Respiratory interface assembly

Abstract

To provide a patient interface system having improved operation, sealing, comfort and adjustment features.SOLUTION: A respiratory interface assembly includes a patient interface and a headgear arrangement. A seal or cushion of the interface assembly can include thickened portions positioned and arranged to improve sealing and / or user comfort. The headgear arrangement can be connectable to the nasal mask by a connection arrangement configured to provide stability to the nasal mask such that a forehead support is not required. The connection arrangement can inhibit or prevent improper connections. The headgear arrangement can have one or more resilient straps having a composite construction of an outer fabric and a plastic core. The outer fabric can be knitted. A rear portion of the headgear arrangement can include a knitted panel or a spacer fabric panel.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 914,923, filed October 14, 2019, the entirety of which is incorporated herein by reference.

[0002] The present disclosure relates to a respiratory interface assembly, and more particularly to a nasal mask assembly having a nasal mask, a headgear, and a connection between the mask and the headgear. [Background technology]

[0003] In assisted breathing, breathing gas is delivered to the patient via one or more flexible breathing tubes through a patient interface, which may be a nasal cannula, a nasal mask, a full-face or oronasal mask, an endotracheal tube, or other known type of interface. The patient interface is held in place on the user's head by a headgear device. Summary of the Invention [Problem to be solved by the invention]

[0004] It would be advantageous to provide a patient interface system with improved handling, sealing, comfort, and adjustability. Such a system may be a nasal mask assembly. Such an improved system may further aid in improving compliance with gas delivery therapy.

[0005] Any reference herein to patents, other external documents, or other sources of information is generally for the purpose of providing a context for considering the features of the present disclosure, and unless otherwise stated, the reference to such external documents should not be construed as an admission that such documents or such sources are prior art or form part of the common general knowledge in the art in any jurisdiction.

[0006] Further aspects and advantages of the present disclosure will become apparent from the following description, which is given by way of example only. [Means for solving the problem]

[0007] The systems, methods, and apparatus described herein have innovative aspects, no single aspect of which is essential or solely responsible for their desirable attributes. Without limiting the scope of the claims, some of the advantageous features will now be summarized.

[0008] One aspect of the present disclosure includes a respiratory interface assembly including an interface configured to communicate with a user's airway. The interface comprises a frame having a post. The frame defines an opening, the post defining a portion of the opening. The frame opening includes a narrow portion defined by opposing upper and lower surfaces, the narrow portion being located adjacent to the post. Headgear is configured to secure the interface in an operable position on the user's head. The headgear includes a clip having a base and a hook portion extending from the base. The hook portion is configured to engage with the post of the frame. The hook portion includes upper and lower surfaces that substantially match the shape of the respective upper and lower surfaces of the narrow portion, such that when the hook portion engages the post, the upper and lower surfaces of the hook portion engage with the opposing upper and lower surfaces of the narrow portion, respectively, to resist rotation of the clip relative to the frame about an axis perpendicular to the longitudinal axis of the post.

[0009] In some configurations, a section of the hook portion between the upper and lower surfaces of the hook portion is shaped to span the space when the hook portion engages the post.

[0010] In some configurations, the post and the opposing upper and lower surfaces cooperate to define a space, and the section of the hook portion between the upper and lower surfaces occupies substantially all of the space when the hook portion engages the post.

[0011] In some configurations, the opposing upper and lower surfaces are parallel to one another.

[0012] In some configurations, the hook portion defines an inner surface facing the post, an outer surface, and a thickness between the inner and outer surfaces, the thickness being greatest at a portion located between opposing upper and lower surfaces when the hook portion engages the post.

[0013] In some configurations, the base of the clip has a height greater than the height of the hook portion so as to be configured to contact portions of the frame adjacent the opposing upper and lower surfaces of the narrow portion to limit rotation of the clip about the longitudinal axis of the post.

[0014] In some configurations, the headgear comprises at least one semi-rigid side strap configured to extend from the breathing interface along each side of the user's face toward the user's ears, and at least one semi-rigid top strap extending from the at least one semi-rigid side strap on a first side of the user's face to the at least one semi-rigid side strap on a second side of the user.

[0015] In some configurations, the at least one semi-rigid side strap includes a branch portion on each side, each branch portion having an upper strap portion and a lower strap portion.

[0016] In some configurations, the headgear further includes a rear portion, the rear strap portion connecting to the rear portion above the level of the user's ears, and the lower strap portion connecting to the rear portion below the level of the user's ears and in front of the ears.

[0017] In some configurations, the rear portion includes a spacer fabric panel.

[0018] In some configurations, the rear portion further comprises an upper strap and a lower strap, the upper strap having less stretch than the lower strap.

[0019] In some configurations, the rear portion comprises a woven panel.

[0020] In some configurations, the knitted panel is less stretchable in the vertical direction than in the horizontal direction.

[0021] In some configurations, one or both of the at least one semi-rigid side strap and the at least one semi-rigid top strap include an inner fabric layer, an outer fabric layer, and an inner plastic layer that are joined by introducing the inner plastic layer in a molten state between the inner and outer fabric layers and allowing it to harden.

[0022] In some configurations, the inner and outer fabric layers are knit.

[0023] In some configurations, the at least one semi-rigid side strap includes a first semi-rigid side strap and a second semi-rigid side strap, each of the first semi-rigid side strap and the second semi-rigid side strap connectable to the frame by one of the clips.

[0024] In some configurations, the at least one semi-rigid top strap includes a first semi-rigid top strap and a second semi-rigid top strap, the first semi-rigid top strap and the second semi-rigid top strap being selectively connectable to one another at one of a plurality of available adjustment positions.

[0025] In some configurations, the interface comprises a nasal mask seal configured to seal around one or both nostrils of a user, the nasal mask seal having a sealing surface defining an opening.

[0026] In some configurations, the opening defined by the sealing surface of the nasal mask seal defines a width-to-height ratio of about 1.3 to 1.6.

[0027] In some configurations, the nasal mask seal height range across all available sizes is approximately 47.8mm to 57.8mm.

[0028] In some configurations, the nasal mask seal comprises a rolling bridge portion.

[0029] In some configurations, the nasal mask seal comprises a rim to which the nasal mask seal is secured to a rigid clip or housing, and the rolling bridge portion is connected to a posterior edge of the rim, while in other configurations the rolling bridge portion is connected to a front edge of the rim.

[0030] In some configurations, the nasal mask seal further comprises a thickened band located between the sealing surface and the rolling bridge, and further comprises a pair of thickened bands extending from the thickened band towards the opening on each side of the nasal mask seal.

[0031] In some configurations, the nasal mask seal further comprises a thickened band located between the sealing surface and the rolling bridge, a pair of thickened pads intermediate the thickened band and the opening and spaced apart from the thickened band, and a pair of interface pads extending between a portion of the thickened band and a portion of each of the pair of thickened pads.

[0032] In some configurations, the thickened band is thicker than the pair of thickened pads, which in turn are thicker than the pair of interface pads.

[0033] In some configurations, the pair of thickened pads and the pair of interface pads each have a length extending circumferentially around the inner periphery of the nasal mask seal, and the length of each of the pair of interface pads is about 15% to 50%, preferably about 20% to 45%, and more preferably about 25% to 33% of the length of each of the pair of thickened pads.

[0034] In some configurations, each of the pair of interface pads extends between a portion of the thickened band and a respective upper portion of the pair of thickened pads.

[0035] In some configurations, a pair of interface pads are provided on side walls of the nasal mask seal on either side of the nasal mask seal, and at least a portion of a pair of thickened pads are provided on end walls that define the sealing surface of the nasal mask seal.

[0036] In some configurations, the nasal mask seal comprises a pair of elongated thickened portions each extending from a first end adjacent to or near a respective lower corner of a side wall of the nasal mask seal at or adjacent to or near the rim to a second end at or adjacent to or near an end wall that defines the sealing surface of the nasal mask seal.

[0037] In some configurations, the pair of thickened portions diverge from one another from the first end toward an intermediate portion of each of the pair of thickened portions.

[0038] In some configurations, the pair of thickened portions converge from their respective intermediate portions toward the second ends.

[0039] In some configurations, each of the pair of elongate thickened portions is curved in a direction substantially perpendicular to their respective major surfaces.

[0040] One aspect of the present disclosure includes headgear for a breathing interface, the headgear including at least one elastic side strap configured to extend from the breathing interface along each side of a user's face toward the user's ears, and at least one elastic top strap extending from the at least one elastic side strap on a first side of the user's face to the at least one elastic side strap on a second side of the user's face.

[0041] One aspect of the present disclosure includes headgear for a breathing interface, the headgear including at least one semi-rigid side strap configured to extend from the breathing interface along each side of a user's face toward the user's ears, and at least one semi-rigid top strap extending from the at least one semi-rigid side strap on a first side of the user's face to the at least one semi-rigid side strap on a second side of the user's face.

[0042] In some configurations, the at least one semi-rigid side strap includes a branch portion on each side, each branch portion having an upper strap portion and a lower strap portion.

[0043] In some configurations, the headgear further includes a rear portion, the rear strap portion connecting to the rear portion above the level of the user's ears, and the lower strap portion connecting to the rear portion below the level of the user's ears and in front of the ears.

[0044] In some configurations, the rear portion includes a spacer fabric panel.

[0045] In some configurations, the rear portion further comprises an upper strap and a lower strap, the upper strap having less stretch than the lower strap.

[0046] In some configurations, the rear portion comprises a woven panel.

[0047] In some configurations, the knitted panel is less stretchable in the vertical direction than in the horizontal direction.

[0048] In some configurations, one or both of the at least one semi-rigid side strap and the at least one semi-rigid top strap include an inner fabric layer, an outer fabric layer, and an inner plastic layer that are joined by introducing the inner plastic layer in a molten state between the inner and outer fabric layers and allowing it to harden.

[0049] In some configurations, the inner and outer fabric layers are knit.

[0050] In some configurations, the at least one semi-rigid strap includes a first semi-rigid side strap and a second semi-rigid side strap, the first semi-rigid side strap and the second semi-rigid side strap being selectively connectable to one another at one of a plurality of available adjustment positions.

[0051] In some configurations, the at least one semi-rigid side strap is formed from at least one tubular knit structure injection molded with a semi-rigid plastic core.

[0052] In some configurations, at least one of the top strap, the upper strap portion and the lower strap portion of the at least one side strap comprises a separate tubular knit structure that is injection molded with a plastic core and joined to the at least one side strap by an overmolded interface.

[0053] One aspect of the present disclosure includes a respiratory interface assembly that includes any of the headgear described above and an interface configured to communicate with a user's airway.

[0054] In some configurations, the interface includes a frame having a post, the frame defining an opening, the post defining a portion of the opening. The frame opening includes a narrow portion defined by opposing upper and lower surfaces. The narrow portion is located adjacent to the post. The headgear includes a clip having a base and a hook portion extending from the base. The hook portion is configured to engage with the post of the frame. The hook portion includes upper and lower surfaces that substantially match the shape of the respective upper and lower surfaces of the narrow portion, such that when the hook portion engages with the post, the upper and lower surfaces of the hook portion engage with the respective upper and lower surfaces of the narrow portion to resist vertical rotation of the clip relative to the frame about an axis perpendicular to the longitudinal axis of the post.

[0055] In some configurations, a section of the hook portion between the upper and lower surfaces of the hook portion is shaped to span the space when the hook portion engages the post.

[0056] In some configurations, the post and opposing upper and lower surfaces cooperate to define a space, and the section of the hook portion between the upper and lower surfaces occupies substantially all of the space when the hook portion engages the post.

[0057] In some configurations, the opposing upper and lower surfaces are parallel to one another.

[0058] In some configurations, the hook portion defines an inner surface facing the post, an outer surface, and a thickness between the inner and outer surfaces, the thickness being greatest at a portion located between opposing upper and lower surfaces when the hook portion engages the post.

[0059] In some configurations, the base of the clip has a height greater than the height of the hook portion so as to be configured to contact portions of the frame adjacent the opposing upper and lower surfaces of the narrow portion to limit rotation of the clip about the longitudinal axis of the post.

[0060] In some configurations, the at least one semi-rigid side strap includes a first semi-rigid side strap and a second semi-rigid side strap, each of the first semi-rigid side strap and the second semi-rigid side strap configured to be connectable to the frame by one of the clips.

[0061] In some configurations, the interface comprises a nasal mask seal configured to seal around one or both nostrils of a user, the nasal mask seal having a sealing surface defining an opening.

[0062] In some configurations, the opening defined by the sealing surface of the nasal mask seal defines a width-to-height ratio of about 1.3 to 1.6.

[0063] In some configurations, the nasal mask seal height range across all available sizes is approximately 47.8mm to 57.8mm.

[0064] In some configurations, the nasal mask seal comprises a rolling bridge portion.

[0065] In some configurations, the nasal mask seal comprises a rim to which the nasal mask seal is secured to a rigid clip or housing, and the rolling bridge portion is connected to the rear edge of the rim.

[0066] In some configurations, the nasal mask seal further comprises a thickened band located between the sealing surface and the rolling bridge, and further comprises a pair of thickened bands extending from the thickened band towards the opening on each side of the nasal mask seal.

[0067] One aspect of the present disclosure includes a cushion for a respiratory interface assembly, the cushion comprising: a rim attached or configured to be attached to a housing of the respiratory interface assembly; an elastic side wall extending from the rim; an elastic end wall extending inward from the elastic side wall, the elastic end wall defining, in use, a sealing surface that seals with a user's face and an opening for receiving the user's nose and / or mouth; a thickened band within the side wall; a pair of thickened pads intermediate the thickened band and the opening and spaced apart from the thickened band; and a pair of thickened pads intermediate respective portions of the thickened band and respective portions of the pair of thickened pads.

[0068] In some configurations, the thickened band is thicker than the pair of thickened pads and / or the pair of thickened pads is thicker than the pair of interface pads.

[0069] In some configurations, the pair of thickened pads and the pair of interface pads each have a length extending circumferentially around the inner periphery of the cushion, and the length of each of the pair of interface pads is about 15% to 50%, preferably about 20% to 45%, and more preferably about 25% to 33% of the length of each of the pair of thickened pads.

[0070] In some configurations, each of the pair of interface pads extends between a portion of the thickened band and a respective upper portion of the pair of thickened pads.

[0071] In some configurations, a pair of interface pads are provided on side walls of the nasal mask seal on either side of the nasal mask seal, and at least a portion of a pair of thickened pads are provided on the face-contacting surface of the nasal mask seal.

[0072] One aspect of the present disclosure includes a cushion for a respiratory interface assembly, the cushion comprising: a rim configured to be attached to a housing of the respiratory interface assembly; an elastic side wall extending from the rim; an elastic end wall extending inward from the elastic side wall, the elastic end wall defining, in use, a sealing surface that seals with a user's face and an opening to receive the user's nose and / or mouth; and a pair of elongated thickened portions each extending from a first end at or adjacent to or near a respective lower corner of the side wall at or adjacent to or near the rim to a second end at or adjacent to or near a respective opposite end wall of the opening.

[0073] In some configurations, the pair of thickened portions extend away from each other from the first end toward an intermediate portion of each of the pair of thickened portions.

[0074] In some configurations, the pair of thickened portions extend toward each other from their respective intermediate portions toward the second ends.

[0075] In some configurations, each of the pair of elongate thickened portions is curved in a direction substantially perpendicular to their respective major surfaces.

[0076] One aspect of the present disclosure includes a connection device for connecting a headgear strap to an interface of a patient interface assembly, the connection device comprising: a post provided on or configured to be provided on one of the headgear strap or the patient interface assembly; a clip provided on the other of the headgear strap or the patient interface assembly, the clip comprising a base portion and a hook portion defining a space therebetween configured to selectively receive the post; a gap provided on one of the post or clip; and a rib provided on the other of the post or clip, the rib and the gap each being asymmetrically positioned such that the rib is received by the gap when the clip is connected to the post, and the rib is configured to discourage or prevent alternative connections.

[0077] In some configurations, a gap is provided on the post and defined between coaxially arranged first and second post portions, a rib is provided on the clip and protrudes into the space, the rib is configured to be received by the gap when the post is received by the space, and the rib is configured to inhibit or prevent connection of the clip to an alternative post.

[0078] In some configurations, a rib is provided on the post and a gap is provided on the clip, the rib is configured to be received by the gap when the post is received by the space, and the rib is configured to inhibit or prevent connection of an alternative clip to the post.

[0079] One aspect of the present disclosure includes a headgear assembly for securing a patient interface to a patient's head, the headgear assembly comprising: two or more straps; and two or more headgear clips provided or configured to be provided on the two or more straps, wherein at least a first clip of the two or more headgear clips comprises a base portion and a hook portion defining a space therebetween configured to selectively receive a post of the patient interface, and further comprises a rib protruding into the space, the rib being asymmetrically positioned along a length of the space such that a gap defined in at least the first post of the patient interface receives the first clip when coupled with the first post and obstructs or prevents coupling of the first clip with a second post of the patient interface.

[0080] In some configurations, a second clip of the two or more headgear clips comprises a base portion and a hook portion defining a space therebetween configured to selectively receive a post of a patient interface, and further comprises a rib protruding into the space, the rib being asymmetrically positioned along the length of the space such that a gap defined in at least the second post of the patient interface receives the second clip when coupled with the second post and impedes or prevents coupling of the second clip with the first post.

[0081] In some configurations, the first clip and the second clip are mirror images of each other.

[0082] One aspect of the present disclosure includes a headgear clip for attaching headgear to a patient interface assembly, the headgear clip comprising a base portion configured to be attached or to be attached to a strap of the headgear at a first end, a hook portion protruding from a second end of the base portion and defining a space configured to selectively receive a post of the patient interface assembly, and a protrusion extending outward from an exterior of the base portion.

[0083] In some configurations, the protrusion is located at, adjacent to, or near the first end of the base portion.

[0084] In some configurations, the headgear clip further comprises a recess on the exterior of the base portion intermediate the second end and the protrusion.

[0085] In some configurations, at least the hook portion and a first portion of the base portion comprise a first material that is resilient and relatively rigid, and at least a second portion of the base portion comprises an elastomeric second material overmolded onto the first material.

[0086] In some configurations, a second material is also overmolded onto the strap.

[0087] In some configurations, the first portion of the base portion includes an inner portion of the protrusion and the second portion of the base portion includes an outer portion of the protrusion.

[0088] In some configurations, the projection spans the width of the base portion.

[0089] In some configurations, the projection provides at least one surface that is substantially perpendicular to the direction of force required to engage or disengage the hook portion and post.

[0090] In some configurations, the frame includes or is configured to be coupled to a cushion that sealingly engages with the patient's face, the frame including a first post and a second post configured to be coupled to a first headgear clip and a second headgear clip of a headgear assembly of the patient interface assembly, the first post including a first portion and a second portion that are coaxially arranged and define a gap therebetween, the gap being axially asymmetrically arranged.

[0091] In some configurations, the second post is a mirror image of the first post.

[0092] In some configurations, the first post is configured to couple with a first headgear clip and is hindered or prevented from coupling with a second headgear clip.

[0093] Further aspects of the present disclosure will become apparent from the following description and accompanying drawings.

[0094] 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, understanding that these drawings illustrate only some embodiments in accordance with the present disclosure and are not to be considered as limiting its scope. [Brief explanation of the drawings]

[0095] [Figure 1] FIG. 1 is a schematic diagram of a respiratory system configured to deliver pressurized and humidified breathing gas to a user via a patient interface. [Figure 2] 1 is a perspective view of a patient interface assembly positioned on a user, the patient interface assembly including an interface in the form of a nasal mask and a headgear arrangement; [Figure 3] 3 is a cross-sectional view of the seal or cushion of the nasal mask of FIG. 2 taken along a central vertical plane that bisects the cushion into a right and left side. [Figure 4] 3 is a cross-sectional view of the cushion of the nasal mask of FIG. 2 along a central vertical plane, illustrating the movement enabled by the rolling bridge feature. [Figure 5] FIG. 3 is a rear view of the cushion of the nasal mask of FIG. 2 showing the face-contacting surface. [Figure 6] FIG. 6 is a bottom view of the cushion of FIG. 5. [Figure 6-1] 5 is a cross-sectional view of the cushion of FIGS. 3 and 4 with a prior art Eson2 cushion superimposed on the cushion of the present invention. FIG. [Figure 6-2]FIG. 6 is a rear view of the cushion of FIG. 5 with a prior art Eson2 cushion superimposed on top of the cushion of the present invention. [Figure 7] FIG. 6 is a perspective view of a portion of the cushion of FIG. 5, illustrating features on the interior surface of the cushion. [Figure 8] FIG. 3 is a perspective view of the connection device between the nasal mask and the headgear of FIG. 2. [Figure 9] 9 is a perspective view of a clip and a portion of the headgear of the connecting device of FIG. 8. [Figure 10] 10 is a perspective view of the frame of the nasal mask of FIG. 2 showing the openings and posts to which the clips of FIG. 9 can be connected. [Figure 11] FIG. 10 is a top view of the clip of FIG. 9. [Figure 12] 9 is a cross-sectional view of a portion of the connection device of FIG. 8. [Figure 12-1] 13 is a cross-sectional view of the connection device of FIG. 12, with example dimensions shown. [Figure 13] 3 is a front view of the nasal mask assembly of FIG. 2 showing the direction in which rotation of the nasal mask is restricted by the connecting device. [Figure 14] 3 is a perspective view of the nasal mask assembly of FIG. 2 showing an alternative angle of the front strap of the headgear arrangement. [Figure 15] FIG. 3 is a front view of the nasal mask assembly of FIG. 2 showing the direction in which rotation of the front straps of the headgear is restricted by the connecting device. [Figure 16] 3 is a perspective view of the nasal mask assembly of FIG. 2 showing possible functional ranges and example ranges of movement of the front straps allowed by the connecting device. FIG. [Figures 17A-D] 1 illustrates how the nasal mask assembly is fitted to a user. [Figure 18] 1 shows the clip and the front strap of the headgear device oriented at an angle relative to the clip. [Figure 19] 10 shows an alternative clip with an enlarged rear portion connected to a mask frame. [Figure 20] FIG. 1 is a front view of a nasal mask assembly including a clip to which an enlarged rear section is connected. [Figure 21] FIG. 12 is a front view of a mask frame including a clip to which an enlarged rear portion is connected. [Figure 22] FIG. 3 is a rear perspective view of the headgear apparatus of FIG. 2. [Figure 23] FIG. 3 is a rear view of the rear portion of the headgear assembly of FIG. 2. [Figure 24] FIG. 24 is a plan view of the rear portion of the headgear of FIG. 23 in a relaxed or laid-out configuration. [Figure 25] FIG. 24 is a cross-sectional view of a panel of the rear portion of the headgear of FIG. 23. [Figure 26] FIG. 25 is a plan view of the rear portion of the headgear of FIG. 24, showing some dimensions of the rear portion. [Figures 27A-E] 24 illustrates a method of manufacturing the panels and rear portion of the headgear of FIG. 23 and the resulting structure. [Figure 28] FIG. 10 is a rear view of an alternative rear portion of the headgear. [Figure 29] FIG. 10 is a plan view of an alternative rear portion of headgear having woven panels. [Figure 30] FIG. 30 is a plan view of a portion of the rear portion of FIG. 29 showing the woven panel. [Figure 31] FIG. 31 is a side view of the woven panel of FIG. 30. [Figure 32] FIG. 31 is a plan view of the woven panel of FIG. 30. [Figure 32-1-2] An example of a method for knitting the knitted panel of Figure 30 is shown. [Figure 33a-l] 10A-10C show various alternative rear portions of headgear having knitted panels. [Figure 34] 10 shows an example of an alternative knitting structure. [Figure 35] FIG. 10 is a side view of an alternative headgear device having a front strap arrangement constructed as a composite of a knitted tubular cover permanently connected to an inner plastic core. [Figure 36a] FIG. 36 is a close-up view of the front strap arrangement of FIG. 35. [Figure 36b] FIG. 36b is an enlarged view of a portion of the front strap arrangement shown in FIG. 36a. [Figure 37] 10 is a cross-sectional view of an alternative seal or cushion configuration taken along a central vertical plane that bisects the cushion into a right and left side. FIG. [Figure 38] FIG. 38 is a perspective view of the cushion of FIG. 37. [Figure 39] FIG. 39 is a cross-sectional view of the cushion of FIGS. 37 and 38 taken along a transverse or horizontal plane of the cushion. [Figure 40] 39. FIG. 40 is a front cross-sectional view of the cushion of FIGS. 37-39 taken along the coronal or frontal plane of the cushion. [Figure 41] FIG. 10 is a perspective view of a modified version of the headgear clip of FIG. [Figure 42] FIG. 10 is a perspective view of another modification of the headgear clip of FIG. [Figure 43] FIG. 10 is a perspective view of yet another modification of the headgear clip of FIG. 9, also showing a portion of the headgear and the patient interface. [Figure 44] FIG. 10 is a perspective view of another modification of the headgear clip of FIG. [Figure 45] FIG. 10 is a perspective view of another modification of the headgear clip of FIG. [Figure 46] FIG. 10 is a perspective view of another modification of the headgear clip of FIG. [Figure 47] FIG. 10 is a perspective view of yet another modification of the headgear clip of FIG. 9, also showing a portion of the headgear and the patient interface. [Figure 48] FIG. 3 is a perspective view of a modified patient interface assembly of FIG. 2; [Figure 49] FIG. 49 is a front view of the frame of the patient interface assembly of FIG. 48. [Figure 50] FIG. 50 is a rear view of the frame of the patient interface assembly of FIG. 49; [Figure 51] FIG. 50 is a detailed plan view of a connection device of the patient interface assembly of FIG. 49. [Figure 52] FIG. 52 is a perspective view of the connection device of FIG. 51. [Figure 53] FIG. 36 is a side view of a portion of a modified front strap arrangement shown in FIG. 35. DETAILED DESCRIPTION OF THE INVENTION

[0096] Embodiments of systems, components, and methods of assembly and manufacture will now be described with reference to the accompanying figures, in which like numerals indicate 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 can include other uses of the invention as well as obvious modifications and equivalents thereof. The terminology used in the description presented herein is not intended to be construed in any limiting or restrictive manner, merely because it is used in conjunction with the detailed description of several specific embodiments of the invention. In addition, embodiments of the present invention may include several novel features, and no single feature is solely responsible for its desirable attributes or is essential to practicing the invention described herein.

[0097] In the following description, certain terminology may be used for reference purposes only and is therefore not intended to be limiting. For example, terms such as "upper," "lower," "top," "lower," "horizontal," and "vertical" refer to directions in the referenced drawings. Terms such as "front," "rear," "left," "right," "rear," "side," "forward," and "rearward" describe the orientation and / or location of a component or part of an element within a consistent, but arbitrary, frame of reference that becomes apparent by reference to the text and associated drawings that describe the component or element being discussed. Furthermore, terms such as "first," "second," and "third" may be used to describe separate components. Such terminology may include the specifically mentioned terms, derivatives thereof, and words of similar import.

[0098] System overview FIG. 1 illustrates an example respiratory therapy system suitable for supplying respiratory gas to a user for positive airway pressure (PAP) therapy (e.g., continuous positive airway pressure (CPAP) therapy) or non-invasive ventilation (NIV) therapy. The example respiratory therapy system 100 may include a gas source 102, a humidifier 104, a patient interface assembly 150, and a respiratory gas circuit 106 connecting the humidifier 104 (or gas source 102) to the patient interface assembly 150. The gas source 102 may provide a supply of respiratory gas to the humidifier 104. The gas source 102 may comprise a blower in which respiratory gas, e.g., ambient air, is drawn into the gas source 102 through an inlet 110 in a gas source casing by an impeller 112. The rotational speed of the impeller 112 may be adjusted to regulate the amount of air drawn into the gas source 102 and the supply of respiratory gas delivered to the respiratory therapy system 100. The breathing gas may include any gas or gases that are breathable by a user of the system 100 .

[0099] The pressure and / or flow rate of breathing gas exiting the gas source 102 may be regulated by the controller 114. The controller 114 may adjust the rotational speed of the impeller 112 according to one or more predetermined algorithms and according to one or more user inputs, which may be provided via a user input 116.

[0100] The gas source 102 represents an actively controlled flow generator. Other gas sources, such as a compressed air cylinder with suitable pressure or flow regulation, can also be used to supply breathing gas. The outlet of the gas source 102 can be coupled to a separate humidifier 104. The humidifier 104 can be configured to heat and / or humidify the breathing gas prior to delivery, e.g., delivery to a user. In some embodiments, the humidifier is integrated with the gas supply. The humidifier 104 can include a base 120 and a humidifier chamber 122. The chamber 122 can be configured to hold a humidifying fluid 124, such as water, and can be disengaged, e.g., temporarily or permanently, from the humidifier base 120 to allow it to be refilled or replaced. The humidifier 104 receives gas from the gas source 102 via a chamber inlet 126. The humidifier base 120 can include a heater, such as a heater plate 130. The chamber 122 rests on a heater plate 130 when engaged with the humidifier base 120. The heater plate 130 dissipates heat, for example, heat generated by electrical resistance, into the chamber 122. The chamber 122 preferably has a thermally conductive base that allows the heat generated by the heater plate 130 to efficiently travel to the humidifying fluid 124. The controller 114 can also control the supply of electrical energy to the humidifier 104, and particularly the heater plate 130, to regulate any function of the humidifier 104, for example, the temperature and humidity of the respiratory gas delivered to the user.

[0101] Respiratory gas may be supplied to the user via chamber outlet 132 and respiratory gas circuit 106, which is in the form of a conduit that may incorporate a heating or warming element, such as a heater wire, that heats or warms (e.g., keeps the temperature elevated or warm) the respiratory gas during transport to patient interface assembly 150. Electrical energy supplied to the heater wire may be controlled by controller 114. Controller 114 may receive feedback from one or more sensors incorporated into a control network throughout the respiratory therapy system to monitor characteristics of the respiratory gas, such as, but not limited to, pressure, flow rate, temperature, and / or humidity.

[0102] The patient interface assembly 150 couples the user to the respiratory therapy system 100 so that gas, e.g., heated and humidified gas from the humidifier 104, can be delivered to the user's respiratory system. Respiratory gas can be delivered to the user at or near the optimal temperature and humidity (e.g., warmed and fully saturated with water vapor at a temperature of 27-37°C) when delivered to the user's nostrils and / or mouth. Mimicking the lung conditions of a healthy adult (37°C, 44 mg / L humidity) can help maintain healthy mucosal function in users with respiratory disorders that affect secretions, and for all patients, humidifying the gas helps maintain comfort and compliance. Several different styles of patient interface assemblies 150, such as those disclosed herein, can be used in the example system 100 or similar systems.

[0103] Interface Assembly Overview Figure 2 shows an example patient interface assembly 150 that can be used in the system 100 of Figure 1. The patient interface assembly 150 generally includes an interface (e.g., a mask) 152 and a headgear arrangement ("headgear") 154. The interface 152 is configured to deliver a flow of respiratory gas to the user's airway. The headgear 154 is configured to secure the interface 152 in place on the user.

[0104] The illustrated interface 152 is a mask that can define a breathing chamber. In particular, the illustrated interface 152 is a nasal mask that forms a seal on the user's face surrounding one or both nostrils. However, other suitable interfaces can be used with the headgear 154, and / or the headgear 154 can be modified for use with different types of interfaces. For example, the interface can be a direct nasal mask having nasal elements (e.g., nasal pillows) configured to deliver a flow of respiratory gas directly to the user's nares. While described in the context of a nasal mask 152, it will be understood that the various features, aspects, and advantages of the patient interface assembly 150 can be used with any other interface configuration, including, for example, without limitation, oronasal and full-face masks that seal around the user's nose and mouth, oral masks that seal around the user's mouth, and nasal pillows or other types of masks that seal under the user's nose.

[0105] The mask 152 may include a frame 156 and a cushion or seal 158. The cushion or seal 158 may be directly coupled to the frame 156 or may form part of a cushion module 160 that is connectable to the frame 156. Such a cushion module 160 may include a relatively rigid housing 162 constructed from a material that is harder than the material of the cushion 158. The relatively rigid housing 162 may interface with the frame 156. The relatively rigid housing 162 may be removably connectable to the frame 156. The relatively rigid housing 162 may incorporate a clip portion that engages with a portion of the frame 156 to connect the cushion module 160 to the frame 156.

[0106] The mask 152 may also include a connection tube 164 configured to connect the mask 152 to a breathing conduit (e.g., the breathing gas circuit 106). The connection tube 164 may be carried by any suitable portion of the mask 152, such as the frame 156 or the cushion module 160 (e.g., the housing 162). In the illustrated configuration, the connection tube 164 is directly connected to a cooperating portion of the mask 152 (e.g., the frame 156 or the cushion module 160). The connection tube 164 may be permanently or removably connected to a cooperating portion of the mask 152. In other configurations, the mask 152 may be connected to the breathing conduit by a connector that may be or include an elbow.

[0107] The mask 152 may also include an exhaust or vent that allows exhaled and excess breathing gas to exit the breathing chamber of the mask 152. In some configurations, the vent may be a bias flow port 166 comprising multiple vent holes ( FIG. 10 ). In the illustrated arrangement, the bias flow port 166 is located in the mask frame 156. In other configurations, the bias flow port 166 may be located in other portions of the mask 152, such as the cushion module 160 or the connecting tube 164. In some configurations, as shown in FIG. 2 , the bias flow port 166 may include a diffuser 168 covering multiple vent holes. The diffuser 168 may be removable from the mask 152 for cleaning or replacement. In some configurations, the diffuser 168 is permanently attached to a portion of the mask 152 by an overmolding process in which diffuser material is positioned in a mold and then a suitable plastic material (e.g., polycarbonate) is injected into the mold to create a one-piece structure. The diffuser material may be overmolded directly with the frame 156. In other embodiments, the diffuser material may be overmolded with clips, which have engaging portions that engage complementary engaging features on another portion of the mask 152 to attach the clip (and associated diffuser material) to that portion of the mask 152.

[0108] The modified patient interface assembly shown in Figures 48-50 illustrates an alternative bias flow port 166 and diffuser 168. The diffuser material has been omitted from the diffuser 168 of Figure 48 for purposes of illustration. The bias flow port 166 includes a plurality of vent holes 167. The vent holes 167 are located within a recessed portion 157 of the frame 156. The recessed portion 157 is wider than the opening 256. An indentation in the wall of the frame 156 immediately above the recessed portion 157 provides an opening to aid in removing the diffuser clip 168 from the frame 156. In use, the recessed portion 157 may be obscured by the diffuser 168. The diffuser 168 is wider than the opening 256. The vent holes 167 are arranged in three arcuate rows above the opening 256. The vent holes 167 span a width approximately equal to the width of the opening 256. The radius of curvature of the first row, closest to the opening 256, is shorter than the second and third rows. The radius of curvature of the third row, farthest from the opening 256, is longer than the first and second rows. The number of vent holes 167 in the first row is fewer than the number of vent holes 167 in the second and third rows. The number of vent holes 167 in the third row is greater than the number of vent holes 167 in the first and second rows. The outermost vent holes 167 in the three rows are approximately aligned vertically. The vent holes 167 may vary in diameter along their length. In particular, the vent holes 167 taper in the direction of the bias flow (i.e., from the inside to the outside of the patient interface assembly 150). Tapering the vent holes 167 can reduce noise from the exhaust gases.

[0109] Referring again to FIG. 2 , headgear 154 is coupled to mask 152. Headgear 154 may be coupled to frame 156 of mask 152. Frame 156 or mask 152 preferably includes a single headgear attachment on each side of frame 156 or mask 152. In the illustrated arrangement, headgear 154 includes a headgear strap on each side of the user's head, the headgear strap bifurcating at a location along the user's face (e.g., cheeks) between mask 152 and the user's ears. The straps on each side may be separate from each other or may form a unitary strap that extends from one side of the user's head to the other and has a middle portion that connects to frame 156 or mask 152. Headgear 154 may also include a rear portion and an optional top portion, which are described in more detail further below.

[0110] interface With continued reference to FIG. 2 and further reference to FIG. 10 , the cushion module 160 can be selectively connected to and separated from the frame 156 of the mask 152. The frame 156 and cushion module 160 preferably connect to one another in a substantially airtight or sealed relationship. For example, the frame 156 can include a connector 170 in the form of a mounting boss, connecting ring, or collar extending rearward from the frame 156 toward the user or cushion module 160. The frame connector 170 supports the housing 162 of the cushion module 160. The frame connector 170 has an inner surface and an outer surface. The housing 162 engages the outer surface of the collar 170 in the illustrated arrangement. However, in alternative arrangements, the housing 162 can engage the inner surface of the frame connector 170. The connector 170 surrounds the opening 256 and the bias air flow vent 166.

[0111] The mask 152 may incorporate arrangements that reduce the likelihood of unintentional or undesired separation of the frame 156 and the cushion module 160. For example, the mask 152 may include an interference or interlocking (e.g., snap-fit) arrangement 320 that helps maintain connection between the frame 156 and the cushion module 160 and / or increases the force required to separate the frame 156 and the cushion module 160. One such arrangement includes at least one protrusion on one of the frame 156 and the cushion module 160 and at least one recess on the other of the frame 156 and the cushion module 160 that is sized and shaped to accommodate the protrusion. Other suitable arrangements, such as friction members and cooperating surfaces, may also be used.

[0112] The cooperating openings in the frame connector 170 and the housing 162 can have a non-circular or non-cylindrical shape that secures the frame connector 170 and the housing 162 against rotation about the axis of the frame connector 170. Alternatively or additionally, other arrangements that prevent rotation between the frame 156 and the cushion module 160 can be used. For example, as shown in the modified patient interface assembly in FIGS. 45-47, a cylindrical collar can be used with an interference fit that inhibits or prevents rotation or misalignment that would otherwise be possible due to the cylindrical shape of the collar. The frame 156 and the cushion module 160 preferably can be attached to each other in only a single orientation. However, in some configurations, the frame 156 and the cushion module 160 can be configured to be selectively attached to each other in two or more predetermined orientations. For example, a user can rotate the frame 156 180° relative to the cushion module prior to attachment to selectively orient the bias flow ports either above or below the opening in the housing 162. The interference fit structure may be tapered to correct for minor misalignments when the frame and cushion module are brought together.

[0113] Cushion Module As described above, the illustrated cushion module 160 includes a relatively rigid housing 162 constructed from a material that is harder than the material of the cushion 158. In some configurations, the housing 162 is constructed partially or entirely from polycarbonate or a similar material. Accordingly, the cushion 158 may be constructed from a material that is softer than the material of the relatively rigid housing 162, such as silicone or a similar material. Unless otherwise indicated, descriptions of the relative stiffness or stiffness of materials herein refer to the difference in elastic modulus between the materials or the difference in stiffness or stiffness of solid bodies of the same size and shape constructed from the materials being compared. Descriptions of the relative stiffness or stiffness of particular structures may refer to the resistance of those structures to deformation, taking into account both the material properties and physical properties (e.g., size, shape, wall thickness) of those structures.

[0114] In some configurations, the cushion 158 can be removably connected to the housing 162 (or directly to the frame 156). However, in the illustrated arrangement, the cushion 158 is permanently connected to the housing 162. A molding process, such as co-molding or overmolding, can be used to permanently attach the cushion 158 to the housing 162. Additionally, a retention structure, such as a mechanical interlock, can be used to securely lock the silicone material of the cushion 158 and the polycarbonate material of the housing 162, thereby strengthening their connection. The retention structure can include a plurality of openings defined by the housing 162 that are occupied by the cushion 158 material. The retention structure can alternatively or additionally include an annular lip positioned along or adjacent an edge of the housing 162 that is surrounded by the cushion 158 material and provides a keyed engagement with the cushion material 158.

[0115] mask cushion Cushion 158 may be an inflatable seal having an internal concave curved wall that expands when the interior of mask 152 is pressurized to provide an adequate seal and a better fit for a particular user's face. Thus, pressure contained within cushion 158 can urge the face-contacting portion against the user's face. However, other types of seals can be used if desired.

[0116] 3-7, the illustrated cushion 158 includes a rim 180 defining an opening 182 through which breathing gas is introduced into the interior of the cushion 158. The housing 162 may be connected to the cushion 158 at the rim 158. The rim 180 may have a greater thickness than the remainder of the cushion 158.

[0117] The cushion 158 includes an end wall 184 that defines a face-contacting surface 186 configured to contact the user's face during use. The end wall 184 is located opposite the rim 180. A side wall 188 extends between the rim 180 and the end wall 184. The end wall 184 extends inwardly from the side wall 188. That is, portions of the end wall 184 on either side of the cushion 158 extend from the side wall 188 toward each other. The end wall 184 includes an edge 190 that at least partially defines an opening 192. In the illustrated configuration, the edge 190 surrounds the opening 192. In some configurations, the cushion 158 tapers or reduces in thickness toward or up to the edge 190. That is, preferably, the cushion 158 does not include a thickened rim or bead at or adjacent the edge 190. In some configurations, as shown in modified versions of cushion 158 in FIGS. 37 and 40 , end wall 184 may include a thickened rim or bead 191 at or adjacent edge 190. The thickened rim or bead 191 can improve noise caused by flapping of end wall 158 in the event of a leak and / or reduce the risk of tearing cushion 158 from opening 192. Thickened rim or bead 191 can have a radius of about 0.1-0.4 mm, preferably about 0.2-0.3 mm, and preferably about 0.26 mm. Opening 192 is designed to accommodate at least the lower portion and tip of the user's nose. Preferably, opening 192 is generally T-shaped, even if it is an inverted T-shape.

[0118] 5, the face-contacting surface 186 includes a lower or lip surface 194 adapted to contact the user's face generally above the vermilion border and below the nostrils. The face-contacting surface 186 also includes two separate cheek surfaces 196 extending between the lip surface 194 and an upper surface 198 of the face-contacting surface 186 on each side of the face-contacting surface 186. The cheek surfaces 196 may contact the user's inner cheek surface and / or the user's outer nasal surface. The upper surface 198 may extend above the user's nose to connect the two cheek surfaces 196.

[0119] End wall 184 may be the thinnest portion or one of the thinnest portions of sealing cushion 158. Advantageously, end wall 184 may easily deform to at least substantially seal against the contours of the user's face, including one or more of the upper lip, inner cheek, outer nose, and bridge of the nose. Advantageously, the reduced wall thickness of end wall 184 within lip surface 194 may provide improved stretchability and minimize pressure applied to the area above the user's lips.

[0120] 3 and 4, a reinforcement in the form of at least one thickened band 200 extends inwardly from the interior surface of the cushion 158. Although a single thickened band 200 is shown in FIGS. 3 and 4, in some configurations, two or more thickened bands or regions may be provided, bearing in mind the desire to achieve the properties provided by the thickened band 200.

[0121] The illustrated thickened band 200 is positioned along the sidewall 188 of the cushion 158. The band 200 preferably includes a relatively large lower region 202 on each side of the cushion 158 and a relatively thin connecting portion 204 that extends between the lower regions 202 by extending around the interior upper portion of the cushion 158. When the cushion 158 is subjected to pressure from the gas source 102 (FIG. 1), the thickened band 200 helps reduce the likelihood and / or extent of outward bulging of the sidewall 188. Outward bulging of the sidewall 188 can result in an undesirable change in the shape of the cushion 158, which can adversely affect performance and potentially lead to undesirable leakage from the cushion 158.

[0122] The cushion 158 may define a region of reduced stiffness 210 between the thickened band 200 and the rim 180. The region of reduced stiffness 210 may allow an upper portion of the cushion 158 to preferentially move forward, allowing the cushion 158 to accommodate a wide range of user nose characteristics and sizes. The upper portion of the cushion 158 may be configured to pivot or hinge relative to the lower portion of the cushion 158 about a hinge axis or hinge region to allow pivotal movement of the upper portion of the cushion 158 in a forward direction (away from the user's face or toward the housing 162). The hinge axis or hinge region may be defined in part by the thickened band 200 and is preferably positioned immediately below the lower region 202. The hinge axis may be defined in part by lower thickened corners 189 at or adjacent to each lower corner of the sidewalls 188. The sidewall 188 tapers upward from the lower thickened corner 189 a relatively short distance toward the lower region 202 of the band 200. The sidewall 188 also tapers downward from the lower thickened corner 189 a relatively long distance.

[0123] In the illustrated arrangement, the reduced stiffness region 210 is configured to roll in response to pivotal movement of the upper portion 154. As shown schematically by the dashed lines in FIG. 4 , the reduced stiffness region 210 is designed to roll toward the front of the mask 152 (i.e., away from the user). Accordingly, the reduced stiffness region 210 may be referred to herein as a rolling portion or rolling bridge. In the rolling bridge 210, the inflection point between the first or upper portion and the second or lower portion of the rolling bridge 210 moves along the rolling bridge 210, and the lengths of the upper and lower portions change during the rolling motion. In some configurations, the rolling bridge 210 rolls across and / or over the outer surface of the mask 152, which may be part of the cushion 158 and / or the housing 162. The rolling bridge 210 may provide one or more of the following advantages: predictable deformation of the cushion 158 without the need for buckling or predefined concertina-type folds; accommodation of the cushion 158 to a wide range of face and nose sizes; limiting the sealing force against the patient's nose; and / or at least partially decoupling the sealing force against the patient's nose from headgear tension and / or tube drag.

[0124] 3, 4, and 7, the illustrated cushion 158 also includes two thickened panels 220. The thickened panels 220 are positioned along the upper portion of the cheek surface 196 of the cushion 158, near the transition from the cheek surface 196 to the upper surface 198. The panels 220 may be formed on the interior surface of the cushion 158. The illustrated panels 220 represent localized thickened areas that have been found to improve the sealing capabilities of the cushion 158. The panels 220 increase lateral pressure against the sides of the user's nose, thereby allowing pressure from the cushion 158 to better conform to the contours of the user's nose. In the illustrated arrangement, the thickness of the panels 220 is less than the thickness of the thickened band 200. In some configurations, the thickness of the panels 220 is less than about half or less than about a quarter of the thickness of the thickened band 200. In some configurations, the panels 220 may be 1.0 mm to 1.5 mm thick. In some configurations, the panel 220 is approximately 1.2 mm to 1.3 mm thick. In some configurations, the panel 220 is approximately 1.25 mm thick. In some configurations, the portion of the sidewall 188 that includes the panel 220 may be approximately 0.8 mm to 1.2 mm thicker than the adjacent portion of the sidewall 188. In some configurations, the portion of the sidewall 188 that includes the panel 220 is approximately 0.9 mm to 1.1 mm thicker. In some configurations, the portion of the sidewall 188 that includes the panel 220 is approximately 1 mm thicker.

[0125] In the illustrated arrangement, each of the panels 220 has a side or boundary portion that extends from or is immediately adjacent to the thickened band 200. The illustrated panels 220 are each generally rectangular in shape. Each of the thickened panels 220 extends from the thickened band 200 along the side wall 188 and the end wall 184. One end (e.g., the forward end 222) of each of the rectangular panels 220 is connected to or immediately adjacent to the thickened band 200. In the illustrated arrangement, each of the thickened panels 220 extends above the end wall 184. Each of the panels 220 has a rearward end 224 that terminates before the edge 190 of the opening 192. In other words, the rearward end 224 of each of the thickened panels 220 is spaced apart from the edge 190.

[0126] In some configurations, the thickened panel 220 may be spaced apart from the thickened band 220, and the cushion 158 may include an interface pad 221 intermediate a portion of the thickened band 220 and at least a portion of the thickened panel 220, as shown in FIG. 37 . The interface pad 221 in the illustrated configuration comprises a generally rectangular thickened region of the sidewall 188 that joins an upper portion of the thickened panel 220 to the thickened band 200. A lower portion of the thickened panel 220 remains spaced apart from the thickened band 200. The interface pad 221 preferably provides support to the sidewall 188 of the cushion 158 to reduce deformation and mitigate leakage in selected areas of the cushion 158, particularly around the patient's eyes, without causing respiratory restriction. The interface pad 221 has a thickness that is less than the thickness of the thickened panel 220 but greater than the thickness of other adjacent portions of the sidewall 188. In some configurations, the portion of the sidewall including the interface pad 221 may be approximately 0.5-0.9 mm thicker than the adjacent portion of the sidewall 188. In some configurations, the portion of the sidewall including the interface pad 221 may be approximately 0.65-0.75 mm thicker. In some configurations, the portion of the sidewall including the interface pad 221 may be approximately 0.2-0.4 mm thinner than the adjacent thickened panel 220. In some configurations, the portion of the sidewall including the interface pad 221 may be approximately 0.25-0.35 mm thinner. The interface pad 221 has a width measured in a forward direction from the thickened panel 220 to the thickened band 200 that spaces at least a portion of the thickened panel 220 a corresponding distance from the thickened band 200. In some configurations, the width of at least a portion of the interface pad 221 is approximately 3-4 mm. In some configurations, the width may be approximately 3.2-3.6 mm. In some configurations, the width may be approximately 3.4 mm. The interface pad 221 is preferably provided only toward the upper end of the thickened panel 220, which may allow the sidewall 188 to deform relatively more toward the lower end of the thickened panel 220 so as to provide less pressure on more sensitive areas of the patient's face. The interface pad 221 has a length that extends circumferentially around the inside of the cushion 158.In some configurations, the length of the interface pad 221 is about 15% to 50% of the length of the adjacent thickened panel 220. In some configurations, the length is about 20% to 45% of the length of the adjacent thickened panel 220. In some configurations, the length is about 25% to 33% of the length of the adjacent thickened panel 220.

[0127] Referring to FIG. 7 , the cushion 158 may include one or more thickened panels 226 in addition to or instead of the thickened panel 220. For convenience, the thickened panels 226 are referred to herein as “secondary” thickened panels 226. In the illustrated arrangement, a pair of secondary thickened panels 226 is provided. Both of the pair of secondary thickened panels 226 are located between the thickened panels 220 toward or within the upper portion of the cushion 158. Each of the illustrated secondary thickened panels 226 is substantially smaller than the thickened panel 220. The secondary thickened panels 226 may be generally rectangular in shape and may have a forward end 228 connected to or immediately adjacent the thickened band 200. Each of the secondary thickened panels 226 may have a rearward end 230 spaced from the edge 190 of the opening 192. In some configurations, the secondary thickened panel 226 has a surface area that is approximately 1 / 10 to 1 / 20 of the surface area of ​​the thickened panel 220 .

[0128] In some configurations, the face-contacting surface 186 is non-planar. For example, the face-contacting surface 186 at the upper portion of the cushion 158 can extend in an anterior direction relative to the middle and / or lower portions of the cushion 158. A portion or all of the upper surface 198 of the face-contacting surface 186 can be located anterior to a portion or all of the cheek surface 196 and / or the lip surface 194. In some configurations, the upper surface 198 can define an angle θ with respect to the middle portion of the cushion 158 or the cheek surface 196 of the cushion 158. In some configurations, the posterior-most edge of the upper surface 198 can define an angle θ with respect to the posterior-most edge of the middle portion of the cushion 158. The middle portion of the cushion 158 is located above the upper lip-contacting portion. In some configurations, when the cushion 158 is in an upright orientation and viewed from the side, the posterior-most edge of the upper surface 198 can define an angle θ with respect to the cheek surface 196 and / or the vertical direction, as shown in FIG. 3 . In the upright orientation, the cheek surfaces 196 can be generally or substantially vertical. The upright orientation can correspond to an in-use orientation of the cushion 158, which is an orientation of the cushion 158 such that it is properly positioned on the user with the user's head in an upright orientation. The angle θ can be less than 55 degrees. In some configurations, the angle θ is about 40-50 degrees or about 42-48 degrees. In some configurations, the angle θ is about 45 degrees.

[0129] 4, the face-contacting surface 186 of the cushion 158 can define a depth 232 of the opening 192 between a rearmost point and a forwardmost point of the opening 192. The rearmost point can be located on the cheek surface 196. The forwardmost point can be located on the top surface 198. In particular, the forwardmost point can be located on the edge 190 of the opening 192. The depth 232 of the face-contacting surface 186 can be greater than 15 mm. In some configurations, the depth 232 is approximately 16-25 mm or approximately 18-22 mm. In some configurations, the depth 232 is 20 mm or 20.5 mm.

[0130] 5, the cushion 158 can define a height 234 and a width 236. The height 234 and / or width 236 can be selected to achieve desirable sealing characteristics while reducing or minimizing the obtrusiveness of the cushion 158 and mask 152 to a user. In particular, the height 234 can be selected so that the upper surface 198 contacts the dorsal ridge of the user's nose. In some configurations, the height 234 can be between about 45 mm and 60 mm or between about 47.8 mm and 57.8 mm for a single cushion 158 or across a range of cushion 158 sizes. For example, the cushion 158 can be offered in at least three sizes, including a small size having a height 234 of between about 47 mm and 48 mm (e.g., 47.8 mm), a medium size having a height 234 of between about 52 mm and 53 mm (e.g., 52.8 mm), and a large size having a height 234 of between about 57 mm and 58 mm (e.g., 57.8 mm). In some configurations, the width 236 can be between about 55 mm and 64 mm or between about 56.5 mm and 63.9 mm for a single cushion 158 or across a range of sizes of cushions 158. For example, a small size can have a width 236 of between about 56 mm and 57 mm (e.g., about 56.5 mm), a medium size can have a width 236 of between about 58 mm and 59 mm (e.g., 58.3 mm), and a large size can have a width 236 of between about 63 mm and 64 mm (e.g., 63.9 mm).

[0131] The ratio of width 236 to height 234 may be about 1.1 to 1.2 for a single cushion 158 or across a range of cushion 158 sizes. For example, the ratio of width 236 to height 234 for a small cushion 158 may be about 1.2 (e.g., 1.18). The ratio of width 236 to height 234 for a medium cushion 158 may be about 1.1. The ratio of width 236 to height 234 for a large cushion 158 may be about 1.1 (e.g., 1.12).

[0132] The opening 192 of the cushion 158 can define a height 240 and a width 242. The height 240 and / or width 242 can be selected to achieve desired sealing characteristics of the cushion 158. In some configurations, the height 240 can be about 20 mm to 35 mm or about 22.8 mm to 32.5 mm for a single cushion 158 or across a range of cushion 158 sizes. For example, a small size can have a height 240 of about 22 mm to 23 mm (e.g., 22.8 mm), a medium size can have a height 240 of about 23 mm to 24 mm (e.g., 23.3 mm), and a large size can have a height 240 of about 32 mm to 33 mm (e.g., 32.5 mm). In some configurations, the width 242 can be about 34 mm to 45 mm or about 34.2 mm to 43.1 mm for a single cushion 158 or across a range of cushion 158 sizes. For example, the small size can have a width 242 of approximately 34 mm to 35 mm (e.g., 34.2 mm), the medium size can have a width 242 of approximately 37 mm to 38 mm (e.g., 37.4 mm), and the large size can have a width 242 of approximately 43 mm to 44 mm (e.g., 43.1 mm).

[0133] The ratio of width 242 to height 240 can be greater than 1.25. In some configurations, the ratio of width 242 to height 240 can be about 1.25 to 1.7 or about 1.3 to 1.65 (e.g., 1.33 to 1.61) for a single cushion 158 or across all cushion 158 sizes. For example, the ratio of width 242 to height 240 for a small cushion 158 can be about 1.5. The ratio of width 242 to height 240 for a medium cushion 158 can be about 1.6 (e.g., 1.61). The ratio of width 242 to height 240 for a large cushion 158 can be about 1.3 (e.g., 1.33).

[0134] Referring to FIG. 6 , the cushion 158 can define a depth 244 between a forward-most point and a rearward-most point along a cross-section of the cushion 158. For example, the depth 244 can be measured along a vertical center plane that bisects the cushion 158 into a right side and a left side. In some configurations, the depth 244 is measured at a lower portion of the cushion 158. For example, the depth 244 can be measured between a forward-most point of the rim 180 and a rearward-most point of the lip surface 194, both of which lie within the vertical center plane. In some configurations, the depth 244 can be approximately 20-30 mm, approximately 23-28 mm, or approximately 25-26 mm for a single cushion 158 or across a range of cushion 158 sizes. In some configurations, the depth 244 can be approximately 25.35 mm.

[0135] 6-1 and 6-2 illustrate some differences between the cushion 158 of the present invention and the prior art cushion 158P sold by the applicant, Fisher & Paykel Healthcare Ltd., as a component of the Eson2 nasal mask. As shown in FIG. 6-1, the height 234 of the cushion 158 of the present invention is smaller than the height 234P of the Eson2 cushion 158P. As a result, the upper portion of the cushion 158 of the present invention is positioned lower on the user's nose compared to the Eson2 cushion 158P. Therefore, compared to the Eson2 cushion 158P, a larger proportion of the cushion 158 can be positioned outside the user's field of vision and / or the upper portion of the cushion 158 can be positioned closer to the edge of the user's field of vision. Therefore, the cushion 158 of the present invention is less obtrusive to the user than the Eson2 cushion.

[0136] 6-1, the depth 232 of the opening 192 of the cushion 158 of the present invention is greater than the depth 232P of the opening 192P of the Eson 2 cushion 158P. This arrangement can facilitate or accommodate a lower position of the cushion 158 of the present invention on the user's nose.

[0137] In some configurations, the rolling bridge 210 of the cushion 158 of the present invention can be connected to the rim 180 at a location spaced from the forward end of the rim 180. In other words, a portion of the rim 180 can protrude forward from the rolling bridge 210. In some configurations, the rolling bridge 210 can extend from the rear end of the rim 180 so that the inner surface of the rim 180 is aligned with the inner surface of the rolling bridge 210 at the transition between the rim 180 and the rolling bridge 210. In contrast, the rolling bridge 210P of the Eson2 cushion 158P is connected to the forward end of the rim 180P. This configuration of the cushion 158 of the present invention allows for simpler and less expensive mold tooling compared to the configuration of the Eson2 cushion 158P. However, in other configurations, the rolling bridge 210 can be connected to the forward end of the rim 180, as shown in the modified version of the cushion 158 shown in FIG. 38.

[0138] As discussed above and shown in FIGS. 6-1 and 7, the thickened panel 220 of the cushion 158 of the present invention extends into or connects to the thickened band 200. In contrast, the anterior end of the thickened panel (not shown) of the Eson2 cushion 158P terminates well before the thickened band 200P. In some configurations, the posterior end of the thickened panel 220 of the cushion 158 of the present invention and the Eson2 cushion 158P are in the same or similar relative positions on the cushions 158, 158P. The longer thickened panel 220 of the cushion 158 of the present invention improves localized strength or stiffness of the cushion 158 for better sealing to reduce leakage.

[0139] Referring to FIG. 6-2, the opening 192 of the cushion 158 of the present invention is shorter and / or wider than the opening 192P of the Eson2 cushion 158P. That is, the height 240 of the opening 192 of the cushion 158 of the present invention is smaller than the height 240P of the opening 192P of the Eson2 cushion 158P. In the illustrated arrangement, the width 242 of the opening 192 of the cushion 158 of the present invention is greater than the width 242P of the opening 192P of the Eson2 cushion 158P. As discussed above, the shorter opening 192 of the cushion 158 of the present invention, at least as compared to the Eson2 cushion 158P and the mask, accommodates a lower position above the user's nose, making the cushion 158 and associated mask 152 less obtrusive to the user. The wider opening 192 of the cushion 158 of the present invention facilitates deflection of the seal 158 around the user's nose when the cushion 158 is positioned over the user's nose. Some differences between one embodiment of the cushion 158 of the present invention and the Eson2 cushion 158P are summarized in the table below.

[0140] [Table 1]

[0141] The differences between the alternative configurations of cushion 158 and Eson cushion 158P are summarized in the table below.

[0142] [Table 2]

[0143] Referring again to FIG. 37 and also to FIGS. 39 and 40, in some configurations, the cushion 158 includes a pair of thickened lower portions 225 (only one of which is shown in FIG. 37). In the illustrated arrangement, each of the thickened lower portions 225 is an elongated thickened portion of the cushion 158 that extends into the interior of the cushion 158. In some configurations, the portion of the sidewall including the thickened lower portion 225 may be approximately 0.1 to 0.6 mm thicker than the adjacent portions of the sidewall 188 and / or end wall 184. In some configurations, the portion of the sidewall including the thickened lower portion 225 may be approximately 0.1 to 0.3 mm thicker. In some configurations, the portion of the sidewall including the thickened lower portion 225 may be approximately 0.2 mm thicker. In some configurations, the thickened lower portion 225 may be approximately 1.2 mm thick. In some configurations, the absolute and / or relative thicknesses of the lower thickened portions may be substantially uniform along their lengths.

[0144] As shown in FIGS. 37, 39, and 40, the lower thickened portions 225 are at least partially curved. When viewed from the side of the cushion 158, as shown in FIG. 37, the lower thickened portions 225 appear to curve upward, particularly in the middle of the lower thickened portions 225 at the transition of the cushion 158 from the side wall 188 to the end wall 184. Each lower thickened portion 225 is curved or rounded in a direction substantially perpendicular to its respective major surface. In other words, the thickened portions 225 form a substantially planar curve, despite having a width that extends substantially perpendicular to the plane of the curve. When viewed from a certain angle, the lower thickened portions 225 may appear substantially linear, as shown in FIG. 38. However, when the cushion 158 is viewed from another angle, the lower thickened portions 225 appear to have a transverse curve, as best shown in FIG. 37. When the lower thickened portion 225 and the adjacent portions of the side wall 188 and end wall 184 are flattened, the lower thickened portion 225 forms a planar curve. The lower thickened portion 225 may have a twist along at least a portion of their length.

[0145] The lower thickened portions 225 have first ends 225a located at or adjacent to or near the rim 180, at or adjacent to or near the lower corners of each of the substantially triangular side walls 188 of the cushion 158. From the first ends, the lower thickened portions 225 extend substantially rearward (i.e., toward the user in use) before curving upward and terminating at second ends of the end walls 184 adjacent the cheek surfaces 196 of the face-contacting surface 186 on either side of the opening 192. When viewed from the top or bottom of the cushion 158, as shown in FIG. 39, the lower thickened portions 225 flare outward from each other and extend rearward away from each other from the first ends 225a toward the middle. When viewed from the front or back of the cushion, as shown in FIG. 40, the lower thickened portions 225 extend upward toward each other from the middle toward the second ends 225b. This approach-away arrangement has been found to be helpful in avoiding contact with relatively sensitive areas of the user's face. Lower thickened portion 225 terminates at a second end vertically above and horizontally spaced apart from lower region 202 of thickened band 200, as shown in FIG. 37 . Lower thickened portion 225 terminates at a second end vertically below and vertically spaced apart from the respective bottom ends of thickened portions 220. Lower thickened portion 225 extends below and terminates at a first end 225 a vertically below and spaced apart from the respective bottom ends of thickened portions 189 of sidewall 188.

[0146] In some configurations, the linear distance (i.e., the most direct path through three-dimensional space) between the first end 225a and the second end 225b of the lower thickened portion 225 is approximately 30-35 mm. In some configurations, the linear distance is approximately 32.9 mm. The second end 225b of the lower thickened portion 225 is spaced from the opening 192 so as not to contact sensitive areas of the patient's nose. In some configurations, the minimum spacing between the lower thickened portion 225 and the opening 192 is at least 4 mm. In some configurations, the minimum spacing is approximately 5-6 mm. In some configurations, the minimum spacing may be approximately 5.2-5.5 mm.

[0147] The lower first end 225a of the lower thickened portion 225 may be narrower than the upper second end 225b. The thickened portion 225 tapers from the second end 225b to the first end 225a, which can help avoid or reduce contact with sensitive areas of the patient's upper lip. In some configurations, the width of the first end is approximately 4-6 mm. In some configurations, the width of the first end is approximately 4.7 mm, 4.8 mm, or 5.0 mm. In some configurations, the width of the second end is approximately 7-8 mm. In some configurations, the width of the second end is approximately 7.4 or 7.8 mm. In some configurations, the second end 225b is at least 50% wider than the first end 225a. In some configurations, the second end 225b is approximately 50%-60% wider than the first end 225a. In some configurations, the second end 225b is approximately 54% wider than the first end 225a.

[0148] The thickened portion 225 has been found to transfer forces towards the housing 162 rather than towards the user, reducing collapse of the cushion and / or providing additional support to transfer sealing forces to the user's cheeks rather than more sensitive areas such as the upper lip and lower nose area.

[0149] 37 , in some configurations, the thickness of the sidewall 188 may gradually taper at the bottom portion of the cushion 158, from the rim 180 rearward toward the lower surface 194 of the face-contacting surface 186. The taper may be non-linear, and in particular, may be substantially abrupt. In contrast, in other regions of the cushion 158, there is a step change in the thickness of the sidewall 188 from the relatively thick rim 180 to the immediately adjacent portion of the sidewall 188, and the thickness of the sidewall 188 remains substantially uniform between the rim 180 and the end wall 184, except for the thickened band 200, the thickened panel 220, and the interface pad 221.

[0150] The taper of the sidewall 188 at the bottom portion of the cushion 158 is more gradual than the taper of the conventional Eson 2 cushion shown in FIG. 6-1. In some configurations, the sidewall 188 may taper to half (50%) of the thickness of the rim 180 at least about 3 mm from the rim 180. In some configurations, the sidewall tapers to half (50%) of the thickness of the rim 180 at least about 4 mm from the rim 180. In some configurations, the sidewall tapers to half (50%) of the thickness of the rim 180 at least about 5.5 mm from the rim 180. In some configurations, the sidewall 188 may taper to one-quarter (25%) of the thickness of the rim 180 at least about 7 mm from the rim 180. In some configurations, the sidewall tapers to one-quarter (85%) of the thickness of the rim 180 at least about 8 mm from the rim 180. In some configurations, the sidewall tapers to 1 / 4 the thickness of the rim 180 at least about 9.4 mm from the rim 180 .

[0151] Headgear-Interface Connection 8-16, the illustrated connection device 248 between the mask 152 and the headgear 154 is configured to secure the mask 152 in an operable position on the user's face. In some configurations, the connection device 248 is configured to provide a suitable level of stability for the mask 152 with a single connection between the headgear 154 and the mask 152 on each side of the mask. Accordingly, the illustrated mask assembly 150 does not include a forehead support or corresponding upper headgear portion. As a result, the illustrated mask assembly 150 avoids any portion of the mask frame 156 extending above the cushion module 160, and is therefore less obtrusive to the user than masks having at least a forehead support.

[0152] In the illustrated mask assembly 150, a connection device 248 is provided on each side of the mask 152. The connection devices 248 may be identical or substantially the same on each side of the mask 152, except that the connection devices 248 may be mirror images of each other. Accordingly, only one connection device 248 will be described herein. However, that description is equally applicable to the other connection device 248. Alternatively, the connection devices 248 on each side of the mask 152 may be slightly different from each other, as described in more detail below. The illustrated connection device 248 is a detachable connection. In an alternative arrangement, the headgear 154 may be permanently connected to the mask 152 on one side and employ a detachable connection (e.g., connection device 248) on the other side.

[0153] Referring to FIG. 8 , the connection device 248 includes headgear clips 250 that are removably connectable to the frame 156. FIG. 8 shows the headgear clips 250 attached to the frame 156. With further reference to FIG. 10 , each side of the frame 156 generally includes an ear 252 associated with each headgear clip 250. The ears 252 preferably extend laterally outward from a central portion 254 of the frame 156, which includes the connector portion 170 and an opening 256 that communicates with the interior of the connector portion 170 and receives the connection tube 164. The ears 252 can be configured to position the clips 250 further forward and / or upward relative to a conventional four-point headgear arrangement, positioning the clips 250 in or further within the user's peripheral vision. This can make it easier for at least some patients to engage and / or disengage the clips 250 from the ears 252.

[0154] In the illustrated arrangement, the connection device 248 is a hook-and-post connector. However, other connector types can be used. In the illustrated arrangement, each of the ears 252 of the frame 156 includes a post 260. However, in other arrangements, the posts 260 can be located on the clips 250. In the illustrated arrangement, each of the clips 250 includes a hook structure 266. However, in other arrangements, the hook structures 266 can be located on the frame 156. The hook structures 262 and posts 260 provide an easily connectable and separable configuration. In some configurations, the clips 250 are symmetrical so that a single clip can be used on both the left and right sides of the frame 156. In other configurations, the posts 260 and / or clips 250 on each side of the mask 152 can be different to reduce the possibility of an improper connection between the headgear 154 and the frame 156.

[0155] The illustrated clip 250 includes a base portion or base 264 and a hook portion or hook 266. The base 264 and hook 266 cooperate to form a hook structure 262. The hook 266 extends from a side of the forward end of the base 264. In some configurations, the forward end of the base 264 is aligned with the forward end of the hook 266. The base 264 defines a height 270 in a direction parallel to the longitudinal axis A of the post 260 when the clip 250 is connected to the post 260. Similarly, the hook 266 defines a height 272 in the same direction. In some configurations, the height 270 of the base 264 is greater than the height 272 of the hook 266. Additionally, a portion of the base 264 can extend beyond both the upper and lower ends of the hook 266 in the directions of the heights 270, 272. In some configurations, the hook 266 may be centered relative to the base 264 in the vertical or height direction 270, 272.

[0156] 11 , the base 264 and the hook 266 cooperate to define a space 274 sized and shaped to accommodate the post 160. The post 160 may be inserted into the space 274 through a generally rearward-facing opening 276. The space 274 may define a maximum width 278 in a direction perpendicular to the longitudinal axis A of the post 260 when the clip 250 is connected to the post 260, or perpendicular to the direction of the heights 270, 272. The opening 276 may define a minimum width 280 in a direction parallel to the maximum width 278 of the space 274. Referring to FIG. 12 , the post 160 may define a maximum width, which may be referred to herein as a diameter 282 because the illustrated post 160 is cylindrical. The width 278 of the space 274 can be equal to or slightly larger than the diameter 282 to provide a tight fit between the post 160 and the clip 250 when the clip 250 is connected to the post 160. This arrangement can improve the stability of the connection device 248, as described further below. In one example configuration, the diameter 282 can be 2.47 mm and the width 278 can be 2.52 mm. In some configurations, the width 278 is approximately 2% larger than the diameter 282. In other configurations, the width 278 of the space 274 can be smaller than the diameter of the post 160, such that the hook 266 does not fully elastically recover when the post 160 is inserted.

[0157] 12-1, in one configuration, the clip 250 has a thickness 402 of approximately 1.5 mm at the tip of the hook 266. In another configuration, the thickness 402 may be approximately 1.3 mm. The diameter 404 of the hook opening is approximately 3.1 mm for a post 260 having a diameter of approximately 3.0 mm, which may provide a clearance of approximately 0.05 mm on each side of the post 260. The amount of interference 406 between the post 260 and the protrusion 284 in this configuration is approximately 0.25 mm.

[0158] The width 280 of the opening 276 can be smaller than the maximum width 278 of the space 274 and / or the diameter of the post 260 to provide an interference fit between the hook structure 262 and the post 260, reducing the likelihood of inadvertent disengagement of the clip 250 during use. It has been found that in one particular configuration, an interference of greater than 0.25 mm and less than 0.30 mm is suitable, with an interference of 0.28 mm being preferred. In the illustrated arrangement, the opening 276 of the clip 250 is defined between the base 264 and a protruding portion, interference protrusion, or simply protrusion 284, of the hook 266. In the illustrated arrangement, the space 274 defines a partial cylindrical shape, such as a semi-cylindrical shape, that can contact a corresponding surface of the cylindrical post 260. The protrusion 284 can be spaced from the portion of the hook 266 that defines the partial cylindrical shape, such that a space exists between the post 260 and the hook 266 when the post 260 is inserted into the space 274, as shown in FIG. 12 .

[0159] The interference fit between the clip 250 and the post 160 can be configured for a desired separation force that is high enough to prevent unintentional disengagement, yet low enough to allow convenient, intentional disengagement by the user. In the illustrated arrangement, it has been determined that an interference, i.e., the difference between the width 280 of the opening 276 and the width of the space 274 and / or the diameter 282 of the post 260, of greater than 0.25 mm and less than 0.3 mm is desirable. For example, the interference can be approximately 0.26 mm to 0.29 mm, approximately 0.27 mm to 0.29 mm, or approximately 0.28 mm. Such interference can be based on the dimensions of the post 260 and / or the space 274 disclosed herein and expressed as a percentage or fraction of those dimensions. Furthermore, the interference can vary based on the shape or size of the hook 266 and / or the material of the clip 250. In some configurations, the lead-in and lead-out angles of the protrusions 284 can be configured so that the required connection force is less than the required separation force to prevent inadvertent separation without making the connection unnecessarily difficult.

[0160] In some configurations, the interference fit between the clip 250 and the post 160 can be configured to provide tactile and / or audible feedback confirming proper connection between the components.

[0161] Referring primarily to FIG. 10 , each ear 252 defines an opening 290 adjacent to the post 260. That is, the post 260 defines a portion of the boundary of the opening 290. The opening 290 is configured to receive and accommodate at least the hook 266 of the clip 250 to enable the clip 250 to be connected to the post 260. In the illustrated configuration, the ears 252 and openings 290 are configured to limit movement of the clip 250 relative to the frame 156. In some configurations, the ears 252 and openings 290 are configured to limit rotational movement of the clip 250 about an axis perpendicular to the longitudinal axis A of the post 260. This arrangement can improve stability of the mask 152 on the user's face, as described further below. In some configurations, the ears 252 and openings 290 are configured to limit rotational movement of the clip 250 about the longitudinal axis A of the post 260. Such an arrangement may prevent undesired separation of clip 250 from mask 152 .

[0162] The illustrated opening 290 is generally trapezoidal in shape, with the end opposite the post 260 having a length greater than the length of the post 260. This arrangement improves the user's ability to thread the hook 266 through the opening 290 without being unable to see the mask 152, which is often the case when the user is wearing the mask 150. However, in other arrangements, the opening 290 can have any desired shape. At least a portion of each side of the opening 290, each extending between the post 260 and the end of the opening 290 opposite the post 260, converges toward the post 260. This arrangement can help guide the clip 250 toward the post 260.

[0163] The illustrated opening 290 includes a narrowed portion 292 relative to an adjacent portion of the opening 290. The narrowed portion 292 is located adjacent to the post 260. The narrowed portion 292, together with the post 260, defines a space for receiving the hook 266 of the clip 250. The narrowed portion 292 may be defined by a first or upper surface 294 and an opposing second or lower surface 296. The upper surface 294 and the lower surface 296 each originate at the post 260 and extend away from the post 260 to a terminal end. The space of the narrowed portion 292 may be defined horizontally between the post 260 and an imaginary line connecting the terminal ends of the upper surface 294 and the lower surface 296, and vertically between the upper surface 294 and the lower surface 296. In some configurations, the opposite portions of the opening 290 that converge toward the post 260 are adjacent to and converge toward the respective upper and lower surfaces 294 and 296 of the narrow portion 292 .

[0164] The size and / or shape of the space in the narrow portion 292 can match or be substantially the same as the size and / or shape, particularly the cross-sectional size and / or shape, of the base or connecting portion of the hook 266 that occupies the narrow portion 292 when the clip 250 is connected to the post 260. In some configurations, the size and / or shape of the space in the narrow portion 292 can be slightly larger than the base or connecting portion of the hook 266 that occupies the narrow portion 292 when the clip 250 is connected to the post 260. Preferably, the relative sizes are selected to allow convenient insertion of the hook 266 into the narrow portion 292, yet provide a tight enough fit to limit any substantial rotation of the clip 250 in a direction perpendicular to the longitudinal axis A of the post 260, as described above. Such rotation can be limited, at least in part, by contact between the base or connecting portion of the hook 266 that occupies the narrow portion 292 and the upper and lower surfaces 294, 296 of the narrow portion 292.

[0165] In some configurations, the hook 266 is shaped to span the space of the narrow portion 292 when the hook 266 engages the post 260. In some configurations, the hook 266 can occupy all or substantially all of the space of the narrow portion 292. Thus, the distance between the upper surface 294 and the lower surface 296 in a direction parallel to the longitudinal axis A of the post 260 is equal to or only slightly greater than the height 272 of the hook 266. This arrangement limits or prevents axial movement of the clip 250 along the longitudinal axis A of the post 260 during use. In some configurations, the base portion of the hook 266, extending from the base 264 of the clip 250, can be the thickest portion of the hook 266 or define the maximum wall thickness of the hook 266. The thickness of part or all of the base portion of the hook 266 can be selected such that the hook 266 extends entirely along one or both of the upper surface 294 and the lower surface 296 of the narrow portion 292. In some configurations, the hooks 266 may extend beyond one or both ends of the upper and lower surfaces 294 and 296 .

[0166] The shape and / or orientation of the upper surface 294 can correspond to the shape and / or orientation of the corresponding upper surface of the hook 266. Similarly, the shape and / or orientation of the lower surface 296 can correspond to the shape and / or orientation of the corresponding lower surface of the hook 266. In the illustrated arrangement, the upper surface 294 is parallel or substantially parallel to the lower surface 296. In addition, the upper and lower surfaces of the hook 266 are parallel or substantially parallel. Thus, when the hook 266 and the narrow portion 292 are tightly fitted together, the hook 266 is in contact with the entire or substantially the entire upper and lower surfaces 294 and 296. Even when some gap is provided between the hook 266 and the narrow portion 292, contact occurs with less angular movement than in an arrangement in which the hook 266 does not correspond in size and / or orientation to the upper and lower surfaces 294 and 296 of the narrow portion 292.

[0167] In some configurations, the clip 250 can be configured to allow pivotal movement relative to the post 260 and / or the frame 156 about the longitudinal axis A of the post 260. This arrangement allows the angular orientation of the clip 250 relative to the frame 156 to be changed to easily accommodate different head shapes. However, in some configurations, the pivotal movement of the clip 250 can be limited. For example, the base 264 of the clip 250 can contact the frame 156 because the base 264 has a height 270 that is greater than a height 272 of the hook 266. In some configurations, the base 264 can contact the post 260 and / or portions of the frame 156 above and / or below the narrow portion 292 to limit the pivotal movement of the clip 250 toward and / or away from the frame 156.

[0168] 13-16 illustrate the interaction between the mask 152 and headgear 154 resulting from or facilitated by the engagement of the clip 250 and post 160 of the connecting device 248. FIG. 13 illustrates the orientation in which rotation is limited, restricted, or prevented by the connecting device 248, specifically the positioning of the hook 266 within the narrow portion 292 of the opening 290 when the clip 250 is connected to the post 260. As discussed above, the connecting device 248 can limit, restrict, or prevent movement of the clip 250 about an axis that is perpendicular to the longitudinal axis A of the post 260. In the context of the mask assembly 150, movement of the clip 250 in a vertical plane or about a horizontal axis is limited, restricted, or prevented. As discussed further below, when the headgear 154 provides sufficient support for the clip 250, the headgear 154, in combination with the connecting device 248, limits, restricts, or prevents excessive rocking of the mask 152 on the user's face. 14 shows that the connector 248 can be configured so that the headgear 154 extends from the mask 152 at a desired angle for a particular application or headgear type. That is, the connector can be secured at a different angle relative to the mask frame to better engage the top of the bottom of the seal.

[0169] 15 and 16 illustrate the direction and extent to which rotation of the clip 250 about the longitudinal axis A of the post 260 is limited relative to the mask 152 to allow the mask assembly 150 to accommodate users with different head widths or sizes. FIG. 15 illustrates that some rotation of the clip 250 about the longitudinal axis A of the post 260 is permitted. In the context of the entire mask assembly 150, this rotation is in a horizontal plane or about a vertical axis. FIG. 16 illustrates an example range of motion that may be permitted. For example, in some configurations, the functional range may be 0 to 90 degrees. However, in some configurations, the allowable or operational range is more limited. For example, the illustrated arrangement provides an operational range α of approximately 15 degrees. The operational range α of approximately 15 degrees is permitted at an angle of approximately 45 to approximately 60 degrees relative to a central vertical plane that bisects the mask assembly 150 into a lateral right and left portion. Such a range may allow for an acceptable range of user head sizes to be accommodated while reducing or minimizing unwanted separation of the connection device 248 that may occur with excessive rotational movement. In other configurations, the range of movement may be from about 10 degrees to about 30 degrees, and may be any angle within the range of about 20 degrees to 80 degrees relative to the central vertical plane.

[0170] 17A-17D illustrate a method of fitting the mask assembly 150 to a user. In some configurations, the mask assembly 150 and connection device 248 can be configured to allow a user to fit (apply or don) the mask assembly 150 in a substantially single motion using one hand to connect the headgear 154 and mask 152. The user's other hand can be used to support the mask 152. FIG. 17A illustrates the direction of motion for separating the headgear 154 from the mask 152. That is, the clips 250 can be separated from the posts 260 by moving the headgear 154 (and clips 250) forward, away from the user, forcing the posts 260 through the openings 276 in the clips 250 against the separation force created by the resilience of the hooks 266. Removal of the headgear 154 shown in FIG. 17A can be performed to allow removal of the mask assembly 150 from the user or to form an open loop before the mask assembly 150 is applied to the user.

[0171] 17B and 17C show that the mask 152 can be positioned near or over the user's nose, and the separated ends of the headgear 154 can be swung toward the mating side of the mask 152 around or over the user's head. As shown in FIG. 17D, the clips 250 can be manipulated to thread the hooks 266 through openings 290 in the frame 156 of the mask 152. The headgear 154 and clips 250 can be moved rearward to force the posts 260 through openings 276 in the clips 250 and into spaces 274, connecting the clips 250 to the frame 156 and the headgear 154 to the mask 152. Because only a single headgear clip 250 is provided on each side of the mask assembly 150, connecting the headgear 154 to the mask 152 can be accomplished with one hand and in a single motion. To remove the mask assembly 150, the user can disengage the clips 250 from the mask 152 as shown and described in connection with FIG. 17A.

[0172] 18 illustrates that the straps or portions of the headgear 154 connected to the clip 250 can be oriented at an angle relative to the clip 250. In other words, the longitudinal axis or centerline of the headgear 154 can define an angle relative to the longitudinal axis or centerline of the clip 250. As used herein, oriented at an angle or defining an angle means that the axes or centerlines do not form a straight line. In other words, two lines or axes that are oriented at an angle do not define an angle of 0 degrees or 180 degrees. This arrangement can allow the headgear 154 to be oriented as desired relative to the user's head, while also allowing the clip 250 to be oriented as desired relative to the frame 156 regardless of the orientation of the frame 156.

[0173] 19-21 show that a rear portion 298 of the clip 250, located rearward of the connection with the frame 156 of the mask 152, can be enlarged relative to the portion connected to the frame 156. The enlarged rear portion 298 can be provided to improve a user's grip on the clip 250. In some configurations, the enlarged rear portion 298 can be configured to contact an end of the frame 156, thereby limiting rotation of the clip 250, as shown in FIG.

[0174] In some configurations, the headgear clip 250 can include additional structure to improve the connection arrangement 248. FIGS. 41-45 show a modified version of the clip 250 in which the base 264 includes a protrusion 265 that extends at least partially outward from the outward-facing major surface of the base 264, preferably in a direction substantially perpendicular to that major surface. In the illustrated clip 250, the protrusion 265 spans the width of the headgear clip 250. However, in some configurations, the protrusion 265 can span only a portion of the width of the base 264. In some configurations, the protrusion 265 is located at, adjacent to, or toward the rear portion 298 of the clip 250, near the front strap portion 306, which can help keep a user's hand clear of the hook 266 so that connection and / or disconnection of the clip 250 is not hindered.

[0175] In some configurations, the protrusion 265 may protrude from the adjacent portion of the base 264 by approximately 2-5 mm. In some configurations, the protrusion 265 may protrude from the base 264 by approximately 3.5 mm. In some configurations, the protrusion 265 may protrude from the base 264 by a height equal to approximately 50%-150% of the thickness of the base 264. In some configurations, the protrusion 265 may have a height approximately equal to the thickness of the base 264.

[0176] The protrusions 265 can assist the user in pushing the headgear clips 250 toward the frame 156 during donning and / or doffing. The protrusions 265 can alternatively or additionally assist the user in pulling the clips 250 away from the mask frame (i.e., pulling the hooks 233 toward the frame) to secure the interference connection between the clips 250 and the posts 260 of the frame 156.

[0177] Each of the headgear clips 250 in FIGS. 41-44 also includes a recess 267 in an outward-facing portion of the base 264. The recess 267 acts as a tactile feature to accommodate a user's fingers, particularly the index finger. The presence of the recess 267 in front of and substantially adjacent to the protrusion 265 can increase the effective height of the protrusion 265 relative to the base 264. The recess can provide a visual cue to the user. Providing a tactile and / or visual cue can help the user position a finger over the clip 250 to connect and / or disconnect the clip 250 from the frame 156. As shown in each of Figures 41-44, at least a portion of the recess 267 may also provide a sloped or substantially vertical ridge or wall 268 against which a user may apply force to guide the clip 250 toward the frame 156 during wear and / or to remove the clip 250 from the frame 156 when donning or doffing the patient interface assembly 150.

[0178] As shown in FIG. 42, the base 264 may include one or more ridges 269. The ridges 269 may provide additional friction with the base 264 of the clip 250 and may help the user grip the clip 250. The ridges 269 may be smaller in size than the recesses 267 and may be located within the recesses 267 as shown. The ridges 269 may provide a visual cue to the user. For example, in FIG. 40, the ridges 269 are arranged as an arrow indicating that the clip 269 is configured to be moved in a certain direction.

[0179] In some configurations, the headgear clip 250 can extend rearward along a forward portion of the front strap portion 306 of the headgear 154. As shown in FIG. 44 , the headgear clip 250 defines a contoured, C-shaped recess 263 that extends rearward from the protrusion 265 along the opposing edges 313 of the front strap portion 306, exposing the outer surface of the front strap portion 306. Like the recess 267, the recess 263 can define a sloped or vertical ridge or wall 268. Like the recess 267, the C-shaped recess 263 can act as a tactile feature to accommodate a user's fingers when connecting and disconnecting the headgear clip 250.

[0180] In some configurations, the plastic core within the front strap portion 306, described in more detail below, can vary in width along the front strap portion 306, particularly adjacent the clip 250. As shown in the configuration of FIG. 43 , the plastic core of the front strap portion 306 has a region of increased width 315 adjacent the headgear clip 250. The region 315 can be substantially planar. The region 315 can extend outward beyond the edge 313 of the front strap portion 306. The relatively wider plastic core adjacent the headgear clip 250 provides a larger area to accommodate the user's fingers when connecting the headgear clip 250 to the frame 156. Similarly, the plastic core of the front strap portion 306 can vary in thickness along the front strap portion 306, particularly adjacent the clip 250. As also shown in FIG. 43 , the plastic core of the front strap portion increases in thickness toward the headgear clip 250. The increased thickness can define an integral ledge 317. The ledge 317 provides a tactile feature that is helpful when a user is gripping the front strap portion 306 and headgear clip 250. As shown, the ledge 317 may be contoured to intuitively accommodate, for example, an index finger. The headgear clip 250 may have an increased thickness immediately adjacent the front strap portion 306. This may provide the protrusion 265, as described above. In other configurations, the rear portion 298 of the clip 250 and the front portion of the front strap portion 306 may be substantially flush with one another.

[0181] In some configurations, the clip 250 may alternatively or additionally be provided with a protrusion 265 from the inward-facing side of the base 264 (i.e., the side facing towards the user), as shown in FIG.

[0182] As shown in the configurations of FIGS. 41, 42, and 44-48, in some configurations, the clip 250 can be formed from two different materials. The front end of the clip 250, including the hook 266, is formed from a first material, and the rear portion 298 is formed from a second material. The first material can be a resilient, relatively hard thermoplastic material, such as polyoxymethylene (also known as acetal), suitable for repeated engagement and disengagement with the post 260. The second material can be a resilient, relatively soft thermoplastic elastomer material, such as polyether block amide (PEBA), sold under the trade name PEBAX® by Arkema Group of Colombes, France. The second material can be overmolded onto the first material, and optionally onto the front strap portion 306 of the headgear 154, to secure the clip 250 to the front portion 300 of the headgear 154. The second material can be selected to provide a desired feel and / or improved grip compared to the first material, while the first material can be selected to provide a secure and / or stable connection of the hook 266 with the frame 156. The first material can be the same material used in the plastic core of the headgear 154, as described below. The protrusions 265 can be at least partially formed from a first, relatively hard material for stability, as shown in FIGS. 42, 45, and 48. Alternatively, or in addition, at least the outer portions of the protrusions 265 can be formed from a second, relatively soft material for improved grip or feel, as shown in FIGS. 41, 44, and 46. With particular reference to FIG. 46, a cross-section of an example clip 250 configuration including a first material and a second material is shown, where the second material is overmolded to and mechanically interlocks with both the first material and the front strap portion 306.

[0183] 47, alternatively or additionally, protrusions 265 may be provided on front strap 306 to allow sufficient clearance for a user's hand from hook 266 and post 260, to provide a more distinct and / or attractive aesthetic for protrusion 265, and / or to provide improved feel and / or grip for protrusion 265. Protrusions 265 may be formed during injection molding of a plastic core within the tubular knitted structure, as described in more detail below.

[0184] As mentioned above, the posts 260 and / or clips 250 on each side of the mask 152 may be different from one another to reduce or eliminate the possibility of an improper connection between the headgear 154 and the frame 156. An example will now be described with reference to another example configuration of the patient interface assembly 150 and its components, as shown in FIGS. 48-52. Except as otherwise described herein and / or apparent from the accompanying drawings, the patient interface assembly 150 of FIGS. 45-48 may be similar to that of FIG. 2. In particular, the patient interface assembly 150 includes a frame 156, a cushion module 160, and headgear 154. Each side of the frame 156 has ears 252 associated with the headgear clips 250. The ears 252 extend laterally outward from a central portion 254 of the frame 156, which includes a frame connector 170 and an opening 256 that communicates with the interior of the connector portion 170 and receives the connecting tube 164. The frame 156 includes a cylindrical frame connector 170 and an oval opening 256. The cooperating opening (not shown) in the housing 162 is circular.

[0185] 48-52, the connection device 248 is modified to prevent or inhibit incorrect connection of the clip 250 to the post 260. That is, the connection device 248 can prevent or inhibit connection of the clip 250 in the wrong orientation and / or to the wrong side of the frame 156. In some configurations, the connection device 248 can limit connection of the clip 250 and the post 260 to a single desired orientation.

[0186] 49 and 50, which show front and rear views, respectively, of the frame 156, it can be seen that the posts 260 in this configuration each define a gap 261 along their respective longitudinal axes A. The illustrated posts 260 can be referred to as a split post configuration, including axially aligned first and second post portions 260a, 260b. The gap 261 is eccentric along the longitudinal axis A of the posts 260. The split posts 260 on either side of the frame 156 are identical to one another; that is, each gap 261 can be offset the same distance and in the same direction from the center of the post 260.

[0187] 51 and 52, clip 250 in this configuration includes rib 275 extending into space 274 intended to receive post 260. Rib 275 is also eccentrically positioned, specifically sized, shaped, and positioned to be received by gap 261 when clip 250 is connected to one of posts 260. The width of rib 275 is less than the length of gap 261 in axial direction A. Gap 261 and rib 275 do not prevent rotation of clip 250 about axis A of post 260 when the clip is properly attached to frame 156. Movement of clip 250 in the direction of longitudinal axis A is limited by the size and / or shape of narrow portion 292 and the base or connecting portion of hook 266, as described above. However, in some configurations, rib 275 and gap 261 can alternatively or additionally limit movement of clip 250 in the direction of longitudinal axis A when clip 250 is connected to frame 156. In some configurations, rib 275, together with either or both of first post portion 260 a and second post portion 260 b, can be configured to provide a snap-fit ​​connection between clip 250 and frame 156, where first post portion 260 a and second post portion 260 b can elastically deform when hook 266 engages frame 156 and partially or fully recover upon engaging rib 275.

[0188] 48-52 , a pair of clips 250 differ from one another such that one clip 250 is configured to connect to a post 260 on one side of the frame 156 and the other clip 250 is configured to connect to a post 260 on the other side of the frame 156. The clips 250 of a pair may be mirror images of one another. If an attempt is made to connect clip 250 to the wrong side of the frame 156, rib 275 and gap 261 will not align, and rib 275 will interfere with post 260, preventing or preventing post 260 from entering space 274. Upside-down connection of clip 250 to post 250 is prevented or prevented by interference between narrow portion 292 and height 270 of base 264.

[0189] In other configurations, the posts 260 may be provided with annular or partially annular ribs 275, and the clips 250 may be provided with corresponding gaps 261 or channels. In some configurations, the posts 260 and clips 250 may be provided with gaps 261 and ribs 275 on only one side of the patient interface assembly 150 (or vice versa), ensuring that at least one of the clips 250, and therefore the headgear 154 as a whole, cannot be accidentally connected to the frame 156. In some configurations, the clips 250 may be identical to one another, and the posts 260 on each side of the frame 156 may be different.

[0190] headgear FIGS. 2, 13-16, and 22-27 show an example of the headgear 154 described above. The headgear 154 will now be described with reference to FIGS. 2, 13-16, and 22-27. In the illustrated arrangement, the headgear 154 has a front portion 300 and a rear portion 302. The front portion 300 is configured to connect to the mask 152 and extends between the mask 152 and the rear portion 302. The rear portion 302 is configured to engage the sides and / or rear portions of the user's head. The illustrated front portion 300 includes front straps or strap arrangements 304 that connect to the mask 152 via clips 250 on each side of the interface assembly 150 or the user's head. In the illustrated arrangement, the front strap arrangements 304 on each side of the interface assembly 150 are separate from each other and connect separately to the mask 152. The front strap arrangements 304 may be mirror images of each other.

[0191] In an alternative configuration, the front strap arrangement 304 on one side can be permanently connected to the mask 152, or can be connected in a manner that is more complex and difficult to remove than the clips 250 located on the opposite side of the mask 152, such that the mask assembly 150 is removed using clips 250. In an alternative arrangement, the front strap arrangement 304 on one side of the headgear 154 can be coupled to the mask 152, and the front strap arrangement 304 on the other side of the headgear 154 can be coupled to the front strap arrangement 304 on the first side.

[0192] Each of the illustrated front strap arrangements 304 includes a single front strap portion 306 that connects to the mask 152 via a clip 250. The front strap arrangement 304 bifurcates to define an upper strap portion 308 and a lower strap portion 310 that extend above and below the level of the user's ears, or are located at least partially above and below the level of the ears, respectively. The front strap portion 306 extends from the mask 152 across the user's cheeks to a bifurcation point. In the illustrated arrangement, the front strap portion 306 extends in a slightly upward direction from the mask end to the bifurcation end. The upper strap portion 308 continues the curve of the front strap portion 306 and extends toward or to a location above the user's ears. In some configurations, the ends of the upper strap portions 308 can be located directly above the user's ears or above the ear line and slightly forward of the ears. The end portion of the upper strap portion 308 can be curved downward to connect with the rear portion 302 of the headgear 154. The lower strap portion 310 extends downward from the branched end of the front strap portion 306 to a location above the user's chin at a level below the user's ears. The end portion of the lower strap portion 310 can be positioned below and in front of the user's ears. The end portion of the lower strap portion 310 can be curved upward to connect with the rear portion 302 of the headgear 154.

[0193] In some configurations, the front strap portion 306, the upper strap portion 308, and the lower strap portion 310 of the front strap arrangement 304 can be configured as a unitary structure. In some configurations, the front strap arrangement 304 can be configured as a molded composite structure having at least one fabric layer and at least one plastic layer permanently connected to one another. In the illustrated arrangement, the front strap arrangement 304 is a molded composite structure having two fabric layers with a plastic core located between the fabric layers. The front strap arrangement 304 can be formed as a unitary structure by dispensing molten plastic into the space between the fabric layers in a mold and allowing the molten plastic to harden and form a plastic core in the shape of the mold cavity. The fabric layers can be separate from one another and joined via the plastic core, or they can be bonded (e.g., a tubular structure surrounding the plastic core).

[0194] Part or all of the front strap arrangement 304 may be semi-rigid. The term "semi-rigid" in this context is intended to mean that the associated structure is flexible and at least somewhat resilient, but has little or no extensibility. In the illustrated arrangement, any one, any combination, or all of the front strap portion 306, upper strap portion 308, and lower strap portion 310 may be semi-rigid. As used herein, semi-rigid means that the semi-rigid portion of the headgear 154 can generally retain its shape under its own weight, but has some flexibility that allows the semi-rigid portion to bend around the user's head. In some configurations, the semi-rigid portion of the headgear 154 is more rigid in one direction and less rigid in a second direction. For example, the semi-rigid portion of the headgear 154 can be substantially rigid in the vertical direction or along the user's face, and relatively flexible in the horizontal direction or toward and away from the user.

[0195] The front strap arrangement 304 can be configured to connect to the rear portion 302 of the headgear 154. In some configurations, the ends of the upper and lower strap portions 308, 310 can include loops 312 configured to receive strap portions of the rear portion 302 of the headgear 154. In the illustrated arrangement, the loops 312 can be plastic loops that are overmolded onto the ends of the upper and lower strap portions 308, 310. In other arrangements, the loops 312 can be formed by the plastic core material of the front strap arrangement 304, or the loops 312 can be formed separately from and attached to the front strap arrangement 304.

[0196] In some configurations, the headgear 154 includes a top strap arrangement 314 that passes over the user's head from one side of the headgear 154 to the other. In the illustrated arrangement, the top strap arrangement 314 connects to rear end portions of the upper strap portions 308 of the front strap arrangement 304 on each side of the headgear 154. In particular, the top strap arrangement 314 can connect to the uppermost portions of the upper strap portions 308 before the upper strap portions 308 begin to curve downward toward the rear portion 302 of the headgear 154. In the illustrated arrangement, each end of the top strap arrangement 314 is connected to the upper strap portions 308 by an overmolded connector 316. The overmolded connectors 316 can be molded over a portion of each of the top strap arrangement 314 and the upper strap portion 308 to join the two components. Alternatively, the overmolded connector 316 can be joined to one of the components by overmolding and can define a connecting structure (e.g., a loop) to which the other component can be connected. For example, the overmolded connector 316 can be overmolded onto the upper strap portion 308 and can define a loop to which the top strap arrangement 314 can be coupled.

[0197] In some configurations, the top strap arrangement 314 includes a first strap portion 320 and a second strap portion 322 ( FIG. 13 ), which can be connected to one another. The first strap portion 320 and the second strap portion 322 can be connectable to one another in an adjustable manner, such as with a buckle, a post-hole structure 324, or a similar connector generally located at the top of the user's head. In the illustrated arrangement, the free end of the second strap portion 322 includes a guide loop through which the first strap portion 320 can pass. The first strap portion 320 can be sized to fit relatively closely with the guide loop so as to maintain a loose connection between the first strap portion 320 and the second strap portion 322 when the straps 320, 322 are not connected by the post-hole structure 324. This arrangement prevents unintentional separation of the straps 320, 322 when adjusting the top strap arrangement 314, making the adjustment process easier for the user. In some configurations, the end of the second strap portion 322 can be slightly larger (e.g., in width and / or thickness) than the opening of the guide loop to provide an interference fit between the strap portion 322 and the guide loop, further reducing the possibility of unintended separation.

[0198] The illustrated rear portion 302 of the headgear 154 includes a first or upper strap 330 and a second or lower strap 332. The upper strap 330 and the lower strap 332 are spaced from one another by a panel 334. Each of the upper strap 330 and the lower strap 332 is configured to extend around the back of the user's head and connect to a front strap arrangement 304 of the front portion 300 of the headgear 154. In particular, opposite ends of the upper strap 330 connect to respective upper strap portions 308 of the front strap arrangement 304 on either side of the user's face. Similarly, opposite ends of the lower strap 332 connect to respective lower strap portions 310 of the front strap arrangement 304. For example, as shown in FIG. 22 , the upper strap 330 extends downward from each end toward or to the vertical centerline of the panel 334 or the rear portion 302. In other words, the ends or loops 312 of the upper strap portions 308 are located at a height above the upper edge of part or all of the panel 334. In some configurations, the lower straps 332 can extend upward from each end toward or to the vertical centerline of the panel 334 or rear portion 302.

[0199] Each of the upper strap 330 and the lower strap 332 may be constructed from a composite material including a pair of fabric layers on either side of a foam layer. In particular, the straps 330, 332 may include a three-layer construction including layers formed from Lycra, foam, and unbroken loop (UBL) material. The UBL material may form the outer layer of each of the straps 330, 332. Each end of each of the upper strap 330 and the lower strap 332 terminates in a tab 336, which may form the hook portion of a hook-and-loop fastener. The tab 336 may be ultrasonically welded to the end of the strap 330, 332 or connected in another suitable manner. The UBL material provides a loop surface to which the hook tab 336 may connect. The ends of the straps 330, 332 may pass through the loop 312 in the front portion 300 of the headgear 154 and double back. The hook tabs 336 can be connected anywhere along the length of the straps 330 , 332 to allow for size adjustment of the headgear 154 .

[0200] In some configurations, the panel 334 can be constructed, in whole or in part, from a spacer fabric, which is a composite material including two spaced-apart cover fabrics connected by filaments positioned between the cover layers. Referring to FIG. 25 , the spacer fabric of the panel 334 is shown in cross section. The spacer fabric can include a first fabric layer 340, a second fabric layer 342, and a central spacer or connecting layer 344. In some configurations, the first fabric layer 340 is Lycra or a similar material, and the second fabric layer 342 is UBL or a similar material. The spacer layer 344 can be constructed from any suitable yarn or filament material, such as polyester. As shown in FIG. 25 , a gap can be formed between the first and second fabric layers 340, 342 at the outer edges of the panel 334. In one configuration, the gap between the first and second fabric layers 340, 342 is at least 0.1 mm.

[0201] In the illustrated arrangement, the upper strap 330 and the lower strap 332 are continuous from one end to the other, and the panel 334 extends between the bottom edge of the upper strap 330 and the top edge of the lower strap 332. This arrangement provides a wider range of adjustment for the rear portion 302 because the ends of the straps 330, 332 can be connected to the portions of the straps 330, 332 that overlap the panel 334. However, in other arrangements, the upper strap 330 and / or the lower strap 332 can be provided in two segments, each extending from a side edge of the panel 334. In other words, the panel 334 can interrupt a portion of the straps 330, 332. This arrangement can limit the adjustability of the rear portion 302 because the ends of the straps 330, 332 can only be connected to the straps 330, 332 up to the edge of the panel 334.

[0202] In the illustrated configuration, in a relaxed or laid-out orientation, the upper strap 330 is linear or straight, and the lower strap 332 is curved such that its ends are below a central portion. Specifically, the lower strap 332 has a curved central section and linear sections extending on either side of the central section. In other configurations, the upper strap 330 can be curved and the lower strap 332 can be straight. In still other configurations, both straps 330, 332 can be straight or curved.

[0203] In some configurations, the straps 330, 332 have different levels of stretch. In other words, the rate of stretch for a given applied force differs between the straps 330, 332. In some configurations, the bottom strap 332 has a higher stretch or rate of stretch than the top strap 330. The greater stretch of the bottom strap 332 may allow a user to move their jaw more easily or comfortably and / or may reduce pressure of the strap 332 against the user's skin. However, in other arrangements, the straps 330, 332 may have the same stretch characteristics, or the top strap 330 may be more stretchy than the bottom strap 332.

[0204] In some configurations, the edges of the straps 330, 332 are radio frequency, dielectric, or radio frequency welded (RF welded), pressed, and cut to give the straps 330, 332 rounded edges that provide increased comfort for the user. The RF welding process also secures the composite fabric materials together to inhibit or prevent delamination.

[0205] Referring to FIG. 26 , the rear portion 302 of the headgear 154 may be offered in multiple sizes. In some configurations, the rear portion 302 of the headgear 154 may provide all of the circumferential adjustment of the headgear 154 (although the top strap arrangement 314 may provide some depth adjustment of the headgear 154). Thus, the front portion 300 of the headgear 154 may be offered in a single size. In some configurations, the rear portion 302 is offered in two sizes: small and large. In some such configurations, the only difference between the sizes is the length of one or both of the straps 330, 332. In the illustrated configuration, the length 350 of the top strap 330 in a size small is approximately 340-400 mm, or approximately 370 mm. In a size large, the length 350 may be approximately 400-460 mm, or approximately 430 mm. In size small, the length 352 of the lower strap 332 (measured as the linear distance between its ends when the lower strap 332 is in its relaxed or natural curved state) is about 300 mm to 400 mm, about 325 mm to 375 mm, or about 350 mm (e.g., 348 mm or 348.14 mm). In size large, the length 352 is about 400 mm to 500 mm, about 450 mm to 475 mm, or about 470 mm (e.g., 470.30 mm). The straps 330, 332 can have a width 354 of about 10 mm to 20 mm, about 12 mm to 16 mm, or about 14 mm or 15 mm.

[0206] In some configurations, the panels 334 may be the same size across multiple sizes of the rear portion 302. For example, the panels 334 may have a maximum height 356 of about 30-50 mm, about 35-40 mm, or about 38 mm (e.g., 38.32 mm). The panels 334 may have a maximum width 358 of about 50 mm-150 mm, about 75 mm-125 mm, or about 90 mm or 100 mm. In some configurations, the panels 334 may taper from the maximum width 358 at the top and / or bottom ends. In the illustrated arrangement, the panels 334 taper at the bottom end by about 10-15 percent of the maximum width 358.

[0207] In some configurations, the straps 330, 332 can define an angle 360 ​​therebetween. As mentioned above, in some configurations, the upper strap 330 can be straight and the lower strap 332 can be curved. Thus, the angle 360 ​​can be defined by the lower strap 332. In other arrangements, the upper strap 330 can be curved and the angle 360 ​​can be defined by the upper strap 330, or both straps 330, 332 can be curved and the angle 360 ​​can be defined by both straps 330, 332. In some configurations, the angle 360 ​​is less than about 30 degrees. In some configurations, the angle 360 ​​is about 10-30 degrees, about 15-25 degrees, or about 20 degrees.

[0208] 27A-27E, an example process or method for constructing the panel 334 and rear portion 302 of the headgear 154 is shown. With reference to FIG. 27A, two separate layers of spacer fabric (or other suitable fabric) are cut or otherwise formed to the general shape of the panel 334. With reference to FIG. 27B, the two layers of spacer fabric are secured together along their side edges. In the illustrated arrangement, the layers are secured together by sewing to create a stitched joint or stitched connection 370. However, other suitable connection arrangements or methods may also be used. With reference to FIG. 27C, the now-joined layers of spacer fabric are inverted, or turned inside out, to conceal the stitched connection 370 and to protect it from snagging or fraying due to external forces. With reference to FIG. 27D, the top and bottom edges of the panel 334 are connected to the upper and lower straps 330 and 332, respectively. In the illustrated arrangement, the top and bottom edges of the panel 334 are connected by sewing to create a sewn connection 372. However, other suitable connection arrangements or methods can be used. In this process, the previously open top and bottom edges of the two spacer fabric layers are closed. The sewn or sewn connection 372 advantageously reduces or prevents tension at the connection 372, allowing the panel 334 and / or straps 330, 332 to stretch during use. Figure 27E shows the clean joint that is exposed when the sewn spacer fabric panel is inverted, as described above with respect to Figure 27C.

[0209] Advantageously, the spacer fabric panel 334, particularly the multi-layer spacer fabric panel 334, provides a lighter and / or more breathable panel 334 compared to panels constructed from conventional materials, such as foam composites (e.g., Breath-o-Prene®). Additionally, the spacer fabric panel 334 of the present invention provides cushioning and support to the back of the user's head and may be less bulky and / or intrusive to the user compared to panels constructed from conventional materials. The breathability of the spacer fabric may reduce the likelihood of the user becoming overheated and may reduce or prevent sweating. The spacer fabric panel 334 may be more compressible than a comparable foam composite panel, allowing the spacer fabric panel 334 to compress to a smaller or minimal thickness depending on the weight of the user's head. With this arrangement, a user may be less likely to feel the panel 334 when lying on it, particularly when lying on their side, due to its compressibility and reduced thickness under load compared to a foam composite panel.

[0210] FIG. 28 illustrates a modification of the rear portion 302 of the headgear 154, which may be the same or similar to the other rear portions 302 described herein, except as noted below. The rear portion 302 of FIG. 28 omits the spacer fabric panel 334 and instead forms a panel portion 380 that utilizes the integral structure of one or both of the straps 330, 332. In the illustrated arrangement, the lower strap 332 defines the panel portion 380, which extends upwardly from the strap portion of the lower strap 332 to space the upper strap 330 and the lower strap 332 apart, similar to the panels 334 of the other embodiments described herein. The panel portion 380 may be joined to the bottom edge of the upper strap 330 by a suitable connection, such as a sewn connection 382. In other arrangements, the panel portion 380 can be defined by the upper strap 330, or the panel portion 380 can be defined by a combination of the protruding portions of each of the straps 330, 332. In some configurations, the upper strap 330 and the lower strap 332 can have the same or similar levels of stretch, which can be similar to the stretch of the lower strap 332 described above.

[0211] Knitted back panel 29-32 show another example of a rear portion 302 of headgear 154, which may be the same as or similar to the other rear portions 302 described herein, except as described below. In the arrangement of FIGS. 29-32, the panel 334 is constructed entirely or in part from a knitted material. Additionally, the upper strap 330 is a single continuous piece, while the lower strap 332 is interrupted by the panel 334. With this arrangement, the knitted material of the panel 334 can define the lower edge of the central portion of the rear portion 302 of the headgear 154. However, in other arrangements, the lower strap 332 can be a single continuous piece. In other arrangements, the upper strap 330 can be interrupted by the panel 334.

[0212] In some configurations, the panel 334 is formed by a knitting process separately from the straps 330, 332 and then connected to the straps 330, 332 in a separate process step in a manner similar to that described herein with respect to the spacer fabric panel 334. Once the knitted panel 334 is formed, it can be joined to the upper strap 330 and lower strap portions 332 by a suitable connection arrangement or process. For example, in the illustrated arrangement, the knitted panel 334 is connected to the upper strap 330 and lower strap portions 332 by a sewing process that creates stitched connections 372. In particular, the knitted panel 334 is connected to the upper strap 330 by stitched connections 372 along the entire top edge of the knitted panel 334. The lower strap portions 332 are each connected to opposite side edges of the knitted panel 334 by stitched connections 372. Lower strap portion 332 is connected at a bottom corner of woven panel 334 such that the lower edge of lower strap portion 332 is aligned with the lower edge of woven panel 334 at the juncture therebetween. Similar to the arrangement described above, lower strap portion 332 extends at a downward angle from woven panel 334.

[0213] In some configurations, the knitted panel 334 is created by a knitting process that constructs the panel 334 in a vertical direction, as oriented in the drawings, for use with the patient's head in an upright position. This arrangement allows the knitted panel 334 to stretch more horizontally than vertically. That is, for a given applied force, the knitted panel 334 has a higher elongation rate in the horizontal direction than in the vertical direction. As a result, the higher horizontal elongation allows the rear portion 302 and associated headgear 154 to accommodate a wider range of head sizes. In some configurations, the knitting process starts at the bottom of the panel 334 or creates the bottom of the panel 334 first and progresses toward the top of the panel 334. However, in other configurations, this direction can be reversed.

[0214] Referring to FIG. 32 , different portions of the panel 334 can be constructed of different materials or different combinations of materials. For example, in the illustrated arrangement, the bottom portion 390 of the knitted panel 334 is constructed using only a first material, such as a first yarn or filament type 502. In some configurations, the first material includes an elastane material (e.g., Lycra). In some configurations, the first material is nylon-coated elastane. As the knitting process progresses upward, or to construct a relatively upper portion 392 of the knitted panel 334 above the bottom portion 390, a second material, such as a second yarn or filament type 504, is introduced. In some configurations, the second material is or includes nylon (e.g., textured nylon). The second material can be used exclusively in the upper portion 392 or can be combined with the first material and / or other materials. The use of two or more materials in the panel 334 can provide advantageous or desirable properties, as discussed further below. However, using a single material for the bottom portion 390 may result in a less bulky structure compared to a bottom portion 390 incorporating multiple materials, which may provide increased comfort for the user.

[0215] The combination of first and second materials, such as the materials including elastane and nylon described above, provides an overall knitted panel 334 with desirable properties. For example, elastane materials provide better recovery with less bulk than nylon materials, which are inelastic and have more bulk, thickness, and depth than elastane materials.

[0216] In some configurations, the knitted panel 334 is knitted to have multiple layers. For example, referring to FIG. 31 , the knitted panel 334 can include a first layer 400 and a second layer 402. The first layer 400 can be an interior layer facing toward or positioned adjacent to the user. The second layer 402 can be an exterior layer facing away from the user. The first layer 400 can be positioned between the second layer 402 and the user. The first layer 400 and the second layer 402 can be joined along their side edges. In some configurations, the first layer 400 and the second layer 402 are created as a unitary structure during the knitting process. In some configurations, the first layer 400 and the second layer 402 can define a tubular structure. However, in the illustrated arrangement, the first layer 400 and the second layer 402 are connected by an interlock stitch 404, which can be created during the knitting process. Alternatively, the interlocking knitted portion 404 can be created by a process separate from the knitting process (e.g., by subsequent sewing). Additionally, the first layer 400 and second layer 402 can be knitted separately and connected by a suitable connecting arrangement or process, such as sewing.

[0217] FIGS. 32-1 and 32-2 illustrate a process for making knitted panel 334 and the resulting structure of knitted panel 334. Panel 334 includes elastane (e.g., Lycra) material 502 and nylon (e.g., textured nylon) material 504. As shown, bottom portion 390 of panel 334 is composed entirely of elastane material 502, which is knitted on all needles. Also shown, nylon material 504 is introduced into top portion 392 of knitted panel 334. In the illustrated arrangement, in top portion 392, elastane material 502 is tucked (e.g., half-gauge tucked, skipping every other needle) and nylon material 504 is knitted on all needles. The tuck stitches of elastane material 502 provide more bulk than knit stitches. However, both materials can be knitted in other configurations. Elastane material 502 and nylon material 504 can be intertwined at intervals, such as every fourth course.

[0218] FIGS. 33A-33I illustrate alternative configurations of the rear portion 302, generally including an upper strap 330, a lower strap, and a panel 334 or corresponding structure. The illustrated panel 334 may be partially or completely knitted. In an alternative arrangement, the panel 334 may be constructed from a sheet of material, such as a spacer fabric or other composite or suitable material. FIG. 33a illustrates a rear portion 302 the same as or similar to the rear portion 302 of FIGS. 29-32, in which a single upper strap 330 is provided and a pair of lower straps 332 are provided. The panel 334 interrupts the lower strap 332. The upper strap 330 may be curved, and the lower strap 332 may form a greater curvature relative to a horizontal line passing through the panel 334 than the curvature of the upper strap 330.

[0219] FIG. 33B shows the rear portion 302 in which both the upper straps 330 and the lower straps 332 are uninterrupted. The rear panel 334 is tapered from top to bottom. The upper straps 330 and the lower straps 332 are straight as shown, although one or both can be curved. The rear portion 302 in FIG. 33C is similar to that in FIG. 33B, except that the bottom straps 332 are interrupted by panel 334, which includes a central tapered section. The upper and lower portions of panel 334 have parallel side edges. The rear portion 302 in FIG. 33D is similar to that in FIGS. 33B and 33C, except that the rear panel 334 is not tapered and is rectangular in shape. The rear portion 302 in FIG. 33E includes a rectangular panel 334. However, both the upper straps 330 and the lower straps 332 are interrupted by panel 334. Additionally, the straps 330, 332 include a connecting portion 410 that extends between the straps 330, 332 along the side of the panel 334. Thus, the straps 330, 332 may be formed in two portions, each of which defines a portion of the upper strap 330 and a portion of the lower strap 332, with the connecting portion 410 therebetween.

[0220] Figure 33F shows a rear portion 302 similar to that of Figure 33A. However, the rear portion of Figure 33F includes a knitted lower strap 332 in addition to a knitted panel 334. Figure 33G shows a rear portion 302 similar to that of Figure 33A, except that the knitted panel 334 forms a lower strap portion 412 that extends from a main body portion 414 of the panel 334. The lower strap 332 connects to a strap extension or strap portion 412 of the knitted panel 334. Figure 33H shows a rear portion 302 similar to that of Figure 33F, except that the knitted panel 334 / lower strap 332 portion interrupts the upper strap 330.

[0221] Figure 33I shows a rear portion 302 that is similar to rear portion 302 of Figure 33C, except that panel 334 forms a lower strap portion 412 similar to that of rear portion 302 of Figure 33G. The main body portion 414 of panel 334 is generally rectangular such that the lower strap portion 412 and main body portion 414 form an inverted T-shape.

[0222] FIG. 33J shows a rear portion 302 that is similar to the rear portion 302 of FIG. 33A , except that the panel 334 includes regions of different stretchability and / or porosity. For example, the upper section 420 of the panel 334 may have a higher porosity and / or lower stretchability than the lower section 422 of the panel 334. In other configurations, the upper section 420 of the panel 334 may have a higher stretchability than the lower section 422. However, in such arrangements, it is preferable that the lower section 422 provide some amount of stretchability. In some configurations, differences in porosity and / or stretchability (or other properties) can be achieved by the knitting process, material selection, or both.

[0223] Figure 33K shows a rear portion 302 similar to rear portion 302 of Figure 33A, except that the bottom edges of panels 334 have a more pronounced curvature to create a greater height difference between the side portions of panels 334 and the center portion of panels 334. Lower straps 332 are shown as horizontal, but can be angled downward in a manner similar to lower straps 332 of Figure 33A.

[0224] FIG. 33L shows a rear portion 302 similar to the rear portion 302 of FIG. 33J, except that the upper section 420 and lower section 422 are shaped differently relative to FIG. 33J. For example, in the rear portion 302 of FIG. 33L, the upper section 420 does not define the side edges of the panel 334. Rather, the entire side edge is defined by the lower section 422. In some configurations, the upper section 420 of the panel 334 can have a higher porosity and / or a lower stretchability than the lower section 422 of the panel 334. In other configurations, the upper section 420 of the panel 334 can have a higher stretchability than the lower section 422. However, in such an arrangement, it is preferable that the lower section 422 provide some amount of stretchability.

[0225] FIG. 34 shows an example knitted structure that can be used to construct, in whole or in part, a knitted portion of headgear 154, such as back panel 334. In the illustrated arrangement, the knitted structure is constructed from a first material 430, such as a material comprising nylon. A second material 432 can be inlaid (inserted) into the knitted first material. The second material can have a higher stretch than the first material. In some configurations, the second material can include elastane (e.g., Lycra). The inlay material is captured by the knitted loops of the knitted material. Such an arrangement can provide high stretch to panel 334 or other knitted portions, but may be rough to the touch.

[0226] Knitted cover FIGS. 35-36B illustrate a modified version of headgear 154. In particular, headgear 154 in FIGS. 35-36B includes a modified version of front strap arrangement 304 described primarily with reference to FIGS. 22-27. Front strap arrangement 304 can include front strap portion 306, upper strap portion 308, and lower strap portion 310 configured as a unitary structure. As discussed above, front strap arrangement 304 can be configured as a molded composite structure having at least one fabric layer and at least one plastic layer permanently connected to one another. In the illustrated arrangement, front strap arrangement 304 is a molded composite structure having a tubular knit structure 440 on each side (inner and outer, or toward and away from the user) of a plastic core that defines inner and outer fabric layers.

[0227] In some configurations, the tubular knitted structure 440 can be formed by a suitable knitting process using suitable materials, such as the processes and materials described herein. The knitted structure 440 can be formed as a single piece including one or more of the front strap portion 306, the upper strap portion 308, and the lower strap portion 310. In other words, the knitted structure 440 can be formed by knitting a single piece including a branch from the front strap portion 306 to the upper strap portion 308 and the lower strap portion 310. The front strap arrangement 304 can be formed as a unitary structure by dispensing molten plastic into the space between fabric layers in a mold and allowing the molten plastic to harden and form a plastic core in the shape of the mold cavity. In particular, the knitted structure 440 can be placed in a mold, and molten plastic can be introduced into the interior space of the hollow knitted structure 440 and allowed to cool and harden.

[0228] The knitted structure 440 can be knitted into a shape that approximates or substantially matches the final shape of the front strap arrangement 304 as defined by the mold tool cavity. With such an arrangement, the stitch structure and knitting direction generally or substantially matches the shape of the plastic core or front strap arrangement 304 as defined by the mold tool cavity. The resulting front strap arrangement 304 has knitted edges that match the curvature of the plastic core, which can reduce material buildup and / or bunching compared to a fabric covering made from a flat sheet of material. While disclosed in the context of the front strap arrangement 304, other portions, straps, or panels of the headgear can be similarly configured.

[0229] In some configurations, the knitted structure 440 can be knitted so that the grain of the knitted structure 440 follows the shape of the plastic core to which it is molded. This arrangement prevents separation of the stitches between wales and maintains the shape of the strap. Additionally, by arranging the grain to follow the direction of the plastic core, the number of bind-off stitches required to create the knitted structure is minimized. This configuration is advantageous because it allows for fast and efficient construction.

[0230] FIG. 53 illustrates a portion of the modified front strap arrangement 304 described above primarily with reference to FIGS. 35-36B. Except as described below and / or apparent from the drawings, the two versions may otherwise be similar. In particular, the front strap arrangement 304 of FIG. 50 includes a front strap portion 306, an upper strap portion 308, a lower strap portion 310, and one of the first strap portion 320 or the second strap portion 322 of the top strap arrangement 314. The front strap arrangement 304 may be constructed as a molded composite structure having at least one fabric layer and at least one plastic layer permanently connected to one another.

[0231] In this variation of the front strap arrangement 304, the front strap portion 306 and the top strap portion 308 are formed from a single, continuous tubular knit structure 440, and the lower strap portion 310 and the first strap portion 320 are each formed from a separate tubular knit structure 440. This configuration can simplify manufacturing by eliminating the need to knit a bifurcated tubular structure. In some configurations, the front strap portion 306 and the top strap portion 308 may be formed from separate tubular knit structures 440, and / or the front strap portion 306 and the bottom strap portion 310 may alternatively be formed as a single, continuous tubular knit structure 440. In some configurations, one or more of the tubular knit structures 440 may be knitted into a shape that approximates or substantially matches the final shape of the respective strap portion, as described above. In some configurations, one or more of the tubular knit structures 440 may be knitted so that the grain direction changes along the length of the tubular knit structure 440, as described above. One or more of the knit structures 440 may be different from another knit structure 440. For example, the tubular knit structure 440 of the lower strap portion 310 and the first strap portion 320 is a different color than the tubular knit structure 440 of the joined front strap portion 306 and the upper strap portion 308. The use of different colors can provide visual cues to help the user orient the headgear 154. In some configurations, two or more of the tubular knit structures 440 may be identical to one another, except perhaps for length, and each may be cut to the appropriate length from the same stock of tubular knit material.

[0232] Each of the tubular knitted structures 440 can be clamped by its edges 313 within a mold, and molten plastic can be injected into the tubular knitted structure 440. The molten plastic cools and hardens, as described above, to form a plastic core in the shape of the mold cavity. The plastic core can have substantially planar, opposing major surfaces with convex side edges free of sharp corners that could cause discomfort or facial markings. Upon removal from the mold, the outer edges 313 of the newly partially flattened tubular knitted structure 440 are substantially free of plastic material. This can leave the resulting strap portions with soft outer edges 313, which can improve user comfort and / or reduce facial markings. Each of the lower strap portion 310 and first strap portion 320, along with the joined front strap portion 306 and upper strap portion 308, can then be placed in a separate tubular mold in the desired arrangement, either simultaneously or sequentially, and joined by overmolding the respective strap portions 306, 308, 310 with the joining portion 311 as shown. In some configurations, the plastic core and interface portion 311 can be formed from the same material. In some configurations, the plastic core and / or interface portion 311 can be formed from a resilient and relatively soft thermoplastic elastomer material, such as PEBAX®. As shown in FIG. 50 , the loop 312 of the upper strap portion 308 can form an integral part of the top interface portion 311.

[0233] conclusion It should be emphasized that many variations and modifications can be made to the embodiments described herein, and that elements thereof should be understood as being part of other acceptable examples. All such modifications and variations are intended to be included herein within the scope of this disclosure and protected by the following claims. Furthermore, any of the steps described herein can be performed simultaneously or in a different order than those ordered herein. Furthermore, as should be apparent, the features and attributes of the specific embodiments disclosed herein can be combined in different ways to form additional embodiments, all of which are within the scope of this disclosure.

[0234] Conditional language used herein, such as "can," "could," "might," "may," "for example," and the like, unless specifically stated otherwise or understood otherwise within the context of use, is generally intended to suggest that some embodiments include certain features, elements, and / or conditions, but not others. Thus, such conditional language is generally not intended to suggest that features, elements, and / or conditions are in any way essential to one or more embodiments, or that one or more embodiments necessarily include logic, with or without authorial input or direction, that determines whether or not those features, elements, and / or conditions are included in or should be implemented in any particular embodiment.

[0235] Additionally, the following terminology may be used herein: The singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, a reference to one item includes a reference to one or more items. The term "some" refers to one, two, or more and generally applies to the selection of some or all of a quantity. The term "plurality" refers to two or more items. The terms "about" or "approximately" mean that quantities, dimensions, sizes, formulations, parameters, shapes, and other characteristics need not be exact and may be approximated and / or larger or smaller as necessary, reflecting allowable tolerances, conversion factors, rounding, measurement errors, etc., and other factors known to those of ordinary skill in the art. The term "substantially" means that the recited characteristic, parameter, or value need not be achieved exactly, but rather that deviations or variations, including, for example, tolerances, measurement errors, measurement accuracy limits, and other factors known to those of ordinary skill in the art, may occur in an amount that does not eliminate the effect the characteristic is intended to provide.

[0236] Numerical data may be expressed or presented in range format herein. Such range format is used merely for convenience and brevity, and thus should be understood to be flexibly interpreted to include not only the numerical values ​​explicitly recited as the upper and lower limits of the range, but also to include all individual numerical values ​​or subranges subsumed within that range, as if each numerical value and subrange were explicitly recited. By way of illustration, a numerical range of "about 1 to 5" should not be interpreted to include only the explicitly recited values ​​of about 1 to about 5, but also to include each individual value and subrange within the stated range. Thus, included within this numerical range are individual values ​​such as 2, 3, and 4, as well as subranges such as "about 1 to about 3," "about 2 to about 4," "about 3 to about 5," "1 to 3," "2 to 4," "3 to 5," etc. This same principle applies to ranges reciting only a single numerical value (e.g., "greater than 1"), regardless of the breadth or characteristics of the range. For convenience, multiple items may be presented in a common list. However, these lists should be construed as though each member of the list is individually identified as a separate and unique element. Accordingly, no individual element of such lists should be construed as a de facto equivalent of any other element of the same list solely based on being presented in a common group, unless otherwise indicated. Furthermore, the terms "and" and "or," when used in conjunction with a list of items, should be interpreted broadly in that any one or more of the listed items can be used alone or in combination with the other listed items. The term "alternatively" refers to a selection of one of two or more options and is not intended to limit the selection to only those options listed at a time or to only one of the listed options, unless the context clearly dictates otherwise.

Claims

1. 1. A cushion for a respiratory interface assembly, comprising: a rim attached to or configured to be attached to a housing of the respiratory interface assembly; a resilient sidewall extending from the rim; a resilient end wall extending inwardly from the resilient side wall, the resilient end wall defining, in use, a sealing surface for sealing against a user's face and an opening for receiving the user's nose and / or mouth; a thickened band within the elastic side wall; a pair of thickened pads intermediate the thickened band and the opening and spaced apart from the thickened band; a pair of interface pads intermediate a respective portion of the thickened band and a respective portion of the pair of thickened pads; Provided with a cushion.

2. The cushion of claim 1 , wherein the thickened band is thicker than the pair of thickened pads.

3. The cushion of claim 1 or 2, wherein the pair of thickened pads are thicker than the pair of interface pads.

4. 4. The cushion of claim 1, wherein the pair of thickened pads and the pair of interface pads each have a length extending circumferentially around the inner periphery of the cushion, and the length of each of the pair of interface pads is 15% to 50% of the length of each of the pair of thickened pads.

5. 5. The cushion of claim 4, wherein the length of each of the pair of interface pads is 20% to 45% of the length of each of the pair of thickened pads.

6. 5. The cushion of claim 4, wherein the length of each of the pair of interface pads is 25% to 33% of the length of each of the pair of thickened pads.

7. The cushion of any one of claims 1 to 6, wherein each of the pair of interface pads extends between a portion of the thickened band and an upper portion of each of the pair of thickened pads.

8. The cushion according to any one of claims 1 to 7, wherein the pair of interface pads are provided on the elastic side walls of the cushion on both sides of the cushion, and at least a portion of the pair of thickened pads is provided on the elastic end walls of the cushion.

9. The thickened band is a lower region on each side of the cushion; a connecting portion extending around an interior upper portion of the cushion to thereby extend between the lower regions; The cushion according to any one of claims 1 to 8, comprising:

10. The cushion according to any one of claims 1 to 9, wherein the pair of interface pads have a thickness less than that of the pair of thickened pads but greater than that of the adjacent portions of the elastic side walls.

11. A cushion according to any preceding claim, wherein the portion of the elastic side wall comprising the pair of interface pads is between 0.5mm and 0.9mm thicker than the adjacent portion of the elastic side wall.

12. 12. The cushion of claim 11, wherein the portion of the resilient sidewall comprising the pair of interface pads is between 0.65 mm and 0.75 mm thicker than the adjacent portion of the resilient sidewall.

13. A cushion according to any one of claims 1 to 12, wherein the portion of the elastic side wall comprising the pair of interface pads is thinner than the pair of thickened pads by 0.2 mm to 0.4 mm.

14. 14. The cushion of claim 13, wherein the portion of the resilient sidewall comprising the pair of interface pads is 0.25 mm to 0.35 mm thinner than the pair of thickened pads.

15. 15. The cushion of any one of claims 1 to 14, wherein the pair of interface pads have a width measured in a forward direction from the pair of thickened pads to the thickened band that spaces at least a portion of the integral thickened pad from the thickened band by a corresponding distance.

16. 16. The cushion of claim 15, wherein the width is between 3 mm and 4 mm.

17. 16. The cushion of claim 15, wherein the width is between 3.2 mm and 3.6 mm.

18. 16. The cushion of claim 15, wherein the width is 3.4 mm.

19. 19. The cushion of claim 1, comprising a pair of lower thickened portions, each having a first end and a second end, the first end being provided at or adjacent to a lower corner of the rim or of the elastic side wall adjacent to the rim, and the second end being provided at or adjacent to the elastic end wall opposite the opening.

20. 20. The cushion of claim 19, wherein the pair of lower thickened portions terminate at second ends vertically above and horizontally spaced from the respective lower regions of the thickened bands.

21. A cushion according to any preceding claim, comprising a rolling bridge portion.

22. 22. The cushion of claim 21, wherein the thickened band is located between the elastic sidewall and the rolling bridge portion.

23. 23. The cushion of claim 21 or 22, wherein the rolling bridge portion is connected to a front edge of the rim.

24. 22. The cushion of any one of claims 1 to 21, wherein an upper portion of the cushion is configured to pivot in a forward direction relative to a lower portion of the cushion about a hinge axis defined in part by the thickened band.

Images