headgear

Abstract

To provide improved respiratory masks, etc.SOLUTION: An interface for positive pressure therapy includes a mask assembly, a headgear assembly, and a connection port assembly. The mask assembly comprises a seal member that has an upper portion movably connected to an integrated lower portion, wherein the upper portion rolls during hinging movement of the upper portion relative to the lower portion. The headgear assembly allows connection to the mask assembly in a direction substantially normal to a direction of strap tension. The connection port assembly includes a swivel elbow with a valve member that controls flow through a port that opens toward the user. The valve member is provided with a tapered bead that helps prevent the valve member from sticking in a given position. Also, a connector for connecting a respiratory tube to an elbow connector.SELECTED DRAWING: Figure 14

Description

[Technical Field]

[0001] Disclosures to be referenced This disclosure references various features of U.S. patent application Ser. No. 62 / 199,513, filed July 31, 2015, U.S. patent application Ser. No. 62 / 199,547, filed July 31, 2015, U.S. patent application Ser. No. 62 / 209,822, filed August 25, 2015, U.S. patent application Ser. No. 62 / 232,293, filed September 24, 2015, U.S. patent application Ser. No. 62 / 305,284, filed March 8, 2016, U.S. patent application Ser. No. 62 / 358,790, filed July 6, 2016, and U.S. patent application Ser. No. 62 / 360,052, filed July 8, 2016. The entire disclosures of those applications, including all that they contain, are hereby incorporated by reference as if fully set forth herein.

[0002] Field of Disclosure The present invention generally relates to patient interfaces for respiratory therapy. The present invention generally relates to an elbow assembly for a patient interface, such as a face mask, that covers at least one of a user's nose and mouth to supply respiratory gas under positive pressure. More particularly, the present invention relates to such an elbow assembly having an anti-asphyxiation valve (AA valve) positioned to allow the user to continue breathing if the respiratory gas supply is switched off or stopped for any reason. The present invention also relates to a connector for connecting a conduit to a patient interface via an elbow assembly, preferably an elbow assembly such as the one disclosed herein. The present invention also relates to headgear used to secure a respiratory mask to a user's head. [Background technology]

[0003] There are many types of headgear used with patient interfaces for respiratory therapy. However, in some applications (e.g., treating obstructive sleep apnea (OSA)), the patient interface is worn frequently and / or for extended periods, requiring continuous improvements that improve convenience and comfort for the user while maintaining or improving the sealing function of the interface.

[0004] Face masks can be used to provide breathing gas under positive pressure to a user. In a configuration where both the user's mouth and nose are covered, full face masks typically fit over the bridge of the nose. A single seal generally surrounds the user's nose and mouth.

[0005] Such full-face masks are typically secured to the user's head by headgear. To substantially reduce leakage, the headgear is typically tightened, thereby exerting high pressure on the user's nose bridge. In other words, as the headgear is tightened, the seal typically exerts a gradually increasing load on the nose bridge. Such masks are typically provided with an elbow assembly that includes a tubular conduit extending at a 90-degree angle, one end of the conduit fluidly connected to the mask and the other end of the conduit connected to a breathing gas delivery tube. A potential problem is that the AA valve in such an elbow assembly does not open or close completely or reliably.

[0006] A wide variety of respiratory masks have been devised. Many of these masks are configured to provide a sealed connection with the user's airway by sealing around a portion of the user's nose and / or mouth. These masks are commonly used to provide treatments such as, but not limited to, non-invasive ventilation (NIV) and continuous positive airway pressure (CPAP). CPAP therapy is commonly used to treat obstructive sleep apnea (OSA) and involves providing a constant supply of pressurized air to the user's airway. This supports the airway in an open state, thus minimizing airway collapse and reducing apneas. As part of this treatment, a bias-flow exhaust system is used to flush exhaled carbon dioxide (CO2) from within the mask, thereby reducing or eliminating the possibility of re-inhalation.

[0007] Bias flow exhaust systems can cause noticeable noise. The drafts can be uncomfortable for the user and / or their bed companions, leading to reduced compliance with treatment. Bias flow exhaust systems can also be difficult to clean, which can lead to contamination or reduced compliance with treatment. Such bias flow exhaust systems can also increase the bulk of the respirator, further reducing the user's comfort while wearing the respirator and therefore further reducing the likelihood of user compliance.

[0008] Other common problems experienced with current headgear include that the headgear is very heavy, bulky, and hot, which can be uncomfortable for the user. Headgear made from traditional materials can be slow to dry after washing. This can affect patients, as the headgear often does not dry within a day, forcing patients to not wear their mask or to wear a mask with damp headgear. This inconvenience associated with cleaning the headgear can lead some patients to choose not to wash their headgear at all, which can be unhygienic. Summary of the Invention [Problem to be solved by the invention]

[0009] It is an object of the present disclosure to provide one or more structures and / or methods that will go some way toward improving at least the above, or at least provide a useful choice for the public or medical professionals. The present disclosure also relates to bias flow exhaust systems for respirators. Such bias flow exhaust systems are configured to diffuse exhaust air while improving ease of cleaning, reducing noise, and / or facilitating compactness of the respirator. It is an object of the present disclosure to provide a respirator with a bias flow exhaust system that will at least provide a useful choice for the public. [Means for solving the problem]

[0010] According to an aspect of the present invention, there is provided an elbow assembly configured to connect a mask assembly to an air and / or other gas conduit, the elbow assembly comprising an elbow and a sleeve, the elbow having an inner wall and an outer wall and defining an air flow path therebetween, the inner wall comprising a port on a side of the elbow, the sleeve coupled to the elbow, the sleeve comprising a flap, when the flap is in a first position, the flap at least partially closes the port to allow gas from the air conduit to pass through the elbow to a user, and when the flap is in a second position, the flap at least partially closes the port to allow gas from the air conduit to pass through the elbow to a user. a flap configured to partially close the air conduit, thereby allowing gas to flow from the user through the port and the air flow passage to a location outside the elbow assembly, the air flow passage directing air away from the side of the elbow; the flap comprising an elongated bead protruding from the flap and configured to contact an inner wall of the elbow when the flap is in the first position to space the flap from the inner wall of the elbow, the bead comprising at least one tapered portion configured such that a portion of the bead protrudes further from the flap than another portion of the bead when the flap is viewed from the side.

[0011] In some embodiments, the bead extends around at least a portion of the periphery of the valve flap.

[0012] In some embodiments, the bead extends around the entire periphery of the valve flap.

[0013] In some embodiments, the flap may include a hinge that pivotally attaches the flap to the elbow, the bead extending around the periphery of the flap to the hinge.

[0014] In some embodiments, the bead includes an arcuate bead portion distal to the hinge, the arcuate bead portion being arcuate when the flap is viewed in plan.

[0015] In some embodiments, the bead includes at least one linear bead portion adjacent the hinge, said bead portion being straight when the flap is viewed in plan.

[0016] In some embodiments, at least one linear bead portion includes a sealing surface that is wider than the width of the remainder of the bead.

[0017] In some embodiments, the width of the at least one linear bead portion is substantially the same as the height of a surface of another portion of the elbow assembly that the at least one linear bead portion seals against when the flap is in the first position.

[0018] In some embodiments, a transition wall is defined between the at least one linear bead portion and the remainder of the flap, the transition wall extending from an edge of the linear bead portion to the main body of the flap, the transition wall being configured to provide structural rigidity to the flap.

[0019] In some embodiments, the transition wall is angled relative to the plane of the valve flap.

[0020] In some embodiments, the bead is substantially "n" shaped when the flap is viewed in plan.

[0021] In some embodiments, the bead is substantially "D" shaped when the flap is viewed in plan.

[0022] In some embodiments, the bead tapers inward toward the valve flap from a position distal to the hinge to a position adjacent to the hinge, i.e., the bead protrudes further from the flap at a position distal to the hinge.

[0023] In some embodiments, the bead is tapered to blend into the valve flap adjacent the hinge.

[0024] In some embodiments, the bead has an upper surface that contacts the inner wall of the elbow when the flap is in the first position, and opposing side walls that extend between the valve flap and the upper surface, the upper surface forming a sealing surface.

[0025] In some embodiments, at least one sidewall is curved.

[0026] In some embodiments, the shape of one sidewall is different from the shape of another sidewall.

[0027] In some embodiments, the profile of one sidewall is such that the sidewall curves from the top surface into the plane of the valve flap.

[0028] In some embodiments, at least one sidewall is substantially straight in profile, such that the sidewall extends in a straight line between the top surface and the valve flap.

[0029] In some embodiments, the straight sidewall is angled relative to the plane of the valve flap.

[0030] In some embodiments, the bead is integrally formed with the valve flap.

[0031] In some embodiments, multiple beads are provided.

[0032] In some embodiments, the elbow assembly further comprises an orientation mechanism arranged to facilitate attachment of the support and valve flap in a desired orientation relative to the elbow and sleeve.

[0033] In some embodiments, the orientation mechanism comprises a slot in one of the support and the elbow or sleeve and a protrusion in the other of the support and the elbow or sleeve, the protrusion being received in the slot when the support and valve flap are installed in the desired orientation.

[0034] In some embodiments, the air flow path includes two air flow paths.

[0035] In some embodiments, the sleeve further comprises a ledge extending on an outer surface of the sleeve and a recess adjacent the ledge.

[0036] In some embodiments, the ledge and recess are adapted to receive a pivot component that incorporates a protuberance to engage the ledge.

[0037] In some embodiments, the sealing surface is substantially straight when viewed from the side.

[0038] In some embodiments, the sealing surface includes a curved or angled portion when viewed from the side.

[0039] In some embodiments, the flap is configured to be biased away from the elbow and towards the sleeve when in at least the second position.

[0040] In some embodiments, the flap is configured to be biased away from the first position when in at least the second position.

[0041] In some embodiments, the flap is biased away from the second position in a direction also away from the first position.

[0042] In some embodiments, the flap includes a recess on the surface of the flap opposite the bead.

[0043] In some embodiments, the recess is rectangular.

[0044] In some embodiments, the recess is adjacent to the hinge of the flap.

[0045] In some embodiments, the bead can include an arcuate bead portion distal to the hinge, which is arcuate when the flap is viewed in a plan view. The bead can also or alternatively include at least one straight bead portion adjacent the hinge, which is straight when the flap is viewed in a plan view. In one example, the bead is substantially "n" shaped when the flap is viewed in a plan view.

[0046] The bead can taper inwardly toward the valve flap from a location distal to the hinge to a location adjacent to the hinge, i.e., the bead protrudes further from the flap at a location distal to the hinge, and the bead can taper to blend into the valve flap at a location adjacent the hinge.

[0047] In some embodiments, the bead preferably comprises an upper surface that contacts the inner wall of the elbow when the flap is in the first position, and opposing sidewalls that extend between the valve flap and the upper surface. At least one sidewall may be curved. At least one sidewall may be straight. The contour shape of one sidewall may differ from the contour shape of another sidewall. In one example, the contour of one sidewall is such that the sidewall curves from the upper surface into the plane of the valve flap. In one example, at least one sidewall is substantially straight in contour, such that the sidewall extends in a straight line between the upper surface and the valve flap. The straight sidewall may be angled relative to the plane of the valve flap.

[0048] In some embodiments, the bead may be integrally formed with the valve flap. Multiple beads may be provided.

[0049] In some embodiments, the flap can include a flap support attached to at least one of the elbow and the sleeve. An orientation mechanism can be provided and positioned to facilitate attachment of the support and valve flap in a desired orientation relative to the elbow and sleeve. The orientation mechanism can include a slot on one of the support and the elbow or sleeve and a protrusion on the other of the support and the elbow or sleeve, the protrusion being received in the slot when the support and valve flap are attached in the desired orientation.

[0050] In some embodiments, the flow path may include two air flow paths.

[0051] In some embodiments, the sleeve may further comprise a ledge extending on an outer surface of the sleeve and a recess adjacent the ledge, the ledge and recess may be adapted to receive a pivot component incorporating a ridge to engage the ledge.

[0052] According to another aspect of the present invention, there is provided an anti-asphyxiation valve attached to an elbow assembly configured to connect a mask assembly to a conduit for air and / or other gases, the elbow assembly comprising an elbow and a sleeve, the elbow having an inner wall and an outer wall and defining a flow path for air and / or other gases therebetween, the inner wall having a port on a side of the elbow, the sleeve being coupled to the elbow, the valve comprising a support and a flap pivotally attached to the support, when the valve flap assembly is attached to the elbow and assembly and when the flap is in a first position, the flap at least partially closes the port to allow gases from the conduit to pass through the elbow to a user or and when the flap is in the second position, the flap at least partially closes the conduit, thereby allowing gas to flow from the user through the port and the flow path to a location outside the elbow assembly, the flow path directing air and / or other gases away from the side of the elbow, the flap comprising an elongated bead protruding from the flap and configured to contact an inner wall of the elbow when the flap is in the first position to space the flap from the inner wall of the elbow, the bead comprising at least one tapered portion configured such that when the flap is viewed from the side, one portion of the bead protrudes further from the flap than another portion of the bead.

[0053] In some embodiments, the elongated bead extends around at least a portion of the periphery of the valve flap.

[0054] In some embodiments, the bead extends around the entire periphery of the valve flap.

[0055] In some embodiments, the valve flap includes a hinge that pivotally connects the valve flap to the conduit, and the elongated bead extends around the periphery of the flap to the hinge.

[0056] In some embodiments, the elongate bead includes an arcuate bead portion distal to the hinge, the arcuate bead portion being arcuate when the flap is viewed in plan.

[0057] In some embodiments, the elongate bead includes at least one linear bead portion adjacent the hinge, the at least one linear bead portion being straight when the flap is viewed in plan.

[0058] In some embodiments, at least one straight bead portion includes a sealing surface that is wider than the width of the remainder of the elongate bead.

[0059] In some embodiments, the width of the at least one linear bead portion is substantially the same as the height of the surface of another portion of the conduit that the at least one linear bead portion seals when the flap is in the first position.

[0060] In some embodiments, a transition wall is defined between the at least one linear bead portion and the remainder of the valve flap, the transition wall extending from an edge of the linear bead portion to the body of the flap, the transition wall being configured to provide structural rigidity to the flap.

[0061] In some embodiments, the transition wall is angled relative to the plane of the valve flap.

[0062] In some embodiments, the elongated bead is substantially "n" shaped when the flap is viewed in plan.

[0063] In some embodiments, the elongated bead is substantially "D" shaped when the flap is viewed in plan.

[0064] According to another aspect, a connector for directly or indirectly connecting an air and / or other gas conduit to a patient interface is provided, the connector comprising first and second ends and a wall defining a gas pathway between the first and second ends, the first end configured to couple to an elbow connector, the second end configured to couple to a respiratory gas tubing, such as via a tubing connector, such as a collar, terminating the respiratory tubing, and the second end of the connector configured to prevent fixed attachment of the second end of the connector to the elbow connector.

[0065] Preferably, the second end of the connector is dimensioned relative to the elbow connector to provide said blocking. More particularly, according to a preferred embodiment, the mating portion of the elbow connector is configured to be received inside the connector, and the inner dimension of the second end is greater than the outer dimension of the mating portion of the elbow connector.

[0066] Preferably, the connector is configured to be releasably and sealably secured to the elbow connector via a click-fit or snap-fit. To this end, a surface (preferably an inner surface) of the connector may be provided with a protrusion or recess, and the mating portion of the elbow connector may include a corresponding recess or protrusion. Thus, the present invention further provides an elbow connector configured to mate with a novel and inventive connector.

[0067] According to a preferred embodiment, the connector includes a protrusion on its exterior surface configured to act as a mechanical stop that limits the extent to which the breathing tube can be pushed onto the connector. The outer protrusion is preferably also configured to provide a grip for the user's fingers to facilitate removal of the connector from the elbow connector. It should be noted that this outer protrusion can be used whether or not the connector is configured to prevent its second end from engaging the mating portion of the elbow connector (e.g., elbow 29 or 29a).

[0068] According to another aspect, a connector for directly or indirectly connecting an air and / or other gas conduit to a patient interface is provided, the connector comprising: a first end and a second end; and a wall defining a gas pathway between the first and second ends. The first end is configured to couple to an elbow connector, the second end is configured to couple to a respiratory gas tube, and the connector further comprises protrusions on an outer surface thereof configured to act as mechanical stops to limit the extent to which the respiratory tube can be pushed onto the connector and / or to provide grips for a user's fingers to facilitate removal of the connector from the elbow connector.

[0069] In some configurations, the elbow connector is configured to mate with a connector of any of the above descriptions.

[0070] According to another aspect, an anti-asphyxiation valve for a respiratory mask is provided, the anti-asphyxiation valve comprising: a conduit having a first end, a second end, and a port on a side of the conduit between the first and second ends, the conduit having the first end configured to receive a gas flow from a gas source and the second end coupled to the respiratory mask; and a valve flap assembly comprising a support and a valve flap pivotally coupled to the support, wherein when the support of the valve flap assembly is coupled to the conduit and the valve flap is in a first position, the valve flap at least partially closes the port, allowing gas entering the first end of the conduit to flow to the second end of the conduit, and the valve flap assembly When the flap is in the second position, the valve flap at least partially closes the first end of the conduit, thereby allowing exhaled gases entering the second end of the conduit to flow from the second end through the port to a location outside the conduit, the valve flap comprising an elongated bead protruding from the valve flap and configured to contact a portion of an inner wall of the conduit surrounding the port when the flap is in the first position to space the valve flap from the inner wall of the conduit, the bead comprising at least one tapered portion configured so that at least a portion of the bead protrudes further from the flap than another portion of the bead when viewed from the side.

[0071] In some embodiments, the elongated bead extends around at least a portion of the periphery of the valve flap.

[0072] In some embodiments, the elongated bead extends around the entire periphery of the valve flap.

[0073] In some embodiments, the flap includes a hinge that pivotally connects the valve flap to the conduit, and the elongated bead extends around the periphery of the flap to the hinge.

[0074] In some embodiments, the elongate bead includes an arcuate bead portion distal to the hinge, the arcuate bead portion being arcuate when the flap is viewed in plan.

[0075] In some embodiments, the bead includes at least one straight bead portion adjacent the hinge, said bead portion being straight when the flap is viewed in plan.

[0076] In some embodiments, at least one straight bead portion includes a sealing surface that is wider than the width of the remainder of the elongate bead.

[0077] In some embodiments, the width of the at least one linear bead portion is substantially the same as the height of the surface of another portion of the conduit that the at least one linear bead portion seals when the flap is in the first position.

[0078] In some embodiments, a transition wall is defined between the at least one linear bead portion and the remainder of the valve flap, the transition wall extending from an edge of the linear bead portion to the body of the flap, the transition wall being configured to provide structural rigidity to the flap.

[0079] In some embodiments, the transition wall is angled relative to the plane of the valve flap.

[0080] In some embodiments, the elongated bead is substantially "n" shaped when the flap is viewed in plan.

[0081] In some embodiments, the elongated bead is substantially "D" shaped when the flap is viewed in plan.

[0082] In some embodiments, the elongated bead tapers inward toward the valve flap from a position distal to the hinge to a position adjacent to the hinge, i.e., the elongated bead protrudes further from the flap at a position distal to the hinge.

[0083] In some embodiments, the elongated bead is tapered to blend into the valve flap adjacent the hinge.

[0084] In some embodiments, the elongated bead has an upper surface that contacts the inner wall of the elbow conduit when the flap is in the first position, and opposing side walls that extend between the valve flap and the upper surface, the upper surface forming a sealing surface.

[0085] In some embodiments, at least one sidewall is curved.

[0086] In some embodiments, the shape of one sidewall is different from the shape of another sidewall.

[0087] In some embodiments, the profile of one sidewall is such that the sidewall curves from the top surface into the plane of the valve flap.

[0088] In some embodiments, at least one sidewall is substantially straight in profile, such that the sidewall extends in a straight line between the top surface and the valve flap.

[0089] In some embodiments, the straight sidewall is angled relative to the plane of the valve flap.

[0090] In some embodiments, the elongated bead is integrally formed with the valve flap.

[0091] In some embodiments, multiple beads are provided.

[0092] In some embodiments, the flap comprises a flap support, the flap support being attached to at least one of the elbow and the sleeve.

[0093] In some embodiments, the anti-asphyxiation valve further comprises an orientation mechanism arranged to facilitate attachment of the support and valve flap in a desired orientation relative to the elbow and sleeve.

[0094] In some embodiments, the orientation mechanism comprises a slot in one of the support and the elbow or sleeve and a protrusion in the other of the support and the elbow or sleeve, the protrusion being received in the slot when the support and valve flap are installed in the desired orientation.

[0095] In some embodiments, the air flow path includes two air flow paths.

[0096] In some embodiments, the sleeve further comprises a ledge extending on an outer surface of the sleeve and a recess adjacent the ledge.

[0097] In some embodiments, the ledge and recess are adapted to receive a pivot component that incorporates a protuberance to engage the ledge.

[0098] In some embodiments, the sealing surface is substantially straight when viewed from the side.

[0099] In some embodiments, the sealing surface includes a curved or angled portion when viewed from the side.

[0100] In some embodiments, the flap is configured to be biased away from the elbow and towards the sleeve when in at least the second position.

[0101] In some embodiments, the flap is configured to be biased away from the first position when in at least the second position.

[0102] In some embodiments, the flap is biased away from the second position in a direction also away from the first position.

[0103] In some embodiments, the flap comprises a recess on the surface of the flap opposite the elongated bead.

[0104] In some embodiments, the recess is rectangular.

[0105] In some embodiments, the recess is adjacent to the hinge of the flap.

[0106] It will be understood that while air may be provided as a respiratory support, this may be supplemented or replaced by other gases. Additionally or alternatively, medication may be provided to the patient via a nebulizer or the like coupled to a patient interface or, more typically, to a portion of the breathing circuit that delivers gas to the patient. Thus, references to "air" and even "gas" should not be construed narrowly.

[0107] In another aspect, a kit for a respiratory mask is provided, the kit including a connection housing that is positioned on a patient's face when in use. The connection housing includes a cushion end portion configured to engage the cushion housing to contact the user's face and a connection ring opposite the cushion end portion. The connection ring includes a first connection housing raised portion and a second connection housing raised portion, each of which is generally arcuate and extends away from the cushion end portion, each of which includes at least one array of holes extending along at least a portion of its respective arc that is configured to pass exhaled gases exhaled by the user to ambient air when in use. The first connection housing raised portion and the second connection housing raised portion define therebetween a first generally arcuate connection housing recessed portion and a second generally arcuate connection housing recessed portion, the arc length of the first connection housing recessed portion being less than the arc length of the second connection housing recessed portion. The kit also includes an annular socket configured to pass inhaled gases from a gas supply to the connection housing. The socket includes a first generally arcuate socket raised portion and a second generally arcuate socket raised portion, the first socket raised portion having an arc length less than the arc length of the second socket raised portion, the first socket raised portion and the second socket raised portion defining a first generally arcuate socket slot and a second generally arcuate socket slot therebetween. The socket is configured to removably engage with the connection housing as a unitary structure, such that upon engagement, the first socket raised portion mates with the first connection housing recessed portion, the second socket raised portion mates with the second connection housing recessed portion, the first connection housing raised portion passes through the frame opening and mates with the first socket slot, and the second connection housing raised portion passes through the frame opening and mates with the second socket slot, and in use, inhaled gases are passed to and exhaled gases are passed from the respiratory mask via the unitary structure.

[0108] In some configurations, the swivel connector is configured to deliver inhaled gas to a user, the swivel connector includes a generally tubular first end and a truncated ball joint at a second end opposite the first end, the truncation defining a ball joint opening configured to pass inhaled gas, and the socket configured to receive the truncated ball joint when in use.

[0109] In some configurations, the first socket slot is opposite the second socket slot.

[0110] In some configurations, the first connection housing raised portion is opposite the second connection housing raised portion.

[0111] In some configurations, a frame is mounted over the connection housing when in use. The frame includes a frame housing with a frame opening and a socket mounted within the frame opening.

[0112] In some configurations, the frame housing is molded to the socket.

[0113] In some configurations, the first connection housing raised portion and the second connection housing raised portion each have a generally L-shaped end in an area furthest from the cushion end portion, the first socket raised portion and the second socket raised portion each have a generally L-shaped side in an area adjacent to the first socket slot and the second socket slot, and the generally L-shaped ends of the first connection housing raised portion and the second connection housing raised portion are configured to seal with the generally L-shaped sides of the first socket raised portion and the second socket raised portion.

[0114] In some configurations, the first connection housing raised portion and the second connection housing raised portion each have a generally straight end in an area furthest from the cushion end portion, the first socket raised portion and the second socket raised portion each have generally straight sides in an area adjacent to the first socket slot and the second socket slot, and the generally straight ends of the first connection housing raised portion and the second connection housing raised portion are configured to seal with the generally straight sides of the first socket raised portion and the second socket raised portion.

[0115] According to another aspect, a kit for a respiratory mask is provided, the kit including a connection housing that is mounted on a patient's face when in use. The connection housing includes a cushion end portion configured to engage the cushion housing to contact the user's face and a connection ring opposite the cushion end portion. The connection ring includes a first connection housing raised portion and a second connection housing raised portion, each of which is generally arcuate and extends away from the cushion end portion, each of which includes at least one array of holes extending along at least a portion of its respective arc that is configured to pass exhaled gases exhaled by the user to ambient air when in use. The first connection housing raised portion and the second connection housing raised portion define therebetween a first connection housing generally arcuate recessed portion and a second connection housing generally arcuate recessed portion, the arc length of the first connection housing recessed portion being smaller than the arc length of the second connection housing recessed portion. The kit further includes a frame that is mounted on the connection housing when in use. The frame includes a frame housing with a frame opening defining a generally annular frame opening periphery, and an annular socket configured to pass intake gas from the gas supply to the connection housing, the socket being within the frame housing in a concentric arrangement with the frame opening and spaced from the frame opening periphery by a generally arcuate first frame raised portion and by a generally arcuate second frame raised portion, the arc length of the first frame raised portion being less than the arc length of the second frame raised portion, and the space between the socket and the frame opening periphery including a first frame gap and a second frame gap. The frame is configured to removably engage with the connection housing as a unitary structure, whereby upon engagement the first frame raised portion mates with the first connection housing recessed portion, the second frame raised portion mates with the second connection housing recessed portion, the first connection housing raised portion passes through the frame opening and mates with the first frame gap, and the second connection housing raised portion passes through the frame opening and mates with the second frame gap, and when in use, inhaled gases are passed to the respiratory mask and exhaled gases are passed from the respiratory mask via the unitary structure.

[0116] In some configurations, the swivel connector is configured to deliver inhaled gas to a user, the swivel connector having a generally tubular first end and a truncated ball joint at a second end opposite the first end, the truncation defining a ball joint opening configured to allow the inhaled gas to pass therethrough, and the socket configured to receive the truncated ball joint when in use.

[0117] In some configurations, the first socket slot is opposite the second socket slot.

[0118] In some configurations, the first connection housing raised portion is opposite the second connection housing raised portion.

[0119] In some configurations, the frame housing is molded to the socket.

[0120] In some configurations, the first connection housing raised portion and the second connection housing raised portion each have a generally L-shaped end in an area furthest from the cushion end portion, the first socket raised portion and the second socket raised portion each have a generally L-shaped side in an area adjacent to the first socket slot and the second socket slot, and the generally L-shaped ends of the first connection housing raised portion and the second connection housing raised portion are configured to seal with the generally L-shaped sides of the first socket raised portion and the second socket raised portion.

[0121] In some configurations, the first connection housing raised portion and the second connection housing raised portion each have a generally straight end in an area furthest from the cushion end portion, the first socket raised portion and the second socket raised portion each have generally straight sides in an area adjacent to the first socket slot and the second socket slot, and the generally straight ends of the first connection housing raised portion and the second connection housing raised portion are configured to seal with the generally straight sides of the first socket raised portion and the second socket raised portion.

[0122] According to another aspect, a kit for a respiratory mask is provided, the kit including: a swivel connector configured to deliver inhaled gas to a user, the swivel connector having a generally tubular first end and a truncated ball joint at a second end opposite the first end, the truncated end defining a ball joint opening configured to pass inhaled gas; and a connection housing configured to be seated on the user's face in use. The connection housing includes a connection housing opening configured to receive inhaled gas from the swivel connector and to receive exhaled gas exhaled by the user in use, and a cushion end portion opposite the connection housing opening configured to engage with the cushion housing to contact the user's face. The kit also includes a hollow socket including a sealed interior region. The sealed interior region includes a generally circumferential connection housing engagement region around the first end of the socket, the connection housing engagement region configured to engage with the connection housing opening in use to receive exhaled gas therefrom. The connection housing engagement region comprises a first diameter; a generally circumferential ball joint engagement region around a second end opposite the first end of the socket, the ball joint engagement region having a second diameter smaller than the first diameter, the ball joint engagement region configured to engage with a truncated ball joint of the swivel connector in use and receive exhaled gas therefrom; and a generally arcuate first bearing region and a generally arcuate second bearing region, each extending from the ball joint engagement region toward the connection housing engagement region and each engaging with a truncated ball joint of the swivel connector in use, defining a generally arcuate first exhalation region and a generally arcuate second exhalation region therebetween, a third diameter between the first and second exhalation regions being greater than the second diameter and less than or equal to the first diameter, the first and second exhalation regions each comprising at least one array of holes configured to pass exhaled gases to ambient air outside the socket.The arc length of the first expiratory region and the arc length of the second expiratory region are greater than the arc length of the first bearing region and the arc length of the second bearing region, and the frame is configured such that, when in use, inhaled gas is passed to the respiratory mask and exhaled gas is passed from the respiratory mask through the socket to the ambient air.

[0123] In some configurations, when in use, a frame is mounted over the connection housing, the frame comprising a frame housing with a frame opening defining a generally annular frame opening periphery, and the socket is mounted within the frame opening.

[0124] In some configurations, the frame housing is molded to the socket.

[0125] In some configurations, the interior of the continuous swivel connector includes the entire second end, the truncated ball joint, and the area immediately adjacent the truncated ball joint extending toward the first end has a continuous cylindrical or continuously tapered cylindrical profile.

[0126] In some configurations, the inner contour of the truncated ball joint generally follows the corresponding outer contour of the truncated ball joint.

[0127] In some configurations, the swivel connector and socket are configured such that when the truncated ball joint of the swivel connector is fully rotated in any direction within the ball joint engagement region of the socket, the second end of the swivel connector fully overhangs the ball joint engagement region within the socket.

[0128] In some configurations, the swivel connector and socket are configured such that when the truncated ball joint of the swivel connector is in a neutral position within the ball joint engagement region of the socket, the second end of the swivel connector fully overhangs the first bearing region and the second bearing region within the socket.

[0129] In some configurations, the outer contour of the ball joint engagement area facing the ambient air has a continuous slope.

[0130] In some configurations, the outer contour of the ball joint engagement region facing the ambient air has a first slope a distance from the second end to a point and a second slope different from the first slope for the remaining length of the ball joint engagement region from the point extending towards the first end.

[0131] According to another aspect, there is provided a respiratory mask assembly including a frame having a cushion housing, an opening and an inner wall defining the opening, a swivel elbow configured to provide inhaled gas from a gas supply, the swivel elbow having a ball joint, and an annular insert disposed within the opening of the frame, the annular insert including a cover portion, a collar portion extending away from a periphery of the cover portion in a direction toward a user in use, an interior region defined by the cover portion and the collar portion, the interior region configured to pass inhaled gas from the gas supply to a connection housing and to receive exhaled gas exhaled by a user, a swivel elbow socket extending through the cover portion and configured to engage the ball joint, and an exhaust region disposed on the cover portion and laterally to the side of the swivel elbow socket, the exhaust region having exhaust holes extending through the cover portion to pass exhaled gas received by the interior region to ambient air in use. The collar portion engages with the inner wall of the opening so that the exhaust insert is positioned within the opening and connected to the frame, and the collar portion engages with the cushion housing so that the cushion housing is attached to the frame via the exhaust insert.

[0132] In some configurations, the swivel elbow socket further comprises lateral socket sidewalls configured to engage the ball joint, the lateral socket sidewalls extending into the interior region of the annular insert away from the inner surface of the cover portion, a central portion of the lateral socket sidewalls extending a greater distance into the interior region of the annular insert than the end portions of the lateral socket sidewalls.

[0133] In some configurations, the swivel elbow socket further includes a lower socket sidewall configured to engage a lower portion of the ball joint, the lower socket sidewall extending away from an inner surface of the cover portion into an interior region of the annular insert, and an end portion of the lower socket sidewall and an end portion of the lateral sidewall extending an equal distance into the interior region of the annular insert.

[0134] In some configurations, the swivel elbow socket further includes an upper socket sidewall configured to engage an upper portion of the ball joint, the upper socket sidewall extending into the interior region of the annular insert away from the inner surface of the cover portion, and an end portion of the upper socket sidewall and an end portion of the lateral sidewall extending an equal distance into the interior region of the annular insert.

[0135] In some configurations, the end portions of the lateral side walls are integrally molded with the inner surface of the collar portion.

[0136] In some configurations, the collar portion is welded to the inner wall of the opening in the frame along the weld area.

[0137] In some configurations, each exhaust region expiates exhaled gases in a different draft direction.

[0138] In some configurations, the exhaust hole has a planar shape.

[0139] In some configurations, the annular insert further comprises a recessed portion disposed between the bottom portion of the ball joint and the collar portion, the recessed portion configured to provide a shallow, user-accessible cavity for removing accumulated dirt within the interior region.

[0140] In some configurations, the ball joint has a cutout area in the bottom portion of the ball joint that engages with the recessed portion.

[0141] According to another aspect, there is provided a respiratory mask assembly including a frame, a cushion housing, a swivel elbow configured to provide inhaled gas from a gas supply, the swivel elbow having a ball joint, and an annular socket attached to the frame, the annular socket including a cover portion, a collar portion extending away from an inner surface of the cover portion in a direction toward a user in use, the collar portion connected to the cushion housing such that the cushion housing is attached to the frame, an interior region defined by the cover portion and the collar portion, the interior region configured to pass inhaled gas from the gas supply to the connection housing and to receive exhaled gas exhaled by the user, and a swivel elbow socket extending through the cover portion and configured to engage with the ball joint, the lateral socket sidewalls configured to engage with the ball joint, the lateral socket sidewalls extending into the interior region of the annular socket away from the inner surface of the cover portion, a central portion of the lateral socket sidewalls extending a greater distance into the interior region of the annular socket than end portions of the lateral socket sidewalls.

[0142] In some configurations, the swivel elbow socket further includes a lower socket sidewall configured to engage a lower portion of the ball joint, the lower socket sidewall extending into the interior region of the annular socket away from the inner surface of the cover portion, and an end portion of the lower socket sidewall and an end portion of the lateral sidewall extending an equal distance into the interior region of the annular socket.

[0143] In some configurations, the swivel elbow socket further includes an upper socket sidewall configured to engage an upper portion of the ball joint, the upper socket sidewall extending into the interior region of the annular socket away from the inner surface of the cover portion, and an end portion of the upper socket sidewall and an end portion of the lateral sidewall extending an equal distance into the interior region of the annular socket.

[0144] In some configurations, the end portions of the lateral side walls are integrally molded with the inner surface of the collar portion.

[0145] In some configurations, a recessed portion is disposed between the bottom portion of the ball joint and the collar portion, the recessed portion being configured to provide a shallow, user-accessible cavity for removing accumulated soil within the interior area.

[0146] In some configurations, the annular socket has a cutout area that engages with a recessed portion in the bottom portion of the ball joint.

[0147] In some configurations, the annular socket is configured to be inserted into and removably fastened to the frame.

[0148] In some configurations, the annular socket further comprises at least one vent region having vent holes extending through the cover portion to pass exhaled gases received by the interior region to ambient air when in use.

[0149] In some configurations, each exhaust region discharges exhaled gases in a different airflow direction.

[0150] In some configurations, the exhaust hole has a planar shape.

[0151] According to another aspect, a respiratory mask assembly is provided, comprising: a frame, a cushion, a connection housing having the cushion attached to a first end thereof; and a connection ring attached to a second end of the connection housing opposite the first end. The connection ring comprises a central opening extending therethrough and at least one raised portion extending away from the connection housing and defining a portion of the central opening, the at least one raised portion comprising at least one array of holes. The respiratory mask assembly further comprises an annular socket attached to the frame. The annular socket comprises a tubular central portion extending through the frame and the gas supply and at least one slot extending through the annular socket and disposed adjacent to the tubular central portion such that a portion of the at least one slot is defined by an outer surface of the tubular central portion. The connecting ring is configured to be removably positioned over the outer surface of the tubular central portion so that the tubular central portion extends through a central opening in the connecting ring, the at least one raised portion is configured to be inserted into the at least one slot so that the at least one raised portion extends through the annular socket, the inner surface of the tubular socket defines a flow path for inhaled gases from the gas supply to the cushion, and the outer surface of the tubular socket defines a flow path from the cushion to at least one array of holes for exhaled gases to be vented to the air.

[0152] In some configurations, the swivel connector is configured to deliver inhaled gas to a user, the swivel connector having a generally tubular first end and a truncated ball joint at a second end opposite the first end, the truncation defining a ball joint opening configured to allow the inhaled gas to pass therethrough, and the tubular central portion configured to receive the truncated ball joint when in use.

[0153] In some configurations, the at least one slot further comprises a first socket slot and a second socket slot opposite the first socket slot, and the at least one raised portion further comprises a first raised portion and a second raised portion opposite the first raised portion.

[0154] In some configurations, the annular socket and the frame are integrally formed.

[0155] In some configurations, the annular socket is configured to be inserted into and removably fastened to the frame.

[0156] In some configurations, the annular socket further comprises an L-shaped end portion disposed at an end of the tubular central portion opposite the cushion, and the connecting ring further comprises an L-shaped side portion disposed at an end of the at least one raised portion opposite the cushion, the L-shaped end portion engaging the L-shaped side portion to form a seal between the annular socket and the connecting ring.

[0157] In some configurations, the annular socket further comprises a straight end disposed at an end of the tubular central portion opposite the cushion, and the connecting ring further comprises a straight side disposed at an end of the at least one raised portion opposite the cushion, the straight end engaging the straight side to form a seal between the annular socket and the connecting ring.

[0158] In some configurations, the respiratory mask assembly includes a frame, a cushion, a connection housing attached to the cushion at a first end opposite a second end, a swivel connector configured to provide inhaled gas from a gas supply and having a truncated ball joint, and an annular socket attached to the frame and to the second end of the connection housing. The annular socket includes a connection housing engagement region configured to engage with the connection housing, a ball joint engagement region configured to engage with the truncated ball joint of the swivel connector, and at least one exhaust region disposed between the connection housing engagement region and the ball joint engagement region, the at least one exhaust region having at least one array of holes extending through the at least one exhaust region and configured to pass exhaled gas to ambient air outside the annular socket. An inner surface of the truncated ball joint defines a flow path for inhaled gas from the gas supply to the cushion, and an outer surface of the truncated ball joint defines a flow path from the cushion to the at least one array of holes for exhaled gas to be exhausted to the air.

[0159] In some configurations, the annular socket and the frame are integrally formed.

[0160] In some configurations, the annular socket is configured to be inserted into and removably fastened to the frame.

[0161] In some configurations, the swivel connector and the annular socket are configured such that when the truncated ball joint is rotated to its fullest extent in any direction within the ball joint engagement region, the open end of the truncated ball joint fully overhangs the ball joint engagement region within the annular socket.

[0162] In some configurations, the swivel connector and the annular socket are configured such that when the truncated ball joint is in a neutral position within the ball joint engagement region of the annular socket, the open end of the truncated ball joint fully overhangs the ball joint engagement region within the annular socket.

[0163] In some configurations, the annular socket further includes first and second bearing regions that engage opposite sides of the truncated ball joint, the first and second bearing regions extending from the ball joint engagement region in a direction toward the cushion, thereby forming a recessed region between the first and second bearing regions.

[0164] In some configurations, the exhaust region is located within the recessed region.

[0165] In some configurations, the flow path to the exhaust region is defined by the first and second bearing regions, the inner surface of the annular socket, and the outer surface of the truncated ball joint.

[0166] According to another aspect, a respiratory mask assembly is provided that includes a cushion including a connecting ring and a frame. The connecting ring includes an opening and at least one raised portion extending away from the cushion and defining a portion of the opening, the raised portion including at least one exhaust hole. The frame includes a central conduit extending through the frame and configured to receive inhaled gas from a gas supply, at least one slot extending through the frame, and an annular collar extending from a patient-facing side of the frame and surrounding the central conduit and the at least one slot. The connecting ring is configured to be removably attachable to the annular collar, and the at least one raised portion is configured to extend into the at least one slot. When attached, the at least one raised portion and the central conduit, at least in part, define a flow path from the cushion to the at least one exhaust hole for exhausting exhaled gas to the atmosphere.

[0167] In some configurations, at least one slot is located adjacent to the central conduit.

[0168] In some configurations, the cushion includes a connection housing disposed between the cushion and the connection ring, whereby the cushion is attached to the first end and the cushion ring is attached to the second end.

[0169] In some configurations, at least one slot is defined in part by an outer surface of the central conduit.

[0170] In some configurations, when attached, the central conduit defines, at least in part, a flow path for inhaled gas from the gas supply to the cushion.

[0171] In some configurations, the device further includes a swivel connector configured to deliver inhaled gas to a user, the swivel connector having a generally tubular first end and a truncated ball joint at a second end opposite the first end, the truncation defining a ball joint opening configured to allow the inhaled gas to pass therethrough, and the central conduit configured to receive the truncated ball joint when in use.

[0172] In some configurations, the at least one slot further comprises a first socket slot and a second socket slot opposite the first socket slot, and the at least one raised portion further comprises a first raised portion and a second raised portion opposite the first raised portion.

[0173] In some configurations, the annular collar and the frame are integrally formed.

[0174] In some configurations, the annular collar is configured to be inserted into and removably fastened to the frame.

[0175] In some configurations, the central conduit further comprises an L-shaped end portion disposed at an end of the tubular central section opposite the cushion, and the connecting ring further comprises an L-shaped side portion disposed at an end of the at least one raised portion opposite the cushion, the L-shaped end portion engaging the L-shaped side portion to form a seal between the central conduit and the connecting ring.

[0176] In some configurations, the central conduit further comprises a straight end disposed at an end opposite the cushion, and the connecting ring further comprises a straight side disposed at an end of the at least one raised portion opposite the cushion, the straight end engaging the straight side to form a seal between the center and the connecting ring.

[0177] According to another aspect, a respiratory mask assembly is provided, comprising: a frame, a cushion, a connection housing attached to the cushion at a first end opposite a second end; a swivel connector configured to provide inhaled gas from a gas supply and having a truncated ball joint; and an annular socket attached to the frame and to the second end of the connection housing. The annular socket comprises a connection housing engagement region configured to engage with the connection housing, a ball joint engagement region configured to engage with the truncated ball joint of the swivel connector, and at least one exhaust region disposed between the connection housing engagement region and the ball joint engagement region, the at least one exhaust region having at least one array of holes extending through the at least one exhaust region and configured to pass exhaled gas to ambient air outside the annular socket. An inner surface of the truncated ball joint defines a flow path to the cushion for exhaled gas from the gas supply. An outer surface of the truncated ball joint defines a flow path from the cushion to the at least one array of holes for exhaled gas to be vented to the air.

[0178] In some configurations, the annular socket and the frame are integrally formed.

[0179] In some configurations, the annular socket is configured to be inserted into and removably fastened to the frame.

[0180] In some configurations, the swivel connector and the annular socket are configured such that when the truncated ball joint is rotated to its fullest extent in any direction within the ball joint engagement region, the open end of the truncated ball joint fully overhangs the ball joint engagement region within the annular socket.

[0181] In some configurations, the swivel connector and the annular socket are configured such that when the truncated ball joint is in a neutral position within the ball joint engagement region of the annular socket, the open end of the truncated ball fully overhangs the ball joint engagement region within the annular socket.

[0182] In some configurations, the annular socket further includes first and second bearing regions that engage opposite sides of the truncated ball joint, the first and second bearing regions extending from the ball joint engagement region in a direction toward the cushion, thereby forming a recessed region between the first and second bearing regions.

[0183] In some configurations, the exhaust region is located within the recessed region.

[0184] In some configurations, the flow path to the exhaust region is defined by the first and second bearing regions, the inner surface of the annular socket, and the outer surface of the truncated ball joint.

[0185] According to another aspect, a respiratory mask assembly is provided, comprising: a frame, a cushion, a swivel connector having first and second ends configured to receive inspiratory gas from a gas supply, and an annular socket attached to the frame, the annular socket comprising: a cushion engagement region configured to engage with the cushion; a swivel connector engagement region configured to engage with the second end of the swivel connector and comprising a first bearing region, a second bearing region, and a recessed region formed between the first and second bearing regions; and at least one exhaust region disposed between the cushion engagement region and the swivel connector engagement region, the at least one exhaust region adjacent to the recessed region.

[0186] According to another aspect, a respiratory mask assembly is provided, comprising: a frame, a cushion, a swivel connector having first and second ends configured to receive inspiratory gas from a gas supply, and an annular socket attached to the frame, the annular socket comprising: a cushion engagement region configured to engage with the cushion; a swivel connector engagement region configured to engage with the second end of the swivel connector and comprising a first bearing region, a second bearing region, and a recessed region formed between the first and second bearing regions; and at least one exhaust region disposed between the cushion engagement region and the swivel connector engagement region, the at least one exhaust region adjacent to the recessed region.

[0187] In some configurations, the inner surface of the swivel connector defines an intake flow path for intake gas from the gas supply to the cushion.

[0188] In some configurations, the swivel connector is a truncated ball joint.

[0189] In some configurations, the exterior surface of the swivel connector defines, at least in part, an exhalation flow path from the cushion to at least one array of holes for venting exhaled gases to the atmosphere.

[0190] In some configurations, the at least one vent region further comprises at least one array of holes extending through the at least one vent region and configured to pass exhaled gases to ambient air outside the annular socket.

[0191] In some configurations, the annular socket and the frame are integrally formed.

[0192] In some configurations, the annular socket is configured to be inserted into and removably fastened to the frame.

[0193] In some configurations, the swivel connector and the annular socket are configured such that when the truncated ball joint is rotated to its fullest extent in any direction within the ball joint engagement region, the open end of the truncated ball joint fully overhangs the ball joint engagement region within the annular socket.

[0194] In some configurations, the swivel connector and the annular socket are configured such that when the truncated ball joint is in a neutral position within the ball joint engagement region of the annular socket, the open end of the truncated ball fully overhangs the ball joint engagement region within the annular socket.

[0195] In some configurations, the annular socket further includes first and second bearing regions that engage opposite sides of the truncated ball joint, the first and second bearing regions extending from the ball joint engagement region in a direction toward the cushion, thereby forming a recessed region between the first and second bearing regions.

[0196] In some configurations, the exhaust region is located within the recessed region.

[0197] In some configurations, the flow path to the exhaust region is defined by the first and second bearing regions, the inner surface of the annular socket, and the outer surface of the truncated ball joint.

[0198] One or more embodiments include a headgear structure having at least a portion made from a three-dimensional (3D) spacer fabric.

[0199] In a first aspect, the present disclosure relates to headgear for use with a respiratory mask, the headgear comprising a component formed from two layers of three-dimensional fabric folded from a sheet or tube of the three-dimensional fabric to have folded edges, the folded edges forming edges of the headgear.

[0200] In some embodiments, the component is a rear panel, the headgear includes lower and upper straps extending from the rear panel to connect to the mask, and the fold forms an edge of the rear panel.

[0201] In some embodiments, the fold forms the bottom edge of the back panel.

[0202] In some embodiments, the bottom edge of the back panel extends across the back of the user's neck in use.

[0203] In some embodiments, the two layers of the three-dimensional fabric are joined together by gluing, stitching, or welding at the other edge of the component.

[0204] In some embodiments, the two layers of three-dimensional fabric are sewn together at the edges to have a seamed edge, which forms the edge of the headgear.

[0205] In some embodiments, the joining edge is on the edge of the component opposite the folded edge of the component.

[0206] In some embodiments, the fold is a first fold and the three-dimensional fabric comprises a second fold at an edge of the component opposite the first fold.

[0207] In some embodiments, the fold is a first fold, and the three-dimensional fabric comprises a second fold at an edge of the component opposite the first fold, and a bond in one of the two layers of the three-dimensional fabric.

[0208] In some embodiments, the bonds are on the outer layer of the three-dimensional fabric.

[0209] In some embodiments, the joint is a welded seam.

[0210] In some embodiments, the two layers of the three-dimensional fabric are joined together by gluing, stitching, or welding on all other edges of the component.

[0211] In some embodiments, the three-dimensional fabric has a front side and a back side and is folded such that the back side of the fabric is on the inside of the component and the front side of the fabric is on the outside of the component.

[0212] In some embodiments, the rear panel includes a perimeter portion formed from a material suitable for use in headgear, such as a foam material or a fabric material, and one or more edges of the two layers of three-dimensional fabric are attached to the perimeter portion.

[0213] In some embodiments, the perimeter portion extends around two layers of the three-dimensional fabric from one edge of the hem to the other edge of the hem.

[0214] In some embodiments, the back panel comprises said peripheral edge along each lateral edge of the back panel.

[0215] In some embodiments, the material of the perimeter portion extends within and forms at least a portion of the straps of the headgear.

[0216] In some embodiments, one or more edges other than the folded edges of the two layers of the three-dimensional fabric are attached to the perimeter portion by gluing, stitching, or welding.

[0217] In some embodiments, the two layers of the three-dimensional fabric are welded or glued together at the perimeter along each lateral edge of the two layers of the three-dimensional fabric.

[0218] In some embodiments, the fold is curved.

[0219] In some embodiments, the three-dimensional fabric is wrapped around or covers another component of the headgear.

[0220] In some embodiments, the headgear comprises a rear panel formed from a material suitable for use in headgear, such as a foam material or a fabric material, with the three-dimensional fabric wrapped around or covering the material.

[0221] In some embodiments, the three-dimensional fabric has folded edges at the top and bottom edges of the back panel and a join at one of the two layers of the three-dimensional fabric.

[0222] In some embodiments, the bond is in the outer layer of the two layers of the three-dimensional fabric.

[0223] In some embodiments, the joint is a welded seam.

[0224] In some embodiments, the bonds in the layer of three-dimensional fabric join the three-dimensional fabric to a material underlying the layer of three-dimensional fabric.

[0225] In some embodiments, the headgear comprises a non-adhesive or non-welded material or film between the material underlying the three-dimensional fabric and one or both layers of the three-dimensional fabric, which prevents one or both layers of the three-dimensional fabric from adhering to the material underlying the headgear.

[0226] In some embodiments, the headgear comprises a non-adhesive or non-weld material or film between the underlying material and the inner layer of the three-dimensional fabric that prevents bonds in the outer layer of the three-dimensional fabric from bonding to the underlying material and the inner layer of the three-dimensional fabric.

[0227] In some embodiments, the component is a strap of headgear, for example a bottom strap or a top strap or a top strap.

[0228] In some embodiments, a bond between layers of a three-dimensional fabric or within one layer of a three-dimensional fabric is created by turning the fabric inside out so that the wrong side is on the outside, and then turning the fabric inside out so that the right side is on the outside, thereby placing the bond on the inside of the two layers of the three-dimensional fabric.

[0229] In some embodiments, one or more edges other than the folded edges of the two layers of three-dimensional fabric are welded to a portion of the headgear, and one of the two layers of three-dimensional fabric overlaps the edge of the other of the two layers of three-dimensional fabric, thereby causing the welded portion to include a first region formed from both of the two layers of three-dimensional fabric and the above portion of the headgear, and a second region formed from one of the two layers of three-dimensional fabric and the above portion of the headgear.

[0230] In some embodiments, the component is a rear panel, the headgear includes lower and upper straps extending from the rear panel to connect to the mask, the fold forms the edge of the rear panel, and said portion of the headgear is a peripheral portion of the rear panel formed from a material suitable for use in headgear, such as a foam material or a fabric material.

[0231] In some embodiments, at the welded portion, the inner layer of the two layers of three-dimensional fabric is positioned between the above-mentioned portion of the headgear and the outer layer of the two layers of three-dimensional fabric, and the outer layer of the three-dimensional fabric overlaps the edge of the inner layer of the three-dimensional fabric.

[0232] In some embodiments, the outer layer of the two layers of the three-dimensional fabric is the outer layer of the two layers of the three-dimensional fabric that faces away from the user's head when in use.

[0233] In another aspect, the disclosure relates to headgear for use with a respiratory mask, comprising a component formed from two layers of three-dimensional fabric, one or more edges of the two layers of three-dimensional fabric welded to a portion of the headgear, with one of the two layers of three-dimensional fabric overlapping an edge of the other of the two layers of three-dimensional fabric, whereby the welded portion includes a first region formed from both of the two layers of three-dimensional fabric and the portion of the headgear, and a second region formed from one of the two layers of three-dimensional fabric and the portion of the headgear.

[0234] In some embodiments, the headgear according to the second aspect comprises any one or more of the features described above in relation to the first aspect.

[0235] In some embodiments, the present disclosure relates to headgear for use in combination with a respiratory mask, the headgear being constructed at least in part from a three-dimensional fabric, with welding used to seal edges and / or provide structure to the headgear and / or define cushioned areas of the headgear.

[0236] In some embodiments, an overmolding process is used to finish and seal the edges.

[0237] In some embodiments, at least one region of the headgear is provided with a reinforcing member.

[0238] In some embodiments of the above aspects of the present disclosure, the three-dimensional fabric is a three-dimensional spacer fabric.

[0239] In another aspect, the present disclosure relates to headgear for use with a respiratory mask. The headgear includes a rear panel formed from a three-dimensional fabric and having a top edge, a bottom edge, and side edges, the top edge having a greater length than the bottom edge, and the side edges connecting the top edge to the bottom edge. The headgear also includes a perimeter portion formed from a foam laminate material and having straps for connecting to the mask, and seams fastening the side edges of the rear panel to the perimeter portion along joints. The side edges and the top edge form an angle θ, the angle θ being between 70 degrees and 120 degrees.

[0240] In some embodiments, the angle θ is between 85 degrees and 105 degrees.

[0241] In some embodiments, the angle θ is approximately 90 degrees.

[0242] In some embodiments, the top edge is curved.

[0243] In some embodiments, the back panel is formed from a folded and sewn sheet of three-dimensional fabric, the back panel further comprising a fold edge opposite the seam allowance.

[0244] In some embodiments, the lateral edges of the seam margin are located laterally inward of the lateral edges of the back panel.

[0245] In some embodiments, the lateral edges of the seam allowance are located laterally inward of the seam.

[0246] In some embodiments, the distance between the lateral edges of the seam allowance is less than the widest distance between the lateral edges of the back panel.

[0247] In some embodiments, the distance between the lateral edges of the seam margin is less than the width of the top edge.

[0248] In some embodiments, the width and length of the seam is consistent along the length of the joint.

[0249] In some embodiments, the seams are formed by utilizing a back and forth stitch.

[0250] In some embodiments, the seams are formed by utilizing a zigzag stitch.

[0251] In some embodiments, the perimeter portion further comprises an upper strap edge connected to an upper strap of the perimeter portion and a receiving edge that engages a lateral edge of the back panel, the upper strap edge and the receiving edge forming a corner having an angle β, the angle β being greater than 70 degrees.

[0252] In some embodiments, the angle β is approximately 90 degrees.

[0253] In some embodiments, the convex regions of the lateral edges are connected to the top edge.

[0254] In some embodiments, the concave regions of the side edges are connected to the bottom edge, and the convex and concave regions are connected at an inflection point.

[0255] In some embodiments, the inflection point is located below the seam allowance.

[0256] In some embodiments, the straight regions of the side edges are connected to the bottom edge, and the convex and straight regions are connected at tangent points.

[0257] In some embodiments, the contact point is located below the seam allowance.

[0258] In some embodiments, the contact point is located below the seam allowance.

[0259] In another aspect, the present disclosure relates to headgear for use with a respiratory mask. The headgear includes a rear panel formed from a three-dimensional fabric and having a top edge, a bottom edge, and side edges, the top edge having a length greater than the bottom edge and the side edges connecting the top edge to the bottom edge; a perimeter portion formed from a foam laminate material and including straps for connecting to the mask; and seams fastening the side edges of the rear panel to the perimeter portion along joints. The side edges extend laterally outward from the top edge.

[0260] In some embodiments, the seams are formed by utilizing a back and forth stitch.

[0261] In some embodiments, the seams are formed by utilizing a zigzag stitch.

[0262] In some embodiments, the lateral edges extend laterally outward from the bottom edge.

[0263] In some embodiments, the top edge is curved.

[0264] In some embodiments, the back panel is formed from a folded and sewn sheet of three-dimensional fabric, the back panel further comprising a fold edge opposite the seam allowance.

[0265] In some embodiments, the lateral edges of the seam margin are located laterally inward of the lateral edges of the back panel.

[0266] In some embodiments, the lateral edges of the seam allowance are located laterally inward of the seam.

[0267] In some embodiments, the distance between the lateral edges of the seam allowance is less than the widest distance between the lateral edges of the back panel.

[0268] In some embodiments, the distance between the lateral edges of the seam margin is less than the width of the top edge.

[0269] In some embodiments, the width and length of the seam is consistent along the length of the joint.

[0270] In some embodiments, the perimeter portion further includes an upper strap edge connected to the upper strap of the perimeter portion and a receiving edge that engages the lateral edge of the back panel, the upper strap edge and the receiving edge forming a corner having an angle β, the angle β being greater than 70 degrees.

[0271] In some embodiments, the angle β is approximately 90 degrees.

[0272] In some embodiments, the convex regions of the lateral edges are connected to the top edge.

[0273] In some embodiments, the concave regions of the side edges are connected to the bottom edge, and the convex and concave regions are connected at an inflection point.

[0274] In some embodiments, the inflection point is located below the seam allowance.

[0275] In some embodiments, the straight regions of the side edges are connected to the bottom edge, and the convex and straight regions are connected at tangent points.

[0276] In some embodiments, the contact point is located below the seam allowance.

[0277] In another aspect, the present disclosure relates to headgear for use with a respiratory mask. The headgear includes a panel formed from a first material having a first set of mechanical properties, the panel having a top edge, a bottom edge, and side edges, the top edge being larger than the bottom edge and the side edges connecting the top edge to the bottom edge; a perimeter portion formed from a second material having a second set of mechanical properties and including straps for connecting to the mask, the second material and second set of mechanical properties being stiffer than the first set of mechanical properties; and a seam fastening the side edges of the rear panel to the perimeter portion along a joint. The bottom edge and the top edge form an angle θ, the angle θ being between 70 and 120 degrees.

[0278] In some embodiments, the angle θ is between 85 degrees and 105 degrees.

[0279] In some embodiments, the angle θ is approximately 90 degrees.

[0280] In some embodiments, the top edge is curved.

[0281] In some embodiments, the back panel is formed from a folded and sewn sheet of three-dimensional fabric, the back panel further comprising a fold edge opposite the seam allowance.

[0282] In some embodiments, the lateral edges of the seam margin are located laterally inward of the lateral edges of the back panel.

[0283] In some embodiments, the lateral edges of the seam allowance are located laterally inward of the seam.

[0284] In some embodiments, the distance between the lateral edges of the seam allowance is less than the widest distance between the lateral edges of the back panel.

[0285] In some embodiments, the distance between the lateral edges of the seam margin is less than the width of the top edge.

[0286] In some embodiments, the width and length of the seam is consistent along the length of the joint.

[0287] In some embodiments, the seams are formed by utilizing a back and forth stitch.

[0288] In some embodiments, the seams are formed by utilizing a zigzag stitch.

[0289] In some embodiments, the perimeter portion further comprises an upper strap edge connected to an upper strap of the perimeter portion and a receiving edge that engages a lateral edge of the back panel, the upper strap edge and the receiving edge forming a corner having an angle β, the angle β being greater than 70 degrees.

[0290] In some embodiments, the angle β is approximately 90 degrees.

[0291] In some embodiments, the convex regions of the lateral edges are connected to the top edge.

[0292] In some embodiments, the concave regions of the side edges are connected to the bottom edge, and the convex and concave regions are connected at an inflection point.

[0293] In some embodiments, the inflection point is located below the seam allowance.

[0294] In some embodiments, the straight regions of the side edges are connected to the bottom edge, and the convex and straight regions are connected at tangent points.

[0295] In some embodiments, the contact point is located below the seam allowance.

[0296] The following drawings and the associated description are provided to illustrate embodiments of the present disclosure and not to limit the scope of the claims. Many of the aspects and attendant advantages of the present disclosure will become more readily appreciated as the same become better understood by reference to the following detailed description, when taken in conjunction with the accompanying drawings, in which: [Brief explanation of the drawings]

[0297] [Figure 1] 1 is a front view of a user wearing an interface arranged and configured in accordance with certain features, aspects and advantages of the present invention; [Figure 2] FIG. 2 is a side view of a user wearing the interface of FIG. 1. [Figure 3] FIG. 2 is a perspective view of a mask seal and a mask seal clip of the interface of FIG. 1. [Figure 4] FIG. 4 is a side view of the mask seal and mask seal clip of FIG. 3. [Figure 5] FIG. 2 is a perspective view of an elbow assembly arranged to be connected to the interface of FIG. 1; [Figure 6] FIG. 6 is a side elevation view of the elbow assembly of FIG. 5. [Figure 7] FIG. 6 is a rear elevation view of the elbow assembly of FIG. 5. [Figure 8] FIG. 6 is a side cross-sectional elevation view of the elbow assembly of FIG. 5. [Figure 9] FIG. 6 is a cross-sectional perspective view of the elbow assembly of FIG. 5. [Figure 10] FIG. 10 is a side view of another configuration of the elbow assembly. [Figure 11] FIG. 11 is an exploded view of the elbow assembly of FIG. [Figure 12] FIG. 12 is a cross-sectional view taken along line 12-12 of FIG. [Figure 13] FIG. 13 is a cross-sectional view taken along line 13-13 of FIG. [Figure 14] FIG. 10 is an enlarged side cross-sectional view of another elbow assembly with the anti-asphyxiation valve flap in an open and closed position. [Figure 15] 15 is an enlarged cross-sectional side and perspective view of a portion of the elbow assembly of FIG. 14. [Figure 16] FIG. 15 is an enlarged perspective view of a portion of the anti-asphyxiation valve of the elbow assembly of FIG. [Figure 17] FIG. 15 is another enlarged perspective view of a portion of the anti-asphyxiation valve of the elbow assembly of FIG. [Figure 18] FIG. 15 is a plan view of a portion of the anti-asphyxiation valve of the elbow assembly of FIG. [Figure 19] FIG. 15 is a side view of a portion of the anti-asphyxiation valve of the elbow assembly of FIG. [Figure 20] FIG. 10 is a perspective view of another embodiment of an anti-asphyxiation valve. [Figure 21] FIG. 21 is a side view of the valve of FIG. 20. [Figure 22] FIG. 10 is a cross-sectional view of a patient interface assembly. [Figure 23A] FIG. 1 is a perspective view of a connector and elbow assembly configuration. [Figure 23B] 23B is a perspective view of the connector and elbow assembly of FIG. 23A with portions removed. [Figure 23C] FIG. 23B is an alternative perspective view of the connector and elbow assembly of FIG. 23A. [Figure 23D] FIG. 23B is a cross-sectional view of the connector and elbow assembly of FIG. 23A. [Figure 24A] FIG. 26 is a side view of the connector and elbow assembly shown in FIGS. 23A-23D. [Figure 24B] FIG. 26 is a perspective view of the connector and elbow assembly shown in FIGS. 23A-23D. [Figure 24C] FIG. 26 is an alternative perspective view of the connector and elbow assembly shown in FIGS. 23A-23D. [Figure 25A] FIG. 23B is a perspective view of the elbow connector shown in FIGS. 23A to 23D. [Figure 25B] FIG. 23B is a perspective view of the elbow connector shown in FIGS. 23A to 23D. [Figure 25C] FIG. 26 is a side view of the elbow connector shown in FIGS. 23A to 23D. [Figure 25D] FIG. 26 is a front view of the elbow connector shown in FIGS. 23A to 23D. [Figure 25E] FIG. 23B is a cross-sectional view of the elbow connector shown in FIGS. 23A to 23D. [Figure 25F] FIG. 26 is a perspective view of the elbow connector shown in FIGS. 23A to 23D as viewed from above. [Figure 26] FIG. 1 is a cutaway side view of an elbow assembly according to the present invention incorporating an anti-asphyxiation valve. [Figure 27] FIG. 27 is an enlarged perspective view from below of the elbow assembly of FIG. 26. [Figure 28A] FIG. 28 shows a top perspective view of the anti-asphyxiation valve of the elbow assembly of FIGS. 26 and 27. [Figure 28B] FIG. 28 shows a side perspective view of the anti-asphyxiation valve of the elbow assembly of FIGS. 26 and 27. [Figure 28C] FIG. 28 shows a bottom perspective view of the anti-asphyxiation valve of the elbow assembly of FIGS. 26 and 27. [Figure 29] FIG. 29 is a plan view of the valve of FIGS. 26 to 28. [Figure 30] FIG. 30 is a front view of the valve of FIGS. 26 to 29. [Figure 31] FIG. 31 is a cross-sectional side view of the valve of FIGS. 28-30 showing non-limiting example dimensions. [Figure 32] FIG. 1 is a diagram of a breathing system with a flow generator, a humidifier, and a user interface. [Figure 33A] 10 illustrates components for bias flow exhaust in a two-piece ball joint socket and connection housing according to an embodiment. [Figure 33B] 33B shows a front view of the two-piece ball joint socket and connection housing of FIG. 33A. FIG. [Figure 33C] 33B shows a side cross-sectional view of the two-piece ball joint socket and connection housing of FIG. 33A. [Figure 34A] 1 illustrates a top cross-sectional view of a seal between a socket and a connection housing according to at least one embodiment. [Figure 34B] 34B shows an enlarged cross-sectional view of the L-shaped side portion of the connection housing raised portion between the socket and connection housing of FIG. 34A. [Figure 35A] FIG. 10 illustrates a front view of a bias flow exhaust in a two-part ball joint socket and connection housing according to another embodiment. [Figure 35B] 35B shows a side cross-sectional view of the two-piece ball joint socket and connection housing of FIG. 35A. [Figure 35C] 35B shows a top cross-sectional view of the two-piece ball joint socket and connection housing of FIG. 35A. [Figure 36] 10 shows details of a seal between a socket and a connection housing according to at least one embodiment. [Figure 37A] 1 illustrates a top cross-sectional view of a bias flow exhaust in a ball joint socket with a recessed channel according to an embodiment. [Figure 37B] 37B shows a top cross-sectional view of the ball joint socket of FIG. 37A without the truncated ball joint. [Figure 37C] 37B shows a side cross-sectional view of the bias flow exhaust at the ball joint socket of FIG. 37A. [Figure 37D]37B shows a top cross-sectional view of the ball joint socket of FIG. 37A showing the generally arcuate second bearing region. [Figure 37E] FIG. 37B shows a top cross-sectional view of the ball joint socket of FIG. 37A in the "extended elbow" configuration. [Figure 38A] 10 illustrates a top cross-sectional view of a bias flow exhaust in a ball joint socket with a recessed channel according to another embodiment. [Figure 38B] 38B shows a side cross-sectional view of the bias flow exhaust at the ball joint socket of FIG. 38A. [Figure 38C] 38B shows an enlarged side cross-sectional view of the bias flow exhaust at the ball joint socket of FIG. 38A. [Figure 38D] 32B shows a top cross-sectional view of the ball joint socket of FIG. 32A showing the generally arcuate second bearing region. [Figure 38E] 38B shows a top cross-sectional view of the ball joint socket of FIG. 38A with the end of the truncated ball joint fully overhanging the ball joint engagement area in the socket. [Figure 39A] FIG. 10 shows a perspective view of the socket showing the arrangement of the hole array. [Figure 39B] 10A and 10B show perspective views of a socket showing alternative arrangements of the hole array. [Figure 39C] 13A and 13B show perspective views of a socket illustrating another alternative arrangement of the hole array. [Figure 39D] FIG. 10 shows a perspective view of a socket showing the arrangement of the slot array. [Figure 40A] 37A-37E and 38A-38E show the arc lengths of the bearing areas of the ball joint sockets with recessed channels; [Figure 40B] 38A-38E show the channel depth of the bias flow exhaust of the ball joint socket with recessed channels. [Figure 40C] 38A-38E show the arc length of the bearing area of ​​the ball joint socket with recessed channels; [Figure 40D] 38A-38E show the inner diameter of the connection housing of the ball joint socket with recessed channels. [Figure 40E]38A-38E show the retention area of ​​the bearing region of the ball joint socket with recessed channels; [Figure 41A] FIG. 1 shows a front view of a respiratory mask assembly with a vent insert having an integrated elbow socket. [Figure 41B] 41B shows a rear view of the respiratory mask assembly with a vent insert with integrated elbow socket of FIG. 41A. [Figure 41C] 41B shows a side view of the respiratory mask assembly with a vent insert with integrated elbow socket of FIG. 41A. [Figure 41D] 41B shows a rear enlarged perspective view of the respiratory mask assembly with an exhaust insert having an integrated elbow socket of FIG. 41A. FIG. [Figure 41E] 41B shows a front enlarged perspective view of the respiratory mask assembly with an exhaust insert having an integrated elbow socket of FIG. 41A. FIG. [Figure 42A] FIG. 10 shows a front view of an alternative respiratory mask assembly with a vent insert having an integrated elbow socket. [Figure 42B] 36B shows a cross-sectional view of the alternative respiratory mask assembly with a vent insert having an integrated elbow socket taken along line 36B-36B of FIG. 35A. [Figure 43] FIG. 1 is a cross-sectional view of a three-dimensional spacer fabric showing two outer sheets of fabric and the inner spacing fibers or filaments between the sheets. [Figure 44] FIG. 1 is a perspective view of a full face patient interface and headgear assembly. [Figure 45] FIG. 1 is an isometric view of a full face headgear configuration when laid flat. [Figure 46A] FIG. 10 is a cross-sectional view of a spacer fabric edge finished by welding and die-cutting techniques. [Figure 46B] FIG. 10 is a cross-sectional view of the edge of a spacer fabric that is finished by welding the top and bottom surfaces together at the center of the fabric. [Figure 46C]10 is a cross-sectional view of an edge of a spacer fabric that is finished by folding the top surface and welding it to the bottom surface. [Figure 46D] FIG. 10 is a cross-sectional view of an edge of a spacer fabric that is finished by welding a separate finishing component to the edge of the spacer fabric. [Figure 46E] FIG. 10 is a cross-sectional view of an edge of a spacer fabric that is finished by overmolding a bead onto the edge of the spacer fabric. [Figure 46F] FIG. 10 is a cross-sectional view of an edge of a spacer fabric that is finished by infiltrating a plastic material through the spacer fabric. [Figure 46G] 10 is a cross-sectional view of an edge of a spacer fabric being finished by a hot knife technique to seal and trim the spacer fabric. FIG. [Figure 47A] 1 shows headgear with spacer fabric laid flat. [Figure 47B] 47B shows a detail of a spacer fabric panel incorporated into the headgear of FIG. 47A. [Figure 48] 1 shows a headgear arrangement in which, in use, the bottom edge of the spacer fabric panel is positioned on or across the user's neck. [Figure 49] 1 shows a headgear arrangement having a back panel formed from two layers of spacer fabric and a perimeter portion formed from another headgear material that extends around the entire perimeter of the spacer fabric. [Figure 50] 1 shows a headgear arrangement having a rear panel formed from two layers of spacer fabric folded from a sheet or blank of spacer fabric. [Figure 51] 1 shows a headgear arrangement formed from two layers of spacer fabric welded together along each lateral edge and sewn along the edge opposite the folded edge. [Figure 52] 1 shows a headgear arrangement having curved fold edges and a pleated layer. [Figure 53]1 shows a headgear arrangement formed from two layers of spacer fabric welded to upper and lower straps along their upper and lower edges, respectively. [Figure 54] 1 shows a headgear arrangement formed from a spacer fabric wrapped around other headgear material with folded edges at the top and bottom edges of the rear panel. [Figure 55] FIG. 55 is a cross-sectional view of the rear panel of the headgear of FIG. [Figure 56] FIG. 52 is a cross-sectional view of a rear panel of the headgear described with reference to the embodiment of FIG. 51. [Figure 57] 10 shows another headgear embodiment laid flat. [Figure 58A] 1 shows a spacer fabric blank. [Figure 58B] 58B shows a perspective overview of the spacer fabric blank of FIG. 58A folded to form two layers of spacer fabric. [Figure 58C] FIG. 58B shows a side view of the spacer fabric blank of FIG. 58A folded to form two layers of spacer fabric. [Figure 58D] 10 shows another blank of spacer fabric for forming a back panel comprising two layers of spacer fabric. [Figure 59A] 1 shows the stack of materials before welding. [Figure 59B] 59B shows an enlarged view of the materials of FIG. 59A welded together at a weld seam. [Figure 60] 1 shows a schematic graph describing optimal weld thickness. [Figure 61] 10 illustrates a headgear arrangement having a rear panel formed from a three-dimensional fabric sewn to a perimeter portion formed from a foam and fabric laminate material. [Figure 62] 10 shows an alternative headgear arrangement having a rear panel formed from a three-dimensional fabric sewn to a perimeter portion formed from a foam and fabric laminate material. [Figure 63] 63 shows the rear panel of the headgear arrangement of FIG. 62 laid flat. [Figure 64] 63 shows the rear panel and perimeter portion of the headgear arrangement of FIG. 62. [Figure 65] FIG. 63 is an enlarged view of the joint between the rear panel and the perimeter portion of the headgear arrangement of FIG. 62. [Figure 66] 63 shows a perimeter portion of the headgear arrangement of FIG. 62. [Figure 67] FIG. 63 is a close-up view of the stitching along the joint of the headgear arrangement of FIG. 62. [Figure 68] 1 shows a headgear arrangement with ball seams. [Figure 69] 10 shows another headgear arrangement with ball seams. [Figure 70] FIG. 10 is a close-up view of the ball-neck seam along the junction between the back panel and the perimeter portion. [Figure 71] FIG. 10 is a close-up view of the ball seam along the joint between the back panel and the perimeter portion, with the top corner of the back panel deforming. [Figure 72] 10 shows an alternative headgear arrangement having an alternative side edge arrangement. [Figure 73] 10 shows another alternative headgear arrangement having an alternative side edge arrangement. [Figure 74] 74 shows the alternative headgear arrangement of FIG. 73 including the dimensions of the seam allowance relative to the lateral edges of the rear panel. DETAILED DESCRIPTION OF THE INVENTION

[0298] In the drawings, the first digit of each reference number indicates the figure in which an element first appears. Reference numbers may be reused throughout the drawings to indicate correspondence between referenced elements. Nevertheless, the use of different numbers does not necessarily indicate that there is no correspondence between elements. Conversely, the reuse of numbers does not necessarily indicate that the elements are the same.

[0299] Although several preferred embodiments and examples are disclosed below, the inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses, and to modifications and equivalents thereof. Accordingly, the scope of the claims appended hereto is not limited by any of the specific embodiments described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable order and are not necessarily limited to any particular disclosed order. To aid in understanding some embodiments, various operations may be described sequentially as multiple separate operations, but the order of description should not be construed to imply that these operations are order-dependent. Furthermore, the structures, systems, and / or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various embodiments, several aspects and advantages of these embodiments are described. Not all of these aspects or advantages are necessarily achieved by any particular embodiment. Thus, for example, various embodiments can be implemented to achieve or optimize one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may also be taught or suggested herein.

[0300]

[0023] Referring now to the figures, details regarding several exemplary embodiments for implementing the apparatus and methods described herein will be described. In the following description, numerous specific details are set forth to provide a more thorough understanding of various embodiments of the present disclosure. However, it will be apparent to one skilled in the art that the systems and methods of the present disclosure may be practiced without one or more of these specific details.

[0301] To facilitate understanding of the systems and methods discussed herein, several terms are defined below. The terms defined below, along with other terms used herein, should be interpreted broadly to include, without limitation, the definitions provided, the ordinary and customary meaning of the terms, and / or any other implied meaning for each term. Thus, the definitions below do not limit the meaning of these terms, but merely provide example definitions.

[0302] With respect to dimensions, the term approximately should be understood to mean within standard manufacturing tolerances or variations that may occur and / or be expected during manufacturing. Additionally, the term approximately can extend up to and including the dimension that is rounded to the stated value.

[0303] The term "approximately" should be understood to mean "for the most part." For example, a component that is approximately cylindrical does not necessarily correspond to a perfect cylinder (a surface or solid bounded by two parallel planes, generated by straight lines running parallel to a given plane, and describing a curve bounded by those planes and lying in a plane perpendicular or oblique to the given plane). Rather, a substantially cylindrical component should be understood to be cylinder-like in that it has a circular profile along a cross section and an elongated longitudinal profile.

[0304] The term respiratory mask is a broad term and should be given its ordinary and customary meaning to those skilled in the art (i.e., should not be limited to a special or customized meaning), and includes, without limitation, a variety of user interfaces for NIV and CPAP.

[0305] The term seal refers to a substantially, but not necessarily completely, airtight closure. For example, a cushion may seal against a user's face to allow bulk flow of gas to be directed through the cushion to and from the user, while potentially allowing a small amount of gas to escape between the cushion and the user's face so as not to disrupt the bulk flow.

[0306] The term apex, when used, refers to the direction closer to the user's nose.

[0307] The term bottom, when used, refers to the direction closer to the user's lower lip.

[0308] The term static noise, as used, refers to the ambient noise from the respiratory system.

[0309] The term dynamic noise, when used, refers to additional noise from the respiratory system beyond the ambient noise from breathing, caused by increases and decreases in airflow and velocity.

[0310] The term perimeter refers to the boundary or edge of a part or object. In the case of an annular (ring-shaped) object, such as a hollow cylinder, the outer perimeter refers to the outermost boundary or edge of the hollow cylinder, facing the surrounding environment. The inner perimeter refers to the inner boundary or edge of the hollow cylinder, facing the central bore. In the case of a solid with an internal hole, the perimeter of the hole refers to the boundary or edge of the hole along the solid, facing towards the center of the hole.

[0311] 1 and 2, an interface 100 is shown in place on a user U. The interface 100 comprises an interface that can be used in the field of respiratory therapy. The interface 100 is particularly useful in multiple forms of positive airway pressure therapy. For example, the interface 100 can be used to administer continuous positive airway pressure ("CPAP") therapy. Additionally, the interface 100 can be used in variable positive airway pressure ("VPAP") therapy and bi-level positive airway pressure ("BiPAP") therapy. The interface can be used with any suitable CPAP system.

[0312] The interface 100 may comprise any suitable mask configuration. For example, some features, aspects, and advantages of the present invention may find utility in a nasal mask, a full-face mask, an oral-nasal mask, or any other positive pressure mask. The illustrated mask is a full-face mask. The illustrated interface 100 generally comprises a mask assembly 102, a connection port assembly 104, and a headgear assembly 106.

[0313] 3 and 4, the mask assembly 102 generally comprises a mask seal 110, which may include a mask seal clip 112, and a mask base 114. The mask seal clip 112 preferably connects the mask seal 110 to the mask base 114. While the illustrated mask seal 110 and mask seal clip 112 are formed separately and secured together, in some configurations the mask seal 110 and mask seal clip 112 may be integrated into a single component. In some configurations, the mask seal 110 is overmolded onto the mask seal clip 112.

[0314] 3, the mask seal clip 112 is relatively stiffer, rigid, or less flexible than the mask seal 110. In some configurations, the mask seal clip 112 is formed from a polycarbonate material. In some configurations, at least a portion of the mask seal clip 112 is formed from polycarbonate or other rigid or semi-rigid material. In some configurations, the mask seal clip 112 is at least partially formed from silicone or another suitable material. In such configurations, at least the silicone portion of the mask seal clip 112 may be formed to be relatively thick compared to the more flexible portions of the mask seal 110. The mask seal clip 112 provides structural support to the mask seal 110 in the configuration shown.

[0315] The illustrated mask seal also includes a generally central passageway 144 defined by wall 136. In the illustrated configuration, wall 136 generally surrounds passageway 144. Preferably, wall 136 is generally cylindrical in configuration and extends through wall 126. Other configurations are possible.

[0316] 4, the mask seal clip 112 is preferably positioned to be generally flush with the inner rim 150 of the mask seal 110. In the configuration shown, the mask seal 110 includes a relatively small radius portion 152 adjacent to an upper portion 154. The upper portion 154 of the mask seal 110 is configured to extend over the nasal region of the user. In some configurations, the upper portion 154 is configured to extend over the nasal bridge region of the user U.

[0317] The upper portion 154 is connected to a lower portion 156 of the seal member 110. The lower portion 156 extends laterally outward from the mask seal clip 112. Additionally, the lower portion 156 wraps rearward and inward, as shown in FIG. 4. At the proximal end of the full-face mask assembly 102, the upper and lower portions 154, 156 join together to define a face-contacting flange 160, shown in FIG. 10. The face-contacting flange 160 is configured to rest beneath a user's lower lip, extend along the outside of the mouth, extend upward along the cheekbones, and extend across the bridge of the user's nose. The illustrated face-contacting flange 160 thus defines a generally teardrop-shaped opening 162. When the mask assembly 102 is placed on a user's face, the flange 160 lies flat over the bridge of the nose, cheekbones, the outside of the mouth, and below the user's lower lip. When supplied with positive air pressure, the mask seal 110 inflates and seals against the user's face, reducing or eliminating the possibility of leakage between the flange 160 and the user's face.

[0318] The upper portion 154 of the mask seal 110 is designed to curl over an outer surface 170 of the mask assembly 102. In the configuration shown, the outer surface of the mask seal 110 curls smoothly and abuts the outer surface of the mask seal clip 112, thereby forming a support surface. In some configurations, the outer surface 170 onto which the upper portion 154 curls comprises at least a portion of the outer surface of the mask seal clip 112. In some configurations, the outer surface 170 onto which the upper portion 154 curls comprises almost exclusively the outer surface of the mask seal clip 112. In some configurations, the upper portion 154 curls over another portion of the mask seal 110. In some configurations, the upper portion 154 curls over the mask seal base 114.

[0319] 1 and 2, the mask assembly 102 includes a mask base 114 that is more rigid than the mask seal 110. The mask base 114 may be formed from any suitable material. In some configurations, the mask base 114 is formed from a polycarbonate material, thereby allowing it to flex so as to connect with the mask seal 110 and / or mask seal clip 112.

[0320] The central passageway 144 may be radiused to receive a ball end 220 of a swivel elbow 222, such as that shown in FIG. 5. As better shown in FIG. 6, the ball end 220 has a curved surface 224 that can snap-fit ​​into a curved surface 214 formed on the mask base 114. The connection between the two curved surfaces 214, 224 allows the surfaces to slide relatively freely with one another, thereby allowing the position of the swivel elbow 222 to be easily changed. In some configurations, the elbow 222 can be configured to rotate or pivot without having a ball joint configuration.

[0321] Referring to FIG. 2 , in addition to strap 260, headgear assembly 106 also includes a rear strap 280 and a top strap 282. Other headgear assemblies may be used. Rear strap 280 extends across the back of user U's head, generally above the nape of the neck but generally below the occipital protuberance. At a location behind the user's ear, rear strap 280 splits into an upper arm 284 and a lower arm 286. Upper arm 284 arcs upward to a location above the user's ear, then arcs downward to a location generally in front of the user's ear. Lower arm 286 arcs downward to a location generally below the user's ear, extending slightly in front of the ear.

[0322] The strap 260 can be connected to the rear strap 280 in any suitable manner. In the configuration shown, the strap 260 connects to an upper arm 284 and a lower arm 286, respectively. Preferably, the upper arm 284 and the lower arm 286 are stiffer than the strap 260, so that the arms 284, 286 generally maintain their shape when the headgear 106 is worn. In some configurations, the upper arm 284 and the lower arm 286 each support their own weight. In some configurations, the upper arm 284 and the lower arm 286 each are structured to prevent tangling when worn. For example, the arms 284, 286 have sufficient torsional stiffness to reduce the likelihood of twisting when worn.

[0323] Preferably, the strap 260 connects to at least one of the upper arm 284 and the lower arm 286 at a location in front of the ears. Such a configuration helps the user to position the strap 260 without much difficulty. Furthermore, because the strap 260 in the illustrated configuration is fitted into the clip 252, the ends of the upper arm 284 and the lower arm 286 may include slots 290, 292 through which the strap 260 can be threaded. Furthermore, the strap 260 may include an adjustment mechanism 294, such as a Velcro or buckle configuration. The adjustment mechanism 294 allows for adjustment of the force between the mask seal 110 and the face of the user U. Any suitable adjustment mechanism 294 may be used.

[0324] 2, top strap 282 is preferably flexible and has an adjustable length. Top strap 282 connects to upper arm 284 through slot 296, which reduces the chance of upper arm 284 slipping off the user's head and contacting the user's ear. Preferably, top strap 282 connects to upper arm 284 at a location generally above the user's ear.

[0325] Advantageously, as shown in Figures 1 and 2, strap 260, while connected to mask base 114, applies a force in the direction of arrow F by movement in direction C, which is generally perpendicular to the force direction F. In other words, strap 260 is tensioned by pulling forward, and clip 252 is connected to mask base 114 by movement in a direction perpendicular to the forward pull. This configuration facilitates securing interface 100 to the user's face.

[0326] Referring again to Figure 5, elbow 222 connects to conduit 300 through separable swivel assembly 302. As shown in cross section in Figure 8, elbow 222 includes a shaft 304 with an inner wall 306 at its base. Inner wall 306 includes a recess 308.

[0327] A sleeve 310 includes a flange 312 that is received within the recess 308. The sleeve 310 can be secured in place within the elbow 222 using any suitable technique. The sleeve 310 includes a generally cylindrical outer wall 314. The flange 312 includes an outwardly extending portion that connects to a lever 316. Preferably, the flange 312 and the lever 316 are integrally formed. Referring to FIG. 9 , the lever 316 includes a lower, inwardly extending catch 320 that can pivot about the portion connecting the lever 316 to the flange 312. Thus, pushing an upper portion 322 of the lever 316 inward moves the catch 320 away from the generally cylindrical outer wall 314 of the sleeve 310.

[0328] Swivel 330 includes a generally cylindrical inner wall 332. Inner wall 332 slides over outer wall 314 of sleeve 310, thereby providing a snug fit between swivel 330 and sleeve 310. Upper portion 334 includes a shoulder 336. A catch 320 on lever 316 can engage shoulder 336 to secure swivel 330 in an axial position relative to sleeve 310. When upper portion 322 of lever 316 is depressed, catch 320 moves away from shoulder 336, thereby allowing swivel 330 to be removed from sleeve 310.

[0329] A flap 350 can be attached between the shaft 304 and the sleeve 310. In the illustrated configuration, the flap 350 extends into the flow passage 352 from a base 354 that is sandwiched between the shaft 304 and the sleeve 310. The flap 350 can pivot upward (see arrow P, as shown in FIG. 8 ) about axis X (see FIG. 9 ) away from the sleeve 310, allowing flow from the positive pressure generator to continue generally unimpeded through the interface 100 to the user. The flap 350 pivots downward to contact the sleeve 310 and seal the flow passage 352 when the positive pressure source stops providing pressurized airflow. In some configurations, the flap 350 does not fully contact the sleeve 310. In some configurations, the flap 350 does not seal the flow passage 352 when in the lowered position.

[0330] 9, a port 360 is defined through the elbow 222 at a location above the flap 350. The port 360 is preferably located along a portion of the elbow 222 near the axis X. In some configurations, the port 360 is positioned such that it is substantially shielded from the exhaled airflow by the flap 350. In other words, when the flap 350 is pivoted to direct air away from the sleeve 310, the flap 350 moves to a position that at least partially or completely covers the port 360.

[0331] In some configurations, the port 360 extends through a wall of the elbow 222 that includes a generally planar inner wall 362. The generally planar inner wall 362 helps to generally seal the port 360 when the flap 350 moves upwardly, away from the flange 312 of the sleeve 310.

[0332] In some configurations, the lever 316 overlies a majority of the port 360, thereby generally blocking the port 360 from view. However, as shown in FIG. 8 , a gap 364 preferably surrounds at least a portion of the lever 316, thereby allowing relatively free airflow through the port 360 when the flap 350 does not overlie the port 360. Furthermore, in some configurations, the port 360 and lever 316 are positioned on the same side of the elbow 222 as an opening 370 defined in the ball end 220, which is located within the mask assembly 102 when the connection port assembly 104 is assembled thereto. Advantageously, such positioning positions the port 360 at a location on the elbow 222 facing the user. This location further blocks the port 360 from view during use, thereby resulting in a more aesthetically pleasing configuration. Furthermore, because flow through the port 360 is extremely rare, positioning the port 360 toward the user does not cause any significant discomfort to the user.

[0333] Although not shown, elbow 222 may also include one or more bias flow vents, which are preferably oriented in a forward direction to prevent any bias flow from impinging directly on the user.

[0334] FIGS. 10-13 illustrate another configuration of an elbow assembly 302. The elbow assembly 302 includes an elbow 222, a sleeve 310, and / or a swivel 330, as shown in FIG. 11. In some configurations, the elbow assembly 302 includes only the elbow 222 and sleeve, omitting the swivel 330. The swivel can be permanently or removably attached to the sleeve 310 and elbow 222; in some configurations, the swivel 330 is integrally formed with the end of the delivery conduit. An anti-asphyxiation valve flap 350 is positioned over the sleeve 310 to at least partially block a flow path 352 in the sleeve. The elbow assembly 302 functions similarly to the elbow assembly 302 of FIGS. 5-9; however, the elbow assembly 302 of FIGS. 10-13 offers the added benefit of directing gas away from the patient when the flap 350 drops to its closed position (as shown in FIGS. 12 and 13).

[0335] 11 , sleeve 310 preferably includes two or more cutout areas or recesses 356. Recesses 356 can have any suitable shape, and in the configuration shown, recesses 356 have a semicircular configuration extending upward into sleeve 310. Sleeve 310 also includes at least one ledge 357, preferably two or more ledges 357. Preferably, each of ledges 357 extends over an arc of approximately 70 degrees. More preferably, each of ledges 357 is generally centered between two recesses 356, and each of ledges 357 extends approximately 70 degrees around the outer surface of sleeve 310.

[0336] Swivel 330 is preferably generally cylindrical in configuration. As shown in FIG. 11 , swivel 330 has an inwardly extending ridge 358. Ridge 358 preferably surrounds the entire inner surface. In some configurations, ridge 358 may be intermittent. However, preferably, ridge 358 does not have any interruptions large enough to accommodate the entire protrusion 357, allowing ridge 358 and protrusion 357 to cooperate to maintain swivel 330 mounted on sleeve 310. When swivel 330 is assembled to sleeve 310, recess 216 biases protrusion 220 inward, allowing protrusion 357 to slide over protrusion 358 and then spring outward to secure protrusion 357 beneath protrusion 358.

[0337] The elbow 222 includes an opening 420 in its side that is in fluid communication with an exhaust passage 422. The exhaust passage 422 is defined by the spacing between the inner wall 362 and the outer wall 424 of the elbow, as shown in Figures 12 and 13.

[0338] 12 and 13, when flap 350 drops to its closed position, air exhaled by the user enters opening 370 in elbow 222. Exhaled air flows through port 360 in inner wall 362 of the elbow and through exhaust flow path 422 until it exits elbow 222 through opening 420.

[0339] 10-13 improves the aesthetic value of the product by reducing the overall length and eliminating an unsightly hole located in the front of elbow 222. Additionally, the configuration of Figures 10-13 improves patient comfort by preventing air from being directed toward the user. Instead, opening 420 directs airflow out the side of elbow 222 and away from the patient.

[0340] 14-19, another configuration of elbow assembly 702 includes elbow 722 and sleeve 710. A swivel 330, as described above, may also be provided, but is not shown in FIGS.

[0341] An anti-asphyxiation valve (AA valve) 750 is provided and positioned on the sleeve 710 to at least partially block the sleeve flow path 352. The elbow assembly 702 functions similarly to the elbow assembly 302 of Figures 10-13 and similarly directs gas away from the patient when the flap 752 of the AA valve 750 drops to its closed position, i.e., a generally horizontal position as shown in Figure 14, blocking the flow path 352 through the sleeve 710.

[0342] The AA valve 750 includes a generally planar valve flap 752 hingedly mounted on a flap support 754. The flap support 754 may be integrally formed with the valve flap 752 and may include one or more orientation features that facilitate precise orientation and installation of the valve 750 on the sleeve 710. In this example, the orientation feature includes a slot 756 formed on the underside of the flap support 754 that receives a corresponding protrusion 758 on the upper portion of the sleeve 710. The engagement between the slot 756 and the protrusion 758 helps to retain the valve 750 on the sleeve 710 during assembly of the elbow assembly 702 and helps to precisely orient the valve 750 relative to the sleeve 710 and elbow 722 and relative to the axis of the sleeve's flow passage 352. The slot 756 and protrusion 758 also prevent the sleeve 750 from being installed on the sleeve 710 upside down, i.e., with the flap 752 and flap support 754 rotated 180 degrees from the orientation shown in FIG. 14 .

[0343] The AA valve 750 includes a hinge 760 that pivotally attaches the flap 752 to a support 754. The hinge 760 may be integrally formed with both the flap 752 and the support 754. The hinge 760 comprises a relatively thin strip of material that is more flexible than the flap 752 and the support 754, allowing the thicker flap 752 to pivot about the support 754 from a generally horizontal position in which the flap 752 closes the flow passage 352 through the sleeve 710, to a generally vertical position in which the flap 752 opens the flow passage 352 in the sleeve 710 but closes the exhaust flow passage 422 formed in the elbow 722.

[0344] The valve flap 752 includes a bead, ridge, or protrusion 762 that protrudes from a planar upper surface 764 of the flap 752. The bead 762 therefore protrudes from the upper surface 764 of the flap 752. When the flap 752 is in a generally vertical position that opens the flow passage 352 of the sleeve 710 but closes the exhaust passage 422 formed in the elbow 722, the bead 762 contacts the portion of the elbow 722 that surrounds the exhaust passage 422, forming a separate sealing surface 764 that seals against the elbow 722 and closes the exhaust passage 422. The bead 762 therefore forms a sealing surface 764 that has a sealing area that is relatively small relative to the area of ​​the valve flap 752 itself. That is, the area 764 of the bead 762 that seals against the elbow 722 when the flap 752 is in a generally vertical position is relatively small, yet still sufficient to close and seal the exhaust passage 422.

[0345] If the elbow 722 has been through multiple cleaning cycles, the plastic surfaces of the elbow 722 may have deteriorated, which may allow water to adhere to those surfaces more easily. Thus, the wetting angle of the water / plastic interface may increase, which may result in water droplets remaining on the interface of the elbow 722 rather than forming a bead and rolling off the interface.

[0346] A problem with prior art AA valves can be that the relatively large sealing surface of the planar valve flap can trap water between the contact surfaces of the elbow and the valve flap. Due to the surface tension of the water, the water can act as an adhesive, adhering the valve flap to the elbow contact surface, thereby causing the valve flap to adhere in a generally perpendicular position and close off the exhaust flow path 422.

[0347] The provision of bead 762 on valve flap 752 provides a much smaller relative sealing surface in contact with the inner sealing surface of the elbow. This reduces the amount of water between the flap and the elbow, lowering the force that the surface tension of the water can withstand and allowing valve flap 752 to more easily separate from the elbow contact surface. Therefore, the provision of bead 762 reduces or prevents sticking of valve flap 752 in positions where exhaust flow path 422 is closed.

[0348] In this example, the bead 762 comprises an arcuate curved portion 765 that follows the curved periphery of the valve flap 752 away from the hinge 760, and a straight portion 766 that extends along the straight side of the valve flap 752 toward the hinge 760. Thus, the bead 762 in this example extends substantially the entire periphery of the valve flap to the hinge 760 and is substantially "n" shaped when viewed in plan.

[0349] In this example, the bead 762 is tapered when viewed from the side. Thus, the portion of the bead 762 distal to the hinge 760 protrudes further from the planar upper surface of the flap 752 than the portion of the bead 762 proximal to the hinge 760. In this example, the apex of the arcuate bead portion 764 protrudes further from the flap 752 than the straight bead portion 766. The bead tapers uniformly from the arcuate portion 764 to the straight portion 766, allowing the bead 762 to blend into the upper planar flap surface adjacent the hinge 760. This tapering along the longitudinal axis of the valve flap 752 allows the bead 762 to completely seal against the sealing surface of the elbow 722 along the entire periphery of the flap 752, closing off the exhaust flow path 422. Thus, when the flap 752 is in an upright position closing off the exhaust passage 422 , it is tilted slightly out of the vertical when sealing against the elbow 722 .

[0350] In this example, the profile of the bead 762 when viewed from the side is rounded or chamfered. Thus, the sealing surface 764 of the bead 762, i.e., the portion of the bead 762 that protrudes most from the valve flap 752, may be flat. However, the sidewall of the bead that supports the bead sealing surface 764 may be contoured, e.g., rounded or chamfered. The contoured sidewalls 768, 770 of the bead 762 may extend the entire distance to the valve flap 752, or may be contoured only adjacent the sealing surface 764. For example, as can be seen in FIG. 17 , the profile of one sidewall 770 of the bead 762 may be different from the profile of the other sidewall 772 of the bead 762. In this example, the inner sidewall 768 of the bead 762 curves downward from the sealing surface 764 and merges into the upper planar surface 772 of the valve flap 752 over a relatively large radius of curvature, i.e., a relatively shallow curve from the bead sealing surface 764 to the valve flap 752. In contrast, the outer sidewall 770 of the bead 762 is straight and has a relatively steep, flat slope from the bead sealing surface 764 to the valve flap 752.

[0351] Other bead profiles and shapes are envisioned. For example, the bead can simply have a square, rectangular, oblong, or triangular cross-sectional profile. For example, the bead cross-section can vary along the length of the bead. Some or all of the bead 762 can have a semicircular or arcuate cross-sectional profile. The sidewalls of the bead 762 may not be rounded or chamfered, but simply be straight sides extending between the bead sealing surface 764 and the valve flap 752. The straight sides may be slanted or substantially perpendicular to the plane of the valve flap 752.

[0352] 19 and 20, another embodiment of an anti-asphyxiation valve 850 includes many similar features as valve 750 described above. However, in this example, valve 850 includes a bead 862 that extends around the entire periphery of valve flap 852, with a portion of bead 862 extending beyond hinge 760. Thus, bead 862 in this example is substantially "D" shaped when viewed in plan, with sealing surface 864A extending away from hinge 760 and sealing surface 864B extending adjacent to and parallel to hinge 760.

[0353] In this example, an alternative bead profile is provided. In this example, the sidewalls of the bead are substantially straight and not angled relative to the plane of the valve flap 852. Similarly, the sealing surface 864A in this example is straight when the bead 862 is viewed from the side, i.e., the sealing surface 864 is a planar surface that slopes downward from the tip of the flap 862 toward the hinge 760. Thus, the bead 862 is tapered like the bead 762, but the sealing surface 864A is straight when viewed from the side, without any curved or angled regions. This can strengthen the seal provided between the sealing surface 864A and the elbow and reduce the likelihood of a leak path forming. The bead 862 is also more rigid in this example, which can help prevent bending of the flap 852 from lifting the flap edge and causing leakage at lower pressures.

[0354] FIG. 22 is a cross-sectional view of a patient interface including a soft seal 261 secured to a rigid or relatively rigid shell component 262. The shell 262 includes a gas entry opening 263, around which is an outwardly (or alternatively, inwardly) projecting annular shell collar 264. The annular mounting collar 265 is attached to the frame 8 by a click-fit or snap-fit ​​into a suitably shaped aperture in the frame 8, or is welded in place, and the mounting collar 265 receives the annular shell collar 264, preferably by a click-fit or snap-fit. The upper annular end 266 of the elbow 29 is attached within the inner diameter of the mounting collar 265, e.g., by a click-fit or snap-fit, when the mask is assembled for use, thereby coupling the elbow to the annular mounting collar 265 (rather than the frame or shell). Alternatively, the seal-shell component can include a single-material seal component. The annular mounting collar 265 can be a material and / or color different from that of the frame 8. Further details of this patient interface are disclosed in WO 2015 / 057087, the entire contents of which are incorporated herein by reference.

[0355] The patient interface of FIG. 22 further includes a connector 267, as shown, or is preferably configured to connect to a connector 267 via a snap fit. An outer surface 268 of the connector 267 is configured to be received by a respiratory tube (not shown) or a collar connector (also not shown) provided at the patient end of the respiratory tube. The connector 267 shown in FIG. 22 is configured to sealably engage with the respiratory tube (or the collar terminating in the respiratory tube) via a friction fit. To this end, one or more of the engaging walls may be tapered. For example, the outer surface 268 of the connector 267 may have a relatively narrow or small outer dimension near the first end 268 and a relatively wide or large outer dimension somewhere between the first end 268 and the second end 269 of the connector 267. Additionally or alternatively, the opening (internal dimension) of the breathing tube may vary from a relatively large dimension near its mouth to a relatively small or narrow dimension at a position axially inward in breathing relation, the size and location of the narrower portion being in comparison to the wider portion. As will be appreciated, if the breathing tube is provided with a collar termination, the taper may be formed in the collar rather than the breathing tube.

[0356] A problem with the arrangement of FIG. 22 is that a user may push the connector 267 in opposite directions relative to the elbow 29, for example, with the end 269 proximal to the patient interface and the end 268 distal from the patient interface. Due to the tapered walls and the fact that the inner dimensions of the connector are roughly the same as the outer dimensions of the elbow 29, the collar 267 may frictionally engage the elbow in this configuration. This is not ideal because it may compromise the connection between the connector 267 and the elbow 29. Furthermore, it may be difficult to remove the connector 267 from the elbow 29, or the respiratory tube (or its terminating collar) from the connector 267. More specifically, providing or engaging the connector 267 on the respiratory tube may apply pressure to the connector 267, tightening the fit between the connector 267 and the elbow 29. This may be exacerbated if the respiratory tube or its collar is pushed too far onto the connector 267 toward the patient interface.

[0357] To address these issues, a new connector 270 has been devised, as shown in Figures 23A-25F. Figures 23A-23D show connector 270 coupled to an elbow similar to elbow 29 of Figure 22. Figures 24A-24C show the elbow of Figures 23A-23D, and Figures 25A-25F show the connector of Figures 23A-23D.

[0358] Connector 270 has a first end 271 and a second end 272. First end 271 is configured to couple to an elbow (such as elbow 29 shown in FIG. 22) or to a protruding collar that would otherwise form a gas passageway with the interior of the patient interface or mask. For example, in a simpler arrangement, the elbow can be omitted and the connector can couple to a collar extending from the patient interface, the collar being integrally formed with or coupled to the patient interface via a shell or the like.

[0359] At least the exterior surfaces of the walls forming connector 270 are preferably tapered along at least a portion of their length, such that at least a portion of connector 270 nearer first end 271 has an outer dimension that is larger than the outer dimension of the portion of connector 270 nearer second end 272. This taper refers to the substantially cylindrical body forming connector 270, rather than the ribs or protrusions 273 proximate first end 271 of connector 270. Tapers are commonly used for tube connectors and are configured to mate with a respiratory tube or a collar terminating such a tube, as will be apparent to those skilled in the art. Additionally or alternatively, the interior of the respiratory tube (or collar terminating the tube) can be tapered, with the interior of the tube (or collar) narrowing from its mouth. The tapering facilitates insertion of second end 272 of connector 270 into the respiratory tube, and a seal is formed upon continued insertion.

[0360] As best shown in FIGS. 23D and 25E, the interior of connector 270 includes ribs 274 that engage one or more protrusions 275 on elbow connector 29a to form a click or snap fit. More generally, elbow connector 29a is substantially the same as or similar to the previous elbow connectors disclosed herein, and only the relevant features of elbow connector 29a will be described. Note that while elbow connector 29a is shown in FIG. 23A as including cover 276, this has been omitted from FIG. 23D to expose multiple vent holes 277. Cover 276 may be a filter that allows gas and / or moisture to pass through, or it may be solid and impermeable so as to seal off vent holes 277 when cover 276 is in place.

[0361] The interior of connector 270, extending from a point toward second end 272, is preferably sized to prevent the inner surface of second end 272 of connector 270 from engaging the outer surface of elbow connector 29a if a user attempts to assemble the components incorrectly. In a preferred embodiment, this is achieved by having the inner dimension (generally diameter) of connector 270 larger than the outer dimension of elbow connector 29a with which it mates, so that it is readily apparent that the two have not been assembled correctly given the play between them. Alternatively, second end 272 of connector 270 can have an inner dimension that prevents elbow connector 29a from being inserted, i.e., be very narrow or include a protrusion that acts as a stop.

[0362] The rib or protrusion 273 serves two functions: first, it provides a grip for the user's fingers that can be used to remove the connector 270 from engagement with the elbow connector 29a, and second, it acts as a mechanical stop, limiting how far the breathing tube can be pushed into the second end 272 of the connector 270.

[0363] Although the illustrated embodiment has ribs or protrusions 273 that arc in a sinusoidal pattern around the circumference of connector 270 proximate first end 271, ribs or protrusions 273 may be formed in other ways. For example, they may extend around only a portion of the circumference, or they may comprise multiple separate elements, each of which extends around a portion of the circumference. Furthermore, protrusions or ribs may be substantially linear and / or comprise linear portions in addition to or in place of arcuate portions.

[0364] 26-31, another embodiment of elbow assembly 902 includes an elbow 922 and sleeve (not shown) with similar features to elbow 722 and sleeve 710 of Figures 14-19. A swivel 330, as described above, may also be provided, but is not shown in Figures 26-31.

[0365] An anti-asphyxiation valve (AA valve) 950 is provided and positioned on the sleeve to at least partially block the flow path of the sleeve. AA valve 950 has similar features to valve 750 of Figures 14-19. Elbow assembly 902 functions similarly to elbow assembly 302 of Figures 10-13 and the elbow assemblies of Figures 14-19, and similarly directs gas away from the patient when flap 952 of AA valve 950 drops to its closed position, i.e., a generally horizontal position, blocking the flow path through the sleeve.

[0366] The AA valve 950 includes a generally planar valve flap 952 hingedly attached to a flap support 954, which may be integrally formed with the valve flap 952. In this example, in contrast to the valve flap 752 as shown in Figures 14-19, the valve flap 952 and flap support 954 are configured such that, at rest, before the sleeve is assembled to the elbow 922, the flap 952 is biased downwardly so that it is inclined relative to a notional horizontal plane, i.e., inclined downwardly relative to the planar underside of the flap support 954. When the valve 950 is attached to the elbow 922 with the sleeve in place in use, the flap 952 is horizontal, and the planar underside of the flap 952 is flush with and parallel to the upper planar sealing surface of the sleeve, as shown, for example, in Figure 14.

[0367] During assembly, the sleeve moves the downwardly tilted valve flap 952 upward to a generally horizontal position when the sleeve is fully assembled to the elbow 922. When the valve flap 952 is in a generally horizontal position at rest, it attempts to pivot downward relative to the sleeve, i.e., the flap 952 is biased downward away from a vertical orientation, helping to maintain the flap 952 in a horizontal orientation with the flow path through the sleeve closed and the exhaust flow path in the elbow 922 open. This biased flap 952 helps ensure that a user of the elbow can still breathe through the exhaust flow path in the elbow 922 when breathing gas is not being delivered through the flow path in the sleeve.

[0368] The degree of bias provided by the initially downwardly tilted flap 952 can be configured by the thickness of the hinge 960 between the support 954 and the flap 952 and the size of the angle of the flap 952 relative to a notional horizontal plane (parallel to the planar underside of the support 954) when the flap 952 is at rest prior to assembly with the sleeve. If the hinge thickness is too large, the flap 952 will not bend easily enough to allow the flap 952 to pivot about the hinge 960 as described above. If the hinge thickness is too thin, the flap 952 may be unstable in that it bends, deforms, and vibrates too much to provide an effective seal when in a vertical and / or horizontal position.

[0369] In this example, valve 950 is provided with additional features that may also be used with other examples of valves 350, 750 described herein. One such feature is that, in this example, sealing bead 964, like bead 764 of valve flap 752, extends around the periphery of the top surface of valve flap 952 to form a "D" shaped seal. However, in the portion of bead 964 adjacent support 954, bead 964 includes an increased surface area, linear bead portion 964a, which seals against vertical front surface 954a of support 954 when flap 952 is in a vertical orientation. Portion 964a includes a rectangular, planar sealing surface that extends from one side to the other across flap 952 adjacent hinge 960. The width and length of the sealing surface 964a closely correspond to, or preferably are the same as, the height and width of the front surface 954a of the support block 954 so that when the flap 952 is in a vertical position, the sealing surface 964a substantially matches in size and shape with and seals against all of the front surface 954a, thereby creating an enhanced seal between the support 954 and the portion of the flap 952 that contacts the support 954.

[0370] The edge of the rectangular sealing surface 964a includes a sloped transition wall 964b where the surface 964a meets a top planar surface 972 of the valve flap 952. The top planar surface 972 is defined as a concave planar area bounded by the sealing bead 964. The thickness of the wall 964b can be configured to control the stiffness of the flap 952; i.e., the wall 964b acts as a reinforcing rib or stiffening member. The wall 964b can help prevent the valve flap 952 from bulging or otherwise bending or distorting under pressure during use, if the flap 952, and particularly the top planar surface 972, were otherwise too thin to withstand the pressures generated during use.

[0371] 28c, the underside of the valve flap 952 adjacent the hinge 960 can include a recess 965 configured to allow a desired amount of flexing in the valve flap 952 adjacent the hinge 960. Some flexing in the valve flap 952 is useful to allow the flap 952 to deform sufficiently to achieve the optimum possible seal against the sealing surfaces of the elbow 922 and sleeve. In this example, the recess 965 is rectangular and defined directly below the upper sealing surface 964a.

[0372] The dimensions and thicknesses of the valve flap 952 and support 954 features can be configured as individual parameters and / or relative to one another to ensure that the valve flap 952 has the desired characteristics to achieve an optimal seal in both horizontal and vertical positions and responds appropriately to changing pressures to effectively move from horizontal to vertical positions and vice versa. See further FIG. 31, which shows some example, non-limiting dimensions of one embodiment of the valve 950.

[0373] Valve 950 can have the following characteristics, each of which can be provided as an individual feature or in combination with the properties of one or more other features.

[0374] a) The angle of the flap 952 before being assembled between the elbow and the sleeve, in particular the angle of the planar underside of the flap 952, can be inclined from the notional horizontal plane by 0° to 90°, preferably by 0.5° to 75°, more preferably by 5° to 60°, more preferably by 5° to 45°, and in one preferred embodiment by 10° to 40°.

[0375] b) For example, the thickness B of hinge 960 when viewed from the side as in Figure 31 can be 0.05 mm to 1.0 mm, preferably 0.1 mm to 0.75 mm, more preferably 0.1 mm to 0.5 mm, more preferably 0.15 mm to 0.4 mm, and in one preferred embodiment is 0.25 mm.

[0376] c) The thickness A of the support 954 when viewed from the side can be 1 mm to 10 mm, preferably 1 mm to 7.5 mm, more preferably 1 mm to 5 mm, and in one preferred embodiment is 4.75 mm.

[0377] d) The thickness E of the valve flap 952 in the region of the upper plane 972 between the sealing beads 964 may be between 0.1 mm and 2 mm, preferably between 0.5 mm and 1.5 mm, more preferably between 0.5 mm and 1 mm, and in one preferred embodiment is 0.75 mm.

[0378] e) The thickness D of the inclined wall 964b when viewed in cross section from the side can be 0.1 mm to 1.5 mm, preferably 0.2 mm to 1 mm, more preferably 0.2 mm to 0.75 mm, more preferably 0.3 mm to 0.6 mm, and in one preferred embodiment is 0.53 mm.

[0379] f) The thickness C of the bead region 964a above the recess 965 when viewed in cross section from the side can be 0.1 mm to 1 mm, preferably 0.1 mm to 0.75 mm, more preferably 0.1 mm to 0.5 mm, and in one preferred embodiment is 0.3 mm.

[0380] g) The width F of the bead region 964a in the direction away from the hinge axis and away from the support 954 when viewed in a plan view can be 2 mm to 6 mm, preferably 2 mm to 5 mm, more preferably 3 mm to 4 mm, and in one preferred embodiment is 3.89 mm.

[0381] h) The length of the valve flap 952 in a direction extending vertically from the hinge 960 to the apex of the valve flap 952 can be between 10 mm and 25 mm, preferably between 10 mm and 20 mm, more preferably between 12 mm and 18 mm, and in one preferred embodiment is approximately 15.5 mm.

[0382] i) The bead 964 preferably tapers toward the hinge 960 so that, when viewed from the side, the bead 964 is relatively thicker away from the hinge 960 and relatively thinner adjacent the hinge 960. The bead 964, particularly the plane of the upper top surface of the bead 964, can be angled at an angle of 0° to 45°, preferably 0° to 30°, and preferably 1° to 15°, relative to the planar undersurface of the flap 952, with one preferred embodiment being angled at approximately 4°. The greater the angle, the more the bead will protrude into the flow path of the elbow assembly. However, the smaller the angle, the greater the likelihood of undesirable adhesion of the flap in a vertical orientation.

[0383] 26-31, the flap 964 is substantially semicircular or horseshoe shaped when viewed from above. However, in other embodiments, the flap can have any other desired shape, for example, a substantially square, rectangular, triangular, circular, or omega shape when viewed in plan.

[0384] In accordance with the present invention, the following ratios of the characteristics of the valve 950 features can be modified as follows:

[0385] k) The support block 954 thickness to hinge 960 thickness may be between 5:1 and 30:1, more preferably between 10:1 and 25:1, more preferably between 15:1 and 25:1, and in one preferred embodiment 19:1.

[0386] l) The valve flap 952 thickness in the region of the upper flat surface 972 between the beads to the hinge 960 thickness may be 1:1 to 10:1, more preferably 1:1 to 8:1, more preferably 2:1 to 5:1, and in one preferred embodiment 3:1.

[0387] m) The thickness of the valve flap 952 in the area of ​​the upper flat surface 972 between the beads to the thickness of the bead area 964a above the recess 965 may be 1:1 to 10:1, more preferably 1:1 to 8:1, more preferably 2:1 to 5:1, and in one preferred embodiment 2.5:1.

[0388] n) The thickness of the valve flap 952 in the region of the upper flat surface 972 between the beads to the thickness of the sloped wall 964b may be 1:1 to 10:1, more preferably 1:1 to 5:1, more preferably 1:1 to 2:1, and in one preferred embodiment 1.4:1.

[0389] o) The thickness of the valve flap 952 in the area of ​​the upper flat surface 972 between the beads to the thickness of the bead area 964a above the recess 965 may be between 1:1 and 10:1, more preferably between 1:1 and 5:1, more preferably between 2:1 and 3:1, and in one preferred embodiment 2.5:1.

[0390] p) The thickness of the angled wall 964b to the thickness of the bead area 964a above the recess 965 may be 1:1 to 10:1, more preferably 1:1 to 5:1, more preferably 1:1 to 2:1, and in one preferred embodiment 1.75:1.

[0391] q) The thickness of the support block 954 to the width of the bead region 964a may be 1:1 to 10:1, more preferably 1:1 to 5:1, more preferably 1:1 to 2:1, and in one preferred embodiment 1.2:1.

[0392] r) The width of the bead region 964a to the thickness of the bead region 964a above the recess 965 may be between 1:1 and 30:1, more preferably between 1:1 and 20:1, more preferably between 1:1 and 15:1, and in one preferred embodiment 13:1.

[0393] Annular bias flow exhaust In order that the present disclosure may be understood in greater detail, reference is first made to Figure 32. Figure 32 illustrates a breathing circuit according to at least one embodiment, including a breathing mask.

[0394] FIG. 32 is a schematic diagram of a positive pressure respiratory therapy system in the form of a continuous positive airway pressure (CPAP) system 1010 that provides a heated and humidified airflow to a user U through an interface 1110 worn by the user and connected to the CPAP system 1010 by a conduit or tubing 1012. The humidification chamber 1014 has a thermally conductive base that contacts a heater plate 1016 of a humidifier 1017 to humidify the airflow. The conduit 1012 is connected to an outlet 1013 of the humidification chamber 1014 to deliver the humidified air to the user interface 1110. The humidifier 1017 includes a controller 1018, such as, for example, without limitation, a microprocessor-based controller that executes computer software commands stored in an associated memory. The controller 1018 receives input commands from multiple input sources, including a user input interface 1019, such as a dial or touch screen, that allows for setting predetermined values ​​for humidity, temperature, or other characteristics of the humidified air provided to the user U. The controller 1018 may also receive input from one or more other sources, such as, for example, temperature and / or flow rate sensors 1020 and 1021, and / or a heater plate temperature sensor 1023, connected through a connector 1022 to communicate with the controller 1018. Depending on the selected humidity or temperature value, the controller 1019 determines when and / or to what level the heater plate 1016 should be energized to suitably heat the water contained in the humidification chamber 1014.

[0395] As the water in the chamber heats, water vapor begins to fill the volume of the chamber above the surface of the water. The water vapor exits the humidification chamber's outlet 1013 along with a flow of air provided from a supply 1025, such as a blower 1027, and entering the humidification chamber 1030 through an inlet 1026. The blower 1027 can be a variable speed fan or can include a variable pressure regulator. The blower 1027 draws air through an inlet 1028. The blower can be controlled, for example, by a controller 1029 or by the controller 1018. The controller 1018 or 1029 can control the blower speed, regulated pressure, etc. according to any suitable criteria. For example, the controller 1029 can be responsive to input from the controller 1018 and to user settings (e.g., preset values) for pressure and / or fan speed, which can be set on a user interface 1030 (e.g., dials).

[0396] The conduit 1012 may include a heater, such as a heater wire, that heats the walls of the conduit to reduce condensation of humidified gas within the conduit.

[0397] The respiratory masks and components of the present disclosure, whether humidified or not, may be used in CPAP systems as described above, or alternatively in other forms of respiratory systems, such as VPAP (variable positive airway pressure) systems, BiPAP (bilevel positive airway pressure) systems, or in conjunction with mechanical ventilators, and are generally described herein in connection with CPAP therapy, by way of example only.

[0398] The bias flow exhaust system used to push exhaust gases from within the respirator is described in more detail below. The exhaust system generally provides a path through which gases exhaled by the user can be vented to the atmosphere.

[0399] III.2 Parts Ball Joint Socket and Connection Housing Bias Flow Exhaust In various embodiments, the bias flow exhaust system can be incorporated into a connection housing that mates with a housing for sealing, such as a cushion. The connection housing directly mates with a socket for a truncated ball joint connector to form a unitary (integral) structure. The unitary structure disassembles into at least two parts (e.g., a separate socket and connection housing) to facilitate cleaning of the bias flow exhaust system. When used with a respirator, the unitary structure is configured to pass inhaled gases received from the truncated ball joint connector to a user of the respirator. Because the unitary structure incorporates the bias flow exhaust system, it can not only deliver inhaled gases to the user, but also remove exhaled gases from the user. The unitary construction facilitates an overall compact respirator.

[0400] A. Assembly through slot in socket 33A-33C, in at least one embodiment, a kit for a respiratory mask 1200 is disclosed. It should be understood that assemblies of one, some, or all of the components of kit 1200 are within the scope of the present disclosure, and such assemblies and respiratory systems including such assemblies should be considered embodiments of the present disclosure.

[0401] The kit 1200 includes a connection housing 1202 that is placed on the patient's face when in use. The connection housing 1202 includes a first end 1204 (FIGS. 33A and 33C) configured to engage a cushion housing that contacts the user's face. To simplify the drawings, the connection housing has been omitted from FIGS. 33A-33C. Suitable connection housings are shown and described, for example, in U.S. Patent Application Nos. 62 / 041,262 and 62 / 096,481, previously incorporated by reference. It should be understood that in some embodiments, the connection housing may be included in the kit 1200, an assembly thereof, or a respiratory system including such an assembly.

[0402] The connection housing 1202 further includes a connection ring 1206 opposite the first end 1204. The connection ring 1206 includes a first connection housing raised portion 1208 ( FIGS. 33A and 33B ) and a second connection housing raised portion 1210 ( FIGS. 33A and 33B ). The first connection housing raised portion 1208 and the second connection housing raised portion 1210 are each generally arcuate and extend away from the first end 1204. In this example, the first connection housing raised portion 1208 is opposite the second connection housing raised portion 1210 around the circumference of the connection ring 1206. Each includes at least one array of holes 1212 ( FIG. 33A ) extending along at least a portion of the respective arc that are configured to pass exhaled air exhaled by a user to ambient air when in use. These holes 1212 can be formed during molding of the connecting ring 1206, or can be drilled (e.g., by a laser) after molding is complete. Many hole array configurations are contemplated and are within the scope of the present disclosure. For example, single linear arrays and double linear arrays are contemplated. The holes 1212 can be circular or non-circular. Other example arrays are shown, for example, with respect to Figures 39A-39D. While Figures 39A-39D relate to a different embodiment than the embodiment of Figures 33A-33C, it should be understood that the example hole arrays shown can be incorporated into this embodiment.

[0403] 33A-33C, the connection housing 1202 includes two connection housing raised portions 1208, 1210. However, it should be understood that the first connection housing raised portion 1208 and the second connection housing raised portion 1210 may be elements of a greater number of connection housing raised portions in other configurations. For example, the connection housing 1202 may include three, four, five, or more connection housing raised portions.

[0404] The first connection housing raised portion 1208 and the second connection housing raised portion 1210 define therebetween a first generally arcuate connection housing recessed portion 1214 ( FIG. 33A ) and a second generally arcuate connection housing recessed portion 1216 ( FIG. 33A ). In this example embodiment, the arc length of the first connection housing recessed portion 1214 is less than the arc length of the second connection housing recessed portion 1216. Advantages of this configuration are discussed below. In the example embodiment of FIGS. 33A-33C , the connection housing 1202 includes two connection housing recessed portions 1214, 1216. However, again, it should be understood that the first connection housing recessed portion 1214 and the second connection housing recessed portion 1216 may be elements of a greater number of connection housing recessed portions in other configurations. For example, the connection housing 1202 may include three, four, five, or more connection housing recessed portions.

[0405] The kit 1200 also includes an annular socket 1218 configured to pass inhaled gas from a gas supply to the connection housing 1202 through a central bore of the socket 1218. The gas supply may be, for example, a swivel connector (not shown) configured to deliver inhaled gas to a user. The swivel connector may include, for example, a generally tubular first end and a truncated ball joint at a second end opposite the first end, the truncation defining a ball joint opening configured to pass inhaled gas. Instead of the truncated ball joint, other configurations are contemplated, such as a swivel elbow configured to rotate on a single axis. Other swivel connector examples are shown and described below, the depictions and descriptions of which are incorporated herein by reference. The socket 1218 is configured to accept the truncated ball joint when in use. It should be understood that in some embodiments, a swivel connector may be included in the kit 1200, assemblies thereof, and respiratory systems including such assemblies.

[0406] Kit 1200 may optionally further include a frame 1228 that, when in use, is mounted over connection housing 1202. In at least one embodiment, frame 1228 includes frame housing 1230 ( FIGS. 33A and 33B ) that includes frame opening 1232 ( FIGS. 33A and 33C ) with a generally annular periphery, and socket 1218 mounted within frame opening 1232. Frame housing 1230 may optionally be molded to socket 1218 as a single piece. Socket 1218 may optionally be permanently attached to frame housing 1230, for example, by adhesive, press fit, welding, or soldering. In some embodiments, socket 1218 may be removably attached to frame housing 1230, for example, by a click-together connection.

[0407] Referring again to socket 1218, socket 1218 includes a generally arcuate first socket ridge portion 1220 (FIGS. 33A and 33B) and a generally arcuate second socket ridge portion 1222 (FIGS. 33A and 33B). The arc length of first socket ridge portion 1220 can be less than the arc length of second socket ridge portion 1222.

[0408] The first socket raised portion 1220 and the second socket raised portion 1222 define therebetween a first generally arcuate socket slot 1224 ( FIGS. 33A-33C ) and a second generally arcuate socket slot 1226 ( FIGS. 33A and 33B ). In this example, the outer peripheral edge of the socket 1218 fully and continuously engages the inner peripheral edge of the frame opening 1232, and the socket 1218 includes socket slots 1224, 1226 within the outer peripheral edge of the socket 1218 for mating with the first connection housing raised portion 1208 and the second connection housing raised portion 1210. Further, in this example, the first socket slot 1224 is opposite the second socket slot 1226. In the illustrated example, the socket raised portions 1220, 1222 are located at the top and bottom of the socket 1218. This configuration advantageously allows the socket slots to be located on the sides of the socket 1218, which is desirable for reasons explained below.

[0409] The socket 1218 is configured to removably engage with the connection housing 1202 as a unitary structure, such that upon engagement, the first socket raised portion 1220 mates with the first connection housing recessed portion 1214, the second socket raised portion 1222 mates with the second connection housing recessed portion 1216, the first connection housing raised portion 1208 passes through a frame opening 1232 to mate with the first socket slot 1224, and the second connection housing raised portion 1210 passes through a frame opening 1232 to mate with the second socket slot 1226. Inhalation gases flow from the swivel connector and through a central bore of the socket 1218 into the connection housing 1202. Exhaled gas flows from the connection housing 1202 radially inward from the first socket slot 1224 through a first space between the first connection housing raised portion 1208 and a first region of the socket 1218, and radially inward from the second socket slot 1226 through a second space between the second connection housing raised portion 1210 and a second region of the socket 1218. From the first and second spaces, exhaled gas passes to the ambient air through at least one array of holes 1212 in each of the first and second connection housing raised portions 1208 and 1210. In this manner, in use, inhaled gas is passed to the respiratory mask and exhaled gas is passed from the respiratory mask via the unitary structure.

[0410] In the example embodiment of Figures 33A-33C, socket 1218 includes two socket raised portions 1220, 1222 and two socket slots 1224, 1226. Again, it should be understood that first socket raised portion 1220 and second socket raised portion 1222 may be elements of a greater number of socket raised portions in other configurations. Similarly, first socket slot 1224 and second socket slot 1226 may be elements of a greater number of socket slots in other configurations. For example, socket 1218 may include three, four, five, or more socket raised portions. Also, socket 1218 may include three, four, five, or more socket slots. In general, the number of socket raised portions and socket slots may be selected to suitably correlate with the number of connection housing raised portions and connection housing recessed portions of connection housing 1202.

[0411] As noted above, in the example of FIGS. 33A-33C , the arc length of first connection housing recessed portion 1214 is less than the arc length of second connection housing recessed portion 1216, and similarly, the arc length of first socket raised portion 1220 is less than the arc length of second socket raised portion 1222. With this configuration, first socket raised portion 1220 mates with first connection housing recessed portion 1214, and second socket raised portion 1222 mates with second connection housing recessed portion 1216. However, first socket raised portion 1220 does not mate with second connection housing recessed portion 1216, and second socket raised portion 1222 does not mate with first connection housing recessed portion 1214. In other words, socket 1218 removably engages with connection housing 1202 in only one direction. This configuration advantageously facilitates engagement by unskilled users. However, it should be understood that, if desired, the arc lengths can be selected so that the socket 1218 engages the connection housing 1202 in any direction or directions. For example, the arc lengths can be equal.

[0412] 34A and 34B , the first connection housing raised portion 1208 ( FIG. 34A ) and the second connection housing raised portion 1210 ( FIG. 34A and 34B ) can each include a generally L-shaped end 1302 in a region furthest from the first end 1204. The first socket raised portion 1220 ( FIG. 34A and 34B ) and the second socket raised portion 1222 (not shown) can each include a generally L-shaped side 1304 in a region adjacent the first socket slot (not shown in FIGS. 34A and 34B ) and the second socket slot (also not shown in FIGS. 34A and 34B ). The generally L-shaped end 1302 of the first connection housing raised portion 1208 and the second connection housing raised portion 1210 can be configured to seal with the generally L-shaped side 1304 of the first socket raised portion 1220 and the second socket raised portion 1222. This configuration can be advantageous because it effectively provides two sealing surfaces between the socket 1218 and connection housing 1202 when the components are unitarily engaged. This configuration has been found to be less prone to leakage and tolerance issues than other sealing arrangements. An alternative engagement arrangement is illustrated and described below with reference to Figure 36. The alternative engagement is equally applicable to the embodiments of Figures 33A and 33B, the discussion and associated figures of which are incorporated by reference in this paragraph.

[0413] B. Assembly through the gap between the frame and the socket 35A-35C, in at least one embodiment, another kit for a respiratory mask 1200 is disclosed. It should be understood that assemblies of one, some, or all of the components of kit 1200 are within the scope of the present disclosure, and that such assemblies and respiratory systems including such assemblies should be considered embodiments of the present disclosure.

[0414] Similar to the kit 1200 described with reference to Figures 33A-33C, the respiratory mask kit 1200 of Figures 35A-35C includes a connection housing 1202 that is placed on a patient's face when in use. The kit 1200 also includes a socket 1218 and a frame 1228 (Figures 35A and 35B). The discussion of the connection housing 1202, frame 1228, and socket 1218 with reference to Figures 33A-33C is incorporated herein by reference. The kit 1200 may further include a swivel connector (not shown) configured to deliver inspiratory gas to a user; the discussion of the swivel connector is also incorporated herein by reference.

[0415] 33A-33C and 35A-35C is the configuration of the socket 1218. In the embodiment of FIGS. 33A-33C, the outer peripheral edge of the socket 1218 fully and continuously engages the frame opening 1232, and the socket 1218 includes socket slots 1224, 1226 in the outer peripheral edge of the socket 1218 for mating with the first and second connection housing raised portions 1208, 1210. In the embodiment of FIGS. 35A-35C, the outer peripheral edge of the socket 1218 does not fully and continuously engage the frame opening 1232. Rather, the outer peripheral edge is not annular like the frame opening 1232, such that there is a space between the outer peripheral edge of the socket 1218 and the frame opening 1232, including the first frame gap 1402 ( FIGS. 35 and 35B ) and the second frame gap 1404 ( FIG. 35A ).

[0416] Also similar to kit 1200 described with reference to Figures 33A-33C (and with reference to those Figures as well as Figures 35A-35C), frame 1228 is configured to removably engage with connection housing 1202 as a unitary structure, except that when engaged, first socket raised portion 1220 mates with first connection housing recessed portion 1214, second socket raised portion 1222 mates with second connection housing raised portion, first connection housing raised portion 1208 passes through frame opening 1232 to mate with first frame gap 1402, and second connection housing raised portion 1210 passes through frame opening 1232 to mate with second frame gap 1404.

[0417] Inhaled gas flows from the swivel connector and passes through the central bore of the socket 1218 into the connection housing 1202. Exhaled gas flows from the connection housing 1202 radially inward from the first frame gap 1402 through a first space between the first connection housing raised portion 1208 and a first region of the socket 1218, and radially inward from the second frame gap 1404 through a second space between the second connection housing raised portion 1210 and a second region of the socket 1218. From the first and second spaces, exhaled gas passes to the ambient air through at least one array of holes in each of the first and second connection housing raised portions 1208, 1210 (shown in FIG. 33A but not shown in FIGS. 35A-35C). Thus, in both embodiments, in use, inhaled gas passes to the respiratory mask and exhaled gas passes from the respiratory mask via a unitary structure.

[0418] 36 , the first and second connection housing raised portions 1208, 1210 can each include a substantially straight end 1502 in a region furthest from the first end 1204. The first and second socket raised portions 1220, 1222 can each include a substantially straight side 1504 in a region adjacent the first and second socket slots 1224, 1226 (not shown in FIG. 36 ). The substantially straight end 1502 of the first and second connection housing raised portions 1208, 1210 can be configured to seal with the substantially straight side 1504 of the first and second socket raised portions 1220 ( FIG. 36 ) and 1222 (not shown), for example, by a friction-fit seal. In an alternative or modified configuration, a complementary seal, such as a gasket, O-ring, or lip seal, can be provided between the sealing surfaces.

[0419] Yet another alternative engagement arrangement (incorporating an L-shaped fitting) is shown and discussed above with reference to Figures 34A and 34B. This alternative engagement is equally applicable to the embodiment of Figures 35A-35C, and the discussion and associated figures are incorporated by reference into this paragraph.

[0420] IV. Bias flow exhaust in ball joint socket with concave passage In various embodiments, the bias flow exhaust system can be incorporated into a socket for a truncated ball joint connector. The socket includes an area that facilitates cleaning of the bias flow exhaust system. When used with a respirator, the socket is configured to deliver inhaled gas received from the truncated ball joint connector to a user of the respirator. Because the socket incorporates the bias flow exhaust system, the socket can not only deliver inhaled gas to the user, but also remove exhaled gas from the user. The socket configuration facilitates an overall compactness of the respirator. Some embodiments have also been found to advantageously reduce noise generated by the respirator when in use.

[0421] 37A-37E and 38A-38E, in at least one embodiment, a kit for a respiratory mask 1600 is disclosed. It should be understood that assemblies of one, some, or all of the components of kit 1600 are within the scope of the present disclosure, and such assemblies and respiratory systems including such assemblies should be considered embodiments of the present disclosure.

[0422] In some embodiments, the kit 1600 includes a swivel connector 1602 (FIGS. 37A, 37C, 37E, 38A, 38B, 38C, and 38E) configured to deliver inhaled gas to a user. The swivel connector 1602 includes a generally tubular first end 1604 (FIGS. 37A, 37C, 37E, 38A, and 38B) and a truncated ball joint 1606 (FIGS. 37A, 37C, 37E, 38A, 38B, and 38E) at a second end opposite the first end 1604, the truncation defining a ball joint opening 1608 (FIGS. 37A, 37C, 37E, 38A, 38B, and 38E) configured to allow inhaled gas to pass therethrough.

[0423] The kit 1600 may further include a connection housing 1610 (FIGS. 37E and 38E) that is seated on the user's face when in use. The connection housing 1610 includes a connection housing opening 1612 (FIGS. 37E and 38E) that is configured to receive inhaled gases from the swivel connector 1602 and to receive exhaled gases exhaled by the user when in use. The connection housing 1610 also includes a cushion end (not shown) opposite the connection housing opening 1612 that is configured to engage the cushion housing for contact with the user's face.

[0424] The kit 1600 also includes a socket 1616. The socket 1616 includes a connection housing engagement region 1620 (FIGS. 37A, 37B, 38A, and 38D). The connection housing engagement region 1620 is generally circumferential about a first end 1622 (FIGS. 37A, 37B, 38A, and 38D) of the socket 1616. The connection housing engagement region 1620 is configured to engage with the connection housing opening 1612 when in use and receive exhaled gas therefrom.

[0425] The socket 1616 is hollow, such that the socket includes a sealed interior region 1618 (FIGS. 37A-37E, 38A, 38B, 38D, and 38E) or bore. The sealed interior region 1618 includes a ball joint engagement region 1624 (FIGS. 37A, 37B, 37D, 37E, 38A, 38B, 38C, 38D, and 38E). The ball joint engagement region 1624 is generally circumferential at a second end 1626 (FIGS. 37A, 37B, 38A, and 38D) of the socket 1616 opposite the first end 1622. The ball joint engagement region 1624 is configured to engage with the truncated ball joint 1606 of the swivel connector 1602 in use and receive intake gas therefrom. In the illustrated example, the diameter of the ball joint engagement region 1624 is smaller than the diameter of the connection housing engagement region 1620 .

[0426] The sealed interior region 618 also has a generally arcuate first bearing region 1628 ( FIGS. 37A , 37B , 37D , 37E , 38D ) and a generally arcuate second bearing region 1630 ( FIGS. 37D , 38D ), each extending from the ball joint engagement region 1624 to the connection housing engagement region 1620 and each engaging with the truncated ball joint 1606 of the swivel connector 1602 in use. That is, the generally arcuate first bearing region 1628 and the second bearing region 1630 engage opposite sides of the truncated ball joint 1606. Thus, a recessed region is formed circumferentially along the inner surface of the socket 1616 between the generally arcuate first bearing region 1628 and the generally arcuate second bearing region 1630. The recessed region provides a shallow gap or clearance between the ball joint engagement region 1624 and the truncated ball joint 1606 that can be easily wiped and cleaned by a user. The bearing regions 1628, 1630 are sized and configured to prevent the truncated ball joint 1606 from dropping into the socket 1616. In the example embodiments of FIGS. 37A-37E and 38A-38E, the socket 1616 includes two bearing regions 1628, 1630. It should be understood that the first bearing region 1628 and the second bearing region 1630 may be elements of a greater number of bearing regions in other configurations. For example, the socket 1616 may include three, four, five, or more bearing regions. In an embodiment including three bearing regions, the first bearing region 1628, the second bearing region 1630, and one additional bearing region may be located at or around the 2 o'clock, 6 o'clock, and 10 o'clock positions, with the 6 o'clock position defining the bottom of the socket 1616.

[0427] The first bearing region 1628 and the second bearing region 1630 define therebetween a generally arcuate first expiratory region 1623 (FIGS. 37A, 37B, 37E, 38A, and 38E) and a generally arcuate second expiratory region 1634 (FIGS. 37A, 37B, 37E, 38A, and 38E). In some embodiments, the generally arcuate first expiratory region 1632 and the generally arcuate second expiratory region 1634 can be disposed in a concave region between the generally arcuate bearing region 1628 and the generally arcuate bearing region 1630. A flow path to the first expiratory region 1632 and the second expiratory region 1634 can be defined by the generally arcuate first bearing region 1628 and the generally arcuate second bearing region 1630, the inner surface of the socket 1616, and the outer surface of the truncated ball joint 1606. Each of the first expiratory region 1632 and the second expiratory region 1634 includes at least one array of holes 1636 ( FIGS. 39A-39D ) configured to pass exhaled gases through the cavity 1634 and the surrounding air outside the socket 1616. The first expiratory region 1632 and the second expiratory region 1634 are discontinuous, i.e., separated by the bearing regions 1628, 1630. Nevertheless, in some embodiments, the distance between the first expiratory region 1632 and the second expiratory region 1634 can be expressed in terms of a diameter, such as a line extending from a point on the arc length of the first expiratory region 1632 to a corresponding point on the arc length of the second expiratory region 1634 and passing through the polar center of the sealed interior region 1618 along that line. In the illustrated example, the diameter between the first expiratory region 1632 and the second expiratory region 1634 is greater than the diameter of the ball joint engagement region 1624 and less than or equal to the diameter of the connection housing engagement region 1620. Also in the illustrated example, the bearing regions 1628, 1630 are located at the top and bottom, respectively, of the socket 1616. This configuration advantageously allows the expiratory regions 1632, 1634 to be located on the sides of the socket 1616, which may be desirable to direct the expiratory flow away from the user's bed partner and away from the user's face when a respiratory mask incorporating the features of the kit 1600 is used.

[0428] It should be understood that the first expiratory region 1632 and the second expiratory region 1634 may be elements of a larger number of expiratory regions in other configurations. For example, the sealed interior region 1618 may include three, four, or more expiratory regions. For example, in an embodiment including three expiratory regions, the first expiratory region 1632, the second expiratory region 1634, and one additional expiratory region may be located at or around the 12 o'clock, 4-5 o'clock, and 7-8 o'clock positions, with the 12 o'clock position defining the top of the socket 1616.

[0429] This configuration is advantageous for several reasons: the bearing regions 1628, 1630 provide structure and support for the socket 1616. Additionally, the exhalation regions 1632, 1634 are recessed from the bearing regions 1628, 1630, which can facilitate ease of cleaning.

[0430] Also in the illustrated example, the arc length of first expiratory region 1632 and the arc length of second expiratory region 1634 are greater than the arc length of first bearing region 1628 and the arc length of second bearing region 1630 .

[0431] FIGS. 39A-39D illustrate example configurations for at least one array of holes 1636 in the exhalation regions 1632, 1634. FIG. 39A illustrates a single array of holes 1636. This configuration may be advantageous because it provides minimal axial spacing of the holes 1636. FIG. 39B illustrates two arrays of holes 1636. This configuration may be advantageous because it allows for more holes 1636 in a given arc length. FIG. 39C illustrates two arrays of holes 1636 in an alternating configuration. The alternating arrangement increases the distance between the holes 1636 in the array. This configuration may provide better flow separation, improving air ejection and noise. This configuration is also advantageous because it allows for more holes 1636 in a given arc length for a given distance between the holes 1636. The elongated holes 1636 in FIG. 39D may be advantageous because it provides a larger exhaust area in a compact configuration. The elongated holes 1636 can be spaced apart to avoid entrainment between the exhaust holes 1636 while still providing sufficient exhaust capacity. In other words, fewer holes 1636 can be spaced closer together because the increased area in the major (longitudinal) axis compensates for the reduced number of holes 1636.

[0432] The kit 1600 can optionally further include a frame 1638 ( FIGS. 37C , 37E , 38B , 38E ) that is mounted over the connection housing 1610 when in use. The frame 1638 can include a frame housing having a frame opening with a generally annular periphery. The socket 1616 is mounted within the frame opening. The frame housing can optionally be permanently engaged with the socket 1616, for example, by molding, gluing, soldering, etc. The socket 1616 can also be removably engaged with the socket 1616, for example, by a snap fit.

[0433] The difference between the embodiment of Figures 37A-37E and the embodiment of Figures 38A-38E is the shape of the inner profile of the truncated ball joint 1606. In the embodiment of Figures 37A-37E, the inner profile of the truncated ball joint 1606 generally follows the corresponding outer profile of the truncated ball joint 1606. As shown in more detail with reference to Figure 37E and discussed later, in this "enlarged elbow" configuration, inlet (intake) gases can spread and / or separate at the truncated ball joint 1606 outlet, resulting in turbulence. In the embodiment of Figures 38A-38E, in contrast, the interior of the swivel connector 1602, including the second end, the entire truncated ball joint 1606, and the area immediately adjacent the truncated ball joint 1606 extending toward the first end 1604, has a continuous cylindrical or continuously tapered cylindrical profile. A continuously tapered cylindrical profile can be advantageous because it can simplify tooling during manufacturing.

[0434] 37A-37E and 38A-38E is in the positioning of the swivel connector 1602 in the socket 1616. In the embodiment of FIGS. 37A-37E, as shown in FIG. 37C, the swivel connector 1602 and socket 1616 are configured such that when the truncated ball joint 1606 of the swivel connector 1602 is in a neutral position within the ball joint engagement region 1628 of the socket 1616, the end of the truncated ball joint 1606 is approximately aligned with the end of the bearing region within the socket 1616. Also, as shown in FIG. 37E, the swivel connector 1602 and socket 1616 are further configured such that when the truncated ball joint 1606 of the swivel connector 1602 is fully rotated in any direction within the ball joint engagement region 1628 of the socket 1616, the ball joint opening 1608 does not fully overhang the ball joint engagement region 1624 within the socket 1616. At least a portion of the ball joint opening 1608 is approximately aligned with an end of the ball joint engagement region 1628 in the socket 1616 .

[0435] However, in the embodiment of FIGS. 38A-38E , as shown in FIG. 38B , the swivel connector 1602 and socket 1616 are configured such that when the truncated ball joint 1606 of the swivel connector 1602 is in a neutral position within the ball joint engagement region 1628 of the socket 1616, the ball joint opening 1608 fully overhangs the bearing regions 1628, 1630 within the socket 1616. This overhang allows the overall socket 1616 to be shorter, facilitating compactness. This configuration also allows for a smaller diameter truncated ball joint 1606. Additionally, as shown in FIG. 38E , the swivel connector 1602 and socket 1616 are configured such that when the truncated ball joint 1606 of the swivel connector 1602 is fully rotated in any direction within the ball joint engagement region 1628 of the socket 1616, the end of the truncated ball joint 1606 fully overhangs the ball joint engagement region 1624 within the socket 1616.

[0436] Yet another difference between the embodiment of Figures 37A-37E and the embodiment of Figures 38A-38E is the outer contour of the ball joint engagement region 1624. In the embodiment of Figures 37A-37E, the outer contour of the ball joint engagement region 1624, which faces the ambient air, has a first slope for the distance from the second end 1626 to point 1650 (Figures 37A-37C) and a second slope, different from the first slope, for the remaining length of the ball joint engagement region 1624, extending from point 1650 toward the first end 1622. In the embodiment of Figures 38A-38E, the outer contour of the ball joint engagement region 1624, which faces the ambient air, has a continuous slope, as shown in Figure 38B. A continuously sloped surface can be advantageous because it provides a cleaner appearance and requires less complex tooling during manufacturing. A continuously sloping surface can also be advantageous because it can allow for a longer exhaust flow path (compare expiratory flow 1642 in FIG. 38E with expiratory flow 1642 in FIG. 37E). A longer exhaust flow path can reduce static noise, and especially dynamic noise. The outer contour of the ball joint engagement region 1628, along with the contour of the truncated ball joint 1606, also affects the rotational movement of the swivel connector 1602 in the socket 1616. The contour of FIG. 38B allows for less rotational movement than the contour of FIG. 37C, and the restriction on rotation reduces the opportunity for cross-flow, which can reduce noise.

[0437] Yet another difference between the embodiment of FIGS. 37A-37E and the embodiment of FIGS. 38A-38E is in the flow paths of inhaled and exhaled gases through the socket 1616. As shown in FIG. 37E, turbulence is low in the straight section of the swivel connector 1602. However, the exhaled flow 1640 spreads and separates as it exits the truncated ball joint 1606, resulting in turbulence and vortices. When the swivel connector 1602 is in the maximum rotation position, a portion of the exhaled flow 1640 contacts the wall of the socket 1616, which can obstruct the exhaled flow 1642. As a result, a portion of the exhaled flow 1642 is restricted while the exhaled flow 1642 increases at the opposite wall of the socket 1616. As mentioned above, the overhang in the embodiment of FIGS. 38A-38E allows for a smaller diameter truncated ball joint 1606. This configuration can help separate the inhaled and exhaled flows 1640 and 1642, as shown in FIG. 38E. In the configuration of FIG. 38E , the continuously tapered cylindrical profile of the internal bore of the truncated ball joint 1606 ensures that the inhalation flow 1640 does not significantly spread or separate as it exits the truncated ball joint 1606. Only slight vortices are generated as the inhalation flow 1640 leaves the truncated ball joint 1606, due to the slight tapered profile. Also, because of the reduced rotation of the truncated ball joint 1606 in the socket 1616, the majority of the inhalation flow 1640 is not directed toward the walls of the socket 1616, even at its maximum rotation position. As a result, the exhalation flow 1642 is not significantly impeded by the exhalation flow 1640, other than slight interference from some turbulence.

[0438] It should be understood that not all variations are limited to the embodiments mentioned. Thus, the embodiments of Figures 38A-38E can be modified by incorporating one or more features of the embodiments of Figures 37A-37E, and vice versa. It should also be understood that the scope of the present disclosure does not exclude the above-mentioned features of Figures 37A-37E, even though those features may include properties that may be considered less advantageous than the features of Figures 38A-38E under certain circumstances.

[0439] FIGS. 40A-40E highlight examples of various dimensional ranges and inventive observations related to the embodiments of FIGS. 38A-38E. Angle A and angle F (i.e., the arc lengths of bearing regions 1628, 1630 in FIGS. 37A-37E and 38A-38E) shown in FIG. 40A can each range from 40° to 80°, with the total arc length of the bearing regions (the sum of angle A and angle F) ranging from 80° to 160°. In this representation, the angles are the same. However, in other embodiments, the angles may be different. Angle B and angle H (i.e., the arc lengths of expiratory regions 1632, 1634 in FIGS. 37A-37E and 38A-38E) shown in FIG. 40A can each range from 80° to 160°, with the total arc length of the expiratory regions (the sum of angle B and angle H) ranging from 200° to 280°. Again, in this representation, the angles are the same. However, in other embodiments, the angles may be different. Because the sum of angles A, B, F, and H is constant (360°), as the total arc length of the expiratory length increases, the total arc length of the bearing region decreases.

[0440] Referring to FIG. 40C, diameter Z (i.e., the inner diameter of connection housing 1610 in FIGS. 37A-37E and 38A-38E) can range from 18 mm to 45 mm. Assuming a 1 mm wall thickness, diameter Y therefore ranges from 16 mm to 43 mm. Diameter X is smaller than diameter Y. Slot width E (FIG. 40E) is related to diameters X and Y according to the formula: E=½(YX). Slot width E is desirably in the range of 1 mm to 12 mm. Thus, in this example, diameter X is greater than 16 mm.

[0441] Referring to FIG. 40D, as the ball retention length M increases to the apex of the ball, leakage is reduced. When the ball retention length M increases beyond the apex of the ball, leakage is reduced and retention is improved. It was also found that channel depth D1 is related to channel depth D2 (FIG. 40B), the inner diameter of the end of the truncated ball joint 1606 (diameter U, FIG. 40D), and the maximum angle of rotation of the truncated ball joint 1606 in any direction at the ball joint engagement region 1628 of the socket 1616 (angle C, FIG. 40B) according to the formula: D1 = D2 + ½(U tan C). It was also observed that dynamic noise improved as channel depth D2 increased. When channel depth D2 equaled 7 mm and diameter U was 20 mm, no dynamic noise was observed.

[0442] The retention area can be defined as the area required to maintain the truncated ball joint 1606 in place. The retention area is a function of angle A, angle G, and ball retention length L. For example, referring to FIG. 40E, the angle subtended by the line representing ball retention length L (angle G) decreases as the total arc length of the bearing area (the sum of angles A and F) increases. The discharge area can be defined as the area required for the bias exhaust port. The discharge area is a function of angle B, slot width E, and ball retention length L. Minimizing the retention area maximizes the discharge area in the exhalation area, improving noise and ventilation. Resistance to undesired housing disengagement can be defined as the resistance to unintended housing disengagement caused by a moment applied to the housing. Resistance to undesired housing disengagement is a function of diameter Z and housing taper length i (FIG. 40D). A maximum ratio of Z:i of 6:1 has been found to be preferred.

[0443] V. Respiratory Mask and Vent Placement 41A-41E show a respiratory mask assembly 1700 with an exhaust insert that includes an integrated elbow socket, making it compact, easy to manufacture, and easy to clean. The respiratory mask assembly 1700 includes a frame 1710, a cushion 1712 attached to a cushion housing 1714, a swivel elbow 1716 with a ball joint 1732, and an exhaust insert 1718. The exhaust insert 1718 is inserted into, received, and supported by the frame 1710. In operation, the exhaust insert 1718 connects the cushion housing 1714 to the elbow 1716, thereby allowing inspiratory gas provided by a gas supply to be delivered to the cushion 1712 by the elbow 1716. The exhaust insert 1718 also receives the ball joint 1732 to provide rotational adjustability of the swivel elbow 1716.

[0444] Frame 1710 has a frame opening 1720 having a generally annular shape defined by an inner wall 1722. Frame opening 1720 has a symmetrical tri-oval shape with its center aligned with the center of frame 1710.

[0445] The exhaust insert 1718 is comprised of a cover portion 1740, an engagement region 1742, and an elbow socket 1744. The cover portion 1740 has a generally planar shape with an outer surface that is substantially flush with the outer surface of the frame 1710. The cover portion 1740 and its outer peripheral edge have a shape that corresponds to the annular shape of the frame opening 1720.

[0446] The engagement region 1742 includes a collar portion 1750 that extends substantially perpendicular from the periphery of the cover portion 1740 in a direction toward the user. In some configurations, the collar portion 1750 extends a distance from the cover portion 1740 that is equal to or greater than the thickness of the frame 1710. The outer surface of the collar portion 1750 has a shape that corresponds to the shape of the frame opening 1720 such that the collar portion 1750 engages the inner wall 1722 of the frame opening 1720.

[0447] The cover portion 1740 and the collar portion 1750 define an interior region 1752 of the exhaust insert 1718. The interior region 1752 provides a cavity within which inhaled and exhaled gases are received from the swivel elbow 1716 and the cushion 1712, respectively. The interior region 1752 includes exhaust regions 1754 disposed to the left and right of the engagement region 1742. The exhaust regions 1754 have exhaust holes 1756 extending through the cover portion 1740, such that the interior region 1752 is in fluid communication with the air through the exhaust holes 1756. The exhaust holes 1756 extend through the cover portion 1740 to allow exhaled gases exhaled by the user to pass to the ambient air when in use.

[0448] Each exhaust area 1754 exhausts exhaled gases in a different direction than the opposite exhaust area 1754, so that the exhaled gases from both exhaust areas 1754 do not combine and cause drafts or noise that may disturb the user. The exhaust areas 1754 and / or exhaust holes 1756 can be angled so that the exhaled gases are exhausted in different directions.

[0449] The exhaust hole 1756 is shown as being cylindrical in shape. That is, the exhaust hole 1756 has a circular cross-section. In some configurations, the exhaust hole 1756 may have a planar shape. A planar shape for the exhaust hole 1756 may improve the ease with which the exhaust hole 1756 can be cleaned. One skilled in the art will understand that the exhaust hole 1756 is not limited to a circular or planar shape, but may include a variety of shapes and geometries.

[0450] The exhaust insert 1718 is inserted into the frame opening 1720 during assembly of the respiratory mask assembly 1700. In some configurations, the collar portion 1750 and the inner wall 1722 of the frame opening 1720 can have a slight interference fit, so that the cover portion 1740 of the exhaust insert 1718 is easily engaged with the outer surface of the frame 1710 prior to welding. In other configurations, the collar portion 1750 can have a rim or beveled edge (not shown) that engages with a corresponding chamfered area located on the inner wall 1722, so that the exhaust insert 1718 is precisely positioned relative to the frame 1710.

[0451] The exhaust insert 1718 is welded to the frame 1710 to provide a permanent bond with the frame. A weld area 1726 of the exhaust insert 1718 is welded to a weld area 1724 of the frame 1710 along a joint 1730 between the exhaust insert 1718 and the frame 1710. In some configurations, the exhaust insert 1718 may be joined to the frame opening 1720 by, for example, adhesive, press fit, welding, or soldering. In other configurations, the exhaust insert 1718 may be removably installed within the frame opening 1720 by, for example, a click-fit interlocking connection. In still other configurations, the exhaust insert 1718 may be integrally molded to the frame 1710 during a molding process.

[0452] The exhaust insert 1718 has an integral elbow socket 1744 with a ball joint bore 1746 and a ball joint engagement region 1748. The ball joint bore 1746 extends through the cover portion 1740 of the exhaust insert 1718. The ball joint engagement region 1748 includes a bearing surface provided by upper and lower socket sidewalls 1760, 1762 and lateral socket sidewalls 1764 that surround the ball joint bore 1746. The inner surfaces of the socket sidewalls 1760, 1762, 1764 support, retain, and provide a sealing engagement, allowing the ball joint 1732 to rotate relative to the exhaust insert 1718. In some configurations, the upper and lower socket sidewalls 1760, 1762 may be integrally formed with the inner surface of the collar portion 750.

[0453] Socket sidewalls 1760, 1762, 1764 extend substantially perpendicularly from the periphery of cover portion 1740. As shown in FIG. 41D , central portions 1770 of lateral socket sidewalls 1764 extend a greater distance from cover portion 1740 than end portions 1772 of lateral socket sidewalls 1764. That is, the height of lateral socket sidewalls 1764 at central portion 1770 (i.e., the height in the direction toward the user) is greater than the height of lateral socket sidewalls 1764 at end portions 1772. The height of lateral socket sidewalls 1764 gradually decreases from a maximum height at central portion 1770 to a minimum height at end portions 1772.

[0454] 41D , the end portions 1772 of the lateral socket sidewalls 1764 have a similar height as the lower socket sidewalls 1762, such that the lower socket sidewalls 1762 are flush with the end portions 1772 of the lateral socket sidewalls 1764. That is, the user-facing surface of the lower socket sidewalls 1762 is flush with the user-facing surface of the end portions 1772 of the lateral socket sidewalls 1764. Thus, the central portions 1770 of the lateral socket sidewalls 1764 have a greater height than the lower socket sidewalls 1762. In some configurations, the upper socket sidewalls 1760 can also have a similar height to the end portions 1772 of the lateral socket sidewalls 1764.

[0455] The relatively increased height of the end portion 1772 of the lower socket sidewall 1762 and the lateral socket sidewalls 1764 creates a recessed area 1780. That is, the user-facing surfaces of the lower socket sidewall 1762 and the lateral socket sidewalls 1764 define the recessed area 1780 between the ball joint 1732 and the collar portion 1750. The recessed area 1780 provides a shallow, user-accessible cavity at a location within the interior region 1752 where dirt may accumulate. The recessed area 1780 provides a shallow gap or gap between the ball joint 1732 and the bottom of the exhaust insert 1718 (i.e., the collar portion 1750) that can be easily wiped clean by a user.

[0456] In some configurations, a portion of the inner surface of the collar portion 1750 adjacent the lower socket sidewall 1762 can have a cutout area that further enlarges the recessed area 1780. That is, the portion of the collar portion 1750 adjacent the recessed area 1780 can be removed or recessed to enlarge the recessed area 1780. The inner surface of the collar portion 1750 can be recessed, which reduces the thickness of the collar portion 1750 and provides additional clearance between the collar portion 1750 and the ball joint 1732.

[0457] In some configurations, the upper socket sidewall 1760 can also have a height similar to the end portions 1772 of the lateral socket sidewalls 1764, thereby forming a recessed area above the ball joint 1732, thereby facilitating cleaning in the upper area of ​​the exhaust insert 1718. Similarly, the portion of the inner surface of the collar portion 1750 adjacent the upper socket sidewall 1760 can have a cutout area that further enlarges the recessed area.

[0458] In some configurations, the ball joint 1732 can have a cutout area (not shown) at the bottom portion of the ball joint that engages with the interior region 1752. The cutout area can be a removed or recessed portion of the ball joint 1732 that aligns with the recessed area 1780 and provides additional clearance between the collar portion 1750 and the ball joint 1732 to allow a user to remove accumulated debris within the interior region 1752 of the exhaust insert 1718.

[0459] Figures 42A and 42B show an alternative respiratory mask assembly 1800 for biased exhaust ports in a full-face mask having an exhaust insert 1818 with an integrated elbow socket. The exhaust insert configuration is substantially similar to the side exhaust port configuration of the respiratory mask assembly 1700 in Figures 41A-41E. However, the location of the bias exhaust port 1854 is located above, rather than to the side of, the swivel elbow 1816. Thus, the mask assembly 1800 is compact, easy to manufacture, and easy to clean. For the sake of brevity, a redundant discussion of similar features between the respiratory mask assembly 1700 in Figures 41A-41E and the alternative respiratory mask assembly 1800 in Figures 42A-42B will be omitted.

[0460] The bias exhaust port 1854 includes a plurality of exhaust holes 1856 disposed in the exhaust insert 1818. The exhaust holes 1856 extend through the exhaust insert 1818 to allow exhaled gases exhaled by the user to pass to the ambient air when in use.

[0461] The exhaust insert 1818 may protrude through an aperture in the frame 1810 to provide a connection between the frame 1810 and the cushion housing 1814. The exhaust insert 1818 is permanently attached to the cushion housing 1814 of the mask. The exhaust insert 1818 may be friction / press fit or welded to provide a permanent bond with the frame 1810. In other configurations, the exhaust insert 1818 may be removably connected to the frame 1810, for example, by a snap fit or click-type interlocking connection. In yet other configurations, the exhaust insert 1818 may be integrally molded into the frame 1810 during a molding process.

[0462] The exhaust insert 1818 also includes an elbow socket 1844 that receives the ball joint 1832 of the swivel elbow 1816. Similar to the elbow socket 1744 in FIGS. 41A-41E, the elbow socket 1844 supports, retains, and provides a sealing engagement, allowing the ball joint 1832 to rotate relative to the exhaust insert 1818. The elbow socket 1844 includes a similar socket sidewall configuration and recessed area as the elbow socket 1844 to allow the exhaust insert 1818 to be easily cleaned.

[0463] headgear A variety of conditions can be treated using a respiratory patient interface / mask. One such condition is that of obstructive sleep apnea (OSA). Although certain features, aspects, and advantages of the invention described herein are described with respect to use in treating OSA with continuous positive airway pressure (CPAP), this is not intended to be limiting, and certain features, aspects, and advantages of the invention can be used to treat other respiratory conditions.

[0464] The most common treatment for OSA is CPAP, which involves providing a constant supply of pressurized air to a patient's airway via a mask system. Most masks include a combination of a sealing interface, a frame, an air supply connection, and a headgear structure. The headgear is attached to the frame and maintains a seal against the patient's face. For therapeutic efficacy, it is desirable to achieve a generally leak-free seal between the mask and the patient's face. Therefore, the headgear structure is essential in securing the mask to the patient.

[0465] Headgear is commonly made from breathable foam and fabric laminates, such as Breath-o-Prene®. Some common problems associated with current headgear designs include they are bulky, heavy, hot, and slow to dry when cleaned. Several features, aspects, and advantages of the present invention seek to provide improvements to these problems.

[0466] three dimensional cloth Some features, aspects, and advantages of the present invention include headgear constructed entirely or partially from three-dimensional fabrics. Two-dimensional fabrics are typically woven from two sets of yarns, known as warp and weft yarns, to form a woven surface or sheet material. The thickness of a two-dimensional fabric is determined by the combined thickness of the yarns at the yarn intersections of the fabric. For example, in a fabric woven from warp and weft yarns, the thickness of the fabric is equal to the thickness of the warp and weft yarns used to construct the fabric. The yarns in a two-dimensional fabric generally extend in a single plane of the fabric. Two-dimensional fabrics lack fibers or yarns that extend in the thickness direction of the fabric, and primarily have yarns that extend in the generally planar direction of the fabric. Two-dimensional textiles or fabrics, such as woven or knitted sheet fabrics, tend to form sharp edges when the folds of the two-dimensional fabric are pressed flat or tension is applied along the fold edges. For example, when the folds of a two-dimensional fabric are subjected to heat and / or pressure (e.g., ironing), sharp, wrinkled edges form. Folded edges in two-dimensional fabrics are generally undesirable in headgear applications because the tension in the headgear components required to maintain the mask in a sealed position on the user's face results in sharp edges that are undesirable in soft tissue or sensitive areas of the user's head, such as around the ears or behind the neck.

[0467] Although all fabrics have a three-dimensional internal structure, most may be macroscopically considered as thin, two-dimensional fabrics. In three-dimensional fabric structures, the thickness or Z dimension is significantly larger than the X and Y dimensions. A three-dimensional fabric is generally described as "a single-fabric system, the constituent yarns of which are considered to be arranged in three mutually perpendicular plane relationships" (Behera BK, Mishra R. (2008), 3-Dimensional Weaving, Indian Journal of Fiber & Textile Research, Vol. 33, pp. 274-287). Khokar provided a similar definition for a three-dimensional woven fabric: "a fabric, the constituent yarns of which are considered to be arranged in three mutually perpendicular plane relationships" (Khokar, N. (2001), 3D-Weaving: Theory and Practice, Journal of the Textile Institute, Vol. 92 No. 2, pp. 193-207).

[0468] A basic common definition for three-dimensional fabrics is that these types of fabrics have a third dimension in thickness. For example, three-dimensional fabrics have yarns in the warp, weft, and thickness directions of the fabric. Khokar classified three-dimensional fabrics into different types, including entangled three-dimensional fabrics, non-entangled three-dimensional fabrics, and fully entangled three-dimensional fabrics.

[0469] In this specification and claims, unless the context indicates otherwise, the term "yarn" is intended to mean a thread, filament, fiber, thread, or any other component that is woven, knitted, braided, or otherwise constructed to form a fabric.

[0470] As mentioned above, three-dimensional fabrics have a greater thickness than the stack of component yarns used to construct the fabric. In other words, three-dimensional fabrics have a relatively lower density of component material thickness relative to the overall fabric thickness compared to conventional two-dimensional textiles. Three-dimensional fabric structures provide thicker fabrics that are lightweight and breathable for a given fabric thickness because they are less dense than conventional two-dimensional fabrics for a given thickness. Furthermore, three-dimensional fabric structures are less likely to wrinkle when folded, and their increased thickness compared to two-dimensional fabrics provides additional cushioning.

[0471] One form of three-dimensional fabric is a three-dimensional spacer fabric or textile (herein, "spacer fabric"), which is a fabric having two sheets formed from a plurality of yarns connected by a continuous thread (e.g., filament or fiber) extending between the sheets, as shown, for example, in FIG. 43. Referring to FIG. 43, the spacer fabric can comprise a first sheet 2101 formed from one or more yarns (e.g., warp and weft) in a first plane, a second sheet 2102 formed from one or more yarns (e.g., warp and weft) in a second plane parallel to the first plane, and one or more yarns 2103 extending between and connecting the two sheets, which together extend through the thickness of the fabric. The spacing between the sheets and the physical properties of the fabric sheets and the filaments extending between or connecting the sheets can be specified to provide various physical properties. In some embodiments, the spacing between the sheets can be in the range of 1 mm to 5 mm.

[0472] Spacer fabrics generally are breathable, provide compressible cushioning, are lightweight, can be anti-allergenic and anti-microbial, and can be stretchable or non-stretchable. Spacer fabrics are commonly made from thermoplastic resins such as polyester, but can be made from a variety of other fibrous materials. Combinations of different materials can be used to provide desired physical properties.

[0473] The disclosed embodiments include a three-dimensional spacer fabric by way of example only. The disclosed embodiments may utilize other types of three-dimensional textiles in place of or in combination with the three-dimensional spacer fabric as described.

[0474] Figure 44 shows a typical headgear design for a full-face mask. It includes four mask attachment points in the form of adjustable upper and lower side straps, and adjustable top and back straps. Figure 45 shows the same headgear in a flattened position. A similar four-point headgear configuration can be used in combination with a nasal mask. Some direct-nasal masks use a two-point headgear configuration. These tend to have more centrally located attachment straps on each side of the headgear. Additionally, the four-point headgear can be attached to the mask with or without a T-piece.

[0475] In some configurations, the headgear configuration may be generally shaped as shown in FIG. 45 but may be made at least in part from spacer fabric. For example, the rear portion or rear panel portion 2301 may be made from spacer fabric, while the remainder of the headgear may be made from conventional materials such as breathable foam and fabric laminate. The rear panel of the headgear provides the portion of the headgear from which the headgear straps extend in the necessary positions and orientations to fit a wide range of different users' heads. The rear panel is often larger and bulkier than other portions of the headgear, such as the headgear straps.

[0476] The rear panel is large enough to provide stability for the headgear on the user's head. The panel contacts a sufficient area of ​​the user's head to help maintain accurate positioning of the headgear on the user's head. However, the larger the area of ​​the user's head that the panel covers, the hotter the headgear may be and the more uncomfortable it may be for the user. Using a spacer fabric in the rear portion 2301 of the headgear can be beneficial in reducing the overall weight and improving the breathability of the headgear, thus improving user comfort, reducing sweating, and / or lowering the temperature that may reach the user's scalp covered by the headgear. The spacer fabric can be more compressible than traditional headgear materials, such as breathable foam and fabric laminates. This is advantageous in that it can make the headgear less noticeable on the patient's head when lying down. The thickness of traditional materials can mean that the patient may feel the headgear between their head and a pillow and / or the edges of the headgear may dig into their head. Because the spacer fabric can compress to a minimum thickness, it is less likely to be felt on the patient's head.

[0477] The use of spacer fabric as a headgear component is not limited to this location. Any component of the headgear can be made from spacer fabric, where the physical properties of the fabric are selected to meet the requirements of a given location. Alternatively, the entire headgear can be made entirely from one or more grades of spacer fabric. A combination of spacer fabrics with different physical properties can be incorporated into a single headgear. For example, the straps connecting to the mask can be non-elastic, and the rear panel can be made of a thicker material to provide additional cushioning.

[0478] There are several physical properties that are beneficial in a headgear fabric, including having a soft surface finish for contact with the patient, being stretchable or non-stretchable depending on the position within the headgear, and having a certain amount of stiffness to maintain the shape of the headgear.

[0479] Spacer fabric is typically manufactured in large sheets, from which headgear components are cut and assembled. The cut edges of the fabric are preferably finished in some way to reduce the likelihood of fraying, a rough appearance, and rough edges against the patient's skin. There are many techniques and methods that can be used to assemble headgear components and finish the edges. Some embodiments of these are detailed below.

[0480] Edge finishing techniques Figures 46A, 46B, 46C, and 46D show several edge finishing methods that can utilize welding and / or stitching techniques. As shown in Figure 46A, welding and die-cutting can be used to create sealed and trimmed edges. Heat generated by welding techniques, such as radio frequency (RF) welding, is used to melt the fabric and bond the outer fabric sheets of the spacer fabric to each other, thus creating a closed edge and sealing the filament areas between the sheets. Once sealed, the edges can be trimmed and trimmed by a die-cutting process. In some configurations, RF welding can be used to bond individual headgear components to each other to form the finished headgear. This allows a combination of different grades or types of fabric to be used within a single headgear; for example, multiple grades of spacer fabric can be bonded to each other, or a spacer fabric component can be bonded to a breathable foam and fabric laminate component.

[0481] Figures 46B and 46C show edge-finished embodiments in which the outer surface of the spacer fabric extends further than the internal filaments and is folded over the exposed edge of the spacer fabric. In Figure 46B, both the top and bottom surfaces are stretched and then folded toward the center of the fabric. The folded edges are secured in place by a welded seam through the outer surface of the spacer fabric. As an alternative or in addition to welding, a continuous stitch can be sewn into the edge of the spacer fabric, securing the folded raw edge. In Figure 46C, one outer surface is stretched further than the other and folded over the entire edge of the spacer fabric. The folded raw edge is then welded and / or sewn in place as in the previous embodiment.

[0482] Figure 46D illustrates further embodiments that may utilize welding techniques. A separate finishing component may be applied to the edge of the spacer fabric, and the finishing component may be made of textile or plastic. For example, a textile, such as bias tape, may be folded over the spacer fabric edge and secured in place by sewing through the fabric outer sheet and the inner spacer element, or by welding the fabric outer sheet and the inner spacer element together. In some configurations, a molded plastic bead or molding may be applied to the spacer fabric edge using welding and / or sewing techniques or any other suitable method. The molded bead or molding may have, for example, without limitation, a circular or curved cross-section.

[0483] Overmolding is another technique that can be used to provide a finished edge to the spacer fabric. Figure 46E shows the cross section of a bead that can be molded onto the edge of a spacer fabric headgear. The cross section of the bead can be substantially trapezoidal in shape, as shown in Figure 46E, or any other suitable cross-sectional shape. The overmolded bead can be made from a soft material, such as a thermoplastic elastomer, to provide a comfortable contact between the headgear and the patient. This finishing technique also provides a source of structural reinforcement to the headgear, providing a non-stretchable or semi-rigid portion within the headgear. The overmolded material can be overmolded onto the outer surface of the edge of the spacer fabric using any suitable molding technique. The overmolded material can be overmolded onto the spacer fabric in a three-dimensional shape to maintain its structure when the headgear is not on the patient's head. This helps reduce the possibility of tangling of the headgear straps and makes the headgear easier to fit. Due to the open structure of the spacer fabric, overmolding allows the plastic material to be placed on the outer surface of the spacer fabric and / or through the spacer fabric layer. Figure 46E shows an overmolded edging material molded onto the outer surface of the fabric. Figure 46F shows one possible configuration where the plastic edging material is infiltrated into all layers of the spacer fabric.

[0484] Another embodiment, shown in Figure 46G, utilizes a hot knife technique to seal and trim the spacer fabric. Using a hot knife, headgear components can be die-cut from a larger sheet of spacer fabric. The hot knife compresses and melts the two outer sheets and filament regions together before cutting the fabric. This method leaves the spacer fabric with a neat edge because the shape of the sealed edge closely matches the shape of the cut piece.

[0485] For neat edges, sewing techniques such as overlocking (seamed edge finishing) and the use of bias tape can be used.

[0486] 47A-57 show several embodiments of headgear incorporating spacer fabric. Each headgear in these figures includes a back panel 2301 from which the headgear straps extend, as described above. As shown, the headgear can include a bottom strap 2156, a top strap 2152, and a top strap 2154. In the illustrated embodiment, the headgear includes left and right bottom straps, left and right top straps, and left and right top straps. The left and right straps (e.g., the left and right bottom straps) are connected to each other during use. However, in some embodiments, one or more of the bottom straps, top straps, and top straps can be provided as a single strap connected to each side of the headgear back panel. The left and right straps, e.g., top strap 2154, may be connectable by buckles or clips or other components and / or may include features that allow the straps to be connected to one another, for example, as described in U.S. Patent Application No. 62 / 187,010, the contents of which are incorporated herein by reference.

[0487] In some embodiments, at least a portion of the back panel 2301 comprises spacer fabric. In some embodiments, at least a portion of the back panel comprises two layers of spacer fabric. For example, as shown in FIGS. 47A and 47B , in some embodiments, the back panel 2301 comprises a spacer fabric pad or panel 2201 including two layers of spacer fabric and a lower back strap 2158. The spacer fabric panel 2201 includes a substantially rectangular portion having scalloped edges with cut-out corners. The cut-out corners are configured to attach to the upper strap 2152 and the lower strap 2156. The spacer fabric panel 2201 comprises two layered spacer fabric layers 2232. The spacer fabric layers have a front side 2233 and a back side 2234. The two layers can be sewn together inside out (i.e., with the back side of the fabric facing outward) to form a seam 2236 near the raw edge 2238 of the spacer fabric layers. Once sewn together, the layers 2232 are turned right-side out, so that the top side 2233 is on the outside and the raw edge 2238 is on the inside. The seam 2236 extends around the periphery of the spacer fabric pad 2201, leaving the bottom edge 2239 open. The open bottom edge 2239 allows the spacer fabric pad 2201 to be turned right-side out. Once turned right-side out, the top straps 2152 and lower back straps 2158 are attached to the spacer fabric pad 2201. The lower and top straps can be sewn to the spacer fabric, although other attachment methods may be suitable, such as, but not limited to, welding or gluing. In the illustrated embodiment of FIG. 47A , the straps and fabric are welded to form a welded seam 2210 between the straps and the two layers of spacer fabric. The open bottom edge 2239 can be sealed (closed) at the same time as it is attached to the lower back straps 2158. The lower rear strap may be integrally formed with the lower strap.

[0488] The lower rear straps 2158 extend along the bottom edge 2239 of the spacer fabric pad. The lower rear straps 2158 may be made from a less stretchy material than the spacer fabric pad 2201. The lower rear straps provide structural reinforcement to the spacer fabric pad 2201 to reduce or eliminate the possibility of excessive stretching that could cause the mask to slip off the user's face during use.

[0489] FIG. 48 illustrates an embodiment in which the bottom edge of the spacer fabric panel lies above or across the user's neck during use. The two layers of spacer fabric can be sewn together with the right sides of the fabric facing inward and then inverted so that the raw edges of the fabric are on the inside of the back panel, as described above. However, in some embodiments, such as those shown in FIG. 48 , one layer of the spacer fabric can include an opening, such as a hole or slit (indicated by dashed line 2203), through which the layer can be inverted so that the right side is on the outside. In this manner, all four edges of the back panel can have the raw edges of the fabric inverted on the inside of the back panel. In such an embodiment, the opening 2203 can be covered by a patch 2205, such as a label bearing the manufacturer's mark or trademark. Alternatively, in some embodiments, the two layers of fabric can be inverted so that the right side is on the outside through one of the cut-out corners of the back panel.

[0490] In some embodiments, the rear panel can comprise a two-layer spacer fabric panel and a perimeter portion extending around the spacer fabric formed from another material suitable for use in headgear, e.g., a typical headgear material such as a breathable foam and fabric laminate. In the embodiment of FIG. 49, the rear panel 2301 comprises two layers of spacer fabric 2201 and a perimeter portion 2160 formed from another headgear material that extends around the entire perimeter of the spacer fabric. In some embodiments, the rear panel can comprise two layers of spacer fabric and a perimeter portion formed from another headgear material that extends around a portion of the perimeter of the spacer fabric. Other headgear materials, such as breathable foam and fabric laminate, can extend into and / or form headgear straps, such as the lower straps 2156 and upper straps 2152. In some embodiments, the lower straps and / or headgear straps can be integrally formed through the perimeter portion of the rear panel, where the perimeter portion and straps are formed from the same material. The two-layer spacer fabric panel 2201 may be attached to the material of the perimeter portion 2160 by gluing, stitching, welding, or other joining methods. In such an embodiment, the edges of the spacer fabric layer may be sealed / closed and attached to the material of the perimeter portion by a joining method, for example, by welding. The perimeter portion extending along the bottom edge of the back panel may be referred to as a back strap, for example, like back strap 2158 in FIG. 47A.

[0491] In the embodiment of FIG. 49, the rear straps 2158 or perimeter portion extending along the bottom edge of the rear panel have a "higher lift" or a pronounced inverted (upside-down) V-shape compared to the back straps in other embodiments, such as the embodiments of FIGS. 47A and 48. The higher lift or pronounced V-shape is provided by shortening the radius of curvature of the bottom edge of the rear panel and / or reducing the angle between the lower straps extending from the rear panel. In some embodiments, the lower straps 2156 are at an angle of 45 to 70 degrees, measured from the vertical centerline of the headgear. If the angle of the lower straps is less than 45 degrees when laid flat (i.e., the straps are oriented "too horizontally" in use), the lower straps 2156 may contact the user's ears in use. If the angle of the lower strap 2156 is greater than 70 degrees (i.e., the strap is oriented "too vertical" when in use), the strap may twist and dig into the user when the lower strap 2156 is aligned to extend forward and upward from its untwisted position to attach to the patient interface.

[0492] In some embodiments, the back panel or the portion of the back panel including the two layers of spacer fabric is folded from a sheet or blank of spacer fabric. The sheet or blank of spacer fabric is folded to provide the two layers of spacer fabric to form at least a portion of the back panel 2301. The spacer fabric can have a front side and a back side and is folded so that the back side of the fabric is on the inside of the panel and the front side of the fabric is on the outside of the panel. Folding the spacer fabric provides a folded edge of the spacer fabric on the back panel. For example, with reference to FIG. 50 , in some embodiments, the folded edge 2220 is provided at the bottom edge of the back panel. The bottom edge of the back panel is located above or on the user's neck. In some applications, the bottom edge of the headgear that extends across the user's neck is preferably soft. Placing the folded edge at the bottom edge of the back panel provides a soft edge at this location, which can improve comfort for the user. The folded edges do not include any joining structures, such as stitching, welding, or gluing, making them particularly soft and providing additional flexibility that may be desirable in some applications. In some embodiments, the other edges of the two layers are joined to each other by gluing, sewing, or welding. For example, in the embodiment of FIG. 50, all edges of the two layers other than the folded edges are welded to each other. In the embodiment of FIG. 50, the back panel has a perimeter portion that extends around the two layers of spacer fabric from one edge of the folded edges to the other edge of the folded edges. The perimeter portion of the back panel is formed from a material suitable for use in headgear, such as a foam material or other fabric material, such as a breathable foam and fabric laminate, or a single layer of spacer fabric. In some embodiments, the other edges of the two layers of spacer fabric are attached to the perimeter portion by gluing, stitching, welding, or other joining methods. In the embodiment of FIG. 50, the other edges of the two layers of spacer fabric other than the folded edges are welded to the perimeter portion of the back panel. In some embodiments, the material of the perimeter portion can extend into and form at least a portion of the straps of the headgear, such as the lower straps and / or the upper straps.

[0493] In some embodiments, edges other than the folded edge of the two layers of spacer fabric can be joined together using one or more joining methods to achieve desired properties. For example, in some embodiments, one or more edges can be sewn, and one or more edges can be welded or glued. In some embodiments, the two layers of spacer fabric are welded or glued together along each horizontal edge of the two layers of spacer fabric. In some embodiments, the two layers of spacer fabric are sewn together along an edge of the two layers of spacer fabric opposite the folded edge of the two layers of spacer fabric. For example, as shown in FIG. 51 , in some embodiments, the two layers of spacer fabric are welded together along each horizontal edge 2221 of the two layers of spacer fabric and sewn together along an edge 2222 opposite the folded edge 2220 of the two layers of spacer fabric. In such embodiments, the bottom folded edge 2220 provides a particularly soft edge. The top sewn edge can also be particularly soft, for example, if sewn together using a soft or elastic thread or sewing thread. In an alternative configuration, the spacer fabric can include a folded edge at one edge 2220 of the back panel and a second folded edge at the opposite edge 2222 of the back panel, with a joint in one of the two layers of spacer fabric. For example, the spacer fabric in the back panel can have a folded edge 2220 at the top edge of the back panel (edge ​​2222 in FIG. 51 ) and a folded edge 2220 at the bottom edge of the back panel (edge ​​2220 in FIG. 51 ). The outer layer of the two layers of spacer fabric can have a joint 2210, which faces away from the user's head during use. An example cross section is shown in FIG. 56. In some embodiments, the joint can be covered with a patch, such as a label bearing a manufacturer's mark or trademark. The joint 2210 can be a welded seam. A non-weld material (not shown in FIG. 56) can be provided between the two layers of spacer fabric so that when the seam 2210 is welded, the two layers are not welded to one another.The non-weldable material can be, for example, a material that is not weldable at the welding temperature of the spacer fabric and underlying material. A non-adhesive or non-weldable film or material prevents the layers of the spacer fabric from bonding to one another. In a further alternative embodiment, the three-dimensional fabric can be formed from a continuous tube, for example, a knitted tube. To achieve a two-layer three-dimensional fabric, the three-dimensional fabric tube is flattened to provide a two-layer three-dimensional fabric with folded edges on each of two opposing edges. A cross-section of the two layers of the three-dimensional fabric can be as depicted in FIG. 56, except that there is no bond 2210 because the two layers are formed from a flattened tube.

[0494] Welded or adhesively bonded joints have a higher stiffness than spacer fabric due to changes in fabric structure resulting from the adhesive or adhesive material. Welded or adhesively bonded seams have less stretch than folded edges. For example, embodiments such as that shown in FIG. 51 can provide a higher level of stretch for the back panel in the horizontal direction (from side to side of the user) compared to the vertical direction (from top to bottom of the user). The approximately vertical welded edges of the two layers of spacer fabric are less flexible than sewn and / or folded horizontal edges. In the embodiment of FIG. 51, the back panel 2301 comprises a panel of two layers of spacer fabric 2201 and a perimeter portion 2160 at each horizontal edge formed from another material suitable for use in headgear, e.g., a typical headgear material such as a breathable foam and fabric laminate. In the illustrated embodiment, the horizontal edges 2221 of the two layers of spacer fabric are welded to the corresponding horizontal perimeter portions 2160. Each perimeter portion 2160 can extend within and form at least a portion of a strap of the headgear, such as lower strap 2156 and / or upper strap 2152. Welding the spacer fabric to the perimeter portions can also close or join the edges of two layers of spacer fabric together.

[0495] 50 and 51, the spacer fabric is folded in a straight fold, so that the fold edge 2220 of the two layers of spacer fabric is a straight edge. In some embodiments, the fold edge 2220 can be curved, for example, by gathering the layers of spacer fabric adjacent the fold edge, for example, by pleating the layers at pleat line 2225, as shown in FIG.

[0496] In some embodiments, such as that shown by the embodiment of FIG. 53 , the fold 2220 can be located at a lateral edge 2221 of the back panel 301. The two layers of spacer fabric can be sewn together along a lateral edge 2222 opposite the fold 2220 of the two layers of spacer fabric. Alternatively, the spacer fabric can have two folds, for example, as described with reference to FIG. 51 , but with the folds at the lateral edges of the two layers of spacer fabric. The upper and lower edges of the two layers of spacer fabric can be glued, welded, or sewn to the upper and lower straps of the headgear. In the embodiment of FIG. 53 , the two layers of spacer fabric are welded 2210 along their upper and lower edges to the upper straps 2159 and lower straps 2158, respectively.

[0497] In some embodiments, the spacer fabric can be applied to the headgear by wrapping it around another component of the headgear. For example, as shown in FIGS. 54 and 49, the headgear can include a rear panel formed from a headgear material, such as a breathable foam and fabric laminate or other suitable material, with a covering of spacer fabric. In the embodiments of FIGS. 54 and 55, the spacer fabric is wrapped around the other headgear material of the rear panel. In some embodiments, the two layers of spacer fabric can be joined at the edges of the two layers of spacer fabric by, for example, sewing, gluing, or welding. As shown in FIGS. 54 and 55, in some embodiments, the spacer fabric is wrapped around the other headgear material to have folded edges 2220 at the top and bottom edges of the rear panel. One of the two layers of spacer fabric can have a joint, such as a sewn, glued, or welded seam, as represented by dashed line 2224 in FIG. 54. The joint can be in the outer layer of the two layers of spacer fabric, which is the layer that does not contact the user's head during use. In the cross-sectional view of FIG. 55 , the joint 2224 is shown as a welded seam 2210. In some embodiments, the joint 2224 in the spacer fabric can be made before wrapping the spacer fabric around the other headgear material. In such embodiments, the fabric is joined to form a continuous piece of fabric with an open end to slide over the other headgear material. Alternatively, in some embodiments, the fabric can be wrapped around the other headgear material and then joined. In some embodiments, the joint in the spacer fabric layer can also join the spacer fabric to the underlying material of the headgear. In some embodiments, a non-adhesive or non-weld material or film can be provided between the underlying material of the headgear and one or both layers of the spacer fabric. The non-adhesive or non-weld material can be a material that is incompatible with the adhesive material so that no bond is formed with the non-adhesive material.The non-weldable material can be, for example, a material that is not weldable at the welding temperatures of the spacer fabric and the underlying material. The non-adhesive or non-weldable film or material prevents one or more layers of the spacer fabric from adhering to the underlying layers of the headgear. For example, a non-weld film 2240 can be provided between the underlying material 2245 of the headgear and the layer 2237 of spacer material (the inner layer of the two layers of spacer fabric) that contacts the user's head during use. The non-weld material or film 2240 prevents the weld seam 2210 of the outer layer 2235 of spacer fabric from penetrating through the underlying material 2245 and the inner layer 2237 of spacer fabric, so that the inner layer of spacer fabric is not welded to the underlying material. However, welds in the outer layer 2235 of spacer fabric can weld the outer layer of spacer fabric to the underlying material 2245. Bonding or welding the outer layer of spacer fabric to the underlying material helps maintain the spacer fabric covering in the correct position over the underlying material. The inner layer 2237 of spacer fabric spaces the underlying material of the headgear from the user's head, thereby improving comfort by providing a cushioning effect and reducing sweating and / or lowering the temperature that the user's scalp, covered by the headgear, may reach.

[0498] The headgear embodiments of Figures 47A-54 include two layers of spacer fabric in at least a portion of the rear panel of the headgear. However, in some embodiments, the two layers of spacer fabric can be used to form other components of the headgear or to form other components. For example, as shown in Figure 57, in some embodiments, the headgear straps 2156 can include two layers of spacer fabric 2232. The spacer fabric 2232 can be formed with a folded edge 2220 at an edge of the strap and a joint at an opposite edge 2222 of the strap, or with a folded edge 2220 at one edge of the strap and a folded edge 2222 at an opposite edge of the strap and a joint in one of the two layers of spacer fabric 2232. For example, as described in connection with the embodiment of Figure 54, the joint can be in the outer layer of the spacer fabric.

[0499] During the manufacture of the embodiments described above with reference to Figures 51-57, in some embodiments, a seam between two layers of spacer fabric or within one of the layers can be created by flipping the fabric so that the wrong side is on the outside. Once the seam is created, for example, as described with reference to the embodiment of Figure 47A, the spacer fabric is flipped so that the seam is located on the inside of the two layers of spacer fabric.

[0500] Welded part details In some embodiments, one or more edges of the panels of the two layers of spacer fabric are welded to another portion of the headgear, such as the perimeter portion of the back panel, as described with reference to, for example, Figure 50. For example, in Figure 50, the edges of the two layers of spacer fabric are welded to the perimeter portion 2160 of the back panel, which extends from one end of the folded edge 2220 to the other end of the folded edge. Also in Figure 51, the lateral edges 2221 of the two layers of spacer fabric 2201 are welded to the lateral perimeter portion 2160. In some embodiments, that portion of the headgear is formed from another material suitable for use in headgear, such as a breathable foam and fabric laminate.

[0501] In some embodiments, the edge regions of the two layers of spacer fabric are overlapped with the edge regions of the portion of the headgear to form a welded area comprising the two layers of spacer fabric and the portion of the headgear. In the welded area, one layer of spacer fabric (the inner layer) is positioned between the portion of the headgear and the other layer of spacer fabric (the outer layer). As is known in the art, the overlapping materials comprising the two layers of spacer fabric and the portion of the headgear are preferably welded together by high-frequency welding, in which the materials are pressed together between two welding heads, for example, a table / platen and a die / horn. However, any other suitable welding technique, such as ultrasonic welding or heat compression welding, can be employed.

[0502] 59B , in the weld area 2250, one layer 2235 of the two layers of spacer fabric (the overlap layer) overlaps the edge of the other layer 2237 of the two layers of spacer fabric, such that the weld comprises a first region 2250A formed from the two layers of spacer fabric and the portion of headgear 2160, and a second region 2250B formed from the one layer of spacer fabric and the portion of headgear. In some embodiments, the weld comprises a first region 2250A formed from the two layers of spacer fabric and the portion of headgear 2160, and a remaining second region 2250B formed from the one layer of spacer fabric and the portion of headgear. This arrangement creates a weld with a "graded thickness" of welded spacer fabric. The thickness of the welded spacer fabric is greater at the edge 2160A of that portion of the headgear than at the edge 2235A of the overlapping layer 2235 of spacer fabric.

[0503] Each of the two layers of spacer fabric has an overlap region that overlaps a portion of the headgear so that the fabric is fused to the two layers of spacer fabric. The width of the overlap region of the first of the two layers is greater than the width of the overlap region of the second of the two layers of spacer fabric. For example, referring to FIGS. 58A-59C, the two layers of spacer fabric can be folded from a single blank 2300 cut from a sheet of spacer fabric. As shown in FIGS. 58B and 58C, the blank is folded to form the two layers of spacer fabric. The fabric is folded along the fold region 2310 shown in FIG. 58A. One portion 2315 of the blank forming one layer 2237 of the two layers of spacer fabric is sized smaller than the corresponding portion 2320 of the blank forming the second layer 2235 of the two layers of spacer fabric, so that when the fabric is folded along the fold region 2310 to form the two layers of spacer fabric, one layer 2235 overlaps the edge of the other layer 2237, as shown in FIGS. 58B and 58C . The overlap of one layer 2235 over the edge of the other layer 2237 provides the two layers of spacer fabric with a "stepped edge." In the illustrated embodiment, the two layers of spacer fabric have a stepped edge at each lateral edge 2221 of the two layers of spacer fabric. At an edge 2222 opposite the folded edge 2220, the edges of the layers are aligned to provide, for example, a sewn edge. Thus, the two layers of spacer fabric shown in FIG. 58B may be suitable for use in constructing the headgear shown in FIG. 51 . As shown in Figure 58B, the folds in the spacer fabric result in a curved edge. Unlike folds in two-dimensional fabrics, which can result in sharp, wrinkled edges, the folds in three-dimensional fabrics result in a curved, soft edge. Due to the thickness and / or structure of the three-dimensional fabric, the fold edge 2220 results in a gap between the two layers of fabric at the fold edge, making the edge particularly soft and suitable for use in headgear.

[0504] Figure 58D shows an alternative blank of material that will form the two layers of spacer fabric. In this embodiment, the blank includes two fold regions 2310A and 2310B. When folded at the two fold regions to form the two layers of spacer fabric, one of the two layers includes a join formed in the join region 2325 of the blank. The portion(s) of the blank that will form one of the two layers of spacer fabric is slightly smaller in size than the corresponding portion(s) of the blank that will form the second of the two layers of spacer fabric, so that when the fabric is folded along the fold regions 2310A and 2310B to form the two layers, one layer 2235 overlaps the edge of the other layer 2237. In the illustrated embodiment, the portion of the blank that forms the overlapping layer comprises two portions 2320A and 2320B that together form the overlapping layer of two layers of spacer fabric, whereby a joint formed in the joint area 2325 of the blank (e.g., joint 2210 in FIG. 56 is formed in the overlapping layer 2235 of the spacer fabric). The blank in FIG. 58D forms two layers of spacer fabric with two fold edges as shown in FIG. 56.

[0505] As described above, in some embodiments, the three-dimensional fabric may be formed from a continuous tube, such as a knitted tube. To achieve two layers of the three-dimensional fabric, the tube of three-dimensional fabric is flattened to provide two layers of the three-dimensional fabric with a folded edge on each of two opposing edges. In such embodiments, a "stepped edge" may be achieved by cutting or otherwise forming a tube with a first tube length extending along a first half of the circumference of the tube and a second tube length extending along the other half of the circumference of the tube, the first and second lengths being different to provide the stepped edge when the tube is flattened to bring the first and second halves of the circumference of the tube together.

[0506] In some embodiments, in the welded area, the outer layer of spacer fabric overlaps the edge of the inner layer of spacer fabric. For example, FIG. 59A shows the stack of materials before welding. The stack shows the portion of the headgear 2160 where the inner layer of spacer fabric 2237 and the outer layer of spacer fabric 2235 overlap. The outer layer of spacer fabric 2235 overlaps the edge 2237A of the inner layer of spacer fabric 2237. In alternative embodiments, the inner layer can overlap the edge of the outer layer. In such an embodiment, both edges of the two layers may be visible at the surface of the weld seam.

[0507] 58A and 59A , the overlap layer 2235 of spacer fabric has an overlap region 2265 that overlaps the headgear portion 2160 so as to be welded to the two layers of spacer fabric. The underlap layer 2237 of spacer fabric has an overlap region 2267 that overlaps the headgear portion so as to be welded to the two layers of spacer fabric. The width 2251 of the overlap region 2265 of the overlap layer 2235 of the two layers of spacer fabric is greater than the width 2252 of the overlap region 2267 of the underlap layer 2237. Thus, as described above, the weld comprises a first region 2250A formed from the two layers 2235, 2237 of spacer fabric and the headgear portion 2160, and a second region 2250B formed from one layer 2235 of spacer fabric and the headgear portion 2160.

[0508] A weld formed from a single layer of spacer fabric may have relatively less welded (melted and solidified) material and therefore may be more flexible and less brittle than a weld formed from two layers of spacer fabric. Thus, a weld comprising two layers of spacer fabric in portion 2250A of the weld width 2250 and one layer of spacer fabric in the remaining portion 2250B of the weld width may be more flexible and / or less brittle than a weld having two layers of spacer fabric for the entire width 2250 of the weld. Thus, a weld comprising one layer 2235 of spacer fabric overlapping edge 2237A of the other layer 2237 of spacer fabric may provide a weld with improved strength compared to a weld comprising two layers of spacer fabric for the entire width of the weld. Figure 59B shows a weld after the welding process (e.g., RF welding) has been completed. The width 2250 of the weld is determined by the width 2251 of the overlap region 2265 of the outer layer 2235 of the spacer fabric that overlaps the headgear portion 2160. The width 2251 of the overlap region of the outer layer that overlaps the headgear portion can be selected to ensure that a weld with adequate peel strength is created. However, because the peel strength of the weld is determined by the width 2251 that the outer layer overlaps the headgear portion, the underlying or inner layer 2237 of the spacer fabric does not need to overlap the headgear portion to the same extent. Thus, the width 2252 ( FIG. 59A ) that the inner layer of the spacer fabric overlaps the headgear portion can be less than the width that the outer layer overlaps the headgear portion to achieve a more flexible and / or less brittle weld without a loss of peel strength. A further benefit is that the outer layer of the two layers of spacer fabric overlaps the edge of the inner layer of the two layers of spacer fabric, thereby simplifying the headgear manufacturing process since there is no need to align the edges of each of the two layers of spacer fabric.The overlapping outer layer conceals the edges of the inner layer and presents a neat edge at the welded seam between the two layers of spacer fabric and that portion of the headgear. In some embodiments, the outer layer of the two layers of spacer fabric faces away from the user's face when the headgear is in place on the user's head during use (in other words, the outer layer is the outer layer of the spacer fabric described above). This allows the weld to be visible on the outside of the headgear during use. In some embodiments, the welded material (melted and solidified material) at the seam does not completely penetrate the portion of the headgear material, so that the welded material is positioned away from the inside of the headgear that would contact the user's head or face. However, in alternative embodiments, the outer layer of the spacer fabric may contact the user's head during use.

[0509] It is preferable to keep the width 2250 of the welds in the three-dimensional fabric as narrow as possible to provide an aesthetic appearance and improve comfort for the user. However, very narrow welds may be prone to cracking during use, especially when the welds join the spacer fabric to a portion of headgear formed from another material, such as a foam material. Molten foam material is very brittle, making very narrow welds prone to cracking. For welding the three-dimensional spacer fabric to a foam material, such as polyurethane foam, preferred welds have a width greater than 3 mm, preferably between about 3 mm and 6 mm, and most preferably between 5 mm and 6 mm. The strength of the weld is also determined by the thickness of the weld, which may be defined in terms of a percentage of the thickness of the material (e.g., foam material) to which the spacer fabric is welded. The foam material in the weld area is very brittle. The thicker the weld, the more brittle and less flexible the weld area may be, and therefore the more susceptible the weld to cracking. However, as weld thickness increases, the peel strength of the weld increases. Therefore, there is an optimal weld depth to achieve a weld with a combination of sufficient peel strength and crack resistance. The optimal weld depth is believed to be 50% to 80% of the thickness of the foam material to which the 3D fabric is welded. Figure 60 illustrates the tradeoff of weld tensile strength versus peel strength. In Figure 60, the graph shows weld strength versus weld thickness as a percentage of material thickness on the x-axis, where P represents peel strength and T represents weld tensile strength (crack resistance). The optimal weld thickness is represented by the window that encompasses the intersection between the peel strength and tensile strength of the weld.

[0510] Some exemplary dimensions that provide improved welds to headgear are listed below. In some embodiments, the spacer fabric can have a thickness of about 3 mm (the two layers have a combined thickness of about 6 mm), and the portion (e.g., the perimeter portion of the rear panel) can be formed from a breathable foam and fabric laminate having a thickness of about 4 mm. The outer layer of the spacer fabric can overlap the breathable foam and fabric laminate by about 4 mm to 6 mm. The inner layer of the spacer fabric can overlap the breathable foam and fabric laminate by about 3 mm to 4.5 mm. The outer layer of the spacer fabric can overlap the inner layer of the spacer fabric by about 1 mm to about 2.5 mm. The total weld width, defined by the extent to which the outer layer overlaps the breathable foam and fabric laminate, is about 4 mm to 6 mm.

[0511] FIGS. 61-67 illustrate a headgear arrangement having a rear panel formed from a three-dimensional fabric sewn to a perimeter portion formed from a foam and fabric laminate material. The headgear arrangement reduces or prevents both bunching of the seams along the joints and bunching of the three-dimensional fabric. Preventing bunching of the seams and the three-dimensional fabric ensures that the joints have a neat aesthetic appearance and that the headgear arrangement is comfortable when worn by a user. As shown in FIGS. 61 and 62, the headgear arrangement includes a rear panel 2301 and a perimeter portion 2302. The perimeter portion includes an upper strap 2152, a top strap 2154, and a lower strap 2156. The rear panel 2301 and the perimeter portion 2302 are sewn together along a joint 2303 by back-and-forth stitching 2305. In some configurations, other variations of back-and-forth stitching may also be used.

[0512] In general, it is difficult to sew materials with different mechanical properties together. By way of non-limiting example, sewing two materials with different material structures, such as a three-dimensional fabric and a stiffer foam and fabric laminate, can present the bunching problem described above due to the different properties (i.e., flexibility, compressibility, hardness, etc.) resulting from the different material structures.

[0513] Similarly, as another non-limiting example, stitching of three-dimensional fabric to plastic-based or intramoulded headgear straps (which are stiffer than the three-dimensional fabric) can also present the above-mentioned bunching problem: in some configurations, bunching can occur when the three-dimensional fabric is joined to the plastic-based portion of the headgear due to the different properties (flexibility, compressibility, hardness, etc.) resulting from the differences in material construction.

[0514] Alternatively, stitching two materials with similar material structure but different mechanical properties, such as, by way of non-limiting example, a foam and fabric laminate with a 7 lb density and a foam and fabric laminate with a 10 lb density (which is stiffer than the 7 lb density), can also present the above-mentioned bunching problem due to the different properties (i.e., flexibility, compressibility, hardness, etc.) resulting from the difference in mechanical properties despite having similar mechanical structures.

[0515] Typically, between rigid and non-rigid materials, the more rigid material retains its shape under the tension of the stitching, while the less rigid material is more likely to deform and distort under the tension applied by the stitching. Therefore, sewing a back panel formed from a three-dimensional fabric to a perimeter portion formed from a foam and fabric laminate material can cause the seams and the three-dimensional fabric to bunch up. The bunching of the seams and the three-dimensional fabric (i.e., the back panel) can result in a cluttered appearance that is aesthetically unpleasing and unappealing to the user. Furthermore, the bunching of the seams and fabric can also result in loose joints, so that the back panel and the perimeter portion are not securely fastened together. For illustrative purposes, FIGS. 68-71 show a bunched seam 2305 along the joint 2303 between the back panel 2301 and the perimeter portion 2302.

[0516] In addition to differences in material structure and / or mechanical properties of the back panel and perimeter portion, the shape of the back panel can also affect seam and fabric bunching. More specifically, a back panel having corners that form sharp angles can result in seam bunching at the corners. For illustrative purposes, FIGS. 68 and 69 show a back panel 2301 with top corners 2304 formed at angles of less than 45 degrees and 30 degrees, respectively. As shown, the top corners 2304 narrow rapidly, thereby reducing the material available for stitching and passing through the back panel 2301 for the seam 2305. FIG. 70 is an enlarged view showing the reduced width of the seam 2305 at the end of the join 2303. As shown, the sharp top corners 2304 of the back panel 2301 reduce the material available for stitching and passing through the seam 2305. Therefore, the width of the seam 2305 also decreases, which causes the seam 2305 to bunch up. As a result, the width of the seam 2305 decreases at the end of the join 2303. That is, as the width of the top corner of the back panel 2301 narrows, the width of the seam 2305 also narrows. Therefore, the reduction in width of the seam 2305 causes the seam 2305 to bunch up at the end of the join 2303.

[0517] FIG. 71 illustrates the bunching of the three-dimensional fabric of the back panel 2301, which is caused by a combination of sharp angles at the top corners 2304 of the back panel 2301 and the high compressibility of the three-dimensional fabric back panel 2301 relative to the perimeter portion 2302 of the foam and fabric laminate. As shown, the stitch shown at 2306 is sewn over the edge 2344 of the sharp top corner 2304 of the back panel 2301, similar to FIG. 70. However, due to the high compressibility of the three-dimensional fabric back panel 2301 relative to the perimeter portion 2302 of the foam and fabric laminate, the top corners 2304 of the back panel 2301 compress and deform under the tension of the seam 2305, while the foam and fabric laminate material of the perimeter portion 2302 remains undeformed. 70, for purposes of illustration, the back panel 2301 and perimeter portion 2302 are shown as if they were formed from ideal materials or materials with similar mechanical properties. Compression causes the three-dimensional fabric at the top corners 2304 of the back panel 2301 to bunch up, which, combined with the bunched stitching, creates stiff lumps or pressure points that dig into the user's head and cause discomfort. Compression of the three-dimensional fabric also further reduces the width of the seams 2305, thereby further increasing the amount of bunching of the seams 2305.

[0518] In contrast, FIGS. 61-67 show a back panel 301 formed from a three-dimensional fabric sewn to a perimeter portion 2302 formed from a foam and fabric laminate material by seams 2305 without bunching of the seams at the juncture 2303 and bunching of the three-dimensional fabric. More specifically, the seams 2305 have a generally consistent width throughout the length of the juncture 2303, such that the seams are substantially uniformly spaced on either side of the juncture 2303 between the back panel 2301 and the perimeter portion 2302. Seams having a generally consistent width reduce bunching of the seams and bunching of the three-dimensional fabric along the juncture 2303. A generally consistent stitch width may be generally defined as having a repeatable pattern along a linear length within standard manufacturing tolerances. One skilled in the art will understand that a seam along a curve may have a smaller stitch width on the inside of the curve than on the outside of the curve.

[0519] As shown in non-limiting embodiments, FIGS. 61 and 62 illustrate a rear panel 2301 having a generally inverted isosceles trapezoidal shape with a top edge, a bottom edge, and a lateral edge connecting the top edge to the bottom edge. That is, the rear panel 2301 has four sides, each of which may be straight or curved, with one pair of opposing sides having a relatively long side and a relatively short side, and a second pair of opposing sides having approximately equal lengths. As shown in FIG. 62, the rear panel 2301 is symmetrical across a vertical centerline. In some configurations, the rear panel 2301 has a generally inverted isosceles trapezoidal shape. The trapezoidal shape is configured to follow the contours of a user's upper neck and lower scalp area. That is, the top edge is positioned slightly below the user's occipital lobe, and the bottom edge is positioned above the user's neck. Thus, the top edge of the rear panel 2301 is wider than the bottom edge, and the lateral edges extend laterally outward (relative to the vertical centerline) from the bottom edge to the top edge to correspond to an increasing width relative to the user's neck up to the user's occipital bone. The top edge of the rear panel may be curved to accommodate the shape of the user's occipital lobe.

[0520] Those skilled in the art will appreciate that the back panel 301 is not limited to having four sides and a generally inverted isosceles trapezoidal shape. In some configurations, the geometric shape of the back panel 2301 can include other quadrilateral or polygonal shapes. Additionally, the length, shape, and curvature of the top, bottom, and side edges of the back panel 2301 can be varied according to the size, shape, and geometry of the user's head.

[0521] FIG. 63 shows the back panel 2301 in an unfolded and unsewn state. The back panel 2301 comprises a single layer of three-dimensional fabric 2330 that is folded along a fold region 2332. When folded, the fold region 2332 provides a fold edge 2336 that provides the back panel 2301 with a natural and soft edge that is comfortable against the user's neck. Similar to the back panel 2201 in FIG. 47B , the three-dimensional fabric 2330 has a front side 2340 and a back side 2342. The free ends 2334 of the three-dimensional fabric 2330 are joined together to form a hollow tubular shape when the three-dimensional fabric 2330 is inside-out (i.e., the back side 2342 of the fabric faces outward). The free ends 2334 are sewn together to form a seam allowance 2338 on the side opposite the fold region 2332. The seam allowance extends radially outward from the center of the tubular shaped three dimensional fabric 2330 when the three dimensional fabric 2330 is inside out.

[0522] During assembly, the three-dimensional fabric 2330 is then turned inside out so that the front side 2340 faces outward and the back side 2342 faces inward, as shown in FIG. 64. Thus, the seam margin 2338 extends radially inward toward the center of the tubular shaped three-dimensional fabric 2330. That is, the seam margin 2338 is disposed within the hollow interior cavity of the back panel 2301.

[0523] The free ends 2334 of the three-dimensional textile 2330 can be sewn together by a seam (not shown) to form a tube. In some configurations, the seam can be formed by stitching a straight stitch, a zigzag stitch, or an overlock stitch. The seam forms a sewn edge 2344 of the back panel 2301 when the three-dimensional textile 2330 is inverted so that the right side is facing out. Similarly, the fold region 2332, similar to the fold region 2310 in FIG. 58B , forms a folded edge 2336 when the three-dimensional textile 2330 is inverted so that the right side is facing out. Thus, the sewn edge 2344 forms the top edge of the back panel 2301, and the folded edge 2336 forms the bottom edge of the back panel 2301. In other configurations, the seam can be formed by bonding, adhesive, welding, etc. instead of stitching.

[0524] As shown in FIGS. 63-65, the back panel 2301 has a lateral edge 2350 extending between the folded edge 2336 and the sewn edge 2344. The lateral edge 2350 has a curved profile with a convex region 2352 and a concave region 2354. The convex region 2352 (i.e., curved outward relative to the centerline of the back panel 2301) is connected to and / or extends toward the sewn edge 2344. The concave region 2354 (i.e., curved inward relative to the centerline of the back panel 2301) is connected to and / or extends toward the folded edge 2336. The convex region 2352 transitions into the concave region 2354 at an inflection point 2356. The inflection point 2356 is located below the seam allowance.

[0525] The lateral edges 2350 in the convex region 2352 have a curved shape such that they substantially intersect the sewn edge 2344 at a perpendicular angle. The sewn edge 2344 curves upward toward the upper edge 2360 of the perimeter portion 2302 and extends away from the center of the back panel 2301. Thus, to form a perpendicular angle with the sewn edge 2344, the lateral edges 2350 transition from extending away from the center of the back panel 2301 (as indicated by the centerline shown in FIG. 64 ) in the concave region 2354 to extending toward the center of the back panel 2301 in the convex region 2352. That is, the lateral edges 2350 in the convex region 2352 extend toward the center of the back panel 2301 to form a perpendicular angle with the upwardly and outwardly extending sewn edge 2344.

[0526] As shown in FIG. 65, the intersection of the lateral edge 2350 and the sewn edge 2344 forms a substantially 90-degree angle. In contrast to the sharp acute angle of the top corner 2304 in FIGS. 68-71, the intersection of the sewn edge 2344 and the lateral edge 2350 provides more material and space on either side of the joint 2303 for the seam 2305 to pass through the three-dimensional fabric. As shown in FIG. 62, the width of the seam 2305 remains generally consistent, and the seam 2305 spans the joint 2303 throughout its entire length. FIG. 67 is a close-up view of the seam 2305 at the top corner 2304. As shown, the seam 2305 has a stitch width Ws that is generally evenly spaced across the joint 2303, such that approximately half the stitch width Ws / 2 is on each side of the joint 2303 and enters each of the back panel 2301 and the perimeter portion 2302.

[0527] As a result, the substantially 90-degree angle between the raised region 2352 of the lateral edge 2350 and the stitched edge 2344 allows the seam 2305 to be finished substantially uniformly between both the back panel 2301 and the perimeter 2302. The width of the seam 2305 does not reduce at the end of the join 2303, resulting in no bunching of the seam 2305 at the end of the join 2303. Thus, compression and deformation of the back panel 2301 at the upper corners 2304 is prevented or reduced. Similarly, reduction in the width of the seam 2305 at the end of the join 2303 is also prevented or reduced.

[0528] The substantially 90 degree angle between the side edges 2350 and the stitched edge 2344 causes the upper portion of the back panel 2301 to be wider between the side edges 2350 in the convex region 2352 compared to the back panel 2301 of FIG. 68 which has straight side edges. The increased width of the convex region 2352 allows the concave region 2354 to allow the side edges 2350 to accommodate the width of the convex region 2352, while the narrowing width towards the fold edge 2336 allows the back panel 2301 to accommodate the narrower width of the user's neck.

[0529] As shown in FIG. 66 , the perimeter portion 2302 can have corresponding cutout areas 2358 defined by receiving edges 2362 having an inward or concave shape corresponding to the convex areas 2352 of the lateral edges 2350. That is, the receiving edges 2362 have shapes that match the convex areas 2352 and the concave areas 2354 of the lateral edges 2350 of the rear panel 2301. Thus, the cutout areas 2358 receive the upper corners 2304 of the rear panel to provide a neat aesthetic appearance.

[0530] 64 and 65, the top edge 2360 of the perimeter portion 2302 forms a substantially continuous curve with the stitched edge 2344 of the back panel 2301. Thus, as a result of the cutout area 2358 of the perimeter portion 2301 having a corresponding shape as the top corner 2304 of the back panel 2301, the receiving edge 2362 of the perimeter portion 2302 also forms a substantially perpendicular angle with the top edge 2360, as shown in FIG. 66. As with the back panel 2301, the substantially 90 degree angle (as opposed to a sharp acute angle) between the top edge 2360 and the receiving edge 2362 of the perimeter portion 2302 provides material and space in the perimeter portion 2302 for the seam 2305 to be fully formed into the fabric and to achieve a substantially uniform finish between both the back panel 2301 and the perimeter portion 2302. In other configurations, the top edge 2360 of the perimeter portion 2302 and the receiving edge 2362 can form an angle less than 90 degrees because the perimeter portion 2302 is formed from a foam and fabric laminate material (e.g., neoprene or Breath-O-Prene) that is stiffer than the back panel 2301 (i.e., the three-dimensional fabric), and the perimeter portion 2302 is less compressed by the stitching 2305 than the back panel 2301.

[0531] As shown in FIG. 64 , the lateral edge 2350 of the back panel 2301 extends at a distance from the sewn edge 2344 of the back panel 2301 in a direction perpendicular to the sewn edge 2344 such that the inflection point 2356 is located below the seam allowance 2338. In some configurations, the convex region 2352 of the lateral edge 2350 has a radius of curvature greater than the stitch width Ws to further prevent bunching of the stitches along the convex region 2352. In other configurations, the convex region 2352 can have a radius greater than the length of the seam allowance 2338 (i.e., the distance between the sewn edge 2344 and the free end 2334). Furthermore, the widest distance between the lateral edges 2346 of the seam allowance 2338 is less than the widest distance between the lateral edges 2350 of the back panel 2301 within the convex region 2352. As a result, the lateral edge 2346 of the seam allowance 2338 does not extend beyond the lateral edge 2350 of the back panel 2301, such that the convex region 2352 completely covers the seam allowance 2338, and the seam allowance 2338 is completely contained and sealed within the confines of the back panel 2301. That is, the lateral edge 2346 of the seam allowance 2338 is disposed laterally inward of the lateral edge 2350 of the back panel 2301. Therefore, when the back panel 2301 and the periphery portion 2302 are sewn together by the seam 2305, the seam allowance 2338 does not extend above the joint 2303 such that the seam 2305 is sewn over the seam allowance 2338. As shown in FIGS. 68 and 69 of the back panel 2301, stitching over the seam allowance 2338 creates a hard lump or pressure point at the top corner 2304 of the back panel 2301 that can dig into a user's head and cause discomfort. In some configurations, the lateral edge 2346 of the seam allowance 2338 is positioned laterally inward of the seam 2305, such that no portion of the seam allowance 2338 is stitched. Thus, the seam 2305 has a more uniform thickness, flexibility, stiffness, etc. throughout its length. Furthermore, because the edge 2346 of the seam allowance 2338 is contained within the cavity of the back panel 2301 and does not overhang above the join 2303, exposure of the raw edge 2346 of the seam allowance 2338 (which could result in a messy appearance and potential fraying of the fabric edges) is prevented or reduced.

[0532] Those skilled in the art will understand that the angle between the sewn edge 2344 and the transverse edge 2350 is not limited to 90 degrees, but can include angles less than or greater than 90 degrees, so long as enough material is provided for the seam to achieve a substantially uniform finish between the back panel and the perimeter portion so that bunching of the seam and / or material does not occur. The minimum or maximum angle between the sewn edge 2344 and the transverse edge 2350 can depend on the width, length and type of seam, the type of material being joined, the shape of the back panel and the perimeter portion, etc.

[0533] Figure 72 shows an alternative configuration of a back panel 2401 (shown by longer dashed lines) having a convex region 2452 of the lateral edge 2450 that extends outward a greater distance from the end of the sewn edge 2444 of the back panel 2401 than the back panel 2301 (shown by solid lines) of Figure 62. Relative to the back panel of Figure 62, the convex region 2452 has a larger radius of curvature and a lower inflection point 2456. The alternative configuration of the back panel 2401 provides additional distance from the seam allowance 2438 (shown by shorter dashed lines) between the lateral edges 2450 of the back panel 2401 such that the seams (not shown) overlap the seam allowance 2438 little or not at all.

[0534] 73 and 74 show alternative back panel and perimeter configurations that offer different aesthetics while maintaining a neat join finish. In the alternative configuration, the lateral edges of the back panel 2501 are straight toward the folded edge 2536 and convex toward the sewn edge 2544. The straight regions 2554 transition into the convex regions 2552 at a tangent point 2556. The tangent point 2556 is below the seam allowance 2538. The straight regions 2554 converge toward the folded edge 2536.

[0535] In contrast to the back panel and perimeter portion arrangements of FIGS. 63-67, the back panel 2501 has a stitched edge 2544 that does not form a continuous curve with the top edge 2560 of the perimeter portion 2502. That is, the intersection of the stitched edge 2544 and the top edge 2560 forms a corner. Thus, the top corner 2504 of the back panel and the top corner 2564 of the perimeter portion also form corners. The top corner 2504 of the back panel has an angle θ close to 90 degrees, which prevents compression of the top corner 2504 by the seams and bunching of the stitches. The top corner 2564 of the perimeter portion has an angle β greater than 90 degrees. In some configurations, the angle θ can be between 70 degrees and 120 degrees. Preferably, the angle β is greater than 70 degrees. The angle β can be less than 90 degrees because the materials of the perimeter portion 2502 (ie, foam and fabric laminate) are less likely to compress and distort under the tension and pressure of the seams.

[0536] As shown in FIG. 74 , the back panel 2501 has a trapezoidal shape that is symmetrical across a vertical centerline. Folded edges 2536 and stitched edges 2544 define the top and bottom edges of the back panel 2501. The folded edges 2536 and stitched edges 2544 define a first width W1 and a second width W2, respectively. As shown, the first width W1 is less than the second width W2. That is, the back panel 2501 has a top edge that is wider than the bottom edge.

[0537] The distance between the lateral edges 2550 of the raised regions 2552 defines a third width W3, which is the widest point of the back panel 2501. The corners of the free ends 2534 of the seam allowance 2538 define a fourth width W4. The fourth width W4 is less than the third width W3, such that the seam allowance 2538 does not extend beyond the lateral edges 2550 of the back panel 2501. Furthermore, the raised regions 2552 of the lateral edges 2550 extend outwardly and spaced apart from the ends of the seam edges 2544 of the back panel 2501 such that the contact points 2556 are below the seam allowance 2538 and the raised regions 2552 completely cover the seam allowance 2538 when the front side of the back panel 2501 is on the outside. Thus, when the back panel 2501 and perimeter portion 2502 are sewn together (seams not shown), the seam allowance 2538 does not extend over the sewn joint 2503. Thus, the sewn joint 2503 has a substantially uniform hardness, flexibility, etc. along the entire length of the joint 2503.

[0538] Those skilled in the art should understand that the above-described techniques for avoiding seam and / or fabric bunching are not limited to joining three-dimensional fabrics and foam / fabric laminates. The above-described techniques can be utilized to join any material or combination of materials having different material structures and / or material properties. Similarly, the above-described techniques can be used to join components formed from the same material where the material has low stiffness, density, hardness, etc. and is prone to bunching.

[0539] VI. Additional Terms Unless the context clearly requires otherwise, throughout the specification and claims, terms such as "comprise," "comprising," and the like should be interpreted in an inclusive sense, i.e., "including, but not limited to," as opposed to an exclusive or exhaustive sense. In particular, conditional language such as "can," "could," "might," or "may," unless specifically stated otherwise or understood otherwise within the context of use, is intended to generally mean that some embodiments include certain features, elements, and / or steps, while other embodiments do not. Thus, such conditional language is generally not intended to mean that features, elements, and / or steps are in any way required for one or more embodiments, or that one or more embodiments necessarily include logic for determining whether or not those features, elements, and / or steps are to be included in or performed in any particular embodiment, with or without user input or direction.

[0540] 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 the field of endeavor in any country throughout the world.

[0541] The invention can be broadly described as consisting of the parts, elements, and features (in any or all combinations of said parts, elements, or features) individually or collectively referred to or shown in the specification of this application. The various features described above can be used independently of one another or can be combined in various ways. All possible combinations and subcombinations are intended to be within the scope of the present disclosure. Furthermore, in some implementations, some features may be omitted. Any methods and processes described herein are not limited to any particular order, and acts or steps associated therewith may be performed in other orders as appropriate. For example, described acts or steps may be performed in orders other than those specifically disclosed, or multiple acts or steps may be combined into a single act or step. Example acts or steps may be performed sequentially, simultaneously, or in some other manner. Features may be added to or removed from the example embodiments disclosed. The example systems and components described herein may be configured differently from those described. For example, elements may be added to, removed from, or rearranged relative to the example embodiments disclosed. Moreover, the invention illustratively disclosed herein may suitably be practiced in the absence of any element not specifically disclosed herein.

[0542] Where the above description refers to whole entities or components that have known equivalents, those whole entities are incorporated herein as if individually set forth.

[0543] It should be emphasized that many variations and modifications can be made to the above-described embodiments, and that these elements should be understood as including other acceptable examples. All such variations and modifications are intended to be included herein within the scope of the present disclosure. The foregoing description details several embodiments of the present invention. However, it will be apparent that no matter how detailed the above appears in text, the invention can be practiced in many ways. Also, as noted above, the use of a particular term when describing several features or aspects of the present invention should not be construed as meaning that the term has been redefined herein to be limited to including any specific characteristics of the feature or aspect of the invention to which the term relates. Accordingly, the scope of the present invention should be construed according to the appended claims and any equivalents thereof.

Claims

1. 1. Headgear for use with a respiratory mask, comprising: a back panel having a top edge, a bottom edge, and a lateral edge connecting the top edge to the bottom edge; the back panel is formed from two layers of three-dimensional fabric folded from a sheet of three-dimensional fabric to have folded edges; the folded edge forms the bottom edge of the back panel; a sewn or folded edge forms the top edge of the back panel; the headgear comprises strap portions comprising a left strap portion and a right strap portion, the left strap portion and the right strap portion each attached along an entire lateral edge of each of the rear panels; the left strap portion comprises a left lower strap, a left upper strap connected to the left lower strap, and a left top strap extending from the left upper strap; the right strap portion includes a lower right strap, an upper right strap connected to the lower right strap, and a top right strap extending from the upper right strap; the left lower strap, the right lower strap, the left upper strap, and the right upper strap are configured to be connected to the respiratory mask, and the left top strap and the right top strap are configured to be connected to each other in use; The headgear wherein the rear panel is configured to have a higher level of stretch in the horizontal direction than in the vertical direction.

2. The headgear of claim 1 , wherein the strap portions are formed from a foam or fabric material.

3. The headgear of claim 2 , wherein the strap portions are attached to each lateral edge of the rear panel by gluing, sewing, or welding.

4. The headgear of any one of claims 1 to 3, wherein the top edge is straight or curved.

5. The headgear of any one of claims 1 to 4, wherein the bottom edge is straight or curved.

6. Headgear according to any one of claims 1 to 5, wherein the rear panel is symmetrical across a vertical centre line.

7. 7. The headgear of claim 1, wherein the rear panel is formed from a first material having a first set of mechanical properties and the strap portions are formed from a second material having a second set of mechanical properties, the second material and the second set of mechanical properties being stiffer than the first material and the first set of mechanical properties.

8. The headgear according to any one of claims 1 to 7, wherein the three-dimensional fabric is a three-dimensional spacer fabric.

9. Headgear according to any one of claims 1 to 8, wherein the upper edges of the strap portions form a substantially continuous curve with the stitched top edge of the rear panel.

10. Headgear according to any one of claims 1 to 9, wherein the lateral edges have a curved profile with convex and concave regions.

11. 11. The headgear of claim 10, wherein the convex region is connected to and / or extends toward the sewn top edge and the concave region is connected to and / or extends toward the folded bottom edge.

12. 12. The headgear of claim 11, wherein the lateral edges in the convex region have a curved shape, the lateral edges intersecting the stitched top edge substantially at a perpendicular angle.

Images