Respiratory mask and related portions, components or sub-assemblies

Abstract

To provide a respiratory mask for providing positive pressure therapy and a bias-flow venting system configured to reduce discernable draft generated by exhausted air.SOLUTION: A respiratory mask has a ball jointed elbow, one or more detachable forehead pieces and a headgear with a spacer fabric region. The elbow is configured to be removable when oriented to a predetermined position. The forehead pieces are provided in one or more sizes. The spacer fabric region has two or more layers, the raw edges being turned to the inside of the layers. A seal has improved seal performance and accommodates a wider variety of facial geometries. A bias-flow system has a tube and exhaust holes radially aligned on a bead of the tube. The bias-flow system also has an annular component exhaust holes and a shroud having a plenum chamber around the exhaust holes.SELECTED DRAWING: Figure 1A

Description

[Technical field]

[0001] INCORPORATION BY REFERENCE OF PRIORITY APPLICATION This application is related to and claims priority to U.S. Provisional Patent Application No. 62 / 041,236, filed August 25, 2014, No. 62 / 096,481, filed December 23, 2014, No. 62 / 041,234, filed August 25, 2014, and No. 62 / 041,262, filed August 25, 2014, the contents of which are incorporated by reference herein and made a part of this disclosure.

[0002] The present disclosure generally relates to a respiratory mask that covers at least one of a user's nose and mouth to deliver breathing gas under positive pressure. More specifically, certain aspects of the present disclosure relate to a respiratory mask that includes one or more detachable ball-and-socket elbow joints, one or more detachable forehead pieces, and spacer fabric headgear. The present disclosure also relates to sealing cushion arrangements. [Background technology]

[0003] Respiratory masks may be used to deliver respiratory gas under positive pressure to a user. In configurations including a ball joint, it may be possible for debris to accumulate between the ball joint and the socket. Removal of this debris may be difficult when the ball joint and the socket are connected. Cleaning agents may also accumulate at the connection between the ball joint and the socket as a result of inaccessible surfaces for manual cleaning. The accumulation of debris and / or cleaning agents may affect the hygiene of the mask and thus limit its service life. The ball joint is usually permanently connected to its corresponding socket or at least very difficult to remove and / or insert. In some cases, removal of the ball joint may require significant force, which may permanently damage the mask.

[0004] Respiratory masks are typically available in a variety of fixed sizes to accommodate users with different facial geometries. This generally involves manufacturing the entire mask, or at least the main mask components, in a variety of sizes, which therefore increases the equipment installation and manufacturing costs associated with the mask. Another problem with fixed mask sizes is that a single fixed size mask may not be appropriate for a particular user's facial geometry. A user's facial shape may be such that the user requires each of the mask components to be differently sized to achieve the best possible fit, which is not possible with a fixed size mask.

[0005] Headgear for respiratory masks has traditionally been heavy, bulky and hot to wear, which can cause discomfort to the user.

[0006] The respirator may have a removable cushion module that may be available in multiple sizes. In some cases, the different sizes are only scaled relative to one another in one or more dimensions. Other dimensions may remain the same across the different sizes.

[0007] Furthermore, a wide variety of respiratory masks have been devised. Many of these masks are configured to provide a sealed communication with the user's airway by sealing around the user's nose and / or mouth area. 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 treatment is commonly used to treat obstructive sleep apnea (OSA) and involves a constant supply of pressurized air to the user's airway. This splints the airway open, thus minimizing airway collapse and reducing apnea. As part of this treatment, a biased airflow system is required to flush exhaled carbon dioxide (CO2) from within the mask to prevent it from being rebreathed.

[0008] A typical bias air system includes an array of holes that may be located on various respiratory mask components such as the elbow joint and the mask frame. These holes are often positioned together and aligned in such a way that a concentrated air flow is exhausted from the holes. The ventilation system may cause noticeable drafts and noise. Drafts and noise can be unpleasant for both the user and / or their bed partner and may lead to reduced compliance with treatment. A number of approaches have been attempted to alleviate these complaints. Summary of the Invention [Problem to be solved by the invention]

[0009] The systems, methods and devices described herein have innovative aspects, no one of which is essential or solely responsible for its desirable attributes. Without limiting the scope of the claims, some of the more advantageous features will now be summarized.

[0010] It is an object of the present disclosure to provide one or more structures or methods that go at least somewhat toward improving upon the above, or at least provide the public with a useful option. [Means for solving the problem]

[0011] According to at least one of the embodiments disclosed herein, a cushion module for a respiratory interface is provided, the cushion module including a seal housing made of a relatively rigid material, the seal housing defining an aperture configured to allow respiratory gas to enter an interior of the cushion module, and a seal supported by the seal housing and having an upper portion and a lower portion. The seal further includes a face contacting surface configured to contact and create at least a substantial seal with the user's face, the face contacting surface having an inner edge defining an opening in the face contacting surface. The upper portion of the seal includes a reduced stiffness portion defined between a first boundary and a second boundary, such that the reduced stiffness portion deforms in response to forward movement of the upper portion of the face contacting surface, the angle defined between the first boundary and the second boundary being at least about 20 degrees.

[0012] According to a further embodiment, the angle between the first boundary and the second boundary is at least about 25 degrees.

[0013] According to a further embodiment, the angle between the first boundary and the second boundary is between about 27 degrees and about 34 degrees.

[0014] According to a further embodiment, the angle between the first boundary and the second boundary is one of about 27 degrees, about 29 degrees, and about 34 degrees.

[0015] According to a further aspect, the distance between a point on the upper centerline and a point on the lower centerline of the face-contacting surface of the seal varies by more than 2 mm between the neutral position and the depressed position of the stiffness reduced region.

[0016] According to further embodiments, the distance between a point on the centerline of the upper portion and a point on the centerline of the lower portion of the face-contacting surface of the seal varies by at least about 5 mm, at least about 6 mm, at least about 8 mm, or at least about 10 mm, or at least about 12 mm between the neutral position and the depressed position of the stiffness-reduced region.

[0017] According to a further aspect, the portion of the seal defining the face-contacting surface includes a pair of nose pads positioned on either side of an opening in a top portion of the seal, each of the nose pads being entirely spaced outwardly from the opening.

[0018] According to a further aspect, the nose pads are the thickest portion of the portion defining the face contacting surface of the seal.

[0019] According to a further aspect, the cushion module includes a pair of thickened perimeter portions defined by a portion defining a face-contacting surface of the seal, at least a portion of the thickened perimeter portions being positioned below the nose pads.

[0020] According to a further aspect, at least a portion of the thickened perimeter portion is positioned above the nose pads.

[0021] According to a further aspect, a continuous portion of the inner edge of the opening defines a thickness of 0.6 mm or less, the continuous portion of the inner edge extending inwardly at least 1 mm from the inner edge and extending along at least the entire top of the seal.

[0022] According to a further aspect, a section of the contiguous portion of the inner edge located within 0.5 mm of the inner edge is no more than 0.4 mm thick.

[0023] According to a further aspect, the top of the seal defines a nasal bridge portion for contacting the bridge of the user's nose, and the nasal bridge portion of the opening defines a continuously curved portion of the inner edge.

[0024] According to a further embodiment, the width of the nasal bridge portion is about 11 mm or less.

[0025] According to a further embodiment, the vertical dimension of the vertical center of the nasal bridge portion is greater than or equal to about 15 mm.

[0026] According to a further embodiment, the depth between the posterior-most point of the nasal bridge portion and the lower edge of the nasal bridge portion on the vertical center of the seal is at least about 4 mm.

[0027] According to a further embodiment, the reduced stiffness portion includes a front wall having a height of at least about 7 mm.

[0028] According to a further embodiment, the height of the front wall is from about 7.3 mm to about 7.7 mm.

[0029] According to a further aspect, the thickness of the anterior and posterior walls increases gradually from the lower end of the anterior wall to the posterior end of the posterior wall.

[0030] According to a further aspect, the distance between a point on the upper centerline and a point on the lower centerline of the face-contacting surface of the seal varies by more than 2 mm between the neutral position and the depressed position of the stiffness reduced region.

[0031] According to further embodiments, the distance between a point on the centerline of the upper portion and a point on the centerline of the lower portion of the face-contacting surface of the seal varies by at least about 5 mm, at least about 6 mm, at least about 8 mm, or at least about 10 mm, or at least about 12 mm between the neutral position and the depressed position of the stiffness-reduced region.

[0032] According to a further aspect, the distance varies from about 90 mm to about 84 mm between the neutral and depressed positions of the stiffened region.

[0033] According to a further embodiment, the distance varies by at least about 5 percent between the neutral position and the depressed position of the stiffened region.

[0034] According to a further embodiment, the distance varies by at least about six and two-thirds percent between the neutral position and the depressed position of the stiffened region.

[0035] According to a further aspect, the angle differs between the sizes of at least two differently sized cushion modules.

[0036] According to a further aspect, the cushioning module includes small, medium, and large sizes, with the angle of the small size being greater than the angle of one or both of the medium and large sizes.

[0037] According to a further aspect, the large size angle is smaller than one or both of the small and medium size angles.

[0038] According to a further embodiment, the small size angle is about 34 degrees, the medium size angle is about 29 degrees, and the large size angle is about 27 degrees.

[0039] According to at least one embodiment disclosed herein, a respiratory mask is provided, the respiratory mask including a frame portion configured to support a seal, the seal configured to form a substantially airtight seal with a face of a user, and a conduit connector including a ball joint end. The frame portion defines an opening configured to receive the ball joint end of the conduit connector, the frame portion including a conduit connector removal notch configured to provide a leverage point for removal of the conduit connector. To facilitate removal of the conduit connector from the frame portion, the conduit connector includes a portion configured to be received in the conduit connector removal notch.

[0040] According to a further aspect, the ball joint includes an end face, the end face including a tapered chamfer that defines an angle relative to a remainder of the end face.

[0041] According to a further aspect, the ball joint includes a rear edge, the rear edge being angled along a truncation axis, the rear edge being angled toward a bottom of the elbow joint. The ball joint is a truncated ball along the truncation axis. In this aspect, the rear edge is angled such that a length of the top edge of the ball or ball joint is greater than a length of the bottom edge of the ball or ball joint.

[0042] According to a further aspect, the opening is defined by an insert in the frame portion.

[0043] According to a further aspect, the conduit connector is an elbow joint.

[0044] According to a further aspect, the frame portion includes a cushion module supporting the seal and a headgear connector portion configured to be connected to headgear.

[0045] According to a further aspect, the frame portion further includes a male forehead piece connector configured to connect to a separate forehead piece to enable connection to headgear.

[0046] According to a further aspect, the forehead pieces are provided in a number of different sizes.

[0047] According to a further aspect, the conduit connector is releasable from the opening when oriented in a predetermined position.

[0048] According to a further aspect, the headgear includes a spacer fabric pad in combination with the headgear and positioned rearwardly of the headgear.

[0049] According to a further embodiment, the spacer fabric region comprises two or more layers.

[0050] According to a further embodiment, two or more layers are sewn together at the edges with the fabric wrong side out, and then turned inside out with the raw edges on the inside and right side out.

[0051] According to at least one of the embodiments disclosed herein, a cushion module for a respiratory interface is provided, the cushion module including a seal housing made of a relatively rigid material and defining an aperture configured to allow respiratory gas to enter an interior of the cushion module, and a seal supported by the seal housing and having a first rolling portion, a second rolling portion, and a lower portion. The seal further includes a face contacting surface configured to contact and create at least a substantial seal with the user's face, the face contacting surface having an inner edge defining an opening in the face contacting surface. The first rolling portion of the seal rotates about a first axis in response to forward movement of an upper portion of the face contacting surface, and the second rolling portion of the seal rotates about a second axis in response to forward movement of an upper portion of the face contacting surface.

[0052] According to a further aspect, when the first and second rolling portions are undeformed, the undeformed length is defined as the length of the seal between the nose contact point and the chin contact point. When the first rolling portion is fully deformed and the second rolling portion is undeformed in response to forward movement of the top of the face contacting surface, the partially deformed length is defined as the length of the seal between the nose contact point and the chin contact point. When the first and second rolling portions are fully deformed in response to forward movement of the top of the face contacting surface, the deformed length is defined as the length of the seal between the nose contact point and the chin contact point. The deformed length is less than both the undeformed length and the partially deformed length.

[0053] According to a further aspect, the difference between the undeformed length and the deformed length is greater than the difference between the undeformed length and the partially deformed length.

[0054] According to a further embodiment, the difference between the undeformed length and the deformed length is approximately 17 mm.

[0055] According to a further aspect, the first and second rolling portions rotate simultaneously in response to forward movement of the upper portion of the face contacting surface.

[0056] According to a further aspect, the seal further includes a first thickened region between the top of the face contacting surface and the first rolling portion and a second thickened region between the first and second rolling portions of the seal, the first and second thickened regions preventing the first and second rolling portions from collapsing in response to forward movement of the top of the face contacting surface.

[0057] In accordance with at least one embodiment disclosed herein, a biased air system for a respiratory mask is provided, the biased air system including a tube providing a flow path for a supply of pressurized air to the respiratory mask, and an annular array of exhaust holes formed in the tube, wherein air exhausted from the respiratory mask exits the tube through the exhaust holes.

[0058] According to a further aspect, the tube further includes a wall and a helical bead positioned on an exterior surface of the wall.

[0059] According to a further aspect, the drain holes extend radially through the tube.

[0060] According to a further aspect, the drainage holes are formed by laser drilling.

[0061] According to a further aspect, the drain holes extend radially through the helical bead.

[0062] According to a further aspect, the drain holes are positioned around the entire circumference of the tube.

[0063] According to a further aspect, the tube is made of a flexible material and is configured to deform along a central axis of the tube.

[0064] According to a further aspect, the drain holes are spaced at regular intervals along the length of the tube.

[0065] According to a further aspect, the spacing between the drain holes increases or decreases along the length of the tube.

[0066] According to a further aspect, the pitch of the helical bead varies along the length of the tube.

[0067] According to a further aspect, the drain holes are disposed at a non-orthogonal angle relative to the central axis of the tube.

[0068] In accordance with at least one of the embodiments disclosed herein, a biased air system for a respiratory mask is provided, the biased air system including an annular component connected to the respiratory mask and providing a flow path for a supply of pressurized air to the respiratory mask, the annular component including an array of exhaust holes extending radially through the annular component, the exhaust holes providing an exit for air exhausted from the respiratory mask to exit the annular component, and a shroud positioned around the annular component and defining a plenum chamber around the exhaust holes.

[0069] According to a further aspect, the drainage holes are formed by laser drilling.

[0070] According to a further aspect, the drain holes are spaced around the entire circumference of the annular component.

[0071] According to a further aspect, the shroud further includes a conical surface facing the annular component, the conical surface defining a portion of the plenum chamber.

[0072] According to a further aspect, the annular component further includes a socket insert portion configured to surround and retain the ball joint within the socket insert.

[0073] According to a further aspect, the socket insert portion further includes an outer periphery, an inner periphery, forward and aft insert faces, and a drain hole. The inner periphery is defined by a forward bearing surface and an aft bearing surface, the aft bearing surface being defined by a series of interrupted surfaces.

[0074] According to a further aspect, the intermittent surfaces are spaced apart by recesses.

[0075] According to a further aspect, the forward bearing surface further includes a substantially spherical and annular surface that contacts the ball joint and provides a substantially air-tight seal with the ball joint.

[0076] According to a further aspect, the recess has a substantially rectangular profile defined by an outer recess wall, a front recess wall, and two side walls.

[0077] According to a further aspect, the drain holes are configured to extend radially through the outer recess wall and the outer periphery.

[0078] According to a further aspect, the insert socket has a substantially C-shaped profile, the socket having an outer periphery and an inner periphery separated by a front wall to define an annular channel between the outer periphery and the inner periphery, the inner periphery having a forward bearing surface that contacts the ball joint and provides a substantially airtight seal with the ball joint, and the outer periphery is connected to the respiratory mask.

[0079] According to a further aspect, the periphery has snap-fit ​​projections that mate with snap-fit ​​connectors on the respiratory mask.

[0080] According to a further aspect, an elbow joint connector positioned between an annular component and a respiratory mask, the annular component further including a flange extending radially outward from an outer wall of the annular component, the shroud and the flange defining a plenum chamber.

[0081] According to at least one of the embodiments disclosed herein, there is provided a respiratory mask assembly including a mask frame, a seal housing configured to form a substantially airtight seal with a face of a user, an elbow connector having a first end connected to an air source and a second end having a ball joint disposed therein, and a socket insert portion positioned between the mask frame and the seal housing and configured to retain the ball joint within the socket insert, the socket insert portion having an array of exhaust holes extending through the socket insert, the exhaust holes providing an exit for air exhausted from the seal housing to exit the socket insert.

[0082] According to a further aspect, the socket insert portion further includes an outer periphery, an inner periphery, forward and aft insert faces, and a drain hole. The inner periphery is defined by a forward bearing surface and an aft bearing surface, the aft bearing surface being defined by a series of interrupted surfaces.

[0083] According to a further aspect, the intermittent surfaces are spaced apart by recesses.

[0084] According to a further aspect, the forward bearing surface further includes a substantially spherical and annular surface that contacts the ball joint and provides a substantially air-tight seal therewith.

[0085] According to a further aspect, the recess has a substantially rectangular profile defined by an outer recess wall, a front recess wall, and two side walls.

[0086] According to a further aspect, the drain holes are configured to extend radially through the outer recess wall and the outer periphery.

[0087] According to a further aspect, the insert socket has a substantially C-shaped profile, the insert socket has an outer periphery and an inner periphery separated by a front wall defining an annular channel between the outer periphery and the inner periphery, the inner periphery having a forward bearing surface that contacts the ball joint and provides a substantially airtight seal with the ball joint, and the outer periphery is connected to the seal housing.

[0088] According to a further aspect, the outer periphery of the insert socket has snap-fit ​​projections that mate with snap-fit ​​connectors on the seal housing.

[0089] According to a further aspect, the mask frame further includes a shroud positioned about the socket insert portion and defining a plenum chamber about the exhaust hole.

[0090] According to at least one of the embodiments disclosed herein, a respiratory mask assembly is provided, the respiratory mask assembly including: a seal housing configured to form a substantially airtight seal with a face of a user, the seal housing having an outer wall with an array of exhaust holes therethrough, the exhaust holes providing an exit for exhausted air to exit the seal housing; an elbow joint connector having a first end connected to an air source and a second end having a ball joint disposed therein; a socket insert portion positioned between the mask frame and the seal housing and configured to retain the ball joint within the socket insert; and a shroud extending from the outer wall and angled towards the elbow joint connector, the shroud and the outer wall defining a plenum chamber around the exhaust holes.

[0091] According to at least one of the embodiments disclosed herein, a respiratory mask is provided that includes a mask body defining a breathing chamber, an opening to the breathing chamber, and a tolerable airflow port including a plurality of vents configured to allow gas to exit the breathing chamber through the plurality of vent holes, the mask body configured for connection to a gas supply conduit such that a supply of respiratory gas may be provided to the breathing chamber through the opening, a seal supported by the mask body and configured to create at least a substantial seal with a user's face, the seal configured to surround at least one of the user's nose and mouth, and a shroud supported against the mask body and spaced from a portion of the mask body including the tolerable airflow port to define a plenum chamber to receive gas exiting the breathing chamber through the plurality of vent holes.

[0092] The foregoing and other features of the present disclosure will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings, in which: The present disclosure will be described with additional specificity and detail through the use of the accompanying drawings, with the understanding that these drawings illustrate only some embodiments according to the present disclosure and are not to be considered as limiting its scope. [Brief description of the drawings]

[0093] [Figure 1A] FIG. 1 is a perspective view of a respiratory mask of the present disclosure. [Figure 1B] FIG. 2 is a front view of the cushion module of the present disclosure. [Figure 2A] FIG. 2 is a front view of the mask frame of the present disclosure. [Figure 2B] FIG. 13 is an enlarged side view of the male forehead piece connector. [Figure 3A] FIG. 1 is a side view of a prior art elbow joint. [Figure 3B] FIG. 13 is a side view of an alternative elbow joint of the present disclosure. [Figure 4A] FIG. 2 is a view of a socket insert of the present disclosure. [Figure 4B] FIG. 2 is a view of a socket insert of the present disclosure. [Figure 4C] FIG. 2 is a view of a socket insert of the present disclosure. [Figure 4D] FIG. 2 is a view of a socket insert of the present disclosure. [Figure 4E] FIG. 2 is a view of a socket insert of the present disclosure. [Diagram 5] FIG. 13 is a cross-sectional view of the elbow and socket insert showing a shape that allows the elbow to be removed. [Figure 6A] 1 shows a view of a forehead piece of the present disclosure. [Figure 6B] 1 shows a view of a forehead piece of the present disclosure. [Figure 6C] 1 shows a view of a forehead piece of the present disclosure. [Figure 6D] 1 shows a view of a forehead piece of the present disclosure. [Figure 6E] 1 shows a view of a forehead piece of the present disclosure. [Figure 7A] 1 shows a diagram of the headgear of the present disclosure. [Figure 7B] 1 shows a diagram of the headgear of the present disclosure. [Figure 8] 1 shows a front view of several cushion modules of different sizes. [Figure 9] 9 shows a side view of each of the cushion modules of FIG. 8. [Figure 10] FIG. 9 is a plan view of the face-contacting surface of one of the seals of the cushion modules of FIG. 8. [Figure 11] FIG. 2 is a plan view of a seal showing several sections. [Figure 12] FIG. 2 is a plan view of the seal showing the widths of the two portions of the seal. [Figure 13] FIG. 13 is a bottom view of the top and particularly the nose bridge portion of the seal. [Figure 14] FIG. 13 is a view of the face-contacting surface of the nasal bridge portion of the seal. [Figure 15] FIG. 2 is a cross-sectional view of the top of the seal. [Figure 16] 9 is a plan view of the face-contacting surface of a seal of one of the cushion modules of FIG. 8 showing areas having varying thicknesses. [Figure 17]17 is a plan view of the face-contacting surface of a seal of one of the cushion modules of FIG. 8 showing additional regions of varying thickness relative to FIG. 16. [Figure 18] FIG. 13 is a perspective view of the inside of the split top of the seal. [Figure 19] FIG. 2 is a plan view of the face-contacting surface of the upper side of the seal. [Figure 20] 3 shows several possible cross-sectional profiles for a portion of the seal. [Figure 21] FIG. 13 is a side view of a cushion module having a deformable top portion. [Figure 22] 13 is a cross-sectional view of the inner surface of the upper portion of a seal of a cushion module having a deformable upper portion. FIG. [Figure 23] 1 shows the relationship between deflection angle and forward movement of the upper part of the seal. [Figure 24] Several seals of different sizes are shown, with different available deflection angles. [Diagram 25] 1 shows the relationship between deflection angle and downward movement of the top of the seal. [Figure 26] Several seals of different sizes are shown having different heights of the top of the seal. [Figure 27] FIG. 13 is a cross-sectional view of the top of a seal with a graduated thickness in the front and top walls. [Figure 28] FIG. 13 is a cross-sectional view of the top of a forwardly deflected seal. [Fig. 29A-29F] 1 illustrates several views of a cushion module having a seal according to one or more embodiments disclosed herein in a neutral position and a depressed position, with a Simplus® cushion module shown in a similar position for comparison. [Diagram 30] For comparison, a side view of a cushioning module having a single rolling part is shown. [Figure 31A] 1 shows a view of a cushion module with multiple rolling parts. [Figure 31B] 1 shows a view of a cushion module with multiple rolling parts. [Figure 31C]1 shows a view of a cushion module with multiple rolling parts. [Figure 32A] FIG. 2 shows a side view of a cushioning module with multiple rolling portions in a non-rolling position. [Figure 32B] 1 shows a side view of a cushioning module with multiple rolling portions in a fully rolled position. [Diagram 33] 1 shows a side cross-sectional view of a cushion module with multiple rolling portions. [Diagram 34] 1 shows a schematic diagram of a system for providing CPAP therapy to a user. [Diagram 35] FIG. 1 shows a side view of a respiratory mask incorporating the biased airflow system of the present disclosure. [Diagram 36] 1 illustrates a cross-sectional view of the biased air flow system of the present disclosure. [Figure 37] 1 shows a cross-sectional view of a cylindrical conduit with radial drainage holes. [Figure 38] 1 shows a perspective view of a respiratory mask including the biased airflow system of the present disclosure. [Figure 39] 1 shows a cross-sectional view of a respiratory mask and biased air system of the present disclosure. [Diagram 40] 1 shows a cross-sectional view of an annular component with radial drainage holes. [Diagram 41] 1 shows a computational fluid dynamics (CFD) analysis of the exhaust hole and shroud configuration of the present disclosure. [Figure 42A] 13 illustrates an alternative embodiment of the shroud shape. [Figure 42B] 13 illustrates an alternative embodiment of the shroud shape. [Figure 43A] 1 illustrates an embodiment of a biased ventilation system attached to an elbow joint. [Figure 43B] 1 illustrates an embodiment of a biased ventilation system attached to an elbow joint. [Figure 44A] FIG. 1 shows a diagram of a biased air system incorporating a ball and socket joint. [Figure 44B] FIG. 1 shows a diagram of a biased air system incorporating a ball and socket joint. [Figure 44C]FIG. 1 shows a diagram of a biased air system incorporating a ball and socket joint. [Fig.44D] FIG. 1 shows a diagram of a biased air system incorporating a ball and socket joint. [Figure 44E] FIG. 1 shows a diagram of a biased air system incorporating a ball and socket joint. [Diagram 45] 13A-13C show cross-sectional views of further biased airflow system configurations. [Figure 46] 13A-13C show cross-sectional views of further biased airflow system configurations. [Figure 47] 13A-13C show cross-sectional views of further biased airflow system configurations. [Figure 48] 13A-13C show cross-sectional views of further biased airflow system configurations. [Figure 49] 1 illustrates a cross-sectional view of an embodiment of a biased air system attached to an elbow joint. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0094] The embodiments of the system, components, and assembly and manufacturing methods are described herein with reference to the accompanying drawings, in which like reference numerals refer to like or similar elements throughout. Although several embodiments, examples, and illustrations are disclosed below, those skilled in the art will appreciate that the invention described herein extends beyond the specifically disclosed embodiments, examples, and illustrations and may include other uses of the invention, as well as obvious modifications and equivalents thereof. The terminology used in the description presented herein should not be construed in any limited or restrictive manner, merely because it is used in conjunction with the detailed description of certain embodiments of the invention. Furthermore, embodiments of the invention may include several novel features, and no single feature is solely responsible for the desirable attributes, nor is it essential to the practice of the invention described herein.

[0095] Certain terminology may be used in the following description for reference purposes only, i.e., not intended to be limiting. For example, terms such as "upper" and "lower" refer to directions in the drawings to which reference is made. As used herein, the terms "forward", "rear", "upper" and "lower" refer to the location of one or more portions of a respiratory mask relative to a user, where "forward" refers to a distal location relative to the user (when the mask is in use) and "rear" refers to a proximal location relative to the user. The terms "upper" and "lower" refer to the location of a part or component of the mask relative to the rest of the mask when the mask is in use and the user is sitting in an upright position. Additionally, terms such as "first", "second", "third", etc. may be used to describe separate components. Such terminology may include the words specifically mentioned above, derivatives thereof, and words of similar meaning.

[0096] The term "seal housing" refers to a respiratory mask component configured to provide a breathing chamber that (in use) substantially surrounds the user's nose and / or mouth. The seal housing may include an integrally formed or removably attached seal that is configured to have a surface that contacts the user's face, thereby providing a substantially airtight connection.

[0097] Respiratory mask 1A illustrates a respiratory mask 100 incorporating a detachable ball and elbow joint and other mask components. The respiratory mask 100 includes a cushion module 110, a mask frame 120, an elbow joint 130, a socket insert 140, headgear 150, a swivel 160, and a forehead piece 170.

[0098] The cushion module 110 is configured to substantially surround the nose and / or mouth of a user (in use). The cushion module 110 includes a seal 180 and a seal housing 190, where the seal 180 is configured to contact the user's face and form a substantially airtight seal. In the illustrated arrangement, the seal 180 is overmolded onto the seal housing 190. The seal housing 190 includes a substantially enclosed breathing chamber 192 and an annular opening 194, as shown in FIG. 1B. The annular opening 194 is configured to receive and connect to the socket insert 140 and is configured to allow airflow into the breathing chamber 192. In other embodiments, the annular opening 194 may be replaced with any other suitable shaped opening.

[0099] Mask Frame: As shown in Figure 2A, the mask frame 120 includes a socket connection opening 200, a headgear connector 210, a beam portion 220, and a male forehead piece connector 230. A socket insert 140 is configured to be insertable into the socket connection opening 200. In some configurations, the socket insert 140 is configured to be permanently connected to the socket connection opening 200. The socket insert 140 provides a socket for the elbow joint 130 (see, e.g., Figure 1A) such that the socket connection opening 200 and the elbow joint 130 provide a pathway through which air is supplied to the breathing chamber 192 (shown in Figures 1A and 1B).

[0100] The headgear connectors provide a means by which the headgear 150 is connected to the mask frame 120 (as shown in FIG. 1A ) so that a retention and sealing force can be applied to the mask 100. The mask frame 120 has a relatively triangular shape, with the headgear connectors forming two lower points (when worn and with the user sitting upright) and the male forehead piece connector 230 forming a third upper point. The edge of the mask frame 120 extending from the headgear connector 210 to the male forehead piece connector 230 has a concave curve that narrows the frame 120 to form an elongated beam portion 220. The beam portion 220 is configured to pass over the user's nose. At the upper end, the beam portion 220 is narrower than the bridge of the user's nose so that obstruction to the user's line of sight is minimized.

[0101] As shown in FIG. 2B, the beam portion 220 terminates at an upper end with a male forehead piece connector 230. The male forehead piece connector 230 includes a step 232 and a notch 234. The step 232 is located at the transition between the beam portion 220 and the male forehead piece connector 230. At this location, there is a step down in the shape of the beam portion such that the male forehead piece connector is narrower and thinner but follows substantially the same lines as the beam portion. This allows the male forehead piece connector 230 to fit inside a corresponding female shape in the forehead piece 170 (see, for example, FIGS. 1A and 6A-E). The male forehead piece connector also includes a notch 234 located proximal to the upper end 236 of the mask frame 120. The notch is configured to provide a snap-fit ​​connection with a corresponding shape in the forehead piece 170.

[0102] Elbow Joint: FIG. 3A shows a prior art elbow joint 130 including a ball joint 300, a lip 310, an elbow joint body 320, and a swivel connection 330. The ball joint 300 includes a spherical elbow joint bearing surface 302 and a rear opening edge 304. In an embodiment of the present disclosure, as shown in FIG. 3B, the ball joint 300A may also include a tapered chamfer 306. The tapered chamfer 306 is positioned at a lower portion of the rear opening edge 304 and provides a non-planar edge that is angled toward the lip 310 relative to the rear opening edge 304. The ball joint 300A is configured to provide a substantially free-rotating connection between the elbow joint 130 and the socket insert 140. The ball joint 300A is connected to the elbow joint body 320 via a cylindrical band 308 and a lip 310. The lip 310 includes an edge formed by a surface extending perpendicularly from the cylindrical band 308 and the shape of the elbow body 320, with the lip 310 generally at the top of the elbow body 320. The lip 310 is configured to interact with the socket insert 140 during removal of the elbow 130 (see, for example, FIG. 5). The swivel connection 330 is positioned on the opposite side of the elbow 130 from the ball joint 300A. It is configured to connect to the swivel 160 (as shown in FIG. 1A).

[0103] In an alternative embodiment, ball joint 300A includes a truncated ball. The ball joint includes a ball 302 that creates a spherical bearing surface. The truncated axis is substantially planar and angled toward band 308. The truncated axis creates an angled edge 304. Edge 304 is angled toward the bottom of the cylindrical band and the bottom of the elbow. Angled edge 304 creates an angled ball such that the distance of the top edge of the ball is greater than the bottom edge of the ball.

[0104] Socket Insert: 4A-4E show the socket insert 140 in more detail. The socket insert is an annular component including an outer wall 400, a front wall 410, an inner wall 420, an elbow joint removal notch 430, a rear channel 440, and an annular array of drift holes 450 (see, for example, FIG. 4D). Although the socket insert 140 is disclosed herein, other configurations may be incorporated into or integrally formed with the mask frame 120. The drift holes 450 may include any suitable cross-sectional shape including, but not limited to, polygonal, chevron, circular or elliptical holes, slots or slots including "U" and "W" shapes, and may be symmetrical or asymmetrical in shape. In other embodiments, the socket insert 140 may not include drift holes 450. The drift holes 450 may be incorporated into another component of the respiratory mask.

[0105] The socket insert 140 provides a socket bearing surface 412 that supports the ball joint 300A when the ball joint 300A is inserted into the socket insert 140. This configuration provides a rotatable connection between the elbow joint 130 and the mask frame 120. The outer wall 400, the front wall 410, and the inner wall 420 are connected to form a substantially "u" shaped rear channel 440, with the front wall 410 being substantially perpendicular to the outer wall 400 and the inner wall 420. The front wall 410 is configured to connect to and support the outer wall 400, radially offset from the inner wall 420.

[0106] The outer wall 400 includes one or more seal housing notches 402, a frame connection 404, and an alignment key 406. The seal housing notch 402 is configured to provide a snap-fit ​​connection between the socket insert 140 and the seal housing 190. The seal housing notch 402 includes an indentation that forms the female component of the snap-fit ​​connection. The frame connection 404 includes two annular ridges that form a permanent push-fit connection with a corresponding shape of the socket connection opening 200 (as shown in FIG. 2A). The alignment key 406 is located at the top rear edge of the outer wall 400. It includes a substantially trapezoidal cutout that aligns with a corresponding tab on the annular opening 194 of the seal housing 190. The alignment key is configured to reduce or eliminate the possibility of a misaligned connection between the seal housing 190 and the socket insert 140. In some embodiments, the permanent connection between the frame connection 404 and the socket connection opening 200 may be achieved via ultrasonic welding or other suitable methods.

[0107] The inner wall 420 includes a socket bearing surface 412 that is substantially spherical and configured to contact and retain the ball joint 300A of the elbow joint 130. The socket bearing surface 412 is configured to contact the elbow joint bearing surface 302, thereby forming a substantially airtight assembly. When the elbow joint 130 and the socket insert 140 are connected, the bearing surfaces 302, 412 are configured to allow rotational movement between the parts while simultaneously limiting translational movement between the front and rear of the mask.

[0108] In the illustrated arrangement, the elbow joint removal notch 430 is located at the bottom of the edge formed where the front wall 410 and the inner wall 420 intersect. The removal notch 430 includes a corrugated portion and the edge is cut to form a tapered concave surface. The elbow joint removal notch is configured to substantially match the shape of the lip 310 of the elbow joint 130 such that when the elbow joint 130 is rotated to the opposite position, as shown in FIG. 5, the lip 310 may seat within the elbow joint removal notch 430. It is this configuration that allows the elbow joint 130 to be removed from the socket insert 140. In other embodiments, the elbow joint removal notch 430 may have a shape different from the shape of the lip 310 such that the two components may contact or may be located elsewhere circumferentially.

[0109] When the elbow joint 130 is rotated to approximately the opposite position, the lip 310 approximately aligns with the removal notch 430. When the lip 310 is positioned within the elbow joint removal notch 430, the ball joint 300 can rotate further within the socket insert 140. This is a result of the elbow joint removal notch surface being offset rearward of the front wall. The additional rotation allows the lowest point (when a mask is used) or tapered chamfer 306 of the rear opening edge 304 to move closer (as shown by dimension x in FIG. 5 ) to the front wall 410 than would be possible without the elbow joint removal notch 430. This reduction in distance x to the front wall 410 reduces the force required to move the rear opening edge 304 or tapered chamfer 306 past the front wall. The elbow joint removal notch 430 also forms a leverage point. The leverage point is created by moving the center of rotation of the ball joint 300 from position y (shown in FIG. 5) to the point of contact between the lip 310 and the elbow joint removal notch 430. The shape of the elbow joint removal notch allows force to be applied through the lip 310 and the new center of rotation, thus creating the leverage point. The leverage point is farther away from the lowest point of the tapered chamfer 306 than the center of rotation y, which reduces the force required to move the rear opening edge 304 past the front wall 410.

[0110] Once at least a portion of the rear opening edge 304 is past the front wall 410, the ball joint 300 may be removed from the socket insert 140. It may be seen that the purpose of the tapered chamfer 306 is to further reduce the distance x that the ball joint 300 needs to be rotated to move the rear opening edge 304 past the front wall 410 and thus removed from the socket insert 140 as compared to a configuration without the tapered chamfer 306. In an alternative embodiment (not shown), the elbow joint removal notch 430 may be replaced by a chamfered or wavy section on the edge formed between the inner wall 420 and the front wall 410 of the socket insert 140. The chamfered edge may have the effect of reducing the distance x that the ball joint needs to be rotated to be removed from the socket insert. In yet another alternative embodiment, the shape of the elbow joint removal notch 430 may extend beyond the socket insert 140 and into the mask frame 120.

[0111] An alternative embodiment of the angled edge 304 for the truncated ball functions in a similar manner as described with respect to FIG. 3B and FIG. 5. The angled truncated axis creates an angled rear opening edge 304 and creates a longer top edge of the ball 302 compared to the bottom edge of the ball. The angled edge 304 allows the ball joint 300 to rotate further within the socket insert 140. This is because the bottom edge of the ball is shorter than the top edge of the ball. The additional rotation allows the lowest point (when the mask is used) of the rear opening edge 304 to move closer to the front wall 410. The additional rotation and the lowest point moving closer to the front wall 410 reduces the force required to move the rear opening edge 304 past the front wall. The elbow joint removal notch 430 also forms a leverage point as described. The leverage point is farther away from the lowest point of the tapered chamfer 306 than the center of rotation, which reduces the force required to move the rear opening edge 304 past the front wall 410.

[0112] The elbow joint 130 and socket insert 140 are generally configured such that the elbow joint 130 can only be removed from the socket insert 140 when oriented in a predetermined rotated position. As shown in FIG. 5, in an embodiment of the invention, the elbow joint 130 can be removed when rotated to a reverse position in which the elbow joint body 320 is oriented upward toward the beam portion 220 (not shown) of the mask frame 120. This reduces or eliminates the possibility of unintentional disengagement of the elbow joint during use. In other embodiments, the elbow joint 130 can be rotated to a different position for removal. Once removed, the elbow joint 130 can be reassembled into the socket insert 140 by reversing the removal action and force.

[0113] The single removal location and mixed shape of the elbow removal notch 430 dictates that the elbow removal action may not be obvious to all users, meaning that users may need to be taught how to remove the elbow. This may be beneficial in some situations, since it may be desirable for only a certain group of users to know how to remove the elbow. For example, removal of the elbow for cleaning and sterilization is particularly important in an environment where a single mask may be used for multiple users, such as a sleep lab, whereas it is less important in a home use environment where the mask has only a single user. Thus, it may be desirable for a doctor or sleep lab technician to know how to remove the elbow, rather than the direct user of the mask. In an alternative embodiment, the shape is such that it is obvious how to remove the elbow.

[0114] Frontal piece: As shown in FIG. 1A, the forehead piece 170 is a removable end cap configured to provide a connection between the mask frame 120 and the headgear 150. FIGS. 6A-6E show that the forehead piece 170 includes a front portion 600 and a rear portion 610, the front and rear portions 600, 610 being connected to form a horizontal loop 620. The horizontal loop 620 provides a hole that extends horizontally from one side of the forehead piece 170 to the other (when the mask is in use). The rear portion 610 includes a rear opening 622. The rear opening 622 is configured to extend through the rear portion 610 in a direction substantially perpendicular to the front portion 600. The rear opening 622 in combination with the horizontal loop 620 is configured to provide a path through which the forehead strap 152 of the headgear 150 may pass. Both of the forehead straps 152 enter the forehead piece through rear openings 622, and one forehead strap 152 exits on each side of horizontal loop 620, as shown in Figure 6B. In this configuration, the forehead piece forms a buckle through which the length of the forehead straps 152 can be adjusted.

[0115] The front portion 600 includes a female frame connector 630. The female frame connector 630 is configured to connect to the male forehead piece connector 230 of the mask frame 120 and includes an internal cavity 640. The internal cavity 640 is shown in more detail in FIG. 6C. The internal cavity includes a frame opening 642, a protrusion 644, and a shaped opening 646. The frame opening 642 is configured to span the male forehead piece connector 230. As shown in FIG. 6D, the shape of the internal cavity 640 is configured to substantially match the shape of the male forehead piece connector 230. The protrusion 644 includes a raised nub configured to fit into the notch 234 of the male forehead piece connector 230. When the protrusion 644 and the notch 234 are mated together, they form a snap-fit ​​connection that allows the forehead piece 170 to be removably connected to the mask frame 120. The shaped opening 646 provides the interior cavity 640 with a second opening opposite the frame opening 642. The opening is substantially perpendicular to the forward portion 600 and is located on a rear surface of the forward portion 600. The shaped opening 646 is configured to provide a means for a forming tool to form the protrusion 644 on the interior surface of the interior cavity 640. The shaped opening 646 is configured to fit within the confines of the rear opening 622 such that a single fixture installation component may form both the shaped opening 646 and the protrusion 644, as well as the rear opening 622.

[0116] In some configurations, as shown in FIG. 6E, the forehead piece 170 is provided in two or more sizes. The different sizes can be provided by varying the height of the forehead piece 170. The different sizes correspond to various facial geometries of users. In an embodiment of the present invention, a medium / large and a small size are provided, with the small size having a height h2 less than the height h1 of the medium / large size. The height of the forehead piece 170 determines the height at which the forehead strap of the headgear is connected to the mask 100, and therefore determines how high up the forehead strap of the user sits. The size of the forehead piece 170 can be selected to fit the user most comfortably. The horizontal loop 620 varies in size depending on the height h of the forehead piece 170. The rear opening 622 has a fixed size corresponding to the width of the forehead strap 152. The fixed size of the rear opening 622 limits the vertical movement of the forehead strap within the horizontal loop.

[0117] In other configurations, the forehead piece 170 and the mask frame 120 may be configured for simultaneous permanent connection (e.g., barbed or angled protrusions and notches). Such a configuration allows for a common mask frame that is connectable to forehead pieces 170 of various shapes and sizes.

[0118] headgear: The headgear 150 is configured to apply a retaining force to the mask frame 120 such that the respiratory mask 100 is held in place on the user's face and a substantially airtight seal is achieved. The headgear 150 includes a pair of forehead straps 152, an upper or top strap 154, a lower or chin strap 156, and a rear headgear portion 158, as shown in FIG. 7A. In use, the forehead straps 152 are configured to extend forward from the rear headgear portion 158 across the user's forehead and connect to the forehead piece 170 as described above. The top straps 154 are configured to form links between the forehead straps 152, such that the top straps 154 extend across the top of the user's head. The chin strap 156 is configured to extend forward from a lower edge of the rear headgear portion 158, across the user's cheeks and chin, to a headgear connector 210 of the mask frame 120. The chin strap 156 is connected to the headgear connector 210 via a separate headgear clip 700. The headgear clip 700 hooks onto post components in the headgear connector and provides a quick means for the user to attach and detach the headgear 150 to the mask frame 120.

[0119] The lengths of the forehead strap 152 and chin strap 156 are secured by hook and loop fastener tabs 710 located at the ends of the straps. The tabs 710 include the hook component of the hook and loop fastener material. The outer surface 720 is configured to have a suitable surface finish for the hook material to attach to. The forehead strap 152, top strap 154 ​​and chin strap 156 are made from a material such as Breath-o-prene™ that includes layers of different fabrics including fibers and foams. Breath-o-prene™ is made from a polyurethane foam with an outer layer of nylon and spandex. The materials are heat laminated together. Each of the straps may be made from materials with different physical properties. For example, the top strap 154 ​​may be stretchable, in comparison to the chin strap 156 which is substantially non-stretchable.

[0120] The rear headgear portion 158 includes a spacer fabric pad 730 and a lower back strap 740. The spacer fabric pad 730 includes a substantially rectangular portion with scalloped edges and cut corners. The cut corners are configured for attachment to the forehead straps 152 and the lower back straps 740. FIG. 7B shows that the spacer fabric pad 730 includes two spacer fabric layers 732 stacked one on top of the other. The spacer fabric layer has a front side 733 and a back side 734. The two layers are sewn together in an inside-out state (i.e., with the back side of the fabric facing outward) to form a seam 736 near a raw edge 738 of the spacer fabric layer. After being sewn together, the layer 732 is then turned right-out so that the front side 733 is on the outside and the raw edge 738 is on the inside. The seam 736 extends around the perimeter of the spacer fabric pad 730, leaving a bottom edge 739 open. The open bottom edge 739 allows for the spacer fabric pad 730 to be exposed. After exposure, the forehead strap 152 and lower back strap 740 are attached to the spacer fabric pad 730. In an embodiment of the invention, they are sewn together, however, other attachment methods such as, but not limited to, welding may also be suitable. The open bottom edge 739 is sealed at the same time as it is attached to the lower back strap 740.

[0121] The inventive headgear configuration incorporates a spacer fabric pad 730 to provide a lightweight, breathable, and cushioned area behind the user's head. These qualities are desirable as they can increase the user's comfort while wearing the headgear. Spacer fabric has a messy edge finish that is prone to fraying when cut. The inventive configuration of the spacer fabric pad 730 provides a neat edge finish by hiding the raw edges inside the pad. The seams 736 can also help reduce or eliminate the possibility of fraying.

[0122] The lower back straps 740 extend along the bottom edge 739 of the spacer fabric pad. The lower back straps 740 are made of a less stretchy material than the spacer fabric pad 730. The lower back straps 740 provide structural reinforcement to the spacer fabric pad 730, reducing or eliminating the possibility of over-stretching that could cause the mask 100 to become displaced from the user's face during use.

[0123] Cushion module: As described above, the cushion module 110 is configured to substantially surround the nose and / or mouth of a user and includes a seal 180 and a seal housing 190. The seal housing 190 provides a type of support structure for the respiratory mask assembly 100 generally and for the mask cushion or more specifically the seal 180. Although the respiratory mask 100 disclosed herein includes a separable cushion module 110 and frame 120, in some configurations these components may be combined into a single structure. Thus, although described herein as part of the cushion module 110, the seal 180 may also include part of the mask frame. Other suitable interface arrangements that define a breathing chamber, support a seal, and allow connection of respiratory gas conduits and headgear (if required) may also be used.

[0124] In some configurations, multiple cushion modules 110 are available for a given respiratory mask 100. For example, the cushion modules 110 may vary in size from one another so that a suitable one of the available cushion modules 110 may be selected for a particular user. However, the cushion modules 110 may also or alternatively vary from one another with respect to characteristics other than size. Figures 8 and 9 show multiple different sizes of cushion modules 110 that may be used as components of the respiratory mask 100 disclosed herein. Each cushion module 110 is substantially of the same configuration except for certain dimensions, some of which are discussed herein.

[0125] The cushion module 110A is smaller in at least one dimension (e.g., seal height) than the cushion modules 110B and 110C. Similarly, the cushion module 110B is smaller in at least one dimension (e.g., seal height) than the cushion module 110C. The cushion modules 110A, 110B, and 110C may be referred to as "small," "medium," and "large" modules in size, respectively. In some configurations, additional modules 110 may be provided, which may be located at either end of the illustrated modules 110A, 110B, 110C, or may have at least one dimension that positions the additional modules between the illustrated modules 110A, 110B, 110C in a relative sense. In some configurations, a fewer number of cushion modules 110 (e.g., two) are provided. As described herein, references to a general cushion module 110 may apply to any of the specific modules 110A, 110B, 110C. When discussing modules 110A, 110B, 110C relative to one another, specific reference numbers 110A, 110B, 110C are generally used. One or both of the seal 180 and the seal housing 190 may vary among the various size modules 110A, 110B, 110C. In the illustrated arrangement, both the seal 180 and the seal housing 190 vary in size among the various size modules 110A, 110B, 110C.

[0126] The seal housing 190 can be formed from any suitable material. In some configurations, the seal housing 190 is formed from a fairly rigid material. In some configurations, the seal housing 190 is formed from a plastic material, such as a polycarbonate material. In some configurations, the seal 180 is overmolded onto the seal housing 190, and in some configurations, the seal 180 may be overmolded directly onto the seal housing 190, which may include, for example, chemical or mechanical overmolding.

[0127] In some configurations, the seal housing 190 occupies a substantial portion of the front wall of the cushion module 110. Such an arrangement provides an advantageous amount of support to the seal 180. For example, the seal housing 190 occupies a substantial portion of the oral portion of the front wall of the cushion module 110. In the illustrated configuration, the seal housing 190 extends rearward from a central portion to opposing side portions. The central portion includes a hole or opening 194 for allowing a flow of supplied breathing gas to enter the interior of the cushion module 110. The opening 194 may allow the cushion module 110 to be assembled to the frame 120, the mask elbow joint 130, or another suitable structure. The width of the seal housing 190 may occupy a substantial portion of the overall width of the oral portion of the cushion module 110, for example at least about three-quarters of the overall width of the oral portion of the mask assembly 100. Such an arrangement of the seal housing 190 may provide a necessary amount of support to the sides of the seal 180. In some configurations, the seal housing 190 may be minimal, such as, for example, as an annular support ring or frame.

[0128] The seal 180 is designed to seal against the face of a user. The seal 180 is preferably formed from a soft material, such as, but not limited to, silicone. In some configurations, at least a portion of the seal 180 may be textured to improve comfort for the user. For example, in some configurations, at least a portion of the mold used to form the illustrated seal 180 may be bead blasted to provide a surface texture in at least the area of ​​the seal 180 that contacts the user's skin. Other techniques for texturing one or more surfaces of the ring seal 180 may also be used. In some configurations, it may be desirable to avoid surface texturing and provide a smooth surface texture on at least the face-contacting surface of the seal 180, which may increase the grip of the seal 180 on the user's face and improve sealing properties.

[0129] As discussed above, the illustrated cushion module 110 comprises a nasal or oral or full face mask. Thus, with reference to Figures 10-15, the seal 180 comprises a nasal or oral mask seal and thus comprises a combined oral-nasal opening 1000. In other configurations, the oral and nasal portions of the opening 1000 may be separate from one another. The opening 1000 preferably communicates with a breathing chamber 192 defined within the cushion module 110. As discussed above, the chamber 192 of the illustrated mask assembly 100 is at least partially defined by the seal housing 190 and the seal 180.

[0130] The illustrated seal 180 includes an upper portion 1002 and a lower portion 1004. The upper portion 1002 includes a nasal portion of the opening 1000 that accommodates the user's nose. The lower portion 1004 includes an oral portion of the opening 1000 that accommodates the user's mouth. Thus, the lower portion 1004 is significantly wider than the upper portion 1002. Together, on the proximal side of the cushion module 110, the upper portion 1002 and the lower portion 1004 combine to define a portion or all of the face-contacting surface 106. The face-contacting surface 106 is configured to be beneath the user's lower lip, to extend along the outside of the mouth, to extend upwardly along the cheekbones, and to extend across the bridge of the user's nose. Thus, the illustrated face-contacting surface 106 defines a generally teardrop-shaped opening 1000. When the cushion module 110 is placed on the user's face, the face-contacting surface 106 is located beneath the bridge of the nose, the cheekbones, the outside of the mouth, and beneath the user's lower lip. The supply of positive air pressure causes seal 180 to inflate and seal against the user's face to reduce or eliminate the possibility of leakage between face-contacting surface 106 and the user's face.

[0131] The illustrated seal 180 is a full-face seal configured for similar applications and / or user preferences as the respirator sold under the trademark Simplus® by the present applicant, Fisher & Paykel Healthcare. Although the Simplus® mask is a highly successful full-face respirator product that provides superior sealing characteristics and comfort for a wide variety of facial geometries, the illustrated seal 180 includes features or modifications that provide improved performance for at least some applications or facial geometries relative to the Simplus® mask. Accordingly, certain features of the seal 180 of the present invention will be described in the context of the seal of the Simplus® mask.

[0132] 11, a plan view of the seal 180 shows the width dimension between the outer edge 1010 of the seal 180 and the inner edge that defines the opening 1000 along several sections of the seal 180, designated as sections 1-5. At least sections 2-3 are preferably identical on each side of the seal 180. In some configurations, sections 2-4 may be identical on each side of the seal 180. Thus, in some configurations, the seal 180 may be generally symmetrical about a central vertical axis. Section 1 is a vertical line in the center top of the seal 180 that coincides with the centerline or lies in the mid-plane of the seal 180. Section 2 is a line that is 45 degrees to the vertical centerline or mid-plane of the seal 180 and 90 degrees to the inner edge 1000 of the seal 180. Section 3 is a line at the widest part of the top 1002 of the seal 180 that is at 90 degrees to the outer edge 1010 of the seal 180, which may be the widest part of the entire seal 180 in some configurations. Section 4 is the narrowest section on the side of the bottom 1004 of the seal 180 below section 3 that is at 90 degrees to the outer edge 1010 of the seal 180. Section 5 is a vertical line at the center bottom of the seal 180. The table below (Table 1) lists exemplary dimensions of sections of several sizes of the seal 180 compared to corresponding locations and sizes of the Simplus® seal. The dimensions listed for the seal 180 are exemplary dimensions and are not intended to be limiting unless otherwise indicated. Additionally, actual dimensions may vary within determined ranges due to normal manufacturing variances, which may be indicated herein by use of the terms "about," "approximately," or other similar terms. The dimensions indicate the width of the various sections relative to each other and relative to the Simplus® seal.

[0133] [Table 1]

[0134] In general, Table 1 shows that in seal 180, sections 1 and 2 are relatively close in width. In some configurations, sections 1 and 2 may have the same width. Section 3 is larger than one or both of sections 1 and 2. In some configurations, sections 1 and 2 may be about 75% of the width of section 3. In some configurations, sections 1 and 2 are at least 70% of the width of section 3. Seal 180 has less variation in width at top 1002, i.e., at least in sections 1, 2, and 3, compared to a Simplus® seal. In some configurations, as described below, sections 1 and 2 of seal 180 are wider than the equivalent sections of a Simplus® seal, while section 3 of seal 180 and the equivalent sections of a Simplus® seal are relatively similar in width.

[0135] One or both of sections 4 and 5 of seal 180 have a width less than the width of one or more of sections 1-3. In the illustrated arrangement, both sections 4 and 5 have a width less than the width of section 3. One or both of sections 4 and 5 of seal 180 may have a width less than the width of one or more of sections 1-3. In the illustrated arrangement, both sections 4 and 5 have a width greater than both the widths of sections 1 and 2. In the illustrated arrangement, the width of section 5 is slightly greater than the widths of sections 1 and 2, but similar. The widths of sections 4 and 5 of seal 180 are relatively similar to the widths at the equivalent locations of the Simplus® seal. In some cases, the widths of one or both of sections 4 and 5 are the same between seal 180 and the Simplus® seal (e.g., large size), or the width of seal 180 is slightly smaller than the equivalent sections of the Simplus® seal (e.g., small size). At the medium size, the width of section 5 is the same, while the width of seal 180 is slightly less than the width of the Simplus® seal at section 4.

[0136] 12, a plan view of the seal 180 illustrates a first width 1012 of the opening 1000 defined between laterally opposed locations at the opening 1000 in a top portion 1002 of the seal 180, and a second width 1014 between laterally opposed locations at an outer edge 1010 of the seal 180 in a bottom portion 1004 of the seal 180. In particular, the illustrated first width 1012 is the width of an upper end of the opening 1000 in the top portion 1002 of the seal 180 that accommodates the bridge of the user's nose. The width 1012 may be defined between relatively vertical sidewall portions of the top end of the opening 1000, or between laterally opposed points at or near a bending or undulating point where each side of the edge defining the opening 1000 transitions between an inward bending and an outward bending in an upper central portion of the top portion 1002 of the seal 180. Width 1012 may be the width that contacts the bridge of the user's nose or determines and influences the fit with the bridge of the user's nose. Width 1014 may be the maximum width of the face-contacting surface 106 in the lower portion 1004 of the seal 180, which may be the maximum width of the seal 180 in a common seal arrangement. Width 1012 is preferably relatively small, at least as compared to width 1014, which is useful as a reference point for comparing width 1012 to other seals. The table below (Table 2) lists exemplary dimensions of widths 1012 and 1014 of several sizes of seal 180 relative to corresponding locations and sizes of Simplus® seals. The listed dimensions for seal 180 are exemplary dimensions and are not intended to be limiting unless otherwise indicated. Additionally, actual dimensions may vary within ranges determined by normal manufacturing variances, which may be indicated herein by use of the terms "about," "approximately," or other similar terms.

[0137] [Table 2]

[0138] Table 2 shows that the width 1012 is less than about 12.5 percent, 12 percent, or 11.5 percent of the width 1014 for all sizes of seal 180. In some configurations, the width 1012 can be equal to about 12.5 percent of the width 1014 or can be equal to about 12 percent for one or more sizes of seal 180. The width 1012 of the illustrated seal 180 can be equal to about 11.5 percent of the width 1014. The width 1012 of the illustrated seal 180 can be about 11.3 to 11.5 percent of the width 1014 for one or more sizes of seal 180. The absolute value of the width 1012 can be about 12 mm or less, about 11.5 mm or less, or about 11 mm or less, regardless of the width 1014. Such arrangements provide a desirable level of sealing for a variety of nose sizes and geometries. In comparison, the width of the Simplus® seal corresponding to width 1012 is 12.5 mm and approximately 12.9 to 13 percent of the width corresponding to width 1014.

[0139] 10, 13 and 14, the top 1002 of the opening 1000 of the illustrated seal 180 defines a substantially continuously curved top section at the top center of the opening 1000. Preferably, the top section of the opening 1000 defining the top center of the opening 1000 does not include any linear portions or does not include linear portions of a length at least not greater than the entire length of the edge of the top 1002 or relative to the width of the top 1002. It is believed that the rounded shape of the top center of the opening 1000 that contacts the top of the user's nose stretches to accommodate relatively squared or pointed nasal geometries while also providing a better seal for smaller and / or rounder nasal geometries by reducing or eliminating gaps.

[0140] 13 and 14, a seal 180 is shown with the edge S of a corresponding Simplus® seal included for comparison. As shown in FIG. 13, the seal 180 defines a depth 1020 from a transition point 1022 between the face-contacting surface 106, i.e., the posterior or proximal-most surface adjacent the inwardly-projecting nasal bridge-accommodating portion that defines the edge 1000 at the upper portion 1002. Preferably, the depth 1020 is deeper than the corresponding depth D of the Simplus® seal. With reference to FIG. 14, a greater depth 1020 (relative to depth D) can be created by extending the inwardly-projecting nasal bridge-accommodating portion further inwardly / forwardly and / or downwardly relative to the Simplus® seal. That is, in the illustrated arrangement, the inwardly projecting, nasal bridge-accommodating portion of the seal 180 continues beyond the terminal edge S of the Simplus® seal and extends deeper into the cushion module 110, resulting in the seal 180 having a greater depth 1020 (relative to depth D) and a smaller width 1012 (relative to width W) than the Simplus® seal. As a result, the seal 180 has a greater contact area, or at least the potential for a greater contact area with the bridge of the user's nose, than the Simplus® seal.

[0141] FIG. 15 shows the upper central portion of the seal 180 split anterior-posterior through the center or along the mid-plane of the seal 180. The seal 180 defines a depth 1024 between the posterior-most point 1026 and the terminal edge 1000 along the center or mid-plane of the seal 180. The depth 1024 may be about 4.26 mm in one or more sizes or configurations of the seal 180. Preferably, the depth 1024 is about 3.5 mm, 3.75 mm, 4 mm or about 4.25 mm or more. In some configurations, the depth 1024 is about 6 mm or less or about 5 mm or less. For comparison, the corresponding depth of the Simplus® seal is about 2.75 mm. As discussed above, the greater depth 1024 of the seal 180 allows the portion that accommodates the nasal bridge to contact or potentially contact the bridge of the user's nose, improving the seal for at least some nasal geometries.

[0142] The illustrated seal 180 of the cushion module 110 includes a fairly complex range and configuration of thicknesses, as shown in FIGS. 16-20. The thicknesses are varied to utilize or provide different characteristics in different regions of the illustrated seal 180. For example, the thicknesses in various regions may be selected to accommodate characteristics desired for that region and / or for the seal 180 as a whole. Such characteristics may include, for example, allowing the seal 180 to conform to the user's facial shape for enhanced sealing properties or comfort, supporting the shape of the mask seal without too much internal gas pressure for a smooth fit and / or in response to internal gas pressure and / or external pressure (e.g., caused by headgear forces), or providing strength or durability.

[0143] 16, in some configurations, the seal 180 includes a continuous thin interior edge section 1030 of at least a portion of the edge defining the opening 1000 at the upper portion 1002 of the seal 180. That is, the thin interior edge section 1030 is a portion of the edge defining the opening 1000 that defines a thickness equal to or less than a certain thickness along a continuous length of the edge defining the opening 1000, as described below. Preferably, the continuous thin interior edge section 1030 extends at least along an upper central portion of the edge defining the opening 1000 and along a portion of the edge that contacts the user's nose bridge laterally and in parallel. In some configurations, the continuous thin interior edge section 1030 extends into the lower portion 1004 of the seal 180. In some configurations, the continuous thin interior edge section 1030 extends along at least the entire upper half of the seal 180. In some configurations, the continuous thin interior edge section 1030 extends along approximately the top two-thirds or at least about the top two-thirds of the seal 180. In some configurations, the continuous thin interior edge section 1030 extends inwardly from the edge defining the opening 1000 by at least about 0.5 mm to about 1 mm. In some configurations, the thin edge section 1030 may extend further inwardly from the edge defining the opening 1000, however, it may be desirable for the more interior portion of the seal 180 to have a greater thickness. In some configurations, the thin edge section 1030 has a thickness of about 0.6 mm or less or about 0.4 mm or less. The thickness of the continuous thin interior edge section 1030 may vary within these desired thickness ranges in the direction or along the length extending inwardly from the edge defining the opening 1000.

[0144] In some configurations, the seal 180 additionally or alternatively includes a thickened nose pad 1032. The thickened nose pad 1032 is preferably positioned on each side of the top 1002 of the opening 1000. Preferably, the thickened nose pad 1032 extends along at least a portion of the face-contacting surface 106 of the seal 180, but does not extend laterally all the way to the edge defining the opening 1000. That is, the innermost edge of the nose pad 1032 terminates before the edge defining the opening 1000. In some configurations, the thickened nose pad 1032 is created by a thickened region of the seal 180 that extends such that additional material enters the interior of the cushion module 110. The thickened nose pad 1032 may have a lateral inner edge 1034 that is curved (e.g., U-shaped) with a center of the curved portion positioned closer to the opening 1000 than the top and bottom of the curved edge 1034.

[0145] Figure 17 illustrates the difference in thickness of seal 180 in various regions or portions. The regions and portions are illustrated in Figure 17. Typically, the outer surface of seal 180 is a substantially smoothly curved shape, and the thickness variations are achieved by inwardly extending portions of the inner surface of seal 180, as is evident, for example, in Figures 18 and 22. Seal 180 can include one or more of the regions or portions described herein.

[0146] The illustrated seal 180 includes a bottom or chin region 1040. The chin region 1040 in the illustrated seal 180 extends along at least a portion of the opening 1000. Preferably, the chin region 1040 extends along at least a lower central portion of the opening 1000 that is positioned below the user's lower lip or near the user's chin. The chin region 1040 may extend along the entire or substantially the entire height of the lower section of the face-contacting surface 106 of the seal 180. In other words, the chin region 1040 may extend from the bottom of the outer edge 1010 to an edge that defines the bottom of the opening 1000. The chin region 1040 may extend along or beyond a significant portion of the width of the seal 180, for example, at least about half of the maximum width of the opening 1000. The illustrated chin region 1040 is centered laterally of the seal 180.

[0147] The chin region 1040 may be a relatively soft region that contacts the area below the user's lower lip and allows the seal 180 to accommodate a variety of jaw geometries. Thus, the chin region 1040 may have a thinner cross-section than other regions of the seal 180. In some configurations, the chin region 1040 has the smallest thickness of the seal 180, which may be equal to the thickness of the other regions. For example, a portion or the entire chin region 1040 may have a thickness of about 0.3 mm. In some configurations, the thickness of the chin region 1040 may be less than 0.3 mm. For example, the thickness may be as low as about 0.15 mm.

[0148] The seal 180 may also include an upper or nasal bridge region 1042 that is centrally located at the top of the seal 180 and extends along the top of the opening 1000. Similar to the chin region 1040, the nasal bridge region 1042 may extend along the entire or substantially the entire height of the upper section of the face-contacting surface 106 of the seal 180. The nasal bridge region 1042 may extend laterally a distance approximately equal to the width 1012 (FIG. 12). In the illustrated arrangement, the nasal bridge region 1042 has a generally inverted trapezoidal shape, with the longer edge above the shorter edge. However, in other configurations, the nasal bridge region 1042 may have other shapes.

[0149] Assuming that a gentle seal against the bridge of the nose is desired, the bridge of the nose region 1042 in the illustrated configuration is fairly thin. In some configurations, the bridge of the nose region 1042 is the thinnest part of the seal 180, which may be equal to the thickness of the rest of the seal 180. For example, a portion or the entire bridge of the nose region 1042 may have a thickness equal to the thickness of the chin region 1040. In some configurations, a portion or the entire bridge of the nose region 1042 is about 0.3 mm thick. In some configurations, the entire bridge of the nose region 1042 is about 0.3 mm thick. In some configurations, the bridge of the nose region 1042 may be less than 0.3 mm thick. For example, the thickness may be as thin as about 0.15 mm. However, it has been found that a thinner thickness may lead to or increase the likelihood of wrinkling of the bridge of the nose region 1042 under some facial geometries and / or some operating gas pressures. Maintaining a thickness of about 0.3 mm or greater throughout most or all of the nasal bridge region 1042 can reduce wrinkling over a significant range of operating pressures, which may include the full range of normal operating pressures.

[0150] The illustrated seal 180 also includes a side portion 1044 located along or adjacent to a side of the opening 1000. In the illustrated arrangement, the side portion 1044 is an elongated strip that extends along a vertical central portion of each side of the opening 1000. The side portion 1044 generally extends from an upper end of the lower portion 1004 of the seal 180 to a lower end of the upper portion 1002 of the seal 180. The side portion 1044 may be positioned on the seal 180 to extend along a user's cheek next to the user's nose.

[0151] Preferably, the sides 1044 have a relatively thin thickness to conform to a wide variety of facial geometries and maintain a seal in the presence of wrinkles, lines, or fine lines that may be present on a user's cheeks and / or caused by facial movements (e.g., smiling). For example, in some configurations, the sides 1044 have the thinnest thickness of the seal 180, which may be equal to the thickness of the remaining portions of the seal 180. For example, a portion or the entirety of each of the sides 1044 may have a thickness equal to the thickness of one or both of the chin region 1040 and the nasal bridge region 1042. In some configurations, a portion or the entirety of each of the sides 1044 has a thickness of about 0.3 mm. In some configurations, the entirety of the sides 1044 has a thickness of about 0.3 mm. In some configurations, a portion or the entirety of each of the sides 1044 may have a thickness less than 0.3 mm. For example, the thickness may be as thin as about 0.15 mm.

[0152] The illustrated seal 180 includes a perimeter 1046 that extends along a side of the perimeter of the seal 180. It has been found that the perimeter 1046 of the seal 180 must be substantially stiff to reduce wrinkling of at least a portion of the face-contacting area of ​​the seal 180 during use. In the illustrated arrangement, the perimeter 1046 extends along a generally vertically extending laterally outward portion of the face-contacting surface 106 of the seal 180.

[0153] In the illustrated arrangement, the perimeter 1046 extends along a substantial portion of the height of the lower portion 1004 of the opening 1000 on each side of the opening 1000. In some configurations, the perimeter 1046 extends along the entire height of the lower portion 1004 of the opening 1000. The upper end of the perimeter 1046 may extend at least to about a vertical position where the opening 1000 significantly narrows to form an upper portion 1002 that accommodates the bridge of the user's nose. The lower end of the perimeter 1046 may extend toward, to, or below the lower end of the opening 1000. The chin region 1040 may be positioned between the lower ends of the perimeter 1046. The perimeter 1046 and the chin region 1040 may each define a portion of the lower edge of the opening 1000.

[0154] In the illustrated arrangement, the top of the perimeter 1046 is spaced outwardly from the edge defining the opening 1000. In some configurations, the outward spacing of the top of the perimeter 1046 accommodates the side 1044 between the opening 1000 and the top of the perimeter 1046. In some configurations, the bottom of the perimeter 1046 extends closer to the opening 1000 than the top of the perimeter 1046. In the illustrated configuration, the bottom of the perimeter 1046 extends substantially to or to the edge defining the opening 1000.

[0155] The relatively thick perimeter 1046 may aid in resisting or preventing the seal 180 from collapsing in response to applied forces (e.g., headgear forces) in situations where there is not much internal gas pressure to facilitate fit and provide feedback to the user. The perimeter 1046 may help maintain the curvilinear shape of the sides of the seal 180 and / or help maintain separation between the rear wall of the seal 180 (which defines the face-contacting surface 106), the front end or wall of the seal 180, and the seal housing 190 or other structure directly forward of the face-contacting surface 106. In some configurations, a portion or the entire perimeter may have a thickness of about 1.0 mm to about 2.0 mm. In the illustrated configuration, a portion or the entire perimeter 1046 preferably has a thickness of about 1.5 mm. The thickness of the perimeter 1046 may be constant or may vary.

[0156] As discussed above, the seal 180 may include thickened nose pads 1032. The thickened nose pads 1032 are preferably positioned on each side of the top 1002 of the opening 1000. In the illustrated configuration, the nose pads 1032 intersect the perimeter 1046 such that a portion of the perimeter 1046 is located both above and below the nose pads 1032. Preferably, the thickened nose pads 1032 extend along at least a portion of the face-contacting surface 106 of the seal 180, but do not extend all the way to the edge defining the opening 1000. That is, the lateral inner edge 1034 of each of the nose pads 1032 terminates before the edge defining the opening 1000. The lateral outward edges of the nose pads 1032 may extend substantially to the outer edge 1010 of the face-contacting surface 106 of the seal 180 or to the outer edge 1010 of the face-contacting surface 106 of the seal 180. The lateral inner edge 1034 may be curved with the center of the curved portion positioned closer to the opening 1000 than the top and bottom of the curved edge 1034. In other words, the curved edge 1034 may be generally U-shaped, with the bottom of the U-shape positioned closer to the opening 1000 and the top of the U-shape positioned farther from the opening 1000.

[0157] 18, in some configurations, thickened nose pads 1032 are created by thickened areas of the seal 180 that extend into the interior of the cushion module 110 with additional material. The nose pads 1032 can extend into a stiffened portion of the seal 180, such as a thickened band 1060, which extends over the top of the seal 180 from one side to the other, as described in more detail below. The inventors have discovered that the presence of the nose pads 1032 can result in a dramatic reduction in leakage occurring at the sides of the user's nose. Additionally, comfort can be maintained by terminating the nose pads 1032 before the opening 1000.

[0158] It has been found that the nose pads 1032 should be relatively thick to improve the sealing performance of the seal 180, but should not be so thick as to cause discomfort. In some configurations, the nose pads 1032 are one of the thickest portions or are the thickest portion of the face contacting surface 106 of the seal 180. In some configurations, the nose pads 1032 are at least as thick as the perimeter 1046. In some configurations, the nose pads 1032 are thicker than the perimeter 1046. In some configurations, the nose pads 1032 are about 1.5 mm to 2.0 mm thick. In some configurations, the nose pads 1032 are about 1.8 mm thick.

[0159] 19, as described above, the illustrated seal 180 includes a continuous thin interior edge section 1030 of an edge that defines at least a portion of the opening 1000 at the top 1002 of the seal 180. The continuous thin interior edge section 1030 need not be a separate section, and may be partially or completely defined by other portions of the seal (e.g., side portion 1044 or nose bridge portion 1042), so long as the entire section 1030 is less than the desired thickness. In some configurations, the continuous thin interior edge section 1030 extends along approximately the entire top half of the seal 180, or at least approximately the entire top half of the seal 180. In some configurations, the continuous thin interior edge section 1030 extends along approximately the top two-thirds of the seal 180 or at least about the top two-thirds of the seal 180. In some configurations, the continuous thin interior edge section 1030 extends at least about 0.5 mm to about 1 mm inward from the edge that defines the opening 1000. In some configurations, the thin edge section 1030 may extend further from the edge defining the opening 1000; however, as discussed above, it may be desirable for the further interior portions of the seal 180 to have a greater thickness.

[0160] In some configurations, the thin edge section 1030 has a thickness of about 0.6 mm or less, or about 0.4 mm or less. In some configurations, at least the first 0.5 mm extending from the edge defining the opening 1000 is less than about 0.4 mm thick. The continuous thin interior edge section 1030 can vary in thickness within these desired thickness ranges in a direction extending inwardly from the edge defining the opening 1000 or along its length. Providing a continuous thin interior edge section 1030 has been discovered by the inventors to improve the sealing characteristics of the seal 180 for at least some conditions or facial geometries.

[0161] The seal 180 may have other portions than those described above. For example, the seal 180 may include one or more transition portions 1048 in the regions between the portions described above. Although the transition portion 1048 is referred to herein in the singular, the transition portion 1048 is not necessarily a single unbroken region, but may include several distinct or broken regions. The transition portion 1048 may define a thickness that transitions between any one or more (including all) of the chin region 1040, the nasal bridge region 1042, the side portion 1044, the perimeter portion 1046, and the nose pads 1032. The transition portion 1048 may extend away from, be located between, or define a thickness that transitions between two regions in any suitable manner, such as, for example, a gradual or abrupt transition. The thickness transition may occur within the transition portion 1048 or along an edge of the transition portion 1048, for example. In the illustrated configuration, the perimeter portion 1046 is substantially surrounded by the transition portion 1048. The chin region 1040 may be separated from the perimeter portion 1046 by a transition portion 1048. The nasal bridge region 1042 may be separated from the perimeter portion 1046 and / or the nose pads 1032 by a transition portion 1048. Similarly, the side portion 1044 may be separated from the perimeter portion 1046 by a transition portion 1048. Other configurations are possible.

[0162] FIG. 20 shows several cross-sectional views of one side of seal 180 of several different designs. The sections are created by a substantially horizontal cut through a portion of seal 180 including side 1044 and perimeter 1046. Design A of FIG. 20 includes an inner surface (surface in FIG. 20) that has a relatively abrupt change in direction identified in the figure as the bending point. Thus, the difference in thickness of seal 180 on each side of the bending point varies quite significantly. As a result, it has been discovered that when seal 180 is pressed against the user's face, seal 180 tends to bend around the bending point instead of deforming in a relatively uniform manner. Design B exhibits a smoother curvilinear shape for the inner surface that improves the ability of seal 180 to deform in a uniform manner. Design C exhibits an even smoother curvilinear shape compared to design B. Thus, designs B and C represent improved cross-sectional shapes for seal 180 compared to design A, with design C being somewhat more preferred than design B. The more uniformly the seal 180 deforms, or the more the cross-section of the seal 180 deforms from approximately circular to approximately squashed or compressed oval, rather than simply collapsing near a point or narrow area, the larger the seal contact area on the face, which reduces pressure on the user's skin and allows the seal to better conform to different facial geometries.

[0163] In at least some configurations, the upper portion 1002 of the seal 180 is designed to roll on the outer surface of the cushion module 110, which allows the nose bridge region 1042 to move in a forward direction relative to the lower portion 1004 of the seal 180. With reference to FIGS. 21-28, to aid in the rolling of the upper portion 1002, the upper portion 1002 may have a variety of thicknesses or a variety of stiffnesses. Although the illustrated configuration uses a region of reduced thickness 172, other means for providing a region of reduced stiffness may also be used to induce the rolling of the seal 180. For example, the material of the seal 180 may be configured to have reduced stiffness through material selection or material properties. Additionally, a composite of materials may be used to provide a region of reduced stiffness or stiffness. Additionally, any combination of suitable techniques may be used. Nonetheless, the illustrated region 172 configured to have reduced thickness provides a simple method of achieving the region of reduced stiffness 172. Additionally, by adjusting the stiffness of the reduced stiffness region 172, the force required to induce rolling of the region 172 can be controlled, which in turn controls the force exerted on the user's nose. For example, by varying the stiffness, movement can be resisted more or less over the range of movement. The reduced stiffness region 172 is also referred to as a rolling portion.

[0164] 21 and 22, one or more reinforcing components, such as bands 1060, may be positioned along at least a portion of the upper portion 1002 to reduce bulging in the upper portion 1002 and to provide a reinforced structure to the upper portion 1002 to facilitate rolling of the seal 180 in desired portions. The bands 1060 may be components formed from a material that is stiffer than the silicone or other material forming the seal 180 or that features increased stiffness relative to the silicone or other material forming the seal 180. For example, a significantly thicker region compared to the reduced stiffness region 172 may be used to increase the stiffness of one or more reinforcing components if the region is formed from the same material forming the seal 180.

[0165] In some configurations, the band 1060 may be a separately formed component that is at least partially encased in the material of the seal 180. For example, the band 1060 may be a comolded plastic component, or the seal 180 may be overmolded onto the band 1060. In some configurations, the band 1060 may be defined by a portion of the upper portion 1002 that has increased stiffness relative to surrounding areas. For example, but not limited to, the band 1060 may be defined by portions of increased thickness, different materials or material properties that provide increased stiffness, etc. In the illustrated arrangement, the band 1060 includes areas of increased thickness of the material of the base seal 180, similar to the different areas described above with reference to FIG.

[0166] In some configurations, the band 1060 extends along at least a portion of the top 1002 of the seal 180. The top 1002 of the seal 180 includes an apex 1070 (FIG. 8) when viewed from the front. The apex 1070 may be defined as the tip, top, and angled apex of the seal 180, which is positioned proximate to the user's nose in use. The first and second side walls 1072, 1074 converge at the apex 1070 in the illustrated configuration. The first and second side walls 1072, 1074 extend along at least a portion of the top 1002 of the seal 180. In some configurations, the first and second side walls 1072, 1074 extend below the top 1002 into the bottom 1004 of the seal 180.

[0167] In some configurations, at least a portion of the first side wall 1072 and at least a portion of the second side wall 1074 are reinforced by the band 1060. In the configuration shown, the band 1060 reinforces at least a portion of the first wall 1072 and at least a portion of the second wall 1074. In some configurations, the band 1060 reinforces at least a portion of the first wall 1072, at least a portion of the second wall 1074, and the top 1070.

[0168] 18 and 22, the illustrated band 1060 has a first end 1076 and a second end (not shown) opposite the first end 1076. The illustrated band 1060, like the seal 180, is symmetrical about a centerline or mid-plane of the seal 180. Thus, the opposite side of the band 1060 including the second end is a mirror image of the illustrated side including the first end 1076. The first end 1076 and the second end may be located at or near the bottom end of the nose pad 1032 as shown in FIG. 18. The first end 1076 and the second end may be located relatively higher or relatively lower to make the band 1060 shorter or longer, respectively, depending on the amount of reinforcement desired. The illustrated band 1060 flares outward at the ends 1076 and tapers in the center in the front-to-back direction. However, other shapes are possible.

[0169] 21 and 22, the illustrated reduced stiffness region 172 includes a first or front wall portion (hereinafter, front wall 1080) and a second or top wall portion (hereinafter, top wall 1082). In the illustrated arrangement, the front wall 1080 is a relatively vertical wall that extends upwardly from a connection portion 1084 between the seal 180 and the seal housing 190. The top wall 1082 is a relatively horizontal wall that extends rearwardly from an upper end of the front wall 1080 toward or into the band 1060. The illustrated front wall 1080 and top wall 1082 are generally L-shaped in cross-section to form an angle therebetween (e.g., approximately a 90 degree angle) in the neutral, or unloaded, condition of the top 1002 of the seal 180. However, in other configurations, the area of ​​reduced stiffness 172 may be defined by a single wall or may have a rounded or curved profile where the distinction between the first and second wall portions is less clear.

[0170] The front wall 1080 and the top wall 1082 extend downwardly from the top 1070 along the first and second walls 1072, 1074 (FIG. 8). In the illustrated arrangement, the front wall 1080 and the top wall 1082 extend and terminate at an inwardly projecting ledge 1086 on each side of the seal 180. In the illustrated arrangement, each of the ledges 1086 is located directly below the end 1076 of the band 1060. The ledges 1086 serve to affect the portion of the seal 180 that deforms in addition to the stiffness reduced region 172 when the top portion 1002 of the seal 180 moves forward. In some configurations, the ledges 1086 encompass or substantially encompass the deformation of the seal 180 as a result of the forward movement of the top portion 1002 into the stiffness reduced region 172.

[0171] In some configurations, the connecting portion 1084 and the forward edges of the band 1060 converge in a direction from the apex 1070 to the shelf 1086. In the illustrated arrangement, the connecting portion 1084 and the forward edges of the band 1060 remain somewhat spaced apart from one another at or near the shelf 1086. When viewed in profile from a side view, the region of reduced stiffness 172 defines a generally triangular or wedge shape, as shown, for example, in FIGS.

[0172] In some configurations, the region of reduced stiffness, i.e., rolling portion 172, may be located between and bounded by a first boundary 1090 and a second boundary 1092, which have a higher stiffness relative to the region of reduced stiffness 172. For example, in the illustrated configuration, the first boundary 1090 is defined by or parallel to a portion of band 1060 (e.g., a front edge of band 1060), while the second boundary 1092 is defined by or parallel to a connecting portion 1084 (e.g., an origin of front wall 1080) or a bend or transition between front wall 1080 and top wall 1082. In some configurations, the second boundary 1092 may be defined by or parallel to an edge of the stiffer seal housing 190. In some configurations, the second boundary 1092 may be defined along a portion of the seal 180 located between the seal housing 190 and the region of reduced stiffness 172. A hinge axis H for movement of the upper portion 1002 of the seal 180 is defined by or located near the intersection or overhang of the first boundary 1090 and the second boundary 1092.

[0173] 28, as the top 1002 of the seal 180 is displaced about the hinge axis H, the rolling portion increases in size. In other words, as the first boundary 1090 initially moves toward the second boundary 1092, a rolling portion is formed in the seal 180. As the first boundary 1090 continues to move toward the second boundary 1092, the rolling portion continues to increase in size. Thus, in at least some configurations, there is initially no rolling portion defined in the top 1002, which progressively increases during the displacement of the top 1002. Preferably, the rolling between the first boundary 1090 and the second boundary 1092 creates a single bend or curve between the first boundary 1090 and the second boundary 1092. The single bend results in legs approaching a bent position that increase in size as the first boundary 1090 moves toward the second boundary 1092. In other words, the rolling created by the movement of the first boundary 1090 towards the second boundary 1092 preferably does not result in a fan-like appearance, such as a pleated configuration.

[0174] In at least some configurations where multiple sizes of cushion modules 110 or seals 180 are provided, it may be desirable for the different sizes of reduced stiffness regions 172 to have different arrangements, characteristics or dimensions from one another. For example, the reduced stiffness regions 172 may define different angles between the boundaries 1090, 1092 in the relaxed position between the various sizes. Additionally or alternatively, the reduced stiffness regions 172 may define different front wall 1080 heights (or different overall lengths of the front wall 1080 and top wall 1082) between the various sizes. Figures 23-26 illustrate different angles and different front wall 1080 heights between the cushion modules 110 or seals 180 of several sizes.

[0175] 23 and 24, three different sizes of seals 180A, 180B, 180C are shown. The seals 180A, 180B, 180C can be, for example, seals of the three cushion modules 110A, 110B, 110C of FIGS. 8 and 9. FIG. 23 shows the relationship between the length of the boundaries 1090, 1092 and the maximum forward displacement of the upper portion 1002. Assuming that the length of the upper portion 1002 increases or decreases with an increase or decrease in the length 180 of the seal, the length of the boundaries 1090, 1092 also increases or decreases. If the available angle of change between the boundaries 1090, 1092 is kept constant between the sizes of the seal 180, the available maximum forward displacement of the upper portion 1002 is smaller for smaller sizes of the seal 180 and larger for larger sizes of the seal 180.

[0176] For example, FIG. 23 illustrates a first boundary 1090 and a second boundary 1092A, 1092B, 1092C for three sizes of seal 180. Assuming that all three illustrated seal 180 sizes are given a maximum available deflection angle (e.g., the angle between boundaries 1090 and 1092) equal to the maximum deflection angle of the larger seal 180C, the maximum available forward displacement of the upper portion 1002 of seals 180A and 180B is indicated by the intersection between boundary 1092C and the arc lines of boundaries 1092A and 1092B. FIG. 23 illustrates that by increasing the angle between boundaries 1090, 1092 at a relatively small angle, the maximum available forward displacement of the upper portion 1002 can be the same or similar between several sizes of seals 180A, 180B, 180C. Thus, preferably, the angle between boundaries 1090, 1092 is maximum for the smallest size seal 180A and minimum for the largest size seal 180C. However, in other configurations, the smallest sized seal may have an angle greater than at least one of the larger sized seals, and similarly, the largest sized seal may have an angle less than at least one of the smaller sized seals.

[0177] In some configurations, the small seal 180A defines an angle between the boundaries 1090, 1092A that is at least about 30 degrees in the relaxed position of the top 1002. In some configurations, this angle is about 34 degrees. In some configurations, the medium size seal 180B defines an angle between the boundaries 1090, 1092B that is about 25 degrees to about 35 degrees in the relaxed position of the top 1002. In some configurations, this angle is about 29 degrees. In some configurations, the large seal 180C defines an angle between the boundaries 1090, 1092C that is about 20 degrees to about 30 degrees in the relaxed position of the top 1002. In some configurations, this angle is about 27 degrees. However, other configurations are possible. For comparison, the angle of the Simplus® seal is approximately 16 degrees for all seal sizes.

[0178] 25 and 26 show the difference in height of the front wall 1080 between various seal sizes. As the rotation angle of the top 1002 of the seal 180 increases, the downward movement of the band 1060 or other boundary 1090 increases. For example, FIG. 25 shows the difference between the downward movement D1 and the movement D2 between a first available maximum deflection angle (indicated by 1092 position 1) and a second available maximum deflection angle (indicated by 1092 position 2), the second angle being greater than the first angle. The downward movement D2 as a result of the greater maximum deflection angle is substantially greater than the downward movement D1 as a result of the smaller maximum deflection angle. Thus, the height of the front wall 1080 in the seal 180 is preferably greater than the height of the front wall in the Simplus® seal. In some configurations, the overall length of the stiffness-reduced region 172 is also greater in the seal 180 than in the Simplus® seal.

[0179] FIG. 26 illustrates three different sizes of seals 180A, 180B, 180C, which may be, for example, seals of the three cushion modules 110A, 110B, 110C of FIGS. 8 and 9. The seals 180A, 180B, 180C each define a height 1100A, 1100B, 1100C, respectively, of the front wall 1080. The height 1100 may be defined by the distance between the top 1070 and the top surface of the seal housing 190 or the connecting portion 1084. In some configurations, the heights 1100A, 1100B, 1100C are greater than about 5 mm or greater than about 6 mm. In some configurations, the heights 1100A, 1100B, 1100C are greater than about 7 mm. In some configurations, at least one of the heights 1100A, 1100B, 1100C is greater than about 7.5 mm. In some configurations, height 1100A is less than one or both of heights 1100B, 1100C. In some configurations, height 1100C is greater than one or both of heights 1100A, 1100B. In some configurations, height 1100A is less than 1100B and height 1100C is greater than 1100B. In some configurations, height 1100A is about 7.3 mm. In some configurations, height 1100B is about 7.6 mm. In some configurations, height 1100C is about 7.7 mm. For comparison, the equivalent height of a Simplus® seal is about 4.4 mm.

[0180] The reduced stiffness region 172 and / or the upper portion 1002 of the seal 180 may include features that facilitate the desired rolling of the upper portion 1002 of the seal 180. For example, with reference to FIG. 27 , at least a portion of the reduced stiffness region 172 includes a gradual or graduated thickness that preferably increases in a direction from the forward boundary 1092 to the aft boundary 1090. Preferably, in the graduated thickness portion, the thickness is lowest at or toward the forward end of the reduced stiffness region 172 and is greatest at or toward the aft end of the reduced stiffness region 172.

[0181] In some configurations, the thickness of one or both of the front wall 1080 and the top wall 1082 gradually or incrementally increases in the direction from the connecting portion 1084 toward the band 1060. In the illustrated arrangement, the wall thickness gradually increases from the lower end or connecting portion 1084 of the front wall 1080 to or near the band 1060 in both the front wall 1080 and the top wall 1082. That is, the rate of change of wall thickness is constant in the front wall 1080 and the top wall 1082 despite the transition from one to the other. Such an arrangement allows for controlled deformation of the reduced stiffness region 172 by allowing the bending point to move from anterior to posterior as the thinner material bends or flexes before the thicker material bends or flexes. In other configurations, the increase in thickness is different in the front wall 1080 and the top wall 1082. For example, the thickness can increase gradually at the front wall 1080 and can remain constant or increase at a different rate at the top wall 1082. In other configurations, the thickness of the top wall 1082 can increase gradually and the thickness of the front wall 1080 can remain constant or increase at a different rate than the top wall 1082.

[0182] 21, the amount of overlap between the seal 180 and the seal housing 190 may vary along the circumference of the seal 180 and the seal housing 190, or along the junction between the seal 180 and the seal housing 190. The dashed lines in FIG. 21 indicate the edges of the seal housing 190. The solid lines in front of (to the right of) the dashed lines indicate the edges of the seal 180. The edges of the seal 180 define a relatively smoothly curved shape, and the edges of the seal housing 190 define a relatively smoothly non-curved shape. The overlap between the seal 180 and the seal housing 190 may be greater at or near the central section of the cushion module 110, in a direction perpendicular to other portions of the cushion module 110. The variation in overlap may be to increase retention of the seal 180 against the seal housing 190, or may simply be to allow the edges of the seal 180 to have a desired aesthetic shape. In some configurations, the increased or relatively large overlap may inhibit or prevent seal 180 from expanding laterally in an outward direction in response to forces caused by headgear forces or gas pressure within seal 180. Additionally, in at least some configurations, the increased or relatively large overlap and / or the location of the edges of seal housing 190 closer to hinge axis H provides stiffness at or near hinge axis H, which may enhance rolling or hinging behavior about hinge axis H.

[0183] 29A-29F, the cushion module 110 is shown in a rear plan view, a side view in a first (e.g., neutral) position, and a side view in a second (e.g., depressed or fully depressed) position. Similarly, a Simplus® cushion module is shown in a rear plan view, a side view in a neutral position, and a side view in a depressed position. The rear plan views of FIGS. 29A-29F show measurement points on a vertical centerline at the top of the seal 180 and at the bottom of the seal 180. In some configurations, the height of the seal 180 is measured between two points on the vertical centerline located at the midpoint of the sealing surface. A first point 1200 is located at the nasal bridge region of the seal 180, and a second point 1202 is located at the chin region of the seal 180. The points 1200, 1202 generally correspond to the location of the user's nose bridge and chin where the seal 180 makes contact and forms a substantially airtight seal.

[0184] The vertical distance between the points 1200, 1202, i.e., the dimension 1204, is an important factor in determining the fit of the seal 180 or cushion module 110 to the user. For example, the dimension 1204 is closely related to the dimension or length of the user's Sublabiale-Sellion (SS) point at which the seal 180 or cushion module 110 provides a proper or desired fit. In at least some configurations, there is a significant difference between the dimension 1204 of the seal 180 in the neutral position and the depressed position, which may be the fully depressed position. For example, the dimension 1204 may differ by more than 2 mm between the neutral position and the depressed position. In some configurations, the dimension 1204 may vary by at least about 4 mm, at least about 5 mm, or at least about 6 mm between the neutral position and the depressed position. In at least one size or embodiment of the seal 180, the dimension 1204 may vary from about 90 mm to about 84 mm between the neutral position and the depressed position. In other words, the variation in dimension 1204 is approximately 6 mm. For comparison, the Simplus® cushion module varies only 2 mm between the neutral and fully depressed positions (from approximately 91 mm to approximately 89 mm, respectively).

[0185] Variation in dimension 1204 may allow a particular size or embodiment of seal 180 (or cushion module 110) to accommodate a wider range of users. For example, variation in dimension 1204 may allow a particular size or embodiment of seal 180 (or cushion module 110) to be deformed or pressed down until dimension 1204 is appropriately sized for a particular user's facial shape (e.g., SS length). Greater variation in dimension 1204 may be provided by greater angular displacement of top 1002 of seal 180 as a result of the rolling action described above, by an increase in the height of front wall 1080 or an increase in the length of reduced stiffness region 172, by other factors, or by any combination thereof. In some configurations, greater variation in dimension 1204 may be provided, for example, at least about 8 mm, at least about 10 mm, at least about 12 mm, or more. In some cases, greater variation is preferred, as long as other performance criteria are not undesirably affected. In some configurations, the deformation may depend on or vary with the size of the seal 180 or cushion module 110, e.g., larger sizes have a greater variation in dimension 1204 than smaller sizes. For example, the variation may be a percentage of dimension 1204, such as any percentage encompassed within the values ​​or ranges disclosed above. In some configurations, the variation in dimension 1204 may be at least about 5 percent, at least about 6 percent, at least about 6-and-a-half percent, at least about 8 percent, at least about 10 percent or more between the neutral and depressed positions.

[0186] In alternative embodiments, the cushion module 2010 may include multiple rolling portions to accommodate different facial geometries. For comparison, FIG. 30 shows a cushion module 2010 with a single rolling beam 2012. To allow the cushion module 2010 to accommodate different sub-lip to mid-nasal lengths among users of different sizes and facial shapes, the single rolling beam 2012 allows the nose contact point 2014 to rotate closer to the housing 2020 about the hinge point H1. The length of the seal 2016 between the nose contact point 2022 and the chin contact point 2024 may roughly correspond to the sub-lip to mid-nasal length of the user's face. Thus, the seal length L1 when the single rolling beam 2012 is not rolling is greater than the seal length L2 when the rolling beam 2012 has rolled to the displaced nose contact point 2026. The difference between L1 and L2 allows the single rolling beam 2012 to accommodate a variety of sublip-nasal midpoint lengths. The cushion module 2010 may be provided in three mask sizes (i.e., small, medium, and large) to accommodate a variety of sublip-nasal midpoint lengths. However, by further rotating the single rolling beam 2012 about the hinge point H1 to provide a larger displacement of the nose contact point 2022 (i.e., shortening the length L2 when the reduced rolling beam is rolled), the number of mask sizes can be reduced while accommodating a similar range of sublip-nasal midpoint lengths.

[0187] In contrast, Figures 31-33 show a cushion module 2110 having a first rolling portion 2112 and a second rolling portion 2114. The first rolling portion 2112 is connected to a hinge point H 11 The second rolling part rotates around the hinge point H 12 30. The second rolling portion 2114 is positioned below the first rolling portion 2112. The first rolling portion 2112 is substantially the same as the single rolling portion 2012 in FIG. 30. However, the housing 2120 is reduced in height relative to the housing 2020 in FIG. 30 to allow for the additional rolling portion.

[0188] 32A and 32B show the cushion module 2110 in an unrolled and rolled configuration, respectively. The first rolling portion 2112 is configured to roll on top of the second rolling portion 2114. In use, the first and second rolling portions 2112, 2114 roll simultaneously as a result of or having similar geometric shapes that provide similar resistance to rolling. As a result, it is unlikely that the first rolling portion 2112 will roll completely without the second portion 2114 rolling completely.

[0189] As shown in FIG. 11 L is the length of the seal 2116 between the nose contact point 2122 and the chin contact point 2124 when the first and second rolling portions 2112, 2114 are not rolling. 12 is the seal length when only the first rolling portion 2112 rolls completely apart from the second rolling portion 2114. 12 L 11 Shorter. L 13 is the seal length when both the first and second rolling portions 2112, 2114 have fully rolled to the displaced nose contact point 2126. 13 L 11 and L 12 Shorter than both. 11 and L 13 The difference is L 11 and L 12 30. In a preferred embodiment, L is greater than the difference between the lateral and medial sides of the cushion module 2110 and the lateral sides of the cushion module 2110. 11 has a length of approximately 102 mm, and L 13 has a length of approximately 85 mm and provides a total range of approximately 17 mm.

[0190] The cushion module 2110 has a first thickened region 2130 that defines an intersection between the first rolling portion 2112 and the top of the sealing surface 2118. A second thickened region 2132 defines the intersection between the first and second rolling portions 2112, 2114. The first and second thickened regions 2130, 2132 provide a reinforcing structure to prevent the first and second rolling portions 2112, 2114 from collapsing as they roll. Thus, the first thickened region 2130 isolates the sealing surface 2118 from the rolling portions 2112, 2114, substantially inhibiting or preventing leakage from occurring as the seal rolls.

[0191] FIG. 34 illustrates a system for providing CPAP therapy to a user. The system includes a CPAP machine 3100 configured to provide a source of breathable pressurized gas (air), an air supply hose 3110, and a respiratory mask 3120. The air supply hose 3110 is configured to provide a flow path through which pressurized air is supplied to the respiratory mask 3120 and thus to the user U. Respiratory masks are available in a variety of configurations including, but not limited to, full face masks, nasal and direct nasal masks. Typically, full face masks are configured to substantially surround the user's nose and mouth, nasal masks generally surround the nose, and direct nasal masks include a pillow or cannula element configured to seal against the inside of the user's nostrils.

[0192] The following disclosure is described in the context of a nasal or direct nasal mask, but it should be understood that alternative embodiments for other mask configurations are possible. Some direct nasal masks are known to include a short tube component between the respiratory mask 3120 and the air supply hose 3110 forming a flexible intermediate connection, such as Pilairo™ by Fisher & Paykel Healthcare Ltd. This tube provides a means to at least partially decouple any forces that the air supply hose 3110 may exert on the respiratory mask 3120. The tube is generally much lighter and more flexible than the air supply hose 3110, and therefore exerts less force on the respiratory mask 3120. This may be particularly beneficial for direct nasal masks, and possibly nasal masks, because they are generally smaller and lighter, and therefore more likely to be removed from the user's face when force is applied. Removing the respiratory mask 3120 from the user's face may result in a weakened effectiveness of the treatment. The inclusion of a tube between the air delivery hose 3110 and the respiratory mask 3120 means that forces exerted by the air delivery hose 3110 must be transmitted through the tube to affect the interaction between the respiratory mask 3120 and the user. Such an intermediate tube may be used as a component of the biased airflow system of the present disclosure.

[0193] 35 illustrates a respiratory mask 3200 including a biased airflow system 3210 of the present disclosure. The respiratory mask 3200 also includes a mask frame 3220, a seal 3230, a head strap 3240, an elbow joint 3250, a tube 3260, and a swivel 3270.

[0194] The bias air system 3210 includes a tube 3260 and an annular array of radially aligned exhaust holes 3280. The tube 3260 includes a wall 3262 and a bead 3264. The wall 3262 is configured to be substantially cylindrical and includes a thin, flexible film that may be made from any suitable thermoplastic material, such as, but not limited to, polyurethane Elastollan 1180A. The bead 3264 is configured to provide structure to the wall 3262 that reduces or eliminates the possibility of collapse and closure of the tube 3260. The bead 3264 extends in a helical configuration along the length 3260 of the tube and has a cross-sectional profile that rises from the outer surface 3300 of the wall 3262, as shown in FIG. 36. The cross-section of the bead 3264 is substantially rectangular and may have rounded edges (not shown). In alternative embodiments, the bead 3264 may have any suitable shape, such as, but not limited to, semicircular, elliptical, polygonal, or asymmetric. The cross-sectional shape of the bead 3264 in conjunction with the choice of material determines the stiffness of the bead 3264 and therefore the structural support provided to the wall 3262. The bead 3264 is made of a material such as, but not limited to, polyurethane Elastollan 1174D that is substantially stiffer than the material of the wall 3262. The flexibility of the wall 3262 compared to the bead 3264 is such that the tube 3260 may be compressed along the central axis in a spring-like manner, allowing the wall 3262 to fold or deform and reduce the pitch of the bead 3264. In an alternative embodiment (not shown), the pitch of the bead 3264 may vary along the length 3260 of the tube such that the amount of deformation along different portions along the length of the tube 3260 may vary. Still further, the pitch of the bead 3264 may vary along portions of the tube 3260 such that the tube 3260 may have a curved shape.

[0195] The exhaust holes 3280 are formed in the bead 3264 and are radially or spirally spaced at regular intervals around the circumference of the tube 3260. The exhaust holes 3280 are configured to provide a path for air to be exhausted from within the respiratory mask 3200. The exhaust of air from within the mask 3200 allows CO2 to flow out, thus preventing the user from rebreathing CO2. The radial alignment of the exhaust holes 3280 allows the exhausted air to be dispersed over 360°. FIG. 37 shows an example of how the exhausted air 3400 can be dispersed over a wide range (360°) by radially aligned holes 3410 in the cylindrical conduit 3420. The radially aligned holes 3410 or exhaust holes 3280 provide a flow path for the exhausted air to dissipate, which minimizes the airflow that can be detected at any one position relative to the cylindrical conduit 3420 or tube 3260. The radial arrangement and spacing of the exhaust holes 3280 in the helical bead 3264 may help minimize air entrainment that may cause a user to detect greater drafts. The formation of the exhaust holes 3280 on the helical bead results in the individual exhaust holes being offset from one another in the longitudinal direction. This further increases the dispersion of the exhausted air. It is desirable to position the exhaust holes 3280 in the bead 3264 to reduce or eliminate the possibility of the holes being crushed or blocked due to deformation of the tube 3260. In an alternative embodiment (not shown), the exhaust holes 3280 may be spaced around only a portion (e.g., 180°) of the circumference of the tube 3260, or may be formed in the tube wall rather than the bead. For example, the exhaust holes 3280 may be positioned only on the portion of the tube 3260 that faces outwardly toward the user, such that the exhausted air exits the tube 3260 in a direction away from the user. In other alternative embodiments (not shown), the exhaust holes 3280 may be angled relative to the axial direction of the tube length 3260. For example, the exhaust holes 3280 may be positioned at a non-orthogonal angle extending axially away from the respirator mask such that the exhausted air is directed away from the user.

[0196] The exhaust holes 3280 may include any suitable cross-sectional shape, including, but not limited to, circular, elliptical, polygonal, or asymmetric. In embodiments where the exhaust holes 3280 are circular, the hole diameter may be at least approximately 0.1 mm and / or no more than approximately 1.5 mm. A diameter of less than 0.5 mm may be advantageous to reduce noise caused by any exhausted air. In a preferred embodiment, the exhaust holes 3280 have a diameter of approximately 0.4 mm. The exhaust holes 3280 are formed by laser drilling or cutting, which allows for radial alignment of the exhaust holes and the formation of holes with small diameters (i.e., less than 0.5 mm). The diameter and spacing of the exhaust holes 3280 may depend on the total number of holes required to effectively flush CO2 from within the respiratory mask 3200. The exhaust holes 3280 may be spaced at a maximum distance from each other that allows the total number of exhaust holes required to fit within the tube 3260. In some embodiments (not shown), the exhaust holes 3280 may be spaced along only a portion of the tube length. For example, the exhaust holes 3280 may be located only at the bottom of the tube 3260 such that the exhaust air exits the tube 3260 away from the user's head. Thus, noise from the exhaust air is less likely to disturb the user due to the increased distance between the user's head and the exhaust holes 3280. In some such embodiments (not shown), the exhaust holes 3280 may be spaced at a maximum distance from each other that allows the total number of exhaust holes to fit within a portion of the length of the tube. In other alternative embodiments (not shown), the exhaust holes may be irregularly spaced along the length of the tube 3260. For example, the spacing between the exhaust holes 3280 may increase or decrease along the length of the tube 3260 depending on the airflow and noise requirements.

[0197] In alternative embodiments (not shown), variations of the biased airflow systems disclosed herein may be incorporated into tubes of different configurations. A wide variety of plastic tube configurations are available in the industry, including, but not limited to, flat cylindrical tubes and corrugated tubes. Drain holes may be incorporated into any suitable portion of the tube structure.

[0198] 38 illustrates a biased airflow system for use in venting exhaled air from within a respiratory mask. A ventilation system generally provides a pathway through which air exhaled by a user may be vented to the atmosphere.

[0199] 38, a respiratory mask 4100 incorporates a biased air system in accordance with the subject matter disclosed herein. The respiratory mask 4100 includes a cushion module 4110, a mask frame 4120, and an air source connection 4130. The cushion module 4110 includes a seal housing 4140 and a seal 4150. The mask frame 4120 includes a shroud 4160.

[0200] As shown in FIG. 39, there is an annular component 4200 extending from the front wall 4240 of the seal housing 4140. The annular component is connected to the mask frame 4120 and forms a fluid connection between the cushion module 4110 and the air source connector 4130. The connection between the annular component 4200 and the mask frame 4120 may be configured to include a snap-fit ​​connection that allows the two components to be disassembled for cleaning. Alternatively, the connection may be permanent and the components may be secured together by any suitable means known in the art, such as adhesive or welding. The air source connector 4130 and the annular component 4200 may be aligned and / or connected such that any air supplied to the mask via the air source connector 4130 passes through the annular component 4200 and into the breathing chamber 4210 formed by the seal housing 4140.

[0201] The annular component 4200 may be formed as a separate component and then attached to a hole in the seal housing 4140. The connection between the annular component 4200 and the seal housing 4140 may be achieved by an interference snap-fit ​​configuration, adhesive, welding or any other suitable connection process. The interference snap-fit ​​may be configured to allow adjustability between the annular component 4200 and the seal housing 4140 by providing separate adjustment positions. Alternatively, the annular component 4200 and the seal housing 4140 may be molded as a unitary component. Alternatively, the mask frame 4120 may be a common size to which cushion modules 4110 of various sizes (e.g. small, medium, large) may be connected.

[0202] The annular component 4200 is configured to include an array of exhaust holes 4220. The exhaust holes 4220 may be radially spaced about the circumference of the annular component 4200. The radial arrangement of the exhaust holes results in exhausted air being distributed 360° around the annular component 4200, as can be seen in FIG.

[0203] 40 shows an example cross-sectional view of a cylindrical or annular component 4300 with radial exhaust holes 4310. The arrows shown in FIG. 40 illustrate how the exhausted air 4320 is distributed through the holes 4310. This distribution is beneficial because it distributes the exhausted air 4320 over a larger area, thereby reducing drafts that may be detected at any one position relative to the annular component 4200. The radial arrangement of the holes and the spacing between the holes can minimize entrainment of atmospheric air that may result in more drafts being detected by the user.

[0204] In one non-limiting exemplary embodiment, the exhaust holes are preferably formed by laser drilling. Laser drilling allows for radial hole configuration and allows for the formation of small hole diameters. The hole diameter may be approximately 0.4 mm. When used herein in relation to dimensions, the term "approximately" should be understood to mean within standard manufacturing tolerances or deviations that may be introduced and / or expected during manufacturing. Furthermore, the term "approximately" may be extended to or include dimensions that can be rounded to the stated value. However, laser drilling of holes may result in tighter tolerances on the hole diameter than traditional forming methods such as molding. Small hole diameters may be beneficial in reducing drafts and noise. Alternatively, traditional molding techniques may be used to form the exhaust holes 4220 in the annular component 4200. The number of holes may be determined by the flow rate required to effectively flush CO2 out of the breathing chamber 4210 of the mask.

[0205] The annular component 4200 and the exhaust holes 4220 may be surrounded by a shroud 4160. The shroud 4160 may be an integrally formed part of the mask frame 4120 and may extend radially from the user end (in use) of the air source connector 4130. The shroud 4160 has a substantially conical shape. The shroud 4160 creates a plenum chamber 4230 between the mask frame 4120 and the front wall 4240 of the seal housing 4140. A radial ventilation path 4250 may be formed between the outer periphery of the shroud 4160 and the front wall 4240. The radial ventilation path 4250 allows the exhausted air to remain distributed over 360°, which may reduce detectable drafts.

[0206] Air may be exhausted through the exhaust holes 4220 and enter a plenum chamber 4230 formed by the shroud 4160, the annular component 4200, and the front wall 4240 of the seal housing 4140. As the exhaust air passes through the exhaust holes 4220, it accelerates. However, by diverting the exhaust air to the plenum chamber 4230 before exiting through the ventilation path 4250, the exhaust air is slowed down and redirected. The space in the plenum chamber forms an expansion chamber that allows the energy present in the exhaust air to dissipate before exiting the shroud 4160 via the ventilation path 4250. This can reduce the fluid velocity and increase the fluid pressure of the air passing through the exhaust holes 4220, resulting in reduced or prevented entrainment of atmospheric air. The reduced fluid velocity and reduced entrainment substantially reduces or prevents the detection of drafts by a user.

[0207] 41 is a screenshot of a computational fluid dynamics (CFD) analysis of the geometry of the exhaust holes 4220 and the shroud 4160. It can be seen from the cross section that the fluid velocity slows substantially as it exits via the ventilation path 4250. It can also be seen that the geometry of the shroud 4160 and plenum chamber 4230 results in recirculation of the exhausted air. This can be seen from the higher velocities (i.e. lighter areas) adjacent the front wall 4240 and the annular component 4200. This recirculation allows energy in the exhausted air to be dissipated before it exits the ventilation path, which further reduces drafts and noise.

[0208] The exhaust flow rate from the mask is determined by the size and number of exhaust holes 4220 rather than the cross-sectional area of ​​the ventilation pathway 4250. The size of the ventilation pathway may be altered to affect the velocity of the exhaust air and therefore the drafts and noise caused by the exhausted air. For example, the ventilation pathway 4250 may be widened or narrowed by adjusting the position of the annular component 4200 relative to the seal housing 4140 to change the distance between the front wall and the shroud 4160. As mentioned above, a separate adjustment position may be provided by an interference-type snap fit between the annular component 4200 and the seal housing 4140 so that the size of the ventilation pathway 4250 may be altered.

[0209] Additional non-limiting exemplary embodiments of shroud shapes can be seen in Figures 42A and 42B. The figures show shrouds 4500, 4510 having rectangular and arcuate cross sections surrounding annular components 4520, 4530, respectively. As in the embodiment of Figures 38 and 39, the shrouds create a plenum chamber adjacent to the annular components 4520, 4530. Still further, the plenum chamber may include flow directors such as fins, vanes, and / or baffles (not shown) positioned within the plenum chamber. For example, the fins and vanes guide the exhaust air through the plenum chamber to the ventilation path 4250. Baffles may be used to dissipate energy from the exhausted air flow. Still further, the size, shape, number, location and / or arrangement of the exhaust holes may vary around the circumference of the annular component 4200 or along its axial length. In other words, the exhaust holes 4220 are not limited to a uniform size and arrangement along the annular component 4200. In conjunction with the shroud shape, the size, number, location and / or arrangement of the exhaust holes may vary around the circumference of the annular component 4200 or along its axial length such that the velocity of the exhausted air may vary within the shroud 4160. For example, the diameter or number of exhaust holes may decrease along the axial length such that the velocity of the exhausted air is higher closest to the shroud 4160. Thus, the flow of exhausted air may vary depending on the location of the exhaust holes relative to the shroud 4160 which may allow noise and turbulence to be optimized.

[0210] In other non-limiting exemplary embodiments of the present disclosure, the exhaust holes and the shroud may be located in different parts of the respiratory mask. For example, the holes and the shroud may be part of an elbow or a swivel conduit connector. An elbow and / or a swivel are commonly used in respiratory masks to provide an intermediate connection between an air supply conduit and a mask. In the non-limiting exemplary embodiment of Figures 43A and 43B, the exhaust holes and the shroud are located in the elbow. Figure 43B shows a simplified cross-sectional view of an embodiment of the present disclosure. This embodiment includes a cylindrical elbow 4600, an exhaust hole 4610 (not shown in Figure 43A), and a shroud 4620.

[0211] As in the previous embodiment, the exhaust holes 4610 may be positioned radially on the annular surface. The exhaust holes 4610 and the shroud 4620 extend only partially around the surface of the elbow. The holes may be positioned to distribute the exhausted air over an angle of about 120°. The shroud 4620 extends slightly beyond the edge of the outer holes. The shroud 4620 may have a partial bicone shape, where the shroud forms a segment of a bicone that is truncated at both apexes. The truncated edges 4630 of the bicone shroud 4620 are attached to the cylindrical elbow 4600 on either side of the exhaust holes 4610, at both the first end 4650 and the bend 4660 of the cylindrical elbow 4600. The shroud edges 4640 are open and not connected to anything. The open shroud edge 4640 provides a path through which exhausted air can escape to atmosphere.

[0212] The size and number of holes can be similar to the previous embodiment and can be based on the exhaust flow rate required to flush the CO2 out of the mask. In other variations of this embodiment, the shroud 4620 can be conical rather than bi-conical, with one end larger than the other. As an alternative to a conical shape, the shroud can be square, round, or have any other suitable shape.

[0213] The inclusion of a shroud component around the exhaust hole in the respirator can take a variety of forms depending on the configuration of the other mask components. It may be desirable for the respirator to have a ball and socket connection between the elbow joint and the mask frame or seal housing. This may reduce hose drag on the mask. In masks with this elbow joint configuration, the exhaust hole and shroud may be incorporated into the ball socket for the elbow joint. Some non-limiting exemplary embodiments of this are shown in Figures 44A-44D and 45.

[0214] 44A shows a non-limiting exemplary embodiment in which a biased air system is incorporated into a respiratory mask having an air supply connection including an elbow joint conduit 4700. The elbow joint 4700 includes a ball joint 4705 configured to connect to a corresponding socket, which may be defined by a socket insert 4710. The socket insert 4710 is configured to provide a connection between a mask frame 4720 and a seal housing (not shown). The connection between the socket insert 4710, the mask frame 4720, and the seal housing may be achieved by any connection mechanism known in the art, including, but not limited to, "snap-fit" and / or press-fit mechanical bonding, welding, and adhesives, or may be integral and unitary.

[0215] 44B-44E show more detailed views of the socket insert 4710. The socket insert 4710 is substantially tubular (as shown in FIG. 44C) and includes an outer periphery 4730, an inner periphery 4740, and front and rear insert faces 4750 and 4760. The outer periphery 4730 is configured to provide an interface between the socket insert 4710 and the mask frame 4720. The inner periphery 4740 includes a front bearing surface 4742 and a rear bearing surface 4744. The front and rear bearing surfaces 4742, 4744 are substantially spherical and match the shape of the ball joint 4705. The front bearing surface 4742 includes a continuous surface that forms a substantially airtight seal with the ball joint 4705. The rear bearing surface 4744 includes a series of interrupted surfaces separated by recesses 4770. In other words, the interrupted surfaces are circumferentially spaced apart by the recesses 4770. The rear bearing surface 4744 connects to and extends rearwardly from the front bearing surface 4742. The substantially spherical bearing surfaces 4742, 4744 are configured to provide a retaining connection between the socket insert 4710 and the ball joint 4705 such that translational movement of the ball from front to rear is restricted, but the ball joint is free to rotate within the socket.

[0216] As shown in FIGS. 44C and 44D, a plurality of recesses 4770 are radially spaced about the inner circumference 4740. The recesses 4770 have a substantially rectangular profile (as shown in FIGS. 44C and 44E) and include an outer recess wall 4772, a forward recess wall 4774, and a sidewall 4776. The outer recess wall 4772 is configured to be offset between the inner circumference 4740 and the outer circumference 4730 and is substantially spherical. The outer recess wall 4772 is connected to the forward bearing surface 4742 by a forward recess wall 4774 and to the rear bearing surface 4744 by a sidewall 4776. The forward recess wall 4774 extends at an obtuse angle between the rear edge 4746 of the forward bearing surface 4742 and the outer recess wall 4772. The sidewall 4776 extends at an obtuse angle between the rear bearing surface 4744 and the outer recess wall 4772.

[0217] The recesses 4770 have open ends that form tooth-like shapes in the rear insert face 4760. The open ends create a pathway between the socket insert 4710 and the ball joint 4705 through which exhaled air can pass. Exhaust holes 4780 extend radially between the outer recess wall 4772 and the outer periphery 4730. The exhaust holes 4780 allow the exhaled air to pass through the recesses 4770 and be exhausted to the atmosphere. An embodiment of the present disclosure includes three exhaust holes 4780 in each recess 4770, although other embodiments may have more or less holes. The number of holes may be determined by the diameter of the holes and the flow rate through the holes required to flush CO2 from within the mask. The exhaust holes 4780 are preferably formed by laser drilling, although other known hole forming techniques (such as in-mold forming) may be used.

[0218] 44A, the mask frame 4720 forms a shroud 4790 in front of the exhaust holes 4780. In some embodiments, the shroud 4790, together with a seal housing (not shown), can form a plenum chamber and a ventilation path, which can reduce drafts caused by the exhausted air. The illustrated shroud 4790 has a substantially conical structure. There can be a gap between the mask frame 4720 and the seal housing that provides a ventilation path for the exhausted air to pass through.

[0219] In some embodiments (not shown), the connection between the socket insert 4710 and the seal housing can be located at the outer periphery 4730. Alternatively, the connection is located at the aft insert face 4760 or any other suitable location.

[0220] In alternative embodiments, the shape of the recess 4770 may vary. The profile of the recess 4770 may not be rectangular. In some embodiments, it may be triangular, asymmetrical, or any other suitable shape that provides a path through which the exhausted air may pass. In further embodiments, the recess 4770 may not have defined front, outer and side walls 4772, 4774, 4776. The recess may include a continuous and contoured surface.

[0221] 45-48 show various non-limiting exemplary embodiments of different socket insert configurations. FIG. 45 shows an embodiment similar to the previous embodiment. It includes an elbow joint 4800 with a ball joint 4805 configured to connect to a socket insert 4810. The socket insert 4810 is configured to connect between a mask frame 4820 and a seal housing 4830. The socket insert 4810 differs from the previous embodiment in that it has an inner periphery 4840 that forms a single bearing surface 4842 without any recesses. The bearing surface 4842 may be spherical, as in the previous embodiment. The socket insert 4810 includes a rear lip 4812 configured to extend rearward of the opening 4807. The socket insert has a series of radially spaced drainage holes 4880 located within the rear lip 4812 such that the holes are substantially free of obstructions. The distance that the rear lip 4812 extends from the ball joint opening 4807 can be defined such that when the ball joint 4805 rotates within the socket insert 4810, the drain hole 4880 is not completely blocked by the ball joint.

[0222] In this embodiment, the exhausted air passes through exhaust holes 4880 in the socket insert 4810 and into the plenum chamber 4850. The plenum chamber 4850 is formed from the mask frame 4820 and the seal housing 4830. This embodiment differs from the previous embodiment in that the seal housing 4830 is configured to provide a substantially conical shroud 4860, rather than the mask frame 4820. This may be beneficial in reducing the size of the mask frame and therefore the dead space within the seal chamber 4830. The exhausted air exits the plenum chamber 4850 via an at least partially annular exhaust vent 4870 formed by the gap between the mask frame 4820 and the seal housing 4830.

[0223] The embodiment of FIG. 46 is similar to that of FIGS. 44A-E. It includes an elbow joint 4900, a socket insert 4910, a mask frame 4920, and a seal housing 4930. As in the previous embodiment, the elbow joint includes a ball joint 4905. The socket insert 4910 is configured to have a substantially "c" shaped cross-sectional profile (when viewed from one circumferential position) and includes a perimeter wall 4912 that defines an annular channel 4918, a front wall 4914, and a bearing surface wall 4916. The perimeter wall 4912 and the bearing surface wall 4916 are connected to and offset from each other by the front wall 4914. The bearing surface wall 4916 has an inner surface and an outer surface, the inner surface including a bearing surface 4940. The bearing surface 4940 is configured to allow rotation of the ball joint 4905 while limiting translational movement.

[0224] The perimeter wall 4912 is configured to provide an interface between the mask frame 4920 and the seal housing 4930. The mask frame 4920 is connected to the front of the perimeter wall 4912 and the seal housing 4930 is connected to the rear. The perimeter wall includes snap-fit ​​protrusions 4913 that mate with snap-fit ​​connectors 4932 that form part of the seal housing 4930. In alternative embodiments, the interface between the mask frame 4920, the socket insert 4910 and the seal housing 4930 may be provided by any suitable means known in the art.

[0225] An array of exhaust holes 4950 are positioned radially within the outer circumferential wall 4912. The exhaust holes provide a path for exhaust air to flow from within the mask through the annular channel 4918 and out to the atmosphere. The number and size of the exhaust holes are determined based on the flow rate required to flush the CO2 from within the mask. The exhaust air passes through the exhaust holes 4950 into a plenum chamber 4960. The plenum chamber 4960 is formed between the mask frame 4920 and the seal housing 4930. The mask frame 4920 includes a substantially conical shroud 4922 similar to that described in the previous embodiment.

[0226] 47 shows an embodiment in which the exhaust hole 5010, shroud 5020 and plenum chamber 5030 are rearward of the elbow joint 5040 and ball joint 5045. The ball socket 5050 may form part of the mask frame or may be a separate insert component.

[0227] FIG. 48 shows a further embodiment of a biased airflow system configuration that may be used to diffuse exhausted air towards the elbow joint, as opposed to away from the elbow joint (as in the previous embodiment). The components of this embodiment are shown separate from other components of the respiratory mask, such as the mask frame and seal chamber. As such, the components may be incorporated into other components of the mask in various ways. Similarly, while FIGS. 45-48 only show the top portion of the socket insert, preferably the socket insert surrounds the ball joint of the elbow joint. This embodiment includes an elbow joint 5100 comprising a ball joint 5102, a socket member 5110, and a shroud member 5120. The socket member 5110 includes a spherical wall section that is rotationally connected to the ball joint 5102.

[0228] The socket member 5110 may be configured to form part of the mask frame or seal housing, or alternatively may be a separate insert component. The shroud member 5120 includes a seal housing wall 5121 and a shroud wall 5125. The seal housing wall 5121 is configured to form part of a connection to a seal housing (not shown). It includes an elbow end 5122 and a distal end 5223, the elbow end connecting to the socket member 5110 and the distal end adjacent the shroud wall 5125. The seal housing wall 5121 also includes an annular array of exhaust holes 5130 located proximal to the distal end 5123. The shroud wall 5125 includes an annular wall section that angles inwardly toward the elbow 5100. The shroud wall is configured to create a plenum chamber 5140 in combination with the seal housing wall 5121 and the socket member 5110. An exhaust vent 5150 is formed by the gap between the forward end of the socket member 5110 and the shroud wall 5125 .

[0229] 49 illustrates a non-limiting exemplary embodiment in which a biased air system 5200 is provided to one end of an elbow joint 5210, the elbow joint being connected to a respiratory mask and configured to supply air to the respiratory mask. The biased air system includes a conduit connector 5220, a shroud 5230, and a cylindrical exhaust member 5240. The elbow joint includes an air source end 5212 and a mask mounting end 5214. In this illustration, the mask mounting end 5214 is shown to include a ball joint 5216, but in other embodiments, it may include an annular swivel connection or any other suitable connection that allows rotation between the elbow joint 5210 and the mask. The conduit connector 5220 includes a cylindrical conduit 5222 and a flange 5224. The cylindrical conduit 5222 is configured to provide a releasable connection with an air supply conduit. The flange 5224 extends perpendicularly from the end of the cylindrical conduit 5222 proximal to the air source end 5316 of the elbow 5210. It is configured to form a wall of the plenum chamber 5250. In alternative embodiments, the flange 5224 may be formed at a greater or lesser angle relative to the cylindrical conduit 5222.

[0230] The shroud 5230 and the cylindrical exhaust member 5240 form the remaining walls of the plenum chamber 5250. The cylindrical exhaust member 5240 is configured to provide a connection between the conduit connector 5220 and the air source end 5212 of the elbow 5210. The connection may be permanent or temporary. The cylindrical exhaust member 5240 includes interior and exterior wall surfaces 5242, 5244 and an array of radial exhaust holes 5260 extending therebetween. The exhaust holes 5260 are angled such that air flowing through the exhaust holes 5260 is directed away from the elbow, although in some embodiments the holes may be perpendicular to the cylindrical exhaust member or angled toward the elbow. The shroud 5330 is configured to connect to the air source end 5212 of the elbow 5210, although in alternative embodiments it may be connected to the cylindrical exhaust member 5240. The shroud 5230 includes a substantially conical shape configured to cover the exhaust hole 5260 in a manner similar to that described in the prior embodiment. The exhaust vent 5262 is formed by an annular gap between the shroud 5230 and the flange 5224. The exhaust vent 5262 provides a path for exhausted air to exit the plenum chamber 5250.

[0231] Unless otherwise expressly stated, throughout the description and claims, the words "comprise", "including", and the like are to be construed in an inclusive sense, i.e., "including but not limited to," as opposed to an exclusive or exhaustive sense.

[0232] Any reference to prior art in this specification is not to be regarded, and should not be regarded, as an admission or any such suggestion that that prior art forms part of the common general knowledge in the art in any country in the world.

[0233] The invention may also be said to exist broadly in all of the parts, elements and features mentioned or shown in the specification of this application, either separately or collectively, and in any combination of two or more of said parts, elements or features.

[0234] Where reference is made in the foregoing description to whole entities or components having known equivalents, those whole entities are incorporated herein as if set forth separately.

[0235] It should be noted that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present invention and without diminishing its attendant advantages. For example, various components can be rearranged as necessary. Accordingly, such changes and modifications are intended to be included within the scope of the present invention. Moreover, not all of the features, aspects and advantages are necessarily required to practice the present invention. Accordingly, the scope of the present invention is intended to be defined solely by the following claims.

Claims

1. 1. A biased airflow system for a respiratory mask, comprising: an annular component connected to the respirator and providing a flow path for a supply of pressurized air to the respirator, the annular component including an array of exhaust holes extending radially therethrough, the exhaust holes providing an exit for air exhausted from the respirator to exit the annular component; a shroud positioned around the annular component and defining a plenum chamber around the exhaust hole.

2. The biased airflow system of claim 1 , wherein the exhaust holes are formed by laser drilling.

3. 3. The biased airflow system of claim 1 or 2, wherein the exhaust holes are spaced around the entire circumference of the annular component.

4. The biased airflow system of any one of claims 1 to 3, wherein the shroud further includes a conical surface facing the annular component, the conical surface defining a portion of the plenum chamber.

5. 5. The biased air system of claim 1, wherein the annular component further comprises a socket insert portion configured to surround and retain a ball joint within the socket insert portion.

6. The biased airflow system of claim 5 , wherein the socket insert portion further includes an outer periphery, an inner periphery, forward and rearward insert faces, and the exhaust hole.

7. 7. The biased airflow system of claim 6, wherein the inner periphery is defined by a forward bearing surface and an aft bearing surface, the aft bearing surface being defined by a series of interrupted surfaces.

8. The biased airflow system of claim 7 , wherein the intermittent surfaces are spaced apart by recesses.

9. 9. The biased air system of claim 7 or 8, wherein the forward bearing surface further includes a spherical annular surface that contacts and provides an airtight seal with the ball joint.

10. 10. The biased air system of claim 8 or 9, wherein the recess has a rectangular profile defined by an outer recess wall, a front recess wall, and two side walls.

11. The biased airflow system of claim 10 , wherein the exhaust holes are configured to extend radially through the outer recess wall and the outer periphery of the socket insert portion.

12. 6. The biased airflow system of claim 5, wherein the socket insert portion has a C-shaped profile, the socket insert portion having an outer periphery and an inner periphery separated by a front wall to define an annular channel between the outer periphery and the inner periphery, the inner periphery having a forward bearing surface that contacts and provides an airtight seal with a ball joint, and the outer periphery is connected to the respiratory mask.

13. 13. The biased airflow system of claim 12, wherein the outer periphery of the socket insert portion has snap-fit ​​projections that mate with snap-fit ​​connectors on the respiratory mask.

14. The biased airflow system of any one of claims 1 to 4, further comprising an elbow joint connector positioned between the annular component and the respiratory mask.

15. 15. The biased airflow system of claim 1, wherein the annular component further includes a flange extending radially outward from an outer wall of the annular component, the shroud and the flange defining the plenum chamber.

16. a cushion module including a seal housing and a seal; Mask frame and an air source connection, an annular element extending from a front wall of the seal housing and connected to the mask frame to form a fluid connection between the cushion module and the air source connection; the annular component includes an array of exhaust holes extending radially therethrough, the exhaust holes providing an exit for air exhausted from the respiratory mask to exit the annular component; a shroud positioned around the annular component, the shroud, the mask frame, and the front wall of the seal housing defining a plenum chamber around the exhaust hole.

17. 17. The respiratory mask of claim 16, wherein a radial ventilation path is formed between an outer periphery of the shroud and the front wall of the seal housing.

18. 18. The respiratory mask of claim 16 or 17, wherein the connection between the annular component and the mask frame allows the two components to be disassembled.

19. A respiratory mask according to any one of claims 16 to 18, wherein the annular component is a separate component that is attached to an aperture in the seal housing.

20. A respiratory mask according to any one of claims 16 to 19, wherein the vent holes are spaced around the entire circumference of the annular component.

21. A respiratory mask according to any one of claims 16 to 20, wherein the shroud is an integrally formed part of the mask frame.

22. A respiratory mask according to any one of claims 16 to 21, wherein the shroud has a conical shape.

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