Respiratory masks and associated parts, components or subassemblies

Abstract

To provide a respiratory mask for providing positive pressure therapy and a biased airflow system configured to reduce perceptible drafts caused by exhaled air. [Solution] The respiratory mask has an elbow joint with a ball joint, one or more detachable forehead pieces, and headgear with a spacer fabric region. The elbow joint is configured to be detachable when oriented in a predetermined position. The forehead piece is provided in one or more sizes. The spacer fabric region has two or more layers with raw edges folded inside the layers. A seal has improved sealing performance and accommodates a wide variety of facial geometries. A flow deflection system has a tube and exhaust holes radially aligned on the bead of the tube. The flow deflection system further has an annular component exhaust hole and a shroud with a plenum chamber around the exhaust hole.

Description

[Technical Field]

[0001] Incorporation by reference of priority applications This application is related to and claims priority from U.S. Provisional Patent Application Nos. 62 / 041,236, filed August 25, 2014, 62 / 096,481, filed December 23, 2014, 62 / 041,234, filed August 25, 2014, and 62 / 041,262, filed August 25, 2014, the contents of which are incorporated herein by reference 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, debris may 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, therefore, limit its useful life. Ball joints are typically permanently connected to their corresponding sockets, or at least very difficult to remove and / or insert. Removal of a ball joint may require significant force, potentially permanently damaging 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 major mask components, in various sizes, which therefore increases the 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 can feel 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] Additionally, a wide variety of respiratory masks have been devised. Many of these masks are configured to provide a sealed connection with the user's airway by forming a seal around the user's nose and / or mouth. These masks are commonly used to provide treatments such as, but not limited to, non-invasive ventilation (NIV) and continuous positive airway pressure (CPAP). CPAP 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 apneas. As part of this treatment, a biased airflow system is required to flush exhaled carbon dioxide (CO2) from within the mask and prevent it from being rebreathed.

[0008] A typical biased airflow system includes an array of holes that may be located on various respirator components, such as the elbow joint and mask frame. These holes are often positioned together and aligned in such a way that a concentrated airflow exits through the holes. The ventilation system can cause noticeable drafts and noise. The drafts and noise can be annoying to both the user and / or their bed partner and can lead to reduced compliance with treatment. Several 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, but no single one of them 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 embodiment 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 the 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 reduced stiffness 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 the opening in the top 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 of the seal that defines the face-contacting surface.

[0019] According to a further aspect, the cushion module includes a pair of thickened perimeter portions defined by a portion that defines 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, the continuous portion of the inner edge of the opening defines a thickness of 0.6 mm or less, and the continuous portion of the inner edge extends at least 1 mm inward from the inner edge and extends 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 0.4 mm or less in thickness.

[0023] According to a further aspect, the top of the seal defines a nasal bridge portion that contacts 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 aspect, 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 aspect, 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 aspect, 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 between about 7.3 mm and 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 reduced stiffness 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 aspect, the distance varies by at least about 5 percent between the neutral position and the depressed position of the reduced stiffness region.

[0034] According to a further aspect, 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 different 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 angle is about 34 degrees, the medium angle is about 29 degrees, and the large 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 user's face; and a conduit connector including a ball-and-socket end. The frame portion defines an opening configured to receive the ball-and-socket end of the conduit connector, and the frame portion includes 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 the 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 lower portion 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 upper edge of the ball or ball joint is greater than a length of the lower 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 that supports the seal and a headgear connector portion configured to connect 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, allowing 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 detachable from the opening when oriented in a predetermined position.

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

[0049] According to a further aspect, 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 facing out, and then turned inside out with the raw edges on the inside and right side facing out.

[0051] According to at least one embodiment 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 the 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 upper part 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 upper part 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 shorter 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 upper portion 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 upper portion 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 outer 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 drain 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 discharge holes are disposed at a non-orthogonal angle relative to the central axis of the tube.

[0068] In accordance with at least one embodiment disclosed herein, there is provided a biased air system for a respirator, the biased air system including: 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 through the annular component, the exhaust holes providing an exit for air exhausted from the respirator 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 drain 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 rearward insert faces, and a drain hole. The inner periphery is defined by a forward bearing surface and a rearward bearing surface, and the rearward bearing surface is 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 airtight seal therewith.

[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 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, there is provided 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 flange defining a plenum chamber.

[0081] According to at least one embodiment 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 user's face, 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 rearward insert faces, and a drain hole. The inner periphery is defined by a forward bearing surface and a rearward bearing surface, and the rearward bearing surface is 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 airtight 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 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 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 around the socket insert portion and defining a plenum chamber around the exhaust hole.

[0090] According to at least one embodiment disclosed herein, there is provided a respiratory mask assembly including: a seal housing configured to form a substantially airtight seal with a user's face, 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, the socket insert portion 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 embodiment disclosed herein, a respiratory mask is provided, the respiratory mask including: a mask body defining a breathing chamber, an opening to the breathing chamber, and a tolerant air 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 openings; 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 tolerant air 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 in accordance with the present disclosure and are not to be considered limiting of its scope. [Brief explanation of the drawings]

[0093] [Figure 1A] FIG. 1 is a perspective view of a respiratory mask of the present disclosure. [Figure 1B] FIG. 1 is a front view of a 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. 10 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. 10 is a side view of an alternative elbow joint of the present disclosure. [Figure 4A] 1 is a view of a socket insert of the present disclosure; [Figure 4B] 1 is a view of a socket insert of the present disclosure; [Figure 4C] 1 is a view of a socket insert of the present disclosure; [Figure 4D] 1 is a view of a socket insert of the present disclosure; [Figure 4E] 1 is a view of a socket insert of the present disclosure; [Figure 5] FIG. 10 is a cross-sectional view of the elbow joint and socket insert showing the shape that allows the elbow joint 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 cushion module of FIG. 8. [Figure 10] FIG. 9 is a plan view of the face-contacting surface of the seal of one of the cushion modules of FIG. 8. [Figure 11] FIG. 1 is a plan view of a seal showing several sections. [Figure 12] FIG. 1 is a plan view of the seal showing the width of the two portions of the seal. [Figure 13] FIG. 10 is a bottom view of the top and particularly the nose bridge portion of the seal. [Figure 14] FIG. 10 is a view of the face-contacting surface of the nose bridge portion of the seal. [Figure 15] FIG. 1 is a cross-sectional view of the top of the seal. [Figure 16] 9 is a plan view of the face-contacting surface of the 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 the seal of one of the cushion modules of FIG. 8, showing additional regions of varying thickness relative to FIG. 16. [Figure 18] FIG. 10 is a perspective view of the interior of the split top portion of the seal. [Figure 19] FIG. 10 is a plan view of the face-contacting surface of the upper side of the seal. [Figure 20] 1 shows some possible cross-sectional profiles for a portion of the seal. [Figure 21] FIG. 10 is a side view of a cushion module having a deformable top portion. [Figure 22] 10 is a cross-sectional view of the inner surface of the top of the seal of the cushion module having a deformable top 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. [Figure 25] 1 shows the relationship between deflection angle and downward movement of the top of the seal. [Figure 26] 1 shows several seals of different sizes with different heights of the top of the seal. [Figure 27] FIG. 10 is a cross-sectional view of the top of the seal, with the front and top walls having graduated thicknesses. [Figure 28] FIG. 10 is a cross-sectional view of the top of the seal deflected in a forward direction. [Figures 29A-29F] 1A-1C show 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. [Figure 30] For comparison, a side view of a cushion module with a single rolling portion 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] 1 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. [Figure 33] 1 shows a cross-sectional side view of a cushion module with multiple rolling portions. [Figure 34] 1 shows a schematic diagram of a system for providing CPAP therapy to a user. [Figure 35] 1 shows a side view of a respiratory mask incorporating the biased airflow system of the present disclosure. [Figure 36] 1 illustrates a cross-sectional view of a biased airflow system of the present disclosure. [Figure 37] 1 shows a cross section of a cylindrical conduit with radial drainage holes. [Figure 38] 1 shows a perspective view of a respiratory mask including a 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. [Figure 40] 1 shows a cross-sectional view of an annular component with radial drainage holes. [Figure 41] 1 shows a computational fluid dynamics (CFD) analysis of the discharge hole and shroud configuration of the present disclosure. [Figure 42A] 10 illustrates an alternative embodiment of the shroud shape. [Figure 42B] 10 illustrates an alternative embodiment of the shroud shape. [Figure 43A] 1 illustrates an embodiment of a biased airflow system attached to an elbow joint. [Figure 43B] 1 illustrates an embodiment of a biased airflow system attached to an elbow joint. [Figure 44A] 1 shows a diagram of a biased airflow system incorporating a ball and socket joint. [Figure 44B] 1 shows a diagram of a biased airflow system incorporating a ball and socket joint. [Figure 44C]1 shows a diagram of a biased airflow system incorporating a ball and socket joint. [Figure 44D] 1 shows a diagram of a biased airflow system incorporating a ball and socket joint. [Figure 44E] 1 shows a diagram of a biased airflow system incorporating a ball and socket joint. [Figure 45] 10 shows a cross-sectional view of a further biased airflow system configuration. [Figure 46] 10 shows a cross-sectional view of a further biased airflow system configuration. [Figure 47] 10 shows a cross-sectional view of a further biased airflow system configuration. [Figure 48] 10 shows a cross-sectional view of a further biased airflow system configuration. [Figure 49] 1 shows a cross-sectional view of an embodiment of a biased air system attached to an elbow joint. DETAILED DESCRIPTION OF THE INVENTION

[0094] Embodiments of systems, components, and methods of assembly and manufacture are described herein with reference to the accompanying drawings, in which like numerals refer to like or similar elements throughout. While several embodiments, examples, and illustrations are disclosed below, those skilled in the art will understand 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 their equivalents. The terminology used in the description presented herein should not be construed in any limiting or restrictive manner, solely because it is used in conjunction with a 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 desirable attributes or is essential to the practice of the invention described herein.

[0095] Certain terminology may be used in the following description for reference purposes only and is 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 "front," "rear," "upper," and "lower" refer to the position of one or more portions of a respiratory mask relative to a user. Here, "front" refers to a distal position relative to the user (when the mask is in use), while "rear" refers to a proximal position relative to the user. The terms "upper" and "lower" refer to the position 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 seated in an upright position. Furthermore, terms such as "first," "second," and "third" may be used to describe separate components. Such terminology may include the words specifically mentioned above, derivatives thereof, and words of similar import.

[0096] The term "seal housing" refers to a respiratory mask component configured to provide a breathing chamber that (in use) substantially surrounds a 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 shows a respiratory mask 100 incorporating a detachable ball-and-socket 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 user's nose and / or mouth (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 to allow airflow into the breathing chamber 192. In other embodiments, the annular opening 194 may be replaced with an opening of any other suitable shape.

[0099] Mask Frame: 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, for example, FIG. 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 FIGS. 1A and 1B).

[0100] The headgear connectors provide a means by which the headgear 150 connects 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 the user is 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 to minimize obstruction to the user's line of sight.

[0101] As shown in FIG. 2B, the beam portion 220 terminates at its 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, the beam portion has a stepped-down profile 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 profile in the forehead piece 170 (see, e.g., 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 profile in the forehead piece 170.

[0102] Elbow joint: FIG. 3A illustrates 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 below 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 freely 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 the lip 310. Lip 310 includes an edge formed by a surface extending perpendicularly from cylindrical band 308 and the shape of elbow body 320, with lip 310 generally at the top of elbow body 320. Lip 310 is configured to interact with socket insert 140 during removal of elbow 130 (see, for example, FIG. 5). Swivel connection 330 is positioned on the opposite side of elbow 130 from ball joint 300A. It is configured to connect to swivel 160 (as shown in FIG. 1A).

[0103] In an alternative embodiment, ball joint 300A includes a truncated ball. The ball joint includes ball 302, which creates a spherical bearing surface. The truncated axis is substantially planar and angled toward band 308. The truncated axis creates an angled edge 304, which angles toward the bottom of the cylindrical band and the bottom of the elbow. The angled edge 304 creates an angled ball such that the distance at 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 deflection holes 450 (see, e.g., FIG. 4D). While the socket insert 140 is disclosed herein, other configurations may be incorporated into or integrally formed with the mask frame 120. The deflection holes 450 may include any suitable cross-sectional shape, including, but not limited to, polygonal, angle-shaped, circular or elliptical holes, slots, including "U" and "W" shapes, and the shapes may be symmetrical or asymmetrical. In other embodiments, the socket insert 140 may not include deflection holes 450. The deflection holes 450 may be incorporated into another component of the respirator.

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

[0106] The outer wall 400 includes one or more seal housing notches 402, frame connections 404, and alignment keys 406. The seal housing notches 402 are configured to provide a snap-fit ​​connection between the socket insert 140 and the seal housing 190. The seal housing notches 402 include indentations that form the female component of the snap-fit ​​connection. The frame connections 404 include two annular ridges that form a permanent push-fit connection with corresponding shapes on the socket connection opening 200 (as shown in FIG. 2A ). The alignment keys 406 are located on the upper rear edge of the outer wall 400. They include substantially trapezoidal notches that align with corresponding tabs on the annular opening 194 of the seal housing 190. The alignment keys are 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 connections 404 and the socket connection opening 200 may be achieved via ultrasonic welding or another suitable method.

[0107] Inner wall 420 includes a socket bearing surface 412 that is substantially spherical and configured to contact and retain ball joint 300A of elbow joint 130. Socket bearing surface 412 is configured to contact elbow joint bearing surface 302, thereby forming a substantially airtight assembly. When elbow joint 130 and socket insert 140 are connected, bearing surfaces 302, 412 are configured to allow rotational movement between the components while simultaneously limiting translational movement between the front and back 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 away 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 so that when the elbow joint 130 is rotated to the opposite position, as shown in FIG. 5 , the lip 310 can 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 so that the two components may contact or be located at different circumferential positions.

[0109] When the elbow joint 130 is rotated to approximately the opposite position, the lip 310 approximately aligns with the removal notch 430. With the lip 310 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 to the front wall 410 (as shown by the dimension x in FIG. 5 ) than would be possible without the elbow joint removal notch 430. This reduction in the 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 creates 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 clears the front wall 410, the ball joint 300 can be removed from the socket insert 140. It can be seen that the purpose of the tapered chamfer 306 is to further reduce the distance x that the ball joint 300 must be rotated to move the rear opening edge 304 past the front wall 410, and thus removed from the socket insert 140, compared to a configuration without the tapered chamfer 306. In an alternative embodiment (not shown), the elbow joint removal notch 430 can be replaced with a chamfered or scalloped section on the edge formed between the inner wall 420 and the front wall 410 of the socket insert 140. The chamfered edge can have the effect of reducing the distance x that the ball joint must be rotated to be removed from the socket insert. In yet another alternative embodiment, the shape of the elbow joint removal notch 430 can 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 to that described with respect to FIGS. 3B and 5. The angled truncation axis creates an angled rear opening edge 304 and creates a longer upper edge of the ball 302 compared to the lower 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 lower edge of the ball is shorter than the upper edge of the ball. The additional rotation allows the lowest point of the rear opening edge 304 (when the mask is in use) 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 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 so that the elbow joint 130 can only be removed from the socket insert 140 when oriented in a predetermined rotational position. As shown in FIG. 5 , in an embodiment of the invention, the elbow joint 130 can be removed when rotated to an inverted 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 trained on how to remove the elbow. This may be beneficial in some situations because it may be desirable for only a specific 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, but less important in a home use environment where the mask only has a single user. Therefore, it may be desirable for a physician or sleep lab technician, rather than the direct user of the mask, to know how to remove the elbow. In an alternative embodiment, the shape is such that removal of the elbow is obvious.

[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, which are 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 forehead straps 152 enter the forehead piece through rear opening 622, with one forehead strap 152 exiting from 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 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 a notch 234 of the male forehead piece connector 230. When the protrusion 644 and the notch 234 fit together, they form a snap-fit ​​connection that allows the forehead piece 170 to be removably connected to the mask frame 120. Molded opening 646 provides interior cavity 640 with a second opening opposite frame opening 642. The opening is substantially perpendicular to forward portion 600 and is located on the rear surface of forward portion 600. Molded opening 646 is configured to provide a means for a forming tool to form protrusion 644 on the interior surface of interior cavity 640. Molded opening 646 is configured to fit within the confines of rear opening 622 such that a single fixture installation component may form both shaped opening 646 and protrusion 644, as well as rear opening 622.

[0116] In some configurations, as shown in FIG. 6E , the forehead piece 170 is provided in two or more sizes. Different sizes can be achieved by varying the height of the forehead piece 170. The different sizes accommodate various facial geometries of users. In an embodiment of the present invention, medium / large and small sizes are provided, with the small size having a height h2 that is less than the height h1 of the medium / large size. The height of the forehead piece 170 determines the height at which the headgear forehead straps connect to the mask 100 and, therefore, determines how high up the forehead straps sit on the user's head. The size of the forehead piece 170 can be selected to provide the most comfortable fit for the user. 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 straps within the horizontal loop.

[0117] In other configurations, the forehead piece 170 and 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 can be coupled 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 so 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 extend forward from the rear headgear portion 158 across the user's forehead and are configured to connect to the forehead piece 170 as described above. The top straps 154 are configured to form links between the forehead straps 152, so that the top straps 154 extend across the top of the user's head. The chin strap 156 is configured to extend forward from the lower edge of the rear headgear portion 158, across the user's cheeks and chin, and to a headgear connector 210 on 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 a post component in the headgear connector, providing 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™, which includes different fabric layers, including fiber and foam. Breath-o-prene™ is made from polyurethane foam with an outer layer of nylon and spandex. The materials are heat-laminated together. Each strap can be made from materials with different physical properties. For example, the top strap 154 ​​can be stretchable, while the chin strap 156 is substantially non-stretchable.

[0120] The rear headgear portion 158 includes a spacer fabric pad 730 and lower back straps 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 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 inside out (i.e., with the wrong 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 side out, with the front side 733 facing out and the raw edge 738 facing inward. 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 the spacer fabric pad 730 to be exposed. After exposure, the forehead straps 152 and lower back straps 740 are attached to the spacer fabric pad 730. In an embodiment of the present invention, these 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 simultaneously with attachment to the lower back straps 740.

[0121] The headgear configuration of the present invention incorporates a spacer fabric pad 730 to provide a lightweight, breathable, and cushioned area behind the user's head. These qualities are desirable because they can improve a user's comfort while wearing the headgear. Spacer fabric has a messy edge finish that is prone to fraying when cut. The present 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] Lower back straps 740 extend along the bottom edge 739 of the spacer fabric pad. Lower back straps 740 are made of a less stretchy material than spacer fabric pad 730. Lower back straps 740 provide structural reinforcement to spacer fabric pad 730, reducing or eliminating the possibility of over-stretching that could cause 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 user's nose and / or mouth and includes the seal 180 and the seal housing 190. The seal housing 190 provides some type of support structure for the respiratory mask assembly 100 generally and for the mask cushion or, more specifically, the seal 180. While 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 comprise part of the mask frame. Other suitable interface arrangements that define the breathing chamber, support the 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 illustrate multiple differently sized cushion modules 110 that may be used as components of the respiratory masks 100 disclosed herein. Each cushion module 110 is substantially identical in configuration except for certain dimensions, several of which are discussed herein.

[0125] Cushion module 110A is smaller in at least one dimension (e.g., seal height) than cushion modules 110B and 110C. Similarly, cushion module 110B is smaller in at least one dimension (e.g., seal height) than cushion module 110C. 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 positioned at either end of the illustrated modules 110A, 110B, and 110C, or may have at least one dimension that positions the additional modules between the illustrated modules 110A, 110B, and 110C in a relative sense. In some configurations, a fewer number (e.g., two) of cushion modules 110 are provided. As described herein, references to a general cushion module 110 may apply to any of the specific modules 110A, 110B, and 110C. When discussing modules 110A, 110B, 110C relative to one another, specific reference numbers 110A, 110B, 110C are generally used. One or both of seal 180 and seal housing 190 may vary among the various size modules 110A, 110B, 110C. In the illustrated arrangement, both seal 180 and 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 can be overmolded directly onto the seal housing 190, which can include, for example, chemical or mechanical overmolding.

[0127] In some configurations, the seal housing 190 occupies a substantial portion of the anterior 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 anterior 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 the 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] Seal 180 is designed to seal against the user's face. Seal 180 is preferably formed from a soft material, such as, but not limited to, silicone. In some configurations, at least a portion of seal 180 may be textured to enhance 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 ​​seal 180 that contacts the user's skin. Other techniques for texturing one or more surfaces of 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 seal 180, which may increase the grip of seal 180 on the user's face and improve sealing properties.

[0129] As noted above, the illustrated cushion module 110 comprises a nasal-oral or full-face mask. Accordingly, with reference to Figures 10-15, the seal 180 comprises a nasal-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 noted 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 below the user's lower lip, extend along the outside of the mouth, extend upward along the cheekbones, and extend across the bridge of the user's nose. 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 positioned over the bridge of the nose, cheekbones, outside of the mouth, and below the user's lower lip. A 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. While the Simplus® mask is a highly successful full-face respirator product that provides excellent 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 present seal 180 will be described in the context of the seal of a Simplus® mask.

[0132] Referring to FIG. 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 at the top center of the seal 180, which coincides with the centerline or lies within the midplane of the seal 180. Section 2 is a line that is 45 degrees to the vertical centerline or midplane of the seal 180 and 90 degrees to the inner edge 1000 of the seal 180. Section 3 is the line at the widest part of the top 1002 of the seal 180 that is at 90 degrees relative 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 relative 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 listed dimensions for the seal 180 are exemplary dimensions and are not intended to be limiting unless otherwise indicated. Furthermore, actual dimensions may vary within determined ranges due to normal manufacturing variations, which may be indicated herein by the use of the terms "about," "approximately," or other similar terms. The dimensions indicate the widths of the various sections relative to each other and relative to the Simplus® seal.

[0133] [Table 1]

[0134] Generally, 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 approximately 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 widths less than the width of one or more of sections 1-3. In the illustrated arrangement, both sections 4 and 5 have widths less than the width of section 3. One or both of sections 4 and 5 of seal 180 can have widths less than the width of one or more of sections 1-3. In the illustrated arrangement, both sections 4 and 5 have widths greater than both the widths of sections 1 and 2. In the illustrated arrangement, the width of section 5 is slightly greater than, but similar to, the widths of sections 1 and 2. The widths of sections 4 and 5 of seal 180 are relatively similar to the widths at 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 section 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 on the opening 1000 in the upper portion 1002 of the seal 180, and a second width 1014 between laterally opposed locations on the outer edge 1010 of the seal 180 in the lower portion 1004 of the seal 180. In particular, the illustrated first width 1012 is the width of the upper end of the opening 1000 in the upper 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 upper 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 within an upper central portion of the upper 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 within the lower portion 1004 of seal 180, which may be the maximum width of seal 180 in a common seal configuration. Width 1012 is preferably relatively small, at least compared to width 1014, which is useful as a reference point for comparing width 1012 with other seals. The table below (Table 2) lists exemplary dimensions of widths 1012 and 1014 for 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. Furthermore, actual dimensions may vary within ranges determined by normal manufacturing variances, which may be indicated herein by the use of the terms "about," "approximately," or other similar terms.

[0137] [Table 2]

[0138] Table 2 indicates 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 that defines the top center of the opening 1000 does not include any linear portions, or does not include linear portions of a length at least significantly greater than the entire length of the edge of the top 1002 or 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 square 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, seal 180 is shown with edge S of the corresponding Simplus® seal included for comparison. As shown in FIG. 13, seal 180 defines a depth 1020 from transition point 1022 to the posterior, or proximal-most, surface adjacent to the inwardly-projecting, nasal-bridge-accommodating portion that defines edge 1000 at face-contacting surface 106, i.e., upper portion 1002. Preferably, depth 1020 is deeper than the corresponding depth D of the Simplus® seal. Referring to FIG. 14, a greater depth 1020 (relative to depth D) can be created by extending the inwardly-projecting, nasal-bridge-accommodating portion further inward / forward and / or downward relative to the Simplus® seal. That is, in the illustrated arrangement, the inwardly projecting portion of seal 180 that accommodates the nasal bridge continues beyond the terminal edge S of the Simplus® seal and extends deeper into the cushion module 110, resulting in seal 180 having a greater depth 1020 (than depth D) and a smaller width 1012 (than width W) than the Simplus® seal. As a result, seal 180 has a greater contact area, or at least the potential for a greater contact area with the user's nasal bridge, than the Simplus® seal.

[0141] FIG. 15 shows the upper central portion of the seal 180, split anteriorly or posteriorly through the center or along the midplane of the seal 180. The seal 180 defines a depth 1024 along the center or midplane of the seal 180 between its posterior-most point 1026 and the terminal edge 1000. The depth 1024 may be approximately 4.26 mm in one or more sizes or configurations of the seal 180. Preferably, the depth 1024 is approximately 3.5 mm, 3.75 mm, 4 mm, or approximately 4.25 mm or greater. In some configurations, the depth 1024 is approximately 6 mm or less or approximately 5 mm or less. For comparison, the corresponding depth of the Simplus® seal is approximately 2.75 mm. As discussed above, the greater depth 1024 of the seal 180 allows the portion that accommodates the bridge of the nose 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 correspond to 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 shape of the user's face 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 particular 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 laterally contacts the bridge of the user's nose. 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 of the seal 180, or at least along approximately the top two-thirds. In some configurations, the continuous thin interior edge section 1030 extends inward 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 can extend further inward 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 can vary within these desired thickness ranges in the direction extending inward from the edge defining the opening 1000 or along its length.

[0144] In some configurations, the seal 180 additionally or alternatively includes thickened nose pads 1032. The thickened nose pads 1032 are preferably positioned on each side of the top 1002 of the opening 1000. 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 laterally all the way to the edges defining the opening 1000. That is, the innermost edges of the nose pads 1032 terminate before the edges defining the opening 1000. In some configurations, the thickened nose pads 1032 are created by thickened regions of the seal 180 that extend such that additional material enters the interior of the cushion module 110. The thickened nose pads 1032 may have lateral inner edges 1034 that are curved (e.g., U-shaped) with the center of the curved portion positioned closer to the opening 1000 than the top and bottom of the curved edges 1034.

[0145] Figure 17 illustrates the thickness variations 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 height 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 lower end of the outer edge 1010 to the edge that defines the lower end 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 approximately half of the maximum width of the opening 1000. The illustrated chin region 1040 is laterally centered on 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 various jaw geometries. Accordingly, 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 all of the chin region 1040 may have a thickness of approximately 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 approximately 0.15 mm.

[0148] The seal 180 may also include an upper or nasal bridge region 1042 located at the top center of the seal 180 and extending along the top of the opening 1000. Like the chin region 1040, the nasal bridge region 1042 may extend along the entire height 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 a gentle seal against the bridge of the nose is desired, the nasal bridge region 1042 in the illustrated configuration has a fairly thin thickness. In some configurations, the nasal bridge region 1042 has the thinnest thickness of the seal 180, which may be equal to the thickness of the rest of the seal 180. For example, part or all of the nasal bridge region 1042 may have a thickness equal to the thickness of the chin region 1040. In some configurations, part or all of the nasal bridge region 1042 has a thickness of approximately 0.3 mm. In some configurations, the entire nasal bridge region 1042 has a thickness of approximately 0.3 mm. In some configurations, the thickness of the nasal bridge region 1042 may be less than 0.3 mm. For example, the thickness may be as thin as approximately 0.15 mm. However, it has been found that a thinner thickness may cause or increase the likelihood of wrinkling of the nasal bridge region 1042 with some facial geometries and / or under 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 side portions 1044 located along or adjacent to the sides of the opening 1000. In the illustrated arrangement, the side portions 1044 are elongated strips extending along the vertical center portion of each side of the opening 1000. The side portions 1044 generally extend from the upper end of the lower portion 1004 of the seal 180 to the lower end of the upper portion 1002 of the seal 180. The side portions 1044 may be positioned on the seal 180 to extend along the user's cheeks beside the user's nose.

[0151] Preferably, the side portions 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 side portions 1044 have the thinnest thickness of the seal 180, which may be equal to the thickness of the rest of the seal 180. For example, a portion or all of each of the side portions 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, the thickness of a portion or all of each of the side portions 1044 is approximately 0.3 mm. In some configurations, the thickness of a portion or all of the side portions 1044 is approximately 0.3 mm. In some configurations, the thickness of a portion or all of each of the side portions 1044 may be less than 0.3 mm. For example, the thickness may be as thin as approximately 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 fairly 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 significant 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 near the vertical position where the opening 1000 significantly narrows to form the 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 outward 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 can help the seal 180 resist or prevent collapse in response to applied forces (e.g., headgear forces) without significant internal gas pressure to facilitate fit and provide feedback to the user. The perimeter 1046 can 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 edge or wall of the seal 180, and the seal housing 190 or other structure directly in front of the face-contacting surface 106. In some configurations, the thickness of a portion or the entire perimeter can be from about 1.0 mm to about 2.0 mm. In the illustrated configuration, the thickness of a portion or the entire perimeter 1046 is preferably about 1.5 mm. The thickness of the perimeter 1046 can be constant or vary.

[0156] As described 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 laterally 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, extending additional material into the interior of the cushion module 110. The nose pads 1032 can extend into a stiffened portion of the seal 180, such as a thickened band 1060, which extends from one side to the other over the top of the seal 180, as described in more detail below. The inventors have discovered that the presence of the nose pads 1032 can dramatically reduce leakage that occurs at the sides of the user's nose. Furthermore, 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 of the face-contacting surface 106 of the seal 180, or are the thickest portion. 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 approximately 1.5 mm to 2.0 mm thick. In some configurations, the nose pads 1032 are approximately 1.8 mm thick.

[0159] Referring to FIG. 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 in the top 1002 of the seal 180. The continuous thin interior edge section 1030 need not be a separate section and can be partially or completely defined by other portions of the seal (e.g., the side portion 1044 or the 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 approximately 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 noted above, it may be desirable for the more interior portion 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 the direction extending inward from the edge defining the opening 1000 or along its length. The inventors have discovered that providing a continuous thin interior edge section 1030 improves the sealing characteristics of the seal 180 for at least some conditions or facial geometries.

[0161] The seal 180 may have portions other than those described above. For example, the seal 180 may include one or more transition portions 1048 in regions between the portions described above. While 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 discontinuous 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 portions 1044, the perimeter portion 1046, and the nose pads 1032. The transition portion 1048 may extend away from, be positioned 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 the 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 that includes side portion 1044 and perimeter portion 1046. Design A in FIG. 20 includes an inner surface (surface in FIG. 20 ) with 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 significantly. As a result, it was discovered that when seal 180 is pressed against a 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 curved shape for the inner surface, improving the ability of seal 180 to deform in a uniform manner. Design C exhibits an even smoother curved 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 preferable than design B. The more uniformly the seal 180 deforms, or the more the cross section of the seal 180 deforms from a generally circular shape to a generally squashed or compressed oval shape, 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, thereby allowing the nasal bridge region 1042 to move forward relative to the lower portion 1004 of the seal 180. With reference to FIGS. 21-28 , to assist the rolling of the upper portion 1002, the upper portion 1002 may have varying thicknesses or varying stiffnesses. While the illustrated configurations use regions of reduced thickness 172, other means for providing regions of reduced stiffness may also be used to induce 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, composites of materials may be used to provide regions of reduced stiffness or stiffness. Additionally, any suitable combination of techniques may be used. Nevertheless, the illustrated regions 172 configured to have reduced thickness provide a simple method of achieving the regions of reduced stiffness 172. Additionally, by adjusting the stiffness of reduced stiffness region 172, the force required to induce rolling of 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 a range of movement. Reduced stiffness region 172 is also referred to as a rolling portion.

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

[0165] In some configurations, the band 1060 may be a separately formed component at least partially encased in the material of the seal 180. For example, the band 1060 may be a co-molded 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, without limitation, the band 1060 may be defined by an area of ​​increased thickness, different material, or material properties that result in increased stiffness, etc. In the illustrated arrangement, the band 1060 includes an area of ​​increased thickness of the material of the base seal 180, similar to the different areas described above with reference to FIG. 17 .

[0166] In some configurations, the band 1060 extends along at least a portion of the upper portion 1002 of the seal 180. The upper portion 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 adjacent to the user's nose in use. The first side wall 1072 and the second side wall 1074 converge at the apex 1070 in the illustrated configuration. The first side wall 1072 and the second side wall 1074 extend along at least a portion of the upper portion 1002 of the seal 180. In some configurations, the first side wall 1072 and the second side wall 1074 extend below the upper portion 1002 into the lower portion 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 the centerline or midplane 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 more anteriorly and posteriorly in the middle. 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 extending upward from a connection 1084 between the seal 180 and the seal housing 190. The top wall 1082 is a relatively horizontal wall extending rearward from the upper end of the front wall 1080 toward or toward the band 1060. The illustrated front wall 1080 and top wall 1082 are generally L-shaped in cross-section to form an angle (e.g., approximately a 90-degree angle) between them in the neutral, or unloaded, condition of the top 1002 of the seal 180. However, in other configurations, the reduced stiffness region 172 may be defined by a single wall or may have a rounded or curved profile with less distinct distinction between the first and second wall portions.

[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 in inwardly projecting ledges 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 influence the portion of the seal 180 that deforms in addition to the reduced stiffness region 172 when the upper 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 upper portion 1002 into the reduced stiffness 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 reduced stiffness region 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, can be located between and bounded by a first boundary 1090 and a second boundary 1092, the first boundary 1090 and the second boundary 1092 having increased stiffness relative to the region of reduced stiffness 172. For example, in the configuration shown, the first boundary 1090 is defined by or parallel to a portion of the band 1060 (e.g., the front edge of the band 1060), while the second boundary 1092 is defined by or parallel to a connecting portion 1084 (e.g., the origin of the front wall 1080) or a bend or transition between the front wall 1080 and the 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 that is positioned between the seal housing 190 and the reduced stiffness region 172. A hinge axis H for movement of the upper portion 1002 of the seal 180 is defined by or located near the intersection of the first boundary 1090 and the second boundary 1092 or an overhanging portion thereof.

[0173] 28 , as the upper portion 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 are initially no rolling portions defined in the upper portion 1002 and they gradually increase in size during the displacement of the upper portion 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. For example, the reduced stiffness regions 172 may define different angles between the boundaries 1090, 1092 in the relaxed position between various sizes. Additionally or alternatively, the reduced stiffness regions 172 may define different heights of the front wall 1080 (or different overall lengths of the front wall 1080 and top wall 1082) between various sizes. Figures 23-26 illustrate different angles and different heights of the front wall 1080 between cushion modules 110 or seals 180 of several sizes.

[0175] Referring to Figures 23 and 24, three different sizes of seals 180A, 180B, and 180C are shown. The seals 180A, 180B, and 180C may be, for example, seals for the three cushion modules 110A, 110B, and 110C of Figures 8 and 9. Figure 23 illustrates the relationship between the length of the boundaries 1090 and 1092 and the maximum forward displacement of the upper portion 1002. Assuming that the length of the upper portion 1002 increases or decreases as the seal length 180 increases or decreases, the length of the boundaries 1090 and 1092 also increases or decreases. If the available angle of change between the boundaries 1090 and 1092 is held constant between seal 180 sizes, the available maximum forward displacement of the upper portion 1002 is smaller for smaller seal 180 sizes and larger for larger seal 180 sizes.

[0176] For example, FIG. 23 illustrates first boundary 1090 and second boundaries 1092A, 1092B, and 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 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 of boundaries 1092A and 1092B. FIG. 23 illustrates that by increasing the angle between boundaries 1090 and 1092 at relatively small angles, the maximum available forward displacement of the upper portion 1002 can be the same or similar among several sizes of seals 180A, 180B, and 180C. Therefore, preferably, the angle between boundaries 1090 and 1092 is greatest for smallest size seal 180A and smallest for largest size seal 180C. However, in other configurations, the smallest size seal may have an angle greater than at least one of the larger size seals, and similarly, the largest size seal may have an angle less than at least one of the smaller size seals.

[0177] In some configurations, the small seal 180A, in the relaxed position of the upper portion 1002, defines an angle between the boundaries 1090, 1092A that is at least approximately 30 degrees. In some configurations, this angle is approximately 34 degrees. In some configurations, the medium seal 180B, in the relaxed position of the upper portion 1002, defines an angle between the boundaries 1090, 1092B that is between approximately 25 degrees and approximately 35 degrees. In some configurations, this angle is approximately 29 degrees. In some configurations, the large seal 180C, in the relaxed position of the upper portion 1002, defines an angle between the boundaries 1090, 1092C that is between approximately 20 degrees and approximately 30 degrees. In some configurations, this angle is approximately 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 illustrate the difference in height of the front wall 1080 between various seal sizes. As the rotation angle of the upper portion 1002 of the seal 180 increases, the downward movement of the band 1060 or other boundary 1090 increases. For example, FIG. 25 illustrates the difference between the downward movement D1 and the downward 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), where the second angle is greater than the first angle. The downward movement D2 resulting from the larger maximum deflection angle is substantially greater than the downward movement D1 resulting from 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 reduced stiffness region 172 is also longer in the seal 180 than in the Simplus® seal.

[0179] FIG. 26 shows three different sized seals 180A, 180B, 180C, which may be seals for the three cushion modules 110A, 110B, 110C of FIGS. 8 and 9, for example. 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 approximately 7.3 mm. In some configurations, height 1100B is approximately 7.6 mm. In some configurations, height 1100C is approximately 7.7 mm. For comparison, the equivalent height of a Simplus® seal is approximately 4.4 mm.

[0180] The reduced stiffness region 172 and / or the upper portion 1002 of the seal 180 may include features that facilitate 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, which 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 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 progressively increases in the direction from the connecting portion 1084 toward the band 1060. In the illustrated arrangement, the wall thickness gradually increases in both the front wall 1080 and the top wall 1082 from the lower end or connecting portion 1084 of the front wall 1080 to or near the band 1060. That is, the rate of change of wall thickness is constant between the front wall 1080 and the top wall 1082, despite the transition from one to the other. This 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 between the front wall 1080 and the top wall 1082. For example, the thickness can increase gradually at the front wall 1080 and 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] Referring to FIG. 21 , the amount of overlap between the seal 180 and the seal housing 190 can vary around the perimeter of the seal 180 and the seal housing 190 or along the junction between the seal 180 and the seal housing 190. The dashed line in FIG. 21 indicates the edge of the seal housing 190. The solid line in front of (to the right of) the dashed line indicates the edge of the seal 180. The edge of the seal 180 defines a relatively smoothly curved shape, while the edge of the seal housing 190 defines a relatively smoothly non-curved shape. The overlap between the seal 180 and the seal housing 190 can 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 can be to increase retention of the seal 180 against the seal housing 190, or simply to allow the edge 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 outward 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 may provide stiffness at or near hinge axis H, which may improve 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 in the nasal bridge region of the seal 180, and a second point 1202 is located in the chin region of the seal 180. 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 points 1200, 1202, i.e., dimension 1204, is an important factor in determining the fit of seal 180 or cushion module 110 to a user. For example, dimension 1204 is closely related to the dimension or length of the user's sublabial-sellion (SS) point at which seal 180 or cushion module 110 provides a proper or desired fit. In at least some configurations, there is a significant difference between dimension 1204 of seal 180 in the neutral position and the depressed position, which may be the fully depressed position. For example, dimension 1204 may differ by more than 2 mm between the neutral and depressed positions. In some configurations, dimension 1204 may vary by at least about 4 mm, at least about 5 mm, or at least about 6 mm between the neutral and depressed positions. In at least one size or embodiment of seal 180, dimension 1204 may vary from about 90 mm to about 84 mm between the neutral and depressed positions. In other words, there is a variation of approximately 6 mm in dimension 1204. For comparison, the Simplus® cushion module varies by 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 fit 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 compressed until dimension 1204 is sized appropriately for a particular user's facial shape (e.g., SS length). Greater variation in dimension 1204 may be provided by greater angular displacement of upper portion 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 any combination thereof. In some configurations, greater variation in dimension 1204 may be provided, e.g., at least about 8 mm, at least about 10 mm, at least about 12 mm, or more. In some cases, greater variation is preferable, as long as other performance criteria are not undesirably affected. In some configurations, the variation 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 by 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 6-3 percent, at least about 8 percent, at least about 10 percent, or more, between the neutral position and the depressed position.

[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 sublip-nasal midpoint 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 generally correspond to the sublip-nasal midpoint 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 hinge point H1 to provide a greater 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. 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 also rolling completely.

[0189] As shown in FIG. 11 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 is L 11 Shorter. L 13 is the seal length when both the first and second rolling portions 2112, 2114 have rolled fully onto the displaced nose contact point 2126. 13 is 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 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 the 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 when 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] Figure 34 shows 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, therefore, to the user U. Respiratory masks are available in a variety of configurations, including, but not limited to, full-face masks, nasal masks, 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] While the following disclosure is described in the context of a nasal or direct nasal mask, it should be understood that alternative embodiments for other mask configurations are possible. Some direct nasal masks are known to include a short tubing component that forms a flexible intermediate connection between the respiratory mask 3120 and the air delivery hose 3110, such as Pilairo™ by Fisher & Paykel Healthcare Ltd. This tubing provides a means to at least partially decouple any forces that the air delivery hose 3110 may exert on the respiratory mask 3120. The tubing is generally much lighter and more flexible than the air delivery hose 3110, and therefore applies less force to the respiratory mask 3120. This can be particularly beneficial for direct nasal masks, and possibly nasal masks, because they are generally smaller and lighter and therefore more likely to become detached from the user's face when force is applied. Removing the respiratory mask 3120 from the user's face can result in a reduction in the effectiveness of 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 intermediary tube may be used as a component of the biased airflow system of the present disclosure.

[0193] 35 shows 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 biased 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, reducing or eliminating 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 protrudes 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 asymmetrical. The cross-sectional shape of the beads 3264 in conjunction with the choice of material determines the stiffness of the beads 3264 and therefore the structural support provided to the wall 3262. The beads 3264 are made from 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 walls 3262 relative to the beads 3264 is such that the tube 3260 can be compressed along its central axis in a spring-like manner, allowing the walls 3262 to fold or deform, reducing the pitch of the beads 3264. In an alternative embodiment (not shown), the pitch of the beads 3264 can vary along the length of the tube 3260 such that the amount of deformation along different portions along the length of the tube 3260 can vary. Still further, the pitch of the beads 3264 can vary along portions of the tube 3260 such that the tube 3260 can have a curved shape.

[0195] The exhaust holes 3280 are formed in the bead 3264 and are spaced radially or spirally 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. 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 area (360°) by radially aligned holes 3410 in a cylindrical conduit 3420. The radially aligned holes 3410 or exhaust holes 3280 provide a flow path for the exhausted air to vent, which minimizes the airflow that may 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 can help minimize air entrainment, which can cause a user to perceive greater drafts. The formation of the exhaust holes 3280 on the helical bead results in the individual exhaust holes being longitudinally offset from one another. This further increases the dispersion of the exhausted air. It is desirable to position the exhaust holes 3280 within 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 within 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, 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 asymmetrical. In embodiments in which 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 small diameter holes (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 respirator 3200. The exhaust holes 3280 may be spaced a maximum distance from each other that allows the total number of required exhaust holes 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 positioned only at the bottom of the tube 3260 so that the exhausted air exits the tube 3260 away from the user's head. Thus, noise from the exhausted air is less likely to disturb the user because of 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 spaced irregularly 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 airflow and noise requirements.

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

[0198] 38 shows a biased ventilation 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 can 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] 39 , there is an annular component 4200 extending from the front wall 4240 of the seal housing 4140. The annular component connects 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, adhesive bonding, 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) can be connected.

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

[0203] Figure 40 shows an example cross-sectional view of a cylindrical or annular component 4300 having radial exhaust holes 4310. The arrows shown in Figure 40 illustrate how the exhausted air 4320 is dispersed through the holes 4310. This dispersion 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, which 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 a radial hole configuration, allowing for the formation of small hole diameters. The hole diameter may be approximately 0.4 mm. When used herein in connection with 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 for 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 from within the breathing chamber 4210 of the mask.

[0205] The annular element 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. Radial ventilation paths 4250 may be formed between the outer periphery of the shroud 4160 and the front wall 4240. The radial ventilation paths 4250 allow the exhausted air to remain distributed 360°, which may reduce detectable drafts.

[0206] Air may be discharged through the discharge holes 4220 and enter a plenum chamber 4230 formed by the shroud 4160, the annular element 4200, and the front wall 4240 of the seal housing 4140. As the discharged air passes through the discharge holes 4220, it accelerates. However, by diverting the discharged air to the plenum chamber 4230 before exiting through the ventilation path 4250, the discharged air is slowed down and redirected. The space in the plenum chamber forms an expansion chamber that allows energy present in the discharged 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 discharge holes 4220, thereby reducing or preventing the entrainment of atmospheric air. The reduced fluid velocity and reduced entrainment substantially reduces or prevents draft detection by a user.

[0207] 41 is a screenshot of a computational fluid dynamics (CFD) analysis of the geometry of the exhaust holes 4220 and shroud 4160. It can be seen from the cross section that the fluid velocity slows substantially as it exits via the airflow 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 regions) adjacent the front wall 4240 and the annular element 4200. This recirculation allows energy in the exhausted air to be dissipated before it exits the airflow path, which further reduces drafts and noise.

[0208] The rate of exhaust flow 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 can be varied 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 can 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 can be changed.

[0209] Additional non-limiting exemplary embodiments of shroud shapes can be seen in FIGS. 42A and 42B. The figures show shrouds 4500, 4510 having rectangular and arcuate cross-sections surrounding annular components 4520, 4530, respectively. As in the embodiments of FIGS. 38 and 39, the shrouds create a plenum chamber adjacent to the annular components 4520, 4530. Further, the plenum chamber may include flow directors, such as fins, vanes, and / or baffles (not shown), positioned within the plenum chamber. For example, fins and vanes guide exhaust air through the plenum chamber and into the ventilation path 4250. Baffles may be used to dissipate energy from the exhausted air flow. 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 nearest 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 shroud may be located in different portions of the respiratory mask. For example, the holes and shroud may be part of an elbow or swivel conduit connector. An elbow and / or swivel are commonly used in respiratory masks to provide an intermediate connection between the air delivery conduit and the mask. In the non-limiting exemplary embodiment of FIGS. 43A and 43B, the exhaust holes and shroud are located in the elbow. FIG. 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 FIG. 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 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 approximately 120°. The shroud 4620 extends slightly beyond the outer hole edges. The shroud 4620 may have a partial bicone shape, where the shroud forms a truncated bicone segment at both its 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 either. The open shroud edge 4640 provides a path through which the exhausted air can be vented to the atmosphere.

[0212] The size and number of holes may be similar to the previous embodiment and may allow CO2 to flow from within the mask. In other variations of this embodiment, the amount of the suction pressure can be based on the amount of suction pressure required to suction the suction pressure. , the shroud 4620 may be conical rather than biconical, with one end being narrower than the other. The shroud may be square, round, or any other shape as an alternative to the conical shape. The shape may be any suitable shape.

[0213] The inclusion of a shroud component around the exhaust hole in a respirator can take various forms depending on the configuration of 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 partial flow 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, mask frame 4720, and 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 forward and rearward insert surfaces 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 forward bearing surface 4742 and a rearward bearing surface 4744. The forward and rearward bearing surfaces 4742, 4744 are substantially spherical and match the shape of the ball joint 4705. The forward bearing surface 4742 includes a continuous surface that forms a substantially airtight seal with the ball joint 4705. The rearward 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, restricting translational movement of the ball from front to rear, but allowing the ball joint to rotate freely 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 the forward recess wall 4774 and to the rearward bearing surface 4744 by the sidewall 4776. The forward recess wall 4774 extends at an obtuse angle between the rearward edge 4746 of the forward bearing surface 4742 and the outer recess wall 4772. The sidewall 4776 extends at an obtuse angle between the rearward 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. Vent holes 4780 extend radially between the outer recess wall 4772 and the outer periphery 4730. The vent holes 4780 allow exhaled air to pass through the recess 4770 and be vented to the atmosphere. While embodiments of the present disclosure include three vent holes 4780 within each recess 4770, other embodiments may have more or fewer holes. The number of holes may be determined by the diameter of the hole and the flow rate through the holes required to flush CO2 from within the mask. The vent holes 4780 are preferably formed by laser drilling, although other known hole forming techniques (such as in-mold forming) may also 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 the 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 illustrate various non-limiting exemplary embodiments of different socket insert configurations. FIG. 45 illustrates an embodiment similar to the previously described 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 drain holes 4880 located within the rear lip 4812 such that the holes are substantially unobstructed. The distance that the rear lip 4812 extends from the ball joint opening 4807 can be defined such that the drain hole 4880 is not completely blocked by the ball joint when the ball joint 4805 rotates within the socket insert 4810 .

[0222] In this embodiment, exhausted air passes through exhaust holes 4880 in the socket insert 4810 and enters 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, rather than the mask frame 4820, is configured to provide a substantially conical shroud 4860. This can be beneficial in reducing the size of the mask frame and therefore 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 Figure 46 is similar to that of Figures 44A-44E. It includes an elbow joint 4900, a socket insert 4910, a mask frame 4920, and a seal housing 4930. As in the previous embodiments, 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 forms 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 a connection 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 connection between the mask frame 4920, socket insert 4910, and 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 exhaled 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 CO2 from within the mask. Exhaled 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 aft 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 illustrates a further embodiment of a biased airflow system configuration that may be used to diffuse exhausted air toward 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 respirator, 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 the seal housing (not shown). It includes an elbow end 5122 and a distal end 5123, with 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 drain holes 5130 located proximal to the distal end 5123. The shroud wall 5125 includes an annular wall section that angles inward 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 shows a non-limiting exemplary embodiment in which a biased air system 5200 is provided at 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 detachable connection with an air supply conduit. A 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 so 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 previous 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 "comprises," "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 herein to prior art is not to be regarded, and should not be regarded, as an admission or any suggestion that that prior art forms part of the common general knowledge in the art anywhere in the world.

[0233] The invention may also be said to broadly reside 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 that have known equivalents, those whole entities are incorporated herein as if separately defined.

[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 needed. Accordingly, such changes and modifications are intended to be included within the scope of the present invention. Furthermore, not all features, aspects, and advantages are necessary 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 cushion module for a respiratory interface, comprising: a seal housing made of a relatively rigid material, the seal housing defining an aperture configured to allow breathing gas to enter an interior of the cushion module; a seal supported by the seal housing and having an upper portion and a lower portion, the seal further including a face contacting surface configured to contact a face of a user and create at least a substantial seal with the face of the user, the face contacting surface having an inner edge defining an opening in the face contacting surface, the upper portion of the seal including 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 first boundary and the second boundary interfering with each other along the reduced stiffness portion; a seal having a reduced stiffness portion configured to roll on the outer surface of the cushion module in response to forward movement of the upper portion of the face-contacting surface, the reduced stiffness portion being a rolling portion configured to roll on the outer surface of the cushion module in response to forward movement of the upper portion of the face-contacting surface, the rolling portion comprising a front wall and an upper wall, the rolling of the rolling portion forming a single bend between the front wall and the upper wall, the front wall having a height defined by the distance between a top of the seal positioned adjacent to a user's nose in use and a top surface of the seal housing, the height being between about 7 mm and about 7.7 mm; a cushion module.

2. 2. The cushion module of claim 1, wherein the portion of the seal defining the face-contacting surface includes a pair of nose pads positioned on either side of the opening in the upper portion of the seal, each of the nose pads being entirely spaced outward from the opening.

3. The cushion module of claim 2 , wherein the nose pads are the thickest portions of the portion of the seal that defines the face-contacting surface.

4. The cushion module of claim 3 , further comprising a pair of thickened perimeter portions defined by the portion defining the face-contacting surface of the seal, at least a portion of the thickened perimeter portions being positioned below the nose pads.

5. The cushion module of claim 4 , wherein at least a portion of the thickened perimeter portion is positioned above the nose pads.

6. 6. The cushion module of claim 1, wherein the continuous portion of the inner edge of the opening defines a thickness of 0.6 mm or less, and the continuous portion of the inner edge extends at least 1 mm inward from the inner edge and extends along at least the entire upper portion of the seal.

7. 7. The cushion module of claim 6, wherein a section of the contiguous portion of the inner edge located within 0.5 mm of the inner edge has a thickness of 0.4 mm or less.

8. 8. The cushion module of claim 1, wherein the upper portion of the seal defines a nasal bridge portion that contacts the bridge of the user's nose, and the nasal bridge portion of the opening defines a continuously curved portion of the inner edge.

9. 9. The cushion module of claim 8, wherein the width of the nasal bridge portion is about 11 mm or less.

10. 10. The cushion module of claim 8 or 9, wherein the vertical dimension of the vertical center of the nasal bridge portion is about 15 mm or greater.

11. 11. The cushion module of claim 8, wherein the depth between the rearmost 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.

12. The cushion module according to any one of claims 1 to 11, wherein the thickness of the front wall and the top wall increases gradually from the lower end of the front wall to the rear end of the top wall.

13. 13. The cushion module of claim 1, wherein 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 more than 2 mm between the neutral position and the depressed position of the stiffened portion.

14. 14. The cushion module of claim 13, wherein the distance between the point on the centerline of the upper portion and the 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 reduced stiffness portion.

15. 14. The cushioning module of claim 13, wherein the distance varies from about 90 mm to about 84 mm between the neutral position and the depressed position of the reduced stiffness portion.

16. 14. The cushion module of claim 13, wherein the distance varies by at least about 5 percent between the neutral position and the depressed position of the reduced stiffness portion.

17. 17. The cushion module of claim 16, wherein the distance varies by at least about six and two-thirds percent between the neutral position and the depressed position of the reduced stiffness portion.

18. A set of cushion modules, comprising a plurality of cushion modules according to any one of claims 1 to 17 of at least two different sizes, wherein the height of the front wall differs between the sizes.

19. 20. The set of cushion modules of claim 18, including small, medium, and large sizes, wherein the height of the front wall of the small size is less than the height of the front wall of one or both of the medium and large sizes.

20. 20. The set of cushion modules according to claim 19, wherein a height of the front wall of the large size is greater than a height of the front wall of one or both of the small and medium sizes.

21. The set of cushion modules according to claim 20, wherein a height of the front wall of the large size is greater than a height of the front wall of the medium size, and a height of the front wall of the medium size is greater than a height of the front wall of the small size.

22. The set of cushion modules according to any one of claims 19 to 21, wherein the height of the front wall of the small size is approximately 7.3 mm, the height of the front wall of the medium size is approximately 7.6 mm, and the height of the front wall of the large size is approximately 7.7 mm.

Images