 18. FIG. 19D shows a rear cross-sectional view taken along line 19D-19D in FIG. 18. FIG. 19E shows a rear cross-sectional view taken along line 19E-19E in FIG. 18. FIG. 19F shows a rear cross-sectional view taken along line 19F-19F in FIG. 18. As shown in FIGS. 19A-19F, the left and right nasal sealing surfaces 2124B, 2124A of the nasal region 2168 can angle away from each other and outward and upward from a central vertical plane in the inferior-to-superior direction. In some embodiments, the angle between the left and right nasal sealing surfaces 2124B, 2124A increases in the posterior-to-anterior direction. In some embodiments, the depth of the nasal region 2168 decreases in the posterior-to-anterior direction. For example, angle 2744A may be approximately 57 degrees, angle 2744B may be approximately 60 degrees, angle 2744C may be approximately 64 degrees, angle 2744D may be approximately 71 degrees, angle 2744E may be approximately 77 degrees, angle 2744F may be approximately 88 degrees, and angles in between may be within these ranges. This configuration allows the nasal region 2168 to engage with the user's nose in use without extending over the tip of the user's nose. This configuration may desirably better conform to the shape of the user's nose, which may provide more stability and / or comfort to the user. This configuration may help reduce air leakage through the mask seal 2104.

[0152] 20A-22C show various views of a cushion module 2150 including a mask seal 2104 and a housing 2102 according to one embodiment. The mask seal 2104 preferably includes a pair of upwardly extending portions or upward extensions 2126 (see, e.g., FIG. 21A). The upwardly extending portions 2126 extend upwardly from either side of a central sealing surface of the seal. The central sealing surface is provided in a central portion of the mask seal 2104. The upwardly extending portions may be referred to as "seal paddles." The upper surface 2130 may define a line that lies along the central plane of the nasal region 2168 of the mask seal 2104 in the anterior-posterior direction. Such a line extends generally along the nasal septum in a direction away from the user's face. The upwardly extending portions 2126 are configured to extend upwardly in line with the nares in some configurations described above. The upwardly extending portion 2126 may contact the edges of the nostrils and / or the sides of the nose. The upwardly extending portion 2126 or the portion of the mask seal 2104 between the upwardly extending portions 2126 may or may not cover the tip of the user's nose. As described herein, preferably, the mask seal 2104 does not contact the bridge of the user's nose.

[0153] In some configurations, the upwardly extending portion 2126 includes air pockets formed by inner and outer walls (including the nose sealing surfaces 2124A,B) of the upwardly extending portion 2126. These air pockets may be in direct fluid communication with the air passages through the mask assembly 2100, and the upwardly extending portion 2126 may be configured to expand in volume in response to increased pressure within the mask seal 2104 and / or flex inward to accommodate various facial and nose shapes and help provide sealing contact with the user's face. The expansion of the upwardly extending portion 2126 may be particularly helpful in sealing against the user's face along the varying contours over and around the user's nose. The inward bending of the upwardly extending portion 2126 allows the central portion (e.g., upper surface 2130) to move downward with less restriction or stretch of the mask seal 2104 material, thereby allowing the mask seal 2104 to better conform to various nose shapes.

[0154] The height of the upwardly extending portion 2126 above the upper surface 2130 can be selected to provide a desired balance between stability (e.g., vertical stability) of the mask seal 2104 on the user's face and being able to accommodate a wider range of nose shapes or reduce visual obstruction caused by the upwardly extending portion 2126. Generally, a taller upwardly extending portion 2126 tends to provide more vertical stability to the mask assembly 2100, while a shorter upwardly extending portion 2126 tends to better accommodate a wider range of users and provide less visual obstruction. In some configurations, the height of the upwardly extending portion 2126 is from about 10 mm to about 30 mm, or from about 15 mm to about 25 mm. In some configurations, the height of the upwardly extending portion 2126 is from about 15 mm to about 22 mm, or from about 18 mm to about 20 mm (including any value or subrange within the aforementioned ranges). In some configurations, the height of the upwardly extending portion height is about 18.5 mm.

[0155] The mask seal 2104 may also include a support structure or support 2163 for the upwardly extending portion 2126, which may be in the form of a suspension member or spring that provides mechanical rigidity and structure to retain the shape of the upwardly extending portion when the mask seal 2104 is donned by a user. The support 2163 may include a thickened region of seal material. The support 2163 is preferably sized, shaped, and / or otherwise configured to transmit force from a rear or user-contacting surface of the upwardly extending portion 2126 toward or to a front surface of the upwardly extending portion 2126. In some configurations, the interface assembly may include a support portion or cover for the upwardly extending portion 2126, such as the upwardly extending support 2179, and the support 2163 may transmit force from a rearward face of the upwardly extending portion 2126 to a forward face or other portion of the upwardly extending portion 2126 or mask seal 2104 that contacts or faces the upwardly extending support 2179 or another portion of the frame 2178. In some configurations, the support 2163 may transmit force from a rearward face of the upwardly extending portion 2126 towards or to another support portion of the mask seal 2104, the housing 2102, or any other component of the interface assembly. The support portion 2163 may resist or prevent collapse of the upwardly extending portion 2126 or other associated or adjacent portions of the mask seal 2104 in response to applied forces (e.g., headgear forces), etc., to facilitate installation and provide feedback to the user. In some configurations, the support portion 2163 may resist or prevent collapse of the upwardly extending portion 2126 or other associated or adjacent portions of the mask seal 2104 in the absence of significant internal gas pressure.

[0156] The support portion 2163 may help maintain the shape of the upwardly extending portion 2126 of the mask seal 2104 and / or help maintain separation between the rear wall of the mask seal 2104 and the front wall of the mask seal 2104 (which define the face-contacting surface), at least in response to forces experienced during normal use. Additionally, the support portion 2163 may provide support to the nasal region 2168. In particular, the support portion 2163 may provide structure to inhibit or prevent folds, wrinkles, or collapse of the nasal region 2168. As discussed above, the nasal region 2168 is preferably relatively thin to allow this portion of the mask seal 2104 to conform to the user's nose. A relatively thin nasal region 2168 may expand and seal around the user's nose. The support portion 2163 provides a relatively rigid portion or element of the seal 2104 adjacent or near the relatively thin nose region 2168 that inhibits or prevents collapse when a user engages their nose within the mask assembly 2100.

[0157] In some configurations, the supports 2163 help reduce the likelihood of wrinkles or creases forming in the nose sealing surfaces 2124A, 2124B of the upwardly extending portion 2126 during use, while allowing the laterally inner portions to be as thin as desired within practical limits. The supports 2163 can inhibit or prevent collapse of the upwardly extending portion 2126 or help maintain a desired shape of the upwardly extending portion 2126. For example, the supports 2163 can help maintain a desired front-to-back shape of the upwardly extending portion 2126 and / or a lateral, i.e., side-to-side, shape of the upwardly extending portion 2126. The level of support provided can be different in different directions. In some configurations, the supports 2163 can be formed as a separate piece or component from the seal material and can be the same or a different material. Such separate supports 2163 may be coupled to the upwardly extending portion 2126 or other portions of the mask seal 2104 as needed. The supports 2163 disclosed herein may be particularly useful in under-the-nose mask assemblies that include both nasal masks and combined nose-and-mouth masks. However, the supports 2163 may also be utilized in other types of mask assemblies or interfaces, including, for example and without limitation, those that cover, contact or seal against the bridge of the user's nose, and / or include a T-piece or other type of forehead support. The supports 2163 may be utilized or modified for use anywhere in an interface where support against collapse and / or support against over-inflation may be desired. Such a location may be at or near the portion of the seal that contacts or extends alongside the user's nose, or may be elsewhere.

[0158] In the illustrated configuration, at least a portion of the support portion 2163 extends along the upwardly extending portion 2126 generally in the anterior-posterior direction. In particular, the support portion 2163 can extend along the upper edge 2169 of the upwardly extending portion 2126 or along the region or ridge joining the nasal sealing surfaces 2124A and 2124B along the upper edge 2169 of the upwardly extending portion 2126. The support portion 2163 can extend along portions of both sides of the nasal region 2168. The support portion 2163 can include a generally narrow, elongated shape. When viewed from above, the support portion 2163 can have a generally triangular shape, with the base of the triangle positioned posterior to the apex or point of the triangle. When viewed from the side, the support portion 2163 can have a generally sickle or crescent shape. Other shapes are possible to achieve a desired level of support or for other design considerations, such as the desired shape of adjacent or nearby structures. The support portion 2163 can have additional portions to provide other levels of support or to provide support in other directions. For example, the support portions 2163 can be connected to each other, such as along one or both of the anterior or posterior sides of the nasal openings 2124. In some configurations, the support portion 2163 can extend completely through the upwardly extending portion 2126, such as all the way to the housing 2102.

[0159] The illustrated mask seal 2104 of the cushion module 2150 has a range and configuration of thicknesses. The thicknesses are varied to utilize or provide different characteristics in different regions of the illustrated mask seal 2104. For example, the thicknesses in various regions can be selected to address desired characteristics for that region and / or for the mask seal 2104 as a whole. Such characteristics can include, for example, allowing the mask seal 2104 to conform to the shape of the user's face to improve sealing properties or comfort, supporting the shape of the mask seal without significant internal gas pressure to facilitate installation and / or in response to internal gas pressure and / or external pressure (e.g., caused by headgear forces), or providing strength or durability.

[0160] As mentioned above, the mask seal 2104 can include various regions of different thicknesses. Examples of such configurations are disclosed in applicant's International Publication No. WO 2015 / 193821 A1, which is incorporated herein by reference in its entirety. Generally, the outer surface of the mask seal 2104 defines a relatively smooth or curved surface without abrupt changes in direction. The different thicknesses can be provided by changes in apparent wall thickness or by changes in the shape of the inner surface of the mask seal 2104.

[0161] The support portion 2163 can have a different thickness than the rest of the upwardly extending portion 2126, and can have a greater thickness than the rest of the upwardly extending portion 2126. In some configurations, the support portion 2163 can have a thickness that is greater than or equal to the maximum thickness of the mask seal 2104. In some configurations, part or all of the support portion 2163 can have a thickness of about 1.5 mm to about 3.5 mm. In some configurations, the support portion 2163 can have a thickness of about 4 mm to about 5 mm. In some configurations, part or all of the support portion 2163 can have a thickness of about 2.5 mm. The thickness of the support portion 2163 can be constant or variable. In some configurations, the support structure 2163 for the upwardly extending portion 2126 is thicker than the nasal region 2168.

[0162] In order to reduce the generation of wrinkles in at least a partial region of the face contact area of the mask seal 2104 during use, it has been found that desirable performance can be provided when the outer peripheral edge portion 2162 of the mask seal 2104 shown in FIG. 21C (generally adjacent to a part or all of the face contact portion of the mask seal 2104) is considerably stiffer or relatively stiffer compared to an adjacent portion or other portion of the mask seal 2104. In the illustrated configuration, the outer peripheral edge portion 2162 extends along a portion that generally extends vertically at the rear of the mask seal 2104 and turns slightly inward at the bottom of the rear of the mask seal 2104. Further, the outer peripheral edge portion 2162 turns from the side facing the rear of the mask seal 2104 to at least a part of the side facing the lateral direction of the mask seal 2104. In some configurations, the outer peripheral edge portion 2162 extends along the user's cheek. The outer peripheral edge portion 2162 can extend toward or to a region below the cheek or the lower lip of the user in the case of a full-face mask or above the upper lip of the user in the case of a nose mask.

[0163] In the illustrated configuration, the outer peripheral edge portion 2162 is located on each side portion of the mouth opening 2122. In some configurations, the outer peripheral edge portion 2162 extends along the entire height of the mouth opening 2122. The upper end portion of the outer peripheral edge portion 2162 can extend at least up to around the upper end portion of the mouth opening 2122. The lower end portion of the outer peripheral edge portion 2162 can extend below the lower end portion of the mouth opening 2122. As described above, in some configurations, the outer peripheral edge portion 2162 turns inwardly below the mouth opening 2122, and a part of the outer peripheral edge portion 2162 is positioned vertically below a part of the mouth opening 2122.

[0164] The relatively increased thickness of the peripheral edge portion 2162 can help to resist or prevent collapse of the mask seal 2104 in the absence of significant internal gas pressure, facilitate installation, provide feedback to the user in response to applied forces (e.g., headgear forces), etc. The peripheral edge portion 2162 can help maintain the curved shape of the sides of the mask seal 2104 and / or help maintain separation between the rear wall of the mask seal 2104 (which defines the face-contacting surface) and the front wall of the mask seal 2104, at least in response to forces experienced during normal use. In some configurations, the thickness of part or all of the peripheral edge portion 2162 can be from about 1.0 mm to about 2.0 mm. In the illustrated configuration, part or all of the peripheral edge portion 2162 preferably has a thickness of about 1.5 mm. The thickness of the peripheral edge portion 2162 can be consistent or vary within the boundaries of the peripheral edge portion 2162.

[0165] In some configurations, an upper portion of the front surface of the seal 2104 adjacent the outer wall or front surface of the upwardly extending portion 2126 includes an upper concave surface 2432 formed in the seal 2104 (see, for example, FIGS. 12 and 21B ). In the illustrated configuration, the upper concave surface 2432 is positioned along the front side of the upwardly extending portion 2126. The upper concave surface 2432 may extend along the outer peripheral edge portion 2162 of the front side of the mask seal 2104. The upper concave surface 2432 may extend rearward around the sides of the mask seal 2104. In some configurations, the upper concave surface 2432 may extend downward approximately half the height of the front side on each side of the seal 2104. In some configurations, the upper concave surface 2432 extends downward less than half the front side, and sometimes about one-third of the front side of the seal 2104. An upper edge portion of the seal 2104 projects forward from the seal 2104, specifically forward from the upper concave surface 2432. This projection, together with each upper concave surface 2432, can form a recess on either side of the seal. When the frame 2178 is assembled to the cushion module 2150, the upwardly extending supports 2179 are received in the respective recesses. The upwardly extending supports 2179 provide support for each upper concave surface 2432. The upwardly extending supports 2179 engage with the upper concave surfaces 2432 when the seal 2104 is inflated in use and / or when the seal 2104 is not in use (uninflated). The forward projection of the upper edge of the seal 2104 forms an overhang that extends above the upper edge of the frame 2178 when the frame 2178 is assembled to the cushion module 2150.

[0166] In some configurations, the upper concave surface 2432 forms a step transition between the upper peripheral edge of the upper front portion or the upper edge of the upwardly extending portion 2126, which extends along the curvature of the peripheral edge. In some embodiments, the support 2163 can form at least a portion of this step transition. In some configurations, the step transition extends to a constant depth or a variable depth. For example, the depth of the step transition can be constant throughout the step transition. However, in some configurations, the step transition varies. For example, the step transition can be tapered. In this configuration, the depth can be smallest at or relatively near the bottom or side ends of the step transition. However, in some embodiments, the depth is smallest at or relatively near the top end of the step transition.

[0167] The seal 2104 may include additional features configured to reduce the likelihood of wrinkles or creases forming in the face-contacting portion of the upwardly extending portion 2126 during use, while allowing the laterally inner portion to have an advantageously small wall thickness. For example, in some embodiments, the front or outer wall of each upwardly extending portion 2126 of the seal 2104 may include a thinned region or thinned pocket 2224, as shown, for example, in FIGS. 20A, 20B, 21B, and 21E. The front wall may have a reduced thickness at the thinned pocket 2224 compared to the surrounding wall portion. For example, the front wall may have a thickness of 0.2 mm to 0.4 mm, preferably approximately 0.3 mm, at the thinned pocket 2224, while the surrounding wall may have a thickness of 0.4 mm to 2.6 mm. In some embodiments, the wall thickness of the thinned pocket 2224 may vary along the region of the thinned pocket 2224. 21E, the change in wall thickness of the thin pocket 2224 can be located on the inner surface 2142 of the front wall of the upwardly extending portion 2126, such that the thin pocket 2224 forms a step in the inner surface 2142, while the outer surface of the front wall in the area of ​​the thin pocket 2224 is smooth and continuous. Thus, in the illustrated configuration, the thin pocket 2224 may not be visible from outside the seal 2104 (FIGS. 20B and 21B include an outline of the thin pocket 2224 to show its location on the inner surface). In other embodiments, the thin pocket 2224 can include a concave outer surface and / or a concave inner surface of the front wall of the upwardly extending portion 2126.

[0168] In some embodiments, the thin pocket 2224 can be substantially teardrop-shaped, with the narrow end or point of the teardrop shape near the center front of the seal 2104. The thin pocket 2224 can taper in height toward the front of the seal and substantially follow the contour of the upper edge of the upwardly extending portion 2126. In some embodiments, the thin pocket 2224 can have any suitable shape, such as an oval shape. In some embodiments, at least a portion of the lower edge of the thin pocket 2224 is bounded by the upper portion of the overmolded region 2106 of the seal 2104. The reduced wall thickness of the thin pocket 2104 can be limited to the upwardly extending portion 2126 or the upper front portion of the seal 2104 and not extend across the front wall of the seal 2104, which can reduce or limit crease formation in the nasal sealing surfaces 2124A, 2124B. The upper edge of the thin pocket 2224 can be at least partially defined by the thickened rib 2222.

[0169] In some embodiments, the front wall of each upwardly extending support portion 2126 of the seal 2104 can include a thickened rib 2222, as shown in FIGS. 20B, 21C, and 21E. The thickened rib 2222 can extend from the lower edge of the support structure 2163 toward the center of the seal 2104 along an upper portion of the outer wall of the upwardly extending portion 2126 to provide additional support to the seal 2104. The thickened rib can be adjacent to the upper edge 2169 of the seal 2104, but can also be spaced apart from the upper edge 2169. When viewed from the front, the thickened rib can curve diagonally downward. The rib 2222 can generally follow the curvature of the upper edge of the upwardly extending portion 2126. In some embodiments, such as shown in FIG. 21E, the thickened rib 2222 can be located on the inner surface 2142 of the front wall of the upwardly extending portion 2126, and the thickened rib 2222 forms a rearwardly protruding structure between the thin pocket 2224 and the nose sealing surface 2168.

[0170] As described above, the thickened rib 2222 can define at least a portion of the upper edge of the thin pocket 2224. For example, as shown in FIGS. 20B and 21B, the rib 2222 can extend at least partially along the corner / step 2144 of the upper concave surface 2432. In some embodiments, the rib 2222 can extend mostly along the corner / step 2144 of the upper concave surface 2432. In some embodiments, as shown in FIG. 20B, there can be a gap 2226 between the thickened rib 2222 and the step 2144 of the upper concave surface 2432 adjacent where the rib 2222 meets the support structure 2613. The gap 2226 can have a reduced thickness relative to the surrounding wall of the seal 2104. In some embodiments, the gap 2226 can have a thickness similar to that of the thin pocket 2224. The gap 2226 can have a thickness of 0.2 mm to 0.4 mm, preferably approximately 0.3 mm. In other embodiments, the thickened rib 2222 can extend along the step within the gap 2226 .

[0171] The thickened rib 2222 can have a thickness sufficient to withstand vertical forces against the upwardly extending portion 2126, reducing or limiting the likelihood of wrinkles or creases forming in the face-contacting portion of the upwardly extending portion 2126. For example, the rib 2222 can have a thickness of 1.0 mm to 2.0 mm, preferably 1.1 mm to 1.4 mm. The thickened rib 2222 can have a thickness that varies along its length. For example, in some embodiments, the thickened rib 2222 can have a thickness that is greatest near the horizontal center of the seal 2104 to provide relatively greater support in the central region of the seal 2104. In some embodiments, the thickened rib 2222 can have a relatively consistent thickness, height, and / or width along its length. The thickened rib 2222 can be uniformly offset from the step 2144.

[0172] 22A-22C show several positions of the seal 2104 that can be facilitated or strengthened by the presence of one or both of the thin pocket 2224 and the thickened rib 2222. FIG. 22A shows the seal 2104 in a natural or relaxed position. The thin pocket 2224 provides flexibility to the outer wall of the upwardly extending portion 2126, allowing the upwardly extending portion 2126 to flex outward when a lateral outward force is applied to each side of the nasal region 2168 and / or the inner wall of the upwardly extending portion 2126, as shown in FIG. 22B. Such a lateral force can be applied to the nasal region 2168 when the width of the user's nose is such that the nasal sealing surface deforms or flexes laterally outward. This can occur, for example, if the user has a nose that is larger than the width of a particular seal size. In some embodiments, the thin pocket 2224 can also allow the upwardly extending portion to expand under positive pressure. This can increase engagement between the nasal region 2168 and the user's nose, thus strengthening the seal. Meanwhile, as shown in FIG. 22C , the thickened ribs 2222 are configured to provide support that reduces or limits crease formation in the nasal region 2168 when a downward force is applied to the upper surface 2130 of the nasal region 2168, resulting in some deformation of the seal 2104. In use, the downward force can cause the upwardly extending portion 2126 to be pulled inward toward the user's nose. If excessive downward force is applied, the nasal region 2168 can collapse inward, sometimes at least partially toward the front of the seal. The thickened ribs 2222 can support the nasal sealing surfaces 2124A and 2124B, and the ribs 2222 can encourage the upwardly extending portion 2126 to curl downward, providing resistance to crease formation while still allowing the seal 2104 to conform to different facial shapes.

[0173] FIG. 28 shows a side view of a patient interface illustrating one embodiment of headgear 2180. FIG. 29 shows an exterior plan view of the exterior surface of the headgear 2180, and FIG. 30 shows an interior plan view of the interior surface of the headgear 2180, with the headgear 2180 lying flat in both FIGS. 29 and 30. As discussed above, the headgear 2180 can include a strap assembly including, among other components or portions, at least two upper side straps 2804, at least two lower side straps 2802, a back panel 2806, and / or a crown strap 2808. As shown in at least FIGS. 29 and 30, the upper side straps 2804 can be connected to the crown strap 2808 at an angle 2818. For example, the angle 2818 between the upper side straps 2804 and the crown strap 2804 can be approximately 144 degrees. In some embodiments, the angle 2818 is 130 degrees, 135 degrees, 140 degrees, 145 degrees, or 150 degrees or more. The angle 2818 allows the upper side straps 2804 to extend downward over the user's ears and onto the frame 2178 in use.

[0174] In use, the upper side straps 2804 can be positioned on either side of the headgear 2180 and can extend downward from the crown strap 2808 towards the mask assembly 2100. In some embodiments, the upper side straps 2804 can be configured to extend across the cheeks of a user when worn. In some embodiments, the upper side straps 2804 can be adjustably and / or directly connected to the frame 2178, such as at the upper strap connectors 2702 of the frame 2178.

[0175] In some embodiments, the lower side straps 2802 can be positioned on either side of the headgear 2180. In use, the lower side straps 2802 can extend substantially horizontally below the user's ears. The lower side straps 2802 can extend from the back panel 2806 to or toward the mask assembly 2100. In some embodiments, the lower side straps 2802 can be configured to extend across the user's face, such as generally along the user's chin, when worn. In some embodiments, the lower side straps 2804 can be adjustably connected to the frame 2178. The connection between the frame 2178 and the lower side straps 2802 can include a direct and / or indirect connection. For example, the lower side straps 2802 can be indirectly connected to the frame 2178 via the headgear clips 2600.

[0176] As shown in FIGS. 28-30 , the upper side straps 2804 and the lower side straps 2802 can be connected by a back panel 2806. The connections between the upper side straps 2804 and the lower side straps 2802 at the back panel 2806 can be positioned behind the user's ears during use. This configuration can provide stability and support to the headgear 2180. This configuration can be more comfortable for the user when worn and / or provide a more aesthetically pleasing appearance.

[0177] In some embodiments, the rear panel 2806 can be positioned approximately in the center of the headgear 2180. The rear panel 2806 can be configured to contact the back of a user's head when worn. In some embodiments, the rear panel 2806 can include at least two or more portions. The rear panel 2806 can include a first portion 2806A and a second portion 2806B. The first portion 2806A can be integrally formed with one or both of the upper side straps 2804 and the lower side straps 2802. In the illustrated configuration, the first portion 2806A is made up of two separate sections that can be spaced apart by the second portion 2806B. In some embodiments, the second portion 2806B can be positioned approximately in the center of the rear panel 2806. The second portion 2806B can be made, at least in part, from a spacer fabric. An example of such a spacer fabric is disclosed in applicant's International Publication No. 2017 / 021836, which is incorporated herein by reference in its entirety. The spacer fabric can provide additional comfort to the user. For example, the spacer fabric can desirably be lightweight and breathable and / or form a cushioned area at the back of the user's head. In some embodiments, the second portion of the spacer fabric can extend inward from the first portion 2806A of the back panel 2806. In some embodiments, the spacer fabric can include two layers of spacer fabric. For example, each of the layers can be layered in an overlapping manner.

[0178] As mentioned above, in some embodiments, the headgear 2180 includes a crown strap 2808. The crown strap 2808 can include a right portion 2810 and a left portion 2812. In some embodiments, the left portion 2812 and the right portion 2810 can form a strap that extends across the top region of the user's head, such as the crown of the user's head.

[0179] In some embodiments, the left portion 2812 and the right portion 2810 can be adjustably coupled. In some embodiments, the left portion 2812 and the right portion 2810 are adjustably coupled by a buckle. In some embodiments, the left portion 2812 includes an aperture 2813. The aperture 2813 can be positioned near an end of the left portion 2812 of the crown strap 2808. In some embodiments, the aperture 2813 can receive at least a portion of the right portion 2810 of the crown strap 2808. In some embodiments, the aperture 2813 allows the left portion 2812 and the right portion 2810 to be adjustably coupled. For example, the left portion 2812 and the right portion 2810 can be slidably adjusted relative to one another.

[0180] In some embodiments, the right portion 2810 includes a first recessed region 2811A and a second recessed region 2811A. The first recessed region 2811A and the second recessed region 2811A can be formed along opposite sides of the right portion 2810. The first recessed region 2811A and the second recessed region 2811A can be aligned with one another and positioned offset from the ends of the right portion 2810. In some embodiments, the first recessed region 2811A and the second recessed region 2811B define a region of reduced width that can slide through the aperture 2813. In some embodiments, the region of reduced width can slide through the aperture 2813 with little or no deformation of the left portion 2812 and / or the right portion 2810.

[0181] Although the left portion 2812 is shown as having an aperture 2813 and the right portion 2810 is shown as having a first recessed area 2811 and a second recessed area 2811B, other configurations are contemplated. For example, the right portion 2810 can include the aperture 2813, and the left portion 2812 can include the first recessed area 2811A and the second recessed area 2811B.

[0182] In some embodiments, the upper side straps 2804 , the lower side straps 2802 and / or the crown strap 2808 can include fastening features 2820 . The fastening features 2820 may include, among other features, one or more hook and loop fasteners (hook and loop). The fastening features 2820 allow the headgear to be adjusted to various lengths, such as a user-defined length. In some embodiments, the fastening features 2820 on the lower side straps 2802 and / or upper side straps 2804 allow the straps 2802, 2804 to be easily adjusted and / or removed from the mask assembly 2100.

[0183] 31A and 31B illustrate one embodiment of an interface assembly including a headgear assembly 2180 that is similar to the headgear assemblies described elsewhere herein. FIG. 31A illustrates front, top, and side perspective views of the interface assembly, and FIG. 31B illustrates front and top perspective views of the interface assembly. Among other components, the headgear assembly 2180 can include at least two upper side straps 2804, at least two lower side straps 2802, which can be similar to corresponding components of the headgear assemblies described elsewhere herein, and the headgear assembly 2180 can be attached to the frame 2178 and the mask assembly 2100, including the seal 2104. As described with respect to FIGS. 3A-11, the frame 2178 can include an air inlet or conduit connector portion 2706 connected to an air delivery conduit 2520A.

[0184] Additionally, the headgear assembly 2180 can also include a headgear connector element 2900. The headgear connector element can be in the form of a tether or a yoke. As shown in FIGS. 31A and 31B , the headgear connector element 2900 can be an elongated flexible member that couples the upper side straps 2804 to the frame 2178. When coupled to the frame 2178, the headgear connector element 2900 can extend laterally across the frame 2178 below the tip of the user's nose, preventing interference between the headgear straps 2800 and the upwardly extending portion 2126. The headgear connector element 2900 can further provide the correct force vector to the seal 2104 below the user's nose. The headgear connector element 2900 can be positioned between the upper side straps 2804 and connect the two upper side straps 2804. The headgear connector element 2900 can be removably attached to the frame 2178 such that the upper side straps 2804 connected to the headgear connector element 2900 can also be removably attached to the frame 2178 .

[0185] In some embodiments, the headgear connector element 2900 can be constructed of a flexible material such that the headgear connector element 2900 can bend and follow the curvature of the frame 2178 when attached to the mask assembly 2100. In some embodiments, the headgear connector element 2900 can be constructed of an elastomeric material such as silicone or a thermoplastic elastomer (TPE), such as the material sold under the name Pebax® 2533. The frame 2178 can include fasteners configured to hold the headgear connector element 2900 when the headgear connector element 2900 is removably attached to the frame 2178. The fasteners 2904 and the headgear connector element 2900 can include any suitable mechanical connection, such as a female / female or button / hole interlocking configuration.

[0186] 32 shows a front view of a headgear connector element 2900, with the upper side straps 2804 not shown, attached to a frame 2178 that is assembled to a mask assembly 2100, which can have a cushion module 2150 including a housing 2102 and a mask seal 2104. As shown in FIG. 32, the headgear connector element 2900 can be positioned below an upper edge of the frame 2178 such that at least a portion of the upwardly extending supports 2179 of the frame 2178 extends above the headgear connector element 2900. In some embodiments, the upwardly extending supports 2179 can act as a backing structure for the headgear connector element 2900 such that the headgear connector element 2900 is spaced from the seal 2104. In some embodiments, the headgear connector element 2900 can curve upward toward the upwardly extending supports 2179. The headgear connector element 2900 can have a length that is less than the width of the frame 2178 so that it is positioned laterally within the lateral edges of the frame 2178, thereby inhibiting or preventing the headgear connector element 2900 or its rigid components such as the strap loops 2940 (described in more detail below) from contacting the seal 2104 or the user's face.

[0187] 33A-33C show front and side perspective views, a side view, and a front view, respectively, of headgear 2180 including a headgear connector element 2900. The headgear assembly 2180 can include, among other parts or components, a strap assembly including at least two upper side straps 2804, at least two lower side straps 2802, a back panel 2806, and / or a crown strap 2808. The components of the headgear 2180 can be similar to the components of the headgear described in connection with FIGS. 28-30. For example, the upper side straps 2804 can connect to the crown strap 2808, and the lower side straps 2802 include headgear clips 2600 at their free ends that are coupled to the frame 2178. As described above, the upper side straps 2804 can also be connected to the headgear connector elements 2900, whereby the upper side straps 2804, headgear connector elements 2900, and crown strap 2808 form a closed loop 2910. In some embodiments, as shown in FIG. 33A , the upper side straps 2804 can be connected to the headgear connector elements 2900 even when the yoke is detached from the frame 2178, such that the closed loop 2910 formed by the upper side straps 2804, headgear connector elements 2900, and crown strap 2808 is maintained when the headgear 2180 is removed from the frame 2178. This allows the user's attachment / sizing settings to be retained when the headgear assembly 2180 and headgear connector elements 2900 are separated from the frame 2708, for example, for cleaning. This makes it faster and easier for the user to attach the interface because there is no need to readjust the straps. Additionally, the headgear connector element 2900 may hold the free ends of the upper side straps 2804 apart, preventing them from hanging loosely and swinging freely when the headgear assembly 2180 is separated from the frame 2178. Such a configuration facilitates coupling of the headgear assembly 2180 to the frame 2178.

[0188] 34A-34G show one embodiment of a headgear connector element 2900. FIGS. 34A-34C show front, back, and side views, respectively, of the headgear connector element 2900. The headgear connector element 2900 can include a body portion ("body") 2920 and strap loops 2940 at each end of the body 2920. The body 2920 can be substantially flat and / or planar and can have a rearward-facing surface 2924 configured to face the frame 2178 when the headgear connector element 2900 is attached to the frame 2178, and a forward-facing surface 2922 opposite the rearward-facing surface 2924. The headgear connector element 2900 can be relatively flat or planar in its natural configuration, but its flexibility allows it to bend to follow the curvature of the frame 2178. By being formed as a flat component, the headgear connector element 2900 can be provided with resilience that biases it toward its flat, natural configuration. This resilience can help maintain the headgear assembly 2180 in an open configuration when not attached to a mask, as shown in FIGS. 33A-33C. Additionally, the body 2920 can have a sufficient level of stiffness to enable it to securely snap into and be retained by the fasteners 2904.

[0189] In the illustrated embodiment, the body 2920 includes a recess or concave portion 2980 in the center of its lower edge. The concave portion 2980 can improve aesthetic appeal by passing over the boss of the air inlet 2706 rather than overlapping it. Additionally, the concave portion 2980 reduces the width of the center portion of the body 2920, thus minimizing bulk at the front of the interface assembly and providing a less obtrusive appearance. The reduced width of the center portion of the body 2920 can also help the headgear connector element 2900 flex to follow the surface contours of the frame 2178. In some embodiments, the body 2920 may not include a concave portion, and the upper and lower edges of the body 2920 can extend at least substantially parallel to one another.

[0190] The strap loops 2940 can have any suitable shape / dimension to receive and retain the upper side straps 2804. For example, in some embodiments, the free end of each of the upper side straps 2804 can be threaded through one of the strap loops 2940, folded back, and secured to itself at a user-defined location to size the headgear 2180. For example, any suitable fastener known in the art, such as hook-and-loop fasteners or Velcro®, can be used to secure the upper side straps 2804 around the loops 2940. The strap loops 2940 can have an internal slot with a length L that can be substantially the same as or greater than the width of the upper side straps 2804, so that the upper side straps 2804 do not kink when coupled to the loops 2940. Further, the main body 2920 can have a width W that is substantially similar to or the same as the width of the upper side straps 2804, and the headgear connector element 2900 and upper side straps 2804 have the appearance of a single strap that extends entirely around the user's head and mask assembly 2100. In the illustrated embodiment, the headgear connector element 2900 has an upwardly concave shape such that the strap loops 2940 are angled upward, so that when the upper side straps 2804 are coupled to the strap loops 2940, the straps 2804 are directed upward to pass between the user's ears and eyes. However, the headgear connector element 2900 and body 2920 can have any suitable shape to conform to the frame 2178 and to orient the upper side straps 2804 in a desired direction.

[0191] The strap loops 2940 can be formed from a more rigid material than the body 2920 so as to maintain their shape when coupled to the straps 2804. Additionally, the strap loops 2940 can have a low-friction surface finish that allows the upper side straps 2804 to slide smoothly through the loops 2940. In some embodiments, the strap loops 2940 can include a higher friction surface or are shaped and / or sized to provide some interference with the straps 2804 so that the straps 2804 do not fall freely through the strap loops 2940. This interference between the strap loops 2940 and the straps 2804 allows the straps to remain assembled to the headgear connector element 2900 even when the straps are folded over and not secured to themselves, thus improving the ease with which the straps 2804 can be attached and adjusted.

[0192] In some embodiments, the strap loops 2940 can be formed from a material other than silicone or a thermoplastic elastomer (TPE), such as nylon. In some embodiments, the strap loops 2904 can be constructed, for example, by molding as a separate component from the body 2920 and later coupled to the body 2920 to form the headgear connector element 2900. FIG. 34D shows a diagram of the headgear connector element 2900, with the body 2920 shown in outline to illustrate one example of a coupling configuration for the strap loops 2940 and the body 2920. In the illustrated embodiment, the body 2920 can be overmolded onto the strap loops 2940 at overmolded tabs 2942 extending from one side of each of the strap loops 2940. In some embodiments, the overmolded tabs 2942 can have one or more holes 2943 therethrough to form a mechanical interlock with the overmolded material of the body 2920. Because the strap loop 2940 and overmolded tab 2942 can serve as an overmolded substrate, they can be made from a very stiff material, which inhibits or prevents the overmolded tab 2942 from flexing or otherwise twisting through the overmolded area during the overmolding process and potentially tearing. In some embodiments, the overmolded tab 2942 can include additional support that prevents the tab 2942 from flexing and tearing through the overmolded area. In addition to or instead of overmolding, in some embodiments, the strap loop 2940 and body 2920 can be joined together by, for example, adhesive and / or heat welding.

[0193] In some embodiments, the body 2920 can further include one or more fastener apertures 2960 in the form of eyelets that receive the fasteners 2904 of the frame 2178. In the illustrated embodiment, the body 2920 has two apertures 2960 that receive two fasteners 2904. In some embodiments, the headgear connector element 2900 and frame 2178 can have three or more apertures 2960 and fasteners 2904 so that there are more attachment points for additional or more secure coupling of the headgear connector element 2900 to the frame 2178. The apertures 2960 can have any suitable shape that can receive and retain the fasteners 2904. For example, as in the illustrated embodiment, the apertures 2960 and fasteners 2904 can have a circular shape. As shown in FIG. 34B , the headgear connector element 2900 can also include one or more rims 2962 that are located around and surround each of the apertures 2960. The rim 2962 can be constructed of a stiffer or more resilient material so that the aperture 2960 can help withstand multiple attachment / detachment cycles of the headgear connector element 2900. In some embodiments, the rim 2962 can be formed of the same material as the body 2920. In some embodiments, the rim 2962 can be constructed of a thermoplastic elastomer (TPE). In some embodiments, the rim 2962 can have a greater thickness than the body 2920. The rim 2962 can be thicker than the body 2920 and thus can protrude from the body 2920. In the illustrated embodiment, the thickened rim 2962 is provided only on the rear surface 2924 of the headgear connector element 2900 so that it is not visible when the headgear connector element 2900 is coupled to the frame 2178. In some embodiments, the rim 2962 can be formed on the front side 2922 or on both the front 2922 and rear 2924 surfaces.

[0194] FIG. 35A shows one embodiment of a frame 2178 having fasteners 2904. In the illustrated embodiment, the frame 2178 includes two male fasteners 2904 protruding from a front surface of the frame 2178. Each male fastener 2904 is configured to pass through one of the apertures 2960 in the headgear connector element 2900 to fasten the headgear connector element 2900 to the frame 2178. However, the fasteners 2904 and apertures 2960 can be replaced with any removable attachment mechanism known in the art. For example, in some embodiments, the frame 2178 can have a female component and the headgear connector element 2900 can have a male component. The frame 2178 and the headgear connector element 2900 can have other mechanical connection mechanisms. For example, the headgear connector element 2900 can be configured to be pressed into a slot in the frame 2178, the headgear connector element 2900 can be configured to stretch fit over the frame 2178, or the headgear connector element 2900 and frame 2178 can have a sliding glider-type configuration. In one such sliding glider-type configuration, one or more attachment members (e.g., filaments or straps) of the headgear connector element 2900 are received by one or more suitable receptacle structures (e.g., cavities) in the frame 2178, allowing some amount of relative sliding movement between the headgear connector element 2900 and the frame 2178. In some embodiments, the headgear connector element 2900 and the frame 2178 can be coupled by one or more hook-and-loop fasteners.

[0195] As shown in FIG. 35B , which shows an enlarged cross-sectional view of the frame 2178, each of the male fastener components 2904 includes a post 2934 with an enlarged head 2932 at the uppermost end of the post 2934. The enlarged head 2932 can have a larger cross-sectional dimension / area than the aperture 2960 of the headgear connector element 2900. The enlarged head 2932 can be in the form of a flange extending from the periphery of the post. The enlarged head 2932 can form a substantially planar surface facing outward, away from the frame. In some embodiments, the enlarged heads 2932 can be offset or asymmetrical laterally relative to the post 2934. The enlarged heads 2932 of each post can be asymmetrical in opposite directions. The asymmetry of the enlarged heads 2932 can aid in fastening the headgear connector element 2900 to the frame 2178 and can prevent the ends of the headgear connector element 2900 from popping out of the frame. Additionally, this design may improve the manufacturability of frame 2178 by simplifying the draw surface of the mold. The height of fastener component 2904 (i.e., the distance fastener component 2904 protrudes from the front surface of frame 2178) may be determined from the draw surface of the mold. In the illustrated embodiment, fastener 2904 has a height of 3.5 mm. In some embodiments, fastener 2904 may have a height that is greater than or less than 3.5 mm, for example, 2-10 mm, 3-7 mm, or 3-4 mm.

[0196] Referring to FIG. 34E, which is a bottom view of the headgear connector element 2900, the headgear connector element 2900 can have a thickness that varies along its length. In some embodiments, as shown in FIG. 34F, the body 2920 can have a thickness A of, for example, 2.5 mm at its thinnest region. In some embodiments, the body 2920 can have a thickness of 1-5 mm, 1.5-4 mm, or 2-3 mm. The thickness of the body 2920, in combination with the properties of the elastic material forming the body 2920, can be selected to provide a desired degree of flexibility. In some embodiments, the body 2920 can have at least a substantially constant thickness along its length. In some embodiments, portions of the body 2920, such as a central portion of the body 2920, can have a smaller thickness, thereby making those portions more flexible to help the headgear connector element 2900 bend.

[0197] As shown in FIG. 34F, which is a close-up of the headgear connector element 2900 shown in FIG. 34E, and as described elsewhere herein, the thickness can be increased around the periphery of the fastener aperture 2960 to form a thickened aperture rim 2962. In the illustrated embodiment, the rim 2962 can have a thickness B of 3.25 mm. In some embodiments, the rim 2962 can have a thickness of 1-7 mm, 2-5 mm, or 3-4 mm.

[0198] The thickness of the rims 2962 can be determined based on the height of the male fastener posts 2934 to which they are attached. In some embodiments, the top of the enlarged heads 2932 can be flush or relatively flush with the forward-facing surface 2922 of the headgear connector element 2900 when the fastener 2904 is coupled to the aperture 2960. This can provide a smoother appearance and can also prevent the posts 2934 from digging into a user's fingers and causing discomfort when fastening the headgear connector element 2900 to the frame 2178. In some embodiments, the thickness B of the rims 2962 can be slightly less than the height of the fasteners 2904 so that the apertures 2960 can pass completely through and be retained by the fasteners 2904. The thickness of the rim 2962 can be determined based on the height of the fastener post 2934, but it may not be desirable for the entire headgear connector element 2900 to have a thickness that matches the thickness of the rim 2962 or the height of the fastener 2904, as this may limit the flexibility of the headgear connector element 2900 and may make the headgear connector element 2900 and interface heavier and more expensive due to increased material usage. Thus, in some configurations, only the rim 2962 can be thickened. In some embodiments, as shown in FIG. 34G, which shows a cross-sectional view of the headgear connector element 2900 along line 34G-34G in FIG. 34D, the inner surface 2964 of the aperture 2960 can be at least partially toroidal in shape. The inner surface 2964 can have a minimum diameter that substantially matches the outer diameter of the post 2934 of the male fastener 2904. As a result, when the headgear connector element 2900 is connected to the frame 2178 to create a snap-fit ​​or interlocking connection, temporary deformation of one or both of the post 2934 and the portion of the headgear connector element 2900 that defines the aperture 2960 occurs. The diameter of the inner surface 2964 of the aperture 2960 can be relatively larger on both the forward-facing surface 2922 and the rearward-facing surface 2924 of the headgear connector element 2900. This provides a lead-in for the post 2934 and / or allows the head 2932 to be at least partially recessed within the headgear connector element 2900 when fully assembled, without the head 2932 protruding too far from the front surface 2922 of the headgear connector element 2900 and becoming caught on clothing or other objects. In some embodiments, the head 2932 can protrude beyond the forward-facing surface 2922 of the headgear connector element 2900, as shown in FIG.

[0199] The strap loop 2940 can have a thickness C that is greater than the body 2920 . In some embodiments, thickness C can be less than thickness B of aperture rim 2962. In other embodiments, thickness C can be the same as or greater than thickness B. In the illustrated embodiment, thickness C of strap loop 2940 can be 3 mm. In some embodiments, strap loop 2940 can have a thickness of 1-5 mm, 2-4 mm, or 2.5-3.5 mm. As shown in FIG. 34G, overmold tab 2942 can have a reduced thickness D that is less than thickness A of body 2920 so that it is completely encapsulated by the material of body 2920. In some embodiments, overmold tab 2942 can have a thickness D of 1 mm. In some embodiments, overmold tab 2942 can have a thickness D of 0.5-1.5 mm or any other suitable thickness.

[0200] 37A and 37B illustrate another embodiment of a headgear connector element 2900. Similar to the headgear connector element 2900 described in connection with FIGS. 31A-36, the headgear connector element 2900 may include a main body 2920, strap loops 2940 attached to each end of the main body 2920, and an aperture 2960. The main body 2920 includes a front surface 2922 and a rear surface 2924. In the illustrated embodiment, the main body 2920 may be constructed of a foam and / or fabric laminate, such as Breath-o-Prene®, and thus may be more flexible than the bodies 2920 constructed of the TPEs described above. In some embodiments, the front-facing surface 2922 may be constructed of a fabric material and the rear-facing surface 2924 may be constructed of a foam material, with the fabric front surface 2922 of the main body 2920 providing continuity in appearance and texture with the upper side straps 2804. In some embodiments, both the front-facing surface 2922 and the rear-facing surface 2924 can be constructed from one or more fabric materials. The strap loops 2940 can be constructed from a stiffer material than the body 2920. In the illustrated embodiment, the body 2920 can be welded to the strap loops 2940. In some embodiments, the body 2920 can be attached to the strap loops 2940 with an adhesive or by stitching.

[0201] As described elsewhere herein, the body 2920 in the area of ​​the aperture 2960 can have a level of stiffness to securely snap onto the enlarged head 2932 of the fastener 2904 and retain the fastener 2904. However, a body 2920 constructed from a fabric laminate and / or foam may not have this level of stiffness. Thus, the headgear connector element 2900 can have an aperture rim 2962 made from a stiffer material. In some embodiments, the rim 2962 can be made from TPE and can be formed as an overmolded grommet that extends through the aperture 2960 and protrudes beyond both the forward-facing surface 2922 and the rearward-facing surface 2924 of the body 2920, providing reinforcement to the aperture 2960.

[0202] 38-87, various embodiments of the mask assembly 2100 are shown that include different configurations of bias vents 2502 and associated diffusers. Some of these examples use a bias vent configuration similar to the example of FIG. 14, in which the housing 2102 includes two bias vents 2502 at the bottom edge of the housing 2012. Some of these examples use different bias vent configurations.

[0203] Further, in the embodiment of Figure 31, a headgear connector element 2900 is provided in the form of a tether or yoke. As shown in Figures 31A and 31B, the headgear connector element 2900 can be an elongated flexible member that couples the headgear's upper side straps 2804 to the frame 2178. As mentioned above, when coupled to the frame 2178, the headgear connector element 2900 can extend laterally across the frame 2178 below the tip of the user's nose.

[0204] 38-44, this embodiment can be modified so that bias vents 2502 are provided in the mask frame 2178 and diffusers 3000 are provided in the headgear connector element 2900. In this example, the diffusers 3000 comprise a section of diffuser material that is attached to the headgear connector element 2900 or held in place between the mask frame 2178 and the headgear connector element 2900.

[0205] As described above, the headgear connector elements 2900 are held in place on the mask frame 2178 using fasteners 2904 that engage with corresponding apertures in the headgear connector elements 2900 .

[0206] The headgear connector element 2900, in this example, is a planar piece of semi-rigid material such as plastic or silicone that flexes around the curved outer front surface of the mask frame 2178. The headgear connector element 2900 includes a central body 2920 that is shaped to provide a pair of opposing laterally extending arms 2920A extending from the central body 2920, and strap loops 2940 at each end of the laterally extending arms 2920A of the body 2920.

[0207] Thus, the headgear connector element 2900 extends laterally across the mask frame 2178 and has a centrally located window or aperture in the body 2920 and a pair of opposing lateral strap loops 2940. The headgear connector element 2900 curves downward from the strap loops 2940 towards a central region to form a "U" shape. The lower central region of the headgear connector element 2900 is located forward of the vent holes of the bias vent 2502 when attached to the mask frame 2178.

[0208] In this example, as can be best seen in FIG. 41, the headgear connector element 2900 is provided with one or more diffuser apertures 2900A, in this case a pair of such apertures 2900A, one on each side of the vertical centerline of the mask assembly 2100 (note that the holes for the bias vent 2502 are not shown in FIG. 41).

[0209] The diffuser aperture 2900A is positioned on the headgear connector element 2900 to align with the bias vents 2502 on the mask frame 2178. The bias vents 2502 therefore include two arrays of bias vents, the arrays being equally spaced about the vertical centerline of the mask assembly 2100. The arrays are arranged to form a U- or V-shape on the mask frame 2178. The vents are located on the front of the mask frame 2178, above the inlet 2706 and below the fasteners 2904. The vents are oriented to direct exhaled air away from the user's face, reducing airflow relative to the user's face, and are positioned within protruding bosses that form the cushion connector 2708 at the rear of the frame 2178. Any number of vents, preferably 0.5-3 mm in diameter, configured to provide sufficient flushing of CO2 may be used.

[0210] The airflow through the vent can have a high velocity (compared to the air inhaled by the user), which can result in noise. This is addressed, at least in part, by using the diffuser 3000, which includes a portion of diffuser material that diffuses the air and reduces its velocity. Diffusion of the air occurs because the composition of the diffuser material creates a tortuous path for the air. The diffuser material can be a single piece or multiple pieces of a suitable material, such as a needle-punched nonwoven fabric (e.g., felt). In one example, the diffuser material is formed as a diffuser mat made from needle-punched, thermally bonded polyester (100% PET). Alternatively, any other fabric material or combination of materials can be used. The fibers comprising this material are entangled or mechanically interlocked to create a tortuous path for the air to pass through. This scatters the airflow, reducing its velocity and therefore noise.

[0211] The diffuser aperture 2900A is covered by a diffuser material (not shown) that may be in, above, or below the aperture 2900A. The diffuser material diffuses the bias flow through the bias vent 2502, thus reducing noise and reducing or preventing any jets or bias flow against the user's face.

[0212] The diffuser material may be permanently attached to the headgear connector element 2900, for example by overmolding, adhesive, or mechanical clips, or may be removably attached, for example by friction engagement, clips, or snap-fit ​​connectors, etc.

[0213] The diffuser 3000 is located on the outer front surface of the headgear connector element 2900 to provide an offset distance between the diffuser material and the vent. This offset ensures that the diffuser material, which retains some moisture from humid exhaled air, is not in direct contact with the vent. As humid exhaled air impinges on / passes through the diffuser, it can condense, thereby retaining moisture within the diffuser. Such moisture retention is undesirable. The offset between the diffuser material and the vent prevents this moisture from contacting the vent, or at least minimizes or reduces such contact. This therefore minimizes moisture from the diffuser material migrating to the vent and clogging or blocking it. The diffuser 3000 can alternatively include a headgear connector element 2900 that includes additional features that create an offset between the vent and the diffuser material, such as a protrusion or recess as shown in FIG. 49, or a rear surface that has a curvature that is steeper than the curvature of the front of the mask frame 2178, thereby attaching to the inner or rear surface of the headgear connector element 2900 that is located away from the front of the mask frame 2178.

[0214] The diffuser 3000 covers the aperture 2900A of the headgear connector element 2900, i.e., it can be a single aperture with a shape corresponding to the area where the vent arrangement is located. As can be best seen in FIG. 41 , this aperture can be divided by dividing structures 2900B to create several separate apertures or windows 2900A. These dividing structures 2900B increase the stiffness of the headgear connector element 2900 and reduce the amount of bending or flexing that the headgear connector element 2900 can undergo. This allows for a more secure attachment of the headgear connector element 2900 to the mask frame, and therefore virtually certain placement of the diffuser 3000 relative to the vent.

[0215] 42 and 43 , an alternative embodiment includes a headgear connector element 2900 that includes a linking structure 2900E that provides additional stability and rigidity to the headgear connector element 2900. The linking structure 2900E includes a linking or connecting element that connects or extends between the left and right lateral strap loops 2940 and 2904 of the headgear connector element 2900. The structure 2900E maintains a constant distance between the two lateral strap loops 2940 of the headgear connector element 2900 to reduce torsion that the center of the headgear connector element 2900 experiences, which can deform it and push it forward and away from the front of the mask frame 2178. This minimizes the distance that the headgear connector element 2900 can be pushed away from the vent when attached to the mask frame 2178. This reduces the increase in distance between the two structures when the center of the headgear connector element 2900 experiences torsion.

[0216] Bending of the headgear connector element 2900 occurs when the side ends of the headgear connector element 2900 move downward or upward and / or twist relative to the mask frame 2178, as indicated by arrow A in FIG. 42. This causes the top edge of the headgear connector element 2900 to bend upward or downward, respectively, in response to the movement of the side ends of the headgear connector element 2900. Positioning features 2178A can be provided on either the mask frame 2178 or the headgear connector element 2900 to engage with the other of the mask frame 2178 or the headgear connector element 2900 to resist such movement. In this example, referring to FIG. 42, the positioning feature 2178A comprises a raised portion or protrusion on the outer surface of the mask frame 2178 that limits this movement. The positioning feature 2178A is complementary to the upper edge of the connecting structure 2900E and limits upward movement of the headgear connector element 2900, thus limiting excessive bending or flexing of the headgear connector element 2900.

[0217] 45-49, the mask frame 2178 is provided with a diffuser 3000 that is aligned with one or more arrays of biased vents 2502 also in the mask frame 2178.

[0218] In this example, the biased vent 2502 comprises a single array of vent holes that extend across the vertical centerline of the mask frame 2178 above the inlet 2706 of the mask frame 2178. The biased vent array extends symmetrically about the vertical centerline in this example.

[0219] The diffuser 3000 includes a diffuser frame 3002 attached to or forming an integral part of the mask frame 2178 and positioned to extend around the bias vent array 2502. The diffuser frame 3002 is configured to hold a portion of the diffuser material 3004 (not shown in FIGS. 4 and 46). When so held, the diffuser material 3004 covers the holes of the bias vents 2502 and diffuses the bias flow through the bias vents 2502.

[0220] This embodiment, like the embodiment of Figures 28-44, features a vent hole that is laser drilled or molded into the center of the mask frame 2178. This vent configuration may be substantially U- or V-shaped, or arranged in any other suitable shape, such as circular, or horizontal, vertical, or angled linear. The hole is oriented to direct exhaled air away from the user's face and reduce airflow against the user's face, and is positioned within a protruding boss that forms the cushion connector 2708 at the rear of the frame 2178.

[0221] This embodiment also features a headgear connector element 2900 to which the upper headgear straps connect. However, in this example, the headgear connector element 2900 does not hold or support the diffuser and does not cover the bias vent 2502.

[0222] Instead, the diffuser 3000 is held by a diffuser frame 3002 that corresponds to the shape of the vent array. The walls of the diffuser frame 3002 surround the edges of the diffuser material 3004, and either the rear or front side of the diffuser frame 3002 features a lip or rim 3006 that extends inward, away from the wall (see particularly FIG. 50 ). The lip 3006 serves as a support structure for the diffuser 3000 and may provide space between the bias vents 2502 and the diffuser material 3004 to prevent condensation from moist air from blocking the vents. The diffuser 3000 may be attached to the diffuser frame 3002 by adhesive, welding, overmolding, or any other suitable method; this attachment may be permanent or non-permanent. In the former, when the diffuser material 3004 needs to be replaced, the diffuser frame 3002 and the diffuser material 3004 must be replaced, whereas in the latter, only the diffuser material 3004 can be easily replaced.

[0223] The diffuser frame 3002 itself is secured to the front wall of the mask frame 2178 via clips 3008 on the mask frame 2178. In this example, pairs of laterally opposed clips 3008 are provided adjacent the vent arrays of the biased vents 2502. Each clip 3008 is located adjacent a respective left and right edge of the vent array and is spaced laterally from the centerline of the mask frame 2178. The clips 3008 protrude forward from the outer surface of the front wall of the mask frame 2178. As can be best seen in FIG. 46 , the clips 3008 are configured to engage and mechanically couple with corresponding structure on the left and right walls of the diffuser frame 3002. The mechanical coupling between the diffuser frame 3002 and the clips 3008 can be achieved through a simple retention mechanism, such as a snap fit mechanism, whereby the clips 3008 are barbed and can flex as the diffuser frame 3002 is pressed against the mask frame 2718, and when the diffuser frame 3002 is fully pressed onto the mask frame 2718, the clips 3008 snap into engagement with the diffuser frame 3002. An alternative embodiment can use a friction fit engagement between the diffuser frame 3002 and the clips 3008.

[0224] In one variation of this embodiment, the diffuser frame 3002 can be integrated with the mask frame 2718, such that these components form a single unit and eliminate the need for clips 3008. In this example, the diffuser material 3004 is removably attached to the diffuser frame 3002 and can be replaced as needed.

[0225] 49, the diffuser frame 3002 features gaps or spaces 3002A in the top, bottom, or side walls to provide a passageway between the mask frame 2178 and the walls of the diffuser frame 3002. These gaps 3002A provide alternative flow paths for exhaled air to flow through. This ensures that the air can exit the mask with less resistance rather than only through the diffuser 3000. In this example, the diffuser frame 3002 spaces (3012) the diffuser material 3004 from the surface of the front wall of the mask frame 2178. This allows more CO2 gas (in the exhaled air) to exit the mask during exhalation or allows the CO2 gas to flow faster.

[0226] 51-60, a mask assembly 2100 is provided that includes a biased vent on a cushion connector structure 2708. As described above and as can be seen, for example, in FIG. 11, the frame 2178 can include a cushion connector 2708 positioned on a rear side of the frame 2178. In some embodiments, the cushion connector 2708 is integral with the frame 2178 and extends rearward from a rear surface 2178A of the front wall 2701 of the frame 2178. The cushion connector 2708 can provide a fluid connection between the inlet 2706 and the cushion module 2150. The cushion connector 2708 can be shaped to fit into at least a portion of the cushion module 2150 to connect the frame 2178 to the cushion module 2150. For example, the cushion connector 2708 can fit into at least a receiving portion of the mask housing 2102, such as the frame connector 2730.

[0227] In this example, the biased vent 2502 vent is not located on the front surface of the mask frame 2178 as in the previous embodiment, but is located on the cushion connector 2708 which provides a gas flow path between the inlet structure 2706 of the mask frame 2178 and the cushion module 2150.

[0228] As best seen in FIG. 51 , the cushion connector 2708 includes a tubular gas flow duct that projects rearward from the rear (inner) surface of the mask frame 2178. The gas flow duct can be any shape in cross section when viewed along its longitudinal axis, but in this example is trapezoidal in shape, with a continuously curved profile. The gas flow duct includes an outer surface, with vent holes provided on the sides and top of the outer surface. In this example, the vent holes are arranged concentrically around the sides and top, such that the vent array diverges from the center of the gas flow duct of the cushion connector 2708, away from the central axis 2708A of the cushion connector 2708 shown in FIG. 53 . The portion provided with vent holes can be equal to approximately half the height of the cushion connector structure 2708. The number of vent holes can be approximately 20 in this example, and can be evenly spaced along a line when the cushion connector 2708 is viewed from the side, as best seen in FIG. 52 . The vents may alternatively be arranged in any other shape and / or location in the vent array around the cushion connector 2708, but preferably are not located in the lower region of the cushion connector 2708, as this is where the vents may be prone to blockage and may result in noise.

[0229] In this example, the vent holes are spaced along the length of the cushion connector (i.e., along its central axis 2708A) in the space between the rear surface 2178A of the mask frame 2178 and the front surface 2150A of the cushion module 2150 when assembled, and are aligned in a portion of the periphery of the cushion connector's gas flow duct. This positioning ensures that the vent holes are aligned to direct airflow into the space between the two surfaces 2178A, 2150A. This air flow path, indicated by arrow A in FIG. 50, directs air generally laterally rather than entirely upwards towards the user's eyes, or at least does not allow airflow directly onto the user's face due to the contour of the rear surface 2178A of the mask frame 2178 which includes a significant lateral component.

[0230] The vents can be arranged in different configurations around the periphery of the cushion connector 2708, i.e., configurations where vents are provided around the entire periphery of the cushion connector 2708, or configurations where vents are only present on the sides of the cushion connector 2708, i.e., no vents on the top or bottom of the cushion connector 2708. Additionally or alternatively, the vents can be arranged in multiple rows or lines or arrays along all or part of the length of the cushion connector duct.

[0231] A ring or arcuate portion of diffuser material (not shown) can be attached around the cushion connector 2708 at its outer periphery to surround and cover all of the vents to diffuse air and reduce noise. The diffuser material can simply be snapped or pressed into the cushion connector. The diffuser material is sandwiched between the rear surface 2178A of the mask frame 2178 and the front surface 2150A of the cushion module 2150 to secure the diffuser material in place when the mask assembly 2100 is assembled.

[0232] 61-73, in this example the biased vent 2502 is located on the mask shell housing 2102, generally below the inlet structure 2706. In this example, the biased vent includes a pair of arrays of vent holes, each array located below and to one side of the inlet aperture 2102A and valve recess 2726 of the mask shell housing 2012, as described above with reference to, for example, Figures 25 and 26.

[0233] 66-70, a diffuser 3000 is provided that is mounted to the mask shell housing 2102 such that the diffuser material 3004 of the diffuser 3000 covers the array of vent holes to diffuse the gas flow and reduce noise. In this example, the diffuser 3000 includes a diffuser frame 3002 that includes a mounting portion in the form of an upper ring-shaped fixture 3002A and a pair of lower tabs or wings in the form of laterally positioned diffuser sub-frames 3002B that are laterally spaced apart such that each is below and to one side of the ring fixture 3002A.

[0234] The ring attachment 3002A is sized, shaped and configured to be removably attached to the mask shell housing 2102, the ring attachment 3002A being received in a corresponding ring-shaped recess 2102B surrounding the entrance aperture 2102A of the mask shell housing 2102, such that in use the ring attachment 3002A is sandwiched between the mask shell housing 2102 and the mask frame 2178 and is held in place by the connection between the mask shell housing 2102 and the mask frame 2178.

[0235] The diffuser frame 3002 is therefore omega shaped in this embodiment, with the size, shape and placement of the ring fittings 3002 A and sub-frames 3002 B matching the size, shape and placement of the inlet and vent arrays in the mask shell housing 2102 . Thus, when the ring fixture 3002A is attached as described above, the diffuser subframe 3002B is aligned with and covers the vent array. As described above, each diffuser subframe 3002B is provided with a section of diffuser material 3004 that can be removably or permanently attached to the subframe 3002B.

[0236] The contour of the rear surface of the diffuser 3000, and in particular the contour of the diffuser sub-frame 3002B, is shaped to match the shape and contour of the front surface of the mask shell housing 2102, and in this example is convexly curved to match the convex curvature of the front surface of the mask shell housing 2102. Thus, when the diffuser 3000 is attached to the mask shell housing 2102, the diffuser 3000 and the mask shell housing 2102 fit together.

[0237] The ring fixture 3002A can be secured within the recess 2012B by a friction fit between the ring fixture 3002A and the surrounding surfaces (ie, the inner and outer walls) of the recess 2012B. Alternatively, the ring attachment 3002A can be held in place between the mask shell housing 2102 and the mask frame 2178 once assembled, i.e., when the cushion connector 2708 of the mask frame 2178 is inserted into the cushion connector structure and the ring attachment 3002A of the diffuser frame 3002 is sandwiched between the mask frame 2178 and the mask shell housing 2102. Alternative attachment methods include snap-fit ​​type connections and other attachment methods.

[0238] The wing-shaped diffuser subframe 3002B is configured to be aligned with and spaced above the vent holes when the support component is held by the housing. The shape and size of the peripheral wall of the subframe 3002B follows that of the vent array, but is slightly larger than this area to avoid blocking the vents. The left and right subframes 3002B are connected by a laterally extending linking member 3104, which extends across the diffuser 3000 to form a brace that provides rigidity and stability to the subframes 3002B. The linking member 3014 is located forward of the valve recess 2726 of the mask shell housing 2102, and when the mask frame 2178 and mask shell housing 2012 are assembled, the linking member 3014 is sandwiched between the valve recess 2726 and the inlet 2706 of the mask frame 2178.

[0239] The vent arrays each have a generally triangular shape, and therefore each subframe 3002B has a corresponding generally triangular shape.

[0240] In this example, there are two connecting members 3014, the first making up the lower region of the ring fixture 3002A and the second connecting member located below the ring portion, which aligns with (follows the curvature of) and extends between the bottom edges of the sub-frames 3002B that surround the vent holes on each opposite side of the mask shell housing 2102.

[0241] The diffuser 3000 is shaped to avoid obstruction of the air flow path or inlet 2706 of the mask frame 2178. To achieve this, the connecting member 3014 has a concave shape (towards the rear) that follows the contour of the outer surface of the valve recess 2726 of the mask shell housing 2102. This allows for complementary positioning of the mask frame inlet 2706 to the connecting member 3014, and therefore also complementary positioning of the mask frame 2178 with respect to the mask shell housing 2102. Complementary positioning refers to the alignment of the rear surface of the mask frame inlet 2706 with the outer / front surface of the connecting member 3014, which further follows the contour of the valve recess 2726. This concave portion may comprise a solid wall or may be formed by multiple connecting members, as in the example shown.

[0242] The bottom region of the sub-frame 3002B may be in the form of a solid wall, which increases the stiffness of the diffuser 3000, at least in part to account for the relatively low stiffness of thin or narrow structures such as the connecting members 3014 and the diffuser frame 3002A and diffuser sub-frame 3002B.

[0243] The connecting member 3014 and / or the diffuser frame 3002A and / or the diffuser sub-frame 3002B may have retention features, such as a snap-fit ​​ledge and recess combination, to allow easier assembly and disassembly of the diffuser 3000 and the mask shell housing 2102. As shown in Figures 62 and 74, the bottom wall of the diffuser 3000 sits directly below the bottom region of the mask shell housing 2102 and "cups" the area below the vent.

[0244] The diffuser frame 3002 is constructed from rigid or semi-rigid material as a unitary structure. The diffuser frame 3002 may also be constructed from a softer material such as silicone to enhance the friction fit attachment of the ring attachment 3002A in the recess 2102B of the mask shell housing 2102.

[0245] A portion of the diffuser material 3004 is attached to each diffuser subframe 3002B. This can be on the front or outer surface of the subframe 3002B (i.e., on the top as shown in FIG. 75). The connecting member 3014 and the subframe 3002B provide a constant offset distance between the air vent and the diffuser material 3004. The method of attachment of the diffuser material to the diffuser subframe 3002B can include, for example, any combination of adhesive, fitting into the space defined between the walls of the subframe 3002, frictional engagement, overmolding, and clips. The shape of some portions of the diffuser material 3004 corresponds to the shape of the subframe 3002B. The subframe 3002B can also include gaps on the top or bottom side of the subframe 3002B to provide alternative air passageways and maintain an unobstructed flow path for exhaled air (CO2 outflow).

[0246] 74-82, in this embodiment, the biased vent 2502 opening is provided in a recess 2102B that surrounds the mounting aperture 2102A of the mask shell housing 2102 of the cushion module 2150. As described above, the aperture 2102A functions as part of the connection between the mask shell housing 2102 and the mask frame 2178 and receives the cushion connector 2708. The diffuser 3000, in this example, includes a ring of diffuser material 3004 that is shaped and dimensioned to be received and retained in the recess 2102B.

[0247] The diffuser material 3004 has a ring shape that is the same as the shape of the recess 2102B and is therefore concentric with the aperture 2102A of the mask shell housing 2102. The diffuser 3000, in this example, is constructed from a single layer of diffuser material, either laser cut or stamped.

[0248] The air vents are concentric with the aperture 2102A and spaced apart from the recess 2102B. The diffuser 3000 and the vent array have the same shape and are concentric with each other. The diffuser 3000 covers all of the air vents and diffuses the air flowing therethrough. Thus, the diffused air flows through the space between the rear surface 2178A of the mask frame 2178 and the front surface 2102C of the mask shell housing 2102. The air vents may be uniformly spaced around the entire periphery of the aperture 2102A, or may have variable spacing, or may extend along only a portion of the recess 2102B. The air vent flow path can be most clearly seen by arrow A in FIG. 82 or also in FIG. 78.

[0249] An example number and spacing of vent holes can be seen in Figure 75. Any other number and spacing of vent holes is possible.

[0250] In Figures 74-82, the vents may be arranged concentrically around the central axis of aperture 2102A, such that the axis of each vent extends generally in the same direction as the axis of aperture 2102A, although each vent axis may be tilted to some extent.

[0251] Alternatively, the vents may be arranged concentrically around and radiating from the central axis of the aperture 2102A, such that the axis of each vent extends generally perpendicular to the axis of the aperture 2102A. In this alternative embodiment, the cushion connector structure 2708 of the mask frame 2178, which is inserted into the aperture 2102A of the mask shell housing 2102 for assembly, also has vents that allow air to flow out of the gas flow path.

[0252] The recess 2102B in which the diffuser 3000 is removably mounted can be modified to further diffuse the air and reduce noise. As shown in Figures 78 and 79, the recess 2102B, when viewed along the axis of the aperture 2102A, can be widened to allow for an increased diffuser width (and therefore diffusing area) and sufficient space for the placement of a ring of vents. Figures 78 and 79 show enlarged views of the area indicated by box A in Figure 76.

[0253] The vent holes located in the recess 2102B can be formed using various techniques, such as laser drilling, and / or in various shapes and arrangements. For example, the diameter of the vent holes may not be constant; i.e., one or more of the vent holes may have a smaller or larger rear radius than the front radius, such that each aperture includes a bore that tapers along its length, resulting in different airflow dynamics and noise levels. A larger rear radius than the front radius may be preferred because the opposite configuration can result in turbulence, and therefore noise; i.e., the vent cross-sectional area increases along its length in the direction of vent gas flow. Figure 78 shows two opposite tapered vent configurations. Figure 78a shows a vent hole with a larger hole inlet (rear) radius and a smaller outlet (front) radius, while Figure 78b shows a diffuser hole with a smaller rear radius than the front radius. Diffuser material 3004 is located at the vent hole outlet.

[0254] The vents can be further modified so that the longitudinal axis of at least one vent is at an offset angle from the central axis of the aperture 2102A. This configuration is shown in FIG. 79. Vents that are angled outward and / or laterally direct the airflow away from the patient's face and away from objects or people that may be directly in front of the mask. This improves the comfort of the user as well as anyone in close proximity to the user. FIGS. 79a and 79c show two examples in which the radially inner vent wall portion is sloped, while FIGS. 79b and 79d show two examples in which the radially outer vent wall is sloped. Further embodiments are envisioned in which both the inner and outer vent walls are sloped and / or in which the vent is uniformly tapered along its length so that its longitudinal axis is sloped. In these figures, the vertical dotted line represents the central axis of aperture 2102A (moved for clarity), and the diagonal dotted line represents the angle of the vent. Arrow A may be an approximation or average of the resulting airflow direction through the vent.

[0255] Providing vent holes in the recess 2102B may require the recess 2102B to be widened, for example, compared to the recess of FIG. 24. FIGS. 78, 79a, and 79b all show the unwidened recess. FIGS. 78, 79c, and 79d show the widened recess 2102B with the vent holes provided. The widened recess in FIG. 78 is shown with hatched lines. In FIG. 78a, dimension (a) indicates the width of the widened head 2102B, which has been widened, for example, compared to the embodiment of FIG. 24, and dimension (b) indicates the width of the original recess 2102B, for example, of FIG. 24. These vent holes can be drilled in line with the central longitudinal axis of the aperture 2102A.

[0256] The modification of the recess 2102B can be accomplished by modifying the curvature of the mask shell housing 2102. For example, a wider recess 2102B may require a laterally shifted curvature of the wall of the mask shell housing 2102 adjacent to the recess 2102B. This wider recess is shown by dashed line B in FIG. 84 (the narrower recess is shown by dashed line A). This is because the seal width must remain substantially constant to effectively or adequately seal with the user's face. The depth of the seal housing cannot also be easily reduced, otherwise the seal housing will come into contact with the user's face. Therefore, the curvature must be modified to account for the increased width of the recess 2102B. A wider recess 2102B can help reduce noise, as air exiting the vent is less likely to impinge on the sidewalls of the recess 2102B.

[0257] In this embodiment, the diffuser 3000, which may be the diffuser material 3004 as described above, is housed within the ring-shaped recess 2102B of the mask shell housing 2102. The diffuser material 3004 may be arranged to float within the recess, i.e., to be able to move between the mask frame 2178 and the rearmost surface of the recess 2102B. However, the diffuser material 3004 and the recess 2102B must be configured together to resist any relative movement between the two components sufficiently that there is a direct flow path to the atmosphere through the recess 2102B and across the diffuser material. Such a direct flow path is undesirable because it would not provide the desired airflow and noise suppression characteristics if the exhaust air bypassed the diffuser 3000.

[0258] Additionally, the diffuser material 3004 and recess 2102B must be further configured to prevent any portion of the diffuser material 3004 from being crushed or flattened in a manner that would obstruct airflow through the diffuser material 3004. Thus, this embodiment provides a diffuser cavity defined between the mask shell housing 2102 and the mask frame 2178 into which the diffuser material fits snugly, where the diffuser material 3004 has a volume slightly smaller than the diffuser cavity. For example, the diffuser 3000 can have a depth that is less than the depth between the rear wall of the recess 2102B and the inner surface of the mask frame 2178. This allows for a gap between the vent and the diffuser 3000, as shown in FIG. 82, which helps prevent or minimize condensation from filling the vent. However, the diffuser 3000 should have a depth greater than the distance between the front surface of the mask shell housing 2102 and the rear surface of the mask frame 2178, to prevent the formation of a direct flow path as described above. The diffuser 3000 can slide back and forth within the recess 2102B.

[0259] Unless the context clearly requires otherwise, throughout the description and claims, terms like "comprises," "including," and the like should be interpreted in an inclusive sense, i.e., "including, but not limited to," rather than an exclusive or exhaustive sense. As used herein, conditional language, particularly "may," "could," "might," "could," "for example," and the like, is generally intended to convey that certain embodiments include certain features, elements, and / or conditions, while other embodiments do not, unless specifically indicated otherwise or understood otherwise by the context in which it is used. Thus, such conditional language is generally not intended to imply that features, elements, and / or conditions are in any way required by one or more embodiments, nor is it intended to imply that one or more embodiments necessarily include logic that determines whether those features, elements, and / or conditions are included or should be implemented in any particular embodiment, with or without author input or direction.

[0260] The term "plurality" refers to two or more of an item. Enumerations of quantities, dimensions, sizes, formulas, parameters, shapes, and other characteristics should be interpreted in the same manner as if the term "about" or "approximately" preceded the quantity, dimension, size, formula, parameter, shape, or other characteristic. The term "about" or "approximately" means that quantities, dimensions, sizes, formulas, parameters, shapes, and other characteristics need not be exact but may be approximated and / or larger or smaller as necessary to reflect tolerances, conversion factors, rounding, measurement error, etc., and other factors known to those skilled in the art. The enumeration of quantities, dimensions, sizes, formulas, parameters, shapes, and other characteristics should be interpreted in the same manner as if the term "substantially" preceded the quantity, dimension, size, formula, parameter, shape, or other characteristic. As used herein, the terms "approximately," "about," and "substantially" refer to an amount close to the referenced amount that still performs a desired function or achieves a desired result. For example, in some embodiments, as may be dictated by context, the terms "about," "substantially," and "substantially" refer to an amount within 10% or less of the stated amount. As used herein, the term "generally" refers to a value, quantity, or characteristic that primarily includes or tends toward a particular value, quantity, or characteristic. For example, as may be dictated by context, the term "generally linear" can mean something that deviates from strictly parallel by no more than 15°.

[0261] Numerical data may be expressed or presented herein in a range format. It should be understood that such range format is used merely for convenience and brevity and, therefore, should be interpreted to include not only the numerical values ​​explicitly recited as the limits of that range, but also all of the individual numerical values ​​or subranges subsumed within that range, as if each numerical value and subrange were explicitly recited. As an example, a numerical range of "1 to 5" should be interpreted to include not only the explicitly recited values ​​of about 1 to about 5, but also each individual value and subrange within the stated range. Thus, within this numerical range, individual values ​​such as 2, 3, and 4 are included, as well as subranges such as "1 to 3," "2 to 4," and "3 to 5." This same principle should also apply to ranges reciting only a single numerical value (e.g., "greater than 1"), regardless of the breadth of the range or characteristic being described.

[0262] For convenience, multiple items may be presented in common lists. However, these lists should be construed as if each element of the list were individually identified as a separate and unique element. Accordingly, individual elements of such lists should not be construed as de facto equivalents to any other element of the same list solely based on their presence in a common grouping, unless indicated to the contrary. Furthermore, the terms "and" and "or," when used in conjunction with a list of items, should be interpreted broadly in that any one or more of the listed items may be used alone or in combination with other listed items. The term "instead" refers to a selection of two or more alternatives and is not intended to limit this selection to only those listed alternatives or to only one of the listed alternatives at a time, unless the context clearly dictates otherwise.

[0263] The reference herein to any prior art is not, and should not be construed as, an acknowledgment or any form of suggestion that that prior art forms part of the common general knowledge in any field of endeavor anywhere in the world.

[0264] The invention may be broadly considered to include the parts, elements and features referred to or illustrated in the specification of this application, individually or collectively, in any combination of two or more of said parts, elements or features.

[0265] Where reference is made in the above description to whole entities or components having known equivalents, those whole entities are incorporated herein as if individually indicated.

[0266] It should be noted that various variations and modifications to the presently preferred embodiments described herein will be 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, the positions of various components can be changed as needed. Accordingly, such variations and modifications are intended to be included within the scope of the present invention. Furthermore, not all features, aspects and advantages are necessarily required to practice the present invention. Accordingly, the scope of the present invention is intended to be defined solely by the following claims.

Claims

1. 1. A respiratory mask assembly comprising: a mask frame and a cushion module, the mask frame including a respiratory gas inlet configured to receive a supply of breathable gas and deliver the breathable gas to the cushion module, the cushion module configured to form a seal with a user's face; Including, the cushion module includes a bias vent configured to allow air to be exhausted from the cushion module through the bias vent to the atmosphere; the mask frame is connected to the cushion module via a cushion connector; The respiratory mask assembly comprises: a diffuser including a diffuser frame and a diffuser material supported by the diffuser frame and configured to extend over the bias vent, the diffuser material providing a tortuous air path from the bias vent through the diffuser, the diffuser frame including a mounting portion configured to be attached to the cushion connector; The respiratory mask assembly further comprises:

2. 10. The respiratory mask assembly of claim 1, wherein the cushion module includes a support structure defining an opening that allows the cushion module to be attached to a conduit connector, and the breathable gas is delivered to the cushion module through the opening.

3. 3. The respiratory mask assembly of claim 2, wherein the support structure is formed from a hard plastic material.

4. 4. The respiratory mask assembly of claim 2 or 3, wherein the bias vent is located above the support structure and includes a pair of arrays of vent holes, each array located below and to one side of the opening.

5. 5. The respiratory mask assembly of claim 4, wherein the mounting portion includes a ring-shaped fitting sized, shaped, and configured for removably mounting to the support structure, the ring-shaped fitting being received in a corresponding ring-shaped recess surrounding the opening.

6. 6. The respiratory mask assembly of claim 5, wherein the mounting portion includes a pair of laterally spaced sub-frames coupled below and to one side of the ring-shaped mounting fixture, the sub-frames covering corresponding arrays of vent holes in use.

7. 7. The respiratory mask assembly of claim 6, wherein the diffuser material is removably or permanently attached to a corresponding diffuser subframe.

8. 4. The respiratory mask assembly of claim 2 or 3, wherein the bias vent is provided in a recess surrounding the opening in the support structure and includes a vent extending along at least a portion of the recess.

9. 9. The respiratory mask assembly of claim 8, wherein the mounting portion is attached to or forms an integral part of the mask frame and is positioned to extend around the vent.

10. 10. A respiratory mask assembly according to claim 8 or 9, wherein the vents are arranged concentrically around a central axis of the opening, such that the axis of each vent extends in generally the same direction as the central axis of the opening, or where at least the axis of a vent is at an offset angle from the central axis of the opening.

11. 11. A respiratory mask assembly according to any one of claims 8 to 10, wherein the diameter of the vent is configured such that in use the radius of the vent at its rear end facing the face is larger than the radius at its front end facing outwards.

12. the cushion module is configured to form a seal under a user's nose; The cushion module includes: a mouth seal portion configured to seal around the mouth of a user; a nose sealing portion configured to seal against the underside of a user's nose and to be positioned completely below the bridge of the user's nose, a first upward extension and a second upward extension, each of the first upward extension and the second upward extension having an inner wall configured to engage a side of the user's nose and an outer wall configured to provide structure to the nose seal portion, the inner wall and the outer wall being joined along an upper edge of the seal, the outer wall including a pocket having a wall thickness less than a surrounding wall thickness; a nose sealing portion including A respiratory mask assembly according to any preceding claim, comprising:

13. the outer wall further includes a thickening rib extending along an upper portion of the outer wall, the thickening rib being proximate to but spaced from the upper edge of the seal, the thickening rib having a wall thickness greater than the peripheral wall thickness, the thickening rib extending from a rear end of the outer wall toward a front of the seal; the seal further includes a suspension member that provides mechanical rigidity and structure to maintain the shape of the first upward extension and the second upward extension when worn by a user; 13. The respiratory mask assembly of claim 12, wherein the thickened rib is distinct from and extends from the suspension member to provide additional support to the seal.

Images